Full Press Release Details
Pharmaceuticals, Inc. Reports Third Fiscal Quarter 2021
Financial Results and Provides General Business Update
$115.7 million in cash and cash equivalents
as of June 30, 2021 to develop pipeline and invest in long-term growth
Mino-Lok Phase 3 superiority
trial advancing following independent Data Monitoring Committee recommendation to proceed without any modifications
CRANFORD, N.J., August 12, 2021 -- Citius Pharmaceuticals, Inc.
("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization
of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products
and stem cell therapy, today reported financial results for the third fiscal quarter of 2021 ended June 30, 2021, and provided a
general business update.
Third Fiscal Quarter 2021 and Recent Business Highlights
"During the quarter, we made progress with all of our programs
despite the ongoing challenges of conducting preclinical work and clinical trials during the extended COVID-19 pandemic. We remain encouraged
by the positive recommendation of the independent DMC to continue the Mino-Lok Phase 3 pivotal superiority trial as planned
and are fully committed to submitting an NDA for the treatment of infected catheters, a potentially life-threatening condition for the
nearly 500,000 patients with catheter-related bloodstream infections in the U.S. each year. Given rising COVID-19 infection rates across
the U.S., hospitals are, understandably, prioritizing COVID-19 patients and studies. Consequently, we expect recruitment for our Mino-Lok
trial will be slower in the near term than we had originally planned. To address this, we are exploring multiple paths to support our
patient recruitment and randomization efforts and are confident that we have the resources in place to complete the trial in a timely
manner. We look forward to updating you on these efforts in due course," stated Myron Holubiak, President and Chief Executive Officer
of Citius Pharmaceuticals.
"The persistence of COVID-19 is a reminder that treatment of
acute respiratory distress syndrome (ARDS) will continue to be an important need worldwide. Accordingly, we remain focused on further
developing our engineered stem cell program, which holds the potential to offer a novel and scalable therapy for all causes of ARDS. We
have initiated a pilot study in mice and are completing our proof-of-concept sheep study, for which we expect to have topline results
by the end of this quarter. Additionally, our IND submission for Halo-Lido is on track for later this year and in vitro CMC work for Mino-Wrap
is underway. With a solid balance sheet to support our activities, we are now better positioned than ever before to execute our strategy
and deliver value to patients and shareholders," added Mr. Holubiak.
Third Fiscal Quarter 2021 Financial Results:
As of June 30, 2021, the Company had $115.7 million in cash and cash
equivalents. During the three months ended June 30, 2021, the Company issued 11.2 million shares of Citius common stock upon the exercise
of warrants for aggregate proceeds of approximately $16.9 million. During the nine months ended June 30, 2021, the Company received $31.1
million in proceeds from the exercise of common stock warrants.
In January 2021, the Company closed a private placement for common
stock and warrants totaling gross proceeds of approximately $20 million. In February 2021, the Company closed a registered direct offering
of its common stock and warrants for gross proceeds of approximately $76.5 million.
On June 21, 2021, stockholders approved an amendment to the Company's
Articles of Incorporation to increase the authorized number of shares from 210,000,000 to 410,000,000 and the authorized number of common
shares from 200,000,000 to 400,000,000. As of June 30, 2021, the Company had 145,979,429 common shares issued and outstanding.
During the first half of 2021, the Company raised a total of $127.6
million through financing activities. We estimate that we will have sufficient funds for our operations through March 2023.
Research and Development (R&D) Expenses
R&D expenses were $2.2 million and $9.9 million for the three and
nine months ended June 30, 2021, respectively, compared to $2.6 million and $7.3 million for the comparable periods in 2020. The decrease
in research and development expenses for the quarter ended June 30, 2021, compared to the prior-year quarter reflects decreases in R&D
expenses for our Mino-Lok and Halo-Lido product candidates, offset by an increase in R&D expenses for Mino-Wrap and our proposed
novel stem cell therapy for acute respiratory distress syndrome (ARDS).
The increase in research and development expenses for the nine months
ended June 30, 2021 compared to the prior year period is primarily due to a $5.5 million increase in R&D expenses related to our proposed
novel stem cell therapy for ARDS, offset by decreases in R&D expenses for our other pipeline products, including a decrease in manufacturing
research and development costs for registration batches of Mino-Lok and a decrease in R&D expenses associated with
manufacturing development and our patient reported outcome tool for Halo-Lido.
We expect that research and development expenses will increase in fiscal
2021 as we continue to focus on our Phase 3 trial for Mino-Lok , 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 $3.4 million and $7.4 million for the three and
nine months ended June 30, 2021, respectively, compared to $1.9 million and $5.7 million for the comparable periods in 2020. The primary
reason for the increase is incremental costs associated with investor relations and legal services, as well as additional compensation
costs for new employees and performance bonuses. General and administrative expenses consist primarily of compensation costs, professional
fees related to our capital raising activities, corporate development services, and investor relations.
Stock-based Compensation Expense
For the three months ended June 30, 2021, stock-based compensation
expense was $0.4 million as compared to $0.2 million for the three months ended June 30, 2020. For the nine months ended June 30, 2021,
stock-based compensation expense was $1.0 million as compared to $0.6 million for the nine months ended June 30, 2020. The increase reflects
expenses related to new grants made by Citius and the recently adopted NoveCite stock option plan.
Net loss was $5.8 million and $18.1 million for the three and nine
months ended June 30, respectively, compared to a net loss of $4.7 million and $13.4 million for the comparable periods in 2020. The increase
in net loss is primarily due to the increase in general and administrative expenses and an increase in our research and development activities
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 anti-infectives in adjunct cancer care, unique prescription
products, and stem cell therapy. The Company's lead product candidate, Mino-Lok , an antibiotic lock solution for
the treatment of patients with catheter-related bloodstream infections (CRBSIs), is currently enrolling patients in a Phase 3 pivotal
superiority trial. Mino-Lok was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Through
its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent
stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on acute respiratory distress syndrome (ARDS) associated with
COVID-19. 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 "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: our ability
to successfully undertake and complete clinical trials and the results from those trials for our product candidates; risks relating to
the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products
under development; our need for substantial additional funds; 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; market and other
conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to attract, integrate, and retain
key personnel; 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 dependence on third-party
suppliers; 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, 2020, filed with the SEC on December 16, 2020 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