Clinical data and cash runway update for Intensity Therapeutics (NASDAQ: INTS)
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Intensity Therapeutics reported a narrower 2025 net loss of $11.6M, improved from $16.3M in 2024, as research and development and general and administrative expenses declined. The company raised over $20M during 2025, ending the year with $11.9M in cash and cash equivalents and a stated cash runway into the second quarter of 2027.
Clinically, preliminary data from the INVINCIBLE-4 breast cancer study showed a pathological complete response rate of 71.4% (5/7) for patients receiving INT230-6 plus standard of care versus 33% (2/6) for standard of care alone, with fewer severe adverse events. A Lancet eBioMedicine publication from the IT-01 study reported a 75% disease control rate and median overall survival of 11.9 months in heavily pretreated metastatic patients. The INVINCIBLE-3 phase 3 sarcoma trial remains paused for new enrollment due to prior funding constraints, though the company continues treating enrolled patients and plans to restart once additional funding is obtained.
Positive
- Strengthened cash position and extended runway: Raised over $20M in 2025, ending with $11.9M in cash and cash equivalents and a stated operating runway into the second quarter of 2027, while reducing the annual net loss from $16.3M to $11.6M.
Negative
- Phase 3 sarcoma trial enrollment paused: The INVINCIBLE-3 study, a phase 3 trial in soft tissue sarcoma, had new site activations and patient enrollment paused in March 2025 due to funding constraints and remains on hold for new patients, pending sufficient additional financing.
Insights
Improved finances and encouraging INT230-6 data, offset by a key trial pause.
Intensity Therapeutics cut its 2025 net loss to $11.6M from $16.3M by lowering R&D and G&A spending, while raising over $20M to finish the year with $11.9M in cash and a stated runway into the second quarter of 2027.
Clinically, preliminary INVINCIBLE-4 data in early-stage triple negative breast cancer showed higher pathological complete response rates and fewer severe adverse events for INT230-6 plus standard of care versus standard of care alone. The IT-01 Lancet eBioMedicine publication reported a 75% disease control rate and 11.9-month median overall survival in heavily pretreated metastatic patients, with no dose-limiting toxicities.
Balancing this, the pivotal INVINCIBLE-3 phase 3 sarcoma trial remains paused for new enrollment after a March 2025 halt tied to funding constraints, though 21 enrolled patients continue treatment. Future progress depends on securing additional capital to restart INVINCIBLE-3 and fully execute the broader development plan.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 27, 2026
(Exact name of Registrant as Specified in Its Charter)
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Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 27, 2026, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the year ended December 31, 2025. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.
The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued March 27, 2026. | |||||||
| 104 | Cover Page Interactive Data File (formatted in Inline XBRL). | |||||||
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 27, 2026. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: March 27, 2026
| Intensity Therapeutics, Inc. | |||||||||||
| By: | /s/ Lewis H. Bender | ||||||||||
| Name: | Lewis H. Bender | ||||||||||
| Title: | Chief Executive Officer | ||||||||||
[Signature Page to the Form 8-K]
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Exhibit 99.1
Intensity Therapeutics Reports 2025 Year End Financial Results and Highlights, and Provides Corporate Update
•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 2027
•IT-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 safety
•Favorable 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
Shelton, Conn., March 27, 2026 – 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 Update
INVINCIBLE-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 Publication
In 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 months
◦In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months
•In 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); P<0.0001
◦Improved survival was consistent across a range of low to high tumor burden and tumor sizes
•Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects
•Fifteen of 64 patients survived for more than 21 months
•INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment
•No 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 events
•Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors
Cash 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 Results
Research 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.
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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 INT230-6
INT230-6, 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 Therapeutics
Intensity 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 Statements
Certain 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
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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 filings, 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@coreir.com
(516) 222-2560
Media Contact:
Matt Cossel
CORE IR
PR@coreir.com
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Intensity Therapeutics, Inc.
Statements of Operations
(in thousands, except share and per share amounts)
(Derived from audited financial statements)
| Year Ended December 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Operating expenses: | |||||||||||
| Research and development | $ | 6,785 | $ | 10,496 | |||||||
| General and administrative | 5,187 | 6,089 | |||||||||
| Total operating expenses | 11,972 | 16,585 | |||||||||
| Loss from operations | (11,972) | (16,585) | |||||||||
| Other income (expense): | |||||||||||
| Interest income | 180 | 314 | |||||||||
| Other income, net | 186 | 3 | |||||||||
| Net 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 diluted | 1,356,358 | 556,279 | |||||||||
Intensity Therapeutics, Inc.
Balance Sheets
(in thousands)
(Derived from audited financial statements)
| December 31, 2025 | December 31, 2024 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 11,921 | $ | 2,590 | |||||||
| Prepaid expenses and other current assets | 788 | 773 | |||||||||
| Total current assets | 12,709 | 3,363 | |||||||||
| Right-of-use asset, net | 96 | 122 | |||||||||
| Other assets | 1,296 | 1,298 | |||||||||
| Total assets | $ | 14,101 | $ | 4,783 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 583 | $ | 1,219 | |||||||
| Accrued expenses | 1,532 | 508 | |||||||||
| Lease liability, current portion | 31 | 28 | |||||||||
| Total current liabilities | 2,146 | 1,755 | |||||||||
| Lease liability, net of current portion | 79 | 110 | |||||||||
| Total liabilities | 2,225 | 1,865 | |||||||||
| Total stockholders’ equity | 11,876 | 2,918 | |||||||||
| Total liabilities and stockholders’ equity | $ | 14,101 | $ | 4,783 | |||||||
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FAQ
How did Intensity Therapeutics (INTS) perform financially in 2025?
Intensity Therapeutics reported a narrower 2025 net loss of $11.6M, improving from $16.3M in 2024. Operating expenses fell as research and development dropped to $6.8M and general and administrative costs declined to $5.2M, reflecting lower clinical, manufacturing, and corporate expenses.
What is Intensity Therapeutics’ cash position and runway after 2025?
The company raised over $20M in 2025 via public offerings, a registered direct deal, and ATM issuances, ending the year with $11.9M in cash and cash equivalents. Management states this supports operations into the second quarter of 2027, assuming current plans and spending levels.
What preliminary results were reported from the INVINCIBLE-4 study of INT230-6?
In INVINCIBLE-4, preliminary data showed 71.4% (5/7) of patients receiving INT230-6 before standard of care achieved pathological complete response, versus 33% (2/6) on standard of care alone. Cohort A also had 44% fewer grade 3 or higher adverse events, indicating both efficacy and tolerability signals.
What key findings came from the IT-01 Lancet eBioMedicine publication?
The IT-01 phase 1/2 study of INT230-6 in metastatic or refractory cancers reported a 75% disease control rate (48/64 patients) and median overall survival of 11.9 months. No dose-limiting toxicities occurred, and most active cytotoxic agents remained localized in the injected tumors.
What is the status of the INVINCIBLE-3 phase 3 sarcoma trial at Intensity Therapeutics?
The INVINCIBLE-3 phase 3 trial testing INT230-6 monotherapy versus standard of care in soft tissue sarcoma paused new site activations and enrollment in March 2025 due to funding constraints. Twenty-one patients were enrolled before the pause, and they continue treatment while the company seeks funding to restart enrollment.
How did Intensity Therapeutics manage its research and development expenses in 2025?
Research and development expenses decreased to $6.8M in 2025 from $10.5M in 2024. The reduction was mainly driven by lower INVINCIBLE-3 clinical trial costs, no new manufacturing batches of INT230-6, and reduced stock-based compensation, partially offset by higher bonus accruals.
Filing Exhibits & Attachments
4 documents
INTENSITY THERAPEUTICS INC
NASDAQ:INTS
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14.39M
2.35M
Biotechnology
Biological Products, (no Diagnostic Substances)
United States
SHELTON