Press Release: BeyondSpring Reports First--Quarter 2025 Financial Results and Provides Corporate Update

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BeyondSpring Reports First--Quarter 2025 Financial Results and Provides Corporate Update

   -- Presentation at IO 360deg conference showed early efficacy for Plinabulin 
      combinations in metastatic NSCLC and Hodgkin lymphoma resistant to 
      PD--1/L1 therapy 
 
   -- SEED's first--in--class RBM39 degrader, reported at AACR 2025 for its 
      total tumor regression data in mechanism targeted cancer indication-Ewing 
      Sarcoma, remains on track for IND filing mid--2025 

FLORHAM PARK, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. $(BYSI)$, a clinical--stage global biopharmaceutical company focused on developing cancer therapeutics, today announced its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update.

"Plinabulin has now been administered to more than 700 patients with a favorable safety profile. By promoting dendritic--cell maturation, it offers a potential option for the approximately 60 percent of cancer patients who progress on PD--1/L1 inhibitors," said Dr. Lan Huang, Co--Founder, Chair, and Chief Executive Officer of BeyondSpring. "Early readouts in metastatic NSCLC and Hodgkin lymphoma who failed PD-1/L1 inhibitors showed durable responses that deserve further evaluation."

Dr. Huang added, "Within SEED, our RBM39 molecular--glue degrader achieved complete tumor regression in mechanism-targeted Ewing sarcoma models and is on track for an IND submission mid--year. We are also pursuing additional mechanism-targeted larger indications including liver cancer and KRAS--mutant tumors with leading centers including Dana--Farber, Memorial Sloan Kettering, and MD Anderson."

Recent Highlights

Plinabulin Clinical Presentations

   -- March 2025 (Oral Presentation at the Immuno-Oncology 360o Summit in 
      Boston): Plinabulin combination regimen showed clinically meaningful 
      responses in patients of multiple cancer types who failed prior 
      immunotherapies, including NSCLC and Hodgkin lymphoma, with prolonged 
      PFS. 
 
          -- Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 
             inhibitor + radiation (MD Anderson Cancer Center) showed promising 
             data in re-sensitizing Hodgkin lymphoma for patients who failed 12 
             to 16 prior lines of treatments including stem cell transplant, 
             CAR-T, and PD-1 inhibitor with duration of response of over 19 
             months. 

SEED Therapeutics Program

   -- RBM39 molecular--glue degrader produced durable tumor regression in Ewing 
      sarcoma animal models; IND--enabling studies underway. 
 
   -- Dual--PROTAC approach using two E3 ligases overcame the hook effect in 
      KRAS G12D cell lines; manuscript in preparation. 

Corporate and Financial

As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED in January 2025, SEED's operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes. SEED's financials results are now presented as "discontinued operations" under U.S. GAAP. SEED continues to operate independently. BeyondSpring currently owns approximately 40% of the outstanding equity interest in SEED.

Selected Unaudited Financial Data

 
                                            Q1 2025  Q1 2024   Change (%) 
------------------------------------------  -------  -------  ------------ 
R&D expense from continuing operations ($ 
 000s)                                          874      721     21% 
------------------------------------------  -------  -------  ----- ---- 
G&A expense from continuing operations ($ 
 000s)                                        1,736    1,334     30% 
------------------------------------------  -------  -------  ----- ---- 
Net loss from continuing operations ($ 
 000s)                                        2,584    2,080     24% 
------------------------------------------  -------  -------  ----- ---- 
 

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 biotechnology company pioneering targeted protein degradation $(TPD.AU)$ through the discovery of novel molecular glues and bifunctional degraders. Powered by its proprietary RITE3$(TM)$ platform, SEED is advancing a pipeline of first-in-class degraders to address traditionally undruggable targets across oncology, neurodegeneration, immunology, and virology. SEED's strategic collaborations with Eli Lilly and Company and Eisai Co., Ltd. support its mission to develop transformational therapies, with its lead RBM39 degrader program expected to enter clinical trials in 2025. 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.

Contacts

Investor Relations: ir@beyondspring.com

Media: pr@beyondspringpharma.com

Financial Tables to Follow

 
 
                            BEYONDSPRING INC. 
                   CONDENSED CONSOLIDATED BALANCE SHEETS 
            (Amounts in thousands of U.S. Dollars ("$"), except 
                 for number of shares and per share data) 
 
                                                     As of 
                                     ------------------------------------- 
                                     December 31, 2024   March 31, 2025 
                                             $                 $ 
                                                          (Unaudited) 
Assets 
Current assets: 
Cash and cash equivalents                        2,922            6,527 
Short-term investments                               -            2,000 
Advances to suppliers                              240              284 
Prepaid expenses and other current 
 assets                                             68               90 
Current assets of discontinued 
 operations                                     25,347           22,625 
                                     -----------------   -------------- 
Total current assets                            28,577           31,526 
                                     -----------------   -------------- 
 
Noncurrent assets: 
Property and equipment, net                        239              221 
Operating right-of-use assets                      513              492 
Other noncurrent assets                            213              215 
Noncurrent assets of discontinued 
 operations                                      4,773            4,650 
                                     -----------------   -------------- 
Total noncurrent assets                          5,738            5,578 
                                     -----------------   -------------- 
 
Total assets                                    34,315           37,104 
                                     =================   ============== 
 
Liabilities and equity 
 
Current liabilities: 
Accounts payable                                   295              358 
Accrued expenses                                   840              909 
Current portion of operating lease 
 liabilities                                       282              301 
Other current liabilities                          780            1,364 
Current liabilities of discontinued 
 operations                                      8,813            9,733 
                                     -----------------   -------------- 
Total current liabilities                       11,010           12,665 
                                     -----------------   -------------- 
 
Noncurrent liabilities: 
Operating lease liabilities                        307              246 
Deferred revenue                                27,400           27,561 
Other noncurrent liabilities                     3,686            3,706 
Noncurrent liabilities of 
 discontinued operations                         6,197            5,593 

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