11/9/2023

speaker
Operator
Call Moderator

Welcome everyone to Accenture's business update call for the third quarter of 2023. After the prepared remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star 1. At this time, I would like to introduce Sarah Sherman, Vice President of Investor Relations. Sarah, you may begin.

speaker
Sarah Sherman
Vice President of Investor Relations

Thank you, Operator. A press release and 6K were issued this morning with our third quarter 2023 financial results and business update. These documents can be found on our website at investors.Xentia.ai, along with the presentation for today's webcast. Before we begin, I'd like to remind you that we may make forward-looking statements on our call. These may include statements about the initiation, timing, and progress of, and data collected during and reported from, the company's clinical trials, expectations regarding the growth of the company's capabilities and the performance of its technology platform, and the company's projected cash runway. Actual results may differ materially from those indicated by these statements. Unless required by law, Accenture does not undertake any obligation to update these statements regarding the future or to confirm these statements in relation to actual results. On today's call, I'm joined by Professor Andrew Hopkins, Chief Executive Officer, Dr. Dave Hallett, Chief Scientific Officer, and Ben Taylor, CFO and Chief Strategy Officer. Dr. Mike Krems, Chief Quantitative Medicine Officer, will also be available for the Q&A session. And with that, I will now turn the call over to Andrew.

speaker
Andrew Hopkins
Chief Executive Officer

Thank you, Sarah. In the food quarter of 2023, we made great strides across our internal and partner programs. We are executing on a focused development pipeline and prioritizing our most differentiated, highest value oncology programs, including GTA, EXS617, our CDK7 inhibitor, in partnership with GTA Perron, which is enrolling patients in a Phase I-II clinical trial, and EXS-74539, our LSD-1 inhibitor, for which we anticipate submitting an IND in the first quarter of 2024. We also advanced partner programs, achieving the first milestone in our Sanofi collaboration, and inked a new partnership with Merck, KGAA, that bolstered our financial strength and expanded our reach. We continue to push forward with clinical validation of our precision medicine platform. EXCITE-1 is a multi-center observational trial evaluating the predictive power of a functional precision medicine platform in ovarian cancer. We also have a similar program with Charite in hematological cancers. As a learning company, we're always looking for ways to advance and develop new tech. Accenture's automation facility recently opened, and we have begun screening biological assays We plan to migrate all the primary assays we can from our CROs to our automated labs. We synthesized our first compound at our automation labs and through 2024 plan to bring you more information on how we integrate an AI to automate chemical synthesis at the facility. Productivity in the automated laboratory will ramp up through 2024. We're expecting a meaningful impact on the quantity of data we generate as well as cycle times from the new labs. We are committed to the integration of AI and automation to improve the way drugs are designed. We also recently presented data on an automated de-nova design tool that is able to deliver potent kinase hits from the alpha-fold structures. We developed this capability based on learnings from prior successful projects. The first exemplification of this design effort was to show how novel, potent, and selective kinase inhibitors can be generated de novo from the AlphaFold Kino models. The method can potentially be applied across the proteome. This tool is a continuation of our philosophy of encoding and automating drug discovery wherever possible, and we look forward to applying this at scale across future projects. We believe we remain well capitalized with $447.8 million in cash at the end of the quarter, providing us with a runway well into 2026. to advance our near-term programs as well as grow our capabilities driven by recent investments in automation as well as other leading technological and scientific advancements, which allow us to reach key inflection points that will drive the value of our platform. We recently prioritized our pipeline to focus internally on the programs we believe will have the greatest clinical impact for patients and which have the highest probability of success. As previously mentioned, our partnership business continues to mature. This is highlighted by the new collaboration we announced in September with Merck KGAA, based in Darmstadt, Germany. Prior to signing the agreement, we identified three potential first-in-class or best-in-class targets in oncology and immunology. Under the terms of the agreement, we will receive an upfront cash payment of $20 million from Merck. If all milestones for all three initial programs are achieved, we will be eligible for discovery, development, regulatory, and sales-based milestone payments of up to $674 million. We are excited to announce this partnership as we believe our integrated technology platform will complement Merck's scientific prowess as we partner to address drug discovery challenges in cancer and immunology. We focus our internal pipeline on oncology targets, where our technology can help improve the probability of success through precision design and precision medicine. Two highly differentiated molecules that demonstrate this strategy are GTA-EXS617 or 617, our CDK7 inhibitor, and EXS74539 or 539, our LSD1 inhibitor. 617 has potential as a best-in-class reversible CDK7 inhibitor. It was designed for improved potency, selectivity, and pharmacokinetics compared to other molecules in development. Enrollment is ongoing in the Phase 1-2 elucidate adaptive clinical trial with advanced solid tumors including head and neck cancer, pancreatic cancer, non-small cell lung cancer, hormone receptor positive HER2 negative breast cancer, colorectal cancer, and ovarian cancer. The model-driven adaptive trial is studied in 6-7 as both a monotherapy and in combination with standard of care. where we expect our precision medicine platform to play a critical role in determining the optimal combinations. 539, our LSD1 inhibitor, also has best-in-class potential. 539 has a high level of differentiation due to its reversible mechanism of action, CNS penetration, preclinical safety profile, and anticipated flexibility of dosing that should help maximize therapeutic index. This unique set of properties provides both first-in-class, and best-in-class potential for small cell lung cancer and acute myeloid leukemia. GLP-TOX studies for this compound are complete, and we expect to submit an IND in the first quarter of 2024. Just behind 539 is our MALT-1 inhibitor, EXS-73565, or 565 for short. We believe that 565 is highly differentiated due to reduced UGT1A1 inhibition, combined reportancy, and sensitivity. 565 is progressing through IND and CT enabling studies, and we look forward to sharing more information on this with you in the first half of 2024. As for our partner programs, we currently have three in the clinic. EXS4318 or 4318, a PKC theta inhibitor designed by Accenture and in-licensed by Bristol-Myers Squibb, is in phase one. And two programs designed by Accenture for summa terma pharma, DSP0038, a bispecific 5-HT1A agonist and 5-HT2A antagonist, and DSP2342, a dual 5-HT2A, 5-HT7 antagonist, also are in phase one studies. We also achieved our first milestone for an immunology and inflammation target within our collaboration with Sanofi. As a reminder, the Sanofi collaboration is for up to 15 oncology and immunological targets and potential milestone payments of up to $343 million per program. Beyond the programs highlighted, we believe we have a well-balanced blend of internal and partnered programs. This means that we're able to de-risk some programs with the help of our partners and fully maximize the value of the programs that we solely own. I'll now hand over to Dave Hallett, our Chief Scientific Officer, to walk us through an update of our LSD1 and MALT1 programs, including data presented last month at ESMO, the European Society for Medical Oncology.

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