NewLink Genetics Corporation (NASDAQ:NLNK) Q3 2019 Earnings Conference Call - Final Transcript

Nov 06, 2019 • 08:30 am ET

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NewLink Genetics Corporation (NASDAQ:NLNK) Q3 2019 Earnings Conference Call - Final Transcript

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Operator
Operator

Good morning, ladies and gentlemen, and welcome to the NewLink Genetics Third Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this conference call is being recorded.

I will now turn the call over to Lisa Miller, Director of Investor Relations.

Executive
Lisa Miller

Thank you. 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 morning and in our Form 8-K, which may be accessed from the Investor page of the company's website.

I will now turn the call over to Carl Langren, our Chief Financial Officer.

Executive
Carl W. Langren

Thank you, Lisa. Good morning, and thank you for joining us. With me today is Dr. Eugene Kennedy, Chief Medical Officer. Earlier this morning, we issued a press release reviewing our financial results for the third quarter of 2019 and recapping our previously announced intent to merge with Lumos Pharma, a private clinical-stage biopharma company focused on targeting rare and neglected diseases.

Before I run through our financials, Gene will review the key points of this proposed merger and merits of the combined companies' lead product candidate, LUM-201. Additional information regarding the proposed merger may be found in the proxy once it has been filed. Gene?

Executive
Eugene P. Kennedy

Thanks, Carl, and good morning, everyone. Should our proposed merger close as anticipated, the initial focus of our combined company which would operate as Lumos Pharma, will be to advance the lead candidate, LUM-201 for pediatric growth hormone deficiency, or PGHD. I'll take just a minute or two to discuss LUM-201 and how we view its potential to disrupt the treatment paradigm of PGHD, a well-established but growing market that's still in need of improvements over its current standard of care.

LUM-201 is a Phase IIb ready program for which we would plan to start a clinical trial in PGHD in mid-2020. PGHD occurs due to inadequate secretion of growth hormone by the pituitary gland during childhood and can be either hereditary or acquired, although the majority of cases are idiopathic. The most obvious symptom is children failing to meet early growth trajectory milestones. The disruption of metabolic processes can also occur as a result of PGHD and cause serious issues for these children.

As to the PGHD market published reports indicate that the incidence of PGHD in the U.S. alone is approximately one in 3,500 children. For well over 30 years, standard-of-care therapy for PGHD has consisted of daily injections of recombinant human growth hormone.