Intensity Therapeutics(INTS) - 2025 Q2 - Quarterly Results

Introduction and Highlights 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 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] - Over $11 million raised since the beginning of Q2 2025, extending cash runway into the second half of 2026[8] - INVINCIBLE-4 Study patients receiving INT230-6 prior to standard of care achieved high levels of tumor necrosis in 8 days[8] Corporate Update 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 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 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] - The study is currently recruiting patients in Switzerland and France, with an expected total of 54 patients[5] - Images from a patient in June 2025 showed diminished live cancer and tumor necrosis after two doses of INT230-6[5][10] INVINCIBLE-3 Study: Phase 3 Soft Tissue Sarcoma 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] - 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][11] - The company plans to restart site activations and patient enrollment once sufficient funding is obtained[11] Capital Raises and Financial Runway 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] - 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] - 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][10] CEO Commentary on Q2 2025 Performance and Outlook 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] - 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] - The company formed a collaboration with breast cancer survivor Christine Handy to raise patient awareness of new treatment options[10] Second Quarter 2025 Financial Results 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 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] - General and administrative expenses decreased due to favorable directors and officers insurance renewal terms and cost savings from new system integration[12] Net Loss and Cash and Cash Equivalents 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] Cash and Cash Equivalents | Metric | As of June 30, 2025 (in thousands) | | :------------------------ | :--------------------------------- | | Cash and cash equivalents | $2,216 | Product and Company Information 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 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] - The drug consists of two anti-cancer agents (cisplatin and vinblastine sulfate) and a diffusion and cell penetration enhancer molecule (SHAO)[15] - 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] About Intensity Therapeutics 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][15][16] - The company has completed two clinical studies and enrolled over 200 patients with INT230-6[16] - Ongoing trials include Phase 3 INVINCIBLE-3 (soft tissue sarcoma) and Phase 2 INVINCIBLE-4 (presurgical triple-negative breast cancer)[16][17] Financial Statements 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) 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) 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 This section includes standard disclaimers regarding forward-looking statements and provides contact information for investor relations and media inquiries Forward-Looking Statements 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] - Actual results may differ materially due to various risks and uncertainties, including funding needs, regulatory approvals, clinical trial outcomes, and market acceptance[18] - 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] Investor Relations Contact 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] - Media Contact: Jules Abraham, CORE IR, julesa@coreir.com[19]