11/3/2021

speaker
Claudia Gunthert
Conference Operator

Good morning. My name is Claudia Gunthert, and I will be the conference operator today. At this time, I would like to welcome everyone to the CarioPharm Therapeutics Third Quarter 2021 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 Jason Zinkelstein of Argot Partners.

speaker
Jason Zinkelstein
Argot Partners

Thank you, Claudia, and thank you all for joining us on today's conference call to discuss CarioFarm's third quarter of 2021 financial results and business update. Today, I'm joined by Mr. Richard Paulson, President and Chief Executive Officer, Ms. Sohanya Chang, Senior Vice President, Sales and Commercial Operations, Dr. Jayden Shah, Chief Medical Officer, Mr. Mike Mason, Chief Financial Officer, Mr. Steven Michener, Chief Business Officer, and Dr. Sharon Shackham, Chief Scientific Officer. During today's call, as outlined on slide two, Richard will provide some introductory remarks, Sohania will provide an update on our Expovio commercial progress, Jeaton will highlight recent pipeline advancements, and then Mike will discuss the third quarter financial result highlights and guidance. We'll conclude with some thoughts from Richard on upcoming milestones and then we'll move to the Q&A portion of the call. Earlier this morning, we issued a press release detailing CarioFarm's results for the third quarter of 2021. This release, along with the slide presentation that we plan to reference during today's call, are available on our website at cariofarm.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995, as outlined on slide three. These include statements about our future expectations, clinical developments and regulatory matters and timelines, the potential success of our products and product candidates, including our expectations relating to the commercialization of Expovio and Nexpovio, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent quarterly report on Form 10-Q, which is on file with the SEC and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements 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 forward-looking statements as representing our views as of any date subsequent to today. I will now turn the call over to Richard Paulson. Please turn to slide four.

speaker
Richard Paulson
President and Chief Executive Officer

Thank you, Jason, and good morning, everyone. Now, please turn to slide five. After joining as President and CEO in May, and now having been in this position for a full fiscal quarter, I've valued the opportunity to meet and speak to many of our shareholders, customers, and investigators. From our insightful conversations, I've enjoyed the enthusiasm and the commitment to our science. With the ability to positively impact patients and work across many different types of cancers, I look forward to continuing these interactions in the future as our future outlook for KaryoPharm is rooted in three key fundamentals. First is our execution in Expovio's launch. Currently, Expovio is approved in three indications in the U.S., in multiple myeloma and diffused large B-cell lymphoma. We have a tremendous opportunity in front of us to continue expanding Expovio's breadth and depth through continued head-down execution in the approved indications and advancement of key late-stage myeloma studies. We delivered strong commercial results in the third quarter with a significant increase in net product revenues compared to the second quarter of 2021, driven by an acceleration in demand growth for Expovio. Expovio continues to move into earlier lines of therapy in multiple myeloma as a new effective modality that can become the standard of care in second line plus, which was Sohania we'll discuss later in the call. In parallel, we will continue to build our foundation globally. We are anticipating that the European Medicine Agency's Committee for Medicinal Products for Human Use will complete the review of our Nexpovial marketing application as a second-line plus treatment for multiple myeloma, which is expected during the first half of 2022. Second is our pipeline. As we advance our pipeline, we are actively working to prioritize our clinical development plan and hematological malignancies and solid tumor indications with the highest unmet need probability of success, and attractive market opportunities. This includes our Phase III Siendo study, Evaluating Cell and XOR in Endometrial Cancer, where there are no approved treatments for maintenance therapy following chemotherapy in any line of treatment. Top line results for this study are expected by the end of this year or early next year, and if positive, will further reinforce the therapeutic potential of Cell and XOR in solid tumor indications. We are also advancing targeted late stage clinical studies across multiple hematological and solid tumor indications that Jayton will review later on our call. And we look forward to hosting a virtual investor day on Wednesday, December 8th to present further details on our commercial and pipeline priorities. To support our focused growth plan, we are well capitalized to fund our operations with a cash runway into the middle of 2023. Third is our people, who foster scientific creativity, pioneering technologies, and are dedicated to delivering Expovio to patients. We support a culture of innovation, courage, urgency, resilience, and energy captured in our iCure values with our employees and our collaborators. I'd like to sincerely thank our team, who are focused on helping patients in need and delivering for shareholders. As we turn now to slide six, I would like to turn the call over to Sohanya Chang, our Senior Vice President of Sales and Commercial Operations, for her review of the commercial results for the quarter. Sohanya?

Disclaimer

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