Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Fiscal
Third Quarter 2022 Financial Results and Provides Business Update
$48.0 million in cash and cash equivalents
as of June 30, 2022 to support ongoing programs through August 2023
International sites for Mino-Lok
Phase 3 trial engaged as recruitment accelerates
I/ONTAK Biologics License Application
(BLA) on track for 2H 2022 submission
CRANFORD, N.J., August 11, 2022 -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing
and commercializing first-in-class critical care products, today reported business and financial results for the third fiscal quarter
of 2022 ended June 30, 2022.
Fiscal Q3 2022 Business Highlights and Subsequent
Financial Highlights
"Citius made solid progress during the quarter
to advance our multiple programs. We expanded the Phase 3 Mino-Lok trial to include international sites with the intention of increasing
and accelerating enrollment. Our efforts remain focused on driving patient recruitment, which we believe will hasten trial completion.
Based on the current the pace of enrollment and the ramp up of our international sites, we expect to enroll the last patient, to complete
the trial by the end of 2022, subsequently with the required number of events," stated Leonard Mazur, Chairman and CEO of Citius.
"Our I/ONTAK program remains on track with
an anticipated BLA submission later this year. Topline results for the Phase 3 trial of I/ONTAK were consistent with the prior FDA-approved
formulation (ONTAK) and we believe there remains a significant unmet medical need in the market for CTCL patients. We recently completed
a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) and appreciate their continued guidance. Additionally, the Halo-Lido
Phase 2b trial for the treatment of hemorrhoids was initiated during the quarter and we remain encouraged that we may complete enrollment
in this trial by the end of the year," added Mazur.
"Our balance sheet remains strong with
$48 million in cash available and no debt, providing us with greater strategic and financing flexibility than many of our peers. We believe
these funds are sufficient to allow us to execute our activities through August 2023. To support our value-creating clinical, regulatory
and commercial efforts, and to further unlock the value of I/ONTAK and Citius, we announced our intent to explore a tax-free non-dilutive
spin-off to create a separate publicly traded oncology company. We believe this remains a viable option, notwithstanding recent market
volatility, and will continue to monitor market conditions as we proceed. In addition to a potential spin-off, there are multiple other
non-dilutive options available to Citius including out-licensing agreements, asset sales or other strategic arrangements, as well as non-equity
financing. Consequently, we remain encouraged in the progress of our pipeline and confident in our ability to advance each of our key
programs," concluded Mazur.
QUARTER ENDED JUNE 30, 2022 Financial Results:
As of June 30, 2022, the Company had $48.0 million
in cash and cash equivalents, no debt, and 146,129,630 common shares issued and outstanding.
The Company estimates that its available cash
resources will be sufficient to fund its operations through August 2023.
Research and Development (R&D) Expenses
R&D expenses were $4.9 million and $13.8 million
for the three and nine months ended June 30, 2022, respectively, compared to $2.2 million and $9.9 million for the comparable periods
ended June 30, 2021. The increase during the quarter is primarily due to additional R&D expenses related to the expansion of the Mino-Lok
trial to include sites outside the United States, start-up costs associated with the Halo-Lido Phase 2b trial which enrolled its
first patient in April, 2022, and R&D expenses related to I/ONTAK for which a BLA submission to the FDA is being prepared.
During the nine months ended June 30, 2022, ARDS-related
R&D expenses decreased by $4.7 million compared to $5.3 million during the prior year period. R&D expense for the nine months
ended June 30, 2021 reflected a $5.0 million license fee paid to Novellus.
We expect that research and development expenses
will increase in fiscal 2022 as we continue to focus on our Phase 3 trials for Mino-Lok and I/ONTAK, progress the Halo-Lido
product candidate, and continue our research and development efforts related to ARDS and Mino-Wrap.
General and Administrative (G&A) Expenses
G&A expenses were $3.1 million and $9.0 million
for the three and nine months ended June 30, 2022, respectively, compared to $3.4 million and $7.4 million for the comparable periods
ended June 30, 2021. The decrease during the quarter is primarily due to reduced costs for performance bonuses. The primary reasons for
the increase over the nine-month period were additional compensation costs for new employees, increased investor relations costs and additional
insurance expense. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory,
accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the fiscal quarter ended June 30, 2022, stock-based
compensation expense was $1.0 million as compared to $0.4 million for the prior year period. For the nine months ended June 30, 2022,
stock-based compensation expense was $2.9 million as compared to $1.0 million for the nine months ended June 30, 2021. The increase primarily
reflects expenses related to new grants made by Citius to employees (including new hires), directors and consultants.
Net loss was $8.9 million, or ($0.06) per share
for the three months ended June 30, 2022, compared to a net loss of $5.8 million, or ($0.05) per share for the three months ended June
Net loss was $25.6 million, or ($0.18) per share
for the nine months ended June 30, 2022, compared to a net loss of $18.1 million, or ($0.20) for the nine months ended June 30, 2021.
The increase in net loss is primarily due to an
increase in research and development expenses, general and administrative expenses and stock-based compensation.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company
dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives
in adjunct cancer care, unique prescription products, and stem cell therapies. The Company has two late-stage product candidates, Mino-Lok ,
an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling
patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous
T-cell lymphoma (CTCL), for which a BLA submission is being prepared for the second half of 2022. Mino-Lok was
granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA
for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). For more information, please visit www.citiuspharma.com.
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 "believe," "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: our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates;
our decision whether to proceed with the planned spinoff, if at all, our ability to successfully complete the planned spinoff if undertaken,
and the benefits achieved by the planned spinoff; our need for substantial additional funds; our ability to commercialize our products
if approved by the FDA; 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; 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; the early
stage of products under development; our ability to attract, integrate, and retain key personnel; our dependence on third-party suppliers;
market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to obtain, perform
under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product
candidates and companies successfully and on a timely basis; our ability to procure cGMP commercial-scale supply; 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. 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, 2021, filed with the SEC on December 15, 2021 and updated by our subsequent filings with the SEC. These forward-looking