11/10/2020

speaker
Operator

Thank you. Thank you. Thank you. Good afternoon ladies and gentlemen. and welcome to the Loomis Farmer third quarter earnings call. At this time, all participant lines are on a listen-only mode. Later, we'll conduct a question and answer session, and instructions will follow at that time. As a reminder, this call is being recorded. I will now turn the call over to Lisa Miller, Director of Investor Relations. Please go ahead.

speaker
Lisa Miller
Director of Investor Relations

Thank you. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the earnings release we issued this afternoon and in our Form 8-K, which may be accessed from the Investors page at the company's website. Joining me on today's call are Rick Hawkins, CEO, President, and Chairman, John McHugh, Chief Operating Officer and Chief Scientific Officer, Gene Kennedy, Chief Medical Officer, and Carl Langren, Chief Financial Officer. Rick Hawkins will provide a corporate update. John McHugh will review the company's lead therapeutic candidate and target indications. Gene Kennedy will discuss our Phase 2B trial initiation and our concurrent pharmacokinetic, pharmacodynamic trial. And Carl Langren will wrap up the call with a review of the Q3 2020 financials and an update of cash guidance. I will now turn the call over to Rick.

speaker
Rick Hawkins
Chief Executive Officer, President & Chairman

Thank you, Lisa. Good afternoon, and thank you for joining us on today's call. After the market closed, we issued a press release announcing the initiation of our Phase 2b Oral Growth 210 trial. This trial will evaluate our oral therapeutic candidate for children with pediatric hormone deficiency, or PGHD. The press release also includes corporate updates related to our planned pharmacokinetic, pharmacodynamic, oral growth 212 trial and our third quarter financial results. The third quarter was an exciting time for Lumos Pharma, marked by significant achievements and corporate updates as we continue to execute on our mission of developing new therapies for patients with rare diseases. Specifically, as I mentioned, we are excited to announce the initiation of our Phase IIb Oral Growth 210 trial evaluating oral LUM201 for PGHD patients. The first focus of our Oral Growth Trials program involving LUM201 as a potential therapy for multiple indications currently treated with injectable growth hormone. The Wargrove 210 trial will evaluate three doses of LUM201 for PGHC patients with the goal of prospectively confirming our predictive enrichment marker, or PEM, strategy and identifying the optimal dose of LUM201 to be used in a registration trial. We eagerly anticipate our Phase 2b data readout, which is expected mid-year 2022. In conjunction with our Phase IIb trial in PGAC, Loomis Pharma also plans to conduct a separate single-site trial in PGAC focused on the pharmacokinetic and pharmacodynamic aspects of Loom 201 to further explore the pulsatile nature of Loom 201's mechanism of action. The initiation of our second concurrent study evaluating Loon 2.1 for PGHD patients remains on track to begin during the first quarter of 2021. While Jean Kennedy, our Chief Medical Officer, will speak about both of these trials in greater depth later on in this call, I want to take the time now to express the excitement that we feel at Lumos Pharma around this potential opportunity for our oral therapeutic to disrupt the injectable PGHD market by bringing long-lasting benefits to patients who are subjected to years of treatment with daily injections, for which there currently exists no available oral alternative. Additionally, the company is pleased to announce that in the third quarter, we received the first tranche $34 million of the $60 million proceeds owed Loomis Pharma from the sale of our Priority Review Voucher, or PRV. These non-diluted funds will be available to support the expansion of the company's pipeline through the acquisition or licensure of another novel therapeutic candidate for rare diseases. Specifically, we're looking to target therapies where the medical unmet need is high and the pathophysiology is clear. We anticipate the receipt of the second tranche of the PRV in the first quarter of 2021, which will serve to further strengthen our balance sheet and support our product candidate acquisition strategy beyond Loom 201. We feel fortunate to have both a solid balance sheet as well as an integrated and experienced management team in place, putting us in a strong position to continue to execute on our mission of developing treatments for patients suffering from rare diseases. With that, I'll turn the call over to John to provide an update on the company's lead therapeutic candidate and target indications. John?

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