BeyondSpring, Inc.

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 financial projections, among others. While management believes that its assumptions, expectations, and projections are reasonable in 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 20F and other filings with the SEC, which are available on the Investors section of BeyondSpring's website. Joining us on today's call is Dr. Fland Wong, BeyondSpring co-founder, chairman, and chief executive officer. Dr. Ramon Mojano, executive vice president, research and development, and chief medical officer. Richard Daly, chief operating officer. And Elizabeth Serpak, chief financial officer. It is now my pleasure to turn the call over to Dr. Lan Huang. Lan?

Hello, everyone, and thank you for joining today's call. We're very pleased to be here today reporting our second quarter results and providing an update on the many meaningful events in the recent weeks. Everyone here at the company is very excited as we have accomplished so much But most importantly, we're most excited for patients who are our North Star, who can be helped by our lead asset, Penabalin. Penabalin is a first-in-class selective immunomodulating microtubule binding agent, or SIMBA. With clinical evidence from Dublin Street and our CIN studies, we have revealed the dual benefit of Penabalin. in a direct anti-cancer benefit of significantly extending overall survivor while also significantly reducing severe neutropenia induced by chemotherapy, which would be beneficial to patients in need. From the execution point, we have much more to look forward to in the next 6 to 12 months, including, first, our FADUFA date is on November 30th this year for penicillin and GCSF combination in CIM prevention and upcoming commercial launch in first quarter next year. Second, a planned MDA filing for penicillin in non-sponsored lung cancer in the first half of 2022. And third, continued development of a rich and deep pipeline, including Pnebulon in IIIO combo in various cancers. Each of our upcoming milestones has the potential to provide significant shareholder value. Let me begin today by recapping the very meaningful events and data from the recent few months. I will then provide a few highlights of what to expect for us in the coming weeks and months before handing over to Ramon and Rich to provide more detail on our scientific and clinical accomplishments and commercialization plans. Again, the past few weeks have truly been transformational for us at BeyondSpring. Most importantly, we were thrilled to announce positive data from our registrational trial of Dublin-3 in penicillin in second and third line non-small cell lung cancer, which showed significant improvement in overall survivor, especially in doubling the two-year and three-year survivor in the penicillin and docetaxel combination arm versus docetaxel alone. This underscores penicillin's immune durable anti-cancer benefit and makes us optimistic for its potential in other cancer combinations like IIIO combos. We have always believed penicillin to be a pipeline in a drug with the potential for approval in several indications. With the direct anti-cancer data in non-small cell lung cancer, were well on our way to realizing our vision for Penabulum. I will let Ramon provide more color on the study and some high-level data. We are presenting additional data in 10 days at the late-breaking oral presentation at ASMO on September 20th. We are planning to host the call after the ASMO presentation. Another meaningful recent announcement was our strategic partnership between Fanchun Buling, our 58% owned China subsidiary, and Henre, a leading R&D and commercialization company with top expertise in oncology in China for the commercialization and co-development of Pnebulin in Greater China. This landmark partnership serves as a validation from a well-respected leading pharma for penicillin as a pipeline in the drug. Over the past 40 years, Henry has successfully grown to become the largest oncology drug sales company in China with the top-selling PD-1 inhibitor and docetaxel product and one of the top three GCSF products. Penabulin's potential for use in combination with these agents represents significant synergies and facilitates the development of Penabulin in additional indications, thereby accelerating and increasing the treatment of peak cells in Greater China. Important to note, Not only have we partnered with the most respected company with the widest and deepest reach in the oncology space in China, we have done so at favorable terms for us. We retain manufacturing rights and have the right to receive 100% sales proceeds while paying a reasonable percentage of the net sales to Henry and having all the commercialization costs covered by Henry. Additionally, we will receive significant upfront and 50% cost sharing of development costs. Of note, we will retain 100% of our benevolent rights in all other global markets outside of China. Finally, the deal has attractive financial terms which gives us more cash runway. This includes an upfront payment of around $30 million and milestones of up to around $170 million, plus a $15 million investment in rent and boolean at a pre-money valuation of around $560 million. As you are aware, our NDA for prevention of CRN had been accepted by China NMPA and the U.S. FDA with prior to review. Richwell provides more details on our plans for commercialization and launch in the U.S. in early 2022, assuming approval by the FDA on our November 30th for DUFA date. Looking forward, I mentioned the most important date BDUFA date of November 30th, 2021 for penicillin in CIM prevention. Additionally, our regulatory team are in high gear preparing for our NDA filing for non-small cell lung cancer indication, which we anticipate in the first half of 2022. Finally, with penicillin's unique immune mechanism as a SIMBA, and its durable anti-cancer clinical evidence shown in the Dublin-3 study, we have a well-planned path of development for penicillin in IO combos in various cancers to target unmet medical needs, which PD-1, PD-L1 could not help. First, in PD-1, PD-L1 fail patient. Second, the CRN issue in PD-1 and chemo combination. Third, immune-related SAE for iocombos, fourth, the cold tumors, and fifth, first-line cancers which need better efficacy in iocombos. We have undergone a few investigator-initiated studies to help to assess cannabinoids' role in addressing these biomedical needs. Ramon will talk more about this in his presentation. To summarize, I would like to thank our team for their commitment and tireless efforts. Everyone here believes in our mission and their passion has been driving us forward towards raising the standard of care for cancer patients in the largest global markets of our first-in-class treatments. We're closer than ever now to achieving this mission and we all look forward to advancing Penebulin and realizing upon our many opportunities to succeed. I will now turn the call over to Dr. Ramon Mohano for a brief review of our recent clinical developments.