6-K
BeyondSpring Inc. (BYSI)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of March, 2020
Commission File Number: 001-38024
BeyondSpring Inc.
BeyondSpring Inc.
28 Liberty Street, 39th Floor
New York, New York 10005
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country“), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
On March 11, 2020, BeyondSpring Inc. issued a press release, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information contained in this report, except the third paragraph of Exhibit 99.1, which contains certain quotes by the Chairman and Chief Executive Officer of BeyondSpring Inc., is hereby incorporated by reference into the Registration Statements on Form F-3, File No. 333-224437 and File No. 333-234193, and Registration Statement on Form S-8, File No. 333-216639.
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, thereunto duly authorized.
| BeyondSpring Inc. | |
|---|---|
| By: | /s/ Lan Huang |
| Name: | Lan Huang |
| --- | --- |
| Title: | Chairman and Chief Executive Officer |
| --- | --- |
Date: March 11, 2020
EXHIBIT INDEX
| Exhibit No. | Exhibit |
|---|---|
| 99.1 | Press release, dated March 11, 2020. |
Exhibit 99.1
BeyondSpring Files for Patent Protection on BPI-002 for the Treatment of Viral Infections Including COVID-19
NEW YORK – March 11, 2020 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced the submission of a provisional U.S. patent application for its pipeline asset BPI-002, for methods of treating viral infections, including COVID-19, when administered alone or in combination with a vaccine. BPI-002 is a novel orally administered small molecule agent that is a potent T-cell co-stimulator.
The agent is targeting two main effects:
| • | BPI-002 can potentially activate the adaptive immune system (including CD4+ helper T cells and CD8+ cytotoxic T cells), the body’s strongest line of defense, to directly attack and kill virally infected cells,<br> including RNA virus, such as those causing COVID-19. |
|---|---|
| • | If combined with a vaccine, including COVID-19 vaccine, BPI-002 can potentially function as an adjuvant to provide improved long-term humoral (B-cell dependent) protection against future viral infection. |
| --- | --- |
“With the COVID-19 outbreak spreading across the globe, BeyondSpring, along with all of our peer biopharmaceutical companies around the world are racing to respond as quickly as possible to stop the virus from spreading and save lives,” said Dr. Lan Huang, co-founder and CEO. “BPI-002 has the potential to directly attack and kill RNA virus without precipitating limiting toxicities, and to potentially provide long term protection against COVID-19 when combined with a vaccine. We are continuing to aggressively advance this agent to provide a therapeutic option offering both near-term treatment and long-term prevention against this deadly disease.”
Dr. Huang and Dr. Ramon Mohanlal, Chief Medical Officer and Executive Vice President, R&D are
co-inventors of the new patent application.
About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Media Contacts
Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
212.896.1241 / 212.896.1276
[email protected] / [email protected]