– Positive Phase 3 data in 2nd/3rd line NSCLC (Dublin-3): Superior efficacy benefit in plinabulin and docetaxel combination in overall survival, 2-year and 3-year OS rate, PFS, ORR, and significant reduction of grade 4 neutropenia vs. docetaxel alone
– IO combination advancement to Phase 2: plinabulin in combination with nivolumab + ipilimumab in patients in extensive-stage SCLC who progressed after at least one platinum-based chemotherapy regimen and checkpoint inhibitors (IIT study)
– Wanchunbulin China subsidiary formed commercial and co-development collaboration with Hengrui for plinabulin in Greater China; upfront of est. US$30M and milestone payments up to est. US$170M. Hengrui will fund the commercial costs, while Wanchunbulin will supply plinabulin. Wanchunbulin to receive all proceeds from sales of plinabulin products and pay Hengrui a pre-determined percentage of such sales
– NDA for plinabulin-G-CSF combination in CIN Prevention under review in China; received complete response letter from U.S. FDA, with plans for further discussions with FDA on future regulatory pathway
NEW YORK, Dec. 30, 2021 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial results for the third quarter ended September 30, 2021, and provided an update on recent corporate events.
“In the third quarter, we continued to move forward in developing plinabulin’s potential as a ‘pipeline in a drug’ for patients in need. We are developing a wealth of clinical data showing plinabulin’s dual benefit as an anti-cancer agent, shown with OS benefit in Dublin-3 study, with additional benefit in preventing CIN, which we believe will support the important role of plinabulin as a versatile cancer treatment option, and potentially, as a ‘cornerstone’ therapy in IO combinations,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring.
“We look forward to executing on our plans for the potential commercial launch of plinabulin in CIN, our first indication in China, where we are excited to work with a leading oncology company, Hengrui, in the commercialization and co-development of plinabulin. Our discussions will continue with the U.S. FDA regarding the potential regulatory pathway for CIN in the U.S. market. At the same time, we are very focused on preparing for our NDA filing for plinabulin in NSCLC. Based on discussions with regulatory agencies in the U.S. and in China, we now anticipate submitting our NDA in the 2H 2022. The year ahead will be very busy and significant for BYSI, and we remain dedicated to enabling plinabulin to achieve its full potential and to bringing added value to the treatment of cancer patients,” concluded Dr. Huang.
Recent Clinical and Corporate Highlights
- Presented positive final Phase 3 DUBLIN-3 data with the plinabulin/docetaxel combination versus docetaxel alone in 2nd/3rd line non-small cell lung cancer patients with EGFR Wild Type at the European Society for Medical Oncology (ESMO) 2021 Congress
- The combination showed superior efficacy benefit in overall survival, progression-free survival (PFS), overall response rate (ORR), and significant reduction of grade 4 neutropenia vs. docetaxel alone.
- The combination also demonstrated superior and clinically meaningful Quality of Life benefit: 18.4% of relative improvement in Q-TWiST (Quality-adjusted Time Without Symptoms of Disease and Toxicity).
- Presented new data on plinabulin from its Chemotherapy-Induced Neutropenia (CIN) prevention program in three posters at the ESMO 2021 Congress (titles below):
- Severe Neutropenia (Grade 4, Gr4N) as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia (CIN)
- Prediction of Febrile Neutropenia (FN), Hospitalization (Hosp) Rates, and Infection (Inf) Rates in Chemotherapy-Induced Neutropenia (CIN) Patients (pts) Treated with the Plinabulin and Pegfilgrastim Combination (Plin+Peg) using a Meta-Analysis (MA)-based Tool
- Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of Chemotherapy Induced Neutropenia (CIN), on Patient Quality of Life (QoL)
- Announced first patient treated in its Phase 2 study of plinabulin in combination with nivolumab + ipilimumab in patients in extensive-stage small-cell lung cancer (SCLC) who progressed after at least one platinum-based chemotherapy regimen and checkpoint inhibitors
- The investigator-initiated study (IIT) is being conducted through the Big Ten Cancer Research Consortium in 7 U.S. clinical centers.
- In Phase 1 study, plinabulin combination with nivolumab + ipilimumab had ORR of 43% in SCLC patients who had progressed on platinum and checkpoint inhibitors (presented at ASCO 2021).
- Announced new patient-derived (PDX) cancer model data for plinabulin monotherapy, which further supports the positive clinical data in the treatment of SCLC
- At the 2021 AACR-NCI-EORTC virtual international conference on molecular targets and cancer therapeutics, the Company presented additional preclinical data in plinabulin monotherapy activity in PDX models in glioblastoma multiforme, bladder cancer, gastric cancer, sarcoma, triple-negative breast cancer, and SCLC, with IC70 at 35 nM in SCLC.
- Entered into an exclusive commercialization and co-development partnership between Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui”) and Wanchunbulin, BeyondSpring’s China subsidiary, for plinabulin in Greater China
- Hengrui, a leading oncology R&D and commercial company in China, has exclusive commercialization and co-development rights to all indications for plinabulin. Hengrui will pay all commercialization costs for all indications of plinabulin, and half of clinical development costs for new indications.
- Wanchunbulin will supply plinabulin, retaining manufacturing rights. Wanchunbulin will receive all proceeds from sales of plinabulin products and pay Hengrui a pre-determined percentage of such sales.
- Wanchunbulin received 200M RMB (est. US$30M) upfront, and will be eligible to receive up to 1.1B RMB (est. US$170M) in regulatory and sales milestones.
- NDA for plinabulin-G-CSF combination in CIN Prevention under review in China; received complete response letter from U.S. FDA, with plans for further discussions with FDA on future regulatory pathway
- Changes to the Company’s Board of Directors
- Mark Santos, RPh joined the Company’s Board of Directors in November 2021. Mr. Santos has more than 30 years of experience in healthcare industries. He is SVP of Pharma Strategy & Contracting at OneOncology and past President of ION Solutions, the leading group purchasing organization (GPO) in the U.S. He serves as a board member for the American Cancer Society (South Texas Center), NY Cancer Foundation, and Leukemia Texas Foundation, among other organizations.
- On December 22, 2021, Dr. Ravi Majeti resigned from the Board.
- On July 27, 2021, Dr. Quanqi Song resigned from the Board of Directors and the Audit Committee, and Brendan Delaney, an independent Director, was appointed to the Audit Committee.
Upcoming Milestones
- 1H 2022: expected regulatory update for CIN indication in China; continuing discussions with FDA on regulatory pathway for CIN in the U.S.
- 2H 2022: NDA Submission for plinabulin in NSCLC
- 2H 2022: Phase 2 data from the Big Ten Cancer Research Consortium, IIT study expected in plinabulin + nivolumab + ipilimumab in platinum and checkpoint inhibitor-resistant SCLC.
- 2H 2022: Preliminary Phase 1 data and plinabulin immune mechanism data from the MD Anderson Cancer Center, IIT study expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in patients with seven cancer types.
Third Quarter Financial Results
- Research and development (“R&D”) expenses were $8.5 million for the quarter ended September 30, 2021, compared to $8.6 million for the quarter ended September 30, 2020. The decrease was primarily due to lower clinical development expenses, which were partially offset by higher personnel and non-cash stock-based compensation expenses.
- General and administrative (“G&A”) expenses were $10.2 million for the quarter ended September 30, 2021, compared to $6.7 million for the quarter ended September 30, 2020. The $3.5 million increase was primarily due to higher personnel costs and expenses associated with plinabulin pre-commercialization activities.
- Net loss attributable to the Company was $18.4 million for the quarter ended September 30, 2021, compared to $14.5 million for the quarter ended September 30, 2020.
- As of September 30, 2021, the Company had cash, cash equivalents, and short-term investments of $91.6 million. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline.
Year-to-Date Financial Results
- R&D expenses were $31.1 million for the nine-month period ended September 30, 2021, compared to $33.4 million for the nine-month period ended September 30, 2020. The $2.3 million decrease was primarily due to lower clinical development expense, partially offset by higher personnel and professional services expenses, as well as PDUFA NDA application fees to FDA.
- G&A expenses were $25.7 million for the nine-month period ended September 30, 2021, compared to $12.2 million for the nine-month period ended September 30, 2020. The $13.5 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense and pre-commercialization expenses for plinabulin.
- Net loss attributable to the Company was $54.7 million for the nine-month period ended September 30, 2021, compared to $43.4 million for the nine-month period ended September 30, 2020.
About BeyondSpring
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), is being developed as a “pipeline in a drug” in various cancer indications as direct anti-cancer agent, and to prevent chemotherapy induced neutropenia (CIN). Plinabulin and G-CSF combination is currently under review in China for the prevention of CIN, where it has received “Breakthrough Designation” and Priority Review. In DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, plinabulin and docetaxel combination has met the primary endpoint of extending overall survival compared to docetaxel alone, in 2nd/3rd line NSCLC (EGFR wild type). Additionally, it 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. In addition to plinabulin, BeyondSpring’s pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics. By leveraging a proprietary targeted protein degradation drug discovery platform, SEED conducts internal research and had formed a R&D partnership with Eli Lilly and Company on a number of targets.
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, 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 our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, 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.
Investor Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
arr@lifesciadvisors.com
Media Contact:
Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
darren@lifescicomms.com
| BEYONDSPRING INC. | ||
| AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2020 AND | ||
| UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF SEPTEMBER 30, 2021 | ||
| (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) | ||
| December 31, | September 30, | |
| 2020 | 2021 | |
| $ | $ | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | 109,537 | 63,434 |
| Short-term investments | – | 28,166 |
| Advances to suppliers | 3,505 | 1,762 |
| Prepaid expenses and other current assets | 358 | 1,306 |
| Total current assets | 113,400 | 94,668 |
| Noncurrent assets: | ||
| Property and equipment, net | 184 | 169 |
| Operating lease right-of-use assets | 2,174 | 2,164 |
| Other noncurrent assets | 1,280 | 1,368 |
| Total noncurrent assets | 3,638 | 3,701 |
| Total assets | 117,038 | 98,369 |
| Liabilities, mezzanine equity and equity | ||
| Current liabilities: | ||
| Accounts payable | 2,216 | 2,128 |
| Accrued expenses | 5,607 | 7,187 |
| Current portion of operating lease liabilities | 787 | 390 |
| Deferred revenue | 1,350 | 1,532 |
| Long-term loans, current portion | – | 1,552 |
| Other current liabilities | 3,806 | 5,768 |
| Total current liabilities | 13,766 | 18,557 |
| Noncurrent liabilities: | ||
| Long-term loans, noncurrent portion | 2,167 | – |
| Operating lease liabilities | 1,359 | 1,623 |
| Deferred revenue | 7,925 | 37,769 |
| Other noncurrent liabilities | – | 1,259 |
| Total noncurrent liabilities | 11,451 | 40,651 |
| Total liabilities | 25,217 | 59,208 |
| Commitments and contingencies | ||
| Mezzanine equity | ||
| Contingently redeemable noncontrolling interests | 5,196 | 5,354 |
| Equity | ||
| Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,141,913 and 39,142,253 shares issued and outstanding as of December 31, 2020 and September 30, 2021, respectively) | 4 | 4 |
| Additional paid-in capital | 366,451 | 371,209 |
| Accumulated deficit | -277,818 | -332,484 |
| Accumulated other comprehensive loss | -297 | -398 |
| Total BeyondSpring Inc.’s shareholders’ equity | 88,340 | 38,331 |
| Noncontrolling interests | -1,715 | -4,524 |
| Total equity | 86,625 | 33,807 |
| Total liabilities, mezzanine equity and equity | 117,038 | 98,369 |
| The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements. | ||
| BEYONDSPRING INC. | |||||
| UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF | |||||
| COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2021 | |||||
| (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) | |||||
| Three months ended September 30, | Nine months ended September 30, | ||||
| 2020 | 2021 | 2020 | 2021 | ||
| $ | $ | $ | $ | ||
| Revenue | – | 337 | – | 1,013 | |
| Operating expenses | |||||
| Research and development | -8,637 | -8,459 | -33,369 | -31,102 | |
| General and administrative | -6,710 | -10,227 | -12,227 | -25,659 | |
| Loss from operations | -15,347 | -18,349 | -45,596 | -55,748 | |
| Foreign exchange gain, net | 174 | 38 | 109 | 82 | |
| Interest income | 10 | 27 | 102 | 88 | |
| Interest expense | -21 | -20 | -63 | -66 | |
| Other income | – | 749 | 3 | 752 | |
| Loss before income tax | -15,184 | -17,555 | -45,445 | -54,892 | |
| Income tax expenses | – | -2,588 | – | -2,588 | |
| Net loss | -15,184 | -20,143 | -45,445 | -57,480 | |
| Less: Net loss attributable to noncontrolling interests | -644 | -1,773 | -2,068 | -2,814 | |
| Net loss attributable to BeyondSpring Inc. | -14,540 | -18,370 | -43,377 | -54,666 | |
| Net loss per share | |||||
| Basic and diluted | -0.48 | -0.47 | -1.51 | -1.4 | |
| Weighted-average shares outstanding | |||||
| Basic and diluted | 30,303,093 | 39,024,892 | 28,658,215 | 39,013,526 | |
| Other comprehensive loss, net of tax of nil: | |||||
| Foreign currency translation adjustment loss | -277 | -41 | -226 | -116 | |
| Comprehensive loss | -15,461 | -20,184 | -45,671 | -57,596 | |
| Less: Comprehensive loss attributable to noncontrolling interests | -677 | -1,782 | -2,107 | -2,829 | |
| Comprehensive loss attributable to BeyondSpring Inc. | -14,784 | -18,402 | -43,564 | -54,767 | |
| The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements. | |||||