Translate Bio Announces Closing of Expanded Collaboration and Licensing Agreement with Sanofi Pasteur to Develop mRNA Vaccines for All Infectious Diseases

Rhea-AI Summary

Translate Bio (Nasdaq: TBIO) has expanded its collaboration with Sanofi Pasteur to develop mRNA vaccines for infectious diseases, closing a licensing agreement following the termination of the Hart-Scott-Rodino waiting period. Translate Bio will receive an upfront payment of $425 million and may earn up to $1.9 billion from potential milestones and royalties. Sanofi will cover all collaboration costs and holds exclusive rights to the vaccines. The collaboration, initiated in 2018, aims to leverage both companies' strengths in the mRNA space.

Positive

• Translate Bio receives an upfront payment of $425 million and potential total payments of up to $1.9 billion.
• Sanofi will handle all costs associated with the collaboration, reducing financial burden on Translate Bio.
• The collaboration expands the scope of mRNA vaccine development beyond COVID-19 to all infectious diseases.

Negative

• None.

LEXINGTON, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today announced the closing of a previously announced expansion of the collaboration and licensing agreement with Sanofi Pasteur to develop mRNA vaccines for all infectious disease pathogens, following notice of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the agreement, Translate Bio will receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones and other payments as well as tiered royalties on worldwide sales of developed vaccines. In turn, Sanofi received exclusive worldwide rights for infectious disease mRNA vaccines.  Sanofi will pay for all costs during the collaboration term.

About the Sanofi Pasteur and Translate Bio collaboration
In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens. This agreement was first expanded in March 2020 to include the collaborative development of a novel mRNA vaccine for COVID-19. The July 2020 expansion agreement covers the development of mRNA vaccines broadly for all infectious diseases. This collaboration brings together Sanofi Pasteur’s leadership in vaccines and Translate Bio’s mRNA research and development expertise. Under the agreement, the companies are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a research term of at least four years after the original signing in 2018. Translate Bio and Sanofi Pasteur have advanced the preclinical development vaccine programs including screening, optimization and production of mRNA and LNP formulations across multiple targets.

About Translate Bio
Translate Bio is a clinical-stage mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction.  Translate Bio is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease. Translate Bio’s lead mRNA therapeutic program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company also believes its technology is applicable to a broad range of diseases, including diseases that affect the liver. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or vaccines in areas such as infectious disease and oncology. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio. (updated)

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Translate Bio within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding:  Translate Bio’s expectations with respect to the benefits of its collaboration with Sanofi; the potential of Translate Bio’s mRNA platform; the amount and receipt of future potential milestone, royalty and other payments under its collaboration with Sanofi; and beliefs regarding the broad applicability of its MRT platform; and Translate Bio’s plans, strategies and prospects for its business, including its lead development programs and continued development of mRNA vaccines for the treatment of infectious diseases. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forward,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: the current and potential future impacts of the COVID-19 pandemic on Translate Bio’s business, financial condition, operations and liquidity; Translate Bio’s ability to advance the development of its platform and programs under the timelines it projects, demonstrate the requisite safety and efficacy of its product candidates and replicate in clinical trials any positive findings from preclinical studies; the successful advancement of the collaboration agreement between Translate Bio and Sanofi;  the content and timing of decisions made by the U.S. Food and Drug Administration, other regulatory authorities and investigational review boards at clinical trial sites, including decisions as it relates to ongoing and planned clinical trials; Translate Bio’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the availability of significant cash required to fund operations; competitive factors; general economic and market conditions and other important risk factors set forth under the caption “Risk Factors” in Translate Bio’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2020 filed with the Securities and Exchange Commission on May 7, 2020 and in any other subsequent filings made by Translate Bio. Any forward-looking statements contained in this press release speak only as of the date hereof, and Translate Bio specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts for Translate Bio

100%; border-collapse:collapse !important;">

Teri Dahlman	Maura Gavaghan
tdahlman@translate.bio	mgavaghan@translate.bio
617-817-8655	617-233-1154

FAQ

What is the recent collaboration agreement between Translate Bio and Sanofi Pasteur?

Translate Bio expanded its collaboration with Sanofi Pasteur to develop mRNA vaccines for all infectious diseases, receiving $425 million upfront and potential total payments of $1.9 billion.

How much is Translate Bio expected to earn from the Sanofi Pasteur partnership?

Translate Bio stands to earn up to $1.9 billion in potential milestone payments and royalties from its partnership with Sanofi Pasteur.

What does the expansion of the agreement entail for Translate Bio?

The expanded agreement now allows Translate Bio to develop mRNA vaccines for all infectious diseases, previously limited to five specific pathogens.

What impact does the collaboration have on Translate Bio's finances?

Translate Bio will receive $425 million upfront and will not bear the collaboration costs, which will be covered by Sanofi, positively impacting its financial position.

When was the collaboration between Translate Bio and Sanofi Pasteur initially established?

The collaboration between Translate Bio and Sanofi Pasteur began in 2018.