UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________to _______________ Commission file number 001-41765 MIRA Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Florida ...

Financial Performance - Total revenue for the three months ended September 30, 2025, was $529,000, a decrease of $810,000 (60.5%) compared to $1,339,000 in the same period of 2024[157]. - Total revenue for the nine months ended September 30, 2025, increased by $8.4 million (182.3%) to $13,032,000, primarily due to recognizing $9.6 million of previously deferred revenue from a partnership with Qilu[159]. - Operating expenses for the three months ended September 30, 2025, were $9,188,000, a decrease of $13,591,000 (59.7%) compared to $22,779,000 in the same period of 2024[160]. - Research and development expenses decreased by $8.5 million (59.7%) for the three months ended September 30, 2025, compared to the same period in 2024, due to a workforce reduction and cessation of discovery efforts[162]. - General and administrative expenses decreased by $1.5 million (33.0%) for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower employee compensation and litigation-related legal fees[164]. - The net loss for the three months ended September 30, 2025, was $7,742,000, compared to a net loss of $19,717,000 in the same period of 2024[157]. - For the nine months ended September 30, 2025, the net loss was $29.7 million, a decrease of $27.6 million compared to a net loss of $57.4 million for the same period in 2024[171]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $35.0 million, down from $54.5 million in 2024, reflecting a decrease of $19.6 million[172]. - Net cash provided by investing activities was $16.9 million for the nine months ended September 30, 2025, compared to $9.5 million in 2024, primarily due to maturities of investments in marketable securities[173]. - As of September 30, 2025, the company had cash, cash equivalents, and investments in marketable securities totaling $93.7 million, with no outstanding debt[175]. - Net cash provided by financing activities was $4.1 million for the nine months ended September 30, 2025, significantly lower than $50.6 million in 2024, which included $44.1 million from common share sales[174]. Restructuring and Cost Management - Arbutus Biopharma Corporation reported a one-time restructuring charge of $12.4 million in Q1 2025 due to workforce reductions and organizational changes[98]. - The company aims to significantly reduce its net cash burn in 2025 compared to 2024 through ongoing cost management efforts[98]. - The company incurred a one-time restructuring charge of $12.4 million in Q1 2025, related to a 57% workforce reduction and exiting its corporate headquarters[166]. - As of September 30, 2025, there was $0.5 million of accrued restructuring costs for severance payments and $0.3 million for lease-related operating expenses[167]. - The company expects to significantly reduce net cash burn in 2025 compared to 2024 due to organizational changes and ongoing cost management efforts[180]. Clinical Development and Trials - Over 250 patients with chronic hepatitis B (cHBV) infection have been dosed with imdusiran in Phase 1 and Phase 2a clinical trials, showing meaningful reductions in HBsAg, HBV DNA, and HBV RNA[106]. - 46% (48 out of 105) of all Phase 2a patients achieved functional cure or remained off nucleos(t)ide analog (NA) therapy after treatment with imdusiran[106]. - The company is currently developing AB-101, a proprietary oral PD-L1 inhibitor, which is in a Phase 1a/1b clinical trial[106]. - The company has streamlined its organization to focus on advancing the clinical development of imdusiran and AB-101, ceasing all discovery efforts and in-house scientific research[98]. - The newly formed Scientific Advisory Board (SAB) will advise on the strategic evaluation of the cHBV pipeline[99]. - The company’s strategy emphasizes maximizing opportunities for its cHBV development programs and its in-house developed lipid nanoparticle technology[101]. - In the IM-PROVE I trial, 50% (3/6) of patients with baseline HBsAg <1000 IU/mL achieved a functional cure, with an overall rate of 25% (3/12)[108]. - In the IM-PROVE II trial, 25% (2/8) of patients with low dose nivolumab and baseline HBsAg <1000 IU/mL achieved functional cure[122]. - Across all cohorts in the IM-PROVE II trial, 52% (32/62) of patients either achieved functional cure or remained off NA therapy for at least 48 weeks after treatment with imdusiran[123]. - In the IM-PROVE I trial, 37% (16/43) of patients either achieved functional cure or remained off NA therapy for at least 48 weeks after treatment with imdusiran[117]. - Imdusiran treatment was generally safe and well-tolerated, with no serious adverse events reported in the IM-PROVE I and II trials[118][123]. - The IM-PROVE I trial demonstrated that patients who achieved functional cure experienced HBsAg seroclearance associated with immune activation markers[116]. - The IM-PROVE II trial included a cohort with low dose nivolumab, which showed increased rates of HBsAg seroclearance[120]. - Imdusiran is designed to reduce HBV DNA, HBV RNA, and HBsAg, potentially allowing cHBV patients to become treatment-free[112]. - AB-101 clinical trial demonstrated 100% receptor occupancy in all five evaluable subjects at the 40mg dose level in Part 1[130]. - In Part 2, 100% receptor occupancy was achieved by six out of eight subjects at the 40mg daily dose over seven days[130]. - Part 3 of the trial showed that a single 10mg dose of AB-101 for 28 days in cHBV patients was well tolerated, with PD-L1 receptor occupancy similar to healthy subjects[131]. Legal Matters - The ongoing lawsuits against Moderna and Pfizer/BioNTech for patent infringement involve the use of Arbutus's lipid nanoparticle technology in their COVID-19 vaccines[97]. - A trial date for the Moderna lawsuit in the U.S. has been set for March 2026, with public oral hearings for related cases scheduled for May 2026[97]. - A lawsuit against Moderna for patent infringement related to lipid nanoparticle technology was filed, with a jury trial scheduled for March 2026[144]. - Five international lawsuits against Moderna were filed in March 2025, targeting alleged infringing activities in 30 countries[145]. - The company is currently preparing responses to multiple revocation actions against its patents filed by Moderna and Merck[150]. Strategic Partnerships - Qilu Pharmaceutical paid a one-time upfront cash payment of $40 million and agreed to pay up to $245 million upon achieving certain milestones related to imdusiran[133]. - Qilu is responsible for all costs related to the development and commercialization of imdusiran in Greater China and Taiwan[134]. - The strategic partnership with Qilu was mutually concluded in June 2025, allowing the company to regain global rights for imdusiran[136]. - The company is exploring strategic alliances to accelerate the development of its pipeline programs[111]. - The company has a royalty entitlement on ONPATTRO, with an aggregate of $26.3 million recorded as non-cash royalty revenue since the inception of the royalty sale through September 30, 2025[178]. - In June 2025, the company concluded its strategic partnership with Qilu, regaining global rights for imdusiran, which had previously been licensed for development in Greater China and Taiwan[179]. - The company may seek funding from various sources, including public or private equity or debt financing, to maintain and advance its business[181]. - The company does not have any off-balance sheet arrangements that could materially affect its financial condition or results of operations[183].

Dividends and Shareholder Returns - The company declared cash dividends of $0.30 per share for three separate periods, totaling $0.90 per share for the nine months ended September 30, 2025, amounting to $12,079,097[127]. - The company established a dividend reinvestment plan (DRIP) on September 3, 2025, allowing shareholders to reinvest cash dividends in additional shares[164]. - The company intends to distribute at least 90% of its REIT taxable income annually to shareholders, with potential tax implications for undistributed income[181]. Financial Performance - Distributable earnings for the three months ended September 30, 2025, were $4,121,401, translating to $0.31 per basic weighted average share[137]. - Net income allocable to common shareholders for the three months ended September 30, 2025, was approximately $4.1 million, or $0.30 per basic common share, compared to $1.7 million, or $0.26 per share for the same period in 2024[139]. - For the three months ended September 30, 2025, interest income increased by approximately $4.3 million, or 132.7%, compared to the same period in 2024, driven by an expansion of the loan portfolio from six to thirteen loans[140]. - Net interest income for the three months ended September 30, 2025, was approximately $6.1 million, compared to $3.2 million for the same period in 2024, reflecting a significant increase[139]. - Total expenses for the three months ended September 30, 2025, were approximately $2.2 million, up from $1.5 million in the same period in 2024, primarily due to increased management and administrative fees[139]. Loan Portfolio and Investments - The company focuses on originating and investing in secured commercial real estate loans, targeting investments across various asset classes[122]. - As of September 30, 2025, the total loan portfolio included thirteen loans held at carrying value, with an aggregate originated commitment of approximately $367.0 million[150]. - The company funded approximately $163.1 million of new loans and additional principal on existing loans during the nine months ended September 30, 2025[150]. - The company committed a total of $30.0 million for a senior bridge loan to refinance a retail property in Houston, Texas, with a maturity date in October 2028[129]. - In September 2025, the company and affiliated co-investors purchased a $60.0 million senior first mortgage loan for a residential property in Miami, Florida, with a cash rate of SOFR plus 4.75%[125]. - The senior loan for the residential property in Sarasota, Florida, was repaid in full, with an outstanding principal of approximately $25.5 million at the time of repayment[126]. - The company entered into two senior secured mortgage loans in October 2025, with an aggregate commitment of $36.6 million for industrial properties in Florida[128]. Capital Structure and Financing - The company aims for a leverage ratio of 1.5:1 debt-to-equity, with a target capitalization of one-third equity, one-third secured debt, and one-third unsecured debt[123]. - The company had $67.2 million outstanding borrowings under the Revolving Credit Facility as of September 30, 2025, with $72.8 million available for borrowing[168]. - The company intends to raise future equity capital and issue debt securities to fund future investments in loans[165]. - The company completed a public offering of 6,400,000 shares in January 2025, generating net proceeds of approximately $71.3 million[162]. Cash Flow and Liquidity - Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $(1.9) million, a decrease of approximately $(4.6) million compared to the same period in 2024[174]. - Net cash used in investing activities was approximately $(105.6) million for the nine months ended September 30, 2025, compared to $(93.9) million in 2024, reflecting an increase in loan issuances[175]. - Net cash used in financing activities was approximately $(71.6) million for the nine months ended September 30, 2025, a decrease of approximately $(201.7) million compared to the same period in 2024[176]. - As of September 30, 2025, the company had unrestricted cash totaling approximately $5.5 million, down from $184.6 million as of December 31, 2024[159]. Risk and Credit Quality - The company is subject to credit risk associated with its loan portfolio, which includes commercial real estate loans[198]. - The provision for current expected credit losses decreased by $0.1 million for the three months ended September 30, 2025, compared to the same period in 2024, while the reserve balance as of September 30, 2025, was approximately $0.4 million, or 0.17% of total loans[146]. - Approximately 96% of loans held at carrying value had floating interest rates as of September 30, 2025, with benchmark rates including one-month SOFR at 4.1%[150]. - A hypothetical 100 basis points increase in the floating benchmark rate would result in an increase in annual interest income of approximately $2.4 million[194]. - The top three borrowers represented approximately 42.0% of the aggregate outstanding principal balances and approximately 41.0% of total loan commitments as of September 30, 2025[202]. - The company has not guaranteed any obligations of unconsolidated entities or entered into any commitment to provide additional funding to such entities[180]. Investment Strategy - The company’s investment mix includes high-quality residential, retail, office, hospitality, and industrial real estate, with capital allocation depending on prevailing market conditions[185]. - The company’s loans are typically valued using a yield analysis, which may fluctuate due to changes in market yields and recovery rates[189]. - The company may be required to fund distributions from working capital or through equity or debt financings if cash available for distribution is less than required[182]. - As of September 30, 2025, total unfunded commitments amounted to $114,065,360, with $96,104,586 due in less than 1-3 years and $17,960,774 due in 3-5 years[178].

Clinical Trials and Drug Development - Denifanstat met all primary and multiple secondary endpoints in the Phase 2b FASCINATE-2 clinical trial for MASH, showing a 49% improvement in fibrosis by ≥ 1 stage compared to 13% for placebo (p=0.0032) [83] - The Phase 3 trial of denifanstat in acne showed a treatment success rate of 33.2% compared to 14.6% for placebo (p<0.0001) [91] - Denifanstat demonstrated a statistically significant difference in progression to cirrhosis (F4) with 5% in the denifanstat group versus 11% in placebo (p=0.0386) [85] - The Phase 1 clinical trial of the combination of denifanstat and resmetirom is expected to provide topline data in the first half of 2026 [88] Financial Performance - Research and development expenses decreased by $2.9 million, or 23%, for the three months ended September 30, 2025, primarily due to a $5.4 million decrease in clinical development costs for the Phase 3 program of denifanstat in MASH [100] - Total operating expenses for the three months ended September 30, 2025, were $14.3 million, a decrease of 15% from $16.9 million in the same period of 2024 [100] - Other income decreased by $2.2 million, or 32%, for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to lower interest income from reduced cash and marketable securities balances [106] - Research and development expenses increased by $8.1 million, or 33%, for the nine months ended September 30, 2025, driven by a $5.3 million increase in clinical development costs related to denifanstat and TVB-3567 [103] - Total operating expenses rose by $9.9 million, or 27%, for the nine months ended September 30, 2025, compared to the same period in 2024 [103] - Net loss increased by $12.1 million, or 41%, for the nine months ended September 30, 2025, compared to the same period in 2024 [103] - Cash used in operating activities was $33.8 million for the nine months ended September 30, 2025, primarily for clinical development and manufacturing activities [120] - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $125.5 million [111] - Net cash used in investing activities was $9.8 million for the nine months ended September 30, 2025, related to marketable securities purchases [123] Administrative Expenses - General and administrative expenses increased by $0.4 million, or 8%, for the three months ended September 30, 2025, primarily due to increased consulting and professional fees [100] - General and administrative expenses increased by $1.8 million, or 15%, for the nine months ended September 30, 2025, primarily due to higher stock-based compensation and consulting fees [105] Company Classification and Accounting Standards - The company is classified as an emerging growth company and can delay the adoption of new accounting standards until they apply to private companies [128] - The company will remain an emerging growth company until it has total annual gross revenues of $1.235 billion or more or until December 31, 2028 [129] - The company is also a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million [130] - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company [130] - The financial statements may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates [128] - The company has elected to use the extended transition period for complying with new accounting standards until it is no longer an emerging growth company [128] - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company [132] - The company has adopted recently issued accounting pronouncements, details of which can be found in the notes to the financial statements [131] - Actual results could differ significantly from estimates made, indicating potential volatility in financial reporting [126] Future Expectations - The company anticipates substantial increases in research and development expenses as it advances drug candidates through clinical trials and regulatory approvals [96] - The company anticipates continuing to incur significant expenses as it advances drug candidates through clinical trials and expands corporate infrastructure [111] - The company has financed operations primarily through public and private equity and debt financings, raising $190.9 million from its IPO and follow-on offering [108]

Financial Performance - Revenue for Q3 2025 reached $23,485,000, a 46.7% increase from $15,977,000 in Q3 2024[16] - Gross profit for Q3 2025 was $8,736,000, compared to $7,001,000 in Q3 2024, reflecting a 24.8% increase[16] - Net income for Q3 2025 was $921,000, down 56.7% from $2,126,000 in Q3 2024[16] - Operating income for Q3 2025 was $2,318,000, down from $3,182,000 in Q3 2024, a decrease of 27.1%[16] - The company reported a comprehensive income of $847,000 for Q3 2025, compared to $2,161,000 in Q3 2024, a decline of 60.8%[16] - Net income for the nine months ended September 30, 2025, was $4,686,000, a decrease of 32.2% compared to $6,914,000 for the same period in 2024[19] - Total revenue for the nine months ended September 30, 2025, was $55,548,000, an increase of 12.3% from $49,456,000 in 2024[40] Assets and Liabilities - Total current assets increased to $37,400,000 in Q3 2025 from $18,143,000 in Q4 2024, a growth of 106.5%[14] - Total liabilities rose to $68,092,000 in Q3 2025, compared to $22,405,000 in Q4 2024, an increase of 203.5%[14] - Stockholders' equity increased to $41,892,000 in Q3 2025 from $36,126,000 in Q4 2024, a rise of 15.5%[14] - Cash and cash equivalents of $3,512,000 as of September 30, 2025, down from $4,468,000 as of December 31, 2024[14] - Cash and restricted cash at the end of the period was $3,512,000, down from $4,720,000 at the end of the same period in 2024, a decrease of 25.6%[19] - The Company reported a total debt of $46,457 as of September 30, 2025, compared to $13,050 as of December 31, 2024[68] Revenue Sources - Online revenue accounted for approximately 56% of net revenue for the nine months ended September 30, 2025, down from 66% in the same period of 2024[37] - Wholesale revenue represented approximately 44% of net revenue for the nine months ended September 30, 2025, compared to 34% in the prior year[37] - The Company’s sales to customers in the U.S. were approximately 95% during the three months ended September 30, 2025, consistent with 96% in the same period of 2024[38] - Net sales to GNC represented 13% of total net revenue for the three months ended September 30, 2025, down from 23% in the same period of 2024[44] Acquisition Details - The Company acquired Irwin Naturals for approximately $42,500,000 in August 2025, funded by a combination of term loans and available cash[24] - The Company acquired substantially all of the assets of Irwin for approximately $42,500 on August 8, 2025, funded primarily through a new term loan and a revolving line of credit[93] - Irwin generated revenue of $6,821 and net income of $504 from August 8, 2025 through September 30, 2025[99] Expenses and Costs - The cost of goods sold for Q3 2025 was $14,749,000, which is a 64.5% increase from $8,976,000 in Q3 2024[16] - SG&A expenses increased 55% to $4,105 for the three months ended September 30, 2025, largely due to the acquisition of Irwin[122] - Cost of goods sold for the nine months ended September 30, 2025 increased 20% to $33,034 million, primarily due to the increase in revenue from the acquisition of Irwin[128] - Gross margin for the nine months ended September 30, 2025 decreased to 40.5% from 44.2% for the comparable prior period, primarily due to the acquisition of Irwin[130] Cash Flow and Financing - Net cash provided by operating activities for the nine months ended September 30, 2025, was $7,195,000, down from $8,653,000 in 2024, reflecting a decline of 16.8%[19] - Cash used in investing activities for the nine months ended September 30, 2025, was $42,537 million, significantly higher than $10 million in the same period of 2024, primarily due to the acquisition of Irwin for $42,500 million[160] - Cash provided by financing activities for the nine months ended September 30, 2025, was $34,009 million, compared to cash used of $5,875 million during the same period in 2024, driven by borrowings under the Credit Agreement for the acquisition of Irwin[161] - The Company entered into a new credit agreement on August 8, 2025, providing a five-year term loan of $40,625 million and a three-year revolving line of credit of up to $10,000 million[155] Tax and Compliance - Cash paid for income taxes in the nine months ended September 30, 2025, was $2,278,000, compared to $1,105,000 in 2024, indicating an increase of 106.5%[19] - The effective income tax rate increased to 32% for the nine months ended September 30, 2025, compared to 25% for the same period in 2024[54] Shareholder Information - Basic weighted average shares outstanding for the three months ended September 30, 2025, were 9,391, up from 9,196 in 2024[56] - The Company has authorized a share repurchase program of up to $5,000 over 24 months, with no repurchases made during the nine months ended September 30, 2025[82][83] - As of September 30, 2025, the intrinsic value of outstanding options was $12,875, based on a closing stock price of $19.89[85] Risk Management - The Company has not entered into any foreign currency hedging transactions during the nine months ended September 30, 2025, increasing exposure to foreign currency fluctuations[182] - Management believes that product returns are immaterial and unlikely to cause significant revenue reversals in the future[179] - The Company is not involved in any litigation that could materially affect its financial condition or results of operations[190] - Management is not aware of any material changes to the risk factors discussed in the Annual Report for the fiscal year ended December 31, 2024[191]

Financial Position - As of September 30, 2025, Traws Pharma had cash and cash equivalents of $6.4 million and an accumulated deficit of $632.5 million, indicating significant financial challenges ahead[113]. - The company does not currently have sufficient cash and cash equivalents to support operations for more than one year, raising substantial doubt about its ability to continue as a going concern[163]. - The company has not achieved profitability since inception and expects to continue incurring operating losses for the foreseeable future[163]. - Net cash used in operating activities was $15.4 million for the nine months ended September 30, 2025, compared to $25.8 million for the same period in 2024[158]. - Net cash provided by financing activities was $3.0 million for the nine months ended September 30, 2025, compared to $14.0 million for the same period in 2024[162]. - The company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[156]. - Traws Pharma is exploring various funding sources for development and ongoing operations, with no assurance of obtaining sufficient financing on acceptable terms[114]. Clinical Development - Traws Pharma has four clinical programs following the merger with Trawsfynydd Therapeutics, Inc., including Tivoxavir marboxil, aimed at treating influenza and bird flu[115]. - The first-in-man clinical study of Tivoxavir marboxil showed good tolerability, with a single dose maintaining plasma drug levels above the EC90 for over 23 days[117]. - Traws Pharma submitted a request for a meeting with the FDA regarding the potential for accelerated approval of Tivoxavir marboxil under the "Animal Rule" for bird flu treatment[117]. - The proposed Phase 2 study for Tivoxavir marboxil will evaluate its effects on seasonal influenza and H5N1 bird flu, pending regulatory review[118]. - Ratutrelvir (TRX01), acquired in the merger, is designed to inhibit the main protease of SARS-CoV-2, showing non-inferiority to existing treatments in animal studies[119]. - TRX01 Phase 1 clinical trial included 40 participants, with no treatment-related adverse events reported up to the highest dose of 600 mg[120]. - The company plans to report results from both Phase 2 studies evaluating ratutrelvir by year-end 2025[120]. - The Phase 1 study of narazaciclib as a monotherapy is now closed to accrual, with data analysis ongoing[120]. - Narazaciclib's maximum tolerated dose was established at 160 mg once daily in combination with letrozole for low-grade endometrioid endometrial cancer, with no dose-limiting toxicities observed in the initial cohort[120]. - Rigosertib showed an overall response rate of 80% in patients with RDEB-SCC, with complete responses in 50% of evaluable patients[122]. Revenue and Expenses - Revenue for the three months ended September 30, 2025 was $0, a decrease of $57,000 from $57,000 in the same period of 2024[141]. - Research and development expenses decreased by $2.8 million, or 55%, to $2.3 million for the three months ended September 30, 2025, primarily due to a $1.7 million decrease in virology expenses[143]. - General and administrative expenses decreased by $1.7 million, or 50%, to $1.7 million for the three months ended September 30, 2025, mainly due to a $1.0 million decrease in professional and consulting fees[146]. - For the nine months ended September 30, 2025, revenue was $2.8 million, an increase of $2.6 million from $0.2 million in the same period of 2024, primarily due to the recognition of $2.7 million of previously deferred revenue[149]. - Research and development expenses for the nine months ended September 30, 2025 decreased by $3.9 million, or 35%, to $7.1 million, with a significant decrease in oncology expenses[151]. - General and administrative expenses for the nine months ended September 30, 2025 decreased by $2.6 million, or 30%, to $6.2 million, primarily due to a $1.3 million decrease in professional and consulting fees[152]. - The change in fair value of warrant liability was $26.7 million during the nine months ended September 30, 2025, reflecting the remeasurement of the warrant liability[153]. Management and Corporate Actions - Management changes included the appointment of Iain Dukes as CEO and Charles Parker as CFO effective October 1, 2025[135][136][137]. - The company entered into an Asset Purchase Agreement with Viriom for $2,350,000 to acquire assets related to a pyrrolidine antiviral compound[123]. - The At The Market Offering Agreement allows the company to sell shares of common stock up to $50,000,000, with 62,003 shares sold for net proceeds of $0.1 million in Q3 2025[124][127]. - A one-for-25 reverse stock split was executed in September 2024, retroactively adjusting all share and per share amounts[139]. Market and Economic Conditions - The business faces significant risks from macroeconomic factors, including financial market volatility, inflation, and potential government shutdowns[165]. - The ultimate impact of global and domestic economic conditions on the business remains highly uncertain and is subject to ongoing monitoring[166]. - Significant expenses and operating losses are expected as the company seeks regulatory approval for its product candidates[164]. - The company may rely on licensing and co-promotion agreements for commercialization of its products in the future[164].

Financial Position - As of September 30, 2025, Traws Pharma had cash and cash equivalents of $6.4 million and an accumulated deficit of $632.5 million, indicating significant financial challenges ahead[113]. - Traws Pharma's ability to continue as a going concern is in doubt due to insufficient cash to support operations for at least the next 12 months[113]. - The company believes it does not have sufficient cash and cash equivalents to support operations for more than one year following the issuance of the financial statements[163]. - Net cash used in operating activities was $15.4 million for the nine months ended September 30, 2025, compared to $25.8 million for the same period in 2024[158]. - Net cash provided by financing activities was $3.0 million for the nine months ended September 30, 2025, compared to $14.0 million for the same period in 2024[162]. - Change in fair value of warrant liability was $26.7 million during the nine months ended September 30, 2025, reflecting the remeasurement of the warrant liability[153]. Operating Losses and Financial Challenges - The company expects to incur substantial operating losses for the foreseeable future as it continues to develop and seek regulatory approval for its product candidates[113]. - The company has not achieved profitability since inception and expects to continue incurring operating losses for the foreseeable future[163]. - Significant expenses and operating losses are expected as the company continues development and clinical trials of product candidates[164]. Funding and Financing - Traws Pharma is exploring various funding sources for development and ongoing operations, with no assurance of obtaining sufficient financing on acceptable terms[114]. - The company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[156]. - The company entered into an At The Market Offering Agreement allowing for the sale of up to $50,000,000 in common stock[124]. - In the quarter ended September 30, 2025, the company sold 62,003 shares under the ATM Agreement for net proceeds of $0.1 million[127]. Clinical Programs and Product Development - Traws Pharma has four clinical programs following the merger with Trawsfynydd Therapeutics, Inc., including Tivoxavir marboxil, aimed at treating influenza and bird flu[115]. - A Phase 1 study of Tivoxavir marboxil showed good overall tolerability, with a single dose maintaining plasma drug levels above the EC90 for over 23 days[117]. - Traws Pharma submitted a request for a meeting with the FDA regarding the potential for accelerated approval of Tivoxavir marboxil under the "Animal Rule" for bird flu treatment[117]. - The proposed Phase 2 study for Tivoxavir marboxil will evaluate its effects on seasonal influenza and H5N1 bird flu, pending regulatory review[118]. - Ratutrelvir (TRX01), another product candidate, is designed to inhibit the main protease of SARS-CoV-2, showing non-inferiority to existing treatments in animal studies[119]. - TRX01 Phase 1 clinical trial included 40 participants, with no treatment-related adverse events reported up to the highest dose of 600 mg[120]. - Narazaciclib's maximum tolerated dose was established at 160 mg once daily in combination with letrozole for low-grade endometrioid endometrial cancer[120]. - Rigosertib showed an overall response rate of 80% in patients with RDEB-SCC, with complete responses in 50% of evaluable patients[122]. - The company intends to report results from both Phase 2 studies of ratutrelvir by year-end 2025[120]. - The Phase 1 study of narazaciclib as a monotherapy is now closed to accrual, with data analysis ongoing[120]. Management and Administrative Changes - Management changes included the appointment of Iain Dukes as CEO effective October 1, 2025[136]. Revenue and Expenses - Revenue for the three months ended September 30, 2025 was $0, a decrease of $57,000 from $57,000 in the same period of 2024[141]. - Research and development expenses decreased by $2.8 million, or 55%, to $2.3 million for the three months ended September 30, 2025, primarily due to a $1.7 million decrease in virology expenses[143]. - General and administrative expenses decreased by $1.7 million, or 50%, to $1.7 million for the three months ended September 30, 2025, mainly due to a $1.0 million decrease in professional and consulting fees[146]. - For the nine months ended September 30, 2025, revenue was $2.8 million, an increase of $2.6 million from $0.2 million in the same period of 2024, primarily due to the recognition of $2.7 million of previously deferred revenue[149]. - Research and development expenses for the nine months ended September 30, 2025 decreased by $3.9 million, or 35%, to $7.1 million, mainly due to a $3.0 million decrease in oncology expenses[151]. - General and administrative expenses for the nine months ended September 30, 2025 decreased by $2.6 million, or 30%, to $6.2 million, primarily due to a $1.3 million decrease in professional and consulting fees[152]. Economic Risks - The business faces significant risks from economic conditions, including financial market volatility, inflation, and potential government shutdowns[165]. - The ultimate impact of global and domestic economic conditions on the business remains highly uncertain[166]. Accounting Policies - There have been no significant changes in critical accounting policies and estimates as of September 30, 2025[168].

Financial Performance - Net loss for Q3 2025 was approximately $25.6 million, or $0.13 per share, compared to a net loss of approximately $24.4 million, or $0.24 per share, in Q3 2024[11]. - The net loss for Q3 2025 was $25,579,000, compared to a net loss of $24,368,000 in Q3 2024, indicating a 5% increase in losses year-over-year[15]. - Other Income for the nine months ended September 30, 2025, was $1.2 million, compared to a loss of $1.1 million for the same period in 2024[8]. - Interest Income for Q3 2025 was $0.4 million, a decrease from $0.8 million in Q3 2024, primarily due to a lower average cash balance[6]. - The company reported interest income of $419,000 for Q3 2025, down from $776,000 in Q3 2024, a decrease of 46%[15]. Cash and Liquidity - Cash and Cash Equivalents as of September 30, 2025, were $35.1 million, insufficient to fund operations for at least 12 months without raising additional capital[11]. - Cash and cash equivalents as of September 30, 2025, were $35,132,000, slightly down from $35,668,000 as of December 31, 2024[17]. - Total current liabilities increased to $30,079,000 as of September 30, 2025, from $22,175,000 as of December 31, 2024, marking a 35% increase[17]. Research and Development - Vidofludimus calcium demonstrated statistically significant 24-week confirmed disability improvement in progressive multiple sclerosis, with consistent signals for slowing disability progression across subgroups[2]. - Long-term data from the phase 2 EMPhASIS trial showed a cumulative exposure of approximately 952 treatment years with an annualized discontinuation rate of only ~6.4%[5]. - Research and development expenses for the nine months ended September 30, 2025, were $62,914,000, up from $58,429,000 in the same period of 2024, representing a 7% increase[15]. - Research and Development (R&D) expenses for Q3 2025 were $20.0 million, a decrease of $1.4 million compared to Q3 2024[6]. Operating Expenses - General and Administrative (G&A) expenses for Q3 2025 were $6.0 million, an increase of $1.6 million compared to Q3 2024[6]. - Total operating expenses for Q3 2025 were $25,993,000, compared to $25,726,000 in Q3 2024, reflecting a slight increase of 1%[15]. Assets and Deficits - The accumulated deficit as of September 30, 2025, was $589,271,000, compared to $511,399,000 at the end of 2024, reflecting a 15% increase[17]. - Total assets as of September 30, 2025, were $40,704,000, slightly down from $40,868,000 as of December 31, 2024[17]. - The weighted-average common shares outstanding for Q3 2025 were 193,897,764, compared to 101,272,580 in Q3 2024[15]. Future Outlook - Top-line data from the twin phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis is expected by the end of 2026[7]. - The company received a Notice of Allowance for a key patent covering dose strengths of vidofludimus calcium, expected to provide protection into 2041[3]. - The company has not provided specific guidance for future revenue or operational milestones in the current release[12].

Revenue Growth - Total revenues for the three months ended September 30, 2025, increased by $6,340,047, or 41.6%, compared to the same period in 2024, reaching $21,596,478[108]. - For the nine months ended September 30, 2025, total revenues increased by $16,494,876, or 38.6%, compared to the same period in the prior year, driven by a 191.3% increase in pharma revenue[118]. Profitability - Gross profit for the three months ended September 30, 2025, increased by $3,677,075, or 43.4%, resulting in a gross margin of 56.3%[108][111]. - Net income for the three months ended September 30, 2025, was $2,215,135, reflecting a 54.2% increase compared to $1,436,837 in 2024[108]. - Gross profit for the nine months ended September 30, 2025 increased by $12,598,054, or 54.8%, resulting from the launch of additional pharma patient affordability programs[121]. - The net income for the nine months ended September 30, 2025 was $6,188,996, an increase of $3,745,961, or 153.3%, compared to the net income of $2,443,035 for the same period in 2024[127]. Operating Expenses - Operating expenses increased by $2,784,973, or 35.8%, totaling $10,568,438 for the same period[108]. - Selling, general and administrative expenses for the nine months ended September 30, 2025 increased by $5,826,732, or 32.1%, primarily due to increased compensation and benefits[122]. Claims Processing - The number of claims processed increased over 60% in Q3 2025 compared to the same period in the prior year[109]. - The number of claims processed increased over 90% for the nine months ending September 30, 2025 compared to the same period in the prior year[119]. Cash Flow and Investments - Net cash provided by operating activities for the nine months ended September 30, 2025, was $4,360,171, a decrease of 49.5% from $8,633,922 in 2024[134]. - Cash used in investing activities increased to $8,436,339 for the nine months ended September 30, 2025, compared to $7,087,867 in 2024, primarily due to investments in software licenses and the Gamma acquisition[137]. - The company repurchased 100,000 shares of common stock at a weighted average price of $3.76 per share during the nine months ended September 30, 2025[138]. Tax and Other Financial Metrics - The effective tax rate for the nine months ended September 30, 2025 was 17.9%, compared to 15.8% for the same period in 2024[126]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $14,512,453, up from $6,756,410 in 2024, reflecting a growth of 114.5%[132]. - EBITDA margin for the three months ended September 30, 2025, improved to 17.5%, compared to 14.8% in the same period of 2024[133]. Future Outlook - The company plans to continue investing in technology improvements, sales and marketing, and regulatory compliance throughout 2025[107]. - The company expects available cash and forecasted revenues to sustain operations for the next twenty-four months[140].

Financial Performance - As of September 30, 2025, Immunic, Inc. has an accumulated deficit of approximately $589.3 million, up from $511.4 million as of December 31, 2024[176]. - The company has incurred operating losses since its inception in 2016, with significant expenses expected to continue as product candidates are developed[177]. - The net loss for the three months ended September 30, 2025, was $25.6 million, a 5% increase from a net loss of $24.4 million in the same period in 2024[217]. - For the nine months ended September 30, 2025, the company reported a net loss of $77.9 million, with cash used in operating activities amounting to $66.5 million, compared to a net loss of $75.3 million and cash used of $61.8 million for the same period in 2024[249][250]. - The company has not generated any revenue from product sales and anticipates needing substantial additional funding for ongoing operations and clinical trials[244][245]. - The company is facing substantial doubt about its ability to continue as a going concern without raising additional capital[228]. Clinical Trials and Development - The Phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) has enrolled 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2, with top-line data expected by the end of 2026[165]. - Positive interim data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) showed substantial reductions in confirmed disability progression and improvements in disability endpoints[166]. - The ongoing development of IMU-856 is aimed at treating gastrointestinal diseases, with positive Phase 1b trial results indicating improvements in celiac disease symptoms and gut architecture[169]. - The company is focused on executing the ongoing Phase 3 ENSURE clinical trials and preparing for additional clinical testing of IMU-856[175]. - Long-term data from the Phase 2 EMPhASIS trial showed that vidofludimus calcium was well-tolerated for treatment durations of up to 5.5 years, with an annualized discontinuation rate of approximately 6.4% among 182 patients[180]. - The Phase 3 ENSURE trials for vidofludimus calcium completed enrollment with a total of 2,221 patients across two trials, with top-line data expected by the end of 2026[185]. - The Phase 2 CALLIPER trial demonstrated that vidofludimus calcium reduced the relative risk of 24-week CDW events in the overall PMS patient population compared to placebo[187]. Financial Position and Liquidity - Immunic has raised approximately $496.3 million from various offerings since inception, but as of September 30, 2025, it has only $35.1 million in cash and cash equivalents, raising concerns about liquidity[178]. - The company may seek additional funding through debt, equity financing, or product licensing to meet long-term liquidity needs[227]. - The company filed a shelf registration statement allowing for the offering of up to $250 million in various securities, with $342.2 million available as of September 30, 2025, after previous offerings[229]. - The company raised gross proceeds of $5.1 million from the April 2025 Offering, selling 5,666,667 shares at $0.90 per share, with net proceeds of approximately $4.7 million after expenses[234][236]. - The May 2025 Offering generated approximately $65 million in gross proceeds, with potential additional proceeds of up to $130 million if warrants are fully exercised[240]. - The company has incurred approximately $441.2 million in research and development expenses since its inception in March 2016, as of September 30, 2025[208]. Strategic Initiatives - Immunic is exploring options for further development of certain assets, including potential spin-offs and licensing transactions[171]. - The company is evaluating potential strategic collaborations to enhance the commercialization of its product candidates[181]. - Immunic's strategy includes maximizing the potential of its development programs by addressing high unmet medical needs and exploring additional indications for its product candidates[174]. Safety and Efficacy - Vidofludimus calcium has shown a favorable safety and tolerability profile, having been tested in approximately 2,700 human subjects across various trials[167]. - The company reported a favorable safety profile for vidofludimus calcium, with no new safety signals identified during the trials[190]. - IMU-856 showed a dose-dependent increase of GLP-1 levels in celiac disease patients, indicating potential for weight management treatment[191]. - The cumulative exposure in the EMPhASIS OLE period totaled approximately 952 treatment years, reinforcing the drug's long-term safety and tolerability[184]. Regulatory and Compliance - The company received a Notice of Allowance for a patent covering dose strengths of vidofludimus calcium for the treatment of primary progressive multiple sclerosis (PMS), expected to provide protection until 2041[182]. - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance period until December 24, 2025[201]. Operational Expenses - Research and development expenses for the three months ended September 30, 2025, decreased by 6% to $20.0 million compared to $21.4 million in the same period in 2024[217]. - General and administrative expenses increased by 37% to $6.0 million for the three months ended September 30, 2025, compared to $4.4 million in the same period in 2024[218]. - Research and development expenses for the nine months ended September 30, 2025, increased by 8% to $58.4 million compared to $62.9 million in the same period in 2024[221]. Currency and Inflation Impact - A hypothetical 10% adverse change in foreign currency exchange rates could result in an increase of approximately $1.4 million in net current liabilities as of September 30, 2025[263]. - A 10% change in foreign currency exchange rates for the nine months ended September 30, 2025, would have impacted the company's net loss by approximately $6.1 million, primarily due to fluctuations in the Euro[263]. - The company experienced a general increase in costs due to global inflation, but it did not have a material impact on the results of operations for the periods presented[264]. - The company has not entered into any foreign currency hedging transactions or derivative financial transactions to mitigate foreign currency exchange risk[261].