New York, US and Vienna, Austria - 20 May 2019 - HOOKIPA Pharma Inc. (“HOOKIPA”), a company developing a new class of immunotherapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform, today reported recent business highlights and financial results for the first quarter ended March 31, 2019. “HOOKIPA’s achievements since the start of 2019 have demonstrated our ability to execute and deliver on key company goals. We reached the first milestones of our collaborative HIV and Hepatitis B programs with Gilead, further validating our technology in the area of infectious diseases. Our Series D financing in February and our initial public offering in April allowed us to continue to expand our strong shareholder base. Also, we now have the financial strength to achieve major milestones on our journey to translate great science into clinical programs. We continue to deliver on our mission to reprogram the immune system to fight severe infectious diseases and cancer,” said Joern Aldag, HOOKIPA’s Chief Executive Officer. Business Highlights In May 2019, HOOKIPA achieved a second research milestone under its collaboration and license agreement with Gilead for development of a therapeutic hepatitis B virus vaccine. Based on the terms of the agreement, HOOKIPA is entitled to a milestone payment from Gilead. HOOKIPA previously completed a first research milestone for HIV in its collaboration with Gilead in December 2018. In April 2019, HOOKIPA completed its initial public offering (IPO), raising $84 million in gross proceeds, and commenced trading on the Nasdaq Global Select Market under the ticker symbol “HOOK”. In February, HOOKIPA completed a $37.4 million Series D Financing, which was led by Redmile Group with participation of additional new investors Invus and Samsara BioCapital, as well as a number of current investors. Michael A. Kelly, an experienced financial and biotech executive with more than 25 years of industry experience, and David R. Kaufman, currently serving as Chief Medical Officer of The Bill & Melinda Gates Medical Research Institute, were appointed to HOOKIPA’s Board of Directors. R&D Pipeline Update HB-101, a prophylactic vaccine for Cytomegalovirus HB-101, HOOKIPA’s prophylactic cytomegalovirus vaccine candidate, is currently in a Phase 2 clinical trial in patients awaiting kidney transplantation from living cytomegalovirus-positive donors. HOOKIPA expects safety and immunogenicity data from the first cohorts enrolled in this trial in the first half of 2020, and preliminary efficacy data to follow in the second half of 2020. HB-201 and HB-202, a program for the treatment of HPV - associated head and neck cancers HOOKIPA plans to initiate a Phase 1/2 clinical trial for HB-201 in patients with treatment-refractory HPV16+ cancers in the second half of 2019. In addition, HOOKIPA also plans to combine HB-201 with a checkpoint inhibitor and to commence a Phase 1/2 trial combining HB-201 and HB-202, both with and without a checkpoint inhibitor, in patients with treatment-refractory HPV16+ cancers in the second half of 2020. First Quarter 2019 Financial Results HOOKIPA’s net loss for the three months ended March 31, 2019 was $9.3 million. This compares to a net loss of $4.6 million, respectively, for the same period in 2018. Revenue was $2.2 million for the three months ended March 31, 2019, with no revenue recognized for the three months ended March 31, 2018. The increase was due to recognition of revenue under the Collaboration Agreement with Gilead, which we entered into in June 2018. HOOKIPA’s research and development expenses for the three months ended March 31, 2019, were $10.2 million, compared to $5.0 million for the three months ended March 31, 2018. The primary driver of the increase were direct research and development expenses for the preparation of clinical trials for our HB-201 and HB-202 programs and the expansion of earlier stage projects. In addition, costs related to the Company’s collaboration with Gilead, also contributed to the increase in direct expenses. General and administrative expenses for the three months ended March 31, 2019 and 2018 were $2.7 million and $1.5 million, respectively. The increase in general and administrative expenses was primarily due to an increase in headcount in our general and administrative functions and increase in professional and consulting fees as well as costs associated with ongoing business activities and our preparations to operate as a public company. HOOKIPA’s cash and cash equivalents as of March 31, 2019 were $70.5 million compared to $48.6 million as of December 31, 2018. The increase was primarily attributable to $37.3 million in net proceeds received from the issuance of shares of our Series D convertible preferred stock in February 2019, offset by cash used in operating and investing activities. On April 23, 2019, HOOKIPA completed an initial public offering of its common stock by issuing 6.0 million shares of its common stock, at $14.00 per share, for gross proceeds of $84.0 million. |