Sierra Oncology Reports 2021 Year End Results

On March 10, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported its financial and operating results for the fourth quarter and fiscal year ended December 31, 2021 (Press release, Sierra Oncology, MAR 10, 2022, View Source [SID1234609925]).

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"Last year was a great year for Sierra. We accelerated timelines in the midst of a global pandemic to over enroll the pivotal MOMENTUM clinical trial, achieving statistical significance in the primary and all pre-specified secondary endpoints. This year, we’ll be focused on our regulatory submission and the continued build out of our commercial team to prepare for the anticipated approval of momelotinib in early 2023," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology. "Financially, we are in a strong position to support ongoing pre-commercialization activities for momelotinib, and continued development of our myelofibrosis franchise with a combination study of momelotinib and our novel BET inhibitor, SRA515."

The pivotal Phase 3 MOMENTUM clinical trial enrolled 195 symptomatic and anemic myelofibrosis patients previously treated with an approved JAK inhibitor. Data from this study, as well as previous data from the SIMPLIFY-1 and SIMPLIFY-2 Phase 3 studies, will serve as the foundation for the submission of a New Drug Application to the US Food & Drug Administration in the second quarter of 2022. If approved, the company anticipates momelotinib being commercially available early in the first half of 2023.

Key 2021 and Recent Business Highlights

Momelotinib achieved positive topline results in the pivotal Phase 3 MOMENTUM clinical trial for myelofibrosis, reporting a statistically significant benefit on symptoms, anemia and splenic size. The company plans to submit a New Drug Application with the US Food & Drug Administration in the second quarter of this year.
Sierra had cash and cash equivalents of $104.7 million as of December 31,2021 and has significantly strengthened its financial position during the first quarter of 2022 by raising a total of $155.3 million in gross proceeds from a public equity offering, and securing a debt facility with Oxford Finance, LLC for up to $125.0 million. Under the terms of the loan agreement, Sierra drew an initial $5.0 million at closing and has the ability to access up to an additional $120 million in a series of tranches (of which $50.0 million is at the discretion of the lender). Also, the company received proceeds of $30.5 million from the cash exercise of Series B warrants. The outstanding Series B warrants will expire on April 10, 2022, and if fully exercised would provide an additional $2.8 million in proceeds to the company. Additionally, in connection with a previously issued securities purchase agreement to Gilead, the related warrant was exercised, providing $9.6 million of proceeds to the company.
On January 19, 2022, the Journal of Hematology and Oncology published a review article on momelotinib, titled "Momelotinib: an emerging treatment for myelofibrosis patients with anemia." The article highlights the use of momelotinib for the potential treatment of myelofibrosis patients who are anemic based on published data from the SIMPLIFY studies as well as earlier Phase 2 studies. The full article is available for review here.
An exclusive global in-licensing agreement for SRA515 (formerly AZD5153), a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode, was announced on August 5, 2021. The initiation of a Phase 2 study examining momelotinib in combination with SRA515 for the treatment of myelofibrosis is planned for the first half of 2022.
Year End 2021 Financial Results

Research and development expenses were $67.2 million for the year ended December 31, 2021, compared to $45.1 million for the year ended December 31, 2020. The increase was attributable to a $9.1 million increase in personnel-related and allocated overhead costs primarily due to headcount additions to support the continued development and preparation for the regulatory submission of momelotinib. Also attributing to the increase was an upfront cash payment of $8.0 million that was made to AstraZeneca for the exclusive global license of SRA515, and external costs for momelotinib, including a $4.4 million increase in third-party manufacturing costs primarily pertaining to the production of pre-approval inventory and a $2.2 million increase in clinical trial and development costs primarily pertaining to the MOMENTUM clinical trial and the related preparation for regulatory submission. These increases were partially offset by a $1.5 million non-cash charge incurred in 2020 to recognize the change in fair value of an obligation to issue securities to Gilead until the issuance of the securities in January 2020 and a $0.2 million decrease in costs for SRA737. Research and development expenses included non-cash stock-based compensation of $7.2 million and $4.3 million for the year ended December 31, 2021 and 2020, respectively.

General and administrative expenses were $27.4 million for the year ended December 31, 2021, compared to $20.1 million for the year ended December 31, 2020. The increase was due to a $4.9 million increase in personnel-related and allocated overhead costs primarily due to headcount additions for the expansion and the continued buildout of our infrastructure to support our potential commercialization efforts, including the establishment of key commercial functions such as marketing and market access. Also attributing to the increase in expense was an increase of $2.4 million in professional fees primarily relating to pre-commercial costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $5.7 million and $5.2 million for the year ended December 31, 2021 and 2020, respectively.

Total other expense (income), net was $0.1 million of total other expense, net for the year ended December 31, 2021, compared to $15.8 million of total other expense, net for the year ended December 31, 2020. The difference was primarily attributable to a non-cash charge of $16.2 million incurred during the year ended December 31, 2020, related to the change in fair value of warrant liabilities until the reclassification to equity in January 2020.

For the year ended December 31, 2021, Sierra incurred a Generally Accepted Accounting Principles (GAAP) net loss of $94.7 million compared to a GAAP net loss of $80.9 million for the year ended December 31, 2020. The GAAP net loss for the year ended December 31, 2021 includes an upfront cash payment of $8.0 million that was made to AstraZeneca for the exclusive global license of SRA515. The GAAP net loss for the year ended December 31, 2020, includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in total other expense (income), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

Non-GAAP adjusted net loss was $81.8 million for the year ended December 31, 2021, compared with a non-GAAP adjusted net loss of $53.7 million for the year ended December 31, 2020. Non-GAAP adjusted net loss for the year ended December 31, 2021 and 2020 excludes expenses related to stock-based compensation. For the year ended December 31, 2020, non-GAAP net loss also excludes expenses related to the change in fair value of warrant liabilities and the change in fair value of the securities issuance obligation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP measure to non-GAAP financial measure.

Cash and cash equivalents totaled $104.7 million as of December 31, 2021, compared to $104.1 million as of December 31, 2020.

As of December 31, 2021, there were 15,571,656 total shares of common stock outstanding and warrants to purchase 11,040,894 shares of common stock, with an exercise price equal to $13.20 per share. There were 4,937,189 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

Recent Financial Highlights

On January 31, 2022, the company completed an underwritten public offering of 4,074,075 shares of common stock and pre-funded warrants to purchase up to 925,925 shares of common stock. As part of the underwritten public offering, on February 3, 2022, the company issued an additional 750,000 shares of common stock representing the underwriters’ full exercise of their over-allotment option. The shares of common stock and the pre-funded warrants were offered by the company at a price to the public of $27.00 and $26.999 per share, respectively. The aggregate net proceeds received by the company from the offering were $145.6 million, net of underwriting discounts and commissions and estimated offering expenses of $9.7 million.

In the first quarter of 2022, the company has issued 18,937, 2,312,257 and 725,283 shares of common stock pertaining to the cash exercise of Series A warrants, Series B warrants, and the previously issued warrant related to a securities purchase agreement, respectively, providing proceeds to the company of $40.3 million. As of March 7, 2022, there were 23,665,100 shares of common stock outstanding and 925,925 pre-funded warrants to purchase shares of common stock. There were Series B warrants with an exercise price of $13.20 to purchase 212,477 shares of common stock which expire on April 10, 2022, and if exercised in full would provide $2.8 million of additional proceeds to the company. In addition, there were Series A warrants that contain a cash and/or cashless exercise provision to purchase 7,791,951 shares of common stock, with an exercise price equal to $13.20 per share. Additionally, there were 4,871,157 shares of common stock issuable upon exercise of stock options and a warrant.

Oncternal Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2021 Financial Results

On March 10, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that fourth quarter and full year 2021 financial results (Press release, Oncternal Therapeutics, MAR 10, 2022, View Source [SID1234609951]).

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"This past year was a decisive one for Oncternal, as we reached consensus with the FDA on our Phase 3 clinical trial ZILO-301 of zilovertamab in patients with MCL, advanced our ROR1-targeting CAR-T cell therapy candidate ONCT-808 towards IND submission, and initiated IND-enabling studies for ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are focusing our resources on hematological malignancies and prostate cancer, areas of high unmet patient need where we believe our potentially first-in-class or best-in-class product candidates can make the greatest difference. We believe our strong balance sheet will enable us to advance these programs into mid-2023, as we navigate a historically challenging macro environment."

Recent Highlights

In January 2022, we announced that we reached consensus with the FDA on the design and major details of the Phase 3 Study ZILO-301 to treat patients with relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib. The agency also provided positive feedback on the proposed key clinical and regulatory requirements of our development program for zilovertamab in patients with MCL.

In December 2021, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial of zilovertamab in combination with ibrutinib for patients with MCL and chronic lymphocytic leukemia (CLL) [NCT03088878] at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 Virtual Annual Meeting.

Objective response rate (ORR) of 81% (21 of 26 evaluable patients) observed for patients with MCL treated with zilovertamab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy

Complete response (CR) rate of 35% for MCL patients treated with zilovertamab plus ibrutinib (9 of 26 evaluable patients), which compares favorably to the historical ORR of 20% for ibrutinib monotherapy, and with CRs remaining durable for up to 32 months

Median progression-free survival (PFS) of 35.9 months for MCL patients with median follow-up of 14.4 months, which compares favorably to the historical ibrutinib monotherapy median PFS of 12.8 months

Landmark PFS of 100% at 36 months for CLL patients who had previously received one or two prior lines of therapy, which compares favorably to historical ibrutinib monotherapy PFS of ~ 75%

Median PFS had not been reached for CLL patients with one or two prior lines of therapy, and median PFS was 36.1 months for patients receiving > 2 prior lines of therapy, with a median follow-up of 29.0 months

The combination of zilovertamab and ibrutinib continued to be well tolerated, with a safety profile consistent with or improved compared with historical data for ibrutinib monotherapy

In November 2021, we announced joining the Karolinska Institutet’s NextGenNK Competence Center to support our next generation ROR1-targeted cell therapy initiatives, and the establishment of a Cell Therapy Scientific Advisory Board, comprised of industry and academic leaders in the cell therapy field.

In October 2021, we presented encouraging preclinical data with ONCT-534, the lead candidate in our preclinical dual-action androgen receptor inhibitor (DAARI) program, during a virtual poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual

International Conference on Molecular Targets showing anti-tumor activity in preclinical studies relevant to important tumor resistance mechanisms, including those involving expression of the androgen receptor splice variant (AR-V7).

In November 2021, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial evaluating ONCT-216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma [CT02657005] at the Connective Tissue Oncology Society 2021 Virtual Annual Meeting. Two patients continue to demonstrate durable complete responses, including one patient with a durable CR for 24 months on treatment, and no evidence of disease off treatment after several months.

Expected Upcoming Milestones

Zilovertamab (ROR1 antibody) program

Initiation of global registrational Phase 3 Study ZILO-301 in the second quarter of 2022

Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study in the second quarter of 2022

Have a Phase 1b investigator sponsored trial of zilovertamab plus docetaxel initiated for patients with metastatic castration-resistant prostate cancer (mCRPC) in mid-2022

ONCT-808, lead candidate in autologous ROR1-targeted CAR-T cell therapy program

Investigational New Drug (IND) application submission in mid-2022

ONCT-534, lead candidate in our DAARI program

IND-enabling GLP toxicology studies and GMP manufacturing initiated in the second quarter of 2022

ONCT-216 (ETS inhibitor) program

Updated interim clinical data for patients with Ewing sarcoma treated in the dose intensified expansion cohort in the fourth quarter of 2022

Fourth Quarter and Full Year 2021 Financial Results

Our grant revenue was $0.6 million for the fourth quarter ended December 31, 2021. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH). For the full year 2021, grant revenue was $4.3 million.

Our total operating expenses for the fourth quarter ended December 31, 2021 were $8.6 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.0 million, and general and administrative expenses for the quarter totaled $2.6 million. Net loss for the fourth quarter was $8.1 million, or a loss of $0.16 per share, basic and diluted. For the full year 2021, total operating expenses were $35.7 million, including $5.9 million in non-cash stock-based compensation expense, and our net loss was $31.3 million, or a loss of $0.64 per share, basic and diluted.

As of December 31, 2021, we had approximately 49.4 million shares of common stock outstanding. $90.8 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations into mid-2023. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.

TRACON Pharmaceuticals Announces FDA Approval of Amended ENVASARC Protocol

On March 10, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the United States, reported that the first patient has been dosed following the approval of the amended ENVASARC protocol by the U.S. Food and Drug Administration ("FDA") (Press release, Tracon Pharmaceuticals, MAR 10, 2022, View Source [SID1234609854]).

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In December 2021, based on the highly tolerable safety profile and the significantly higher objective response rate (ORR) observed in lower weight patients in ENVASARC, the IDMC recommended increasing the dose of envafolimab to 600 mg every three weeks (Q3W), which is double the original envafolimab dose of 300 mg Q3W. Given the robust activity demonstrated by higher doses of envafolimab in previously completed studies, including in the pivotal trial in MSI-H/dMMR cancer that was the basis for approval of envafolimab in China, TRACON submitted the amended ENVASARC protocol in January that was cleared by the FDA in February. Patient dosing is now underway at this 600 mg Q3W dose.

"We are pleased to have initiated envafolimab dosing at 600 mg following FDA approval of the amended ENVASARC protocol," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Given the ENVASARC data to date, particularly the highly tolerable safety profile and response rate in lower weight patients, we believe a doubling of the dose will be well tolerated and result in higher envafolimab exposures, thereby optimizing envafolimab’s efficacy for the largest number of sarcoma patients. The new envafolimab dose is higher than the dose that produced the 45% ORR in MSI-H/dMMR cancer that was the basis for approval in China. We look forward to the interim ENVASARC efficacy data review by the IDMC which we expect will occur in the second half of 2022."

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first subcutaneously injected PD-(L)1 inhibitor approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is overall response rate by central review with duration of response a key secondary endpoint.

Amgen To Present At The 32nd annual Oppenheimer Healthcare Conference

On March 10, 2022 Amgen (NASDAQ:AMGN) reported that it will virtually present at the 32nd Annual Oppenheimer Healthcare Conference at 11:20 a.m. ET on Wednesday, March 16, 2022 (Press release, Amgen, MAR 10, 2022, View Source [SID1234609877]). Rob Lenz, M.D., Ph.D., senior vice president of Global Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference . The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Lumos Pharma Reports Full Year 2021 Financial Results and Announces Plan to Perform Interim Analyses of OraGrowtH Trials

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.