Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Second
Fiscal Quarter 2021 Financial Results and Provides General Business Update
Raised gross proceeds of $96.5 million
from financing activities during the quarter providing financial runway into 2023
$103.7 million in cash and cash equivalents
as of March 31, 2021 to support clinical development and business growth
Advanced four pipeline programs, including
the Mino-Lok Phase 3 superiority trial despite challenges recruiting subjects due to COVID-19
CRANFORD, N.J., May 13, 2021 -- Citius Pharmaceuticals, Inc.
("Citius" or the "Company") (Nasdaq: CTXR) today reported financial results for the second fiscal quarter of 2021
and provided a general business update.
"The Citius team is focused on advancing a growing pipeline of
first-in-class treatment options that have the potential to transform the current standards of care for patients around the world. We
believe our near-term milestones, including an upcoming meeting with the Drug Monitoring Committee (DMC) for our lead product candidate,
Mino-Lok , will continue to drive momentum. Although COVID-19 slowed enrollment in the Mino-Lok Phase 3
pivotal superiority trial, we remain on track to meet our milestones for the upcoming DMC meeting, which will clarify our clinical path
forward. Our expectation, currently, is that we will file an NDA for Mino-Lok in 2022, at which time Mino-Lok 's
Fast Track designation would make it eligible for expedited review," stated Myron Holubiak, President and Chief Executive Officer
of Citius Pharmaceuticals.
"In parallel, we continue to advance our other clinical and pre-clinical
programs. The U.S. Food and Drug Administration (FDA) guided us in developing a patient reported outcome (PRO) tool as the primary endpoint
to assess clinical outcomes and efficacy for Halo-Lido. We have now submitted the PRO for FDA review and are awaiting feedback. Importantly,
we remain focused on supporting our pre-clinical programs: a novel stem cell therapy to treat Acute Respiratory Distress Syndrome (ARDS)
in COVID-19 patients, and Mino-Wrap, an anti-microbial film to prevent infection associated with post-mastectomy breast implants in cancer
patients. Preparations are currently underway for in vitro studies for Mino-Wrap. Additionally, based on guidance from the FDA
on our proprietary stem cell program, we are engaged in preclinical work, including the creation of an accession cell bank, development
of a cGMP manufacturing process, and a proof of concept and dosing study in a large animal model. As we advance this program, we are mindful
that this would be an important treatment option for patients suffering from ARDS, for which there are currently no FDA-approved therapies,"
"I am also pleased to report that we successfully raised $96.5
million during the quarter, strengthening our balance sheet and providing us with significant runway into 2023. This will allow us to
support our multiple development programs and invest in the long-term growth of our business. We are committed to developing novel first-in-class
products that provide clear benefits compared to current standards of care for patients, physicians and caregivers. This is an exciting
time at Citius and we appreciate the continued support of our shareholders in our mission," concluded Mr. Holubiak.
Second Fiscal Quarter 2021 and Recent Business Highlights
Corporate Highlights:
Citius is developing Mino-Lok, an antibiotic lock solution to treat
patients with catheter-related blood stream infections that was licensed from The University of Texas MD Anderson Cancer Center. We believe
Mino-Lok provides a superior alternative to removing and replacing a central venous catheter (CVC), leading to a reduction
in serious adverse events and cost savings to the healthcare system. A multicenter Phase 3 pivotal superiority trial is currently underway.
During the quarter, several participating clinical trial sites were closed as a result of the COVID-19 pandemic, slowing enrollment. However,
we remain on track for an upcoming DMC meeting. Pending DMC review and guidance, Citius expects to file an NDA in 2022.
If approved, Mino-Lok would be the first and only FDA-approved
treatment that salvages central venous catheters that cause central line-related blood stream infections.
Halo-Lido (CITI-102) is a topical formulation of halobetasol and lidocaine
to provide anti-inflammatory and anesthetic symptomatic relief to people with hemorrhoids. The FDA guided Citius to develop a novel patient-reported
outcome (PRO) instrument to assess clinical outcomes and efficacy of Halo-Lido. The PRO is currently being reviewed by the FDA. Pending
feedback from the FDA, we expect to file an IND and initiate the Phase 2b trial.
If approved, Halo-Lido would be the first and only FDA-approved prescription-strength
product for the treatment of hemorrhoids for the more than 10 million individuals suffering each year.
In September 2020, Citius formed NoveCite, Inc. to develop a novel
stem-cell therapy that would initially target Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. ARDS is the most common
cause of respiratory failure and mortality in COVID-19 patients. The manufacturing process for development of NoveCite's proprietary
mesenchymal stem cells (NC i-MSCs) is currently underway. Reported interim results of an ongoing proof-of-concept large animal
study are encouraging. Once completed, we expect to initiate pilot and toxicology studies shortly thereafter. We anticipate filing an
Currently, there is no FDA-approved drug therapy for ARDS.
Mino-Wrap (CITI-101), also licensed from MD Anderson, is a liquefying
gel-based wrap containing minocycline and rifampin designed to provide inflammatory tissue protection and prevent infection and biofilm
formation in tissue expanders and breast implants post-mastectomy. Citius is developing this novel approach to reducing post-operative
infections associated with surgical implants. Following guidance from the FDA, we are conducting in vitro experiments and product
characterization studies for Mino-Wrap. Animal studies are underway.
Second Fiscal Quarter 2021 Financial Results:
As of March 31, 2021, the Company had $103.7 million in cash and cash
equivalents. During the three months ended March 31, 2021, the Company raised approximately $96.5 million in gross proceeds from the issuance
of common stock and 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 raised net proceeds of approximately $4.5 million from the exercise of warrants,
and closed a registered direct offering of its common stock and warrants for gross proceeds of approximately $76.5 million. We estimate
that we will have sufficient funds for our operations through March 2023.
Research and Development (R&D) Expenses
R&D expenses were $1.6 million and $7.7 million for the three and
six months ended March 31, 2021, respectively, compared to $2.0 million and $4.7 million for the comparable periods in 2020. The decrease
in research and development expenses for the quarter ended March 31, 2021 compared to the prior year quarter reflects decreases in R&D
expense for our Mino-Lok , Halo-Lido and Mino-Wrap product candidates, offset by an increase in R&D expense for our recently in-licensed
proposed novel stem cell therapy for Acute Respiratory Distress Syndrome (ARDS). During the three months ended March 31, 2020, we recorded
a milestone expense of $0.6 million associated with the Mino-Lok Phase 3 trial.
The increase in research and development for the six months ended March
31, 2021 compared to the prior year period reflects a decrease in manufacturing research and development for registration batches of Mino-Lok
produced in the six months ended December 31, 2020, and a decrease in R&D expenses for our other pipeline candidates, offset by an
increase of $5.4 million in R&D expense related to our recently in-licensed proposed novel stem cell therapy for ARDS.
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 $2.3 million and $4.0 million for the three and
six months ended March 31, 2021, respectively, compared to $2.3 million and $3.8 million for the comparable periods in 2020. 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 March 31, 2021, stock-based compensation
expense was $0.3 million as compared to $0.2 million for the three months ended March 31, 2020. For the six months ended March 31, 2021,
stock-based compensation expense was $0.6 million as compared to $0.4 million for the six months ended March 31, 2020. The increase reflects
expenses related to new grants made by Citius and the recently adopted NoveCite stock option plan.
Net loss was $4.1 million and $12.3 million for the three and six months
ended March 31, 2021, respectively, compared to a net loss of $4.4 million and $8.7 million for the comparable periods in 2020. The decrease
in net loss during the three months ended March 31, 2021 compared to the prior year period is primarily due to the decrease in research
and development expenses. The increase in net loss during the six months ended March 31, 2021 compared to the prior year period reflects
the increase in our research and development activities related to ARDS.
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