6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of May 2023

Commission File Number: 001-39431

 

 

Freeline Therapeutics Holdings plc

(Translation of registrant’s name into English)

 

 

Sycamore House

Gunnels Wood Road

Stevenage, Hertfordshire SG1 2BP

United Kingdom

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F  ☒            Form 40-F  ☐

 

 

 


2023 Annual General Meeting of Freeline Therapeutics Holdings plc

On May 31, 2023, Freeline Therapeutics Holdings plc (“Freeline” or the “Company”) published its UK Annual Report and Accounts for the fiscal year ended December 31, 2022 (the “2022 UK Annual Report”) and distributed a notice of its 2023 Annual General Meeting (the “2023 AGM”) and a form of proxy to its shareholders. The 2023 AGM will be held at Skadden, Arps, Slate, Meagher & Flom (UK) LLP, 22 Bishopsgate, London, EC2N 4BQ, United Kingdom, on June 28, 2023 at 2:00 p.m. British Summer Time (BST). The notice of the 2023 AGM, the form of proxy and the 2022 UK Annual Report are furnished hereto as Exhibits 99.1, 99.2 and 99.3 respectively.

On or about May 31, 2023, Citibank, N.A., in its capacity as the depositary (the “Depositary”) for the Company’s American Depositary Shares (“ADSs”), commenced mailing notice materials and voting instructions to ADS holders to enable ADS holders of record as of May 22, 2023 to instruct the Depositary to vote the ordinary shares represented by their ADSs. A copy of the Depositary’s notice to ADS holders and the Depositary’s voting instructions to ADS holders are furnished hereto as Exhibits 99.4 and 99.5, respectively.

The 2022 UK Annual Report and other materials related to the AGM are posted on the investor relations section of the Company’s website at https://freeline.life/investors/AGM.

The information contained in this “2023 Annual General Meeting of Freeline Therapeutics Holdings plc” section of this Report on Form 6-K, as well as the documents furnished as Exhibits 99.1, 99.2, 99.3, 99.4 and 99.5 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and are not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.

 

Exhibit

  

Description

99.1    Notice of Annual General Meeting dated May 31, 2023
99.2    Form of Proxy for Holders of Ordinary Shares
99.3    Freeline Therapeutics Holdings plc Annual Report and Accounts for the fiscal year ended December 31, 2022
99.4    Depositary’s Notice of Annual General Meeting
99.5    2023 Voting Instructions for Holders of American Depositary Shares


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

FREELINE THERAPEUTICS HOLDINGS PLC
By:  

/s/ Chip McCorkle

  Name: Chip McCorkle
  Title: Vice President, Legal & Company Secretary

Date: May 31, 2023

EX-99.1

Exhibit 99.1

THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION.

If you are in any doubt as to any aspect of the proposals referred to in this notice or as to the action you should take, please take advice from a stockbroker, solicitor, accountant or other independent professional adviser.

If you have sold or otherwise transferred all of your shares, please send this document, together with the enclosed documents, at once to the purchaser or transferee, or to the stockbroker, bank or other agent through whom the sale or transfer was effected for transmission to the purchaser or transferee.

Whether or not you propose to attend the AGM, please complete and submit a form of proxy in accordance with the instructions printed on the enclosed form (the “Form of Proxy”). The Form of Proxy must be received not less than 48 hours (without taking account of any part of a day that is not a working day) before the time of the holding of the AGM (i.e. by 2:00 p.m. (London time) on 26 June 2023).

 

LOGO

NOTICE OF THE ANNUAL GENERAL MEETING

OF FREELINE THERAPEUTICS HOLDINGS PLC (THE “COMPANY”)

to be held at the offices of Skadden, Arps, Slate, Meagher & Flom (UK) LLP

22 Bishopsgate, London, EC2N 4BQ, United Kingdom

on 28 June 2023 at 2:00 p.m. (London time) (the “AGM”)

Notice to overseas persons

The distribution of this document in certain jurisdictions may be restricted by law and therefore persons into whose possession this document comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction.

FREELINE THERAPEUTICS HOLDINGS PLC NOTICE OF ANNUAL GENERAL MEETING


Contents

 

Letter from the Chairman of Freeline Therapeutics Holdings plc

     3  

Notice of Annual General Meeting

     7  

Cautionary note regarding forward-looking statements

This document contains statements about the Company that are or may be “forward-looking statements”. All statements, other than statements of historical facts, included in this document may be forward-looking statements. Without limitation, any statements preceded or followed by, or that include, the words “targets”, “plans”, “believes”, “expects”, “aims”, “intends”, “will”, “may”, “should”, “anticipates”, “estimates”, “projects” or words or terms of similar substance, or the negative thereof, are forward-looking statements. These forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of the Company. These factors are discussed in the “Risk Factors” section of filings that the Company makes with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended 31 December 2022. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of any such person, or industry results, to be materially different from any results, performance or achievements expressed or implied by such forward-looking statements. These forward-looking statements are based on numerous assumptions regarding the present and future business strategies of such persons and the environment in which each will operate in the future. Past performance is not a guarantee of future performance. Investors should not place undue reliance on such forward-looking statements and, save as is required by law or regulation, the Company does not undertake any obligation to update publicly or revise any forward-looking statements (including to reflect any change in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based). All subsequent forward-looking statements attributed to the Company or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements contained in this document are based on information available to the Directors of the Company at the date of this document, unless some other time is specified in relation to them, and the posting or receipt of this document shall not give rise to any implication that there has been no change in the facts set forth herein since such date.

 

2


LOGO

Letter from the Chairman of Freeline Therapeutics Holdings plc

(Registered and incorporated in England and Wales with Company number 12546479)

Registered Office:

Sycamore House

Gunnels Wood Road

Stevenage

Hertfordshire, SG1 2BP

England

31 May 2023

Directors

Chris Hollowood

Colin A. Love

Jeffrey A. Chodakewitz

Julia P. Gregory

Martin Andrews

Michael J. Parini

Paul Schneider

Dear Shareholder,

Notice of 2023 Annual General Meeting

 

1.

Introduction

The purpose of this document is to provide you with details of the resolutions to be proposed at the Annual General Meeting (the “AGM”) of the Company to be held on 28 June 2023 at 2:00 p.m. (London time) and convened by the formal Notice of AGM set out on pages 7 to 12 of this document.

In addition to highlighting the usual business to be transacted at the AGM, this letter explains the background to the resolutions which will be considered at the AGM, why the board of directors (hereinafter, the “Directors” or “Board”) consider the resolutions to be in the best interests of shareholders of the Company as a whole and why they recommend that you vote in favour of the resolutions. It also contains important information about the arrangements for the administration of the AGM.

 

2.

Attendance and voting

The AGM will be held as a hybrid general meeting so that shareholders will be able to participate in the meeting virtually or in person. The Company has made arrangements for you to be able to participate online. Details of the online arrangements, including how to join the AGM, vote and ask questions during the meeting, are set out in the notes on pages 8 to 12 and the guide on page 13 of this document. On behalf of the Board, I hope that you will be able to join us either in person or virtually on 28 June 2023.

I encourage all shareholders to exercise their right to vote on the resolutions being put to the AGM in advance of the meeting by submitting a proxy vote, either by completing and returning the Form of Proxy posted to shareholders or by providing voting instructions electronically through www.investorcentre.co.uk/eproxy. Further details on how to register a proxy vote, along with information for CREST members who wish to appoint a proxy via the CREST electronic proxy appointment services, are set out on the notes on pages 8 to 12. Shareholders are advised to appoint me, the Chairman of the meeting, as your proxy to ensure that your vote is counted if for any reason you are not able to attend on the day.

 

3


In accordance with the Company’s Articles of Association, all resolutions will be voted on by way of a poll.

 

3.

Resolutions

The business to be conducted at the AGM consists of consideration of the following resolutions. Each of the resolutions will be proposed as ordinary resolutions. This means that for each of the resolutions to be passed, more than half of the votes cast must be in favour of the resolution.

Resolution 1 — Annual Report and Accounts

The Directors are obliged to present the annual financial statements, the strategic report, the directors’ report and the independent auditor’s report (the “U.K. Annual Report and Accounts”) to shareholders at the AGM.

Resolution 2 — Directors’ Remuneration Report

In accordance with the U.K. Companies Act 2006, we are required to seek an annual non-binding advisory vote from our shareholders to approve the Directors’ Remuneration Report and we are therefore seeking shareholders’ approval, on an advisory basis, of the Directors’ Remuneration Report. The approval sought does not include the U.K. Directors’ Remuneration Policy, which was approved by shareholders by way of binding vote at the Company’s AGM on 28 June 2021 and remains valid for a period of three financial years without the need for new shareholder approval, unless changes are proposed.

The report sets out the remuneration that has been paid to each person who has served as a Director at any time during the financial year ended 31 December 2022.

We encourage shareholders to read the U.K. Directors’ Remuneration Report, which can be found in our U.K. Annual Report and Accounts.

As this vote is advisory and not binding on our Board or our remuneration committee, a vote against this proposal will not overrule any decisions made by our Board or our remuneration committee, or require our Board or our remuneration committee to take any action with respect to the remuneration decisions set out therein. However, our remuneration committee will take into account the outcome of the vote when considering future compensation decisions.

Resolutions 3 and 4 — Appointment and remuneration of Deloitte LLP

The Company is required to appoint auditors at each general meeting at which accounts are presented to shareholders to hold office until the next such meeting.

Resolution 3 proposes the re-appointment of Deloitte LLP as auditors of the Company. Resolution 4 authorises the Directors to determine Deloitte LLP’s remuneration.

You are asked to authorise the Directors to re-appoint Deloitte LLP as auditors and to authorise the Directors to determine their remuneration. Deloitte LLP have indicated that they are willing to continue to act as the Company’s auditors for a further year.

Resolutions 5 to 11 (inclusive) — Re-appointment and appointment of Directors

In accordance with the Company’s Articles of Association, each of the current Directors who has held office since last year’s AGM will retire and stand for re-appointment. Resolutions 5 to 10 (inclusive) propose their re-appointment by the Company’s shareholders. Paul Schneider is standing for appointment as a Director by the Company’s shareholders for the first time, having been appointed by the Board on 30 March 2023. Resolution 11

 

4


proposes his appointment by the Company’s shareholders. Biographical details of each of the Directors can be found on the Company’s Investor Relations website (www.freeline.life/investors/corporate-governance) to enable shareholders to take an informed decision on their re-appointment or appointment. Each of the Directors are recommended by the Board for re-appointment or appointment.

Resolution 12 — Approval of option repricing

This resolution seeks approval of the Option Repricing (as defined below),

As a result of the Company’s depressed share price, all of the outstanding options over Company shares granted under the (i) Freeline Therapeutics Holdings plc 2021 Equity Inducement Plan; and (ii) Freeline Therapeutics Holdings plc 2020 Equity Incentive Plan (together the “Plans”) are, as at the date of this notice of AGM, “underwater” (meaning the per share option exercise price is higher than the Company’s share price).

Additionally, on 12 May 2023, the Company changed its American Depositary Share (“ADS”) to ordinary share ratio from one (1) ADS representing one (1) ordinary share to the new ratio of one (1) ADS representing fifteen (15) ordinary shares (the “Ratio Change”). The Ratio Change was effected to enable the Company to regain compliance with the Nasdaq Stock Market’s $1.00 minimum bid price requirement. As a result of the Ratio Change, each option if and when exercised will be settled by 15-times fewer ADSs than before, and the exercise price of each option when presented as the per ADS exercise price has been multiplied by 15.

The Company faces significant competition for experienced and talented personnel with critical and high-demand skills in its industry. While the Company’s compensation packages generally include a number of different components, the Board and its remuneration committee believe that equity compensation generally and options in particular are a critical part of the Company’s compensation program. The Board designed the Plans to incentivise the successful execution of business strategy over the longer term, to attract, provide long-term retention and motivate persons who make (or are expected to make) important contributions to the Company, and to increase alignment of interests with shareholders.

The In-Scope Options (as defined below) have exercise prices ranging from $0.47 to $8.15 per ordinary share (or $7.05 to $122.25 per ADS, after adjusting for the Ratio Change). They were also all granted within the last two years and accordingly are all majority unvested. While the Board remains optimistic regarding the potential of the Company’s FLT201 product candidate for the treatment of Gaucher disease, the price of the Company’s shares remains depressed. On 16 May 2023, the closing market value of an ADS as reported on the Nasdaq Capital Market was $3.28 per ADS.

While the Board and its remuneration committee strive to maintain a market-appropriate balance between employee and investor ownership, the In-Scope Options do not currently incentivise option holders and are unlikely to be exercised and dilute shareholders in the near term. The Board and its remuneration committee have determined that the lack of incentive could materially interfere with the Company’s efforts to retain the service of the holders of the In-Scope Options. Therefore, on 17 May 2023, the Board approved, subject to the approval of the shareholders at the AGM, the Option Repricing, to encourage an increasing alignment of their interests with those of shareholders and their stake in the long-term performance and success of the Company. The Board has determined that the Option Repricing is in the best interest of the Company and its shareholders as a whole.

In accordance with the applicable rules of the Plans, and in line with U.K. investors’ expectations, you are being asked to consider, and if thought fit, approve (by way of ordinary resolution), the repricing of certain underwater options (the “Option Repricing”), the key terms of which are as follows:

 

  i.

an option will only be within the scope of the Option Repricing, and therefore amended accordingly if:

 

  a.

the option was granted under one of the Plans, on or after 1 June 2021;

 

  b.

its exercise price is greater than or equal to $0.42 per ordinary share (or $6.27 per ADS);

 

5


  c.

the option is outstanding and unexercised (whether vested or unvested), as at 30 June 2023 (the “Repricing Date”); and

 

  d.

the option is held by an option holder who is an employee of the Company as at the Repricing Date,

(each an “In-Scope Option”); and

 

  ii.

the per share exercise price set at the date of grant of each In-Scope Option will be disregarded and replaced with a revised per share exercise price. The revised per share exercise price will be equal to the closing sales price for ADSs as quoted on the Nasdaq Capital Market for the last day preceding the Repricing Date during which a sale occurred, as reported in The Wall Street Journal or another source the Board deems reliable.

There would be no changes to the vesting schedules or any other terms and conditions to the In-Scope Options, and options held by an option holder who is a non-executive director of or consultant to the Company will not be considered an “In-Scope Option” and will therefore remain unaffected by the proposed Option Repricing.

The Board also considered implementing a program to exchange underwater options for new options. However, the exchange ratios for such an exchange would likely result in fewer replacement awards being granted, and the Board did not believe such a program would provide sufficient incentives for retention under the Company’s current circumstances. In addition, any exchange proposal would require compliance with the U.S. Securities and Exchange Commission’s tender offer rules and result in additional costs, complexities and burdens on the Company’s resources.

Even if the Option Repricing is approved by shareholders, the Board will have discretion to not proceed with the Option Repricing.

 

4.

Action to be taken

You will find a Form of Proxy enclosed with this document for use in connection with the AGM. Whether or not you intend to be present at the AGM, you are requested to complete and return the Form of Proxy in accordance with the instructions printed thereon as soon as possible. To be valid, forms of proxy must be completed and received by the Company’s registrars, Computershare Investor Services PLC, at the Pavilions, Bridgwater Road, Bristol, BS99 6ZY, United Kingdom not later than 2:00 p.m. (London time) on 26 June 2023, being 48 hours before the time appointed for holding the AGM (without taking account of any part of a day that is not a working day) or completed electronically in accordance with the notes to this document. Completion of the Form of Proxy will not preclude you from attending the AGM and voting in person if you so wish.

 

5.

Recommendation

The Directors consider that the resolutions to be proposed at the AGM are in the best interests of the Company and its shareholders as a whole and are likely to promote the success of the Company. The Directors unanimously recommend that you vote in favour of the proposed resolutions as they intend to do in respect of their own beneficial holdings.

Yours faithfully,

Chris Hollowood

Chairman

 

6


FREELINE THERAPEUTICS HOLDINGS PLC

(the “Company”)

(Registered and incorporated in England and Wales with company number 12546479)

NOTICE OF ANNUAL GENERAL MEETING

NOTICE IS HEREBY GIVEN that an Annual General Meeting (the “AGM”) of the Company will be held at the offices of Skadden, Arps, Slate, Meagher & Flom (UK) LLP at 22 Bishopsgate, London, EC2N 4BQ, United Kingdom on 28 June 2023 at 2.00 p.m. (London time) to consider and, if thought fit, to pass the resolutions below. Each of resolutions 1 to 12 will be proposed as an ordinary resolution.

Ordinary resolutions

 

1.

That the Annual Report and Accounts for the financial year ended 31 December 2022, together with the Directors’ Report and independent Auditor’s Report thereon, be received and adopted.

 

2.

That the Directors’ Remuneration Report (excluding the Directors’ Remuneration Policy) as set out in the Annual Report and Accounts for the financial year ended 31 December 2022 be approved.

 

3.

That Deloitte LLP be re-appointed as auditors to hold office from the conclusion of this AGM until the conclusion of the next AGM at which the Company’s Annual Report and Accounts are presented.

 

4.

That the Directors of the Company be authorised to determine Deloitte LLP’s remuneration.

 

5.

That Chris Hollowood be re-appointed as a director of the Company.

 

6.

That Martin Andrews be re-appointed as a director of the Company.

 

7.

That Jeffrey A. Chodakewitz be re-appointed as a director of the Company.

 

8.

That Julia P. Gregory be re-appointed as a director of the Company.

 

9.

That Colin A. Love be re-appointed as a director of the Company.

 

10.

That Michael J. Parini be re-appointed as a director of the Company.

 

11.

That Paul Schneider, who was appointed by the Board since the last AGM, be appointed as a director of the Company.

 

12.

That the amendment of the exercise price of each outstanding underwater option granted to an employee of the Company on or after 1 June 2021 with an exercise price greater than or equal to $0.42 per ordinary share (or $6.27 per ADS) under the (i) Freeline Therapeutics Holdings plc 2021 Equity Inducement Plan; and (ii) Freeline Therapeutics Holdings plc 2020 Equity Incentive Plan, from the existing applicable per ADS exercise price to a new replacement per ADS exercise price equal to the closing sales price for ADSs as quoted on the Nasdaq Capital Market for the last day preceding 30 June 2023 (being the Repricing Date) during which a sale occurred, as reported in The Wall Street Journal or another source the Board deems reliable, be hereby approved.

 

Pope McCorkle IV

Company Secretary

31 May 2023

 

BY ORDER OF THE BOARD

  

REGISTERED OFFICE

Sycamore House

Gunnels Wood Road

Stevenage

Hertfordshire, SG1 2BP

England

 

7


Notes:

Entitlement to attend and vote

 

1.

Shareholders are invited to attend and participate in the AGM in person or online. The Directors are enabling shareholders to attend and participate in the AGM electronically by accessing the AGM website at meetnow.global/FTLAGM2023.

 

2.

Pursuant to the Articles of Association of the Company and Regulation 41 of the Uncertificated Securities Regulations 2001, the Company specifies that only those shareholders registered on the Company’s register of members at:

 

  a.

close of business on 26 June 2023; or

 

  b.

if the AGM is adjourned, close of business on the day that is two working days prior to the adjourned meeting,

shall be entitled to attend and vote at the AGM or adjourned meeting (as applicable) in respect of the number of ordinary shares registered in their name at the time.

Changes to entries on the register of members after this time shall be disregarded in determining the rights of any person to attend or vote at the AGM.

Entry to the virtual AGM

 

3.

If you wish to attend the meeting virtually, rather than in person, you will need to visit meetnow.global/FTLAGM2023 on your electronic device (smart phone, tablet or PC) operating a compatible browser using the latest version of Chrome, Firefox, Edge or Safari. Please note that Internet Explorer is not supported. It is highly recommended that you check your system capabilities in advance of the date of the AGM.

 

4.

If you are a shareholder, you can use your unique Shareholder Reference Number and PIN as displayed on your Form of Proxy. If you are an appointed proxy or a corporate representative you will have had to be provided with a unique invite code to enter the meeting and exercise rights on behalf of the relevant shareholder. Please see ‘Appointment of proxy electronically’ and ‘Corporate representatives’ below for instructions on how to request access credentials for a proxy or corporate representative. These credentials will be issued one working day prior to the meeting, conditional on evidence of your proxy appointment or corporate representative appointment having been received and accepted. If you have not been provided with your meeting access credentials, please ensure you contact Computershare by calling +44 (0370) 703 6147 on the morning of the meeting, but no later than 1 hour before the start of the meeting.

 

5.

Access to the meeting via meetnow.global/FTLAGM2023 will be available from 1:30 p.m. (London time) on 28 June 2023. During the meeting, you must ensure you are connected to the internet at all times in order to vote when the Chairman commences polling on resolutions being put to the meeting. It is your responsibility to ensure connectivity for the duration of the meeting.

Website giving information regarding the AGM

 

6.

Information regarding the AGM can be found at https://www.freeline.life/investors/agm.

Appointment of proxies

 

7.

If you are a shareholder of the Company at the time set out in note 2 above, you are entitled to appoint a proxy to exercise all or any of your rights to attend, speak and vote at the AGM and you should have received a Form of Proxy with this notice of AGM. You can only appoint a proxy using the procedures set out in these notes and the notes to the Form of Proxy. Shareholders are encouraged to appoint the Chairman of the AGM as their proxy to ensure they can exercise their vote and be represented at the meeting in the event they are unable to attend on the day.

 

8


8.

A proxy does not need to be a shareholder of the Company but must attend the AGM (whether virtually or in person) to represent you. Details of how to appoint the Chairman of the AGM or another person as your proxy using the Form of Proxy are set out in the notes to the Form of Proxy. If you wish your proxy to speak on your behalf at the AGM you will need to appoint your own choice of proxy (not the Chairman) and give your instructions directly to them.

 

9.

You may appoint more than one proxy provided each proxy is appointed to exercise rights attached to different shares. You may not appoint more than one proxy to exercise rights attached to any one share. If you are appointing more than one proxy you must indicate the number of shares in respect of which you are making this appointment. You should include the number in the box provided for your first named proxy and either obtain (an) additional form(s) of proxy from the registrar of the Company, Computershare Investor Services PLC, or you may photocopy the Form of Proxy. Please return all the forms together and tick the box to indicate each form is one of multiple instructions being given. Please take care when completing the number of shares; if the total number of shares exceeds the total number held by the shareholder, all appointments may be invalid. All forms of proxy must be signed and should be returned together in the same envelope.

 

10.

Appointment of a proxy does not preclude a shareholder from attending the AGM and voting in person. If you wish to attend the AGM in person, please bring with you the attendance card included in the Form of Proxy accompanying this notice of AGM. This will authenticate your right to attend, speak and vote at the AGM and assist us in registering your attendance without delay.

 

11.

The right to appoint a proxy does not apply to persons whose shares are held on their behalf by another person and who have been nominated to receive communications from the Company in accordance with Section 146 of the U.K. Companies Act 2006 (nominated persons). Nominated persons may have a right under an agreement with the registered shareholder who holds the shares on their behalf to be appointed (or to have someone else appointed) as a proxy. Alternatively, if nominated persons do not have such a right, or do not wish to exercise it, they may have a right under such an agreement to give instructions to the person holding the shares as to the exercise of voting rights.

Appointment of proxy using hard copy Form of Proxy

 

12.

The notes to the Form of Proxy explain how to direct your proxy to vote on the resolution or withhold their vote. To validly appoint a proxy using the Form of Proxy, the form must be:

 

  a.

completed and signed; and

 

  b.

sent or delivered to the Company’s registrar’s address at the Pavilions, Bridgwater Road, Bristol, BS99 6ZY, United Kingdom, so as to be received not less than 48 hours (without taking account of any part of a day that is not a working day) before the time appointed for holding the AGM or adjourned meeting to which it relates.

 

13.

In the case of a shareholder which is a company, the Form of Proxy must be executed under its common seal or signed on its behalf by a duly authorised officer or director of the company or a duly authorised attorney for the company.

 

14.

Any power of attorney or any other authority under which the Form of Proxy is signed (or a duly certified copy of such power of authority) must be included with the Form of Proxy, so as to be received not less than 48 hours before the time appointed for holding the AGM or adjourned meeting to which it relates.

Appointment of proxy electronically

 

15.

As an alternative to completing the hard copy Form of Proxy, you can appoint a proxy electronically by visiting www.investorcentre.co.uk/eproxy. You will be asked to enter your control number, shareholder reference number and PIN, which can be found on the Form of Proxy. For an electronic proxy appointment to be valid, your appointment must be received by Computershare Investor Services PLC not less than 48 hours (without taking account of any part of a day that is not a working day) before the time appointed for holding the AGM or adjourned meeting to which it relates.

 

9


16.

If your proxy wishes to attend the AGM virtually, please contact Computershare Investor Services PLC by email at corporate-representatives@computershare.co.uk or alternatively call +44 (0370) 703 6147, providing details of your proxy appointment including their email address so that unique credentials can be issued to allow the proxy to access the electronic meeting. Access credentials will be emailed to the appointee one working day prior to the meeting. Lines are open 8:30 a.m. to 5:30 p.m. Monday to Friday (excluding bank holidays).

Appointment of proxies through CREST

 

17.

CREST members who wish to appoint a proxy or proxies by utilising the CREST electronic appointment service, may do so for the AGM and any adjournment(s) thereof by utilising the procedures described in the “CREST Reference Manual” issued by Euroclear UK & Ireland Limited (the “CREST Manual”). CREST personal members or other CREST sponsored members and those CREST members who have appointed a voting service provider(s) should refer to their CREST sponsor or voting service provider(s), who will be able to take the appropriate action on their behalf.

 

18.

In order for a proxy appointment made by means of CREST to be valid, the appropriate CREST message must be properly authenticated in accordance with Euroclear UK & Ireland Limited’s specifications and must contain the information required for such instructions, as described in the CREST Manual. The message, regardless of whether it constitutes the appointment of a proxy or an amendment to the instruction given to a previously appointed proxy, must, in order to be valid, be transmitted so as to be received by the Company’s agent, Computershare Investor Services PLC (ID: 3RA50), by the latest time for receipt of proxy appointments specified in these notes. For this purpose, the time of receipt will be taken to be the time (as determined by the timestamp applied to the message by the CREST Applications Host) from which the Company’s agent is able to retrieve the message by enquiry to CREST in the manner prescribed by CREST. After this time any change of instructions to proxies appointed through CREST should be communicated to the appointee through other means.

 

19.

CREST members and, where applicable, their CREST sponsors or voting service provider(s) should note that Euroclear does not make available special procedures in CREST proxy instructions. It is the responsibility of the CREST member concerned to take (or, if the CREST member is a CREST personal member or sponsored member or has appointed a voting service provider(s), to procure that his CREST sponsor or voting service provider(s) take(s)) such action as shall be necessary to ensure that a message is transmitted by means of the CREST system by any particular time. In this regard, CREST members and, where applicable, their CREST sponsors or voting service provider(s) are referred, in particular, to those sections of the CREST Manual concerning practical limitations of the CREST system and timings.

 

20.

The Company may treat as invalid a CREST proxy instruction in the circumstances set out in Regulation 35(5)(a) of the Uncertificated Securities Regulations 2001.

Appointment of proxy by joint holders

 

21.

In the case of joint holders, where more than one of the joint holders purports to appoint a proxy, only the appointment submitted by the most senior holder will be accepted. Seniority is determined by the order in which the names of the joint holders appear in the Company’s register of members in respect of the joint holding (the first-named being the most senior).

Changing proxy instructions

 

22.

To change your proxy instructions simply submit a new proxy appointment using the methods set out above. Note that the cut-off time for receipt of proxy appointments (see above) also applies in relation to amended instructions; any amended proxy appointment received after the relevant cut-off time will be disregarded.

 

23.

Where you have appointed a proxy using the hard-copy Form of Proxy and would like to change the instructions using another hard-copy Form of Proxy, please contact Computershare Investor Services PLC to request a form.

 

10


24.

If you submit more than one valid proxy appointment, the appointment received last before the latest time for the receipt of proxies will supersede all previous instructions.

Termination of proxy appointments

 

25.

Any appointment under a Form of Proxy may only be revoked by delivering a notice in writing given by or on behalf of the person by whom or on whose behalf the Form of Proxy was given to Computershare Investor Services PLC at the Pavilions, Bridgwater Road, Bristol, BS99 6ZY, United Kingdom.

 

26.

A notice revoking a proxy appointment only takes effect if it is delivered no later than 48 hours (without taking account of any part of a day that is not a working day) before the time of the AGM or adjourned meeting to which it relates.

 

27.

Appointment of a proxy does not preclude you from attending the AGM (or any adjournment thereof) and voting in person. If you have appointed a proxy and attend the AGM (or any adjournment thereof) in person, your proxy appointment will automatically be terminated.

Corporate representatives

 

28.

A corporation which is a shareholder can appoint one or more corporate representatives who may exercise, on its behalf, all of its powers as a shareholder, provided that no more than one corporate representative exercises powers over the same ordinary shares.

 

29.

If a corporate representative wishes to attend the AGM virtually, please contact Computershare Investor Services PLC by emailing corporate-representatives@computershare.co.uk or alternatively call +44 (0370) 703 6147, providing details of your appointee including their email address, confirmation of the meeting they wish to attend and a copy of a signed letter of representation on headed paper confirming the authorisation referred to in section 323 of the U.K. Companies Act 2006, so that unique credentials can be issued to allow the corporate representative to access the electronic meeting. Access credentials will be emailed to the appointee one working day prior to the meeting. If documentation supporting the appointment of the corporate representative is supplied later than 48 hours (without taking account of any part of a day that is not a working day) before the time of the AGM or adjourned meeting to which it relates, the unique credentials to access the meeting will be issued on a best endeavours basis.

Verification of identity

 

30.

Shareholders, proxies and authorised representatives will be required to provide their names and addresses for verification against the register of members and proxy appointments received by the Company before entering the AGM.

Electronic address

 

31.

You may not use any electronic address (within the meaning of Section 333(4) of the U.K. Companies Act 2006) provided in this notice of AGM (or in any related documents including the Form of Proxy) to communicate with the Company for any purposes other than those expressly stated.

Requests under section 527 of the U.K. Companies Act 2006

 

32.

Under section 527 of the U.K. Companies Act 2006, shareholders meeting the threshold requirements set out in that section have the right to require the Company to publish on a website a statement setting out any matter relating to:

 

  a.

the audit of the Company’s Accounts (including the auditor’s report and the conduct of the audit) that are to be laid before the AGM; or

 

11


  b.

any circumstance connected with an auditor of the Company ceasing to hold office since the previous meeting at which the Annual Report and Accounts were laid in accordance with section 437 of the U.K. Companies Act 2006.

The Company may not require the shareholders requesting any such website publication to pay its expenses in complying with sections 527 or 528 of the U.K. Companies Act 2006. Where the Company is required to place a statement on a website under section 527 of the U.K. Companies Act 2006, it must forward the statement to the Company’s auditor not later than the time when it makes the statement available on the website. The business which may be dealt with at the AGM includes any statement that the Company has been required under section 527 of the U.K. Companies Act 2006 to publish on a website.

 

12


LOGO

HOW TO PARTICIPATE IN ONLINE MEETINGS

 

Attending the AGM online

 

This year we will be conducting a hybrid meeting, giving you the opportunity to attend the meeting in-person or to participate online, using your smartphone, tablet or computer.

 

If you choose to participate online you will be able to view a live webcast of the meeting, ask questions and submit your votes in real time.

   LOGO

 

Visit: meetnow.global/FTLAGM2023

 

You will need the latest version of Chrome, Safari, Edge or Firefox to participate online.

 

Please ensure your browser is compatible in advance of the meeting.

  

Meeting Access

 

To login you must have your Shareholder Reference Number and PIN as set out on the Form of Proxy.

  

28 June 2023 @ 2.00pm (UK)

 

You will be able to log into the meeting 30mins before the meeting start time above.

 

 

LOGO   

Access

 

   LOGO    Navigation
   Click JOIN MEETING NOW
  

Once the webpage above has loaded into your web browser, select ‘Shareholder’ on the login screen and enter your Shareholder Reference Number and PIN.

 

If you are a third-party proxy, corporate representative or an invited guest, use the link on the email you will receive from Computershare prior to the meeting. Otherwise select ‘Invitation’ on the login screen then enter your personalised invitation code from the email.

 

If you have trouble logging in, please follow the instructions on screen.

 

If you are a guest:

 

Select ‘Guest’ on the login screen. As a guest you will be prompted to complete all relevant fields including title, first name, last name and email address.

  

LOGO

  

When successfully authenticated, the home screen will be displayed. You can view company information, ask questions, and watch the webcast.

 

If viewing on a computer, the webcast will appear automatically once the meeting has started.

 

Voting

 

Once the voting has opened, the options will be on your screen.

 

To vote, simply select your voting direction from the options shown on screen.

 

Your vote has been cast when the check mark appears. To change your vote, select ‘Change My Vote’.

  

Please note, guests will not be able to ask questions or vote at the meeting.

 

Technical Issues

 

If you experience any technical issues with the site you may either call our registrar on the telephone number provided on the site or once you have entered the meeting, you can raise your question using the chat function. If you have technical issues prior to the start of the meeting you should contact our registrar on the shareholder helpline.

   LOGO   

Messaging

 

Any eligible member attending the meeting remotely is permitted to partake in the discussion. Press the Q&A icon to submit your question.

 

Type your message into the box at the bottom of the screen and press the ‘Send’ button.

 

13


LOGO

FREELINE THERAPEUTICS HOLDINGS PLC

Sycamore House

Gunnels Wood Road

Stevenage

Hertfordshire, SG1 2BP

England

EX-99.2

Exhibit 99.2

 

 

Freeline Therapeutics Holdings plc

   Attendance Card
   Please bring this card with you to the Meeting and present it at Shareholder registration/accreditation.
  

 

The Chairman of FREELINE THERAPEUTICS HOLDINGS PLC invites you to attend the Annual General Meeting of the Company to be held at the offices of Skadden, Arps, Slate, Meagher & Flom (UK) LLP, 22 Bishopsgate, London, EC2N 4BQ on 28 June 2023 at 2.00 pm UK time.

   Shareholder Reference Number

Please detach this portion before posting this proxy form.

 

 
Form of Proxy - Annual General Meeting to be held on 28 June 2023

 

LOGO

To be effective, all proxy appointments must be lodged with the Company’s Registrars at:

Computershare Investor Services PLC, The Pavilions, Bridgwater Road, Bristol BS99 6ZY by 26 June 2023 at 2.00 pm UK time.

 

 

Explanatory Notes:

 

1.

Every holder has the right to appoint some other person(s) of their choice, who need not be a shareholder, as his proxy to exercise all or any of his rights, to attend, speak and vote on their behalf at the meeting. If you wish to appoint a person other than the Chairman, please insert the name of your chosen proxy holder in the space provided (see reverse). Shareholders are encouraged to appoint the Chairman as their proxy to ensure they can exercise their vote and be represented at the AGM in the event they are unable to attend on the day. If the proxy is being appointed in relation to less than your full voting entitlement, please enter in the box next to the proxy holder’s name (see reverse) the number of shares in relation to which they are authorised to act as your proxy. If returned without an indication as to how the proxy shall vote on any particular matter, the proxy will exercise his discretion as to whether, and if so how, he votes (or if this proxy form has been issued in respect of a designated account for a shareholder, the proxy will exercise his discretion as to whether, and if so how, he votes).

 

2.

To appoint more than one proxy, an additional proxy form(s) may be obtained by contacting the Registrar’s helpline on +44 0370 703 6147 or you may photocopy this form. Please indicate in the box next to the proxy holder’s name (see reverse) the number of shares in relation to which they are authorised to act as your proxy. Please also indicate by marking the box provided if the proxy instruction is one of multiple instructions being given. All forms must be signed and should be returned together in the same envelope.

 

3.

The ‘Vote Withheld’ option overleaf is provided to enable you to abstain on any particular resolution. However, it should be noted that a ‘Vote Withheld’ is not a vote in law and will not be counted in the calculation of the proportion of the votes ‘For’ and ‘Against’ a resolution.

4.

Pursuant to the Articles of Association of the Company and Regulation 41 of the Uncertificated Securities Regulations 2001, entitlement to attend and vote at the meeting and the number of votes which may be cast thereat will be determined by reference to the Register of Members of the Company at close of business on the day which is two working days before the day of the meeting. Changes to entries on the Register of Members after that time shall be disregarded in determining the rights of any person to attend and vote at the meeting.

 

5.

To appoint one or more proxies or to give an instruction to a proxy (whether previously appointed or otherwise) via the CREST system, CREST messages must be received by the Company’s agent (ID number 3RA50) not later than 48 hours (without taking account of any part of a day that is not a working day) before the time appointed for holding the meeting. For this purpose, the time of receipt will be taken to be the time (as determined by the timestamp generated by the CREST system) from which the Company’s agent is able to retrieve the message. The Company may treat as invalid a proxy appointment sent by CREST in the circumstances set out in Regulation 35(5)(a) of the Uncertificated Securities Regulations 2001.

 

6.

The above is how your address appears on the Register of Members. If this information is incorrect please ring the Registrar’s helpline on +44 0370 703 6147 to request a change of address form or go to www.investorcentre.co.uk to use the online Investor Centre service.

 

7.

Any alterations made to this form should be initialled.

 

8.

The completion and return of this form will not preclude a shareholder from attending the meeting and voting in person.

 

 

 

 

Kindly Note: This form is issued only to the addressee(s) and is specific to the unique designated account printed hereon. This personalised form is not transferable between different: (i) account holders; or (ii) uniquely designated accounts. The Company and Computershare Investor Services PLC accept no liability for any instruction that does not comply with these conditions.

 

 

            

  

 

All Named Holders

 

   183069_224064_RUN_ONS/000001/000001/SG625//i    12V4XD D01


Poll Card To be completed only at the AGM if a Poll is called.

 

Ordinary Resolutions   For   Against   Vote Withheld

1.  That the Annual Report and Accounts for the financial year ended 31 December 2022, together with the Directors’ Report and independent Auditor’s Report thereon, be received and adopted.

 

     

2.  That the Directors’ Remuneration Report (excluding the Directors’ Remuneration Policy) as set out in the Annual Report and Accounts for the financial year ended 31 December 2022 be approved.

 

     

3.  That Deloitte LLP be re-appointed as auditors to hold office from the conclusion of this AGM until the conclusion of the next AGM at which the Company’s Annual Report and Accounts are presented.

 

     

4.  That the Directors of the Company be authorised to determine Deloitte LLP’s remuneration.

 

     

5.  That Chris Hollowood be re-appointed as a director of the Company.

 

     

6.  That Martin Andrews be re-appointed as a director of the Company.

 

     

 

Signature

 

In the case of a Corporation, a letter of representation will be required (in accordance with S323 of the Companies Act 2006) unless this has already been lodged at registration.

  For   Against   Vote Withheld

7.  That Jeffrey A. Chodakewitz be re-appointed as a director of the Company.

 

     

8.  That Julia P. Gregory be re-appointed as a director of the Company.

 

     

9.  That Colin A. Love be re-appointed as a director of the Company.

 

     

10.  That Michael J. Parini be re-appointed as a director of the Company.

 

     

11.  That Paul Schneider, who was appointed by the Board since the last AGM, be appointed as a director of the Company.

 

     

12.  That the amendment of the exercise price of each outstanding underwater option granted to an employee of the Company on or after 1 June 2021 with an exercise price greater than or equal to $0.42 per ordinary share (or $6.27 per ADS) under the (i) Freeline Therapeutics Holdings plc 2021 Equity Inducement Plan; and (ii) Freeline Therapeutics Holdings plc 2020 Equity Incentive Plan, from the existing applicable per ADS exercise price to a new replacement per ADS exercise price equal to the closing sales price for ADSs as quoted on the Nasdaq Capital Market for the last day preceding 30 June 2023 (being the Repricing Date) during which a sale occurred, as reported in The Wall Street Journal or another source the Board deems reliable, be hereby approved.

 

     
 

— — — — — — — — — — — — —  — — — — — — — — — — — — — — — — — — — —  — — — — — — — — — —

Form of Proxy

 

Shareholders are encouraged to appoint the Chairman as their proxy to ensure they can exercise their vote and be represented at the AGM in the event they are unable to attend on the day. Please complete this box only if you wish to appoint a third party proxy other than the Chairman. Please leave this box blank if you want to select the Chairman. Do not insert your own name(s).   

 

LOGO    +

I/We hereby appoint the Chairman of the Meeting OR the person indicated in the box above as my/our proxy to attend, speak and vote in respect of my/our full voting entitlement* on my/our behalf at the Annual General Meeting of FREELINE THERAPEUTICS HOLDINGS PLC to be held at the offices of Skadden, Arps, Slate, Meagher & Flom (UK) LLP, 22 Bishopsgate, London, EC2N 4BQ on 28 June 2023 at 2.00 pm UK time, and at any adjourned meeting.

* For the appointment of more than one proxy, please refer to Explanatory Note 2 (see front).

  Please mark here to indicate that this proxy appointment is one of multiple appointments being made.   

Please use a black pen. Mark with an X

inside the box as shown in this example.

  

 

Ordinary Resolutions   For   Against   Vote Withheld      
 

1.  That the Annual Report and Accounts for the financial year ended 31 December 2022, together with the Directors’ Report and independent Auditors’ Report thereon, be received and adopted.

 

           
 

2.  That the Directors’ Remuneration Report (excluding the Directors’ Remuneration Policy) as set out in the Annual Report and Accounts for the financial year ended 31 December 2022 be approved.

 

 

 

 

     
 

3.  That Deloitte LLP be re-appointed as auditors to hold office from the conclusion of this AGM until the conclusion of the next AGM at which the Company’s Annual Report and Accounts are presented.

 

 

 

 

     
 

4.  That the Directors of the Company be authorised to determine Deloitte LLP’s remuneration.

 

 

 

 

     
 

5.  That Chris Hollowood be re-appointed as a director of the Company.

 

 

 

 

     
 

6.  That Martin Andrews be re-appointed as a director of the Company.

 

 

 

 

     
 

7.  That Jeffrey A. Chodakewitz be re-appointed as a director of the Company.

 

 

 

 

     
 

8.  That Julia P. Gregory be re-appointed as a director of the Company.

 

 

 

     
  For   Against   Vote Withheld

9.  That Colin A. Love be re-appointed as a director of the Company.

 

 

 

 

10. That Michael J. Parini be re-appointed as a director of the Company.

 

 

 

 

11. That Paul Schneider, who was appointed by the Board since the last AGM, be appointed as a director of the Company.

 

 

 

 

12. That the amendment of the exercise price of each outstanding underwater option granted to an employee of the Company on or after 1 June 2021 with an exercise price greater than or equal to $0.42 per ordinary share (or $6.27 per ADS) under the (i) Freeline Therapeutics Holdings plc 2021 Equity Inducement Plan; and (ii) Freeline Therapeutics Holdings plc 2020 Equity Incentive Plan, from the existing applicable per ADS exercise price to a new replacement per ADS exercise price equal to the closing sales price for ADSs as quoted on the Nasdaq Capital Market for the last day preceding 30 June 2023 (being the Repricing Date) during which a sale occurred, as reported in The Wall Street Journal or another source the Board deems reliable, be hereby approved.

 

 

 

 

Intention to Attend                                                                                                     

Pleaseindicate if you intend to attend the AGM

     

 

 

I/We instruct my/our proxy as indicated on this form. Unless otherwise instructed the proxy may vote as he or she sees fit or abstain in relation to any business of the meeting.

 

Signature

 

     Date     

 

In the case of a corporation, this proxy must be given under its common seal or be signed on its behalf by an attorney or officer duly authorised, stating their capacity (e.g. director, secretary).

         

DD/MM/YY

    
    

                                                                                                                  W K F 1 7 6 1             02                     F T L       +

12V4XD D01

EX-99.3

Exhibit 99.3

Freeline Therapeutics Holdings plc

Annual Report and Accounts

for the year ended 31 December 2022

Registered number: 12546479


   
      Page
   

  Company Information

   1
   

  UK Financial Documents

   2
   

  Strategic Report

   3
   

  Directors’ Report

   7
   

  Directors’ Remuneration Report

   13
   

  Independent Auditor’s Report

   28
   

  Balance sheet

   40
   

  Statement of changes in equity

   41
   

  Notes to the financial statements

   42
   

  Appendix 1: Form 20-F as filed 4 April 2023

   59

 

i


Company Information

 

  Directors
  Executive Directors
  Michael J. Parini
  Paul M. Schneider
  Non-Executive Directors
  Martin Andrews
  Jeffrey A. Chodakewitz
  Julia P. Gregory
  Christopher Hollowood
  Colin A. Love
  Secretary
  Chip McCorkle
  Auditor
  Deloitte LLP
  Abbots House
  Abbey Street

  Reading

  United Kingdom

  RG1 3BD
  Bankers

  HSBC UK Bank plc

  1 Centenary Square

  Birmingham
  B1 1HQ
  Solicitors

  Skadden, Arps, Slate, Meagher & Flom (UK) LLP

  22 Bishopsgate

  London
  EC2N 4BQ
  Registered office
  Sycamore House
  Gunnels Wood Road
  Stevenage
  Hertfordshire
  SG1 2BP
  Registered number
  12546479

 

1


UK Financial Documents

Introduction

Freeline Therapeutics Holdings plc (the “Company”) is a public limited company incorporated under the laws of England and Wales, with American Depositary Shares (“ADSs”) (representing its ordinary shares on a 1:15 basis) listed on the Nasdaq Capital Market and traded under the symbol “FRLN”. To meet US securities law reporting requirements, the Company is required to file an annual report on Form 20-F with the United States Securities and Exchange Commission (the “SEC”), which includes the audited consolidated financial statements of the Company and its subsidiaries (the “Group”) prepared in accordance with US GAAP. To meet UK statutory reporting requirements, the Company is required to file UK consolidated accounts. Freeline Therapeutics Holdings plc is applying Statutory Instrument (SI) 2022/943, which allows the option to adopt US GAAP until September 2023 in relation to the preparation and filing of consolidated financial statements in the UK. The contents of this Annual Report and Accounts are, as follows:

 

   

UK Statutory Strategic Report

   

UK Statutory Directors’ Report

   

Directors’ Remuneration Report

   

Independent Auditor’s Report to the Shareholders of Freeline Therapeutics Holdings plc

   

Balance sheet of Freeline Therapeutics Holdings plc

   

Statement of Change in Equity of Freeline Therapeutics Holdings plc

   

Notes to the Financial Statements

This document (the “Annual Report and Accounts”) is comprised of the reports listed above and the Annual Report on Form 20-F (the “Form 20-F”) filed with the SEC on 4 April 2023. For the purposes of this Annual Report and Accounts, the exhibits to the Form 20-F are not incorporated by reference. The Annual Report on Form 20-F is also included in this set of Accounts.

 

2


Strategic Report

Principal Activity

The Company is a clinical-stage biotechnology company with the ambition of developing transformative adeno-associated virus (“AAV”) vector-mediated gene therapies. The Group is dedicated to improving patient lives through innovative, potential one-time treatments for chronic debilitating diseases.

The Group uses its proprietary, rationally designed AAV vector and capsid along with novel promoters and transgenes to deliver a functional copy of a therapeutic gene into human liver cells, thereby expressing a persistent functional level of the missing or dysfunctional protein into the patient’s bloodstream.

The Group’s pipeline includes a program in the clinic for Gaucher disease, deprioritised product candidates in Fabry disease and haemophilia B and research programs targeting novel applications for gene therapy, for which it has, through owned and in-licensed intellectual property rights, development and worldwide commercial rights.

Other information required within the Strategic Report which is included in Form 20-F

Where the requirements of the strategic report in accordance with the Companies Act 2006 have been met in the Form 20-F, details of this have been provided in the table below and referenced to the Form 20-F accordingly. Additional requirements which are not met by the Form 20-F have been disclosed separately at the end of the Strategic Report. The Form 20-F is attached in Appendix 1, and forms part of this report by cross reference.

 

   
Required item in the Strategic Report  

Where information can be found in

the Annual Report on Form 20-F

   

•   A fair review of the Group’s business

 

Part I, Item 4B – Business overview

   

•   A description of the principal risks and uncertainties facing the company

 

Part I, Item 4B – Business overview – Legal Proceedings

Part I, Item 5A – Operating results – Components of Our Results of Operations – Operating expenses – “Research and Development Expenses”

Part I, Item 5B – Liquidity and Capital Resources – “Funding Requirements”

Note 1 to the Consolidated Financial Statements – Nature of the Business – “ Going Concern”

   

•   Analysis of the development and performance of the company’s business during the financial year and the position of the company’s business at the end of that year, consistent with the size and complexity of the business

 

Part I, Item 4B – Business overview

Part I, Item 5A – Operating results

Part I, Item 5B – Liquidity and capital resources

   

•   Main trends and factors likely to affect the future development, performance and position of the company’s business

 

Part I, Item 4B – Business overview

Part I, Item 5A – Operating results

Part I, Item 5B – Liquidity and capital resources

   

•   A description of the company’s strategy and business model

 

Part I, Item 4B – Business overview

Part I, Item 5 – Operating and Financial Review and Prospects

 

3


   
Required item in the Strategic Report  

Where information can be found in

the Annual Report on Form 20-F

   

•   References to, and additional explanation of, amounts included in the Group’s annual accounts

 

Part I, Item 5A – Operating results –“Results of Operations”

   

•   Information about the company’s employees

 

Part I, Item 6D – Employees

   

•   Description of how the company’s directors have had regard to the matters set out in section 172(a) to (f) of the Companies Act 2006 when performing their obligation to promote the success of the company

 

Consequences of decisions in the long term

Part I, Item 4B – Business overview

Part I, Item 5A – Operating results –“ Overview”

Business relationships with suppliers

Part I, Item 3D – Risk factors – Risk Factor Summary “Risks Related to our Reliance on Third Parties”

Note 12 to the Consolidated Financial Statements – Commitments and Contingencies –“Legal Proceedings”

See also Strategic Report below “Corporate Governance and Section 172 Statement”

Information required within the Strategic Report which is not included in Form 20-F

Key Performance Indicators (“KPIs”)

The Company’s key performance indicators allow the business to measure both the financial value created for its stakeholders and the strategic value in growing the business and delivering on its purpose.

The directors consider that the Company has the following financial and non-financial KPIs as a measure of its performance and position:

Financial KPIs

The directors and management regularly review the Group’s total liquidity position, operating and investing cash flows as part of the management of overall liquidity, financial flexibility and capital structure. Total liquidity is the total of cash and cash equivalents and short-term deposits and operating and investing cash flows is defined as cash-flows before financing income.

At 31 December 2022, the total liquidity position was $47.3 million and the average monthly cash burn rate of the Group was $8.0 million, excluding financing activities. At 31 December 2021, the total liquidity position was $117.7 million and the average monthly cash burn rate of the Group was $10.7 million, excluding financing activities.

Non-Financial KPIs

Given the size of the Company and the nature of its activities, the directors consider that the Company does not have any non-financial KPIs.

 

4


Corporate Governance and Section 172 Statement

The board of the Company is responsible for the Group’s corporate governance policies and recognises the importance of this in sustaining and growing the business. The board is committed to listening to and communicating openly with its shareholders to ensure the Group’s strategy and performance are clearly understood. Understanding what investors and analysts think about the Group and helping them to understand the Group’s business is a key part of driving its business forward.

The directors of companies incorporated in England and Wales, such as the Company, must act in accordance with certain general duties set out in the Companies Act 2006 and certain other duties and obligations, including (but not limited to) a duty to act in a way they consider, in good faith, would be most likely to promote the success of the company for the benefit of its members as a whole, having regard (amongst other matters) to:

 

   

the likely consequences of any decision in the long term,

   

the interests of the company’s employees,

   

the need to foster the company’s business relationships with suppliers, customers and others,

   

the impact of the company’s operations on the community and the environment,

   

the desirability of the company maintaining a reputation for high standards of business conduct, and

   

the need to act fairly as between members of the company.

The directors of the Company are mindful of their duties and obligations under section 172 of the Companies Act 2006 when making decisions. Further detail on how the board takes into account the interests of various stakeholders in promoting the success of the Company is set out in the remainder of this Strategic Report.

Social, Community and Human Rights Matters

The Group has a Code of Business Conduct and Ethics which is published on its website and can be found here: https://www.freeline.life/media/1408/freeline-code-of-conduct_cpol-001-v11-_website.pdf. The Code of Business Conduct and Ethics sets out, amongst other things, the Group’s commitment to the highest level of ethical conduct in all of its business activities, including but not limited to relationships with employees, partners, suppliers, competitors, the government, the public and the Company’s shareholders. Wherever the Group operates, it strives to make a positive and meaningful contribution to the surrounding community and to ensure the distribution of a fair share of benefits to all stakeholders impacted by its activities, including the surrounding community. The Group also has an anti-bribery and anti-corruption policy.

The Group does not, at present, have a specific policy on human rights. However, the Group has a number of measures in place to ensure that it respects the human rights of its employees and other stakeholders, including through:

 

   

provision of a safe, clean working environment;

   

ensuring employees are free from discrimination and coercion; and

   

respecting the rights of privacy and protecting access and use of employee personal information.

Environmental Matters

The Group’s activities have a minimal environmental impact. The Group leases all its facilities and outsources manufacturing of its product candidates for its clinical trials. The Group complies with all applicable environmental laws and regulations. The Group takes positive steps to reduce its carbon footprint, where possible. For a full report on the carbon emissions for the Group please see the Carbon Emissions section in the Directors’ Report.

 

5


Employee Engagement

The Group’s employees are fundamental to the delivery of its success, and so the Group takes the time to recruit the right people in the right job. The Group regularly invests in its employees’ professional development to ensure each employee reaches their full potential. The Group aims to be a responsible employer in its approach to the pay and benefits its employees receive, and aims to understand the needs of its employees. In doing so, the Group has spent time investing in wellbeing for its employees. While the Group implemented workforce reductions in November 2021, October 2022 and March 2023, the Group took steps to retain and motivate its remaining personnel.

The Group uses communication cascades with all employees to provide employees with information on matters of concern to them and to make all employees aware of financial and economic factors affecting the performance of the Group. The chief executive officer and his management team engage with employees by regular communication updates and virtual town hall meetings where employees have been welcomed to ask questions of the chief executive officer and his management team.

The Group actively promotes benefits to its staff, including medical insurance and life insurance, and will continue to develop its offerings to employees around health and wellbeing.

Diversity and Equality

Diversity and inclusion are integral to the Group’s strategy and align with the Group’s values of integrity and respect. The Group recognises that valuing and promoting a culture of diversity and inclusion enables employees to contribute their unique perspective and fully leverages their individual talents.

Appointments within the Group are made on merit according to the balance of skills and experience offered by prospective candidates. Whilst acknowledging the benefits of diversity, individual appointments are made irrespective of personal characteristics such as race, disability, gender, sexual orientation, religion or age.

A breakdown of the employment statistics as of 31 December 2022 is as follows:

 

     Male      Female      Total  

Executive director of the Company

            –          

Senior managers of the Group

                           15   

All other employees of the Group

             53                 83         136   

Non-executive directors of the Company

                    
  

 

 

    

 

 

    

 

 

 

Total directors and employees

     67         91         158   
  

 

 

    

 

 

    

 

 

 

Approval

This report was approved by the board of directors on 31 May 2023 and signed on its behalf by:

 

/s/ Michael J. Parini

 

Executive Director & Chief Executive Officer

Michael J. Parini

 

 

6


Directors’ Report

The directors present their report on the Group for the year ended 31 December 2022.

Where the requirements of the Directors’ Report in accordance with the Companies Act 2006 have been met in the Form 20-F, details of this have been provided in the table below and referenced to the Form 20-F accordingly. Additional requirements which are not met by the Form 20-F have been disclosed separately at the end of the Directors’ Report. The Form 20-F is attached in Appendix 1.

 

   
Required item in the Directors’ Report   Where information can be found in
the Annual Report on Form 20-F
   

The amount (if any) of the recommended dividend

 

None. See Part I, Item 8A –Consolidated Statements and other Financial Information – “Dividend Policy”

   

Any:

 

•  qualifying third party indemnity provision; and

 

•  qualifying pension scheme indemnity provision,

 

for the benefit of one or more directors of the company or directors of an associated company

 

Part I, Item 7B – Related Party Transactions – “Transactions with Our Principal Shareholders, Directors and Members of our Senior Management – Indemnification Agreements”

See also Directors’ Report below “Statement on directors’ third-party indemnity provision”

 

   

 

In relation to the use of financial instruments by the company, an indication of the company’s financial risk management objectives and policies, including its policy for hedging each major type of forecasted transaction for which hedge accounting is used and exposure of the company to price, credit, liquidity or cash flow risk, unless such information is not material for the assessment of the company’s assets, liabilities, financial position and profit or loss

 

 

Part I, Item 3D – Risk factorsRisk Factor Summary “Risks Related to Our Financial Position and Need For Additional Capital”

 

Price Risk: Part I, Item 3D – Risk factors – Risk Factor Summary “Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates”

 

Credit Risk: Notes to Consolidated Financial StatementsSummary of Significant Accounting Policies “Concentrations of Credit Risk and Off-Balance Sheet Risk”

 

Liquidity Risk: Part I, Item 11 – Quantitative and Qualitative Disclosures about Market Risk

   

Indication of the Group’s research and development activities

 

Part I, Item 3D – Risk factors – “Risks Related to Our Financial Position and Need for Additional Capital”

 

Part I, Item 4B – Business overview

 

Part I, Item 5A – Operating results

Part I, Item 5B – Liquidity and capital resources

 

7


Other information required within the Directors’ Report which is not included in Form 20-F

Directors

The directors who served during the year and to the date of signing were as follows:

 

  Michael J. Parini

  

  Christopher Hollowood

  

  Amit C. Nathwani

  

Resigned on 30 March 2023

  Julia P. Gregory

  

  Jeffery A. Chodakewitz

  

  Martin Andrews

  

  Colin A. Love

  

  Paul M. Schneider

  

Appointed on 30 March 2023

Statement on directors’ third-party indemnity provision

The Company has entered a deed of indemnity with each of its directors and members of its senior management. The Company’s articles of association provide that it shall indemnify its directors and members of senior management to the fullest extent permitted by applicable law.

The amount set aside or accrued by the Company to provide pension, retirement or similar benefits to members of its board of directors amounted to a total of $0 in the year ended 31 December 2022.

Political donations and expenditure

The Group did not make any political donations or incur any political expenditure (including in respect of any non-UK political party) in the year ended 31 December 2022.

Branches outside of the UK

The Company has a number of subsidiaries incorporated outside of the UK, as detailed in Note 9 to the financial statements. The Company has no branches outside the UK.

Going Concern

The directors have assessed the going concern and believe that there is material uncertainty that may cast significant doubt upon the Company’s ability to continue in operational existence for twelve months from the date of signing the accounts. Further information may be found in Note 1 to the financial statements.

Carbon Emissions

This annual report for the year ended 31 December 2022 is the third annual report in which the Group is reporting its carbon emissions footprint.

 

8


The carbon footprints for the Group for the years ended 31 December 2022 and 2021 are as follows:

 

     
     

Year ended 31 December 2022

    

Year ended 31 December 2021

 
             
  Scope        tCO2e          % Total Emissions      Per FTE*      tCO2e      % Total
  Emissions  
     Per
  FTE*  
 
             

  Scope 1

     -        0.0%        -        -        0.0%        -  
             

  Scope 2

     117,521        40.8%        0.7995        167,145        66.3%        0.7236  
             

  Scope 3

     170,424        59.2%        1.1593        84,980        33.7%        0.3679  
             

  Total

     287,946        100.0%        1.9588        252.125        100.0%        1.0915  

*Full Time Employee

By Country:

 

     
      Year ended 31 December 2022      Year ended 31 December 2021  
             
  Scope        tCO2e          % Total Emissions      Per FTE*      tCO2e      % Total
  Emissions  
     Per
  FTE*  
 
             

  UK

     88,625        30.8%        1.3428        126,684        50.2%        0.9212  
             

  Germany

     17,678        6.1%        0.6547        14,164        5.6%        0.2114  
             

  USA

     181,642        63.1%        3.3637        111,277        44.1%        3.2729  
             

  Total

     287,946        100.0%        1.9588        252,125        100.0%        1.0614  

*Full Time Employee

The Group was unable to obtain certain US-related emission figures from its partners and therefore these are not reflected in the numbers above.

For clarity, Scope 1 emissions are direct emissions produced by the burning of fuels. Scope 2 emissions are indirect emissions related to the generation of the electricity consumed and purchased by the Group. Scope 3 emissions are indirect emissions produced by the Group’s activity; these emissions are not owned or controlled by the Group. Scope 3 emissions primarily relate to business travel.

The organisational footprint of the Group is calculated in accordance with the Greenhouse Gas protocol for corporate accounting using an operational control approach. Scope 2 emissions are calculated using the location-based methodology. Currently, the Group reports on Scope 3 emissions relating to business travel only, in accordance with the Greenhouse Gas protocol for corporate accounting using a distance-based method.

The electricity consumption for the Group for Scope 2 activities was 415,454 KwH in 2022 and 583,906 KwH in 2021.

Where practical the Group enables remote working and also utilises online conferencing facilities to reduce business travel.

Future Developments

The Company’s research and development activities include one program in the clinic, two deprioritised product candidates and research programs targeting novel applications for gene therapy, for which it has, through owned and in-licensed intellectual property rights, development and worldwide commercial rights.

 

9


In the next year, the Company will continue to develop and seek to identify gene therapies for the treatment of chronic debilitating diseases with high unmet need.

Events after the balance sheet date

On 8 February 2023, the Company closed the previously announced sale of its German subsidiary, Freeline Therapeutics GmbH, and certain intellectual property rights pertaining to the business of Freeline Therapeutics GmbH, to Ascend Gene and Cell Therapies Limited (“Ascend”), for $25 million, subject to purchase price adjustments. At closing, the Company and Ascend entered into an intellectual property deed of assignment and license and a transition services agreement (the “Transition Services Agreement”), pursuant to which Ascend will provide certain services in the area of development and manufacturing to the Company. The Company agreed to utilise, and Ascend agreed to make exclusively available to the Company, no fewer than 15 full-time employee equivalents, or “FTEs” (as defined in the Transition Services Agreement), per annum for a guarantee period of 18 months following the Transition Services Agreement’s effective date. The Company also agreed to pay Ascend a guaranteed minimum of approximately $7.9 million in respect of FTE costs during such period, $2.6 million of which were paid upfront.

On 21 March 2023, we entered into an exclusive patent and know-how license agreement with Forcefield Therapeutics Limited (“Forcefield”), a company controlled by Syncona Limited (“Syncona”). Under the terms of the agreement, Forcefield granted us an exclusive license under certain patent rights to develop and commercialise AAV gene therapies for certain cardiac conditions and a non-exclusive license to certain know-how. We were required to make an upfront payment to Forcefield of £0.5 million or $0.6 million and may be required to make up to £18.3 million ($22.0 million) in development and regulatory milestone payments, and pay Forcefield a mid-single-digit percentage royalty on net sales of certain royalty products on a product-by-product and country-by-country basis, until the later of (a) the expiration of the last valid licensed patent claim covering such product in such country or (b) ten years from the first commercial sale of such product sold in that country or 20 years from the date upon which the agreement was signed. We also agreed to make payments to Forcefield in accordance with a workplan to be agreed in connection with a sponsored research agreement entered into between Forcefield and a non-profit organisation.

On 24 March 2023, we entered into an exclusive patent and know-how license agreement with Syncona IP Holdco (2) Limited (“Syncona Holdco”), a company controlled by Syncona. Under the terms of the agreement, we granted Syncona Holdco an exclusive license under certain patent rights related to an immune-modifying protein to develop and commercialise the technology other than in respect of liver-directed gene therapies and a non-exclusive license to certain know-how. Syncona Holdco was required to make an upfront payment to us of £0.5 million or $0.6 million and may be required to make up to £12.5 million or $15.1 million in development and regulatory milestone payments, and pay us a low-single-digit percentage royalty on net sales of certain licensed products and know-how products on a product-by-product and country-by-country basis, commencing on the date of the first commercial sale of such product in such country until (in respect of licensed products) the expiration of the last valid licensed patent claim covering such product in such country or (in respect of know-how products) 20 years from the date upon which the agreement was signed.

During the first quarter of 2023, the Company completed a financial and organisational assessment to increase efficiencies and reduce operating expenses. As a result of this assessment, the Company reduced its U.S. and U.K. workforce by nearly 30%. The Company incurred total expenses relating to the workforce reduction of $1.1 million of charges, consisting of severance and termination-related costs, which will be recognized as operating expenses.

On 12 May 2023, the Company changed the ratio of its ADSs to its ordinary shares (the “ADS Ratio”) from the previous ADS Ratio of one ADS to one ordinary share to a new ADS Ratio of one ADS to fifteen ordinary shares. The change in the ADS Ratio had the same effect as a one-for-fifteen reverse ADS split and was intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement.

 

10


On 18 May 2023, the Group entered into a Mutual Release and Settlement Agreement (the “Settlement Agreement”), with Brammer Bio MA, LLC (“Brammer”) to resolve the arbitration arising from the Dedicated Manufacturing and Commercial Supply Agreement, dated 30 June 2020, by and between Freeline Therapeutics Limited and Brammer (the “DMCSA”). Pursuant to the terms of the Settlement Agreement, the Group will pay to Brammer a total of $2.25 million. Subject to specified conditions and exceptions, the parties will dismiss the arbitration, and each party will release the other party from any and all claims arising from the parties’ business relationship.

Disclosure of information to auditor

In accordance with Section 418 of the Companies Act 2006, each director in office at the date the Directors’ Report is approved confirms that:

 

   

so far as the director is aware, there is no relevant audit information of which the Group’s and the Company’s auditor is unaware; and

   

he/she has taken all the steps that he/she ought to have taken as a director in order to make himself/herself aware of any relevant audit information and to establish that the Group’s and the Company’s auditor is aware of that information.

Independent auditor

The Group’s auditor, Deloitte LLP, have indicated their willingness to continue in office, and a resolution that they be re-appointed will be proposed at the annual general meeting.

Directors’ Responsibilities Statement

The directors are responsible for preparing the Annual Report and the Financial Statements, in accordance with applicable law and regulations.

Company law requires the directors to prepare Financial Statements for each financial year. Under that law, the Directors elected to prepare the Group’s consolidated Financial Statements in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) and the Company’s Financial Statements in accordance with applicable law and United Kingdom Accounting Standards (United Kingdom Generally Accepted Accounting Practice), including Financial Reporting Standard 102 (“FRS 102”). Under company law, the directors must not approve the accounts unless they are satisfied that they give a true and fair view of the state of affairs of the Group and the Company and of the profit or loss of the Group and Company for that period.

In preparing the Company’s Financial Statements, the directors are required to:

 

   

select suitable accounting policies and then apply them consistently;

   

make judgements and accounting estimates that are reasonable and prudent;

   

state whether applicable United Kingdom Generally Accepted Accounting Practices including FRS 102, have been followed, subject to any material departures disclosed and explained in the Company’s Financial Statements, respectively; and

   

prepare the Financial Statements on the going concern basis unless it is inappropriate to presume that the Company will continue in business.

In preparing the Group’s Financial Statements, US GAAP requires that directors:

 

   

properly select and apply accounting policies;

   

present information, including accounting policies, in a manner that provides relevant, reliable, comparable, and understandable information;

 

11


   

provide additional disclosures when compliance with the specific requirements in US GAAP are insufficient to enable end users to understand the impact of transactions, other events and conditions on the entity’s financial position and financial performance; and

   

make an assessment of the Company’s ability to continue as a going concern.

The directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Group’s transactions and disclose with reasonable accuracy at any time the financial position of the Group and enable them to ensure that the Financial Statements comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the Group and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.

The directors are responsible for the maintenance and integrity of the corporate and financial information included on the Group’s website. Legislation in the United Kingdom governing the preparation and dissemination of Financial Statements may differ from legislation in other jurisdictions

Responsibility statement

We confirm that to the best of our knowledge:

 

   

the Financial Statements, prepared in accordance with the relevant financial reporting framework, give a true and fair view of the assets, liabilities, financial position and profit or loss of the Group and the undertakings included in the consolidation taken as a whole;

   

the Strategic Report includes a fair review of the development and performance of the business and the position of the Group and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face; and

   

the Annual Report and Financial Statements, taken as a whole, are fair, balanced, and understandable and provide the information necessary for shareholders to assess the Group’s position and performance, business model and strategy.

This responsibility statement was approved by the board of directors on 31 May 2023 and is signed on its behalf by:

 

/s/ Michael J. Parini

 

Executive Director & Chief Executive Officer

Michael J. Parini

 

 

12


Directors’ Remuneration Report

Annual statement by the Chair of the Remuneration Committee

The information provided in this part of the Directors’ Remuneration Report is not subject to audit:

Dear Shareholder,

As the Chair of the Remuneration Committee (the “Committee”), I am pleased to present, on behalf of the board of directors (the “Board”) of Freeline Therapeutics Holdings plc (the “Company” or “Freeline”), the Directors’ Remuneration Report for the year ended 31 December 2022 (the “Report”).

The Report will be subject to an advisory vote at the forthcoming Annual General Meeting on 28 June 2023 (the “AGM”). The Directors’ Remuneration Policy (the “Policy”) was approved by shareholders at the Annual General Meeting on 28 June 2021 and will remain in force for three years from that date (until the Annual General Meeting in 2024, or until a revised remuneration policy is approved by shareholders).

Introduction

Against the backdrop of a challenging market environment for the pre-commercial biotechnology sector with high inflation and rising interest rates, Freeline took necessary steps during 2022 to streamline the organisation and extend its cash runway through a series of difficult but important strategic and cost-saving initiatives, including:

 

   

prioritising the development of FLT201 in Gaucher Disease, a potentially first- and best-in-class asset, and deprioritising development of FLT190 for Fabry disease (in April 2023) and FLT180a for haemophilia B;

   

selling its German subsidiary, Freeline Therapeutics GmbH, which employed approximately 55 employees and focused on chemistry, manufacturing and controls (“CMC”), for $25 million, subject to purchase price adjustments; and

   

executing a series of workforce reductions which have resulted in Freeline’s overall headcount falling from 235 employees at the end of 2021 to roughly 100 employees at the end of 2022 (after adjusting for the sale of Freeline’s Germany subsidiary, which completed in February 2023). A further workforce reduction announced in April 2023 brought the overall workforce down to approximately 65 employees.

The Company has made important investments in senior executive talent over 2022, through the appointment of several key executives, including Henning R. Stennicke, PhD, as Chief Scientific Officer to lead research and discovery, Nicole Jones as Chief People Officer and Paul Schneider as Chief Financial Officer and, from 30 March 2023, as an executive director.

With a streamlined organisation and new leadership team in place, the Company is looking ahead to key milestones in the development of FLT201 in Gaucher disease and is actively screening patients for dosing in its GALILEO-1 Phase 1/2 trial. The first data read-out from the first cohort is expected in the third quarter of 2023.

From 2023 and beyond, the Committee’s role will be to ensure that directors and senior executives at Freeline are appropriately compensated and incentivised to deliver growth to shareholders in a long-term and sustainable manner. The Committee will seek to accomplish this by implementing remuneration programmes that are grounded in market practice, effective at driving proper executive behaviours, clearly link pay with performance and are cost-efficient overall to shareholders. The Committee also considers non-executive directors within the Policy and considers that the current remuneration strategy provides an appropriate level of remuneration for their services.

As many of the previously issued and outstanding equity awards have been recycled and returned to the pool of shares available for award grants (as a result of workforce reductions), the Committee has continued to leverage

 

13


the available share pool to deliver competitive equity ownership to the remaining organisation. Where required, management, with the support of the Committee, has taken decisive action to make off-cycle retention grants to wider critical-to-retain employees. In doing so, the Committee strives to maintain a market-appropriate balance between employee and investor ownership, acknowledging that many of the options issued immediately post-IPO are significantly underwater and are unlikely to be exercised and dilute shareholders in the near term.

The Board is committed to continued remuneration-related dialogue with shareholders. The Committee will consider shareholder feedback received following the AGM, as well as any additional feedback and guidance received from time to time. This feedback will be considered by the Committee as it develops the Company’s remuneration framework and practices going forward. Assisted by its independent adviser, the Committee also actively monitors developments in the expectations of institutional investors and their representative bodies.

The Global Marketplace for Talent

Freeline is a global biopharmaceutical company with operations in both the United Kingdom and the United States. The majority of its senior executive team and Board is based in the United States. Although the Company intends for both countries to be areas of growth and importance both now and in the future, the US biopharmaceutical market is very competitive and continues to serve as the primary market reference for the Committee when evaluating remuneration levels and practices. This helps attract and retain directors and motivate the superior talent needed to successfully manage the Company’s operations worldwide. Where executives have been based outside of the United States, secondary regional benchmarks have also been considered to manage cash remuneration at an appropriate local market level, particularly where exchange rates against the US Dollar have been volatile.

While the Committee references US market practice as the primary benchmark for both executive and non-executive director remuneration, it also takes account of UK market practice and any additional relevant local market practice. Freeline will consider both local market practice and the interests of shareholders when making pay decisions that are globally consistent in philosophy and approach but are adapted to meet local market requirements.

In taking any actions, the Committee is mindful of general UK compensation frameworks, including investor bodies’ guidance and the UK Corporate Governance Code, and has incorporated practices into its remuneration programs and policies where it believes they best serve the long-term interests of shareholders.

Corporate Governance Standards

Freeline is a “foreign private issuer,” as defined by the US Securities and Exchange Commission. As a result, in accordance with Nasdaq listing requirements, the Company may rely on home country governance requirements and certain exemptions thereunder rather than complying with Nasdaq corporate governance standards. Freeline complies with the directors’ remuneration reporting regulations under Schedule 8 of the Large and Medium-sized Companies and Groups (Accounts and Reports) 2008 (as amended), as required by the UK Companies Act 2006, and voluntarily follows most Nasdaq corporate governance rules.

The Board presently has seven members. As a foreign private issuer, under the listing requirements and rules of Nasdaq, Freeline is not required to have independent directors on the Board, except that the audit committee is required to consist fully of independent directors, subject to certain phase-in schedules. The Board determined that Chris Hollowood, Colin A. Love, Jeffrey A. Chodakewitz, Julia P. Gregory and Martin Andrews, representing five of our seven directors, do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these directors is “independent” as that term is defined under Nasdaq general independence rules. For audit committee purposes, the Board has determined that each of Martin Andrews, Julia P. Gregory and Colin A. Love are independent directors under Nasdaq listing rules and under Rule 10A-3 under the US Securities Exchange Act of 1934, as amended.

 

14


Remuneration Programme Highlights

During 2022, the Committee undertook a number of activities to review and update, as appropriate, a broad range of remuneration programmes and policies, including:

 

   

reviewing the Company’s executive compensation peer group and making changes to reflect current market conditions;

   

approving several compensation packages for critical executive new hires and promotions;

   

reviewing the Company’s wider equity strategy, managing the equity pool to ensure sufficient funding for competitive equity grants to new hires and ongoing staff;

   

adopting a short-term incentive plan to enhance the Company’s ability to provide a framework for rewarding employees with an annual bonus based on individual and business performance;

   

adopting a malus policy to provide for the reduction or forfeiture of certain remuneration from executives and directors in the event of certain malus conduct;

   

awarding both employees (including the executive directors) and non-executive directors with market value awards under the Company’s equity incentive plan;

   

reviewing workforce reductions that would extend the cash runway of the organisation;

   

conducting a benchmarking review covering both executive and non-executive directors;

   

developing and receiving shareholder approval of the Company’s second Directors’ Remuneration Report;

   

considering, reviewing and approving the short-term objectives for the annual bonus for the financial year; and

   

exercising discretion in assessing performance against the short-term objectives for the financial year and approved the level of bonuses to be paid to the CEO, as discussed below.

2023 Salary Outcome

Salaries are normally reviewed annually in the first quarter of the year with an effective date of 1 April. For 2023, it was agreed by the Committee that the CEO would be awarded a salary increase of 2.5%, which was agreed upon evaluation of a range of factors, including his position relative to the Company’s executive compensation peer group and his performance over the prior year. This increase was below the 4% overall budget for salary increases for the wider eligible employee base.

2022 Bonus Outcome

The CEO was once again eligible to receive a target bonus of 55% of salary for 2022. In 2021, 50% of the target bonus was subject to strategic corporate goals with the remaining 50% tied to individual performance. In 2022, a multiplier based on performance against strategic corporate goals and a multiplier based on a qualitative assessment of the CEO’s individual performance by the Committee were applied to the CEO’s target bonus. A corporate multiplier of 117% was awarded, and an individual bonus multiplier of 125% was awarded (each within a minimum of 0% and a maximum of 150%). This resulted in a total bonus of 146% of target (within a minimum of 0% and a maximum of 225%), which payment equalled 80% of salary. The Committee noted that the CEO had exceeded expectations through his strong leadership through a difficult period of cost rationalisation that has put the Company on more solid financial footing to focus its resources on advancing FLT201, which has the potential to be a first- and best-in-class gene therapy for Gaucher disease Type 1.

2023 Equity Approach

With all of the historical option grants to employees underwater and a critical two-year time horizon to retain and motivate the team to execute on its clinical strategy, the Committee agreed to shorten the overall vesting period of the 2023 annual awards from four to three years. Notwithstanding the service-based vesting, the 2023 awards granted across the employee organisation are also subject to vesting acceleration upon achievement of two

 

15


distinct milestones related to progression of the Company’s FLT201 product candidate toward initiation of a Phase 3 clinical trial. The Committee believes this performance-based vesting will create alignment across the employee organisation towards achieving these critical value-driving milestones for shareholders.

Conclusion

I would like to finish by thanking Freeline co-founder Amit Nathwani, following his retirement from the Board in March 2023. I have greatly appreciated the support that Amit has provided me since we co-founded Freeline in 2015, and I am pleased that he will continue to be involved with the Company as a Clinical and Scientific Adviser.

I hope that you find the information in this Report helpful, and look forward to the AGM, where we hope to have your support.

Yours sincerely

 

LOGO

Dr. Chris Hollowood

Remuneration Committee Chair

31 May 2023

 

16


Directors’ Remuneration Policy

The current Policy for the Company’s directors was put forward for approval by shareholders in a binding vote at the Annual General Meeting on 28 June 2021 and approved with a vote of 82.44% of all ordinary shares represented in favour. The Policy took effect from the date of approval and applies for a period of three years, until 2024. It can be found on page 16 of the Company’s 2020 Annual Report and Accounts at https://www.freeline.life/media/1395/freeline-ar-combo-2up_revised.pdf .

Annual Report on Remuneration

This part of the Report has been prepared in accordance with Schedule 8 of the Large and Medium-sized Companies and Groups (Accounts and Reports) (Amendment) Regulations 2008 (as amended). Since the Company does not have a premium listing on the London Stock Exchange, it is under no obligation to comply with the UK Corporate Governance Code, but best practice and good governance have been considered when preparing this Report. The Report on Remuneration and the Annual Statement by the Chair of the Committee will be put to a single advisory shareholder vote at the AGM on 28 June 2023.

Remuneration Committee

The remuneration of the executive directors is determined by the Committee.

The members of the Committee during the year were all non-executive directors. Chris Hollowood chaired the Committee, and Martin Andrews and Jeffrey A. Chodakewitz were members of the Committee throughout the year.

No conflicts of interest have arisen during the period and none of the members of the Committee has any personal financial interest in the matters discussed, other than as shareholders. Chris Hollowood is currently the Chief Executive Officer of Syncona and served as the Chief Investment Officer during 2022 until his promotion to CEO on 1 January 2023. He acts as Syncona’s representative on the Board of Freeline. The fees of the non-executive directors are approved by the Board on the recommendation of the Committee. During the reporting period, the Committee met six times formally. Details of attendees are as below.

Meetings Attendance

 

     Attendance

Chris Hollowood

   6 of 6

Martin Andrews

   6 of 6

Jeffrey A. Chodakewitz

   6 of 6

The CEO is invited to attend meetings where appropriate. No individual is present when matters relating to their own remuneration are discussed.

Advisors to the Remuneration Committee

During the year, the Committee received independent advice from the executive compensation practice of Aon Solutions UK Limited (“Aon”). Aon advises the Committee on all aspects of director and senior executive remuneration. Since the IPO, Aon has assisted with the drafting of the Policy and the Report and has updated the Committee on UK and US remuneration reporting and corporate governance best practice. In relation to work carried out in 2022, fees charged by Aon for advice provided to the Committee amounted to approximately $143,000 (excluding VAT).

Activity in the Period

What has the Committee done in the year:

 

   

evaluated the efficacy of the Company’s Policy and strategy;

 

17


   

reviewed and determined remuneration to be paid to the Company’s CEO;

 

   

reviewed and made recommendations to the Board regarding remuneration for non-executive directors;

 

   

established the design and set the performance targets (where relevant) of the Company’s share incentive plans;

 

   

assessed the appropriateness and subsequent achievement of the performance targets related to the Company’s bonus plan;

 

   

prepared any report on executive remuneration required by the rules and regulations of the US Securities and Exchange Commission, Nasdaq and as required under English law;

 

   

reviewed, evaluated, and approved employment agreements, service contracts, severance agreements, change-of-control protections, corporate performance goals and objectives, and other compensatory arrangements of the executive officers and other senior management and adjusted remuneration, as appropriate; and

 

   

evaluated and approved remuneration plans and programs and established equity remuneration policies.

The Committee is formally constituted and operates on a written Remuneration Committee Charter, which is available on the Company’s website, https://www.freeline.life/investors/corporate-governance/.

Statement of Shareholder Voting at AGM

The latest votes cast by proxy and at the applicable AGM with respect to the 2022 Report and the 2021 Policy were as follows:

 

     Votes For      Votes Against      Votes Withheld  
Resolution    Year
of
AGM
     % of
votes cast
    Number of
votes
     % of
votes cast
    Number
of votes
     Number of
votes
 

2. To approve the Directors’ Remuneration Report

     2022        90.9     44,332,434        9.1     4,440,995        5,960,354  

3. To approve the Directors’ Remuneration Policy

     2021        82.4     25,003,075        17.6     5,327,023        284,835  

Single Figure of Remuneration (audited)

The table below provides a breakdown of the various elements of the directors’ pay for the years ended 31 December 2022 and 31 December 2021:

 

Director   Year     Salary/Fees
($000s)
    Benefits
($000s)
    Pension
($000s)
    Total Fixed
Remuneration
($000s)
    Annual
Bonus
($000s)
    Share-
Based
Payment
Expense
($000s)5
    Total
Variable
Remuneration
($000s)
    Other
($000s)
    Total
Remuneration
($000s)
 

Executive Directors

                   

Michael J. Parini1

    2022       $591       $0       $0       $591       $485       $1,084       $1,569       $0       $2,160  
      2021       $169       $0       $0       $169       $196       $171       $367       $0       $536  

Theresa Heggie2

    2022       $0       $0       $0       $0       $0       $0       $0       $0       $0  
      2021       $387       $0       $21       $408       $0       $4,114       $4,114       $419       $4,940  

Non-Executive Directors

 

               

Chris Hollowood3

    2022       $0       $0       $0       $0       $0       $93       $93       $0       $93  
      2021       $0       $0       $0       $0       $0       $103       $103       $0       $103  

Amit Nathwani4

    2022       $180       $0       $0       $180       $0       $275       $275       $0       $455  
      2021       $193       $0       $0       $193       $0       $320       $320       $0       $512  

Martin Andrews

    2022       $52       $0       $0       $52       $0       $102       $102       $0       $154  
      2021       $58       $0       $0       $58       $0       $110       $110       $0       $168  

Jeffrey Chodakewitz

    2022       $52       $0       $0       $52       $0       $114       $114       $0       $166  
      2021       $53       $0       $0       $53       $0       $110       $110       $0       $163  

 

18


Director   Year     Salary/Fees
($000s)
    Benefits
($000s)
    Pension
($000s)
    Total Fixed
Remuneration
($000s)
    Annual
Bonus
($000s)
    Share-
Based
Payment
Expense
($000s)5
    Total
Variable
Remuneration
($000s)
    Other
($000s)
    Total
Remuneration
($000s)
 

Julia P. Gregory

    2022       $58       $0       $0       $58       $0       $114       $114       $0       $172  
      2021       $59       $0       $0       $59       $0       $111       $111       $0       $170  

Colin A. Love

    2022       $47       $0       $0       $47       $0       $46       $46       $0       $93  
      2021       $38       $0       $0       $38       $0       $21       $21       $0       $60  

Total

    2022       $979       $0       $0       $979       $485       $1,827       $2,312       $0       $3,291  
    2021       $957       $0       $21       $978       $196       $5,060       $5,256       $419       $6,652  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Notes to the table:

 

1.

Appointed as CEO and executive director on 15 August 2021. The 2021 figures exclude Mr. Parini’s remuneration as Chief Operating Officer before his appointment to CEO and executive director.

2.

Salary represents Ms. Heggie’s salary and accrued vacation to 15 August 2021, the date of her termination. Share-based payment expense for Ms. Heggie reflects (i) $2.6 million cash payment upon vesting of 75% of an upfront option grant over 174,898 shares that were cash-settled automatically at a fixed price (limiting both upside and downside exposure) on the first anniversary of Ms. Heggie’s employment commencement date (Ms. Heggie forfeited the remaining unvested 25% portion of this option on 15 August 2021, and the Company has issued no other cash-settled equity grants or arrangements to anyone else) and (ii) $1.5 million in share-based compensation expense recognised during the year ended 31 December 2021 in connection with her vested equity awards. The “Other” column includes (i) $240,467 cash severance payment paid pursuant to Ms. Heggie’s separation agreement, (ii) $96,773 of payments in lieu of the 12 months of notice Ms. Heggie was entitled to under her employment agreement, paid from the date of her termination through 31 December 2021 pursuant to her separation agreement and (iii) $81,550 of payments in lieu of notice accrued and payable from 31 December 2021 through the first anniversary of the date of her termination. In line with the general workforce, the Company contributed an amount equal to 6% of Ms. Heggie’s salary to a defined contribution pension scheme to fulfil statutory pension requirements.

3.

As the representative of Syncona, Mr. Hollowood does not receive fees from the Company.

4.

Consists of Mr. Nathwani’s consulting fees as the Company’s Clinical and Scientific Adviser.

5.

Except as otherwise indicated, represents the share-based compensation expense recognised during the year ended 31 December 2022 in connection with each director’s vested equity awards. The Company recognises compensation expense for equity awards based on the grant date fair value of the award. For equity awards that vest based on a service condition, the share-based compensation expense is recognised on a straight-line basis over the requisite service period. For a description of the assumptions used in valuing option awards, see Note 8 to the audited consolidated financial statements included in this Annual Report.

 

19


2022 Annual Bonus

In 2022, the CEO’s bonus of $485,384 was based on a mix of corporate measures that make progress towards the Company’s strategic goals and personal performance objectives based on a qualitative review by the Committee. In 2021, 50% of the target bonus was subject to strategic corporate goals with the remaining 50% tied to individual performance. In 2022, multipliers based on achievement of both strategic corporate goals and individual performance objectives were applied to the CEO’s target bonus. The overall bonus outcome resulted in a pay-out of 80.44% of salary (146% of target, within a minimum of 0% and a maximum of 225%) as set forth below:

 

2022 Objectives

  Achievement     Target     Maximum     Achievement
Percentage
   

Bonus Outcome

    CORPORATE / STRATEGIC TARGETS      

Clinical Programmes

    Exceeds       36.0     60.0     37.0  

Research and Platform

    Exceeds       31.0     40.0     36.0  

Corporate and Financial

    Exceeds       15.0     25.0     23.0    

Organizational and Corporate Development

    Exceeds       18.0     25.0     21.0  

Total corporate / strategic targets

    Exceeds       100.0     150.0     117.0  

117% * 55% of salary at target =

64.35% of salary

    INDIVIDUAL PERFORMANCE
MULTIPLIER
     

Individual performance

    Exceeds       100.0     150.0     125.0  

125% * 64.35% of salary

= 80.44% of salary

                                     

TOTAL BONUS

                                 

80.44% of Salary

146% of Target within Minimum 0% and Maximum 225%

Each of the corporate objectives above was divided into a series of sub-areas of specific target and stretch goals. Although the Company received no or only partial credit in certain clinical and research objectives, stretch achievement goals were achieved in other clinical and research areas, alongside strong performance on corporate, financial and organisational and corporate development objectives. This included the Companys $26.1 million registered direct offering, the sale of its German subsidiary for $25 million and its success recruiting senior executive talent and reducing cash burn.

Based on a qualitative assessment of the CEOs individual performance by the Committee, an individual performance multiplier of 125% of the target was awarded. The Committee noted that the CEO had exceeded expectations through his strong leadership through a difficult period of cost rationalisation. This included rigorously assessing the Companys strategic priorities based on its financial position and the capital needs associated with advancing three clinical-stage programs in parallel and steering the sale of the Companys German subsidiary, Freeline Therapeutics GmbH, which closed in February 2023. His strategic delivery has put the Company on more solid financial footing to focus its resources on advancing FLT201, which has the potential to be a first- and best-in-class gene therapy for Gaucher disease Type 1. The Committee is satisfied that the overall bonus outcome is appropriate. The CEO is not required to defer any part of his bonus.

Omnibus Incentive Plan (OIP) (audited)

Awards Granted in the Year

The CEO was granted the following market value options in the year, with the exercise price equal to the closing sales price of an ADS on the last trading day before the grant date and vesting subject to continued employment only:

 

Executive
Director

   Form of
award
    Date of
grant
     Number of
shares
     Per share
exercise
price ($)
     Face value
at date of
grant
($000s)2
     Fair value
at date of
grant
($000s)3
     Vesting
end date
     Expiry date  

Michael Parini

     Options 1      31/01/2022        900,000        1.18        1,062        655        31/01/2026        31/01/2032  

 

20


Notes to the table:

 

1.

Vesting commences 12 months from the grant date with 25% vesting on the first anniversary of the grant date and the remaining 75% vesting pro rata on a monthly basis for the next 36 months.

2.

The face value at the date of grant of the option was calculated using the closing sales price of an ADS ($1.18) on the last trading day before the grant date (31 January 2022).

3.

The fair value of the option is based on a Black-Scholes calculation. For a description of the assumptions used in valuing options, see Note 8 to the audited consolidated financial statements included in this Annual Report.

The Committee considered a variety of factors in determining the number of shares granted subject to awards to the CEO, including external competitive market assessments by Aon, corporate and individual performance and rate of use of the equity pool on an annual basis.

Non-executive directors were also granted the following options during the year, each vesting based on continued service only:

 

Non-Executive

Director

  Form of
award1
    Date of
grant
    Number of
shares
    Per
share
exercise
price($)2
    Face value
at date of
grant
($000s)
    Fair value
at date of
grant
($000s)
    Vesting
end date
    Expiry
date
 

Martin Andrews

    Options       30/06/2022       27,000       0.88       24       16       30/06/2026       29/06/2032  

Jeffrey Chodakewitz

    Options       30/06/2022       27,000       0.88       24       16       30/06/2026       29/06/2032  

Julia Gregory

    Options       30/06/2022       27,000       0.88       24       16       30/06/2026       29/06/2032  

Colin Love

    Options       30/06/2022       27,000       0.88       24       16       30/06/2026       29/06/2032  

Amit Nathwani

    Options       30/06/2022       27,000       0.88       24       16       30/06/2026       29/06/2032  

Chris Hollowood

    N/A - Did not receive due to relationship with Syncona    

 

Notes to the table:

 

1.

Vesting in full 12 months from the grant date.

2.

The per share exercise price of all of these options is equal to the closing sales price of an ADS on the last trading day before the grant date.

In addition, Dr. Nathwani was granted restricted share units (“RSUs”) over 10,000 shares on 8 April 2022, at a grant date value of $10,154, in connection with services provided to the Company during 2021 as interim Chief Scientific Officer outside of his role as a non-executive director. The RSUs vested in full six months from the first full month of grant on 31 October 2022.

 

21


Awards Vesting in the Year

The following awards vested in the year based on continued service. No options were exercised during the reporting year. See detail below:

 

Executive Director

  Form of award   Date of
grant
    Number
of shares
    Unvested
on 1/1/22
    Vested
in period
    Lapsed
in period
     Exercised/settled
in period
    Unvested
on
31/12/22
    Outstanding
on 31/12/22
 

Michael Parini

  Options     31/03/2021       296,000       296,000       129,500       -        -       166,500       166,500  
    Options     16/08/2021       775,000       775,000       258,333       -        -       516,667       516,667  

Non-Executive

Director

  Form of award   Date of
grant
    Number
of shares
    Unvested
on 1/1/22
    Vested
in period
    Lapsed
in period
     Exercised
in period
    Unvested
on
31/12/22
    Outstanding
on 31/12/22
 

Amit Nathwani

  Restricted Shares     22/05/2015       9,481       -       -       -        N/A       -       -  
  Restricted Shares     22/05/2015       13,474       -       -       -        N/A       -       -  
  Restricted Shares     22/05/2015       19,839       2,067       2,067       -        N/A       -       -  
  Restricted Shares     11/09/2019       18,779       2,348       2,348       -        N/A       -       -  
  Restricted Shares     11/09/2019       2,478       1,085       620       -        N/A       465       465  
  Option     29/06/2020       61,117       38,199       15,280       -        -       22,919       61,117  
  Option     07/08/2020       25,344       16,896       6,336            10,560       25,344  
    Option     30/06/2021       19,000       16,625       4,750       -        -       11,875       19,000  

Colin Love

  Option     30/06/2021       28,667       28,667       12,541       -        -       16,126       28,667  

Martin Andrews

  Option     29/06/2020       5,764       3,603       1,441       -        -       2,162       5,764  
  Option     29/06/2020       21,763       4,081       4,081       -        -       -       21,763  
  Option     29/06/2020       13,951       6,104       3,488       -        -       2,616       13,951  
    Option     30/06/2021       19,000       16,625       4,750       -        -       11,875       19,000  

Jeffrey Chodakewitz

  Option     29/06/2020       5,764       3,603       1,441       -        -       2,162       5,764  
  Option     29/06/2020       35,714       15,624       8,928            6,696       35,714  
    Option     30/06/2021       19,000       16,625       4,750       -        -       11,875       19,000  

Julia P. Gregory

  Option     29/06/2020       41,478       25,924       10,369       -        -       15,555       41,478  
    Option     30/06/2021       19,000       16,625       4,750       -        -       11,875       19,000  

Chris Hollowood

  Option     07/08/2020       33,288       22,192       13,870       -        -       8,322       33,288  

Payments to Past Directors and Loss of Office (audited)

No payments were made to former directors of the Company during the year.

External Directorships

The Board believes that it may be beneficial to the Company for executives to hold certain roles outside the Company, provided that the Company’s business takes priority. Any such appointments are subject to the prior written consent of the Board and the director may retain any fees received. Michael Parini did not at any point during 2022 (and does not currently), hold any external directorships.

Directors’ Shareholding and Share Interests (audited)

The share interests of each director as at 31 December 2022 (together with interests held by their connected persons) are set out in the table below. As a direct link between executive remuneration and the interests of shareholders, the Committee has implemented shareholding guidelines for executive directors. The guidelines require that executive directors build up and maintain an interest in the ordinary shares of the Company that is 200% of their salary within five years from the later of the introduction of the guidelines or appointment. As Mr. Parini became an executive director on 15 August 2021, he has until 15 August 2026 to be in compliance.

Executive directors are required to retain at least 50% of shares (net of tax) from awards made under the OIP until the target shareholding is attained.

 

22


Non-executive directors are not subject to any shareholding guidelines.

 

          Shares     Options          
Director   Beneficially
owned shares
as at 31
December
2022
    Unvested
without
performance
conditions
    Unvested with
performance
conditions
    Vested but
unexercised
    Unvested
without
performance
conditions
    Unvested
with
performance
conditions
    Current
shareholding
(% of salary)
  Shareholding
requirement
met?

Michael J. Parini

    -       -       -       387,833       1,583,167       -     0%   No

Chris Hollowood

    -       -       -       19,418       13,870       -     N/A   N/A

Amit Nathwani

    73,586       465       -       60,107       72,354       -     N/A   N/A

Martin Andrews

    -       -       -       43,825       11,875       -     N/A   N/A

Jeffrey Chodakewitz

    -       -       -       39,745       47,733       -     N/A   N/A

Julia P. Gregory

    -       -       -       33,048       54,430       -     N/A   N/A

Colin A. Love

    -       -       -       12,541       43,126       -     N/A   N/A

The information provided in this part of the Report is not subject to audit:

TSR Performance Graph (not audited)

The graph below shows the Company’s Total Shareholder Return (“TSR”) performance compared with that of the SPDR S&P Biotech ETF (“XBI”) over the period from the date of the Company’s admission to Nasdaq (7 August 2020) to 31 December 2022. As the XBI is a modified equal weight index, it places a greater relative weighting on small- and mid-cap biotechnology organisations, which the Company believes offers the best industry comparison for relative performance. TSR is defined as the return on investment obtained from holding a company’s shares over a period. It includes dividends paid, the change in the capital value of the shares and any other payments made to or by shareholders within the period. Relative to Freeline’s executive compensation peer group of biotechnology companies at early stages of clinical development with a therapeutic focus on gene therapy and other rare diseases, Freeline’s 2022 one-year TSR of -76% was consistent with the median performance of the group, reflecting the particularly challenging year for biotechnology companies with this focus.

 

LOGO

 

23


Total shareholder return

Source: FactSet

This graph shows the value, by 31 December 2022, of $100 invested in Freeline Therapeutics on the date of Admission (07 August 2020), compared with the value of $100 invested in the SPDR S&P Biotech (XB) Index on a daily basis.

Aligning Pay with Performance

The total remuneration figure for the CEO is shown in the table below, along with the value of bonuses paid and performance-based OIP awards that vested, as a percentage of the maximum opportunity:

 

Chief Executive Officer

       2020              2021              2022      

Total remuneration ($000s)1

             $1,950                $5,476                $2,160  

Actual bonus (% of maximum)

     76%        68%        100%  

OIP vesting (% of maximum)

     N/A        N/A        N/A  

Notes to the table:

 

1.

Total remuneration in 2021 reflects the sum of the compensation for the outgoing CEO, including her separation payments, and the incoming CEO (from the point of his election as an executive director). Excluding the one-time payments associated with the outgoing CEO’s separation, the CEOs’ total remuneration in 2021 was approximately $3.5 million, $2.6 million of which was associated with the vesting of 75% of an upfront equity grant to Ms. Heggie of an option over 174,898 shares that were cash-settled automatically at a fixed price (limiting both upside and downside exposure) on the one-year anniversary of her employment commencement date. Ms. Heggie forfeited the remaining unvested 25% portion of her cash-settled option on 15 August 2021 and the Company has issued no other cash-settled equity grants or arrangements to anyone else.

Percentage Change in the Remuneration of the Directors Compared to Other Employees

The table below shows a comparison of the annual change of each individual director’s pay to the annual change in average employee pay in the years ended 31 December 2022 and 2021:

 

     Change in pay between 31
December 2021 and 31 December
2022
     Change in pay between 31
December 2020 and 31 December
2021
 
Director    Salary  
Change  
     Bonus
Change
     Pension and
benefits
change
     Salary
Change2
     Bonus
Change
     Pension and
benefits
change
 

Executive Directors

                 

Michael J. Parini1

     2%        86%        n/a        n/a        n/a        n/a  

Theresa Heggie

     n/a        n/a        n/a        -17%        -100%        50%  

Non-Executive Directors

                 

Chris Hollowood3

     n/a        n/a        n/a        n/a        n/a        n/a  

Amit Nathwani

     -7%        n/a        n/a        127%        n/a        n/a  

Colin Love

     23%        n/a        n/a        n/a        n/a        n/a  

Martin Andrews

     -10%        n/a        n/a        164%        n/a        n/a  

Jeffrey Chodakewitz

     -2%        n/a        n/a        130%        n/a        n/a  

Julia P. Gregory

     -2%        n/a        n/a        136%        n/a        n/a  

Average Employee

     7%        80%        10%        30%        -5%        119%  

 

24


Notes to the table:

 

1.

The 2021 baseline for Mr. Parini based on change in salary from his appointment as CEO in 2021 to 2022. Bonus amount reflects change in full bonus paid for 2021 performance, including the portion relating to his service as Chief Operating Officer of the Company before 15 August 2021.

2.

The increases to non-executive director pay during 2021 are a result of the figures for the period ended 31 December 2020 relating to the period from the initial public offering in August 2020 to the end of the financial year only, compared with the full year figures for the year ended 31 December 2021. The employee figures have been based on full year figures for both years.

3.

As the representative of Syncona, Mr. Hollowood does not receive fees from the Company; therefore, no change in compensation is shown.

Relative Importance of the Spend on Pay

The table below illustrates the Company’s expenditure on pay, in comparison to distributions to shareholders by way of dividend payments:

 

     2021
  ($000)  
   2022
  ($000)  
    Change 

Distributions to shareholders

   $0    $0    N/A
  

 

  

 

  

 

Total employee pay expenditure1

     $34,054        $26,273        -23%  
  

 

  

 

  

 

Notes to the table:

 

1.

Total employee pay expenditure consists of cash payments for wages and salaries, which fell year-on-year due to workforce reductions.

Statement of Implementation of the Policy for 2023

Annual Base Salary

On 1 April 2023, Mr. Parini’s salary was increased by 2.5%. This decision was made upon evaluation of a range of factors, including his position relative to the Company’s executive compensation peer group and his performance over the prior year. This increase was below the 4% overall budget for salary increases for the wider eligible employee base.

 

     2022 Base
Salary
     2023 Base
Salary
     %
Change
 

    Michael J. Parini

   $ 603,430      $ 618,500        2.5

Benefits and Pension

No changes and in line with the Policy.

Annual Bonus

The 2023 annual bonus target opportunity for the CEO remains unchanged at 55% of base salary. The maximum potential bonus for 2023 is set at 225% of target, or 123.75% of salary.

 

25


Bonuses will be paid entirely in cash and will be based on both corporate and individual performance with the following weightings:

 

2023 Objectives

   Target             Maximum              
CORPORATE / STRATEGIC TARGETS  

Clinical Execution

     40.0     55.0

Scientific Engine for Growth

     16.0     26.0

Build a Sustainable Organization

     29.0     49.0

Create a Culture of Performance & Growth

     15.0     20.0

Total corporate / strategic targets

     100.0     150.0
INDIVIDUAL PERFORMANCE MULTIPLIER  

Individual assessment over year

     100.0     150.0

Specific targets are commercially sensitive and therefore are not disclosed in advance.

However, a description of the targets and performance against them will be disclosed in next year’s Annual Report and Accounts.

Omnibus Incentive Plan

The Committee granted an option over 1,039,500 shares and RSUs over 258,500 shares to the CEO on 31 January 2023. The option and RSUs vest in three equal annual tranches, subject to continued service, as detailed below:

 

Executive
Director

   Form of
award
     Date of
grant
     Number
of shares
     Per share
exercise
price ($)
     Face value
at date of
grant
($000s)
     Fair value
at date of
grant
($000s)
     Vesting
end date
     Expiry
date
 

Michael Parini

     Options        31/01/2023        1,039,500        0.59        613,305        378,381        31/01/2026        31/01/2033  
       RSUs        31/01/2023        258,500        n/a        152,515        152,515        31/01/2026        n/a  

With all of the historical option grants to the CEO currently underwater (i.e. the per share exercise price is higher than the market value of an ADS) and a critical two-year time horizon to retain and motivate the team, the Committee agreed to shorten the overall vesting period of the 2023 annual awards from four to three years. Notwithstanding the service-based vesting, the 2023 awards are also subject to vesting acceleration upon achievement of two distinct milestones related to progression of the Company’s FLT201 product candidate toward initiation of a Phase 3 clinical trial. 50% of each award vests upon achievement of the first milestone and the remaining 50% vests upon achievement of the second milestone. If the milestones are not achieved, the awards would continue to vest based on their three-year service-based vesting schedule.

 

26


Non-Executive Director Fees

There are no changes proposed to non-executive director cash fees for 2023. Non-executive directors will receive the following annual retainers, which will be paid in cash:

 

Base fee:

Chairperson

   $70,000

Board member

   $40,000

Additional fees:

Audit Committee Chair

   $15,000

Audit Committee member

   $7,500

Remuneration Committee Chair

   $10,000

Remuneration Committee member

   $5,000

Nomination & Corporate Governance Committee Chair

   $8,000

Nomination & Corporate Governance Committee member

   $4,000

The Company provides an initial, one-time equity award (in the form of a share option) to each new non-executive director upon his or her election to the Board. Under normal circumstances, initial share awards vest monthly over three years. The Company also provides an annual equity incentive award (in the form of a share option) to each non-executive director. Options awarded annually will usually vest upon the first anniversary of the grant date. Each non-executive director will also be entitled to reimbursement of reasonable expenses.

 

27


INDEPENDENT AUDITOR’S REPORT TO THE MEMBERS OF FREELINE THERAPEUTICS HOLDINGS PLC

Report on the audit of the financial statements

 

1.

Opinion

 

In our opinion:

 

 

the financial statements of Freeline Therapeutics Holdings PLC (the ‘parent company’) and its subsidiaries (the ‘group’) give a true and fair view of the state of the group’s and of the parent company’s affairs as at 31 December 2022 and of the group’s loss for the year then ended;

 

 

the group financial statements have been properly prepared in accordance with accounting principles generally accepted in the United States of America;

 

 

the parent company financial statements have been properly prepared in accordance with United Kingdom Generally Accepted Accounting Practice, including Financial Reporting Standard 102 “The Financial Reporting Standard applicable in the UK and Republic of Ireland”; and

 

 

the financial statements have been prepared in accordance with the requirements of the Companies Act 2006.

We have audited the financial statements which comprise:

   

the consolidated statement of operations;

   

the consolidated statement of comprehensive loss;

   

the consolidated and parent company balance sheets;

   

the consolidated statement of shareholders’ equity;

   

the parent company statement of changes in equity;

   

the consolidated statement of cash flows;

   

the related notes 1 to 20.

The financial reporting framework that has been applied in the preparation of the group financial statements is applicable law for the United Kingdom and accounting principles generally accepted in the United States of America. The financial reporting framework that has been applied in the preparation of the parent company financial statements is applicable law and United Kingdom Accounting Standards, including FRS 102 “The Financial Reporting Standard applicable in the UK and Republic of Ireland” (United Kingdom Generally Accepted Accounting Practice).

 

2.

Basis for opinion

We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards are further described in the auditor’s responsibilities for the audit of the financial statements section of our report.

We are independent of the group and the parent company in accordance with the ethical requirements that are relevant to our audit of the financial statements in the UK, including the

 

28


Financial Reporting Council’s (the ‘FRC’s’) Ethical Standard as applied to listed entities, and we have fulfilled our other ethical responsibilities in accordance with these requirements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.

 

3.

Material uncertainty related to going concern

We draw attention to Note 1(c) in the consolidated and parent company’s financial statements, which indicates that a material uncertainty exists that may cast significant doubt on the group and parent company’s ability to continue as a going concern.

The group has incurred net losses for the year ended 31 December 2022 of $89.1 million ($140.4 million for the year ended 31 December 2021) and has an accumulated deficit of $445.4 million as at 31 December 2022 ($356.3 million as at 31 December 2021). The group’s operations to date have been funded primarily through proceeds from sale of equity securities. It has cash and cash equivalents on hand as at 31 December 2022 of $47.3 million as well as the post year end completed sale of its German subsidiary, Freeline Therapeutics GmbH for $25.0 million, subject to purchase price adjustments.

The group has incurred recurring losses since inception and expects to continue to incur significant expenses and generate operating losses for the foreseeable future. Additional funding is required to support its continuing operations. If funds are not available, the group will be required to reduce spending and potential delay, limit, reduce or terminate its product research and development efforts in order to meet its obligations as they fall due for the foreseeable future.

As stated in note 1(c), these events or conditions, along with the other matters as set forth in note 1(c), indicate that a material uncertainty exists that may cast significant doubt over the group’s and parent company’s ability to continue as a going concern. Our opinion is not modified in respect of this matter.

In auditing the financial statements, we have concluded that the Directors’ use of the going concern basis of accounting in the preparation of the financial statements is appropriate.

Our evaluation of the directors’ assessment of the group’s and parent company’s ability to continue to adopt the going concern basis of accounting included:

 

   

Obtained an understanding of the relevant controls relating to going concern;

   

Challenging management’s assumptions used in the supporting cashflow forecasts, including the impact of restructuring programmes, sale of subsidiary and reprioritisation of clinical programmes;

   

Assessing management plans to address these;

   

Comparing forecasted results to subsequent actual results to consider accuracy of forecasts;

   

Considering the consistency of management’s forecasts with other areas of the audit, including the right-of-use asset impairment review and fair value model;

   

Assessing the impact of reverse stress testing on the Group’s funding position, including the appropriateness of performance recovery assumptions;

   

Considering contradictory evidence and subsequent events that could impact the going concern basis of accounting; and

 

29


   

Assessing appropriateness of the going concern disclosure including the associated risk on the assumptions.

Our responsibilities and the responsibilities of the directors with respect to going concern are described in the relevant sections of this report.

 

4.

Summary of our audit approach

 

   

Key audit matters

 

The key audit matters that we identified in the current year were:

 

•  Going concern (see material uncertainty related to going concern section);

•  Completeness of accrued research and development expenses;

•  Valuation of non-cash share-based compensation; and

•  Valuation of investments in subsidiaries (Company Only)

 

Within this report, key audit matters are identified as follows:

 

 

LOGO

  

Newly identified

 

LOGO

  

Increased level of risk

 

LOGO

  

Similar level of risk

   

LOGO

 

  

Decreased level of risk

 

Materiality

 

The materiality that we used for the group financial statements was $3.6 million which was determined on the basis of 3% operating expenses.

Scoping

 

Our audit scoping provides full scope coverage of 100% of operating expenses and 100% of total assets.

Significant changes in
our approach

 

There have been no significant changes in our approach.

 

5.

Key audit matters

Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the financial statements of the current period and include the most significant assessed risks of material misstatement (whether or not due to fraud) that we identified. These matters included those which had the greatest effect on: the overall audit strategy, the allocation of resources in the audit; and directing the efforts of the engagement team.

These matters were addressed in the context of our audit of the financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. In addition to the matter described in the material uncertainty related to going concern section, we have determined the matters described below to be the key audit matters to be communicated in our report.

 

30


5.1. Completeness of accrued research and development expenses LOGO

 

   

Key audit matter description

 

Accrued research and development expenses recognised as at 31 December 2022 was $1,923k (as at 31 December 2021: $6,726k). The group’s disclosure in the consolidated financial statements is included in note 2 and critical accounting policies and significant judgements and estimates within Item 5.B. Accrued research and development expenses include services with respect to Contract Research Organisations (CROs) performing clinical studies and trials, Contract Manufacturing Organisations (CMOs) performing drug substance and drug product formulation and other third-party providers supporting preclinical development activities. Given the timing of receipt of invoices, prevalence of pass-through costs, changes in scope of contracts, and milestone related activities (such as patient enrolment), the year-end accrual requires management to estimate the services received to date.

 

Completeness of accrued research and development expenses has been determined to be a key audit matter due to the management estimates involved in recognising the progress of the CRO and CMO contracts based on clinical activities performed as described above. This required increased audit effort to evaluate the appropriateness of management’s estimates.

How the scope of our audit
responded to the key audit matter

 

We have evaluated management’s estimate for accrued research and development expenses through performing the following procedures:

 

•  Obtained an understanding of relevant controls relating to the accrued research and development expenses;

•  Inquiry with third party vendors to evaluate the recognition of expense of CRO and CMO contracts, determination of progress to date and assessing the impact of any scope changes of the contract;

•  Tested a sample of accrued expenses and agreed to subsequently received invoice, communication from third party or other relevant evidence; and

•  Assessed post year-end bank statements and invoices received post year-end for any unrecorded liabilities.

 

Key observations

 

The results of our procedures were satisfactory, and we concluded accrued research and development expenses to be appropriate.

 

31


5.2. Valuation of non-cash share-based compensation LOGO

 

   

Key audit matter description

 

Non-cash share-based compensation expense recognised for the year ended 31 December 2022 was $5,077k (for the year ended 31 December 2021: $10,723k). The group’s disclosure in the consolidated financial statements is included in note 2 and critical accounting policies and significant judgements and estimates within Item 5.B.

 

Share-based awards granted to employees, non-employees and directors have been measured based on the fair value on the date of the grant. Compensation expense is recognised on a straight-line basis over the vesting period, and any associated performance-based condition recognised only if considered probable.

 

Fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model. Assumptions include volatility, expected term, risk free rate, expected dividend and fair value of ordinary shares.

The valuation of non-cash share-based compensation was considered a key audit matter because there is significant management judgement involved within the assumptions used in the valuation models requiring increased audit effort to evaluate its appropriateness.

 

How the scope of our audit
responded to the key audit matter

 

We have evaluated management’s estimate for valuation of non-cash share-based compensation through performing the following procedures:

 

•  Obtained an understanding of relevant controls relating to valuation of non-cash share-based compensation;

•  Assessed the methodology applied;

•  Assessed the reasonableness of valuation assumptions selected with reference to other peer companies;

•  Evaluated the accuracy of the Black-Scholes calculation for the valuation output based on the selected assumptions;

•  Tested a sample of share-based compensation and agreed through to relevant supporting audit evidence including share certificates; and

•  Recalculation of expenses recognised.

 

Key observations

 

The results of our procedures were satisfactory, and we concluded the valuation of non-cash share-based compensation to be appropriate.

 

32


5.3. Valuation of investment in subsidiaries (Parent company only) LOGO

 

   

Key audit matter description

 

The Parent company recognises an investment in subsidiaries at cost less impairment as at 31 December 2022 of $76,069k (as at 31 December 2021: $70,992k). The parent company’s disclosure of the impairment identified is presented in the financial statements included in note 9 and critical accounting policies and key sources of sources of estimation uncertainty within note 2.

 

Under FRS 102, management is required to consider indicators of impairment. If there is an indication of impairment management perform a full impairment review.

 

Management identified an indicator of impairment as a result of the market capitalisation of the group as at 31 December 2022 being lower than cost of investment. As such management calculated the recoverable amount, which is the higher of value in use and fair value less cost to sell. In determining the value in use, management prepared discounted cash flow forecasts including key assumptions for future revenue and margins dependant on the volume, price and launch date, and discount rates. When applying risk adjusted discount rates or probability of success to the cash flows, the fair value less cost to sell was calculated to be higher based on the share price as at 31 December 2022. As a result of management’s review an impairment of $45,246k was recognised.

Due to the significant estimate and assumptions related to the valuation of investments, we considered this to be a key audit matter.

 

How the scope of our audit
responded to the key audit matter

 

We have evaluated management’s estimate for valuation of investments through performing the following procedures:

 

•  Obtained an understanding of the relevant controls relating to valuation of investment in subsidiaries;

•  Evaluated management’s assessment of impairment indicators considering internal and external sources of information;

•  Evaluated the reasonableness of management’s assumptions in the value in use calculations by comparing to relevant peer companies and third-party industry reports;

•  Involved our valuation specialists in examining the company’s valuation model and analysing underlying key assumptions, including discount rates; and

•  Considered any contradictory evidence that could indicate additional impairment to valuation.

 

Key observations

 

The results of our procedures were satisfactory, and we concluded the valuation of investments to be appropriate.

 

33


6.

Our application of materiality

6.1. Materiality

We define materiality as the magnitude of misstatement in the financial statements that makes it probable that the economic decisions of a reasonably knowledgeable person would be changed or influenced. We use materiality both in planning the scope of our audit work and in evaluating the results of our work.

Based on our professional judgement, we determined materiality for the financial statements as a whole as follows:

 

     
  

 

   Group financial statements   

Parent company financial statements

Materiality

   $3,609k (2021: $4,817k)   

$3,487k (2021: $4,576k)

Basis for

determining

materiality

   3% (2021: 3%) of operating expenses   

Parent company materiality is set at 3% (2021: 3%) of net assets, which is capped at 80% of group materiality.

Rationale for

the benchmark

applied

   We consider operating expenses to be an appropriate basis to set materiality, since the Group is in the development stage of life cycle investing in research and development and not generating any operating income to date.   

As the parent is a holding company with purpose to raise funding for the Group, net assets is considered an appropriate basis to set materiality.

 

 

LOGO

 

34


6.2. Performance materiality

We set performance materiality at a level lower than materiality to reduce the probability that, in aggregate, uncorrected and undetected misstatements exceed the materiality for the financial statements as a whole.

 

     
  

 

   Group financial statements    Parent company financial statements

Performance materiality

   60% (2021: 50%) of group materiality    60% (2021: 50%) of parent company materiality

Basis and rationale for determining performance materiality

  

In determining performance materiality, we considered our risk assessment, including our assessment of previous findings in the group’s overall control environment and changes in the executive team.

Performance materiality has increased due to the remediation of a controls weakness identified in the prior year.

6.3. Error reporting threshold

We agreed with the Audit Committee that we would report to the Committee all audit differences in excess of $174,300 (2021: $240,000) as well as differences below that threshold that, in our view, warranted reporting on qualitative grounds. We also report to the Audit Committee on disclosure matters that we identified when assessing the overall presentation of the financial statements.

 

7.

An overview of the scope of our audit

7.1. Identification and scoping of components

Freeline Therapeutics Holdings PLC is the parent holding company of Freeline Holdings (UK) Limited, which in turn is the intermediate holding company of Freeline Therapeutics Limited. As at 31 December 2022, Freeline Therapeutics Limited held 100% shares of Freeline Therapeutics GmbH, Freeline Therapeutics Inc and Freeline Therapeutics (Ireland) Limited. The control environment is consistent across components.

Consistent with the prior year, full scope audits were performed for Freeline Therapeutics Holdings PLC, Freeline Therapeutics Limited, Freeline Therapeutics GmbH and Freeline Therapeutics Inc. This covered 100% (2021: 100%) of operating expenses and total assets. The selected component materiality varied between 25% to 80% (2021: 25% to 80%) of group materiality depending on the component.

All work was performed by the group engagement team; there was no involvement of other component auditors. At Group level we also tested the consolidation process and carried out analytical procedures to confirm our conclusion that there were no significant risks of material misstatement of the aggregated financial information of the remaining components not subject to full scope or specific balances audits.

 

35


7.2. Our consideration of the control environment

Consideration of IT controls

In planning our 2022 audit work, we undertook testing of general IT controls over NetSuite, the relevant financial system used in the group. This was used by all components in the group, to support the processing of all accounting transactions including operating expenses, fixed assets and payroll. We did not take any reliance on the general IT controls or automated controls due to the maturity of the control environment.

Consideration of business process and financial reporting controls

In planning our 2022 audit work, we obtained an understanding of the relevant controls across the significant account balances, class of transactions and disclosures. We did not plan to take a control reliance approach based due to the maturity of the control environment.

 

8.

Other information

The other information comprises the information included in the annual report, other than the financial statements and our auditor’s report thereon. The directors are responsible for the other information contained within the annual report.

Our opinion on the financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon.

Our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the course of the audit, or otherwise appears to be materially misstated.

If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether this gives rise to a material misstatement in the financial statements themselves. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact.

 

We have nothing to report in this regard.

 

9.

Responsibilities of directors

As explained more fully in the directors’ responsibilities statement, the directors are responsible for the preparation of the financial statements and for being satisfied that they give a true and fair view, and for such internal control as the directors determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the financial statements, the directors are responsible for assessing the group’s and the parent company’s ability to continue as a going concern, disclosing as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the group or the parent company or to cease operations, or have no realistic alternative but to do so.

 

36


10.

Auditor’s responsibilities for the audit of the financial statements

Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.

A further description of our responsibilities for the audit of the financial statements is located on the FRC’s website at: www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditor’s report.

 

11.

Extent to which the audit was considered capable of detecting irregularities, including fraud

Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities, including fraud is detailed below.

 

  11.1.

Identifying and assessing potential risks related to irregularities

In identifying and assessing risks of material misstatement in respect of irregularities, including fraud and non-compliance with laws and regulations, we considered the following:

 

   

the nature of the industry and sector, control environment and business performance including the design of the group’s remuneration policies, key drivers for directors’ remuneration, bonus levels and performance targets;

 

   

results of our enquiries of management, general counsel and the audit committee about their own identification and assessment of the risks of irregularities:

 

   

any matters we identified having obtained and reviewed the group’s documentation of their policies and procedures relating to:

 

   

identifying, evaluating and complying with laws and regulations and whether they were aware of any instances of non-compliance;

 

   

detecting and responding to the risks of fraud and whether they have knowledge of any actual, suspected or alleged fraud;

 

   

the internal controls established to mitigate risks of fraud or non-compliance with laws and regulations;

 

   

the matters discussed among the audit engagement and relevant internal specialists, including tax and IT specialists regarding how and where fraud might occur in the financial statements and any potential indicators of fraud.

As a result of these procedures, we considered the opportunities and incentives that may exist within the organisation for fraud. In common with all audits under ISAs (UK), we are also required to perform specific procedures to respond to the risk of management override.

We also obtained an understanding of the legal and regulatory frameworks that the group operates in, focusing on provisions of those laws and regulations that had a direct effect on the determination

 

37


of material amounts and disclosures in the financial statements. The key laws and regulations we considered in this context included the UK Companies Act and tax legislation.

In addition, we considered provisions of other laws and regulations that do not have a direct effect on the financial statements but compliance with which may be fundamental to the group’s ability to operate or to avoid a material penalty. These included the Good Clinical Practice, the FDA regulations and General Data Protection requirements.

 

  11.2.

Audit response to risks identified

As a result of performing the above, we did not identify any key audit matters related to the potential risk of fraud or non-compliance with laws and regulations.

Our procedures to respond to risks identified included the following:

 

   

reviewing the financial statement disclosures and testing to supporting documentation to assess compliance with provisions of relevant laws and regulations described as having a direct effect on the financial statements;

 

   

enquiring of management, the audit committee, in-house and external legal counsel concerning actual and potential litigation and claims;

 

   

performing analytical procedures to identify any unusual or unexpected relationships that may indicate risks of material misstatement due to fraud;

 

   

reading minutes of meetings of those charged with governance,

 

   

in addressing the risk of fraud through management override of controls, testing the appropriateness of journal entries and other adjustments; assessing whether the judgements made in making accounting estimates are indicative of a potential bias; and evaluating the business rationale of any significant transactions that are unusual or outside the normal course of business.

We also communicated relevant identified laws and regulations and potential fraud risks to all engagement team members including internal specialists and remained alert to any indications of fraud or non-compliance with laws and regulations throughout the audit.

Report on other legal and regulatory requirements

 

12.

Opinions on other matters prescribed by the Companies Act 2006

 

In our opinion the part of the directors’ remuneration report to be audited has been properly prepared in accordance with the Companies Act 2006.

In our opinion, based on the work undertaken in the course of the audit:

•  the information given in the strategic report and the directors’ report for the financial year for which the financial statements are prepared is consistent with the financial statements; and

•  the strategic report and the directors’ report have been prepared in accordance with applicable legal requirements.

 

In the light of the knowledge and understanding of the group and the parent company and their environment obtained in the course of the audit, we have not identified any material misstatements in the strategic report or the directors’ report.

 

38


13.

Matters on which we are required to report by exception

 

  13.1.

Adequacy of explanations received and accounting records

Under the Companies Act 2006 we are required to report to you if, in our opinion:

 

   

we have not received all the information and explanations we require for our audit; or

 

   

adequate accounting records have not been kept by the parent company, or returns adequate for our audit have not been received from branches not visited by us; or

 

   

the parent company financial statements are not in agreement with the accounting records and returns.

 

We have nothing to report in respect of these matters.

 

  13.2.

Directors’ remuneration

Under the Companies Act 2006 we are also required to report if in our opinion certain disclosures of directors’ remuneration have not been made or the part of the directors’ remuneration report to be audited is not in agreement with the accounting records and returns.

 

We have nothing to report in respect of these matters.

 

14.

Use of our report

This report is made solely to the company’s members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state to the company’s members those matters we are required to state to them in an auditor’s report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the company and the company’s members as a body, for our audit work, for this report, or for the opinions we have formed.

/s/ Andrew Hornby

Andrew Hornby, FCA (Senior statutory auditor)

For and on behalf of Deloitte LLP

Statutory Auditor

Reading, United Kingdom

31 May 2023

 

39


Balance Sheet as at 31 December 2022

 

         Note          2022
($)
     2021
($)
 

Fixed assets

        

Investments

     9        30,823,078         70,992,090   
     

 

 

    

 

 

 

Current assets

        

Debtors

     10        59,557,252         6,968,411   

Cash and cash equivalents

     11        1,884,194         13,160   

Creditors: amounts falling due within one year

     12        (2,670,732)        (1,869,681)  
     

 

 

    

 

 

 

Net current assets

        58,770,714         5,111,890   
     

 

 

    

 

 

 

Total assets less current liabilities

        89,593,792         76,103,980   
     

 

 

    

 

 

 

Net assets

        89,593,792         76,103,980   
     

 

 

    

 

 

 

Capital and reserves

        

Called-up share capital

     13        140,541         140,160   

Share premium account

     14        457,851,473         429,360,990   

Equity reserve

     15        22,004,138         16,927,180   

Profit and loss account

     16        (415,195,346)        (367,025,109)  

Other reserves

     17        24,792,986         (3,299,241)  
     

 

 

    

 

 

 

Shareholders’ funds

                   89,593,792                    76,103,980   
     

 

 

    

 

 

 

As permitted by section 408 of the Companies Act 2006, the Company has elected not to present its own profit and loss account for the year. The Company reported a loss for the year ended 31 December 2022 of $48,170,237 compared to a loss of $347,320,154 for the year ended 31 December 2021. In addition, the Company has taken advantage of the legal dispensation contained in Section 408 of the Companies Act 2006 allowing it not to publish a separate statement of comprehensive income.

The notes on page 42 onwards are an integral part of these financial statements.

These financial statements of the Company were approved by the board of directors and authorised for issue on 31 May 2023.

/s/ Michael J. Parini

Executive Director & Chief Executive Officer

Michael J. Parini

 

40


Statement of Changes in Equity

 

    Called-up
share
capital
        ($)         
    Share
premium
account
        ($)        
    Equity
reserve
        ($)        
    Profit
and loss
account
        ($)        
    Other
reserves
        ($)        
    Total
        ($)        
 

At 1 January 2021

               170,838             429,330,312            6,204,012       (19,704,955)       (1,197,500)       414,802,707  

Loss for the financial year

                      (347,320,154)             (347,320,154)  

Other comprehensive loss

                            (2,101,741)       (2,101,741)  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss

          (347,320,154)       (2,101,741)         (349,421,895)  

Issue of share capital

    (30,678)       30,678                          

Share-based payment

                10,723,168                   10,723,168  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At 31 December 2021

    140,160       429,360,990       16,927,180            (367,025,109)            (3,299,241)       76,103,980  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the financial year

                      (48,170,237)             (48,170,237)  

Other comprehensive gain

                               28,092,227       28,092,227  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss

                      (48,170,237)       28,092,227       (20,078,010)  

Issue of share capital

    381       28,490,483                         28,490,864  

Shares-based payment

                5,076,958                   5,076,958  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At 31 December 2022

    140,541       457,851,473       22,004,138       (415,195,346)       24,792,986       89,593,792  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

41


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

1.

Accounting policies

The principal accounting policies are summarised below. They have all been applied consistently throughout the year.

 

a.

General information and basis of accounting

The Company is a public company limited by shares incorporated on 3 April 2020 in England and Wales under the Companies Act 2006. The Company’s registered number is 12546479 and its registered office is at Sycamore House, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2BP, United Kingdom. The nature of the Company’s operations is to act as the holding and financing company for its subsidiary entities and other entities which form part of the Group.

The Company’s ADSs, each representing fifteen ordinary shares of £0.00001 each in the capital of the Company, are listed on the Nasdaq Capital Market and trade under the symbol “FRLN”.

The financial statements have been prepared under the historical cost convention, modified to include certain items at fair value, and in accordance with Financial Reporting Standard 102 (FRS 102) issued by the Financial Reporting Council. The particular accounting policies adopted are described below.

The functional currency of the Company is considered to be British Pound Sterling (“GBP”) given the underlying accounting records are recorded in GBP and this is the currency of the Company’s primary operations. Presentation currency is United States Dollars (“USD”) for consistency with the Group’s financial presentation.

The Company meets the definition of a qualifying entity under FRS 102 and has therefore taken advantage of the disclosure exemptions available to it in respect of:

 

   

presentation of statement of cash flows as required by Section 7 “Statement of Cash flows” and Section 3, paragraph 3.17 “Financial Statement Presentation”; and

 

   

disclosure of transactions with other group entities that are wholly owned subsidiaries within the Group as required by Section 33, paragraph 33.7 “Related Party Disclosures”.

The Companies Act 2006 allows a qualifying entity certain disclosure exemptions, subject to certain conditions that have been complied with. Accordingly, the Company has taken advantage of the exemption contained in section 408 of the Companies Act 2006 allowing it not to disclose its individual profit and loss account.

 

b.

Basis of consolidation

The consolidated financial statements comprise the financial statements of the Group as at 31 December 2022. The financial statements of subsidiaries for use in the consolidation are prepared for the same reporting year as the Company and are based on consistent accounting policies. All intra-group balances and transactions, including unrealised profits arising from intragroup transactions, have been eliminated in full. See Appendix 1 for the Form 20-F, including the consolidated financial statements.

 

c.

Going concern

The financial statements have been prepared using the going concern basis of accounting.

 

42


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

1.

Accounting policies (continued)

 

The Group is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including clinical testing and regulatory approval, prior to any commercialisation. These efforts require significant amounts of capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Group’s product development efforts are successful, it is uncertain when, if ever, the Group will realise revenue from any product sales.

The Group has funded its operations primarily with proceeds from the sale of its equity securities. As at 31 December 2022, the Group had unrestricted cash reserves of $47.3 million. On 11 November 2022, the Group signed a definitive agreement to sell its German subsidiary, Freeline Therapeutics GmbH, and certain intellectual property rights pertaining to the business of Freeline Therapeutics GmbH, to Ascend Gene and Cell Therapies Ltd. for $25.0 million, subject to purchase price adjustments. Subsequent to the balance sheet date, the Group closed this transaction. See Note 18. However, the Group has incurred recurring losses since its inception, including net losses of $89.0 million and $140.4 million for the years ended 31 December 2022 and 2021, respectively. In addition, the Group had an accumulated deficit of $445.4 million as at 31 December 2022. The net cash used in operating and investing activities was $85.2 million for the year ended 31 December 2022. The Group expects to continue to incur significant expenses and generate operating losses for the foreseeable future.

As a result, the Group will need additional funding to support its continuing operations. There can be no assurances, however, that additional funding will be available on favourable terms, or at all. If adequate funds are not available, the Group will be required to reduce spending and potentially delay, limit, reduce or terminate its product research and development efforts in order to enable it to meet its obligations as they fall due for the foreseeable future.

These conditions indicate that there is material uncertainty that may cast significant doubt regarding the Group’s ability to continue as a going concern and such that it may be unable to realise its assets or discharge its liabilities in the normal course of business.

On the basis of the directors’ assessment of the Group’s financial position, and the mitigating actions available to the Group for additional fund raises, the directors have assessed that although a material uncertainty exists, the Group has adequate resources to continue as a going concern for the foreseeable future. The directors therefore continue to adopt the going concern basis of accounting in preparing the financial statements.

 

d.

Financial instruments

Financial assets and financial liabilities are recognised when the Company becomes a party to the contractual provisions of the instrument.

Financial liabilities and equity instruments are classified according to the substance of the contractual arrangements entered into. An equity instrument is any contract that evidences a residual interest in the assets of the Company after deducting all of its liabilities.

 

(i)

Financial assets and liabilities

All financial assets and liabilities are initially measured at transaction price (including transaction costs), except for those financial assets classified as at fair value through profit or loss, which are initially measured at fair

 

43


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

1.

Accounting policies (continued)

 

value (which is normally the transaction price excluding transaction costs), unless the arrangement constitutes a financing transaction. If an arrangement constitutes a financing transaction, the financial asset or financial liability is measured at the present value of the future payments discounted at a market rate of interest for a similar debt instrument.

Financial assets and liabilities are only offset in the balance sheet when, and only when, there exists a legally enforceable right to set off the recognised amounts and the Company intends either to settle on a net basis, or to realise the asset and settle the liability simultaneously.

Financial liabilities are derecognised only when the obligation specified in the contract is discharged, cancelled or expires.

 

(ii)

Investments

Investments in subsidiaries and associates are measured at cost less impairment.

 

e.

Impairment of assets

Assets, other than those measured at fair value, are assessed for indicators of impairment at each balance sheet date. If there is objective evidence of impairment, an impairment loss is recognised in profit or loss as described below.

Non-financial assets

An asset is impaired where there is objective evidence that, as a result of one or more events that occurred after initial recognition, the estimated recoverable value of the asset has been reduced. The recoverable amount of an asset is the higher of its fair value less costs to sell and its value in use.

Where indicators exist for a decrease in impairment loss, the prior impairment loss is tested to determine reversal. An impairment loss is reversed on an individual impaired asset to the extent that the revised recoverable value does not lead to a revised carrying amount higher than the carrying value had no impairment been recognised.

Financial assets

For financial assets carried at amortised cost, the amount of impairment is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the financial asset’s original effective interest rate.

For financial assets carried at cost less impairment, the impairment loss is the difference between the asset’s carrying amount and the best estimate of the amount that would be received for the asset if it were to be sold at the reporting date.

Where indicators exist for a decrease in impairment loss, and the decrease can be related objectively to an event occurring after the impairment was recognised, the prior impairment loss is tested to determine reversal. An impairment loss is reversed on an individual impaired financial asset to the extent that the revised recoverable value does not lead to a revised carrying amount higher than the carrying value had no impairment been recognised.

 

44


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

1.

Accounting policies (continued)

 

f.

Taxation

Current tax, including UK corporation tax and foreign tax, is provided at amounts expected to be paid (or recovered) using the tax rates and laws that have been enacted or substantively enacted by the balance sheet date.

A provision is recognised for those matters for which the tax determination is uncertain, but it is considered probable that there will be a future outflow of funds to a tax authority. The provisions are measured at the best estimate of the amount expected to become payable. The assessment is based on the judgement of finance professionals within the Company supported by previous experience in respect of such activities and in certain cases based on specialist independent tax advice.

Deferred tax is recognised in respect of all timing differences that have originated but not reversed at the balance sheet date where transactions or events that result in an obligation to pay more tax in the future or a right to pay less tax in the future have occurred at the balance sheet date. Timing differences are differences between the Company’s taxable profits and its results as stated in the financial statements that arise from the inclusion of gains and losses in tax assessments in periods different from those in which they are recognised in the financial statements.

Unrelieved tax losses and other deferred tax assets are recognised only to the extent that, on the basis of all available evidence, it can be regarded as more likely than not that there will be suitable taxable profits from which the future reversal of the underlying timing differences can be deducted.

Deferred tax liabilities are recognised for timing differences arising from investments in subsidiaries and associates, except where the Company is able to control the reversal of the timing difference and it is probable that it will not reverse in the foreseeable future.

Deferred tax is measured using the tax rates and laws that have been enacted or substantively enacted by the balance sheet date that are expected to apply to the reversal of the timing difference.

Deferred tax assets and liabilities are offset only if (i) the Company has a legally enforceable right to set off current tax assets against current tax liabilities, and (ii) the deferred tax assets and deferred tax liabilities relate to income taxes levied by the same taxation authority on either the same taxable entity or different taxable entities which intend either to settle current tax liabilities and assets on a net basis, or to realise the assets and settle the liabilities simultaneously, in each future period in which significant amounts of deferred tax liabilities or assets are expected to be settled or recovered.

 

g.

Employee benefits

The Company does not have any employees. The Company provides benefits to its directors, including salaries or fees and share-based payment awards, on which see Note 6a below and the Directors’ Remuneration Report above.

 

h.

Foreign currency

Transactions in foreign currencies are recorded at the rate of exchange at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies at the balance sheet date are reported at the rates of exchange prevailing at that date.

 

45


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

1.

Accounting policies (continued)

 

Exchange differences are recognised in profit or loss in the period in which they arise.

 

i.

Provisions

Provisions are recognised when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that the Company will be required to settle that obligation and a reliable estimate can be made of the amount of the obligation.

The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at the balance sheet date, taking into account the risks and uncertainties surrounding the obligation. Where a provision is measured using the cash flows estimated to settle the present obligation, its carrying amount is the present value of those cash flows (when the effect of the time value of money is material).

When some or all of the economic benefits required to settle a provision are expected to be recovered from a third party, a receivable is recognised as an asset if it is virtually certain that reimbursement will be received and the amount of the receivable can be measured reliably.

 

j.

Share-based payment

The Company issues equity-settled share-based payments to its directors. Equity-settled share-based payments are measured at fair value (excluding the effect of non-market-based vesting conditions) at the date of grant. The fair value determined at the grant date of the equity-settled share-based payments is recognised as an expense in profit or loss on a straight-line basis over the vesting period. The credit is recognised as a separate reserve within equity.

The fair value of each share option award, restricted share unit award and restricted share award is estimated on the date of grant using the Black-Scholes valuation model.

 

2.

Critical accounting judgements and key sources of estimation uncertainty

In the application of the Company’s accounting policies, which are described in Note 1, the directors are required to make judgements (other than those involving estimations) that have a significant impact on the amounts recognised and to make estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods.

Critical judgements in applying the Company’s accounting policies

The directors have not made any critical judgements, apart from those involving estimates (which are dealt with separately below), in the process of applying the Company’s accounting policies that have the most significant effect on the amounts recognised in the financial statements.

 

46


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

2.

Critical accounting judgements and key sources of estimation uncertainty (continued)

 

Key source of estimation uncertainty

The key source of estimation uncertainty at the balance sheet date that has a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year is the identification of indicators of the impairment of assets discussed below.

Indicators of impairment of assets

The directors are required to identify if there have been any indicators of impairment of assets. In making this judgement, the directors have considered both external and internal sources of information such as market conditions, internal technological conditions, counterparty credit ratings and experience of recoverability, and underlying profitability of the subsidiary undertakings.

There have been indicators of impairment identified in the current financial year in relation to the investment in the Company’s subsidiary Freeline Holdings (UK) Limited, due to the status of the Group’s ongoing program, macro-economic conditions impacting the biotechnology industry and the decrease in the Company’s market capitalisation. An impairment of $45,245,970 was recorded in the year as further described in Note 9.

There were indicators of impairment identified in the previous financial year in relation to the investment in the Company’s subsidiary Freeline Holdings (UK) Limited. An impairment of $ 344,316,346 was recorded in the year ended 31 December 2021.

 

3.

Loss before tax

Loss before tax is stated after charging:

 

     2022
    in US dollars ($)    
    2021
    in US dollars ($)    
 

Legal and professional fees

     5,726,733       4,449,685  

Audit fees

     598,756       708,458  

Foreign exchange (gain)/loss

     (3,286,466     (2,154,680

Impairment of investment

     45,245,970       344,316,346  

 

4.

Auditor’s remuneration

Fees payable to Deloitte LLP and their associates for the audit of the Company’s annual accounts were $49,484 in the year ended 31 December 2022 and $27,513 in the year ended 31 December 2021.

During the period the Group obtained the following services from the auditor and its associates:

 

     2022
    in US dollars ($)    
  2021
    in US dollars ($)    

Audit of Parent Company accounts

     49,484        27,513    

Audit of US GAAP financial statements

     543,087       639,676  

Audit-related assurance services

     6,185       41,269  
  

 

 

 

 

 

 

 

     598,756       708,458  
  

 

 

 

 

 

 

 

 

47


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

5.

Staff numbers and costs

The Company did not have any employees in 2022 and 2021. The Company pays salaries or fees to its directors, on which see Note 6a below and the Directors’ Remuneration Report above.

 

6.

Directors’ remuneration and transactions

 

a.

Directors’ remuneration

 

Executive directors    2022
    in US dollars ($)    
     2021
    in US dollars ($)    
 

Emoluments

     1,076,056        1,066,707  

Amounts receivable under long-term incentive schemes

     1,083,567        4,985,541  

Company contributions to money purchase pension schemes

            21,071  

Non-executive directors

     

Sums paid to third parties in respect of directors’ services

     388,322        400,924  

Amounts receivable under long-term incentive schemes

     743,308        775,218  
  

 

 

    

 

 

 
     3,291,254        7,249,461  
  

 

 

    

 

 

 
     2022      2021  

The number of directors who:

     

Are members of a defined benefit pension scheme

     —              —        

Are members of a money purchase pension scheme

     —              1        

Exercised options over shares in the parent company

     —              —        

Had awards receivable in the form of shares in the Company under a long-term incentive scheme

     7              8        

 

b.

Remuneration of the highest paid director

The Company’s highest paid director is the chief executive officer, who was remunerated through a subsidiary of the Company, Freeline Therapeutics, Inc. and whose remuneration is disclosed above in the Directors’ Remuneration Report.

The highest paid director did not exercise any share options in the year ended 31 December 2022 and had no shares receivable under long-term incentive schemes.

 

7.

Tax on loss

 

     2022
    in US dollars ($)    
     2021
    in US dollars ($)    
 

Total current tax

                     —                         —   

Total deferred tax

     —         —   
  

 

 

    

 

 

 

Total tax on loss

     —         —   
  

 

 

    

 

 

 

The standard rate of tax applied to reported loss on ordinary activities is 19% (2021: 19%). The applicable tax rate has changed following the substantive enactment of the Finance Act 2019.

 

48


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

7.

Tax on loss (continued)

 

The difference between the total tax charge shown above and the amount calculated by applying the standard rate of UK corporation tax to the profit before tax is as follows:

 

     2022
    in US dollars ($)    
     2021
    in US dollars ($)    
 

Loss before tax

     (48,170,237)        (347,320,154)  
  

 

 

    

 

 

 

Tax on loss at standard UK corporation tax rate of 19%

     (9,152,345)        (65,990,829)  

Effects of:

     

- Expenses not deductible for tax purposes

     8,067,334        65,796,399  

- Remeasurement of deferred tax for changes in tax rates

     (342,635)        (85,371)  

- Movement in deferred tax not recognised

     1,427,646        279,801  

- Income not taxable

             
  

 

 

    

 

 

 

Total tax charge for the year

             
  

 

 

    

 

 

 

In the Spring Budget 2021, the Government announced that from 1 April 2023, the corporation tax rate will increase to 25%. Since the proposal to increase the tax rate to 25% had not been substantively enacted at the balance sheet date, its effects are not included in the financial statements.

 

8.

Share-based payments

On 31 July 2020, the Company adopted an equity incentive plan (the “2020 Plan”). The 2020 Plan provides for the grant of options, share appreciation rights (“SARs”), restricted shares, dividend equivalents, restricted share units (“RSUs”) and other share-based awards. The maximum number of equity awards originally authorised under the 2020 Plan was 5,898,625 shares, which consisted of 3,474,469 new ordinary shares and 2,424,156 ordinary shares that were subject to awards under prior equity incentive plans that may become available for issuance under the 2020 Plan. Additionally, the number of ordinary shares reserved for issuance under the 2020 Plan automatically increases on 1 January of each year, for a period of not more than ten years, by an amount equal to the lesser of (i) 4% of the total number of ordinary shares outstanding on 31 December of the prior calendar year or (ii) such fewer number of ordinary shares as the board of directors may designate prior to the applicable 1 January date. On 1 January 2022 and 2021, the number of shares reserved automatically increased by 1,434,184 and 1,434,198 shares, respectively. Any equity awards granted under the 2020 Plan that expire, lapse or are terminated, exchanged for cash, surrendered, repurchased or cancelled, without having been fully exercised, or forfeited, will be added back to shares issuable under the 2020 Plan.

On 31 July 2020, the Company adopted an employee share purchase plan (the “ESPP”). The purpose of the ESPP is to provide employees the opportunity to purchase ordinary shares or ADSs at 85% of the fair market value of the ADSs on the offering date or the exercise date, whichever is lower, for up to 15% of such employee’s compensation for each pay period. The Company reserved 347,447 ordinary shares for the ESPP. The ESPP provides for an annual increase in the number of ordinary shares to be reserved for future issuance under the ESPP.

On 27 September 2021, the Company adopted an equity inducement plan (the “Inducement Plan”). The purpose of the Inducement Plan is to enhance the Company’s ability to attract employees who are expected to make important contributions to the Company by providing these individuals with equity ownership opportunities.

 

49


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

8.

Share-based payments (continued)

 

Awards under the Inducement Plan are granted as an inducement material to employees entering into employment with the Company. The Inducement Plan provides for the grant of options, SARs, restricted shares, dividend equivalents, RSUs and other share-based awards. On 30 May 2022, the Board amended the Inducement Plan to increase the maximum number of equity awards authorised to 3,000,000 shares. Any equity awards granted under the Inducement Plan that expire, lapse, or are terminated, exchanged for cash, surrendered, repurchased or cancelled, without having been fully exercised or forfeited, will be added back to shares issuable under the Inducement Plan.

Unvested Employee Shares are forfeited upon termination of employment. The forfeited shares are converted into deferred shares, with a repurchase right for a nominal amount in favour of the Company. As of 31 December 2022, the Company had not repurchased any shares.

 

a.

Employee Shares

The Company measures all non-cash share-based awards using the fair value on the date of grant and recognises compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. Prior to the Company’s IPO, the Company granted share-based compensation in the form of ordinary shares, collectively referred to as “Employee Shares”, to employees and non-employees with both performance and service-based vesting conditions. The Company records expense for these awards using the straight-line method.

The grant date fair value of Employee Shares was calculated on the grant date fair value of the underlying ordinary shares.

During the year ended 31 December 2022, the Company did not issue any ordinary shares to employees of the Group.

As of 31 December 2022, the Group recognised total expense of $213,702 (2021: $572,330) in relation to share based payment transactions settled in ordinary shares and the Company recognised them as an increase in investments.

As of 31 December 2022, the Group recognised a total expense of $74,985 (2021: $89,591) in relation to share-based payment transactions settled in ordinary shares under the ESPP and the Company recognised them as an increase in investments.

 

50


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

8.

Share-based payments (continued)

 

b.

Share options

The fair value of the share options at the grant date were calculated using the Black-Scholes model, which is considered to be the most appropriate generally accepted valuation method of measuring fair value.

 

     For the year ended
  31 December 2022  
       For the period ended  
31 December 2021
 

Expected option life (years)

     6.3        6.3  

Expected volatility

     74.7%        76.9%  

Risk-free interest rate

     2.2%        1.1%  

Expected dividend yield

             

 

    Number of
      Shares      
    Weighted
Average
Exercise
Price
        ($)        
    Weighted
Average
Remaining
Contractual
Term
    (in years)    
    Aggregate
Intrinsic Value
(in thousands)
($)
 

Outstanding as of 1 January 2021

    3,687,086       13.03       9.59                9,931      

Granted

    4,352,281       6.87      

Exercised

               

Expired

    (145,638)       13.02      

Cancelled or Forfeited

        (2,472,014)                    13.20      
 

 

 

   

 

 

     

Outstanding as of 31 December 2021

    5,421,715       9.23                      8.37    
 

 

 

   

 

 

   

 

 

   

 

 

 

Granted

    5,284,810       1.05         570      

Exercised

               

Expired

    (298,143)       13.57      

Cancelled or Forfeited

    (2,489,882)       5.74      
 

 

 

   

 

 

     

Outstanding as of 31 December 2022

    7,918,500       4.76       8.40       —      
 

 

 

   

 

 

   

 

 

   

 

 

 

Exercisable as of 31 December 2022

    2,044,228       10.98      

Vested and expected to vest as of 31 December 2022

    7,918,500       4.76       8.40       —      

As of 31 December 2022 the Group recognised total expense of $4,747,543 (2021: $9,404,181) in relation to share-based payment transactions settled in share options, and the Company recognised this in investments.

 

51


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

8.

Share-based payments (continued)

 

c.

Restricted share units

The Company has granted (i) RSUs that generally vest over a period of four years from the date of grant and (ii) RSUs to certain new employees in order to compensate them for equity awards forfeited to their previous employers. The latter RSUs generally vest over a period of under one year from the date of grant. The Company granted share options and RSUs as its annual equity incentive awards to employees during the year ended 31 December 2022. In 2021, the annual equity incentive awards consisted only of share options. The following table summarises the activity related to RSUs during the years ended 31 December 2022 and 2021:

 

     Number of
RSUs
     Weighted
Average
Grant Date
Fair Value
($)
 

Outstanding as of 1 January 2021

                           2,500                            17.56  

Granted

     120,375        9.64  

Vested and settled

             

Forfeited

     (34,125)        8.63  

Outstanding as of 31 December 2021

     88,750        10.01  

Granted

     669,270        1.03  

Vested and settled

     (44,688)        5.63  

Forfeited

     (267,742)        3.03  

Outstanding as of 31 December 2022

     445,590        0.98  

As of 31 December 2022, the Group recognised total expense of $40,728 (2021: $657,066) in relation to share-based payment transactions settled in RSUs, and the Company recognised this in investments.

 

9.

Investments

 

     2022
    in US dollars ($)    
 

As at 1 January 2022

     70,992,090  

Share-based payments

     5,076,958  

Impairment

     (45,245,970)  
  

 

 

 
             30,823,078  
  

 

 

 

The Company performed an assessment of the recoverable amount of the investment in its subsidiary Freeline Holdings (UK) Limited at 31 December 2022 triggered by the status of the Group’s programs, macro-economic conditions impacting the biotechnology industry and the decrease in the Company’s market capitalisation. The recoverable amount was assessed in accordance with FRS 102 Section 27 Impairment of Assets by determining the higher of value in use of the investment and fair value of the investment less costs to sell.

In considering the value in use, future cash flows were determined by using forecasts and strategic plans based on specific assumptions with respect to future revenues, results of operations, working capital, capital investments and other general assumptions for the projected period. The forecast assumptions were based on the historical results combined with expected probability of success of its clinical program, FLT201, expected launch date of product of its FLT201 program combined with external market data.

 

52


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

9.

Investments (continued)

 

The recoverable amount was ultimately determined by considering fair value less cost to sell based on the Company’s market capitalisation at 31 December 2022, although other internal and external available information assessing the value of net assets and liabilities including off-balance sheet commitments were considered as well. This assessment resulted in an impairment charge of $45,245,970.

Determining the estimated recoverable amount is judgemental and requires the use of certain estimated inputs that represent key sources of estimation uncertainty. It is reasonably possible that the estimates and assumptions used in determining the impairment as at 31 December 2022 may result within the next financial year in a material further impairment or reversal of impairment to the carrying amount of the investment value.

The Company has investments in the following subsidiary undertakings, associates and other significant investments.

 

      

Registered office address

   %
Holding
 

Subsidiary undertakings

       
Direct Holdings        
Freeline Holdings (UK) Limited      Sycamore House, Gunnels Wood Road, Stevenage,
SG1 2BP, UK
     100  
Indirect Holdings        
Freeline Therapeutics Limited      Sycamore House, Gunnels Wood Road, Stevenage,
SG1 2BP, UK
     100  
Freeline Therapeutics GmbH      Semmelweissstraße 3, 82152, Planegg, Germany      100  
Freeline Therapeutics Inc.      915 Broadway, Suite 1005, New York, 10010, USA      100  
Freeline Therapeutics (Ireland) Limited      6th Floor, 2 Grand Canal Square, Dublin 2      100  

 

     In US dollars ($)  

Cost

  

As at 1 January 2022

     70,992,090  

Additions

     5,076,958  

Impairment

     (45,245,970)  
  

 

 

 

Carrying value

         30,823,078  
  

 

 

 

 

10.

Debtors

 

    2022
    in US dollars ($)    
    2021
    in US dollars ($)    
 

Amounts falling due within one year

   

Amounts owed by group undertakings

    58,391,248       5,581,284  

Other debtors

    1,166,004       1,387,127  
 

 

 

   

 

 

 
    59,557,252       6,968,411  
 

 

 

   

 

 

 

 

53


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

10.

Debtors (continued)

 

Amounts owed by group undertakings are unsecured, non-interest bearing, have no fixed date of repayment and are repayable on demand.

 

11.

Cash and cash equivalents

 

    2022
    in US dollars ($)    
    2021
    in US dollars ($)    
 

Cash and cash equivalents

    1,884,194       13,160  
 

 

 

   

 

 

 
    1,884,194       13,160  
 

 

 

   

 

 

 

 

12.

Creditors: amounts falling due within one year

 

    2022
    in US dollars ($)    
    2021
    in US dollars ($)    
 

Amounts owed to group undertakings

    296,468       962,972  

Accruals

    1,215,367       906,709  

Other Creditors

    1,158,898        
 

 

 

   

 

 

 
    2,670,732       1,869,681  
 

 

 

   

 

 

 

Amounts owed to subsidiary undertakings are unsecured, non-interest bearing, have no fixed date of repayment and are repayable on demand.

 

13.

Called-up share capital and reserves

 

    2022
    in US dollars ($)    
    2021
    in US dollars ($)    
 

Allotted, called-up and fully-paid

   

35,872,749 ordinary shares of £0.00001 each

          490  

64,915,502 ordinary shares of £0.00001 each

    871        

1 deferred share of £100,000 each

    139,670       139,670  
 

 

 

   

 

 

 
    140,541       140,160  
 

 

 

   

 

 

 

The Company has one class of ordinary shares of nominal value £0.00001 each which carry no right to fixed income.

Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the board of directors and approved by the shareholders. As of 31 December 2022, the Company has not declared any dividends.

On 6 January 2022, the Company completed an “at the market” equity offering, pursuant to which it issued 655,594 ADSs, each representing one ordinary share of nominal value £0.00001 in the capital of the Company (“ADSs”), at an average price of $2.0385 per ADS, raising approximately $1.3 million in net proceeds.

On 10 March 2022, the Company entered into a purchase agreement with its majority shareholder, Syncona Portfolio Limited, a subsidiary of Syncona Limited, and certain other existing shareholders, providing for the

 

54


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

13.

Called-up share capital and reserves (continued)

 

issuance and sale by the Company of approximately 24.9 million ADSs at a price of $1.05 per ADS, resulting in net proceeds of approximately $24.2 million. The offering closed on 15 March 2022.

On 18 March 2022, the Company entered into a purchase agreement with Lincoln Park under which the Company may, at its discretion, sell to Lincoln Park up to $35.0 million of its ADSs over a 36-month period, subject to certain daily limits, applicable prices, and conditions. In addition, under the purchase agreement, the Company issued 954,208 ADSs to Lincoln Park as consideration for its commitment to purchase ADSs under the purchase agreement.

On 8 April 2022, the Company completed an “at the market” equity offering, pursuant to which it issued 2,382,022 ADSs at an average price of $1.0512 per ADS, raising approximately $2.4 million in net proceeds.

Deferred shares

Deferred shares are a unit of equity which confer to the holder no rights to participate in the profits of the Company or any voting rights. Other than the return of capital following payment of any preferred and ordinary shares, the holders of deferred shares have no further right of participate in the assets of the Company. The Company, without the consent of the shareholder, can transfer or cancel deferred shares.

 

14.

Share Premium

 

     2022
   in US dollars ($)   
 

As at 1 January 2022

    429,360,990  

Shares issued

    28,490,483  
 

 

 

 

At 31 December 2022

    457,851,473  
 

 

 

 

Share premium reserve represents any premium received on issue of share capital. Any transaction costs associated with the issuing of shares are deducted from the share premium.

 

15.

Equity reserve

 

    2022
   in US dollars ($)   
 

As at 1 January 2022

    16,927,180  

Issue of share-based payments

    5,076,958  
 

 

 

 

At 31 December 2022

    22,004,138  
 

 

 

 

The equity reserve is made up of the share-based payments granted by the Group. Refer to Note 8 for more details on the issues of share-based payments.

 

55


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

16.

Profit and loss account

 

    2022
   in US dollars ($)   
 

As at 1 January 2022

    (367,025,109)  

Loss for the year

    (48,170,237)  
 

 

 

 

At 31 December 2022

    (415,195,346)  
 

 

 

 

 

17.

Other reserves

 

    2022
   in US dollars ($)   
 

As at 1 January 2022

    (3,299,241)  

Other comprehensive gain

    28,092,227  
 

 

 

 

At 31 December 2022

    24,792,986  
 

 

 

 

Other comprehensive gain relates to the difference between the closing and average exchange rates for the year ended 31 December 2022.

 

18.

Subsequent events

On 8 February 2023, the Company closed the sale of its German subsidiary, Freeline Therapeutics GmbH, and certain intellectual property rights pertaining to the business of Freeline Therapeutics GmbH, to Ascend Gene and Cell Therapies Limited (“Ascend”), for $25 million, subject to purchase price adjustments. At closing the Company and Ascend entered into an intellectual property deed of assignment and license and a transition services agreement (the “Transition Services Agreement”), pursuant to which Ascend will provide certain services in the area of development and manufacturing to the Company. The Company agreed to utilise, and Ascend agreed to make exclusively available to the Company, no fewer than 15 full-time employee equivalents, or FTEs (as defined in the Transition Services Agreement), per annum for a guarantee period of 18 months following the Transition Services Agreement’s effective date. The Company also agreed to pay Ascend a guaranteed minimum of approximately $7.9 million in respect of FTE costs during such period, $2.6 million of which were paid upfront.

On 21 March 2023, we entered into an exclusive patent and know-how license agreement with Forcefield Therapeutics Limited (“Forcefield”) a company controlled by Syncona Limited (“Syncona”). Under the terms of the agreement, Forcefield granted us an exclusive license under certain patent rights to develop and commercialise AAV gene therapies for certain cardiac conditions and a non-exclusive license to certain know-how. We were required to make an upfront payment to Forcefield of £0.5 million or $0.6 million and may be required to make up to £18.3 million or $22.0 million in development and regulatory milestone payments, and pay Forcefield a mid-single-digit percentage royalty on net sales of certain royalty products on a product-by-product and country-by-country basis, until the later of (a) the expiration of the last valid licensed patent claim covering such product in such country or (b) ten years from the first commercial sale of such product sold in that country or 20 years from the date upon which the agreement was signed. We also agreed to make payments to Forcefield in accordance with a workplan to be agreed in connection with a sponsored research agreement entered into between Forcefield and a non-profit organisation.

On 24 March 2023, we entered into an exclusive patent and know-how license agreement with Syncona IP Holdco (2) Limited, (“Syncona Holdco”), a company controlled by Syncona. Under the terms of the agreement,

 

56


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

18.

Subsequent events (continued)

 

we granted Syncona Holdco an exclusive license under certain patent rights related to an immune-modifying protein to develop and commercialise the technology other than in respect of liver-directed gene therapies and a non-exclusive license to certain know-how. Syncona Holdco was required to make an upfront payment to us of £0.5 million or $0.6 million and may be required to make up to £12.5 million or $15.1 million in development and regulatory milestone payments, and pay us a low-single-digit percentage royalty on net sales of certain licensed products and know-how products on a product-by-product and country-by-country basis, commencing on the date of the first commercial sale of such product in such country until (in respect of licensed products) the expiration of the last valid licensed patent claim covering such product in such country or (in respect of know-how products) 20 years from the date upon which the agreement was signed.

In the first quarter of 2023, the Group completed a financial and organisational assessment to increase efficiencies and reduce operating expenses. As a result of this assessment, the Company reduced its U.S. and U.K. workforce by nearly 30%. The Group incurred total expenses relating to the workforce reduction of $1.1 million of charges, consisting of severance and termination-related costs, which will be recognized as operating expenses.

On 12 May 2023, the Company changed the ratio of its ADSs to its ordinary shares (the “ADS Ratio”) from the previous ADS Ratio of one ADS to one ordinary share to a new ADS Ratio of one ADS to fifteen ordinary shares. The change in the ADS Ratio had the same effect as a one-for-fifteen reverse ADS split and was intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement.

On 18 May 2023, the Group entered into a Mutual Release and Settlement Agreement (the “Settlement Agreement”) with Brammer Bio MA, LLC (“Brammer”) to resolve the arbitration arising from the Dedicated Manufacturing and Commercial Supply Agreement, dated 30 June 2020, by and between Freeline Therapeutics Limited and Brammer (the “DMCSA”). Pursuant to the terms of the Settlement Agreement, the Group will pay to Brammer a total of $2.25 million. Subject to specified conditions and exceptions, the parties will dismiss the arbitration, and each party will release the other party from any and all claims arising from the parties’ business relationship.

 

19.

Related party transactions

Transactions with key management personnel

The directors are considered to be the key management personnel for the Company. Refer to Note 6 for details of their compensation. There were no other transactions with key management personnel during the year.

Transactions with group undertakings

The company has taken advantage of the exemption available within FRS 102 Section 33 “Related Party Disclosures” not to disclose transactions with other group entities that are wholly-owned subsidiaries within the Group.

On March 10, 2022, the Company entered into a purchase agreement with its majority shareholder, Syncona Portfolio Limited, a subsidiary of Syncona Limited, and certain other existing shareholders providing for the issuance and sale by the Company of $26.1 million of the Company’s ADSs at a price of $1.05 per ADS, in a

 

57


Freeline Therapeutics Holdings plc

Notes to the financial statements

For the year ended 31 December 2022

 

19.

Related party transactions (continued)

 

registered direct offering. The offering closed on March 15, 2022. The Company received net proceeds of approximately $24.2 million from the offering, after deducting offering expenses payable by the Company.

 

20.

Controlling party

Syncona Portfolio Limited, a company incorporated and registered in Guernsey was the Company’s immediate parent undertaking as at 31 December 2022.

Syncona Limited, a company incorporated in Guernsey and registered as a closed-ended investment company, is the Company’s ultimate controlling party. Its registered address is 8 Bloomsbury St, London, WC1B 3SR, United Kingdom.

The Syncona Limited group’s financial statements are available from the London Stock Exchange and on the website, www.synconaltd.com.

The Company-only results for the year ended 31 December 2022 have been consolidated in the Group financial statements. The Company is the smallest and largest parent undertaking to prepare group financial statements.

 

58


Freeline Therapeutics Holdings plc

Appendix 1: Form 20-F as filed 4 April 2023

The exhibits referred to in this Appendix 1 may be found in the Company’s Annual Report on Form 20-F for the year ended 31 December 2022, which may be found by visiting EDGAR on the US Securities and Exchange Commission website at www.sec.gov.

 

59

EX-99.4

Exhibit 99.4

 

Time Sensitive

    Materials

Depositary’s Notice of

Annual General Meeting of

Freeline Therapeutics Holdings plc

 

ADSs:    American Depositary Shares (“ADSs”).
ADS CUSIP No.:    35655L206 (freely transferable ADSs).
   35655L875 (restricted ADSs).
ADS Record Date:    May 22, 2023.
Meeting Specifics:    Annual General Meeting to be held on Wednesday, June 28, 2023 at 2:00 P.M. (UK time) at the offices of Skadden, Arps, Slate, Meagher & Flom (UK) LLP, 22 Bishopsgate, London, EC2N 4BQ, United Kingdom (the “Meeting”).
Meeting Agenda:    The Notice of Meeting and Annual Report and Accounts for the period ended December 31, 2022 are available to view and download from the Company’s website at: https://www.freeline.life/investors/agm.
ADS Voting Instructions Deadline:    On or before 10:00 A.M. (New York City time) on June 22, 2023.
Deposited Securities:    Ordinary Shares of £0.00001 each (the “Shares”) of Freeline Therapeutics Holdings plc, a public limited company incorporated under the laws of England and Wales (the “Company”).
ADS Ratio:    Fifteen (15) Shares to one (1) ADS.
Depositary:    Citibank, N.A.
Custodian of Deposited Securities:    Citibank, N.A. (London).
Deposit Agreement:    Deposit Agreement, dated as of August 11, 2020, by and among the Company, the Depositary, and all Holders and Beneficial Owners of ADSs (as amended from time to time, the “Deposit Agreement”). All capitalized terms used but not otherwise defined herein shall have the meanings given to such terms in the Deposit Agreement.

To be counted, your Voting Instructions need to be received by the Depositary prior to 10:00 A.M. (New York City time) on June 22, 2023.

Note that if you do not timely return the Voting Instructions to the Depositary, the Shares represented by your ADSs may nevertheless be voted upon the terms set forth in the Deposit Agreement.


The Company has announced that the Meeting will be held at the date identified above. The information with respect to the Meeting and the ADS Voting Instructions contained herein and in any related materials may change after the date hereof as a result of a change in circumstances (e.g. an adjournment or cancellation of the Meeting, a change in location and/or manner of holding the Meeting). The Company intends to announce any material changes and updates via its website at https://www.freeline.life/investors. We encourage you to check the referenced Company website for any updates to the information with respect to the Meeting and the ADS Voting Instructions. Please note that the Company’s Notice of Meeting and Annual Report and Accounts for the period ended December 31, 2022 are available to view and download from the Company’s website: https://www.freeline.life/investors/agm.

As set forth in Section 4.10 of the Deposit Agreement, Holders of record of ADSs, as of the close of business on the ADS Record Date, will be entitled, subject to applicable law, the rights attaching to the Deposit Agreement, the Articles of Association of the Company, and the rights attaching to the Shares, to vote, or cause the Custodian to vote, the Shares (in person or by proxy) represented by such Holder’s ADSs.

Holders of ADSs wishing to give Voting Instructions to the Depositary must sign, complete, and return the enclosed Voting Instructions prior to the ADS Voting Instructions Deadline in the enclosed pre-addressed envelope.

Voting Instructions may be given only in respect of a number of ADSs representing an integral number of Shares. Upon the timely receipt from a Holder of ADSs as of the ADS Record Date of Voting Instructions in the manner specified by the Depositary, the Depositary shall endeavor, insofar as practicable and permitted under any applicable law, the rights attaching to the Deposit Agreement, the Articles of Association of the Company and the rights attaching to the Shares, to vote, or cause the Custodian to vote, the Shares (in person or by proxy) represented by such Holder’s ADSs in accordance with the Voting Instructions received from the Holders of ADSs.

Shares represented by ADSs for which no timely Voting Instructions are received by the Depositary from the Holder shall not be voted (except as contemplated below). Neither the Depositary nor the Custodian shall under any circumstances exercise any discretion as to voting and neither the Depositary nor the Custodian shall vote, attempt to exercise the right to vote, or in any way make use of, for purposes of establishing a quorum or otherwise, the Shares represented by ADSs, except pursuant to and in accordance with the Voting Instructions timely received from Holders or as otherwise contemplated below. If the Depositary timely receives Voting Instructions from a Holder which fail to specify the manner in which the Depositary is to vote the Shares represented by such Holder’s ADSs, the Depositary will deem such Holder to have instructed the Depositary to vote in favor of the items set forth in such Voting Instructions. Notwithstanding anything else contained herein, the Depositary shall, if so requested in writing by the Company, represent all Shares (whether or not Voting Instructions have been received in respect of such Shares from Holders as of the ADS Record Date) for the sole purpose of establishing quorum at a meeting of shareholders.

Please further note that in accordance with and subject to the terms of Section 3.5 of the Deposit Agreement, the Company may, in its sole discretion but subject to applicable law, instruct the Depositary to take action with respect to the ownership interest of any Holder or Beneficial Owner, including, but not limited to, the imposition of restrictions on the transfer of ADSs, the removal or limitation of voting rights or mandatory sale or disposition on behalf of a Holder or Beneficial Owner of the Shares represented by the ADSs held by such Holder or Beneficial Owner if and to the extent such disposition is permitted by applicable law and the Articles of Association of the Company.

The information contained herein with respect to the Meeting has been provided by the Company. Citibank, N.A. is forwarding this information to you solely as Depositary and in accordance with the terms of the Deposit Agreement and disclaims any responsibility with respect to the accuracy of such information. Citibank, N.A. does not, and should not be deemed to, express any opinion with respect to the proposals to be considered at the Meeting. The rights and obligations of Holders and Beneficial Owners of ADSs the Company, and the Depositary are set forth in its entirety in the Deposit Agreement and summarized in the ADSs. If you wish to receive a copy of the Deposit Agreement, please contact the Depositary at the number set forth below.

If you have any questions about the way in which Voting Instructions may be delivered to the Depositary, please contact Citibank, N.A. - ADR Shareholder Services at (877)248-4237.

Citibank, N.A., as Depositary

EX-99.5

Exhibit 99.5

 

 

2023 Annual General Meeting

 

The Voting Instructions must be signed, completed and received at the indicated address prior to

10:00 A.M. (New York City time) on June 22, 2023 for action to be taken.

 

2023 VOTING INSTRUCTIONS    AMERICAN DEPOSITARY SHARES
   Freeline Therapeutics Holdings plc (the “Company”)
ADS CUSIP No.:   

35655L206 (freely transferable ADSs).

  

35655L875 (restricted ADSs).

ADS Record Date:   

May 22, 2023.

Meeting Specifics:   

Annual General Meeting to be held on Wednesday, June 28, 2023 at 2:00 P.M. (UK time) at the offices of Skadden, Arps, Slate, Meagher & Flom (UK) LLP, 22 Bishopsgate, London, EC2N 4BQ, United Kingdom (the “Meeting”).

Meeting Agenda:   

The Notice of Meeting and Annual Report and Accounts for the period ended December 31, 2022 are available to view and download from the Company’s website at: https://www.freeline.life/investors/agm.

Depositary:   

Citibank, N.A.

Deposit Agreement:   

Deposit Agreement, dated as of August 11, 2020 by and among the Company, the Depositary and all Holders and Beneficial Owners of ADSs (as amended from time to time, the “Deposit Agreement”). All capitalized terms used but not otherwise defined herein shall have the meanings given to such terms in the Deposit Agreement.

Deposited Securities:   

Ordinary Shares of £0.00001 each of the Company (“Shares”).

Custodian:   

Citibank, N.A. (London).

The undersigned being the Holder and Beneficial Owner, as of the ADS Record Date, of the American Depositary Share(s) issued under the Deposit Agreement and identified on the reverse side hereof (such American Depositary Shares, the “ADSs”) hereby authorizes and directs the Depositary to cause to be voted at the Meeting (and any adjournment or postponement thereof) the Shares represented by the ADSs in the manner indicated on the reverse side hereof but subject to the terms of the Deposit Agreement. The Depositary has been advised by the Company that under the Articles of Association of the Company as in effect on the date of the Deposit Agreement and to be in effect at the time of the Meeting, voting at any meeting of shareholders of the Company will be decided on a poll.

Voting instructions may be given only in respect of a number of ADSs representing an integral number of Shares. Upon the timely receipt from a Holder of ADSs as of the ADS Record Date of voting instructions in the manner specified by the Depositary, the Depositary shall endeavor, insofar as practicable and permitted under any applicable law, the provisions of the Deposit Agreement, the Articles of Association of the Company and the rights attached to the Shares, to vote, or cause the Custodian to vote, the Shares (in person or by proxy) represented by such Holder’s ADSs in accordance with the voting instructions received from the Holders of ADSs.

Shares represented by ADSs for which no timely voting instructions are received by the Depositary from the Holder shall not be voted (except as contemplated below). Neither the Depositary nor the Custodian shall under any circumstances exercise any discretion as to voting and neither the Depositary nor the Custodian shall vote, attempt to exercise the right to vote, or in any way make use of, for purposes of establishing a quorum or otherwise, the Shares represented by ADSs, except pursuant to and in accordance with the voting instructions timely received from Holders or as otherwise contemplated below. If the Depositary timely receives voting instructions from a Holder which fail to specify the manner in which the Depositary is to vote the Shares represented by such Holder’s ADSs, the Depositary will deem such Holder to have instructed the Depositary to vote in favor of the items set forth in such voting instructions. Notwithstanding anything else contained herein, the Depositary shall, if so requested in writing by the Company, represent all Shares (whether or not voting instructions have been received in respect of such Shares from Holders as of the ADS Record Date) for the sole purpose of establishing quorum at a meeting of shareholders.

Please further note that in accordance with and subject to the terms of Section 3.5 of the Deposit Agreement, the Company may, in its sole discretion but subject to applicable law, instruct the Depositary to take action with respect to the ownership interest of any Holder or Beneficial Owner, including, but not limited to, the imposition of restrictions on the transfer of ADSs, the removal or limitation of voting rights or mandatory sale or disposition on behalf of a Holder or Beneficial Owner of the Shares represented by the ADSs held by such Holder or Beneficial Owner if and to the extent such disposition is permitted by applicable law and the Articles of Association of the Company.

Please indicate on the reverse side hereof how the Shares are to be voted.

The Voting Instructions must be marked, signed and returned on time in order to be counted.

By signing on the reverse side hereof, the undersigned represents to the Depositary and the Company that the undersigned is duly authorized to give the voting instructions contained therein.


RESOLUTIONS

Ordinary Resolutions

 

1.

That the Annual Report and Accounts for the financial year ended 31 December 2022, together with the Directors’ Report and independent Auditor’s Report thereon, be received and adopted.

2.

That the Directors’ Remuneration Report (excluding the Directors’ Remuneration Policy) as set out in the Annual Report and Accounts for the financial year ended 31 December 2022 be approved.

3.

That Deloitte LLP be re-appointed as auditors to hold office from the conclusion of this AGM until the conclusion of the next AGM at which the Company’s Annual Report and Accounts are presented.

4.

That the Directors of the Company be authorised to determine Deloitte LLP’s remuneration.

5.

That Chris Hollowood be re-appointed as a director of the Company.

6.

That Martin Andrews be re-appointed as a director of the Company.

7.

That Jeffrey A. Chodakewitz be re-appointed as a director of the Company.

8.

That Julia P. Gregory be re-appointed as a director of the Company.

9.

That Colin A. Love be re-appointed as a director of the Company.

10.

That Michael J. Parini be re-appointed as a director of the Company.

11.

That Paul Schneider, who was appointed by the Board since the last AGM, be appointed as a director of the Company.

12.

That the amendment of the exercise price of each outstanding underwater option granted to an employee of the Company on or after 1 June 2021 with an exercise price greater than or equal to $0.42 per ordinary share (or $6.27 per ADS) under the (i) Freeline Therapeutics Holdings plc 2021 Equity Inducement Plan; and (ii) Freeline Therapeutics Holdings plc 2020 Equity Incentive Plan, from the existing applicable per ADS exercise price to a new replacement per ADS exercise price equal to the closing sales price for ADSs as quoted on the Nasdaq Capital Market for the last day preceding 30 June 2023 (being the Repricing Date) during which a sale occurred, as reported in The Wall Street Journal or another source the Board deems reliable, be hereby approved.

The Depositary has been informed by the Company that its board of directors unanimously recommends a “FOR” vote on all of the proposed resolutions.

 

 A      Resolutions                                 Freeline Therapeutics Holdings plc

 

             Vote                 Vote
Ordinary Resolutions    For   Against   Withheld    Ordinary Resolutions    For   Against   Withheld
Resolution 1           Resolution 7       
Resolution 2           Resolution 8       
Resolution 3           Resolution 9       
Resolution 4           Resolution 10       
Resolution 5           Resolution 11       
Resolution 6           Resolution 12       

 

B

    Authorized Signatures - Sign Here - This section must be completed for your instructions to be executed.

If these Voting Instructions are signed and timely returned to the Depositary but no specific direction as to voting is marked above as to an Issue, the undersigned shall be deemed to have directed the Depositary to give Voting Instructions “FOR” the unmarked Issue.

If these Voting Instructions are signed and timely returned to the Depositary but multiple specific directions as to voting are marked above as to an Issue, the undersigned shall be deemed to have directed the Depositary to give an “VOTE WITHHELD” Voting Instruction for such Issue.

Please be sure to sign and date this Voting Instructions Card.

Please sign your name to the Voting Instructions exactly as printed. When signing in a fiduciary or representative capacity, give full title as such. Where more than one owner, each MUST sign. Voting Instructions executed by a corporation should be in full name by a duly authorized officer with full title as such.

 

Signature 1 - Please keep signature within the line     Signature 2 - Please keep signature within the line     Date (mm/dd/yyyy)

 

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