Core Insights - Intensity Therapeutics (INTS.US) experienced a pre-market drop of 37.88% to $0.82 after a significant increase of 394.57% the previous day, recovering losses from over six months [1] - The company announced results from its Phase 1/2 clinical trial for its cancer candidate INT230-6, showing an increase in activated CD4+ and CD8+ T cells in the tumor microenvironment [1] - The trial involved 64 patients across more than 20 cancer types, all of whom had undergone extensive prior treatments, achieving a disease control rate of 75% [1] Company Performance - The closing price on October 30 was $1.32, with a significant trading volume of 1.434 billion shares [1] - The stock reached a high of $1.74 and a low of $0.64 during the trading session, with a previous close of $0.267 [1] - The market capitalization stood at approximately $64.75 million, with a total share count of about 49.06 million [1] Clinical Trial Results - The clinical trial results indicated a promising potential for a new cancer treatment method, resonating positively with the market [1] - CEO Lewis Bender highlighted the early data's significance in the field of solid tumor treatment, expressing hope for broader patient benefits [1]

Core Insights - Intensity Therapeutics (INTS.US) announced significant results from its Phase 1/2 clinical trial for the candidate drug INT230-6, leading to a nearly 395% surge in stock price [1] Group 1: Drug Mechanism and Clinical Data - INT230-6 operates by directly injecting into tumors, facilitating the diffusion of cisplatin and vinblastine sulfate, along with a cell-penetrating enhancer molecule (SHAO) [1] - The trial involved 64 patients across over 20 cancer types, all of whom had undergone extensive prior treatments, achieving a disease control rate of 75% [1] - The median overall survival (mOS) for the entire patient group was 11.9 months, with a notable 21.3 months for the metastatic sarcoma subgroup [1] - No grade 4 or 5 treatment-related adverse events were reported, with only 7 patients experiencing grade 3 adverse events, and no dose-limiting toxicities observed [1] Group 2: Market Reaction and Future Plans - The market reacted positively to the trial data, indicating strong interest in the field of solid tumor treatments [2] - Intensity Therapeutics has partnered with Merck (MRK.US) and Bristol-Myers Squibb (BMY.US) to explore combination therapies with Keytruda and Yervoy [2] - A conference call is scheduled for October 31 to discuss the clinical trial results, which have been published in the journal eBioMedicine [2]

Core Insights - Recent market movements have led to notable changes in stock prices of several companies, influenced by clinical trial updates and strategic corporate developments [1] Company Summaries - Intensity Therapeutics, Inc. (NASDAQ:INTS) experienced a stock price surge of 435.63% to $1.42, driven by advancements in its lead product candidate INT230-6 through Phase 2 clinical trials and collaborations with major pharmaceutical companies [2][8] - Harvard Bioscience, Inc. (NASDAQ:HBIO) saw a stock price increase of 101.19% to $0.89, attributed to its comprehensive range of lab research instruments and anticipation of its Q3 2025 financial results [3][8] - NextPlat Corp's stock price rose by 62.5% to $0.13, supported by its expansion in mobile satellite services and innovative solutions for various sectors [4] - Shineco, Inc. (NASDAQ:SISI) experienced a 59.38% increase in stock price to $1.02, linked to its unique market position in specialized textiles and significant strategic developments [5] - Jasper Therapeutics, Inc. saw a stock price increase of 49.36% to $0.11, driven by its focus on therapeutic agents for hematopoietic stem cell transplantation and gene therapies [6] Market Dynamics - The stock market reflects a dynamic nature where company developments, strategic partnerships, and advancements in product pipelines significantly impact stock prices, with investors closely monitoring these companies for further developments [7][8]

Core Insights - Intensity Therapeutics, Inc. announced the publication of its phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers, demonstrating promising efficacy and safety of its investigational product INT230-6 [1][4][5] Study Results - The phase 1/2 trial showed a disease control rate of 75% (48 out of 64 patients) and a median overall survival (mOS) of 11.9 months, which is significantly better than historical mOS of 4 to 7 months for similar patient populations [4][5] - In a subset of metastatic sarcoma patients treated with INT230-6, the mOS was reported at 21.3 months [4] - An exploratory analysis indicated that patients receiving INT230-6 at doses treating more than 40% of their tumor burden had an 83.3% disease control rate and an mOS of 18.7 months, compared to 50% and 3.1 months for those treated with less than 40% [4] Mechanism of Action - INT230-6 utilizes a diffusion process for local treatment, directly injected into tumors, leading to tumor cell death and systemic immune activation [4][6] - The treatment resulted in a qualitative decrease in proliferating cancer cells and an increase in activated T-cells within the tumor microenvironment [4][5] Safety Profile - The trial reported no dose-limiting toxicities among the 64 patients, with only 10.9% experiencing grade 3 adverse events and no grade 4 or 5 treatment-related adverse events [4][5] - Pharmacokinetic data showed over 95% of active cytotoxic agents remained localized within the injected tumors, indicating a favorable safety profile [5] Future Directions - The company plans to initiate randomized controlled studies, including a Phase 3 trial in sarcoma, to further evaluate the efficacy of INT230-6 [5][10]

Financial Data and Key Metrics Changes - The meeting confirmed that a majority of votes were cast in favor of the reverse stock split proposal and the adjournment proposal, indicating shareholder support for these strategic decisions [8]. Business Line Data and Key Metrics Changes - No specific business line data or key metrics were discussed during the meeting. Market Data and Key Metrics Changes - No specific market data or key metrics were provided during the meeting. Company Strategy and Development Direction and Industry Competition - The company plans to implement a reverse stock split with a ratio between one for five and one for thirty, allowing the Board of Directors to set the exact ratio at their discretion [5]. Management's Comments on Operating Environment and Future Outlook - Management indicated that the decision regarding the timing and specifics of the reverse stock split will be made by the Board of Directors when deemed necessary, emphasizing a careful approach to this strategic move [9]. Other Important Information - The meeting was held virtually to enhance accessibility for shareholders, and a quorum was established with 22,631,128 shares present, representing 46.13% of the outstanding voting stock [4]. Q&A Session Summary Question: When would the company decide to do the reverse stock split and what number of shares would be reduced to? - Management stated that the decision will be determined by the Board of Directors at the appropriate time, with the intention to make a decision before any deadlines [9].

Financial Data and Key Metrics Changes - The meeting confirmed that a majority of votes were cast in favor of the reverse stock split proposal and the adjournment proposal, indicating shareholder support for these strategic decisions [8]. Business Line Data and Key Metrics Changes - No specific business line data or key metrics were discussed during the meeting. Market Data and Key Metrics Changes - No specific market data or key metrics were provided during the meeting. Company Strategy and Development Direction - The company intends to implement a reverse stock split by a ratio of not less than one for five and not more than one for thirty, with the exact ratio to be determined by the Board of Directors [5]. Management's Comments on Operating Environment and Future Outlook - Management indicated that the decision regarding the reverse stock split will be made at a time deemed necessary by the Board of Directors, emphasizing the flexibility in timing [9]. Other Important Information - The meeting was held virtually to enhance accessibility for shareholders, and a quorum was established with 22,631,128 shares present, representing 46.13% of the outstanding voting stock [4]. Q&A Session Summary Question: When would the company decide to do the reverse stock split and what number of shares would be reduced to? - Management stated that the decision will be determined by the Board of Directors in their sole discretion, with the implementation occurring before the deadline if the vote is favorable [9].

Financial Data and Key Metrics Changes - The meeting confirmed the approval of a reverse stock split of the company's common stock by a ratio of not less than one for five and not more than one for thirty, with the exact ratio to be determined by the Board of Directors [5][8]. Company Strategy and Development Direction - The company intends to implement the reverse stock split to potentially enhance the stock's marketability and attract institutional investors, although the specific timing and ratio will be decided at the Board's discretion [9]. Management's Comments on Operating Environment and Future Outlook - Management indicated that the decision regarding the reverse stock split will be made when deemed necessary, emphasizing the importance of timing and market conditions [9]. Other Important Information - A quorum was established with 22,631,128 shares present, representing 46.13% of the outstanding voting stock [4]. - The results of the voting will be disclosed in a current report on Form 8-K within four business days of the meeting [9]. Q&A Session Summary Question: When would the company decide to implement the reverse stock split and determine the number of shares to reduce it to? - Management stated that the decision will be made by the Board of Directors at the appropriate time, with the intention to act before any deadlines [9].

Financial Data and Key Metrics Changes - A majority of votes were cast in favor of the approval of the reverse stock split proposal and the adjournment proposal, indicating shareholder support for these strategic decisions [9][10]. Business Line Data and Key Metrics Changes - No specific business line data or key metrics were discussed during the meeting [0]. Market Data and Key Metrics Changes - No specific market data or key metrics were provided during the meeting [0]. Company Strategy and Development Direction and Industry Competition - The company plans to implement a reverse stock split by a ratio of not less than one for five and not more than one for thirty, with the exact ratio to be determined by the Board of Directors [7]. Management's Comments on Operating Environment and Future Outlook - Management indicated that the decision regarding the reverse stock split will be made at a time deemed necessary by the Board of Directors, emphasizing the importance of timing in this strategic move [12]. Other Important Information - The meeting was conducted virtually to enhance accessibility for shareholders, and a quorum was established with 46.13% of the outstanding voting stock present [6]. Q&A Session All Questions and Answers Question: When would you decide to do the reverse split? And when would you decide what number of shares to reduce it to? - The decision will be determined by the Board of Directors in their sole discretion, with the implementation expected to occur before the deadline [12]. Question: Do we have any further questions? - No further questions were received, and the Q&A portion of the meeting was closed [13].

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)