Product Development and Approval - The lead product candidate, LYMPHIR, is approved by the FDA for the treatment of persistent or recurrent CTCL, with an estimated market exceeding $400 million[304]. - In the primary efficacy analysis, LYMPHIR demonstrated an overall response rate (ORR) of 36.2%, with 8.7% achieving a complete response and 27.5% achieving a partial response[308]. - The median progression-free survival (PFS) for patients achieving clinical benefit was reported at 57 weeks, ranging from 30 to 96 weeks[331]. - The company has accrued a $5.9 million development milestone payment to Eisai as of September 30, 2024, related to LYMPHIR's FDA approval[343]. - The company has undertaken two investigator-initiated trials to evaluate LYMPHIR's safety and efficacy as an immuno-oncology combination therapy[329]. - The efficacy population included 69 patients with a median age of 64 years, with 65% being male and 73% White[324]. - LYMPHIR was included in the NCCN guidelines based on a Category 2A recommendation, which may assist in obtaining coverage from CMS[361]. Commercialization and Market Strategy - The company plans to develop its sales and marketing capabilities by partnering with a third-party organization to assist in launching LYMPHIR[322]. - The company believes there is an opportunity to expand the addressable U.S. market for LYMPHIR with the introduction of new therapeutics[339]. - The company is dependent on third-party suppliers and must manage risks associated with commercialization and market establishment for LYMPHIR[293]. - The company is required to pay an aggregate of $27.5 million under the license agreements covering LYMPHIR upon FDA approval[346]. - The company has entered into a contract manufacturing agreement that runs through calendar 2026, with minimum annual purchase obligations[384]. - The company relies on third-party manufacturers for drug production, exposing it to risks related to supply chain and regulatory compliance[367]. Financial Position and Obligations - The company has a federal net operating loss carryforward of approximately $28.7 million as of September 30, 2024[377]. - Minimum purchase commitments under commercial supply agreements amount to approximately $4.5 million, with $2.9 million due in 2025 and $1.6 million in 2026[379]. - The weighted average grant date fair value of stock options granted during the year ended September 30, 2024, was estimated at $1.66 per share[374]. - The company has recorded a valuation allowance against deferred tax assets, increasing by $4.9 million in 2024 and $4.0 million in 2023[377]. - Citius Pharma issued an unsecured promissory note to itself for $3,800,111, which is repayable upon raising at least $10 million[388]. - The likelihood of achieving the $10 million financing raise is currently uncertain[388]. Human Resources and Support - The company has access to more than 30 professionals through consulting and collaboration arrangements for clinical and regulatory support[355]. - The company expects to hire or contract additional qualified personnel for ongoing development and commercialization efforts[348]. Adverse Reactions and Safety - Adverse reactions in patients receiving LYMPHIR included nausea (43%), fatigue (38%), and headache (25%), with most being low grade[327]. Compliance and Accounting - The company has elected to use the extended transition period under the JOBS Act for complying with new or revised accounting standards[392].
TenX Keane Acquisition(TENK) - 2024 Q4 - Annual Report