New York, US and Vienna, Austria, March 18, 2021 - HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and provided a corporate update for the fourth quarter and full year 2020.
“Despite the global pandemic, 2020 was a break-out year for HOOKIPA, a testament to the strength of our novel scientific platform and our dedicated team. We reported compelling, early clinical data with both our replicating and non-replicating technologies in oncology and infectious diseases, respectively, and advanced the HBV and HIV cures towards the clinic in our strategic collaboration with Gilead Sciences. With the appointment of Jean-Charles Soria, M.D., Ph.D., we added a globally recognized oncology expert to our board to help guide our clinical development progress,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Our strong year-end cash balance of $143 million positions us well to advance our CMV and HPV16+ cancer programs and to expand our pipeline. Given the strength of the interim data reported in 2020, we are excited about the further potential of our platform and additional read-outs this year, particularly from our HB-201/HB-202 two-vector alternating immunotherapy, which has the potential to deliver even greater immune response than HB-201 alone.”
R&D Pipeline Update and Clinical Progress
Oncology Portfolio (HB-201 and HB-202)
Infectious Disease Portfolio (HB-101)
Fourth Quarter and Full Year 2020 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of December 31, 2020 was $143.2 million compared to $113.6 million as of December 31, 2019. The increase was primarily attributable to $75.0 million in net proceeds from the issuance of common stock and convertible preferred stock in a follow-on financing in December 2020, offset by cash used in operating activities.
Revenue was $5.2 million for the three months ended December 31, 2020, and $19.6 million for the year ended December 31, 2020 compared to $3.6 million for the three months ended December 31, 2019 and $11.9 million for the year ended December 31, 2019. The increase was primarily due to higher cost reimbursements received under the collaboration agreement with Gilead and the partial recognition of a milestone payment we received from Gilead in February 2020.
Research and Development Expenses: HOOKIPA’s research and development expenses were $15.7 million for the three months ended December 31, 2020, and $54.8 million for the year ended December 31, 2020 compared to $11.2 million for the three months ended December 31, 2019, and $46.3 million for the year ended December 31, 2019.
The primary driver of the increase in research and development expenses by $8.5 million compared to 2019 was an increase in internal research and development expenses, partially offset by a decrease in direct research and development expenses.
Internal research and development expenses increased primarily due to higher personnel expenses, including stock based compensation and an increase in facility related expenses. The decrease in direct expenses was primarily due to a decrease in research and development service expenses, along with a decrease in manufacturing and quality control expenses and a decrease of other direct research and development expenses, partially offset by an increase in clinical trial expenses and an increase in laboratory expenses.
General and Administrative Expenses: General and administrative expenses amounted to $4.7 million for the three months ended December 31, 2020 and $18.1 million for the for the year ended December 31, 2020 compared to $5.7 million for the three months ended December 31, 2019, and $16.7 million for the year ended December 31, 2019. The increase was mainly due to the growth in personnel related expenses as well as costs associated with ongoing business activities and costs to operate as a public company, partially offset by a decrease in professional and consulting fees.
Net Loss: HOOKIPA’s net loss was $12.5 million for the three months ended December 31, 2020 and $44.1 million for the year ended December 31, 2020 compared to a net loss of $10.2 million for the three months ended December 31, 2019 and $43.0 million for the year ended December 31, 2019. This increase was due to an increase in research and development expenses, mainly driven by the progression of HOOKIPA’s oncology programs, and an increase in general and administrative expenses to operate as a public company.
Conference call: HOOKIPA will host a conference call and live webcast at 8:30 am EST to discuss its financial results. Please register here to access the conference call. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at https://ir.hookipapharma.com/events. An archived replay will be accessible for 30 days following the event.
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body’s immune system.
HOOKIPA’s proprietary arenavirus-based technologies, non-replicating and replicating, induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy not used in combination, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.
HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.
HOOKIPA’s non-replicating prophylactic Cytomegalovirus vaccine candidate, HB-101, is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic hepatitis B infections.
Find out more about HOOKIPA online at www.hookipapharma.com.
HOOKIPA 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 for HB-101 and other programs, and other matters that could affect the sufficiency of existing cash to fund operations and HOOKIPA’s ability to achieve the milestones under the agreement with Gilead. 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-K for the quarter ended December 31, 2020 which is available on the Security and Exchange Commission’s website at www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.
Investors and others should note that we announce material financial information to our investors using our investor relations website (https://ir.hookipapharma.com/), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our members and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the U.S. social media channels listed on our investor relations website.
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