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Kezar Life Sciences to Participate at Cowen 41st Annual Virtual Health Care Conference

On February 25, 2021 Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its Chief Executive Officer, John Fowler, will participate in the "Autoimmune/Complement" panel discussion at the Cowen 41st Annual Virtual Health Care Conference on Wednesday, March 3, 2021 at 11:40am EST (Press release, Kezar Life Sciences, FEB 25, 2021, View Source [SID1234575689]). The panel discussion will be available to live conference attendees.

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Lantheus Reports Fourth Quarter and Full Year 2020 Financial Results

On February 25, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, reported financial results for its fourth quarter and full year ended December 31, 2020 (Press release, Lantheus Medical Imaging, FEB 25, 2021, View Source [SID1234575688]).

"While 2020 presented extraordinary challenges, I thank our team for continuing to manufacture and deliver products to our customers throughout the year"

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The Company’s worldwide revenue for the fourth quarter of 2020 totaled $94.2 million, compared with $89.3 million for the fourth quarter of 2019, representing an increase of 5.4% over the prior year period. Full year 2020 worldwide revenues were $339.4 million, compared with $347.3 million for the full year 2019, representing a decrease of 2.3% over the prior year period.

The Company’s fourth quarter 2020 net loss was $3.4 million, or $0.05 per fully diluted share, as compared to net income of $10.5 million, or $0.26 per fully diluted share for the fourth quarter of 2019. Full year 2020 net loss was $13.5 million, or $0.25 per fully diluted share, as compared to net income of $31.7 million, or $0.79 per fully diluted share for the full year 2019.

The Company’s fourth quarter 2020 adjusted fully diluted earnings per share were $0.07, as compared to $0.34 for the fourth quarter of 2019, representing a decrease of 79.9% over the prior year period. The Company’s full year 2020 adjusted fully diluted earnings per share were $0.47, as compared to $1.17 for the full year 2019, representing a decrease of 59.5% over the prior year period.

Lastly, net cash provided by operating activities was $0.6 million and $16.4 million for the fourth quarter and full year 2020. Free Cash Flow was $(3.2) million for the fourth quarter of 2020, representing a decrease of approximately $20.9 million from the prior year period. Full year 2020 free cash flow was $3.9 million, as compared to $58.3 million for the full year 2019, representing a decrease of approximately $54.4 million from the prior year period.

"While 2020 presented extraordinary challenges, I thank our team for continuing to manufacture and deliver products to our customers throughout the year," said Mary Anne Heino, President and CEO. "Our fourth quarter revenue growth was 5.4% over the prior year period and also represented steady improvement over the prior two quarters of 2020. During 2020, we advanced our strategic mandate by closing the Progenics acquisition in June and receiving FDA approval for DEFINITY RT in November as well as FDA acceptance and Priority Review designation for our PyL NDA in December. In 2021, we will continue to drive sustainable growth, expand product offerings to our customers, improve the lives of the patients we serve, and create value for our shareholders."

Outlook

The Company guidance for the first quarter and full year 2021 is as follows:

On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of adjusted fully diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.

Internet Posting of Information

The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Thursday, February 25, 2021 at 4:30 p.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 5247866. A live webcast will be available in the Investors section of the Company’s website at www.lantheus.com.

A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

Harvard University and Kyowa Kirin Enter Strategic Research Alliance

On February 25, 2021 Harvard University and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151) reported that they have entered into a strategic research alliance (Press release, Harvard University, FEB 25, 2021, View Source [SID1234575687]). The 5-year alliance, established by Harvard’s Office of Technology Development (OTD), aims to fuel scientific collaboration among academic and industry researchers to accelerate discovery and early-stage innovation in translational biomedical science.

Kyowa Kirin is a Japan-based global specialty pharmaceutical company with drug discovery and commercialization capabilities focused in core therapeutic areas of nephrology, oncology, immunology and allergy, and the central nervous system. By creating opportunities for formal scientific collaboration, the alliance will leverage industry insight and drug development expertise to advance biomedical innovations developed in Harvard labs toward the clinical development of important new therapies.

"Fundamental research conducted in Harvard’s life-science labs expands our basic understanding of the biological mechanisms of disease and identifies promising new approaches to treatment," said Vivian Berlin, Managing Director of Strategic Partnerships in Harvard OTD. "By building collaborative scientific relationships around the world, like this alliance with Kyowa Kirin, we are crafting an environment where industry leadership, resources, and new scientific perspectives may help to validate and develop those innovations toward life-changing treatments for the benefit of patients."

"I am very pleased that Kyowa Kirin will have the opportunity to work and collaborate with the faculty at one of the world’s leading institutions to advance drug discovery and biomedical science," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. "One of our most important R&D strategies is to pursue external opportunities to generate scientific innovative value through strategic collaborations with industry and academia. I’m confident that this alliance will lead us toward novel and promising therapies for patients in the future."

Projects under the alliance will be initiated by Harvard’s leading life-science faculty through a proposal process. Projects selected for funding and scientific collaboration will be identified by a Joint Steering Committee, comprising membership from both Harvard and Kyowa Kirin.

Harvard OTD’s long-running alliance program creates multi-year, collaborative relationships between the University and corporate partners. These alliances support faculty-initiated research projects that can advance early-stage discoveries and rapidly drive innovation in a broad area of science. In establishing discussions with Kyowa Kirin that led to the creation of this research alliance, OTD was assisted by Gemseki, Inc., a subsidiary of Shin Nippon Biomedical Laboratories (SNBL), a preclinical CRO in Japan.

Omeros Corporation to Announce Fourth Quarter and Year-End Financial Results on March 1, 2021

On February 25, 2021 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its fourth quarter and year-end financial results for the period ended December 31, 2020, on Monday, March 1, 2021, after the market closes (Press release, Omeros, FEB 25, 2021, View Source [SID1234575686]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3399452. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3399452.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

Applied DNA Granted U.S. Patent Covering Methods of Utilizing DNA Tagged Submicron Particles for Authentication

On February 25, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it has received United States Patent No. 10,920,274 entitled "Nucleic Acid Coated Submicron Particles for Authentication" from the United States Patent and Trademark Office (Press release, Applied DNA Sciences, FEB 25, 2021, View Source [SID1234575685]). The newly issued patent strengthens the Company’s intellectual property position which includes 92 issued patents and 40 pending patent applications.

The claims of the issued patent cover methods of authenticating an object through the attachment and later authentication of submicron particles coated with a nucleic acid taggant. Claimed exemplary submicron particles include metal oxides, which encompass titanium dioxide and silicon dioxide that are commonly used as pharmaceutical and nutraceutical excipients for solid oral dosage forms and powdered formulations. In addition, submicron metal oxide particles are commonly used in the cosmetic industry.

"We are excited by our recent patent issuance, which we believe helps protect our CertainT platform and its Signature DNA molecular taggants as physical-chemical identifiers (PCID) for solid oral dosage forms and powders utilized in the pharmaceutical and nutraceutical markets," said Dr. James Hayward, President and CEO, Applied DNA. "While much of our recent focus has been on the biotherapeutic applications of our LinearDNATM platform, the global problem of counterfeit or adulterated pharmaceuticals and nutraceuticals has not gone away with the onset of the COVID-19 pandemic. We continue to pursue the implementation of the CertainT platform in the pharmaceutical and nutraceutical markets as an important business vertical with our industry partners."