Citius Pharmaceuticals, Inc. 10-K

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes included elsewhere in this annual report on Form 10-K. Management’s discussion and analysis contains forward-looking statements, such as statements of our plans, objectives, expectations, and intentions. Any statements that are not statements of historical fact are forward-looking statements. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like, and/or future tense or conditional constructions (“will,” “may,” “could,” “should,” etc.), or similar expressions, identify these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including those under “Risk Factors” in Item 1A in this Form 10-K that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the filing date of this report. 56 Historical Background We are a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products and stem cell therapies. On September 12, 2014, we acquired Citius Pharmaceuticals, LLC as a wholly-owned subsidiary. On March 30, 2016, we acquired all of the outstanding stock of Leonard-Meron Biosciences, Inc. (“LMB”) by issuing shares of our common stock. We acquired identifiable intangible assets of $19,400,000 related to in-process research and development and recorded goodwill of $9,346,796 for the excess of the purchase consideration over the net assets acquired. On September 11, 2020, we formed NoveCite, Inc. (“NoveCite”), a Delaware corporation, of which we own 75% of the issued and outstanding capital stock. On August 23, 2021, we formed Citius Oncology, Inc. (formerly Citius Acquisition Corp.) as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, but Citius Oncology did not begin operations until April 2022, when Citius Pharma transferred the assets related to LYMPHIR to Citius Oncology, including the related license agreement with Eisai and the related asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s. In-process research and development of $19,400,000 represents the value of LMB’s leading drug candidate (Mino-Lok), which is an antibiotic solution used to treat catheter-related bloodstream infections and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill of $9,346,796 represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized but will be tested at least annually for impairment. In-process research and development of $40,000,000 represents the value of our September 2021 acquisition of an exclusive license for LYMPHIR (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma and is expected to be amortized on a straight-line basis over a period of twelve years commencing upon revenue generation. Through September 30, 2023, we have devoted substantially all our efforts to product development, raising capital, building infrastructure through strategic alliances and coordinating activities relating to our proprietary products. We have not yet realized any revenues from our operations. Recent Developments On October 23, 2023, Citius Pharma and Citius Oncology entered into the Merger Agreement with TenX and Merger Sub. The Merger Agreement provides, among other things, (i) on the terms and subject to the conditions set forth therein, that Merger Sub will merge with and into Citius Oncology, with Citius Oncology surviving as a wholly owned subsidiary of TenX, and (ii) that prior to the Effective Time, TenX will migrate to and domesticate as a Delaware corporation. The publicly traded Combined Company is to be named “Citius Oncology, Inc.” Patent and Technology License Agreements Mino-Lok® – LMB has a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc. (“NAT”) to develop and commercialize Mino-Lok on an exclusive, worldwide sub-licensable basis, as amended. Since May 2014, LMB has paid an annual maintenance fee, which began at $30,000 and has increased over five years to $90,000, where it will remain until the commencement of commercial sales of a product subject to the license. LMB will also pay annual royalties on net sales of licensed products, with royalties ranging from the mid-single digits to the low double digits. In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties that increase in subsequent years. LMB must also pay NAT up to $1,100,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub licensees. Mino-Wrap – On January 2, 2019, we entered into a patent and technology license agreement with the Board of Regents of the University of Texas System on behalf of the University of Texas M. D. Anderson Cancer Center (“Licensor”), whereby we in-licensed exclusive worldwide rights to the patented technology for any and all uses relating to breast implants. We intend to develop a liquefying gel-based wrap containing minocycline and rifampin for the reduction of infections associated with breast implants following breast reconstructive surgeries. We are required to use commercially reasonable efforts to commercialize Mino-Wrap under several regulatory scenarios and achieve milestones associated with these regulatory options leading to an approval from the FDA. 57 Under the license agreement, we paid a nonrefundable upfront payment of $125,000. We are obligated to pay an annual maintenance fee of $30,000, commencing in January 2020 that increases annually by $15,000 per year up to a maximum of $90,000. Annual maintenance fees cease on the first sale of product. We also must pay up to an aggregate of $2.1 million in milestone payments, contingent on the achievement of various regulatory and commercial milestones. Under the terms of the license agreement, we also must pay a royalty of mid- to upper-single digit percentages of net sales, depending on the amount of annual sales, and subject to downward adjustment to lower- to mid-single digit percentages in the event there is no valid patent for the product in the U.S. at the time of sale. After the first sale of product, we will owe an annual minimum royalty payment of $100,000 that will increase annually by $25,000 for the duration of the term. We will be responsible for all patent expenses incurred by Licensor for the term of the agreement although Licensor is responsible for filing, prosecution, and maintenance of all patents. NoveCite – On October 6, 2020, our subsidiary NoveCite entered into a license agreement with Novellus Therapeutics Limited (“Licensor”), whereby NoveCite acquired an exclusive, worldwide license, with the right to sublicense, to develop and commercialize a stem cell therapy based on the Licensor’s patented technology for the treatment of acute pneumonitis of any etiology in which inflammation is a major agent in humans. Upon execution of the license agreement, NoveCite paid an upfront payment of $5,000,000 to Licensor and issued to Licensor shares of Novecite’s common stock representing 25% of NoveCite’s currently outstanding equity. We own the other 75% of NoveCite’s currently outstanding equity. In July 2021, Novellus was acquired by Brooklyn ImmunoTherapeutics (“Brooklyn”). Pursuant to this transaction, the NoveCite license was assumed by Brooklyn with all original terms and conditions. In October 2021, Brooklyn changed its name to Eterna Therapeutics Inc. (“Eterna”). As part of the Novellus and Brooklyn merger transaction, the 25% non-dilutive position per the subscription agreement between Novellus and NoveCite was removed. Under the license agreement, NoveCite is obligated to pay Licensor up to an aggregate of $51,000,000 in regulatory and developmental milestone payments. NoveCite also must pay a royalty equal to low double-digit percentages of net sales, commencing upon the first commercial sale of a licensed product. This royalty is subject to downward adjustment on a product-by-product and country-by-country basis to an upper-single digit percentage of net sales in any country in the event of the expiration of the last valid patent claim or if no valid patent claim exists in that country. The royalty will end on the earlier of (i) date on which a biosimilar product is first marketed, sold, or distributed by Licensor or any third party in the applicable country or (ii) the 10-year anniversary of the date of expiration of the last-to-expire valid patent claim in that country. In the case of a country where no licensed patent ever exists, the royalty will end on the later of (i) the date of expiry of such licensed product’s regulatory exclusivity and (ii) the 10-year anniversary of the date of the first commercial sale of the licensed product in the applicable country. In addition, NoveCite will pay to Licensor an amount equal to a mid-twenties percentage of any sublicensee fees it receives. Under the terms of the license agreement, in the event that Licensor receives any revenue involving the original cell line included in the licensed technology, then Licensor shall remit to NoveCite 50% of such revenue. 58 LYMPHIR - In September 2021, the Company announced that it had entered into a definitive agreement with Dr. Reddy’s to acquire its exclusive license of E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. Citius Pharma subsequently renamed E7777 as LYMPHIR. Under the terms of this agreement, Citius Pharma acquired Dr. Reddy’s exclusive license of LYMPHIR from Eisai and other related assets owned by Dr. Reddy’s (now owned by Citius Oncology). Our exclusive license rights, through our subsidiary, include rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. Additionally, we, through our subsidiary, have an option on the right to develop and market the product in India. Eisai retains exclusive development and marketing rights for the agent in Japan and Asia. Dr. Reddy’s received a $40 million upfront payment and is entitled to up to $40 million in development milestone payments related to CTCL approvals in the U.S. and other markets, up to $70 million in development milestones for additional indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales. Eisai is to receive a $6 million development milestone payment upon initial approval and additional commercial milestone payments related to the achievement of net product sales thresholds. Eisai was responsible for completing the CTCL clinical trial, and CMC activities through the filing of a Biologics License Application (“BLA”) for LYMPHIR with the FDA. The BLA was filed in September 2022. We, through Citius Oncology, will be responsible for development costs associated with potential additional indications. On July 29, 2023, we received a Complete Response Letter, (“CRL”) from the FDA regarding the BLA seeking approval for LYMPHIR. The FDA has required that we incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review. The FDA raised no concerns relating to the safety and efficacy clinical data package. On September 8, 2023, we announced that the FDA agreed with our plans to address the requirements outlined in the CRL. The guidance from the FDA provides a path for completing the necessary activities to support the resubmission of the BLA. No additional clinical efficacy or safety trials have been requested by the FDA for the resubmission. Based on the feedback from the FDA, we plan to complete the CRL remediation activities by the end of the year and file the resubmission in early 2024. Results of Operations for Year Ended September 30, 2023 compared to Year Ended September 30, 2022 Year Ended September 30, 2023 Year Ended September 30, 2022 Revenues $ — $ — Operating expenses: Research and development 14,819,729 17,655,482 General and administrative 15,295,584 11,754,609 Stock-based compensation – general and administrative 6,616,705 3,905,954 Total operating expenses 36,732,018 33,316,045 Operating loss (36,732,018 ) (33,316,045 ) Interest income 1,179,417 251,399 Gain on sale of New Jersey net operating losses 3,585,689 — Loss before income taxes (31,966,912 ) (33,064,646 ) Income tax expense 576,000 576,000 Net loss $ (32,542,912 ) $ (33,640,646 ) 59 Revenues We did not generate any revenues for the years ended September 30, 2023 and 2022. Research and Development Expenses For the year ended September 30, 2023, research and development expenses were $14,819,729 as compared to $17,655,482 for the year ended September 30, 2022, a decrease of $2,835,753. Research and development costs for Mino-Lok® decreased by $33,894 to $4,216,761 for the year ended September 30, 2023 as compared to $4,250,655 for the year ended September 30, 2022, driven primarily by decreased start-up costs associated with the global clinical research organization, Biorasi, LLC, that assisted in the opening of international sites, primarily in India, for the Phase 3 Mino-Lok trial. Research and development costs for our Halo-Lido product candidate increased by $1,378,662 to $4,076,010 for the year ended September 30, 2023 as compared to $2,697,348 for the year ended September 30, 2022 due to higher costs associated with the initiation of the Phase 2 study for the year ended September 30, 2023. On June 20, 2023, we announced that the high dose formulation of CITI-002, a lidocaine and halobetasol propionate combination formulation, provided a meaningful reduction in symptom severity, as reported by patients, when compared to individual components alone. Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study. Citius intends to schedule an end of Phase 2 meeting with the FDA to begin planning the next steps in the regulatory and clinical development program for CITI-002. During the year ended September 30, 2023, research and development costs for our proposed novel cellular therapy for acute respiratory distress syndrome (ARDS) were $193,898 as compared to $1,777,288 for the year ended September 30, 2022. The decrease of $1,583,390 was primarily related to lower preclinical and manufacturing costs in the year ended September 30, 2023. During the year ended September 30, 2023, research and development expenses for our LYMPHIR product candidate were $6,081,385 as compared to $8,693,775 during the year ended September 30, 2022. The decrease of $2,612,390 was primarily due to reduced costs associated with the completion of the Phase 3 clinical trial, as well as the completion and submission of the Biologics License Application to the FDA, which we filed in September 2022. We expect that research and development expenses will continue to stabilize in fiscal 2024 as we continue to focus on the commercialization of LYMPHIR, and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido. 60 General and Administrative Expenses For the year ended September 30, 2023, general and administrative expenses were $15,295,584 as compared to $11,754,609 for the year ended September 30, 2022, an increase of $3,540,975. The primary reason for the increase was costs associated with pre-launch and market research activities associated with LYMPHIR. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting and corporate development services, and investor relations expenses. Stock-based Compensation Expense For the year ended September 30, 2023, stock-based compensation expense was $6,616,705 as compared to $3,905,954 for the year ended September 30, 2022. Stock-based compensation expense includes options granted to directors, employees, and consultants. The primary reason for the $2,710,751 increase in stock-based compensation expense was the grant of options under the Citius Oncology stock plan. Option expense under the Citius Oncology stock plan was $1,965,500 during the year ended September 30, 2023. For the years ended September 30, 2023 and 2022, stock-based compensation expense also includes $130,382 and $133,332, respectively, for the NoveCite stock option plan. In fiscal year 2023, we granted options to our new employees and additional options to other employees, our directors, and consultants. At September 30, 2023, unrecognized total compensation cost related to unvested options for Citius Pharma common stock of $4,840,874 is expected to be recognized over a weighted average period of 1.5 years, unrecognized total compensation cost related to unvested options for Citius Oncology common stock of $18,882,500 is expected to be recognized over a weighted average period of 2.6 years, and unrecognized total compensation cost related to unvested options for NoveCite common stock of $47,575 is expected to be recognized over a weighted average period of 0.7 years. Other Income During the year ended September 30, 2023, the Company earned $1,179,417 of interest income compared to $251,399 of interest income during the year ended September 30, 2022. The increase of $928,018 was due to higher interest rates earned on the investment of the remaining proceeds from our equity offerings and common stock warrant exercises in money market accounts. Other income for the year ended September 30, 2023 also includes the $3,585,689 gain recognized in connection with the sale of certain New Jersey income tax net operating losses to a third party under the New Jersey Technology Business Tax Certificate Transfer Program. 61 Income Taxes The Company recorded deferred income tax expense of $576,000 for in each of the years ended September 30, 2023 and 2022 related to the amortization for taxable purposes of its in-process research and development asset. Net Loss For the year ended September 30, 2023, we incurred a net loss of $32,542,912 compared to a net loss of $33,640,646 for the year ended September 30, 2022. The $1,097,734 decrease in the net loss was primarily due to the increase in other income of $4,513,707 offsetting the increase in our operating expenses of $3,415,973. LIQUIDITY AND CAPITAL RESOURCES Liquidity and Working Capital Citius Pharma has incurred operating losses since inception and incurred net losses of $32,542,912 and $33,640,646 for the years ended September 30, 2023 and 2022, respectively. At September 30, 2023, Citius Pharma had an accumulated deficit of $162,231,379. Citius Pharma’s net cash used in operations during the years ended September 30, 2023 and 2022 was $29,060,212 and $28,361,256, respectively. As a result of our common stock offerings and common stock warrant exercises in fiscal year 2021 and the May 2023 registered direct offering, the Company had working capital of approximately $29,000,000 at September 30, 2023. We expect that we will have sufficient funds to continue our operations through August 2024. At September 30, 2023, Citius Pharma had cash and cash equivalents of $26,480,928 available to fund its operations. The Company’s only source of cash flow since inception has been from financing activities. During the year ended September 30, 2023, the Company received net proceeds of $13,829,450, from the issuance of equity. Our primary uses of operating cash were for in-licensing of intellectual property, product development and commercialization activities, employee compensation, consulting fees, legal and accounting fees, insurance, and investor relations expenses. Financing Activities In November 2022, the Company was selected to participate in New Jersey’s Technology Business Tax Certificate Transfer (NOL) Program and received $3,585,689 million in non-dilutive capital through the New Jersey Economic Development Authority on December 29, 2022. On May 8, 2023, the Company closed a registered direct offering with certain institutional investors for 12,500,001 common shares and warrants to purchase 12,500,001 common shares, at a purchase price of $1.20 per share of common stock and accompanying warrant, for gross proceeds of $15,000,001. The warrants have an exercise price of $1.50 per share, are exercisable six months from the date of issuance, and expire five years from the date of issuance. The Company also issued 875,000 warrants to the placement agent as part of the transaction. Net proceeds of the offering totaled approximately $13,798,183. During the year ended September 30, 2023, we received $31,267 in proceeds from the exercise of common stock options. Based on our cash and cash equivalents at September 30, 2023, we expect that we will have sufficient funds to continue our operations through August 2024. We expect to raise additional capital in the future to support our operations beyond August 2024. There is no assurance, however, that we will be successful in raising the needed capital or that the proceeds will be received in an amount or in a timely manner to support our operations. 62 Inflation Our management believes that inflation has not had a material effect on our results of operations. Off Balance Sheet Arrangements We do not have any off-balance sheet arrangements. CRITICAL ACCOUNTING POLICIES Our discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and related disclosure of contingent assets and liabilities. We review our estimates on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates. We believe the judgments and estimates required by the following accounting policies to be critical in the preparation of our financial statements. Research and Development Research and development costs, including upfront fees and milestones paid to collaborators who are performing research and development activities under contractual agreement with us, are expensed as incurred. We defer and capitalize our nonrefundable advance payments that are for research and development activities until the related goods are delivered or the related services are performed. When we are reimbursed by a collaboration partner for work we perform, we record the costs incurred as research and development expenses and the related reimbursement as a reduction to research and development expenses in our statement of operations. Research and development expenses primarily consist of clinical and non-clinical studies, materials and supplies, third-party costs for contracted services, and payments related to external collaborations and other research and development related costs. In-process Research and Development and Goodwill In-process research and development of $19,400,000 represents the value of LMB’s drug candidate, Mino-Lok, an antibiotic lock solution in Phase 3 clinical development, which if approved, would be used to treat catheter-related bloodstream infections, and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. In-process research and development of $40,000,000 represents the value of our September 2021 acquisition of an exclusive license for LYMPHIR (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma and is expected to be amortized on a straight-line basis over a period of twelve years commencing upon revenue generation. Goodwill represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized and will be tested at least annually for impairment. 63 The Company reviews intangible assets annually to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining useful life of any intangible asset. If the carrying value of an asset exceeds its undiscounted cash flows, the Company writes down the carrying value of the intangible asset to its fair value for the period identified. No impairments have occurred since the acquisitions of our intangible assets through September 30, 2023. The Company evaluates the recoverability of goodwill annually or more frequently if events or changes in circumstances indicate that the carrying value of an asset might be impaired, in accordance with Accounting Standard Update (“ASU”) 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment . Goodwill is first qualitatively assessed to determine whether further impairment testing is necessary. Factors that management considers in this assessment include macroeconomic conditions, industry and market considerations, overall financial performance (both current and projected), changes in management and strategy and changes in the composition or carrying amount of net assets. If this qualitative assessment indicates that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, a one-step test is then performed in accordance with ASU 2017-04. Under the simplified model, a goodwill impairment is calculated as the difference between the carrying amount of the reporting unit and its fair value. The Company performed a qualitative assessment for its 2023 analysis of goodwill. Based on this assessment, management does not believe that it is more likely than not that the carrying value of the reporting unit exceeds its fair value. Accordingly, no further testing was performed as management believes that there are no impairment issues with respect to goodwill as of September 30, 2023. Income Taxes We follow accounting guidance regarding the recognition, measurement, presentation, and disclosure of uncertain tax positions in the financial statements. Tax positions taken or expected to be taken in the course of preparing our tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authorities. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded in the financial statements. We recognize deferred tax assets and liabilities based on differences between the financial reporting and tax basis of assets and liabilities using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. We provide a valuation allowance for deferred tax assets for which we do not consider realization of such assets to be more likely than not. Item 7A. Quantitative and Qualitative Disclosures About Market Risk Not required. 64