INTENSITY THERAPEUTICS, INC.

Previous wording

In July 2024, we initiated and dosed our first patient in a Phase 3 open-label, randomized study (the “INVINCIBLE-3 Study”) testing INT230-6 as a monotherapy compared to the standard of care (“SOC”) drugs in second- and third-line treatment for certain soft tissue sarcoma subtypes. This 333-patient study with an endpoint of overall survival has been authorized by the FDA, Health Canada, the European Medicines Authority, and Australia's Therapeutic Goods Administration. In March 2025, we paused new site activations and patient enrollments due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. We have continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations (“CRO”) to reduce ongoing costs during this pause. In April 2026, we initiated activities to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study using an FDA-reviewed amended protocol based on important learnings from patients enrolled prior to the pause. Patient enrollment will likely begin in the third quarter of 2026. Increased site activation and patient enrollment rates are expected as sufficient incremental funding is obtained.

Current wording

In July 2024, we initiated and dosed our first patient in a Phase 3 open-label, randomized study (the “INVINCIBLE-3 Study”) testing INT230-6 as a monotherapy compared to the standard of care (“SOC”) drugs in second- and third-line treatment for certain soft tissue sarcoma subtypes. This 333-patient study with an endpoint of overall survival has been authorized by the FDA, Health Canada, the European Medicines Agency, and Australia's Therapeutic Goods Administration. In March 2025, we paused new site activations and patient enrollments due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. We have continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations (“CRO”) to reduce ongoing costs during this pause. In April 2026, we initiated activities to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study using an FDA-reviewed amended protocol based on important learnings from patients enrolled prior to the pause. New patient enrollment activities resumed in the third quarter of 2026. Increased site activation and patient enrollment rates are expected as sufficient incremental funding is obtained.

Previous wording

In October 2024, in collaboration with the Swiss Cancer Institute, formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), we initiated and dosed our first patient in a Phase 2 study (the “INVINCIBLE-4 Study”) to treat patients with localized triple-negative breast cancer. The endpoint is the change in the pathological complete response (“pCR”) rate for the combination compared to the SOC alone. In September 2025, we paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site. Preliminary data from the first 14 patients (seven in each cohort) showed a 71% pCR in patients receiving INT230-6 in Cohort A and a 42% pCR in patients receiving the SOC alone (Cohort B). There was also a 44% reduction in grade 3 adverse events in Cohort A compared to Cohort B and fewer immune-related adverse events when our INT230-6 was added prior to the immunochemotherapy. In March 2026, a protocol amendment was approved by the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6, and patient enrollment was resumed in the second quarter of 2026. In July 2026, the Company restarted patient treatment and is currently targeting to complete enrollment by the end of 2027, and will likely add resources to help sites enroll new patients. In August 2026, the Company opened its first site in France for accrual following EU submission of the modified protocol.

Current wording

In October 2024, in collaboration with the Swiss Cancer Institute (“SCI”), formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), we initiated and dosed our first patient in a Phase 2 study (the “INVINCIBLE-4 Study”) to treat patients with localized triple-negative breast cancer. The endpoint is the change in the pathological complete response (“pCR”) rate for the combination compared to the SOC alone. In September 2025, we paused new patient enrollment after 14 patients had been enrolled to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site. In March 2026, a protocol amendment was approved by Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6. In July 2026, the Company restarted patient treatment and is currently targeting to complete enrollment by the end of 2027, and will likely add resources to help sites enroll new patients. SCI has established an independent data monitory board (“IDMB”) comprised of qualified experts to review the safety data and images of these newly treated patients to assess whether the skin irritation issue has been resolved. We plan to provide an update upon completion of IDMB review in the first quarter of 2027. In August 2026, the Company opened its first site in France for accrual following EU submission of the modified protocol. Preliminary data from the first 14 patients (seven in each cohort) showed a 71% pCR in patients receiving INT230-6 in Cohort A and a 42% pCR in patients receiving the SOC alone (Cohort B). There was also a 44% reduction in grade 3 adverse events in Cohort A compared to Cohort B and fewer immune-related adverse events when our INT230-6 was added prior to the immunochemotherapy. In addition, no invasive breast cancer cells were detected in the axillary lymph nodes in 6 of the 7 patients in Cohort A after INT230-6 treatment, despite 5 (71%) of these patients being initially biopsy-proven node-positive. Results also showed tumor necrosis after 1 or 2 injections in all 7 Cohort A patients. In the pre-surgery MRI at the completion of neoadjuvant immuno-chemotherapy, four (57%) patients had RECIST 1.1 radiological complete response and three patients (43%) partial response.

Previous wording

We have also successfully developed Phase 3 quality analytical methods for the three INT230-6 components and successfully manufactured multiple large-scale batch of INT230-6. In a meeting with the FDA in the fourth quarter of 2023, we agreed on a chemical manufacture and control (“CMC”) plan for Phase 3 and product registration for our three key ingredients and INT230-6. If we successfully execute the agreed-upon plan, we expect that the CMC portion of a New Drug Application (“NDA”) should be acceptable to the FDA for product approval and registration (subject to final NDA review).

Current wording

We have also successfully developed Phase 3 quality analytical methods for the three INT230-6 components and successfully manufactured multiple large-scale batches of INT230-6. In a meeting with the FDA in the fourth quarter of 2023, we agreed on a chemistry, manufacturing, and control (“CMC”) plan for Phase 3 and product registration for our three key ingredients and INT230-6. If we successfully execute the agreed-upon plan, we expect that the CMC portion of a New Drug Application (“NDA”) should be acceptable to the FDA for product approval and registration (subject to final NDA review).

Previous wording

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing both research and development on our product candidates. Our research has been selected for oral presentations at major oncology conferences including the American Society of Clinical Oncology (“ASCO”), the Society for Immunotherapy of Cancer (“SITC”), the Connective Tissue Oncology Society (“CTOS”) and the San Antonio Breast Cancer Society (“SABCS”). Our research has undergone peer review and been published in high-impact journals such as OncoImmunology (a paper written jointly with the NCI) and The Lancet’s journal eBioMedicine. We have incurred net losses since inception and expect to incur net losses in the future as we continue our research and development activities. To date, we have funded our operations primarily through net proceeds received from issuances of our common stock, preferred stock and convertible notes. As of June 30, 2026, we had approximately $9.5 million of cash and cash equivalents. Subsequent to June 30, 2026, we raised an additional $1.3 million in net proceeds under the Sales Agreement. Since our inception, we have incurred significant operating losses. We incurred net losses of $5.4 million and $5.9 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $83.8 million.

Current wording

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing both research and development on our product candidates. Our research has been selected for oral presentations at major oncology conferences including the American Society of Clinical Oncology (“ASCO”), the Society for Immunotherapy of Cancer (“SITC”), the Connective Tissue Oncology Society (“CTOS”) and the San Antonio Breast Cancer Society (“SABCS”). Our research has undergone peer review and been published in high-impact journals such as OncoImmunology (a paper written jointly with the NCI) and The Lancet’s journal eBioMedicine. We have incurred net losses since inception and expect to incur net losses in the future as we continue our research and development activities. To date, we have funded our operations primarily through net proceeds received from issuances of our common stock, preferred stock and convertible notes. As of September 30, 2026, we had approximately $8.5 million of cash and cash equivalents. Since our inception, we have incurred significant operating losses. We incurred net losses of $9.0 million and $8.6 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $87.4 million.

Previous wording

•Consulting services provided by non-employees for general and administrative tasks, include accounting, tax, human resources, finance, investor relations, board compensation, and internet support.

Current wording

•Consulting services provided by non-employees for general and administrative tasks, include accounting, tax, human resources, finance, investor relations, board compensation, and information technology support.

Previous wording

The following tables summarize our results of operations for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following tables summarize our results of operations for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

•INVINCIBLE-3 Study costs decreased $0.8 million. In March 2025, we 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. We have continued to treat all patients enrolled in this study in cooperation with our third-party CROs during this pause. In April 2026, we initiated plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and we have prioritized commencing full patient enrollment and site activations once sufficient incremental funding is obtained.

Current wording

•INVINCIBLE-3 Study costs increased $0.5 million. In March 2025, we paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. During the third quarter of 2026, we resumed new patient enrollment activities in the INVINCIBLE-3 Study in a limited number of U.S. sites, and have prioritized commencing full patient enrollment and site activations once sufficient incremental funding is obtained.

Previous wording

•INVINCIBLE-3 Study costs increased $0.3 million. In March 2025, we 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. We have continued to treat all patients enrolled in this study in cooperation with our third-party CROs during this pause. In April 2026, we initiated plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and we have prioritized commencing full patient enrollment and site activations once sufficient incremental funding is obtained.

Current wording

•INVINCIBLE-3 Study costs decreased $0.3 million. In March 2025, we 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. We have continued to treat all patients enrolled in this study in cooperation with our third-party CROs during this pause. In April 2026, we initiated plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites, and new patient enrollment activities resumed in the third quarter of 2026. Submission of documentation necessary for restarting in the EU is in process. Increased site activation and patient enrollment rates are expected as sufficient incremental funding is obtained.

Previous wording

General and administrative expenses during the six months ended June 30, 2026 increased marginally by $0.2 million or 9%, compared to the six months ended June 30, 2025, and were primarily due to the following:

Current wording

General and administrative expenses during the nine months ended September 30, 2026 increased by $0.2 million or 6%, compared to the nine months ended September 30, 2025, and were primarily due to the following:

Previous wording

•Other expenses increased during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 due to higher Delaware franchise costs related to our Reverse Stock Split in February 2026.

Current wording

•Other expenses increased during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 due to higher Delaware franchise costs related to our Reverse Stock Split in February 2026.

Previous wording

On March 23, 2026, we filed a prospectus supplement to adjust the maximum that we may sell and issue under the Sales Agreement to $60.0 million of our shares of common stock, not including the shares previously sold under the Sales Agreement. Since inception through June 30, 2026, we have issued 1,659,087 shares of common stock under the Sales Agreement for net proceeds of $13.1 million. As of June 30, 2026, we may issue and sell up to $58.4 million of Shares remaining under the Sales Agreement. Subsequent to June 30, 2026, we have issued an additional 319,327 shares of common stock under the Sales Agreement for net proceeds of $1.3 million.

Current wording

On March 23, 2026, we filed a prospectus supplement to adjust the maximum that we may sell and issue under the Sales Agreement to $60.0 million of our shares of common stock, not including the shares previously sold under the Sales Agreement. Since inception through September 30, 2026, we have issued 2,009,329 shares of common stock under the Sales Agreement for net proceeds of $14.5 million. As of September 30, 2026, we may issue and sell up to $56.9 million of Shares remaining under the Sales Agreement.

Previous wording

On April 24, 2025, we commenced a best efforts public offering (the “April 2025 Offering”) of an aggregate of (i) 125,333 shares (the “Shares”) of our common stock, (ii) 125,333 Series B-1 Common Warrants (the “Series B-1 Common Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-1 Common Warrant Shares”), (iii) 125,333 Series B-2 Common Warrants (the “Series B-2 Common Warrants” and together with the Series B-1 Common Warrants, the “Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-2 Common Warrant Shares” and together with the Series B-1 Common Warrant Shares, the “Warrant Shares”). In connection with the April 2025 Offering, we entered into a Securities Purchase Agreement on April 24, 2025 with certain institutional investors participating in the April 2025 Offering. The April 2025 Offering closed on April 28, 2025. Each Share was sold together with one Series B-1 Common Warrant to purchase one share of common stock and one Series B-2 Common Warrant to purchase one share of common stock. The combined offering price for each Share and accompanying Warrants was $18.75. Each Warrant has an exercise price of $21.25 and was immediately exercisable upon issuance. The Series B-1 Common Warrants will expire on the five-year anniversary of the date of issuance, and the Series B-2 Common Warrants will expire on the eighteen-month anniversary of the date of issuance. We raised an aggregate of $2.35 million in the April 2025 Offering, and net proceeds of the April 2025 Offering, after deducting the fees and expenses were approximately $1.9 million.

Current wording

On April 24, 2025, we commenced a best efforts public offering (the “April 2025 Offering”) of an aggregate of (i) 125,333 shares (the “Shares”) of our common stock, (ii) 125,333 Series B-1 Common Warrants (the “Series B-1 Common Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-1 Common Warrant Shares”), and (iii) 125,333 Series B-2 Common Warrants (the “Series B-2 Common Warrants” and together with the Series B-1 Common Warrants, the “Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-2 Common Warrant Shares” and together with the Series B-1 Common Warrant Shares, the “Warrant Shares”). In connection with the April 2025 Offering, we entered into a Securities Purchase Agreement on April 24, 2025 with certain institutional investors participating in the April 2025 Offering. The April 2025 Offering closed on April 28, 2025. Each Share was sold together with one Series B-1 Common Warrant to purchase one share of common stock and one Series B-2 Common Warrant to purchase one share of common stock. The combined offering price for each Share and accompanying Warrants was $18.75. Each Warrant has an exercise price of $21.25 and was immediately exercisable upon issuance. The Series B-1 Common Warrants will expire on the five-year anniversary of the date of issuance, and the Series B-2 Common Warrants will expire on the eighteen-month anniversary of the date of issuance. We raised an aggregate of $2.35 million in the April 2025 Offering, and net proceeds of the April 2025 Offering, after deducting the fees and expenses were approximately $1.9 million.

Previous wording

As of June 30, 2026, our cash and cash equivalents were approximately $9.5 million. Based on our balances in cash and cash equivalents, our ability to continue our operations is dependent on obtaining additional capital, which is not within our control. As a result, we believe there is substantial doubt about our ability to continue as a going concern.

Current wording

As of September 30, 2026, our cash and cash equivalents were approximately $8.5 million. Based on our balances in cash and cash equivalents, our ability to continue our operations is dependent on obtaining additional capital, which is not within our control. As a result, we believe there is substantial doubt about our ability to continue as a going concern.

Previous wording

Our cash used in operating activities for the six months ended June 30, 2026 was $4.2 million, comprising of (i) our net loss of $5.4 million, as adjusted for $0.8 million in non-cash expenses (primarily for non-cash stock based compensation of $0.8 million), and (ii) net changes in operating assets and liabilities of $0.5 million.

Current wording

Our cash used in operating activities for the nine months ended September 30, 2026 was $6.7 million, comprising of (i) our net loss of $9.0 million, as adjusted for $1.3 million in non-cash expenses (primarily for non-cash stock based compensation of $1.3 million), and (ii) net changes in operating assets and liabilities of $1.0 million.

Previous wording

Our cash used in operating activities for the six months ended June 30, 2025 was $4.4 million, comprising of (i) our net loss of $5.9 million, as adjusted for $1.1 million in non-cash expenses (primarily for non-cash stock based compensation of $1.1 million), and (ii) net changes in operating assets and liabilities of $0.3 million.

Current wording

Our cash used in operating activities for the nine months ended September 30, 2025 was $6.8 million, comprising of (i) our net loss of $8.6 million, as adjusted for $1.6 million in non-cash expenses (primarily for non-cash stock based compensation of $1.6 million), and (ii) net changes in operating assets and liabilities of $0.2 million.

Previous wording

There were no investing activities during the six months ended June 30, 2026 or June 30, 2025.

Current wording

There were no investing activities during the nine months ended September 30, 2026 or September 30, 2025.

Previous wording

Our cash provided by financing activities during the six months ended June 30, 2026 was $1.8 million, comprised primarily from net proceeds received from the issuance of common stock under the Sales Agreement.

Current wording

Our cash provided by financing activities during the nine months ended September 30, 2026 was $3.2 million, comprised primarily from net proceeds received from the issuance of common stock under the Sales Agreement.

Previous wording

Our cash provided by financing activities during the six months ended June 30, 2025 was $4.1 million, primarily comprising of (i) $1.9 million in net proceeds received from the issuance of common stock and warrants in the April 2025 Offering, (ii) $1.8 million in net proceeds received from the issuance of common stock in the June 2025 Offering, and (iii) $0.3 million in net proceeds received from the issuance of common stock under the Sales Agreement.

Current wording

Our cash provided by financing activities during the nine months ended September 30, 2025 was $11.3 million, primarily comprising of (i) $1.9 million in net proceeds received from the issuance of common stock and warrants in the April 2025 Offering, (ii) $1.8 million in net proceeds received from the issuance of common stock in the June 2025 Offering, and (iii) $7.6 million in net proceeds received from the issuance of common stock under the Sales Agreement.

Previous wording

Critical accounting estimates are those policies which are both important to the presentation of a company’s financial condition and results and require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a further discussion of our critical accounting estimates, see our 2025 Annual Report. No significant changes to our accounting policies took place during the six months ended June 30, 2026.

Current wording

Critical accounting estimates are those policies which are both important to the presentation of a company’s financial condition and results and require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a further discussion of our critical accounting estimates, see our 2025 Annual Report. No significant changes to our accounting policies took place during the nine months ended September 30, 2026.