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[28]. - The Phase 3 trial for LYMPHIR demonstrated an overall response rate (ORR) of 36.2% among 69 subjects, with 8.7% achieving a complete response[39]. - The median duration of response for LYMPHIR was 6.5 months, with 52% of responders maintaining their response for at least 6 months[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 for LYMPHIR included 69 patients with a median age of 64 years, and the median number of prior therapies was 4[43]. - 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 its appropriateness for CTCL patients[89]. - The FDA assigned a PDUFA goal date of August 13, 2024, for the Biologics License Application (BLA) resubmission for LYMPHIR[81]. Commercialization Strategy - The Company has established a targeted oncology sales force for LYMPHIR, focusing on major cancer centers in the U.S.[29]. - The Company plans to commercialize products independently in the U.S. while partnering for international markets[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 plans to focus its commercial efforts on a targeted group of prescribing hematologists, oncologists, and dermatologist-oncologists[87]. - The company has contracted with Innovation Partners and three national companies to assist in the commercialization of LYMPHIR, indicating reliance on third-party infrastructure[154]. - The company has contracted with third-party organizations for sales, marketing, and distribution of LYMPHIR, which may require significant resources[176]. 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 remaining balance of $19.75 million 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 of LYMPHIR for CTCL[98]. - The Company is required to commercially launch a product within six months of receiving regulatory approval, which was satisfied with the launch of LYMPHIR in December 2025[158]. - The company has raised $6.0 million in October 2025 and $18.0 million in December 2025 to support operations through March 2026[137]. - As of September 30, 2025, the company had approximately $3.9 million in cash and cash equivalents and an accumulated deficit of approximately $64 million[140]. - The company has generated no operating revenue to date and relies on equity instruments and funding through Citius Pharma for financing[138]. - 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]. Market and Competitive Landscape - The addressable U.S. market for LYMPHIR is estimated to exceed $400 million, potentially expanding with new therapeutic introductions[85]. - The estimated incidence rate of mycosis fungoides and Sézary syndrome in the U.S. is approximately 0.5 per 100,000, translating to about 2,500 to 3,000 new cases annually[84]. - Citius Oncology's revenues are expected to depend substantially on the market acceptance of LYMPHIR, which may not be guaranteed[175]. - Market acceptance of LYMPHIR may be limited by factors such as pricing, reimbursement, and perceptions of healthcare providers[174]. - The actual market for LYMPHIR may be smaller than projected, affecting the company's ability to achieve profitability[178]. - 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]. Regulatory Compliance and Risks - The FDA requires substantial time and resources for marketing approval, including nonclinical studies and clinical trials[112]. - The Company must comply with ongoing FDA regulations post-approval, including recordkeeping and reporting of adverse experiences[116]. - 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, such as the Inflation Reduction Act of 2022, could materially affect the healthcare industry and the company's business[129]. - The company is subject to increased scrutiny over drug pricing, which may lead to legislative changes that could limit reimbursement amounts from federal health care programs[188]. - Regulatory compliance is critical, as failure to maintain compliance could result in significant costs and hinder the ability to market future products[210]. - The approval process for future product candidates may be delayed by changes in government regulation or FDA policy, impacting commercialization timelines[212]. Operational Challenges - The company faces challenges in obtaining adequate reimbursement levels for its products due to increasing restrictions from governmental authorities and private insurers[122]. - The company has a limited operating history and has not yet demonstrated the ability to successfully commercialize any product candidates beyond LYMPHIR[154]. - The company faces substantial additional costs due to milestone payments and obligations under license agreements, which could adversely affect the profitability of LYMPHIR[159]. - The company faces risks related to reliance on third-party manufacturers, which could delay clinical trials and commercialization[167]. - The company is dependent on third parties and Citius Pharma under the A&R Shared Services Agreement[226]. - Recruitment or departure of key scientific or management personnel could impact the company's operations[226]. - 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 Risks - 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 company may face substantial costs if its product candidates infringe on third-party proprietary rights, which could harm earnings and financial condition[222]. - The company has registered the trademark "LYMPHIR," but inadequate protection could impede brand recognition and market competitiveness[223]. - The company has limited product liability insurance coverage of $5 million per occurrence, which may not be sufficient to cover all liabilities from product liability claims[211]. - The company relies on trade secret protections through confidentiality agreements, but breaches could adversely affect business prospects[221]. Financial Performance - 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]. - The company recorded $218,032 in interest expense related to the payment schedule with Eisai during the year ended September 30, 2025[162]. - 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]. - Future issuances of debt or equity securities may influence the company's financial condition and operating results[226].
Citius Oncology, Inc.(CTOR) - 2025 Q4 - Annual Report