Full Press Release Details
Citius Pharmaceuticals Announces Key Management
Realignment to Support Commercialization of Two Late-Stage Product Candidates
Leonard Mazur named Chairman of the Board
of Directors and CEO of Citius
Citius co-founder, Myron Holubiak to transition
from President & CEO to Executive Vice Chairman of the Board of Directors to build commercial capabilities, effective May 1, 2022
Jaime Bartushak, Chief Financial Officer,
to assume additional responsibilities as Chief Business Officer
Commercial capabilities strengthened with
addition of Michael McGuire as VP, Program Leader for Anti-Infectives
CRANFORD, N.J., April 13, 2022 -
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 with a focus on oncology, anti-infective products
in adjunct cancer care, unique prescription products, and stem cell therapies, today announced that the Board of Directors has approved
key management changes to strengthen the Company's commercial capabilities as its two late Phase 3 programs for I/ONTAK (E7777)
and Mino-Lok near completion. The organizational alignment will enable Citius to focus its resources on advancing both
of these near-term opportunities and will be effective as of May 1, 2022.
The Board of Directors has appointed Mr. Holubiak
to the newly created position of Executive Vice Chairman with responsibility for building the Citius commercial team and guiding the anticipated
product launches of the Company's first commercial products. Mr. Holubiak will drive the overall commercial strategy in support
of the Citius pipeline. The near-term focus will be on the successful launch of I/ONTAK for the systemic treatment of cutaneous T-cell
lymphoma (CTCL), which recently released topline results from its Phase 3 trial, and Mino-Lok which is expected to complete
Phase 3 trial enrollment later this year. Leonard Mazur, Citius co-founder and Executive Chairman has been named as CEO and Chairman by
the Board of Directors. Additionally, in recognition of the incremental needs of a growing Citius team, Chief Financial Officer Jaime
Bartushak will assume additional responsibilities as Chief Business Officer.
"Myron and I co-founded Leonard Meron
Biosciences, which ultimately merged with Citius, to bring life-altering therapies to patients in need. He continues to be an outstanding
partner and dedicated CEO who, together with me, has driven continued growth in Citius including leading the expansion of our portfolio
to five active programs, taking the company public and successfully raising capital to advance our strategy. With a planned BLA submission
for I/ONTAK later this year, along with the expected completion of enrollment in the Mino-Lok trial in 2022, now is the
ideal time to reposition the organization to take full advantage of our in-house expertise. We intend to leverage the momentum in our
programs to focus on developing robust marketing, sales and distribution capabilities to support successful market entry for the assets
in our pipeline. Myron will direct our efforts to build a world-class commercial team as Executive Vice Chairman of the Board,"
stated Leonard Mazur, Executive Chairman of Citius.
Mr. Holubiak is uniquely experienced to drive
the commercialization strategy for Citius. While President of Roche Laboratories, he led the organization in successfully launching important
oncology and antibiotic products including Xeloda for the treatment of breast and colorectal cancer, and Rocephin ,
the most successful injectable cephalosporin antibiotic at the time.
Jamie Bartushak, Citius' Chief Financial
Officer, will assume additional operational responsibilities in his expanded role as Chief Business Officer. He will oversee all aspects
of finance, business development and operations at the Company.
In order to efficiently bring the Company's
products to market, Michael McGuire will join Citius as VP, Program Leader for Anti-Infectives effective May 1, 2022. Mr. McGuire will
work closely with Mr. Holubiak and the rest of the Citius team to leverage his broad pharmaceutical experience and network.
"With two pipeline programs in final development,
our commercial activities targeted at key cancer centers in the U.S. will begin to accelerate. Our recently released topline data for
I/ONTAK positions us to potentially be in the market in 2023. And, as the COVID pandemic abates, we expect continued pickup in the Mino-Lok
trial recruitment with anticipated enrollment completion this year. This positions us for potential Mino-Lok regulatory
submissions in 2023. In my new role as Executive Vice Chairman, I look forward to continuing to work closely with the entire Citius team
to prepare for the successful commercial launches of each of our products, beginning with I/ONTAK and Mino-Lok ,"
added Myron Holubiak, Chief Executive Officer of Citius.
About Michael McGuire, VP, Program Leader
Michael McGuire has extensive business leadership
experience within the pharmaceutical industry, including P&L management, strategic planning, marketing, and new product development.
While at Roche Laboratories, Michael led the Tamiflu franchise to become the first billion-dollar product for Roche in
the United States, and designed an award-winning direct-to-consumer (DTC) Tamiflu educational campaign that raised consumer awareness
Most recently, Mr. McGuire was Senior Vice President
Commercial, Government Affairs, and Customer Engagement at Melinta Therapeutics. In this role, he called on members of the House and Senate
and met with representatives from the Centers for Medicare and Medicaid Services (CMS) and the Biomedical Advanced Research and Development
Authority (BARDA) to develop support for the DISARM Act that would change the reimbursement landscape for anti-infectives. Additionally,
he integrated three commercial organizations (Melinta, Cempra, and The Medicines Company) while launching two new anti-infective drugs.
Prior to joining Melinta, Michael served as
Senior Vice President, Global Infectious Disease at The Medicines Company, a developer of hospital products in the anti-infective and
cardiovascular therapeutic areas. He managed global commercial operations for an anti-infective portfolio of products, and successfully
launched the drug Orbactiv in a highly competitive generic and branded marketplace. As a seasoned executive, Mr. McGuire has successfully
launched multiple anti-infective products, including a blockbuster drug, built alliances with government agencies, launched consumer
awareness programs, and effectively managed commercial organization costs.
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 attract, integrate, and retain key personnel; our ability to successfully undertake and complete clinical trials and
the results from those trials for our product candidates; 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; our need for substantial additional funds;
the early stage of products under development; 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 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.
Investor Relations for Citius Pharmaceuticals:
Vice President, Investor Relations and Corporate Communications
T: 908-967-6677 x113