Ownership Structure - As of March 1, 2023, Decheng Capital beneficially owned 12.74% of the Company's total outstanding shares, amounting to 4,958,142 ordinary shares[5] - Fairy Eagle Investment Limited held 11.87% of the Company's total outstanding shares as of March 1, 2023[5] - Ever Regal Group Limited owned 8.30% of the Company's total outstanding shares as of March 1, 2023[6] - Dr. Lan Huang and Mr. Linqing Jia together beneficially owned 26.23% of the Company's total outstanding shares as of March 1, 2023[6] Regulatory Status - BeyondSpring Inc. was conclusively identified as a Commission-Identified Issuer by the SEC on May 13, 2022, due to its annual report filed for the year ended December 31, 2021[3] - The Company believes it is not owned or controlled by a governmental entity in mainland China[4] - The Company is not aware of any governmental entity in mainland China that can direct its management and policies[7] Financial Reporting - The audit report for the Company's financial statements was issued by Ernst & Young Hua Ming LLP, a firm based in mainland China[3] - The Company filed its annual report on Form 20-F for the year ended December 31, 2022, on April 18, 2023[6] - The report is incorporated by reference into multiple registration statements filed by the Company[7]

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, 2022 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2023 Commission File Number: 001-38024 BeyondSpring Inc. BeyondSpring Inc. 28 Liberty Street, 39th Floor New York, New York 10005 (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20 ...

Financial Data and Key Metrics Changes - R&D expenses in Q4 2021 were $5.8 million, down from $8.4 million in the same period last year, a decrease of $2.6 million primarily due to lower clinical development expenses and personnel costs [14] - G&A expenses were $5.0 million in Q4 2021, compared to $10.4 million for the prior year, driven by lower share-based compensation expenses [14] - The net loss attributable to the company in Q4 2021 was $9.5 million, compared to $17.6 million for the same period last year [15] - For the full year 2021, R&D expenses were $36.9 million, down from $41.8 million in the prior year [15] - The net loss attributable to the company for the full year was $64.2 million, compared to $61.0 million for the prior year [16] - Cash balance at December 31, 2021, was $41.6 million, with short-term investments of $30.7 million, totaling $72.4 million [17] Business Line Data and Key Metrics Changes - The company is focused on the Plinabulin program, with ongoing discussions with the China NMPA regarding the review of Plinabulin NDA in combination with G-CSF for the prevention of chemotherapy-induced neutropenia (CIN) [4][5] - Positive top-line data from the Phase 3 DUBLIN-3 study for non-small cell lung cancer (NSCLC) was announced, showing significant improvement in overall survival rates [5][11] - The company is developing Plinabulin in immuno-oncology combinations for various cancers, targeting unmet medical needs [6] Market Data and Key Metrics Changes - The G-CSF market in China was valued at $1.2 billion in 2020, with around 30% annual growth since 2017 [4] - Hengrui Pharmaceuticals, a strategic partner, had $4.2 billion in sales in 2020, with $2.4 billion from oncology drug sales [7] Company Strategy and Development Direction - The company aims to bring Plinabulin to market, with patent protection extending to 2037 in 40 jurisdictions [8] - A strategic partnership with Hengrui Pharmaceuticals for the development and commercialization of Plinabulin in Greater China has been established [6][7] - The company is committed to continuing clinical and regulatory discussions in the U.S. while prioritizing NDA filing in China for NSCLC [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential approval of Plinabulin in China based on strong clinical data [20] - Discussions with the U.S. FDA regarding additional studies for CIN and NSCLC are ongoing, with a focus on the relevance of clinical data derived from Chinese populations [25][32] - The company remains committed to addressing unmet medical needs in cancer treatment through its innovative therapies [10][11] Other Important Information - The company is making progress in its subsidiary Seed Therapeutics, focusing on differentiated molecular glue technology [8] Q&A Session Summary Question: Update on China approval for CIN - The CIN NDA application is under independent review with the China NMPA, with positive meetings held [20] Question: Additional study for CIN in the U.S. - Active discussions with the U.S. FDA are ongoing regarding the design of the additional study [23] Question: Path forward for non-small cell lung cancer in the U.S. - Discussions with the U.S. FDA are ongoing, focusing on the relevance of the data derived from the Chinese population [25] Question: Role of Hengrui in regulatory filing in China - Hengrui is assisting in preparing answers for the NMPA review questions and attending meetings [45]

Financial Activities - BeyondSpring Inc. completed its initial public offering in March 2017, raising gross proceeds of $54.3 million from selling 174,286 ordinary shares[369] - In November 2020, the company raised $86.3 million from an underwritten offering, selling 8,625,000 ordinary shares[372] - Wanchunbulin received an upfront payment of RMB 200 million (approximately $31 million) from Hengrui for the exclusive commercialization of Plinabulin in Greater China[374] - The company is eligible to receive up to approximately $780 million in potential milestones from its collaboration with Lilly for the development of new chemical entities[373] - SEED received a $15 million upfront payment and could earn up to approximately $780 million in potential milestones from the collaboration with Lilly[435] - Wanchunbulin received an upfront payment of RMB 200 million (approximately $31 million) and could receive regulatory and sales milestones of up to RMB 1.1 billion (approximately $171 million) from Hengrui[442] Drug Development and Clinical Trials - Plinabulin, the lead drug candidate, has been administered to over 700 patients with advanced cancer and is generally well-tolerated[381] - The DUBLIN-3 Phase 3 study for Plinabulin in combination with docetaxel has completed global enrollment of 559 patients, with positive topline results reported in August 2021[377] - The company has completed two Phase 2/3 trials for CIN and submitted NDAs in the U.S. and China[440] - The ongoing Phase 1/2 trial of Plinabulin in combination with nivolumab has enrolled 18 patients, with preliminary safety data showing no serious immune-related adverse events[423] - The Phase 1/2 study at MD Anderson includes seven cancer types, with updates allowing for any tumor type with checkpoint inhibitor approval[427] - The company aims to develop Plinabulin as a "pipeline in a drug" across multiple cancer indications[439] - The company is conducting clinical trials under two INDs, with all trials supervised by qualified investigators in accordance with Good Clinical Practice (GCP) regulations[472] Clinical Efficacy and Market Potential - The PROTECTIVE-2 Phase 3 study demonstrated a statistically significant improvement in the prevention of grade 4 neutropenia, improving from 13.6% to 31.5% (p=0.0015) when Plinabulin was combined with pegfilgrastim[387] - The current U.S. CIN market is approximately $4 billion and is expected to grow significantly due to updated NCCN guidelines, which now qualify over 70% of chemotherapy patients for prophylaxis[384] - The addressable market for CIN prevention has increased by over 100% due to changes in treatment guidelines, targeting intermediate-risk chemotherapy patients[384] - The global NSCLC market is projected to grow at a rate of 10% per year, with estimated sales of $26.7 billion in 2021 and $44.6 billion by 2026[8] - Approximately 230,000 patients are diagnosed with lung cancer annually in the U.S., with NSCLC accounting for about 87% of cases[9] Regulatory and Compliance - The NDA submission for Plinabulin in combination with G-CSF for CIN prevention was accepted by both the FDA and NMPA, seeking a broad label for concurrent administration with myelosuppressive regimens[7] - The FDA aims to review 90% of NDA applications with "Priority" status within 6 months and 90% of "Standard" applications within 10 months[479] - The FDA may issue a complete response letter detailing deficiencies that must be addressed before approval, which can range from minor labeling changes to requiring additional clinical trials[480] - The Hatch-Waxman Act allows for a patent restoration term of up to five years, but cannot extend the total patent term beyond 14 years from the product's approval date[486] - The FDCA provides a five-year period of non-patent marketing exclusivity for the first applicant to gain approval of an NDA for a new chemical entity[488] - The NMPA in China oversees the approval and regulation of pharmaceutical products, requiring compliance with multiple laws and regulations[504] - The PRC Drug Administration Law has undergone several revisions to strengthen the supervision and administration of pharmaceutical products, with the latest revision in August 2019[506] Competitive Landscape - The competition includes large pharmaceutical companies like Bristol-Myers Squibb and Merck, which market drugs for cancer treatment that may compete with the company's product candidates[458] - The company faces competition from firms with greater resources, which could impact its commercial opportunities if they develop more effective or safer products[462] - The patent landscape is complex, with the potential for existing patents to limit the company's ability to commercialize its product candidates[455] Intellectual Property - The patent portfolio includes 122 patents in 40 jurisdictions, with 21 issued U.S. patents as of March 21, 2022[446] - The company has secured a number of issued patents for its product candidates, but the breadth of claims from pending applications remains uncertain[452] - The biotechnology and pharmaceutical industries face extensive litigation regarding patents and intellectual property rights, impacting the ability to protect inventions[453] Safety and Adverse Events - Plinabulin demonstrated a statistically significant reduction in grade 3 and 4 neutropenia adverse events from 26% in the docetaxel monotherapy arm to 7% in the Plinabulin plus docetaxel arm in Study 101 (p=0.002) [1] - In the Phase 3 DUBLIN-3 study, Plinabulin reduced docetaxel-induced grade 4 neutropenia in NSCLC patients with a p-value of less than 0.0001 [2] - The PROTECTIVE-1 trial showed that Plinabulin had a non-inferiority outcome compared to Neulasta for days with grade 4 neutropenia (DSN) in the first cycle of chemotherapy [3] - In the Phase 2 portion of PROTECTIVE-1, 14% of patients treated with either Plinabulin or Neulasta experienced grade 4 neutropenia, establishing a recommended dose of 40 mg for Phase 3 [4] - The PROTECTIVE-2 trial demonstrated a primary endpoint of 31.5% prevention of grade 4 neutropenia in the Plinabulin and pegfilgrastim combination compared to 13.6% in pegfilgrastim alone (p=0.0015) [5] - In the Phase 3 portion of PROTECTIVE-2, the incidence of profound neutropenia was 21.6% in the combination group versus 46.4% in the pegfilgrastim group (p=0.0001) [6] Future Directions and Innovations - Plinabulin has shown potential to enhance the activity of other immuno-oncology agents, with preclinical studies indicating it activates immune responses earlier in the immune activation process[414] - In a preclinical colon cancer model, the combination of Plinabulin and a PD-1 antibody resulted in tumors that were approximately 25% smaller compared to control[417] - The triple combination of Plinabulin, anti-PD-1, and radiation achieved a 100% complete response in a breast cancer model unresponsive to PD-1 antibody alone[418] - Plinabulin combined with PD-1/PD-L1 antibodies and radiation showed 100% tumor shrinkage in pre-clinical studies[426] - The combination of Plinabulin, nivolumab, and ipilimumab in SCLC showed a 46% ORR, indicating potential efficacy synergy and re-sensitization of tumors previously resistant to PD-1/PD-L1 inhibitors[424] Regulatory Changes and Impact - The NMPA's revised Provisions for Drug Registration adopted a conditional approval mechanism for vaccines urgently needed for public health emergencies[540] - The NMPA has established priority procedures for drugs with significant clinical value, including urgently needed clinical drugs and innovative vaccines[533] - The National People's Congress released the Fourteenth Five-Year Plan, aiming to improve the accelerated review and approval mechanism for innovative drugs, vaccines, and medical devices[534] - Conditional approval may be granted for drugs treating severe diseases or those urgently needed for public health, based on early clinical trial indicators showing efficacy[537]

BeyondSpring Inc. (NASDAQ:BYSI) Q2 2021 Earnings Conference Call September 10, 2021 8:00 AM ET Company Participants Monique Kosse - LifeSci Advisors Lan Huang - Co-Founder, Chairman and Chief Executive Officer Ramon Mohanlal - EVP, Research & Development and Chief Medical Officer Richard Daly - Chief Operating Officer Elizabeth Czerepak - Chief Financial Officer Conference Call Participants Josh Schimmer - Evercore ISI Jason Gerberry - Bank of America Maurice Raycroft - Jefferies Andy Hsieh - William Bla ...