Ikena Oncology(US:IKNA)2025-11-12 12:30Clinical Development - IMG-007, a non-depleting anti-OX40 monoclonal antibody, showed 54% of patients achieving EASI-75 after three treatments in the Phase 1b/2a trial[147] - IMG-007 is the only product candidate in clinical development following the divestiture of the Non-OX40 Business[157] Financial Performance - For the three months ended September 30, 2025, total operating expenses rose to $26.6 million, a 380% increase from $5.5 million in the same period in 2024[169] - Research and development expenses for the three months ended September 30, 2025 were $15.6 million, a 300% increase from $3.9 million in the same period in 2024, primarily due to a $10 million increase in stock-based compensation[171] - General and administrative expenses for the three months ended September 30, 2025 were $11.0 million, up 568% from $1.7 million in the same period in 2024, driven by increased stock-based compensation and professional services costs[172] - The company reported a net loss of $24.8 million for the three months ended September 30, 2025, compared to a net loss of $3.2 million in the same period in 2024, representing a 678% increase in losses[169] - For the nine months ended September 30, 2025, the company incurred a net loss of $38.4 million, compared to a net loss of $31.8 million for the same period in 2024, reflecting a 21% increase in losses[181] - The company had cash, cash equivalents, and marketable securities of $142.6 million as of September 30, 2025, with an accumulated deficit of $223.1 million[181] - Net cash used in operating activities for the nine months ended September 30, 2025 was $40.6 million, significantly higher than $17.8 million for the same period in 2024[187] - Net cash used in operating activities for the nine months ended September 30, 2024, was $17.8 million, primarily due to a net loss of $31.8 million and a net change of $2.8 million in operating assets and liabilities, partially offset by $16.7 million in non-cash charges[189] Funding and Financing - PIPE Financing raised approximately $75 million through the issuance of 2,508,339 shares at about $29.90 per share[154] - The company raised approximately $75 million through a private placement of 2,508,339 shares at approximately $29.90 per share to support its pipeline and general corporate purposes[183] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $135.5 million, consisting of $15.0 million from a Term Loan, $54.6 million from reverse recapitalization, and $71.1 million from issuance of common stock[192] - The Term Loan included three tranches totaling $22.5 million, with an interest rate of 6.0% per annum, which was forgiven upon consummation of the Merger[198][199] - The company expects to require substantial additional funding to support ongoing operations and development activities, with potential financing through equity offerings and grants[185] Market Overview - The global immunology market is projected to grow from approximately $103 billion in 2024 to approximately $257 billion by 2032[146] Corporate Actions - The merger with Inmagene Biopharmaceuticals was completed on July 25, 2025, with Legacy Inmagene shareholders receiving 4,601,375 shares of Ikena Common Stock[150] - A reverse stock split of 1-for-12 was executed on July 25, 2025, with shares trading under the new ticker symbol "IMA" starting July 28, 2025[152] - The Non-OX40 Divestiture involved the sale of non-IMG-007 related assets for a promissory note of $8.9 million, accruing interest at 4.61%[156] Operating Expenses - Research and development expenses are primarily incurred for the development of IMG-007, with costs expensed as incurred[162] - General and administrative expenses include personnel-related costs and legal fees, impacting overall operating expenses[163] - General and administrative expenses are expected to increase significantly as the company expands operations and prepares for commercialization of IMG-007, with increases related to hiring and compliance costs[164] Cash Flow - Net cash provided by investing activities for the nine months ended September 30, 2024, was $11.0 million, mainly from $10.2 million in cash proceeds from maturities and sales of available-for-sale securities[191] Internal Controls - A material weakness in internal control over financial reporting was identified, related to inadequate segregation of duties in the period-end financial reporting process[212][213] - Management plans to implement control activities to remediate the identified material weakness, focusing on segregation of duties related to journal entries and account reconciliations[215] - There were no changes in internal control over financial reporting during the quarterly period ended September 30, 2025, that materially affected the company's internal control[217]