Citius Pharmaceuticals, Inc.
For the period ended Mar 31, 2026. Filed May 15, 2026.
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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.
Mar 31, 2026 · Filed May 15, 2026
CTXR$0.55-2.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-12-31; filed 2026-02-13.
0001213900-26-015878
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001213900-26-057842
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 64 previous paragraphs and 105 current paragraphs.
38 unchanged; 21 reworded; 37 added; 5 removed; 0 previous and 9 current paragraphs rearranged.
Tables are not compared: 5 previous and 14 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 (37)
Current report
Recent Events
Current report
Commercial Launch Activities
Current report
On March 31, 2026, Citius Oncology provided an update on the U.S. commercial launch of LYMPHIR, highlighting continued adoption across leading oncology centers, broad payer coverage progress, and advancing investigator-led clinical studies. Citius Oncology expects continued expansion in prescribing activity, together with further clinical validation through ongoing investigator-led studies. These trends support LYMPHIR's potential not only for continued integration in the CTCL treatment landscape, but also its potential as a part of a combination immunotherapy regimen in other cancers.
Current report
Key Early Launch Metrics:
Current report
On April 29, 2026, Citius Oncology announced the initial shipment of LYMPHIR to Europe through a regional distribution partner, marking an important milestone in expanding access to the therapy for patients outside the US. LYMPHIR will be made available to eligible patients through Named Patient Programs in accordance with local regulations in each country. The initiation of European distribution represents a strategic step in Citius Oncology’s effort to extend access to LYMPHIR.
Current report
US Distribution Agreements
Current report
International Distribution Agreements
Current report
On October 7, 2025, Citius Oncology entered into an exclusive distribution agreement with Integris Pharma S.A., headquartered in Athens, Greece to make LYMPHIR available to eligible patients through country-specific Named Patient Programs (“NPPs”). The partnership covers Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia. NPPs are formally recognized pathways designed to give patients earlier access to promising new medicines in advance of full marketing authorization and commercial availability in markets outside the U.S. Under these programs, a treating physician may request a therapy for an individual patient when no adequate approved alternatives exist. In doing so, NPPs bridge a critical gap between the completion of clinical trials in each region and broad market introduction, ensuring that patients with serious illnesses are not left waiting for life-extending innovations. These programs provide access, where permitted by local law, and do not constitute commercial approval of LYMPHIR outside the U.S.
Current report
On December 4, 2025, Citius Oncology announced an exclusive distribution agreement with Er-Kim İlaç Sanayi ve Ticaret A.Ş. ("Er-Kim"), a leading pharmaceutical distributor based in Turkey, for LYMPHIR. Under the agreement, Er-Kim will be the exclusive distributor of LYMPHIR in Turkey and key Gulf Cooperation Council (GCC) countries, including Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates.
Current report
On February11, 2026, Citius Oncology announced an exclusive distribution agreement with Uniphar ("Uniphar"), a leading international healthcare services company, to support access to LYMPHIR. Under the agreement, Uniphar will serve as Citius Oncology’s uexclusive distribution partner in designated international territories in Western and stern Europe. Citius Oncology will supply finished product and provide ongoing support in accordance with the agreement. LYMPHIR is not approved for commercial use outside the U.S. and, will be provided solely through country-specific managed access programs, which do not constitute marketing authorization or a commercial launch.
Current report
Investigator Initiated Trials
Current report
On March 4, 2026, Citius Oncology announced positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR administered prior to commercial CD19 directed CAR T therapy in patients with high risk relapsed or refractory diffuse large B cell lymphoma (DLBCL).
Current report
On March 10, 2026, Citius Oncology announced positive topline results from a completed investigator-initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory (Treg) cell depletion activity of LYMPHIR in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies.
Current report
Discussions are ongoing regarding next-stage development with respect to both investigator-initiated trials.
Current report
Research and development costs for LYMPHIR decreased by $2,085,664 to $1,555,815 during the three months ended March 31, 2026, as compared to $3,641,479 for the three months ended March 31, 2025 was primarily related to expense recognized in the three months ended March 31, 2025 for a pre-license inspection batch of LYMPHIR previously manufactured.
Current report
Stock-based compensation expense for the three months ended March 31, 2026, includes $261,565 for Citius Pharma options, $1,858,443 for Citius Oncology options and $1,668,267 for Citius Oncology restricted stock awards. Stock-based compensation expense for the three months ended March 31, 2025 includes $613,459 for Citius Pharma options and $2,088,572 for Citius Oncology options.
Current report
Other Income (Expense)
Current report
We recognized a gain of $3,833,277 for the three months ended March 31, 2026, in connection with the sale of certain New Jersey income tax net operating losses to a third party under the New Jersey Technology Business Tax Certificate Transfer Program.
Current report
For the three months ended March 31, 2026, we incurred a net loss of $28,109,746, as compared to a net loss of $11,511,505 for the three months ended March 31, 2025. The increase of $16,598,241 in the net loss was due to the increase of $22,272,528 in operating expenses offset by the increase in gross profit of $1,338,420, the increase in other income of $3,840,417 and the decrease in income tax expense of $495,450.
Current report
Revenues
Current report
We believe that revenues will increase in the future as LYMPHIR gains market acceptance as Citius Oncology has already seen initial accounts placing repeat orders, and on April 29, 2026, Citius Oncology announced our initial shipment to Europe.
Current report
Research and Development Expenses
Current report
For the six months ended March 31, 2026, research and development expenses were $3,233,237, as compared to $5,893,563 during the six months ended March 31, 2025, a decrease of $2,660,326.
Current report
Research and development costs for LYMPHIR decreased by $2,303,609 to $3,065,410 during the six months ended March 31, 2026, as compared to $5,369,019 for the six months ended March 31, 2025, was primarily related to expense recognized in the three months ended March 31, 2025 for a pre-license inspection batch LYMPHIR previously manufactured.
Current report
General and Administrative Expenses
Current report
For the six months ended March 31, 2026, general and administrative expenses were $32,111,828, as compared to $10,179,874 during the six months ended March 31, 2025. General and administrative expenses increased by $21,931.954 in comparison with the prior period. The increase of $21,931,954 was primarily related to a notice of termination from a contract manufacturing organization received in February 2026. In March 2026, we recorded a contract cancellation fee of $19,733,307. Other general and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Current report
Stock-based compensation expense under all plans for the six months ended March 31, 2026 and 2025 was $8,068,502 (including $585,742 for Citius Pharma options, $4,110,478 for Citius Oncology options and $3,372,282 for Citius Oncology restricted stock unit awards) and $5,226,825 (including $1,329,775 for Citius Pharma options and $3,897,050 for Citius Oncology options), respectively.
Current report
Other Income (Expense)
Current report
We recognized a gain of $3,833,277 for the six months ended March 31, 2026, in connection with the sale of certain New Jersey income tax net operating losses to a third party under the New Jersey Technology Business Tax Certificate Transfer Program.
Current report
Income Taxes
Current report
The Company recorded a deferred income tax expense of $33,030 for the six months ended March 31, 2026 and a deferred income tax expense of $528,480 for the six months ended March 31, 2025. Deferred income tax expense is related to the amortization for taxable purposes of our in-process research and development asset offset by the financial statement amortization of our in-process research and development asset.
Current report
Net Loss
Current report
For the six months ended March 31, 2026, we incurred a net loss of $37,503,635, as compared to a net loss of $21,792,751 for the six months ended March 31, 2025. The increase of $15,710,884 in the net loss was due to the increase of $24,407,025 in operating expenses offset by the increase in gross profit of $4,493,323, the increase in other income of $3,707,368 and the decrease in income tax expense of $495,450.
Current report
On April 24, 2026, Citius Pharma closed a registered direct offering for the sale of 5,076,143 shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $0.985 per share. The Company also issued immediately exercisable unregistered warrants to purchase 5,076,143 shares of common stock at $0.86 per share. Gross proceeds were approximately $5.0 million, before deducting the placement agent fees and expenses.
Current report
On May 5, 2026, Citius Oncology, entered into an agreement with the holder of certain existing warrants to purchase 12,777,778 shares of Citius Oncology common stock, which consists of all of the 6,818,182 shares underlying warrants originally issued on July 16, 2025, all of the 5,142,858 shares underlying warrants originally issued on September 10, 2025, and 816,738 shares underlying warrants originally issued December 10, 2025, each with an exercise price of $1.09 per share. As an inducement to the holder for exercising the warrants in cash at a reduced exercise price of $0.90 per share, Citius Oncology issued the holder new warrants to purchase up to an aggregate of 25,555,556 shares of Citius Oncology common stock, which have similar terms to the exercised warrants and an exercise price of $0.90. Gross proceeds were approximately $11.5 million, before deducting the placement agent fees and expenses.
Current report
On May 5, 2026 Citius Oncology, entered into a Loan Agreement that makes available term loans in an aggregate principal amount of up to $25.0 million (collectively, the “Loans”), with (i) $10.0 million to be funded on May 6, 2026, (ii) up to $7.0 million beginning on the later of (A) the date on which certain net revenue and liquidity milestones are achieved and (B) October 1, 2026, and continuing through December 31, 2026, and (iii) up to $8.0 million beginning on the later of (A) the date on which certain additional net revenue milestones are achieved and one or more Tranche 2 Loans have been drawn and (B) January 1, 2027, and continuing through March 31, 2027.
Current report
The Loans bear interest at an annual rate equal to the greater of (x) prime plus 6.00% or 12.75%. and mature on November 1, 2029.
Removed paragraphs (5)
Previous report
Research and development costs for LYMPHIR decreased by $217,945 to $1,509,595 during the three months ended December 31, 2025, as compared to $1,727,540 for the three months ended December 31, 2024 primarily related pre commercial manufacturing implementation services related to product labeling and serialization.
Previous report
Stock-based Compensation Expense
Previous report
Interest Income (Expense)
Previous report
For the three months ended December 31, 2025, we incurred a net loss of $9,393,889, as compared to a net loss for the three months ended December 31, 2024 of $10,281,246. The $887,357 decrease in net loss was primarily due to our gross profit on revenues of $3,154,903 offset by an increase of $2,134,497 in our total operating expenses, primarily related to the granting of restricted stock awards.
Previous report
During the three months ended December 31, 2025, Citius Pharma received net proceeds of approximately $5.8 million from equity offerings and Citius Oncology received approximately $15.1 million from an equity offering.
Reworded paragraphs (21)
Previous wording
The following discussion and analysis of our financial condition and results of operations for the three months ended December 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 Pharmaceuticals, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended on January 28, 2026. 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 six months ended March 31, 2026 and 2025 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 Pharmaceuticals, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended on January 28, 2026. 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
At the time of the FDA approval for LYMPHIR, a $27.5 million milestone payment became payable to Dr. Reddy’s under the terms of the asset purchase agreement for which a balance of $18.25 million remains due as of December 31, 2025. Dr. Reddy’s agreed to a partial deferral without penalty of this milestone payment.
Current wording
At the time of the FDA approval for LYMPHIR, a $27.5 million milestone payment became payable to Dr. Reddy’s under the terms of the asset purchase agreement for which a balance of $17.65 million remains due as of March 31, 2026. Dr. Reddy’s agreed to a partial deferral without penalty of this milestone payment.
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. We agreed to pay Eisai $2,535,318 on July 15, 2025, $2,350,000 on the 15 th of each of the subsequent four months, and make a final payment of $2,197,892 on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of payment at the rate of 2% per annum. During the three months ended December 31, 2025, we recorded $45,841 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 our failure 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 December 15, 2025, we paid Eisai the balance of the outstanding milestone approval fee and accumulated interest on the license fee. At December 31, 2025, we owe Eisai approximately $6.8 million for certain other unpaid invoices.
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. We agreed to pay Eisai $2,535,318 on July 15, 2025, $2,350,000 on the 15 th of each of the subsequent four months, and make a final payment of $2,197,892 on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of payment at the rate of 2% per annum. During the six months ended March 31, 2026, we recorded $78,872 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 our failure 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 December 15, 2025, we paid Eisai the balance of the outstanding milestone approval fee and accumulated interest on the license fee. At March 31, 2026, we owe Eisai approximately $6.3 million for certain other unpaid invoices.
Previous wording
The term of the license agreement will continue until (i) March 30, 2026, if there has not been a commercial sale of a licensed product in the territory, or (ii) if there has been a first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale on a country-by-country basis. The first commercial sale occurred in December 2025. 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.
Current wording
The term of the license agreement will continue until the 10-year anniversary of the first commercial sale on a country-by-country basis. The first commercial sale in the United States occurred in December 2025. 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.
Previous wording
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; though approved in August 2024, Dr. Reddy’s waived the six months requirement and the launch of LYMPHIR in December 2025 satisfied this requirement in the U.S.
Current wording
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; though approved in August 2024, Dr. Reddy’s waived the six-month requirement and the launch of LYMPHIR in December 2025 satisfied this requirement in the U.S.
Previous wording
In 2025, the Company executed three service agreements with pharmaceutical specialty distributors who are our customers and who distribute LYMPHIR to healthcare organizations which include academic centers, community oncology practices, as well as infusion centers. The transaction price for gross product revenues under these customer specialty distributor agreements are based on the contractually stated wholesale acquisition cost (“WAC”). The transaction price is reduced for variable considerations, including product returns, chargebacks, co-payment assistance, and other gross-to-net adjustments, which are reasonably estimated by the Company and constrained to amounts that are probable not to result in a significant revenue reversal. As LYMPHIR is a newly launched product, any reasonable estimates made by the Company regarding certain gross-to-net adjustments will result from certain information, such as inventory held by distributors, market data or comparable products, until sufficient historical data becomes available.
Current wording
In 2025, Citius Oncology executed three service agreements with U.S. pharmaceutical specialty distributors who are the customers and who distribute LYMPHIR to healthcare organizations, which include academic centers, community oncology practices, as well as infusion centers. The transaction price for gross product revenues under these customer specialty distributor agreements are based on the contractually stated wholesale acquisition cost. The transaction price is reduced for variable considerations, including product returns, chargebacks, co-payment assistance, and other gross-to-net adjustments, which are reasonably estimated by Citius Oncology and constrained to amounts that are probable not to result in a significant revenue reversal. As LYMPHIR is a newly launched product, any reasonable estimates made by Citius Oncology regarding certain gross-to-net adjustments will result from certain information, such as inventory held by distributors, market data or comparable products, until sufficient historical data becomes available.
Previous wording
Net product revenues for the three months ended December 31, 2025 were $3,944,111, as we began commercial distribution of LYMPHIR in December 2025. Gross profit on net product revenues for the three months ended December 31, 2025 was approximately 80%.
Current wording
Product revenues for the three months ended March 31, 2026 were $1,667,298, as Citius Oncology began commercial distribution of LYMPHIR in December 2025. Gross profit on product revenues for the three months ended March 31, 2026 was approximately 80%.
Previous wording
The Company believes that revenues will increase in the future as LYMPHIR gains market acceptance.
Current wording
We believe that revenues will increase in the future as LYMPHIR gains market acceptance and have already seen initial accounts placing repeat orders, and on April 29, 2026, Citius Oncology announced its initial shipment to Europe.
Previous wording
For the three months ended December 31, 2025, research and development expenses were $1,599,719, as compared to $2,127,038 during the three months ended December 31, 2024, a decrease of $527,319.
Current wording
For the three months ended March 31, 2026, research and development expenses were $1,633,518, as compared to $3,766,525 during the three months ended March 31, 2025, a decrease of $2,133,007.
Previous wording
Amortization of in-process research and development commenced upon revenue generation in December 2025. For the three months ended December 31, 2025 amortization was $573,438. In-process research and development is being amortized on a straight-line basis over the remaining FDA product exclusivity period which ends in August 2036.
Current wording
Amortization of in-process research and development commenced upon revenue generation in December 2025. For the three months ended March 31, 2026, amortization was $1,720,312. In-process research and development is being amortized on a straight-line basis over the remaining FDA product exclusivity period, which ends in August 2036.
Previous wording
For the three months ended December 31, 2025, general and administrative expenses were $5,720,727, as compared to $5,387,752 during the three months ended December 31, 2024. General and administrative expenses increased by $332,975 in comparison with the prior period. Overall general and administrative expenses were consistent with the prior period. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Current wording
For the three months ended March 31, 2026, general and administrative expenses were $26,391,101, as compared to $4,792,122 during the three months ended March 31, 2025. General and administrative expenses increased by $21,598,979 in comparison with the prior period. The increase was primarily related to a notice of termination from a contract manufacturing organization received in February 2026. In March 2026, we recorded a contract cancellation fee of $19,733,307. Other general and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Previous wording
For the three months ended December 31, 2025 stock-based compensation expense was $4,280,227, as compared to $2,524,824 for the three months ended December 31, 2024. Stock-based compensation expense includes $324,177 for Citius Pharma stock options, $2,252,035 for Citius Oncology stock options and $1,704,015 for Citius Oncology restricted stock awards for the three months ended December 31, 2025. Stock-based compensation expense includes $716,345 for Citius Pharma stock options and $1,808,479 for Citius Oncology stock options for the three months ended December 31, 2024. Stock-based compensation expense for the most recently completed quarter increased by $1,755,403 in comparison to the prior period primarily due to the Citius Oncology restricted stock awards granted in September 2025.
Current wording
For the three months ended March 31, 2026, stock-based compensation was $3,788,275 as compared to $2,702,031 for the three months ended March 31, 2025. Stock-based compensation increased by $1,086,244 primarily due to the Citius Oncology restricted stock awards granted in September 2025.
Previous wording
For the three months ended December 31, 2025, interest income was $45,097, as compared to interest income of $22,608 for the three months ended December 31, 2024. We have invested the remaining proceeds of our equity offerings in money market accounts.
Current wording
For the three months ended March 31, 2026, interest income was $53,584, as compared to interest income of $13,413 for the three months ended March 31, 2025. We have invested the remaining proceeds of our equity offerings in money market accounts.
Previous wording
The Company recorded deferred income tax expense of $264,240 for both the three months ended December 31, 2025 and 2024 related to the amortization for taxable purposes of our in-process research and development asset.
Current wording
The Company recorded a deferred income tax benefit of $231,210 in the three months ended March 31, 2026 and a deferred income tax expense of $264,240 in the three months ended March 31, 2025. Deferred income tax expense or benefit is related to the difference in amortization for taxable purposes of our in-process research and development asset and the financial statement amortization.
Previous wording
Research and development costs for Mino-Lok decreased by $304,186 to $80,830 for the three months ended December 31, 2025, as compared to $385,016 for the three months ended December 31, 2024, due primarily to decreased costs since the completion of the Phase 3 trial as well as catheter validation and combination studies. In November 2024, the Company held a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok.
Current wording
Research and development costs for Mino-Lok decreased by $360,278 to $147,308 for the six months ended March 31, 2026, as compared to $507,586 for the six months ended March 31, 2025, due primarily to decreased costs for the Mino-Lok combination studies, as well as decreased development related manufacturing costs. In November 2024, the Company held a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok. Update?
Previous wording
Research and development costs for Halo-Lido decreased by $8,377 to $2,319 for the three months ended December 31, 2025, as compared to $10,696 for the three months ended December 31, 2024. The Phase 2 study was completed in April 2023. Citius subsequently met with the FDA for an end of Phase 2 meeting to discuss next steps in the clinical development program.
Current wording
Research and development costs for Halo-Lido decreased by $6,627 to $4,069 for the six months ended March 31, 2026, as compared to $10,696 for the six months ended March 31, 2025. The Phase 2 study was completed in April 2023. Citius subsequently met with the FDA for an end of Phase 2 meeting to discuss next steps in the clinical development program.
Previous wording
For the three months ended December 31, 2025, interest expense was $155,538, as compared to $0 for the three months ended December 31, 2024. For the three months ended December 31, 2025, interest expense of $45,841 was related to the March 28, 2025 letter agreement with Eisai and interest expense on the note payable, including the fair value of the warrant issued to the lender was $109,697.
Current wording
For the six months ended March 31, 2026, interest expense was $188,569, as compared to $0 for the six months ended March 31, 2025. For the six months ended March 31, 2026, interest expense of $78,872 was related to the March 28, 2025 letter agreement with Eisai and interest expense on the note payable, including the fair value of the warrant issued to the lender was $109,697.
Previous wording
We have incurred operating losses since inception and incurred a net loss of approximately $9.4 million for the three months ended December 31, 2025. At December 31, 2025, we had an accumulated deficit of approximately $247 million. At December 31, 2025, we had $7.7 million in cash and a negative working capital of approximately $262,000. Our net cash used in operations during the three months ended December 31, 2025 was approximately $13 million. Our primary source of cash flow since inception has been from financing activities. We have had limited revenue from sales of LYMPHIR, which commenced in December 2025.
Current wording
We have incurred operating losses since inception and incurred a net loss of approximately $37.5 million for the six months ended March 31, 2026. At March 31, 2026, we had an accumulated deficit of approximately $268.3 million. At March 31, 2026, we had approximately $4.6 million in cash and a negative working capital of approximately $23.3 million. Our net cash used in operations during the six months ended March 31, 2026 was approximately $14.3 million. Our primary source of cash flow since inception has been from financing activities. We have had limited revenue from sales of LYMPHIR, which commenced in December 2025.
Previous wording
In order to satisfy our outstanding milestone payment obligations, as well as meet minimum purchase commitments under our agreements for the manufacture and supply of our drug product, in addition to generating income from the sale of LYMPHIR, we need to obtain substantial additional financing and cannot be sure that any additional funding will be available on terms favorable to us, or at all. As of December 31, 2025, our outstanding milestone payments and purchase commitments for 2025 include:
Current wording
In order to satisfy our outstanding milestone payment obligations, as well as meet minimum purchase commitments under our agreements for the manufacture and supply of our drug product, in addition to generating income from the sale of LYMPHIR, we need to obtain substantial additional financing and cannot be sure that any additional funding will be available on terms favorable to us, or at all. As of March 31, 2026, our outstanding milestone payments and purchase commitments include:
Previous wording
After giving effect to our recent equity offerings during the three months ended December 31, 2025, we expect that we and Citius Oncology collectively will have sufficient funds to continue our operations through May 2026. We will need to raise additional capital in the future to support our operations beyond May 2026. There is no assurance, however, that we will be successful in raising 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 our April 24, 2026 registered direct offering and the Citius Oncology May 5, 2026 warrant exercise and loan agreement, we expect that we and Citius Oncology collectively will have sufficient funds to continue our operations through November 2026. We will need to raise additional capital in the future to support our operations beyond November 2026. There is no assurance, however, that we will be successful in raising needed capital or that the proceeds will be received in an amount or in a timely manner to support our operations.
Previous wording
During the three months ended December 31, 2025, we paid the final $2,900,000 due to Eisai in connection with the LYMPHIR approval milestone and paid $1,500,000 in connection with the milestone payment due to Dr. Reddy’s. At December 31, 2025, we owe Dr. Reddy’s $18,250,000 representing the balance of the approval milestone.
Current wording
During the six months ended March 31, 2026, we paid the final $2,900,000 due to Eisai in connection with the LYMPHIR approval milestone and paid $2,100,000 in connection with the milestone payment due to Dr. Reddy’s. At March 31, 2026, we owe Dr. Reddy’s $17,650,000 representing the balance of the approval milestone.
Rearranged current paragraphs (9)
Current report — wording carried from elsewhere
Research and development costs for Mino-Lok decreased by $56,092 to $66,478 for the three months ended March 31, 2026, as compared to $122,570 for the three months ended March 31, 2025 primarily related to lower costs related to Mino-Lok combination studies. In November 2024, the Company held a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok.
Current report — wording carried from elsewhere
Research and development costs for Halo-Lido were $1,750 for the three months ended March 31, 2026, as compared to no costs for the three months ended March 31, 2025. The Phase 2 study was completed in April 2023. Citius subsequently met with the FDA for an end of Phase 2 meeting to discuss next steps in the clinical development program.
Current report — wording carried from elsewhere
For the three months ended March 31, 2026, interest expense was $33,031, as compared to $0 for the three months ended March 31, 2025 all related to the March 28, 2025 letter agreement with Eisai.
Current report — wording carried from elsewhere
Six months ended March 31, 2026 compared with the six months ended March 31, 2025
Current report — wording carried from elsewhere
Product revenues for the six months ended March 31, 2026 were $5,611,409, as Citius Oncology began commercial distribution of LYMPHIR in December 2025. Gross profit on product revenues for the six months ended March 31, 2026 was approximately 80%.
Current report — wording carried from elsewhere
Amortization of in-process research and development
Current report — wording carried from elsewhere
Amortization of in-process research and development commenced upon revenue generation by LYMPHIR in December 2025. For the six months ended March 31, 2026 amortization was $2,293,750. In-process research and development is being amortized on a straight-line basis over the remaining FDA product exclusivity period which ends in August 2036.
Current report — wording carried from elsewhere
Stock-based compensation expense for the six months ended March 31, 2026 increased by $2,841,647 in comparison to the prior period primarily due to the Citius Oncology restricted stock unit awards granted in September 2025.
Current report — wording carried from elsewhere
For the six months ended March 31, 2026, interest income was $98,681, as compared to interest income of $36,021 for the six months ended March 31, 2025. We have invested the remaining proceeds of our equity offerings in money market accounts.