Intensity Therapeutics(INTS) - 2025 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION This part provides unaudited condensed financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures for the reporting period Item 1. Condensed Financial Statements (Unaudited) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes explaining the company's business, liquidity, accounting policies, and specific financial accounts Condensed Balance Sheets This table provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Key Financial Data | Metric | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (Audited) (in thousands) | | :-------------------------------- | :--------------------------------------- | :-------------------------------------- | | Cash and cash equivalents | $2,216 | $2,590 | | Total current assets | $3,038 | $3,363 | | Total assets | $4,443 | $4,783 | | Total current liabilities | $2,164 | $1,755 | | Total liabilities | $2,259 | $1,865 | | Accumulated deficit | $(72,667) | $(66,783) | | Total stockholders' equity | $2,184 | $2,918 | - Total assets decreased by $340 thousand from December 31, 2024, to June 30, 2025, while total current liabilities increased by $409 thousand[16] Condensed Statements of Operations This statement outlines the company's financial performance, showing revenues, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Key Financial Data | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,541 | $3,563 | $3,730 | $6,378 | | General and administrative | $1,164 | $1,506 | $2,369 | $3,434 | | Total operating expenses | $2,705 | $5,069 | $6,099 | $9,812 | | Net loss | $(2,537) | $(4,971) | $(5,884) | $(9,574) | | Loss per share, basic and diluted | $(0.13) | $(0.36) | $(0.35) | $(0.70) | - Net loss significantly decreased for both the three-month period (from $(4.971) million to $(2.537) million) and the six-month period (from $(9.574) million to $(5.884) million) year-over-year, primarily due to reduced operating expenses[18] Condensed Statements of Changes in Stockholders' Equity This statement details the changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit, over the reporting period Key Financial Data | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Common Stock Shares | 15,122,873 | 26,166,423 | | Common Stock Amount | $2 | $3 | | Additional Paid-in Capital | $69,699 | $74,848 | | Accumulated Deficit | $(66,783) | $(72,667) | | Total Stockholders' Equity | $2,918 | $2,184 | - The company issued 10,809,583 shares of common stock in public offerings, contributing to an increase in common stock and additional paid-in capital, while net losses increased the accumulated deficit[21] Condensed Statements of Cash Flows This statement summarizes the cash inflows and outflows from operating, investing, and financing activities, showing the overall change in cash and cash equivalents Key Financial Data | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,445) | $(8,580) | | Net cash provided by investing activities | $0 | $3,254 | | Net cash provided by financing activities | $4,071 | $11 | | Net decrease in cash and cash equivalents | $(374) | $(5,315) | | Cash and cash equivalents at end of period | $2,216 | $3,241 | - Net cash used in operating activities decreased by $4.135 million, and net cash provided by financing activities increased significantly by $4.060 million, primarily from public offerings, leading to a much smaller net decrease in cash and cash equivalents compared to the prior year[24] Notes to the Unaudited Condensed Financial Statements These notes provide essential context and detailed explanations for the figures presented in the condensed financial statements Note 1. Description of Business This note describes the company's core business, its technology platform, and its lead drug candidate in cancer treatment - Intensity Therapeutics, Inc. is a biotechnology company focused on cancer treatment using its DfuseRxSM technology platform, with INT230-6 as its lead drug candidate[27] - The company initiated a Phase 3 trial (INVINCIBLE-3 Study) in soft tissue sarcoma and a Phase 2 study (INVINCIBLE-4 Study) in collaboration with the Swiss Cancer Institute for triple-negative breast cancer in 2024[28] Note 2. Liquidity and Plan of Operation This note discusses the company's financial viability, accumulated deficit, and future funding requirements to sustain operations - The company has an accumulated deficit of $72.7 million as of June 30, 2025, and has experienced net losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[30][32] Key Financial Data | Metric | Amount (in millions) | | :-------------------- | :------------------- | | Accumulated Deficit (June 30, 2025) | $(72.7) | | Net Loss (H1 2025) | $(5.9) | | Cash and Cash Equivalents (June 30, 2025) | $2.2 | | Net Proceeds from ATM Sales Agreement (Subsequent to June 30, 2025) | $6.6 | - Despite recent capital raises, the company expects to incur substantial losses and will need additional funding, primarily through equity offerings and convertible debt, to finance operations into the second half of 2026[30][31][32] Note 3. Basis of Presentation and Summary of Significant Accounting Policies This note explains the basis for preparing the financial statements and summarizes the key accounting policies applied - The interim condensed financial statements are unaudited, prepared in conformity with GAAP, and include only normal, recurring adjustments[33] - There have been no changes to the company's significant accounting policies, including those for stock-based compensation and research and development costs, during the six months ended June 30, 2025[35][36][39] - The company is evaluating the impact of new accounting pronouncements (ASU 2023-09 and ASU 2024-03), with ASU 2023-09 not expected to have a material impact[45][46] Note 4. Cash and Cash Equivalents This note provides a breakdown of the company's cash and cash equivalents, including their composition and changes over the period Key Financial Data | Component (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Savings and checking accounts | $118 | $428 | | U.S. Treasury securities money market fund | $2,098 | $2,162 | | Total | $2,216 | $2,590 | - Cash and cash equivalents decreased by $374 thousand from December 31, 2024, to June 30, 2025, with the majority held in U.S. Treasury securities money market funds[47] Note 5. Prepaid Expenses and Other Current Assets This note details the components of prepaid expenses and other current assets, highlighting changes between reporting periods Key Financial Data | Component (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Prepaid insurance | $282 | $421 | | Prepaid research and development costs | $312 | $239 | | Prepaid other | $228 | $113 | | Total | $822 | $773 | - Total prepaid expenses and other current assets increased by $49 thousand, driven by increases in prepaid research and development costs and other prepaid items, partially offset by a decrease in prepaid insurance[48] Note 6. Accrued Expenses This note itemizes the company's accrued expenses, explaining the primary drivers of changes in these liabilities Key Financial Data | Component (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Accrued research and development costs | $849 | $374 | | Accrued employee compensation-related expenses | $43 | $56 |\n| Accrued other | $49 | $78 | | Total | $941 | $508 | - Total accrued expenses increased by $433 thousand, primarily due to a significant increase in accrued research and development costs[49] Note 7. Stockholders' Equity This note describes the various equity financing activities undertaken by the company, including public offerings and their financial impact - The company engaged in multiple equity financing activities, including an At The Market (ATM) offering, a November 2024 Registered Direct Offering, an April 2025 Public Offering, and a June 2025 Public Offering[50][51][52][53] Key Financial Data | Offering | Net Proceeds (in millions) | | :-------------------------------- | :------------------------- | | ATM Sales Agreement (H1 2025) | $0.3 | | April 2025 Public Offering | $1.9 | | June 2025 Public Offering | $1.8 | - Subsequent to June 30, 2025, the company issued an additional 20,891,304 shares under the ATM Sales Agreement, generating $6.6 million in net proceeds[50] Note 8. Stock Based Compensation This note details the company's stock-based compensation expenses and the outstanding equity instruments, including options and warrants Key Financial Data | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Research and development | $423 | $783 | | General and administrative | $656 | $963 | | Total stock-based compensation expense | $1,079 | $1,746 | Key Financial Data | Equity Instrument | Outstanding at Dec 31, 2024 | Outstanding at June 30, 2025 | | :---------------- | :-------------------------- | :--------------------------- | | Stock Options | 2,587,129 | 4,040,801 | | Warrants | 2,041,563 | 8,637,041 | - Total unrecognized compensation cost related to options was approximately $4.3 million (expected over 2.5 years) and for warrants was approximately $0.2 million (expected over 2.4 years) as of June 30, 2025[61][64] Note 9. Leases This note describes the company's operating lease commitments for office space and related expenses - The company has a 5.5-year operating lease for office space in Shelton, Connecticut, signed in July 2023[66] Key Financial Data | Metric (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------- | :------------------------------- | :----------------------------- | | Rent expense | $9 | $17 | | Cash paid for operating leases | $17 | $33 | Key Financial Data | Future Minimum Lease Payments (in thousands) | | :----------------------------------- | | 2025 (remainder) | $18 | | 2026 | $37 | | 2027 | $39 | | 2028 | $39 | | 2029 | $7 | | Total Lease Payments | $140 | | Present Value of Lease Liabilities | $125 | Note 10. Other Uncertainties This note addresses potential risks related to the company's intellectual property in regions affected by military actions - The company holds patents in Russia and Israel, and ongoing military actions in these regions could impact its ability to maintain and protect these patents[70] Note 11. Related Parties This note discloses transactions and expenses involving related parties, including warrant issuances and service payments - In October 2023, the company issued 80,000 warrants valued at $198 thousand to two shareholders for consulting services, expensing $44 thousand (Q2 2024) and $89 thousand (H1 2024) to general and administrative expense[71] - The company expensed $32,985 (Q2 2025) and $34,785 (H1 2025) to a service organization controlled by a board member for services performed, recognized in research and development expenses[72] Note 12. Segments This note clarifies that the company operates as a single reportable segment, with resource allocation based on overall financial planning - The company operates as a single segment, with resource allocation based on cash resources and operating expense projections[73] Key Financial Data | Expense Category (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Clinical trial expenses | $936 | $2,467 | $2,594 | $4,043 | | Contract manufacturing | $6 | $417 | $29 | $631 | | Salaries and benefits related (R&D) | $292 | $448 | $622 | $842 | | Salaries and benefits related (G&A) | $234 | $300 | $464 | $624 | Note 13. Subsequent Events This note reports significant events that occurred after the reporting period but before the financial statements were issued - Subsequent to June 30, 2025, the company issued an additional 20,891,304 shares of common stock under the ATM Sales Agreement, generating net proceeds of $6.6 million[76] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, detailing its business overview, clinical programs, components of expenses, and liquidity position, including recent financing activities and future funding needs Overview This overview introduces the company's biotechnology focus, lead drug candidate, clinical trial progress, and financial challenges - Intensity Therapeutics is a late-stage clinical biotechnology company developing INT230-6, an intratumoral treatment designed to overcome drug delivery challenges in solid tumors and induce systemic immune activation[78][79][80][81] - The company has completed Phase 1/2 IT-01 and Phase 2 INVINCIBLE-2 studies, initiated Phase 3 INVINCIBLE-3 (sarcoma) and Phase 2 INVINCIBLE-4 (TNBC) studies, but paused new enrollments for INVINCIBLE-3 due to funding constraints[82][83][84][85][86] - The company has an accumulated deficit of $72.7 million as of June 30, 2025, and expects significant expenses and operating losses, requiring substantial additional funding to support its growth strategy and clinical trials[88][89][90][91] Components of Results of Operations This section defines the key components of the company's financial performance, including revenue, research and development, and general and administrative expenses - The company has not generated any revenue from product sales or licensing to date and does not expect to in the foreseeable future[93] - Research and Development Expenses include salaries, clinical trial costs (CROs, patient care), contract manufacturing, consulting, and stock-based compensation[94][97] - General and Administrative Expenses cover employee-related costs, legal, audit, consulting, insurance, and other corporate overheads[95][97] Results of Operations This section analyzes the company's financial performance by comparing operating results for the current and prior periods Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024 This subsection compares the company's financial results for the three-month periods ended June 30, 2025, and 2024, highlighting key changes in expenses and net loss Key Financial Data | Metric (in thousands) | Q2 2025 | Q2 2024 | Change | | :-------------------- | :------ | :------ | :----- | | Research and development | $1,541 | $3,563 | $(2,022) | | General and administrative | $1,164 | $1,506 | $(342) | | Total operating expenses | $2,705 | $5,069 | $(2,364) | | Net loss | $(2,537) | $(4,971) | $2,434 | - Research and development expenses decreased by $2.0 million (57%) primarily due to lower INVINCIBLE-3 Study costs (pause in new enrollments) and no manufacturing batches of INT230-6 in 2025[99][100] - General and administrative expenses decreased by $0.3 million (23%) due to reduced bonus accruals and other cost savings[100] Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024 This subsection compares the company's financial results for the six-month periods ended June 30, 2025, and 2024, detailing changes in operating expenses and net loss Key Financial Data | Metric (in thousands) | H1 2025 | H1 2024 | Change | | :-------------------- | :------ | :------ | :----- | | Research and development | $3,730 | $6,378 | $(2,648) | | General and administrative | $2,369 | $3,434 | $(1,065) | | Total operating expenses | $6,099 | $9,812 | $(3,713) | | Net loss | $(5,884) | $(9,574) | $3,690 | - Research and development expenses decreased by $2.6 million (42%) primarily due to lower INVINCIBLE-3 Study costs and no manufacturing batches of INT230-6 in 2025[101][105] - General and administrative expenses decreased by $1.1 million (31%) due to reduced bonus accruals, lower stock-based compensation, favorable insurance renewal terms, and cost savings from new administrative systems[101][105] Liquidity and Capital Resources This section assesses the company's ability to meet its short-term and long-term financial obligations, including its cash position and funding strategies - The company has incurred significant operating losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern, and requires additional capital to fund operations[103][104][106] Key Financial Data | Metric | June 30, 2025 (in thousands) | | :-------------------------------- | :--------------------------- | | Cash and cash equivalents | $2,200 | | Net proceeds from ATM Sales Agreement (subsequent to June 30, 2025) | $6,600 | - Recent financing activities, including ATM offerings and public offerings in April and June 2025, provided $4.1 million in net cash from financing activities for the six months ended June 30, 2025, extending the cash runway into the second half of 2026[118][112] - The company believes it has at least $2.5 million in stockholders' equity, meeting Nasdaq listing requirements, but awaits formal confirmation[113] Off-Balance Sheet Arrangements This section confirms the absence of any off-balance sheet arrangements that could materially affect the company's financial position - The company did not have any off-balance sheet arrangements as of June 30, 2025[120] Critical Accounting Policies and Estimates This section states that there were no significant changes to the company's critical accounting policies and estimates during the reporting period - No significant changes to the company's critical accounting policies and estimates occurred during the six months ended June 30, 2025[121] JOBS Act Accounting Election This section explains the company's irrevocable election regarding the extended transition period for new accounting standards under the JOBS Act - As an 'emerging growth company' under the JOBS Act, the company has irrevocably elected not to use the extended transition period for new or revised accounting standards, thus adhering to the same standards as other public companies[122] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that quantitative and qualitative disclosures about market risk are not applicable to the company - This item is not applicable to the company[124] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025, and reported no material changes in internal control over financial reporting during the quarter - As of June 30, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[126] - There have been no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025[128] PART II - OTHER INFORMATION This part covers other important information not included in the financial statements, such as legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings The company is not currently involved in any legal proceedings that would individually or collectively have a material adverse effect on its business, operating results, cash flows, or financial condition - The company is not currently a party to any legal actions, claims, or suits that would have a material adverse effect on its business[129] Item 1A. Risk Factors This section highlights new and existing risk factors, including potential adverse effects from changes to U.S. tariff and import/export regulations, and the risk of not satisfying Nasdaq Capital Market's continued listing requirements, particularly regarding minimum stockholders' equity and bid price - Changes to U.S. tariff and import/export regulations may have a material adverse effect on the company's business, financial condition, and results of operations[131] - The company received notices of non-compliance with Nasdaq's minimum stockholders' equity requirement ($2.5 million) and the $1.00 minimum bid price requirement for continued listing[132] - Subsequent to June 30, 2025, the company raised an additional $6.6 million in net proceeds, believing it now meets the $2.5 million stockholders' equity rule, but awaits Nasdaq's formal confirmation[133] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the quarter ended June 30, 2025, that were not previously disclosed in a Current Report on Form 8-K - There were no unregistered sales of the company's securities during the quarter ended June 30, 2025, that were not previously reported[134] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[135] Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company - This item is not applicable to the company[136] Item 5. Other Information During the quarter ended June 30, 2025, no director or officer of the company adopted, modified, or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[137] Item 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including corporate organizational documents, warrant forms, offering agreements, and certifications required by the Sarbanes-Oxley Act - The exhibits include the Sixth Amended and Restated Certificate of Incorporation, Second Amended and Restated Bylaws, various forms of Series B-1, Series B-2, and Representative's Warrants[141] - Key agreements such as the Placement Agent Agreement, Securities Purchase Agreement, and Underwriting Agreement related to recent offerings are also listed[141] - Certifications of the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included, along with Inline XBRL documents[141] SIGNATURES This section provides the official signatures of the company's authorized officers, certifying the accuracy of the report - The report was signed on August 7, 2025, by Lewis H. Bender, President, Chief Executive Officer and Chairman, and Joseph Talamo, Chief Financial Officer[145][146]