BeyondSpring Provides Business Update and Reports Year End 2023 Financial Results
BeyondSpring, a biopharmaceutical company, reported positive results for 2023. The company dosed patients in Phase 2 trials for Plinabulin and Keytruda combinations, achieved milestones in molecular glue discovery, and made director appointments. SEED Therapeutics, a subsidiary, reached important pre-clinical milestones. The company's lead drug candidate, Plinabulin, showed promise in various studies, aiming to address unmet medical needs in cancer treatment. Financially, R&D and G&A expenses decreased, resulting in a net loss of $21.0 million for 2023.
BeyondSpring reported positive results for 2023, with advancements in Plinabulin and Keytruda combination studies and molecular glue discovery through SEED Therapeutics.
The company's lead drug candidate, Plinabulin, showed promising results in Phase 1 IIT studies, highlighting its potential in innovative cancer therapies.
SEED Therapeutics, a BeyondSpring subsidiary, achieved significant milestones with Eli Lilly collaboration and announced an IND candidate status for lead oncology internal program.
BeyondSpring reported a net loss of $21.0 million for 2023, despite decreased R&D and G&A expenses compared to the previous year.
The company needs to address the financial challenges to ensure sustainable growth and development of its innovative cancer therapies.
Insights
The financial results of BeyondSpring Inc. indicating a decrease in R&D expenses from
Focusing on the cash position, the reported funds of
Targeting an unmet medical need in the oncology space, particularly for patients who have failed PD-1/PD-L1 inhibitors, is a strategic move by BeyondSpring. Their lead candidate, Plinabulin, has the potential to provide a new treatment avenue in a market where the current standard of care is insufficient. The approach to use IIT studies is cost-efficient and can expedite the understanding of Plinabulin's efficacy when combined with other therapies, like Keytruda. Early indications of a >50% disease control rate in certain cancers suggest a promising therapeutic benefit.
Moreover, the focus on a Tau degrader for neurodegeneration and the progression of an oncology asset towards IND status in collaboration with Eli Lilly could lead to diversification of the company's portfolio. This strategy might mitigate investment risks by not relying solely on Plinabulin's market success.
The partnership with heavyweight Eli Lilly and the featuring of SEED Therapeutics in 'Nature Biotechnology' highlight BeyondSpring's rising credibility in the field of targeted protein degradation. The molecular glue technology is an avant-garde approach in drug discovery, which could yield breakthrough treatments. This strategic alliance, along with the advancement of their internal programs, puts BeyondSpring in a favorable position for future collaborations and investments. Investors should however consider the long timeframes and inherent risks of drug development when evaluating potential long-term benefits.
In addition, leveraging the clinical expertise of institutions like MD Anderson and Memorial Sloan Kettering for IIT studies is a deft move. This not only validates the research through association with prestigious institutions but also leverages their infrastructure and expertise, potentially speeding time to market and reducing development costs.
- BeyondSpring Dosed First Patient of Two Phase 2 Investigator-Initiated Trials (IIT) in Plinabulin and Keytruda Combination Studies
- SITC 2023 Presentation of the Phase 1 Topline Clinical and Mechanism Data of BeyondSpring’s Lead Asset Plinabulin in Combination with PD-1 Inhibitor and Radiation in a Number of Immune Checkpoint Inhibitor Failed Cancers (Disease Control Rate >
- SEED Therapeutics (“SEED”), a BeyondSpring Subsidiary, Achieves Second and Third Molecular Glue Discovery Milestones in the Eli Lilly R&D Collaboration; Selected Investigational New Drug (IND) Candidate for Lead Oncology Internal Program
- SEED was Featured in “Nature Biotechnology” March 2024 Review Article “The Glue Degraders”
FLORHAM PARK, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today provided a business update and reported results for the year ended December 31, 2023.
“2023 has been a year of building fundamental values for BeyondSpring. It is such an honor for our majority-owned subsidiary SEED Therapeutics to be featured among leading companies using target protein degradation molecular glue for innovative drug discovery. With our proprietary RITE3 platform, SEED continues to attract increased partnering interest. I am also pleased to report that SEED has made significant headway in advancing internal programs, with one oncology asset (expected to enter clinics in 1H 2025), Tau degrader(s), and external collaboration projects with Eli Lilly,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring.
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, a potent dendritic cell maturation agent, on the regulatory front in the U.S. and in China, and through a number of Plinabulin’s IIT studies at MD Anderson, Memorial Sloan Kettering and other institutions in the U.S. and China.”
“PD-1/PD-L1 inhibitors had changed the treatment landscape in cancer, with annual sales well over
Recent Business and Clinical Updates
Plinabulin Clinical Updates
- Conference Presentation at ASCO and SITC for Plinabulin
- In May 2023, the Company and Memorial Sloan Kettering Cancer Center (MSKCC) presented a poster on new data from a Phase 1 IIT study, highlighting Plinabulin’s ability to reduce infectious neutropenic fever for multiple myeloma patients undergoing Autologous Hematopoietic Stem Cell Transplantation (AHCT), at the American Society of Clinical Oncology (ASCO) Annual Meeting.
- In November 2023, the Company and The University of Texas MD Anderson Cancer Center presented new clinical data from a Phase 1 IIT study, highlighting preclinical and clinical POC immunomodulating activity of Plinabulin inducing dendritic cell maturation and re-sensitization in immunotherapy refractory tumors when combined with radiation and PD-1 inhibitors, at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting.
- First Patient Enrollment in Two Phase 2 IIT Studies for Plinabulin Combined with Keytruda
- 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 second and third line (2/3L) advanced and metastatic NSCLC who had failed immunotherapy alone or in combination with platinum-doublet chemotherapy.
- In March 2024, the first patient was enrolled in a Phase 2 IIT study with Keytruda, Plinabulin, plus Etoposide/Platinum (EP) for first-line (1L) Extensive-Stage Small-Cell Lung Cancer (ES-SCLC).
Business Updates
- SEED Therapeutics
- Milestone Achievements
- In February 2023 and March 2024, SEED achieved two milestones for pre-clinical developments with Eli Lilly.
- Milestone Achievements
- Appointments of Directors
- In June 2023, SEED appointed Mr. Jackson Tai, a former director at Eli Lilly, HSBC and Mastercard, to the board of directors. Mr. Tai brings almost five decades of experience in finance, strategy, and risk governance.
- In October 2023, SEED appointed Mr. Ko-Yung Tung, a former board member at Eisai, former general counsel at World Bank, and a lecturer at Harvard Law School and Yale Law School to the board of directors. Mr. Tung brings five decades of experience in global health, law, governance, and international business.
- Announcement of IND Candidate for Oncology at “Targeted Protein Degradation (TPD) Think Tank” Symposium
- In October 2023, SEED held its first “TPD Think Tank” Symposium, in which SEED co-founders invited TPD thought leaders to present. Domestic and foreign attendees engaged in a collaborative and interactive session to advance the TPD field research.
- During the “TPD Think Tank” Symposium, it was announced that SEED had successfully discovered a new chemical entity (NCE) molecular glue. SEED has declared an IND Candidate status, targeting first human dose in 1H 2025.
- Advancement in Tau Degrader Molecular Glue Discovery
- SEED is targeting the protein Tau for degradation with a molecular glue, for the treatment of neurodegeneration. Within 6 months of starting the project, SEED has discovered multiple compound scaffolds with predicted brain permeability that glue tau to a novel E3 ligase selected by SEED’s RITE3 platform. Compounds are now being optimized for relevant activities and properties, including reduced Tau levels in cultured human neurons. SEED is targeting IND Candidate status for the Tau Project in 2H 2025.
- SEED is targeting the protein Tau for degradation with a molecular glue, for the treatment of neurodegeneration. Within 6 months of starting the project, SEED has discovered multiple compound scaffolds with predicted brain permeability that glue tau to a novel E3 ligase selected by SEED’s RITE3 platform. Compounds are now being optimized for relevant activities and properties, including reduced Tau levels in cultured human neurons. SEED is targeting IND Candidate status for the Tau Project in 2H 2025.
Expected Milestones in 2024
- Plinabulin: Generate preliminary data in 2H 2024 for the Phase 2 IIT Study in combination with Keytruda and docetaxel in 2/3L NSCLC patients who failed PD-1/PD-L1 inhibitors.
- SEED: Significantly advance lead oncology asset in IND-enabling studies to enable its IND filing.
Full Year 2023 Financial Results
Research and development (“R&D”) expenses were
General and administrative (“G&A”) expenses were
Net loss attributable to the Company was
As of December 31, 2023, the Company had cash, cash equivalents, restricted cash, and short-term investments of
About BeyondSpring
BeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, as a direct anti-cancer agent in various cancer indications and to prevent chemotherapy-induced neutropenia. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring’s subsidiary, SEED Therapeutics, leverages a proprietary TPD drug discovery platform and has an initial R&D collaboration with Eli Lilly. Learn more by visiting https://beyondspringpharma.com.
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.
Investor Contact:
IR@beyondspringpharma.com
Media Contact:
PR@beyondspringpharma.com
Financial Tables to Follow
| 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, | ||||||
| 2022 | 2023 | |||||
| $ | $ | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | 34,396 | 7,809 | ||||
| Restricted Cash | - | 9,941 | ||||
| Short-term investments | 2,872 | 193 | ||||
| Advances to suppliers | 492 | 306 | ||||
| Prepaid expenses and other current assets | 763 | 170 | ||||
| Total current assets | 38,523 | 18,419 | ||||
| Noncurrent assets: | ||||||
| Property and equipment, net | 1,868 | 1,628 | ||||
| Operating right-of-use assets | 5,484 | 4,397 | ||||
| Other noncurrent assets | 347 | 364 | ||||
| Total noncurrent assets | 7,699 | 6,389 | ||||
| Total assets | 46,222 | 24,808 | ||||
| Liabilities and equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | 1,081 | 1,407 | ||||
| Accrued expenses | 2,470 | 2,581 | ||||
| Current portion of operating lease liabilities | 966 | 631 | ||||
| Deferred revenue | 1,351 | 1,751 | ||||
| Other current liabilities | 1,484 | 1,588 | ||||
| Total current liabilities | 7,352 | 7,958 | ||||
| Noncurrent liabilities: | ||||||
| Operating lease liabilities | 3,995 | 3,364 | ||||
| Deferred revenue | 34,221 | 33,242 | ||||
| Other noncurrent liabilities | 3,661 | 3,705 | ||||
| Total noncurrent liabilities | 41,877 | 40,311 | ||||
| Total liabilities | 49,229 | 48,269 | ||||
| Commitments and contingencies | ||||||
| Mezzanine equity | ||||||
| Contingently redeemable noncontrolling interests | 11,074 | 11,874 | ||||
| Shareholders’ deficit | ||||||
| Ordinary shares ( | 4 | 4 | ||||
| Additional paid-in capital | 368,857 | 368,599 | ||||
| Accumulated deficit | (375,276 | ) | (396,302 | ) | ||
| Accumulated other comprehensive income | 436 | 894 | ||||
| Total BeyondSpring Inc.’s shareholders’ deficit | (5,979 | ) | (26,805 | ) | ||
| Noncontrolling interests | (8,102 | ) | (8,530 | ) | ||
| Total shareholders’ deficit | (14,081 | ) | (35,335 | ) | ||
| Total liabilities, mezzanine equity and shareholders’ deficit | 46,222 | 24,808 | ||||
| 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, | ||||||||
| 2021 | 2022 | 2023 | ||||||
| $ | $ | $ | ||||||
| Revenue | 1,351 | 1,351 | 1,751 | |||||
| Operating expenses | ||||||||
| Research and development | (36,888 | ) | (25,582 | ) | (14,635 | ) | ||
| General and administrative | (30,703 | ) | (13,008 | ) | (10,230 | ) | ||
| Loss from operations | (66,240 | ) | (37,239 | ) | (23,114 | ) | ||
| Foreign exchange gain (loss), net | 231 | (429 | ) | (123 | ) | |||
| Interest income | 98 | 195 | 421 | |||||
| Interest expenses | (87 | ) | (17 | ) | - | |||
| Other income, net | 1,360 | 1,373 | 974 | |||||
| Loss before income tax | (64,638 | ) | (36,117 | ) | (21,842 | ) | ||
| Income tax expenses | (3,570 | ) | (163 | ) | (106 | ) | ||
| Net loss | (68,208 | ) | (36,280 | ) | (21,948 | ) | ||
| Less: Net loss attributable to noncontrolling interests | (4,029 | ) | (3,001 | ) | (922 | ) | ||
| Net loss attributable to BeyondSpring Inc. | (64,179 | ) | (33,279 | ) | (21,026 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | (1.64 | ) | (0.85 | ) | (0.54 | ) | ||
| Weighted-average shares outstanding | ||||||||
| Basic and diluted | 39,023,643 | 39,093,246 | 38,996,463 | |||||
| Other comprehensive loss, net of tax of nil: | ||||||||
| Foreign currency translation adjustment (loss) gain | (296 | ) | 1,483 | 725 | ||||
| Unrealized holding gain (loss) | 5 | (5 | ) | - | ||||
| Comprehensive loss | (68,499 | ) | (34,802 | ) | (21,223 | ) | ||
| Less: Comprehensive loss attributable to noncontrolling interests | (4,094 | ) | (2,482 | ) | (655 | ) | ||
| Comprehensive loss attributable to BeyondSpring Inc. | (64,405 | ) | (32,320 | ) | (20,568 | ) | ||
FAQ
<p>What were the financial results for BeyondSpring in 2023?</p>
BeyondSpring reported a net loss of $21.0 million for the year ended December 31, 2023, with cash, cash equivalents, restricted cash, and short-term investments of $17.9 million.
<p>What milestones did SEED Therapeutics achieve in 2023?</p>
SEED Therapeutics achieved two pre-clinical milestones with Eli Lilly and appointed new directors to the board in 2023.
<p>What is Plinabulin's role in cancer treatment?</p>
Plinabulin, BeyondSpring's lead drug candidate, is a potent dendritic cell maturation agent showing promise in IIT studies for cancer patients.
