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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  March 27, 2025

_______________________________

BeyondSpring Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Cayman Islands 001-38024 Not Applicable
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

100 Campus Drive, West Side, 4th Floor, Suite 410

Florham Park, New Jersey 07932

(Address of Principal Executive Offices) (Zip Code)

+1 (646) 305-6387

(Registrant's telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

_______________________________

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(s) Name of each exchange on which registered
Ordinary Shares, par value $0.0001 per share BYSI 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 2.02. Results of Operations and Financial Condition.

On March 27, 2025, BeyondSpring Inc. (the “Company”) issued a press release announcing its financial results for the full year ended December 31, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information provided in this Form 8-K, including Exhibit 99.1 hereto, 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, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.   Exhibit
     
99.1   Press release, dated March 27, 2025.
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 hereunto duly authorized.

  BeyondSpring Inc.
     
   
Date: March 27, 2025 By:  /s/ Lan Huang        
    Lan Huang
    Chairperson and Chief Executive Officer
   

 

EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling

EXHIBIT 99.1

BeyondSpring Reports 2024 Year-End Financial Results and Highlights Key Clinical & Strategic Milestones

  • Plinabulin Final Phase 3 Data Published in The Lancet Respiratory Medicine, Demonstrating Overall Survival Benefit in 2L/3L NSCLC EGFR Wild Type vs. Docetaxel
  • Plinabulin Phase 2 Data Highlights Potential to Resensitize Tumors Progressed on PD-1/PD-L1 Inhibitors in Metastatic NSCLC
  • SEED Therapeutics Enters into Targeted Protein Degradation Research Collaboration with Eisai with potential payment to SEED of up to $1.5 Billion and Completes $24 Million First Close of Series A-3 Financing
  • SEED Therapeutics’ Lead Oncology Asset RBM39 Degrader Granted Rare Pediatric Disease and Orphan Drug Designations by the FDA

FLORHAM PARK, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, today announced its financial results for the year ended December 31, 2024, and provided a business update on key clinical and corporate developments.

“2024 was a pivotal year for BeyondSpring, with significant clinical progress for our first-in-class agent Plinabulin and strategic advancements for SEED Therapeutics (SEED), which BeyondSpring co-founded and owns an equity stake in. We believe these developments create value benefiting all stakeholders,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring.

“Plinabulin demonstrated a statistically significant survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild-type), a setting where no new therapies have been approved in over a decade. This Phase 3 data, now published in The Lancet Respiratory Medicine, strengthens our regulatory strategy as we prepare for submission to the Chinese National Medical Products Administration (NMPA) and potentially regulatory authorities in other jurisdictions.”

“BeyondSpring is also advancing Plinabulin’s potential as a next-generation immuno-oncology agent, with its potent effect in dendritic cell maturation. An ongoing Phase 2 study showed that Plinabulin, in combination with a PD-1 inhibitor and docetaxel, produced promising efficacy in patients with metastatic NSCLC who had progressed on prior PD-1/PD-L1 inhibitors with good tolerability. While PD-1 and PD-L1 antibody annual sales have exceeded $50 billion, with most sales coming from lung cancer, 60% of patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors, which we believe represents a significant opportunity for Plinabulin to impact the treatment landscape and create substantial value.”

“SEED also made significant progress in 2024, securing a strategic research collaboration with Eisai Co., Ltd. (“Eisai”), a second global pharma partnership in addition to the Eli Lilly and Company (“Lilly”) partnership. Under this collaboration, SEED will be eligible to receive upfront payments and potential preclinical, clinical, regulatory and sales milestone payments of up to $1.5 billion, plus tiered royalties on net sales. In parallel, SEED is advancing its internal lead oncology asset, RBM39 degrader, toward clinical development. SEED’s recognition in two Nature review papers as a leader in targeted protein degradation (TPD), along with recent granting of Rare Pediatric Disease and Orphan Drug Designations by the FDA for its RBM39 degrader ST-01156, further underscore its unique platform and reinforce its leadership in this emerging field.”

“With strongly anchored pipelines, key global partnerships and deliberate plans to navigate regulatory pathways, we believe BeyondSpring and SEED are well-positioned to drive transformative advancements in oncology and TPD in 2025,” Dr. Lan Huang concluded.

Recent Clinical and Business Updates

Plinabulin Clinical Updates

  • Plinabulin Phase 3 Data Published in The Lancet Respiratory Medicine and Presented at the IASLC 2024 conference
    • Demonstrated a statistically significant overall survival, PFS and ORR benefit in second- and third-line NSCLC (EGFR wild-type) compared to standard-of-care docetaxel.
    • Supports planned regulatory submissions to NMPA and potentially regulatory authorities in other jurisdictions.
  • Plinabulin Combination Therapy in multiple cancers which failed PD-1/PD-L1 therapies at MD Anderson Cancer Center
    • Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 inhibitor + radiation showed encouraging data in re-sensitizing NSCLC, Head and Neck cancer, and Hodgkin’s Lymphoma.
    • Responding patients showed dendritic cell maturation.
  • Plinabulin Combination Therapy in NSCLC
    • Ongoing Phase 2 investigator-initiated study (Study 303) of Plinabulin + PD-1 inhibitor + Docetaxel showed encouraging efficacy and safety outcomes in metastatic NSCLC patients who had progressed on prior PD-1/PD-L1 inhibitors.
    • Supports Plinabulin’s potential to resensitize tumors to checkpoint inhibitors.
  • Other Ongoing Clinical Trial
    • Enrolled first patient in a Phase 2 investigator-initiated study (Study 302) of Plinabulin + PD-1 inhibitor + Etoposide/Platinum (EP) for first-line extensive-stage small-cell lung cancer (ES-SCLC).

BeyondSpring Business Update

  • Entered into definitive agreements to sell a portion of BeyondSpring’s Series A-1 Preferred Shares of SEED for gross proceeds of approximately $35.4 million to advance late-stage clinical development of Plinabulin. First closing of approximately $7.35 million completed in February 2025.

SEED Updates

  • Strategic Collaborations & Financing
    • Research collaboration with Eisai to develop molecular glue degraders for oncology and neurodegenerative diseases with potential payments to SEED of up to $1.5 billion.
    • $24 million Series A-3 financing first close, led by Eisai.
    • Achieved third milestone with Lilly R&D collaboration.
  • Industry Recognition & FDA Designations
    • SEED was recognized in two Nature review articles as a leading company in TPD.
    • Received Rare Pediatric Disease and Orphan Drug Designations from the FDA for RBM39 degrader ST-01156, reinforcing its potential as a breakthrough therapy for hard-to-treat cancers.

Full-Year 2024 Financial Results1
Continuing operations:

  • R&D expenses: $2.6 million (vs. $7.3 million in 2023), reflecting completion of Plinabulin Dublin-3 and Protective Studies.
  • G&A expenses: $6.1 million (vs. $7.8 million in 2023), driven by cost optimization measures.
  • Net loss: $8.9 million (vs. $14.0 million in 2023).
  • Cash, cash equivalents, and short-term investments: $2.9 million as of December 31, 2024.

Discontinued operations:

  • Net loss: $7.8 million (vs. $7.9 million in 2023).
  • Current assets: $25.3 million as of December 31, 2024.

Expected 2025 Milestones
Plinabulin

  • 1H 2025: Updated data from Phase 2 of Study 303 in metastatic NSCLC progressed on PD-1/PD-L1 inhibitors.
  • 2H 2025: Preliminary data from Phase 2 of Study 302 in 1L ES-SCLC.

SEED

  • Mid-2025: Expected IND filing of RBM39 degrader.
  • 2H 2025: RBM39 degrader expected to begin patient enrollment.
  • 2H 2025: Tau degrader expected to achieve in vivo efficacy.

Note: 1. As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes.

About BeyondSpring
BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and a range of cancer indications. Plinabulin’s novel mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors to checkpoint inhibitors. Learn more at beyondspringpharma.com.

About SEED Therapeutics
SEED Therapeutics is a biotech company pioneering targeted protein degradation (TPD). Its proprietary RITE3™ platform is advancing novel molecular glue degraders across oncology, neurodegeneration, immunology, and virology. SEED collaborates with Eli Lilly and Company and Eisai Co., Ltd. and is advancing its RBM39 degrader into clinical development. Learn more at seedtherapeutics.com.

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 the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq’s continued listing requirements, and other risks described in BeyondSpring’s most recent Form 10-K 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: IR@beyondspringpharma.com
Media Contact: PR@beyondspringpharma.com

Financial Tables to Follow

 
BEYONDSPRING INC.

CONSOLIDATED BALANCE SHEETS

(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
 
    As of December 31,  
    2023     2024  
    $     $  
Assets                
Current assets:                
Cash and cash equivalents     5,396       2,922  
Restricted Cash     9,941       -  
Advances to suppliers     292       240  
Prepaid expenses and other current assets     168       68  
Current assets of discontinued operations     2,622       25,347  
Total current assets     18,419       28,577  
                 
Noncurrent assets:                
Property and equipment, net     317       239  
Operating right-of-use assets     730       513  
Other noncurrent assets     123       213  
Noncurrent assets of discontinued operations     5,219       4,773  
Total noncurrent assets     6,389       5,738  
                 
Total assets     24,808       34,315  
                 
Liabilities and equity                
                 
Current liabilities:                
Accounts payable     561       295  
Accrued expenses     2,347       840  
Current portion of operating lease liabilities     258       282  
Other current liabilities     1,069       780  
Current liabilities of discontinued operations     3,723       8,813  
Total current liabilities     7,958       11,010  
                 
Noncurrent liabilities:                
Operating lease liabilities     589       307  
Deferred revenue     28,170       27,400  
Other noncurrent liabilities     3,705       3,686  
Noncurrent liabilities of discontinued operations     7,847       6,197  
Total noncurrent liabilities     40,311       37,590  
                 
Total liabilities     48,269       48,600  
                 
Commitments and contingencies (Note 13)                
                 
Mezzanine equity                
Contingently redeemable noncontrolling interests – discontinued operations     11,874       -  
                 
Shareholders’ deficit                
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,029,163 and 40,316,320 shares issued and outstanding as of December 31, 2023 and 2024, respectively)     4       4  
Additional paid-in capital     368,599       373,185  
Accumulated deficit     (396,302 )     (407,425 )
Accumulated other comprehensive income     894       1,336  
                 
Total BeyondSpring Inc.’s shareholders’ deficit     (26,805 )     (32,900 )
Noncontrolling interests     (8,530 )     18,615  
Total shareholders’ deficit     (35,335 )     (14,285 )
                 
Total liabilities, mezzanine equity and shareholders’ deficit     24,808       34,315  

 

 
BEYONDSPRING INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
 
    Year ended December 31,  
    2023     2024  
    $     $  
                 
Revenue     -       -  
                 
Operating expenses                
Research and development     (7,272 )     (2,644 )
General and administrative     (7,809 )     (6,110 )
                 
Loss from operations     (15,081 )     (8,754 )
Foreign exchange loss, net     (128 )     (96 )
Interest income     322       59  
Other income, net     964       22  
                 
Loss before income tax     (13,923 )     (8,769 )
Income tax expenses     (92 )     (96 )
                 
Net loss from continuing operations     (14,015 )     (8,865 )
                 
Discontinued operations                
Loss from discontinued operations     (7,919 )     (7,828 )
Income tax expenses     (14 )     -  
Net loss from discontinued operations     (7,933 )     (7,828 )
                 
Net loss     (21,948 )     (16,693 )
Less: Net loss attributable to noncontrolling interests from continuing operations     (922 )     (388 )
Less: Net loss attributable to noncontrolling interests from discontinued operations     -       (5,182 )
Net loss attributable to BeyondSpring Inc.     (21,026 )     (11,123 )
                 
Net loss per share, basic and diluted                
Continuing operations     (0.34 )     (0.21 )
Discontinued operations     (0.20 )     (0.07 )
Basic and diluted loss per share     (0.54 )     (0.28 )
                 
Weighted-average shares outstanding                
Basic and diluted     38,996,463       39,733,191  
                 
Other comprehensive loss, net of tax of nil:                
Foreign currency translation adjustment gain from continuing operations     760       710  
Foreign currency translation adjustment (loss) gain from discontinued operations     (35 )     17  
Comprehensive loss     (21,223 )     (15,966 )
Less: Comprehensive loss attributable to noncontrolling interests from continuing operations     (655 )     (131 )
Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations     -       (5,154 )
Comprehensive loss attributable to BeyondSpring Inc.     (20,568 )     (10,681 )