On March 10, 2022 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported that financial results for the year ended December 31, 2021, announced plans to conduct interim analyses of its OraGrowtH210 and OraGrowtH212 Trials, and provided an update on clinical activities and financial guidance for 2022 (Press release, NewLink Genetics, MAR 10, 2022, View Source [SID1234609893]).

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"We are excited to announce that we plan to conduct interim analyses on two of our OraGrowtH Trials evaluating orally administered LUM-201 in PGHD," commented Rick Hawkins, Chairman and CEO of Lumos Pharma. "With continued positive trends in screening and enrollment, we wanted to provide interim clinical and safety data from our OraGrowtH210 and OraGrowtH212 Trials in order to offer an early look at the potential for LUM-201 to treat idiopathic PGHD patients who would otherwise face years of burdensome injections as their only course of treatment. Based upon prior trials of growth hormone in PGHD, we believe these data should be adequate to provide an initial indication of LUM-201’s impact on height velocity compared to growth hormone."

Clinical and Business Updates

•Phase 2 OraGrowtH210 Trial of Oral LUM-201 in PGHD – Approaching 50% Enrollment, Interim Analysis Planned
•We are approaching the 50% enrollment milestone for the OraGrowtH210 Trial, and as a result we anticipate reporting top line data from an interim analysis by the end of 2022. The interim analysis will evaluate the safety and annualized height velocity at three dose levels of LUM-201 against a standard dose of injectable recombinant human growth hormone (rhGH) in 40 subjects at six months on therapy.
•The Phase 2 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 PGHD, which is less severe than organic PGHD, when fully enrolled. 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.
•Due to the ongoing conflict between Ukraine and Russia and the resulting uncertainty in the region, we are unable to enroll patients in Ukraine, and all of our clinical sites in both Ukraine and Russia are suspended until further notice. No patients had been randomized to treatment in the clinical trial at any of our nine sites in Ukraine and Russia. Given the encouraging screening and enrollment trajectory at our other clinical sites, we continue to anticipate the 6-month primary outcome data on all 80 subjects in the second half of 2023. The ongoing conflict may, however, adversely impact our business in the future, and it remains too early to evaluate the potential effects of this crisis.

Exhibit 99.1

•OraGrowtH212 Trial to Evaluate PK/PD and Pulsatility of Oral LUM-201 in PGHD – Interim Analysis Planned
•The OraGrowtH212 Trial continues to enroll, with an interim analysis to evaluate the safety and height velocity data anticipated by the end of 2022. Enrollment in the trial is approaching the minimum number of 10 patients for the interim analysis.
•The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of LUM-201 in up to 24 PGHD patients at two dose levels, 1.6 and 3.2 mg/kg/day. The objective of the OraGrowtH212 Trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone unique to LUM-201 and its potential for this mechanism of action to contribute to efficacy in PGHD. The primary endpoint is six months of PK/PD and height velocity data, with a total of 12 months of height velocity data to be captured.

•Switch Study, OraGrowtH213 Trial, in PGHD – Initiated
•We initiated our OraGrowtH213 Trial, an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of orally administered LUM-201 following 12 months of daily injectable rhGH in up to 20 PGHD subjects 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.

Financial Results for the Year Ended December 31, 2021

•Cash Position – Lumos Pharma ended the year on December 31, 2021, with cash and cash equivalents totaling $94.8 million compared to $98.7 million on December 31, 2020. The Company expects an average cash use of approximately $8.5 to $9.5 million per quarter through 2022. Cash on hand as of year-end 2021 is expected to support operations through the primary outcome data readout from our OraGrowtH210 and OraGrowtH212 Trials anticipated in the second half of 2023.
•R&D Expenses – Research and development expenses were $16.2 million, an increase of $7.0 million for the year ended December 31, 2021 compared to the same period in 2020, primarily due to increases of $5.5 million in clinical trial and contract manufacturing expenses, $2.0 million in personnel-related expenses and $0.7 million in stock compensation expenses, offset by decreases of $0.3 million in legal and consulting expenses, $0.4 million in operating expenses for supplies, depreciation, and rent, and $0.5 million in other expenses.
•G&A Expenses – General and administrative expenses were $15.3 million, a decrease of $1.9 million for the year ended December 31, 2021, as compared to the same period in 2020, primarily due to decreases of $1.9 million in legal and consulting expenses, which were higher in 2020 due to merger-related expenses, $1.1 million in personnel-related expenses, and $0.5 million in operating expenses for rent, supplies, and depreciation, offset by increases of $1.0 million in stock compensation expense and $0.6 million in traveling, licensing, and other expenses.
•Net Loss – The net loss for the year ended December 31, 2021 was $30.4 million compared to a net loss of $5.7 million for the same period in 2020.
•Lumos Pharma ended Q4 2021 with 8,357,391 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 (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

Exhibit 99.1

dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 9248229. The replay will be available for two weeks from the date of the call.