On August 5, 2021 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported that financial results for the second quarter ending June 30, 2021 and provided an update on clinical and corporate activities (Press release, NewLink Genetics, AUG 5, 2021, View Source [SID1234585887]).
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"The enhancement of Lumos Pharma’s leadership team and encouraging recent trends in screening and enrollment for both OraGrowtH210 and OraGrowtH212 Trials are exciting developments for the Company," commented Rick Hawkins, Chairman and CEO of Lumos Pharma. "John McKew, David Karpf, and Mark Bach each bring significant clinical development and management expertise to their new roles with the Company, strengthening our ability to execute on our clinical and corporate strategy. The majority of our trial sites are now open, and we continue to work to bring the remainder online. Additionally, as children return to school this fall and regular pediatrician visits resume, we believe these factors should lead to increased referrals and an acceleration of enrollment in our trials."
Corporate Update:
John McKew, PhD, Chief Operating Officer & Chief Scientific Officer, Promoted to President
Our Chief Operating Officer and Chief Scientific Officer, John McKew, was recently promoted to President of Lumos Pharma effective August 1, 2021 as part of a planned succession process. Dr. McKew has nearly 30 years of experience developing novel therapeutics during which he successfully advanced multiple therapies through preclinical and into clinical development, both at the NIH and in the pharmaceutical industry. Dr. McKew has served as Chief Operating Officer of Lumos Pharma since April 2020 and as Chief Scientific Officer since he joined the Company in 2016.
David B. Karpf, MD, Experienced Endocrinologist and Pharma Executive, Named Chief Medical Officer
Pharma industry veteran and academician, David B. Karpf, MD, joined Lumos Pharma as Chief Medical Officer on August 3, 2021. Dr. Karpf is an Adjunct Clinical Professor in the Division of Endocrinology at Stanford University School of Medicine with over 35 years of expertise in all aspects of clinical endocrinology. He is also an accomplished executive with 30 years of experience in the development of biopharmaceuticals and small molecular weight drugs in the areas of endocrinology and rare diseases, among others. Most recently, Dr. Karpf served as Vice President, Clinical Development for Ascendis Pharma where he was responsible for several compounds in clinical development, including TransCon GH, long-acting growth hormone for once weekly treatment of growth hormone deficiency, and TransCon PTH. Dr. Karpf has held leadership positions at several biopharmaceutical and pharma companies, including Merck where he originally gained experience with Lumos Pharma’s oral growth hormone secretagogue, LUM-201.
Pediatric Endocrinologist and Biopharma Executive, Mark Bach, MD, PhD, Joins Advisory Board
Mark Bach, MD, PhD, pediatric endocrinologist and seasoned pharmaceutical executive, joined Lumos Pharma’s Clinical Scientific Advisory Board on July 15, 2021. Dr. Bach is currently the Chief Medical Officer for ShouTi Inc., having recently joined from Ascendis Pharma where he served as Senior Vice President, Endocrine Medical Sciences. Dr. Bach is a pediatric endocrinologist with 30 years of clinical research and pharmaceutical development experience. Prior to Ascendis, Dr. Bach held successive leadership roles in research and development at both Johnson & Johnson and Merck. While at Merck, he conducted extensive clinical and preclinical research on growth hormone, IGF-1 and LUM-201 (MK-0677).
Clinical Update:
OraGrowtH210 Trial of LUM-201 in PGHD
As the Company announced on July 21, 2021, given the slower pace of site initiation and enrollment of the Phase 2 OraGrowtH210 Trial of LUM-201 in PGHD primarily due to the impact of COVID, the 6-month primary outcome data for OraGrowtH210 is now anticipated in the second half of 2023. The treatment period for this trial has been extended to 12 months to capture additional data for future regulatory filings and to meet FDA requirements to initiate our proposed 3-year long-term extension study, the OraGrowtH211 Trial. We do not anticipate these protocol changes, on a stand-alone basis, to extend the time to initiation of our Phase 3 clinical trial. The primary outcome for the Phase 2 OraGrowtH210 Trial continues to be the preliminary validity of our Predictive Enrichment Marker (PEM) strategy with the goal of selecting the optimal dose for a pivotal Phase 3 study in PGHD.
PK/PD OraGrowtH212 Trial of LUM-201 in PGHD Initiated Q2 2021
The OraGrowtH212 Trial was initiated in June and is currently enrolling patients. This study will evaluate the PK/PD effects of LUM-201 in PGHD patients at two dose levels, 1.6 and 3.2 mg/kg/day, to confirm prior clinical data illustrating the increased pulsatile release of endogenous growth hormone unique to LUM-201 and its potential for this mechanism of action to contribute to efficacy in PGHD. This open-label trial will be extended from six months to twelve months to capture additional PK/PD and height velocity data. The PD pulsatility assessment will continue to occur at six months on therapy as planned.
Pipeline Expansion
We have been conducting an assessment of the range of disease areas where LUM-201 would have medical utility for purposes of prioritizing our next indication and longer-term life cycle planning. These assessments reinforce our conviction that LUM-201 represents a pipeline-in-a-product and look forward to advancing the next phase of LUM-201 opportunities. In addition, with a heightened sensitivity toward value creation, we continue to evaluate select rare disease assets under consideration to add to our product portfolio.
Financial Results for the Quarter Ended June 30, 2021
Cash Position – Lumos Pharma ended the second quarter on June 30, 2021, with cash and cash equivalents totaling $107.7 million compared to $98.7 million on December 31, 2020. Cash on hand as of the end of Q2 2021 is expected to support operations through the primary outcome data readout from OraGrowtH210 Trial in the second half of 2023 and the OraGrowtH212 Trial.
R&D Expenses – Research and development expenses were $4.1 million, an increase of $1.4 million for the three months ended June 30, 2021 compared to the same period in 2020, primarily due to increases of $1.8 million in clinical trial and contract manufacturing expenses, offset by a decrease of $0.4 million in personnel-related and operating expenses for insurance, rent, supplies and depreciation.
G&A Expenses – General and administrative expenses were $4.6 million, an increase of $0.4 million for the three months ended June 30, 2021, compared to the same period in 2020, primarily due to increases of $0.6 million in personnel-related expenses, of which $0.9 million relates to severance expense recorded for the departure of our former CFO, Carl W. Langren on June 30, 2021 and $0.5 million in stock compensation expenses, of which $0.4 million relates to the accelerated vesting of all non-vested equity awards held by Mr. Langren upon his departure. These increases were offset by a $0.4 million decrease in legal and consulting expenses and a $0.3 million reduction in operating expenses for insurance, rent, supplies, and depreciation.
Net Loss – The net loss for the second quarter ended June 30, 2021 was $8.7 million compared to net loss of $5.4 million for the same period in 2020.
Lumos Pharma ended Q2 2021 with 8,357,391 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 11:00 a.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question-and-answer session following management’s prepared remarks.
Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at View Source in the "Investors & Media" section under "Events and Presentations" or through this link: View Source To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 8050625. The replay will be available for two weeks from the date of the call.