4/30/2021

speaker
Operator
Conference Call Moderator

Good morning and welcome to BeyondSpring's fourth quarter and full year 2020 financial results conference call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a brief question and answer session. To join the question queue, you may press star then 1 on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and 0. As a reminder, this call is being recorded today, April 30th, 2021. I would now like to turn the conference over to Andrew Erickson, Investor Relations. Please go ahead.

speaker
Andrew Erickson
Investor Relations

Thank you, everyone, for joining today's call. I'd like to advise listeners that comments made on today's call may reflect forward-looking statements that are related to such matters as BeyondSpring's clinical and preclinical research and development activities and results. regulatory and commercial plans, industry trends, market potential, collaborative initiatives, and financial projections, among others. While management believes that assumptions, expectations, and projections are reasonable in view of the currently available information, we are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during this call for a variety of reasons. including those described in the forward-looking statements and risk factors sections of the company's 20F and other filings with the SEC, which are available on the investor section of BeyondSpring's website. Joining us on today's call is Dr. Lan Huang, BeyondSpring co-founder, chairwoman, and chief executive officer, Dr. Ramon Mohanla, executive vice president, research and development, and chief medical officer, Richard Daly, chief operating officer, and Elizabeth Serapak, chief financial officer. It is now my pleasure to turn the call over to Dr. Lan Huang. Lan?

speaker
Dr. Lan Huang
Co-Founder, Chairwoman & Chief Executive Officer

Well, thank you, Andrew. Hello, everyone, and thank you for joining today's call. I'm very pleased to be here with an update of the tremendous progress we have made in 2020 and to provide an update on our upcoming milestones for 2021. 2020 was a truly momentous year in setting us up for future value creation. Specifically, we had key accomplishments in building clinical evidence for our lead asset, Pnebulon, filing NDA for our lead program in two major global markets, U.S. and China, building our pipeline, adding key scientific and business leadership, and bolstering our balance sheet to execute on our vision. Let me briefly share with you our three key areas for value creation. First, we continue to develop penicillin as a pipeline in the drug, not only as an agent to prevent chemotherapy-induced neutropenia or CRM, but also as an immune anti-cancer agent for potential durable anti-cancer benefit. For our lead program in the CRM prevention indication, penicillin and GCSF combination regime was granted breakthrough destination from both US and China FDA in September 2020. We're excited about this destination as this signals the severe unmet medical needs in CRN and that our regime could be superior to standard care. For the last five years, we have worked closely with regulatory agencies to advance benevolence in combination with CSSF for the prevention of CRN. We are also grateful to have the support of Dr. Blaney and Dr. Crawford USCIN, NCCN guideline founding member, and former chairman who have guided us for trial design and quality. Overall, we had over 1,200 patients in one pivotal trial, which is Protector 2, and five supportive clinical studies demonstrating benevolence-consistent early onset of action in protecting neutrophils in various chemo and various cancers in week one, where over 75% of clinical consequences occur, or the neutropenia vulnerability gap, a recognized severe unmet medical need. By combining penicillin's week one benefit with that of GCSF, including pacfew grassens with two benefits, the combination can maximize the neutrophil protection in the full chemo cycle. This combination's superior benefit compared to GCS alone was also confirmed in Protector 2, our pivotal global study with data released in November 2020. Based on that, we filed an NDA in the U.S. and China in March this year. And I'm now moving forward towards becoming a commercial stage company with a differentiated therapy that really has the potential to improve lives and clinical outcomes for millions. Cannabinoid and GCSR combination could potentially reduce the incidence and duration of fibroneutropenia and hostilization which we will present at upcoming ASCO meeting in June. With consistent improvement in clinically meaningful endpoints and ANC-based endpoints on the combination of cannabinoid and GCSF compared to GCSF long, we believe we can deliver on our promise of raising the standard care for CRM prevention in cancer patients treated with chemotherapy with or without checkpoint inhibitors. This is the first breakthrough in 30 years since GCSF was approved in 1991. Very importantly, 2021 will be a defining year where we expect to showcase benevolent anti-cancer efficacy data including top-line overall survivor data in the Dublin III study in mid-year. It took us five years to enroll all of 559 patients in approximately 60 centers in the U.S., Australia, and China. Dublin III compares penicillin and docetaxel versus docetaxel alone in second- and third-line non-small-cell lung cancer for EGFR-Y type patients, which compromises approximately 75 of Asian patients or approximately 85% of Western lung cancer patients. This is a severely unmet medical needs indication where TKI, tyrosine kinase inhibitors, do not work. And only four therapies have been proved with limited survivor benefit and severe side effects, such as over 40% incidence of severe neutropenia. In addition, we continue to round out penicillin's anti-cancer profile by adding it to the mix in triple IO therapies, as penicillin is a potent antigen presentation agent with potential synergy with checkpoint inhibitors and chemo or radiation, and help to revert PD-1 failed patients to resume responding to treatment. At upcoming ASCO meeting, we will release promising anti-cancer efficacy data on a phase one study of PNAVIN adding to NEVO and IPI in second and third line small cell lung cancer patients. who were checkpoint inhibitor naive or failed. This study included 10 U.S. leading clinical centers, and the BMS provided NEVO and IPI for free for the study. In addition, while conducting another IIIO combo study, penicillin adding to PD-1 or PD-L1 inhibitor and radiation at MD Anderson in seven cancers in PD-1, PD-L1 antibody-failed patients. Second, we are building out our pipeline in our subsidiary, Seed Therapeutics, using our unique molecular group targeted protein degradation, or TPD, platform. This platform demonstrated validation through our 800 million R&D collaboration with Eli Lilly in November 2020, including a substantial upfront payment and investment from Lilly. Currently, we are moving forward with Lilly's first target and our internal targets, including KRAS G12D. Third, On the business front, we have strengthened our board and management team and broasted our balance sheet to enable the execution of our vision. In 2020, we have added key scientific and business leadership to our board. In December 2020, Dr. Jeff Vesica joined our board. Dr. Vesica is a board-certified hematologist and oncologist and serves as CEO and Chairman of the Board of New York Cancer and Blood Specialists, and is a board member of One Oncology, which treats around half a million cancer patients a year in the U.S. His wealth of expertise and demonstrated ability to collaborate with different groups of stakeholders within the oncology market will be instrumental in helping guide the company as we seek commercial approval of Penabulin. We also added additional industry leaders in 2020 to our board. We added Dr. Ravi Majeti, Chief of Hematology at Stanford Medical School and a co-founder of 47. He is helping us in translating Penabulin's compelling scientific and clinical data into business value. as his formal company, 47, was acquired by Gilead for $4.9 billion. And Dr. Zabrowski was a veteran business development executive in large pharma, including formal global head of pharma partnering at Roche, where he led over 300 partnership deals. He has been helping us with business development and partnership strategies. And we are proud and honored to have a pharmaceutical and biotech veteran, Elizabeth Serapak, joining us last September as our CFO. Elizabeth has over 30 years of senior finance leadership, board, and venture capital experience in both large pharma, including Roche and Merck, and high-growth stage companies. Under Elizabeth's leadership, in November 2020, we successfully completed a financing of approximately $86.3 million in growth proceeds before deducting underwriting discounts and commissions and other estimated offering expenses. This financing strengthened our investor base and extended the cash runway by another 12 to 15 months. I will now turn the call over to Dr. Ramon Mahano, who will discuss our recent clinical developments in more detail. Ramon.

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