UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 21, 2021 (
(Exact name of registrant as specified in its charter)
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Emerging growth company
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| Item 1.01. | Entry into a Material Definitive Agreement. |
On April 15, 2021, CytoDyn Inc. (the “Company”) entered into an Exclusive Supply and Distribution Agreement, as amended by Amendment No. 1 dated April 19, 2021 (the “Agreement”), with Chiral Pharma Corporation, a Philippine pharmaceutical company and subsidiary of New Marketlink Pharmaceutical Corporation engaged in the business of importation, sales, and promotion and distribution of a diverse specialty line of pharmaceutical and healthcare products in the Philippines (“Chiral”), pursuant to which the Company granted Chiral the exclusive right to distribute and sell within the next twelve months up to 200,000 vials of the Company’s product, Vyrologix™ (leronlimab), to treat critically ill COVID-19 patients in the Philippines under Compassionate Special Permit (“CSP”) or Emergency Use Authorization (“EUA”) from the Food and Drug Administration of the Philippines.
Under the Agreement, Chiral would hold the exclusive right to distribute Vyrologix in the Philippines for one year in accordance with the treatment protocols approved under the applicable CSPs or EUAs, and purchase all required quantities of Vyrologix in accordance with such CSP or EUA. The parties shall negotiate in good faith and use commercially reasonable efforts to enter into a Quality Agreement upon execution of the Agreement. Either party may terminate the Agreement for a material breach not cured within thirty (30) days of written notice or for convenience upon sixty (60) days-notice.
The above description of the Agreement does not purport to be complete and is qualified in its entirety by the full text of the Agreement, which the Company intends to file as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended May 31, 2021.
Item 7.01 Regulation FD Disclosure
On April 15, 2021, the Company issued a press release announcing its entry into the Exclusive Supply and Distribution Agreement with Chiral as described above under Item 1.01. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (“Current Report”).
The information in Exhibit 99.1 shall not be deemed as “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of such Section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.
Forward-Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about Vyrologix, its ability to have positive health outcomes, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales once approval has been granted. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this report.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release dated April 15, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) | |
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 thereunto duly authorized.
| CYTODYN INC. | ||||||
| Dated: April 21, 2021 | By: | /s/ Michael D. Mulholland | ||||
| Michael D. Mulholland | ||||||
| Chief Financial Officer | ||||||