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 13, 2020
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Citius Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Nevada
(State or other jurisdiction of incorporation)
|
333-206903 |
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
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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 | ||
| Warrants to purchase common stock | CTXRW | 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 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
(e)
On July 13, 2020, Citius Pharmaceuticals, Inc. (the “Company”) entered into an employment agreement with Myron Czuczman, M.D. (the “Employment Agreement”), which was effective as of July 14, 2020. In exchange for his services as the Company’s Executive Vice President, Chief Medical Officer, Mr. Czuczman will receive an annual base salary of $400,000 and he will be eligible for an annual bonus of up to 35% of his annual base salary at the discretion of the Company’s Chief Executive Officer and Board of Directors. Mr. Czuczman will also be entitled to participate in the Company’s then-current benefit plans that the Company may establish for similarly situated employees.
Mr. Czuczman will also be granted an option to purchase 500,000 shares of the Company’s common stock (the “Options”) under the Company’s 2020 Omnibus Stock Incentive Plan. The exercise price of the Options will be the fair market value of the Company’s common stock on the date of grant. One-third of the Options will vest on the first anniversary of the Employment Agreement and the remainder will vest in 24 equal monthly installments thereafter, subject to Employee’s continued employment on the applicable vesting dates.
Under the Employment Agreement, Mr. Czuczman’s employment will be at will and continue until terminated by either party. If the Company terminates Mr. Czuczman’s employment without Cause, or Mr. Czuczman resigns for Good Reason within 12 months following a Change in Control, then conditioned upon Mr. Czuczman executing a release following such termination, Mr. Czuczman will receive (i) an amount of pay equal to his then-current base salary, less applicable taxes and withholdings over a period of 12 months following the date of termination, (ii) a pro-rated portion of his annual bonus based on his date of termination, and (iii) certain benefits for a period of up to 12 months following the effective date of termination.
The description of the Employment Agreement set forth above does not purport to be complete and is qualified in its entirety by reference to the full text of the agreement, which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. Capitalized terms appearing above and not otherwise defined have the meaning set forth in the Employment Agreement. A copy of the press release issued by the Company on July 14, 2020 is filed as Exhibit 99.1 to this report.
| Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit No. | Description of Exhibit | |
| 99.1 | Press release dated July 14, 2020. | |
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: July 14, 2020 | /s/ Myron Holubiak |
| Myron Holubiak | |
| President and Chief Executive Officer |
Exhibit 99.1
Citius Pharmaceuticals Brings on Myron S. Czuczman, M.D. as Chief Medical Officer (CMO) and Executive Vice President
| ● | Recent executive at Celgene, Dr. Czuczman brings decades of experience in the strategic design and worldwide clinical development of novel therapeutics for hematologic malignancies |
| ● | Strengthens position for Citius as a developer of adjunctive cancer therapies (Mino-Lok and Mino-Wrap) and the “NoveCite” induced allogeneic mesenchymal stem cell program |
| ● | Formerly at Roswell Park Comprehensive Cancer Center, he was instrumental in the development of the current global era of combination antibody-based immunochemotherapy of B-cell neoplasms and was the first to discover the synergy between rituximab and lenalidomide against malignant B-cells |
| ● | Dr. Czuczman has published greater than 180 peer-reviewed journal articles |
CRANFORD, N.J., July 14, 2020 -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that Myron S. Czuczman, M.D., has joined the company as Chief Medical Officer (CMO) and Executive Vice President. Dr. Czuczman was most recently Therapeutic Area Head, Vice President, Clinical Research and Development Global Lymphoma/CLL Program at Celgene Corporation. At Celgene, he was responsible for worldwide clinical development in Lymphoma/CLL and for the development of all compounds from Proof-of-Principle through registration globally.
Myron Holubiak, Citius CEO stated, “We are honored to have a colleague as qualified as Dr. Czuczman join the Citius team. He will be enormously helpful in furthering our development program for our planned iPSC-derived mesenchymal stem cell (iMSC) for the treatment of ARDS associated with CoVid-19. This, coupled with the advanced Phase 3 trials underway for Mino-Lok® and preparing an IND for Mino-Wrap, add to the importance of bringing in an executive of Dr. Czuczman’s expertise, experience, and caliber to the team.”
Prior to his tenure at Celgene, Dr. Czuczman served as Chief, Lymphoma/Myeloma Service in the Department of Medicine and Head of the Lymphoma Translational Research Laboratory in the Immunology Department at Roswell Park Comprehensive Cancer Center in Buffalo, NY where he attained the title of tenured Professor of Medicine and Oncology prior to joining Celgene.
Dr. Czuczman received his M.D. from Pennsylvania State University of Medicine after graduating magna cum laude in Biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York, NY.
Dr. Czuczman was a Founding Member and reviewer for the National Comprehensive Cancer Network (NCCN) Lymphoma Guidelines compendium panel for nearly twenty years and he has greater than 180 peer-reviewed publications. He is a Diplomate in Internal Medicine, and is Board Certified in Medical Oncology and received numerous awards and accolades during his academic career.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit www.citiuspharma.com.
About Mino-Lok®
Mino-Lok® is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients, for whom venous access presents a challenge. There are currently no approved therapies for salvaging infected CVCs.
About Citius iMSC
Citius’s planned mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.
About Acute Respiratory Distress Syndrome (ARDS)
ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.
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 "will," "anticipate," "estimate," "expect," "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 need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned Novecite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; risks relating to the results of research and development activities; 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; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. 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.
Contact:
Andrew Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
ascott@citiuspharma.com