8-K
Lunai Bioworks Inc. (LNAI)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of theSecurities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 24, 2020
ENOCHIAN BIOSCIENCES INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-54478 | 45-2559340 |
|---|---|---|
| (State or other jurisdiction | (Commission File Number) | (I.R.S. Employer |
| of incorporation) | Identification No.) | |
| 2080 Century City East<br><br> <br>Suite 906<br><br> <br>Los Angeles, CA 90067<br><br> <br>(Address of principal executive offices) | ||
| --- |
+1(786) 888-1685
(Registrant’s telephone number, including area code)
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 | Name of Each Exchange on Which Registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | ENOB | The Nasdaq Stock Market LLC |
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. ☐
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Item 8.01 Other Events.
On February 24, 2020, Enochian Biosciences, Inc. issued a press release announcing that the U.S. Food & Drug Administration has scheduled an Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meeting for early June focused on Enochian’s ENOB-HV-01. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included in this Item 8.01 and in Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
| (d) | Exhibits: | |
|---|---|---|
| EXHIBIT NO. | DESCRIPTION | LOCATION |
| --- | --- | --- |
| 99.1 | Press Release dated February 24, 2020 | Furnished herewith |
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SIGNATURES
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.
| ENOCHIAN BIOSCIENCES, INC. | |
|---|---|
| By: | /s/ Mark R. Dybul |
| Name: Mark R. Dybul<br><br>Title: Executive Vice Chair |
Date: February 24, 2020
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Exhibit99.1
EnochianBiosciences Announces FDA INTERACT Meeting for a Potential Cure for HIV
| - | FDA has granted Enochian an INTERACT meeting for its innovative approach to autologous stem cell transplantation as a potential cure for HIV. |
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| - | INTERACT is the first available FDA interaction and is a key step in the process towards an Investigational New Drug (IND) to study first-in-human products leading to potential marketing approval. |
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LOS ANGELES, Feb. 24, 2020 (GLOBE NEWSWIRE) Enochian Biosciences, a company focused on genetically modified cellular and immune therapy for infectious diseases and cancer, announces that the FDA has scheduled an Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meeting for early June. The meeting is focused on Enochian’s ENOB-HV-01, a novel approach to autologous stem cell transplantation with the potential to increase engraftment of genetically modified cells that are resistant to HIV infection, as a potential cure for HIV. The FDA’s Center for Biologics Evaluation and Research (CBER) has numerous INTERACT requests and only grants meetings that are deemed appropriate for this early FDA engagement. The INTERACT meetings are a new program at CBER, FDA, as part of their commitment to help accelerate the development and approval of innovative medical products.
Forward-LookingStatements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline or the results of any meeting with the FDA. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” plans,” “expects,” “aims,” “intends” “potential” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Enochian’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Enochian undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
Contact:
ir@enochianbio.com