HOOKIPA Pharma Reports Third Quarter 2024 Financial Results and Provides Recent Business Updates
HOOKIPA Pharma (NASDAQ: HOOK) reported Q3 2024 financial results and business updates. Key highlights include completion of Phase 2 study enrollment for eseba-vec + pembrolizumab in HPV+ HNSCC with 68 patients, and first patients dosed in Phase 2 adjuvant therapy study with MSKCC. The company reported Q3 revenue of $4.7 million, down from $6.9 million in Q3 2023. Net loss was $13.8 million compared to $19.1 million in the same period last year. Cash position stood at $60.0 million as of September 30, 2024. The company received a $5.0 million milestone payment from Gilead for HB-500 HIV-1 treatment trial initiation.
HOOKIPA Pharma (NASDAQ: HOOK) ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti aziendali. I punti salienti includono il completamento dell'arruolamento nello studio di Fase 2 per eseba-vec + pembrolizumab in HNSCC positivo per HPV con 68 pazienti, e i primi pazienti trattati nello studio di terapia adiuvante di Fase 2 con MSKCC. La società ha riportato ricavi del terzo trimestre di $4,7 milioni, in calo rispetto ai $6,9 milioni del terzo trimestre del 2023. La perdita netta è stata di $13,8 milioni rispetto ai $19,1 milioni nello stesso periodo dell'anno scorso. La posizione di cassa si attestava a $60,0 milioni al 30 settembre 2024. L'azienda ha ricevuto un pagamento di $5,0 milioni da Gilead per l'avvio della sperimentazione del trattamento HB-500 per l'HIV-1.
HOOKIPA Pharma (NASDAQ: HOOK) informó sobre los resultados financieros y las actualizaciones comerciales del tercer trimestre de 2024. Los aspectos más destacados incluyen la finalización de la inscripción en un estudio de Fase 2 para eseba-vec + pembrolizumab en HNSCC positivo para HPV con 68 pacientes, y los primeros pacientes tratados en un estudio de terapia adyuvante de Fase 2 con MSKCC. La empresa reportó ingresos del tercer trimestre de $4.7 millones, una disminución de $6.9 millones en el tercer trimestre de 2023. La pérdida neta fue de $13.8 millones en comparación con $19.1 millones en el mismo período del año pasado. La posición de efectivo se situó en $60.0 millones al 30 de septiembre de 2024. La compañía recibió un pago de hito de $5.0 millones de Gilead por el inicio del ensayo de tratamiento HB-500 para el VIH-1.
HOOKIPA Pharma (NASDAQ: HOOK)는 2024년 3분기 재무 결과 및 사업 업데이트를 발표했습니다. 주요 내용으로는 HPV+ HNSCC에서 eseba-vec + pembrolizumab에 대한 2상 연구 참가자 모집 완료와 MSKCC와의 2상 보조요법 연구에서 첫 환자 투여가 포함됩니다. 이 회사는 3분기 수익이 470만 달러로, 2023년 3분기 690만 달러에서 감소했다고 보고했습니다. 순손실은 1380만 달러로, 작년 동기 1910만 달러와 비교되었습니다. 2024년 9월 30일 현재 현금 보유액은 6000만 달러로 집계되었습니다. 이 회사는 Gilead로부터 HB-500 HIV-1 치료 시험 시작에 대한 500만 달러의 마일스톤 지급을 받았습니다.
HOOKIPA Pharma (NASDAQ: HOOK) a annoncé les résultats financiers et les mises à jour commerciales pour le troisième trimestre de 2024. Les points saillants incluent l'achèvement de l'inscription à l'étude de Phase 2 pour eseba-vec + pembrolizumab dans le cas du HNSCC positif pour HPV avec 68 patients, ainsi que les premiers patients traités dans l'étude de thérapie adjuvante de Phase 2 avec MSKCC. L'entreprise a rapporté des revenus de 4,7 millions de dollars au T3, en baisse par rapport à 6,9 millions de dollars au T3 2023. La perte nette s'élevait à 13,8 millions de dollars contre 19,1 millions de dollars pour la même période l'année dernière. La position de trésorerie était de 60,0 millions de dollars au 30 septembre 2024. L'entreprise a reçu un paiement de jalon de 5,0 millions de dollars de Gilead pour le lancement de l'essai de traitement HB-500 pour le VIH-1.
HOOKIPA Pharma (NASDAQ: HOOK) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und Unternehmensupdates. Zu den Highlights zählt der Abschluss der Patienteneinschreibung für die Phase-2-Studie zu eseba-vec + Pembrolizumab bei HPV+ HNSCC mit 68 Patienten, sowie die ersten Patienten, die in der Phase-2-Studie zur adjuvanten Therapie mit MSKCC behandelt wurden. Das Unternehmen meldete Umsätze von 4,7 Millionen US-Dollar im dritten Quartal, ein Rückgang von 6,9 Millionen US-Dollar im dritten Quartal 2023. Der Nettoverlust betrug 13,8 Millionen US-Dollar im Vergleich zu 19,1 Millionen US-Dollar im gleichen Zeitraum des Vorjahres. Die Barbestände beliefen sich zum 30. September 2024 auf 60,0 Millionen US-Dollar. Das Unternehmen erhielt eine Meilensteinzahlung in Höhe von 5,0 Millionen US-Dollar von Gilead für den Beginn der HB-500-HIV-1-Behandlungsstudie.
- Received $5.0 million milestone payment from Gilead collaboration
- Reduced net loss to $13.8 million from $19.1 million YoY
- Completed Phase 2 study enrollment ahead of schedule
- Revenue decreased to $4.7 million from $6.9 million YoY
- Cash position declined to $60.0 million from $117.5 million since December 2023
- Restructuring expenses of $0.9 million due to workforce reduction
- Impairment charges of $0.2 million for laboratory equipment
Insights
The Q3 2024 results reveal concerning financial metrics for HOOKIPA Pharma. Cash position declined significantly to
The clinical development updates show mixed signals. The accelerated enrollment completion for eseba-vec Phase 2 study in HPV+ HNSCC is positive, with 68 patients enrolled ahead of schedule. The expansion into adjuvant therapy through the MSKCC investigator-led trial could broaden market potential. However, the pause of HB-300 development and workforce reduction suggest resource constraints affecting pipeline advancement. While the HB-700 KRAS program shows promising preclinical data and the Gilead collaboration continues with HIV and HBV programs, the overall pipeline progress appears to be slowing due to financial limitations.
Enrollment of 68 patients completed Phase 2 study for eseba-vec + pembrolizumab in HPV+ HNSCC four months ahead of schedule
SITC 2024 late-breaking poster highlights Phase 2 eseba-vec data updates for increased number of patients reflecting ORR and durability in line with prior data
First patients dosed in Phase 2 investigator led study with MSKCC in new clinical setting as adjuvant therapy for head and neck cancer
Strength of HB-700 KRAS-inhibitor program highlighted by preclinical dataset presented at recent RAS Targeted Drug Development Summit
NEW YORK and VIENNA, Austria, Nov. 14, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, “HOOKIPA”, the “Company”), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, today reported financial results for the third quarter ended September 30, 2024 and provided recent business highlights, including an update on the progress of the lead clinical program, eseba-vec.
“HOOKIPA made excellent progress across each program in our pipeline in the third quarter,” said Malte Peters, MD, Chief Executive Officer of HOOKIPA. “We advanced the development of eseba-vec for HPV16+ head and neck squamous cell carcinoma (HNSCC), through the start of an investigator-initiated study in the new clinical setting of adjuvant care, and presented continued positive, updated data from our Phase 2 study in first-line recurrent/metastatic disease as a late breaking abstract at SITC 2024. In parallel, we have made significant progress with our review of the business strategy and operations, having implemented a number of initiatives to optimize spending and ensure prioritization of resources.”
Recent Developments
Oncology
Eseba-vec: Pivotal-trial ready immunotherapy for human papilloma virus type 16 positive (HPV16+) cancers, including head and neck squamous cell carcinoma (HNSCC) and oropharyngeal squamous cell carcinoma (OPSCC). HOOKIPA owns all rights to this program.
- Enrollment completed in the Phase 2 H200-001 study for eseba-vec in combination with pembrolizumab in HPV+ HNSCC with 68 patients enrolled as of October 2024.
- First Patients Dosed in Phase 2 Adjuvant Therapy IIT with MSKCC: On October 30, 2024, HOOKIPA announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) dosed the first patients in an investigator-initiated trial (IIT) evaluating eseba-vec in patients with minimal residual disease positive (MRD+) HPV-16+ driven, locally advanced HNSCC, following treatment for curative intent. The study could pave the way to broaden the eseba-vec HNSCC opportunity into adjuvant care.
- Updated Phase 2 Data Presented as SITC 2024 Late-Breaker: On November 9, 2024, HOOKIPA’s clinical collaborator, Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at MSKCC, presented a late-breaking poster at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The presentation provided updated results, including data from additional patients enrolled in the Phase 2 trial evaluating eseba-vec plus pembrolizumab as 1L treatment of recurring/metastatic HPV16+ HNSCC in patients with PD-L1 CPS levels of greater than or equal to 20. Eseba-vec treatment resulted in continued, durable clinical responses and antigen-specific T cell responses.
HB-700: The HB-700 program is a novel Phase 1-ready immunotherapy for KRAS-mutated cancers, including pancreatic, colorectal and lung cancer. The investigational therapy was designed to target the most prevalent KRAS mutations of these cancers in a single therapy. HOOKIPA owns all rights to this program and the Investigational New Drug Application (IND) received FDA clearance in April 2024.
- Presentation of Strong Preclinical Dataset: On September 25, 2024, HOOKIPA presented the preclinical proof-of-concept dataset for HB-700 at the 6th Annual RAS-Targeted Drug Development Summit. The dataset demonstrated that HB-700 induced target-specific CD8+ T cells and target cell killing in several different animal and translational models.
Infectious Diseases
HOOKIPA is advancing two independent anti-viral programs (HB-400 for HBV and HB-500 for HIV-1) through a collaboration and license agreement with Gilead Sciences, Inc. (Gilead).
HB-400: An investigational therapeutic vaccine for the treatment of chronic hepatitis B (CHB).
- Enrollment Completed in Phase 1a/1b Clinical Trial: The vaccine is being evaluated in a Phase 1a/1b clinical trial (NCT05770895) in 83 subjects to assess the safety and immune response induced by HB400 in healthy participants and in participants with CHB on oral antiviral therapy.
HB-500: An investigational therapeutic vaccine for the treatment of human immunodeficiency virus-1 (HIV-1).
- Ongoing Phase 1b Clinical Trial: The vaccine is being evaluated in a Phase 1b clinical trial (NCT06430905) to assess the safety and magnitude of cellular immune response against HIV-1 induced by HB-500 in people living with HIV who are taking anti-retroviral treatment. Under the collaboration agreement with Gilead, HOOKIPA received a
$5 million milestone payment associated with dosing of the first subject in this trial in July 2024.
Corporate and Financial Updates
Corporate Highlights
- Board of Director Changes: On August 30, 2024, Director Julie O’Neill was appointed to be Non-Executive Chair of the Company’s Board of Directors, succeeding Jan van de Winkel, who decided to step down from the Board due to increased time commitments from other executive responsibilities. Tim Reilly also stepped down from the Board to dedicate more time to his other professional responsibilities. HOOKIPA is grateful for the years of service each Director dedicated to the Company.
- Leadership Changes: On July 22, 2024, the Board of Directors appointed Malte Peters, MD, as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer to lead the Company through its next phase of development and to realize the significant opportunity of HOOKIPA’s pipeline.
- Board Appointment: On July 22, 2024, Sean Cassidy was appointed to the Board of Directors. Mr. Cassidy serves as the chair of the Audit Committee and as a member of the Compensation and the Nominating and Corporate Governance Committees.
- Reverse Split: On July 9, 2024, the Company effected a reverse stock split of the outstanding shares of its common stock on a one-for-ten (1:10) basis. 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.
Financial Highlights: Milestone Payments
- Gilead: In July, HOOKIPA received a
$5.0 million milestone payment under its collaboration and license agreement with Gilead. The success-based milestone payment was achieved in connection with the dosing of the first subject in the Phase 1b clinical trial of HB-500 for the treatment of HIV-1, initiated on July 1, 2024.
Third Quarter 2024 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2024 was
Revenue: Revenue was
Research and Development Expenses: HOOKIPA’s research and development expenses were
General and Administrative Expenses: General and administrative expenses amounted to
Restructuring Expenses: Restructuring expenses amounted to
Impairment Expenses: Impairment expenses amounted to
Net Loss: HOOKIPA’s net loss was
| HOOKIPA Pharma Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data) | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue from collaboration and licensing | $ | 4,703 | $ | 6,867 | $ | 42,592 | $ | 12,722 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (15,565 | ) | (24,625 | ) | (55,482 | ) | (65,262 | ) | ||||||||
| General and administrative | (6,732 | ) | (4,912 | ) | (14,733 | ) | (14,259 | ) | ||||||||
| Restructuring | (878 | ) | — | (2,201 | ) | — | ||||||||||
| Impairment | (172 | ) | — | (172 | ) | — | ||||||||||
| Total operating expenses | (23,347 | ) | (29,537 | ) | (72,588 | ) | (79,521 | ) | ||||||||
| Loss from operations | (18,644 | ) | (22,670 | ) | (29,996 | ) | (66,799 | ) | ||||||||
| Total interest, other income and taxes, net | 4,803 | 3,604 | 11,443 | 10,037 | ||||||||||||
| Net loss | $ | (13,841 | ) | $ | (19,066 | ) | $ | (18,553 | ) | $ | (56,762 | ) | ||||
| Net loss per share — basic and diluted | (1.10 | ) | (1.73 | ) | (1.48 | ) | (6.41 | ) | ||||||||
| Condensed Balance Sheets (Unaudited) (In thousands) | ||||||||
| As of | As of | |||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and restricted cash | $ | 59,957 | $ | 117,521 | ||||
| Total assets | 109,730 | 161,337 | ||||||
| Total liabilities | 37,928 | 71,480 | ||||||
| Total stockholders’ equity | 71,802 | 89,857 | ||||||
About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing next generation immunotherapeutics based on its proprietary arenavirus platform. The company’s product candidates are designed to induce specific, robust and durable CD8+ T cells and antibodies to eliminate cancers and serious infectious diseases. HOOKIPA’s pipeline includes biological therapies for oncology, targeting human papillomavirus type 16-positive (HPV16+) cancers, KRAS mutated cancers, and other targets. In addition, HOOKIPA has partnered with Gilead Sciences, Inc. to develop therapies that are intended to provide functional cures for hepatitis B virus (HBV) and human immunodeficiency virus-1 (HIV-1). Find out more about HOOKIPA online at www.hookipapharma.com.
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 “anticipates”, “believes”, “could”, “expects”, “plans”, “potential”, “will”, “would” or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA’s statements regarding the potential of its product candidates to improve the care of the patients it seeks to treat, the potential of its Phase 2 IIT to support the use of eseba-vec in adjuvant care, and other statements that are not historical fact. 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, plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical studies and clinical trials, the ability to initiate new clinical programs, the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical studies and clinical trials, including those for eseba-vec (also known as HB200), HB-700, HB-400 and HB-500, 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, and HOOKIPA’s ability to continue as a going concern and other matters that could affect the sufficiency of existing cash to fund operations. 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 Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA’s subsequent filings with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at https://sec.gov and HOOKIPA’s website at www.hookipapharma.com. All information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law.
Availability of Other Information About HOOKIPA
Investors and others should note that we announce material financial information to our investors using our investor relations website, www.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 investors and the public about our company, 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 social media channels listed on our investor relations website.
For further information, please contact:
Investors
Chuck Padala
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