Product Development and Approval - The Company’s lead product, LYMPHIR, is projected to address a market estimated to exceed $400 million for the treatment of persistent or recurrent CTCL [28]. - LYMPHIR received FDA approval in August 2024 and was launched in December 2025, with a targeted oncology sales force established for its commercialization [28][29]. - The Phase 3 trial (E7777-G000-302) demonstrated an overall response rate (ORR) of 36.2% among 69 subjects treated with LYMPHIR at a dose of 9 µg/kg/day [39][46]. - The median duration of response for LYMPHIR was 6.5 months, with 52% of responders maintaining their response for at least 6 months [40][46]. - Serious adverse reactions occurred in 38% of patients, with capillary leak syndrome (10%) and infusion-related reactions (9%) being the most common [49]. - The pivotal trial included a diverse patient population, with a median age of 64 years and a median of 4 prior therapies per patient [43]. - The FDA accepted the trial data demonstrating both tolerability and clinical benefit, despite a marginal shortfall in the statistical confidence interval for the primary endpoint [47]. - The Phase I Clinical Trial of Pembrolizumab and LYMPHIR demonstrated a partial response rate of 27% (4 out of 15 evaluable patients) and a clinical benefit rate of 33% (5 out of 15) among evaluable patients [64][65]. - The median progression-free survival (PFS) for patients achieving clinical benefit was 57 weeks, with a range of 30 to 96 weeks [65]. - LYMPHIR was included in the National Comprehensive Cancer Network (NCCN) guidelines with a Category 2A recommendation, indicating it is an appropriate treatment option for CTCL patients [89]. Commercialization Strategy - The commercialization strategy includes direct sales revenue and royalty income, with anticipated incremental operating expenses [29]. - The Company has entered into distribution agreements with Cardinal Health, Cencora, and McKesson Corporation to support the launch and commercialization of LYMPHIR [88]. - The Company has contracted with EVERSANA to provide an integrated suite of pre- and post-launch services for LYMPHIR [88]. - The Company plans to focus its commercial efforts on a targeted group of prescribing hematologists, oncologists, and dermatologist-oncologists to facilitate the successful launch of LYMPHIR [87]. - The Company has secured supply agreements for LYMPHIR with third-party cGMP facilities, ensuring compliance with FDA standards [92]. - Contract manufacturers have sufficient capacity to support demand for LYMPHIR and future products as the business grows [93]. - The Company has contracted with third-party commercial sales and marketing organizations to assist in the commercialization of LYMPHIR, indicating reliance on external infrastructure [154]. - The market acceptance of LYMPHIR is uncertain, and its success will depend on factors such as pricing, reimbursement, and perceptions by healthcare professionals [175]. Financial Obligations and Funding - The Company is obligated to pay up to $40 million related to CTCL approvals and up to $300 million for commercial sales milestones under the asset purchase agreement with Dr. Reddy's [104]. - A $27.5 million milestone payment became payable to Dr. Reddy's upon FDA approval for LYMPHIR, with a balance of $19.75 million remaining due as of September 30, 2025 [107]. - The Company has accrued a $2.9 million unpaid balance of the development milestone payment to Eisai as of September 30, 2025 [98]. - The license agreement with Eisai includes a $5.9 million development milestone payment upon initial FDA approval and up to $22 million related to net product sales thresholds [98]. - The Company is required to make aggregate payments of $33.4 million under the license and asset purchase agreements for LYMPHIR upon FDA approval [161]. - The company has raised $6.0 million in October 2025 and $18.0 million in December 2025, estimating sufficient capital to continue operations through March 2026 [137]. - The company has raised $18 million in capital raises through December 10, 2025, with an uncertain likelihood of raising an additional $12 million to trigger repayment obligations on a $3.8 million promissory note [145]. - The company incurred a net loss of $24.7 million for the year ended September 30, 2025, with stockholders' equity of $44.9 million and an accumulated deficit of $64 million [143]. - As of September 30, 2025, the company has outstanding commitments totaling $38.4 million due to third-party suppliers and manufacturers, primarily related to the development and commercialization of LYMPHIR [144]. Regulatory and Compliance Challenges - The FDA requires substantial time and financial resources for marketing approval, including extensive testing and compliance with cGMP regulations [112]. - The company must achieve specific milestones and launch products within six months of receiving regulatory approval in each jurisdiction [105]. - The regulatory approval of LYMPHIR was granted by the FDA in August 2024, but ongoing compliance with extensive regulations will incur significant expenses and limit commercialization efforts [208]. - The FDA has substantial discretion in the drug approval process, which could impact the approval of future product candidates [172]. - The company must obtain separate approvals from foreign regulatory authorities for product marketing in other countries, which may involve different requirements than those of the FDA [132]. Market and Competitive Landscape - The competitive landscape in the pharmaceutical industry is intense, with several companies targeting the same conditions as LYMPHIR, many of which have greater resources and experience [184]. - Legislative and regulatory changes, including healthcare reform measures, could impact the pricing and reimbursement of LYMPHIR, potentially reducing demand for the product [186]. - The company faces significant uncertainty regarding the reimbursement status of LYMPHIR, which could affect its market acceptance and revenue generation [179]. - The company faces potential challenges in obtaining sufficient reimbursement rates from health administration authorities in countries outside the U.S., which could adversely affect profitability [181]. - Legislative changes, including the Inflation Reduction Act of 2022, could materially affect the healthcare industry and the company's business [129]. Operational Risks and Strategic Alternatives - The company is evaluating strategic alternatives, including partnerships, joint ventures, mergers, acquisitions, and licensing to secure additional funding [139]. - The company may face significant challenges in obtaining adequate reimbursement levels for its therapeutic product candidates due to increasing restrictions from governmental authorities and private insurers [122]. - The company is dependent on third parties and Citius Pharma under the A&R Shared Services Agreement [226]. - The company faces risks from the recruitment or departure of key scientific or management personnel [226]. - The loss of key personnel could harm the company's ability to attract capital and successfully commercialize LYMPHIR [193]. - The company anticipates needing to increase its organizational size to support the commercialization of LYMPHIR and future product candidates, which may strain existing infrastructure [197]. - Cybersecurity threats pose a risk to the company's information technology systems, which are critical for operations and could lead to significant disruptions if compromised [199]. Intellectual Property and Legal Considerations - The company is responsible for preparing, filing, and maintaining all patent applications and patents included in the licensed patents [102]. - The company anticipates filing additional patent applications in the U.S. and other countries, but the patent process is fraught with risks and uncertainties that may limit competitive advantages [215]. - The time from patent application to issuance often exceeds three years, resulting in market exclusivity that is likely less than 20 years due to regulatory delays [217]. - The company faces risks related to potential changes in patent law and regulations that could weaken its ability to obtain and enforce patents [218]. - The company relies on trade secret protections through confidentiality agreements, but breaches of these agreements could adversely affect its business [221]. - If the company infringes on third-party rights, it may incur substantial costs and be forced to abandon product candidates or pay damages [222]. - The company has registered the trademark "LYMPHIR," but inadequate protection could hinder brand recognition and market competitiveness [223]. Financial Performance and Future Outlook - The company has generated no operating revenue to date and relies on equity instruments and funding through Citius Pharma to finance operations [138]. - The commercialization of LYMPHIR is critical for the company to generate substantial revenue and continue operations beyond March 2026 [138]. - The company expects to incur additional expenses as it continues to develop future product candidates and seeks regulatory approval [139]. - The company's cash resources are critical for successfully commercializing LYMPHIR, covering costs of licensing payments and product manufacturing [226]. - The company's ability to meet contractual obligations and commercialize LYMPHIR or future product candidates is essential for performance [226]. - Marketing efforts for LYMPHIR and future product candidates will impact success and associated costs [226]. - Unanticipated serious safety concerns related to LYMPHIR or other product candidates could adversely affect the company [226]. - Announcements of significant acquisitions or strategic partnerships could impact market perception and stock performance [226]. - The company's failure to meet investment community estimates may lead to negative market reactions [226].
TenX Keane Acquisition(TENK) - 2025 Q4 - Annual Report