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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)
July 29, 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 July 29, 2023, Citius Pharmaceuticals, Inc. issued
a press release to announce that it has received a complete response letter from the U.S. Food and Drug Administration 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. |
|
|
|
By: |
/s/ Leonard Mazur |
|
|
Leonard Mazur Chairman and Chief Executive Officer |
Date: July 31, 2023
Exhibit 99.1
Citius Pharmaceuticals,
Inc. Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (Denileukin Diftitox)
for the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
No clinical
efficacy or safety issues raised
Citius committed
to working toward approval
CRANFORD, N.J., July 29, 2023 -- Citius Pharmaceuticals, Inc.
(“Citius” or the “Company”) (Nasdaq: CTXR) today announced that the U.S. Food and Drug Administration (FDA)
has issued a Complete Response Letter regarding the Company’s Biologics License Application (BLA) seeking approval for denileukin
diftitox (“LYMPHIRTM”), 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 required Citius to incorporate enhanced product testing,
and additional controls agreed to with the FDA during the market application review. Importantly, there were no concerns relating
to the safety and efficacy clinical data package submitted with the BLA, or the proposed prescribing information.
“We appreciate the FDA's expeditious review
of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval.
We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed
or refractory CTCL and make a meaningful difference in their lives,” stated Leonard Mazur, Chairman and CEO of Citius.
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 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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