Aadi Bioscience, Inc.

Good day and welcome to the Addi Bioscience first quarter 2023 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. Now I'll turn the call over to Marci Graham, Senior Vice President of Investor Relations and Corporate Communications at Addi Bioscience. Ms. Graham, please go ahead.

Thank you. Good morning and welcome to the Addi Bioscience conference call to provide an operational update and review results for the first quarter of 2023. Joining me on the call today is Scott Giacobbello, our CFO and Interim President and CEO, who will provide an overview of financial and operational activity during the period, including an update on our continued commercial progress, followed by our Chief Medical Officer, Dr. Loretta Itri, who will provide an update on our Precision I study and clinical development plans for 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.addiebio.com. In addition, any forward-looking statements made on this call represent our views only as of today, May 10th, 2023, and should not be relied upon as representing our view as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. With that, I will turn the call over to Scott for his opening statements. Scott?

Thank you, Marcy, and hello, everyone. Thank you for joining us this morning to review our financial and operational results for the first quarter of 2023. We're off to a strong start this year as our performance continued to drive results and the first quarter closed out well. Our focus on successful commercial execution of FIARO for the treatment of advanced malignant pachoma resulted in sales of $5.9 million during the quarter, a 12% sequential increase over the previous quarter. The efforts of our commercial team to expand our reach and increase the visibility of 5-0 are driving our success in the market, and we are pleased with the continued growth resulting from their hard work. We look forward to delivering continued benefits to these patients suffering from this rare and now treatable disease. On the clinical front, today we will provide an initial update on our tumor-agnostic Precision 1 registration-directed trial for patients harboring inactivating alterations in TSC1 or TSC2 genes. This trial has the potential to significantly broaden the future application of Napsterilinus across many different tumor types and in a much larger patient population than we currently address in Vekoma, presenting an exciting opportunity for additional growth. We are encouraged by initial enrollment data on the types of tumors we are seeing in the trial, as well as the enrollment distribution in the two arms. Loretta will share further details on the conduct of the Precision 1 trial shortly. Beyond the Precision study, Initiation of the Phase I-II trial in KRAS G12C is expected to begin with first patient dosing in the second quarter of 2023. The study, in collaboration with Muradi Therapeutics, will evaluate the combination of adegraftin with nabsterolimus and is intended to determine the optimal dose and recommend Phase II dose in patients with KRAS G12C mutant solid tumors. Additionally, we continue to evaluate the potential for use of nabsterolimus and a number of new clinical indications, either as a single agent or in combination with other targeted therapies, with the potential for new clinical programs later this year. We are aligning for success on several fronts in a key executional year, building on the achievements of prior periods and are working hard to attain our goals as the year progresses. Before we review operational and financial results for the quarter, Loretta is up next to provide an update on our Precision I trial and discuss our ongoing clinical activity. Loretta?