- SEED Therapeutics, a BeyondSpring Subsidiary, Achieved Milestones on the Eli Lilly Collaboration
- BeyondSpring Completed Enrollment of Three Investigator-Initiated Trials (IIT) with Plinabulin in the U.S. for Multiple Cancer Indications
NEW YORK, April 18, 2023 – BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on using its novel technology platform for drug discovery and development of innovative therapies to improve clinical outcomes for patients with high unmet medical needs, today provided a business update and reported results for the year ended December 31, 2022.
“I am pleased to report that BeyondSpring’s subsidiary, SEED Therapeutics, has made significant headway in advancing internal and external collaboration assets with Eli Lilly, achieving on-time delivery of R&D objectives, which triggered milestones and investment payments,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. “SEED Therapeutics, which specializes in ‘molecular glue’ development with its proprietary targeted protein degradation (TPD) platform for novel drug discovery, continues to attract increased partnering interest.”
Dr. Huang continued, “BeyondSpring remains strategically positioned to advance our programs to near-term important inflection points. The Company continues to make progress in advancing our lead drug candidate, Plinabulin, as a ‘pipeline in a drug’ on the regulatory front in the U.S. and in China, and in a number of Plinabulin IIT studies at MD Anderson, Memorial Sloan Kettering and other institutions in the U.S. and China.”
Recent Business and Clinical Updates
Business Updates
- SEED Milestone Achievements
SEED Therapeutics received investment payment in June 2022 and milestone payment in February 2023 for pre-clinical development from Eli Lilly, totaling $7 million.
- Plinabulin
In March 2023, BeyondSpring withdrew its NDA submission for the CIN indication from China’s National Medical Products Administration (NMPA) review. The Company will continue to communicate with the NMPA regarding its re-filing of the NDA for the CIN indication and plan to re-file the NDA by mid-2023. In addition, the Company plans to submit the NDA for the NSCLC indication with the NMPA by mid-2023.
Clinical Updates
- Conference Presentations at ASH, SABCS, and ESMO Asia for Plinabulin
- In December 2022, the Company exhibited two posters and gave one oral presentation on positive data with Plinabulin for the prevention of docetaxel-induced neutropenia (DIN) in patients with NSCLC and breast cancer at the American Society of Hematology (ASH) Annual Meeting, European Society for Medical Oncology (ESMO) Asia Congress and San Antonio Breast Cancer Symposium (SABCS).
- Enrollment Completion for Three IIT Studies in the U.S. for Plinabulin
- In February 2023, the Phase 2 IIT study enrollment was completed for Plinabulin combined with Bristol Myers Squibb’s Opdivo and Yervoy in 2nd/3rd line extensive-stage small cell lung cancer (ES-SCLC) patients who had failed prior immunotherapy. In the Phase 1 IIT study, the preliminary data showed over 40% of tumor response in this population.
- In March 2023, the Phase 1 IIT study enrollment was completed for Plinabulin, combined with PD-1 / PD-L1 inhibitors and radiation, in a variety of cancer patients who had failed prior immunotherapies at the MD Anderson Cancer Center.
- In March 2023, the Phase 1 IIT study enrollment was completed for Plinabulin in combination with Pegfilgrastim in multiple myeloma (MM) patients who had undergone autologous hematopoietic cell transplantation (AHCT) at the Memorial Sloan Kettering Cancer Center (MSKCC). The topline data will be presented at the upcoming ASCO meeting in June 2023.
- First Patient Enrollment in Phase 2 IIT Study for Plinabulin Combined with Keytruda and Docetaxel in 2nd/3rd line NSCLC
- In March 2023, the first patient was enrolled in a Phase 2 IIT study for Plinabulin in combination with Merck’s anti-PD-1 therapy, Keytruda, and docetaxel for patients with metastatic NSCLC who had failed immunotherapy alone or in combination with platinum-doublet chemotherapy.
Expected Milestones in 2023
- Advance a lead SEED-owned new chemical entity (NCE) to the IND-candidate milestone
- Advance a second SEED-owned NCE to the Hit milestone with efficacy in animal model
- Complete three IIT studies in the U.S. with Topline Data Readout
- Plan to Submit NSCLC NDA in China by mid-2023
- Plan to Re-submit CIN NDA in China by mid-2023
Full Year 2022 Financial Results
Research and development (“R&D”) expenses were $25.6 million for the year ended December 31, 2022, compared to $36.9 million for the year ended December 30, 2021. The $11.3 million decrease was primarily due to lower clinical development expense, lower regulatory fees and professional service expense to support NDA submission and lower personnel costs as a result of the organizational streamlining announced in January 2022.
General and administrative (“G&A”) expenses were $13.0 million for the year ended December 31, 2022, compared to $30.7 million for the year ended December 31, 2021. The $17.7 million decrease was primarily due to lower pre-commercialization expenses for Plinabulin and lower personnel costs, as results of the organizational streamlining announced in January 2022. There were also decreases in professional service expenses.
Net loss attributable to the Company was $33.3 million for the year ended December 31, 2022, compared to $64.2 million for the year ended December 31, 2021.
As of December 31, 2022, the Company had cash, cash equivalents, and short-term investments of $37.3 million.
About BeyondSpring
Headquartered in New York City, BeyondSpring is a clinical-stage global biopharmaceutical company focused on using its novel technology platform for drug discovery and development of innovative therapies to improve clinical outcomes for patients with high unmet medical needs. Its subsidiary SEED Therapeutics is leveraging a proprietary targeted protein degradation drug discovery platform with an initial R&D collaboration with Eli Lilly. Its first-in-class lead asset, Plinabulin, is being developed as a potential “pipeline in a drug” in various cancer indications as a direct anti-cancer agent and to prevent chemotherapy-induced neutropenia (CIN). The Plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data in the PROTECTIVE-2 study. In the DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, the Plinabulin and docetaxel combination met the primary endpoint of extending overall survival compared to docetaxel alone in 2nd/3rd line non-small cell lung cancer (NSCLC) (EGFR wild type). Additionally, Plinabulin is being broadly studied in combination with various immuno-oncology regimens that could boost the efficacy of PD-1/PD-L1 antibodies in seven different cancers. Lastly, BeyondSpring’s pipeline includes three preclinical immuno-oncology assets and a subsidiary.
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, our ability to continue as a going concern, 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 20-F 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.
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Financial Tables to Follow
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BEYONDSPRING INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
| As of December 31, | ||||
| 2021 | 2022 | |||
| $ | $ | |||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | 41,625 | 34,396 | ||
| Short-term investments | 30,743 | 2,872 | ||
| Advances to suppliers | 1,735 | 492 | ||
| Prepaid expenses and other current assets | 1,020 | 763 | ||
| Total current assets | 75,123 | 38,523 | ||
| Noncurrent assets: | ||||
| Property and equipment, net | 1,422 | 1,868 | ||
| Operating lease right-of-use assets | 1,984 | 5,484 | ||
| Other noncurrent assets | 3,119 | 347 | ||
| Total noncurrent assets | 6,525 | 7,699 | ||
| Total assets | 81,648 | 46,222 | ||
| Liabilities and equity | ||||
| Current liabilities: | ||||
| Accounts payable | 1,656 | 1,081 | ||
| Accrued expenses | 3,858 | 2,470 | ||
| Current portion of operating lease liabilities | 538 | 966 | ||
| Deferred revenue | 1,369 | 1,351 | ||
| Long-term loans, current portion | 1,569 | – | ||
| Other current liabilities | 6,165 | 1,484 | ||
| Total current liabilities | 15,155 | 7,352 | ||
| Noncurrent liabilities: | ||||
| Operating lease liabilities | 1,468 | 3,995 | ||
| Deferred revenue | 37,939 | 34,221 | ||
| Other noncurrent liabilities | 709 | 3,661 | ||
| Total noncurrent liabilities | 40,116 | 41,877 | ||
| Total liabilities | 55,271 | 49,229 | ||
| Commitments and contingencies | ||||
| Mezzanine equity | ||||
| Contingently redeemable noncontrolling interests | 5,454 | 11,074 | ||
| Equity | ||||
| Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 38,927,563 and 38,999,597 shares issued and outstanding as of December 31, 2021 and 2022, respectively) | 4 | 4 | ||
| Additional paid-in capital | 369,200 | 368,857 | ||
| Accumulated deficit | (341,997) | (375,276) | ||
| Accumulated other comprehensive (loss) income | (523) | 436 | ||
| Total BeyondSpring Inc.’s shareholders’ equity (deficit) | 26,684 | (5,979) | ||
| Noncontrolling interests | (5,761) | (8,102) | ||
| Total equity (deficit) | 20,923 | (14,081) | ||
| Total liabilities, mezzanine equity and equity | 81,648 | 46,222 | ||
BEYONDSPRING INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
| Year ended December 31, | |||||
| 2020 | 2021 | 2022 | |||
| $ | $ | $ | |||
| Revenue | 180 | 1,351 | 1,351 | ||
| Operating expenses | |||||
| Research and development | (41,793) | (36,888) | (25,582) | ||
| General and administrative | (22,598) | (30,703) | (13,008) | ||
| Loss from operations | (64,211) | (66,240) | (37,239) | ||
| Foreign exchange gain (loss), net | 355 | 231 | (429) | ||
| Interest income | 116 | 98 | 195 | ||
| Interest expenses | (85) | (87) | (17) | ||
| Other income, net | 4 | 1,360 | 1,373 | ||
| Loss before income tax | (63,821) | (64,638) | (36,117) | ||
| Income tax expenses | – | (3,570) | (163) | ||
| Net loss | (63,821) | (68,208) | (36,280) | ||
| Less: Net loss attributable to noncontrolling interests | (2,848) | (4,029) | (3,001) | ||
| Net loss attributable to BeyondSpring Inc. | (60,973) | (64,179) | (33,279) | ||
| Net loss per share | |||||
| Basic and diluted | (2.03) | (1.64) | (0.85) | ||
| Weighted-average shares outstanding | |||||
| Basic and diluted | 29,984,284 | 39,023,643 | 39,093,246 | ||
| Other comprehensive loss, net of tax of nil: | |||||
| Foreign currency translation adjustment gain | (530) | (296) | 1,483 | ||
| Unrealized holding gain (loss) | – | 5 | (5) | ||
| Comprehensive loss | (64,351) | (68,499) | (34,802) | ||
| Less: Comprehensive loss attributable to noncontrolling interests | (2,941) | (4,094) | (2,482) | ||
| Comprehensive loss attributable to BeyondSpring Inc. | (61,410) | (64,405) | (32,320) | ||