Corporate Presentation
January 2022 | NASDAQ: BYSI
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Disclaimer
This presentation has been prepared for informational purposes only. No money or other consideration is being solicited, and if sent in response, will not be accepted. This presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The Company is not under any obligation to make an offering. It may choose to make an offering to some, but not all, of the people who indicate an interest in investing. The information included in any registration statement will be more complete than the information the Company is providing now, and could differ in important ways.
This presentation and any accompanying oral commentary contain forward-looking statements about BeyondSpring Inc. ("BeyondSpring" or the "Company"). Forward- looking statements are based on our management's beliefs and assumptions and on information currently available to our management, including those described in the forward-looking statements and risk factors sections of the Company's 20-F filed on April 30, 2021 and other filings with the United States Securities and Exchange Commission (SEC).
Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends," or "continue," or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates and our research and development programs; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; and (v) the timing or likelihood of regulatory filings and approvals.
Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
The market data and certain other statistical information used throughout this presentation are based on independent industry publications, governmental publications, reports by market research firms or other independent sources. Some data are also based on our good faith estimates. Although we believe these third-party sources are reliable, we have not independently verified the information attributed to these third-party sources and cannot guarantee its accuracy and completeness. Similarly, our estimates have not been verified by any independent source.
By attending this presentation, you acknowledge that you will be solely responsible for your own assessment of the market and our market position and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of our business.
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BeyondSpring Investment Highlights (Nasdaq: BYSI)
Committed to raising the standard of care for cancer patients with first- in-class treatments that improve lives and clinical outcomes for millions of patients in need
Headquarters | New York, NY |
Lead Asset | Plinabulin for CIN: NDA under review in China, CRL received |
in US | |
Plinabulin for NSCLC: NDA filing est. 2H 2022 | |
Partnerships | Plinabulin in Greater China - Co-development & |
Commercial Partnership with Hengrui | |
Affiliates | Subsidiary SEED Therapeutics (proprietary TPD Platform) |
$800M partnership with Eli Lilly |
Cash position | $91.6M as of September 30, 2021 |
Plinabulin: "A Pipeline in a Drug"
NSCLC
CIN | IO |
- DUBLN-3:Plinabulin + docetaxel for 2nd/3rd line NSCLC, EGFR wild type
- Positive topline Ph 3 results reported Aug. '21
- Late-breakingESMO oral presentation Sept. '21
- NDA filing planned for 2H 2022
- Plinabulin + G-CSF for CIN Prevention Indication
- Breakthrough Designation (BTD)
- NDA accepted with Priority Review (US and China)
- CRL from US FDA received Nov. 2021, ongoing regulatory pathway discussions
- China NMPA review ongoing
- Triple I/O combo in multiple cancer indications in early development, including 7 cancers at MD Anderson
- Efficacy data for Ph 1 SCLC at ASCO '21
- Phase 2 SCLC in I/O failed patients expected in 2H 2022
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Robust Plinabulin Pipeline: 2 Near-Term NDAs & I/O Clinical Trials
Indication / | Program | Trial Name / | Preclinical | Phase 1 | Phase 2 | Phase 3 | Commercial | Status/Next Milestone |
Target | Collaborator | Rights1 | ||||||
NSCLC | • Positive topline Ph 3 data August '21 | |||||||
Plinabulin + docetaxel | DUBLIN-3 | Ph. 3 primary and secondary endpoints | presented at ESMO '21 | Global | • Late-breaking presentation at ESMO '21 | |||
stage | (2nd/3rd line) | |||||||
• Hengrui partnership in Greater China | ||||||||
• Priority review for NDA in US and China | ||||||||
Late | ||||||||
CIN (All cancer, all | Plinabulin + pegfilgrastim | PROTECTIVE-1 | Global | • NDA under review in China; ongoing | ||||
Ph. 3 primary endpoint met Nov. '20 | ||||||||
chemo) | & PROTECTIVE-2 | discussions with FDA on Nov '21 CRL | ||||||
• Hengrui partnership in Greater China | ||||||||
IO | Plinabulin + nivolumab + | US sites, including | ||||||
SCLC | Rutgers University as | Global | Phase 2 | |||||
Combo (IIT) | ipilimumab | |||||||
lead site | ||||||||
Triple | 7 cancers | Plinabulin + PD-1/PD-L1 + | ||||||
(PD-1/PD-L1 | Global | Phase 1 in 7 cancers in June '21 | ||||||
radiation/chemo | ||||||||
failed) | ||||||||
IO | Oral T cell | BPI-002 | Global | |||||
co-stimulator | ||||||||
-initiated | ||||||||
IKK inhibitor | BPI-003 | Global | ||||||
Investigator | ||||||||
Oral neo-antigen | BPI-004 | Global | ||||||
generator | ||||||||
Therapeutics | KRAS and | Targeted Protein Degradation | Global | Potential additional partnerships | ||||
additional targets | (TPD, molecule glue platform) | |||||||
SEED | Multiple | Global | $800M collaboration | |||||
1Global rights to Plinabulin ex-China. 58% ownership of Chinese subsidiary, Dalian Wanchunbulin Pharmaceuticals Ltd., which owns Chinese | 4 |
rights to Plinabulin. BeyondSpring owns 100% of global rights to Plinabulin. SEED Therapeutics is a ~60%-owned BeyondSpring subsidiary. | |
Plinabulin Franchise: "Pipeline in a Drug"
Clinical Confirmation | Expand |
Positive phase 3 OS data (n=559)
Confirmed in 6 clinical studies (n>1200)
& Filed for NDA approval
Transform
Promising early clinical efficacy data
- 7 different cancers in phase 1/2 study
CIN (BTD & Priority Review)
- Superior regimen vs. SOC
- China NMPA review ongoing
- Discussions with FDA on regulatory pathway
NSCLC | Multiple Cancers (I/O Combo) | ||
• | Strong MOA rationale | • Synergistic MOA with checkpoint inhibitors | |
• Successful DUBLIN-3 phase 3 study | • Promising preclinical & early clinical efficacy data | ||
• | Expected 2H 2022 NDA filing | ||
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BeyondSpring Inc. published this content on 03 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 January 2022 17:38:02 UTC.