Le Lézard
Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Conference Call, Webcast

Moderna Provides Business Updates and Reports Second Quarter 2019 Financial Results


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 for the second quarter of 2019 and provided business updates.

New updates announced today include:

Infectious Diseases

Immuno-Oncology

Rare Diseases

Research

"Since our last quarterly update, our personalized cancer vaccine program with Merck has advanced into Phase 2, the cytomegalovirus vaccine Phase 1 study has completed enrollment and four new Phase 1 trials in immuno-oncology and infectious diseases have begun," said Stéphane Bancel, Moderna's chief executive officer. "We are pleased by the advancement of our programs and look forward to sharing new clinical data in the near term. Additionally, we are excited that Vertex extended our research collaboration based on the teams' progress to date. Our balance sheet remains strong, and we continue to deploy our capital toward the advancement and expansion of our development pipeline and the creation of potential new modalities."

Moderna currently has 21 mRNA development candidates in its portfolio with 13 in clinical studies. Across Moderna's pipeline, more than 1,000 subjects have been enrolled in clinical studies. The Company's updated pipeline can be found at https://www.modernatx.com/pipeline. Moderna and collaborators have published more than 35 peer-reviewed papers, including 23 over the last 12 months.

Summary of Recent 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

Annual R&D Day

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, August 7, 2019. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international), and refer to conference ID 4799277. 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.

Second Quarter 2019 Financial Results

2019 Expected Cash Position

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. The Company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna 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 ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com.

Forward Looking Statement

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: sharing new clinical data in the near term; the advancement and expansion of Moderna's development pipeline and the creation of potential new modalities; the anticipated commencement of Moderna's clinical studies, including the Phase 1b study of mRNA-1653 in seropositive toddler subjects and the Phase 2 expansion cohort of mRNA-2416 in patients with advanced ovarian carcinoma; whether mRNA-5671 will generate and present KRAS neoantigens from the four most prevalent KRAS mutations; and the Company's expected cash, cash equivalents, and investments at December 31, 2019. 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: 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.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. IMFINZI is a registered trademark of AstraZeneca AB.

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands)

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2019

 

2018

 

2019

 

2018

Revenue:

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

10,030

 

 

$

25,831

 

 

$

24,145

 

 

$

53,291

 

Grant revenue

 

3,053

 

 

3,020

 

 

4,963

 

 

4,599

 

Total revenue

 

13,083

 

 

28,851

 

 

29,108

 

 

57,890

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

128,496

 

 

104,479

 

 

259,071

 

 

194,603

 

General and administrative

 

28,523

 

 

21,387

 

 

55,806

 

 

37,704

 

Total operating expenses

 

157,019

 

 

125,866

 

 

314,877

 

 

232,307

 

Loss from operations

 

(143,936

)

 

(97,015

)

 

(285,769

)

 

(174,417

)

Interest income

 

10,322

 

 

6,401

 

 

21,294

 

 

11,610

 

Other (expense) income, net

 

(1,764

)

 

171

 

 

(3,584

)

 

(12

)

Loss before income taxes

 

(135,378

)

 

(90,443

)

 

(268,059

)

 

(162,819

)

(Benefit from) provision for income taxes

 

(324

)

 

158

 

 

(348

)

 

158

 

Net loss

 

$

(135,054

)

 

$

(90,601

)

 

$

(267,711

)

 

$

(162,977

)

MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

(Unaudited, in thousands)

 

 

June 30,

 

December 31,

 

2019

 

2018

Cash, cash equivalents and investments

$

1,435,378

 

 

$

1,694,417

 

Total assets

1,685,279

 

 

1,962,149

 

Total liabilities

346,725

 

 

431,908

 

Total stockholders' equity

1,338,554

 

 

1,530,241

 

 

 

 

Six Months Ended June 30,

 

2019

 

2018

Net cash used in operating activities

$

(256,147

)

 

$

(159,634

)

Cash used for purchases of property and equipment

(18,181

)

 

(65,989

)

 


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