BeyondSpring, Inc.

Good morning, and welcome to BeyondSpring's fourth quarter and year-end 2021 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. As a reminder, this call is being recorded today, April 14, 2022. I will now turn the call over to Ashley Sergio of LifeSciAdvisors.

Thank you, everyone, for joining today's call. I would 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 other financial projections, among others. While management believes that its assumptions, expectations, and projections are reasonable in the view of the currently available information, you 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 20-F 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's co-founder, chairman, and chief executive officer, Dr. Ramon Mohanlal, executive vice president, research and development, and chief medical officer, and Elizabeth Serpak, chief financial officer. It is now my pleasure to turn the call over to Dr. Lan Huang.

Good morning, everyone, and thank you for joining today's call. It's a pleasure to be here today reporting our fourth quarter and year-end results and providing an update on our progress in the past few months. After the complete response letter from the US FDA last November, we took steps to streamline our operations in order to extend the cash runway. Now we are focused on executing near-term opportunities for value creation. First, we are pleased with our ongoing discussions with China NMPA on the review of benevolence NDA in combination with GCSF for the prevention of chemotherapy-induced neutropenia, or CIS. The GCSF market in China is significant with $1.2 billion in sales in 2020 and around 30% annual growth since 2017. In addition, we continue our discussions with the FDA regarding the clinical and regulatory pathway for penicillin in CIN in the US. Second, moving to our penicillin program in non-small cell lung cancer, where we announced in August and September 2021 at ESMO conference positive top-line data from our Phase III Dublin III study. In the second and third line, non-sponsored lung cancer with EGFRY type, which represents severe unmet medical needs with limited treatment options, cannabinoid and docetaxel combinations showed significant improvement in overall survivor, especially in doubling the two-year and three-year survivor rate compared to docetaxel alone. We believe the data supports the role of penicillin as a potential anti-cancer treatment option in this indication. We are moving forward to target an NDA filing in China by year end. Dr. Ramon Mojano, our chief medical officer, will provide additional details during his remarks shortly. Finally, we continue to develop penicillin as a potential pipeline in the drug. Using cost-effective investigator-initiated studies, we continue our development plans for penicillin in immuno-oncology combinations in various cancers. to target unmet medical needs in patients who have failed PD-1 or PD-L1 inhibitors. We continue to see strong interest by investigators and will share additional data and updates as they become available. Overall, we are proud of the support we have received as we continue our efforts to bring Penabalin to market. One of our validating steps was announcing last fall a strategic partnership between Venture Bullying, our 58% owned China subsidiary, and Chi Ray Pharmaceuticals, a leading oncology, R&D, and commercialization company in China, for the development and commercialization of penicillin in greater China. Tenray is a well-respected company with over 10,000 salespeople in China. In 2020, the company had $4.2 billion in sales, of which $2.4 billion was for oncology drug sales. In addition, Tenray has a leading market position with its long-acting GCSF in China. In September 2021, will receive a 200 million renminbi, estimated to be around $31 million upfront payment from Henry, and will be eligible to receive up to 1.1 billion renminbi, estimated to be $171 million in regulatory and sales milestones. We will receive all proceeds from sales of benevolent products and pay Henry a predetermined percentage of such sales. We will provide updates on commercialization plans as we get closer to potential approval in China. In conclusion, we remain committed in bringing Penabalan to market. As Penabalan has a long patent life with patent protection to 2037 in 40 jurisdictions, which includes 19 granted patents in the US, we would have a long, long way to realize penicillin's potential to help many patients in need. One more note, we are making good progress in our subsidiary, Seed Therapeutics. Seed focuses on differentiated molecular blue technology in the targeted protein degradation field. We signed the R&D collaboration agreement on a number of targets with Eli Lilly in November 2020. Now I will turn the call over to Dr. Ramon Mojano, our Chief Medical Officer, for some additional details on our development programs. Ramon.