On February 14, 2025 Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, reported business and financial results for the fiscal first quarter ended December 31, 2024 (Press release, Citius Oncology, FEB 14, 2025, View Source [SID1234650297]).

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Fiscal First Quarter 2025 Business Highlights and Subsequent Developments

Engaged Jefferies as exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value, with multiple active discussions underway;
Progressed commercial readiness for the planned launch of LYMPHIR in the first half of 2025, with key initiatives including:
Manufactured sufficient inventory for launch and initial sales estimates, with additional production in process,
Secured a new permanent J-code, J9161, (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram) for LYMPHIR, assigned by the Centers for Medicare & Medicaid Services (CMS), with an expected effective date of April 1, 2025;
Supported two investigator-initiated trials to explore LYMPHIR’s potential as an immuno-oncology combination therapy being conducted at the University of Pittsburgh Medical Center and the University of Minnesota:
Shared interim trial results with the clinical community at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (SITC) (Free SITC Whitepaper) of University of Pittsburgh Medical Center’s Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab.
Supported expansion of the University of Minnesota’s investigator-initiated Phase I clinical trial to evaluate the safety and efficacy of denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for the treatment of B-cell lymphomas with the dosing of the first patient at City of Hope cancer center.
Financial Highlights

R&D expenses were $1.3 million for the first quarter ended December 31, 2024, compared to $1.2 million for the first quarter ended December 31, 2023;
G&A expenses were $3.3 million for the first quarter ended December 31, 2024, compared to $1.5 million for the first quarter ended December 31, 2023;
Stock-based compensation expense was $1.8 million for the first quarter ended December 31, 2024, compared to $1.9 million for the first quarter ended December 31, 2023; and,
Net loss was $6.7 million, or ($0.09) per share for the first quarter ended December 31, 2024, compared to a net loss of $4.7 million, or ($0.07) per share for the first quarter ended December 31, 2023.
"During the first fiscal quarter of 2025, Citius Oncology advanced key initiatives to bring LYMPHIR to market and focused on exploring strategic options to maximize shareholder value. With FDA approval of LYMPHIR for the treatment of cutaneous T-cell lymphoma (CTCL), we are determined to deliver this much-needed therapy to patients. LYMPHIR remains the only targeted systemic therapy approved for CTCL since 2018 and the only treatment with a mechanism of action that targets the IL-2 receptor. More than 84% of CTCL patients in the Phase III trial experienced skin relief from this debilitating disease," stated Leonard Mazur, Chairman and CEO of Citius Oncology.

"To support the long-term growth potential of LYMPHIR, we engaged Jefferies as our exclusive financial advisor to evaluate strategic alternatives. Active discussions are currently underway; our goal remains to bring LYMPHIR to market expeditiously. We are making strong progress toward our planned commercial launch in the first half of 2025. The inventory for launch is ready and our market access efforts continue with the successful assignment of a new permanent J-code (J9161) by the Centers for Medicare & Medicaid Services set to take effect on April 1, 2025, and the inclusion of LYMPHIR in the NCCN guidelines. These are critical milestones that will help drive clinical adoption and reimbursement," added Mazur.

"Beyond commercial readiness, we are actively supporting two investigator-initiated trials evaluating LYMPHIR’s potential as an immuno-oncology combination therapy. Positive interim results from the University of Pittsburgh Medical Center’s Phase I trial combining LYMPHIR with pembrolizumab were shared at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference in November, highlighting its potential to enhance treatment efficacy in recurrent solid tumors. Furthermore, the University of Minnesota has expanded its Phase I trial exploring denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for B-cell lymphomas, with the first patient dosed at City of Hope cancer center."

"These initiatives reflect our commitment to bringing innovative cancer therapies to patients with high unmet medical needs. With the expected launch of LYMPHIR on the horizon, we remain focused on executing our commercial strategy while exploring strategic opportunities to drive long-term value," concluded Mazur.

FISCAL FIRST QUARTER 2025 FINANCIAL RESULTS:

Research and Development (R&D) Expenses

R&D expenses were $1.3 million for the first quarter ended December 31, 2024, compared to $1.2 million for the first quarter ended December 31, 2023. The increase primarily reflects costs associated with the two investigator immuno-oncology trials which are in process.

General and Administrative (G&A) Expenses

G&A expenses were $3.3 million for the first quarter ended December 31, 2024, compared to $1.5 million for the first quarter ended December 31, 2023. The increase was primarily due to costs associated with pre-commercial and commercial launch activities of LYMPHIR including market research, marketing, distribution and drug product reimbursement from health plans and payers.

Stock-based Compensation Expense

For the first quarter ended December 31, 2024, stock-based compensation expense was $1.8 million as compared to $1.9 million for the prior year. The primary reason for the decrease in stock-based compensation expense was the decrease in the weighted average grant date fair value of the options granted during the three months ended December 31, 2024 to $0.80 per share as compared to the weighted average grant date fair value of the options granted of $1.66 per share during the year ended September 30, 2024.

Net loss

Net loss was $6.7 million, or ($0.09) per share for the first quarter ended December 31, 2024, compared to a net loss of $4.7 million, or ($0.07) per share for the first quarter ended December 31, 2023. The increase in net loss was primarily due to the increase in our operating expenses.