INTENSITY THERAPEUTICS, INC.
For the period ended Mar 31, 2025. Filed May 13, 2025.
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Mar 31, 2025 · Filed May 13, 2025
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Notes to the Unaudited Condensed Financial Statements
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Note 1. Description of Business
Intensity Therapeutics, Inc. (the “Company”) is a biotechnology company whose treatment approach addresses both the regional and systemic nature of a patient’s cancer. The Company’s DfuseRxSM technology platform has identified a lead drug, INT230-6. The Company is based in Connecticut and was incorporated in Delaware in December 2012.
The Company has completedtwo clinical studies and enrolled over 200 patients using INT230-6 in a Phase 1/2 dose escalation study in metastatic cancers including sarcomas, and a Phase 2 randomized control clinical trial in locally advanced breast cancer in women without undergoing chemotherapy prior to their surgery. In 2024, the Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study"), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Also in 2024, the Company initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4 Study") evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer, with pathological complete response as the endpoint.
Note 2. Liquidity and Plan of Operation
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”), which contemplate continuation of the Company as a going concern.
The Company is a research and development company and has not generated any revenue from its product candidates. The Company has experienced net losses and negative cash flows from operations each year since its inception. Through March 31, 2025, the Company has an accumulated deficit of $70.1 million. The Company’s operations have been financed primarily through the sale of equity securities and convertible notes. The Company’s net loss for the three months ended March 31, 2025 was $3.3 million. The Company expects to incur significant expenses to complete development of its product candidates. The Company may never be able to obtain regulatory approval for the marketing of any of its product candidates in the United States or internationally and there can be no assurance that the Company will generate revenues or ever achieve profitability. The Company does not expect to receive significant product revenue in the near term. The Company, therefore, expects to continue to incur substantial losses for the foreseeable future.
Cash and cash equivalents totaled $0.9 million as of March 31, 2025. In April 2025, the Company completed a public offering of $2.35 million, for net proceeds of $1.9 million after deducting the fees and expenses (see Note 12). Until such time the Company can generate substantial product revenue, the Company plans to finance its operations through a combination of equity offerings and convertible debt financings. The Company does not have any committed external source of funds. To the extent that the Company can raise additional capital through the sale of equity or convertible debt securities, the ownership interest of the existing Company stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of the common stockholders. If the Company is unable to raise additional funds through equity or debt financings when needed, the Company may be required to delay, limit, reduce or terminate its research and product development.
Based on the cash and cash equivalents as of March 31, 2025, plus the net proceeds received in the April 2025 public offering (see Note 12), the Company believes that it has sufficient cash into the third quarter of 2025 for its projected current operations. As a result, the Company believes there is substantial doubt about its ability to continue as a going concern.
Note 3. Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation
The interim condensed financial statements included herein are unaudited. In the opinion of management, these statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair presentation of the financial position of the Company at March 31, 2025, and its results of operations and its cash flows for the three months ended March 31, 2025 and 2024. The interim results of operations are not necessarily indicative of the results to be expected for a full year. These interim unaudited financial statements should be read in conjunction with the audited financial statements for the years ended December 31, 2024 and 2023 and notes thereto. The accompanying financial statements have been prepared in accordance with GAAP and reflect the operations of the Company. Certain information and note disclosures normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to such rules and regulations of the Securities and Exchange Commission relating to interim financial statements. The December 31, 2024 balance sheet information was derived from the audited financial statements as of that date. The Company neither owns nor controls any subsidiary companies.
The significant accounting policies used in preparation of the condensed consolidated financial statements are disclosed in our 2024 Annual report, and there have been no changes to the Company's significant accounting policies during the three months ended March 31, 2025.
Stock-based compensation
The Company accounts for stock-based compensation to employees and non-employees, which consists of stock option grants, through the Statements of Operations based on their fair values at the date of grant.
The Company calculates the fair value of option grants utilizing the Black-Scholes pricing model. The resulting stock-based compensation expense for both employee and non-employee awards is generally recognized on a straight-line basis over the requisite service period of the award. Forfeitures are recognized as they occur.
The Company had been a private company and lacked company-specific historical and implied volatility information for its shares. Therefore, the Company estimated its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price.
Research and development costs
The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, consultants, contract research organizations (“CRO”), and contract manufacturing organizations (“CMO”) in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts.
Research and development costs are expensed in the period in which they are incurred. External costs consist primarily of payments to outside consultants, third-party CROs, CMOs, clinical trial sites and central laboratories in connection with the Company’s clinical manufacturing and clinical development activities. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its service providers or its estimate of the level of service that has been performed at each reporting date. The Company tracks external costs based on research and development initiative, including preclinical, individual clinical study, and manufacturing for our product candidate. Internal costs consist primarily of employee-related costs and costs related to compliance with regulatory requirements. The Company does not track internal or consulting costs by research and development initiative because these costs are deployed across multiple programs and, as such, are not separately classified.
The Company makes estimates of accrued expenses as of each balance sheet date based on facts and circumstances known at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The significant estimates in its accrued research and development expenses include the costs incurred for services performed by vendors in connection with research and development activities for which the Company has not yet been invoiced.
In July 2024, the Company initiated a Phase 3 open-label, randomized study for certain soft tissue sarcoma subtypes, which is expected to span several years. In connection with this study, the Company recorded an advance payment of $1.7 million in December 2023, which will be applied to future invoices during and at the end of the study. As of both March 31, 2025 and December 31, 2024, the advance payment balance was $1.2 million, and were recorded in Other Assets in the Balance Sheet.
Basic and dilutive loss per share
Basic net loss per share is determined using the weighted average number of shares of common stock outstanding during each period. Dilutive net loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as stock options and stock warrants, which would result in the issuance of incremental shares of common stock. The computation of diluted net loss per share does not include the conversion of securities that would have an anti-dilutive effect. Potential shares of common stock issuable upon the exercise of stock options and warrants are excluded from the computation of diluted weighted average shares outstanding listed in the table below because, when the Company is in a net loss position, they are anti-dilutive. There were no preferred shares outstanding at March 31, 2025 and 2024.
As of March 31, 2025 and 2024, the following shares of common stock underlying options and warrants were excluded from the computation of diluted weighted average shares outstanding:
| March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Options outstanding | 2,543,067 | 1,939,129 |
| Warrants outstanding | 2,041,563 | 804,450 |
| 4,584,630 | 2,743,579 | |
Recently issued pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company discloses its income tax rate reconciliation in its annual financial statements only and does not expect the adoption of ASU 2023-09 to have a material impact on its financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, as subsequently amended by ASU 2025-01 to clarify the effective date, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented in the statement of operations. The guidance in this ASU is effective for annual reporting periods in fiscal years beginning after December 15, 2026, and interim periods in fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its financial statement disclosures.
Note 4. Cash and Cash Equivalents
Cash and cash equivalents consisted of the following (in thousands):
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Savings and checking accounts at major U.S. financial institutions | $94 | $428 |
| U.S. Treasury securities money market fund | 835 | 2,162 |
| Total | $929 | $2,590 |
Note 5. Prepaid Expenses and Other Current Assets
Prepaid expenses consisted of the following (in thousands):
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Prepaid insurance | $262 | $421 |
| Prepaid research and development costs | 219 | 239 |
| Prepaid other | 241 | 113 |
| Total | $722 | $773 |
Note 6. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Accrued research and development costs | $910 | $374 |
| Accrued employee compensation-related expenses | — | 56 |
| Accrued other | 104 | 78 |
| Total | $1,014 | $508 |
Note 7. Stockholders’ Equity
At The Market Offering Agreement
On July 3, 2024, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may sell and issue, from time to time, up to $15.0 million of shares of its common stock (the “Shares”) through Wainwright as the Company’s sales agent (the “ATM Offering”). The Company has no obligation to sell any of the Shares and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement pursuant to its terms. On November 21, 2024, the Company filed a prospectus supplement to reduce the maximum the Company may sell and issue under the Sales Agreement to $7.0 million of its Shares, not including the Shares previously sold under the Sales Agreement. For the three months ended March 31, 2025, the Company issued 141,996 shares of common stock under the ATM Agreement for net proceeds of $0.3 million. Since inception, we have issued 193,816 shares of common stock under the ATM Agreement for net proceeds of $0.5 million.
Registered direct offering
On November 21, 2024, the Company entered into a Securities Purchase Agreement with a single healthcare focused institutional investor (the “Investor”), pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the Investor,1,237,113 shares of common stock to the Investor, at a price of $2.425 per share, for aggregate gross proceeds of approximately $3.0 million before deducting the placement agents’ fees and related offering expenses. In a concurrent private placement, the Company agreed to issue to the Investor common stock warrants to purchase up to 1,237,113 shares (the “Common Warrants”) at an exercise price of $2.950 per share, with a relative fair value of $1.1 million. Each Common Warrant will be exercisablesix months from the issuance date and will expire five and one-half years from the issuance date.
Note 8. Stock Based Compensation
The Company has a 2013 Stock Option Plan (the “2013 Plan”), which is administered by the Compensation Committee of the Company’s board of directors. Under the 2013 Plan, stock options to purchase shares of common stock could be granted to eligible employees, officers, directors and consultants of the Company. The 2013 Plan terminated in August 2023 on the tenth anniversary of the 2013 Plan’s date of adoption by the board. No new awards were made under the 2013 Plan after such termination date, but awards previously granted may extend beyond such date.
In 2021, the Company established the 2021 Stock Incentive Plan (the “2021 Plan”), authorizing the granting of equity awards for the issuance of up to 3,000,000 shares of common stock. Upon adoption of the 2021 Plan, no more shares would be issued under the 2013 Plan. Starting on January 1, 2022, the shares authorized under the 2021 Plan shall have an annual increase of the lessor of (a)3.5% of the aggregate number of shares of common stock outstanding on the final day of the preceding calendar year, or (b) such smaller amount as determined by the Board. On January 1, 2023 and January 1, 2024, an additional 238,700 and 479,828 shares were authorized under the 2021 Plan. On January 1, 2025, an additional 529,300 shares were authorized under the 2021 Plan. As of March 31, 2025,2,455,011 shares were available for issuance under the 2021 Plan.
The Company recorded total stock-based compensation for its outstanding stock options and warrants in its Statements of Operations as follows (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development | $160 | $566 |
| General and administrative | 275 | 589 |
| Total stock-based compensation expense | $435 | $1,155 |
Stock options
The following table summarizes the range of assumptions used to estimate the fair value of stock options issued using the Black-Scholes-Merton option pricing model:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock price | n/a | $5.19 |
| Exercise price | n/a | $5.19 |
| Expected volatility | n/a | 97.06% |
| Risk free interest rates | n/a | 4.12% |
| Expected term (years) | n/a | 5 to 6.25 |
The Company didnot issue stock options for the three months ended March 31, 2025. For the three months ended March 31, 2024, a dividend yield of 0% was used because the Company has not historically paid and does not intend to pay a dividend on common stock in the foreseeable future. The expected stock price volatility assumption was estimated based on the historical volatilities for industry peers, as the Company had no active market for its stock prior to the IPO and limited history for issuance price of its stock. The risk-free rate assumption is determined using the yield currently available on U.S. Treasury zero coupon issues with a remaining term commensurate with the expected term of the award. The expected term of the option represents the period the options are expected to be outstanding.
The following table summarizes the activity for stock options for the three months ended March 31, 2025:
| Options | Weighted-Average Exercise Price | Weighted Average Remaining Contractual Term (in years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2024 | 2,587,129 | $6.14 | 7.9 | $— |
| Issued | — | $— | ||
| Exercised | — | $— | ||
| Forfeited and cancelled | (44,062) | $3.55 | ||
| Outstanding at March 31, 2025 | 2,543,067 | $6.18 | 7.6 | $— |
| Exercisable at March 31, 2025 | 1,435,229 | $7.40 | 6.4 | $— |
All options expire 10 years from date of grant. Options outstanding begin to expire in September 2025. Options that were granted to employees and consultants have vesting periods that vary by award to recipient and range from immediate vesting to a period of up to 4 years.
As of March 31, 2025, total unrecognized compensation cost related to options was approximately $4.0 million and is expected to be recognized over the remaining weighted average service period of 2.5 years.
Warrants
The following table summarizes the range of assumptions used to estimate the fair value of warrants issued using the Black-Scholes-Merton option pricing model:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock price | n/a | $5.19 |
| Exercise price | n/a | $5.19 |
| Expected volatility | n/a | 97.06% |
| Risk free interest rates | n/a | 4.12% |
| Expected term (years) | n/a | 6.25 |
The Company didnot issue warrants for the three months ended March 31, 2025. For the three months ended March 31, 2024, a dividend yield of 0% was used because the Company has not historically paid and does not intend to pay a dividend on common stock in the foreseeable future. The expected stock price volatility assumption was estimated based on the historical volatilities for industry peers, as the Company had no active market for its stock prior to the IPO and limited history for issuance price of its stock. The risk-free rate assumption is determined using the yield currently available on U.S. Treasury zero coupon issues with a remaining term commensurate with the expected term of the award. The expected term of the warrant represents the period the warrants are expected to be outstanding.
The following table summarizes the activity for warrants for the three months ended March 31, 2025:
| Warrants | Weighted-Average Exercise Price | Weighted Average Remaining Contractual Term (in years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2024 | 2,041,563 | $4.32 | 4.7 | $— |
| Issued | — | $— | ||
| Exercised | — | $— | ||
| Forfeited and cancelled | — | $— | ||
| Outstanding at March 31, 2025 | 2,041,563 | $4.32 | 4.4 | $— |
| Exercisable at March 31, 2025 | 753,450 | $6.50 | 3.2 | $— |
All warrants outstanding are exercisable for purchase of common stock.
As of March 31, 2025, total unrecognized compensation cost related to warrants was approximately $0.2 million and is expected to be recognized over the remaining weighted average service period of 2.6 years.
Restricted Stock
In September 2024, the Company issued 11,750 restricted shares of its common stock (the “Restricted Stock”) to a consultant as compensation for its services to the Company through the end October 2024 valued at $51,000. The Restricted Stock included a restricted legend for a period of at leastsix months from the date of issuance. The six-month period has elapsed, and the Restricted Stock is no longer restricted.
Note 9. Leases
In July 2023, the Company signed a 5.5-year lease for approximately 2,700 square feet of office space in Shelton, Connecticut, (the “Shelton Lease”). The Company has a one-time option to cancel the Shelton Lease after 36 months if it provides written notice before the end of month 30. A payment of approximately $47,000 would be due at the end of month 36 if the Company exercises this option. This option is not reasonably certain to occur.
Rent expense for each of the three months ended March 31, 2025 and 2024 was approximately $9,000.
Cash paid for operating leases for the three months ended March 31, 2025 was approximately $17,000. The Company paid $3,000 for operating leases for the three months ended March 31, 2024.
The following table summarizes the balance sheet classification of the operating lease asset and related lease liabilities as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Right-of-use asset, net | $116 | $122 |
| Lease liability, current portion | 29 | 28 |
| Lease liability, net of current portion | 102 | 110 |
| $131 | $138 |
The following variables were used to determine the right-of-use asset and the operating lease liabilities at March 31, 2025 and 2024:
| March 31,2025 | March 31,2024 | |
|---|---|---|
| Weighted average remaining lease term | 3.9 years | 5.4 years |
| Weighted average operating lease discount rate | 6.4% | 6.4% |
Future minimum lease payments under the lease agreement as of March 31, 2025 were as follows (in thousands):
| Year ended | |
|---|---|
| 2025 (remainder of year) | $27 |
| 2026 | 37 |
| 2027 | 39 |
| 2028 | 39 |
| 2029 | 7 |
| Total lease payments | 149 |
| Less: Amounts representing interest | (18) |
| Present value of lease liabilities | $131 |
Note 10. Other Uncertainties
The Company holds patents in Russia and Israel, both of which are currently involved in military action. The outcomes of these military actions could impact our ability to maintain and protect these patents.
Note 11. Related Parties
In October 2023, the Company issued 80,000 warrants for consulting services to be rendered bytwo shareholders, which vested over the subsequent twelve months. These warrants are valued at $198,000 and were expensed to general and administrative expense over the subsequent twelve-month period, of which $45,000 was expensed during the three months ended March 31, 2024.
In April 2024, the Company entered into a non-material agreement with a service organization controlled by a board member. For the three months ended March 31, 2025, the Company expensed $1,800 and paid $1,800 to the service organization for services performed, which is recognized in research and development expenses on the statement of operations. As of March 31, 2025, the Company recognized $1,800 in accrued expenses.
Note 12. Segments
The Company has a single segment and allocates resources based on cash resources and operating expense projections. The table below summarizes the significant expense categories regularly reviewed by the Company’s president and chief executive officer, who is the Company’s chief operating decision maker (“CODM”), for the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development expenses: | ||
| Clinical trial expenses: | ||
| IT-01 Study (Phase 1/2 Metastatic Cancers) | $— | $53 |
| INVINCIBLE-2 Study (Phase 2 Breast) | — | 103 |
| INVINCIBLE-3 Study (Phase 3 Sarcoma) | 1,596 | 1,419 |
| INVINCIBLE-4 Study (Phase 2 Breast) | 63 | — |
| Clinical trial expenses | 1,659 | 1,575 |
| Contract manufacturing | 24 | 214 |
| Salaries and benefits related | 329 | 394 |
| Consulting & Other(a) | 17 | 66 |
| Stock-based compensation | 160 | 566 |
| Research and development expenses | 2,189 | 2,815 |
| General and administrative expenses: | ||
| Salaries and benefits related | 230 | 324 |
| Legal fees | 167 | 257 |
| Audit fees | 77 | 115 |
| Consulting | 196 | 173 |
| Insurance | 157 | 286 |
| Other(b) | 103 | 184 |
| Stock-based compensation | 275 | 589 |
| General and administrative expenses | 1,205 | 1,928 |
| Loss from operations | (3,394) | (4,743) |
| Other segment items(c) | 47 | 140 |
| Net loss | $(3,347) | $(4,603) |
(a)Consulting & Other includes research and development consulting costs and travel-related costs.
(b)Other includes facility expenses, office supplies, computer and software related costs, public relations costs, and travel-related costs.
(c)Other segment items include interest income, interest expense, and foreign exchange gains and losses.
Note 13. Subsequent Events
Public offering
On April 24, 2025, the Company commenced a best efforts public offering (the “Offering”) of an aggregate of (i)3,133,333 shares (the “Shares”) of the Company’s 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 “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, the Company 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 withone Series B-1 Common Warrant to purchaseone share of Common Stock andone Series B-2 Common Warrant to purchaseone 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 thefive-year anniversary of the date of issuance, and the Series B-2 Common Warrants will expire on theeighteen-month anniversary of the date of issuance. The Company 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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.