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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C.
20549
__________________
FORM 8-K
__________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) September
8, 2023
__________________
Citius Pharmaceuticals,
Inc.
(Exact name of registrant as specified in its charter)
__________________
Nevada
(State or other jurisdiction of incorporation)
001-38174 |
|
27-3425913 |
(Commission File Number) |
|
(IRS Employer Identification No.) |
11 Commerce Drive, 1st Floor,
Cranford, NJ |
|
07016 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant's telephone number, including area code
(908) 967-6677
__________________
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
Common stock, $0.001 par value |
|
CTXR |
|
The Nasdaq Capital Market |
Indicate by check mark whether
the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On September 8, 2023, Citius Pharmaceuticals,
Inc. (the “Company”) issued a press release to announce that it has received additional guidance from the U.S. Food and Drug
Administration regarding the Company’s response to the complete response letter received on July 28, 2023 for LYMPHIR for the treatment
of patients with relapsed or refractory cutaneous T-cell lymphoma. A copy of the press release is attached hereto as Exhibit 99.1 and
is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is filed
herewith:
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
CITIUS PHARMACEUTICALS, INC. |
|
|
Date: September 8, 2023 |
By: |
/s/ Leonard Mazur |
|
|
Leonard Mazur
Chairman and Chief Executive Officer |
Exhibiti 99.1
Citius Pharmaceuticals,
Inc.
Receives Regulatory Guidance from the U.S. Food and Drug Administration (FDA) regarding the Planned Resubmission of the BLA for LYMPHIR™
Resubmission to FDA planned for early 2024
CRANFORD, N.J., September 8, 2023 – Citius Pharmaceuticals,
Inc. (“Citius” or the “Company”) (Nasdaq: CTXR) is pleased to announce the Company has received additional
guidance from the U.S. Food and Drug Administration (FDA) regarding the planned resubmission of the Company’s Biologics License
Application (BLA) for LYMPHIRTM (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment
of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
The FDA has agreed with the Company’s plans to address the
requirements outlined in the complete response letter (CRL) received July 28, 2023. The guidance from the FDA provides Citius with a path
for completing the necessary activities to support the resubmission of the Company’s Biologics License Application (BLA) for denileukin
diftitox. No additional clinical efficacy or safety trials have been requested by FDA for the resubmission.
“We are encouraged by the constructive
engagement with the FDA,” stated Leonard Mazur, Chairman and CEO of Citius. “Based on the clear feedback from the FDA, Citius
plans to complete the CRL remediation activities by the end of the year and file the resubmission in early 2024. We do not expect these
efforts will impact our cash runway.”
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 Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous
non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type
of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality
of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise
the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to
upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can
spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle
through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients
between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients
qualify, there is currently no curative therapy for advanced CTCL.
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’s diversified pipeline includes two late-stage
product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream
infections, which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and LYMPHIR, a novel IL-2R immunotherapy for
an initial indication in CTCL. Mino-Lok® was granted Fast Track designation by the FDA. LYMPHIR has received
orphan drug designation by the FDA for the treatment of CTCL and PTCL. At the end of March 2023, Citius completed enrollment in its Phase
2b trial of CITI-002, a topical formulation for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com.
Safe Harbor
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: the cost and timing of the resubmission of the BLA for LYMPHIR; the FDA may not approve our BLA for LYMPHIR; our need for substantial
additional funds; the estimated markets for our product candidates and the acceptance thereof by any market; our ability to commercialize
our products if approved by the FDA; our dependence on third-party suppliers; the ability of our product candidates to impact the quality
of life of our target patient populations; our ability to successfully undertake and complete clinical and non-clinical trials and the
results from those trials for our product candidates; 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; market and other conditions; our ability to attract, integrate, and retain key personnel; 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, 2022, filed with the SEC on December 22, 2022 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 Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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Citius Pharmaceuticals (NASDAQ:CTXR)
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