IPO and Financing - The company completed its initial public offering (IPO) on September 19, 2024, selling 6,000,000 units at $10.00 per unit, generating gross proceeds of $60,000,000[94]. - A private placement of 250,000 units was also completed simultaneously, raising an additional $2,500,000[95]. - The total transaction costs for the IPO amounted to $2,840,203, including $960,000 in underwriting fees[107]. - The underwriters were granted a 45-day option to purchase up to 900,000 additional units, which was not exercised[116]. Financial Performance - For the nine months ended September 30, 2025, the company reported a net income of $1,041,201, compared to a net loss of $17,788 for the same period in 2024[103]. - For the three months ended September 30, 2025, the basic and diluted net income per share for redeemable ordinary shares was $0.09, compared to a loss of $(0.02) for the same period in 2024[121]. - For the nine months ended September 30, 2025, the basic and diluted net income per share for redeemable ordinary shares was $0.21, compared to a loss of $(0.12) for the same period in 2024[121]. - The total allocation to redeemable ordinary shares for the three months ended September 30, 2025, was $548,681, while for the same period in 2024, it was $70,432[121]. Cash and Investments - As of September 30, 2025, the company had cash of $95,142, with approximately $750,000 available outside the trust account for operational purposes[105][109]. - The company has invested the net proceeds from its Initial Public Offering in U.S. government treasury bills and money market funds, mitigating exposure to market and interest rate risk[122]. - As of September 30, 2025, the company was not subject to any market or interest rate risk due to the short-term nature of its investments[122]. Business Combination and Obligations - The company has entered into a Business Combination Agreement with Mingde Technology Limited, with an aggregate consideration of $280,000,000 plus up to $80,000,000 in earnout consideration[100][101]. - The company has until December 18, 2025, to complete its initial business combination, or it will cease operations and redeem public shares[110][111]. - The company has no long-term debt or off-balance sheet financing arrangements as of September 30, 2025[113][114]. Redemption and Share Value - As of September 30, 2025, the ordinary shares subject to possible redemption amounted to $63,023,976, an increase from $61,089,076 as of December 31, 2024, reflecting a remeasurement of $1,934,900[119]. - The gross proceeds from the ordinary shares subject to possible redemption were $60,000,000, with offering costs of $2,661,858 deducted[119]. - The accretion of carrying value to redemption value for 2024 was $6,729,431, contributing to the increase in ordinary shares subject to possible redemption[119]. - The weighted-average shares outstanding for redeemable ordinary shares for the three months ended September 30, 2025, was 6,000,000, consistent with the previous year[121]. - The company recognizes changes in the redemption value of ordinary shares immediately, treating the accretion as a deemed dividend[120]. Future Expenses - The company expects to incur increased expenses as a result of being a public entity, particularly in legal and compliance areas[102].

Revenue Performance - Total revenue for the three months ended September 30, 2025, was $4,054,000, a 96.1% increase from $2,069,000 for the same period in 2024[17]. - Revenue for the nine months ended September 30, 2025, was $8,311 million, up 54% from $5,383 million in the same period of 2024[171]. - Revenue from the USA for the three months ended September 30, 2025, was $3.426 million, up from $1.722 million for the same period in 2024[72]. - The Falcon's Creative Group segment generated revenue of $15.8 million for the nine months ended September 30, 2025, with significant contributions from two major customers[45]. - For the three months ended September 30, 2025, total consolidated revenue was $4,054 million, a decrease from $13,503 million for the same period in 2024[130][131]. Operating Loss and Expenses - Operating expenses for the three months ended September 30, 2025, were $7,738,000, up 70.5% from $4,530,000 in the prior year[17]. - The company reported a loss from operations of $3,684,000 for the three months ended September 30, 2025, compared to a loss of $2,461,000 in the same period of 2024[17]. - The Company incurred project design and build expenses of $(18,775) million for the nine months ended September 30, 2025[131]. - Selling, general and administrative expenses for the nine months ended September 30, 2025, were $(8,447) million[131]. - Selling, general and administrative expenses for the three months ended September 30, 2025, increased by $1,684 million, primarily due to a $2.1 million rise in payroll and related costs[173]. Net Income and Loss - The net loss for the three months ended September 30, 2025, was $10,412,000 compared to a net income of $39,301,000 for the same period in 2024[19]. - Net income for the nine months ended September 30, 2025, was $6,608, compared to $161,353 for the same period in 2024, indicating a significant decline[21]. - The total comprehensive loss for the three months ended September 30, 2025, was $10,318,000, compared to a comprehensive income of $39,305,000 for the same period in 2024[19]. - The Company reported a net loss before taxes of $10,413 million for the three months ended September 30, 2025, compared to a net income of $39,301 million for the same period in 2024[132]. - For the nine months ended September 30, 2025, the company experienced a net loss of $161.4 million, a decrease of $154.7 million from a net income of $6.6 million in the same period of 2024[198]. Cash Flow and Liquidity - Net cash used in operating activities increased to $(20,280) for the nine months ended September 30, 2025, from $(8,758) in 2024, reflecting a worsening cash flow situation[21]. - Cash and cash equivalents increased significantly to $4,257,000 as of September 30, 2025, compared to $825,000 as of December 31, 2024[15]. - Cash flows from financing activities generated $2,768 in 2025, down from $8,926 in 2024, indicating reduced financing activity[21]. - As of September 30, 2025, the Company had cash and cash equivalents of $4.3 million and a working capital deficiency of $27.0 million, including $8.2 million of debt that matured on May 16, 2025[39]. - The Company does not currently have sufficient cash or liquidity to pay maturing liabilities and fund ongoing operations, raising substantial doubt about its ability to continue as a going concern[40]. Assets and Liabilities - Total assets increased to $66,793,000 as of September 30, 2025, from $61,231,000 as of December 31, 2024, reflecting a growth of 9.3%[15]. - Current liabilities decreased to $38,943,000 as of September 30, 2025, from $45,640,000 as of December 31, 2024, a reduction of 14.7%[15]. - The total equity deficit as of September 30, 2025, was reported at $9,475 thousand, indicating a need for improved financial performance[25]. - The company's long-term debt as of September 30, 2025, totals $16,060 million, with a current portion of long-term debt and short-term debt of $10,069 million[95]. - Total accrued expenses and other current liabilities as of September 30, 2025, amount to $21,131 million, a decrease from $25,870 million as of December 31, 2024[94]. Investments and Acquisitions - The company completed a merger with FAST II on October 5, 2023, followed by an acquisition merger with Falcon's Opco on October 6, 2023, establishing a new corporate structure[27]. - The company issued 1,655,416 Series B preferred shares, raising significant capital to support its operations[25]. - The Company acquired tangible assets and intellectual property from Oceaneering Entertainment Systems for $1.6 million, expanding its attractions services business[65]. - The company recognized a cash dividend distribution of $27.0 million from its joint venture PDP following the sale of a hotel in Tenerife[77]. - The share of net income from PDP for the nine months ended September 30, 2025, included a $30 million gain from the sale of Tertian, contributing to the overall financial performance[179]. Strategic Plans and Future Outlook - The company plans to continue expanding its market presence following the merger, leveraging synergies from the combined entities[26]. - The company anticipates an increase in capital expenditures and working capital requirements in the near future due to growth initiatives and operating as a public company[210]. - The Company has committed to develop venues themed with Hershey's trademarks in at least four locations by 2028, with a one-time development fee of $0.3 million and a 6% royalty fee on gross sales starting in 2025[123]. - The contracted pipeline for the company as of September 30, 2025, was $48.3 million, reflecting potential future revenue[204]. - The Company aims to expand its operations through equity method investments and developing new product offerings[168]. Legal and Regulatory Matters - The Company accrued $11.1 million for alleged fees and expenses related to a lawsuit filed by Guggenheim Securities, LLC, which is linked to the Business Combination completed on October 6, 2023[120]. - The Company is facing a claim from FAST Sponsor II LLC for $9.1 million regarding two loans related to the deSPAC transaction that closed in October 2023[121]. - The company is actively negotiating transaction costs related to the Business Combination, which total $16.3 million and are not yet settled as of September 30, 2025[212]. Impairments and Losses - An impairment charge of $5.3 million was recognized for the investment in PDP as of June 30, 2025, due to a significant change in circumstances[79]. - The Company recognized an other-than-temporary impairment charge of $3.0 million for its investment in Karnival, reducing its fair value to $4.2 million as of September 30, 2025[82]. - The share of loss from Karnival for the nine months ended September 30, 2025, was $2.94 million, compared to a gain of $0.24 million for the same period in 2024[85]. - The Company recognized a $5.3 million impairment charge related to its investment in PDP as of June 30, 2025[180]. - The Sierra Parima investment was sold for nominal consideration on May 30, 2025, after being deemed other-than-temporarily impaired as of December 31, 2023[85].

Commercialization of ORLYNVAH™ - ORLYNVAH™ was commercially launched in the United States in August 2025, with modest sales expected during the early stages of commercialization efforts[166]. - The commercialization partner EVERSANA will provide sales and commercial operations services for ORLYNVAH™ under a five-year agreement[168][169]. - The company plans to continue commercialization efforts for ORLYNVAH™ and expand its research and development programs, which will require additional capital[243][246]. - The company has limited net product sales to date since the launch of ORLYNVAH™ in August 2025, with revenues expected to fluctuate in future periods[182]. - Product revenue for the three months ended September 30, 2025, was $0.4 million, compared to $0.0 million for the same period in 2024, reflecting the launch of ORLYNVAH™ in August 2025[198]. - For the nine months ended September 30, 2025, product revenue was $0.4 million, up from $0.0 million in 2024, driven by ORLYNVAH™ sales[208]. Financial Performance and Losses - The company incurred net losses of $20.4 million and $18.2 million for the nine months ended September 30, 2025 and 2024, respectively, and an accumulated deficit of $506.5 million as of September 30, 2025[172]. - The company expects to continue incurring significant expenses and increased operating losses as it focuses on maximizing the commercial potential of ORLYNVAH™[167]. - The operating loss for the three months ended September 30, 2025, was $7.7 million, compared to a loss of $4.9 million in 2024, an increase of $2.8 million[197]. - Loss before income taxes for the nine months ended September 30, 2025, was $20.1 million, compared to a loss of $18.0 million in 2024, an increase of $2.1 million[207]. - Total operating expenses for the three months ended September 30, 2025, were $8.1 million, an increase of $3.2 million from $4.9 million in 2024[197]. - Total operating expenses for the nine months ended September 30, 2025, were $17.4 million, an increase of $2.3 million from $15.0 million in 2024[207]. Cash Position and Funding - As of September 30, 2025, the company had cash and cash equivalents of $11.0 million, raising substantial doubt about its ability to continue as a going concern[176]. - The company had cash and cash equivalents of $11.0 million as of September 30, 2025, but does not believe this will cover operating expenses for the next 12 months, raising substantial doubt about its ability to continue as a going concern[243][244]. - The company sold 11,875,589 ordinary shares under the Sales Agreement at an average net price of $1.07 per share, generating net proceeds of $12.7 million[220]. - The company registered for sale up to $150.0 million of various securities under the 2025 Shelf Registration Statement, effective February 19, 2025[219]. - During the nine months ended September 30, 2025, net cash provided by financing activities was $2.2 million, primarily from the sale of ordinary shares and the April 2025 Registered Direct Offering[241]. - The company generated net proceeds of approximately $42.1 million from the February 2021 Underwritten Offering, which included the sale of 2,666,666 ordinary shares[233]. Expenses and Cost Management - Selling, general and administrative expenses increased significantly to $6.5 million for the three months ended September 30, 2025, compared to $1.8 million in 2024, an increase of $4.7 million[202]. - Research and development expenses decreased to $1.3 million for the three months ended September 30, 2025, from $3.1 million in 2024, a reduction of $1.8 million[201]. - Research and development expenses for the nine months ended September 30, 2025, were $2.9 million, down from $9.2 million in 2024, a decrease of $6.3 million[211]. - Personnel related costs decreased by $0.3 million due to a reduction in accrued bonuses, while professional and consulting fees increased by $8.2 million, primarily for pre-commercialization and commercialization activities[212]. - The company anticipates increased expenses due to inflation and a competitive wage environment, which may affect future operating costs[245]. Strategic Planning and Future Outlook - The company is continuously evaluating corporate, strategic, financial, and financing alternatives to maximize value for stakeholders[178]. - The company is actively considering contingency plans, including alternative sourcing strategies, to mitigate potential future impacts from increased tariffs and trade tensions[249]. - The company is evaluating corporate, strategic, financial, and financing alternatives to maximize shareholder value while managing resources prudently[251]. Regulatory and Market Considerations - The company received FDA approval for ORLYNVAH™ on October 25, 2024, for the treatment of uncomplicated urinary tract infections[225]. - The company is obligated to pay Pfizer sales milestones upon achievement of net sales ranging from $250.0 million to $1.0 billion for each product type, as well as royalties ranging from single-digit to mid-teens percentage based on marginal net sales of each licensed product[252]. - Payments to holders of RLNs will be due within 75 days of the end of each six-month payment measuring period, with a payment rate of 15% based on specified net revenues from U.S. sales of sulopenem products[254]. - The company has agreements with contract service providers that represent significant costs in research and development and commercial activities[253]. - The new reciprocal tariff rates range from 10% to 41%, with imports from Switzerland receiving a 39% rate, while the baseline tariff on China remains at 10%[248]. - The company may face a 100% tariff on all branded or patented drugs imported into the U.S. starting October 1, 2025, unless manufacturing facilities are built in the U.S.[248]. Foreign Currency and Inflation Impact - The company has not engaged in any hedging activities against foreign currency exchange rate risk, and realized net foreign currency gains and losses did not materially affect operations[257]. - Inflation has not had a material effect on the company's financial statements to date, but future operations may be adversely affected by inflation[258]. - The company experienced a net cash decrease of $13.1 million for the nine months ended September 30, 2025, compared to an increase of $7.3 million in the same period of 2024[237].

Revenue Growth - Record revenue of $376.6 million in Fiscal 2025, an increase of 20% from $313.0 million in Fiscal 2024[1] - Q4FY25 revenue reached $99.0 million, up 17% from $84.7 million in Q4FY24, marking the 11th consecutive quarter of sequential growth[1] - SynBio revenue grew 17% to $145.0 million in FY25 compared to $123.5 million in FY24[3] - NGS revenue increased by 23% to $208.1 million in FY25 from $169.1 million in FY24[3] - Biopharma revenue rose 15% to $23.5 million in FY25 compared to $20.3 million in FY24[3] - For FY26, total revenue is expected to be between $425 million and $435 million, representing a growth of 13% to 15.5% year-over-year[10] - Revenues for the three months ended September 30, 2025, increased to $99,009,000, up 16.9% from $84,710,000 in 2024[22] Profitability and Margins - Gross margin improved to 50.7% in FY25, an increase of 8.1 percentage points from 42.6% in FY24[1] - Gross margin for FY26 is projected to be above 52%[10] - Adjusted EBITDA for FY25 was $(46.9) million, an improvement from $(93.5) million in FY24[5] - Adjusted EBITDA for the three months ended September 30, 2025, was $(7,848,000), an improvement from $(17,042,000) in 2024[26] Expenses and Losses - Net loss attributable to common stockholders for the three months ended September 30, 2025, was $27,138,000, compared to a loss of $34,655,000 in 2024, representing a 21.5% improvement[22] - Research and development expenses for the three months ended September 30, 2025, were $17,014,000, down 19.5% from $21,134,000 in 2024[22] - Selling, general and administrative expenses increased to $63,758,000 for the three months ended September 30, 2025, up 19.9% from $53,143,000 in 2024[22] Assets and Liabilities - Total current assets decreased to $332,966,000 as of September 30, 2025, from $346,776,000 in 2024, a decline of 4.0%[24] - Total liabilities increased to $168,903,000 as of September 30, 2025, compared to $141,634,000 in 2024, an increase of 19.2%[24] - Cash and cash equivalents decreased to $183,049,000 as of September 30, 2025, down from $226,316,000 in 2024, a decrease of 19.1%[24] Other Financial Highlights - The company shipped approximately 938,000 genes in FY25, up from approximately 772,000 in FY24[9] - The company reported a gain on the sale of business amounting to $48,847,000 for the twelve months ended September 30, 2025[22] - The weighted average shares used in computing net loss per share attributable to common stockholders increased to 60,424,000 in 2025 from 58,554,000 in 2024[22]

Clinical Development - MT-601 achieved a 66% objective response rate and a 50% complete response rate in relapsed Non-Hodgkin lymphoma patients during the APOLLO study[4] - The first patient was treated in the Off-the-Shelf (OTS) program investigating MAR-T cells for Acute Myeloid Leukemia or Myelodysplastic Syndrome[4] - The company anticipates additional clinical data from the APOLLO study in the first half of 2026[8] - Marker was awarded $2.0 million from the NIH and $9.5 million from CPRIT to support the development of MT-601 in metastatic pancreatic cancer[8] Financial Performance - The net loss for Q3 2025 was $2.0 million, an improvement from a net loss of $2.3 million in Q3 2024[11] - For the nine months ended September 30, 2025, the net loss was $10,460,410, compared to a net loss of $6,893,691 for the same period in 2024, indicating an increase in losses of approximately 51%[21] - Net cash used in operating activities for the nine months ended September 30, 2025, was $10,113,975, up from $6,207,189 in 2024, reflecting a 63% increase in cash outflow[21] - Cash, cash equivalents, and restricted cash at the end of the period were $18,942,953, a decrease from $19,192,440 at the beginning of the period[21] - The net decrease in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2025, was $249,487, compared to a much larger decrease of $6,111,786 in 2024[21] Expenses - Research and development expenses for Q3 2025 were $2.3 million, down from $3.5 million in Q3 2024[10] - General and administrative expenses for Q3 2025 were $1 million, compared to $0.9 million in Q3 2024[10] - The company reported stock-based compensation of $426,409 for the nine months ended September 30, 2025, compared to $195,320 in 2024, representing a 118% increase[21] Cash Management - The company raised approximately $10 million through its ATM facility, extending its cash runway into 2026[4] - As of September 30, 2025, Marker had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million, expected to fund operations through Q3 2026[9] - The company raised $9,863,883 from the issuance of common stock during the nine months ended September 30, 2025, compared to $36,902 in 2024, showing a significant increase in financing activities[21] Other Financial Metrics - Deferred revenue increased to $1,352,975 for the nine months ended September 30, 2025, indicating potential future revenue recognition[21] - The company experienced a significant change in accounts payable and accrued expenses, which decreased by $901,449 from the previous year[21] - Proceeds from the exercise of warrants and stock options were $605 for the nine months ended September 30, 2025, down from $58,501 in 2024, indicating a decline in stock option activity[21] - Other receivables increased to $681,550 for the nine months ended September 30, 2025, compared to $283,405 in 2024, reflecting improved collection or new receivables[21] Manufacturing Collaboration - Marker entered a cGMP manufacturing collaboration with Cellipont Bioservices to scale up production of MT-601[2]

Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $23.3 million compared to a net loss of $15.7 million for the same period in 2024, reflecting an increase in operating losses [109]. - As of September 30, 2025, the company had an accumulated deficit of $134.4 million and cash and cash equivalents of $2.7 million [109][113]. - The company has not generated any revenue from product sales and does not expect to do so in the near future [125]. - The company has incurred significant operating losses since inception, with a net loss of $22.6 million for the year ended December 31, 2024 [109]. - The net loss attributable to common shareholders for the three months ended September 30, 2025, was $7.10 million, compared to a loss of $6.54 million in 2024, an increase of 8.4% [136]. - Net losses for the nine months ended September 30, 2025, and 2024, were $23.3 million and $15.7 million, respectively, with an accumulated deficit of $134.4 million as of September 30, 2025 [153]. - Stock-based compensation expense for the nine months ended September 30, 2025, was $4.3 million, contributing to the overall net loss [160]. Operating Expenses - Research and development expenses increased to $4.97 million for the three months ended September 30, 2025, compared to $2.95 million for the same period in 2024, representing a 68.5% increase [136]. - General and administrative expenses rose to $1.76 million for the three months ended September 30, 2025, up from $0.78 million in 2024, marking a 124.8% increase [138]. - Total operating expenses for the three months ended September 30, 2025, were $6.73 million, compared to $3.73 million in 2024, reflecting an increase of 80.4% [136]. - For the nine months ended September 30, 2025, research and development expenses totaled $14.48 million, up from $9.36 million in 2024, an increase of 54.7% [145]. - General and administrative expenses for the nine months ended September 30, 2025, were $9.15 million, compared to $2.60 million in 2024, indicating a 250.0% increase [147]. Financing Activities - The company completed a private placement on June 2, 2025, raising approximately $12.6 million by issuing 4,759,309 shares of common stock and warrants [114]. - The company entered into a Secured Promissory Note and Loan Agreement on October 27, 2025, for up to $3 million to support working capital [122]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $13.4 million, including $12.1 million from the issuance of common stock [163]. - The company raised approximately $41.6 million through preferred stock sales and $36.0 million through convertible notes since inception [155]. - The company issued 4,759,309 shares of common stock in a private placement for an aggregate offering amount of $12.6 million on June 2, 2025 [157]. Product Development - The company initiated a Phase 3 trial for its lead product candidate IFx-2.0 in June 2025, targeting advanced or metastatic Merkel cell carcinoma patients [105]. - The company is planning to investigate TBS-2025 in a randomized Phase 2 trial for mutated NPM1 acute myeloid leukemia [106]. - The company expects to incur significant pre-commercialization and commercialization expenses if it obtains marketing approval for any product candidate [110]. - The company plans to substantially increase research and development expenses in the foreseeable future to support ongoing product development [128]. Acquisitions and Mergers - The company acquired rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody, through the acquisition of Kineta, Inc. on June 30, 2025 [106]. - The Kineta acquisition was completed on June 30, 2025, through a cash and stock transaction, with Kineta becoming a wholly-owned subsidiary [177]. - Each share of Kineta was converted into the right to receive approximately 0.185298 shares of common stock, totaling about 2,868,169 shares [178]. - Goodwill and other intangible assets related to the Kineta Merger were recorded on the balance sheet as of September 30, 2025 [180]. - Indefinite-lived intangible assets from acquired IPR&D will not be amortized until regulatory approval is received [181]. - A third-party valuation firm will assist in valuing the acquired IPR&D, which has significant measurement uncertainty [182]. Cash Flow and Liquidity - Cash and cash equivalents as of September 30, 2025, were $2.7 million, with an additional $1.5 million received from a bridge loan in October 2025 [154]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $22.1 million, primarily due to a net loss of $23.3 million [160]. - The company expects to incur additional costs associated with operating as a public company and anticipates needing substantial additional funding for development programs [165]. Market Risks - The company is exposed to market risks, including interest rate and inflation risks, but does not believe inflation has materially affected operations [186][188].

Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $23.3 million, compared to a net loss of $15.7 million for the same period in 2024, reflecting an increase in operating losses [109]. - The company incurred significant operating losses since inception, with a net loss of $22.6 million for the year ended December 31, 2024 [109]. - The net loss attributable to common shareholders for the three months ended September 30, 2025, was $7.10 million, compared to a loss of $6.54 million in 2024, an increase of 8.4% [136]. - Net losses for the nine months ended September 30, 2025, and 2024, were $23.3 million and $15.7 million, respectively, with accumulated deficits reaching $134.4 million as of September 30, 2025 [153]. Cash and Funding - As of September 30, 2025, the company had an accumulated deficit of $134.4 million and cash and cash equivalents of $2.7 million [109][113]. - The company completed a private placement on June 2, 2025, raising approximately $12.6 million by issuing 4,759,309 shares of common stock and warrants [114]. - The company entered into a Secured Promissory Note and Loan Agreement on October 27, 2025, for up to $3 million to support working capital [122]. - The company has initiated an at-the-market offering program with an aggregate offering price of up to $50 million, pending SEC approval [123]. - The company anticipates needing substantial additional funding for development programs and operations, with existing cash expected to meet requirements through the end of 2025 [165]. Research and Development - The company initiated a Phase 3 trial for its lead product candidate IFx-2.0 in June 2025, targeting advanced or metastatic Merkel cell carcinoma patients [105]. - The company is planning to investigate TBS-2025 in a randomized Phase 2 trial for mutated NPM1 acute myeloid leukemia [106]. - Research and development expenses increased to $4.97 million for the three months ended September 30, 2025, compared to $2.95 million for the same period in 2024, representing a 68.5% increase [136]. - For the nine months ended September 30, 2025, research and development expenses totaled $14.48 million, up from $9.36 million in 2024, an increase of 54.7% [145]. - Research and development expenses for the nine months ended September 30, 2025, included $5.65 million for IFx-2.0, an increase of 8.7% from $5.19 million in 2024 [146]. Operating Expenses - General and administrative expenses rose to $1.76 million for the three months ended September 30, 2025, up from $0.78 million in 2024, marking a 124.8% increase [138]. - General and administrative expenses for the nine months ended September 30, 2025, were $9.15 million, compared to $2.60 million in 2024, indicating a 253.5% increase [147]. - Total operating expenses for the three months ended September 30, 2025, were $6.73 million, compared to $3.73 million in 2024, reflecting an increase of 80.4% [136]. Income and Expenses - Grant income for the three months ended September 30, 2025, was $0.14 million, a new revenue stream following the assumption of the Kintara Health and Human Services grant [139]. - Interest expense decreased significantly to $16,532 for the three months ended September 30, 2025, from $2.00 million in 2024, a reduction of 99.2% [141]. - The total other income (expense) for the three months ended September 30, 2025, was a loss of $372,852, compared to a loss of $1.85 million in 2024, reflecting an improvement of 80.8% [136]. - Interest expense for the nine months ended September 30, 2024, was $3.6 million, with a total of $31.3 million in convertible notes issued under the TuHURA Notes at an interest rate of 20% per annum [149]. Acquisition and Merger - The company acquired rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody, through the acquisition of Kineta, Inc. on June 30, 2025 [106]. - The Kineta acquisition was completed on June 30, 2025, through a cash and stock transaction, with Kineta becoming a wholly-owned subsidiary [177]. - Each share of Kineta was converted into 0.185298 shares of common stock, totaling approximately 2,868,169 shares, plus a pro rata portion of 1,129,885 shares to be issued after six months [178]. - Goodwill and other intangible assets related to the Kineta Merger were recorded on the balance sheet as of September 30, 2025 [180]. - Acquired in-process research and development (IPR&D) is capitalized as indefinite-lived intangible assets and will not be amortized until regulatory approval is received [181]. Valuation and Fair Value - The estimated fair value of the aggregate share component of the Kineta Merger was calculated using the closing stock price on the merger date [179]. - A third-party valuation firm will assist in valuing the IPR&D, which has significant measurement uncertainty due to a lack of historical data [182]. - The company tests indefinite-lived intangible assets for impairment by assessing qualitative factors and performing quantitative tests if necessary [183]. - Following the reverse merger with Kintara, the fair value of common stock will be based on quoted market prices, with all preferred shares converted to common stock [176]. Cash Flow Activities - Net cash used in operating activities for the nine months ended September 30, 2025, was $22.1 million, primarily due to a net loss of $23.3 million and changes in operating assets and liabilities [160]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $13.4 million, including $12.1 million from the issuance of common stock [163]. - For the nine months ended September 30, 2025, net cash used in investing activities was $1.3 million, primarily for property and equipment purchases and payments related to the Kineta acquisition [162].

Revenue Performance - Revenue for the three months ended September 30, 2025, was $3,807,274, an increase of $1,329,053 or 53.6% compared to $2,478,221 for the same period in 2024[75] - Revenue for the nine months ended September 30, 2025, was $13,382,304, an increase of $2,183,677 or 19.5% compared to $11,198,627 for the same period in 2024[83] Gross Profit - Gross profit for the three months ended September 30, 2025, was $747,878, representing a gross profit margin of 19.6%, compared to a gross profit loss of $209,533 with a margin of -8.5% for the same period in 2024, marking an increase of $957,411 or 456.9%[76] - Gross profit for the nine months ended September 30, 2025, was $1,357,512, representing a gross profit margin of 10.1%, compared to $778,780 with a margin of 7.0% for the same period in 2024, marking an increase of $578,732 or 74.3%[82] Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $2,080,880, a decrease of $299,560 or 12.6% compared to $2,380,440 for the same period in 2024[77] - Total operating expenses for the nine months ended September 30, 2025, were $6,985,712, a decrease of $515,580, or 6.9% compared to $7,501,292 for the same period in 2024[85] Specific Expense Categories - Selling expenses for the three months ended September 30, 2025, were $541,259, a decrease of $69,454 or 11.4% compared to $610,713 for the same period in 2024[78] - General and administrative expenses for the three months ended September 30, 2025, were $1,270,195, a decrease of $221,171 or 14.8% compared to $1,491,366 for the same period in 2024[79] - Research and development expenses for the three months ended September 30, 2025, were $269,426, a decrease of $8,935 or 3.2% compared to $278,361 for the same period in 2024[80] - Selling expenses increased by $88,429, or 4.5%, to $2,071,843 for the nine months ended September 30, 2025, primarily due to lower sales commissions in 2024 and costs associated with a joint venture[86] - General and administrative expenses decreased by $405,649, or 8.9%, to $4,171,764 for the nine months ended September 30, 2025, mainly due to non-recurring costs in the prior year[87] - Research and development expenses decreased by $198,360, or 21.1%, to $742,105 for the nine months ended September 30, 2025, attributed to one-time exit costs from a prior project[88] Net Loss - Net loss for the three months ended September 30, 2025, was $1,459,762, a favorable change of $1,380,764 or 48.6% compared to a net loss of $2,840,526 for the same period in 2024[81] - The net loss for the nine months ended September 30, 2025, was $5,978,890, a decrease of $1,361,631, or 18.5% compared to the net loss of $7,340,521 in the same period in 2024[90] Cash Flow - Cash flows used in operating activities for the nine months ended September 30, 2025, were $3,977,121, a favorable change of $1,551,321 compared to $5,528,442 for the same period in 2024[96] - Cash flows provided from financing activities were $787,024 for the nine months ended September 30, 2025, a favorable change of $912,742 compared to cash flows used by financing activities of $125,718 in the prior year[98] Financial Position - As of September 30, 2025, the company had cash of $7,354,024 and net working capital of $13,406,883, a decrease of $2,329,926 compared to December 31, 2024[92]

Financial Performance - The company reported a net loss of $287.0 million for the nine months ended September 30, 2025, with an accumulated deficit of $1.2 billion[96]. - The net loss for the three months ended September 30, 2025, was $102.2 million, representing a 58.5% increase from a net loss of $64.5 million in 2024[108]. - The company reported a net loss of $287.0 million for the nine months ended September 30, 2025, which is a 59.6% increase from a net loss of $179.8 million in 2024[114]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $224.5 million, compared to $151.4 million for the same period in 2024[127][129]. - Cash and cash equivalents increased to $286.8 million as of September 30, 2025, compared to $177.9 million at the end of 2024[122]. - The total cash, cash equivalents, and marketable securities decreased by $67.6 million during the nine months ended September 30, 2025, primarily due to operating expenses[122]. Research and Development - Apitegromab achieved its primary endpoint in the pivotal Phase 3 SAPPHIRE clinical trial for SMA, with positive top-line results announced in October 2024[88]. - Over 90% of patients in the Phase 2 TOPAZ trial for apitegromab remained on treatment at 48 months, showing sustained clinical benefit[89]. - The FDA granted priority review designation for the Biologics License Application (BLA) for apitegromab, indicating potential significant improvement in treatment for SMA[88]. - The company plans to initiate dosing of SRK-439 in healthy volunteers in Q4 2025, following FDA clearance of its investigational new drug application[93]. - In the Phase 2 EMBRAZE trial, patients receiving apitegromab with tirzepatide showed a 54.9% preservation of lean mass compared to tirzepatide alone (p=0.001)[93]. - Research and development expenses are expected to remain substantial as the company progresses its clinical development programs[101]. - The company expects continued substantial research and development expenses driven by employee compensation and clinical program development, particularly for apitegromab and SRK-439[111]. - The company expects substantial expenses related to the research and development of apitegromab and other product candidates[135]. Operating Expenses - For the three months ended September 30, 2025, total operating expenses increased by 59.8% to $103.6 million compared to $64.8 million in the same period of 2024[108]. - Research and development expenses for the three months ended September 30, 2025, were $50.5 million, up 3.6% from $48.7 million in 2024[109]. - General and administrative expenses surged by 230.4% to $53.1 million for the three months ended September 30, 2025, compared to $16.1 million in 2024[112]. - For the nine months ended September 30, 2025, research and development expenses totaled $161.6 million, an increase of 20.4% from $134.2 million in 2024[115]. - General and administrative expenses for the nine months ended September 30, 2025, were $131.2 million, up 170.4% from $48.5 million in 2024[118]. Future Outlook - The company continues to build its commercialization capabilities to support future product sales and marketing activities[96]. - The company expects to incur significant commercialization expenses related to the marketing approval and sales of apitegromab[132]. - The company anticipates that existing cash and marketable securities will fund operations into 2027, but additional capital will be required for clinical development and commercialization[133]. - The company will continue to rely on additional financing to achieve business objectives, with potential dilution of common stockholder ownership interests[136]. Capital and Financing - As of September 30, 2025, the company has sold 3,386,290 shares under the ATM program, generating net proceeds of $96.9 million[123]. - Net cash provided by investing activities was $179.7 million for the nine months ended September 30, 2025, up from $119.3 million in 2024[130]. - Net cash provided by financing activities was $155.1 million for the nine months ended September 30, 2025, significantly higher than $6.7 million in 2024[131]. - The company had 17,362,147 pre-funded warrants outstanding as of September 30, 2025, with none exercised during the nine months ended[125]. - The company had 8,220,620 common warrants outstanding with an exercise price of $7.35, which expire on December 31, 2025[126].

Product Launch and Sales - Iterum Therapeutics launched ORLYNVAH™ in the United States in August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs) after over 25 years without new branded launches in this space[3] - Net product revenues for the third quarter of 2025 were $0.4 million, reflecting initial sales of ORLYNVAH™[7] - The company expects net product sales of ORLYNVAH™ to range between $5 million and $15 million in 2026, depending on market uptake and payer coverage[3] Financial Performance - The net loss for the third quarter of 2025 was $9.0 million, compared to a net loss of $6.1 million for the same period in 2024[13] - Product revenue for the three months ended September 30, 2025, was $390 million, with no revenue reported for the same period in 2024[25] - The net loss for the three months ended September 30, 2025, was $8,979 million, compared to a net loss of $6,094 million for the same period in 2024, indicating a 47% increase in losses[25] - Non-GAAP net loss for the three months ended September 30, 2025, was $7,342 million, compared to $4,837 million for the same period in 2024, reflecting a 52% increase[25] Expenses - Research and development expenses decreased to $1.3 million in Q3 2025 from $3.1 million in Q3 2024, primarily due to lower chemistry, manufacturing, and control expenses[10] - Selling, general, and administrative expenses increased to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, attributed to the commercialization of ORLYNVAH™[11] - Total operating expenses for the three months ended September 30, 2025, were $8,121 million, compared to $4,887 million for the same period in 2024, representing a 66% increase[25] - Research and development expenses for the three months ended September 30, 2025, were $1,261 million, compared to $3,107 million for the same period in 2024, showing a decrease of 59%[25] Cash and Assets - Cash and cash equivalents were $11.0 million as of September 30, 2025, with an extended cash runway projected into Q2 2026[6] - Cash, cash equivalents, and short-term investments decreased to $11,002 million as of September 30, 2025, down from $24,125 million as of December 31, 2024[27] - Total assets decreased to $32,503 million as of September 30, 2025, from $44,595 million as of December 31, 2024[27] - Total liabilities decreased to $39,884 million as of September 30, 2025, from $48,676 million as of December 31, 2024[27] Shareholder Information - The company reported a weighted average of 45,801,927 ordinary shares outstanding for the three months ended September 30, 2025, compared to 20,044,270 for the same period in 2024[25] Intellectual Property and Research - Iterum has been granted a patent in China for a combination treatment related to sulopenem, projected to expire in March 2041[4] - The company presented two posters at the IDWeek 2025 conference, highlighting its focus on urinary tract infections[5] Derivatives and Amortization - Adjustments to the fair value of derivatives for Q3 2025 were $0.7 million, compared to $0.4 million for the same period in 2024[12] - The amortization of intangible assets for the three months ended September 30, 2025, was $349 million, with no amortization reported for the same period in 2024[25]