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BeyondSpring Inc. (BYSI): Business Model Canvas [Dec-2025 Updated] |
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You're looking to understand how BeyondSpring Inc. (BYSI) is positioning itself for a potential inflection point, and honestly, the entire business model hinges on successfully monetizing their lead asset, Plinabulin, through strategic execution. As someone who spent a decade analyzing biotech balance sheets, I see a company managing a tight runway, holding $12.5 million in cash as of September 30, 2025, while pushing through late-stage trials against tough competition in immuno-oncology. This canvas distills their strategy-from the value proposition of offering durable survival benefits to NSCLC patients to the $28.094 million in deferred revenue they carry-so you can see the precise levers they are pulling right now. Keep reading to see the full nine-block framework that dictates their near-term risk and opportunity.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Key Partnerships
You're looking at the network that supports BeyondSpring Inc.'s pipeline, especially for Plinabulin and the SEED Therapeutics platform. These aren't just names on a slide; these are concrete financial and research commitments that de-risk the business.
The relationship with SEED Therapeutics is central, though evolving. BeyondSpring co-founded SEED, which focuses on Targeted Protein Degradation (TPD). As of the third quarter of 2025, BeyondSpring Inc. held approximately 38% equity in SEED Therapeutics before the completion of future sale transactions. This stake is set to decrease significantly; for instance, definitive agreements announced in January 2025 to sell a portion of its Series A-1 Preferred Shares are expected to reduce BeyondSpring's ownership to approximately 14.4% upon completion. This strategic divestiture is designed to unlock value, with the proceeds, including approximately $35.4 million from the announced transactions, intended to advance late-stage clinical trials for Plinabulin.
The clinical validation for Plinabulin heavily relies on external academic expertise. BeyondSpring Inc. maintains active clinical collaborations with institutions like the MD Anderson Cancer Center. These collaborations provide critical translational data:
- Mechanism studies with MD Anderson collaborators confirmed Plinabulin drives dendritic cell (DC) maturation and M1 macrophage polarization via a specific GEF-H1 dependent mechanism in responding patients.
- A Med (Cell Press) Publication detailing this human study showed that Plinabulin, in combination with radiation and a checkpoint inhibitor, was associated with tumor responses across eight types of cancer in patients previously refractory to immune checkpoint inhibitor (ICI) therapy.
- This specific combination reported an Objective Response Rate (ORR) of 23% and a Disease Control Rate (DCR) of 54% in that refractory patient group.
For Plinabulin's global commercialization, BeyondSpring Inc. has established key regional alliances. The most significant is the exclusive commercialization and co-development agreement in Greater China with Jiangsu Hengrui Pharmaceuticals (Hengrui), which was established in August 2021. This partnership structures the financial upside and development costs:
| Commercialization Aspect | Financial/Structural Detail |
| Total Potential Milestone Payments (Wanchunbulin/Hengrui) | Up to 1.3B RMB (est. $200M USD) |
| Upfront Payment (Wanchunbulin/Hengrui) | 200M RMB (est. $30M USD) |
| Regulatory/Sales Milestone Potential (Wanchunbulin/Hengrui) | Up to 1.1B RMB (est. $170M USD) |
| Hengrui Equity Investment in Wanchunbulin | 100M RMB (est. $15M USD) |
| Wanchunbulin Pre-money Valuation for Equity Investment | 3.6B RMB (est. $560M USD) |
| BeyondSpring Global Rights Outside Greater China | 100% retained |
Beyond the China agreement, BeyondSpring Inc. is actively exploring further business development partnerships to extend Plinabulin's outreach. The company's R&D spending reflects this focus on partnership support. For the nine months ended September 30, 2025, Research and Development (R&D) expenses were $2.9 million, an increase of $0.7 million compared to the same period in 2024, driven in part by higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.
Partnerships are also key for SEED Therapeutics' R&D expertise, which leverages its proprietary TPD platform. These alliances provide external validation and funding streams for the TPD pipeline:
- SEED Therapeutics has an initial R&D collaboration with Eli Lilly and Company.
- SEED Therapeutics entered into a Targeted Protein Degradation Research Collaboration with Eisai, which includes potential payments to SEED of up to $1.5 Billion.
- Eisai also led SEED's Series A-3 financing, which completed at a pre-money valuation of $100 million.
These external research and development collaborations help manage the cost structure; for example, in Q3 2025, General and Administrative (G&A) expenses decreased by $0.9 million year-over-year, partly due to lower professional service costs in consulting for business development and partnership initiatives.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Key Activities
You're looking at the core engine driving BeyondSpring Inc. (BYSI) right now-the Key Activities that consume their capital and define their near-term value. It's all about pushing Plinabulin through the final stages and managing the strategic value of their SEED Therapeutics stake. Here's the breakdown based on their late 2025 reporting.
Late-stage clinical development of lead asset, Plinabulin
The primary activity is advancing Plinabulin, which is firmly in late-stage clinical development for Non-Small Cell Lung Cancer (NSCLC) and other indications. This involves generating and presenting compelling data to support future regulatory submissions. You should note that Plinabulin has now been administered to over 700 patients while maintaining a favorable safety profile.
The clinical narrative is heavily focused on its potential to resensitize tumors resistant to existing treatments. Specifically, data from the Phase 2 303 Study (NCT05599789) evaluating the combination of pembrolizumab plus Plinabulin and docetaxel in metastatic NSCLC patients who had progressed on prior PD-1/L1 inhibitors showed strong signals. The company is actively using these results to support its strategic direction.
Here are the key efficacy numbers from the data presented around mid-2025:
| Metric | Plinabulin Combination Data (n=47) | Comparison/Context |
| Median Progression-Free Survival (PFS) | 6.8 months (Q2 data) or 8 months (interim Phase 2) | Nearly double the 3.7 months seen with standard of care docetaxel |
| Confirmed Objective Response Rate (ORR) | 18.2% (Q2 data) | Higher than the 12.8% seen with SOC docetaxel |
| Disease Control Rate (DCR) | 77% (Q2 data) or 85% (SITC 2025 presentation) | Indicates clinical benefit for the majority of patients |
| Overall Survival (OS) at 15 months | 78% | Demonstrates durable survival benefits |
The Phase 3 DUBLIN-3 trial results, published in The Lancet Respiratory Medicine, reinforced Plinabulin's potential to advance the standard of care by showing durable survival benefits and reduced chemotherapy-induced neutropenia when combined with docetaxel in 2L/3L NSCLC EGFR Wild Type patients.
Research into Plinabulin's immune-modulating mechanism (DC maturation)
BeyondSpring Inc. is actively researching and publishing on Plinabulin's unique mechanism of action, which centers on dendritic cell (DC) maturation and T cell priming. This activity is crucial for differentiating the asset in the crowded immuno-oncology space.
Research collaborations, such as the one with MD Anderson, have highlighted that Plinabulin rapidly induces DC maturation and M1 macrophage polarization through a specific GEF-H1 dependent pathway. This mechanistic understanding helps in patient selection. In a study combining Plinabulin + radiation + PD-1 inhibitors in ICI-refractory patients, the combination elicited tumor responses with an ORR of 23% and a DCR of 54% in non-irradiated lesions.
The financial commitment to this research is visible in the operating expenses. For the nine months ended September 30, 2025, Research and Development (R&D) expenses totaled $2.9 million, an increase from $2.2 million for the same period in 2024. This increase was partly due to higher volume of Plinabulin combination therapy research.
Regulatory filings (e.g., IND clearance for SEED's RBM39 degrader)
A significant, though separate, key activity involves supporting SEED Therapeutics, where BeyondSpring Inc. held approximately 38% ownership as of Q3 2025, following the first closing of a divestiture in February 2025. This activity is focused on advancing SEED's pipeline toward the clinic.
The major regulatory milestone here is the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for SEED's lead program, the RBM39 degrader. Furthermore, the RBM39 degrader, ST-01156, already secured Rare Pediatric Disease and Orphan Drug Designations from the FDA back in 2024.
The costs associated with these regulatory efforts are embedded in the R&D spend; for instance, Q3 2025 R&D expenses increased due to higher professional service expenses in regulatory affairs.
Strategic business development to secure licensing deals
Securing partnerships is vital for non-commercial-stage companies like BeyondSpring Inc. to fund late-stage trials and maximize asset value. This activity involves engaging with potential partners using the clinical data generated from Plinabulin studies.
BeyondSpring is actively pursuing strategic business development, as evidenced by the higher volume of Plinabulin combination therapy research in Q3 2025 intended to support these initiatives. The company's affiliate, SEED Therapeutics, already has established global partnerships, including a strategic research collaboration with Eisai Co., Ltd. and a prior partnership with Eli Lilly and Company.
The potential financial upside from these deals is substantial. Under the Eisai collaboration, SEED is eligible to receive upfront payments and potential milestone payments up to $1.5 billion, plus tiered royalties on net sales. On the expense side, General and Administrative (G&A) expenses for the quarter ending September 30, 2025, decreased partly due to lower professional service costs in consulting for business development and partnership initiatives.
Managing intellectual property portfolio and patents
Managing the IP portfolio involves protecting the novel mechanisms of both Plinabulin and the SEED platform. BeyondSpring's IP strength is anchored by its lead asset and the Targeted Protein Degradation (TPD) platform.
For the SEED platform, leadership in the emerging TPD field was underscored in 2024 when SEED was recognized in two Nature review papers. The company's focus on filing necessary documentation is confirmed by the filing of BeyondSpring Inc.'s annual report on Form 10-K on March 27, 2025.
The overall financial structure reflects this focus: R&D expenses for the six months ended June 30, 2025, were $1.9 million, up from $1.6 million in the prior year, driven in part by costs related to regulatory and CMC (Chemistry, Manufacturing, and Controls) activities necessary to maintain and advance the IP-protected assets.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Key Resources
You're looking at the core assets BeyondSpring Inc. (BYSI) is relying on to drive value right now, as of late 2025. These aren't just ideas; they're tangible, data-backed components that form the foundation of their strategy.
Plinabulin, a first-in-class dendritic cell maturation agent
The primary tangible asset is Plinabulin, which BeyondSpring Inc. positions as a first-in-class anti-cancer agent. Its mechanism centers on being a potent inducer of dendritic cell (DC) maturation, which helps activate both the innate and adaptive immune systems against cancer. This is a key differentiator, especially for patients whose disease has progressed after receiving checkpoint inhibitors.
Here are some key operational and clinical metrics related to this asset:
- Plinabulin has been used in over 700 cancer patients.
- It is a differentiated tubulin binder, distinct from other agents in its class.
- Mechanism studies with MD Anderson collaborators showed DC maturation and M1 macrophage polarization via a specific GEF-H1 dependent pathway in responding patients.
Intellectual property and clinical data from global Phase 3 DUBLIN-3 trial
The clinical data package supporting Plinabulin is a critical resource. Specifically, the results from the global Phase 3 DUBLIN-3 trial are significant. You'll want to note that these results were published in The Lancet Respiratory Medicine, which lends considerable credibility.
The DUBLIN-3 study was a global Phase 3 randomized, controlled clinical trial. It compared the combination of Plinabulin and docetaxel against an active control arm of docetaxel alone in second- and third-line Non-Small Cell Lung Cancer (NSCLC) patients who were Epidermal Growth Factor Receptor (EGFR) wild-type and had failed first-line platinum doublet therapies. The data showed that the combination achieved durable survival benefits and reduced chemotherapy-induced neutropenia.
To give you a snapshot of the data points supporting the asset's value, consider this comparison:
| Clinical Endpoint/Data Point | Plinabulin + Docetaxel (DUBLIN-3) | Phase 2 NSCLC Cohort (n=47) |
| Durable Survival Benefits | Achieved in Phase 3 | 12-month OS Rate: 79% |
| Chemotherapy-Induced Neutropenia | Reduced | 24-month OS Rate: 66% |
| Disease Control Rate (DCR) | Supports potential standard of care advancement | 85% (in combination with docetaxel and Keytruda) |
Equity stake in SEED Therapeutics, a targeted protein degradation company
BeyondSpring Inc. maintains an interest in SEED Therapeutics, a company focused on Targeted Protein Degradation (TPD) technology, which BeyondSpring Inc. co-founded with Eli Lilly and Company in 2020. This represents a strategic, albeit diminishing, asset in the TPD space.
The structure around this asset has seen recent changes, which you need to track closely. BeyondSpring Inc. executed definitive agreements in January 2025 to sell a portion of its Series A-1 Preferred Shares in SEED for gross proceeds of approximately $35.4 million. This move was intended to unlock value and fund Plinabulin trials without diluting shareholder equity.
Here's the ownership status as of the latest reports:
- Initial ownership was approximately 38%.
- Following the January 2025 transaction, BeyondSpring Inc. is expected to retain approximately 14.4% of SEED's outstanding shares upon completion of future sale transactions.
- SEED itself is a credible entity, having completed a $30 million Series A-3 financing led by Eisai, at a pre-money valuation of $100 million.
- SEED's lead RBM39 degrader program received Investigational New Drug (IND) clearance from both the US FDA and China NMPA.
To be fair, BeyondSpring Inc. now reports SEED's financial results as discontinued operations, which signals a strategic pivot away from direct operational reliance on this asset.
Cash and cash equivalents of $12.5 million as of September 30, 2025
Liquidity is always a primary resource for a clinical-stage company. As of the end of the third quarter of 2025, BeyondSpring Inc. reported its balance of readily available funds.
The reported figure is $12.5 million in cash and cash equivalents as of September 30, 2025. This represents an improvement from the $2.9 million reported as of December 2024. This cash position is what fuels the ongoing R&D expenses, which were $2.9 million for the nine months ended September 30, 2025, for continuing operations.
Finance: draft 13-week cash view by Friday.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Value Propositions
You're looking at the core value BeyondSpring Inc. (BYSI) offers its target customers, primarily oncologists and patients facing advanced Non-Small Cell Lung Cancer (NSCLC) after initial immunotherapy failure. This value centers on its lead asset, Plinabulin, acting as a first-in-class dendritic cell (DC) maturation agent.
Durable survival benefits for NSCLC patients in combination with docetaxel
The data from the global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, supports the durable survival benefit when Plinabulin is added to docetaxel. For patients in that trial who received at least 4 cycles of treatment, the Overall Survival (OS) Hazard Ratio (HR) was 0.64 (p=0.0027), translating to a median OS benefit of 4.8 months in the plinabulin/docetaxel arm compared to the docetaxel arm.
Interim data from the Phase 2 investigator-initiated Study 303 (Plinabulin, docetaxel, and pembrolizumab in progressed metastatic NSCLC) also points to this durability:
| Metric (Study 303, n=47) | Plinabulin Combination Data | Standard of Care (SOC) Docetaxel Data |
| Median Progression-Free Survival (PFS) | 6.8 months | 3.7 months |
| 15-Month Overall Survival (OS) Rate | 78% | Median OS of 11.8 months |
| 24-Month OS Rate | 66% | N/A |
This is a significant step up, considering docetaxel alone was approved over 20 years ago.
Potential to re-sensitize tumors resistant to PD-1/L1 checkpoint inhibitors
A major value driver is Plinabulin's mechanism for immune re-sensitization. This addresses the high percentage of patients, estimated at over 60% of NSCLC patients, whose disease progresses after initial PD-1/L1 therapy.
- Phase 2 Study 303 (Plinabulin + docetaxel + Keytruda, n=47) showed a Disease Control Rate (DCR) of 85%.
- The Confirmed Objective Response Rate (ORR) in Study 303 was 18.2%.
- A separate Phase 1 study (NCT04902040) showed a DCR of 54% across eight cancer types in patients previously refractory to immune checkpoint inhibitor (ICI) therapy.
Reduced chemotherapy-induced neutropenia (CIN) for patients
Beyond efficacy, BeyondSpring Inc. offers a safety benefit by addressing a major dose-limiting toxicity of chemotherapy. Standard docetaxel can result in severe neutropenia rates over 40%.
- The DUBLIN-3 Phase 3 trial demonstrated an 82% relative reduction in Grade 4 neutropenia in Cycle 1 Day 8 (p<0.0001) when Plinabulin was added to docetaxel.
- The company aims to offer full protection throughout the chemotherapy cycle, with Plinabulin showing protection in Week 1, complementary to G-CSF agents protecting in Week 2.
- Data across six independent clinical trials involving over 1,200 patients support its potential to prevent severe neutropenia, not just reduce it.
Addressing high unmet medical needs in immuno-oncology
The market need is clear: second- and third-line NSCLC without targetable mutations after ICI failure has seen no new agent approval in the last decade. BeyondSpring Inc. is actively funding research to support this need, with Research and Development (R&D) expenses for the nine months ended September 30, 2025, at $1.0 million, up from $0.6 million for the same period in 2024, driven partly by Plinabulin combination therapy research.
Finance: draft 13-week cash view by Friday.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Customer Relationships
You're navigating a complex biotech landscape where every interaction with a key stakeholder directly impacts clinical timelines and funding. For BeyondSpring Inc. (BYSI), the Customer Relationships block is less about mass marketing and more about deep, targeted engagement with the scientific and financial communities supporting its lead asset, Plinabulin, and its subsidiary SEED Therapeutics.
High-touch, collaborative relationships with clinical investigators and KOLs
The relationship with clinical investigators and Key Opinion Leaders (KOLs) is foundational, especially given Plinabulin's mechanism as a dendritic cell maturation agent. This requires close collaboration to interpret and present complex data from combination trials. BeyondSpring Inc. reports that Plinabulin has now been administered to more than 700 patients with a favorable safety profile as of Q3 2025.
Collaboration is evidenced by the presentation of data generated in investigator-initiated studies (IITs) and sponsored trials, which KOLs help design and interpret. For instance, early readouts in metastatic NSCLC patients who failed PD-1/L1 inhibitors showed a median progression-free survival (PFS) of 6.8 months and a 15-month overall survival rate of 78% from the 303 Study. Furthermore, a Phase 1 IIT study at MD Anderson showed a duration of response of over 19 months in heavily pretreated Hodgkin lymphoma patients. A publication in Med (Cell Press) on July 7, 2025, highlighted an overall response rate of 23% and a disease control rate of 54% in non-irradiated lesions from a combination study.
Here's a quick look at some of the reported clinical engagement outcomes:
| Clinical Endpoint/Setting | Combination Regimen | Key Metric | Value/Duration |
| Metastatic NSCLC (Post-PD-1/L1) | Plinabulin + Docetaxel + Keytruda (SITC 2025) | Disease Control Rate (DCR) | 85% |
| Heavily Pretreated Hodgkin Lymphoma (Phase 1 IIT) | Plinabulin + PD-1/PD-L1 inhibitor + Radiation | Duration of Response (DOR) | Over 19 months |
| Metastatic NSCLC (Post-PD-1/L1) (Q2 2025 Data) | Plinabulin + Pembrolizumab + Docetaxel | Median Progression-Free Survival (PFS) | 6.8 months |
| NSCLC (Post-PD-1/L1) (Med Publication July 2025) | Plinabulin + Radiation + Checkpoint Inhibitor | Disease Control Rate (DCR) in non-irradiated lesions | 54% |
These data points underscore the active, data-driven relationship with the clinical community.
Direct engagement with regulatory bodies (FDA, NMPA)
Direct interaction with the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) is critical for advancing Plinabulin through the approval process. The Phase 3 DUBLIN-3 trial data, published in The Lancet Respiratory Medicine, directly supports regulatory strategy, particularly for submission to the NMPA.
Engagement extends to the subsidiary's pipeline. SEED Therapeutics, co-founded by BeyondSpring Inc., successfully achieved U.S. FDA and China NMPA clearance for its Investigational New Drug (IND) application for its lead RBM39 degrader program. This is a significant milestone achieved through direct regulatory dialogue. It is important to note that for the CIN indication of Plinabulin, the FDA issued a Complete Response Letter (CRL) in December 2021, indicating that a second well-controlled trial would be required to satisfy the substantial evidence requirement.
Investor relations and transparent reporting of clinical milestones
BeyondSpring Inc. maintains a relationship with investors through regular, transparent financial and clinical updates. The company's financial reporting structure reflects strategic decisions, such as reporting SEED Therapeutics' results as discontinued operations following definitive agreements in January 2025 to sell a majority of its Series A-1 Preferred Shares.
The focus on transparency is visible in expense management related to investor communications. General and administrative (G&A) expenses for the nine months ended September 30, 2025, were $3.4 million, a decrease of $1.5 million compared to the same period in 2024, partly due to lower investor relations services. For the quarter ending September 30, 2025, G&A was $0.8 million, down from $1.7 million in Q3 2024, again citing lower investor relations services. The company reported a net loss of $1.7 million for the nine months ended September 30, 2025. Cash management is also key to this relationship; cash and cash equivalents stood at $12.5 million as of September 30, 2025, an increase from $2.9 million at the end of 2024.
Key financial and ownership metrics related to investor reporting include:
- Ownership stake in SEED Therapeutics reduced to approximately 38% as of Q3 2025.
- Expected final ownership stake in SEED Therapeutics after future sales transactions is approximately 14%.
- Proceeds from the January 2025 definitive agreements to sell a portion of SEED shares totaled approximately $35.4 million.
- Net loss for Q3 2025 was $4.944 million.
Strategic outreach to potential pharmaceutical licensing partners
Strategic outreach focuses on unlocking value from its assets, particularly through the SEED Therapeutics platform. The January 2025 definitive agreements to sell a portion of SEED equity for $35.4 million were explicitly aimed at advancing Plinabulin to anti-cancer registrational studies. This divestiture strategy is a form of strategic partnership/transactional outreach to optimize resource allocation.
Past agreements provide a benchmark for potential future licensing deals. A prior agreement for Plinabulin in Greater China markets involved Hengrui being responsible for all commercialization costs, with potential regulatory and sales milestones up to RMB 1.1 billion (approximately $171 million). Furthermore, SEED's RBM39 degrader program is mentioned in the context of research collaborations with Eli Lilly and Company and Eisai Co. Ltd.. SEED also completed its Series A-3 financing of $30 million.
Finance: review the cash runway based on the $12.5 million cash position as of September 30, 2025, against projected R&D spend by next Tuesday.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Channels
You're looking at how BeyondSpring Inc. gets its critical data and science out into the world, which is the lifeblood of a clinical-stage company. This isn't about selling widgets; it's about validating science to attract partners and eventually, secure market access.
Global clinical trial sites for generating pivotal data are the foundation. The data that matters most for regulatory filings, like the survival benefit from the Phase 3 DUBLIN-3 trial, comes from a global network of sites. This global reach is essential for generating the robust data needed for international submissions.
The validation of this data through scientific publications in peer-reviewed journals is a key channel for credibility. For instance, the final Phase 3 data from the DUBLIN-3 trial, showing a survival benefit in second- and third-line non-small cell lung cancer (NSCLC) patients, was published in The Lancet Respiratory Medicine. This is a top-tier channel for establishing scientific acceptance.
Presentations at major oncology conferences are where BeyondSpring Inc. actively communicates its clinical progress to the medical community and potential commercial partners. You can see the density of this activity in late 2025:
| Conference/Study | Patient Cohort (n) | Key Efficacy Metric | Value/Amount |
| SITC 2025 (Triple IO Combo) | 30 metastatic NSCLC patients | Disease Control Rate (DCR) | 89.3% |
| SITC 2025 (Triple IO Combo) | 30 metastatic NSCLC patients | Median Progression-Free Survival (PFS) | 8.6 months |
| ASCO 2025 (303 Study Interim) | 47 patients | Median Progression-Free Survival (PFS) | 6.8 months |
| ASCO 2025 (303 Study Interim) | 47 patients | Disease Control Rate (DCR) | 77.3% |
| Q3 2025 Data Update (Phase 2 Cohort) | 47 patients | Disease Control Rate (DCR) | 85% |
| Q3 2025 Data Update (Phase 2 Cohort) | 47 patients | 12-month Overall Survival (OS) | 79% |
| Phase 1 Data (Across Cancer Types) | Not specified | Disease Control Rate (DCR) | 54% |
The mechanism of action data, showing dendritic cell (DC) maturation and M1 macrophage polarization via a GEF-H1 dependent mechanism, was also a key communication point at SITC 2025. Also, BeyondSpring Inc. had a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2025.
For future pharmaceutical distribution networks via commercial partners, the focus is on strategic groundwork. The company has been conducting higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives. The CEO has also stated plans to explore business development partnerships to bring Plinabulin to cancer patients.
You should track these communication efforts closely, as they directly feed into the perceived value for future licensing deals:
- Global Phase 3 Trial (DUBLIN-3) publication in The Lancet Respiratory Medicine.
- Presentations at major meetings like SITC 2025 and ASCO 2025.
- Data points like the 85% DCR and 7.0 months median PFS from the Phase 2 cohort.
- The ongoing focus on business development and partnership initiatives.
Finance: review the Q3 2025 R&D expense of $1.0 million for the quarter, noting a portion supports these partnership initiatives.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Customer Segments
You're hiring before product-market fit, so knowing exactly who needs your solution is the first step in building value. For BeyondSpring Inc. (BYSI), the customer segments center on specific, underserved oncology populations and the entities that treat and fund them.
The primary patient segment is Oncology patients with Non-Small Cell Lung Cancer (NSCLC). The global NSCLC therapeutics market size was valued at USD 21.85 billion in 2024, and the American Cancer Society estimates around 226,650 new lung cancer cases will be reported in the U.S. by the end of 2025.
A critical subset is Patients who have progressed after prior PD-1/L1 inhibitor therapy. BeyondSpring's CEO noted that approximately 60 percent of cancer patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors. The Phase 2 303 Study specifically targeted this group, enrolling 47 patients, of which 72.3% were current or former smokers. The PD-1/L1 checkpoint inhibitors market itself was projected to be approximately USD 25,000 million in 2025.
The next segment includes Oncologists and hematologists who prescribe cancer therapies. These prescribers are influenced by clinical data presented at major medical meetings, such as the 2025 ASCO Annual Meeting and SITC 2025. Data from the Plinabulin combination study showed a median Progression-Free Survival (PFS) of 6.8 months, nearly double the 3.7 months seen with standard of care docetaxel, and a Disease Control Rate of 77.3% in this refractory population. Still, the therapy showed 51.1% of participants experiencing grade 3 or higher adverse effects.
The final segment involves Large pharmaceutical companies seeking late-stage oncology assets. These companies represent potential partners or acquirers. BeyondSpring has existing relationships, evidenced by financial support from Merck's Investigator Studies Program for the 303 Study. Furthermore, BeyondSpring's equity stake in SEED Therapeutics is tied to collaborations with major players like Eli Lilly and Company ("Lilly") and Eisai Co., Ltd. ("Eisai"). SEED Therapeutics recently completed its Series A-3 financing, with a first close of approximately $7.35 million in February 2025, part of a larger financing effort.
Here's a quick look at the key entities and associated numbers relevant to these customer segments as of late 2025:
| Customer Segment Group | Specific Entity/Population | Key Metric/Value (2025 Data) |
|---|---|---|
| Patient Population (NSCLC) | U.S. New Lung Cancer Cases (Est.) | 226,650 (by end of 2025) |
| Patient Population (Post-ICI) | Patients Progressed on PD-1/L1 Inhibitors (Est.) | Approximately 60 percent |
| Clinical Trial Data Point | Phase 2 Study Enrollment (N) | 47 patients |
| Prescribing Professionals | Key Data Point: Median PFS (Plinabulin Combo) | 6.8 months |
| Prescribing Professionals | Key Data Point: Median PFS (SOC Docetaxel) | 3.7 months |
| Potential Partners/Acquirers | SEED Therapeutics Series A-3 Financing (First Close) | Approximately $7.35 million (February 2025) |
| Financial Context (R&D Spend) | R&D Expenses (9 Months Ended Sept 30, 2025) | $2.9 million |
You should note that BeyondSpring's cash and cash equivalents stood at $12.5 million as of September 30, 2025, which supports the ongoing engagement with these segments.
- Oncology patients with NSCLC who have progressed post-immunotherapy.
- Oncologists presenting at 2025 ASCO and SITC 2025.
- Pharmaceutical companies with existing relationships like Merck, Lilly, and Eisai.
- The segment of patients who are current or former smokers in the trial was 72.3%.
Finance: draft 13-week cash view by Friday.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Cost Structure
You're looking at the core expenses driving BeyondSpring Inc.'s operations as of late 2025, focusing on the cash burn required to keep Plinabulin moving forward. Honestly, for a clinical-stage biotech, the Cost Structure is almost entirely tied up in R&D.
Research and development (R&D) expenses for the third quarter ending September 30, 2025, were reported at $1.0 million for continuing operations. This is up from $0.6 million in Q3 2024. For the nine months ended September 30, 2025, R&D totaled $2.9 million.
General and administrative (G&A) expenses were leaner in Q3 2025, coming in at $0.8 million, a significant drop from $1.7 million in the prior year's quarter. Year-to-date through September 30, 2025, G&A was $3.4 million.
The cost drivers for R&D are clear, reflecting a late-stage focus. The increase in R&D spending quarter-over-quarter was primarily fueled by:
- Higher drug manufacturing expenses.
- Higher professional service expenses in regulatory affairs.
- Higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.
Clinical trial operations and drug manufacturing costs are embedded within that R&D spend. Specifically, the higher drug manufacturing expenses contributed to the quarter-over-quarter R&D increase. This is what you expect when you are running late-stage studies and preparing for potential commercialization batches.
Regulatory affairs and professional service fees are also a component of the R&D increase, noted as higher professional service expenses in regulatory affairs for Q3 2025. On the G&A side, the decrease in spending was due to lower professional service costs in consulting for business development and partnership initiatives, plus lower salary expenses from administrative headcount reduction. That's smart cost control, defintely.
Costs associated with maintaining intellectual property are a standard, though often less granularly reported, part of the overall R&D structure, covering patent filings and maintenance fees globally for assets like Plinabulin.
Here's a quick look at the key operating expenses for continuing operations:
| Expense Category | Q3 2025 Amount (USD) | Nine Months Ended Sept 30, 2025 Amount (USD) |
| Research and Development (R&D) | $1.0 million | $2.9 million |
| General and Administrative (G&A) | $0.8 million | $3.4 million |
| Total Operating Expenses (R&D + G&A) | $1.8 million | $6.3 million |
You should also note the spending on discontinued operations, which relates to the SEED Therapeutics interests that were partially divested. The net loss from discontinued operations was $3.2 million for Q3 2025.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Revenue Streams
You're looking at the current state of BeyondSpring Inc.'s revenue generation, and honestly, it's a story of non-product revenue streams funding the core drug development right now. The company isn't seeing sales from its main product candidate yet, so the focus is on asset monetization and past deal structures.
Here's a quick look at the key financial figures shaping the Revenue Streams block of the Business Model Canvas as of late 2025:
| Revenue Component | Amount/Status | Period/Context |
| Product Revenue (Continuing Operations) | $0.0 | Q3 2025 |
| Gain from Sale of SEED Equity Interests | $6.99 million | Q1 2025 transaction realization |
| Deferred Revenue (Balance Sheet) | $28.094 million | As of late 2025 |
| Potential Future Milestone Payments (SEED) | Up to $1.5 billion (Eisai) plus royalties | From SEED Therapeutics collaboration |
The $0.0 in product revenue from continuing operations in Q3 2025 tells you that Plinabulin, the lead asset, is still pre-commercial. That's expected for a clinical-stage company, but it underscores the reliance on other funding mechanisms.
The most concrete recent financial boost came from the SEED Therapeutics transaction. You saw a recognized gain of $6.99 million in Q1 2025 related to the definitive agreements made in January 2025 to sell a portion of the Series A-1 Preferred Shares of SEED. This move was strategic, designed to provide capital to advance Plinabulin without diluting the core equity too much at that time.
Looking at the balance sheet, the deferred revenue figure stands at $28.094 million as of the latest reporting period. This isn't cash from new sales; rather, it represents upfront payments received from past licensing or collaboration deals that BeyondSpring Inc. has yet to earn through performance obligations.
The real upside potential in the Revenue Streams block is tied to the success of SEED Therapeutics, where BeyondSpring Inc. retains a significant, though decreasing, ownership stake. These future payments are contingent on clinical and regulatory success for SEED's pipeline assets, not Plinabulin directly, but they flow back to BeyondSpring Inc. shareholders:
- Potential milestone payments from the collaboration with Eisai Co., Ltd. are up to $1.5 billion, plus tiered royalties on net sales.
- The earlier collaboration with Eli Lilly and Company carries potential milestone payments up to $780 million, also plus tiered royalties.
- BeyondSpring Inc. held approximately 38% of SEED as of Q3 2025, though this is expected to fall to around 14% after future sale transactions close.
So, you have zero current product revenue, a one-time gain from an asset sale, a liability/asset on the books from prior deals, and massive contingent future revenue tied to a subsidiary's success. Finance: draft 13-week cash view by Friday.
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