Aadi Bioscience, Inc.

Greetings and welcome to the Addi Bioscience Incorporated first quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Andrew Kwan, VP of Business Development and Corporate Strategy. Thank you. You may begin.

I would like to welcome everyone to the first Addi Bioscience Quarterly Results Call for Q1 2022. With us on the call today from Addi Bioscience are Neil Desai, founder, president, and CEO, who will give a quick overview of the quarter, Brendan Delaney, Chief Operating Officer, who will provide early commercial uptake commentary and metrics, Dr. Loretta M. Eitri, Chief Medical Officer, who will walk us through clinical development priorities and forthcoming updates, and Scott Giacobbello, Chief Financial Officer, who will provide an overview of our financials this quarter. Before we get started, I would like to remind everyone that statements we make on this conference call 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 Security and Exchange Commission, and can be found at www. 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, May 12, 2022, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. With that, let me turn the call over to Neil.

Thank you, Andrew. Good morning, everyone, and thank you for joining. The first quarter of 2022 was transformative for Addi Bioscience. We successfully transitioned into a fully integrated biopharmaceutical company, commercializing and launching our first product, Phyaro, an albumin-bound mTOR inhibitor, also known as Napsirolimus, for advanced malignant pachoma on February 22nd of this year. We delivered on our promise to begin enrolling patients in our new registration-directed tumor agnostic trial, known as Precision 1, in March. In the first quarter, we have continued our company building and recruitment of high-quality talent in all areas of the organization. And our cash position remains strong at approximately $130 million and is expected to continue funding our commercial and R&D operations into 2024. Our key priorities in 2022 are to maximize the clinical and commercial potential of FIRO to further strengthen our ability to create long-term value. FIRO is now the first and only FDA-approved treatment specifically indicated for advanced malignant picoma patients, and the first and only NTOR inhibitor approved for this indication. Even though advanced malignant pachoma is an ultra-rare sarcoma with around 100 to 300 new patients per year in the U.S., the launch parameters for FIARO in advanced malignant pachoma are encouraging. While we are still early in our launch, it is clear that FIARO has been well-received by patients and their treating physicians alike. In six weeks since launch to the end of the first quarter, we achieved 2.3 million in net sales of FIARO. We attribute this encouraging performance in part to both pent-up demand and transitioning of expanded access program and MPEG clinical trial patients to commercial product, and Brendan will discuss this further. In general, we are very pleased with the high level of awareness and interest among physicians, favorable payer sentiment, and strong patient demand. Early in the first quarter, we received recommendation by the NCCM guidelines highlighting FIRO as the preferred treatment for PECOMA. And very recently, we have secured a permanent J code for FIRO, which will be effective July 1, 2022, and should make prescribing FIRO even easier for physicians. I would like to thank Brendan and his entire commercial team for executing such a great start. We believe this quick adoption of FIRO is clear evidence that we have a highly differentiated product in a difficult-to-treat cancer with a dire unmet need. And Brendan will have a lot more to say on this topic in a few moments. On the R&D front, we are very pleased with our progress on Precision-1, our registration-directed tumor agnostic trial for MAP serolimus in TSC-1 or TSC-2 alterations in solid tumors. This trial has the potential to significantly broaden the future application of MAP serolimus across many different tumor types. We enrolled our first patient in March and are steadily working to open high-quality clinical sites. We are further augmenting enrollment via partnerships with NGS providers and community oncology networks. With these patient recruitment strategies in place, we feel confident about our intention to present preliminary data from Precision 1 in the first half of 2023 and complete the study in 2024. In addition to the PRECISION-1 trial, our team is also evaluating options for new single-agent or combination treatments with Napsirolimus with the goal to kick off new clinical studies in 2023. Loretta and her clinical team have done a terrific job in getting the PRECISION-1 trial up and running. She will give additional color on this topic shortly. In addition, in the first quarter, we have continued our company expansion and recruitment of high-quality talent in all areas of the organization. We have recently established a new office in Morristown, New Jersey, a national hub in the Northeast for oncology expertise and industry talent. And so we are now officially bi-coastal. In summary, Addi is firing on all cylinders and working to maximize the value of FIRO for our shareholders. while helping the many patients with unmet need to gain access to this important and novel drug that efficiently targets the mTOR pathway. Our goal, indeed, is to establish Addi as the leading company in precision oncology. Brendan will now discuss our launch and commercial progress in greater detail.