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5/14/2024
Good afternoon, and welcome to the BOLT Biotherapeutics Strategic Update Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, we will conduct a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would like to hand the call over to Willie Quinn, incoming Chief Executive Officer of BOLT Biotherapeutics. Please go ahead, sir.
Thank you, and good afternoon, everyone. This afternoon, we issued our first quarter 2024 financial results and business update, which outlines the topics we plan to discuss today. You can access the press release by going to the investors and media section of our website at www.boltbio.com. I am joined today by Randy Schatzman, outgoing chief executive officer, and Edith Perez, outgoing chief medical officer. I am also joined by some newly promoted members of BOLT's senior leadership team, including Michael Alonso, co-founder of BOLT and newly promoted senior vice president of research, and Don Colburn, newly promoted senior vice president of clinical development. Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements that are subject to a number of risks and uncertainties. These may cause our actual results to differ materially, and I encourage you to read our SEC filings for more details on these risks and uncertainties. You are cautioned not to place any undue reliance on these forward-looking statements, and BOLT disclaims any obligations to update such statements. To start, I'd like to thank everyone for joining us today. As you all know, we don't normally have earnings calls, but we decided it would be a good idea to have a call today to clearly communicate our new vision for BOLT. On today's call, we will provide details regarding strategic pipeline and leadership changes, as well as reviewing our progress during the first quarter. We believe these strategic changes will enable us to optimize the company's operations, maximize shareholder value, and most importantly, deliver meaningful benefit to the many patients with cancer who could benefit from more effective treatment options. I'd like to start the call by addressing our decision to discontinue development of BDC-1001. And for that, I'd like to call on my colleague, Dr. Edith Perez. As one of the foremost experts on HER2-positive breast cancer, Edith helped us navigate this landscape and recruit a stellar group of investigators. Edith?
Thank you, Willie. I am proud of the work that we've done to establish that are both body immune stimulating antibody conjugates or both body ISACs can be safely delivered and can produce anti-tumor activity in patients with metastatic solid malignancies. I am grateful for the collaboration with world leading investigators who understood and understand the promise of the ISAC approach. And I want to thank them and their patients for all they have done to help advance the scientific understanding of how this brand-new platform of ISACs may ultimately improve cancer care. We continue to build upon that foundation with our next-generation ISAC programs. We have decided to discontinue all development of BDC-1001 and will work with our investigators to achieve an orderly shutdown of our trials. Deciding to discontinue a program is never easy, especially when one sees signs of activity and evidence supporting our proposed mechanism of action. However, we have limited resources and most focused resources on our product candidates that have the highest potential. We set out to reproduce a 30% overall response rate that we saw in BDC-101's dose escalation trial, and we did not see that in the phase two portion of the program. However, the clinical activity of BDC-1001, along with the significant advances in our next-generation ISAC technology, have encouraged us to shift resources to our Clouding 18.2 targeting next-generation ISAC program, and our ongoing Phase 1 study of our DEC-102 agonist antibody. With these changes, I have decided to transition to an advisory role and hand over the reins to Dawn Colburn, who is being promoted to Senior Vice President of Clinical Development. Dawn joined BOLT in 2023, bringing over two decades of experience in oncology clinical development. Prior to joining BOLT, she was Vice President of Clinical Science at Algenus and Arcus Biosciences, where she built and led the Clinical Science Organization and the National Cell Lung Cancer Development Strategy at both organizations. I am happy that Bolt's clinical programs are in good hands, and I look forward to continuing to work with Don and the team in the advisory role. And with that, I'll now hand over the call to Randy. Randy?
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