AP NEWS
Press release content from Business Wire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Business Wire
Press release content from Business Wire. The AP news staff was not involved in its creation.

Moderna Provides Business Updates and Reports Third Quarter 2019 Financial Results

November 6, 2019 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 6, 2019--

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 provided business updates and reported financial results for the third quarter of 2019.

New updates and recent progress include:

Infectious Diseases

Immuno-Oncology

Rare Diseases

Research

“The positive Phase 1 cytomegalovirus vaccine results announced this quarter represent an important step toward the prevention of congenital CMV infections. These data resulted from investment in our mRNA technology platform, which has now generated six positive infectious disease vaccine clinical readouts. Additionally, the recent positive Phase 1 chikungunya antibody results help de-risk a delivery technology shared by our rare disease programs, further validating our approach into new areas where mRNA medicines have the potential to treat a wide range of diseases,” said Stéphane Bancel, Moderna’s chief executive officer. “We ended the quarter with a strong cash balance of $1.34 billion and up to $187 million in additional untapped grant funding, giving us up to $1.5 billion to invest in the Company moving forward. We expect investment levels in 2020 to be approximately $500 million, similar to 2019. We intend to expand our group of biopharmaceutical partners and bring in additional non-dilutive grant and government funding as we advance our development pipeline and create new modalities.”

Moderna currently has 21 mRNA development candidates in its portfolio with 13 in clinical studies. Across Moderna’s pipeline, more than 1,400 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 40 peer-reviewed papers, including 23 over the last 12 months.

The Company has established a wide range of strategic alliances with leading biopharmaceutical companies, as well as government-sponsored and private organizations focused on global health initiatives. Strategic collaborators contribute their therapeutic expertise, help to validate Moderna’s mRNA platform and have provided a quarter of the Company’s total capital to date. As of September 30, 2019, Moderna had up to $187 million in additional funding available from grants (including amounts not yet committed) 1.

Summary of Program Highlights by Modality

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 epidemic and pandemic threats to global public health.

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.

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

Systemic Secreted Therapeutics:In this modality, mRNA is delivered systemically to create proteins that are secreted outside the cell with the aim of producing pharmaceutically active proteins with therapeutic effects across the human body.

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.

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: https://investors.modernatx.com.

Research Update

Corporate Updates

Financial Guidance

Third Quarter 2019 Financial Results

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, November 6, 2019. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 6287715. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at https://investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for 30 days following the call.

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 have a therapeutic or preventive benefit with 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 and cardiovascular diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense and 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). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

_________________________________________________________________________________________
1 Biomedical Advanced Research and Development Authority (BARDA), Defense Advanced Research Projects Agency (DARPA) and The Bill and Melinda Gates Foundation (BMGF). Additional funding is subject to agreement on scope of additional projects.

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: initiating clinical trial sites outside of the U.S. for mRNA-3704; study start-up for mRNA-3927; anticipated commencement of a dose-confirmation Phase 2 study and planning for a pivotal Phase 3 study for mRNA-1647; the Company’s intent to expand its group of biopharmaceutical partners and bring in additional non-dilutive grant and government funding; the availability of additional funding from grants (including amounts not yet committed); the dosing of two additional cohorts in the near term for mRNA-1944; projected protection against chikungunya infection for at least sixteen weeks at the 0.3 and 0.6 mg/kg doses of mRNA-1944; the Company’s expected cash, cash equivalents, and investments at December 31, 2019; and the Company’s expected net cash used in operating activities and purchases of property and equipment in 2019 and 2020. 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-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 mRNA drug has been approved in this new potential class of medicines, 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 our regulatory approval strategies, components of our or filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; 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, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

2019

 

2018

 

2019

 

2018

Revenue:

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

13,338

 

 

$

36,662

 

 

$

37,483

 

 

$

89,696

 

Grant revenue

 

3,708

 

 

5,095

 

 

8,671

 

 

9,951

 

Total revenue

 

17,046

 

 

41,757

 

 

46,154

 

 

99,647

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

119,715

 

 

109,050

 

 

378,786

 

 

303,653

 

General and administrative

 

28,188

 

 

18,525

 

 

83,994

 

 

56,229

 

Total operating expenses

 

147,903

 

 

127,575

 

 

462,780

 

 

359,882

 

Loss from operations

 

(130,857

)

 

(85,818

)

 

(416,626

)

 

(260,235

)

Interest income

 

9,252

 

 

6,519

 

 

30,546

 

 

18,129

 

Other expense, net

 

(1,767

)

 

(1,032

)

 

(5,351

)

 

(1,044

)

Loss before income taxes

 

(123,372

)

 

(80,331

)

 

(391,431

)

 

(243,150

)

(Benefit from) provision for income taxes

 

(178

)

 

 

 

(526

)

 

158

 

Net loss

 

$

(123,194

)

 

$

(80,331

)

 

$

(390,905

)

 

$

(243,308

)

MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

(Unaudited, in thousands)

 

 

September 30,

December 31,

 

2019

2018

Cash, cash equivalents and investments

$

1,338,400

$

1,694,417

Total assets

 

1,590,899

 

1,962,149

Total liabilities

 

339,092

 

431,908

Total stockholders’ equity

 

1,251,807

 

1,530,241

Total liabilities and stockholders’ equity

 

1,590,899

 

1,962,149

 
 

Nine Months Ended September 30,

2019

2018

Net cash used in operating activities

$

363,195

$

239,845

Purchases of property and equipment

 

24,892

 

92,129

 

View source version on businesswire.com:https://www.businesswire.com/news/home/20191106005332/en/

CONTACT: Media:

Colleen Hussey

Senior Manager, Corporate Communications

203-470-5620

Colleen.Hussey@modernatx.comDan Budwick

1AB

973-271-6085

Dan@1abmedia.com Investors:

Lavina Talukdar

Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL GENETICS HEALTH

SOURCE: Moderna, Inc.

Copyright Business Wire 2019.

PUB: 11/06/2019 07:00 AM/DISC: 11/06/2019 07:01 AM

http://www.businesswire.com/news/home/20191106005332/en