11/5/2024

speaker
Jenny
Conference Operator

Good morning. My name is Jenny, and I will be your conference operator today. At this time, I would like to welcome everyone to Carryform Therapeutics' third quarter 2024 financial results conference call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Alhan Webb, Senior Vice President, Investor Relations. Please go ahead.

speaker
Alhan Webb
Senior Vice President, Investor Relations

Thank you, and thank you all for joining us on today's conference call to discuss Kero Farms' third quarter 2024 financial results and recent company progress. We issued a press release this morning detailing our financial results for the third quarter 2024. This release, along with a slide presentation that we'll reference during our call today, are available on our website. For today's call, as seen on slide two, I'm joined by Richard, Reshma, Sohani, and Mike, who will provide an update on our results for the third quarter 2024 and recent clinical development. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements, FLS, for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, outlined on slide three. Actual results may differ materially from those indicated by these FLS as a result of various important factors, including those discussed in the risk factors section of our most recent form 10Q, which is on file with the SEC and in other filings that we may make with the SEC in the future. Any FLS represents our views as of today only. While we may elect to update these FLS at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these FLS as representing our views as of any later date. I will now turn the call over to Richard. Please turn to slide four.

speaker
Richard Paulson
President and Chief Executive Officer

Good morning. Thank you, Elhan, and thank you all for joining us today for CarioFarm's Q3 2024 earnings call. Turning to slide five, I want to begin with the exciting news that we shared last week regarding our phase three Sentry trial in myelofibrosis. We announced a very favorable regulatory update as we are changing the co-primary endpoint of Sentry to Absolute TSS following productive discussions with the FDA. Absolute TSS is supported by leading investigators and patient advocacy organization, and increases our overall confidence in our trial. We remain on track to report top-line data from Century in the second half of next year. Cell and XOR's unique mechanism of action, compelling data, our targeted approach to clinical development, and ongoing disciplined cost management position us well to advance our prioritized late-stage pipeline which may enable two transformative opportunities as we build on our multiple myeloma foundation. With our existing commercialization capabilities, we are pleased to deliver our third consecutive quarter of net product revenue growth in the U.S. and are on track to deliver revenue in the upper half of the guidance outlined at the start of the year. Our established commercial organization is well set up to potentially drive successful and rapid launches in myelofibrosis and endometrial cancer. Turning to slide six, in myelofibrosis, if the data from our phase three sensory trial is supportive, we believe we will have the opportunity to transform the treatment paradigm by providing the first combination therapy in JAK-naive myelofibrosis. While ruxolitinib alone has remained the standard of care for over a decade, less than half of all patients achieve meaningful spleen reduction. We believe that combination therapy with a novel mechanism of action like XPO1 inhibition holds the key for driving rapid, deep, and durable responses for the vast majority of myofibrosis patients. We continue to estimate that our annual U.S. peak revenue opportunity of myofibrosis is approximately $1 billion in the multibillion-dollar myofibrosis market. In endometrial cancer, the opportunity remains substantial given the evolution in the molecularly-driven therapies. Our data in TP53 wild-type endometrial cancer offers the potential of a meaningful and unique mechanism in maintenance therapy for approximately half of all endometrial cancer patients. This represents approximately a billion dollars annual U.S. peak revenue opportunity as well. So, Hanya and Reshma will expand in detail on both these near-term transformative opportunities. Now, I'd like to turn the call over to Reshma, who will give an update on our clinical programs. Reshma?

Disclaimer

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