HOOKIPA Pharma Achieves $5 Million Milestone Payment from Gilead Sciences for Progress in the Development of Hepatitis B Vaccine

NEW YORK and VIENNA, Austria, Jan. 04, 2023 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, today announced that it has achieved a $5 million non-dilutive milestone payment under its collaboration agreement with Gilead Sciences, Inc. HOOKIPA completed and delivered a regulatory support package for Gilead’s Phase 1 clinical trial of an investigational therapeutic vaccine for chronic hepatitis B using HOOKIPA’s arenaviral platform. The first participant in the Phase 1 clinical trial is expected to be dosed in 2023.

“We’re proud of our team for achieving this milestone in our collaboration with Gilead and excited that the hepatitis B candidate is progressing to the clinic,” said Joern Aldag, Chief Executive Officer. “Chronic hepatitis B infection remains an area of considerable unmet need, and we look forward to seeing the potential impact of our novel arenaviral platform as a component of care.”

Of note, preclinical data on the hepatitis B vaccine as a potential component for a curative regimen were recently presented at the American Association for the Study of Liver Diseases (AASLD) and selected by AASLD as a “Best of the Liver Meeting” highlight (Balsitis S et al, Abstract 23, page 7). Gilead is solely responsible for further development and commercialization of the hepatitis B product candidate. HOOKIPA is eligible to receive milestone payments based on the achievement of specified development, regulatory, and commercial milestones up to a total of more than $190 million. HOOKIPA is also eligible to receive tiered royalties on net sales.

The hepatitis B program is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead. The other program aims to develop a novel arenaviral vaccine as a component of a potential functional curative regimen for human immunodeficiency virus (HIV). HOOKIPA is responsible for advancing the investigational HIV therapeutic vaccine through completion of a Phase 1b clinical trial.

About HOOKIPA

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, prostate cancers, and other undisclosed programs. HOOKIPA is collaborating with Roche on an arenaviral immunotherapeutic for KRAS-mutated cancers. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.

Find out more about HOOKIPA online at www.hookipapharma.com.

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Forward Looking Statements

Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises, the impact of COVID-19 on the enrollment of patients and timing of clinical results, and other matters that could affect the sufficiency of existing cash to fund operations. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended September 30, 2022, which is available on the Security and Exchange Commission’s website at www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.

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