CITIUS ONCOLOGY, INC.
For the period ended Jun 30, 2025. Filed Aug 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0001213900-25-043359
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001213900-25-074992
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 55 previous paragraphs and 63 current paragraphs.
39 unchanged; 15 reworded; 9 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
On June 9, 2025, we announced that we entered into a distribution services agreement with Cardinal Health (NYSE: CAH), a leading provider of pharmaceutical and specialty pharmaceutical distribution services in the United States. This agreement is designed to help provide access to LYMPHIR in support of its anticipated U.S. commercial launch.
Current report
On June 17, 2025, we announced that preparations for the commercial launch of LYMPHIR™, an FDA-approved immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL), are nearing completion. The Company believes it is now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization, with all major launch-enabling activities underway. Final preparations are in process for an anticipated U.S. launch of LYMPHIR in the second half of 2025.
Current report
On July 15, 2025, we announced the execution of a distribution services agreement with Cencora (formerly AmerisourceBergen), a global pharmaceutical services company. This agreement marks another significant step forward in the Company's commercial launch strategy for LYMPHIR.
Current report
Interest Expense
Current report
For the nine months ended June 30, 2025, interest expense was $160,755 as compared to $0 for the three months ended June 30, 2024. This was related to the letter agreement with Eisai.
Current report
Interest Expense
Current report
For the nine months ended June 30, 2025, interest expense was $160,755 as compared to $0 for the nine months ended June 30, 2024. This was related to the letter agreement with Eisai.
Current report
During the three months ended June 30, 2025, Citius Pharma received net proceeds from equity offerings of approximately $10.5 million.
Current report
On July 17, 2025, we completed a public offering of 6,818,182 shares of common stock and warrants to purchase 6,818,182 shares of common stock for gross proceeds of $9,000,000. The shares and warrants were sold at a per unit price of $1.32. The immediately exercisable five-year warrants have an exercise price of $1.32 per share. Gross proceeds from the offering were approximately $9.0 million and net proceeds were approximately $7.44 million, after deducting placement agent fees and other offering expenses.
Removed paragraphs (1)
Previous report
On April 2, 2025, Citius Pharma closed on a registered direct offering to an institutional investor of its common stock and pre-funded warrants to purchase common stock. The net proceeds to Citius Pharma from the offering were approximately $1.735 million, after deducting placement agent fees and other offering expenses payable by Citius Pharma.
Reworded paragraphs (15)
Previous wording
The following discussion and analysis of our financial condition and results of operations for the three and six months ended March 31, 2025 and 2024 should be read together with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Report and in conjunction with the audited financial statements of Citius Oncology, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on December 27, 2024, as amended on January 27, 2025. 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 “Cautionary Note Regarding Forward-Looking Statements” on page iii of this Report.
Current wording
The following discussion and analysis of our financial condition and results of operations for the three and nine months ended June 30, 2025 and 2024 should be read together with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Report and in conjunction with the audited financial statements of Citius Oncology, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on December 27, 2024, as amended on January 27, 2025. 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 “Cautionary Note Regarding Forward-Looking Statements” on page iii of this Report.
Previous wording
On March 28, 2025, Citius Oncology and Eisai entered into a letter agreement that amended the license agreement to provide for a payment schedule to Eisai for the milestone payment and certain unpaid invoices. Citius Oncology has agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,318 and thereafter on the 15 th of each of the next four months to pay Eisai $2,350,000 and make a final payment of $2,197,892 to Eisai on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at the rate of 2% per annum. The parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to the failure of Citius Oncology to pay the milestone payment or the other incurred costs under the license agreement except for any claims arising out of a breach of the letter agreement. All other terms of the license agreement remain in full force and effect.
Current wording
On March 28, 2025, Citius Oncology and Eisai entered into a letter agreement that amended the license agreement to provide for a payment schedule to Eisai for the milestone payment and certain unpaid invoices. Citius Oncology has agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,318 and thereafter on the 15 th of each of the next four months to pay Eisai $2,350,000 and make a final payment of $2,197,892 to Eisai on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at the rate of 2% per annum. During the nine months ended June 30, 2025 we recorded $160,755 in interest expense under the agreement. The parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to the failure of Citius Oncology to pay the milestone payment or the other incurred costs under the license agreement except for any claims arising out of a breach of the letter agreement. All other terms of the license agreement remain in full force and effect. On July 15, 2025, we paid Eisai $2,535,318 plus accrued interest of $172,371.
Previous wording
For the six months ended March 31, 2025, research and development expenses were $4,403,921 as compared to $2,497,461 for the six months ended March 31, 2024, an increase of $1,906,460 primarily related to costs associated with the expense of a drug substance batch needed for the pre-license inspection of the manufacturer.
Current wording
For the three months ended June 30, 2025, research and development expenses were $938,277 as compared to $1,131,439 for the three months ended June 30, 2024, a decrease of $193,162 primarily related to lower costs associated with product validation studies.
Previous wording
For the three months ended March 31, 2025, general and administrative expenses were $2,243,327 as compared to $1,385,580 for the three months ended March 31, 2024, an increase of $857,747. The primary reason for the increase was the efforts associated with the pre-commercial and commercial launch activities of LYMPHIR associated with market research, marketing, distribution and drug product reimbursement from health plans and payers.
Current wording
For the three months ended June 30, 2025, general and administrative expenses were $1,881,447 as compared to $1,540,411 for the three months ended June 30, 2024, an increase of $341,036. The primary reason for the increase was the efforts associated with the pre-commercial and commercial launch activities of LYMPHIR associated with market research, marketing, distribution and drug product reimbursement from health plans and payers.
Previous wording
For the three months ended March 31, 2025, stock-based compensation expense was $2,088,572 as compared to $1,957,000 for the three months ended March 31, 2024. The primary reason for the $131,572 increase in stock-based compensation expense was the new options granted in December 2024.
Current wording
For the three months ended June 30, 2025, stock-based compensation expense was $2,125,237 as compared to $1,957,000 for the three months ended June 30, 2024. The primary reason for the $168,237 increase in stock-based compensation expense was the new options granted in December 2024.
Previous wording
For the six months ended March 31, 2025, we incurred a net loss of $14,394,757 compared to a net loss of $9,562,949 for the six months ended March 31, 2024. The $4,831,808 increase in the net loss was primarily due to the increases of $1,906,460 in research and development and 2,661,818 in general and administrative expenses.
Current wording
For the three months ended June 30, 2025, we incurred a net loss of $5,369,956 compared to a net loss of $4,772,850 for the three months ended June 30, 2024. The $597,106 increase in the net loss was primarily due to the increases of $341,036 in general and administrative expenses and $168,237 in stock-based compensation expense.
Previous wording
Six months ended March 31, 2025 compared with the six months ended March 31, 2024
Current wording
Nine months ended June 30, 2025 compared with the nine months ended June 30, 2024
Previous wording
We did not generate any revenues for the six months ended March 31, 2025 and 2024.
Current wording
We did not generate any revenues for the nine months ended June 30, 2025 and 2024.
Previous wording
For the three months ended March 31, 2025, research and development expenses were $3,139,413 as compared to $1,348,966 for the three months ended March 31, 2024, an increase of $1,790,447 primarily related to costs associated with the expense of a drug substance batch needed for the pre-license inspection of the manufacturer.
Current wording
For the nine months ended June 30, 2025, research and development expenses were $5,342,198 as compared to $3,628,900 for the nine months ended June 30, 2024, an increase of $1,713,298 primarily related to costs associated with the expense of a drug substance batch needed for the pre-license inspection of the manufacturer.
Previous wording
For the six months ended March 31, 2025, general and administrative expenses were $5,565,306 as compared to $2,903,488 for the six months ended March 31, 2024, an increase of $2,661,818. The primary reason for the increase was the efforts associated with the pre-commercial and commercial launch activities of LYMPHIR associated with market research, marketing, distribution and drug product reimbursement from health plans and payers.
Current wording
For the nine months ended June 30, 2025, general and administrative expenses were $7,446,753 as compared to $4,443,899 for the nine months ended June 30, 2024, an increase of $3,002,854. The primary reason for the increase was the efforts associated with the pre-commercial and commercial launch activities of LYMPHIR associated with market research, marketing, distribution and drug product reimbursement from health plans and payers.
Previous wording
For the six months ended March 31, 2025, stock-based compensation expense was $3,897,050 as compared to $3,874,000 for the six months ended March 31, 2024. The primary reason for the $23,050 increase in stock-based compensation expense was the new options granted in December 2024.
Current wording
For the nine months ended June 30, 2025, stock-based compensation expense was $6,022,287 as compared to $5,831,000 for the nine months ended June 30, 2024. The primary reason for the $191,287 increase in stock-based compensation expense was the new options granted in December 2024.
Previous wording
The Company recorded deferred income tax expense of $528,480 in the six months ended March 31, 2025 as compared to $288,000 in the six months ended March 31, 2024 related to the amortization for taxable purposes of its in-process research and development asset.
Current wording
The Company recorded deferred income tax expense of $792,720 in the nine months ended June 30, 2025 as compared to $432,000 in the nine months ended June 30, 2024 related to the amortization for taxable purposes of its in-process research and development asset.
Previous wording
For the three months ended March 31, 2025, we incurred a net loss of $7,735,552 compared to a net loss of $4,835,546 for the three months ended March 31, 2024. The $2,900,006 increase in the net loss was primarily due to the increases of $1,790,447 in research and development and $857,747 in general and administrative expenses.
Current wording
For the nine months ended June 30, 2025, we incurred a net loss of $19,764,713 compared to a net loss of $14,335,799 for the nine months ended June 30, 2024. The $5,428,914 increase in the net loss was primarily due to the increases of $1,713,298 in research and development and $3,002,854 in general and administrative expenses.
Previous wording
Citius Oncology has incurred operating losses since inception and incurred a net loss of $14,394,757 for the six months ended March 31, 2025. At March 31, 2025, we had an accumulated deficit of $53,673,344. The Company has no revenue and has relied on funding from Citius Pharma to finance its operations. At March 31, 2025, we had $112 in cash and a negative working capital of approximately $31.7 million.
Current wording
Citius Oncology has incurred operating losses since inception and incurred a net loss of $19,764,713 for the nine months ended June 30, 2025. At June 30, 2025, we had an accumulated deficit of $59,043,300. The Company has no revenue and has relied on funding from Citius Pharma to finance its operations. At June 30, 2025, we had $112 in cash and a negative working capital of approximately $34.7 million.
Previous wording
After giving effect to the Citius Pharma April 2, 2025 financing, we expect that Citius Pharma will have sufficient funds to continue our operations through May 2025. We will need to raise additional capital in the future to support our operations beyond May 2025. There is no assurance, however, that we will be successful in raising the needed capital or that the proceeds will be received in an amount or in a timely manner to support our operations.
Current wording
After giving effect to the Citius Pharma equity offerings during the three months ended June 30, 2025 and our July 2025 public offering, we expect that we and Citius Pharma collectively will have sufficient funds to continue our operations through September 2025. We will need to raise additional capital in the future to support our operations beyond September 2025, including to complete the launch of LYMPHIR. There is no assurance, however, that we will be successful in raising the needed capital or that the proceeds will be received in an amount or in a timely manner to support our operations.