Corporate Presentation
September 2021 | 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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Investment Highlights (NASDAQ Ticker - 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
Headquarter | New York, NY |
Plinabulin for CIN, US NDA PDUFA November 30, 2021 | |
Lead Asset | Plinabulin for NSCLC, est. NDA filing 1H 2022 |
Partnerships: | Plinabulin in Greater China - Co-development & |
Commercial Partnership with Hengrui | |
Subsidiary SEED Therapeutics (proprietary TPD Platform) | |
$800M partnership with Eli Lilly |
Lead Asset Plinabulin:
"A Pipeline in a Drug"
Cash position
$76.3 million as of June 30, 2021 + $45 M from Hengrui upfront and investment
CIN | NSCLC | IO | ||
• | Plinabulin + G-CSF for CIN Prevention | • | DUBLN-3: Plinabulin + Docetaxel for | • Triple I/O combo in multiple cancer |
2nd/3rd line NSCLC, EGFR wild type | indications in early development, | |||
Indication | ||||
• Positive Topline Final phase 3 OS data | including 7 cancers at MD Anderson | |||
• | Breakthrough Designation (BTD) and NDA | |||
reported in August 2021 | • Efficacy data for phase 1 SCLC at ASCO | |||
accepted with Priority Review from US | ||||
• | Late-breaking oral presentation of | 2021 | ||
and China FDA | ||||
DUBLIN-3 data at ESMO on 9/20/2021 | ||||
3 |
Two Near-Term NDAs & Robust Drug Development Pipeline
Indication / | Program | Trial Name / | Preclinical | Phase 1 | Phase 2 | Phase 3 | Commercial | Status/Next Milestone |
Target | Collaborator | Rights1 | ||||||
• U.S. and China NDA accepted with Priority | ||||||||
CIN | PROTECTIVE-1 | Review; US PDUFA Nov. 30, 2021 | ||||||
• Hengrui Co-development and- | ||||||||
(All cancer, all | Plinabulin + pegfilgrastim | Phase 3 primary endpoint met in pivotal data announced November 2020 | Global | |||||
stage | & PROTECTIVE-2 | Commercialization partnership in Greater | ||||||
chemo) | ||||||||
China | ||||||||
Late | ||||||||
Phase 3 primary and secondary endpoints | met in pivotal data | announced | • Positive topline Phase 3 data August 2021 | |||||
NSCLC | Plinabulin + docetaxel | DUBLIN-3 | August 2021 | Global | • Late-breaking presentation at ESMO | |||
(2nd/3rd line) | Sept 20, 2021 | |||||||
• Hengrui partnership in Greater China | ||||||||
IO | Plinabulin + nivolumab + | US sites, including | ||||||
SCLC | Rutgers University as | Global | Phase 1 completed | |||||
Combo (IIT) | ipilimumab | |||||||
lead site | ||||||||
Triple | 7 cancers | Plinabulin + PD-1/PD-L1 + | ||||||
(PD-1/PD-L1 | Global | Initiate Phase 1 in 7 cancers in June 2021 | ||||||
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 | |||
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1Global rights to Plinabulin ex-China. 58% ownership of Chinese subsidiary, Dalian Wanchunbulin Pharmaceuticals Ltd., which owns Chinese |
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 Topline OS data (n=559) & potential NDA filing 1H 2022
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) | NSCLC | Multiple Cancers (I/O Combo) | ||
Synergistic MOA with Checkpoint | ||||
Superior Regimen vs. SOC | Strong MOA Rationale & | |||
Inhibitors & Promising Preclinical & | ||||
PDUFA 11/30/2021 | Successful DUBLIN-3 phase 3 Study | |||
Early Clinical Efficacy Data | ||||
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BeyondSpring Inc. published this content on 12 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 September 2021 04:01:04 UTC.