Financial Performance - The company reported a net loss of $13.8 million and $18.6 million for the three and nine months ended September 30, 2024, respectively, with an accumulated deficit of $387.8 million [151]. - The net loss for the three months ended September 30, 2024, was $13.8 million, an improvement of $5.2 million compared to a net loss of $19.1 million in the same period of 2023 [200]. - The net loss for the nine months ended September 30, 2024, was $18.6 million, compared to a net loss of $56.8 million for the same period in 2023 [229][230]. - The accumulated deficit as of September 30, 2024, was $387.8 million, with expectations of continued significant losses for the foreseeable future [218]. - The company does not expect positive cash flows from operations in the foreseeable future and anticipates incurring net operating losses for at least the next several years [214]. - Management has concluded that substantial doubt exists about the company's ability to continue as a going concern for at least 12 months from the issuance date of the financial statements [216]. Revenue and Income - Revenue from collaboration and licensing was $4.7 million for the three months ended September 30, 2024, down from $6.9 million in the same period of 2023, representing a decrease of approximately 31.6% [182]. - For the nine months ended September 30, 2024, revenue increased to $42.6 million from $12.7 million in 2023, marking an increase of approximately 234.6% [182]. - The company recognized $36.4 million in revenue related to the terminated Roche Collaboration Agreement during the nine months ended September 30, 2024 [190]. - Other income for the three months ended September 30, 2024, was $1.8 million, compared to other expenses of $0.8 million for the same period in 2023, primarily due to exchange rate differences [205]. - For the nine months ended September 30, 2024, other income was $1.3 million, compared to other expenses of $1.0 million for the same period in 2023, also attributed to exchange rate differences [206]. Expenses - Research and development expenses for the three months ended September 30, 2024, totaled $15.6 million, compared to $24.6 million for the same period in 2023 [168]. - Total research and development expenses for the nine months ended September 30, 2024, were $55.5 million, compared to $65.3 million for the same period in 2023 [168]. - The company expects research and development expenses to increase substantially as it advances existing and future product candidates through clinical trials [165]. - General and administrative expenses increased to $6.7 million for the three months ended September 30, 2024, compared to $4.9 million in 2023, an increase of approximately 36.7% [195]. - Restructuring expenses for the three months ended September 30, 2024, were $0.9 million, with $0.8 million attributed to severance and other personnel costs [198]. - The company has established a full valuation allowance for deferred tax assets as of September 30, 2024, due to uncertainty in realizing benefits [180]. Cash and Funding - The company has cash, cash equivalents, and restricted cash of $60.0 million as of September 30, 2024 [147]. - Cash used in operating activities for the nine months ended September 30, 2024, was $56.0 million, an increase from $46.3 million in the same period of 2023 [229][230]. - Cash used in investing activities decreased to $0.2 million in the nine months ended September 30, 2024, from $3.7 million in the same period of 2023 [231][232]. - Cash used in financing activities was $1.3 million for the nine months ended September 30, 2024, compared to cash provided of $44.4 million in the same period of 2023 [233][234]. - The company anticipates requiring additional funding to support clinical and preclinical development, regulatory approvals, and operational expansions [219]. - The company has no committed external source of funds for its development efforts and expects to finance future cash needs through a combination of equity offerings, debt financings, and collaborations [225]. Research and Development - The eseba-vec program for HPV16+ head and neck cancers showed an overall response rate (ORR) of 55.0% in the selected Phase 3 dose group, with a disease control rate (DCR) of 75% [137]. - The combination treatment of eseba-vec with pembrolizumab demonstrated a favorable safety profile, with serious adverse events in only 7.6% of participants [139]. - The company received FDA clearance for HB-700 in April 2024, targeting KRAS mutated cancers, including lung, colorectal, and pancreatic cancers [140]. - The collaboration with Gilead for the HBV program has the potential for up to $185.0 million in milestone payments, plus tiered royalties [142]. - The company regained full control of the HB-700 program after Roche terminated their collaboration agreement, receiving a non-refundable upfront payment of $25.0 million and milestone payments of $20.0 million [141]. - The company regained full control of the intellectual property portfolio associated with the terminated Roche Collaboration Agreement effective April 25, 2024 [158]. - The company recognized $0.6 million in cost reimbursements for research and development activities related to a first human trial [160]. Market Risks - The company is subject to market risks from changes in interest rates, foreign exchange rates, and inflation, which may impact financial performance [241][243]. - The company anticipates that a significant portion of its expenses will continue to be denominated in euros, exposing it to foreign currency risk [241].

Clinical Trials - Enrollment of 68 patients completed in Phase 2 study for eseba-vec + pembrolizumab in HPV+ HNSCC, four months ahead of schedule[1] - First patients dosed in Phase 2 investigator-initiated study for eseba-vec in adjuvant therapy for head and neck cancer[3] - The HB-700 program is ready for Phase 1 trials, targeting KRAS-mutated cancers, with FDA clearance received in April 2024[5] - HOOKIPA received a $5 million milestone payment from Gilead in July 2024 related to the HB-500 clinical trial[12] Financial Performance - Revenue for Q3 2024 was $4.7 million, a decrease of 31.6% from $6.9 million in Q3 2023, primarily due to lower partnering revenues[14] - Net loss for Q3 2024 was $13.8 million, compared to a net loss of $19.1 million in Q3 2023, representing a 27.3% improvement[18] Expenses - Research and development expenses decreased to $15.6 million in Q3 2024 from $24.6 million in Q3 2023, reflecting lower personnel and laboratory-related expenses[15] - General and administrative expenses increased to $6.7 million in Q3 2024 from $4.9 million in Q3 2023, driven by higher personnel-related expenses and consulting fees[16] Cash Position - Cash position as of September 30, 2024, was $60.0 million, down from $117.5 million as of December 31, 2023, primarily due to cash used in operating activities[13] - As of September 30, 2024, cash, cash equivalents, and restricted cash totaled $59,957,000, down from $117,521,000 as of December 31, 2023[24] Assets and Liabilities - Total assets decreased to $109,730,000 from $161,337,000[24] - Total liabilities reduced to $37,928,000 compared to $71,480,000[24] - Total stockholders' equity declined to $71,802,000 from $89,857,000[24] Corporate Actions - A reverse stock split of 1-for-10 was executed on July 9, 2024, to comply with Nasdaq listing requirements[11]

NEW YORK and VIENNA, Sept. 24, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK) ("HOOKIPA" or the "Company"), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious diseases, today announced that the Company will present preclinical data related to the HB-700 program for the treatment of KRAS mutated cancers at the 6th Annual RAS-Targeted Drug Development Summit being held in Boston, Massachusetts from September ...

NEW YORK and VIENNA, Aug. 30, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK) ("HOOKIPA" or the "Company"), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced the appointment of Director Julie O'Neill as NonExecutive Chair of the Company's Board of Directors. She succeeds Jan van de Winkel, who has decided to step down from the Board effective August 30, 2024, due to increasing time commitments from his executive position as Chief ...

New Leadership Appointments; Positive Clinical and Regulatory Reports for the Lead Product Candidate, HB200 (eseba-vec); On track to initiate the Phase 2/3 "AVALON-1" study with eseba-vec in Q4 2024 ASCO 2024 Presentation: Reported best-in-class Phase 2 data for first-line HPV16+ head and neck cancer patients treated with eseba-vec (formerly HB-200) in combination with pembrolizumab during oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting Regulatory Progress: Announce ...

Shares of HOOKIPA Pharma Inc. (HOOK) have gained 0.6% over the past four weeks to close the last trading session at $5.12, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $37.60 indicates a potential upside of 634.4%. The average comprises five short-term price targets ranging from a low of $15 to a high of $60, with a standard deviation of $18.61. While the lowest estimate indi ...

NEW YORK and VIENNA, July 22, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK) ("HOOKIPA" or the "Company"), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced the appointment of Directors Dr. Malte Peters as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer, effective July 22, 2024. They will both retain their positions on the Board of Directors ("Board"). Dr. Jan van de Winkel, Chair ...

Availability of Other Information About HOOKIPA About HOOKIPA At the effective time of the reverse split, every 10 issued and outstanding shares of the Company's common stock will automatically be combined into one issued and outstanding share of the Company's common stock without any change in the par value per share. Fractional shares will not be issued in connection with the reverse stock split. Stockholders who would otherwise be entitled to receive a fractional share will be entitled to receive a cash ...

The Company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on July 10, 2024. Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "HOOK" with the new CUSIP number 43906K209. The reverse stock split is part of the Company's plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. Find out more about HOOKIPA online at ...

Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (Gilead), to be evaluated as a potential component of a curative regimen for human immunodeficiency virus (HIV) HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial NEW YORK and VIENNA, July 01, 2024 (GLOBE NEWSWIR ...