NEW YORK and VIENNA, July 18, 2025 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, “HOOKIPA”), a clinical-stage biopharmaceutical company developing next-generation immunotherapeutics for the treatment of cancer and serious infectious diseases, today announced its intention to voluntarily delist from the Nasdaq Capital Market (“Nasdaq”) and to deregister its common stock under Section 12(b) and Section 12(g) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and suspend its repo ...

HB-200 Program and Clinical Trials - Hookipa Pharma's HB-200 is a targeted immunotherapy for HPV16+ cancers, with a pivotal Phase 2/3 trial expected to start in Q4 2024[14, 16] - The FDA has aligned on the pivotal Phase 2/3 design and protocol for HB-200, and the EMA has granted PRIME designation[16] - A Phase 1/2 study of HB-200 in recurrent/metastatic HPV16+ HNSCC showed promising antitumor activity as a monotherapy[25, 26] - The combination of HB-200 and pembrolizumab demonstrated a manageable safety profile, in line with monotherapy profiles[28, 30] - The Phase 2/3 trial will be a seamless study with approximately 250 patients, with a Phase 2 primary analysis expected in 2026 and a Phase 3 primary analysis in 2028[47, 48] Clinical Data and Efficacy - In patients with PD-L1 CPS ≥1, HB-200 + pembrolizumab showed an objective response rate (ORR) of 371% and a disease control rate (DCR) of 686%[32] - In the PD-L1 CPS ≥20 sub-population, the confirmed ORR was 529%, with a complete response (CR) rate of 176% and a DCR of 824%[37] - Preliminary progression-free survival (PFS) in the PD-L1 CPS ≥20 population was 163 months, and median overall survival (OS) was unreached, with 158% of subjects experiencing death events[42, 43, 44] - Neoadjuvant HB-200 plus chemotherapy showed an early efficacy signal with a deep response rate of 81% (17 of 21 patients)[51] Oncology Strategy and Market - Hookipa Pharma is pursuing a patient-centric oncology strategy, starting with HB-200 in head and neck cancer, with potential applicability to additional antigens and HPV16+ targets[55, 56]

Financial Position - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash of $40.5 million, including $19.9 million received from the Austrian government research incentive program for 2022 and 2023 [170]. - The accumulated deficit reached $428.2 million as of March 31, 2025, with expectations of continued significant losses in the foreseeable future [238]. - The company raised approximately $142.5 million from redeemable convertible preferred stock prior to its IPO and $84.0 million from its IPO in April 2019 [228]. - The company has total non-cancellable obligations under contracts with manufacturing organizations amounting to $3.9 million as of March 31, 2025 [232]. - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $40.5 million [230]. - The company expects to require additional funding to support ongoing operations and product development, with substantial doubt regarding its ability to continue as a going concern for at least the next 12 months [236]. - The company has entered into a Sales Agreement with Jefferies LLC to issue and sell up to $50.0 million of common stock, but no sales had been made as of March 31, 2025 [231]. Revenue and Income - The company has not generated any revenue from product sales to date and does not expect to do so in the near future [176]. - Revenue from collaboration and licensing decreased to $2.0 million for the three months ended March 31, 2025, down from $36.6 million in the same period of 2024, a decline of $34.6 million [207][208]. - Grant income for the three months ended March 31, 2025 was $0.2 million, compared to $2.2 million in the same period of 2024, a decrease of $2.0 million [223]. - Interest income decreased to $0.2 million for the three months ended March 31, 2025, down from $1.3 million in the same period of 2024, a decline of $1.1 million [224]. - The company experienced a significant decrease in revenue due to the termination of the Roche Collaboration Agreement, which previously contributed $35.7 million in revenue in Q1 2024 [208][211]. - Other income for Q1 2025 was $2.0 million, a significant increase from other expenses of $0.3 million in Q1 2024, primarily due to exchange rate differences [226]. Expenses - The company incurred a net loss of $15.4 million for the three months ended March 31, 2025, with an accumulated deficit of $428.2 million [174]. - Total research and development expenses for the three months ended March 31, 2025 were $12.9 million, compared to $20.2 million for the same period in 2024, reflecting a decrease of $7.3 million [214][215]. - General and administrative expenses increased to $6.9 million for the three months ended March 31, 2025, up from $4.1 million in the same period of 2024, an increase of $2.8 million [217][218]. - Restructuring expenses decreased to $0.1 million for the three months ended March 31, 2025, down from $1.3 million in the same period of 2024 [219][220]. - The company expects to continue incurring net operating losses for the foreseeable future due to ongoing research and development costs [174]. Strategic Changes - The company announced a workforce reduction of approximately 80% as part of its restructuring plan, which is expected to be substantially completed by the end of the first half of 2025 [167]. - The company is collaborating with Gilead Sciences Inc. on its Hepatitis B and HIV programs, with Gilead responsible for further development and commercialization of the Hepatitis B product candidate [165]. - The company received a non-refundable upfront payment of $10.0 million from Gilead under the Gilead Collaboration Agreement, with potential milestone payments totaling up to $140.0 million for the Hepatitis B program [178]. - The company has paused clinical development in its eseba-vec program for HPV16+ cancers to focus on the phase 1-ready HB-700 program for KRAS mutant cancers [163]. - The company is focusing on the continued development of infectious disease therapies in partnership with Gilead, indicating a strategic shift in R&D priorities [216]. Cash Flow - Net cash provided by operating activities for Q1 2025 was $52, a recovery from a net cash used of $24,156 in Q1 2024 [247]. - For the three months ended March 31, 2025, cash provided by operating activities was $0.1 million, with a net loss of $15.4 million adjusted by non-cash charges of $0.1 million and cash provided due to changes in operating assets and liabilities of $15.4 million [248]. - During the same period, cash used in operating activities was $24.2 million, consisting of a net income of $14.4 million adjusted by non-cash charges of $0.4 million and cash used due to changes in operating assets and liabilities of $38.9 million [249]. - Cash used in investing activities for the three months ended March 31, 2025, was less than $0.1 million, primarily related to land in Vienna, Austria [251]. - There was no cash used in financing activities for the three months ended March 31, 2025, while cash used in financing activities for the same period in 2024 was $0.1 million, mainly for costs related to Gilead's purchase of common stock [252]. Market and Economic Conditions - A hypothetical 10% weakening of the U.S. dollar compared to the euro would have increased the net loss for the three months ended March 31, 2025, by approximately $1.2 million [259]. - Inflation may impact labor costs, clinical trial costs, and operational costs, potentially affecting the company's financial condition and results of operations [261]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million [256]. - The company evaluates its estimates and judgments on an ongoing basis, which may differ from actual results under different assumptions or conditions [253].

Immunotherapy Development - The company is developing a new class of immunotherapeutics based on a proprietary arenavirus platform, targeting T cell and immune responses to combat diseases [25]. - The oncology portfolio includes two primary programs in development, with the HB-700 program targeting KRAS mutated cancers and being Phase 1 ready [26][34]. - The HB-400 and HB-500 programs for Hepatitis B and HIV, respectively, are in Phase 1 clinical development in partnership with Gilead [27]. - The eseba-vec program targets HPV16+ cancers using alternating dual-vector therapy, with components HB-201 and HB-202 expressing the E7E6 fusion protein [75]. - The company presented positive preliminary Phase 2 data for eseba-vec, showing a 52% objective response rate in 25 evaluable patients, which is a significant increase compared to historical data [34]. - The disease control rate for HB-200 in HPV16+ HNSCC was 44%, with a median overall survival of approximately 13 months [87]. - The company reported a 52% confirmed objective response rate (ORR) and an 80% disease control rate (DCR) across 25 evaluable patients with PD-L1 CPS ≥20 [104]. - The combination of eseba-vec with pembrolizumab resulted in approximately a 2-fold increase in response rates compared to historical data for pembrolizumab monotherapy [108]. Clinical Trials and Milestones - The company has paused the development of the HB-300 program for prostate cancer to conserve capital and ensure operational efficiency [26]. - The HB-400 program completed enrollment with 83 participants, with primary completion expected in the first half of 2025 [39]. - The HB-500 program's Phase 1b trial completed enrollment with 30 participants, and primary completion is expected in the second half of 2025 [39]. - The Phase 1/2 clinical trial for Eseba-vec was paused, with final Phase 2 data expected in the second half of 2025 [83]. - The Phase 1 study of HB-200 enrolled 93 patients, with a median of three prior anticancer therapies [85]. - In the Phase 2 trial of Eseba-vec with pembrolizumab, 30 out of 66 participants (45.5%) remained on treatment as of September 30, 2024 [98]. - The Phase 1b clinical trial for HB-500 is expected to complete primary outcomes in the second half of 2025 [129]. Financials and Collaborations - The company received a payment of $19.8 million related to a research incentive program from the Austrian government, including $17.3 million for 2022 and 2023 [32]. - The company received a $10.0 million milestone payment related to the IND application for HB-700 and a $5.0 million milestone payment for the first person dosed in the HB-500 trial [39]. - The company received $51.2 million in upfront and milestone payments and $43.0 million in cost reimbursements from Gilead for the collaboration on chronic HBV and HIV infections [117]. - A $5.0 million milestone payment was achieved for the first person dosed in a Phase 1b clinical trial of HB-500 for HIV treatment [118]. - The company received a non-refundable upfront payment of $25.0 million from Roche under the Roche Collaboration Agreement [167]. - Roche made milestone payments totaling $20.0 million for the HB-700 program, including $10.0 million for GMP manufacturing and $10.0 million for an IND submission [167]. Patent and Intellectual Property - As of January 13, 2025, the company holds 13 issued U.S. patents and 12 pending U.S. patent applications, along with approximately 210 issued foreign patents and about 90 foreign patent applications [131]. - The non-replicating technology patent family includes five granted patents in the U.S. and patents in multiple European countries, with expiration expected no earlier than 2028 [132]. - The replicating technology patent family includes a U.S. patent expected to expire in April 2037, with European and other international patents expected to expire in 2035 [133]. - The oncology technology portfolio consists of three patent families with expiration dates ranging from 2036 to 2043, covering potential clinical uses of product candidates [136]. - The company relies on trade secrets and confidentiality agreements to protect its proprietary technology, which may be at risk of breach or independent discovery by competitors [148]. - The company has established robust manufacturing processes and relies on qualified CMOs and CLOs for GMP production and testing [202]. Regulatory and Compliance - The FDA regulates the company's product candidates under the Federal Food, Drug, and Cosmetic Act, requiring substantial time and financial resources for compliance [204]. - The company must submit a Biologics License Application (BLA) to the FDA, which includes proof of safety, purity, and potency for marketing approval [207]. - The FDA requires annual progress reports and immediate notification of serious adverse events during clinical trials, ensuring participant safety and compliance with regulations [216]. - A Biologics License Application (BLA) must include comprehensive data from clinical trials, demonstrating the investigational product's safety, purity, and potency to the FDA [219]. - The FDA has a ten-month review period for standard BLAs and six months for priority reviews, although these timelines may be extended due to requests for additional information [221]. - Preapproval inspections of manufacturing facilities are mandatory to ensure compliance with current Good Manufacturing Practices (cGMP) before a BLA can be approved [222]. Market and Competition - The company faces competition from various biotechnology firms and must compete on product safety, efficacy, convenience, and treatment cost [201]. - The incidence of pancreatic cancer has increased by over 50% in the last 25 years, with a 5-year survival rate of approximately 9% [63]. - Colorectal cancer had an estimated incidence of 1.9 million cases in 2020, causing 0.9 million deaths worldwide, with a 5-year survival rate of less than 15% for metastatic cases [64].

Group 1 - HOOKIPA Pharma Inc. has announced that it does not intend to make an offer for Poolbeg Pharma plc following non-binding discussions for an all-share acquisition [3] - The announcement is made in accordance with Rule 2.8 of the City Code on Takeovers and Mergers [3][4] - The Board of HOOKIPA had previously extended discussions regarding the potential acquisition, but has now decided against proceeding [3] Group 2 - HOOKIPA and associated parties reserve the right to set aside restrictions under Rule 2.8 under certain circumstances, including agreement from Poolbeg's board or a firm intention to make an offer by a third party [4] - The announcement constitutes inside information as per the Market Abuse Regulation [2]

Core Viewpoint - HOOKIPA Pharma Inc. is advancing the development of HB-500, a next-generation therapeutic vaccine for HIV, in collaboration with Gilead Sciences, with the completion of a Phase 1b clinical trial expected in the second half of 2025 [1][2][4]. Company Overview - HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapeutics targeting cancer and serious infectious diseases [9]. - The company utilizes a proprietary arenavirus platform to create product candidates designed to induce robust CD8+ T cells and antibodies [9]. Clinical Trial Details - Enrollment in the Phase 1b clinical trial for HB-500 is complete, with 30 participants enrolled across five sites in the United States [2]. - The trial evaluates the safety, tolerability, reactogenicity, and immunogenicity of HB-500 in participants with HIV on suppressive antiretroviral treatment [4]. - The trial design includes two dose escalation cohorts, with participants randomized to receive either HB-500 or a placebo [4]. Collaboration with Gilead - HOOKIPA is responsible for advancing the HIV program through the completion of the Phase 1b clinical trial, after which Gilead has the exclusive right to assume further development [6]. - HB-500 is one of two developmental programs under the collaboration and license agreement with Gilead [6]. Vaccine Mechanism - HB-500 consists of two genetically engineered replicating vectors based on the Pichinde virus and lymphocytic choriomeningitis virus, designed to deliver HIV antigens that cover over 80% of circulating HIV-1 variants [7]. - The vaccine aims to induce robust and durable immunity as part of a combination strategy for a potential functional cure for HIV [5]. HIV Context - HIV remains a significant global public health challenge, with over 38 million people living with the virus worldwide [8]. - Current treatments have improved the lives of those with HIV, but there is still no cure for HIV or AIDS [8].

Key Information - The disclosure is made by HOOKIPA Pharma Inc. as the offeror in relation to its own securities [1] - The position held as of January 7, 2025, indicates no interests or short positions in HOOKIPA common stock [3][4] - The disclosure includes details of interests held by directors of HOOKIPA Pharma Inc., with minimal shareholding percentages [6][7] Positions of the Party to the Offer - HOOKIPA Pharma Inc. has reported zero interests and short positions in its common stock [3] - No cash-settled or stock-settled derivatives are held by the company [3] Rights to Subscribe for New Securities - There are no rights to subscribe for new securities reported [5] Positions of Persons Acting in Concert - Directors of HOOKIPA Pharma Inc. hold minimal shares, with Julie O'Neill holding 496 shares and David R. Kaufman holding 457 shares, both representing 0.00% of total shareholding [6] - Various stock options and awards are detailed for directors, with vesting dates and exercise prices specified [7][8] Other Information - There are no indemnity or option arrangements reported that may influence dealings in relevant securities [13] - No agreements or understandings regarding voting rights or future acquisitions/disposals of relevant securities are disclosed [14] - No supplemental forms are attached to the disclosure [15]

Core Viewpoint - HOOKIPA Pharma Inc. is in the process of a potential all-share acquisition of Poolbeg Pharma plc, with relevant U.K. disclosure requirements highlighted for shareholders [2][3][8]. Group 1: Acquisition Details - The acquisition was announced on January 2, 2025, and is subject to U.K. City Code on Takeovers and Mergers [2][3]. - Rule 8.3 of the Takeover Code mandates disclosures for shareholders holding 1% or more of relevant securities during the offer period [3]. - Relevant securities include HOOKIPA's common stock, Class A common stock, and various series of convertible preferred stock [3]. Group 2: Company Overview - HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company focused on developing immunotherapeutics for cancer and serious infectious diseases [5]. - The company utilizes a proprietary arenavirus platform to induce CD8+ T cells and antibodies targeting various cancers, including HPV16+ and KRAS mutated cancers [5]. - HOOKIPA has partnered with Gilead Sciences to develop therapies aimed at functional cures for hepatitis B and HIV-1 [5].

Potential Combination Update - Poolbeg Pharma and HOOKIPA Pharma are in discussions regarding a potential combination, with significant shareholder Gilead Sciences indicating its intention to vote in favor of the deal if a formal offer is made [2][3] - Gilead owns 1,875,947 HOOKIPA common shares, representing 19.4% of HOOKIPA's existing issued share capital [3] Fundraise Details - HOOKIPA has amended the details of its planned Fundraise, now expecting to undertake a 100% primary private placement fundraise of approximately $30 million+, up from the previously stated $30 million [4] - Oppenheimer & Co Inc has been engaged as the placement agent for the private placement fundraise [5] Advisors and Contacts - Poolbeg has engaged Cavendish Capital Markets, Canaccord Genuity, Shore Capital, and J&E Davy as financial advisers and brokers [6][7][14][15] - HOOKIPA has engaged Moelis & Company as its financial adviser [8][16] - Contact details for key executives and investor relations teams at both companies are provided [6][7]

Core Points - HOOKIPA Pharma Inc. has amended its previous announcement regarding the potential combination with Poolbeg Pharma plc, specifically correcting the ISIN of its common stock [2][3] - The correct ISIN for HOOKIPA's common stock is US43906K2096, effective after a 1-for-10 reverse stock split on July 9, 2024 [3][4] - HOOKIPA currently has 9,655,022 shares of common stock issued, along with additional classes of stock including Class A common stock and various series of convertible preferred stock [4][5] Stock Structure - HOOKIPA has 2,399,517 shares of Class A common stock, which can be converted into common stock at a ratio of 10:1, subject to ownership limitations [5][6] - The company also has 370 shares of Series A convertible preferred stock, 10,800 shares of Series A-1 convertible preferred stock, and 15,268 shares of Series A-2 convertible preferred stock, each convertible into 100 shares of common stock [5][6] - HOOKIPA has granted 369,070 shares of common stock in the form of restricted stock units as part of its incentive plans [7]