Form 6-K BeyondSpring Inc. For: Jul 14

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 July 2021

 

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.

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On July 14, 2021, 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 second and fourth paragraphs of Exhibit 99.1, which contain certain quotes by the Chairperson and Chief Executive Officer of BeyondSpring Inc. and Brendan Delaney, is hereby incorporated by reference into the Registration Statements on Form F-3, File No. 333-257639, File No. 333-249816 and File No. 333-234193, and the Registration Statements on Form S-8, File No. 333-216639 and File No. 333-240082.

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.

 

EXHIBIT INDEX

 

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Exhibit 99.1

BeyondSpring Strengthens Board with the Addition of Ex-Immunomedics and Constellation Commercial Head Brendan Delaney

 

NEW YORK, July 14, 2021 -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced the appointment of Brendan Delaney to its Board of Directors, effective immediately.  Mr. Delaney brings his significant expertise in commercial oncology drug launches. BeyondSpring's lead developmental asset, plinabulin, is currently under Priority Review by the U.S. Food and Drug Administration (FDA) for the prevention of chemotherapy-induced neutropenia (CIN) with a U.S. Prescription Drug User Free Act (PDUFA) action date of November 30, 2021. Mr. Delaney is expected to play an important role in the commercial launch planning for plinabulin and implementation, pending successful regulatory review.

“We couldn't be more pleased to have Brendan join our team at this critical juncture for the Company, with plinabulin under Priority Review by the FDA and pending Phase 3 trial anti-cancer efficacy results from the Dublin-3 trial in non-small cell lung cancer,” said Dr. Lan Huang, co-founder, Chair and Chief Executive Officer of BeyondSpring. “While we're working with regulatory agencies on our NDA submissions, we’re actively adding to our already-experienced commercial readiness team to have everything in place for successful potential global launch of plinabulin as early as the beginning of 2022, with the goal of making this much-needed treatment widely available.”

Mr. Delaney brings more than 25 years of global product strategy and launch experience to his role leading commercial organizations. Currently he serves as the Chief Commercial Officer of Constellation Pharma starting in January 2021.  Constellation was recently acquired by MorphoSys for $1.4B. Prior to joining Constellation, Mr. Delaney was the Chief Commercial Officer at Immunomedics, where he led the buildout of the marketing, sales, market access and commercial operations teams. He was instrumental in successfully launching Trodelvy, the first TROP-2 directed antibody-drug conjugate for the treatment of triple-negative breast cancer. Immunomedics was acquired by Gilead Sciences for $21B in September 2020.  Previously, he served as Vice President of U.S. Hematology-Oncology at Celgene Corporation. Prior to joining Celgene, he held various commercial roles at both Novartis Oncology and Genentech, where he led several successful product launches for blockbuster brands. He earned an MBA from the Stern School of Business at NYU and a B.A. in biology from Rutgers University.

Mr. Brendan Delaney added, “I am thrilled to be joining BeyondSpring at this important time when the organization is transforming into a commercial stage company and preparing for its first product launch. Plinabulin is a differentiated, first-in-class oncology product with a unique mechanism of action, so I look forward to working with the entire team at BeyondSpring to ensure that it becomes available to help as many patients as possible.”

About BeyondSpring
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), is being developed a “pipeline in a drug.” It is filed for approval and has received Priority Review in the U.S. and China for the prevention of chemotherapy-induced neutropenia (CIN) with a PDUFA date of November 30, 2021 in the U.S., and has a fully enrolled pivotal study (Dublin-3) to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

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.

Investor Contact:

Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
[email protected]

Media Contact:

Darren Opland, Ph.D.

LifeSci Communications

+1 646-627-8387

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