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].

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 ...

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].

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]

[Corporate Update](index=1&type=section&id=Corporate%20Update) In 2024, Intensity Therapeutics advanced its clinical programs by initiating two key studies: the INVINCIBLE-3 Phase 3 trial for soft tissue sarcoma and the INVINCIBLE-4 Phase 2 trial for triple-negative breast cancer. The company has successfully obtained regulatory authorizations in nine countries, engaged leading global hospitals, and is actively enrolling patients across the US, Canada, Europe, and Australia. Enrollment for INVINCIBLE-3 is expected to complete in the first half of 2026, and for INVINCIBLE-4 by the end of the first quarter of 2026 - Initiated INVINCIBLE-3, a Phase 3 study for soft tissue sarcoma, expected to enroll **333 patients** across eight countries. The first patient was dosed in July 2024, with **32 sites contracted** and **25 patients screened** to date[4](index=4&type=chunk)[5](index=5&type=chunk)[9](index=9&type=chunk) - Initiated INVINCIBLE-4, a Phase 2 study for early-stage triple-negative breast cancer (TNBC) in collaboration with SAKK, expected to enroll approximately **54 patients**. The first patient was dosed in October 2024, with **eight sites activated** in Switzerland[6](index=6&type=chunk)[7](index=7&type=chunk)[9](index=9&type=chunk) - CEO Lewis H. Bender highlighted that in 2024, the company finalized protocols, engaged leading hospitals worldwide, and obtained regulatory authorization to recruit patients in **9 countries**[8](index=8&type=chunk) [2024 Year-End Financial Results](index=3&type=section&id=2024%20Year%20End%20Financial%20Results) For the year ended December 31, 2024, Intensity Therapeutics reported a net loss of **$16.3 million**, an increase from the **$10.5 million** loss in 2023. This was primarily driven by a significant rise in research and development expenses to **$10.5 million** due to the initiation of the INVINCIBLE-3 and INVINCIBLE-4 studies. General and administrative costs also increased. The company ended the year with **$2.6 million** in cash and cash equivalents Key Financial Metrics | Financial Metric | 2024 | 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | Research and Development Expenses | $10.5 million | $4.8 million | +$5.7 million | | General and Administrative Expenses | $6.1 million | $3.5 million | +$2.6 million | | Net Loss | $16.3 million | $10.5 million | +$5.8 million | | Cash and Cash Equivalents (at Dec 31) | $2.6 million | $14.8 million | -$12.2 million | - The increase in R&D expenses was mainly due to a **$5.6 million** increase for the INVINCIBLE-3 Study and a **$0.5 million** increase for the INVINCIBLE-4 Study[10](index=10&type=chunk) - The rise in G&A expenses was attributed to higher salary, benefits, stock-based compensation, legal and consulting fees, and directors and officers insurance[11](index=11&type=chunk) [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) The company's operating loss widened to **$16.6 million** in 2024 from **$8.3 million** in 2023, primarily due to a more than doubling of R&D expenses. The net loss attributable to common stockholders was **$16.3 million**, or **($1.17)** per share, compared to a net loss of **$11.9 million**, or **($1.38)** per share, in the prior year Statements of Operations (in thousands, except per share data) | (in thousands, except per share data) | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | **Operating Expenses** | | | | Research and development | $10,496 | $4,786 | | General and administrative | $6,089 | $3,533 | | **Total operating expenses** | **$16,585** | **$8,319** | | **Loss from operations** | **($16,585)** | **($8,319)** | | Interest income | $314 | $324 | | **Net loss** | **($16,268)** | **($10,538)** | | **Net loss attributable to common stockholders** | **($16,268)** | **($11,862)** | | Loss per share, basic and diluted | ($1.17) | ($1.38) | | Weighted average number of shares | 13,906,973 | 8,616,324 | [Balance Sheets](index=6&type=section&id=Balance%20Sheets) As of December 31, 2024, total assets decreased significantly to **$4.8 million** from **$17.3 million** in the prior year, primarily due to a reduction in cash and cash equivalents from **$14.8 million** to **$2.6 million**. Total liabilities also decreased to **$1.9 million** from **$4.1 million**, while total stockholders' equity fell to **$2.9 million** from **$13.2 million** Balance Sheets (in thousands) | (in thousands) | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and marketable debt securities | $2,590 | $14,776 | | Total current assets | $3,363 | $15,464 | | **Total assets** | **$4,783** | **$17,295** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $1,755 | $3,959 | | **Total liabilities** | **$1,865** | **$4,133** | | **Total stockholders' equity** | **$2,918** | **$13,162** | | **Total liabilities and stockholders' equity** | **$4,783** | **$17,295** | [About INT230-6](index=3&type=section&id=About%20INT230-6) Intensity Therapeutics is a late-stage clinical biotechnology company focused on a new approach to cancer treatment. Its lead product, INT230-6, is an investigational drug designed for direct intratumoral injection. It combines two proven anti-cancer agents (cisplatin and vinblastine) with a proprietary penetration enhancer to kill tumors locally and stimulate a systemic anti-tumor immune response. The company has completed two clinical studies with over 200 patients and is advancing into pivotal trials - INT230-6 is the lead proprietary candidate, designed for direct intratumoral injection, and was discovered using the DfuseRx℠ technology platform[13](index=13&type=chunk) - The drug comprises two potent anti-cancer agents, cisplatin and vinblastine, plus a penetration enhancer molecule (SHAO) to help disperse the drugs throughout the tumor[13](index=13&type=chunk) - INT230-6 is designed to kill tumors locally and induce a systemic anti-tumor immune response by releasing neoantigens, without the immunosuppression often seen with systemic chemotherapy[13](index=13&type=chunk) - The company has completed a Phase 1/2 study in metastatic cancers and a Phase 2 trial in locally advanced breast cancer, and has now initiated a Phase 3 trial in soft tissue sarcoma (INVINCIBLE-3) and a Phase 2 trial in presurgical triple-negative breast cancer (INVINCIBLE-4)[14](index=14&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section serves as a legal disclaimer, cautioning that statements in the press release regarding future plans, clinical trials, financial projections, and business activities are forward-looking. It warns that actual results may differ materially from these projections due to various risks and uncertainties, including clinical trial outcomes, funding needs, and regulatory approvals, as detailed in the company's SEC filings - The press release contains forward-looking statements concerning future plans, development activities, projected milestones, and financial needs[15](index=15&type=chunk) - These statements are subject to risks and uncertainties, such as the timing and results of clinical trials, the need for additional funding, regulatory approvals, and market acceptance of products[16](index=16&type=chunk) - Readers are advised not to place undue reliance on these statements, and the company does not plan to update them except as required by law[16](index=16&type=chunk)

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].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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 as specified in its charter) | Dela ...

SHELTON, Conn., Nov. 21, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or the "Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the issuance and sale of 1,237,1 ...

First patient dosed in randomized, Phase 2 study in presurgical triple negative breast cancerSHELTON, Conn., Nov. 13, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces third quarter 2024 financial results and provides a corporate ...

SHELTON, Conn., Nov. 8, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune system recognition of cancers, today announced that its Phase 3 trial has been selected for an oral podium presentation at the 2024 Connective Tissue Oncology Society (CTOS) on ...