Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Fiscal
Second Quarter 2024 Financial Results and Provides Business Update
Mino-Lok data analysis on track with topline results
anticipated this quarter
LYMPHIR biologics license application accepted
with PDUFA target action date set for August 13, 2024
CRANFORD, N.J., May 14, 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 second quarter 2024 ended March 31, 2024.
Second Quarter 2024 Business Highlights and
Subsequent Developments
Financial Highlights
"I am pleased to share that we made solid
progress this quarter as we focused on execution and managing our finances. The data analysis of our late-stage asset, Mino-Lok, the only
treatment of its kind in development to salvage infected catheters, remains on track. We look forward to reporting the topline results
later this quarter. Once we review the results, we plan to engage with the FDA to determine the optimal next steps in the program and
look forward to advancing this much-needed alternative to the current standard of care, which often involves painful and costly catheter
removal and replacement," stated Leonard Mazur, Chairman and CEO of Citius.
"Importantly, the BLA submission for LYMPHIR,
our novel IL-2 receptor targeted oncology therapy, was accepted by the FDA, and assigned a late summer 2024 PDUFA target action date.
In anticipation of potential approval, we continue to align the organization for a successful launch," added Mazur.
"Despite a tough capital market environment
for pre-revenue companies, we successfully completed a $15 million registered direct offering, expanding our cash runway and providing
capital to support the execution of our strategic plan. We believe that the merger of our oncology subsidiary with TenX to form a publicly
listed company will make our company more attractive to investors and increase the value of our assets. This transaction is progressing,
and we expect it to be completed in the coming months as we finalize SEC review and await approval by TENK shareholders. As we continue
to meet our goals, we believe additional opportunities to strengthen our capital structure will become available," concluded Mazur.
QUARTER 2024 Financial Results:
As of March 31, 2024, the Company had $12.6 million
in cash and cash equivalents.
As of March 31, 2024, the Company had 159,094,781
common shares outstanding.
Based on our cash and cash equivalents as of March
31, 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 raise additional capital in the future to support our operations beyond December 2024.
Research and Development (R&D) Expenses
R&D expenses were $3.6 million for the quarter
ended March 31, 2024, compared to $4.7 million for the quarter ended March 31, 2023. For the six months ended March 31, 2024, R&D
expenses were $6.2 million as compared to $8.2 million during the six months ended March 31, 2023, a decrease of $1.9 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, complete our Phase 3 trial 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 $4.3 million for the quarter
ended March 31, 2024, compared to $4.8 million for the quarter ended March 31, 2023. The decrease was primarily due to lower costs for
pre-launch and market research activities associated with LYMPHIR during the period.
For the six months ended March 31, 2024, G&A
expenses were $7.9 million as compared to $7.4 million during the six months ended March 31, 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 March 31, 2024, stock-based
compensation expense was $3.1 million as compared to $1.2 million for the quarter ended March 31, 2023. For the six months ended March
31, 2024, stock-based compensation expense was $6.1 million as compared to $2.4 million for the six months ended March 31, 2023. The increase
is primarily due to the Citius Oncology stock plan.
Net loss was $8.5 million, or ($0.05) per share
for the quarter ended March 31, 2024, compared to a net loss of $10.5 million, or ($0.07) per share for the quarter ended March 31, 2023.
The $2 million decrease in the net loss was due to decreases of $1.1 million in research and development expenses and $0.5 million in
general and administrative expenses, and the increase in other income of $2.3 million, being partially offset by the increase in stock-based
compensation expense of $1.9 million.
Net loss was $17.8 million, or ($0.11) per share
for the six months ended March 31, 2024, compared to a net loss of $14.1 million, or ($0.10) per share for the six months ended March
31, 2023. The increase in the net loss was primarily due to the increase in stock-based compensation expense.
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.
The Biologics License Application for LYMPHIR , a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma,
is currently under review by the FDA with August 13, 2024 assigned as the PDUFA target action date. Citius previously 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: risks relating to the results of research and development activities, including those from existing and new pipeline assets; our
need for substantial additional funds; uncertainties relating to preclinical and clinical testing; the FDA may not approve LYMPHIR; 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; 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 ability to realize some or all of the benefits expected to result
from the anticipated spinoff of Citius Oncology or the delay of such benefits; 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 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 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