- Multiple catalysts for potentially transformative assets in
second half of 2024
- Strong momentum expected from positive topline results of
Phase 3 Mino-Lok® trial, commercialization of LYMPHIR™
if approved
- First-and-only advantage for Mino-Lok with no current
FDA-approved or investigational products; LYMPHIR expected to be
additive to current treatment options with mechanism of action
supporting market advantage
- Financial platform and pending oncology spin-off support
pipeline development and investment in long-term growth
- Clinical and operational achievements offer powerful levers
for value creation
- National Sales Director onboarded to recruit and lead the
sales organization in preparation for anticipated launch of
LYMPHIR
CRANFORD, N.J., July 10,
2024 /PRNewswire/ -- 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
announced expected milestones in the second half of calendar 2024
and recapped key achievements year-to-date
Leonard Mazur, Chairman and CEO
of Citius stated, "Our solid execution since the beginning of the
year sets us up for potentially transformative catalysts in the
coming months. Mino-Lok's strong Phase 3 topline results support
its potential to become part of the standard of care for treating
catheter-related bloodstream infections. Mino-Lok would also have a
first and only advantage in a market with no approved or
investigational products for salvaging infected central venous
catheters. For LYMPHIR™, the FDA is currently reviewing our
Biologics License Application, with an expected decision on
August 13th. We are preparing for
near-term commercialization of LYMPHIR if approved. These near-term
catalysts should enable the company to optimize its current cash
runway, future cash needs, as well as create potential non-dilutive
cash opportunities.
"Our primary purpose and mission for these late-stage assets is
to provide best-in-class, highly effective treatment
options for patients and caregivers," Mazur added.
"Ultimately, we believe our achievements and milestones offer
powerful levers for value creation."
Late-Stage Assets: Mino-Lok® and
LYMPHIR™
Citius significantly advanced its two late-stage product
candidates in the first six months of 2024, and expects several key
milestones in the near term.
- Mino-Lok: Citius recently announced positive topline
data from the Phase 3 study of Mino-Lok® in catheter-related
bloodstream infections (CRBSIs). Primary and secondary endpoints
were met with statistical significance.
- Next steps for the Mino-Lok program are to prepare a submission
to the U.S. Food and Drug Administration (FDA) and schedule a Type
B meeting.
- LYMPHIR™: In March 2024,
the FDA accepted the Company's Biologics License Application (BLA)
for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for
the treatment of patients with relapsed or refractory cutaneous
T-cell lymphoma (CTCL).
- A decision on the LYMPHIR BLA is expected on August 13, 2024, the FDA's assigned Prescription
Drug User Fee Act (PDUFA) action date. If approved, Citius is
preparing for LYMPHIR commercialization in 2024.
- Considered a new biologic by the FDA, LYMPHIR would potentially
be eligible for 12 years of exclusivity, if approved.
- In addition to the initial indication, two
investigator-initiated Phase 1 studies of LYMPHIR are underway to
explore how the differentiated mechanism-of-action may offer
potential indications beyond CTCL. The studies are in progress at
the University of Pittsburgh and the
University of Minnesota.
Specialty Pharma Asset: Halo-Lido
- An end of Phase 2b trial meeting
with the FDA was held to discuss the positive data for Halo-Lido, a
prescription strength topical for symptomatic hemorrhoid treatment.
The data showed a meaningful reduction in symptom severity when
compared to individual components alone.
- Continuing engagement with the FDA will guide the Company's
next phase of development for Halo-Lido.
Operational Milestones
Operational achievements by Citius in the first six months of
2024 delivered additional capital and stronger levers for value
creation.
- Citius took steps to strengthen its capital structure in
preparation for LYMPHIR™ commercialization, if approved. A
$15 million registered direct
offering was completed in April 2024,
extending the Company's cash runway.
- Citius plans to merge a wholly owned subsidiary with TenX Keane
Acquisition (Nasdaq: TENK) to form
publicly listed company, Citius Oncology, Inc. The transaction is
pending review by the U.S. Securities and Exchange Commission (SEC)
and TENK shareholder approval as well
as contractual and customary closing conditions.
About Mino-Lok
Mino-Lok (MLT), a novel antibiotic lock solution that
combines minocycline, ethanol and edetate disodium, is
designed to treat patients with catheter-related blood stream
infections. Citius licensed Mino-Lok from an affiliate of The
University of Texas MD Anderson Cancer
Center. Mino-Lok is designed to offer an alternative to
removing and replacing a central venous catheter (CVC), which may
lead to a reduction in serious adverse events and cost savings to
the healthcare system. 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.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a recombinant fusion protein that combines the
interleukin-2 (IL-2) receptor binding domain with diphtheria toxin
fragments. The agent specifically binds to IL-2 receptors on the
cell surface, causing diphtheria toxin fragments that have entered
cells to inhibit protein synthesis. In 2011 and 2013, the FDA
granted orphan drug designation to LYMPHIR for the treatment of
PTCL and CTCL, respectively. In 2021, denileukin diftitox received
regulatory approval in Japan for
the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
Subsequently in 2021, Citius acquired an exclusive license with
rights to develop and commercialize LYMPHIR in all markets except
for Japan and certain parts of
Asia.
About Halo-Lido
Halo-Lido (CITI-002) is a proprietary topical formulation
intended to provide symptomatic relief to individuals suffering
from hemorrhoids. Hemorrhoids are a gastrointestinal disorder
characterized by pain, swelling, itching, tenderness, and bleeding.
Although hemorrhoids are not life-threatening, individual patients
often suffer painful symptoms that can limit social activities and
have a negative impact on the quality of life. More than half of
the U.S. population will experience hemorrhoidal disease at least
once in their life. Each year, nearly 10 million patients in the
U.S. report symptoms.
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. In
May 2024, Citius announced positive
topline results of Mino-Lok®, its antibiotic lock solution to
salvage catheters in patients with bloodstream infections. The
Biologics License Application for LYMPHIR™, a novel IL-2R
immunotherapy for an initial indication in the treatment of
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 contains "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 related to an approval of
LYMPHIR and Mino-Lok by the FDA; our ability to commercialize our
products, including LYMPHIR and Mino-Lok, if approved by the FDA;
our need for substantial additional funds; 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; risks relating to the results of research and
development activities, including those from our existing and any
new pipeline assets; our dependence on third-party suppliers;
uncertainties relating to preclinical and clinical testing; the
early stage of products under development; our ability to obtain,
perform under and maintain financing and strategic agreements and
relationships; market and other conditions; risks related to our
growth strategy; 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 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, 2023, filed with the SEC on
December 29, 2023, 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 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:
Investor Contact:
Ilanit
Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.