NovaBridge Biosciences

morning everyone and thank you for joining us this morning and for standing by i'd like to take this opportunity to welcome you all to the imap biopharma mid-year 2023 financial results and business update conference call my name is tyler ehler and i'm imap's senior director for investor relations at this time all participants are in a listen only mode at the end of this call we'll conduct a q a session and instructions will follow at that time earlier today We issued a press release providing a review of our financial results for the mid-year ended June 30th, 2023, as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the investor relations tab on our website at ir.i-mabbiopharma.com. Joining me today on the call from IMAP senior management team are Raj Kanan, CEO, Dr. John Haislip, Chief Medical Officer, Dr. Andrew Zhu, President and Head of R&D, and Richard Yeh, Interim CFO and COO. Raj will provide a high-level overview of our recent achievements and upcoming milestones, and John will provide an update on our R&D progress. Richard will then provide a summary of our financial results for the six months ended June 30, 2023, before we turn the call over to Raj for a few final comments, and then back to the operator to take your questions. Please note that today's discussion will contain forward-looking statements relating to the company's future performance, and the forward-looking statements are made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, of 1995. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions, and other factors. Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and on this earnings call. A general discussion of the risk factors that could affect IMAP's business and financial results is included in certain filings of the company with the Securities and Exchange Commission including but not limited to the risk factor section in IMAP's most recent annual report on Form 20F, as well as discussions of potential risks, uncertainties, and other important factors in IMAP's subsequent filings with the SEC. Moreover, we operate in an evolving environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor affects or combination of factors may cause actual results to differ materially from those contained in any forward looking statements. We qualify all of our forward looking statements by these cautionary statements. You should not rely upon forward looking statements as predictions of future events. The forward looking statements made in today's press release and on this earnings call relate only to the events or information as of the date on which the statements are made. Except as required by law, we undertake no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events, or otherwise. after the date on which the statements are made or to reflect the occurrence of unanticipated events. We'll also discuss specific non-GAAP financial measures during today's call, the presentation of which is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with U.S. GAAP. Please see the financial results press release issued earlier today for a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial results. And with that, I'll now turn the call over to our CEO, Raj Kanan. Raj, please go ahead.

Thank you, Tyler. And good morning, everyone. And thank you for joining us. It has been an energizing few weeks for me since I came on board as CEO in June. I came to this new role with much confidence in IMAP's innovative programs and an understanding that we have a great deal of work ahead of us. Today, I'm pleased to speak with you and set out a clear direction for IMAP that could potentially unlock the significant inherent value that I see in this company for our shareholders. During our call, I will provide you with a high-level update on our performance in the first half of 2023, and importantly, frame our strategic direction and plan. I will ask John Haislip, our Chief Medical Officer, to provide you with an update on the two prioritized clinical assets in oncology that we plan to rapidly advance in the US and globally. And finally, review the recently released positive phase three results from our lead program in China. Richard Yeh, our interim chief financial officer, will review the financial results for the first six months of 2023 and then hand it back to me for closing remarks. The first eight months of 2023 have been productive for IMAP. We made significant progress on our innovative assets, including Ulidadlamab, our differentiated CD73 antibody, Givastomic, our novel Claudin 18.2 and 4.1 BB bispecific antibody, and F10 somatropin alpha, our long-acting human growth hormone that reported out positive phase 3 results today. As we look to building out the future for IMAP, we plan to focus on three strategic pillars. First, rapidly advance our two promising clinical assets globally within oncology. Two, maintain our strong balance sheet. And three, focus on establishing a new operating model to become a US-based global biotech company. Taking them one at a time, One, we plan to advance ulilidlamab, our novel CD73 antibody, and Givostomic, our differentiated Claudine 18.2 and 4-1-BB bispecific antibody in the U.S. and globally. We believe that both ulilidlamab and Givostomic each have interesting biology, encouraging early clinical data and differentiated characteristics that enable them to stand out from other drugs in development. We believe that ulilidlamab could be a critical value driver for IMAP, and if approved, could be a unique and differentiated immuno-oncology agent, which has the potential to be the preferred adjunct to immunotherapies across a wide range of tumors. Our goal is to submit an IND in the first half of 2024 for ulilidlamab in combination with chemotherapy and checkpoint inhibitors in newly diagnosed patients with advanced non-small cell-linked cancer. John will further provide details on the data that we presented at ASCO and why these results give us the confidence that ulilidlamab can be a differentiated entrant and a significant value driver for IMAP. We believe that GivaStomach has the potential to be a differentiated agent in gastric cancer. This unique bispecific antibody was designed to target Claudine 18.2 positive tumors and stimulate pro-immune 4,1-BB signaling. GivaStomach was designed to selectively target 4,1-BB expressing cells in the tumor microenvironment potentially reducing the risk of systemic toxicity. Claudine 18.2 targeted therapies could represent an important new treatment option, especially for patients with gastric cancers, including tumors of the gastroesophageal junction, or GEJ, and esophageal cancer. With encouraging signs of monotherapy efficacy, including in tumors with lower levels of Claudine 18.2 expression, We believe that Jivastomic has the characteristics that could potentially position the program as a leading candidate in these tumors where there remains a significant unmet medical need. Our goal is to initiate a phase 1B dose escalation study in the US, Japan, and China. in combination with standard chemotherapy and immunotherapy regimens for patients with treatment-naive gastric, GEJ, and esophageal cancer in the first half of 2024. John will review our early results and explain why we believe our program could potentially be a valuable treatment option for patients. Lastly, We're pleased to report hot off the press positive phase three data from F10 somatropin alpha, our long acting human growth hormone candidate being developed for the market in China. This represents a significant milestone for the company as it is the first completed phase three data that we have reported. The new F10 somatropin alpha data met the primary endpoint and achieved non-inferiority compared to Novo Nordisk's Norditopin. These results and the Kampon's weekly delivery formulation should position F10 somatropin alpha to be a key player in the human growth hormone market in China, which is a market currently dominated by once daily injectables. This multi-billion dollar market in China is expected to grow over the next five to eight years with long-acting growth hormones estimated to significantly build market share. As you may know, we have an agreement in place with Jumcan to commercialize F-tansomatropin alpha in China. We have two other clinical assets specifically being developed for the China market. Pelzardimab, our CD38 antibody, and Lemzoparlimab, our CD47 antibody. We expect to commercialize these assets through partners, and John will review the clinical results to date and provide an overview of next steps with these programs being developed for the China market. Now, moving on to our second strategic pillar, continue to maintain a strong balance sheet. IMAP's $414 million cash balance adequately supports the execution of the company's strategic plan. We've begun streamlining our spend for the second half of this year to support our key global assets in oncology and rationalizing our spend in other areas. In addition, we will continue monetizing non-global core assets and make the difficult choices where needed in our pipeline to earmark cash for the most promising programs, including exploring external opportunities. And now the third strategic pillar, We're focused on establishing a new operating model as a US-based global biotech company, as this will position us to unlock the inherent value in the single largest pharmaceutical market in the world, and the area in particular where our stakeholders expect to derive the most value from our innovative assets. We embark on this change by building on a company's strong foundation from a core set of differentiated oncology assets a strong balance sheet, and a skilled R&D organization in China. As I just noted, we also remain open to bringing in new assets that we view as value-driving to complement our existing pipeline. We recognize that to make this company into a truly US-based global biotech, It'll involve significant changes ranging from governance, stock market listing, culture, to talent management. It is important to emphasize that the full IMAP board and I are in full alignment with regard to the future direction of the company. I look forward to providing you with those updates on our progress on this strategic pillar in early 2024. Now, before I hand the call over to John, I would like to recognize the leadership of Dr. Andrew Zhu during his time as interim CEO. Also, I'm grateful for the dedication and hard work shown by the entire IMAP team. With that overview, I'd like to hand it over to John to provide clinical details on our key global assets and the novel programs being developed specifically for the China market. John? John?

Thank you, Raj. And good day to everyone on the call. My name is John Haislip, and I'm pleased to provide you with a clinical overview. First, I'd like to provide updates about udalimumab, our CD73 targeting antibody designed to block a key pathway that tumor cells may use to evade the immune system, adenosine production. As previously reported, uliledumab is differentiated by design to avoid hook effect biology, which is a potential liability of other competitor drugs in development. Simply put, the hook effect may prevent other drugs from achieving complete inhibition of enzyme function, though uliledumab is designed to allow up to 100% inhibition due to its unique functionality. At the American Society of Clinical Oncology meeting in June of this year, we shared encouraging clinical and translational findings from a Phase 1b2 study indicating patients with advanced non-small cell lung cancer receiving uleleumab and PD-1 inhibitor toripalimab. Uleleumab was well tolerated using an every three-week dosing regimen in combination with toripalimab. Most treatment-related adverse events were grade 1 or 2 in severity. In the 67 efficacy-evaluable patients, the objective response rate, or ORR, was 31%, regardless of CD73 or PD-L1 expression. Notably, patients whose tumors had high levels of CD73 expression experienced a higher response rate than those with lower CD73 expression. the response rate increased to 63% in patients who had both high levels of CD73 expression and a PD-L1 tumor proportion score, or TPS, of greater or equal to 1%, whereas patients with low CD73 expression had an ORR of 20%. We are excited by these preliminary findings of a correlation between higher CD73 expression and an increased response rate, with this chemotherapy-free uliledumab and checkpoint inhibitor combination. Data from other studies have suggested that chemotherapy may increase CD73 expression in cancer cells, and we are eager to begin combination studies of uliledumab with chemotherapy in the near future. Additionally, at the time of the data cutoff, with a median follow-up of 10.4 months, 18 of the 21 patients whose tumors had achieved an objective response remained on treatment, and the median duration of response was not yet reached. Progression-free survival and overall survival data will be analyzed when the data are fully mature. Additionally, we continue to enroll patients with previously treated ovarian cancer to the combination regimen of ululilumab and toripalimab. and expect to report preliminary results in 2024 for this phase two cohort of patients. Building upon these encouraging clinical findings and other non-clinical investigations, we plan to file a new IND with the FDA to expand the ulileplumab program and combine with chemotherapy and checkpoint inhibitors for patients with newly diagnosed advanced non-small cell lung cancer. Owing to the potential effect of chemotherapy to upregulate CD73 in tumors, we hope this combination may benefit an even broader group of patients, potentially regardless of pretreatment CD73 expression. I'd like to emphasize this important point. We plan to evaluate ulileblumab with chemotherapy and checkpoint inhibitors in patients regardless of the CD73 expression before initiating treatment. Non-small-cell lung cancer is one of the most common and deadly cancer diagnoses globally, and we believe that uleleumab has the potential to improve upon currently available care. We plan to discuss further details regarding the planned studies in the first half of 2024 after we have had initial discussions and alignment with regulatory agencies. Next, I'd like to provide an update on Gevastomic, our clot in 18.2 by 4-1-BB bispecific antibody, a program that has made significant clinical progress. As you may know, other groups have attempted to develop 4-1-BB engaging drugs in the past because 4-1-BB is a strong stimulant to the immune system. Unfortunately, earlier attempts to develop 401BB drugs caused severe toxicities because the widespread effects of 401BB stimulation could not be tolerated by patients. Therefore, we developed the unique approach of this bispecific antibody in that it first binds to tumor cells expressing the clodin 18.2 protein, and then the 401BB arm can stimulate immune cells in the immediate environment of the tumors. More specifically, Gevastomig was designed to do two important things. First, to become conditionally active only upon tumor engagement while remaining silent elsewhere to avoid or minimize liver toxicity and systemic immunotoxicity, commonly seen with 401BB antibodies as a drug class. And second, to effectively maintain strong tumor binding and antitumor activity attributable to a synergistic effect of the bispecific clotin-18.2 antibody and 4-1B antibodies. We believe Givostomig has achieved our design goals for this molecule based on early clinical data. This July, the Journal of Immunotherapy of Cancer, or JITC, published a paper detailing the significant potential of Givostomig in treating gastric cancer. and its unique molecular design and properties. Looking forward, I am happy to report that the first clinical abstract for Givostomic has been accepted for a presentation at the European Society of Medical Oncology, or ESMO, in October of this year. While the specifics of the study results are embargoed until the meeting, I'm happy to report that in the dose escalation phase 1 study, Objective responses have been observed with single agent geovastomic amongst patients who have received multiple previous treatments for their cancer, including chemotherapy and checkpoint inhibitors. A dose expansion cohort in this phase one study continues to enroll patients with previously treated CLOD and 18.2 positive gastric, gastroesophageal junction, or GEJ, and esophageal cancer with geovastomic monotherapy. and interim results for these patients are anticipated in the first half of 2024. Additionally, based upon these encouraging observations and recent non-clinical studies indicating a positive benefit for the combination, we plan to launch new investigations of the combination of Givostomic with standard chemotherapy and immunotherapy regimens for patients with treatment-naive gastric, GEJ, and esophageal cancers. We anticipate enrollment to begin by the first half of 2024 and plan to provide further details once we finalize the trial design. Speaking of our clinical bispecific programs, TJL14B was designed to treat PD-1 or PD-L1 antibody-resistant tumors. Like G-vastomic, the antibody acts by inducing conditional activation of 4,1-BB when it binds to its target, in this case, PD-L1. A phase one dose escalation study is underway in patients with progressive, locally advanced, or metastatic solid tumors that have relapsed or are refractory, falling prior lines of treatment. A preliminary efficacy signal has been observed, and a maximal tolerated dose has not yet been reached. The dose expansion portion of the phase one study is underway in the U.S. and South Korea. The program is being developed in collaboration with ABL Bio. Today, we reported the first positive phase three results from an IMAP-sponsored program with the successful trial of F-tansomatropin-alpha with weekly dosing for children with human growth hormone deficiencies. The results we are sharing today highlight that the Phase III study met its primary endpoint of annualized height velocity, or AHV, at week 52 and demonstrated that F-tansomatropin alpha was non-inferior to Novo Nordisk's Nordotropin. As a reminder, F-tansomatropin alpha was given as a weekly injection, while Nordotropin was given as a daily injection in this study. The mean AHV was 10.76 centimeters per year for F-tansomatropin alpha versus 10.28 centimeters per year for nortotropin with a non-inferiority p-value of less than 0.0001. F-Tansomatropin-alpha was well-tolerated, and no drug discontinuations were reported due to treatment emergent adverse events. We believe the safety profile of F-Tansomatropin-alpha appears comparable to Nordotropin in this study. These data create a strong clinical database supporting the potential clinical utility of IMAP's long-acting human growth hormone candidate. We plan to submit a BLA in China in 2024. Next, I'd like to turn to felzartumab, a fully human monoclonal antibody directed against CD38 in development for the treatment of multiple myeloma. We have successfully completed the first trial with registration potential in China for felzartumab as a third-line treatment for multiple myeloma. Our study confirmed the efficacy of filzartamab with additional benefits such as a shorter infusion time and lower infusion-related reaction rate than reported for daratumumab in its IV form. These product attributes may allow filzartamab to be used in an outpatient clinic setting and together create a potentially differentiated product profile. We are evaluating our regulatory strategy and plan to provide an update following further discussions with the China CDE. We plan to share additional clinical data after those discussions are completed. In terms of the Phase III randomized study of felzartumab in combination with lenalidomide for patients who have received one prior line of treatment, enrollment was completed in September of 2021. The primary endpoint for this study is progression-free survival. and we expect the study to read out in 2024, followed by a planned BLA submission. Lastly, the development of limzoparlamab focused on China has the potential to be the first-in-class CB47 antibody for hematologic malignancies in this market. The Phase III program is evaluating limzoparlamab in combination with azacitidine, as first line treatment for patients with newly diagnosed higher risk myelodysplastic syndrome. Enrollment in the phase three trial was initiated in April of 2023. The company will continue to review follow-up data from our phase two clinical study in higher risk MDS, while at the same time analyzing details from trials evaluating other CD47 targeted agents as they are released. to inform our decisions on the future steps for the program. I'll now hand the call over to Richard to discuss our financial results.