INTENSITY THERAPEUTICS INC

Previous wording

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 with the necessary chemistry to overcome this local delivery challenge and achieve tumor killing with 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 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 with the necessary chemistry to overcome this local delivery challenge and achieve tumor killing with systemic immune activation and T-cell repertoire expansion in certain cancers.

Previous wording

Our platform creates patented anti-cancer product candidates comprising active anti-cancer agents and amphiphilic molecules. Amphiphilic molecules have two distinct components: one part is soluble in water and the other is soluble in fat or oils. When an amphiphilic compound is mixed with therapeutic agents, such as chemotherapies, the agents also become soluble in both fat and water. Our product candidates include novel formulations consisting of potent anti-cancer drugs mixed together with these amphiphilic agents.

Current wording

Our platform has enabled us to create patented anti-cancer product candidates comprising active anti-cancer agents and amphiphilic molecules. Amphiphilic molecules have two distinct components: one part is soluble in water and the other is soluble in fat or oils. When an amphiphilic compound is mixed with therapeutic agents, such as chemotherapies, the agents also become soluble in both fat and water. Our product candidates include novel formulations consisting of potent anti-cancer drugs mixed together with these amphiphilic agents.

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 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 sarcoma. The drug is also used in breast and lung cancer.

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 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 sarcoma. The drug is also used in breast and lung cancer.

Previous wording

In July 2024, we dosed the first patients in the U.S. in a Phase 3 open-label, randomized study, or the INVINCIBLE-3 Study, testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. We plan to enroll 333 patients and initiate sites in eight countries in the INVINCIBLE-3 Study, and are in contract negotiations to approve and activate these sites, which we estimate could take between two to six months per site. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

Current wording

In July 2024, we dosed the first patients in the U.S. in a Phase 3 open-label, randomized study, or the INVINCIBLE-3 Study, testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. In the third quarter of 2024, we also received authorization from Health Canada and The European Medicines Agency to initiate the INVINCIBLE-3 Study in Canada and Europe, respectively. We plan to enroll 333 patients and initiate sites in eight countries in the INVINCIBLE-3 Study, and are in contract negotiations to approve and activate additional sites, which we estimate could take several months per site. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

Previous wording

In 2017, we initiated a Phase 1/2 dose escalation study, IT-01, 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. Study IT-01 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

Current wording

In 2017, we initiated a Phase 1/2 dose escalation study, IT-01, 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. Study IT-01 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 BMS Yervoy® (ipilimumab). We completed enrollment of IT-01 in June 2022, locked the IT-01 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.

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, or 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 (the current standard of care (“SOC”)) or a saline injection. Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence. Other endpoints of the INVINCIBLE-2 Study were to understand the percentage of necrosis that can be achieved in tumors for a given dose, especially tumors larger than two centimeters in longest diameter, and whether either 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. An increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and blood was also shown. There was also an increase in the T-cells repertoire relative to control. In July 2024, we finalized the clinical study report for the INVINCIBLE-2 Study.

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, or 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 (the current SOC) or a saline injection. Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence. Other endpoints of the INVINCIBLE-2 Study were to understand the percentage of necrosis that can be achieved in tumors for a given dose, especially tumors larger than two centimeters in longest diameter, and whether either 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. An increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and blood was also shown. There was also an increase in the T-cells repertoire relative to control. In July 2024, we finalized the clinical study report for the INVINCIBLE-2 Study.

Previous wording

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing 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 approximately $54.5 million in cash received from the net proceeds of sales of our common stock, preferred stock and convertible notes. As of June 30, 2024, we had approximately $3.2 million of cash and cash equivalents plus approximately $3.1 million in investments in U.S. Treasury bills. Since our inception, we have incurred significant operating losses. We incurred net losses of $9.6 million and $5.0 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $60.1 million. We expect to incur significant expenses and operating losses for the next several years.

Current wording

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing 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 approximately $54.5 million in cash received from the net proceeds of sales of our common stock, preferred stock and convertible notes. As of September 30, 2024, we had approximately $2.8 million of cash and cash equivalents. Since our inception, we have incurred significant operating losses. We incurred net losses of $13.1 million and $7.4 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $63.6 million. We expect to incur significant expenses and operating losses for the next several years.

Previous wording

The following tables summarize our results of operations for the three and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following tables summarize our results of operations for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

Research and development expenses during the three months ended June 30, 2024 increased $2.7 million or 315%, compared to the three months ended June 30, 2023, and were primarily due to the following:

Current wording

Research and development expenses during the three months ended September 30, 2024 increased $0.8 million or 59%, compared to the three months ended September 30, 2023, and were primarily due to the following:

Previous wording

•Salaries and benefits related costs increased $0.3 million due to the hiring of research employees in the fourth quarter of 2023 and first quarter of 2024.

Current wording

•Salaries and benefits related costs increased $0.4 million due to the hiring of research employees in the fourth quarter of 2023 and first quarter of 2024.

Previous wording

•Clinical trial expenses increased $2.0 million due to preliminary work related to the INVINCIBLE-03 Study, which was partially offset by a decrease in our IT-01 study due to the completion of enrollment in this study in mid-2022.

Current wording

•Clinical trial expenses increased $0.7 million due to the initiation of the INVINCIBLE-03 Study, which was partially offset by lower costs in our completed IT-01 and INVINCIBLE-02 studies.

Previous wording

General and administrative expenses during the three months ended June 30, 2024 increased $1.1 million or 316%, compared to the three months ended June 30, 2023, and were primarily due to the following:

Current wording

General and administrative expenses during the three months ended September 30, 2024 increased $0.3 million or 25%, compared to the three months ended September 30, 2023, and were primarily due to the following:

Previous wording

•Salaries and benefits related costs increased by $0.4 million due to salary and bonus increases and the hiring of a new chief financial officer in the fourth quarter of 2023, along with $0.8 million in higher stock-based compensation expense due to option grants in the first quarter of 2024.

Current wording

•Salaries and benefits related costs increased by $0.2 million due to salary and bonus accrual increases and the hiring of a new chief financial officer in the fourth quarter of 2023, along with $0.1 million in higher stock-based compensation expense due to option and stock grants in 2024.

Previous wording

Six Months Ended June 30, 2024 Compared to Six Months Ended June 30, 2023

Current wording

Nine Months Ended September 30, 2024 Compared to Nine Months Ended September 30, 2023

Previous wording

•Salaries and benefits related costs increased $0.5 million due to the hiring of research employees in the fourth quarter of 2023 and first quarter of 2024, along with $0.3 million in higher stock-based compensation expense.

Current wording

•Salaries and benefits related costs increased $0.9 million due to the hiring of research employees in the fourth quarter of 2023 and first quarter of 2024, along with $0.3 million in higher stock-based compensation expense.

Previous wording

•Clinical trial expenses increased $3.3 million due to preliminary work related to the INVINCIBLE-03 Study, which was partially offset by a decrease in our IT-01 study due to the completion of enrollment in this study in mid-2022.

Current wording

•Clinical trial expenses increased $4.0 million due to the initiation of the INVINCIBLE-03 Study, which was partially offset by lower costs in our completed IT-01 and INVINCIBLE-02 studies.

Previous wording

•Contract manufacturing expenses increased entirely due to costs for manufacturing a new batch of INT230-6.

Current wording

•Contract manufacturing expenses increased entirely due to costs for manufacturing a new batch of INT230-6 in the first half of 2024.

Previous wording

•Salaries and benefits related costs increased by $0.2 million due to salary and bonus increases and the hiring of a new chief financial officer in the fourth quarter of 2023, along with $0.3 million in higher stock-based compensation expense due to option grants in the first quarter of 2024.

Current wording

•Salaries and benefits related costs increased by $0.7 million due to salary and bonus increases and the hiring of a new chief financial officer in the fourth quarter of 2023, along with $0.9 million in higher stock-based compensation expense due to option grants in the first quarter of 2024.

Previous wording

•Insurance expense increased by $0.3 million due to the additional directors and officers insurance obtained in connection with our IPO.

Current wording

•Insurance expense increased by $0.4 million due to the additional directors and officers insurance obtained in connection with our IPO, net of a decrease in premiums due to favorable renewal terms beginning in July 2024.

Previous wording

On July 3, 2024, we filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on July 11, 2024, on which we registered for sale up to $150 million of any combination of our common stock, preferred stock, debt securities, warrants, and/or units from time to time and at prices and on terms that we may determine, which includes up to $15 million of common stock that we may issue and sell from time to time, through H.C. Wainwright & Co., LLC (“Wainwright”) acting as our sales agent, pursuant to the sales agreement that we entered into with Wainwright on July 3, 2024 for our “at-the-market” equity program. We have not issued any securities under this shelf registration statement to date.

Current wording

On July 3, 2024, we filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on July 11, 2024, on which we registered for sale up to $150 million of any combination of our common stock, preferred stock, debt securities, warrants, and/or units from time to time and at prices and on terms that we may determine, which includes up to $15 million of common stock that we may issue and sell from time to time, through H.C. Wainwright & Co., LLC (“Wainwright”) acting as our sales agent, pursuant to the sales agreement that we entered into with Wainwright on July 3, 2024 for our “at-the-market” equity program (the “ATM Agreement”). Since inception, we have issued 51,820 shares of common stock under the ATM Agreement for net proceeds of $0.2 million.

Previous wording

We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible notes, private equity financings, and the IPO, after which shares of our common stock began trading on The Nasdaq Capital Market under the symbol “INTS” on June 30, 2023. As of June 30, 2024, our cash, cash equivalents and investments were approximately $6.3 million. Based on our balances in cash, cash equivalents, and investments, we project to have sufficient cash to fund our current operating plan into the first quarter of 2025.

Current wording

We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible notes, private equity financings, and the IPO, after which shares of our common stock began trading on The Nasdaq Capital Market under the symbol “INTS” on June 30, 2023. As of September 30, 2024, our cash, cash equivalents and investments were approximately $2.8 million. Based on our balances in cash and cash equivalents, we project to have sufficient cash to fund our current operating plan into the first quarter of 2025.

Previous wording

Our cash used in operating activities for the six months ended June 30, 2024 was $8.6 million, comprising of (i) our net loss of $9.6 million, as adjusted for $1.8 million in non-cash expenses (primarily for non-cash stock based compensation of $1.7 million), and (ii) net changes in operating assets and liabilities of $0.8 million.

Current wording

Our cash used in operating activities for the nine months ended September 30, 2024 was $12.6 million, comprising of (i) our net loss of $13.1 million, as adjusted for $2.3 million in non-cash expenses (primarily for non-cash stock based compensation of $2.2 million), and (ii) net changes in operating assets and liabilities of $1.7 million.

Previous wording

Our cash used in operating activities for the six months ended June 30, 2023 was $1.1 million, comprising of (i) our net loss of $5.0 million, as adjusted for $3.2 million in non-cash expenses (primarily for non-cash stock based compensation of $0.6 million and the loss on debt extinguishment of $2.3 million), and (ii) net changes in operating assets and liabilities of $0.7 million.

Current wording

Our cash used in operating activities for the nine months ended September 30, 2023 was $6.3 million, comprising of (i) our net loss of $7.4 million, as adjusted for $3.5 million in non-cash expenses (primarily for non-cash stock based compensation of $1.0 million and the loss on debt extinguishment of $2.3 million), and (ii) net changes in operating assets and liabilities of $2.4 million.

Previous wording

Our cash provided by investing activities during the six months ended June 30, 2024 was $3.3 million and was due to the redemption of marketable debt securities of $6.3 million, partially offset by the purchase of marketable debt securities of $3.1 million.

Current wording

Our cash provided by investing activities during the nine months ended September 30, 2024 was $6.4 million and was due to the redemption of marketable debt securities of $9.4 million, partially offset by the purchase of marketable debt securities of $3.1 million.

Previous wording

Our cash provided by financing activities during the six months ended June 30, 2024 related to proceeds received from the exercise of options and warrants.

Current wording

Our cash provided by financing activities during the nine months ended September 30, 2024 related to $0.3 million in proceeds received from the exercise of options and warrants, and $0.2 million in net proceeds received from the issuance of common stock.

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 2023 Annual Report. No significant changes to our accounting policies took place during the six months ended June 30, 2024.

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 2023 Annual Report. No significant changes to our accounting policies took place during the nine months ended September 30, 2024.

Previous wording

Subject to certain conditions set forth in the JOBS Act, if, as an “emerging growth company”, we choose to rely on such exemptions we may not be required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the CEO’s compensation to median employee compensation.

Current wording

Subject to certain conditions set forth in the JOBS Act, if, as an “emerging growth company”, we choose to rely on such exemptions we may not be required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the CEO’s compensation to median employee compensation. These exemptions will apply for a period of five years following the completion of our IPO or until we are no longer an “emerging growth company,” whichever is earlier.