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]

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]

Core Insights - HOOKIPA Pharma Inc. is presenting preclinical data for its HB-700 program targeting KRAS mutated cancers at the 6th Annual RAS-Targeted Drug Development Summit in Boston from September 24-26, 2024 [1][2] Company Overview - HOOKIPA is a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapeutics using its proprietary arenavirus platform [3] - The company aims to induce specific, robust, and durable CD8+ T cells and antibodies to combat cancers and serious infectious diseases [3] - HOOKIPA's pipeline includes therapies for HPV16+ cancers, KRAS mutated cancers, and partnerships with Gilead for hepatitis B and HIV-1 treatments [3] Product Development - The HB-700 program is designed to target the most prevalent KRAS mutations found in pancreatic, colorectal, and lung cancers [2] - The preclinical dataset for HB-700 has shown safety, induction of target-specific CD8+ T-cells, and effective target cell killing in various animal and translational models [2] - The program has received IND clearance from the FDA in Q2 2024, making it ready for Phase 1 trials [2]

Core Viewpoint - HOOKIPA Pharma Inc. has announced leadership changes in its Board of Directors, with Julie O'Neill appointed as Non-Executive Chair, succeeding Jan van de Winkel, who stepped down due to increased commitments as CEO of Genmab A/S, and Tim Reilly also stepping down to focus on other responsibilities [1][2]. Company Overview - HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies based on its proprietary arenavirus platform, aimed at mobilizing and amplifying targeted T cells to combat serious diseases [3]. - The company's pipeline includes investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and other undisclosed programs, as well as efforts to develop functional cures for HBV and HIV in collaboration with Gilead [3].

Core Insights - HOOKIPA Pharma Inc. has made significant progress in its clinical development pipeline, particularly with its lead product candidate eseba-vec, which is on track for a pivotal Phase 2/3 trial initiation in Q4 2024 [1][3][4] - The company has received positive regulatory feedback, including alignment with the FDA for the AVALON-1 trial design and PRIME designation from the EMA for eseba-vec [1][3] - HOOKIPA has also expanded its oncology portfolio with the FDA clearance of its IND application for HB-700, targeting KRAS-mutated cancers [5] Leadership and Corporate Updates - Malte Peters has been appointed as the new CEO, emphasizing optimism about the company's prospects and the strength of its pipeline [2] - The company executed a reverse stock split on a one-for-ten basis to comply with Nasdaq listing requirements [7] Clinical Development Highlights - The Phase 2 data for eseba-vec presented at ASCO 2024 has generated significant momentum, enhancing enrollment in ongoing studies [2][4] - The AVALON-1 trial for eseba-vec is expected to start in Q4 2024, with a focus on HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma [3][4] Financial Performance - HOOKIPA reported a revenue of $1.3 million for Q2 2024, down from $2.7 million in Q2 2023, primarily due to the termination of the Roche collaboration [10] - The company's net loss for Q2 2024 was $19.1 million, slightly higher than the $18.0 million loss in the same period of 2023 [14] - As of June 30, 2024, HOOKIPA's cash position was $77.4 million, a decrease from $117.5 million at the end of 2023 [9][16] Research and Development Updates - HOOKIPA is actively enrolling patients in the Phase 1b trial for HB-500, an investigational therapeutic vaccine for HIV, in collaboration with Gilead [6] - The company is also evaluating partnerships for the HB-700 program targeting KRAS-mutated cancers [3][5]

Core Viewpoint - HOOKIPA Pharma Inc. (HOOK) has seen a 0.6% increase in share price over the past four weeks, closing at $5.12, with Wall Street analysts suggesting a potential upside of 634.4% based on a mean price target of $37.60 [1] Price Targets - The average price target consists of five estimates ranging from a low of $15 to a high of $60, with a standard deviation of $18.61, indicating variability among analysts [2] - The lowest estimate suggests a 193% increase from the current price, while the highest indicates a 1071.9% upside [2] Analyst Consensus and Earnings Estimates - Analysts are increasingly optimistic about HOOK's earnings prospects, as evidenced by a positive trend in earnings estimate revisions, which historically correlate with stock price movements [4][9] - Over the last 30 days, the Zacks Consensus Estimate for the current year has risen by 25.7%, with one estimate increasing and no negative revisions [10] Zacks Rank - HOOK currently holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [11]

Core Insights - HOOKIPA Pharma Inc. has appointed Dr. Malte Peters as CEO and Terry Coelho as CFO, effective July 22, 2024, both retaining their positions on the Board of Directors [1][9][22] - The company is entering a critical phase for its lead candidate HB-200, having received PRIME designation from the European Medicines Agency and aligning on a clinical development strategy with the U.S. FDA for potential accelerated approval [2][30] - The company is also advancing its other programs, including HB-500 for HIV treatment, with the first patient recently dosed in a Phase 1b clinical trial [2][30] Leadership Changes - Dr. Malte Peters has extensive experience in the pharmaceutical and biotech industries, previously serving as Chief Research and Development Officer at MorphoSys [4][11] - Terry Coelho has over 35 years of experience in finance and business development, having held various executive roles, including CFO at Gamida Cell and CinCor Pharma [6][13] - Sean Cassidy has been appointed to the Board of Directors, bringing over 20 years of experience in the biotechnology and pharmaceutical sectors [10][28] Product Development - HB-200 is HOOKIPA's lead oncology candidate, engineered with a proprietary replicating arenaviral vector platform, targeting HPV16-positive cancers [8][30] - The company is conducting a review of its business operations and strategy to maximize shareholder value and the potential of HB-200 [9][23] - HOOKIPA's pipeline includes investigational immunotherapies targeting various cancers and aims to develop functional cures for HBV and HIV in collaboration with Gilead [18][30]

Core Viewpoint - HOOKIPA Pharma Inc. will implement a 1-for-10 reverse stock split effective July 9, 2024, to comply with Nasdaq's minimum bid price requirement, reducing the number of outstanding shares from approximately 96.6 million to about 9.7 million [5][10]. Company Overview - HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary arenavirus platform, targeting serious diseases such as Human Papillomavirus 16-positive cancers and KRAS-mutated cancers [6]. Reverse Stock Split Details - The reverse stock split will combine every 10 shares of common stock into one share, with no change in par value, and will not issue fractional shares, instead providing cash payments for them [3]. - Following the split, the number of authorized shares will decrease from 400 million to 40 million, with proportional adjustments made to various stock options and convertible preferred stock [3]. - The common stock will continue trading on the Nasdaq under the symbol "HOOK" with a new CUSIP number [5]. Market Impact - The reverse stock split is part of the company's strategy to regain compliance with Nasdaq's minimum bid price requirement, which is crucial for maintaining its listing on the exchange [5].

Core Points - HOOKIPA Pharma Inc. will implement a 1-for-10 reverse stock split effective July 9, 2024, to comply with Nasdaq's minimum bid price requirement [11] - The reverse stock split will reduce the number of outstanding shares from approximately 96.6 million to about 9.7 million [4] - Following the split, the company's common stock will continue trading on the Nasdaq under the symbol "HOOK" with a new CUSIP number [1] Company Overview - HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies based on its proprietary arenavirus platform [12] - The company's pipeline includes investigational immunotherapies targeting Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and aims to develop functional cures for HBV and HIV in collaboration with Gilead [12] - HOOKIPA's technologies are designed to mobilize and amplify targeted T cells to fight or prevent serious diseases [12] Reverse Stock Split Details - At the effective time of the reverse split, every 10 shares will be combined into one share without changing the par value [8] - Fractional shares will not be issued; stockholders entitled to a fractional share will receive a cash payment [8] - The number of authorized shares will be reduced from 400 million to 40 million, with proportional adjustments made to various stock options and convertible securities [8]