Accessibility StatementSkip Navigation "While efficacy of INT230-6 is quite promising, and we are excited by the early radiological and pathological results, an essential aspect of any treatment for breast cancer patients is to have a good cosmetic result post- surgery," said Ursina Zürrer, M.D. Chief Physician for Genetic Counseling, Department of Medical Oncology and Hematology, Cantonal Hospital Winterthur, Switzerland, and the Coordinating Investigator for the INVINCIBLE-4 Study. "We believe that the IN ...

[Introduction and Highlights](index=1&type=section&id=Introduction%20and%20Highlights) Intensity Therapeutics announced its second quarter 2025 financial results and provided a corporate update, highlighting significant capital raises, progress in clinical trials, and an extended cash runway [Q2 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) Intensity Therapeutics announced its second quarter 2025 financial results and provided a corporate update, highlighting significant capital raises, progress in clinical trials, and an extended cash runway - Intensity Therapeutics, a late-stage clinical biotechnology company, announced Q2 2025 financial results and a corporate update[3](index=3&type=chunk) - **Over $11 million** raised since the beginning of Q2 2025, extending **cash runway into the second half of 2026**[8](index=8&type=chunk) - INVINCIBLE-4 Study patients receiving INT230-6 prior to standard of care achieved **high levels of tumor necrosis** in 8 days[8](index=8&type=chunk) [Corporate Update](index=1&type=section&id=Corporate%20Update) The company updated on clinical trial progress, capital raises, and CEO commentary, noting a paused Phase 3 study and an active Phase 2 study [Clinical Trial Progress](index=1&type=section&id=Clinical%20Trial%20Progress) The company provided updates on its two key clinical trials, INVINCIBLE-4 (Phase 2) for triple-negative breast cancer and INVINCIBLE-3 (Phase 3) for soft tissue sarcoma, noting progress in one and a temporary pause in the other due to funding [INVINCIBLE-4 Study: Phase 2 Triple-Negative Breast Cancer](index=1&type=section&id=INVINCIBLE-4%20Study:%20Phase%202%20Triple-Negative%20Breast%20Cancer) The INVINCIBLE-4 Study, a Phase 2 trial for early-stage, operable triple-negative breast cancer, was authorized in France and is actively recruiting patients in Switzerland and France. Initial scans showed substantial decrease in tumor activity post-INT230-6 injections - The INVINCIBLE-4 Study, a Phase 2 trial for early-stage, operable triple-negative breast cancer, was authorized in France by the European Medicines Agency in April 2025[4](index=4&type=chunk) - The study is currently recruiting patients in Switzerland and France, with an expected total of 54 patients[5](index=5&type=chunk) - Images from a patient in June 2025 showed diminished live cancer and tumor necrosis after two doses of INT230-6[5](index=5&type=chunk)[10](index=10&type=chunk) [INVINCIBLE-3 Study: Phase 3 Soft Tissue Sarcoma](index=1&type=section&id=INVINCIBLE-3%20Study:%20Phase%203%20Soft%20Tissue%20Sarcoma) The INVINCIBLE-3 Study, a Phase 3 trial for soft tissue sarcoma, received multiple regulatory authorizations but paused new patient enrollment and site activations in March 2025 due to funding issues. Enrolled patients continue to receive treatment - The INVINCIBLE-3 Study, a Phase 3 trial for soft tissue sarcoma, is authorized by the US FDA, Health Canada, European Medicines Agency, and Australia's TGA[6](index=6&type=chunk) - New patient enrollment and site activations were paused in March 2025 due to funding issues, but already enrolled patients continue to be dosed and monitored[6](index=6&type=chunk)[11](index=11&type=chunk) - The company plans to restart site activations and patient enrollment once sufficient funding is obtained[11](index=11&type=chunk) [Capital Raises and Financial Runway](index=1&type=section&id=Capital%20Raises%20and%20Financial%20Runway) Intensity Therapeutics successfully raised **$11.3 million** in gross proceeds since the beginning of Q2 2025 through public offerings and an At-the-Market (ATM) facility, extending its cash runway into the second half of 2026 and aiming for Nasdaq listing compliance - The Company **raised an aggregate of $11.3 million** since the beginning of Q2 2025, with **net proceeds of approximately $10.1 million**[7](index=7&type=chunk) - Capital raises included: **$2.35 million (net $1.9M)** in April 2025, **$2.3 million (net $1.8M)** in June 2025, and **$6.6 million (net $6.3M)** via ATM in July 2025[9](index=9&type=chunk) - The **cash runway has been extended into the second half of 2026**, and the company believes it is now **compliant with Nasdaq's minimum stockholders' equity listing requirements**[7](index=7&type=chunk)[10](index=10&type=chunk) [CEO Commentary on Q2 2025 Performance and Outlook](index=2&type=section&id=CEO%20Commentary%20on%20Q2%202025%20Performance%20and%20Outlook) CEO Lewis H. Bender highlighted the company's success in raising capital and lowering its burn rate in a challenging market, extending the operating runway. He also emphasized positive early data from the INVINCIBLE-4 study and the company's commitment to patient awareness - CEO Lewis H. Bender stated the company successfully raised capital and **lowered its burn rate** in Q2 2025, extending the operating runway[10](index=10&type=chunk) - Scan images from the INVINCIBLE-4 Study indicate a **substantial decrease in tumor activity** after two doses of INT230-6, with pathology data expected in 2H 2026[10](index=10&type=chunk) - The company formed a collaboration with breast cancer survivor Christine Handy to raise patient awareness of new treatment options[10](index=10&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a significant reduction in operating expenses and net loss for Q2 2025, with cash and cash equivalents detailed as of June 30, 2025 [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses significantly decreased in Q2 2025 compared to Q2 2024, primarily driven by lower research and development costs due to the pause in the INVINCIBLE-3 Study and reduced general and administrative expenses Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------------------------- | :--------------------- | :--------------------- | :----------- | | Research and development | $1,541 | $3,563 | -$2,022 | | General and administrative | $1,164 | $1,506 | -$342 | | **Total operating expenses** | **$2,705** | **$5,069** | **-$2,364** | - Research and development expenses **decreased by $1.5 million** primarily due to lower INVINCIBLE-3 Study costs following the pause in new site activations and patient enrollments[11](index=11&type=chunk) - General and administrative expenses decreased due to favorable directors and officers insurance renewal terms and cost savings from new system integration[12](index=12&type=chunk) [Net Loss and Cash and Cash Equivalents](index=2&type=section&id=Net%20Loss%20and%20Cash%20and%20Cash%20Equivalents) The company reported a reduced net loss for Q2 2025 compared to the prior year, reflecting decreased operating expenses. Cash and cash equivalents stood at **$2.2 million** as of June 30, 2025 Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :--------- | :--------------------- | :--------------------- | | Net loss | $(2,537) | $(4,971) | - Net loss for the three months ended June 30, 2025, **was $2.5 million**, a **significant reduction from $5.0 million** for the same period in 2024[13](index=13&type=chunk) Cash and Cash Equivalents | Metric | As of June 30, 2025 (in thousands) | | :------------------------ | :--------------------------------- | | Cash and cash equivalents | $2,216 | [Product and Company Information](index=2&type=section&id=Product%20and%20Company%20Information) This section details INT230-6, the company's lead investigational product, and provides an overview of Intensity Therapeutics as a late-stage clinical biotechnology company [About INT230-6](index=2&type=section&id=About%20INT230-6) INT230-6 is Intensity's lead investigational product, an intratumoral injection designed to kill tumors and engage the immune system. It combines cisplatin and vinblastine sulfate with a diffusion enhancer, facilitating drug dispersion within tumors and eliciting systemic anti-tumor effects without immunosuppression - INT230-6 is Intensity's lead proprietary investigational product candidate, designed for direct intratumoral injection[15](index=15&type=chunk) - The drug consists of two anti-cancer agents (cisplatin and vinblastine sulfate) and a diffusion and cell penetration enhancer molecule (SHAO)[15](index=15&type=chunk) - INT230-6 causes local disease control, direct tumor killing, and releases neoantigens to engage the immune system, leading to systemic anti-tumor effects without immunosuppression[15](index=15&type=chunk) [About Intensity Therapeutics](index=2&type=section&id=About%20Intensity%20Therapeutics) Intensity Therapeutics is a late-stage clinical biotechnology company focused on novel intratumoral cancer therapies. Its DfuseRx℠ technology enables INT230-6 to kill tumors and elicit an adaptive immune response, with over 200 patients enrolled across various clinical studies, including Phase 1/2, Phase 2 (INVINCIBLE-2, INVINCIBLE-4), and Phase 3 (INVINCIBLE-3) trials - Intensity is a late-stage clinical biotechnology company developing novel intratumoral cancer therapies using its DfuseRx℠ technology platform[3](index=3&type=chunk)[15](index=15&type=chunk)[16](index=16&type=chunk) - The company has completed two clinical studies and enrolled **over 200 patients** with INT230-6[16](index=16&type=chunk) - Ongoing trials include Phase 3 INVINCIBLE-3 (soft tissue sarcoma) and Phase 2 INVINCIBLE-4 (presurgical triple-negative breast cancer)[16](index=16&type=chunk)[17](index=17&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) Unaudited financial statements for Q2 2025 show reduced net loss and provide a snapshot of the company's balance sheet as of June 30, 2025 [Statements of Operations (Unaudited)](index=4&type=section&id=Statements%20of%20Operations%20(Unaudited)) The unaudited Statements of Operations show a significant reduction in net loss for both the three and six months ended June 30, 2025, compared to the prior year, driven by decreased operating expenses Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,541 | $3,563 | $3,730 | $6,378 | | General and administrative | $1,164 | $1,506 | $2,369 | $3,434 | | Total operating expenses | $2,705 | $5,069 | $6,099 | $9,812 | | Loss from operations | $(2,705) | $(5,069) | $(6,099) | $(9,812) | | Net loss | $(2,537) | $(4,971) | $(5,884) | $(9,574) | | Loss per share, basic and diluted | $(0.13) | $(0.36) | $(0.35) | $(0.70) | | Weighted average shares, basic and diluted | 18,868,124 | 13,712,152 | 17,030,867 | 13,710,819 | [Balance Sheets (Unaudited)](index=5&type=section&id=Balance%20Sheets%20(Unaudited)) The unaudited Balance Sheets show a slight decrease in total assets and stockholders' equity as of June 30, 2025, compared to December 31, 2024, while total liabilities increased Balance Sheets (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :---------------------------- | :------------------------ | :-------------------------- | | Cash and cash equivalents | $2,216 | $2,590 | | Total current assets | $3,038 | $3,363 | | Total assets | $4,443 | $4,783 | | Total current liabilities | $2,164 | $1,755 | | Total liabilities | $2,259 | $1,865 | | Total stockholders' equity | $2,184 | $2,918 | | Total liabilities and equity | $4,443 | $4,783 | [Additional Disclosures](index=3&type=section&id=Additional%20Disclosures) This section includes standard disclaimers regarding forward-looking statements and provides contact information for investor relations and media inquiries [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, outlining the inherent risks and uncertainties associated with future plans, development activities, and financial projections, and advises readers not to place undue reliance on them - The press release contains forward-looking statements regarding future plans, cash runway, development activities, and projected milestones[18](index=18&type=chunk) - Actual results may differ materially due to various risks and uncertainties, including funding needs, regulatory approvals, clinical trial outcomes, and market acceptance[18](index=18&type=chunk) - Readers are cautioned not to place undue reliance on these statements, and the company does not plan to update them except as required by law[18](index=18&type=chunk) [Investor Relations Contact](index=3&type=section&id=Investor%20Relations%20Contact) Contact information for investor relations and media inquiries is provided for interested parties - Investor Relations Contact: Justin Kulik, justin@coreir.com, (558) 230-6401[19](index=19&type=chunk) - Media Contact: Jules Abraham, CORE IR, julesa@coreir.com[19](index=19&type=chunk)

Core Viewpoint - Intensity Therapeutics, Inc. reported its second quarter 2025 financial results and provided updates on its clinical studies, highlighting progress in cancer therapy development and capital raises to extend its operational runway [1][5][6]. Corporate Update - The INVINCIBLE-4 Study is a Phase 2 trial analyzing the efficacy of INT230-6 in combination with standard of care for early-stage triple-negative breast cancer, with the primary endpoint being the change in pathological complete response rate [2][3]. - The INVINCIBLE-3 Study is a Phase 3 trial testing INT230-6 as a monotherapy for specific soft tissue sarcoma subtypes, with overall survival as the primary endpoint; patient enrollment was paused due to funding issues, but treatment for enrolled patients continues [4][7]. - The company has raised a total of $11.3 million since the beginning of Q2 2025, extending its cash runway into the second half of 2026 [5][11]. Financial Results - Research and development expenses for Q2 2025 were $1.5 million, a decrease from $3.6 million in Q2 2024, primarily due to lower costs associated with the INVINCIBLE-3 Study [7]. - General and administrative expenses were $1.2 million for Q2 2025, down from $1.5 million in the same period in 2024, attributed to cost-saving measures [8]. - The net loss for Q2 2025 was $2.5 million, compared to a net loss of $5.0 million in Q2 2024, indicating improved financial performance [9][15]. Product Information - INT230-6 is the lead investigational product candidate designed for direct intratumoral injection, combining cisplatin and vinblastine sulfate with a penetration enhancer to improve drug dispersion within tumors [10][13]. - The drug has shown promising results in preclinical models, achieving a 100% complete response rate in malignant peripheral nerve sheath tumors [11].

PART I - FINANCIAL INFORMATION This part provides unaudited condensed financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures for the reporting period [Item 1. Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes explaining the company's business, liquidity, accounting policies, and specific financial accounts [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20(Unaudited)%20and%20December%2031%2C%202024) This table provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Key Financial Data | Metric | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (Audited) (in thousands) | | :-------------------------------- | :--------------------------------------- | :-------------------------------------- | | Cash and cash equivalents | $2,216 | $2,590 | | Total current assets | $3,038 | $3,363 | | Total assets | $4,443 | $4,783 | | Total current liabilities | $2,164 | $1,755 | | Total liabilities | $2,259 | $1,865 | | Accumulated deficit | $(72,667) | $(66,783) | | Total stockholders' equity | $2,184 | $2,918 | - Total assets decreased by **$340 thousand** from December 31, 2024, to June 30, 2025, while total current liabilities increased by **$409 thousand**[16](index=16&type=chunk) [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This statement outlines the company's financial performance, showing revenues, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Key Financial Data | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,541 | $3,563 | $3,730 | $6,378 | | General and administrative | $1,164 | $1,506 | $2,369 | $3,434 | | Total operating expenses | $2,705 | $5,069 | $6,099 | $9,812 | | Net loss | $(2,537) | $(4,971) | $(5,884) | $(9,574) | | Loss per share, basic and diluted | $(0.13) | $(0.36) | $(0.35) | $(0.70) | - Net loss significantly decreased for both the three-month period (from **$(4.971) million** to **$(2.537) million**) and the six-month period (from **$(9.574) million** to **$(5.884) million**) year-over-year, primarily due to reduced operating expenses[18](index=18&type=chunk) [Condensed Statements of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This statement details the changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit, over the reporting period Key Financial Data | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Common Stock Shares | 15,122,873 | 26,166,423 | | Common Stock Amount | $2 | $3 | | Additional Paid-in Capital | $69,699 | $74,848 | | Accumulated Deficit | $(66,783) | $(72,667) | | Total Stockholders' Equity | $2,918 | $2,184 | - The company issued **10,809,583 shares** of common stock in public offerings, contributing to an increase in common stock and additional paid-in capital, while net losses increased the accumulated deficit[21](index=21&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities, showing the overall change in cash and cash equivalents Key Financial Data | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,445) | $(8,580) | | Net cash provided by investing activities | $0 | $3,254 | | Net cash provided by financing activities | $4,071 | $11 | | Net decrease in cash and cash equivalents | $(374) | $(5,315) | | Cash and cash equivalents at end of period | $2,216 | $3,241 | - Net cash used in operating activities decreased by **$4.135 million**, and net cash provided by financing activities increased significantly by **$4.060 million**, primarily from public offerings, leading to a much smaller net decrease in cash and cash equivalents compared to the prior year[24](index=24&type=chunk) [Notes to the Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Financial%20Statements) These notes provide essential context and detailed explanations for the figures presented in the condensed financial statements [Note 1. Description of Business](index=9&type=section&id=Note%201.%20Description%20of%20Business) This note describes the company's core business, its technology platform, and its lead drug candidate in cancer treatment - Intensity Therapeutics, Inc. is a biotechnology company focused on cancer treatment using its DfuseRxSM technology platform, with INT230-6 as its lead drug candidate[27](index=27&type=chunk) - The company initiated a Phase 3 trial (INVINCIBLE-3 Study) in soft tissue sarcoma and a Phase 2 study (INVINCIBLE-4 Study) in collaboration with the Swiss Cancer Institute for triple-negative breast cancer in 2024[28](index=28&type=chunk) [Note 2. Liquidity and Plan of Operation](index=9&type=section&id=Note%202.%20Liquidity%20and%20Plan%20of%20Operation) This note discusses the company's financial viability, accumulated deficit, and future funding requirements to sustain operations - The company has an accumulated deficit of **$72.7 million** as of June 30, 2025, and has experienced net losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[30](index=30&type=chunk)[32](index=32&type=chunk) Key Financial Data | Metric | Amount (in millions) | | :-------------------- | :------------------- | | Accumulated Deficit (June 30, 2025) | $(72.7) | | Net Loss (H1 2025) | $(5.9) | | Cash and Cash Equivalents (June 30, 2025) | $2.2 | | Net Proceeds from ATM Sales Agreement (Subsequent to June 30, 2025) | $6.6 | - Despite recent capital raises, the company expects to incur substantial losses and will need additional funding, primarily through equity offerings and convertible debt, to finance operations into the second half of 2026[30](index=30&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) [Note 3. Basis of Presentation and Summary of Significant Accounting Policies](index=9&type=section&id=Note%203.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note explains the basis for preparing the financial statements and summarizes the key accounting policies applied - The interim condensed financial statements are unaudited, prepared in conformity with GAAP, and include only normal, recurring adjustments[33](index=33&type=chunk) - There have been no changes to the company's significant accounting policies, including those for stock-based compensation and research and development costs, during the six months ended June 30, 2025[35](index=35&type=chunk)[36](index=36&type=chunk)[39](index=39&type=chunk) - The company is evaluating the impact of new accounting pronouncements (ASU 2023-09 and ASU 2024-03), with ASU 2023-09 not expected to have a material impact[45](index=45&type=chunk)[46](index=46&type=chunk) [Note 4. Cash and Cash Equivalents](index=11&type=section&id=Note%204.%20Cash%20and%20Cash%20Equivalents) This note provides a breakdown of the company's cash and cash equivalents, including their composition and changes over the period Key Financial Data | Component (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Savings and checking accounts | $118 | $428 | | U.S. Treasury securities money market fund | $2,098 | $2,162 | | Total | $2,216 | $2,590 | - Cash and cash equivalents decreased by **$374 thousand** from December 31, 2024, to June 30, 2025, with the majority held in U.S. Treasury securities money market funds[47](index=47&type=chunk) [Note 5. Prepaid Expenses and Other Current Assets](index=11&type=section&id=Note%205.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note details the components of prepaid expenses and other current assets, highlighting changes between reporting periods Key Financial Data | Component (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Prepaid insurance | $282 | $421 | | Prepaid research and development costs | $312 | $239 | | Prepaid other | $228 | $113 | | Total | $822 | $773 | - Total prepaid expenses and other current assets increased by **$49 thousand**, driven by increases in prepaid research and development costs and other prepaid items, partially offset by a decrease in prepaid insurance[48](index=48&type=chunk) [Note 6. Accrued Expenses](index=12&type=section&id=Note%206.%20Accrued%20Expenses) This note itemizes the company's accrued expenses, explaining the primary drivers of changes in these liabilities Key Financial Data | Component (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Accrued research and development costs | $849 | $374 | | Accrued employee compensation-related expenses | $43 | $56 |\n| Accrued other | $49 | $78 | | Total | $941 | $508 | - Total accrued expenses increased by **$433 thousand**, primarily due to a significant increase in accrued research and development costs[49](index=49&type=chunk) [Note 7. Stockholders' Equity](index=12&type=section&id=Note%207.%20Stockholders'%20Equity) This note describes the various equity financing activities undertaken by the company, including public offerings and their financial impact - The company engaged in multiple equity financing activities, including an At The Market (ATM) offering, a November 2024 Registered Direct Offering, an April 2025 Public Offering, and a June 2025 Public Offering[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) Key Financial Data | Offering | Net Proceeds (in millions) | | :-------------------------------- | :------------------------- | | ATM Sales Agreement (H1 2025) | $0.3 | | April 2025 Public Offering | $1.9 | | June 2025 Public Offering | $1.8 | - Subsequent to June 30, 2025, the company issued an additional **20,891,304 shares** under the ATM Sales Agreement, generating **$6.6 million** in net proceeds[50](index=50&type=chunk) [Note 8. Stock Based Compensation](index=13&type=section&id=Note%208.%20Stock%20Based%20Compensation) This note details the company's stock-based compensation expenses and the outstanding equity instruments, including options and warrants Key Financial Data | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Research and development | $423 | $783 | | General and administrative | $656 | $963 | | Total stock-based compensation expense | $1,079 | $1,746 | Key Financial Data | Equity Instrument | Outstanding at Dec 31, 2024 | Outstanding at June 30, 2025 | | :---------------- | :-------------------------- | :--------------------------- | | Stock Options | 2,587,129 | 4,040,801 | | Warrants | 2,041,563 | 8,637,041 | - Total unrecognized compensation cost related to options was approximately **$4.3 million** (expected over 2.5 years) and for warrants was approximately **$0.2 million** (expected over 2.4 years) as of June 30, 2025[61](index=61&type=chunk)[64](index=64&type=chunk) [Note 9. Leases](index=15&type=section&id=Note%209.%20Leases) This note describes the company's operating lease commitments for office space and related expenses - The company has a **5.5-year** operating lease for office space in Shelton, Connecticut, signed in July 2023[66](index=66&type=chunk) Key Financial Data | Metric (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------- | :------------------------------- | :----------------------------- | | Rent expense | $9 | $17 | | Cash paid for operating leases | $17 | $33 | Key Financial Data | Future Minimum Lease Payments (in thousands) | | :----------------------------------- | | 2025 (remainder) | $18 | | 2026 | $37 | | 2027 | $39 | | 2028 | $39 | | 2029 | $7 | | Total Lease Payments | $140 | | Present Value of Lease Liabilities | $125 | [Note 10. Other Uncertainties](index=16&type=section&id=Note%2010.%20Other%20Uncertainties) This note addresses potential risks related to the company's intellectual property in regions affected by military actions - The company holds patents in Russia and Israel, and ongoing military actions in these regions could impact its ability to maintain and protect these patents[70](index=70&type=chunk) [Note 11. Related Parties](index=16&type=section&id=Note%2011.%20Related%20Parties) This note discloses transactions and expenses involving related parties, including warrant issuances and service payments - In October 2023, the company issued **80,000 warrants** valued at **$198 thousand** to two shareholders for consulting services, expensing **$44 thousand** (Q2 2024) and **$89 thousand** (H1 2024) to general and administrative expense[71](index=71&type=chunk) - The company expensed **$32,985** (Q2 2025) and **$34,785** (H1 2025) to a service organization controlled by a board member for services performed, recognized in research and development expenses[72](index=72&type=chunk) [Note 12. Segments](index=16&type=section&id=Note%2012.%20Segments) This note clarifies that the company operates as a single reportable segment, with resource allocation based on overall financial planning - The company operates as a single segment, with resource allocation based on cash resources and operating expense projections[73](index=73&type=chunk) Key Financial Data | Expense Category (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Clinical trial expenses | $936 | $2,467 | $2,594 | $4,043 | | Contract manufacturing | $6 | $417 | $29 | $631 | | Salaries and benefits related (R&D) | $292 | $448 | $622 | $842 | | Salaries and benefits related (G&A) | $234 | $300 | $464 | $624 | [Note 13. Subsequent Events](index=17&type=section&id=Note%2013.%20Subsequent%20Events) This note reports significant events that occurred after the reporting period but before the financial statements were issued - Subsequent to June 30, 2025, the company issued an additional **20,891,304 shares** of common stock under the ATM Sales Agreement, generating net proceeds of **$6.6 million**[76](index=76&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, detailing its business overview, clinical programs, components of expenses, and liquidity position, including recent financing activities and future funding needs [Overview](index=18&type=section&id=Overview) This overview introduces the company's biotechnology focus, lead drug candidate, clinical trial progress, and financial challenges - Intensity Therapeutics is a late-stage clinical biotechnology company developing INT230-6, an intratumoral treatment designed to overcome drug delivery challenges in solid tumors and induce systemic immune activation[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) - The company has completed Phase 1/2 IT-01 and Phase 2 INVINCIBLE-2 studies, initiated Phase 3 INVINCIBLE-3 (sarcoma) and Phase 2 INVINCIBLE-4 (TNBC) studies, but paused new enrollments for INVINCIBLE-3 due to funding constraints[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - The company has an accumulated deficit of **$72.7 million** as of June 30, 2025, and expects significant expenses and operating losses, requiring substantial additional funding to support its growth strategy and clinical trials[88](index=88&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) [Components of Results of Operations](index=21&type=section&id=Components%20of%20Results%20of%20Operations) This section defines the key components of the company's financial performance, including revenue, research and development, and general and administrative expenses - The company has not generated any revenue from product sales or licensing to date and does not expect to in the foreseeable future[93](index=93&type=chunk) - Research and Development Expenses include salaries, clinical trial costs (CROs, patient care), contract manufacturing, consulting, and stock-based compensation[94](index=94&type=chunk)[97](index=97&type=chunk) - General and Administrative Expenses cover employee-related costs, legal, audit, consulting, insurance, and other corporate overheads[95](index=95&type=chunk)[97](index=97&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance by comparing operating results for the current and prior periods [Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024](index=22&type=section&id=Three%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20Three%20Months%20Ended%20June%2030%2C%202024) This subsection compares the company's financial results for the three-month periods ended June 30, 2025, and 2024, highlighting key changes in expenses and net loss Key Financial Data | Metric (in thousands) | Q2 2025 | Q2 2024 | Change | | :-------------------- | :------ | :------ | :----- | | Research and development | $1,541 | $3,563 | $(2,022) | | General and administrative | $1,164 | $1,506 | $(342) | | Total operating expenses | $2,705 | $5,069 | $(2,364) | | Net loss | $(2,537) | $(4,971) | $2,434 | - Research and development expenses decreased by **$2.0 million** (57%) primarily due to lower INVINCIBLE-3 Study costs (pause in new enrollments) and no manufacturing batches of INT230-6 in 2025[99](index=99&type=chunk)[100](index=100&type=chunk) - General and administrative expenses decreased by **$0.3 million** (23%) due to reduced bonus accruals and other cost savings[100](index=100&type=chunk) [Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024](index=23&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20Six%20Months%20Ended%20June%2030%2C%202024) This subsection compares the company's financial results for the six-month periods ended June 30, 2025, and 2024, detailing changes in operating expenses and net loss Key Financial Data | Metric (in thousands) | H1 2025 | H1 2024 | Change | | :-------------------- | :------ | :------ | :----- | | Research and development | $3,730 | $6,378 | $(2,648) | | General and administrative | $2,369 | $3,434 | $(1,065) | | Total operating expenses | $6,099 | $9,812 | $(3,713) | | Net loss | $(5,884) | $(9,574) | $3,690 | - Research and development expenses decreased by **$2.6 million** (42%) primarily due to lower INVINCIBLE-3 Study costs and no manufacturing batches of INT230-6 in 2025[101](index=101&type=chunk)[105](index=105&type=chunk) - General and administrative expenses decreased by **$1.1 million** (31%) due to reduced bonus accruals, lower stock-based compensation, favorable insurance renewal terms, and cost savings from new administrative systems[101](index=101&type=chunk)[105](index=105&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, including its cash position and funding strategies - The company has incurred significant operating losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern, and requires additional capital to fund operations[103](index=103&type=chunk)[104](index=104&type=chunk)[106](index=106&type=chunk) Key Financial Data | Metric | June 30, 2025 (in thousands) | | :-------------------------------- | :--------------------------- | | Cash and cash equivalents | $2,200 | | Net proceeds from ATM Sales Agreement (subsequent to June 30, 2025) | $6,600 | - Recent financing activities, including ATM offerings and public offerings in April and June 2025, provided **$4.1 million** in net cash from financing activities for the six months ended June 30, 2025, extending the cash runway into the second half of 2026[118](index=118&type=chunk)[112](index=112&type=chunk) - The company believes it has at least **$2.5 million** in stockholders' equity, meeting Nasdaq listing requirements, but awaits formal confirmation[113](index=113&type=chunk) [Off-Balance Sheet Arrangements](index=25&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements that could materially affect the company's financial position - The company did not have any off-balance sheet arrangements as of June 30, 2025[120](index=120&type=chunk) [Critical Accounting Policies and Estimates](index=25&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section states that there were no significant changes to the company's critical accounting policies and estimates during the reporting period - No significant changes to the company's critical accounting policies and estimates occurred during the six months ended June 30, 2025[121](index=121&type=chunk) [JOBS Act Accounting Election](index=26&type=section&id=JOBS%20Act%20Accounting%20Election) This section explains the company's irrevocable election regarding the extended transition period for new accounting standards under the JOBS Act - As an 'emerging growth company' under the JOBS Act, the company has irrevocably elected not to use the extended transition period for new or revised accounting standards, thus adhering to the same standards as other public companies[122](index=122&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable to the company - This item is not applicable to the company[124](index=124&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025, and reported no material changes in internal control over financial reporting during the quarter - As of June 30, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[126](index=126&type=chunk) - There have been no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025[128](index=128&type=chunk) PART II - OTHER INFORMATION This part covers other important information not included in the financial statements, such as legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings that would individually or collectively have a material adverse effect on its business, operating results, cash flows, or financial condition - The company is not currently a party to any legal actions, claims, or suits that would have a material adverse effect on its business[129](index=129&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section highlights new and existing risk factors, including potential adverse effects from changes to U.S. tariff and import/export regulations, and the risk of not satisfying Nasdaq Capital Market's continued listing requirements, particularly regarding minimum stockholders' equity and bid price - Changes to U.S. tariff and import/export regulations may have a material adverse effect on the company's business, financial condition, and results of operations[131](index=131&type=chunk) - The company received notices of non-compliance with Nasdaq's minimum stockholders' equity requirement (**$2.5 million**) and the **$1.00** minimum bid price requirement for continued listing[132](index=132&type=chunk) - Subsequent to June 30, 2025, the company raised an additional **$6.6 million** in net proceeds, believing it now meets the **$2.5 million** stockholders' equity rule, but awaits Nasdaq's formal confirmation[133](index=133&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the quarter ended June 30, 2025, that were not previously disclosed in a Current Report on Form 8-K - There were no unregistered sales of the company's securities during the quarter ended June 30, 2025, that were not previously reported[134](index=134&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[135](index=135&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the company - This item is not applicable to the company[136](index=136&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) During the quarter ended June 30, 2025, no director or officer of the company adopted, modified, or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[137](index=137&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate organizational documents, warrant forms, offering agreements, and certifications required by the Sarbanes-Oxley Act - The exhibits include the Sixth Amended and Restated Certificate of Incorporation, Second Amended and Restated Bylaws, various forms of Series B-1, Series B-2, and Representative's Warrants[141](index=141&type=chunk) - Key agreements such as the Placement Agent Agreement, Securities Purchase Agreement, and Underwriting Agreement related to recent offerings are also listed[141](index=141&type=chunk) - Certifications of the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included, along with Inline XBRL documents[141](index=141&type=chunk) SIGNATURES This section provides the official signatures of the company's authorized officers, certifying the accuracy of the report - The report was signed on August 7, 2025, by Lewis H. Bender, President, Chief Executive Officer and Chairman, and Joseph Talamo, Chief Financial Officer[145](index=145&type=chunk)[146](index=146&type=chunk)

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].

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]

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]

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].

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]

[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)