Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Fiscal
Third Quarter 2024 Financial Results and Provides Business Update
Granted FDA approval of LYMPHIR in treatment
of cutaneous T-cell lymphoma
Completed merger of oncology subsidiary with TenX
Keane; Citius Oncology expected to begin trading on Nasdaq on August 13, 2024 under ticker CTOR
Achieved primary and secondary endpoints of Mino-Lok
CRANFORD, N.J., August 12, 2024 -- Citius
Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage
biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported
business and financial results for the fiscal third quarter 2024 ended June 30, 2024.
Third Quarter 2024 Business Highlights and
Subsequent Developments
Financial Highlights
"We continued to achieve multiple value-driving
milestones during and since the end of the quarter. Last week, LYMPHIR was approved by the FDA for the treatment of a rare and incurable
cancer. This the first FDA-approved product in our portfolio and paves the way for Citius Oncology to transition from a development stage
company to a commercial biopharmaceutical organization," stated Leonard Mazur, CEO of Citius Pharma and Citius Oncology.
"The completion of our Phase 3 Pivotal Trial
for Mino-Lok, followed by highly statistically significant topline results that met primary and secondary endpoints, further underscores
our commitment to developing life-saving treatments. Operationally, we secured $15 million in additional funding to extend our runway,
continued expanding our organizational resources to support the planned launch of LYMPHIR, and completed the spin-off of this asset into
our majority-owned standalone, publicly traded oncology company. This should provide us with access to a broader investment community
and enable both companies to begin to focus on their respective development and commercialization paths. In addition to the spin-off,
Citius is evaluating opportunities to optimize the Company's capital allocation, current cash runway, future cash needs, and potential
non-dilutive sources of capital. We believe Citius is poised for a transformative second half of 2024," concluded Mazur.
QUARTER 2024 Financial Results:
As of June 30, 2024, the Company had $17.9 million
in cash and cash equivalents.
As of June 30, 2024, the Company had 158,857,798
common shares outstanding.
Based on our cash and cash equivalents as of June
30, 2024, and after giving effect to a capital raising that closed on April 30, 2024, we expect to have sufficient funds to continue our
operations through December 2024. We expect to identify additional sources of capital in the future to support our operations beyond December
Research and Development (R&D) Expenses
R&D expenses were $2.8 million for the quarter
ended June 30, 2024, compared to $3.8 million for the quarter ended June 30, 2023. For the nine months ended June 30, 2024, R&D expenses
were $9.0 million as compared to $11.9 million during the nine months ended June 30, 2023, a decrease of $2.9 million. The decrease primarily
reflects incremental costs related to the completion of the Mino-Lok Phase 3 trial and remediation activities for the LYMPHIR BLA resubmission,
offset by lower costs in the current period due to the completion of the Halo-Lido Phase 2b trial.
We expect that research and development expenses
will stabilize at current levels in fiscal 2024 as we focus on the commercialization of LYMPHIR, prepare a submission to the FDA and schedule
a Type B meeting for Mino-Lok, and analyze the data from our Phase 2b trial and begin planning our Phase 3 trial for Halo-Lido
General and Administrative (G&A) Expenses
G&A expenses were $4.8 million for the quarter
ended June 30, 2024, compared to $3.7 million for the quarter ended June 30, 2023. The increase was primarily due to lower costs for pre-launch
and market research activities associated with LYMPHIR during the period.
For the nine months ended June 30, 2024, G&A
expenses were $12.8 million as compared to $11.1 million during the nine months ended June 30, 2023. The primary reason for the increase
was higher costs for pre-launch and market research activities associated with LYMPHIR.
General and administrative expenses consist primarily
of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations
Stock-based Compensation Expense
For the quarter ended June 30, 2024, stock-based
compensation expense was $3.1 million as compared to $1.2 million for the quarter ended June 30, 2023. For the nine months ended June
30, 2024, stock-based compensation expense was $9.2 million as compared to $3.5 million for the nine months ended June 30, 2023. The increase
is primarily due to the Citius Oncology stock plan.
Net loss was $10.6 million, or ($0.06) per share for the quarter ended
June 30, 2024, compared to a net loss of $8.5 million, or ($0.06) per share for the quarter ended June 30, 2023. The $2.1 million increase
in the net loss was primarily due to increases of $1.0 million in general and administrative expenses and $1.9 million in stock-based
compensation expense, partially offset by the $1.0 million decrease in research and development expenses.
Net loss was $28.3 million, or ($0.17) per share
for the nine months ended June 30, 2024, compared to a net loss of $22.6 million, or ($0.15) per share for the nine months ended June
30, 2023. The increase in the net loss was primarily due to the increase in stock-based compensation expense.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. is a biopharmaceutical
company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved
LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage
pipeline also includes Mino-Lok , an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections,
and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial
for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius is actively engaged with
the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting
Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate,"
"expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future
dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could
negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ
materially from those currently anticipated, and that apply to Citius Pharma and Citius Oncology as our majority owned subsidiary,
are: the anticipated benefits of the transaction between TenX Keane Acquisition
and Citius Pharma to form Citius Oncology may not be realized fully, if at all, or may take longer to realize than expected; Citius Oncology's
ability to commercialize LYMPHIR; our need for substantial additional funds; risks
relating to the results of research and development activities, including those from existing and new pipeline assets; uncertainties relating
to preclinical and clinical testing; our ability to commercialize our other product candidates if approved by the FDA; our dependence
on third-party suppliers; our ability to procure cGMP commercial-scale supply; the estimated markets for our product candidates and the
acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations;
our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the early stage of products under
development; market and other conditions; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy;
our ongoing businesses which may be adversely affected and subject to certain risks and consequences as a result of the anticipated spinoff
transaction; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies
successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks
may be further impacted by any future public health risks or geopolitical events. Accordingly, these forward-looking statements do not
constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks
regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including
in our Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, and updated by our subsequent
filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking
to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations
or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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