Financial Data and Key Metrics Changes - R&D expenses in Q1 2021 were $11.3 million, down from $13.7 million in the same period last year, a decrease of $2.4 million primarily due to reduced clinical trial expenses and noncash stock-based compensation [18] - G&A expenses increased to $6.4 million in Q1 2021 from $2.9 million in Q1 2020, an increase of $3.5 million mainly due to higher personnel costs and pre-commercialization activities for plinabulin [19] - The net loss for Q1 2021 was $17.0 million compared to $16.1 million for the same period last year [19] - Cash balance at the end of Q1 was $90.6 million, expected to support ongoing clinical programs and preparations for the potential launch of plinabulin in early 2022 [19] Business Line Data and Key Metrics Changes - The company is focused on the commercialization and development of plinabulin, a first-in-class agent for CIN prevention and non-small-cell lung cancer [7][8] - Progress in the DUBLIN-3 Phase 3 study for non-small-cell lung cancer, with 559 patients enrolled, aiming to validate plinabulin's efficacy [9][10] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity due to updated NCCN guidelines, which have expanded the addressable market for plinabulin [41][43] - The high-risk patient population represents 35% and the intermediate-risk population represents 37%, indicating a substantial market potential for plinabulin [43] Company Strategy and Development Direction - The company plans to launch plinabulin in early 2022, with a comprehensive prelaunch strategy including awareness campaigns and stakeholder outreach [16][17] - Focus on developing plinabulin as a treatment in oncology, particularly in reversing resistance to immunotherapy and addressing unmet medical needs [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date of November 30, 2021, and the potential for plinabulin to improve treatment standards for cancer patients [8][20] - The company is optimistic about the results from the DUBLIN-3 study and the potential for plinabulin to capture significant market share [20] Other Important Information - An R&D Day is scheduled for June 25, 2021, to discuss the anti-cancer development strategy for plinabulin [13] - The company is evaluating options for non-dilutive financing to strengthen its balance sheet ahead of the product launch [48] Q&A Session Summary Question: Confidence level regarding FDA advisory committee for plinabulin - Management indicated that there is currently no plan for an AdCom, supported by positive FDA interactions and inspections [24][25][26] Question: Data on triple plinabulin plus I/O in non-small-cell lung cancer - Management confirmed plans to explore this combination in non-small-cell lung cancer after DUBLIN results [28][29] Question: Status of Phase 3 DUBLIN study events - Management confirmed reaching the required 439 death events for final analysis, with data cleaning ongoing [33] Question: Patient baseline characteristics in Phase 3 DUBLIN study - Management stated that baseline characteristics are balanced and will be detailed at the upcoming R&D Day [36] Question: Regulatory sentiment and NCCN guideline impact - Management noted that updated NCCN guidelines have expanded the addressable market significantly, with physicians adapting to new recommendations [41][43]

Plinabulin Clinical Development & Regulatory Status - Plinabulin's U S NDA for Chemotherapy-Induced Neutropenia (CIN) has been accepted with Priority Review, and a China NDA has been submitted [13] - Phase 3 DUBLIN-3 trial for Non-Small Cell Lung Cancer (NSCLC) is fully enrolled, with topline Overall Survival (OS) data expected mid-2021 [13] - PROTECTIVE-2 (Phase 3) study met primary endpoint, showing a statistically significant reduction in Grade 4 neutropenia in Cycle 1: 31 5% vs 13 6% (p=0 0015) [36] Plinabulin Commercial Opportunity in CIN - The global market for G-CSF (used in CIN prevention) is approximately $7 billion annually, involving 4 million cycles [49] - Top 3 deciles of Pegfilgrastim Patient Distribution contribute 81% of patients (~360 accounts) [54] - The combination of Plinabulin and G-CSF addresses the "Neutropenia Vulnerability Gap" (NVG) in week 1 after chemotherapy [29, 33] Plinabulin in Immuno-Oncology (I/O) - A Phase 1 study of Plinabulin + Nivolumab + Ipilimumab in Small Cell Lung Cancer (SCLC) showed an Overall Response Rate (ORR) of 46% in 13 evaluable patients [102] - In the same study, 2nd line Platinum failed patients showed ORR of 50% (3/6) and 3rd line Platinum and CPI failed patients showed ORR of 43% (3/7) [102] - The triple I/O combo is initiating Phase 1 trials in 7 cancers at MD Anderson in Q2 2021 [14, 94] Financial Position & Pipeline Expansion - The company's cash position was $109 5 million as of December 31, 2020 [9] - SEED Therapeutics, a research subsidiary, has an $800 million partnership with Eli Lilly [9]

Financial Data and Key Metrics Changes - Research and development expenses in Q4 2020 were $8.4 million, down from $12.6 million in the same period last year, primarily due to decreased preclinical and clinical trial expenses [37] - General and administrative expenses increased to $10.4 million in Q4 2020 from $2.7 million in Q4 2019, driven by higher employee salaries, pre-commercialization expenses, and noncash share-based compensation [38] - Net loss attributable to BeyondSpring Inc. was $17.6 million in Q4 2020, compared to $14.1 million in the same period last year [39] - For the full year 2020, net loss was $61.0 million, up from $38.1 million in 2019 [39] - As of December 31, 2020, cash and cash equivalents were $109.5 million, sufficient to support ongoing clinical programs for the next year [40] Business Line Data and Key Metrics Changes - The company is focused on developing plinabulin for chemotherapy-induced neutropenia (CIN) prevention and as an immune anti-cancer agent, with significant progress made in 2020 [7][8] - Plinabulin's combination with G-CSF received breakthrough designation from both U.S. and China FDA, indicating its potential to address severe unmet medical needs in CIN [9][10] Market Data and Key Metrics Changes - The addressable population for CIN prophylaxis has more than doubled to over 70% of the entire chemotherapy patient population due to recent NCCN guideline changes [26] - Each year, over 650,000 patients receive chemotherapy, with G-CSFs being used more than 1.4 million times annually in the U.S. [26] Company Strategy and Development Direction - The company aims to position plinabulin as a standard of care in CIN prevention, leveraging its unique mechanism of action to fill the neutropenia vulnerability gap [29][30] - BeyondSpring is preparing for the commercial launch of plinabulin, focusing on awareness of unmet medical needs, positioning with decision-makers, and activating key accounts [27][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming milestones for 2021, including the anticipated anticancer efficacy data from the DUBLIN-3 study [41] - The company is optimistic about the success of its NDA filings after extensive interactions with regulatory agencies [17] Other Important Information - The company completed financing of approximately $86.3 million in November 2020, strengthening its balance sheet and extending its cash runway by 12 to 15 months [15][16] Q&A Session Summary Question: Will there be a placeholder for a late-breaking abstract at ASCO regarding DUBLIN data? - Management confirmed that there will be no DUBLIN-3 data presented at ASCO, guiding the market to expect results mid-year [45] Question: What additional analyses will be shown beyond the topline PROTECTIVE-2 Phase III CIN data? - Management indicated that additional analyses will include clinical meaningful endpoint correlations and reductions in febrile neutropenia and hospitalization [47] Question: How are payers responding to launch pricing in light of positive Phase III CIN data? - Management noted that payers are responding positively to the CIN benefits and believe that the potential for improved cancer outcomes will enhance pricing power [51] Question: How is the company preparing for launch readiness? - Management stated that they are hiring sales representatives on a contingency basis and are focused on ensuring a targeted launch strategy [56][59] Question: What is the rationale for the small cell lung cancer study? - The rationale is to demonstrate that plinabulin can provide additional survival benefits and reduce immune-related adverse effects when added to existing I/O regimens [65][66]

Financing and IPO - BeyondSpring Inc. completed its initial public offering in March 2017, raising gross proceeds of $54.3 million from selling 174,286 ordinary shares [335]. - In November 2020, the company raised $86.3 million from an underwritten offering, selling 8,625,000 ordinary shares [339]. - The company is exploring strategic financing options, including equity offerings and potential licensing arrangements, to support operations and future growth [361]. - SEED, a subsidiary, entered a collaboration with Lilly, receiving a $15 million upfront payment and potential milestones of up to $780 million [340]. - SEED, a subsidiary focused on targeted protein degradation, received a $15 million upfront cash payment from Lilly and is eligible for up to $780 million in potential milestones [508]. Product Development and Clinical Trials - Plinabulin, the company's lead asset, is at NDA-stage for preventing chemotherapy-induced neutropenia (CIN) and has received Breakthrough Therapy Designation from both the FDA and NMPA [341]. - The PROTECTIVE-2 Phase 3 study demonstrated a statistically significant improvement in the rate of prevention of grade 4 neutropenia, improving from 13.6% to 31.5% (p=0.0015) [346]. - The DUBLIN-3 Phase 3 trial has completed global enrollment of 559 patients, focusing on Plinabulin's efficacy in combination with docetaxel for advanced NSCLC [345]. - The company has developed three small molecule immune agents currently in preclinical stages, expanding its pipeline of innovative therapies [341]. - The company has completed two Phase 2/3 trials for CIN and submitted NDAs in both the U.S. and China, with ongoing global clinical trials for Plinabulin [397]. Market Potential and Growth - The U.S. CIN market is approximately $4 billion and is expected to grow significantly, with over 70% of chemotherapy patients qualifying for prophylaxis under updated NCCN guidelines [343]. - The global NSCLC market is projected to grow at a rate of 11.7% per year, with estimated sales of $24.7 billion in 2020 and $48.1 billion by 2026 [462]. - The current U.S. CIN market is approximately $4 billion and is expected to grow significantly due to updated NCCN guidelines, which now include over 70% of chemotherapy patients qualifying for CIN prophylaxis [363]. - Plinabulin aims to address the "Neutropenia Vulnerability Gap" by providing protection in the first week after chemotherapy, where over 75% of CIN-related complications occur [414]. Efficacy and Safety of Plinabulin - Plinabulin has shown a 20% reduction in grade 4 Treatment Emergent Adverse Events (TEAE) compared to pegfilgrastim, indicating a better safety profile [346]. - The combination of Plinabulin and pegfilgrastim met all primary and key secondary endpoints in the PROTECTIVE-2 study, including a reduction in the duration of severe neutropenia and clinical complications [366]. - Plinabulin demonstrated a statistically significant reduction in the incidence of grade 3 and 4 neutropenia adverse events from 26% in the docetaxel monotherapy arm to 7% in the Plinabulin plus docetaxel arm in the Phase 2 portion of Study 101 [367]. - The hospitalization rate for patients with profound neutropenia was 8.3% in the Plinabulin and pegfilgrastim combination arm, compared to 11.8% in the pegfilgrastim arm [356]. - Patients treated with Plinabulin experienced no cases of sepsis or severe infections, while 3.6% of patients in the docetaxel monotherapy arm did [422]. Mechanism of Action - Plinabulin's mechanism of action differs from G-CSF, allowing it to protect neutrophil precursors without inducing their proliferation, which may result in less bone pain compared to G-CSF [431]. - Plinabulin's mechanism as a potent agent to mature dendritic cells and activate T-cells is being explored in combination with checkpoint inhibitors in various trials [358]. - Plinabulin significantly increased dendritic cell MHC-II expression and T-cell infiltration in tumors [490]. Competitive Landscape and Intellectual Property - The company faces competition from large pharmaceutical and biotechnology companies, including Bristol-Myers Squibb and Merck, which market PD-1 inhibitors for cancer treatment [529]. - As of April 23, 2021, the company owned or co-owned 81 patents across 37 jurisdictions, including 19 issued U.S. patents [518]. - The patent portfolio includes 17 issued U.S. patents related to Plinabulin, covering its composition, synthesis, and treatment methods for various disorders, with expiration dates ranging from 2021 to 2036 [519]. - The company plans to seek patent term extensions for one of its U.S. patents directed to Plinabulin, which could extend the patent term by up to five years following FDA approval [520]. Future Plans and Strategic Direction - The company plans to either partner with national pharmaceutical companies or build its own sales force to commercialize Plinabulin in China and the U.S. [401][402]. - The company plans to advance one preclinical immuno-oncology agent into clinical development annually, starting with BPI-002 in 2022 [392]. - The company is exploring molecular glue technology to target dysfunctional proteins, although other companies are also pursuing similar approaches [533].

Financial Data and Key Metrics Changes - R&D expenses in Q2 2020 were $11 million, up from $5.2 million in the same period last year, primarily due to a $4.9 million increase in clinical trial expenses [40] - SG&A expenses were $2.6 million in Q2 2020, compared to $2.1 million for the same quarter last year, mainly due to pre-launch preparation costs for Plinabulin [40] - Net loss attributable to BeyondSpring in Q2 2020 was $12.8 million, compared to $7.4 million for the same period last year [40] - Cash and cash equivalents at the end of Q2 were $38.1 million, sufficient to support clinical trials and NDA submissions [41] Business Line Data and Key Metrics Changes - The company is preparing for the NDA filing for Plinabulin for chemotherapy-induced neutropenia (CIN) by the end of 2020, with significant clinical data supporting its efficacy [8][10] - The PROTECTIVE-2 trial for CIN has completed enrollment ahead of schedule, with top-line data expected in Q4 2020 [10] - The DUBLIN-3 trial for non-small cell lung cancer (NSCLC) continues without modification based on favorable benefit-risk ratios [11][20] Market Data and Key Metrics Changes - The CIN market is significant, with over 1.3 million cycles of G-CSF administered annually, indicating a strong unmet need [29] - The NCCN guidelines have expanded prophylaxis to include both high and intermediate-risk patients, increasing the addressable market by over 100% [31] Company Strategy and Development Direction - BeyondSpring aims to transform into a commercial-stage company within the next 6 to 18 months through significant clinical and NDA catalysts [42] - The company is focusing on a triple combination strategy in oncology, which includes Plinabulin as a dendritic cell enhancer [24] - The company has initiated an Expanded Access Program (EAP) for Plinabulin to assist patients during the COVID-19 pandemic [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that while COVID-19 has impacted timelines, the effect on ongoing trials is minimal, with expectations for data analysis in early 2021 [20][53] - The company is optimistic about the potential for Plinabulin to improve patient outcomes in oncology, particularly in combination with existing therapies [39] Other Important Information - The company has appointed Paul Friel as Chief Commercial Officer and Dr. Ravi Majeti to the Board of Directors, enhancing its leadership team [14][15] - Plinabulin's patent protections extend until 2036 in multiple jurisdictions, providing a substantial runway for commercialization [13] Q&A Session Summary Question: Can you discuss the NCCN guidelines submission prep for CIN? - The guidelines submission process is straightforward, and the next meeting is scheduled for mid-October [46][48] Question: Is it possible to get reimbursement for use ahead of official approval? - Payers will follow the label and NCCN guidelines, which will influence their reimbursement policies [50][51] Question: Can you provide more granularity on the timeline shifts related to COVID for non-small cell lung cancer? - COVID-19 has had minimal impact on timelines, with enrollment expected to finish this year [53] Question: What are the expectations for the CIN label? - Discussions with the FDA suggest a broad label for Plinabulin in combination with G-CSF across various cancers [55][56] Question: Any update on PROTECTIVE-1? - PROTECTIVE-1 has completed its interim analysis and is a supportive study for the combination label [64]

BeyondSpring Inc. (NASDAQ:BYSI) Q4 2019 Earnings Conference Call April 30, 2020 8:00 AM ET Company Participants Caitlin Kasunich - Senior Vice President, KCSA Strategic Communications Lan Huang - Co-Founder, Chairman & Chief Executive Officer Ramon Mohanlal - Executive Vice President of Research & Development & Chief Medical Officer Richard Daly - Chief Operating Officer Edward Liu - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Andy Hsieh - William Blair Christopher Marai ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...