INTENSITY THERAPEUTICS, INC.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 11, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001567264-26-000046
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001567264-26-000059
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 82 previous paragraphs and 94 current paragraphs.
49 unchanged; 30 reworded; 11 added; 2 removed; 1 previous and 4 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
Research and development expenses during the three months ended June 30, 2026 increased $0.3 million or 19%, compared to the three months ended June 30, 2025, and were primarily due to the following:
Current report
•Stock-based compensation decreased during the three months ended June 30, 2026 compared to the three months ended June 30, 2025 as no stock-based compensation awards were granted during the first half of 2026.
Current report
•Stock-based compensation decreased during the three months ended June 30, 2026 compared to the three months ended June 30, 2025 as no stock-based compensation awards were granted during the first half of 2026.
Current report
Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025
Current report
•Salaries and benefits related costs increased due to an estimated bonus accrual during the six months ended June 30, 2026 compared to no estimated accrual during the six months ended June 30, 2025.
Current report
•Stock-based compensation decreased during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 as no stock-based compensation awards were granted during the first half of 2026.
Current report
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 report
•Salaries and benefits related costs increased due to an estimated bonus accrual during the six months ended June 30, 2026 compared to no estimated accrual during the six months ended June 30, 2025
Current report
•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 report
•Stock-based compensation decreased during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 as no stock-based compensation awards were granted during the first half of 2026.
Current report
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.
Removed paragraphs (2)
Previous report
•Salaries and benefits related costs decreased due to lower headcount in 2026, which was entirely offset by an estimated bonus accrual during the three months ended March 31, 2026 compared to no estimated accrual during the three months ended March 31, 2025.
Previous report
•Salaries and benefits related costs increased due to an estimated bonus accrual during the three months ended March 31, 2026 compared to no estimated accrual during the three months ended March 31, 2025, which were partially offset by lower stock-based compensation.
Reworded paragraphs (30)
Previous wording
Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company passionately committed to applying scientific leadership in the field of localized cancer reduction leading to anti-cancer immune activation. Our new approach involves the direct injection into tumors of a unique product created from our DfuseRx SM discovery platform.
Current wording
Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company passionately committed to applying scientific leadership in the field of localized cancer reduction leading to anti-cancer immune activation. Our new approach involves the direct injection into tumors of a unique product created from our DfuseRx SM discovery platform. Our technology makes use of non-covalent conjugation between transporter molecules and potent drug payloads.
Previous wording
Intratumoral (“IT”) treatment, or treatment designed to contain a drug inside a tumor without spreading to the rest of the body, has been an objective of clinicians since discovery of chemotherapeutic agents. The challenge with IT treatment approaches is that a tumor’s lipophilic, high fat, dense and pressurized microenvironment is incompatible with and does not absorb water-based products. We believe that this drug delivery challenge limits the effectiveness of prior and current IT treatments, which involve injecting aqueous drugs into a tumor without sufficient consideration of the tumor environment (regardless of the drug’s mechanism or approach, i.e. the stimulation of an inflammatory response or efforts to attract immune cells into a hostile live tumor). Accordingly, there remains a continued unmet need for the development of direct IT therapies for solid tumors that provide high local killing efficacy coupled with nontoxic systemic anti-cancer effects. We believe we have created a product candidate, using our non-covalent conjugation chemistry, with the necessary physical properties to overcome this local delivery challenge. Evidence shows the mechanism of tumor killing achieved by our drug candidate also leads to systemic immune activation and T-cell repertoire expansion in certain cancers.
Current wording
Intratumoral (“IT”) treatment, or treatment designed to contain a drug inside a tumor without harming the rest of the body, has been an objective of clinicians since discovery of chemotherapeutic agents. The challenge with IT treatment approaches is that a tumor’s lipophilic, high fat, dense and pressurized microenvironment is incompatible with and does not absorb water-based products. We believe that this drug delivery challenge limits the effectiveness of prior and current IT treatments, which involve injecting aqueous drugs into a tumor without sufficient consideration of the tumor environment, regardless of the drug’s mechanism or approach. Accordingly, there remains a continued unmet need for the development of direct IT therapies for solid tumors that provide high local killing efficacy coupled with nontoxic systemic anti-cancer effects. We believe we have created a product candidate, using our non-covalent conjugation chemistry, with the necessary physical properties to overcome this local delivery challenge. Evidence shows the mechanism of tumor killing achieved by our drug candidate also leads to systemic immune activation and T-cell repertoire expansion in certain cancers.
Previous wording
Our lead product candidate, INT230-6, is primarily comprised of three components: (i) cisplatin, a proven anti-cancer cytotoxic agent, (ii) vinblastine sulfate, also a proven anti-cancer cytotoxic agent, and (iii) an amphiphilic molecule (“SHAO”) which enables the two cytotoxic agents to disperse through a tumor and diffuse into cancer cells following a direct intratumoral injection. These three components are mixed and combined into one vial at a fixed ratio. Cisplatin and vinblastine sulfate are both generic and available to purchase in bulk supply commercially. The United States Food & Drug Administration (“FDA”) has approved both drugs as intravenous agents for several types of cancers. Cisplatin was first approved in 1978 for testicular cancer, and is also approved in ovarian and bladder cancer. The drug is also used widely in several other cancers including pancreatic and bile duct cancer. Vinblastine sulfate was first approved in 1965, and is also approved in generalized Hodgkin’s disease, lymphocytic lymphoma, advanced carcinoma of the testis, and certain types of sarcomas. The drug is also used in breast and lung cancer treatments.
Current wording
Our lead product candidate, INT230-6, is primarily comprised of three components: (i) cisplatin, a proven anti-cancer cytotoxic agent, (ii) vinblastine sulfate, also a proven anti-cancer cytotoxic agent, and (iii) an amphiphilic molecule (“SHAO”) which enables the two cytotoxic agents to disperse through a tumor and diffuse into cancer cells following a direct intratumoral injection. These three components are mixed and combined into one vial at a fixed ratio. Cisplatin and vinblastine sulfate are both available to purchase in bulk supply commercially. The United States Food & Drug Administration (“FDA”) has approved both drugs as intravenous agents for several types of cancers. Cisplatin was first approved in 1978 for testicular cancer, and is also approved in ovarian and bladder cancer. The drug is also used widely in several other cancers including pancreatic and bile duct cancer. Vinblastine sulfate was first approved in 1965, and is also approved in generalized Hodgkin’s disease, lymphocytic lymphoma, advanced carcinoma of the testis, and certain types of sarcomas. The drug is also used in breast and lung cancer treatments.
Previous wording
In 2017, we initiated a Phase 1/2 dose escalation study (“IT-01 Study”) using INT230-6 in the United States under an investigational new drug application authorized by the FDA and in Canada under a preclinical trial application approved by Health Canada. The study tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms: (i) INT230-6 used as a monotherapy, (ii) INT230-6 in combination with Merck’s Keytruda® (pembrolizumab), and (iii) INT230-6 in combination with Bristol Myers Squibb’s Yervoy® (ipilimumab). We completed enrollment of the IT-01 Study in June 2022, locked the IT-01 Study database in February 2023 and finalized the clinical study report in September 2023. We delivered the combination-specific reports and other information to our partners in the fourth quarter of 2023.
Current wording
In 2017, we initiated a Phase 1/2 dose escalation study (“IT-01 Study”) using INT230-6 in the United States under an investigational new drug application authorized by the FDA and in Canada under a preclinical trial application approved by Health Canada. The study tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms: (i) INT230-6 used as a monotherapy, (ii) INT230-6 in combination with Merck’s Keytruda® (pembrolizumab), and (iii) INT230-6 in combination with Bristol Myers Squibb’s Yervoy® (ipilimumab). We completed enrollment of the IT-01 Study in June 2022, locked the IT-01 Study database in February 2023 and finalized the clinical study report in September 2023.
Previous wording
In 2021, we initiated a Phase 2 randomized study that tested INT230-6 as a monotherapy treatment in early-stage breast cancer for patients not suitable for presurgical chemotherapy (the “INVINCIBLE-2 Study”). The study enrolled 91 subjects and the database was locked in November 2023. The key endpoint was whether INT230-6 could reduce a patient’s cancer compared to no treatment, which is the current standard of care (“SOC”) for the majority of patients with early-stage breast cancer, or a saline injection. Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence. The key endpoints of the INVINCIBLE 2 Study were to understand the percentage of necrosis that can be achieved in tumors of varying sizes for a given dose, especially for tumors larger than 2 centimeters in longest diameter. We also sought to determine whether a local or whole-body anti-cancer immune response could be induced. The INVINCIBLE-2 Study demonstrated a high order of necrosis in presurgical breast cancer tumors in the period from diagnosis to surgery, with some patients experiencing greater than 95% necrosis of the tumor. Data from the INVINCIBLE-2 Study demonstrated that INT230-6 had a favorable safety profile. There was also an increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and blood. Additionally, there was an increase in the T-cells repertoire relative to control.
Current wording
In 2021, we initiated a Phase 2 randomized study that tested INT230-6 as a monotherapy treatment in early-stage breast cancer for patients not suitable for presurgical chemotherapy (the “INVINCIBLE-2 Study”). The study enrolled 91 subjects and the database was locked in November 2023. The key endpoint was whether INT230-6 could reduce a patient’s cancer compared to no treatment or saline injections. Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence. The key endpoints of the INVINCIBLE-2 Study were to understand the percentage of necrosis that can be achieved in tumors of varying sizes for a given dose, especially for tumors larger than 2 centimeters in longest diameter. We also sought to determine whether a local or whole-body anti-cancer immune response could be induced. The INVINCIBLE-2 Study demonstrated a high order of necrosis in presurgical breast cancer tumors in the period from diagnosis to surgery, with some patients experiencing greater than 95% necrosis of the tumor. Data from the INVINCIBLE-2 Study demonstrated that INT230-6 had a favorable safety profile. There was also an increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and blood. Additionally, there was an increase in the T-cells repertoire relative to control.
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 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 Therapeutics 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 decided 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
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.
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. In March 2026, we reported preliminary data from the first 14 patients showing a 71% pCR in patients receiving INT230-6 in Cohort A and a 33% pCR in patients receiving the SOC alone. There was also 44% reduction in grade 3 adverse events in Cohort A compared to Cohort B. In March 2026, a protocol amendment was submitted to the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6. Full approval to resume enrollment was granted on March 26, 2026, and we plan to resume enrollment in the second quarter of 2026. We are currently targeting to complete enrollment by the end of 2027 and will likely add resources to help sites enroll new patients. In the event we are unable to obtain sufficient additional funding, we may have to delay the completion of the INVINCIBLE-4 Study until such funding is obtained.
Current 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.
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. 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 March 31, 2026, we had approximately $10.2 million of cash and cash equivalents. Since our inception, we have incurred significant operating losses. We incurred net losses of $2.4 million and $3.3 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $80.8 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 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.
Previous wording
•Salaries and Benefits Related Costs include employee-related expenses such as salaries and related benefits for employees engaged in research and development functions.
Current wording
•Salaries and Benefits Related Costs include employee-related expenses such as salaries, bonuses and related benefits for employees engaged in research and development functions.
Previous wording
•Clinical Trial Expenses includes payments to third parties in connection with the clinical development of our product candidates, including CROs, and costs due to clinical trials for patient care.
Current wording
•Clinical Trial Expenses include payments to third parties in connection with the clinical development of our product candidates, including CROs, and costs due to clinical trials for patient care.
Previous wording
◦Manufacture and labelling of GMP product candidate;
Current wording
◦Manufacture and labeling of GMP product candidate;
Previous wording
•Audit Fees consist of fees billed for professional services rendered for the audit of our annual financial statements, review of our interim financial statements, comfort and consent letters.
Current wording
•Audit Fees consist of fees billed for professional services rendered for the audit of our annual financial statements, review of our interim financial statements, and comfort and consent letters.
Previous wording
•Consulting services provided by non-employees for general and administrative tasks, includes 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 internet support.
Previous wording
We earned interest income on our cash balances and investments in U.S. Treasury bills.
Current wording
We earned interest income on our cash balances.
Previous wording
The following tables summarize our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):
Current wording
The following tables summarize our results of operations for the three and six months ended June 30, 2026 and 2025 (in thousands):
Previous wording
General and administrative expenses during the three months ended March 31, 2026 increased marginally by $0.1 million or 10%, compared to the three months ended March 31, 2025, and were primarily due to the following:
Current wording
General and administrative expenses during the three months ended June 30, 2026 increased marginally by $0.1 million or 7%, compared to the three months ended June 30, 2025, and were primarily due to the following:
Previous wording
•Higher one-time expenses related to our Reverse Stock Split in February 2026 during the three months ended March 31, 2026.
Current wording
•Other expenses increased during the three months ended June 30, 2026 compared to the three months ended June 30, 2025 due to higher Delaware franchise costs related to our Reverse Stock Split in February 2026.
Previous wording
Interest income in 2026 and 2025 related to interest earned on cash and investment balances.
Current wording
Interest income in 2026 and 2025 related to interest earned on cash.
Previous wording
Research and development expenses during the three months ended March 31, 2026 decreased $1.0 million or 45%, compared to the three months ended March 31, 2025, and was primarily due to the following:
Current wording
Research and development expenses during the six months ended June 30, 2026 decreased $0.7 million or 19%, compared to the six months ended June 30, 2025, and were primarily due to the following:
Previous wording
•INVINCIBLE-3 Study costs decreased $1.1 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. We plan 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 $0.8 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.
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 March 31, 2026, we have issued 1,297,655 shares of common stock under the Sales Agreement for net proceeds of $11.5 million. Subsequent to March 31, 2026, we have issued an additional 124,553 shares of common stock under the Sales Agreement for net proceeds of $0.6 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 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.
Previous wording
On October 30, 2025, the Company entered into a Securities Purchase Agreement with an institutional investor, pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the investor 200,000 shares of common stock at a price of $20.00 per share, for aggregate gross proceeds of $4.0 million before deducting the placement agent’s fees and related offering expenses.
Current wording
On October 30, 2025, we entered into a Securities Purchase Agreement with an institutional investor, pursuant to which we agreed to issue and sell, in a registered direct offering by us directly to the investor 200,000 shares of common stock at a price of $20.00 per share, for aggregate gross proceeds of $4.0 million before deducting the placement agent’s fees and related offering expenses.
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 the 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 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”), (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 March 31, 2026, our cash and cash equivalents were approximately $10.2 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 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.
Previous wording
Our cash used in operating activities for the three months ended March 31, 2026 was $1.8 million, comprising of (i) our net loss of $2.4 million, as adjusted for $0.4 million in non-cash expenses (primarily for non-cash stock based compensation of $0.4 million), and (ii) net changes in operating assets and liabilities of $0.2 million.
Current 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.
Previous wording
Our cash used in operating activities for the three months ended March 31, 2025 was $2.0 million, comprising of (i) our net loss of $3.3 million, as adjusted for $0.4 million in non-cash expenses (primarily for non-cash stock based compensation of $0.4 million), and (ii) net changes in operating assets and liabilities of $0.9 million.
Current 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.
Previous wording
There were no investing activities during the three months ended March 31, 2026 or March 31, 2025.
Current wording
There were no investing activities during the six months ended June 30, 2026 or June 30, 2025.
Previous wording
Our cash provided by financing activities during the three months ended March 31, 2026 was $0.2 million, comprised entirely from net proceeds received from the issuance of common stock under the Sales Agreement.
Current 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.
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 three months ended March 31, 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 six months ended June 30, 2026.
Previous wording
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
Current wording
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use the extended transition period for new or revised accounting standards during the period in which we remain an emerging growth company; however, we may adopt certain new or revised accounting standards early.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
•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 report — wording carried from elsewhere
•Salaries and benefits related costs increased due to an estimated bonus accrual during the three months ended June 30, 2026 compared to no estimated accrual during the three months ended June 30, 2025.
Current report — wording carried from elsewhere
•Salaries and benefits related costs increased due to an estimated bonus accrual during the three months ended June 30, 2026 compared to no estimated accrual during the three months ended June 30, 2025.
Current report — wording carried from elsewhere
Interest income in 2026 and 2025 related to interest earned on cash.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Our cash provided by financing activities during the three months ended March 31, 2025 was $0.3 million, comprised entirely from net proceeds received from the issuance of common stock under the Sales Agreement.