Connect Biopharma Holdings Limited

Ladies and gentlemen, thank you for standing by, and welcome to the Connect Biopharma first half 2021 financial results conference call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star then one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star then zero. I would now like to hand the conference over to your host today, Matt Steinberg of FinPartners. Please go ahead.

Thank you, Operator, and welcome to Connect Biopharma's first half 2021 financial results call. Joining me today is Dr. Zhang Wei, co-founder and CEO, Selwyn Ho, Chief Business Officer, and Eric Hall, Interim CFO. Today's call is being webcast and will be posted on the company's website for playback. During today's call, management will provide an update across our pipeline programs and review our first half 2021 financial results. Following our prepared remarks, we will open the call to Q&A. Before we begin, let me briefly review our forward-looking statements. During today's call, we will make various forward-looking statements. Investors are cautioned that our forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements. Please read the safe harbor statement contained in our press release that we issued yesterday afternoon, as well as risk factors contained in Connect Biopharma's registration statement on Form F-1, for a more complete discussion of these risks and uncertainties. Now, I'd like to turn the call over to Wei.

Thank you, Matt, and good day to everyone. I would like to welcome everyone to our first financial results conference call. Before providing an update to each of our exciting clinical trials and recent progress, let me first provide a brief overview of our company and the team. Connect Biopharma is a global, Clinical State Biopharmaceutical Company focused on improving the lives of patients by developing therapies for the treatment of T-cell-driven inflammatory diseases. Connect has a growing team of more than 80 full-time employees comprised of seasoned industry leaders with significant global experience in immunology drug discovery and development. Headquartered in China, we have ongoing clinical development and operations in the U.S., China, Australia, and Europe. We specialize in designing and developing product candidates that moderate the immune system, with a particular focus on B cells. By leveraging our internal expertise and unique insights in therapeutic targeting of the immune system, our goal is to identify highly differentiated, potentially best-in-class product candidates against validated targets, as well as potential first-in-class molecules against novel targets. We focus on targeting inflammatory diseases with significant unmet medical needs affecting millions of patients worldwide. Since our founding, we have advanced two internally discovered molecules into Phase II clinical development. The first being our lead product candidate that is designed to treat atopic dermatitis, or AD, severe persistent asthma, chronic rhinosinusitis with nasal polyps, and other Type II inflammatory diseases Our second clinical candidate is an immune modulator for the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease. We also have a third molecule that recently entered in a phase one trial in healthy volunteers for the potential treatment of chronic inflammatory colitis. Our innovative approach to drug discovery is designed to speed up the identification of potentially highly differentiated immune modulators. Now let me turn to an update on our recent milestones and pipeline updates. In March, we completed an IPO listing of our American depository shares on the NASDAQ Global Select Market. The offering raised net proceeds of approximately $204.5 million, which significantly enhanced our cash balance, enabling us to invest in and advance our pipeline. Our strong investor support is further underscored by the $440 million raised today from top-tier investors, which includes $135 million from a Series C financing that we completed in December 2020. In addition to this successful listing, we have expanded our executive leadership team, the hiring of Dr. Sarin Ho as Chief Business Officer, Mr. Yawing Yu, Felix, as our Vice President of Finance, and Mr. Jianbian as General Counsel and Chief Compliance Officer are important steps in advancing our organizational growth strategy. Each of our new team members have extensive experience in their respective fields, and we look forward to their many contributions to our growing team. In January, we established a scientific advisory board which is comprised of clinical development and program medication experts with deep experience in dermatology, inflammatory bowel disease, asthma, and other diseases that have resulted in many successful drug approvals. These seven world-class experts have already provided invaluable insight, driving our efforts in building a highly efficient discovery and development organization. We thank them for their support as we continue to advance our clinical pipeline which I will now discuss in greater detail. We have a pipeline of potentially highly differentiated product candidates against validated targets, and for all of these, CONNECT has full global development and commercialization rights. Starting with our lead product candidate, GBP201 is currently in a Phase IIb trial for the treatment of adult patients with moderate to severe atopic dermatitis. The global market size for atopic dermatitis is large and growing. At the end of 2020, we estimate there was approximately $10.4 billion, and it's expected to grow to $19.3 billion by 2025. CBP201 is a novel human monoclonal IgG4 antibody directed against IL-4R alpha, a common subunit for IL-4 and IL-13 receptors. which is a validated target for the only currently FDA-approved biologic therapy. In a randomized placebo-controlled phase 1A trial in healthy volunteers, administration of a single dose of CBP201 was well-tolerated and led to suppression of a serum biomarker of inflammation. In a randomized placebo-controlled phase 1B trial in AD patients, we observed meaningful results which demonstrated rapid improvement in signs and symptoms of aging, arthritis, AD disease severity, and patient quality of life. Although no head-to-head trials have been conducted, we believe that CBP201 may have three potential advantages over the current standard of care. First, It binds to a region of IL-4R-alpha that is distinct from that bound by dupilumab and associated with high binding affinity and potency for IL-4R-alpha, which we believe may lead to improved clinical response. Second, it may have a faster onset of action as demonstrated by data in a Phase 1B trial. And finally, it may provide a longer duration of drug exposure after subcutaneous injections as evidenced by data from our Phase 1A trial and unpublished data from our Phase 1B trial. In April, we announced that we completed full enrollment of our Phase 2B trial, this global, randomized, double-blind placebo-controlled trial to assess the efficacy, safety, PK and PD profile of CBP201. was designed to enroll 220 patients and has been conducted at 60 sites across the U.S., China, Australia, and New Zealand. In this trial, CBP201 or placebo was administered to eligible adults with moderate to severe AD for 16 weeks with eight weeks of follow-up. We remain on track to report top-line results from this trial in the fourth quarter of 2021. We also plan to initiate a China standalone pivotal trial for CVP201 in 80 patients in the third quarter of 2021 as part of our country-specific development strategy. In addition to atopic dermatitis, we are conducting clinical trials to assess the potential of CVP201 in other diseases driven by the dysregulation of the Th2 immune response, where dupilumab has already demonstrated efficacy. These include phase two trials of CBP201 in asthma and chronic rhinosinusitis with nasal polyps. In May, we dose the first patient from the phase two clinical trial evaluating CBP201 in adult patients with moderate to severe persistent asthma. We believe that the global market opportunity for asthma biologic is growing rapidly, with a total market size projected to grow to $6.1 billion by 2024. This asthma trial is a global, randomized, double-blind placebo-controlled trial to assess the efficacy and safety of two doses of CBP201 administered subcutaneously to eligible patients. It's expected to enroll approximately 300 patients across 80 study sites and is divided into a treatment period of 24 weeks and a follow-up period of eight weeks. With regard to our global phase two nasal polyps trial, we remain on track to dose the first patient in the second half of 2021. Now, turning to our second molecule that's in Phase IIb. GVP307 is a potentially differentiated, orally administered immune modulator for the treatment of inflammatory bowel disease. It's a small molecule modulator of S1P1, a regulator of T cell mobilization out of lymph nodes into the periphery. Blocking S1P1 leads to reductions in the levels of these T cells in circulation and a reduction at the site of inflammation. S1P1 is a validated therapeutic target with three drugs approved to treat multiple sclerosis, and the FDA approved one of these drugs for UC in May 2021. The estimated global market for UC was approximately $5.4 billion in 2020. and the estimated global market for CD was approximately $7.4 billion in 2019. We believe that CBP307 as an oral therapy has the potential to address these diseases due to its specificity, PK and PD properties observed in preclinical studies and early clinical trials. We are conducting a global phase 2b trial in UC and anticipate reporting top-line results in the first quarter of 2022. In addition, we intend to initiate a global clinical trial in CD based on the preliminary clinical responses observed in a limited number of patients in an earlier CD clinical trial. Finally, We initiated a Phase I trial in healthy volunteers to explore the potential of CBP174, a peripherally-restricted histamine-free receptor antagonist for oral administration, to treat chronic itch associated with skin inflammation. We believe that the ability to quickly alleviate itch in a setting of AD has the potential to complement the antipyretic effects of disease-modifying IL-4 alpha blockers. such as CBP201 or dupilumab. Our preclinical model have indicated that CBP174 led to reductions in scratching within the first 30 minutes of dosing, which could potentially translate to rapid reduction in characters in a clinic. This randomized double-blind placebo control single ascending dose trial in healthy volunteers aims to evaluate the safety, tolerability, and PK of CBP 174 given orally. Following dosing, each volunteer will be followed for up to seven days. We expect to report top-line results in the second half of 2021. To summarize, the first half of 2021 has been a period of significant progress for Connect. Highlights include our initial public offering in March and execution against our objectives and strategies, despite the uncertainties stemming from the global pandemic. We now have several important upcoming data readouts expected in the second half of 2021 and into the beginning of 2022. We believe our growing body of evidence will validate our approach in developing differentiated therapies for T-cell-driven inflammatory diseases with significant unmet medical needs. Now, I would like to turn the call over to Eric Hall for an overview of our first half 2021 financial results.