[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 ...

First patient dosed in global randomized, Phase 3 study in metastatic soft tissue sarcoma Collaboration agreement with The Swiss Group for Clinical Cancer Research SAKK ("SAKK") to conduct a Phase 2 randomized, study in early-stage breast cancer in Europe Cash and investments of $6.3 million expected to fund operations into the first quarter of 2025 SHELTON, Conn., Aug. 8, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology com ...

Financial Data and Key Metrics Changes - The company reported a quorum of 8,522,652 shares present, representing 62.15% of the outstanding voting stock [6] - Preliminary results indicated that a majority of votes were cast in favor of the election of directors and the approval of the employee stock purchase plan [10][11] Business Line Data and Key Metrics Changes - No specific business line data or key metrics were discussed in the provided content Market Data and Key Metrics Changes - No specific market data or key metrics were discussed in the provided content Company Strategy and Development Direction and Industry Competition - The company is focused on improving stockholder access by conducting meetings virtually [2] - The company has proposed an employee stock purchase plan to enhance employee engagement and investment in the company [11] Management's Comments on Operating Environment and Future Outlook - Management indicated that forward-looking statements may differ significantly from actual results due to various factors, including those outlined in SEC filings [13] Other Important Information - The meeting was held virtually to enhance accessibility for stockholders [2] - The appointment of Eisner Amper LLP as auditors for fiscal year 2024 was ratified [11] Q&A Session Summary - No questions were received during the Q&A session, and it was subsequently closed [13]

Testing the efficacy and safety of our lead product candidate, INT230-6, as Monotherapy Compared with Systemic U.S. Standard-of-Care Chemotherapy "We have now dosed our first patient in the U.S. and have filed regulatory documents to initiate this trial in Canada and Europe. Over the next several months, we anticipate initiating sites in eight countries. Sarcoma is a deadly cancer with a median overall survival following second and third-line drug treatments of between 10 and 15 months," said Intensity Ther ...

SHELTON, Conn., May 15, 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 the appointment of Thomas Dubin, J.D., MPH, to the Intensity Board of Directors, effective May 14, 2024. Mr. Dubin will serve as a member of the Audit Commi ...