INTENSITY THERAPEUTICS, INC.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
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, 2025 · Filed Aug 7, 2025
INTS$3.00-3.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001567264-25-000039
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001567264-25-000077
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 85 previous paragraphs and 97 current paragraphs.
61 unchanged; 22 reworded; 9 added; 1 removed; 1 previous and 5 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 (9)
Current report
•Salaries and benefits related costs decreased $0.2 million as we did not accrue current year bonus accruals due to insufficient cash reserves and the current assessment that current year bonus payments are not reasonably probable to occur.
Current report
•Clinical trial expenses decreased $1.5 million primarily due to lower INVINCIBLE-3 Study costs. 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 23 patients. We will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, we plan to restart site activations and patient enrollment.
Current report
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024
Current report
Research and development expenses during the six months ended June 30, 2025 decreased $2.6 million or 42%, compared to the six months ended June 30, 2024, and were primarily due to the following:
Current report
•Clinical trial expenses decreased $1.4 million primarily due to lower INVINCIBLE-3 Study costs. 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 23 patients. We will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, we plan to restart site activations and patient enrollment.
Current report
General and administrative expenses during the six months ended June 30, 2025 decreased $1.1 million or 31%, compared to the six months ended June 30, 2024, and were primarily due to the following:
Current report
On June 18, 2025, we filed a prospectus supplement to adjust the maximum that we may sell and issue under the ATM Sales Agreement to $9.65 million of our shares of common stock (“ATM Adjustment”), not including the shares previously sold under the ATM Sales Agreement. Since inception through the ATM Adjustment, we had issued 193,816 shares of common stock under the ATM Sales Agreement for net proceeds of $0.5 million. Subsequent to June 30, 2025, we have issued an additional 20,891,304 shares of common stock under the ATM Sales Agreement for net proceeds of $6.6 million.
Current report
On June 11, 2025, we entered into an underwriting agreement (the “Underwriting Agreement”) with ThinkEquity LLC (the “Underwriter”) relating to the issuance and sale of an aggregate of 6,675,000 shares (the “Firm Shares”) of our common stock to the Underwriter at a price to the public of $0.30 per share (the “June 2025 Offering”). Pursuant to the terms of the Underwriting Agreement, we granted to the Underwriter a 45-day option to purchase up to an additional 1,001,250 shares of common stock in the June 2025 Offering (the “Option Shares” and together with the Firm Shares, the “Shares”). The Underwriter exercised its option in full to purchase the 1,001,250 Option Shares at the public offering price on June 12, 2025. The June 2025 Offering, including the exercise of the Underwriter’s over-allotment option, closed on June 13, 2025. All of the Shares were sold by us. Pursuant to the Underwriting Agreement, we also agreed to issue to the Underwriter and/or its designees warrants to purchase up to 383,812 shares of common stock (the “Representative’s Warrants”), which equals 5% of the Shares purchased in the June 2025 Offering, such warrants to be exercisable as set forth in the Representative’s Warrant Agreement. The net proceeds from the June 2025 Offering, including the exercise of the Underwriter’s over-allotment option, were approximately $1.8 million after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.
Current report
Based on the foregoing, as of the date of this filing, we believe that we have at least $2.5 million in stockholders’ equity, which is the minimum amount necessary to evidence compliance with the equity requirement under Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”). We await Nasdaq’s formal confirmation that we have evidenced compliance with the Equity Rule. In any event, the Listing Qualifications Staff of The Nasdaq Stock Market LLC will continue to monitor our compliance with the Equity Rule and if upon the filing of our next periodic report we fail to satisfy the Equity Rule, we may be subject to delisting from Nasdaq.
Removed paragraphs (1)
Previous report
•Clinical trial expenses increased marginally by $0.1 million due to the ongoing site initiations and patient enrollment of the INVINCIBLE-03 Study. In March 2025, we paused new site activations and patient enrollments due to funding constraints, and prioritized funding for the INVINCIBLE-4 Study. Prior to this pause, the trial had enrolled 23 patients. We will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause. Once sufficient funding is obtained, we plan to restart site activations and patient enrollment in the INVINCIBLE-3 Study.
Reworded paragraphs (22)
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 with the necessary chemistry 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 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.
Previous wording
In October 2024, in collaboration with the Swiss Group for Clinical Cancer Research SAKK (“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 (“TNBC”). We plan to enroll 54 patients and expect to complete enrollment by the end of the first quarter of 2026 provided that we are able to obtain sufficient additional funding, and the endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In the event we are unable to obtain sufficient additional funding, we may have to defer completion of the study until such funding is obtained.
Current wording
In October 2024, in collaboration with the Swiss Cancer Group, 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 (“TNBC”). We plan to enroll 54 patients and expect to complete enrollment by the end of the first half of 2026 provided that we are able to obtain sufficient additional funding, and the endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In the event we are unable to obtain sufficient additional funding, we may have to defer completion of the study until such funding is obtained.
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, 2025, we had approximately $0.9 million of cash and cash equivalents. Since our inception, we have incurred significant operating losses. We incurred net losses of $3.3 million and $4.6 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $70.1 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. 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, 2025, we had approximately $2.2 million of cash and cash equivalents. Subsequent to June 30, 2025, we raised an additional $6.6 million in net proceeds under ATM Sales Agreement. Since our inception, we have incurred significant operating losses. We incurred net losses of $5.9 million and $9.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $72.7 million.
Previous wording
To date, we have not generated any revenue from product sales and we do not expect any revenue from the sale of product in the foreseeable future. We have not generated any revenue from licensing of our technology or product candidates yet either. If our development efforts for any of our product candidates are successful and result in regulatory approval, then we may generate revenue in the future from product sales or licensing. We cannot predict if, when, or to what extent we will generate revenue from the commercialization, licensing or sale of any of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.
Current wording
To date, we have not generated any revenue from product sales and we do not expect any revenue from the sale of any products in the foreseeable future. We have not generated any revenue from licensing of our technology or product candidates yet either. If our development efforts for any of our product candidates are successful and result in regulatory approval, then we may generate revenue in the future from product sales or licensing. We cannot predict if, when, or to what extent we will generate revenue from the commercialization, licensing or sale of any of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.
Previous wording
The following tables summarize our results of operations for the three months ended March 31, 2025 and 2024 (in thousands):
Current wording
The following tables summarize our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
Research and development expenses during the three months ended March 31, 2025 decreased $0.6 million or 22%, compared to the three months ended March 31, 2024, and were primarily due to the following:
Current wording
Research and development expenses during the three months ended June 30, 2025 decreased $2.0 million or 57%, compared to the three months ended June 30, 2024, and were primarily due to the following:
Previous wording
•Contract manufacturing costs declined by $0.2 million, as there were no manufacturing batches of INT230-6 in the first quarter of 2025.
Current wording
•Contract manufacturing costs declined by $0.4 million, as there were no manufacturing batches of INT230-6 in 2025.
Previous wording
General and administrative expenses during the three months ended March 31, 2025 increased $0.7 million or 38%, compared to the three months ended March 31, 2024, and were primarily due to the following:
Current wording
General and administrative expenses during the three months ended June 30, 2025 decreased $0.3 million or 23%, compared to the three months ended June 30, 2024, and were primarily due to the following:
Previous wording
•Insurance expense decreased by $0.1 million due to the favorable directors and officers insurance renewal terms obtained in June 2024 compared to the prior policy year.
Current wording
•Insurance expense decreased $0.1 million due to the favorable directors and officers insurance renewal terms obtained in June 2024 compared to the prior policy year.
Previous wording
•Legal, audit and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas.
Current wording
•Legal and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas.
Previous wording
•Salaries and benefits related costs decreased $0.1 million as the Company did not accrue current year bonus accruals due to insufficient cash reserves and the current assessment that current year bonus payments are not reasonably probable to occur. In addition, stock-based compensation was $0.4 million lower as no new equity grants were awarded in the first quarter of 2025.
Current wording
•Salaries and benefits related costs decreased $0.2 million as we did not accrue current year bonus accruals due to insufficient cash reserves and the current assessment that current year bonus payments are not reasonably probable to occur. In addition, stock-based compensation was $0.4 million lower during the current year period.
Previous wording
•Salaries and benefits related costs decreased $0.1 million as the Company did not accrue current year bonus accruals due to insufficient cash reserves and the current assessment that current year bonus payments are not reasonably probable to occur. In addition, stock-based compensation was $0.3 million lower as no new equity grants were awarded in the first quarter of 2025.
Current wording
•Salaries and benefits related costs decreased $0.2 million as we did not accrue current year bonus accruals due to insufficient cash reserves and the current assessment that current year bonus payments are not reasonably probable to occur. In addition, stock-based compensation was $0.3 million lower during the current year period.
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 (the “ATM Agreement”). Since inception, we have issued 193,816 shares of common stock under the ATM Agreement for net proceeds of $0.5 million.
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 Sales Agreement”).
Previous wording
“Series B-1 Common Warrant Shares”), (iii) 3,133,333 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 3,133,333 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 Offering, we entered into a Securities Purchase Agreement on April 24, 2025 with certain institutional investors participating in the Offering. The 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 $0.75. Each Warrant has an exercise price of $0.85 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 Offering, and net proceeds of the 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) 3,133,333 shares (the “Shares”) of the our common stock, (ii) 3,133,333 Series B-1 Common Warrants (the “Series B-1 Common Warrants”) to purchase up to 3,133,333 shares of common stock (the “Series B-1 Common Warrant Shares”), (iii) 3,133,333 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 3,133,333 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 $0.75. Each Warrant has an exercise price of $0.85 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
We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible notes, and private and public equity financings. As of March 31, 2025, our cash and cash equivalents were approximately $0.9 million. Based on our balances in cash and cash equivalents plus cash raised in our April 2025 Public Offering, we project to have sufficient cash to fund our current operating plan into the third 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, and private and public equity financings. As of June 30, 2025, our cash and cash equivalents were approximately $2.2 million. Based on our balances in cash and cash equivalents plus cash raised under our ATM Sales Agreement in July 2025, we project to have sufficient cash to fund our current operating plan into the second half of 2026.
Previous wording
Our cash used in operating activities for the three months ended March 31, 2024 was $4.4 million, comprising of (i) our net loss of $4.6 million, as adjusted for $1.2 million in non-cash expenses (primarily for non-cash stock based compensation), 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
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, 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.
Previous wording
There were no investing activities during the three months ended March 31, 2025.
Current wording
There were no investing activities during the six months ended June 30, 2025.
Previous wording
Our cash provided by investing activities during the three months ended March 31, 2024 was $3.3 million and was due to the redemption of marketable debt securities.
Current 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.
Previous wording
Our cash provided by financing activities during the three months ended March 31, 2025 related $0.3 million in net proceeds received from the issuance of common stock.
Current 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 ATM Sales Agreement.
Previous wording
Our cash provided by financing activities during the three months ended March 31, 2024 related to proceeds received from the exercise of warrants.
Current 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.
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 2024 Annual Report. No significant changes to our accounting policies took place during the three months ended March 31, 2025.
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 2024 Annual Report. No significant changes to our accounting policies took place during the six months ended June 30, 2025.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
•Salaries and benefits related costs decreased $0.1 million as we did not accrue current year bonus accruals due to insufficient cash reserves and the current assessment that current year bonus payments are not reasonably probable to occur.
Current report — wording carried from elsewhere
•Contract manufacturing costs declined by $0.6 million, as there were no manufacturing batches of INT230-6 in 2025.
Current report — wording carried from elsewhere
•Insurance expense decreased by $0.2 million due to the favorable directors and officers insurance renewal terms obtained in June 2024 compared to the prior policy year.
Current report — wording carried from elsewhere
•Legal and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas.
Current report — wording carried from elsewhere
Interest income in 2025 and 2024 related to interest earned on cash and investment balances.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
On April 24, 2025, we commenced a best efforts public offering (the “Offering”) of an aggregate of (i) 3,133,333 shares (the “Shares”) of the our common stock, $0.0001 par value per share (the “Common Stock”), (ii) 3,133,333 Series B-1 Common Warrants (the “Series B-1 Common Warrants”) to purchase up to 3,133,333 shares of Common Stock (the