On August 9, 2022 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported financial results for the quarter ended June 30, 2022 (Press release, Lumos Pharma, AUG 9, 2022, View Source [SID1234618011]).
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"During our second quarter of 2022 we continued to execute on our clinical programs evaluating orally administered LUM-201 in PGHD and are delighted to reaffirm our commitment to announcing interim data for our OraGrowtH210 and OraGrowtH212 Trials by the end of this year," said Rick Hawkins, Chairman and CEO of Lumos Pharma. "Additionally, we continue to be pleased with our enrollment trends and now expect to release primary outcome data from both OraGrowtH Trials in the second half of 2023. We also continue to support our collaboration with Mass General on an investigator-initiated trial evaluating LUM-201 in NAFLD, which is now prescreening subjects. We look forward to advancing these programs and to the release of interim data from our OraGrowtH Trials later this year."
Recent Highlights
Interim analyses for Phase 2 OraGrowtH210 and PK/PD OraGrowtH212 Trials by end of 2022. Both the OraGrowtH210 and OraGrowtH212 Trials in subjects with idiopathic, Predictive Enrichment Marker-(PEM)-positive Pediatric Growth Hormone Deficiency (PGHD) are progressing well, and we confirm our plan to conduct interim analyses in Q4. We believe the interim data should provide an early indication of efficacy and safety of oral LUM-201 versus standard of care daily recombinant human growth hormone (rhGH) injections in idiopathic PGHD. In addition, we are progressing toward full enrollment of both trials, enabling a readout of our primary outcome data on 80 subjects from the OraGrowtH210 Trial in the second half of 2023. The OraGrowtH212 Trial has recently been extended to follow subjects to near adult height. The primary outcome data for this trial on up to 24 subjects is now expected in the second half of 2023, concurrent with the OraGrowtH210 Trial. Our trials are being conducted in the idiopathic subset of the PGHD population, and prior studies demonstrate a slower growth trajectory on rhGH in this subset. Therefore, the appropriate yardstick for growth on LUM-201 in the OraGrowtH210 Trial is the growth on rhGH in the control arm of this trial, not the growth in other trials that typically enroll more severely growth hormone deficient subjects. Baseline characteristics will determine whether we combine the annualized height velocity (AHV) data from both trial datasets at the interim and final analyses.
Prescreening continues in Massachusetts General Investigator-Initiated Trial evaluating LUM-201 in NAFLD. As previously announced, we entered into a clinical collaboration with Dr. Laura Dichtel and Massachusetts General Hospital to explore the potential of LUM-201 in Nonalcoholic Fatty Liver Disease (NAFLD) in an investigator sponsored pilot study. Prescreening in the trial is ongoing, and we expect this trial to begin enrollment in the near future. While we remain focused on our core LUM-201 program in PGHD, we are pleased to support Mass General’s exploration of LUM-201’s potential in this indication, a condition estimated to be prevalent in approximately 25% of adults worldwide. NAFLD can often advance to the more serious liver disease non-alcoholic steatohepatitis (NASH) with fibrosis, and NASH-associated liver failure is one of the leading causes of liver transplants in the United States.
Financial Results for the Quarter Ended June 30, 2022
Cash Position – Lumos Pharma ended the quarter on June 30, 2022 with cash and cash equivalents totaling $79.5 million compared to $94.8 million on December 31, 2021. The Company expects an average cash use of approximately $8.5 to $9.5 million per quarter through 2022. Cash on hand as of June 30, 2022 is expected to support operations into the second quarter of 2024, inclusive of the primary outcome data readout from OraGrowtH210 and OraGrowtH212 Trials anticipated in the second half of 2023.
R&D Expenses – Research and development expenses were $4.6 million for the quarter ended June 30, 2022, an increase compared to $4.1 million for the same period in 2021, primarily due to an increase of $0.3 million in personnel and stock option expense and $0.3 million in legal and consulting expenses, offset by a decrease of $0.1 million in clinical trial and contract manufacturing expenses.
G&A Expenses – General and administrative expenses were $3.7 million for the quarter ended June 30, 2022, a decrease as compared to $4.6 million for the same period in 2021, primarily due to decreases of $0.6 million in personnel-related expenses, $0.4 million in stock compensation expenses and $0.3 million in legal and other expenses, offset by an increase of $0.3 million in royalty expenses.
Net Loss – The net loss for the quarter ended June 30, 2022 was $7.8 million compared to net loss of $8.7 million for the same period in 2021.
Lumos Pharma ended the second quarter 2022 with 8,377,567 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical programs. 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 (833) 634-2295 (U.S.) or (412) 902-4176 (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 (877) 344-7529 (U.S.) or (412) 317-0088 (international) and using the passcode 1602592. The replay will be available for two weeks from the date of the call.
About Lumos Pharma’s Clinical Trials
Phase 2 OraGrowtH210 Trial of Oral LUM-201 in PGHD
The OraGrowtH210 Trial is a multi-site, global trial evaluating orally administered LUM-201 at three dose levels (0.8, 1.6, 3.2 mg/kg/day) against a standard dose of injectable rhGH in approximately 80 subjects diagnosed with idiopathic (moderate) PGHD, which is less severe than organic PGHD. The objective of this trial is to identify the optimal dose of LUM-201 to be used in a Phase 3 registration trial, based on annualized height velocity from a 6-month dataset, and to prospectively confirm the preliminary validation of our Predictive Enrichment Marker (PEM) strategy. The interim analysis will evaluate the safety and annualized height velocity of the three dose levels of LUM-201 against a standard dose (0.24 mg/kg/week, dosed daily) of injectable recombinant human growth hormone (rhGH) in a minimum of 40 subjects at six months on therapy. The complete set of 6-month, primary outcome data for 80 patients is anticipated in the second half of 2023. Subjects will be dosed for a total of 24 months.
OraGrowtH212 Trial Evaluating PK/PD and Pulsatility of Oral LUM-201 in PGHD
The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of oral LUM-201 in up to 24 PGHD subjects at two dose levels, 1.6 and 3.2 mg/kg/day. The primary objective of the OraGrowtH212 Trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone from LUM-201 therapy, contributes to its efficacy in PGHD. The primary endpoint for this trial is six months of PK/PD (pulsatility) and height velocity data in up to 24 subjects. Subjects will be allowed to remain on treatment until they reach a bone age of 14 for females and 16 for males reflecting near-adult height. Primary data readout in up to 24 patients is anticipated in the second half of 2023.
Switch Study, OraGrowtH213 Trial, Evaluating LUM-201 in OraGrowtH210 Subjects Previously on rhGH
The OraGrowtH213 Trial is an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of LUM-201 following 12 months of daily rhGH in up to 20 idiopathic PGHD patients who have completed the OraGrowtH210 Trial. Subjects will be administered LUM-201 at a dose level of 3.2 mg/kg/day for up to 12 months.
Lumos Pharma Collaboration with Massachusetts General Hospital Evaluating LUM-201 in NAFLD
Lumos Pharma has entered a collaboration with Massachusetts General Hospital (MGH) to evaluate LUM-201 in patients with nonalcoholic fatty liver disease (NAFLD). GH is a critical stimulator of lipolysis, and shows anti-inflammatory effects, and preclinical data suggest that amplifying GH secretion has the potential to reduce hepatic steatosis and prevent NAFLD progression. Interestingly, enhancing the natural pulsatile release of GH has been shown clinically in short-term studies to be more efficacious in inducing lipolysis than continuous infusions of GH. This MGH investigator-initiated trial is a single-site, 6-month, open-label pilot study of daily oral LUM-201 in adults with NAFLD. The trial will evaluate a dose of 25 mg/day of LUM-201 in 10 subjects with NAFLD and relative IGF-1 deficiency. The primary endpoints will be to determine the reduction in liver lipid content, inflammation, and fibrosis in these subjects administered LUM-201 compared to each subject’s baseline.