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Intensity Therapeutics, Inc. Raises $6.6 Million from At The Market Offering (ATM) Stock Sales in July 2025
Prnewswire· 2025-08-04 11:47
Core Viewpoint - Intensity Therapeutics, Inc. successfully raised $6.6 million in gross proceeds through an At-the-Market (ATM) offering, enhancing its financial position to support ongoing clinical trials into the second half of 2026 [1][2]. Financial Summary - The company sold 19,868,658 shares at an average price of $0.3323 per share, resulting in $6.3 million net proceeds after costs [1]. - The average sales price per share was over 10% higher than the price from a public offering completed in June 2025 [2][6]. Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing intratumoral cancer therapies using proprietary non-covalent conjugation technology [1][5]. - The lead product candidate, INT230-6, is designed for direct intratumoral injection and combines two potent anti-cancer agents, cisplatin and vinblastine sulfate, with a diffusion enhancer [4][5]. - INT230-6 aims to kill tumors while engaging the immune system without causing immunosuppression, representing a novel approach to cancer treatment [4][5]. Clinical Development - The company has completed two clinical studies with over 200 patients enrolled, including a Phase 1/2 study in metastatic cancers and a Phase 2 randomized control trial in locally advanced breast cancer [5]. - A Phase 3 trial in soft tissue sarcoma and a Phase 2 study in collaboration with the Swiss Cancer Group are currently underway [5].
Intensity Therapeutics(INTS) - 2025 FY - Earnings Call Transcript
2025-07-17 15:30
Financial Data and Key Metrics Changes - The meeting confirmed that 10,989,589 shares of the company's voting capital stock were present, representing 59.73% of the outstanding voting stock [6][7] - The appointment of Eisner Amper LLP as auditors for the fiscal year 2025 was ratified with 10,922,860 shares in favor, 17,438 against, and 49,291 abstaining [12] Business Line Data and Key Metrics Changes - No specific data on business lines or key metrics was provided during the meeting Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting Company Strategy and Development Direction and Industry Competition - The company did not provide detailed insights into its strategy or competitive landscape during the meeting Management's Comments on Operating Environment and Future Outlook - Management indicated that remarks and responses would include forward-looking statements, cautioning that actual results may differ significantly from those discussed [14] Other Important Information - The meeting was conducted virtually to enhance stockholder access, and the agenda was made available for review [3] - The final results of the voting will be disclosed in a current report on Form 8-K within four business days of the meeting [13] Q&A Session All Questions and Answers Question: Were there any questions from stockholders? - No questions were received during the Q&A portion, leading to its closure [15]
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, Inc.'s Phase 3 INVINCIBLE-3 Sarcoma Study Selected for Presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting
Prnewswire· 2025-05-29 12:00
Core Insights - Intensity Therapeutics is presenting its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for metastatic soft tissue sarcomas at the ASCO 2025 Annual Meeting [1][2] - The trial aims to compare the efficacy and safety of INT230-6 with standard systemic chemotherapy in adults with locally recurrent, inoperable, or metastatic soft tissue sarcomas [2][6] Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies [1][9] - The lead investigational product, INT230-6, combines cisplatin and vinblastine with a penetration enhancer to improve drug distribution within tumors [5][9] - The company has completed two clinical studies with over 200 patients enrolled, demonstrating the potential of INT230-6 to elicit an adaptive immune response [9] Clinical Trial Details - The INVINCIBLE-3 trial is a multicenter, randomized, global Phase 3 study assessing INT230-6 as a monotherapy compared to standard care [2][6] - Participants will be randomized in a 2:1 ratio to receive either INT230-6 or standard chemotherapy agents [6] - The trial includes specific inclusion and exclusion criteria to ensure appropriate patient selection [7][8] Previous Study Results - In earlier studies, patients with refractory metastatic sarcoma showed a disease control rate of 93% and a median overall survival of 21.3 months with minimal adverse events [4] - The Phase 1/2 trial indicated immune engagement and regression of uninjected tumors post-treatment [4] Future Plans - The company has paused new enrollment for the Phase 3 study until additional funding is secured, while continuing to treat enrolled patients [4]
Intensity Therapeutics(INTS) - 2025 Q1 - Quarterly Results
2025-05-13 20:08
[Corporate Update](index=1&type=section&id=Corporate%20Update) The company advanced its breast cancer trial, paused its sarcoma study due to funding, and raised capital via a public offering - The company is prioritizing funding for the INVINCIBLE-4 study (presurgical breast cancer) over the INVINCIBLE-3 study (sarcoma) due to **cash constraints**[6](index=6&type=chunk)[8](index=8&type=chunk) - Completed a public offering in April 2025, raising aggregate gross proceeds of **$2.35 million**, with net proceeds of approximately **$1.9 million**[7](index=7&type=chunk) [INVINCIBLE-4 Study (Triple-Negative Breast Cancer)](index=1&type=section&id=INVINCIBLE-4%20Study) - A Phase 2 study analyzing INT230-6 before standard of care (SOC) treatment in patients with **early-stage, operable triple-negative breast cancer (TNBC)**[3](index=3&type=chunk) - The study is **actively recruiting patients in Switzerland** and is expected to enroll a total of **54 patients** across Switzerland and France[2](index=2&type=chunk)[3](index=3&type=chunk) - In April 2025, the European Medicines Agency **authorized the initiation of the study in France** in collaboration with Unicancer[4](index=4&type=chunk) [INVINCIBLE-3 Study (Soft Tissue Sarcoma)](index=1&type=section&id=INVINCIBLE-3%20Study) - A Phase 3 study testing INT230-6 as a monotherapy compared to SOC drugs for **second and third-line treatment of certain soft tissue sarcoma subtypes**[5](index=5&type=chunk) - In March 2025, the company **paused new site activations and patient enrollments** for this study due to funding constraints[6](index=6&type=chunk) - The company will **continue to treat all 23 patients already enrolled** in the study during the pause[6](index=6&type=chunk)[8](index=8&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) The company reported a reduced net loss of $3.3 million for Q1 2025, driven by lower R&D and G&A expenses Key Financial Metrics | Financial Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expenses | $2.2 million | $2.8 million | | General and administrative expenses | $1.2 million | $1.9 million | | Net loss | $3.3 million | $4.6 million | | Loss per share | $(0.22) | $(0.34) | | Cash and cash equivalents (as of quarter end) | $0.9 million | N/A | - The decrease in R&D expenses was driven by a **$0.2 million decline in contract manufacturing costs** and a **$0.4 million reduction in stock-based compensation**[9](index=9&type=chunk) - G&A expenses decreased due to cost savings from new administrative systems and a **$0.3 million reduction in stock-based compensation**[10](index=10&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) Unaudited Statements of Operations and Balance Sheets detail the company's financial performance and position as of March 31, 2025 [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) | | Three Months Ended March 31, | | :--- | :--- | :--- | | (in thousands, except per share amounts) | **2025** | **2024** | | **Operating expenses:** | | | | Research and development | $2,189 | $2,815 | | General and administrative | $1,205 | $1,928 | | **Total operating expenses** | **$3,394** | **$4,743** | | **Loss from operations** | **$(3,394)** | **$(4,743)** | | Interest income | $15 | $140 | | Other income, net | $32 | $— | | **Net loss** | **$(3,347)** | **$(4,603)** | | **Loss per share, basic and diluted** | **$(0.22)** | **$(0.34)** | | Weighted average number of shares | 15,173,196 | 13,709,487 | [Balance Sheets](index=6&type=section&id=Balance%20Sheets) | | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | (in thousands) | | | | **Assets** | | | | Cash and cash equivalents | $929 | $2,590 | | Total current assets | $1,651 | $3,363 | | **Total assets** | **$3,065** | **$4,783** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $2,629 | $1,755 | | **Total liabilities** | **$2,731** | **$1,865** | | **Total stockholders' equity** | **$334** | **$2,918** | | **Total liabilities and stockholders' equity** | **$3,065** | **$4,783** | [About INT230-6 and Intensity Therapeutics](index=3&type=section&id=About%20INT230-6%20and%20Intensity%20Therapeutics) INT230-6 is an investigational intratumoral drug designed to kill tumors locally and stimulate a systemic immune response - INT230-6 is composed of two anti-cancer agents, **cisplatin and vinblastine**, and a penetration enhancer molecule (SHAO)[13](index=13&type=chunk) - The drug is designed to kill tumors locally while causing a release of neoantigens that leads to a **systemic anti-tumor immune response**[13](index=13&type=chunk) - The company has initiated a **Phase 3 trial in soft tissue sarcoma** and a **Phase 2 trial in presurgical triple-negative breast cancer**[14](index=14&type=chunk)
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(INTS) - 2025 Q1 - Quarterly Report
2025-05-13 20:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q _________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-41109 INTENSITY THERAPEUTICS, INC. (Exact name of registrant a ...
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].
Is Cencora, Inc. (COR) Outperforming Other Medical Stocks This Year?
ZACKS· 2025-04-21 14:46
Company Performance - Cencora (COR) has returned 27.6% year-to-date, significantly outperforming the Medical group, which has lost about 5.6% on average [4] - Cencora currently holds a Zacks Rank of 2 (Buy), indicating a positive earnings outlook [3] - Over the past 90 days, the Zacks Consensus Estimate for Cencora's full-year earnings has increased by 0.1%, reflecting improving analyst sentiment [3] Industry Context - Cencora is part of the Medical Services industry, which consists of 58 stocks and is currently ranked 86 in the Zacks Industry Rank, with an average loss of 3% this year [5] - In comparison, Intensity Therapeutics Inc. (INTS), another outperforming stock in the Medical sector, has returned 5.1% year-to-date and belongs to the Medical - Biomedical and Genetics industry, which has seen a decline of 7.7% [4][6] - The Medical group includes 1002 companies and is currently ranked 3 in the Zacks Sector Rank, which evaluates the average Zacks Rank of individual stocks within the sector [2]