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Moderna Reports Third Quarter 2020 Financial Results and Provides Business Updates

Phase 3 study of COVID-19 vaccine candidate (mRNA-1273) fully enrolled with 30,000 participants, including 37% from diverse communities and 42% at high-risk of severe disease (>65 years or co-morbid risk factors)

Positive interim data from Phase 2 study of CMV vaccine candidate (mRNA-1647) announced during R&D Day; pivotal Phase 3 trial expected to begin in 2021

Received $1.1 billion of customer deposits for supply of mRNA-1273 in Q3 2020, recorded as deferred revenue

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a 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 third quarter of 2020 and highlighted pipeline progress.

“The Moderna team continued to execute on our plan in the third quarter. We now have four programs in Phase 2 studies, in addition to the Phase 3 study of our COVID-19 vaccine, mRNA-1273, which is fully enrolled. Our CMV vaccine showed positive interim Phase 2 data and we are now preparing for the Phase 3 start in 2021. We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world. Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I believe that if we launch our COVID-19 vaccine, 2021 could be the most important inflection year in Moderna’s history. We will have the resources to scale Moderna to maximize the impact we can have on patients in the next 10 years through numerous new medicines.”

New updates and recent progress include:

Infectious Diseases

Oncology

Rare Diseases

Moderna currently has 21 mRNA development candidates in its portfolio with 13 in clinical studies. Across Moderna’s pipeline, more than 32,000 healthy volunteers and patients have been enrolled in clinical studies, including the Phase 3 study of mRNA-1273. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 55 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

Vaccines against respiratory infections

Vaccines against highly prevalent viral infections

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.

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.

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

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

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: investors.modernatx.com.

Research Updates

Management Updates

“I would like to thank Lori for her significant contributions during her time at Moderna, including helping us transition Moderna from a private to a public company and building a legal team to support the company during its rapid growth and expansion. She has been a great partner and champion of our people and our mission for patients. On behalf of Moderna, I thank Lori for her continued leadership and wish her all the best on her new life in retirement,” said Stéphane Bancel.

COVID-19 Vaccine Supply Agreements & Regulatory Filings

Corporate Update

2020 Financial Update

Third Quarter 2020 Financial Results

Contacts

Moderna Contacts


Media:
Colleen Hussey

Director, Corporate Communications

617-335-1374

Colleen.Hussey@modernatx.com

Investors:
Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

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