5/9/2023

speaker
Operator
Conference Call Operator

Good morning, and welcome to Mursano Therapeutics' first quarter 2023 conference call and webcast. Currently, all participants are in listen-only mode. There will be a question and answer session at the end of this call. Please note, this event is being recorded. I would now like to turn the call over to Jason Fredette, Senior Vice President, Investor Relations and Corporate Communications. Please proceed.

speaker
Jason Fredette
Senior Vice President, Investor Relations and Corporate Communications

Good morning, everyone. Before we begin, please note that this call will contain forward-looking statements within the meaning of federal securities laws. These statements include, but are not limited to, those related to the therapeutic potential of our product candidates and the potential of our platforms, business strategy, clinical trial design, execution, and data releases, regulatory plans and objectives, commercial opportunities, collaborations, and potential associated payments, operating expenses, and cash runways. Each of these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. These risks and uncertainties are discussed in our annual report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2023, and in subsequent SEC files. Our filings are available at sec.gov and on our website, mursana.com. except as required by law, we assume no obligation to update forward-looking statements publicly, even if new information becomes available in the future. So with that, let me turn the call over to Anna Protopapas, our president and chief executive officer.

speaker
Anna Protopapas
President and Chief Executive Officer

Thank you, Jason, and hello, everyone. Welcome to our conference call. Joining me today with prepared remarks are Mursana's chief medical officer, Arvin Yang, and Chief Financial Officer, Brian Descheidner. We also have other members of management here who will be available to answer your questions. 2023 is shaping up to be a potentially transformational year for Mursana. We are on the verge of a top-line data readout for a first-in-class ADC, APRI, while we also execute on a comprehensive clinical development plan for this candidate, with the potential to address significant unmet medical needs for patients suffering from ovarian cancer. We are advancing our own pipeline and are also collaborating with several other organizations, utilizing our three proprietary ADC platforms. And thanks in a large part to the successes we've had on the business development front, we are doing all of this on a strong financial footing. We are pursuing our objectives during a historic period for ADCs, as evidenced by numerous new collaborations, additional approvals, exciting new data presentations, and one of the largest biotech acquisitions to date. In platinum-resistant ovarian cancer specifically, virvotuximab just recently reaffirmed the single-arm accelerated approval pathway. And from a commercial perspective, the early uptake of testing and treatment for this product has demonstrated both the high unmet medical need in platinum-resistant ovarian cancer and the willingness of treating physicians to embrace a targeted approach to therapy. And so we're in the midst of a very exciting period. Thanks to a decade of hard work by the team here at Mursana, the innovative approach that we have taken to ADC platform development and our advanced stage of clinical development with Apri, we believe we're well-positioned to add to the momentum in the field. We are putting a heavy emphasis on our strategy to establish Apri as a foundation on medicine in ovarian cancer as we advance three ongoing clinical trials that seek to address areas of high unmet medical needs. The first is UPLIFT, a single arm registration trial in platinum resistant ovarian cancer. As evidenced by a rapid enrollment of approximately 270 patients in this trial and recent product uptake in the platinum resistance phase, the unmet medical need for these late stage patients is very high. Up next is our Phase III clinical trial of UPRI as a monotherapy maintenance treatment in recurrent platinum-sensitive ovarian cancers. This trial is designed to serve as a post-approval confirmatory trial of UPRI in the U.S., significantly increase our potential market opportunities by supporting expansion into earlier lines of therapy and support potential approvals outside the U.S. And then there's UPGRADE-A, our phase one combination trial of UPRI with carboplatin in platinum-sensitive ovarian cancer. We hope this data will inform our path to earlier lines of treatment. With top-line data from UPLIFT planned for mid-year after the upcoming oncology conferences in June and a potential BLA submission around the end of the year, we have began to prepare for potential commercialization. For instance, we have formed a small core team of commercial professionals with deep ovarian cancer experience, build our medical affairs function, and we're working diligently to ensure we can hit the ground running with NAPI GP testing. Beyond UPRI, we continue to make progress in our phase one trial of XMT1660 our B7H4 dollar Simpson product candidate, and our working to address the clinical hold the FDA recently placed on our Phase I clinical trial of XMP2056. To further discuss our clinical plans and progress, I turn the call over to Arvind.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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