Financial Performance - As of September 30, 2025, CervoMed had approximately $27.3 million in cash, cash equivalents, and marketable securities, down from $38.9 million as of December 31, 2024[4]. - Grant revenue for the three months ended September 30, 2025, was approximately $0.3 million, a decrease from approximately $1.9 million for the same period in 2024, due to the completion of the initial phase of the RewinD-LB trial[5]. - Net loss for the three months ended September 30, 2025, was approximately $7.7 million, compared to a net loss of approximately $4.8 million for the same period in 2024[8]. - Total operating expenses increased to $8,366,768 in Q2 2025 from $7,336,024 in Q2 2024, marking a rise of approximately 14.1%[17]. - Net loss for Q2 2025 was $7,726,639, compared to a net loss of $4,753,541 in Q2 2024, indicating an increase in losses of about 62.5%[17]. - Total comprehensive loss for the first half of 2025 was $18,929,450, compared to $9,461,619 in the first half of 2024, indicating a year-over-year increase of approximately 99.5%[17]. - Interest income decreased to $318,787 in Q2 2025 from $646,172 in Q2 2024, a decline of about 50.7%[17]. - Net loss per share for Q2 2025 was $0.84, compared to $0.55 in Q2 2024, representing a decline of 52.7%[17]. - CervoMed's total stockholders' equity decreased to approximately $26.0 million as of June 30, 2025, from $39.2 million as of December 31, 2024[15]. Research and Development - Research and Development (R&D) expenses for the quarter ended September 30, 2025, were approximately $6.0 million, an increase from approximately $5.1 million in the same period in 2024[7]. - Research and development expenses rose to $6,040,442 in Q2 2025 from $5,125,097 in Q2 2024, reflecting an increase of approximately 17.9%[17]. - The 32-week treatment data from the Phase 2b RewinD-LB trial showed a 64% risk reduction in clinically significant worsening compared to control over 32 weeks of neflamapimod treatment (p<0.001)[6]. - CervoMed plans to initiate a global pivotal Phase 3 trial for neflamapimod in DLB in the second half of 2026[1]. - The company received a $21.0 million grant from the National Institute on Aging in January 2023 to support the RewinD-LB trial[5]. - The company is preparing for a global pivotal trial initiation and meeting with global regulators in the coming months[1]. General and Administrative Expenses - General and Administrative (G&A) expenses were approximately $2.3 million during the three months ended September 30, 2025, compared to approximately $2.2 million in the same period in 2024[8]. - General and administrative expenses rose to $2,326,326 in Q2 2025 from $2,210,927 in Q2 2024, reflecting an increase of about 5.2%[17]. Grant Revenue - Grant revenue for Q2 2025 was $322,569, compared to $1,939,751 in Q2 2024, representing a significant decline[17]. - Total other income, net for Q2 2025 was $317,560, compared to $642,732 in Q2 2024, indicating a decrease of approximately 50.6%[17]. Shareholder Information - Weighted average shares outstanding increased to 9,252,719 in Q2 2025 from 8,702,764 in Q2 2024, an increase of approximately 6.3%[17].

Financial Position - The company has approximately $27.3 million in cash and cash equivalents and marketable securities as of September 30, 2025[120]. - The accumulated deficit as of September 30, 2025, is $89.6 million, with a net loss of $18.9 million for the nine months ended September 30, 2025[121]. - As of September 30, 2025, the company had approximately $27.3 million in cash and cash equivalents, with an accumulated deficit of approximately $89.6 million[149]. - The company completed a private placement in April 2024, raising approximately $50.0 million, with potential additional proceeds of up to $99.4 million from warrant exercises[150]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $4.6 million, a significant decrease from $46.4 million in the same period of 2024, reflecting a decline of approximately 90%[161]. - Cash used in investing activities for the nine months ended September 30, 2025, was $12.7 million, compared to $38.0 million in the same period of 2024, showing a reduction of about 66%[160]. - As of September 30, 2025, the company does not believe its existing cash and cash equivalents will fund operations for at least twelve months, raising substantial doubt about its ability to continue as a going concern[154]. Revenue and Grant Funding - The company has not generated any revenue from product sales and does not expect to do so in the near future[123]. - Grant funding recognized for the nine months ended September 30, 2025, was $4.0 million, compared to $7.6 million for the same period in 2024[123]. - Grant revenue decreased to $0.3 million for the three months ended September 30, 2025, down from $1.9 million in 2024, representing an 83% decline due to the completion of the Initial Phase of the RewinD-LB Trial[132]. - For the nine months ended September 30, 2025, grant revenue was $4.0 million, down 47% from $7.6 million in 2024, attributed to the transition phases of the RewinD-LB Trial[141]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, increased to $8.4 million, a 14% rise from $7.3 million in 2024, driven by higher research and development costs[131]. - Research and development expenses rose to $6.0 million for the three months ended September 30, 2025, an 18% increase from $5.1 million in 2024, primarily due to a $1.1 million increase in personnel costs[135]. - Total research and development expenses for the nine months ended September 30, 2025, were $16.0 million, a 37% increase from $11.7 million in 2024, mainly due to increased personnel and CMC-related costs[145]. - General and administrative expenses for the nine months ended September 30, 2025, totaled $8.0 million, a 16% increase from $6.9 million in 2024, driven by higher personnel costs and insurance expenses[146]. - The company expects to continue incurring losses and increasing research and development expenses, general and administrative expenses, and capital expenditures in the foreseeable future[153]. Clinical Trials and Research - The RewinD-LB Trial demonstrated a 54% risk reduction in clinically significant worsening compared to control at Week 32 of Batch B neflamapimod treatment (p=0.0037)[116]. - The planned Phase 3 clinical trial will evaluate neflamapimod in approximately 300 patients with DLB, expected to start in the second half of 2026[117]. - The company has received Orphan Drug Designation for neflamapimod for certain forms of frontotemporal dementia (FTD) in November 2024[118]. - The RewinD-LB Trial included 159 participants, funded primarily by a $21.3 million grant from the NIA[115]. - The company plans to implement manufacturing improvements to ensure the stability of neflamapimod's active ingredient in future trials[119]. Losses and Cash Flow - Net loss for the three months ended September 30, 2025, was $7.7 million, a 63% increase compared to a net loss of $4.8 million in 2024[131]. - For the nine months ended September 30, 2025, net cash used in operating activities was $16.9 million, compared to $8.5 million for the same period in 2024, representing a 99% increase in cash outflow[157][158]. - The net loss for the nine months ended September 30, 2025, was $18.9 million, up from a net loss of $9.6 million in the same period of 2024, indicating a 97% increase in losses[158][159]. - The company incurred a non-cash expense of $1.1 million for stock-based compensation during the nine months ended September 30, 2025[158]. Financing and Future Outlook - The company plans to finance its cash needs through equity offerings, debt financings, or other capital sources, which may dilute existing stockholders' ownership[154]. - The company is actively seeking additional financing to advance its product candidates and fund operations, but may face challenges in raising funds on favorable terms[154]. - The company has no off-balance sheet arrangements that could materially affect its financial condition[164].

Financial Performance - CervoMed reported a net loss of approximately $6.3 million for Q2 2025, compared to a net loss of approximately $2.3 million for the same period in 2024[8]. - Net loss for Q2 2025 was $(6,258,404), which is a 170.5% increase from $(2,316,905) in Q2 2024[16]. - Net loss per share for Q2 2025 was $(0.70), compared to $(0.27) in Q2 2024[16]. - Total comprehensive loss for Q2 2025 was $(6,280,410), compared to $(2,336,607) in Q2 2024, indicating a significant increase in overall losses[16]. - Loss from operations for Q2 2025 was $(6,616,275), compared to $(2,995,099) in Q2 2024, reflecting a 121.9% increase in losses[16]. Revenue and Expenses - Grant revenue for Q2 2025 was approximately $1.8 million, a decrease from approximately $3.3 million for the same period in 2024 due to the transition to the Extension phase of the RewinD-LB trial[5]. - Grant revenue for Q2 2025 was $1,757,724, a decrease of 46.5% compared to $3,288,971 in Q2 2024[16]. - Total operating expenses increased to $8,373,999 in Q2 2025, up 33.4% from $6,284,070 in Q2 2024[16]. - R&D expenses for Q2 2025 were approximately $5.1 million, an increase from approximately $3.8 million in Q2 2024, primarily due to increased CMC activities and clinical trial costs[7]. - Research and development expenses rose to $5,108,625 in Q2 2025, a 35.3% increase from $3,772,391 in Q2 2024[16]. - General and administrative expenses were approximately $3.3 million in Q2 2025, compared to approximately $2.5 million in Q2 2024, mainly due to headcount costs[8]. - General and administrative expenses increased to $3,265,374 in Q2 2025, up 30.1% from $2,511,679 in Q2 2024[16]. - Interest income decreased to $368,127 in Q2 2025, down 45.7% from $678,441 in Q2 2024[16]. Clinical Trials and Developments - In the Phase 2b RewinD-LB trial, patients treated with neflamapimod showed a 54% risk reduction in clinically significant worsening compared to control at Week 32 (p=0.0037)[3]. - Among patients with minimal evidence of Alzheimer's disease co-pathology, the risk reduction improved to 64% (p=0.0001) at Week 32[3]. - At Week 32, there was a statistically significant reduction in GFAP plasma levels, with a mean change of -18.4±4.0 pg/mL in all participants (N=107)[3]. - CervoMed enrolled the first patients in a Phase 2a trial of neflamapimod in patients recovering from acute stroke in Q2 2025[6]. - CervoMed plans to meet with the FDA in Q4 2025 to align on the design of the planned Phase 3 trial, which is expected to initiate in mid-2026[6]. Cash and Securities - As of June 30, 2025, CervoMed had approximately $33.5 million in cash, cash equivalents, and marketable securities, down from $38.9 million as of December 31, 2024[4]. - Weighted average shares outstanding for Q2 2025 was 8,950,521, an increase from 8,702,764 in Q2 2024[16].

PART I – FINANCIAL INFORMATION [ITEM 1. FINANCIAL STATEMENTS](index=8&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Presents CervoMed Inc.'s unaudited condensed consolidated interim financial statements and notes for periods ended June 30, 2025 and 2024 [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $8,320,713 | $8,999,496 | $(678,783) | -7.54% | | Marketable securities | $25,210,453 | $29,922,523 | $(4,712,070) | -15.75% | | Total current assets | $38,081,399 | $43,081,610 | $(5,000,211) | -11.61% | | Total assets | $38,081,399 | $43,081,610 | $(5,000,211) | -11.61% | | Total liabilities | $4,641,620 | $3,879,282 | $762,338 | 19.65% | | Total stockholders' equity | $33,439,779 | $39,202,328 | $(5,762,549) | -14.70% | | Accumulated deficit | $(81,883,922) | $(70,731,484) | $(11,152,438) | 15.77% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :----------- | :----------- | :--------- | :--------- | | Grant revenue | $1,757,724 | $3,288,971 | $(1,531,247) | -46.56% | | Research and development | $5,108,625 | $3,772,391 | $1,336,234 | 35.42% | | General and administrative | $3,265,374 | $2,511,679 | $753,695 | 30.01% | | Total operating expenses | $8,373,999 | $6,284,070 | $2,089,929 | 33.26% | | Loss from operations | $(6,616,275) | $(2,995,099) | $(3,621,176) | 120.90% | | Interest income | $368,127 | $678,441 | $(310,314) | -45.74% | | Net loss | $(6,258,404) | $(2,316,905) | $(3,941,499) | 170.12% | | Net loss per share (basic & diluted) | $(0.70) | $(0.27) | $(0.43) | 159.26% | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :------------ | :----------- | :--------- | :--------- | | Grant revenue | $3,675,215 | $5,636,221 | $(1,961,006) | -34.80% | | Research and development | $9,946,423 | $6,586,649 | $3,359,774 | 51.01% | | General and administrative | $5,647,951 | $4,639,609 | $1,008,342 | 21.73% | | Total operating expenses | $15,594,374 | $11,226,258 | $4,368,116 | 38.91% | | Loss from operations | $(11,919,159) | $(5,590,037) | $(6,329,122) | 113.22% | | Interest income | $777,112 | $759,074 | $18,038 | 2.38% | | Net loss | $(11,152,438) | $(4,831,240) | $(6,321,198) | 130.84% | | Net loss per share (basic & diluted) | $(1.26) | $(0.65) | $(0.61) | 93.85% | [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) - As of June 30, 2025, the number of common stock shares outstanding increased to **9,252,719** from **8,702,719** at December 31, 2024, primarily due to the sale of **550,000** common stock shares, net of issuance costs, generating **$4,588,687**[26](index=26&type=chunk) - The accumulated deficit increased significantly from **$(70,731,484)** at December 31, 2024, to **$(81,883,992)** at June 30, 2025, reflecting the net loss incurred during the period[26](index=26&type=chunk) - Stock-based compensation expense for the six months ended June 30, 2025, was **$858,182**, contributing to additional paid-in capital[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Cash Flow Activity | 2025 | 2024 | | :-------------------------------------- | :------------- | :------------- | | Net cash used in operating activities | $(10,409,054) | $(3,625,319) | | Net cash provided by (used in) investing activities | $5,141,584 | $(40,570,256) | | Net cash provided by financing activities | $4,588,687 | $46,411,946 | | Net (decrease) increase in cash and cash equivalents | $(678,783) | $2,216,371 | | Cash and cash equivalents at end of period | $8,320,713 | $10,009,217 | - The company experienced a net decrease in cash and cash equivalents of **$678,783** for the six months ended June 30, 2025, a significant shift from a net increase of **$2,216,371** in the prior year[29](index=29&type=chunk) - Cash used in operating activities increased substantially to **$10.4 million** in 2025 from **$3.6 million** in 2024, primarily due to a higher net loss[29](index=29&type=chunk) [Notes To Unaudited Condensed Consolidated Interim Financial Statements](index=13&type=section&id=Notes%20To%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) [1. The Company and Description of Business](index=13&type=section&id=1.%20The%20Company%20and%20Description%20of%20Business) - CervoMed Inc. is a clinical-stage biotechnology company focused on developing treatments for age-related neurologic disorders, with its lead drug candidate, neflamapimod, inhibiting p38α in neurons[30](index=30&type=chunk) - The company recently completed its RewinD-LB Trial, a Phase 2b study of neflamapimod in patients with Dementia with Lewy Bodies (DLB), primarily funded by a **$21.3 million** grant from the NIA[30](index=30&type=chunk) - For accounting purposes, the August 2023 merger with EIP Pharma, Inc. is treated as a reverse recapitalization, with EIP considered the accounting acquirer, meaning EIP's historical results are deemed the Company's historical results prior to the merger[10](index=10&type=chunk) [2. Liquidity and Capital Resources](index=13&type=section&id=2.%20Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the Company had an accumulated deficit of **$81.9 million** and negative cash flows from operations[31](index=31&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$33.5 million**, combined with remaining NIA Grant funds, are expected to cover operating expenses and capital expenditures for at least **twelve months** from the financial statement issuance date[31](index=31&type=chunk) - The Company will require additional financing to advance product candidates and fund future operations, intending to seek funds through equity offerings, debt financings, or collaborations, with potential risks of dilution or restrictive covenants[31](index=31&type=chunk) [3. Summary of Significant Accounting Policies](index=13&type=section&id=3.%20Summary%20of%20Significant%20Accounting%20Policies) - The unaudited condensed consolidated interim financial statements are prepared in conformity with U.S. GAAP and SEC rules, with certain information condensed or omitted[33](index=33&type=chunk)[34](index=34&type=chunk) - The Company classifies marketable securities as available-for-sale, carried at fair value with unrealized gains and losses reported in comprehensive loss and accumulated other comprehensive (loss) income[40](index=40&type=chunk) - Research and development costs are expensed as incurred, including salaries, consultant fees, process development, stock-based compensation, and fees to third parties for clinical and preclinical activities[48](index=48&type=chunk)[49](index=49&type=chunk) - The Company adopted ASU No. 2023-07, "Segment Reporting," on January 1, 2024, and operates as a single reportable segment focused on developing treatments for age-related neurologic disorders[67](index=67&type=chunk)[68](index=68&type=chunk) [4. Fair Value of Financial Instruments](index=20&type=section&id=4.%20Fair%20Value%20of%20Financial%20Instruments) - The Company's financial instruments, including cash, cash equivalents, accounts payable, and accrued liabilities, approximate fair value due to their short maturities[73](index=73&type=chunk) Assets Measured at Fair Value (June 30, 2025) | Asset Category | Level 1 | Level 2 | Level 3 | | :----------------------------- | :---------- | :------------ | :-------- | | Cash equivalents (money market accounts) | $6,859,363 | — | — | | Commercial paper | — | $17,741,598 | — | | U.S. treasury bonds | — | $3,995,520 | — | | U.S. government agency bonds | — | $1,981,780 | — | | Corporate debt securities | — | $1,491,555 | — | | **Total assets measured at fair value** | **$6,859,363** | **$25,210,453** | **—** | Marketable Securities Amortized Cost vs. Fair Value (June 30, 2025) | Security Type | Amortized Cost | Unrealized gains | Unrealized losses | Fair Value | | :---------------------- | :------------- | :--------------- | :---------------- | :----------- | | Commercial paper | $17,745,445 | — | $(3,847) | $17,741,598 | | U.S. treasury bonds | $3,993,661 | $1,859 | — | $3,995,520 | | U.S. government agency bonds | $1,979,313 | $2,467 | — | $1,981,780 | | Corporate debt securities | $1,492,817 | — | $(1,262) | $1,491,555 | | **Total** | **$25,211,236** | **$4,326** | **$(5,109)** | **$25,210,453** | [5. Significant Agreements and Contracts](index=22&type=section&id=5.%20Significant%20Agreements%20and%20Contracts) - The Company holds an exclusive worldwide license from Vertex Pharmaceuticals for VX-745 (neflamapimod) for AD and related CNS disorders, with potential milestone payments up to **$117.0 million** and low-to-mid teens royalties on net sales[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - The NIA Grant, totaling **$21.3 million**, supports the RewinD-LB Trial; as of June 30, 2025, **$18.2 million** has been received, with approximately **$2.9 million** remaining[80](index=80&type=chunk)[81](index=81&type=chunk) - Receipt of remaining NIA Grant funds is subject to U.S. congressional approval of a final appropriations bill and ongoing administrative changes/political uncertainty at the NIH[82](index=82&type=chunk) [6. Prepaid Expenses](index=23&type=section&id=6.%20Prepaid%20Expenses) Prepaid Expenses (June 30, 2025 vs. December 31, 2024) | Category | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------- | :------------ | :---------------- | :--------- | :--------- | | Clinical expenses | $1,602,810 | $1,149,343 | $453,467 | 39.45% | | Insurance | $96,769 | $443,141 | $(346,372) | -78.16% | | Professional services | $142,365 | $95,218 | $47,147 | 49.51% | | Dues and memberships | $80,642 | $11,777 | $68,865 | 584.75% | | Other | $41,741 | $205,881 | $(164,140) | -79.73% | | **Total** | **$1,964,327** | **$1,905,360** | **$58,967** | **3.09%** | [7. Accrued Expenses and Other Current Liabilities](index=23&type=section&id=7.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued Expenses and Other Current Liabilities (June 30, 2025 vs. December 31, 2024) | Category | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------------- | :------------ | :---------------- | :--------- | :--------- | | Employee compensation costs | $1,301,907 | $803,193 | $498,714 | 62.09% | | Clinical development costs | $1,055,360 | $1,158,783 | $(103,423) | -8.92% | | Professional fees | $334,604 | $249,527 | $85,077 | 34.09% | | State franchise and excise tax | $20,456 | $40,456 | $(20,000) | -49.44% | | Other | $83,684 | $115,883 | $(32,199) | -27.79% | | **Total** | **$2,796,011** | **$2,367,842** | **$428,169** | **18.09%** | - Employee compensation costs increased significantly by **$0.5 million**, partly due to **$0.6 million** in severance-related charges recognized in connection with the Former COO's departure[84](index=84&type=chunk) [8. Commitments and Contingencies](index=24&type=section&id=8.%20Commitments%20and%20Contingencies) - The Company has a short-term office lease in Boston, with lease expense of approximately **$19,660** for the six months ended June 30, 2025[85](index=85&type=chunk) - The Company is involved in a legal proceeding initiated in 2014 by a former CEO, Paul Feller, asserting claims including breach of contract; the case has been subject to multiple postponements and is currently set for trial on November 26, 2025[88](index=88&type=chunk) - The Company provides a safe harbor match of up to **4%** of participant compensation for its 401(k) Plan, with total contributions of **$0.3 million** for the six months ended June 30, 2025[87](index=87&type=chunk) [9. Stockholders' Equity and Common Stock Warrants](index=25&type=section&id=9.%20Stockholders'%20Equity%20and%20Common%20Stock%20Warrants) - In April 2024, the Company completed a private placement, raising approximately **$50.0 million** in gross proceeds from the sale of common shares, Series A Warrants, and Pre-Funded Warrants[90](index=90&type=chunk) Common Stock Warrants Outstanding (June 30, 2025) | Warrant Type | Outstanding | Range of exercise price per share | Expiration dates | | :------------------------------ | :---------- | :------------------------------ | :----------------------------- | | Historical Diffusion common stock warrants | 25,768 | $44.55 - $96.12 | November 2025 through February 2026 | | Historical EIP common stock warrants | 43,618 | $19.81 | April 2028 | | Series A common stock warrants | 2,532,285 | $39.24 | April 2027 | | **Total** | **2,601,671** | | | - In May 2025, the Company entered into a Sales Agreement for an 'at-the-market' offering program of up to **$50.0 million**, under which **550,000** shares were sold for **$4.7 million**, net of issuance costs, during the three and six months ended June 30, 2025[95](index=95&type=chunk) [10. Stock-Based Compensation Expense](index=26&type=section&id=10.%20Stock-Based%20Compensation%20Expense) Stock-Based Compensation Expense by Category | Expense Category | 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 | $121,159 | $40,337 | $244,861 | $104,134 | | General and administrative | $375,856 | $538,244 | $613,321 | $692,662 | | **Total** | **$497,015** | **$578,581** | **$858,182** | **$796,796** | - Total stock-based compensation expense for the six months ended June 30, 2025, increased to **$858,182** from **$796,796** in the prior year[100](index=100&type=chunk) - The Company granted **375,400** stock options during the six months ended June 30, 2025, with a weighted-average exercise price of **$3.63** per share[100](index=100&type=chunk) - In connection with the Former COO's separation, the Company recognized **$0.1 million** in expense for the modification of unvested stock options and an additional **$0.1 million** for the extension of the exercise period for vested options during the three and six months ended June 30, 2025[103](index=103&type=chunk) [11. Subsequent Events](index=28&type=section&id=11.%20Subsequent%20Events) - The Company has evaluated subsequent events through the filing date of this Quarterly Report and determined that no events require adjustments to the disclosures in the condensed consolidated interim financial statements[104](index=104&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=29&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses CervoMed Inc.'s financial condition, operations, liquidity, and outlook, detailing performance and financing needs [Overview](index=29&type=section&id=Overview) - CervoMed is a clinical-stage biotechnology company developing neflamapimod, an orally administered small molecule, to treat age-related neurologic disorders by inhibiting p38α and addressing synaptic dysfunction[107](index=107&type=chunk)[108](index=108&type=chunk) - The company completed its Phase 2b RewinD-LB Trial for Dementia with Lewy Bodies (DLB), funded by a **$21.3 million** NIA grant, showing statistically significant improvements in **16-week** and **32-week** Extension data[107](index=107&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk) - Neflamapimod is also being evaluated for frontotemporal dementia (FTD), having received Orphan Drug designation, and for recovery after ischemic stroke, with Phase 2 trials initiated in **Q2 2025** and **July 2025**, respectively[113](index=113&type=chunk) [Financial Summary](index=30&type=section&id=Financial%20Summary) - As of June 30, 2025, CervoMed had approximately **$33.5 million** in cash, cash equivalents, and marketable securities[114](index=114&type=chunk) - The company reported an accumulated deficit of **$81.9 million** as of June 30, 2025, and has historically incurred net losses, with a net loss of **$11.2 million** for the six months ended June 30, 2025[115](index=115&type=chunk) - CervoMed expects increased expenses due to advancing neflamapimod through clinical trials (including a potential Phase 3), manufacturing, intellectual property protection, hiring, and public company operations[115](index=115&type=chunk) [Financial Operations Overview](index=31&type=section&id=Financial%20Operations%20Overview) [Revenue](index=31&type=section&id=Revenue) - The Company has not generated product sales revenue to date and does not expect to in the near future[117](index=117&type=chunk) Grant Revenue (Six Months Ended June 30) | Period | Grant Revenue | | :-------------------- | :-------------- | | June 30, 2025 | $3,675,215 | | June 30, 2024 | $5,636,221 | | **Change** | **$(1,961,006)** | | **Change (%)** | **-34.80%** | - Grant revenue decreased due to the completion of the Initial Phase of the RewinD-LB Trial and the transition to the Extension Phase in December 2024[126](index=126&type=chunk) [Research and Development Expenses](index=31&type=section&id=Research%20and%20Development%20Expenses) - Research and development expenses are a significant portion of operating expenses, recognized as incurred, and include costs for CROs, preclinical testing, clinical material production, personnel, and regulatory submissions[118](index=118&type=chunk)[121](index=121&type=chunk) - R&D expenses are expected to increase substantially due to continued investment in neflamapimod's clinical trials (including a potential Phase 3), manufacturing, regulatory approval, and hiring[120](index=120&type=chunk) Research and Development Expenses (Six Months Ended June 30) | Period | R&D Expenses | | :-------------------- | :------------- | | June 30, 2025 | $9,946,423 | | June 30, 2024 | $6,586,649 | | **Change** | **$3,359,774** | | **Change (%)** | **51.01%** | [General and Administrative Expenses](index=32&type=section&id=General%20and%20Administrative%20Expenses) - General and administrative expenses primarily consist of personnel-related costs (including stock-based compensation), legal fees, professional fees for accounting and auditing, insurance, and facility costs[122](index=122&type=chunk) - G&A expenses are anticipated to increase due to headcount growth supporting R&D activities, development activities under the NIA Grant, and costs associated with operating as a public company[123](index=123&type=chunk) General and Administrative Expenses (Six Months Ended June 30) | Period | G&A Expenses | | :-------------------- | :------------- | | June 30, 2025 | $5,647,951 | | June 30, 2024 | $4,639,609 | | **Change** | **$1,008,342** | | **Change (%)** | **21.73%** | [Interest Income](index=32&type=section&id=Interest%20Income) - Interest income is generated from marketable securities and cash/cash equivalent balances held with financial institutions[124](index=124&type=chunk) Interest Income (Six Months Ended June 30) | Period | Interest Income | | :-------------------- | :-------------- | | June 30, 2025 | $777,112 | | June 30, 2024 | $759,074 | | **Change** | **$18,038** | | **Change (%)** | **2.38%** | - Interest income remained relatively flat year-over-year for the six months ended June 30, 2025, as a higher average cash balance was offset by lower interest rates[136](index=136&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) [Comparison of the Three Months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) - Net loss increased by **170%** to **$(6,258,404)** for the three months ended June 30, 2025, compared to **$(2,316,905)** in the prior year[125](index=125&type=chunk) - Grant revenue decreased by **47%** to **$1.8 million**, primarily due to the completion of the Initial Phase of the RewinD-LB Trial[125](index=125&type=chunk)[126](index=126&type=chunk) - Research and development expenses increased by **35%** to **$5.1 million**, driven by higher costs for CMC activities, non-clinical studies, headcount, and outsourced CRO costs for new clinical trials (Restore Trial and PPA trial)[125](index=125&type=chunk)[127](index=127&type=chunk) - General and administrative expenses rose by **30%** to **$3.3 million**, mainly due to increased headcount costs and outsourced services[125](index=125&type=chunk)[128](index=128&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) - Net loss increased by **131%** to **$(11,152,438)** for the six months ended June 30, 2025, compared to **$(4,831,240)** in the prior year[131](index=131&type=chunk) - Grant revenue decreased by **35%** to **$3.7 million**, primarily due to the completion of the Initial Phase of the RewinD-LB Trial[131](index=131&type=chunk)[132](index=132&type=chunk) - Research and development expenses increased by **51%** to **$9.9 million**, driven by higher costs for CMC activities, non-clinical studies, headcount, and outsourced CRO costs for new clinical trials (Restore Trial and PPA trial)[131](index=131&type=chunk)[133](index=133&type=chunk) - General and administrative expenses rose by **22%** to **$5.6 million**, mainly due to increased headcount costs and outsourced services[131](index=131&type=chunk)[134](index=134&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the Company had **$33.5 million** in cash, cash equivalents, and marketable securities, and an accumulated deficit of **$81.9 million**[137](index=137&type=chunk) - The Company believes its current capital, along with remaining NIA Grant funds (**$2.9 million**), will fund operations for at least **twelve months**, but acknowledges this estimate may be wrong and additional financing will be required[137](index=137&type=chunk)[142](index=142&type=chunk) - Future capital requirements are highly uncertain and depend on factors such as clinical trial progress, regulatory approvals, milestone payments, hiring, manufacturing, commercialization, intellectual property costs, and the ability to secure additional non-dilutive funding or collaborations[144](index=144&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2025 | 2024 | | :-------------------------------------- | :------------- | :------------- | | Net cash used in operating activities | $(10,409,054) | $(3,625,319) | | Net cash provided by (used in) investing activities | $5,141,584 | $(40,570,256) | | Net cash provided by financing activities | $4,588,687 | $46,411,946 | | Net (decrease) increase in cash and cash equivalents | $(678,783) | $2,216,371 | - Cash used in operating activities significantly increased to **$10.4 million** in 2025 from **$3.6 million** in 2024, primarily due to a higher net loss[146](index=146&type=chunk)[147](index=147&type=chunk) - Investing activities shifted from using **$40.6 million** in 2024 (due to marketable securities purchases) to providing **$5.1 million** in 2025 (due to maturities of marketable securities offsetting purchases)[148](index=148&type=chunk)[150](index=150&type=chunk) - Cash provided by financing activities decreased substantially to **$4.6 million** in 2025 (from common stock sales under the Sales Agreement) from **$46.4 million** in 2024 (from the 2024 Private Placement)[151](index=151&type=chunk)[152](index=152&type=chunk) [Contractual Obligations and Other Commitments](index=37&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) - The Company enters into contracts with third-party organizations for clinical trials, nonclinical studies, manufacturing, and other services, with the ability to discontinue work under these agreements at any time[153](index=153&type=chunk) - Future agreements may involve upfront payments and long-term cash commitments, but the amount and timing of these obligations can vary[153](index=153&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=Off-Balance%20Sheet%20Arrangements) - The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a material effect on its financial condition, results of operations, liquidity, or capital resources[154](index=154&type=chunk) [Critical Accounting Policies and Estimates](index=37&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - There were no material changes to the Company's critical accounting policies and estimates during the six months ended June 30, 2025, from those disclosed in its Annual Report[155](index=155&type=chunk) [Recently Adopted Accounting Pronouncements](index=37&type=section&id=Recently%20Adopted%20Accounting%20Pronouncements) - Information on recently issued accounting pronouncements that may impact the Company's financial position and results of operations is disclosed in Note 3, Summary of Significant Accounting Policies[156](index=156&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=38&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, CervoMed Inc. is not required to provide quantitative and qualitative disclosures about market risk - CervoMed Inc. is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a 'smaller reporting company' under SEC regulations[158](index=158&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=38&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Addresses CervoMed Inc.'s disclosure controls, reports material weaknesses in internal control, and outlines remediation efforts [Evaluation of Disclosure Controls and Procedures](index=38&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, including the principal executive and financial officers, concluded that the Company's disclosure controls and procedures were ineffective as of June 30, 2025, due to an identified material weakness[159](index=159&type=chunk) [Material Weaknesses in Internal Control over Financial Reporting](index=38&type=section&id=Material%20Weaknesses%20in%20Internal%20Control%20over%20Financial%20Reporting) - A material weakness was identified in the absence of effective controls regarding the accurate identification, evaluation, and proper recording of various expense accounts for the years ended December 31, 2024, 2023, and 2022[160](index=160&type=chunk) - The Company is actively implementing measures to remediate this material weakness, including adding additional review procedures by qualified personnel, with completion expected during the year ending December 31, 2025[162](index=162&type=chunk) - Despite the material weaknesses, management concluded that the consolidated financial statements in this Quarterly Report are fairly stated in all material respects in accordance with U.S. GAAP[163](index=163&type=chunk) [Change in Internal Control Over Financial Reporting](index=39&type=section&id=Change%20in%20Internal%20Control%20Over%20Financial%20Reporting) - Except for the material weakness discussed, there were no other changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[164](index=164&type=chunk) PART II – OTHER INFORMATION [ITEM 1. LEGAL PROCEEDINGS](index=40&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) This section refers to the detailed disclosure of legal proceedings found in Note 8 of the financial statements - Information regarding legal proceedings is incorporated by reference from Note 8, Commitments and Contingencies, in the notes accompanying the unaudited condensed consolidated interim financial statements[166](index=166&type=chunk) [ITEM 1A. RISK FACTORS](index=40&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section states that there have been no material changes to the risk factors previously disclosed in the Company's Annual Report - As of the date of this Quarterly Report, there have been no material changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K[167](index=167&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=40&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report - There were no unregistered sales of equity securities or use of proceeds to report for the period[168](index=168&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=40&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) This section states that there were no defaults upon senior securities - There were no defaults upon senior securities for the period[169](index=169&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=40&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This section indicates that mine safety disclosures are not applicable to the Company - Mine safety disclosures are not applicable to the Company[170](index=170&type=chunk) [ITEM 5. OTHER INFORMATION](index=40&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Reports no directors or officers adopted, terminated, or modified Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - During the three months ended June 30, 2025, none of the Company's directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement[171](index=171&type=chunk) [ITEM 6. EXHIBITS](index=41&type=section&id=ITEM%206.%20EXHIBITS) This section lists all exhibits filed as part of the Quarterly Report, including agreements, certifications, and XBRL data - The report includes various exhibits such as the Sales Agreement, employment agreements, the Separation Agreement, the 2025 Equity Incentive Plan, and certifications from executive officers[172](index=172&type=chunk) - XBRL (Extensible Business Reporting Language) information is furnished for purposes of the Securities Act and Exchange Act but is not considered filed or subject to liability under certain sections[173](index=173&type=chunk) SIGNATURES [Signatures](index=42&type=section&id=Signatures) This section contains the required signatures for the Quarterly Report, certifying its submission on behalf of CervoMed Inc. - The report was signed by John Alam, President and Chief Executive Officer (Principal Executive Officer), and William Elder, Chief Financial Officer and General Counsel (Principal Financial Officer), on August 8, 2025[178](index=178&type=chunk)

Stock Issuance and Sale - The Company plans to issue and sell up to $50,000,000 of common stock through Leerink Partners LLC as the Agent[1] - The common stock has a par value of $0.001 per share, and the issuance will be subject to the limitations set forth in the Agreement[1] - The Registration Statement for the common stock was filed with the SEC on October 3, 2024, and declared effective on October 10, 2024[2] - The Company will provide the Agent with copies of the base prospectus and the Prospectus Supplement related to the Placement Shares[2] - Each Placement will require a Placement Notice specifying the maximum number of shares, time period for sales, and any minimum price[4] - The Agent will use commercially reasonable efforts to sell the Placement Shares as per the terms of the Placement Notice[6] - Settlement for sales of Placement Shares will occur on the first Trading Day following the date of sale[10] - The Net Proceeds delivered to the Company will be the gross sales price minus the Agent's commission and any transaction fees[10] - The Company must deliver the Placement Shares electronically on or before each Settlement Date[11] - If the Company defaults on its obligation to deliver shares, it must return the Net Proceeds and indemnify the Agent for any losses incurred[11] - The Company has filed a Registration Statement with the Commission, which has been declared effective prior to the issuance of any Placement Notices[13] - The Company has filed a Notification of Listing of Additional Shares with Nasdaq regarding the Placement Shares[21] - The Placement Shares have been duly authorized for issuance and will be validly issued, fully paid, and nonassessable when delivered[26] - The issuance and sale of the Placement Shares will not be subject to any preemptive rights or similar rights[26] - The Company will use commercially reasonable efforts to list the Placement Shares on Nasdaq[86] - The Company will comply with all requirements imposed by the Securities Act and the Exchange Act to permit the sales of Placement Shares[105] - The Company will file a new shelf registration statement if any Placement Shares remain unsold by the third anniversary of the initial effective date[110] - The Company must notify the Agent if it is no longer eligible to use Form S-3 and file a new prospectus supplement within two business days[111] - The Company will indemnify the Agent against any documentary, stamp, or similar issue tax related to the sale of Placement Shares[113] - The Registration Statement must be effective for all offers and sales of Placement Shares issued pursuant to prior Placement Notices[114] - The Company is required to file the Prospectus Supplement with the Commission no later than the second business day following the date of the Agreement[115] - The Placement Shares must be approved for listing on Nasdaq or an application for listing must be filed prior to the First Placement Notice Date[128] - The Company reported a Material Adverse Effect that may impair the ability to sell Placement Shares[138] - The Company must deliver required certifications and opinions within 15 calendar days to avoid termination by the Agent[138] - The Agent can terminate the Agreement if trading in Placement Shares is suspended or limited on Nasdaq[138] - The Company has the right to terminate the Agreement with 10 days' notice at its discretion[139] - The Agreement will automatically terminate upon the issuance and sale of all Placement Shares[142] - The Company is obligated to reimburse the Agent's expenses even after termination[144] - The Agent is not liable for any settlement without its written consent[139] - The Company and the Agent will contribute to total losses in proportion to the benefits received from the sale of Placement Shares[135] Compliance and Legal Matters - The Company is in compliance with the reporting requirements of Section 13 or Section 15(d) of the Exchange Act, and its Common Stock is listed on Nasdaq[21] - The Company has not received any notice from the Commission objecting to the use of the shelf registration statement form[13] - The Company is not considered an "ineligible issuer" as defined in Rule 405[16] - The Company has filed all required federal income tax returns and paid all taxes due, with no material tax deficiencies expected[42] - The Company is not in violation of any organizational documents or agreements that would have a material adverse effect[39] - There are no pending legal proceedings that could reasonably be expected to have a material adverse effect on the Company's operations[37] - The Company has not incurred any material liabilities or obligations outside the ordinary course of business[33] - The Company is not classified as an "investment company" under the Investment Company Act of 1940[29] - The Company has obtained all necessary consents and approvals for the execution and delivery of agreements related to its operations[30] - The Company has no knowledge of any labor disputes that could have a material adverse effect on its operations[43] - The Company and its Subsidiaries are not subject to any sanctions and have not engaged in dealings with sanctioned entities[59] - The Company has conducted all research and clinical trials in accordance with applicable laws and standards, with no material unexpected adverse events reported[65] - The Company is in full compliance with all applicable laws and regulations regarding the development and distribution of its products, with no adverse findings from regulatory authorities[62] - There are no ongoing legal proceedings that could materially affect the Company or its Subsidiaries, and no claims have been received alleging violations of applicable laws[63] - The Company has not engaged in any unlawful payments or actions that would violate anti-corruption laws[55] - The Company is compliant with financial recordkeeping and reporting requirements, with no pending investigations related to money laundering laws[58] - The Company has filed all necessary patents and trademarks and is in compliance with the PTO's duty of candor and disclosure[80] Financial Condition and Reporting - The financial statements present a fair and accurate representation of the consolidated financial position of the Company and its Subsidiaries, prepared in compliance with GAAP[36] - There has been no material adverse change in the financial condition or operations of the Company and its Subsidiaries since the last reporting period[33] - The Company has not distributed any offering material other than the Registration Statement and the Prospectus in connection with the offering of the Placement Shares[19] - The interactive data in eXtensible Business Reporting Language included in the Registration Statement fairly presents the required information[20] - The Company will make generally available an earnings statement covering a 12-month period within 15 months after the end of the current fiscal quarter[88] - All financial projections included in the Registration Statement were made in good faith and are accompanied by cautionary statements regarding potential risks[74] - The Company does not possess any material non-public information[181] - The maximum amount of Placement Shares authorized for sale has been duly approved by the Company's board of directors[181] Insurance and Property - The Company and its Subsidiaries are insured by reputable institutions with adequate coverage for risks including theft and clinical trial liability claims[45] - The Company holds good and marketable title to all real and personal property material to its business, free of significant liens or encumbrances[46] - The Company possesses all necessary permits required by regulatory agencies to conduct its business, with no material adverse effects expected from non-compliance[47] - The Company maintains accurate books and records, ensuring compliance with GAAP and internal accounting controls[48] - The Company has established effective disclosure controls and procedures, with no material weaknesses reported in internal control over financial reporting[50] - The Company will maintain insurance covering risks that are reasonable and customary for its business[102] Agreement and Relationship with Agent - The Agreement is governed by the laws of the State of New York, and any disputes will be adjudicated in the state and federal courts in New York City[162] - The Agent may assign its rights and obligations under the Agreement to an affiliate without the Company's consent, provided the affiliate is a registered broker-dealer[148] - The Company acknowledges that no fiduciary or advisory relationship has been created between the Company and the Agent[160] - The Agreement constitutes the entire agreement between the parties and supersedes all prior agreements regarding the subject matter[151] - All stock-related numbers in the Agreement will be adjusted for any stock splits or similar events[149] - The Company has the capability to evaluate and understand the terms, risks, and conditions of the transactions contemplated by the Agreement[160] - The Agent is prohibited from providing any information gained in connection with the Agreement to third parties without the Company's written consent[163] - The Company has waived any claims against the Agent for breach of fiduciary duty in connection with the transactions contemplated by the Agreement[160] - The Agreement may be executed in multiple counterparts, each of which will be deemed an original[162] - The Company has complied with all agreements and satisfied all conditions as per the Sales Agreement[178]

Financial Position - The company has approximately $35.2 million in cash and cash equivalents and marketable securities as of March 31, 2025[116]. - The accumulated deficit as of March 31, 2025, is $75.6 million, with a net loss of $4.9 million for the three months ended March 31, 2025, compared to a net loss of $2.5 million for the same period in 2024, representing a 95% increase in loss[117][128]. - Interest income for the three months ended March 31, 2025, was $0.4 million, a 407% increase from $0.1 million in the same period in 2024, due to higher cash equivalents and marketable securities[133]. - Total operating expenses for the three months ended March 31, 2025, were $7.2 million, a 46% increase from $4.9 million in the same period in 2024[128]. - For the three months ended March 31, 2025, net cash used in operating activities was $3.9 million, compared to $1.4 million for the same period in 2024[140][142]. - Cash used in investing activities for the three months ended March 31, 2025, was $5.4 million due to the purchase of marketable securities[144]. - The net cash outflow from operations for the three months ended March 31, 2025, was primarily due to a net loss of $4.9 million[141]. - The company has no off-balance sheet arrangements that could materially affect its financial condition[148]. Research and Development - Research and development expenses increased by 72% to $4.8 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024, primarily due to increased clinical trial costs[130]. - The company is conducting the RewinD-LB Trial, a Phase 2b study involving 159 participants with DLB, funded primarily by a $21.3 million grant from the NIA[114]. - The company plans to initiate a Phase 2 trial (Restore Trial) evaluating neflamapimod in up to 90 participants recovering from ischemic stroke in Q2 2025[115]. - The company expects to report 32-week results from the Extension of the RewinD-LB Trial in the second half of 2025 and plans to meet with the FDA to discuss Phase 3 plans thereafter[114]. - The company anticipates continued increases in research and development expenses, general and administrative expenses, and capital expenditures[137]. Capital Needs - The company has never been profitable and will continue to require additional capital for the foreseeable future to develop neflamapimod[117]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources, including collaborations and licenses[138]. - The company may need additional funds to advance product candidates through clinical development and to fund operations[138]. - As of March 31, 2025, the company believes its existing cash and cash equivalents will fund operations for at least twelve months[138]. - The company completed a private placement on April 1, 2024, raising approximately $50.0 million, with potential additional proceeds of up to $99.4 million from Series A Warrants[135].