Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Fiscal
Full Year 2023 Financial Results and Provides Business Update
Mino-Lok Pivotal Phase 3 trial
enrollment completed; topline data expected 2Q 2024
LYMPHIR BLA resubmission on track for early
CRANFORD, N.J., January 2, 2024 -- Citius
Pharmaceuticals, Inc. ("Citius" 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 full year ended September 30, 2023.
Fiscal Full Year 2023 Business Highlights and
Subsequent Developments
Financial Highlights
"In 2023, we made substantial progress in
our pipeline, positioning us for an exciting 2024. Concentrating on execution, we completed enrollment in two trials. With the Mino-Lok
pivotal Phase 3 trial enrollment completed, we expect topline results to be available in the second quarter of 2024. We also completed
the Halo-Lido Phase 2b trial in 2023. Based on the data from the trial, in which more patients receiving the high dose formulation reported
meaningful improvement compared to either lidocaine or halobetasol alone, Citius filed patent applications for the formulation and is
actively pursuing intellectual property protections for the groundbreaking fit for purpose PRO instrument. In early 2024, we plan to meet
with the FDA to discuss the results of the trial and next steps in the Halo-Lido program," stated Leonard Mazur, Chairman and CEO
"Despite receiving a complete response letter
at the end of July 2023 for our LYMPHIR BLA, we were encouraged that the items noted by the FDA were addressable in a timely manner and
unrelated to clinical efficacy or safety. Over the past several months, our team has engaged with the FDA and endeavored to remediate
the agency's concerns. Consistent with progress on this front, we plan to resubmit the BLA in early 2024 with a subsequent PDUFA
date expected this year. Concurrently, we announced a definitive agreement to merge our oncology subsidiary with TenX Kean Acquisition
to form a separate publicly traded company. Now undergoing SEC review, the intent of the spin-out is to align our oncology-related resources
and unlock value for Citius shareholders," added Mazur.
"As we begin 2024, Citius will continue
to focus on execution. With anticipated topline results for Mino-Lok, the LYMPHIR BLA resubmission and potential approval, additional
clarity in our development plan for Halo-Lido, and the planned spin-off of our oncology subsidiary, we believe Citius is well-positioned
to deliver value to shareholders in 2024," concluded Mazur.
Year 2022 Financial Results:
As of September 30, 2023, the Company had $26.5
million in cash and cash equivalents.
As of September 30, 2023, the Company had 158,857,798
common shares outstanding.
The Company estimates that its available cash
resources will be sufficient to fund its operations through August 2024.
Research and Development (R&D) Expenses
R&D expenses were $14.8 million for the full
year ended September 30, 2023, compared to $17.7 million for the full year ended September 30, 2022. The decrease of $2.9 million is primarily
associated with the completion of the LYMPHIR Phase 3 trial and the completion and submission of the related Biologics License Application
to the FDA which was filed in September 2022.
We expect that research and development expenses
will continue to stabilize in fiscal 2024 as we continue to focus on the commercialization of LYMPHIR and complete the Phase 3 trial for
Mino-Lok and the Phase 2b trial for Halo-Lido.
General and Administrative (G&A) Expenses
G&A expenses were $15.3 million for the full
year ended September 30, 2023, compared to $11.8 million for the full year ended September 30, 2022. The increase was primarily due to
costs associated with 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 full year ended September 30, 2023, stock-based
compensation expense was $6.6 million as compared to $3.9 million for the prior year. The increase of $2.7 million is largely due to the
grant of options under the Citius Oncology stock plan. Option expense under the Citius Oncology stock plan was $1.97 million during the
year ended September 30, 2023. In fiscal year 2023, we granted options under the Citius Pharma and Citius Oncology stock plans to our
new employees and additional options to other employees, our directors, and consultants.
At September 30, 2023, unrecognized total compensation
cost related to unvested options for Citius Pharma common stock of $4.8 million is expected to be recognized over a weighted average period
of 1.5 years, unrecognized total compensation cost related to unvested options for Citius Oncology common stock of $18.9 million is expected
to be recognized over a weighted average period of 2.6 years, and unrecognized total compensation cost related to unvested options for
NoveCite common stock of $0.5 million is expected to be recognized over a weighted average period of 0.7 years
Net loss was $32.5 million, or ($0.22) per share
for the year ended September 30, 2023, compared to a net loss of $33.6 million, or ($0.23) per share for the year ended September 30,
2022. The decrease in net loss reflects an increase in operating expenses of $3.4 million offset by an increase of $4.5 million in other
About Citius Pharmaceuticals, Inc.
Citius Pharma is a late-stage biopharmaceutical
company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline
includes two late-stage product candidates. At the end of 2023, Citius completed enrollment in a Phase 3 Pivotal superiority trial of
Mino-Lok , an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. Citius is preparing
to resubmit the Biologics License Application for LYMPHIR, a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma,
in early 2024, and announced plans to form Citius Oncology, a standalone publicly traded company with LYMPHIR as its primary asset. LYMPHIR
received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In addition, Citius completed enrollment in its Phase
2b trial of CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
This 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
are: the cost and timing of the resubmission of the BLA for LYMPHIR; the FDA may not approve LYMPHIR; risks relating to the results of
research and development activities, including those from the Mino-Lok Phase 3 trial and other existing and new pipeline assets; our need
for substantial additional funds; our ability to commercialize our products 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; uncertainties relating to preclinical and clinical testing;
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; 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 have been and may be further impacted by Covid-19 and could be impacted by any future public health risks.
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 Securities and Exchange Commission
("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 Securities
and Exchange Commission. 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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