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): May 13, 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. ☐
Item 8.01 Other Events.
On May 13, 2020, Enochian Biosciences, Inc. issued a press release announcing three scientific presentations on studies related to potential HIV and HBV cures to be given at the Annual Meeting of the American Society of Cell and Gene Therapy. 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 May 13, 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: May 13, 2020
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Exhibit 99.1
Enochian Biosciences Announces Three Scientific Presentations on Potential HIV and HBV Cures
| • | First presentation of a novel approach to potentially cure HIV |
|---|---|
| - | An in vivo study demonstrated a 164 percent increase in engraftment of geneticallymodified cells |
| --- | --- |
oPosterPresentation - hhttp://www.enochianbio.com/wp-content/uploads/2020/05/Final-Poster-SyngeneicMouse_431_ASGCT_Poster_Final-05112020-2.pdf
oSlidePresentation - hhttp://www.enochianbio.com/wp-content/uploads/2020/05/Final-Presentation-SyngeneicMouse_431_ASGCT_Final-05112020.pdf
| - | A second study provides an in-depth explanation for how the increase in engraftment occurred |
|---|
o Poster Presentation - hhttp://www.enochianbio.com/wp-content/uploads/2020/05/FINAL-InVitroChemoselection_ASGCT_Poster1219_05112020_RH.pdf
oSlide Presentation- hhttp://www.enochianbio.com/wp-content/uploads/2020/05/InVitroChemoSelection_1219_ASGCT_Presentation_05112020.pdf
| • | An innovative potential cure for Hepatitis B virus (HBV) infection |
|---|
-In vivo studies validate previously reported in vitro results showing an average killing of up to 97 percent of HBV-infectedcells
o Poster Presentation - http://www.enochianbio.com/wp-content/uploads/2020/05/HBV_592_ASGCT_Poster_-Final_05112020.pdf
o Slide Presentation- http://www.enochianbio.com/wp-ontent/uploads/2020/05/HBV_592_ASGCT_Presentation_FinalCorrect.pdf
LOS ANGELES, May 13, 2020 (GLOBE NEWSWIRE) -- Enochian Biosciences (NASDAQ:ENOB), a company focused on gene-modified cellular therapy in infectious disease and cancer, announces three scientific presentations given yesterday at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). All three abstracts submitted to the conference were accepted for presentation.
APotential Cure for HIV
More than 39 million people live with HIV worldwide. There were approximately 2 million deaths and 1 million new infections last year.
Two presentations provide the first description of a novel approach to potentially cure HIV. Genetic modification of cells to overexpress an important enzyme (ALDH1) protected them from dying when they were treated with low doses of a chemotherapeutic drug, cyclophosphamide. This innovative strategy resulted in a one hundred and sixty-four percent (164%) increase in engraftment of transplanted cells in a mouse model.
At the HEP DART meeting in December 2019, we showed that a novel approach killed up to 97 percent of cells infected with HBV in vitro. Today, we presented new data from several in vivo studies providing a further scientific foundation for the mechanism of action of that killing and further validation of the approach as a potential therapy to cure HBV.
APotential Cure for HBV
Approximately 257 million or five percent (5%) of the people in the world are infected with HBV, and nearly 1 million people die per year.
At the HEP DART meeting in December 2019, we showed that a novel approach killed up to 97 percent of cells infected with HBV in vitro. Today, we presented new data from several in vivo studies providing a further scientific foundation for the mechanism of action of that killing and further validation of the approach as a potential therapy to cure HBV.
“As we do not have a cure for HIV or HBV, this new research is compelling. Currently, we have good oral, safe and effective therapies that patients with HIV or chronic HBV must take daily, for life. This is challenging for many individuals. Non-compliance can lead to HIV and HBV viral resistance or to acute liver flares in patients with chronic liver disease. Patients and physicians all look to a future that could offer a cure.” Carol L. Brosgart, MD, Clinical Professor of Medicine, Epidemiologyand Biostatistics, University of California, San Francisco and a member of the Enochian Board of Directors.
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. 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: [email protected]