Immune - based intratumoral cancer therapies

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Intensity Therapeutics, Inc. Announces Pricing of Public Offering
Prnewswire· 2025-06-12 03:46
Core Viewpoint - Intensity Therapeutics, Inc. has announced a public offering of 6,675,000 shares at a price of $0.30 per share, aiming to raise approximately $2,002,500 before expenses, with a closing date expected on June 13, 2025 [1][2] Group 1: Offering Details - The public offering consists of 6,675,000 shares priced at $0.30 each, generating gross proceeds of $2,002,500 [1] - The underwriters have a 45-day option to purchase an additional 1,001,250 shares to cover over-allotments [1] - The offering will close on June 13, 2025, pending customary closing conditions [1] Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for patient enrollment and data readout in the INVINCIBLE-4 Study, treatment of patients in the INVINCIBLE-3 Study, and for general corporate purposes [2] Group 3: Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies [5] - The investigational drug INT230-6 has shown potential in killing tumors and eliciting immune responses, with over 200 patients enrolled in clinical trials [5] - The company has completed two clinical studies and initiated a Phase 3 trial in soft tissue sarcoma and a Phase 2 study for presurgical triple-negative breast cancer [5]
Intensity Therapeutics, Inc. Announces Proposed Public Offering of Common Stock
Prnewswire· 2025-06-11 20:06
Core Viewpoint - Intensity Therapeutics, Inc. plans to conduct an underwritten public offering of its common stock to fund clinical trials and general corporate purposes [1][2]. Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies that aim to kill tumors and enhance immune system recognition of cancers [1][5]. - The company has developed a novel drug, INT230-6, which has shown the ability to kill tumors and elicit an adaptive immune response shortly after injection, potentially transforming the treatment of various cancers [5]. Clinical Trials and Studies - Intensity has completed two clinical studies involving over 200 patients, including a Phase 1/2 dose escalation study in metastatic cancers and a Phase 2 randomized control trial in locally advanced breast cancer [5]. - The company is currently conducting a Phase 3 trial in soft tissue sarcoma (INVINCIBLE-3 Study) and a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research (INVINCIBLE-4 Study) [5]. Use of Proceeds - The net proceeds from the public offering will be allocated to patient enrollment and data readout for the INVINCIBLE-4 Study, treatment of patients in the INVINCIBLE-3 Study, and for working capital and general corporate purposes [2]. Offering Details - The securities will be offered under a shelf registration statement filed with the SEC, and a preliminary prospectus supplement will be available for interested parties [3].
Intensity Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Prnewswire· 2025-05-13 20:06
Core Viewpoint - Intensity Therapeutics, Inc. reported its first quarter 2025 financial results and provided updates on its clinical studies, particularly focusing on the INVINCIBLE-3 and INVINCIBLE-4 studies for its lead product candidate INT230-6, which targets various cancer types [1][7]. Corporate Update - The INVINCIBLE-4 Study is a Phase 2 trial assessing the efficacy of INT230-6 in combination with standard of care for early-stage operable triple-negative breast cancer, with a primary endpoint of pathological complete response rate [2]. - The study is currently recruiting patients in Switzerland and is expected to enroll 54 patients across Switzerland and France, with authorization from the European Medicines Agency [3]. - The INVINCIBLE-3 Study is a Phase 3 trial evaluating INT230-6 as a monotherapy for certain soft tissue sarcoma subtypes, with a planned enrollment of 333 patients across eight countries [4]. - The Company paused new site activations and patient enrollments for the INVINCIBLE-3 Study due to funding constraints, having previously enrolled 23 patients [5]. Financial Results - For the first quarter of 2025, research and development expenses were $2.2 million, down from $2.8 million in the same period of 2024, while general and administrative expenses decreased to $1.2 million from $1.9 million [8][10]. - The overall net loss for the quarter was $3.3 million, an improvement from a net loss of $4.6 million in the first quarter of 2024 [11]. - As of March 31, 2025, the Company had cash and cash equivalents totaling $0.9 million, a decrease from $2.6 million at the end of 2024 [11][17]. Product Information - INT230-6 is designed for direct intratumoral injection and combines two anti-cancer agents, cisplatin and vinblastine, with a penetration enhancer to improve drug distribution within tumors [12]. - The drug aims to elicit both local tumor control and systemic immune responses without the immunosuppression typically associated with systemic chemotherapy [13].
Intensity Therapeutics, Inc. Announces $2.35 Million Public Offering
Prnewswire· 2025-04-25 12:00
Core Viewpoint - Intensity Therapeutics, Inc. has announced a public offering of 3,133,333 shares of common stock and accompanying warrants, aiming to raise approximately $2.35 million to fund clinical studies and general corporate purposes [1][3]. Group 1: Offering Details - The public offering includes Series B-1 and Series B-2 common warrants, both with an exercise price of $0.85 per share [2]. - The Series B-1 warrants will expire 5 years from issuance, while the Series B-2 warrants will expire 18 months from issuance [2]. - The offering is expected to close on or about April 28, 2025, subject to customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for patient enrollment in the INVINCIBLE-4 Study, treatment of patients in the INVINCIBLE-3 Study, and for working capital and general corporate purposes [3]. Group 3: Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies [7]. - The company has completed two clinical studies and enrolled over 200 patients using its lead product, INT230-6, which has shown potential in treating various cancers [7]. - Ongoing studies include a Phase 3 trial in soft tissue sarcoma and a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research [7].
Intensity Therapeutics Reports 2024 Year End Financial Results and Provides Corporate Update
Prnewswire· 2025-03-13 20:07
Core Viewpoint - Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies, with recent updates on clinical trials and financial results for 2024 [1][6]. Corporate Update - The INVINCIBLE-3 Study is a Phase 3 trial testing INT230-6 as a monotherapy against standard of care drugs for certain soft tissue sarcoma subtypes, with an expected enrollment of 333 patients across eight countries [2]. - The INVINCIBLE-4 Study is a Phase 2 trial analyzing the safety and efficacy of INT230-6 in early-stage triple-negative breast cancer patients, with an expected enrollment of approximately 54 patients in Switzerland and France [4]. - The company has initiated and dosed its first patient in both the INVINCIBLE-3 and INVINCIBLE-4 studies, with ongoing patient recruitment and site activation [3][5]. Financial Results - Research and development expenses for 2024 were $10.5 million, up from $4.8 million in 2023, primarily due to costs associated with the INVINCIBLE-3 Study [7]. - General and administrative expenses increased to $6.1 million in 2024 from $3.5 million in 2023, driven by higher salaries, legal fees, and insurance costs [9]. - The net loss for 2024 was $16.3 million, compared to a net loss of $10.5 million in 2023, with a loss per share of $1.17 [9][15]. Cash Position - As of December 31, 2024, the company reported cash and cash equivalents totaling $2.6 million, a decrease from $14.8 million in 2023 [10][16]. Product Information - INT230-6 is the company's lead investigational product, designed for direct intratumoral injection, combining cisplatin and vinblastine with a penetration enhancer to improve drug distribution within tumors [11][12]. - The drug aims to elicit an immune response while maintaining a favorable safety profile, representing a potential shift in cancer treatment paradigms [12].