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.

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.

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.

On March 10, 2022 XOMA Corporation (Nasdaq: XOMA), a biotechnology royalty aggregator playing a distinctive role in helping companies achieve their goal of improving human health, reported its Chairman and Chief Executive Officer, Jim Neal, will present at Oppenheimer’s 32nd Annual Healthcare Conference (virtual) on Thursday, March 17, 2022, at 12:40 PM ET (Press release, Xoma, MAR 10, 2022, View Source [SID1234609910]).

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The presentation can be accessed at https://bit.ly/3truAX8 or by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the presentation will be available and archived on the site for 90 days after the event.

On March 10, 2022 BioCurity, a preclinical biotech company focused on developing novel mechanism-based nanoparticle drugs designed to transform radiation therapy for cancer patients worldwide, reported the Company’s presentation at the American College of Radiation Oncology (ACRO) 2022 Summit on March 11, 2022, from 12:00-1:00pm EST at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, Florida (Press release, BioCurity Pharmaceuticals, MAR 10, 2022, View Source [SID1234609926]). Details of the presentations are as follows:

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Title: Harnessing Cerium Oxide Nanoparticles Combined with Tolfenamic Acid to Sensitize Head and Neck Cancer to Radiation
Session: Poster Walk with Professors – Bonnet
Presenter: Cheryl Baker, PhD, Scientific Co-Founder, BioCurity

The agenda for the ACRO 2022 Summit can be found here.

"Our IV and topical drug candidate consistent with positive preclinical data in lead indications such as head and neck, lung, and breast cancer was demonstrated to prevent radiation side effects without impairing the effectiveness of radiation killing cancer cells and shrinking tumors. BioCurity’s discovery could have a material positive impact for the millions of cancer patients that undergo radiation therapy annually. Approximately 70% of head and neck cancer patients treated with radiation therapy will develop severe oral mucositis, limiting their ability to eat or drink. We look forward to sharing our positive preclinical data with the leaders in radiation oncology at ACRO this week," said Dr. Cheryl Baker, PhD, Scientific Co-Founder, and a Board Member of BioCurity.

About Cerium Oxide Nanoparticles

The production of hydrogen peroxide, a Reactive Oxygen Species (ROS) from radiation is a critical function for how radiation damages the DNA of cells of the tissue it passes through. BioCurity’s cerium oxide nanoparticles possess fast catalase activity in a normal tissue’s neutral pH environment and reduces radiation-induced hydrogen peroxide to molecular oxygen, thereby preventing radiation damage of normal tissue. BioCurity’s cerium oxide nanoparticles also possess superoxide dismutase activity in a cancerous tissue’s acidic pH environment and converts superoxide to hydrogen peroxide, thereby enhancing radiation-induced ROS damage of cancerous tissue.

BioCurity’s extensive preclinical studies in models of head and neck, lung, breast, pancreatic, prostate, and colorectal cancer show cerium oxide nanoparticles are regenerative and are not consumed in the reaction. Administration of cerium oxide nanoparticles at 1,000 times the effective dose did not produce toxicity in a small animal model.