8/9/2023

speaker
Call Operator
Conference Call Operator

Good day and thank you for standing by. Welcome to the Addi Bioscience Incorporated second 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. To ask a question during the session you will need to press star 1 1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Marci Graham, Senior Vice President of Investor Relations and Corporate Communications at Addi Biosciences. Ms. Graham.

speaker
Marci Graham
Senior Vice President of Investor Relations and Corporate Communications

Thank you. Good morning and welcome to the Addi Bioscience conference call to provide an operational update and review results of the second quarter 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. And he will be followed by our chief medical officer, Dr. Loretta Etri, who will provide an update on our Precision 1 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 factor 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, August 9th, 2023, 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, I will turn the call over to Scott for his opening comments. Scott?

speaker
Scott Giacobbello
CFO and Interim President & CEO

Thank you, Marcy, and good morning, everyone. Thank you for joining us today to review our financial and operational results for the second quarter of 2023. We continue to see solid performance from our commercial and clinical organizations during the quarter, each focused on driving results as we enter the second half of the year. FiOro sales for the quarter were $6.2 million, showing continued growth with a 6% sequential increase over the previous quarter and 80% growth over the prior year quarter. Efforts by our sales and marketing teams in the field are driving awareness and educating key stakeholders, reaching healthcare providers in varied channels, and we are pleased with the positive feedback from physicians on the efficacy and safety of FIARO as we see greater utilization in the first-line setting. Separately, the Precision 1 trial is progressing well, and we're looking forward to providing results on an interim analysis of 40 patients with appropriate follow-up before the end of the year. We are enthusiastic about the potential of this trial to significantly broaden the future application of NAB serolimus across many different tumor types and in a much larger patient population than we currently address in Pacoma, presenting an exciting opportunity for additional growth. Beyond the PRECISION-1 study, we have continued to evaluate the potential use of NAB serolimus in a number of new clinical indications, either as a single agent or in combination with other target therapies. Today, we're announcing the expansion of our FireOil pipeline through the further investigation of mTOR pathway inhibition in endometrial cancer and neuroendocrine tumors, or NETs. Our preclinical data in these indications is promising, and we believe in the potential of our technology to harness the unique pharmacology of NAB serolimus to provide enhanced therapeutic benefit for patients. Loretta will join us shortly to provide greater detail on these and other aspects of our clinical programs. This is a year of execution on many fronts, which now includes the launch of new programs that we believe will reflect the value of NAB-serolimus as a potential treatment and additional indications targeting genetically defined cancers with mTOR pathway alterations. Loretta is up next to provide an update on our Precision 1 trial and discuss our ongoing clinical activity. Loretta?

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