CTOR 8-K/A
Citius Oncology, Inc. (CTOR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Amendment No. 1)
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
| (State
or other jurisdiction of incorporation) |
(Commission File Number) | (IRS
Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code: (
420 Lexington Avenue, Suite 2446
New York, NY 10170
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
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If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
INTRODUCTORY NOTE
As used in this Amendment No. 1 to the Current Report on Form 8-K (“Amendment No. 1”), unless otherwise stated or the context clearly indicates otherwise, the terms the “Company,” “we,” “us,” and “our” refer to Citius Oncology, Inc., formerly named TenX Keane Acquisition.
In accordance with “reverse acquisition” accounting treatment, TenX’s historical financial statements as of period ends, and for periods ended, prior to the closing of the Business Combination have been replaced with the historical financial statements of SpinCo prior to the Closing, and will be in all future filings with the SEC.
In connection with the Closing, as previously disclosed in the Original Report, the Registrant changed its fiscal year end from December 31 to September 30, effective as of August 14, 2024, SpinCo’s fiscal year end prior to the Business Combination.
This Amendment No. 1 to the Original Report is being filed for the purpose of amending the disclosure required by Item 2.01 — Completion of Acquisition or Disposition of Assets under “Form 10 Information — Management’s Discussion and Analysis of Financial Condition and Results of Operations and Quantitative and Qualitative Disclosures About Market Risk” and the historical financial statements provided under Item 9.01 — Financial Statements and Exhibits in the Original Report to include:
| (i) | Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three and nine months ended June 30, 2024; |
| (ii) | the unaudited balance sheets as of June 30, 2024 and September 30, 2023, the unaudited statements of operations for the three and nine months ended June, 2024 and 2023, the unaudited statements of changes in shareholders’ equity for the three and nine months ended June 30, 2024 and 2023, and the unaudited statements of cash flows for the nine months ended June 30, 2024 and 2023; and |
| (iii) | the unaudited pro forma condensed combined financial information of SpinCo and the Company as of and for the six months ended June 30, 2024 and year ended December 31, 2024. |
Except as described above, no other changes have been made to the Original Report and this Amendment No. 1 does not modify or update any other information in the Original Report. Information not affected by the changes described above is unchanged and reflects the disclosures made at the time of the Original Report.
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Item 2.01. Completion of Acquisition or Disposition of Assets.
FINANCIAL INFORMATION
Reference is made to the disclosure set forth in Item 9.01 of this Amendment No. 1 concerning the financial information of the Company and such information is incorporated herein by reference.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The information set forth in Exhibit 99.2 to this Amendment No. 1 is incorporated herein by reference.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information set forth in sections (a), (b) and (d) of Item 9.01 of this Amendment No. 1 is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(a) Financial Statements of Businesses Acquired
Included as Exhibit 99.1 and incorporated herein by reference are the unaudited financial statements of SpinCo as of and for the nine months ended June 30, 2024 and 2023.
Included as Exhibit 99.2 and incorporated herein by reference is Management’s Discussion and Analysis of Financial Condition and Results for the three and nine months ended June 30, 2024.
(b) Unaudited Pro Forma Financial Information
The unaudited pro forma condensed combined financial information of SpinCo and the Company as of and for six months ended June 30, 2024 and the year ended December 31, 2023 is attached hereto as Exhibit 99.3 and is incorporated herein by reference.
(d) Exhibits
| Exhibit No. | Description of Exhibits | |
| 99.1 | Unaudited Financial Statements of SpinCo as of and for the Nine Months Ended June 30, 2024 and 2023. | |
| 99.2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Nine Months Ended June 30, 2024. | |
| 99.3 | Unaudited Pro Forma Condensed Combined Financial Information as of and for the Six Months Ended June 30, 2024 and 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: August 26, 2024
| CITIUS ONCOLOGY, INC. | ||
| By: | /s/ Leonard Mazur | |
| Name: | Leonard Mazur | |
| Title: | Chief Executive Officer (Principal Executive Officer) | |
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Exhibit 99.1
CITIUS ONCOLOGY SUB, INC.
FINANCIAL STATEMENTS
(UNAUDITED)
INDEX
1
BALANCE SHEETS
(UNAUDITED)
| June 30, 2024 |
September 30, 2023 |
|||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | — | $ | — | ||||
| Prepaid expenses | 10,006,815 | 7,734,895 | ||||||
| Total Current Assets | 10,006,815 | 7,734,895 | ||||||
| Other Assets: | ||||||||
| In-process research and development | 40,000,000 | 40,000,000 | ||||||
| Total Other Assets | 40,000,000 | 40,000,000 | ||||||
| Total Assets | $ | 50,006,815 | $ | 47,734,895 | ||||
| LIABILITIES AND STOCKHOLDER’S EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | — | $ | 1,289,045 | ||||
| Accrued expenses | 445,001 | 259,071 | ||||||
| Due to related party | 30,946,953 | 19,499,119 | ||||||
| Total Current Liabilities | 31,391,954 | 21,047,235 | ||||||
| Deferred tax liability | 1,584,000 | 1,152,000 | ||||||
| Total Liabilities | 32,975,954 | 22,199,235 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholder’s Equity: | ||||||||
| Preferred stock - $0.0001 par value; 10,000,000 shares authorized at June 30, 2024 and September 30, 2023; no shares issued and outstanding | — | — | ||||||
| Common stock - $0.0001 par value; 100,000,000 shares authorized at June 30, 2024 and September 30, 2023; 67,500,000 shares issued and outstanding | 6,750 | 6,750 | ||||||
| Additional paid-in capital | 49,489,750 | 43,658,750 | ||||||
| Accumulated deficit | (32,465,639 | ) | (18,129,840 | ) | ||||
| Total Stockholder’s Equity | 17,030,861 | 25,535,660 | ||||||
| Total Liabilities and Stockholder’s Equity | $ | 50,006,815 | $ | 47,734,895 | ||||
See notes to the unaudited financial statements.
Reflects a 675,000-for-1 stock split effective July 5, 2023.
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STATEMENTS OF OPERATIONS
FOR THE THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023
(UNAUDITED)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| June 30, | June 30, | June 30, | June 30, | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues | $ | — | $ | — | $ | — | $ | — | ||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | 1,131,439 | 1,235,068 | 3,628,900 | 3,088,661 | ||||||||||||
| General and administrative | 1,540,411 | 1,348,527 | 4,443,899 | 3,988,893 | ||||||||||||
| Stock-based compensation – general and administrative | 1,957,000 | — | 5,831,000 | — | ||||||||||||
| Total Operating Expenses | 4,628,850 | 2,583,595 | 13,903,799 | 7,077,554 | ||||||||||||
| Loss before Income Taxes | (4,628,850 | ) | (2,583,595 | ) | (13,903,799 | ) | (7,077,554 | ) | ||||||||
| Income tax expense | 144,000 | 144,000 | 432,000 | 432,000 | ||||||||||||
| Net Loss | $ | (4,772,850 | ) | $ | (2,727,595 | ) | $ | (14,335,799 | ) | $ | (7,509,554 | ) | ||||
| Net Loss Per Share – Basic and Diluted | $ | (0.07 | ) | (0.04 | ) | (0.21 | ) | (0.11 | ) | |||||||
| Weighted Average Common Shares Outstanding – Basic and Diluted | 67,500,000 | 67,500,000 | 67,500,000 | 67,500,000 | ||||||||||||
See notes to the unaudited financial statements.
Reflects a 675,000-for-1 stock split effective July 5, 2023.
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STATEMENTS OF CHANGES IN STOCKHOLDER’S EQUITY
FOR THE THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023
(UNAUDITED)
| Common Stock | Additional Paid-In |
Accumulated | Stockholder’s | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance, September 30, 2023 | 67,500,000 | $ | 6,750 | $ | 43,658,750 | $ | (18,129,840 | ) | $ | 25,535,660 | ||||||||||
| Stock-based compensation | — | — | 1,917,000 | — | 1,917,000 | |||||||||||||||
| Net loss | — | — | — | (4,727,403 | ) | (4,727,403 | ) | |||||||||||||
| Balance, December 31, 2023 | 67,500,000 | 6,750 | 45,575,750 | (22,857,243 | ) | 22,725,257 | ||||||||||||||
| Stock-based compensation | — | — | 1,957,000 | — | 1,957,000 | |||||||||||||||
| Net loss | — | — | — | (4,835,546 | ) | (4,835,546 | ) | |||||||||||||
| Balance, March 31, 2024 | 67,500,000 | 6,750 | 47,532,750 | (27,692,789 | ) | 19,846,711 | ||||||||||||||
| Stock-based compensation | — | — | 1,957,000 | — | 1,957,000 | |||||||||||||||
| Net loss | — | — | — | (4,772,850 | ) | (4,772,850 | ) | |||||||||||||
| Balance, June 30, 2024 | 67,500,000 | $ | 6,750 | $ | 49,489,750 | $ | (32,465,639 | ) | $ | 17,030,861 | ||||||||||
| Balance, September 30, 2022 | 67,500,000 | $ | 6,750 | $ | 41,693,250 | $ | (5,432,599 | ) | $ | 36,267,401 | ||||||||||
| Net loss | — | — | — | (1,852,435 | ) | (1,852,435 | ) | |||||||||||||
| Balance, December 31, 2022 | 67,500,000 | 6,750 | 41,693,250 | (7,285,034 | ) | 34,414,966 | ||||||||||||||
| Net loss | — | — | — | (2,929,524 | ) | (2,929,524 | ) | |||||||||||||
| Balance, March 31, 2023 | 67,500,000 | 6,750 | 41,693,250 | (10,214,558 | ) | 31,485,442 | ||||||||||||||
| Net loss | — | — | — | (2,727,595 | ) | (2,727,595 | ) | |||||||||||||
| Balance, June 30, 2023 | 67,500,000 | $ | 6,750 | $ | 41,693,250 | $ | (12,942,153 | ) | $ | 28,757,847 | ||||||||||
See notes to the unaudited financial statements.
Reflects a 675,000-for-1 stock split effective July 5, 2023.
4
STATEMENTS OF CASH FLOWS
FOR THE NINE MONTHS ENDED JUNE 30, 2024 AND 2023
(UNAUDITED)
Nine Months Ended June 30, 2024 | Nine Months Ended June 30, 2023 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | (14,335,799 | ) | $ | (7,509,554 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation expense | 5,831,000 | — | ||||||
| Deferred income tax expense | 432,000 | 432,000 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses | (2,271,920 | ) | (5,044,713 | ) | ||||
| Accounts payable | (1,289,045 | ) | 1,177,539 | |||||
| Accrued expenses | 185,930 | (549,424 | ) | |||||
| Due to related party | 11,447,834 | 11,494,152 | ||||||
| Net Cash Used In Operating Activities | — | — | ||||||
| Net Change in Cash and Cash Equivalents | — | — | ||||||
| Cash and Cash Equivalents – Beginning of Period | — | — | ||||||
| Cash and Cash Equivalents – End of Period | $ | — | $ | — | ||||
See notes to the unaudited financial statements.
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NOTES TO FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JUNE 30, 2024 AND 2023
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Citius Oncology Sub, Inc. (formerly Citius Acquisition Corp. and Citius Oncology, Inc.) (“SpinCo” or the “Company”) is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products targeting unmet needs with a focus on oncology products. We are developing E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma. We have obtained the trade name of LYMPHIR for E7777.
The Company was formed in August 2021 as a wholly-owned subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharmaceuticals”), but did not begin operations until April 1, 2022. On April 29, 2023, we changed our name to Citius Oncology, Inc. and in connection with the closing of the Business Combination (as defined below), we changed our name to Citius Oncology Sub, Inc.
Since its inception, the Company has devoted substantially all its efforts to business planning, research and development, and recruiting management and technical staff. Citius Oncology is subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by Citius Oncology or its competitors of research and development stage products, market acceptance of any of its products approved for marketing, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to obtain additional financing and the Company’s compliance with governmental and other regulations.
Stock Split
On July 5, 2023, the Company executed a stock split of its shares of common stock at a ratio of 675,000-for-1 (the “Stock Split”). All of the Company’s historical share and per share information related to issued and outstanding common stock in these financial statements have been adjusted, on a retroactive basis, to reflect this 675,000-for-1 stock split.
Basis of Presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The accompanying unaudited condensed financial statements of the Company have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the condensed financial position of the Company as of June 30, 2024, and the results of its operations and cash flows for the three- and nine-month periods ended June 30, 2024 and 2023. The operating results for the three- and nine-month periods ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending September 30, 2024. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto included in the final proxy statement/prospectus supplement of TenX Keane Acquisition (File No. 333-275506) (the “Final Prospectus”), filed on July 12, 2024, with the Securities and Exchange Commission (the “SEC”).
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2. GOING CONCERN UNCERTAINTY AND MANAGEMENT’S PLAN
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company had a net loss of $14,335,799 for the nine months ended June 30, 2024. The Company has no revenue and has relied on funding from Citius Pharmaceuticals to finance its operations. At June 30, 2024, the Company had no cash and a negative working capital of $21,385,139. Citius Pharmaceuticals has sufficient capital to fund Citius Oncology through at least December 2024, which raises substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the accompanying financial statements are issued.
The Company plans to continue to rely on funding from Citius Pharmaceuticals and to raise capital through equity financings from outside investors (see Note 9). There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that it will be available on terms acceptable to the Company. The accompanying financial statements do not include any adjustments that might result from the outcome of the above uncertainty.
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A summary of the significant accounting policies followed by the Company in the preparation of the financial statements is as follows:
Use of Estimates
The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates having relatively higher significance include the accounting for in-process research and development and income taxes. Actual results could differ from those estimates and changes in estimates may occur.
Research and Development
Research and development costs, including upfront fees and milestones paid to collaborators who are performing research and development activities under contractual agreements with the Company, are expensed as incurred. The Company defers and capitalizes its nonrefundable advance payments that are for research and development activities until the related goods are delivered or the related services are performed. When the Company is reimbursed by a collaboration partner for work the Company performs, it records the costs incurred as research and development expenses and the related reimbursement as a reduction to research and development expenses in its 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
In-process research and development (“IPR&D”) of $40,000,000 represents the purchase price paid by Citius Pharmaceuticals for the exclusive license for LYMPHIR via the asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”) (See Note 4). LYMPHIR is 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. Included in the IPR&D is the historical know-how, formula protocols, designs, and procedures expected to be needed to complete the Phase 3 trial. In addition, the contracts acquired in connection with the Dr. Reddy’s transaction with the clinical research and manufacturing organization are at market rates and could be provided by multiple vendors in the marketplace Therefore, there is no fair value associated with the contracts acquired. The Company capitalized the technology acquired pursuant to the asset purchase agreement as IPR&D. The technology has an alternative future use and is not contingent on further product development as all formulation work on LYMPHIR has been completed and the Company has the ability to pursue additional clinical indications. The Company expects future economic benefit from the alternative use and has also initiated additional projects that were planned using the technology as acquired.
Incremental costs incurred on IPR&D after the acquisition date are expensed as incurred.
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The Company reviews intangible assets 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 in the period identified. No impairment has occurred since the acquisition through June 30, 2024.
Patents and Trademarks
Certain costs of outside legal counsel related to obtaining trademarks for the Company are capitalized. Patent costs are amortized over the legal life of the patents, generally twenty years, starting at the patent issuance date. There are no capitalized patents and trademarks as of June 30, 2024.
The costs of unsuccessful and abandoned applications are expensed when abandoned. The costs of maintaining existing patents are expensed as incurred.
As part of the definitive agreement with Dr. Reddy’s, Citius Pharmaceuticals acquired method of use patents in which LYMPHIR is administered in combination with the programmed cell death protein 1 (“PD-1”) pathway inhibitor drug class. PD-1 plays a vital role in inhibiting immune responses and promoting self-tolerance through modulating the activity of T-cells, activating apoptosis of antigen-specific T cells and inhibiting apoptosis of regulatory T cells.
The following patents were acquired and subsequently transferred to the Company:
| ● | US Provisional Application No. 63/070,645, which was filed on August 26, 2020, and subsequently published as US 2022/0062390 A1 on March 3, 2022, entitled Methods of Treating Cancer. |
| ● | International Patent Application Number: PCT/IB2021/0576733, which was filed with the World Intellectual Property Organization on August 23, 2021, and subsequently published as WO 2022/043863 A1 on March 3, 2022, entitled, Combination for Use in Methods of Treating Cancer. |
Stock-Based Compensation
The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees and directors as an expense in the statements of operations over the requisite service period based on the fair value for each stock award on the grant date. The fair value of each option grant is estimated as of the date of grant using the Black-Scholes option pricing model. Because the Company’s stock options have characteristics significantly different from those of traded options, and because changes in the input assumptions can materially affect the fair value estimate, the existing model may not necessarily provide a reliable single measure of fair value of the Company’s stock options.
The Company recognizes compensation costs resulting from the issuance of stock-based awards to non-employees as an expense in the statements of operations over the service period based on the measurement of fair value for each stock award and records forfeitures as they occur.
Income Taxes
The Company files consolidated income tax returns with Citius Pharmaceuticals. The Company follows 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 the Company’s 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. There are no uncertain tax positions that require accrual or disclosure as of June 30, 2024. Any interest or penalties are charged to expense. During the nine months ended June 30, 2024 and 2023, the Company did not recognize any interest and penalties. The Company is subject to examination by federal and state authorities for all tax years since inception.
8
The Company recognizes deferred tax assets and liabilities based on differences between the financial reporting and tax basis of assets and liabilities, and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, for deferred tax assets for which it does not consider realization of such assets to be “more-likely-than-not.” The deferred tax benefit or expense for the period represents the change in the deferred tax asset or liability from the beginning to the end of the period.
Basic and Diluted Net Loss per Common Share
Basic and diluted net loss per common share applicable to common stockholders is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding during such period.
Concentrations of Credit Risk
The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements.
Recently Issued Accounting Standards
Management does not believe that any recently issued, but not yet effective, accounting standards, if currently adopted, would have a material effect on the Company’s financial statements.
4. PATENT AND TECHNOLOGY LICENSE AGREEMENTS
In September 2021, Citius Pharmaceuticals entered into an asset purchase agreement with Dr. Reddy’s and a license agreement with Eisai Co., Ltd. (“Eisai”) to acquire an exclusive license for E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. Citius Pharmaceuticals renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIR for the product. Citius Pharmaceuticals assigned these agreements to us effective April 1, 2022.
Under the terms of the agreements, Citius Pharmaceuticals acquired Dr. Reddy’s exclusive license for LYMPHIR from Eisai and other related assets owned by Dr. Reddy’s. The exclusive license includes rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. Additionally, we retain 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, China, Korea, Taiwan, Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India (subject to the India option), Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia, and Papua New Guinea. Citius Pharmaceuticals paid a $40 million upfront payment which represents the acquisition date fair value of the in-process research and development acquired from Dr. Reddy’s. Dr. Reddy’s 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 (within a range of 10% to 15%), and up to $300 million for commercial sales milestones. We also must pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages of net product sales (within a range of 10% to 15%). The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of net sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters prior to the first commercial sale of the biosimilar product. We will also pay to Dr. Reddy’s an amount equal to a low-thirties percentage of any sublicense upfront consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net sales.
Under the license agreement, 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 (which increases to $7 million in the event we have exercised our option to add India to the licensed territory prior to FDA approval) and an aggregate of up to $22 million related to the achievement of net product sales thresholds. The Company was also required to reimburse Eisai for up to $2.65 million of its costs to complete the Phase 3 pivotal clinical trial for LYMPHIR for the CTCL indication and reimburse Eisai for all reasonable costs associated with the preparation of the Biologics License Application (the “BLA”) for LYMPHIR. Eisai was responsible for completing the CTCL clinical trial, and chemistry, manufacturing and controls (“CMC”) activities through the filing of the BLA for LYMPHIR with the FDA. The BLA was filed with the FDA on September 27, 2022. We will also be responsible for development costs associated with potential additional indications.
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The term of the license agreement will continue until (i) if there has not been a commercial sale of a licensed product in the territory, the 10-year anniversary of the original license effective date, which will be March 30, 2016, or (ii) if there has been a first commercial sale of a licensed product in the territory within the 10-year anniversary of the original license effective date, the 10-year anniversary of the first commercial sale on a country-by-country basis. The term of the license may be extended for additional 10-year periods for all countries in the territory by notifying Eisai and paying an extension fee equal to $10 million. Either party may terminate the license agreement upon written notice if the other party is in material breach of the agreement, subject to cure within the designated time periods. Either party also may terminate the license agreement immediately upon written notice if the other party files for bankruptcy or takes related actions or is unable to pay its debts as they become due. Additionally, either party will have the right to terminate the agreement if the other party directly or indirectly challenges the patentability, enforceability or validity of any licensed patent.
Also under the purchase agreement with Dr. Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology trials (both of which have been initiated), (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the definitive agreement, which will be September 1, 2025. Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory approval for such product in each such jurisdiction.
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 FDA for the resubmission. On February 13, 2024, we filed the BLA resubmission package with the FDA and on March 14, 2024, the FDA accepted the BLA resubmission package and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of August 13, 2024.
5. PREPAID EXPENSES
Prepaid expenses at June 30, 2024 and September 30, 2023, consist of advance payments made for the preparation of long-lead time drug substance and product costs, which will be utilized in the manufacturing of LYMPHIR for sales upon approval.
6. STOCKHOLDER’S EQUITY
Authorized Capital Stock and Stock Split
On April 29, 2023, the Company amended its certificate of incorporation to authorize an increase in the total number of shares of capital stock to 110,000,000 shares, of which 100,000,000 shares are common stock with a par value of $0.0001, and 10,000,000 shares are preferred stock with a par value of $0.0001. On July 5, 2023, the Board of Directors approved a 675,000-for-1 stock split of the outstanding 100 shares of common stock.
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All share and per share amounts in these financial statements have been retroactively restated to reflect the amendment to the certificate of incorporation and the stock split.
Stock Plan
Under the Citius Oncology Stock Plan, adopted on April 29, 2023, we reserved 15,000,000 common shares for issuance. The stock plan provides incentives to employees, directors, and consultants through grants of options, SARs, dividend equivalent rights, restricted stock, restricted stock units, or other rights.
The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Volatility is estimated using the trading activity of Citius Pharmaceuticals common stock. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. The expected term of stock options granted to employees and directors, all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally 10 years) and the vesting period. For non-employee options, the expected term is the contractual term.
A summary of option activity under the plan is presented below:
| Shares | Weighted- Average Exercise Price | Weighted- Average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at September 30, 2023 | 12,600,000 | $ | 2.15 | 9.77 years | $ | — | ||||||||||
| Granted | — | — | — | — | ||||||||||||
| Forfeited | — | — | — | — | ||||||||||||
| Outstanding at June 30, 2024 | 12,600,000 | $ | 2.15 | 9.02 years | $ | — | ||||||||||
| Exercisable at June 30, 2024 | 3,605,556 | $ | 2.15 | 9.02 years | $ | — | ||||||||||
Stock-based compensation expense for the three and nine months ended June 30, 2024 was $1,957,000 and $5,831,000.
At June 30, 2024, unrecognized total compensation cost related to unvested awards under the stock plan of $13,011,500 is expected to be recognized over a weighted average period of 2.0 years.
7. RELATED PARTY TRANSACTIONS
The Company’s officers and directors also serve as officers of Citius Pharmaceuticals. As of June 30, 2024, the Company does not have any employees. Effective April 1, 2022, the Company and Citius Pharmaceuticals entered into a shared services agreement. Under the terms of the agreement, Citius Pharmaceuticals provides management and scientific services to the Company.
During the three months ended June 30, 2024, Citius Pharmaceuticals charged the Company $474,688 for reimbursement of general and administrative payroll, $515,838 for reimbursement of research and development payroll, and $30,368 for the use of shared office space. During the three months ended June 30, 2023, Citius Pharmaceuticals charged the Company $422,282 for reimbursement of general and administrative payroll, $483,063 for reimbursement of research and development payroll, and $30,368 for the use of shared office space.
During the nine months ended June 30, 2024, Citius Pharmaceuticals charged the Company $1,330,364 for reimbursement of general and administrative payroll, $1,481,964 for reimbursement of research and development payroll, and $91,103 for the use of shared office space. During the nine months ended June 30, 2023, Citius Pharmaceuticals charged the Company $1,244,532 for reimbursement of general and administrative payroll, $1,068,563 for reimbursement of research and development payroll, and $91,103 for the use of shared office space.
The Company has no cash account at June 30, 2024, therefore all SpinCo’s expenditures are paid by Citius Pharmaceuticals and reflected in the due to related party account.
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8. INCOME TAXES
The Company files consolidated income tax returns with Citius Pharmaceuticals. The Company recorded deferred income tax expense of $432,000 and $432,000 for the nine months ended June 30, 2024 and 2023, respectively, related to the amortization for taxable purposes of its in-process research and development asset.
9. MERGER AGREEMENT
On October 24, 2023, Citius Pharmaceuticals announced that it entered into a definitive agreement for a proposed merger of its wholly owned subsidiary, SpinCo, with TenX Keane Acquisition (NASDAQ: TENKU), a publicly traded special purpose acquisition company. On August 12, 2024, we completed the previously announced Business Combination and TenX Keane Acquisition acquired SpinCo as a wholly owned subsidiary (see Note 10).
A more detailed description of the transaction terms and a copy of the business combination agreement are included in a Current Report on Form 8-K filed on October 24, 2023 by each of Citius Pharmaceuticals and TenX with the United States Securities and Exchange Commission (“SEC”) and the Current Report on Form 8-K filed on August 16, 2024 by Citius Oncology, Inc. In connection with the transaction, TenX filed a registration statement (which contains a proxy statement/prospectus) with the SEC on November 13, 2023, as amended on January 30, 2024, May 3, 2024 and July 11, 2024. The registration statement was declared effective and a final proxy/statement prospectus was filed on July 12, 2024.
10. SUBSEQUENT EVENTS
Lymphir Approval
On August 7, 2024, the FDA approved LYMPHIR.
Closing of Business Combination
On August 12, 2024, Citius Oncology completed the previously announced business combination (the “Closing”) pursuant to that certain Agreement and Plan of Merger and Reorganization, dated as of October 23, 2023 (the “Merger Agreement”), by and among Citius Pharma, SpinCo, TenX (now Citius Oncology, Inc.) and TenX Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of TenX (“Merger Sub”), and the related transaction documents described therein (the “Business Combination”).
As contemplated by the Merger Agreement, on or prior to the Closing Date the following occurred:
| i. | Effective August 5, 2024, TenX’s jurisdiction of incorporation was changed by its deregistering as an exempted company in the Cayman Islands and continuing and domesticating as a corporation incorporated under the laws of the State of Delaware (the “Domestication”). In connection with the consummation of the Domestication, TenX changed its name to “Citius Oncology, Inc.” pursuant to the filing of a certificate of incorporation and adopted bylaws. |
| ii. | As a result of and upon the effective time of the Domestication, (i) each then-issued and outstanding ordinary share, par value $0.0001 per share, of TenX, converted automatically, on a one-for-one basis, into shares of common stock, par value $0.0001 per share, of Citius Oncology; (ii) each then-issued and outstanding right to receive two-tenths of one share of TenX ordinary shares (“TenX Rights”) converted automatically into a right to receive two-tenths of one share of Citius Oncology common stock (“Company Rights”); and (iii) each then-issued and outstanding unit of TenX was canceled and each holder was entitled to one share of Citius Oncology common stock and one Citius Oncology Right. |
| iii. | Following the above steps, Merger Sub merged with and into SpinCo, with SpinCo continuing as the surviving company in the Merger and a wholly-owned subsidiary of Citius Oncology. As a result of the Merger, the existing common stock of SpinCo, par value $0.0001 per share, automatically converted into the right to receive shares of Citius Oncology common stock in accordance with an exchange ratio. |
| iv. | Upon Closing, Citius Pharma (formerly SpinCo’s sole shareholder) received 65,627,262 shares of Citius Oncology common stock. In addition, upon Closing, Maxim Group LLC received 1,872,738 shares of Citius Oncology common stock and Newbridge Securities received 50,000 shares of Citius Oncology common stock, in each case as payment of financial advisory fees. All options to purchase shares of SpinCo common stock were converted into options to purchase shares of Citius Oncology common stock. |
| v. | All closing conditions as referenced in the Merger Agreement were either met or waived by the parties. |
| vi. | Pursuant to the Merger Agreement and the sponsor support agreement entered into concurrently with the execution of the Merger Agreement, Citius Oncology issued 119,500 shares of Citius Oncology common stock to the Sponsor for amounts outstanding under the promissory notes TenX Keane Acquisition issued to the Sponsor on July 18, 2023 and October 18, 2023. Both of the promissory notes issued to the Sponsor evidenced deposits into the Trust Account (as defined in the Merger Agreement) to extend the timeline to complete a business combination. |
| vii. | Immediately after the Closing, Citius Oncology issued a promissory note to the Sponsor, dated August 12, 2024, for $1,288,532 of transaction expenses, which automatically converted into 128,854 shares of Citius Oncology common stock on August 13, 2024. |
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Exhibit 99.2
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 for the three and nine months ended June 30, 2024 and 2023 should be read together with our unaudited financial statements and related notes included elsewhere in this report and in conjunction with our audited financial statements for the years ended September 30, 2023 and 2022 incorporated by reference in this report. The following discussion contains “forward-looking statements” that reflect our future plans, estimates, beliefs and expected performance. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors. We caution that assumptions, expectations, projections, intentions, or beliefs about future events may, and often do, vary from actual results and the differences can be material. Please see “Forward-Looking Statements” in the Original Report, as well as “Risk Factors- Risks Related to SpinCo’s Business and its Industry” beginning on page 62 of the Final Prospectus and incorporated herein by reference. Capitalized terms used but not defined herein are defined in the in the final proxy statement/prospectus supplement (File No. 333-275506), filed by Citius Oncology, Inc., a Delaware corporation (“Citius Oncology” or the “Company”) on July 12, 2024 (the “Final Prospectus”), the Current Report on Form 8-K, filed by the Company on August 16, 2024 (the “Original Report”), or this Amendment No. 1 to the Original Report to which these in these unaudited pro forma condensed combined statements of operations are an exhibit (“Amendment No. 1”).
Business
Citius Oncology, Inc. is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products targeting unmet needs with a focus on oncology products. We are developing LYMPHIR (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma.
We were formed as a Cayman Islands company on March 1, 2021 as an exempted company with limited liability. We were formed for the purpose of entering into a merger, share exchange, asset acquisition, share purchase, recapitalization, reorganization or similar business combination with one or more businesses or entities. On August 5, 2024, we deregistered as an exempted company in the Cayman Islands and continued and domesticated as a corporation incorporated under the laws of the State of Delaware at which time we changed our name from Tenx Keane Acquisition to “Citius Oncology, Inc.” On August 12, 2024, we completed the previously announced Business Combination pursuant to that certain Agreement and Plan of Merger and Reorganization, dated as of October 23, 2023, by and among us, Citius Pharmaceuticals, Inc., Citius Oncology, Inc. (now known as Citius Oncology Sub, Inc., “SpinCo”), and TenX Merger Sub, Inc. In the Business Combination, we acquired SpinCo as a wholly owned subsidiary.
As a result of the Business Combination, our business is that of SpinCo. Since its inception, SpinCo had devoted substantially all its efforts to business planning, research and development, and recruiting management and technical staff for the development of LYMPHIR. We are subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by us or our competitors of research and development stage products, market acceptance of our products, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, our ability to obtain additional financing and our compliance with governmental and other regulations.
Upon closing of the Business Combination, we continue to operate under a shared services agreement with Citius Pharma.
License Agreement with Eisai
In September 2021, Citius Pharma entered into an asset purchase agreement with Dr. Reddy’s and a license agreement with Eisai to acquire an exclusive license for E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. Citius Pharma assigned these agreements to SpinCo effective April 1, 2022. SpinCo has obtained the trade name of LYMPHIR for E7777.
Under the terms of the agreements, Citius Pharma acquired Dr. Reddy’s exclusive license for E7777 from Eisai and other related assets owned by Dr. Reddy’s. The exclusive license includes rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia. Additionally, we retain 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, China, Korea, Taiwan, Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India (subject to the India option), Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia, and Papua New Guinea. Citius Pharma paid $40 million upfront payment which represents the acquisition date fair value of the in-process research and development acquired from Dr. Reddy’s. Dr. Reddy’s 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 (within a range of 10% to 15%), and up to $300 million for commercial sales milestones. We also must pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages of net product sales (within a range of 10% to 15%). The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of net sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters prior to the first commercial sale of the biosimilar product. We will also pay to Dr. Reddy’s an amount equal to a low-thirties percentage of any sublicense upfront consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net sales.
Under the license agreement, Eisai is to receive a $6.0 million development milestone payment upon initial approval and additional commercial milestone payments related to the achievement of net product sales thresholds (which increases to $7 million in the event we have exercised our option to add India to the licensed territory prior to FDA approval) and an aggregate of up to $22 million related to the achievement of net product sales thresholds. Citius Oncology was also required to reimburse Eisai for up to $2.65 million of its costs to complete the Phase 3 pivotal clinical trial for LYMPHIR for the CTCL indication and reimburse Eisai for all reasonable costs associated with the preparation of a Biologics License Application (“BLA”) for LYMPHIR. Eisai was responsible for completing the CTCL clinical trial, and CMC activities through the filing of the BLA for LYMPHIR with the FDA. The BLA was filed with the FDA on September 27, 2022. We will be responsible for development costs associated with potential additional indications.
The term of the license agreement will continue until (i) if there has not been a commercial sale of a licensed product in the territory, the 10-year anniversary of the original license effective date, March 30, 2016, or (ii) if there has been a first commercial sale of a licensed product in the territory within the 10-year anniversary of the original license effective date, the 10-year anniversary of the first commercial sale on a country-by-country basis. The term of the license may be extended for additional 10-year periods for all countries in the territory by notifying Eisai and paying an extension fee equal to $10 million. Either party may terminate the license agreement upon written notice if the other party is in material breach of the agreement, subject to cure within the designated time periods. Either party also may terminate the license agreement immediately upon written notice if the other party files for bankruptcy or takes related actions or is unable to pay its debts as they become due. Additionally, either party will have the right to terminate the agreement if the other party directly or indirectly challenges the patentability, enforceability or validity of any licensed patent.
Also under the purchase agreement with Dr. Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology trials (both of which have been initiated), (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) to complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the definitive agreement. Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory approval for such product in each such jurisdiction.
On July 29, 2023, we received a Complete Response Letter (“CRL”) from the FDA regarding the BLA seeking approval for LYMPHIR. The FDA 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 provided a path for completing the necessary activities to support the resubmission of the BLA. No additional clinical efficacy or safety trials were requested by FDA for the resubmission. On February 13, 2024, we filed the BLA resubmission package with the FDA and on March 18, 2024, the FDA accepted the resubmission of the BLA and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of August 13, 2024. On August 7, 2024, the FDA approved LYMPHIR.
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RESULTS OF OPERATIONS
Results of Operations for Three Months Ended June 30, 2024 compared to Three Months Ended June 30, 2023
Prior to the close of the Business Combination, our only operations consisted of seeking a business combination target. SpinCo did not begin operations until April 1, 2022. As a result, we have a limited operating history.
| Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | |||||||
| Revenues | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| Research and development | 1,131,439 | 1,235,068 | ||||||
| General and administrative | 1,540,411 | 1,348,527 | ||||||
| Stock-based compensation - general and administrative | 1,957,000 | — | ||||||
| Total operating expenses | 4,628,850 | 2,583,595 | ||||||
| Operating loss | (4,628,850 | ) | (2,583,595 | ) | ||||
| Income tax expense | 144,000 | 144,000 | ||||||
| Net loss | $ | (4,772,850 | ) | $ | (2,727,595 | ) | ||
Revenues
We did not generate any revenues for the three months ended June 30, 2024 and 2023.
Research and Development Expenses
We incurred $1,131,439 in research and development expenses for our proposed product candidate LYMPHIR during the three months ended June 30, 2024 compared to $1,235,068 during the three months ended June 30, 2023. The $103,629 decrease was primarily due to due to completion of the BLA resubmission package in the prior quarter. On February 13, 2024, we filed the BLA resubmission package with the FDA and on March 18, 2024, the FDA accepted the resubmission of the BLA and assigned a PDUFA goal date of August 13, 2024. On August 7, 2024, the FDA approved LYMPHIR.
Pursuant to the shared services agreement, during the three months ended June 30, 2024, Citius Pharma charged us $515,838 for reimbursement of research and development payroll compared to $483,063 for the three months ended June 30, 2023.
We expect that research and development expenses will stabilize in fiscal 2024 as we continue to focus on the commercialization of LYMPHIR.
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General and Administrative Expenses
For the three months ended June 30, 2024, general and administrative expenses were $1,540,411 compared to $1,348,527 for the three months ended June 30, 2023. The $191,884 increase was primarily due to higher costs for pre-launch and market research activities associated with LYMPHIR in the current period. Pursuant to the shared services agreement, during the three months ended June 30, 2024, Citius Pharma charged us $474,688 for reimbursement of general and administrative payroll, and $30,368 for the use of shared office space. During the three months ended June 30, 2023, Citius Pharma charged us $422,282 for reimbursement of general and administrative payroll, and $30,368 for the use of shared office space. General and administrative expenses consist primarily of reimbursement costs and market research expenses. We expect that general and administrative expenses will continue to increase in fiscal 2024 as we focus on our pre-launch efforts to commercialize LYMPHIR, and incur additional consulting fees, legal and accounting fees, insurance, and investor relations expenses.
Stock-based Compensation Expense
For the three months ended June 30, 2024, stock-based compensation was $1,957,000. SpinCo adopted a stock plan on April 29, 2023 and granted options to purchase 12,750,000 shares of common stock to directors, employees and consultants during the year ended September 30, 2023. We assumed the stock plan and the outstanding options at the close of the Business Combination. At June 30, 2024, unrecognized total compensation cost related to unvested awards of $13,011,500 is expected to be recognized over a weighted average period of 2.0 years.
Income Taxes
We recorded deferred income tax expense of $144,000 for both of the three-month periods ended June 30, 2024 and 2023 related to the amortization for taxable purposes of its in-process research and development asset.
Net Loss
For the three months ended June 30, 2024, we incurred a net loss of $4,772,850 compared to a net loss of $2,727,595 for the three months ended June 30, 2023. The $2,045,255 increase in the net loss was primarily due to the $1,957,000 stock-based compensation expense incurred during the three months ended June 30, 2024.
Results of Operations for Nine Months Ended June 30, 2024 compared to Nine Months Ended June 30, 2023
Nine
Months | Nine
Months | |||||||
| Revenues | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| Research and development | 3,628,900 | 3,088,661 | ||||||
| General and administrative | 4,443,899 | 3,988,893 | ||||||
| Stock-based compensation - general and administrative | 5,831,000 | — | ||||||
| Total operating expenses | 13,903,799 | 7,077,554 | ||||||
| Operating loss | (13,903,799 | ) | (7,077,554 | ) | ||||
| Income tax expense | 432,000 | 432,000 | ||||||
| Net loss | $ | (14,335,799 | ) | $ | (7,509,554 | ) | ||
Revenues
We did not generate any revenues for the nine months ended June 30, 2024 and 2023.
Research and Development Expenses
We incurred $3,628,900 in research and development expenses for our proposed product candidate LYMPHIR during the nine months ended June 30, 2024 compared to $3,088,661 during the nine months ended June 30, 2023. The $540,239 increase was primarily due to costs associated with new analytical testing methods related to the remediation activities to respond to the CRL. On February 13, 2024, we filed the BLA resubmission package with the FDA and on March 18, 2024, the FDA accepted the resubmission of the BLA and assigned a PDUFA goal date of August 13, 2024. On August 7, 2024, the FDA approved LYMPHIR.
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Pursuant to the shared services agreement, during the nine months ended June 30, 2024, Citius Pharma charged us $1,481,694 for reimbursement of research and development payroll compared to $1,068,563 for the nine months ended June 30, 2023.
We expect that research and development expenses will stabilize in fiscal 2024 as we continue to focus on the commercialization of LYMPHIR.
General and Administrative Expenses
For the nine months ended June 30, 2024, general and administrative expenses were $4,443,899 compared to $3,988,893 for the nine months ended June 30, 2023. The $455,006 increase was primarily due to higher costs associated with pre-launch and market research activities. Pursuant to the shared services agreement, during the nine months ended June 30, 2024, Citius Pharma charged us $1,330,364 for reimbursement of general and administrative payroll, and $91,103 for the use of shared office space. During the nine months ended June 30, 2023, Citius Pharma charged us $1,244,532 for reimbursement of general and administrative payroll, and $91,103 for the use of shared office space. General and administrative expenses consist primarily of reimbursement costs and market research expenses. We expect that general and administrative expenses will continue to increase in fiscal 2024 as we focus on our pre-launch efforts to commercialize LYMPHIR, and incur additional consulting fees, legal and accounting fees, insurance, and investor relations expenses.
Stock-based Compensation Expense
For the nine months ended June 30, 2024, stock-based compensation was $5,831,000. SpinCo adopted a stock plan on April 29, 2023 and granted options to purchase 12,750,000 shares of common stock to directors, employees and consultants during the year ended September 30, 2023. We assumed the stock plan and the outstanding options at the close of the Business Combination. At June 30, 2024, unrecognized total compensation cost related to unvested awards of $13,011,500 is expected to be recognized over a weighted average period of 2.0 years.
Income Taxes
We recorded deferred income tax expense of $432,000 for both of the nine-month periods ended June 30, 2024 and 2023 related to the amortization for taxable purposes of its in-process research and development asset.
Net Loss
For the nine months ended June 30, 2024, we incurred a net loss of $14,335,799 compared to a net loss of $7,509,554 for the nine months ended June 30, 2023. The $6,826,245 increase in the net loss was primarily due to the increase of $5,831,000 in stock-based compensation expense incurred during the nine months ended June 30, 2024.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity and Working Capital
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We had a net loss of $14,335,799 for the nine months ended June 30, 2024. We have no revenue and have relied on funding from Citius Pharma to finance our operations. At June 30, 2024, we had negative working capital of $21,385,139. Citius Pharma has sufficient capital to fund us through December 2024 which raises substantial doubt about our ability to continue as a going concern within one year after the financial statements are issued.
We plan to continue to rely on funding from Citius Pharma and to raise capital through equity financings from outside investors. There is no assurance, however, that Swe will be successful in raising the needed capital and, if funding is available, that it will be available on terms acceptable to us. The accompanying financial statements do not include any adjustments that might result from the outcome of the above uncertainty.
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At June 30, 2024, we had no cash available to fund our operations. Our only source of cash flow since inception has been from Citius Pharma. Our primary expenses were for product development and commercialization activities, market research and reimbursement costs under the shared services agreement.
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 GAAP. 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
In-process research and development (“IPR&D”) of $40,000,000 represents the acquisition value 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. Included in the IPR&D is the historical know-how, formula protocols, designs, and procedures expected to be needed to complete Phase 3. In addition, the contracts acquired in connection with Dr. Reddy’s transaction with the clinical research and manufacturing organization are at market rates and could be provided by multiple vendors in the marketplace Therefore, there is no fair value associated with the contracts acquired.
Incremental costs incurred on IPR&D after the acquisition date are expensed as incurred, unless there is an alternative future use.
We review 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, we write down the carrying value of the intangible asset to its fair value in the period identified. No impairment has occurred since the acquisition through June 30, 2024.
Income Taxes
We file consolidated income tax returns with Citius Pharma. 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.
6
Exhibit 99.3
UNAUDITED PRO FORMA
CONDENSED COMBINED FINANCIAL INFORMATION
The unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2024 and the year ended December 31, 2023 give pro forma effect to the Business Combination as if it had occurred on January 1, 2023. The unaudited pro forma condensed combined balance sheet as of June 30, 2024 gives pro forma effect to the Business Combination as if it was completed on January 1, 2024. Capitalized terms used but not defined herein are defined in the in the final proxy statement/prospectus supplement (File No. 333-275506), filed by Citius Oncology, Inc., a Delaware corporation (“Citius Oncology” or the “Company”) on July 12, 2024 (the “Final Prospectus”), the Current Report on Form 8-K, filed by the Company on August 16, 2024 (the “Original Report”), or this Amendment No. 1 to the Original Report to which these in these unaudited pro forma condensed combined statements of operations are an exhibit (“Amendment No. 1”).
The unaudited pro forma condensed combined financial information is based on and should be read in conjunction with:
| ● | the accompanying notes to the unaudited pro forma condensed combined financial information; |
| ● | the historical financial statements and related notes of TenX Keane Acquisition (now Citius Oncology, Inc.) (prior to the Merger, referred to herein as “TenX Keane Acquisition”) as of and for the six months ended June 30, 2024 included in the Quarterly Report on Form 10-Q, filed by Citius Oncology, Inc. on August 9, 2024, and for the year ended December 31, 2023 included in the Final Prospectus beginning on page F-19; |
| ● | the historical financial statements and related notes of Citius Oncology Sub, Inc. (“SpinCo”) as of and for the nine months ended June 30, 2024 included elsewhere in this Amendment No. 1, and for the year ended September 30, 2023 included in the Final Prospectus beginning on page F-47. The pro forma statement of operations for SpinCo for the six months ended June 30, 2024 was prepared by subtracting the results of operations for SpinCo for the three months ended December 31, 2023 from the statement of operations for SpinCo for the nine months ended June 30, 2024. The pro forma statement of operations for SpinCo for the year ended December 31, 2023 was prepared by (1) subtracting the results of operations for SpinCo for the three months ended December 31, 2022 from (2) the statement of operations for SpinCo for the year ended September 30, 2023, and (3) adding the results of operations for SpinCo for the three months ended December 31, 2023; and |
| ● | other information relating to Citius Oncology and SpinCo included in the Original Report and this Amendment No. 1 and the Final Prospectus, including the Merger Agreement and the description of certain terms thereof set forth under “Proposal No. 1 — The Business Combination Proposal — The Merger Agreement”, as well as the disclosures contained in the sections titled “Citius Oncology’s Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Spin Co’s Management’s Discussion and Analysis of Financial Condition and Results of Operations.” |
The pro forma financial information has been prepared in accordance with Regulation S-X Article 11, Pro Forma Financial Information, as amended by the final rule, Amendments to Financial Disclosures about Acquired and Disposed Businesses, as adopted by the SEC in May 2020 (“Article 11”). The amended Article 11 became effective on January 1, 2021. The unaudited pro forma condensed combined financial statements have been presented for illustrative purposes only and do not necessarily reflect what Citius Oncology’s financial condition or results of operations would have been had the Business Combination occurred on the dates indicated. Further, the unaudited pro forma condensed combined financial information also may not be useful in predicting the future financial condition and results of operations of Citius Oncology. The actual financial position and results of operations may differ significantly from the pro forma amounts reflected herein due to a variety of factors. The unaudited pro forma transaction accounting adjustments represent management’s estimates based on information available as of the date of these unaudited pro forma condensed combined financial statements and are subject to change as additional information becomes available and analyses are performed.
On October 23, 2023, Citius Oncology, Merger Sub, Inc., Citius Pharma, and SpinCo entered into the Merger Agreement, pursuant to which Merger Sub was merged with and into SpinCo, with SpinCo surviving the Merger. SpinCo became a wholly-owned subsidiary of Citius Oncology. In connection with the Business Combination, which was completed on August 12, 2024, TenX changed its name to “Citius Oncology, Inc.” and SpinCo changed its name to “Citius Oncology Sub, Inc.” Citius Oncology adopted September 30 as its fiscal year-end, effective August 14, 2024.
The unaudited pro forma condensed combined financial information has been prepared using the actual redemption of TenX Keane Acquisition Ordinary Shares that were subject to possible redemption into cash:
| ● | Actual Redemptions: This presentation reflects the actual redemption of 4,297,828 TenX Keane Acquisition Ordinary Shares that were subject to possible redemption at June 30, 2024 upon consummation of the Business Combination at a redemption price of approximately $11.40 per share. Pursuant to the terms of the underwriting agreement dated as of October 13, 2022, Maxim Group LLC (“Maxim”), the sole Book Running Manager in the TenX Keane Acquisition initial public offering and current M&A advisor to Citius Pharma, agreed to waive its right to redeem 297,000 TenX Keane Acquisition Ordinary Shares in connection with the Business Combination. |
As a result of the Business Combination and the actual redemptions, the former stockholder of SpinCo (Citius Pharma) owned approximately 92.3% of the issued and outstanding shares of Citius Oncology’s common stock following the closing of the Business Combination, TenX Keane Acquisition’s public stockholders owned approximately 1.3% of the issued and outstanding shares of Citius Oncology’s common stock, the private placement investors in TenX Keane Acquisition owned approximately 0.7% of the issued and outstanding shares of Citius Oncology’s common stock, Maxim held approximately 3.0% of Citius Oncology’s common stock (including 297,000 shares issued in the TenX Keane Acquisition initial public offering and 1,872,738 shares issued to Maxim in connection with the Business Combination as payment for M&A advisory services), Newbridge Securities owned approximately 0.1% of the issued and outstanding shares of Citius Oncology’s common stock as payment for M&A advisory services, and the Sponsor of TenX Keane Acquisition held approximately 2.6% of the issued and outstanding shares of Citius Oncology’s common stock.
In order to finance transaction costs in connection with a Business Combination, other than in connection with the Extension Fees, the Sponsor or an affiliate of the Sponsor, or certain of the Citius Oncology officers and directors could, but were not obligated to, loan Citius Oncology funds as may be required (“Working Capital Loans”). Such Working Capital Loans would be evidenced by promissory notes. The notes would be repaid upon completion of a Business Combination, without interest, or, at the lender’s discretion, up to $1,500,000 of the notes could be converted into units, at the price of $10.00 per unit at the option of the lender. Such units would be identical to the Private Placement Units. In the event that a Business Combination did not close, Citius Oncology could use a portion of proceeds held outside the trust account to repay the Working Capital Loans but no proceeds held in the trust account would be used to repay the Working Capital Loans. As of June 30, 2024, there was $1,720,000 outstanding under Working Capital Loans.
2
UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET
As of June 30, 2024
($ in thousands)
| Citius | Actual Redemptions | |||||||||||||||||
| Citius Oncology, Inc. |
Oncology Sub, Inc. “SpinCo” |
Pro Forma Adjustments |
Notes to Pro Forma Adjustments |
Pro Forma Combined |
||||||||||||||
| ASSETS | ||||||||||||||||||
| Current assets | ||||||||||||||||||
| Cash | $ | — | $ | — | $ | 10,163 | A | $ | 3,963 | |||||||||
| (6,200 | ) | B | ||||||||||||||||
| Prepaid expenses | 41 | 10,007 | — | 10,048 | ||||||||||||||
| Total current assets | 41 | 10,007 | 3,963 | 14,011 | ||||||||||||||
| In-process research and development | — | 40,000 | — | 40,000 | ||||||||||||||
| Investments held in trust account | 49,153 | — | (48,990 | ) | C | — | ||||||||||||
| (163 | ) | A | ||||||||||||||||
| Total other assets | 49,153 | 40,000 | (49,153 | ) | 40,000 | |||||||||||||
| Total assets | $ | 49,194 | $ | 50,007 | $ | (45,190 | ) | $ | 54,011 | |||||||||
| LIABILITIES | ||||||||||||||||||
| Current liabilities | ||||||||||||||||||
| Accounts payable and accrued expenses | $ | 491 | $ | 445 | $ | (419 | ) | B | $ | 517 | ||||||||
| Notes payable | 1,720 | — | (1,720 | ) | G | 3,800 | ||||||||||||
| 3,800 | ||||||||||||||||||
| Due to related parties | 870 | 30,947 | (30,947 | ) | A | — | ||||||||||||
| (870 | ) | B | ||||||||||||||||
| Total current liabilities | 3,081 | 31,392 | (30,156 | ) | 4,317 | |||||||||||||
| Deferred tax liability | — | 1,584 | — | 1,584 | ||||||||||||||
| Total liabilities | 3,081 | 32,976 | (30,156 | ) | 5,901 | |||||||||||||
| Ordinary shares subject to possible redemption 4,312,077 shares at $11.40 per share | 49,153 | — | (48,990 | ) | C | — | ||||||||||||
| (163 | ) | A | ||||||||||||||||
| Stockholders’ Equity | ||||||||||||||||||
| Preferred Stock | — | — | — | — | ||||||||||||||
| Common Stock | — | 7 | — | A | 7 | |||||||||||||
| — | B | |||||||||||||||||
| — | D | |||||||||||||||||
| — | E | |||||||||||||||||
| — | F | |||||||||||||||||
| — | G | |||||||||||||||||
| Additional Paid in Capital | — | 49,490 | 37,147 | A | 80,569 | |||||||||||||
| (4,911 | ) | B | ||||||||||||||||
| 163 | A | |||||||||||||||||
| (3,040 | ) | D | ||||||||||||||||
| — | E | |||||||||||||||||
| — | F | |||||||||||||||||
| 1,720 | G | |||||||||||||||||
| Retained Earnings (Deficit) | (3,040 | ) | (32,466 | ) | 3,040 | D | (32,466 | ) | ||||||||||
| Total Stockholder’s Equity (Deficit) | (3,040 | ) | 17,031 | 34,119 | 48,110 | |||||||||||||
| Total Liabilities and Stockholders’ Equity | $ | 49,194 | $ | 50,007 | $ | (45,190 | ) | $ | 54,011 | |||||||||
3
UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS
For the Six Months Ended June 30, 2024
(amounts in thousands except share and per share data)
| Citius | Actual Redemptions | |||||||||||||||||
| Citius Oncology, Inc. | Oncology Sub, Inc. “SpinCo” | Pro Forma Adjustments | Notes to Pro Forma Adjustments | Pro Forma Combined | ||||||||||||||
| Operating expenses | ||||||||||||||||||
| Research and development | $ | — | $ | 2,480 | $ | $ | 2,480 | |||||||||||
| General and administrative | 653 | 2,926 | 3,579 | |||||||||||||||
| Stock-based compensation – general and administrative | — | 3,914 | 3,914 | |||||||||||||||
| Total operating expenses | 653 | 9,320 | 9,973 | |||||||||||||||
| Loss from operations | (653 | ) | (9,320 | ) | (9,973 | ) | ||||||||||||
| Interest income on investments held in trust account | 1,395 | — | (1,395 | ) | aa | — | ||||||||||||
| Income (loss) before taxes | 742 | (9,320 | ) | (1,395 | ) | (9,973 | ) | |||||||||||
| Taxes | — | 288 | 288 | |||||||||||||||
| Net income (loss) | $ | 742 | $ | (9,608 | ) | $ | (1,395 | ) | $ | (10,261 | ) | |||||||
| Income per share: | ||||||||||||||||||
| Weighted average shares outstanding subject to redemption, basic and diluted | 4,525,784 | — | bb | — | ||||||||||||||
| Weighted average shares outstanding not subject to redemption, basic and diluted | 2,341,000 | 67,500,000 | bb | 71,765,801 | ||||||||||||||
| Basic and diluted net income per share subject to redemption | $ | 0.11 | $ | — | $ | — | ||||||||||||
| Basic and diluted net income (loss) per share not subject to redemption | $ | 0.11 | $ | (0.14 | ) | $ | (0.14 | ) | ||||||||||
4
UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS
For the Year Ended December 31, 2023
(amounts in thousands except share and per share data)
| Citius | Actual Redemptions | |||||||||||||||||
| Citius Oncology Inc. | Oncology Sub, Inc. “SpinCo” | Pro Forma Adjustments | Notes to Pro Forma Adjustments | Pro Forma Combined | ||||||||||||||
| Operating expenses | ||||||||||||||||||
| Research and development | $ | — | $ | 4,455 | $ | $ | 4,455 | |||||||||||
| General and administrative | 1,013 | 6,659 | 7,672 | |||||||||||||||
| Stock-based compensation – general and administrative | — | 3,882 | 3,882 | |||||||||||||||
| Total operating expenses | 1,013 | 14,996 | 16,009 | |||||||||||||||
| Loss from operations | (1,013 | ) | (14,996 | ) | (16,009 | ) | ||||||||||||
| Interest income on investments held in trust account | 3,432 | — | (3,432 | ) | aa | — | ||||||||||||
| Income (loss) before taxes | 2,419 | (14,996 | ) | (3,432 | ) | (16,009 | ) | |||||||||||
| Taxes | — | 576 | 576 | |||||||||||||||
| Net income (loss) | $ | 2,419 | $ | (15,572 | ) | $ | (3,432 | ) | $ | (16,585 | ) | |||||||
| Income per share: | ||||||||||||||||||
| Weighted average shares outstanding subject to redemption, basic and diluted | 6,600,000 | — | bb | — | ||||||||||||||
| Weighted average shares outstanding not subject to redemption, basic and diluted | 2,347,986 | 67,500,000 | bb | 71,559,389 | ||||||||||||||
| Basic and diluted net income per share subject to redemption | $ | 0.27 | $ | — | $ | — | ||||||||||||
| Basic and diluted net income (loss) per share not subject to redemption | $ | 0.27 | $ | (0.23 | ) | $ | (0.23 | ) | ||||||||||
5
NOTES TO THE UNAUDITED PRO FORMA
CONDENSED COMBINED FINANCIAL STATEMENTS
| 1. | Description of the Business Combination |
On October 23, 2023, Citius Oncology, Inc. (formerly TenX Keane Acquisition), Merger Sub, Inc., Citius Pharma, and SpinCo entered into the Merger Agreement, pursuant to which Merger Sub was merged with and into SpinCo, with SpinCo surviving the Merger. SpinCo became a wholly-owned subsidiary of Citius Oncology. In connection with the Business Combination which was completed on August 12, 2024, TenX changed its name to “Citius Oncology, Inc.” and SpinCo changed its name to “Citius Oncology Sub, Inc.”
As a result of the Merger Agreement and application of the Base Exchange Ratio, the former stockholder of SpinCo (Citius Pharma) received 65,627,262 shares of Citius Oncology common stock.
Citius Pharma also contributed $10 million in cash, of which $6.2 million was a capital contribution and $3.8 million is represented by a note payable. In addition, Citius Pharma contributed the $30.9 million balance of the due to related party account to the additional paid-in capital of Citius Oncology.
In connection with the Business Combination, TenX Keane Acquisition Ordinary Shares automatically converted into Citius Oncology common stock.
| 2. | Basis of Presentation |
The unaudited pro forma condensed combined financial information has been prepared in accordance with Article 11. The historical financial information of Citius Oncology and SpinCo have been adjusted in the unaudited pro forma condensed combined financial information to reflect transaction accounting adjustments related to the Business Combination, in accordance with GAAP.
The Business Combination is accounted for as a “reverse recapitalization” in accordance with GAAP. Under the guidance in ASC 805, Citius Oncology is treated as the “acquired” company for financial reporting purposes. Accordingly, the Business Combination is reflected as the equivalent of SpinCo issuing stock for the net assets of TenX Keane Acquisition, accompanied by a recapitalization whereby no goodwill or other intangible assets are recorded. Operations prior to the Business Combination will be those of SpinCo.
In addition, the values will be based on the actual values as of the Closing Date. The differences that may occur between the preliminary estimates and the final purchase accounting could have a material impact on the accompanying unaudited pro forma condensed combined financial information.
SpinCo has been determined to be the accounting acquirer in the Business Combination based on the following predominate factors:
| ● | SpinCo’s existing stockholders have the greatest voting interest in Citius Oncology with over 75% of the voting interest; |
| ● | SpinCo nominated a majority of the initial members of the Citius Oncology board of directors; |
| ● | SpinCo’s senior management is the senior management of Citius Oncology; |
| ● | SpinCo is the larger entity based on historical operating activity and has the larger employee base; and |
| ● | TenX Keane Acquisition assumed SpinCo’s branded name: “Citius Oncology, Inc.” |
6
| 3. | Transaction Accounting Adjustments |
Adjustments to the Unaudited Pro Forma Condensed Combined Balance Sheet as of June 30, 2024
The transaction accounting adjustments included in the unaudited pro forma condensed combined balance sheet as of June 30, 2024 are as follows:
| A | Cash released from trust account and capital contributions received from Citius Pharma |
Adjustment to transfer the remaining balance of approximately $163,000 of investments held in the trust account by TenX Keane Acquisition and converted into cash resources upon close of the Business Combination. This adjustment will also reduce the balance of the ordinary shares subject to possible redemption by approximately $163,000 and increase additional paid-in capital by approximately $163,000 and common stock par value by approximately $16.
Citius Pharma contributed a total of $10 million in cash, of which approximately $6.2 million was a capital contribution and approximately $3.8 million is represented by a note payable. In addition, Citius Pharma contributed the approximately $30.9 million balance of the due to related party account to the additional paid-in capital of Citius Oncology.
| B | Transaction costs |
Adjustment to decrease cash and additional paid-in capital by $6.2 million for the estimated direct and incremental transaction costs comprised of advisory, legal, D&O tail, accounting, industry diligence and miscellaneous fees.
In addition, the TenX Keane Acquisition founders were issued 128,854 shares of Citius Oncology common stock for transaction cost liabilities of approximately $1.3 million, based on a par value of $0.0001, the adjustment to the Citius Oncology common stock par value balance was approximately $13 and the increase in additional paid-in capital was approximately $1.3 million.
| C | Reclassification of the actual redemption of TenX Keane Acquisition Ordinary Shares subject to possible redemption |
To record the actual 4,297,828 TenX Keane Acquisition Ordinary Share redemptions at a redemption price of approximately $11.40 per share. The adjustment reduced investments held in the trust account by $49.0 million. The holders of the underlying TenX Keane Acquisition Rights issued in the TenX Keane Acquisition initial public offering received 1,320,000 shares of the Citius Oncology common stock on completion of the merger, resulting in an increase in common stock par value of $132.
| D | Conversion of SpinCo common stock into Common Stock |
The pro forma adjustment of the reverse recapitalization is as follows:
Adjustment to eliminate Citius Oncology’s retained deficit of approximately $3,040,000 and the $167 par value of the TenX Keane Acquisition Ordinary Shares.
Using a Base Exchange Ratio of approximately 0.97-for-1 the total number of shares of Citius Oncology common stock issued to the SpinCo stockholder was 65,627,262 shares. Based on a par value of $0.0001, the adjustment to the Citius Oncology common stock par value balance was approximately $187. The 65,627,262 shares issued to the SpinCo stockholder was calculated by applying the Base Exchange Ratio to the outstanding 67,500,000 shares of common stock of SpinCo.
| E | Issuance of Common Stock for advisory fees |
Maxim was issued 1,872,738 shares of Citius Oncology common stock and Newbridge Securities was issued 50,000 shares of Citius Oncology common stock, both for M&A advisory fees, based on a par value of $0.0001, the adjustment to the Citius Oncology common stock par value balance was approximately $192. The estimated fair value of the approximately 1,922,738 shares of the Citius Oncology common stock after the increase in par value resulted in no change to additional paid-in capital.
| F | Issuance of Common Stock for underlying Private Placement Rights |
The holders of the Private Placement Rights received 78,800 shares of Citius Oncology common stock on completion of the Merger, resulting in an increase in Citius Oncology common stock par value of $8.
| G | Reclassification of Notes Payable |
Approximately $1.3 million of the notes payable were converted into 119,500 shares of Citius Oncology common stock resulting in an increase of approximately $1.3 million in additional paid-in capital and an increase in common stock par value of $13. Approximately $525,000 of notes payable held by Citius Pharma were contributed to additional paid-in capital.
7
Pro forma Citius Oncology Common Stock outstanding as of June 30, 2024 consists of the following:
| Actual Redemptions |
||||
| Shares issued for outstanding Citius Oncology public shares | 14,249 | |||
| Shares issued for Citius Oncology public shares underlying Citius Oncology Rights | 1,320,000 | |||
| Shares issued to Citius Pharma | 65,627,262 | |||
| Shares issued to Maxim for advisory fees | 1,872,738 | |||
| Shares issued to Newbridge Securities for advisory fees | 50,000 | |||
| Shares issued for outstanding Citius Oncology Private Placement Shares | 394,000 | |||
| Shares issued for outstanding Citius Oncology Private Placement Rights | 78,800 | |||
| Shares issued for outstanding Citius Oncology underwriter shares | 297,000 | |||
| Shares issued for outstanding Citius Oncology founders shares | 1,650,000 | |||
| Shares issued for notes payable to Citius Oncology founders | 119,500 | |||
| Shares issued for Citius Oncology transaction cost liabilities | 128,854 | |||
| Pro forma New Citius Oncology Common Stock outstanding | 71,552,403 |
|||
Adjustments to the Unaudited Pro Forma Condensed Combined Statement of Operations for the Six Months Ended June 30, 2024
The transaction accounting adjustments included in the unaudited pro forma condensed combined statement of operations for the six months ended June 30, 2024 are as follows:
| aa | Represents elimination of interest earned on investments held in the trust account |
| bb | Represents net loss attributable to Citius Oncology Common Stockholders |
Represents the net loss attributable to Citius Oncology common stockholders per share calculated using the historical weighted average shares of common stock outstanding, and the issuance of additional shares in connection with the Business Combination, assuming the shares were outstanding since January 1, 2023. As the Business Combination and related transactions are being reflected as if they had occurred at the beginning of the period presented, the calculation of weighted average shares of common stock outstanding for basic and diluted net loss attributable to common stockholders per share assumes that the shares issuable relating to the Business Combination have been outstanding for the entire period presented. The calculation is retroactively adjusted for the actual redemptions to eliminate such shares for the period. There were no outstanding dilutive securities during the six months ended June 30, 2024, after adjusting for the conversion of the TenX Keane Acquisition Rights and Private Placement Rights issued in the TenX Keane Acquisition IPO and the TenX Keane Acquisition Private Placement, respectively.
|
Actual Redemptions |
||||
| Pro forma net loss | $ | (10,261,000 | ) | |
| Citius Oncology Common Stock weighted average shares outstanding, basic and diluted | 71,765,801 | |||
| Net loss per share of Citius Oncology Common Stock, basic and diluted | $ | (0.14 | ) | |
8
Adjustments to the Unaudited Pro Forma Condensed Combined Statement of Operations for the Year Ended December 31, 2023
The transaction accounting adjustments included in the unaudited pro forma condensed combined statement of operations for the year ended December 31, 2023 are as follows:
| aa | Represents elimination of interest earned on investments held in the trust account |
| bb | Represents net loss attributable to Citius Oncology Common Stockholders |
Represents the net loss attributable to Citius Oncology common stockholders per share calculated using the historical weighted average shares of common stock outstanding, and the issuance of additional shares in connection with the Business Combination, assuming the shares were outstanding since January 1, 2023. As the Business Combination and related transactions are being reflected as if they had occurred at the beginning of the year presented, the calculation of weighted average shares of common stock outstanding for basic and diluted net loss attributable to common stockholders per share assumes that the shares issuable relating to the Business Combination have been outstanding for the entire year presented. The calculation is retroactively adjusted for the actual redemptions to eliminate such shares for the entire year. There were no outstanding dilutive securities during the year ended December 31, 2023, after adjusting for the conversion of the TenX Keane Acquisition Rights and Private Placement Rights issued in the TenX Keane Acquisition IPO and the TenX Keane Acquisition Private Placement, respectively.
| Actual Redemptions |
||||
| Pro forma net loss | $ | (16,585,000 | ) | |
| Citius Oncology Common Stock weighted average shares outstanding, basic and diluted | 71,559,389 | |||
| Net loss per share of Citius Oncology Common Stock, basic and diluted | $ | (0.23 | ) | |
COMPARATIVE SHARE INFORMATION
The following tables set forth:
| ● | historical per share information of TenX Keane Acquisition as of and for the six months ended June 30, 2024, and for the year ended December 31, 2023; |
| ● | historical per share information of SpinCo as of and for the six months ended June 30, 2024, and for the year ended December 31, 2023; and |
| ● | unaudited pro forma per share information of Citius Oncology as of and for the six months ended June 30, 2024, and for the year ended December 31, 2023, after giving effect to the Business Combination, and the actual redemptions is as follows: |
| ● | Actual Redemptions: This presentation reflects the actual redemption of 4,297,828 TenX Keane Acquisition Ordinary Shares that were subject to possible redemption at June 30, 2024 upon consummation of the Business Combination at a redemption price of approximately $11.40 per share. Pursuant to the terms of the underwriting agreement dated as of October 13, 2022, Maxim, the sole Book Running Manager in the TenX Keane Acquisition initial public offering and current M&A advisor to Citius Pharma, agreed to waive its right to redeem 297,000 TenX Keane Acquisition Ordinary Shares in connection with the Business Combination. |
| ● | The following tables should be read in conjunction with the selected historical financial information included elsewhere in the Original Report, this Amendment No. 1 and the Final Prospectus, and the historical financial statements of TenX Keane Acquisition and SpinCo and the related notes thereto that are included elsewhere in the Original Report, this Amendment No. 1 and the Final Prospectus. The unaudited Citius Oncology and SpinCo pro forma combined per share information is derived from, and should be read in conjunction with, the unaudited pro forma condensed combined financial statements and the related notes thereto included elsewhere in this Form 8-K. |
| ● | The unaudited pro forma combined net income (loss) per share information below does not purport to represent the actual results of operations that would have occurred had the companies been combined during the periods presented, nor does it purport to represent the actual results of operations for any future date or periods. The unaudited pro forma combined book value per share information below does not purport to represent what the value of Citius Oncology and SpinCo would have been had the companies been combined during the periods presented. |
9
| Historical | Pro Forma | |||||||||||
| Citius Oncology, Inc. | Citius Oncology Sub, Inc. “SpinCo” | Actual Redemptions | ||||||||||
| As of and for the six months ended June 30, 2024 | ||||||||||||
| Book value per share(1) | $ | (1.30 | ) | $ | 0.25 | $ | 0.67 | |||||
| Shares outstanding not subject to redemption | 2,341,000 | 67,500,000 | 71,564,594 | |||||||||
| Net income (loss) per share, basic and diluted(2) | $ | 0.11 | $ | (0.14 | ) | $ | (0.14 | ) | ||||
| Weighted average shares outstanding – basic and diluted | 6,866,784 | 67,500,000 | 71,765,801 | |||||||||
| For the year ended December 31, 2023 | ||||||||||||
| Net income (loss) per share, basic and diluted(2) | $ | 0.27 | $ | (0.23 | ) | $ | (0.23 | ) | ||||
| Weighted average shares outstanding – basic and diluted | 8,947,986 | 67,500,000 | 71,559,389 | |||||||||
| (1) | Book value per share is calculated as total equity divided by historical and pro forma information outstanding basic shares not subject to redemption. |
| (2) | Net income (loss) per share is based on the historical and pro forma information. |
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