On May 28, 2020 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases reported its financial results for the first quarter ended March 31, 2020 and provided an update on clinical activities (Press release, NewLink Genetics, MAY 28, 2020, View Source [SID1234558622]).

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"This has been an exciting and busy time for Lumos Pharma," commented Rick Hawkins, Chairman, CEO and President. "With the recent close of our merger, the Company continues to execute its strategy to develop its oral therapeutic candidate, LUM-201, for pediatric growth hormone deficiency. Furthermore, we are now engaging in activities that we hope will lead to the expansion of our pipeline through the licensure of other rare disease assets. While we acknowledge that the worldwide coronavirus pandemic will adversely impact the conduct of our Phase 2b clinical trial, with our strong balance sheet and expected non-dilutive funds from the monetization of our priority review voucher, we believe Lumos Pharma is well positioned to execute on our clinical and business development plans."

Clinical Update and COVID-19 Impact
Phase 2b trial of LUM-201 in Pediatric Growth Hormone Deficiency (PGHD) – Lumos Pharma continues to prioritize the clinical development of LUM-201, its orally administered therapeutic candidate for a subset of children with PGHD. The Company is proceeding with the necessary steps to initiate this trial, from site preparation through readying the clinical drug supply. The coronavirus pandemic, however, has caused pervasive interruptions to clinical trials industrywide. Facing similar near-term impediments, the Company now expects to initiate its Phase 2b clinical trial in PGHD prior to the end of 2020 with the possibility of further delays should the pandemic persist.
Pipeline Expansion – The Company is also actively pursuing other business development opportunities to expand its rare disease portfolio. With an experienced team in place, we believe we are well-positioned to be successful in our pursuit of opportunities to expand our pipeline and build shareholder value.

Corporate Update
Completion of Merger – On March 18, 2020, the merger of privately held Lumos Pharma, Inc. with publicly listed NewLink Genetics Corporation was completed, and a 1-for-9 reverse stock split was effected, upon an overwhelmingly favorable vote by the stockholders of NewLink Genetics. In conjunction with the transaction, NewLink Genetics assumed the name Lumos Pharma, Inc. and on March 19, 2020 began trading on the Nasdaq under the symbol "LUMO."

New Board of Directors Formed – Upon the completion of the merger, the new Board of Directors of Lumos Pharma, Inc. was formed. Members include Rick Hawkins, CEO; Emmett T. Cunningham, Jr., M.D., Ph.D., Senior Managing Director, Blackstone Life Sciences group; Kevin Lalande, Co-founder and Managing Director, Santé Ventures; Lota S. Zoth, Chairman, Zymeworks and former CFO, MedImmune; Thomas A. Raffin, M.D., co-founder and partner, Telegraph Hill Partners and Professor Emeritus, Stanford School of Medicine; and Chad Johnson, General Counsel, Stine Seed Company. Subsequently, the Board named Rick Hawkins Chairman along with President and CEO and

Exhibit 99.1

appointed its seventh member, Joseph S. McCracken, DVM, MS, currently a director on the boards of Savara, Inc. and Kindred Biosciences.
Executive Team Strengthened – Just after the close of Q1, John McKew, PhD, was promoted to the position of Chief Operating Officer and Chief Scientific Officer. Dr. McKew has twenty-seven years of public and private sector experience developing novel therapeutics where he successfully advanced therapies through preclinical and into clinical development. In addition, on May 6, 2020, Aaron Schuchart joined Lumos Pharma as its Chief Business Officer where he will support the Company’s strategy of expanding its pipeline through the addition of other assets. Aaron Schuchart has over twenty years of experience in key leadership roles for both large multinationals and small biotech companies, including Amgen, Novartis Diagnostics/Grifols, and Coherus Biosciences.
Financial Results for the Three-Month Period Ended March 31, 2020 and Updated Cash Guidance
The Coronavirus Aid, Relief, and Economic Security (CARES) Act: To respond to the devastating effect the coronavirus pandemic has had on businesses worldwide, on March 27, 2020, Congress passed The CARES Act to provide rapid financial assistance to American workers, families, and businesses. As a result, the Company’s Q1 2020 financial results include a tax benefit of $4.5 million resulting from changes in the treatment of tax net operating losses under the provisions of The CARES Act and the refund the Company anticipates receiving.
Cash Position: Lumos Pharma ended the quarter on March 31, 2020, with cash and cash equivalents totaling $85.8 million compared to $5.0 million December 31, 2019 and pro forma December 31, 2019 cash of $95.5 million. The Company expects its cash on hand is sufficient to fund current operations through the Phase 2b LUM-201 trial read-out.
R&D Expenses: Research and development expenses for the three months ended March 31, 2020 were $1.9 million, an increase of $450,000 from $1.5 million for the same period in 2019. The increase is primarily due to additional expenses incurred as a result of the Merger including the write-off of the acquired NewLink in-process research and development of $426,000, increase of $84,000 in personnel-related and stock compensation expense, and an increase of $68,000 in equipment and supplies expense, offset by a decrease in research and development consulting of $128,000.
G&A Expenses: General and administrative expenses for the three months ended March 31, 2020 were $3.3 million, an increase of $2.6 million from $683,000 for the same period in 2019. The increase was due primarily to increases of $1.6 million in legal and professional fees incurred mainly related to the Merger, $663,000 in personnel-related expense, $295,000 due to increased operating expenses for rent, supplies, and depreciation and $91,000 due to insurance.
Net Income (Loss): The net income for the three months ended March 31, 2020 was $340,000 compared to a net loss of $2.1 million for the same period in 2019.
Lumos Pharma ended Q1 2020 with 8,292,803 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 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 www.lumos-pharma.com 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 9129999. The replay will be available for two weeks from the date of the call.

On May 28, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) for treating all stages of cancer, reported a clinical collaboration with Merck (known as MSD outside the U.S. and Canada) to evaluate the safety and efficacy of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with BgRT in multiple late-stage cancers, including non-small cell lung cancer (NSCLC), in two randomized controlled clinical trials (Press release, RefleXion Medical, MAY 28, 2020, View Source [SID1234558638]).

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"It is exciting to see these companies from different fields collaborating to investigate immuno-radiotherapy approaches for patients with metastatic cancer," said Jason Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center and associate professor of medicine at the University of Pittsburgh School of Medicine. "Several published clinical and translational studies laid the foundation for combining immunotherapy and radiotherapy, but despite their promise, available conventional radiotherapy techniques are limited in their general ability to reach more than 1-2 tumors.

"We hypothesize that BgRT may improve treatment efficacy and expand the immunologic impact of therapy by overcoming this limitation and treating more tumors," continued Dr. Luke. "This expanded treatment potential allows the field to pose new questions such as: What outcomes can combination therapy achieve when BgRT treats 5, 10 or even more sites of disease?"

This clinical collaboration reflects interest by researchers, clinicians and industry in exploring external beam radiotherapy to potentially expand the application of immunotherapy and improve outcomes for patients with advanced-stage cancer. Worldwide, over 1,000 clinical trials registered with the National Institutes of Health seek to determine the effect of combining immunotherapy and radiotherapy. Currently, very few of these trials reflect collaboration between radiotherapy and pharmaceutical companies.1

The aim of the clinical collaboration between RefleXion and Merck is to establish whether treating multiple tumors with BgRT, a novel external beam radiotherapy treatment modality in development, is safe and amplifies KEYTRUDA’s therapeutic effect. The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that restrict radiotherapy delivery to one or two sites of disease, and instead allow it to reach multiple sites during the same treatment session, even those sites that move due to breathing or digestion.

"We believe BgRT will one day treat all visible tumor sites, which could lead to better patient outcomes, particularly when used with immunotherapy," said Todd Powell, CEO and president of RefleXion. "The collaboration with Merck will allow us to explore this combined effect in randomized controlled clinical trials that, if successful, may lead to significant changes in the way physicians approach cancer care for patients with late-stage disease."

RefleXion recently announced the close of a $100M equity financing round, the sale of their first commercial system and FDA clearance for the X1 machine for conventional radiotherapy applications. The X1 is the only platform that includes high quality computed tomography (CT) imaging to reduce motion artifacts during patient setup and x-ray treatment delivery, resulting in accurate targeting of the radiation dose to a patient’s tumor.

About Combining Immunotherapy and External Beam Radiotherapy

External Beam Radiotherapy (EBRT) by itself treats a discrete target to provide local tumor control; however, clinical evidence suggests that EBRT potentially converts the locally radiated tumor into an in situ vaccine that contributes to systemic control of the cancer.2 The exploration of EBRT with immunotherapy began in earnest after a rapid succession of advances led to a corresponding acceleration of clinical trials and FDA approvals of different drugs for various cancer indications. Ongoing clinical trials for this combined approach are aimed at confirming safety and demonstrating clinical efficacy, determining the appropriate dosing and sequencing of each treatment, and developing biomarkers to identify the patients most likely to benefit.3

On May 28, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that warrants to purchase approximately 5.4 million shares of common stock issued in connection with capital raises in May 2018 and November 2019 with two institutional investors have been exercised at a price of $0.46 per share, resulting in cash proceeds of approximately $2.5 million to the Company (Press release, Genprex, MAY 28, 2020, View Source [SID1234558605]). The warrants were exercised on or about May 22, 2020, the first day they became exercisable under the terms of their respective agreements.

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The exercised warrants include all warrants that have been issued to investors in the Company’s public financings to date and represent approximately 70% of the Company’s overall outstanding warrants. Warrants remaining after the exercise carry a weighted average exercise price of approximately $3.93. Genprex believes that the elimination of the majority of its outstanding warrants is a significant milestone for the Company in that it provides a dramatically simplified capital structure.

In 2020, Genprex has raised gross proceeds of $25.5 million in two registered direct offerings, both priced at the market, with no warrants issued. The additional capital from these recent warrant excercises brings the equity capital raised during 2020 for advancing the Company’s research and development programs and other corporate initiatives, which could include strategic transactions, to roughly $28 million.

With the Company’s significantly strengthened balance sheet (the warrant exercise proceeds added to the more than $23 million in cash on the Company’s balance sheet as of March 31, 2020), Genprex believes it is in a strong position to pursue its planned clinical trial of its lead gene therapy drug candidate, Oncoprex immunogene therapy, combined with targeted therapy Tagrisso (marketed by AstraZeneca) in non-small cell lung cancer (NSCLC) patients whose tumors progressed on Tagrisso, for which the Company was granted United States FDA Fast Track Designation in January 2020; and a planned clinical trial of Oncoprex combined with Keytruda (marketed by Merck) for late stage NSCLC.

On May 28, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported that the Company will present at the upcoming Jefferies 2020 Virtual Healthcare Conference taking place June 2-4, 2020 (Press release, Zymeworks, MAY 28, 2020, View Source [SID1234558623]).

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The Company’s presentation will be on Thursday, June 4, 2020 at 2:30 p.m. ET.

Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source events-and-presentations, which will also host a recorded replay available afterwards.

On May 28, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, reported the change of name of its subsidiary ITG Isotope Technologies Garching GmbH (Press release, ITM Isotopen Technologien Munchen, MAY 28, 2020, View Source [SID1234558639]). With effect from May 28, 2020, the company responsible specifically for the production of medical isotopes within the ITM Group will operate under the name ITM Medical Isotopes GmbH. The background to the decision is to present a uniform external image of the ITM group of companies, which, alongside ITM Medical Isotopes GmbH, includes among others the highly specialized companies ITM Oncologics GmbH and ITM Solucin GmbH.

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The change of name will have no other impact on business partners, customers and staff. The legal form of the company and the ownership structure will remain unchanged. The fields of activity of radioisotope production, the product portfolio and all contracts concluded up to the rebranding will remain unchanged under the new company name. The head office address, the commercial register number and all known contact partners will remain unchanged.

ITG Isotope Technologies Garching GmbH, or ITM Medical Isotopes GmbH, is a 100% subsidiary of ITM Isotopen Technologien München AG. Over the course of the company’s 16-year history, from a start-up housed on the Technical University of Munich (TUM) site, ITM has established itself as a worldwide biotechnology and radiopharmaceutical group of companies in Targeted Radionuclide Therapy with a global distribution network. ITM develops, produces and distributes radiopharmaceuticals and medical radioisotopes for the diagnosis and therapy of cancer. The current product portfolio and focus of research includes targeted candidates for the treatment of neuroendocrine tumors, glioblastoma, osteosarcoma and bone metastases, as well as folate receptor α positive tumors such as lung, ovarian or breast cancer.