Pfizer Enters into Agreement with Acuitas Therapeutics for Lipid Nanoparticle Delivery System for Use in mRNA Vaccines and Therapeutics

Expands Pfizer’s access to lipid nanoparticle (LNP) formulation technology, offering a strong strategic fit with Pfizer’s mRNA strategy

Pfizer gains option to license Acuitas’ LNP technology for up to 10 targets for vaccine or therapeutic development

Pfizer Inc. (NYSE: PFE) and Acuitas Therapeutics, a company focused on developing lipid nanoparticle (LNP) delivery systems to enable messenger RNA (mRNA)-based therapeutics, today announced they have entered into a Development and Option agreement under which Pfizer will have the option to license, on a non-exclusive basis, Acuitas’ LNP technology for up to 10 targets for vaccine or therapeutic development.

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Acuitas’ clinically-validated LNP technology is used in COMIRNATY^®, the Pfizer-BioNTech COVID-19 vaccine.

“Our swift delivery of the world’s first mRNA-LNP-based vaccine made clear the promise of mRNA-LNP technology,” said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer Inc. “We are making significant investments to harness the power of the mRNA-LNP technology and deliver potential new breakthrough vaccines and therapeutics that address significant unmet needs for patients. This agreement expands our LNP capabilities and allows us to explore more projects within our existing vaccines area and new therapeutic areas where mRNA-LNP technology holds potential for success.”

“Acuitas is extremely proud that its LNP technology contributes to the success of COMIRNATY^® and is excited to be working with Pfizer to advance new vaccines and therapeutic products,” said Dr. Thomas Madden, President & CEO of Acuitas Therapeutics.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

About Acuitas Therapeutics

Founded in February 2009, Vancouver-based Acuitas Therapeutics (www.acuitastx.com) is a private biotechnology company that specializes in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles. The company partners with pharmaceutical and biotechnology companies and academic institutes to advance nucleic acid therapeutics into clinical trials and to the marketplace. The team works with partners to develop new therapies to address unmet clinical needs based on its internationally recognized capabilities in delivery technology. Acuitas Therapeutics has agreements in place with several partners to use its proprietary lipid nanotechnology in the development of COVID-19 vaccines. These include Pfizer/BioNTech for COMIRNATY^®, which has received full approval in the U.S. and Canada and is authorized for Emergency Use in Europe, the UK and many other countries.

Pfizer Disclosure Notice

The information contained in this release is as of January 10, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the potential of mRNA-LNP technology and a development and option agreement under which Pfizer will have the option to license, on a non-exclusive basis, Acuitas’ LNP technology for up to 10 targets for vaccine or therapeutic development, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; whether the agreement between Pfizer and Acuitas will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

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