Intesity Therapeutics Inc (INTS)

Intensity Therapeutics Recognized with GHP Magazine's 2026 Healthcare & Pharmaceutical AwardMay 14, 2026 8:00 AM
PR Newswire (US) Company receives the Cancer Treatment Technology Innovator of the Year awardSHELTON, Conn., May 14, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc., (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, announces it has been named a winner of the 2026 GHP Magazine Healthcare & Pharmaceutical Awards as the Cancer Treatment Technology Innovator of the Year 2026 – USA award recipient. This recognition comes as Intensity's treatment paradigm has demonstrated encouraging clinical outcomes in patients with advanced cancers, including those with no remaining treatment options, such as sarcoma and breast cancer. Intensity's approach represents a new, unique methodology to cancer cell death that holds the potential to shift the cancer treatment from a short-term death sentence to chronic diseases, even for malignancies that are unresponsive to immunotherapy."Winning a GHP award reflects our unwavering commitment to changing the trajectory of cancer care," stated Intensity Therapeutics Co-Founder and CEO Lewis H. Bender. "By offering a novel methodology for inducing cancer cell death reducing tumor burden without significant off target toxicities - the drug stays in the tumor, and inducing a systemic anticancer immune response, INT230-6 has the potential to turn aggressive, immunotherapy-resistant malignancies into manageable, chronic conditions.  We greatly appreciate the Magazine's panel of judges' recognition of our Company."GHP Magazine's expert judging panel has recognized Intensity Therapeutics as a leader in the research and development of intratumoral injection drug delivery technology. This recognition follows a rigorous, merit-based evaluation of the Company's innovation, business performance, and overall impact on patient outcomes.The global healthcare and pharmaceutical sector is experiencing unprecedented growth fueled by digital therapeutics, biotechnology, and AI-driven medicine. Since 2015, GHP's Healthcare and Pharmaceutical Awards have championed this evolution by honoring the industry's most dedicated innovators. The 2026 Awards highlight the visionaries redefining modern medicine, celebrating the life-changing treatments and breakthrough technologies that are actively reshaping how we deliver patient-centered care.About INT230-6INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx? technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the patient's malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.About Global Health & Pharma MagazineGlobal Health & Pharma Magazine is part of AI Global Media, an internationally focused B2B digital publishing group founded in 2010. The group is committed to delivering content you can trust to every one of its readers, subscribers, clients, contributors, advertisers and visitors. Global Health & Pharma Magazine is a quarterly digital publication dedicated to the Healthcare, Pharmaceutical and Life Science industries. Each quarter Global Health & Pharma Magazine brings to its readers the need-to-know news and updates from key sectors and magnify the work of those that are setting the pace and looking to change their respective sectors for the better. Utilising this reach, we aim to provide support and help showcase the latest developments, most promising innovations and leading companies across the medical and health industries.About Intensity TherapeuticsIntensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional chemotherapy or immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. The pathological complete response rate is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings.Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC ?lings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.Investor Relations Contact:
Justin Kulik
CORE IR

Intensity Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate UpdateMay 7, 2026 4:06 PM
PR Newswire (US) Cash and cash equivalents of $10.2 million as of March 31, 2026Favorable efficacy and safety reported in a small sample of triple negative breast cancer ("TNBC") patients receiving INT230-6 prior to the standard of care ("SOC") compared to SOC alone in the INVINCIBLE-4 Study (as defined below)Approval to resume enrollment obtained in the INVINCIBLE-4 Study; plans to resume enrollment in the second quarter of 2026Decision to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study (as defined below) by the third quarter of 2026SHELTON, Conn., May 7, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces first quarter 2026 financial results and provides a corporate update. Corporate UpdateINVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone.In March 2026, the Company reported the following:Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B.A protocol amendment was submitted to Swissmedic, Switzerland's regulatory authority, and the Switzerland Ethics Committee to resume enrollment.  Full approval to resume enrollment was granted on March 26, 2026. The Company plans to resume enrollment in the second quarter of 2026.The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company has continued to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. In April 2026, the Company decided to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations in this study once sufficient incremental funding is obtained.Lewis H. Bender, Founder, President, and CEO, stated, "The Company made excellent progress in the first quarter. We announced early data from the INVINCIBLE-4 Study, our randomized controlled study in TNBC, showing the possibilities for INT230-6 to increase efficacy while also potentially improving safety. We are now seeking additional patients in our INVINCIBLE-4 Study in Switzerland and expect to initiate enrollment in France in the second or third quarter of 2026.  Further, after a successful funding campaign in 2025 and the establishment of a $60 million ATM facility in March 2026, we have made the decision to reinitiate enrollment of our INVINCIBLE-3 Study and plan to manage our cash burn judiciously. Both of our clinical trials focus on indications with high unmet medical need."First Quarter 2026 Financial ResultsResearch and development expenses were $1.2 million for the three months ended March 31, 2026, compared to $2.2 million for the same period in 2025. The decrease was primarily due to lower INVINCIBLE-3 Study costs.  In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients.  The Company has continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause. The Company plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations once sufficient funding is obtained. In addition, lower headcount-related costs in 2026 were entirely offset by an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025.General and administrative expenses were $1.3 million for the three months ended March 31, 2026, compared to $1.2 million for the same period in 2025. The increase was due to an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025.  This increase was partially offset by lower stock-based compensation and one-time expenses related to our reverse stock split in February 2026.Overall, net loss was $2.4 million for the three months ended March 31, 2026, compared to a net loss of $3.3 million for the three months ended March 31, 2025.As of March 31, 2026, cash and cash equivalents totaled $10.2 million.  About Triple Negative Breast Cancer in the Presurgical SettingWomen with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11 to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50 to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.About SarcomaSoft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body's soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and belly. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.About INT230-6INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx? technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.About Intensity TherapeuticsIntensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings.  Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in the Company's subsequent SEC ?lings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.Investor Relations Contact:
Justin Kulik
CORE IR
justin @W.E.J.Media Contact:
Matt Cossel
CORE IR
PR@coreir.com Intensity Therapeutics, Inc.Statements of Operations(in thousands, except share and per share amounts)(Unaudited)

Three Months Ended March 31,
2026
2025Operating expenses:


Research and development$             1,195
$             2,189General and administrative1,331
1,205Total operating expenses2,526
3,394Loss from operations(2,526)
(3,394)



Other income (expense):


Interest income94
15Other (expense) income, net(2)
32Net loss $            (2,434)
$            (3,347)



Loss per share, basic and diluted$             (0.96)
$             (5.51)Weighted average number of shares of common stock, basic and diluted2,533,918
606,928 Intensity Therapeutics, Inc.Balance Sheets(in thousands)

March 31, 2026
December 31, 2025
(Unaudited)
*Assets


Current assets:


Cash and cash equivalents$               10,245
$               11,921Prepaid expenses and other current assets661
788Total current assets10,906
12,709Right-of-use asset, net89
96Other assets1,296
1,296Total assets$               12,291
$               14,101



Liabilities and Stockholders' Equity


Current liabilities:


Accounts payable$                   636
$                   583Accrued expenses1,574
1,532Lease liability, current portion32
31Total current liabilities2,242
2,146Lease liability, net of current portion70
79Total liabilities2,312
2,225Total stockholders' equity9,979
11,876Total liabilities and stockholders' equity$               12,291
$               14,101



*Derived from audited financial statements


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Intensity Therapeutics Recognized with Pinnacle Award for Excellence in Healthcare InnovationApril 15, 2026 9:15 AM
PR Newswire (US)

Company receives the Platinum Award for Innovator in Biotech Solutions CategorySHELTON, Conn., April 15, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc., (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, announces it has been named a winner of the 2026 Pinnacle Awards for Healthcare for its intratumoral injection platform and lead drug candidate INT230-6.







The Company was selected a Platinum award winner in the Innovator in Biotech Solutions Category. INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. INT230-6 is being developed in combination with standard-of-care therapies to improve the durability of response across multiple solid tumor indications."The recognition from the Pinnacle Award is a testament to Intensity's commitment to changing the future of cancer care," said Intensity Therapeutics Co-Founder and CEO Lewis H. Bender. "INT230-6 represents a new, unique methodology for cancer cell death that holds the potential to shift the cancer treatment from a short-term death sentence to chronic diseases, even for malignancies that are unresponsive to immunotherapy."The Pinnacle Awards is an esteemed annual awards program dedicated to recognizing and celebrating outstanding achievements across various industries. Its mission is to honor companies, products, and individuals that have demonstrated exceptional innovation, creativity, and impact in their fields. Each year, nominees are evaluated by industry experts, media professionals, and consultants who ensure that only the most deserving candidates receive recognition.About Intensity TherapeuticsIntensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. The pathological complete response rate is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings.Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC ?lings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.Investor Relations Contact:Justin Kulik
CORE IR

Intensity Therapeutics Reports 2025 Year End Financial Results and Highlights, and Provides Corporate UpdateMarch 27, 2026 4:12 PM
PR Newswire (US)

Raised over $20 million in gross proceeds in 2025 and held $11.9 million in cash and cash equivalents as of December 31, 2025, with a cash runway into the second quarter of 2027IT-01 Study manuscript of INT230-6 used alone in 64 refractory metastatic cancer patients published in the Lancet's journal eBioMedicine, including data for disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safetyFavorable efficacy and safety reported in a small sample of triple negative breast cancer ("TNBC") patients receiving INT230-6 prior to the standard of care ("SOC") compared to SOC alone in the INVINCIBLE-4 StudySHELTON, Conn., March 27, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces 2025 year-end financial results and highlights, and provides a corporate update.







Corporate UpdateINVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone.In March 2026, the Company reported the following:Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B.A protocol amendment was submitted to Swissmedic, Switzerland's regulatory authority, and the Switzerland Ethics Committee to resume enrollment.  Full approval to resume enrollment was granted on March 26, 2026.The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. The Company has prioritized reinitiating patient enrollment and site activations during 2026 once sufficient funding is obtained.IT-01 Study Manuscript PublicationIn October 2025, the Company reported that eBioMedicine, a Lancet Discovery Science journal, published the Company's phase 1/2 IT-01 clinical study manuscript, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," for the treatment of metastatic or refractory cancers. The manuscript included the following data results:In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved:A disease control rate of 75% (48/64 patients) and median overall survival ("mOS") of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 monthsIn a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 monthsIn an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient's total tumor burden ("TTB") compared to those treated with less than 40% of their TTB, the:Disease control rate was 83.3% (40/48) compared to 50% (8/16)Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P40% group had uninjected tumors shrink, abscopal effectsFifteen of 64 patients survived for more than 21 monthsINT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironmentNo dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse eventsPharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumorsCash and Cash Runway In 2025, the Company raised over $20 million in gross proceeds through two public offerings, one registered direct offering, and ATM issuances. These successful capital-raising efforts strengthened Intensity's balance sheet with cash and cash equivalents of $11.9 million as of December 31, 2025, and extended its current operating runway into the second quarter of 2027.Lewis H. Bender, Founder, President, and CEO, stated, "Our data published in the Lancet's eBioMedicine journal for the treatment of metastatic disease, and the results reported on the safety and efficacy in the INVINCIBLE-4 study were promising and unique for a locally-delivered oncology drug. With the capital raised in 2025 and an unused $60 million ATM facility in place, we intend to resume patient enrollment in both studies as soon as possible. The American Cancer Society ("ACS") estimates that roughly 6,400 more deaths occurred in 2025 than in 2024, a trend that continues every year. Intensity remains committed to helping patients live longer, healthier lives with less toxicity. The ACS data supports the conclusion that today's cancer treatments have many limitations, and that the unmet medical need for new ideas and better cancer therapies remains as strong as ever."2025 Year End Financial ResultsResearch and development expenses were $6.8 million for the year ended December 31, 2025, compared to $10.5 million for the same period in 2024. Clinical trial expenses decreased $2.8 million primarily due to lower INVINCIBLE-3 Study costs.  In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients.  The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and the Company plans to restart site activations and patient enrollment as soon as possible. Contract manufacturing costs declined by $0.6 million, as there were no new manufacturing batches of INT230-6 in 2025, along with $0.5 million of lower stock-based compensation. These decreases were partially offset by $0.3 million of bonus accruals for 2025 compared to zero bonus accruals for 2024.General and administrative expenses were $5.2 million for the year ended December 31, 2025, compared to $6.1 million for the same period in 2024. Stock-based compensation decreased $0.6 million in 2025, and legal, audit, consulting, insurance and other general & administrative costs decreased due to cost efficiencies and less corporate development activity compared to the prior year period. These decreases were partially offset by $0.5 million of bonus accruals for 2025 compared to zero bonus accruals for 2024.Overall, net loss was $11.6 million for the year ended December 31, 2025, compared to a net loss of $16.3 million for the year ended December 31, 2024.As of December 31, 2025, cash and cash equivalents totaled $11.9 million.About INT230-6INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx? technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.About Intensity TherapeuticsIntensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings.  Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in the Company's subsequent SEC ?lings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.Investor Relations Contact:
Justin Kulik
CORE IR
justin @W.E.J.Media Contact:
Matt Cossel
CORE IR
PR@coreir.com Intensity Therapeutics, Inc.Statements of Operations(in thousands, except share and per share amounts)(Derived from audited financial statements)

Year Ended December 31,
2025
2024Operating expenses:


Research and development$             6,785
$           10,496General and administrative5,187
6,089Total operating expenses11,972
16,585Loss from operations(11,972)
(16,585)



Other income (expense):


Interest income180
314Other income, net186
3Net loss $          (11,606)
$          (16,268)



Loss per share, basic and diluted$             (8.56)
$            (29.24)Weighted average number of shares of common stock, basic and diluted1,356,358
556,279 Intensity Therapeutics, Inc.Balance Sheets(in thousands)(Derived from audited financial statements)

December 31, 2025
December 31, 2024Assets


Current assets:


Cash and cash equivalents$               11,921
$                 2,590Prepaid expenses and other current assets788
773Total current assets12,709
3,363Right-of-use asset, net96
122Other assets1,296
1,298Total assets$               14,101
$                 4,783



Liabilities and Stockholders' Equity


Current liabilities:


Accounts payable$                   583
$                 1,219Accrued expenses1,532
508Lease liability, current portion31
28Total current liabilities2,146
1,755Lease liability, net of current portion79
110Total liabilities2,225
1,865Total stockholders' equity11,876
2,918Total liabilities and stockholders' equity$               14,101
$                 4,783 



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Original: Intensity Therapeutics Reports 2025 Year End Financial Results and Highlights, and Provides Corporate Update

Intensity Therapeutics, Inc. Provides Update on the Phase 2 Presurgical Triple-Negative Breast Cancer INVINCIBLE-4 StudyMarch 12, 2026 7:30 AM
PR Newswire (US)

Preliminary observations of the INVINCIBLE-4 Study to date showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to standard of care ("SOC") ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.
 Forty-four percent (44%) fewer grade 3 or higher Adverse Events ("AEs") were observed in Cohort A compared to Cohort B.A protocol amendment has been submitted to the Swiss Agency for Therapeutic Products ("Swissmedic"), Switzerland's regulatory authority, and the Swiss Ethics Committee to resume enrollment.SHELTON, Conn., March 12, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, provided an update on the INVINCIBLE-4 Study. In September 2025, enrollment was paused by the Company due to skin irritations observed in Cohort A. In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6.







The SOC in the INVINCIBLE-4 Study is the Keynote-522 study regimen, a 6-month presurgical treatment consisting of pembrolizumab every three weeks, then paclitaxel, followed by carboplatin and 4 doxorubicin or epirubicin with cyclophosphamide. The INVINCIBLE-4 Study enrollment criteria is limited to patients with tumors sizes ≥ 1.5 cm, whereas the Keynote-522 study enrolled tumors > 1.0 cm.  As a result, patients in the INVINCIBLE-4 Study, on average, have larger tumors than patients in the Keynote-522 study. Patients undergo the Keynote-522 regimen in an attempt to obtain a pCR, which has been shown to significantly reduce the risk of disease recurrence. pCR is an endpoint that the U.S Food and Drug Administration ("FDA") and the European Medicines Agency could allow for an accelerated or conditional marketing approval.Overall, fourteen (14) patients have been treated to date in the INVINCIBLE-4 Study, with seven (7) in each cohort. The expected total enrollment is up to sixty-one (61) patients.  Preliminary observations for the fourteen patients treated to date are as follows:pCR Data Observations Cohort A: A pCR was achieved in five (5) out of seven (7) patients (71.4%) who received injections of INT230-6 prior to SOC. Six (6) patients received two (2) injections and one patient, who achieved a pCR, received one (1) injection.Cohort B: A pCR was achieved in two (2) out of six (6) patients (33%) who received the SOC alone, with one patient still to be evaluated.The pCR analysis is ongoing, and results are preliminary and early.Safety Data Observations (through March 2, 2026)Cohort A: There has been a total of fourteen (14) grade 3 or higher AEs, only one (1) of which is considered a common immune-related side effect of checkpoint immunotherapy.Cohort B: There has been a total of twenty-five (25) SOC-related grade 3 AEs, of which four (4) are considered common or rare side effects of immune checkpoint inhibitors (three grade 3 and one grade 4).The safety data for patients who received INT230-6 plus SOC remain favorable compared with SOC alone.In the Company's first presurgical Breast Cancer study completed in 2023 (the "INVINCIBLE-2 Study"), fifty-eight (58) women received one (1) to three (3) injections of only INT230-6. Additionally, skin issues were rare, and surgery was performed without complications.The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.Lewis H. Bender, Founder, President & CEO, said, "The pCR data observations to date in the INVINCIBLE-4 study are promising, though preliminary and early. We are also pleased to see fewer total grade 3 or higher adverse events and fewer adverse events associated with checkpoint inhibitors when our drug is combined with immunochemotherapy in Cohort A than seen in Cohort B. The safety observed to date is consistent with our prior results using our drug with immunotherapy in mice1 and humans, which have been presented at oncology conferences or published in peer-reviewed journals."2      Mr. Bender continued, "Triple-negative breast cancer is one of the most aggressive and difficult to treat subtypes. As reported in the Keynote-5223 study, 77% of patients using the current SOC immunochemotherapy regimen alone have grade 3 or higher systemic adverse events, and 0.5% of patients died from the regimen. Reducing the total number of grade 3 or higher adverse events by 44%, especially immune-related adverse events, and the potential for a higher pCR rate with INT230-6 prior to SOC, could be life-saving for patients. With the amendment now filed with Swissmedic, we look forward to dosing the next patient."About Triple Negative Breast Cancer in the Presurgical SettingWomen with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11 to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50 to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients. About a Potential INT230-6 Approval Pathway in the Presurgical SettingThe FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. pCR is an accepted FDA accelerated approval criterion for approval in high-risk breast cancer, such as TNBC subtype. Pathological complete response is defined as the absence of residual invasive and in situ cancer after evaluation of the completely resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy. If a product is approved using pCR, companies must still seek full approval using event-free survival as an endpoint.About INT230-6INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx? technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.About the INVINCIBLE-4 StudyThe INVINCIBLE-4 study is a Phase 2 non-comparative, hypothesis-driven randomized open-label, two-cohort multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC immunochemotherapy treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the pathological complete response rate for the combination and the SOC alone. pCR is the absence of cancer at the time of surgery in the tumor and nodes. pCR is an FDA accelerated approval endpoint. Clinical evidence is strong that the risk of a patient's cancer returning is significantly reduced when there is a pCR at the time of surgery.  The Swiss Medic and the European Medicines Agency authorized the initiation of the INVINCIBLE-4 Study in Switzerland and France. The SCI led study is also being done in collaboration with Unicancer (UCBG), the French referent cooperative group in breast cancer accredited by the French National Cancer Institute. The expected total enrollment is up to sixty-one (61) patients.About Intensity TherapeuticsIntensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings.Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC ?lings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.Investor Relations Contact:Justin Kulik
CORE IR
coreirteam @W.E.J.Media Contact:Matt Cossel
CORE IR
pr@coreir.com1 Bloom, Bender, OncoImmunology June 2019
2 Thomas_ASCO_2022_poster
3 Shmid_NEJM_2020;



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Original: Intensity Therapeutics, Inc. Provides Update on the Phase 2 Presurgical Triple-Negative Breast Cancer INVINCIBLE-4 Study

Intensity Therapeutics Regains Compliance with Nasdaq's Minimum Bid Price RequirementMarch 6, 2026 7:47 AM
PR Newswire (US)

SHELTON, Conn., March 6, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, today announced that it has received formal notice from the Listings Qualifications staff of The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share. Nasdaq confirmed that for the last 10 consecutive business days, from February 19, 2026 through March 4, 2026, the closing bid price of the Company's common stock was at or above $1.00, and as a result, the matter is now closed.







About Intensity TherapeuticsIntensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study (the "INVINCIBLE-4 Study") (NCT06358573) in collaboration with the Swiss Cancer Group, formerly the Swiss Group for Clinical Cancer Research SAKK, as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com.  About INT230-6INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx? technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC ?lings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.Investor Relations Contact:
Justin Kulik
IR @W.E.J.Media Contact:
Matt Cossel
CORE IR
PR@coreir.com



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Original: Intensity Therapeutics Regains Compliance with Nasdaq's Minimum Bid Price Requirement

Intensity Therapeutics Announces Reverse Stock SplitFebruary 13, 2026 8:58 AM
PR Newswire (US)

Intensity's common stock is expected to begin trading on a post-split adjusted basis on February 19, 2026SHELTON, Conn., Feb. 13, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, today announced that the board of directors of the Company approved a 1-for-25 reverse stock split (the "Reverse Split") of the Company's common stock. The Reverse Split was approved by the stockholders of the Company at a special meeting of the Company held on October 22, 2025. The Reverse Split will legally take effect at 4:01 p.m. Eastern Time, on February 18, 2026. The Company's common stock will open for trading under a new CUSIP number 45828J 202 on The Nasdaq Capital Market on February 19, 2026, on a split-adjusted basis under the current ticker symbol "INTS." The Reverse Split is intended to increase the per share trading price of the Company's common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.







The 1-for-25 Reverse Split will automatically convert every twenty-five (25) current shares of the Company's common stock into one (1) share of common stock. No fractional shares will be issued in connection with the Reverse Split. Stockholders who would otherwise hold a fractional share of the Company's common stock following the Reverse Split will receive a cash payment in lieu thereof at a price equal to that fractional share to which the stockholder would otherwise be entitled multiplied by the closing sale price of the common stock on The Nasdaq Capital Market, as adjusted for the Reverse Split, on February 18, 2026.The Reverse Split will reduce the number of shares of outstanding common stock from approximately 63,346,579 shares, the number of shares outstanding as of February 12, 2026, to approximately 2,533,863 shares. The total authorized number of shares will not be reduced. Proportional adjustments will also be made to the exercise and conversion prices of the Company's outstanding stock options, warrants, and convertible securities, and to the number of shares issued and issuable under the Company's stock incentive plans.Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares through a bank, broker, or other nominee will have their positions automatically adjusted to reflect the Reverse Split, subject to brokers' particular processes, and will not be required to take any action in connection with the Reverse Split. For those stockholders holding physical stock certificates, the Company's transfer agent, Continental Stock Transfer & Trust, will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-split number of shares, and any payments in cash in lieu of fractional shares, if applicable.About INT230-6INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx? technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.About Intensity TherapeuticsIntensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study (the "INVINCIBLE-4 Study") (NCT06358573) in collaboration with the Swiss Cancer Group, formerly the Swiss Group for Clinical Cancer Research SAKK, as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com.Forward-Looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC ?lings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.Investor Relations Contact:
Justin Kulik
CORE IR
coreirteam @W.E.J.Media Contact:
Matt Cossel
CORE IR
pr@coreir.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-announces-reverse-stock-split-302687690.htmlSOURCE Intensity Therapeutics Inc.

Original: Intensity Therapeutics Announces Reverse Stock Split

this is silly who's whacking this down they have a cure for cancer

Feels like news coming ..again

Favorite bio stock

Moving

INTS..........................................https://stockcharts.com/sc3/ui/?s=INTS&p=W&b=5&g=0&id=p86431144783

YES sorry for not answering you sooner - Presentations Thursday and Friday

The presentations?

They Filed for offering and its ripping higher anyway

BIG WEEK NEXT WEEK

INTS.................................https://stockcharts.com/sc3/ui/?s=INTS&p=W&b=5&g=0&id=p86431144783

.56... approved a reverse stock split at a special meeting on October 22, 2025, allowing the board to set a split ratio between 1-for-5 and 1-for-30. As of November 5, 2025, the board has not yet announced the exact ratio or the effective date for the reverse split; it will be determined and communicated in the following weeks. This corporate action aims to help INTS meet Nasdaq listing requirements and increase its share price above $1.

.58     ...Squeeze some more juice cancer results too good here.... "INT230-6 is a local treatment that kills cancer using a diffusion process following direct injection into tumors. The trial demonstrated favorable safety and promising efficacy in patients with advanced metastatic cancers who had failed a median of three prior lines of therapy. The disease control rates and median survival compare favorably to those historically seen for such a diverse set of refractory cancer types in a phase 1/2 study," said Jacob S. Thomas, M.D. "There were also several learnings about INT230-6 dosing and safety gained during this trial. The pharmacokinetic data indicated that high rates of the drug are absorbed by the injected tumor, with minimal leakage, even at doses as high as 175 mL administered to a single tumor. These results are consistent with the low incidence of grade 3 adverse events observed.""The mechanism by which cancer is killed through the diffusion of cytotoxic agents following intratumoral injection of INT230-6 and systemic immune activation, as observed in preclinical models, translated well in the human setting. Uninjected tumors shrinking from a locally administered therapy, referred to as abscopal effects, are generally rare for local therapies. Yet, an abscopal effect was observed in at least 20% of 48 patients who received drug volumes above 40% of their tumor burden. In addition, in thirteen of fourteen matched pair biopsy slides, a notable increase in activated CD4+ and CD8+ T cells was observed in the tumor microenvironment in response to INT230-6 treatment. Representative images can be found in the paper," said Anthony El-Khoueiry M.D. "The abscopal effects and immune cell infiltration observed in this study highlight this intratumoral therapy's potential to drive both a local and systemic anti-cancer activity.""This comprehensive paper is the culmination of over a decade of nonclinical and clinical research. The article describes the development of a new technology to destroy tumors using molecular agents that can disperse potent anti-cancer compounds within injected tumors and deliver them into cancer cells. We believe these are the first clinical results where a locally administered therapy used alone could potentially extend survival for patients with metastatic disease," said Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics, Inc. "As Drs. Thomas and El-Khoueiry noted, our paper reports that INT230-6 injected into visible tumors in metastatic patients at an amount based on the size of the injected tumors supports the hypothesis that INT230-6 causes immunologic cancer cell death, even in cancers that are considered immunologically cold. Given the drug's mechanism of action and the data reported in this paper from over 20 types of metastatic solid cancers, such as breast, sarcoma, pancreatic, lung, and head and neck, we believe the study results show the potential of INT230-6 to achieve clinical benefit for metastatic patients of multiple cancer types with or without the use of radiation, systemic drugs or immunotherapy. As a result, we have initiated randomized controlled studies, including a Phase 3 study in sarcoma (NCT06263231)." ..

.56 ..offering 5m shares at .80 little room to move up 

Now underpriced?

Great call. Not.

Are there only 50 million shares in this company?

How DDAmanda Found $INTS Early: +395%. Best Early Alert Stock Finder

DDAmanda finds these before they run.



Z

0.90-0.8 now . Take it and don’t scream if you don’t buy and it goes above $2!

Dam! Should have grabbed trhose .72's!

Not to be a party pooper, or anything........But if this thing stays above a dollar or so, do you all think they would "undo" the recently approved reverse split......I've never seen such a thing happen.......Any thoughts......

HOD $1.74 😃

$INTS

INTS $1.58.. appears halted for the moment?

This has $2 written all over it

What the Hell billion shares at 1:30PM

INTS $1.26

Nice move $1.15+ 😃

Intensity Therapeutics, Inc. Announces Publication of Clinical Results of INT230-6 for the Treatment of Metastatic or Refractory Cancers in eBioMedicine, a Lancet Discovery Science Journal

Oct 30, 2025

https://investorshub.advfn.com/stock-market/NASDAQ/intesity-therapeutics-INTS/stock-news/97112849/intensity-therapeutics-inc-announces-publication

$INTS 💹

INTS $0.97

Link to Ebiomedicine, the publication where the INTS article is supposed to be in. I didn't have time to look for it, perhaps someone here can locate it. I did glance at the many articles, but either I was looking in the wrong place or it's not obvious that the article was about what's going on with INTS. https://www.thelancet.com/journals/ebiom/home

Here's a link that will explain today's jump: https://marketchameleon.com/articles/b/2025/10/30/ints-clinical-results-published-in-ebiomedicine-disease-control-rate-hits-75-with-promising-survival-outcomes-for-int230-6-in-metastatic-cancers

Wow! As of August 6, 2025, the registrant had 47,057,727 shares of common stock outstanding.???????????? Shares traded 10X's over?
R/S approved? Interesting to say the least.

INTS $0.85

Thanks Glenn, money made here because of your charts. Much appreciated!

Bang Zoom

Surprised nobody talking about this today

ints.......................................https://stockcharts.com/sc3/ui/?s=INTS&p=W&b=5&g=0&id=p86431144783

Feels like news coming

INTS 0.2959

https://drug-dev.com/executive-interview-intensity-therapeutics-providing-cancer-patients-with-treatments-that-work/

INTS...........................https://stockcharts.com/h-sc/ui?s=INTS&p=W&b=5&g=0&id=p86431144783

INTS.............................................p/m

Wonder when that might be 🤔

will be a nice pop when the pause on new patients is removed