A clinical-stage Genentech, focused on developing new cancer therapies and supportive care.

An aspiring Gilead Sciences, but aiming for breakthrough cancer treatments instead of antivirals.

• Plinabulin for Chemotherapy-Induced Neutropenia (CIN): A drug candidate aimed at preventing a common side effect of chemotherapy.
• Plinabulin for Non-Small Cell Lung Cancer (NSCLC): A drug candidate for treating later-stage non-small cell lung cancer.
• Plinabulin Combination Therapies: Drug candidates combining Plinabulin with immuno-oncology agents for various cancers, including NSCLC and SCLC.
• Preclinical Small Molecule Immune Agents: Early-stage drug candidates focused on modulating the immune system.

BeyondSpring Inc. (BYSI) is a clinical-stage biopharmaceutical company focused on the development of cancer therapies. As such, the company is primarily engaged in research and development and conducting clinical trials for its drug candidates, such as Plinabulin.

At its current stage, BeyondSpring Inc. does not have approved commercial products on the market. Therefore, it does not have major customers in the traditional sense of companies or individuals purchasing its products. Its primary sources of funding and "stakeholders" are typically investors, who provide capital for its ongoing development efforts.

• WuXi AppTec Co., Ltd. (603259.SS, 2359.HK)

Dr. Lan Huang, Co-founder, Chairman & Chief Executive Officer, Principal Financial and Accounting Officer

Dr. Lan Huang co-founded BeyondSpring in 2013, and in 2010, she founded Wanchun Biotech, the former holding company of BeyondSpring's U.S. subsidiary. She possesses over two decades of entrepreneurial experience within the Chinese and U.S. biotechnology sectors. Prior to BeyondSpring, Dr. Huang co-founded Wuxi MTLH Biotechnology Co. Ltd., where she served as CEO in 2010; the China rights for a cancer peptide drug she developed were subsequently acquired by Shanghai Pharmaceutical Group in 2010. She also co-founded Paramax International, a clinical Contract Research Organization (CRO) in China, which was acquired by RPS (a global CRO) in 2009 and later sold to Warburg Pincus in 2011. Her experience also includes leading partnering initiatives between Forward Ventures' portfolio companies and Chinese pharmaceutical companies. Dr. Huang earned her Ph.D. in chemistry from the University of California at Berkeley. She also serves as the Principal Financial and Accounting Officer for BeyondSpring.

Dr. June Lu, Chief Scientific Officer

Dr. June Lu was appointed as Chief Scientific Officer for BeyondSpring, effective March 31, 2024. She brings nearly 25 years of industry experience to her role and joined BeyondSpring in October 2021, most recently serving as the Executive Director of Translational Medicine.

Dr. John Mao, SVP, Development

Dr. John Mao has over 30 years of leadership experience in biotechnology and pharmaceutical development. His expertise spans preclinical and clinical research, regulatory strategy, and global product development, with a track record of advancing novel therapeutics across various therapeutic areas, including oncology.

Here are the key risks to BeyondSpring Inc. (BYSI):

1. Regulatory Approval and Clinical Trial Efficacy Risk: BeyondSpring faces significant risk related to obtaining regulatory approval for its lead asset, Plinabulin. The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in December 2021 for Plinabulin's New Drug Application (NDA) for the prevention of chemotherapy-induced neutropenia (CIN), stating that the results from the single registrational Phase 3 trial were not sufficiently robust and required an additional well-controlled trial. This rejection caused a substantial drop in the company's stock price. Furthermore, there are analyst concerns regarding the potential for similar issues with the Non-Small Cell Lung Cancer (NSCLC) approval pathway due to questions about the robustness and disclosure of trial data. The company also withdrew its NDA for CIN in China in March 2023, though it plans to re-file.
2. Funding and Going Concern Risk: As a clinical-stage biopharmaceutical company, BeyondSpring currently generates no revenue and operates with a negative net margin. Its continued operations, advancement of its clinical pipeline, and potential commercialization efforts are heavily dependent on its ability to raise additional capital. Difficulties in securing adequate financing on acceptable terms could significantly impede its ability to fund future operations and raise concerns about its ability to continue as a going concern.
3. Commercialization Challenges and Competition: Even if Plinabulin eventually receives regulatory approval, BeyondSpring faces substantial challenges in successfully commercializing the drug. The company has acknowledged that marketing in the U.S. is not its strength and plans to seek partners for commercialization in this key market. The markets for both CIN and immuno-oncology are highly competitive, with established therapies and numerous other companies developing new treatments, which could make market penetration and adoption difficult for Plinabulin.

Chemotherapy-Induced Neutropenia (CIN)

• The global chemotherapy-induced neutropenia market was valued at approximately USD 371.2 million in 2023 and is projected to reach USD 455.7 million by 2034. Other estimates place the global market at USD 580.79 million in 2023, growing to USD 775.84 million by 2032.
• Another estimate for the global market size was USD 1.63 billion in 2024, with a projection to reach USD 1.51 billion by 2030.
• For the top 7 markets (U.S., EU4, UK, and Japan), the chemotherapy-induced neutropenia market reached USD 378.2 million in 2024 and is expected to grow to USD 472.2 million by 2035.
• In North America, the chemotherapy-induced neutropenia treatment market accounted for USD 212.7 million in 2023.

Non-Small Cell Lung Cancer (NSCLC)

• The global non-small cell lung cancer market was estimated at USD 20.2 billion in 2024 and is expected to grow to USD 53.9 billion by 2034. Another report valued the global market at USD 15.3 billion in 2021, with a projection to reach USD 36.9 billion by 2031.
• In the 7 Major Markets (7MM), which include the U.S., EU4 (Germany, France, Italy, Spain), UK, and Japan, the NSCLC market is projected to reach approximately USD 65 billion by 2034, growing from USD 32.442 billion in 2025.
• The global non-small cell lung cancer therapeutics market size was valued at USD 38.49 billion in 2025 and is projected to grow to USD 74.99 billion by the end of 2034.
• North America is noted as the largest non-small cell lung cancer market. The U.S. market alone is projected to reach USD 18.05 billion by 2026.

BeyondSpring Inc. (BYSI), a clinical-stage biopharmaceutical company focused on cancer therapies, has several potential drivers for future revenue growth over the next 2-3 years, primarily centered around its lead asset Plinabulin and its strategic investment in SEED Therapeutics.

1. Commercialization of Plinabulin for Non-Small Cell Lung Cancer (NSCLC): BeyondSpring has reported promising Phase 3 DUBLIN-3 study results for Plinabulin in combination with docetaxel for EGFR wild-type non-squamous NSCLC patients who have progressed after anti-PD-(L)1 immunotherapy. The company plans to initiate a global Phase 3 DUBLIN-4 trial to further support a New Drug Application (NDA) submission for this patient population. This represents a significant market opportunity in addressing acquired resistance to checkpoint inhibitors, potentially leading to product revenue upon regulatory approval.

2. Milestone and Royalty Payments from SEED Therapeutics Collaborations: BeyondSpring co-founded and holds an equity stake in SEED Therapeutics, a company focused on targeted protein degradation (TPD). SEED has established strategic research collaborations with major pharmaceutical companies, including Eli Lilly and Company and Eisai Co., Ltd. These collaborations involve potential upfront payments, as well as significant preclinical, clinical, regulatory, and sales milestone payments, along with tiered royalties. For instance, the Eisai collaboration alone could yield up to $1.5 billion in potential payments to SEED. As BeyondSpring currently owns approximately 40% of SEED, these payments, or the increasing valuation of its stake, serve as a substantial indirect revenue driver for BeyondSpring.

3. Commercialization of Plinabulin in Greater China through the Hengrui Partnership: BeyondSpring entered into an exclusive commercialization and co-development agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. for Plinabulin in Greater China. This partnership covers both the prevention of chemotherapy-induced neutropenia (CIN) and the co-development of Plinabulin for new cancer indications, such as NSCLC, in the region. The agreement includes potential milestone payments and a predetermined percentage of net sales for BeyondSpring's China subsidiary, Wanchunbulin, with Hengrui covering commercialization costs. This partnership offers a pathway for revenue generation from the Chinese market.

4. Advancement of SEED Therapeutics' Internal Pipeline: SEED Therapeutics is actively advancing its internal lead oncology asset, an RBM39 degrader, towards clinical development. An Investigational New Drug (IND) filing for this asset is expected in mid-2025, with patient enrollment anticipated in the second half of 2025. Successful progression of SEED's internal pipeline could lead to further licensing deals, expanded collaborations, or eventual direct product revenue for SEED, thereby benefiting BeyondSpring through its equity ownership.

Share Issuance

• A public offering of 7,500,000 ordinary shares at $10.00 per share was priced in November 2020, expected to generate approximately $75.0 million in gross proceeds.
• The company has had equity offerings under an effective shelf registration statement, indicating an ongoing potential for capital raises through share issuances.
• BeyondSpring's cash burn, which was $15 million over the trailing twelve months as of June 2025, suggests that funding growth has involved share issuances, potentially leading to dilution.

Inbound Investments

• BeyondSpring's subsidiary, SEED Therapeutics, completed a $24 million first close of its Series A-3 Financing in 2024.
• SEED Therapeutics also entered into a targeted protein degradation research collaboration with Eisai, which includes potential payments to SEED of up to $1.5 billion.

Outbound Investments

• BeyondSpring co-founded and holds an equity stake in SEED Therapeutics, representing a strategic outbound investment in a subsidiary focused on therapeutic development.
• BeyondSpring maintains approximately 40% ownership in SEED following a partial sale of Series A-1 Preferred Shares.

Capital Expenditures

• Capital expenditures for the most recent reported quarter (Q3 2025) totaled $0.000 million.
• As of September 30, 2025, the company's Property, Plant, and Equipment was valued at $0.18 million.
• Financial reports consistently indicate minimal or no significant capital expenditures, reflecting the nature of a clinical-stage biopharmaceutical company focused on R&D.