Product Launch and Market Potential - Citius Oncology launched LYMPHIR™, a novel immunotherapy, in the U.S. in December 2025 for treating adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy [3] - The initial market for LYMPHIR is estimated to exceed $400 million, indicating significant growth potential in an underserved market [5] - Citius Oncology secured access to LYMPHIR in 19 international markets through regional distribution partners via Named Patient Programs, marking a step in its global access strategy [6] - The company announced a collaboration with Verix to enhance commercial targeting and provider engagement for LYMPHIR's U.S. commercialization [6] Financial Performance - The net loss for the fiscal year ended September 30, 2025, was $24.8 million, or ($0.34) per share, compared to a net loss of $21.1 million, or ($0.31) per share, in 2024 [6] - Net loss for 2025 was $(24,761,369), compared to $(21,148,747) in 2024, indicating a worsening financial position [16] - Cash and cash equivalents stood at $3.9 million as of September 30, 2025, compared to $112 in 2024 [11] - Cash and cash equivalents at the end of 2025 were $3,924,908, a significant increase from $112 at the beginning of the year, indicating improved liquidity [16] Expenses and Costs - Research and development expenses increased to $6.4 million for the fiscal year ended September 30, 2025, up from $4.9 million in 2024 [6] - General and administrative expenses rose to $8.8 million for the fiscal year ended September 30, 2025, compared to $8.1 million in 2024 [6] - Stock-based compensation expense increased to $8,320,419 in 2025 from $7,498,817 in 2024, reflecting higher employee compensation costs [16] - License payments for 2025 totaled $(5,750,000), consistent with $(5,000,000) in 2024, reflecting ongoing investment in intellectual property [16] Cash Flow and Financing - Net cash used in operating activities was $(5,492,046) in 2025, a decline from a positive cash flow of $126,353 in 2024, indicating operational challenges [16] - Net cash provided by financing activities rose to $15,166,842 in 2025, up from $4,873,759 in 2024, showing increased capital raising efforts [16] - Interest paid in 2025 was $187,389, while no interest was reported in 2024, indicating new financing arrangements [16] Inventory and Assets - Citius Oncology's total assets increased to $100.9 million as of September 30, 2025, compared to $84.4 million in 2024 [11] - Inventory changes resulted in a significant increase of $(12,649,207) in 2025, compared to $(2,133,871) in 2024, suggesting potential overstock issues [16] - Net prepaid manufacturing transferred to inventory was $1,368,720 in 2025, down from $6,134,895 in 2024, indicating a shift in production strategy [16] - The company reported a capital contribution of due to related party by parent of $33,180,961 in 2024, which was not repeated in 2025 [16]

Financial Performance - Citius Pharmaceuticals reported a net loss of $39.7 million, or $3.38 per share, for the fiscal year ended September 30, 2025, compared to a net loss of $40.2 million, or $5.97 per share, for the previous year[6]. - Net loss for 2025 was $(39,740,269), slightly higher than $(39,425,839) in 2024[15]. - Stock-based compensation decreased to $10,836,291 from $11,839,678 year-over-year[15]. - Net cash used in operating activities improved to $(26,552,738) from $(28,201,375) in the previous year[15]. - Net cash used in investing activities increased to $(5,750,000) from $(5,000,000) in 2024[15]. - Net proceeds from common stock offerings rose significantly to $32,303,148 compared to $13,803,684 in 2024[15]. - Cash and cash equivalents stood at $4.3 million as of September 30, 2025, compared to $3.3 million in the previous year[6]. - Cash and cash equivalents at the end of 2025 were $4,252,290, up from $3,251,880 in 2024[15]. - Inventory changes resulted in a significant increase in cash outflow of $(12,649,207) compared to $(2,133,871) in 2024[15]. - Accounts payable increased to $8,766,481 from $1,999,877 year-over-year, indicating improved supplier financing[15]. - Operating lease right-of-use asset and liability recorded was $786,697, reflecting new lease agreements[15]. - Interest paid in 2025 was $187,389, indicating ongoing financing costs[15]. Research and Development - Research and development expenses decreased to $9.2 million for the fiscal year 2025, down from $11.9 million in 2024, while general and administrative expenses slightly increased to $18.5 million from $18.2 million[6]. - Citius is actively engaging with the FDA to advance Mino-Lok and explore additional indications and markets for LYMPHIR[2]. Product Launch and Market Access - Citius Oncology launched LYMPHIR™, a novel immunotherapy for cutaneous T-cell lymphoma, in December 2025, with an estimated initial market exceeding $400 million[3][5]. - Citius secured access to LYMPHIR in 19 international markets through regional distribution partners, allowing access under named patient programs[3]. - The company executed service agreements with three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR throughout the U.S.[3]. - Citius ensured production and sufficient supply of LYMPHIR for up to 18 months of estimated commercial demand[3]. Assets and Financial Position - The total assets of Citius Pharmaceuticals increased to $130.9 million as of September 30, 2025, compared to $116.7 million in 2024[11].

IPO and Fundraising - The Company completed its IPO on February 11, 2021, raising gross proceeds of $276.0 million from the sale of 27,600,000 units at $10.00 per unit, with offering costs of approximately $15.8 million[140]. - The company raised gross proceeds of $276,000,000 from its IPO of 27,600,000 Units at a price of $10.00 per Unit, including an additional 3,600,000 Units sold to cover over-allotments[172]. - The company incurred $16,505,915 in transaction costs related to the IPO, including $5,520,000 in underwriting fees and $9,660,000 in deferred underwriting fees[173]. Business Combination Extensions - Following the IPO, approximately $276.0 million was placed in a Trust Account, invested in U.S. government securities or money market funds until a business combination is completed[142]. - On February 9, 2024, shareholders approved an extension for the Company to consummate a business combination until August 11, 2024, with 2,195,847 Class A ordinary shares redeemed for $23,724,846 (approximately $10.80 per share)[146][147]. - On August 9, 2024, shareholders approved another extension to May 11, 2025, with 1,487,025 Class A ordinary shares redeemed for $16,484,256 (approximately $11.09 per share)[150][151]. - On May 9, 2025, shareholders approved a further extension to March 11, 2026, with 21,807 Class A ordinary shares redeemed for approximately $0.25 million (approximately $11.47 per share)[154][155]. Delisting and Compliance Issues - The Company was delisted from the NYSE on February 12, 2024, due to non-compliance with the requirement to complete a business combination within the specified time frame[159][160]. - The company has until March 11, 2026, to consummate a business combination, raising substantial doubt about its ability to continue as a going concern if not completed by this date[185]. Financial Performance - For the three months ended September 30, 2025, the company reported a net loss of $187,187, with operating costs of $281,409 partially offset by a change in fair value of warrant liabilities of $35,533 and trust dividend income of $58,689[170]. - For the nine months ended September 30, 2025, the company had a net loss of $2,103,992, driven by operating costs of $2,059,665 and non-redemption agreement expense of $223,138, partially offset by trust dividend income of $178,797[171]. - As of September 30, 2025, the company had cash outside the trust account of $425 and working capital deficits of $4,917,295, indicating significant liquidity challenges[176]. - As of September 30, 2025, the company reported $1,567,897 due to related parties on the balance sheets, reflecting advances and borrowings[182]. Proposed Business Combination - A proposed business combination agreement was entered into on July 2, 2025, involving the merger with Mkango (Cayman) Limited and Lancaster Exploration Limited, with the new entity expected to trade on Nasdaq[162][163]. - The Company engaged Jett Capital Advisors, LLC as a financial advisor for the proposed business combination on June 1, 2025[165]. - Lancaster agreed to issue a convertible promissory note of $500,000 in connection with the proposed business combination on June 2, 2025[166]. - The company has engaged Jett Capital as a financial advisor for a proposed business combination, with fees payable only upon consummation of the transaction[188]. Regulatory and Reporting Considerations - The company is evaluating the benefits of reduced reporting requirements under the JOBS Act as an "emerging growth company" for a period of five years post-IPO[199]. - The company may not be required to provide an auditor's attestation report on internal controls over financial reporting under Section 404[199]. - The company may also avoid disclosing certain executive compensation items, including the correlation between executive compensation and performance[199]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[200]. Non-Redemption Agreements - The company has entered into non-redemption agreements with certain investors, estimating the fair value of Class B ordinary shares attributable to non-redeeming investors at $223,138 for the nine months ended September 30, 2025[192].

Product Development and Launch - Citius Pharmaceuticals launched LYMPHIR in December 2025, marking its transition to a commercial company[26] - The company is developing three proprietary products: Mino-Lok, Halo-Lido, and NoveCite, focusing on unmet medical needs in critical care[27] - Citius Pharma has paused most development initiatives for NoveCite to prioritize other product candidates, including LYMPHIR[138] - Citius Pharma plans to submit a New Drug Application (NDA) based on the positive outcomes from the Phase 3 trial and ongoing discussions with the FDA[97] Clinical Trial Results - LYMPHIR achieved a 36.2% overall response rate (ORR) in a pivotal trial with 69 patients, with 8.7% achieving a complete response[37][44] - The median duration of response for LYMPHIR was 6.5 months, with a median time to response of 1.4 months[38][44] - LYMPHIR demonstrated an overall response rate (ORR) of 27% (4 out of 15 patients) and a clinical benefit rate of 33% (5 out of 15 patients) among evaluable participants[58] - The median progression-free survival (PFS) for patients achieving clinical benefit was 57 weeks, with a range of 30 to 96 weeks[58] - The trial enrolled 21 patients with recurrent or metastatic solid tumors, with one patient showing durable stable disease lasting over six months[59] - The combination regimen of LYMPHIR and pembrolizumab was generally well tolerated, with only one case of dose-limiting toxicity (capillary leak syndrome) reported at the highest dose level of 12 mcg/kg[61] - The Phase 2b study of Halo-Lido showed that 42% of patients in the high dose CITI-002 group reached the meaningful change threshold (MCT) compared to 29% for high dose halobetasol alone and 21% for lidocaine alone[123] - The Phase 2a study of Halo-Lido demonstrated symptom improvement in hemorrhoids, with combination products showing favorable results compared to placebo[113] Market Potential and Financials - The addressable U.S. market for LYMPHIR is estimated to exceed $400 million, with potential for expansion with new therapeutic introductions[76] - The potential market for Mino-Lok in the U.S. is estimated to be approximately $500 million to $1 billion based on a target price of up to $400 per dose of each salvage flush treatment[106] - There are approximately 472,000 catheter-related bloodstream infections (CRBSIs) annually in the U.S., with an associated mortality rate of 12% to 35% and an attributable cost of $35,000 to $56,000 per episode[104] - Citius Pharma has a milestone payment obligation of $5.9 million to Eisai upon initial FDA approval of LYMPHIR, with additional payments tied to sales thresholds[149] - A $27.5 million milestone payment became due upon FDA approval for LYMPHIR, with a remaining balance of $19.75 million as of September 30, 2025[158] Regulatory and Compliance - The FDA required a new clinical study for LYMPHIR due to substantial manufacturing formulation improvements compared to the previously approved ONTAK[35] - The FDA issued a complete response letter (CRL) in July 2023, requiring enhanced product testing and additional controls, but did not raise concerns regarding safety and efficacy[70] - The FDA accepted the resubmission of the Biologics License Application (BLA) for LYMPHIR in March 2024, with a PDUFA goal date set for August 13, 2024[72] - The FDA granted Fast Track designation to Mino-Lok, expediting its review process due to its potential to treat a serious condition with unmet medical needs[98] - The FDA requires substantial time and financial resources for marketing approval, including extensive testing and compliance with cGMP regulations[201] - Post-approval, the FDA continues to regulate drugs, including requirements for recordkeeping and reporting of adverse experiences[206] Competitive Landscape - Citius Pharma has faced common pharmaceutical industry risks, including competition and dependence on key personnel[28] - Citius Oncology faces significant competition from established pharmaceutical companies and research institutions in the development of its drug candidates[179] - Mino-Lok is currently the only product approved for the treatment of infected central venous catheters (CVCs) in patients with CRBSI/CLABSI[181] - Halo-Lido, if approved, would be the only prescription product for the treatment of hemorrhoids, competing against non-prescription OTC products[187] Intellectual Property and Agreements - Citius Pharma acquired patents related to LYMPHIR, including methods of use with PD-1 pathway inhibitors, enhancing its competitive position in the market[159] - The stability patent for Mino-Lok enhances its intellectual property protection until November 2036, allowing for longer storage of the ready-to-use solution[101] - The license agreement with Eisai allows for a potential extension of 10 years after the first commercial sale, expected in December 2025[152] - NoveCite is obligated to pay up to $51 million in milestone payments and royalties based on net sales for the stem cell therapy developed under its license agreement[171] Distribution and Commercialization - Citius Pharma has entered into distribution agreements with Cardinal Health, Cencora, and McKesson Corporation to support the launch of LYMPHIR[144] - The company has developed a dedicated field force through a third-party commercial sales organization to facilitate the launch of LYMPHIR[143] - The commercial success of the company's product candidates will depend on governmental authorities and third-party payers providing adequate coverage and reimbursement levels, which are increasingly being restricted[211] Healthcare Environment and Challenges - The Affordable Care Act (ACA) has significantly impacted the pharmaceutical industry by broadening access to health insurance and imposing new taxes and fees on manufacturers[216] - Legislative changes have reduced Medicare payments to various healthcare providers, which could decrease utilization and reimbursement for the company's products[218] - The Inflation Reduction Act of 2022 includes provisions to lower prescription drug costs for Medicare patients, potentially affecting the company's business[219] - Future healthcare reform measures could limit government payments for healthcare products and services, resulting in reduced demand for the company's products[221]

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].

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].

Production and Sales - Barnwell's annual net production for fiscal 2025 was 1,105,000 Mcf of natural gas, 174,000 Bbls of oil, and 56,000 Bbls of natural gas liquids, resulting in a total production of 414,000 Boe[41]. - The average sales price per Mcf of natural gas in fiscal 2025 was $1.27, down from $2.64 in fiscal 2023, while the average price per Bbl of oil decreased to $60.49 from $69.77[41]. - In fiscal 2025, Barnwell amended contracts to fix the sales price for 1,055 gross Mcf per day of natural gas at $1.95 CAD, representing approximately 38% of daily production[56]. Capital Expenditures and Financials - Capital expenditures for fiscal 2025 were $939,000, significantly lower than $4,805,000 in fiscal 2024, primarily focused on equipment and facility upgrades[43][44]. - Barnwell received cash distributions of $1,071,000 from the Kukio Resort Land Development Partnerships, resulting in a net amount of $953,000 after distributing $118,000 to non-controlling interests in fiscal 2024[78]. Wells and Acreage - As of September 30, 2025, Barnwell had interests in 109 gross (62.9 net) producing wells, with 76 gross (58.2 net) being oil wells[49]. - Barnwell's undeveloped acreage as of September 30, 2025, included 22,506 gross acres, with 81% not subject to expiration[52]. - The company did not drill any new wells in fiscal 2025, following the drilling of one well in fiscal 2024[45][47]. Environmental and Regulatory Compliance - Barnwell is subject to extensive environmental laws and regulations, which can be costly to comply with and carry substantial penalties for non-compliance[82]. - Barnwell's cash deposits to the Orphan Well Association for site closure amounted to $975,000, with $462,000 spent on closure activities as of September 30, 2025[67]. Competition and Market Position - Barnwell competes in the oil and natural gas market against major companies and independent operators, highlighting its position as a minor participant in the industry[69]. - The competition in Barnwell's land investment segment is intense, with numerous independent companies and factors such as project location and pricing affecting market dynamics[79]. Land Development - Increment I consisted of 80 single-family lots, all sold between 2006 and 2024, while Increment II encompasses approximately 870 acres, with 420 developable acres entitled for up to 350 homesites[74]. - Kaupulehu Developments is entitled to 15% of the distributions from KD II, with a priority payout of 10% of KDK's cumulative net profits from Increment II sales, capped at $3,000,000[77]. - Barnwell holds a 19.6% interest in KDK, which agreed to sell its interests in Increment II for $2,109,000, subject to due diligence and no certainty of closing[73]. - The last two remaining single-family lots in Increment I were sold in fiscal 2024, marking the completion of sales in that segment[75]. - Barnwell has a 10.8% indirect non-controlling ownership interest in KD II through KDK, which is accounted for using the equity method[76]. - The company has not made definitive development plans for the remaining areas of Increment II, and there is uncertainty regarding future sales from this segment[74]. Employment - As of December 1, 2025, Barnwell employed 18 individuals, with 16 full-time and 2 part-time[81].

Company Overview - Gloo Holdings, Inc. began trading on Nasdaq under the ticker "GLOO" on November 19, 2025, following the completion of its IPO[326]. - The company acquired XRI Global, Inc. for a total contractual purchase price of approximately $4.1 million, which includes 346,244 shares of Class A common stock and about $1.3 million in cash[328]. - The company completed six acquisitions during the nine months ended October 31, 2025, including acquiring the remaining 56.8% of Sermons Tech for $6.4 million in cash[375]. - The company raised $72.3 million in net proceeds from its IPO in November 2025, after underwriting discounts and expenses[376]. - Management expressed substantial doubt about the company's ability to continue as a going concern for at least 12 months from the date the financial statements are available to be issued[377]. Revenue and Financial Performance - Gloo generates revenue from four types: subscriptions, marketplace, advertising, and platform solutions, with the first three categorized as platform revenue[323]. - Total revenue for the three months ended October 31, 2025, was $32,552,000, a significant increase from $6,123,000 in the same period of 2024, marking a growth of 433%[359]. - Total revenue increased by $26.4 million, or 431.6%, for the three months ended October 31, 2025, and by $44.3 million, or 265.0%, for the nine months ended October 31, 2025, compared to the same periods in 2024[360]. - Platform revenue reached $19,824,000 for the three months ended October 31, 2025, compared to $6,087,000 in the prior year, reflecting an increase of 226%[359]. - Platform revenue rose by $13.7 million and $20.5 million during the three and nine months ended October 31, 2025, respectively, primarily driven by an increase in advertising revenue of $10.5 million and $13.8 million[361]. - Platform solutions revenue increased by $12.7 million and $23.8 million for the three and nine months ended October 31, 2025, respectively, due to contributions from acquired companies and the Gloo360 offering[362]. Expenses and Losses - Net loss attributable to common members of Gloo Holdings, LLC was $38,049,000 for the three months ended October 31, 2025, compared to a loss of $13,626,000 for the same period in 2024, representing an increase of 179%[344]. - The company incurred a net loss of $39.0 million and $110.1 million for the three and nine months ended October 31, 2025, respectively[374]. - Operating expenses for the three months ended October 31, 2025, totaled $59,245,000, up from $18,835,000 in the same period of 2024, indicating a rise of 214%[359]. - Operating expenses rose by $40.4 million, or 134.2%, for the three months ended October 31, 2025, and by $56.3 million, or 138.3%, for the nine months ended October 31, 2025, compared to the same periods in 2024[363]. - Interest expense for the three months ended October 31, 2025, was $6,390,000, compared to $1,779,000 in the same period of 2024, marking an increase of 259%[359]. - Interest expense increased by $4.6 million and $9.5 million for the three and nine months ended October 31, 2025, respectively, due to a rise in net outstanding debt balances[370]. Cash Flow and Investments - Net cash used in operating activities was $63.0 million for the nine months ended October 31, 2025, compared to $33.2 million for the same period in 2024, indicating a significant increase in cash outflow[381]. - Net cash used in investing activities was $16.9 million for the nine months ended October 31, 2025, up from $6.2 million in the same period in 2024, primarily due to increased investments in capitalized software and acquisitions[383]. - Net cash provided by financing activities was $81.6 million for the nine months ended October 31, 2025, compared to $45.7 million for the same period in 2024, driven by proceeds from the issuance of Senior Secured Convertible Notes[384]. Strategic Initiatives - The company is developing Gloo AI, a vertical-specific AI aimed at enhancing engagement, data insights, and content creation for its ecosystem[335]. - Gloo's business model integrates enterprise NCP sales and digital-led growth, driving platform adoption and sustainable revenue[337]. - The company aims to enhance its capabilities through strategic acquisitions and investments focused on mission-aligned companies with strong recurring revenue[330]. - The company expects product development expenses to continue increasing as it invests in expanding AI capabilities and enhancing its offerings[350]. Accounting and Reporting - Adjusted EBITDA is used to evaluate core operating performance, supporting planning and forecasting, and is a non-GAAP financial measure[340]. - The company remains classified as an "emerging growth company," allowing it to delay the adoption of new accounting standards until they apply to private companies[385]. - The company does not have any off-balance sheet arrangements that could materially affect its financial condition or results of operations[386]. - There were no material changes to the company's critical accounting policies during the nine months ended October 31, 2025, compared to those discussed in the Prospectus[388]. - The company is not required to provide certain market risk disclosures as it qualifies as a "smaller reporting company" under the Exchange Act[390].

Financial Transactions - The company completed its Initial Public Offering on October 12, 2021, raising total gross proceeds of $230 million from the sale of 23 million Units at $10.00 per Unit[210]. - The company generated an additional $7.15 million from the sale of 7.15 million Private Placement Warrants at $1.00 each[211]. - A PIPE Investment of $35 million at $11.50 per share was agreed upon concurrently with the Merger Agreement, with efforts to secure a total of at least $65 million[222][224]. - The underwriters fully exercised the over-allotment option to purchase an additional 3,000,000 Units at an offering price of $10.00 per Unit, generating additional gross proceeds of $30,000,000[302]. - The total deferred underwriting commissions were initially set at $12,100,000, but a Fee Reduction Agreement resulted in a reduction of $8,100,000, leaving a remainder of $4,000,000[304]. - The cash underwriting discount paid to underwriters was $0.20 per Unit, totaling $4,000,000 upon the closing of the Initial Public Offering[303]. Business Combination and Agreements - The company entered into a Merger Agreement with AERKOMM Inc. on March 29, 2024, to facilitate a business combination[213]. - The company has established a Capital Markets Advisory Agreement with Benchmark for a private placement of approximately $30 million, with fees structured based on gross proceeds[229]. - AERKOMM committed to filing its Form 10-K with the SEC by July 21, 2025, as part of the Commercial Funding and Repayment Agreement[235]. - The Company approved the Second Extension Amendment, allowing the board to extend the deadline for a Business Combination up to ten times until October 12, 2024, with a monthly contribution of $50,000 required[272]. - The Fourth Extension Amendment Proposal was approved, allowing monthly extensions up to twelve times until October 12, 2026[263]. - The Company extended the Deadline Date for business combinations multiple times, with the latest extension to December 12, 2023, and provisions for further monthly extensions[252][256]. Financial Position and Performance - As of September 30, 2025, the Company had approximately $19.8 million in cash held in the Trust Account, intended for the initial business combination[297]. - The Company reported a working capital deficit of approximately $6.7 million as of September 30, 2025[294]. - For the three months ended September 30, 2025, the Company reported a net loss of approximately $771,000, primarily due to a $1.3 million change in fair value of derivative warrant liability[287]. - The Company incurred a net loss of approximately $1 million for the nine months ended September 30, 2025, with significant contributions from cash held in the Trust Account[288]. Shareholder Activities - Shareholders redeemed 18,336,279 Class A ordinary shares at approximately $10.31 per share, totaling around $189 million, leaving approximately $48 million in the Trust Account[245][269]. - In connection with the Second Extension Amendment Proposal, 1,817,650 public shares were redeemed at approximately $11.00 per share, totaling about $19.99 million[258]. Compliance and Regulatory Matters - The Company received a Total Shareholders Notice from Nasdaq on October 9, 2023, indicating non-compliance with the requirement of at least 400 total holders[279]. - The Company successfully requested a hearing before the Nasdaq Hearings Panel, resulting in continued listing on the Nasdaq Global Market on August 5, 2024[282]. Working Capital and Financing - The company has made provisions for working capital financing, including a $520,000 wire to cover operational needs[236]. - AERKOMM provided the Company with $520,000 for working capital needs on June 12, 2025, and $100,000 on September 10, 2025, recorded as working capital financing[237][239]. - The Company amortized $570,000 of working capital financing, with $50,000 remaining as of September 30, 2025, impacting operating and formation expenses[241]. - The outstanding principal under the Third Amended and Restated Extension Promissory Note was $3,955,175 as of September 30, 2025[277]. Future Plans and Evaluations - The Company plans to address liquidity concerns through the initial business combination, with a deadline of October 12, 2026, for completion[298]. - The Company is currently evaluating the impact of adopting ASU 2024-03, which requires additional disclosures about specific expense categories[316]. - The Company does not believe that the adoption of ASU 2023-09 will have a material impact on its financial statements and disclosures[315]. - The adoption of ASU 2023-07 had no material impact on the Company's condensed consolidated financial statements[314]. Miscellaneous - The Company has no off-balance sheet arrangements as of September 30, 2025[306]. - The Company entered into an Administrative Support Agreement to pay up to $10,000 per month for office space and administrative services, which will cease upon completion of a Business Combination[305]. - The deferred fee to underwriters is payable only upon the completion of a business combination, subject to the terms of the Underwriting Agreement[303]. - The Company has 23,000,000 Class A ordinary shares subject to possible redemption, which are classified outside of permanent equity due to redemption provisions not solely within the Company's control[309].

Financing Activities - The company completed its Initial Public Offering on October 12, 2021, raising total gross proceeds of $230 million from the sale of 23 million Units at $10.00 per Unit[210]. - The company also generated gross proceeds of $7.15 million from the sale of 7.15 million Private Placement Warrants at $1.00 per warrant[211]. - AERKOMM is expected to secure a minimum PIPE Investment Amount of at least $45 million, with a total target of $65 million[224]. - The company has entered into a Capital Markets Advisory Agreement for a private placement of approximately $30 million, with Benchmark receiving a fee of 5% of gross proceeds[229]. - The underwriters fully exercised the over-allotment option to purchase an additional 3,000,000 Units at an offering price of $10.00 per Unit, generating additional gross proceeds of $30,000,000[302]. - The total deferred underwriting commissions originally agreed upon was $12,100,000, of which $8,100,000 was forfeited under the Fee Reduction Agreement, resulting in a remainder of $4,000,000[304]. - The cash underwriting discount paid to underwriters upon the closing of the Initial Public Offering was $4,000,000, with additional deferred fees totaling $12,100,000[303]. Merger and Acquisition Activities - The company entered into a Merger Agreement with AERKOMM Inc. on March 29, 2024, with customary representations and warranties[213]. - The company has amended the Merger Agreement to change the percentage of Founder Shares treated as escrowed from 50% to 25%[216]. - The SAFE Agreements will automatically convert upon the closing of the merger at $11.50 per share, potentially resulting in the issuance of 735,423 additional shares[228]. - The Company plans to address liquidity concerns through the initial business combination, with a deadline of October 12, 2026, for completion[298]. Trust Account and Cash Management - The Company has placed $231.15 million from the IPO proceeds in a Trust Account, which will be held in an interest-bearing demand deposit account until the completion of the initial business combination[212]. - As of September 30, 2025, the Company had approximately $19.8 million in cash held in the Trust Account, intended for the initial business combination[297]. - Shareholders redeemed 18,336,279 Class A ordinary shares at approximately $10.31 per share, totaling around $189 million, leaving approximately $48 million in the Trust Account[245][269]. - The sponsor agreed to deposit $160,000 into the Trust Account for each month of extension from April to November 2023, totaling $1.28 million[270]. Business Combination Extensions - The Company extended the Deadline Date for business combinations multiple times, with the latest extension announced on October 12, 2023, moving the date to November 12, 2023[252]. - The Company approved the Second Extension Amendment, allowing the board to extend the deadline for a Business Combination up to ten times until October 12, 2024, with a monthly contribution of $50,000 required[272]. - The Fourth Extension Amendment Proposal was approved, allowing the Board to extend the business combination deadline monthly up to twelve times until October 12, 2026[263]. - The Company made twelve deposits of $48,311 each for extension contributions to maintain the business combination deadline until October 12, 2025[276]. Financial Performance - For the three months ended September 30, 2025, the Company reported a net loss of approximately $771,000, primarily due to a $1.3 million change in fair value of derivative warrant liability[287]. - The Company incurred a net loss of approximately $1 million for the nine months ended September 30, 2025, with significant contributions from cash held in the Trust Account[288]. - The Company reported a working capital deficit of approximately $6.7 million as of September 30, 2025[294]. Compliance and Regulatory Matters - The Company received a Total Shareholders Notice from Nasdaq on October 9, 2023, indicating non-compliance with the requirement of at least 400 total holders[279]. - The Company successfully requested a hearing before the Nasdaq Hearings Panel, resulting in continued listing on the Nasdaq Global Market on August 5, 2024[282]. Accounting and Financial Reporting - The Company does not anticipate any material impact from the adoption of ASU 2023-09 on its financial statements[315]. - The Company is currently evaluating the impact of adopting ASU 2024-03, which requires additional disclosures about specific expense categories[316]. - Management does not believe there are any material recently issued accounting standards that would significantly affect the financial statements[317].