Aadi Bioscience, Inc.

Good day, and thank you for standing by. Welcome to Addy Bioscience fourth quarter 2023 earnings conference call. At this time, all participants are on 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 11 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that this conference is being recorded. I will now turn the call over to Audrey Gross, Head of Corporate Communications for Addi Bioscience. Ms. Gross, please go ahead.

Thank you. Good morning and welcome to the Addi Bioscience conference call to provide an operational update and review results of the fourth quarter and full year 2023. On the call is Dr. Dave Lennon, our President and CEO, Scott Giacobbello, our CFO, and Chief Medical Officer, Dr. Loretta Itri. Today we will provide an overview of operational activity and financial results for the fourth quarter and full year of 2023. We will open the line for questions at the end of the call following closing comments. A quick reminder that statements made on the call today will include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in the risk factors section of our annual and quarterly filing with the Securities and Exchange Commission, which can be found at www.sec.gov or on our website at www.addibio.com. In addition, any forward-looking statements made on this call represent our views only as of today, March 13, 2024, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update or revise any forward-looking statements. With that, I'll turn the call over to Dave for his opening statements. Dave?

Good morning, everyone, and thank you for joining us today to review our financial and operational results for the fourth quarter and full year of 2023. At Addi, we are focused on unlocking the full potential of mTOR inhibition by uniquely combining NAP technology and the potent mTOR inhibitor, sirolimus. We believe NAP sirolimus has the potential to deliver deeper inhibition and ultimately better outcomes for patients living with cancers that are dependent on the mTOR pathway. And 2023 was the year marked by progress and increasing momentum for the company as we delivered strong execution against both commercial and development goals. First, VRO sales remained solid, achieving a cumulative $24.4 million for the full year of 2023, representing a 60% growth over prior years. VRO achieves high penetration in the academic and community settings and is considered the preferred treatment for malignant PECOMA. Clinically, a key focus for our organization has been realizing the potential of nabsterolimus for patients with solid tumors harboring either TSC1 or TSC2 and activating alterations. These types of genetic alterations are thought to activate the mTOR pathway, leading to uncontrolled cell growth, and our PRECISION-1 trial is an interventional study designed to elucidate the potential of nabsterolimus to treat all types of solid tumors with either of these alterations. As a reminder, the unmet need in TFC1 and TFC2 mutated cancers is sizable, whether considering together or independently, and represents about 2% of all solid tumor cancer patients. Our latest internal analysis indicates there are approximately 16,000 new patients with these mutations across a variety of tumor types each year in the U.S. alone. With mutations roughly evenly split between genes, each mutation represents a potential multibillion-dollar addressable market for NAP-serial alignment. TSC1 or TSC2-driven cancers are found across a wide range of tumor types clustering in lung, gastrointestinal, general urinary, breast, and gynecological locations, and are often very difficult to treat. We believe PRECISION1 is a cutting-edge trial testing our innovative therapy, Napserolimus, in these cancer types. Although PRECISION1 is designed as a single trial, each arm is independently evaluated, providing us with the ability to assess one arm separately from the other. Given this design, Precision 1 can effectively be viewed as two separate studies, each with its own outcome. In Q4, we provided top-line results from a planned interim evaluation of the first 40 patients enrolled in Precision 1. These data demonstrated sustained tumor reductions in a heavily pretreated population based on investigator-assessed responses in the first 40 patients across both arms. As a reminder, for the TFC1 arm, 19 efficacy-valuable patients were included in the cutoff date for the interim analysis who had at least one post-baseline scan. We reported an overall response rate of 26%, which was within the range of our expectations. Importantly, responses appeared to be early, deep, and durable. Medium time to response was 1.4 months, and all responses were ongoing at the time of data cutoff. This is especially noteworthy given that this was a heavily pretreated population with a median of three prior lines of therapy. Lastly, these responses were seen across four different tumor types supporting a tumor agnostic indication. In the TSC2 arm, we reported a lower response rate, but given these patients were heavily pretreated, including 50% who had had at least five prior lines of therapy, these early TSC2 results are challenging to interpret. Precision 1 continues to enroll steadily, and we now expect the trial to be fully enrolled by May. We are still on track for our next planned interim readout, which is expected in Q3 of 2024. This readout will include a total of 80 patients who have been followed for a minimum of six months and will evaluate the primary input in the study, independently assessed overall response rate, as opposed to our December analysis, which reported investigative responses. We expect the study to be completed by the end of 2024 with full data in early 2025. In addition to precision one, enrollment is underway for both of the previously announced phase two single indication trials for two promising mTOR-driven cancer targets. Overactivation and dysregulation of the mTOR pathway is commonly found in various tumors, and unique delivery and excellent safety profile of napserolimus provides the opportunity to combat these difficult-to-treat cancers. The first trial is evaluating napserolimus in neuroendocrine tumors, or NETs. NETs are rare, with approximately 3,500 patients per year. NETs have historically had a low response rate to treatment with oral rapalogs and other agents, which nonetheless are used clinically and recommended in treatment guidelines today. In preclinical animal models, NAP serolimus demonstrated improved target suppression relative to other mTORs, warning further exploration of NAP serolimus in this indication. We're excited about this trial because it provides the opportunity to demonstrate what we believe is napserolimus' best-in-class efficacy in a known mTOR-sensitive tumor type. The second trial we started last year is evaluating the therapeutic potential of napserolimus in advanced and recurrent endometrioid-type endometrial cancer in combination with the aromatase inhibitor letrozole. Endometrial cancer is the most common cancer of the female reproductive tract and one of the few cancers with increasing mortality. There's an estimated 10,000 cases of EEC diagnosed annually in the U.S. alone. Prior clinical studies of the mTOR inhibitors combined with letrozole have yielded promising results, and recent changes in the recommended standard of care for early-stage disease creates a potential opportunity for our combination to be used in these first- and second-line settings. Both of these open-label studies are actively enrolling, and we plan to present initial data later this year. Rounding out our clinical development program, we also have ongoing trial with combination of varieties KRAS inhibitor and lung cancer and other solid tumors. With a solid commercial foundation provided by FIARA, robust and bold clinical development programs spanning genetically driven tumors and other mTOR sensitive tumors and a cash runway into Q4 2025, we are well positioned to realize our ambition of becoming a multi-indication precision oncology company. I will now turn the call over to Scott for updates on our financial progress.