UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 5, 2020

 

 

MODERNA, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38753   81-3467528

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

200 Technology Square

Cambridge, MA

  02139
(Address of principal executive offices)   (Zip code)

(Registrant’s telephone number, including area code): (617) 714-6500

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

symbol(s)

 

Name of each exchange

on which registered

Common stock, par value $0.0001 per share   MRNA   The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On May 7, 2020, Moderna, Inc. (the “Company”) issued a press release announcing its results of operations and financial condition for the first quarter ended March 31, 2020. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 5.02.

Departure of Directors or Principal Officers; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers.

(e) On May 5, 2020 (the “Effective Date”), the Company entered into an Executive Retention and Separation Agreement (the “Agreement”) with Lorence Kim, M.D., the Company’s Chief Financial Officer (“CFO”), which sets forth the terms of Dr. Kim’s continued services as the Company’s CFO through, and Dr. Kim’s separation from employment on, August 31, 2020.

Until the date of termination of employment, Dr. Kim’s annual base salary will continue to be no less than $582,000, except for across the board salary reductions impacting all executives proportionately. As of the Effective Date, Dr. Kim will no longer participate in the Company’s Amended and Restated Executive Severance Plan (the “Severance Plan”) and instead will be entitled to the benefits and payments set forth in the Agreement.

Provided that (i) Dr. Kim does not voluntarily terminate his employment with the Company for a reason other than material breach by the Company of the Agreement, and (ii) Dr. Kim has not been terminated by the Company for Cause (as defined in the Severance Plan), and subject to Dr. Kim’s agreement to a general release and certain other standard terms and conditions, the Company will pay Dr. Kim a cash lump sum in an amount equal to six months of Dr. Kim’s annual base salary as in effect on the Separation Date (the “Severance Payment”) and a one-time cash lump sum in an amount equal to 50% of his annual target bonus (the “Retention Bonus”). The Severance Payment and Retention Bonus will be paid in a single lump sum in accordance with the Company’s normal payroll practices, subject to tax withholding under applicable law.

Any options to purchase the Company’s common stock or other equity granted to Dr. Kim under the Company’s equity plans as of the Effective Date will continue to be governed by the terms and conditions of such plans and the applicable award agreements.

The above summary is not complete and is qualified in its entirety by the Agreement, a copy of which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

10.1    Executive Retention and Separation Agreement, dated May 5, 2020, by and between Moderna, Inc. and Lorence Kim, M.D.
99.1    Press Release issued by Moderna, Inc. on May 7, 2020


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 hereunto duly authorized.

 

Date: May 7, 2020   MODERNA, INC.
  By:  

/s/ Lori Henderson

    Lori Henderson
    General Counsel and Secretary

Exhibit 10.1

EXECUTIVE RETENTION AND SEPARATION AGREEMENT

This Executive Retention Agreement (this “Agreement”) is entered into effective as of May 5, 2020 (the “Effective Date”) between Lorence Kim, M.D. (the “Executive”) and Moderna, Inc. (the “Company,” together with Executive, the “Parties”).

WHEREAS, the Executive currently serves as the Company’s Chief Financial Officer; and

WHEREAS, the Board of Directors wishes to enter into this Agreement with the Executive to set forth the terms of the Executive’s continued services to the Company through August 31, 2020 (the “Retention Date”) and Executive’s separation from employment on the Retention Date;

NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. Retention Period; Duties.

a. Term and Position. This Agreement shall be effective from the Effective Date through the Retention Date (the “Retention Period”). The Retention Date may be modified if mutually agreed to in writing by the Parties. The Executive shall continue to serve as the Company’s Chief Financial Officer during the Retention Period. Nothing in this Agreement changes the “at will” nature of the Executive’s employment with the Company.

b. Duties. During the Retention Period, the Executive shall continue to report to the Company’s Chief Executive Officer (the “CEO”) and shall have the duties and responsibilities as set out by the CEO and the Company’s Board of Directors that are consistent with the Executive’s position with the Company. As part of such duties, Executive shall review and execute the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2020 in his role as Chief Financial Officer of the Company; provided the Company agrees to provide the Executive with such information and access as he believes is reasonably necessary to perform such duties.

c. Work Location and Travel. The Executive’s place of work during the Retention Period shall continue to be as established as of the Effective Date, with such business travel upon which the CEO and the Executive shall mutually agree; provided, however, that the Executive will not be required to come in to the office regularly after June 30, 2020; but instead shall work remotely and be available as necessary to perform his duties as set forth herein. The Executive’s place of work and any business travel shall at all times be subject to any applicable government guidelines and any policies and procedures then in effect and established by the Company regarding such subject matter.


2. Compensation During the Retention Period.

a. Salary. During the Retention Period, the Executive’s base salary shall continue to be no less than $582,000, except for across the board salary reductions impacting all executives proportionately, payable semi-monthly in accordance with the Company’s normal payroll practices, subject to tax withholding under applicable law. The Executive’s base salary will continue to be subject to periodic increase at the discretion of the CEO and the Company’s Compensation and Talent Committee (the “Compensation Committee”), and shall be referred to herein as the “Base Salary”.

b. Expenses. The Executive shall be entitled to receive reimbursement for all reasonable business expenses incurred by him during the Retention Period in performing services hereunder, in accordance with the policies and procedures then in effect and established by the Company.

c. Other Benefits. During the Retention Period, the Executive shall continue to be eligible to participate in or receive benefits under the Company’s retirement, health, welfare and fringe benefit plans for employees in effect from time to time, subject to the terms and conditions of such plans.

d. Vacations. During the Retention Period, the Executive shall be entitled to vacation in accordance with the Company’s vacation policy, as in effect from time to time.

3. Severance and Retention Bonus.

a. Severance. As of the Effective Date, the Executive agrees and acknowledges (i) he will no longer participate in the Company’s Amended and Restated Executive Severance Plan (the “Severance Plan”) and instead shall be entitled to the benefits and payments set forth herein in lieu of any benefits and payments to which he may otherwise be entitled pursuant to the terms and conditions of the Severance Plan and that (ii) any change to the Executive’s duties as set forth herein shall not constitute Good Reason as defined in and for purposes of the Severance Plan. Subject to the conditions set forth in this Section 3, the Company shall pay the Executive a cash lump sum in an amount equal to six (6) months of the Executive’s Base Salary as in effect on the Retention Date (the “Severance Payment”).

b. Retention Bonus. Subject to the conditions set forth in this Section 3, the Company shall pay the Executive a cash lump sum in an amount equal to fifty percent (50%) of the Executive’s annual target bonus which shall be equal to $145,500 (the “Retention Bonus”).

c. Payment. The Severance Payment and the Retention Bonus will be paid in accordance with the Company’s normal payroll practices, subject to tax withholding under applicable law, in a single lump sum within sixty (60) days of the Release Effective Date (as defined in the Release Agreement attached hereto as Exhibit A (the “Release Agreement”)), but in no event later than December 31, 2020; provided that (i) the Executive does not voluntarily terminate his employment with the Company before the Retention Date for a reason other than a material breach by the Company of this Agreement that is not cured within five (5) days of written notice by the Executive; (ii) the Executive has not been terminated by the Company for Cause (as defined in the Severance Plan); and (iii) the Executive signs and does not revoke the Release Agreement.

 

2


4. Treatment of Equity Awards. All outstanding equity awards held by or granted to the Executive under the Moderna Therapeutics, Inc. 2016 Stock Option and Grant Plan (as amended, the “2016 Plan”) or the Moderna, Inc. 2018 Stock Option and Incentive Plan (the “2018 Plan” and together with the 2016 Plan, the “Plans”) as of the Effective Date shall continue to be governed by the terms and conditions of the Plans and the applicable award agreements.

5. Restrictive Covenants; Injunctive Relief. Executive’s obligations set forth in the Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement by and between the Executive and the Company, dated as of February 20, 2014 shall be referred to as the “Restrictive Covenants” and are incorporated herein by reference and shall survive the termination or expiration of this Agreement. In consideration of the benefits received under this Agreement, the Executive hereby reconfirms his obligations under the Restrictive Covenants in all respects.

6. Section 409A.

a. Anything in this Agreement to the contrary notwithstanding, if at the time of the Executive’s separation from service within the meaning of Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), the Executive is a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that the Executive becomes entitled to under this Agreement on account of the Executive’s separation from service would be considered deferred compensation otherwise subject to the twenty percent (20%) additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i) of the Code, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (A) six months and one day after the Executive’s separation from service, or (B) the Executive’s death. If any such delayed cash payment is otherwise payable on an installment basis, the first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six-month period but for the application of this provision, and the balance of the installments shall be payable in accordance with their original schedule.

b. All in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be provided by the Company or incurred by the Executive during the time periods set forth in this Agreement. All reimbursements shall be paid as soon as administratively practicable, but in no event shall any reimbursement be paid after the last day of the taxable year following the taxable year in which the expense was incurred. The amount of in-kind benefits provided or reimbursable expenses incurred in one taxable year shall not affect the in-kind benefits to be provided or the expenses eligible for reimbursement in any other taxable year (except for any lifetime or other aggregate limitation applicable to medical expenses). Such right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.

c. To the extent that any payment or benefit described in this Agreement constitutes “non-qualified deferred compensation” under Section 409A of the Code, and to the

 

3


extent that such payment or benefit is payable upon the Executive’s termination of employment, then such payments or benefits shall be payable only upon the Executive’s “separation from service.” The determination of whether and when a separation from service has occurred shall be made in accordance with the presumptions set forth in Treasury Regulation Section 1.409A-1(h).

d. The parties intend that this Agreement will be administered in accordance with Section 409A of the Code. To the extent that any provision of this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that all payments hereunder comply with, or are exempt from, Section 409A of the Code. Each payment pursuant to this Agreement is intended to constitute a separate payment for purposes of Treasury Regulation Section 1.409A-2(b)(2). The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may be necessary to fully comply with, or be exempt from, Section 409A of the Code and all related rules and regulations in order to preserve the payments and benefits provided hereunder without additional cost to either party.

e. The Company makes no representation or warranty and shall have no liability to the Executive or any other person if any provisions of this Agreement are determined to constitute deferred compensation subject to Section 409A of the Code but do not satisfy an exemption from, or the conditions of, such Section.

7. Entire Agreement. This Agreement, and the Release Agreement attached hereto, constitute the entire agreement between the Executive and the Company concerning the Executive’s relationship with the Company, and supersedes and replaces any and all prior agreements and understandings between the Parties concerning the Executive’s relationship with the Company, including that certain Offer Letter by and between the Company and the Executive, dated as of February 20, 2014; provided that, for the avoidance of doubt, this Agreement shall not supersede or replace the Restrictive Covenants or any of the award agreements applicable to the Executive’s outstanding equity awards.

8. Withholding. All payments made by the Company to the Executive under this Agreement shall be net of any tax or other amounts required to be withheld by the Company under applicable law.

9. Enforceability. If any portion or provision of this Agreement (including, without limitation, any portion or provision of any section of this Agreement) shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law.

10. Survival. The provisions of Section 5 of this Agreement shall survive the termination of this Agreement and/or the termination of the Executive’s employment to the extent necessary to effectuate the terms contained herein.

11. Waiver. No waiver of any provision hereof shall be effective unless made in writing and signed by the waiving party. The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.

 

4


12. Notices. Any notices, requests, demands and other communications provided for by this Agreement shall be sufficient if in writing and delivered in person or sent by a nationally recognized overnight courier service or by registered or certified mail, postage prepaid, return receipt requested, to the Executive at the last address the Executive has filed in writing with the Company or, in the case of the Company, at its main offices, attention of the Board.

13. Amendment. This Agreement may be amended or modified only by a written instrument signed by the Executive and by a duly authorized representative of the Company.

14. Governing Law. This is a Massachusetts contract and shall be construed under and be governed in all respects by the laws of the Commonwealth of Massachusetts, without giving effect to the conflict of laws principles of such Commonwealth. With respect to any disputes concerning federal law, such disputes shall be determined in accordance with the law as it would be interpreted and applied by the United States Court of Appeals for the First Circuit.

15. Counterparts. This Agreement may be executed in any number of counterparts, each of which when so executed and delivered shall be taken to be an original; but such counterparts shall together constitute one and the same document.

 

5


IN WITNESS WHEREOF, the Parties, intending to be legally bound, have executed this Agreement effective as of the Effective Date.

 

MODERNA, INC.
By:  

/s/ Stephane Bancel

  Name: Stephane Bancel
  Title: Chief Executive Officer
EXECUTIVE

/s/ Lorence Kim

Lorence Kim, M.D.

 

6


Exhibit A

To Be Signed on the Last Day of Employment

Release Agreement

 

  1.

Release of Claims.

In consideration for the payments and benefits set forth in the Executive Retention and Separation Agreement (the “Agreement”) to which this Release Agreement (the “Release Agreement”) is attached, and to which the Executive acknowledges he would otherwise not be entitled, the Executive voluntarily releases and forever discharges the Company, its affiliated and related entities, its and their respective predecessors, successors and assigns, its and their respective employee benefit plans and fiduciaries of such plans, and the current and former officers, directors, shareholders, employees, attorneys, accountants and agents of each of the foregoing in their official and personal capacities (collectively referred to as the “Releasees”) generally from all claims, demands, debts, damages and liabilities of every name and nature, known or unknown (“Claims”) that, as of the date when the Executive signs this Release Agreement, the Executive has, ever had, now claims to have or ever claimed to have had against any or all of the Releasees. Capitalized terms not otherwise defined herein shall have the meanings set forth in the Agreement. This release includes, without limitation, all Claims:

 

   

relating to the Executive’s employment by and termination of employment with the Company;

 

   

of wrongful discharge or violation of public policy;

 

   

of breach of contract;

 

   

of defamation or other torts;

 

   

of retaliation or discrimination under federal, state or local law (including, without limitation, Claims of discrimination or retaliation under the Age Discrimination in Employment Act, the Americans with Disabilities Act, Title VII of the Civil Rights Act of 1964, M.G.L. c. 151B, New York State Human Rights Law, the New York Labor Law, the New York State Civil Rights Law, Section 125 of the New York Workers’ Compensation Law, the New York City Human Rights Law, and The Massachusetts Civil Rights Act);

 

   

under any other federal or state statute (including, without limitation, Claims under the Worker Adjustment and Retraining Notification Act or the Fair Labor Standards Act);

 

   

for wages, bonuses, incentive compensation, stock, stock options, vacation pay or any other compensation or benefits, either under New York wage and hour laws and the Massachusetts Wage Act, M.G.L. c. 149, §§148-150C, or otherwise; and

 

   

for damages or other remedies of any sort, including, without limitation, compensatory damages, punitive damages, injunctive relief and attorney’s fees;

provided, however, that nothing in this release shall release or impair any Claim or right (a) that may arise after the date of this Release Agreement; (b) for unemployment or workers’ compensation benefits; (c) for vested rights under ERISA-covered employee benefit plans as applicable on the date the Executive signs this Release Agreement; (d) to be covered under applicable indemnification agreements and policies and under applicable directors and officers liability insurance for acts or omissions while serving as an officer of the Company; (e) under the Agreement or (f) that by law cannot be waived.


The Company represents and warrants that it is not aware of any claims, demands, debts, damages or liabilities of any name or nature that it or any of its subsidiaries may pursue against the Executive.

The Executive agrees not to accept damages of any nature, other equitable or legal remedies for the Executive’s own benefit or attorney’s fees or costs from any of the Releasees with respect to any Claim released by this Release Agreement. As a material inducement to the Company to enter into the Agreement, the Executive represents that he has not assigned any Claim to any third party.

 

  2.

Consideration Period and Release Effective Date.

The Executive acknowledges that he has knowingly and voluntarily entered into this Release Agreement and that the Company has advised him to consult with an attorney before signing this Release Agreement. The Executive understands and acknowledges that the Executive has been given the opportunity to consider this Release Agreement for twenty-one (21) days from the Executive’s last day of employment before signing it (the “Consideration Period”). To accept this Release Agreement, the Executive must return a signed original or a signed PDF copy of this Release Agreement so that it is received by Lori Henderson at or before the expiration of the Consideration Period. If the Executive signs this Release Agreement before the end of the Consideration Period, the Executive acknowledges that such decision was entirely voluntary and that the Executive had the opportunity to consider this Release Agreement for the entire Consideration Period. For the period of seven (7) days from the date when the Executive signs this Release Agreement, the Executive has the right to revoke this Release Agreement by written notice to Ms. Henderson, provided that such notice is delivered so that it is received at or before the expiration of the seven (7) -day revocation period. This Release Agreement shall not become effective or enforceable during the revocation period. This Release Agreement shall become effective on the first business day following the expiration of the revocation period (the “Release Effective Date”).

 

  3.

Termination of Payments.

If the Executive fails to cure a material breach of any of the Executive’s obligations under this Release Agreement within ten (10) days of written notice from the Company, in addition to any other legal or equitable remedies it may have for such breach, the Company shall have the right to terminate its payments to the Executive under the Agreement. The termination of such payments in the event of the Executive’s breach will not affect the Executive’s continuing obligations under this Release Agreement or under the Agreement.

 

  4.

Protected Disclosures.

Nothing contained in this Release Agreement limits the Executive’s ability to file a charge or complaint with any federal, state or local governmental agency or commission (a “Government Agency”). In addition, nothing contained in this Release Agreement limits the Executive’s ability to communicate with any Government Agency or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency, including the Executive’s ability


to provide documents or other information, without notice to the Company, nor does anything contained in this Release Agreement apply to truthful testimony in litigation. If the Executive files any charge or complaint with any Government Agency and if the Government Agency pursues any claim on the Executive’s behalf, or if any other third party pursues any claim on the Executive’s behalf, the Executive waives any right to monetary or other individualized relief (either individually or as part of any collective or class action); provided that nothing in this Release Agreement shall prohibit the Executive from receiving any monetary award to which the Executive becomes entitled pursuant to Section 922 of the Dodd-Frank Wall Street Reform and Consumer Protection Act. In addition, for the avoidance of doubt, pursuant to the federal Defend Trade Secrets Act of 2016, the Executive shall not be held criminally or civilly liable under any federal or state trade secret law or under this Release Agreement or the Restrictive Covenants for the disclosure of a trade secret that (a) is made (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.

 

  5.

Enforceability.

If any portion or provision of this Release Agreement (including, without limitation, any portion or provision of any section of this Release Agreement) shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Release Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Release Agreement shall be valid and enforceable to the fullest extent permitted by law.

 

  6.

Acknowledgments.

The Executive understands and agrees that this Release Agreement is part of the Agreement to which it is attached. All terms and obligations of the Agreement remain in full force and effect.

The Executive is advised to consult with an attorney before signing this Release Agreement. This is a legal document. The Executive’s signature will commit the Executive to its terms. By signing below, the Executive acknowledges that the Executive has carefully read and fully understands all of the provisions of this Release Agreement and that he is knowingly and voluntarily entering into this Release Agreement.

 

 

   

 

Lorence Kim, M.D.

   

Date

Exhibit 99.1

Moderna Reports First Quarter 2020 Financial Results and Provides Business Updates

Progress on novel coronavirus vaccine (mRNA-1273) includes FDA clearance to proceed with Phase 2 study

Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020

Awarded up to $483 million funding from BARDA for accelerated development of mRNA-1273

Entered strategic collaboration with Lonza Ltd. to manufacture up to one billion doses of mRNA-1273 per year

Up to $2.4 billion to invest, including cash and investments of $1.7 billion and up to $0.7 billion in potentially available grants and awards; reconfirms 2020 guidance that net cash used in operating activities and for purchases of property and equipment is expected to be approximately $500 million

CAMBRIDGE, Mass., May 7, 2020 — Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today reported financial results and provided business updates for the first quarter of 2020 and highlighted pipeline progress.

“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021. We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We also are continuing to progress our development pipeline and invest in our future. We are very pleased with Vertex’s decision, based on our preclinical progress, to extend our strategic collaboration working to develop the technology to allow for delivery of mRNA in the lung.”

New updates and recent progress include:

Infectious Diseases

 

   

The U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for its novel coronavirus (SARS-CoV-2 or COVID-19) vaccine candidate (mRNA-1273) allowing it to proceed to Phase 2 study, expected to begin shortly; finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020

 

   

Positive interim results announced from Phase 1 Zika vaccine candidate (mRNA-1893) study

Oncology

 

   

Positive data from the monotherapy arm of the Phase 1/2 study of OX40L (mRNA-2416) presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting

Rare Diseases

 

   

Due to COVID-19, enrollment and new site initiation paused for methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) clinical trials. During the pause, the Company is implementing changes that the Company believes will ultimately help to accelerate clinical development


   

Given current strategic priorities, the Fabry disease program (mRNA-3630) is being discontinued

Research Update

 

   

In March 2020, based on promising preclinical data generated to date, Vertex Pharmaceuticals, Inc. extended the conduct of the initial cystic fibrosis (CF) research plan for an additional 18 months by making an additional payment to Moderna

Moderna currently has 23 mRNA development candidates in its portfolio with 13 in clinical studies. Across Moderna’s pipeline, more than 1,900 participants have been enrolled in clinical studies. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 45 peer-reviewed papers.

Summary of Program Highlights by Modality

Core Modalities Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company’s global public health portfolio is focused on epidemic and pandemic diseases for which funding has been sought from governments and non-profit organizations.

Infections transmitted from mother to baby

 

   

Cytomegalovirus (CMV) vaccine (mRNA-1647): In March, Moderna announced completion of enrollment for the Phase 2 dose-confirmation study of mRNA-1647. The first Phase 2 interim analysis is expected in the third quarter of 2020. Manufacturing and planning are underway for the pivotal Phase 3 study, which is designed to evaluate the efficacy of mRNA-1647 against primary CMV infection in women of childbearing age and is expected to start in 2021. Moderna owns worldwide commercial rights for mRNA-1647.

 

   

Zika virus vaccine (mRNA-1893): The 10 µg, 30 µg and 100 µg cohorts in the Phase 1 study of mRNA-1893 have completed enrollment. In April 2020, Moderna announced positive interim Phase 1 data showing the 10 µg and 30 µg dose levels of mRNA-1893 induced a neutralizing antibody response in both flavivirus infection-naïve (seronegative) participants and in participants with pre-existing flavivirus antibodies (seropositive) following a two-dose vaccination schedule given 28 days apart. The 10 µg and 30 µg dose levels were both generally well-tolerated, and there were no vaccine-related serious adverse events (SAEs) or adverse events of special interest (AESI). The most frequent solicited adverse reaction was local pain at the injection site. The safety profile did not appear affected by the second vaccination nor a flavivirus-positive baseline serostatus. mRNA-1893 is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna owns worldwide commercial rights to mRNA-1893.

Vaccines against respiratory infections

 

   

Novel coronavirus (SARS CoV-2) vaccine (mRNA-1273): The U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for its novel coronavirus (SARS-CoV-2 or COVID-19) vaccine candidate (mRNA-1273) allowing it to proceed to the Phase 2 study. A 600 participant Phase 2 study is expected to begin shortly. The Company is finalizing the protocol for the Phase 3 study, which is expected to begin in the early summer of 2020.


   

Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Due to the pandemic, the Company previously decided to pause new enrollment of participants in the ongoing hMPV/PIV3 study (mRNA-1653), which had been actively enrolling seropositive pediatric participants (12-36 months of age). The Company intends to work with appropriate medical and site personnel to determine when to resume new enrollment. Moderna owns worldwide commercial rights to mRNA-1653.

 

   

Pediatric respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV in young children encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. The Company intends to combine mRNA-1345 with mRNA-1653, its vaccine against hMPV and PIV3, to create a combination vaccine against RSV, hMPV and PIV3. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to the combined mRNA-1345/mRNA-1653 vaccine.

 

   

RSV vaccine (mRNA-1172 or V172): The Phase 1 study of mRNA-1172 led by Merck is ongoing. Moderna has licensed worldwide commercial rights to mRNA-1172 to Merck.

 

   

Influenza H7N9 vaccine (mRNA-1851): Discussions regarding funding the Company’s influenza H7N9 vaccine program through approval are ongoing.

Vaccines against highly prevalent viral infections

 

   

Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna’s CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.

Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

 

   

Antibody against the chikungunya virus (mRNA-1944): Moderna has been notified that the enrollment of further subjects in the Phase 1 study of mRNA-1944 has been paused by the site due to the impact of COVID-19. Moderna owns worldwide commercial rights to mRNA-1944.

 

   

IL-2 (mRNA-6231): mRNA-6231 is an mRNA encoding for a long-acting tolerizing IL-2. This new autoimmune development candidate is designed to preferentially activate and expand the regulatory T cell population. The Company plans to conduct a Phase 1 study of mRNA-6231 in healthy adult volunteers. mRNA-6231 uses the same LNP formulation as mRNA-1944. The Phase 1 study of mRNA-6231 will be the first clinical demonstration of subcutaneous administration of this delivery technology. Moderna owns worldwide commercial rights to mRNA-6231.

 

   

PD-L1 (mRNA-6981): mRNA-6981 is an mRNA encoding for PD-L1. This new autoimmune development candidate is designed to augment cell surface expression of PD-L1 on myeloid cells to provide co-inhibitory signals to self-reactive lymphocytes. As an initial step to addressing a range of autoimmune indications, the Company intends to pursue proof-of-concept in a Phase 1 study of mRNA-6981 in type 1 autoimmune hepatitis (AIH), a condition that involves liver inflammation and can lead to cirrhosis and liver failure. mRNA-6981 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-6981.


   

Relaxin (AZD7970): Partnered with AstraZeneca, AZD7970 is in preclinical development for the treatment of heart failure. Under the terms of the collaboration, AstraZeneca would sponsor the Phase 1 trial to assess safety, tolerability and duration of systemic exposure to the Relaxin protein. Moderna shares worldwide commercial rights to AZD7970 with AstraZeneca.

 

   

Fabry disease (mRNA-3630): Given current strategic priorities, the Fabry disease program (mRNA-3630) is being discontinued.

 

   

Publication of note: In April, in collaboration with Seattle Children’s Research Institute, Moderna published preclinical data in Molecular Therapy Nucleic Acids showing administration of mRNA encoding the factor VIII (FVIII) protein led to rapid and prolonged FVIII expression in mouse models of Hemophilia A. This work is part of Moderna’s research to explore the potential of mRNA therapy across various rare diseases.

Exploratory Modalities

Cancer Vaccines: These programs focus on stimulating a patient’s immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

 

   

Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck’s pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. The Phase 1 study is ongoing. The Company is evaluating the impact of COVID-19 related challenges that are leading to delays in enrollment. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.

 

   

KRAS vaccine (mRNA-5671 or V941): The Phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.

Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

 

   

OX40L (mRNA-2416): The Phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The Company is evaluating the impact of COVID-19-related challenges that are leading to delays in enrollment. Moderna owns worldwide commercial rights to mRNA-2416. 

 

   

Presentation of Note: Data from the monotherapy arm of the Phase 1/2 study of OX40L (mRNA-2416) were presented at the AACR Virtual Annual Meeting showing that mRNA-2416 was well-tolerated at all dose levels studied with the majority of adverse events reported as grade 1 and 2; no grade 3 adverse events were reported. Best overall response observed was stable disease in 14/39 patients with 6 of these patients at stable disease for >14 weeks. Patients treated with monotherapy mRNA-2416 showed increased OX40L protein expression, upregulation of PD-L1 levels and evidence of increased pro-inflammatory activity demonstrating proof of mechanism and supporting the evaluation of intratumoral mRNA-2416 with the anti-PD-L1 inhibitor durvalumab in solid tumors, which is ongoing in Part B of this study with a focus on advanced ovarian carcinoma.


   

OX40L/IL-23/IL-36y (Triplet) (mRNA-2752): The Phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. mRNA-2752 is an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators. The Company is evaluating the impact of COVID-19-related challenges that are leading to delays in enrollment. Moderna owns worldwide commercial rights to mRNA-2752. 

 

   

IL-12 (MEDI1191): The Phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

 

   

VEGF-A (AZD8601): The Phase 2a study of AZD8601 for VEGF-A for ischemic heart disease in patients undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing at one site. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.

Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

 

   

Methylmalonic acidemia (MMA) (mRNA-3704): Due to the COVID-19 pandemic, Moderna previously decided to pause new enrollment and new site initiation for its Phase 1/2 study of mRNA-3704 to ensure the safety of these pediatric patients and their caregivers. No patients have been dosed to date. During the pause, the Company is implementing changes that the Company believes will ultimately help to accelerate clinical development. mRNA-3704 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3704.

 

   

Propionic acidemia (PA) (mRNA-3927): Due to the COVID-19 pandemic, Moderna previously decided to pause new enrollment and new site initiation for its Phase 1/2 study of mRNA-3927 to ensure the safety of these pediatric patients and their caregivers. No patients have been dosed to date. During the pause, the Company is implementing changes that the Company believes will ultimately help to accelerate clinical development. mRNA-3927 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3927.

 

   

MMA and PA Natural History Study (MaP): This is a global, multi-center, non-interventional study for patients with confirmed diagnosis of MMA due to MUT deficiency or PA and is designed to identify and correlate clinical and biomarker endpoints for these disorders. Enrollment in the study has been completed.

 

   

Phenylketonuria (PKU) (mRNA-3283): Individuals with PKU have a deficiency in phenylalanine hydroxylase (PAH) resulting in a reduced or complete inability to metabolize the essential amino acid phenylalanine into tyrosine. mRNA-3283 encodes human PAH to restore the deficient or defective intracellular enzyme activity in patients with PKU. mRNA-3283 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3283.


   

Glycogen storage disease type 1a (GSD1a) (mRNA-3745): Individuals with GSD1a have a deficiency in glucose-6-phosphatase resulting in pathological blood glucose imbalance. mRNA-3745 is an IV- administered mRNA encoding human G6Pase enzyme, designed to restore the deficient or defective intracellular enzyme activity in patients with GSD1a. mRNA-3745 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3745.

Information about each development candidate in Moderna’s pipeline, including those discussed in this press release, can be found on the investor relations page of its website: investors.modernatx.com.

Research Update

 

   

Vertex cystic fibrosis research collaboration: In July 2016, Moderna and Vertex announced an exclusive research collaboration and licensing agreement aimed at the discovery and development of mRNA therapeutics for the treatment of CF. In July 2019, Vertex elected to extend the initial research period by six months. Based on promising preclinical work to date, in March 2020 Vertex extended this collaboration through August 2021 with options to extend further based on future progress. Pulmonary mRNA delivery represents a potential new route of administration for Moderna.

Management Updates

 

   

Moderna’s Chief Financial Officer, Lorence Kim, M.D., will be leaving the Company in August after six years of service. The Company has retained Russell Reynolds to recruit for a new CFO with public company, global and commercial experience as the Company scales up to file several biologics license applications (BLAs) over the next few years with the Company’s first potential launch, for its SARS-CoV-2 vaccine, as soon as 2021.

I would like to thank Lorence for his tremendous impact on Moderna’s success over the last six years. Lorence brought unique skills with a medical degree and financial market experience, which has helped us build our financial foundation. His leadership and contributions were vital in helping Moderna get to where we are today. I have enjoyed having him as my partner and wish him all the best as he embarks on the next leg of his successful career,” said Stéphane Bancel.

 

   

Charbel Haber, M.P.H., Ph.D. joined Moderna on April 21 as SVP, Regulatory Affairs joining from Biogen where he served as Vice President, Global Safety and Regulatory Sciences since 2017. Prior to Biogen, Dr. Haber was Head, Global Regulatory Affairs-Immunology and Neurology at EMD Serono, Inc. Dr. Haber brings significant global regulatory experience and led numerous successful regulatory development and registration of drugs in different modalities and disease areas.

 

   

Jacqueline Miller, M.D., FAAP will join Moderna on May 11 as SVP, Infectious Disease Development. Dr. Miller joins the Company from GlaxoSmithKline where she held a variety of leadership roles since 2005. Most recently, Dr. Miller was the Vice President and Head, Clinical R&D and Epidemiology where she built and led the clinical and epidemiology research teams at the first GSK vaccines research and development center in the U.S.

 

   

Patrick Bergstedt will join Moderna on June 1 as SVP, Commercial Vaccines. Prior to Moderna, Mr. Bergstedt held various progressive leadership positions with the Infectious Diseases and Global Human Health groups at Merck & Co, Inc. since 2001. Mr. Bergstedt most recently served as Head of Global Marketing & Commercial Operations: Vaccines at Merck where he led global initiatives with a focus on revenue growth and access expansion, and played a pivotal role in the transformation of the vaccines business.


We are excited to welcome these three new senior leaders, who bring extensive clinical development, regulatory and commercial experience, as we begin to pivot towards late-stage development and commercialization,” said Stéphane Bancel.

Corporate Updates

 

   

The Company hosted its first Vaccines Day on April 14, 2020.

Financial Guidance

 

   

The Company has up to $2.4 billion to invest, including cash and investments of $1.7 billion and up to $0.7 billion in potentially available grants and awards.

 

   

In 2020, the Company expects net cash used in operating activities and for purchases of property and equipment to be approximately $500 million.

 

   

While the Company expects to incur significant expenses this year in relation to the BARDA award for the development of mRNA-1273 to FDA licensure and manufacturing process scale-up, the Company expects in general a close matching of expenses and reimbursements for those expenses covered by the BARDA award.

Key 2020 Investor and Analyst Event Dates

 

   

Science Day – June 2 (virtual)

 

   

R&D Day – September 17

First Quarter 2020 Financial Results (Unaudited)

 

   

Cash Position: Cash, cash equivalents and investments as of March 31, 2020 and December 31, 2019 were $1.7 billion and $1.3 billion, respectively.

 

   

Net Cash Used in Operating Activities: Net cash used in operating activities was $106.2 million for the three months ended March 31, 2020 compared to $144.3 million for the three months ended March 31, 2019. Net cash used in operating activities includes $22.0 million for the three months ended March 31, 2019, of in-licensing payments to Cellscript, LLC and its affiliate, mRNA RiboTherapeutics, Inc., to sublicense certain patent rights. After the first quarter of 2019, the Company has no further in-licensing payment obligations to Cellscript and its affiliate.

 

   

Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $6.2 million for the three months ended March 31, 2020 compared to $7.6 million for the three months ended March 31, 2019.

 

   

Revenue: Total revenue was $8.4 million for the three months ended March 31, 2020 compared to $16.0 million for the three months ended March 31, 2019. The total revenue decrease in 2020 was mainly attributable to cumulative catch-up adjustments in revenue due to changes in estimated costs for our future performance obligations under the collaboration agreements with Merck and AstraZeneca, and a decrease in revenue from Merck, primarily driven by the timing of amortization of deferred revenue due to the satisfaction of the Company’s performance obligation.


   

Research and Development Expenses: Research and development expenses were $115.1 million for the three months ended March 31, 2020 compared to $130.4 million for the three months ended March 31, 2019. The decrease was primarily attributable to decreases in lab supplies and materials, clinical trial and manufacturing costs, consulting and outside services, partially offset by increases in personnel related costs, depreciation and amortization and stock-based compensation.

 

   

General and Administrative Expenses: General and administrative expenses were $24.1 million for the three months ended March 31, 2020 compared to $27.3 million for the three months ended March 31, 2019. The decrease was mainly due to a decrease in legal related costs and consulting and outside services.

 

   

Net Loss: Net loss was $124.2 million for the three months ended March 31, 2020 compared to $132.6 million for the three months ended March 31, 2019.


MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except share and per share data)

 

     Three Months Ended March 31,  
     2020     2019  

Revenue:

    

Collaboration revenue

   $ 4,457   $ 14,115

Grant revenue

     3,932     1,910
  

 

 

   

 

 

 

Total revenue

     8,389     16,025
  

 

 

   

 

 

 

Operating expenses:

    

Research and development

     115,137     130,413

General and administrative

     24,114     27,253
  

 

 

   

 

 

 

Total operating expenses

     139,251     157,666
  

 

 

   

 

 

 

Loss from operations

     (130,862     (141,641

Interest income

     7,852     10,972

Other expense, net

     (1,154     (1,931
  

 

 

   

 

 

 

Loss before income taxes

     (124,164     (132,600

Provision for (benefit from) income taxes

     66     (24
  

 

 

   

 

 

 

Net loss

   $ (124,230   $ (132,576
  

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.35   $ (0.40
  

 

 

   

 

 

 

Weighted average common shares used in net loss per share, basic and diluted

     353,105,021     328,809,986
  

 

 

   

 

 

 


MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

(Unaudited, in thousands)

 

     March 31,      December 31,  
     2020      2019  

Cash, cash equivalents and investments

   $ 1,720,180    $ 1,262,987

Total assets

     2,067,541      1,589,422

Total liabilities

     426,667      414,612

Total stockholders’ equity

     1,640,874      1,174,810

Total liabilities and stockholders’ equity

     2,067,541      1,589,422

 

     Three Months Ended March 31,  
     2020      2019  

Net cash used in operating activities

   $ 106,191    $ 144,268

Cash used for purchases of property and equipment

     6,223      7,595

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 7, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 6698719. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

About Moderna

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning: the impact of the SARS-CoV-2 pandemic on the Company’s clinical trials and operations, including mRNA-1653, mRNA-3704, mRNA-3927, mRNA-3630 and mRNA-1944; the status, timing and results of the Phase 1 trial of mRNA-1273 being conducted by the NIH; the timing of and proposed design for the planned Phase 2 study of mRNA-1273; the next steps, including the Phase 3 study design and the timing thereof, and ultimate commercial plan for mRNA-1273; the ability to scale dosing capacity for mRNA-1273; the size of the potential market opportunity for mRNA-1273; the timing and results of the Phase 2 dose confirmation study of mRNA-1647; the timing and design of the Phase 3 study of mRNA-1647; the Company’s intention to create a combination therapy with mRNA-1345 and mRNA-1653 against RSV, hMPV and PIV3; the timing and status of the Phase 1 study of mRNA-6231 in healthy volunteers; the continuing success of the extended strategic collaboration with Vertex; the probability of success of the Company’s vaccines individually and as a portfolio; and the ability of the Company to accelerate the research and development timeline for any individual product or the platform as a whole. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: whether the interim Phase 1 results for mRNA-1893 will be predictive of study results and any future clinical studies for mRNA-1893 or other development candidates; whether the interim Phase 1 results for mRNA-1944 will be predictive of any future clinical studies for mRNA-1944 or other development candidates with the same LNP formulation, including mRNA-3704 and mRNA-3927; preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no commercial product using mRNA technology has been approved , and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.


Moderna Contacts

Media:

Colleen Hussey

Senior Manager, Corporate Communications

203-470-5620

Colleen.Hussey@modernatx.com

Dan Budwick

1AB 973-271-6085

Dan@1abmedia.com

Investors:

Lavina Talukdar

Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com