Market Newsdesk

Bethesda, Maryland, Nov. 30, 2020 (GLOBE NEWSWIRE) — Ten months into the COVID-19 pandemic, Americans remain divided along party lines about how serious the virus is and what steps should be taken to contain it, according to a new poll by pollster Frank Luntz and the nonpartisan de Beaumont Foundation. The poll also reveals language that political and health leaders can use to reach all audiences, build trust in public health measures, and save lives. Details are available at debeaumont.org/changing-the-covid-conversation.

“We don’t have a partisan divide — it’s a chasm,” said Dr. Luntz, who conducted the poll Nov. 21-22. “The words our leaders are using need an immediate upgrade. What they’re saying isn’t working. Democrats and Republicans simply think differently and act differently. We need to accept this as fact.

“Based on our findings, our leaders need to remove politics and partisanship from their messaging and give Americans a better reason to comply other than because it’s good for them. They must remind people that it’s also good for the people they love and will speed up the return to a strong economy and a normal day-to-day activities.”

Brian C. Castrucci, DrPH, president and CEO of the de Beaumont Foundation, which focuses on improving state and local public health, said, “Effective communication is always important in public health, but it’s never been more important for health leaders to understand the perceptions of Americans and modify their language accordingly. We approached Frank Luntz to do this work because we need to build bridges and use language that builds trust and improves compliance with urgent public health measures.”

The poll, “Changing the COVID Conversation,” reflects the views of 1,100 respondents, including an oversample of 300 African Americans. It highlights how much of the messaging and language being used by public health experts, state and local officials, and the White House is missing the mark – and failing to motivate millions of Americans to get behind life-saving public health precautions, such as masking, testing, social distancing, and vaccinations. Insights include:

• Political and health leaders need to focus on the benefits of success, not just the consequences of failure.
• Public health leaders must make the case that the science about steps that can prevent the spread of COVID-19 is settled. When asked what would make them not take precautions like mask wearing, hand washing, and social distancing, nearly one-third of Republicans selected the response “the jury is still out on how we should best combat the virus, as health recommendations have changed over time.”
• Politicians are not credible messengers about the pandemic — it will be most effective to use scientists and medical and public health leaders as spokespeople.
• Public health and the economy cannot be separated. Leaders need to emphasize that doing the right thing now means a faster economic recovery. 
• Vaccine hesitancy is real. Among all respondents, 10% said “I would never take the vaccine for COVID-19” – compared with 6% of Democrats, 13% of Republicans, and 19% of African Americans. Only 4% of African Americans said they would take the vaccine “without hesitation,” compared with 16% of the national total, 15% of Democrats, and 16% of Republicans.

Highlights of Poll Findings:

• While Americans agree that the COVID pandemic is getting worse, there is a chasm between Democrats and Republicans about how serious the situation is, with 62% of Democrats saying the current situation with COVID is “extremely serious,” compared with only 33% of Republicans feeling the same way. In total, 74% of respondents said the situation is “very serious” or “extremely serious,” while for African Americans that number was 86%.
• When asked “What should our strategy and approach be with COVID-19 right now?” the most favored approach by Republicans was to “open everything now/learn to live with the virus,” while Democrats favored “close down a little more since the virus has gotten worse.”
• Overall, 23% of respondents know someone close to them who has died from COVID-19 — 30% of Democrats and only 18% of Republicans. Even higher is the number of African Americans (34%) who know someone who has died.
• Americans most trust scientists and public health officials to deliver factual information — more than President Trump, President-elect Biden, governors, mayors, and members of Congress. Trust in the CDC and Dr. Anthony Fauci remains high.
• Support for wearing masks may be stronger than people think. When asked to identify the most “sensible, responsible, and impactful” public health measure to reduce the spread of COVID-19, 59% of respondents chose “wearing a face mask in public,” more than any other approach.

Language to Reset the COVID Conversation

The poll highlights the urgent need to change our pandemic lexicon in order to help bridge key differences and rally Americans across the country and across the political spectrum to adopt life-saving public health precautions. For example: 

• Forty-nine percent of Americans consider a “pandemic” more “significant, serious, and scary” than “COVID-19” (39%) or “the coronavirus (13%).
• Respondents had a much more positive reaction to “a stay-at-home order” than a “lockdown” or “aggressive restrictions.”
• Saying that policies to combat the pandemic are “fact-based” is more effective than saying they’re based on “science,” “data,” or “medicine.”
• Americans have a more positive reaction when rules and regulations to address COVID-19 are called “protocols” rather than “mandates,” “directives,” “controls,” or “orders.”
• More than 4 in 5 respondents prefer “face masks” over “facial coverings.”

See more language tips at debeaumont.org/changing-the-covid-conversation.

Poll Methodology

The poll represents a nationwide survey of 1,100 registered voters from across the country, including an oversample of 300 African Americans, and has a margin of error of +3%. A representative sample of the nation’s demographics, including age, gender, race, education, and income, were polled on the preferred words, sentences, phrases, and attributes Americans need to hear to change their behavior and stop the spread of the coronavirus pandemic.

About the de Beaumont Foundation

Founded in 1998, the de Beaumont Foundation creates and invests in bold solutions that improve the health of communities across the country. The foundation advances policy, builds partnerships, and strengthens public health to create communities where people can achieve their best possible health. For more information, visit debeaumont.org. 

About Frank Luntz

Frank I. Luntz, PhD, has written, supervised, and conducted more than 2,500 surveys, focus groups, ad tests, and dial sessions in more than two dozen countries and six continents over the past 30 years. He has worked for more than 50 Fortune 500 companies and CEOs, but he’s best known for political commentary. More media outlets have turned to Dr. Luntz to understand the hopes and fears of Americans than to any other political pollster. For more information, visit filuntz.com.

 

Attachment

• Poll Toolkit_1pger

Mark Miller
de Beaumont Foundation
301-802-6783
[email protected]

BETHLEHEM, Pa., Nov. 30, 2020 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point of care diagnostic tests and specimen collection devices, today announced that Dr. Stephen S. Tang, President and CEO, will speak to the investment community at the 2020 Evercore ISI HealthCONx Conference. The conference will be simultaneously webcast over the Internet.

Dr. Tang is scheduled to speak on December 3, 2020, at approximately 9:40 AM Eastern Standard Time (6:40 AM Pacific Time). Interested investors can access the live webcast of the presentation by going to OraSure Technologies’ web site, www.orasure.com and clicking on the Investor Info link. A replay of the webcast will be available on OraSure Technologies’ web site for fourteen days. Alternatively, you can access the live webcast of the presentation via the following link: https://wsw.com/webcast/evercore11/osur/2405541.

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, CoreBiome (now operating under the Diversigen brand), UrSure and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Company contacts:

Sam Martin
Argot Partners
212-600-1902
[email protected]

Jeanne Mell
VP Corporate Communications
484-353-1575
[email protected]
www.orasure.com

NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the European Commission has granted orphan designation for PR006 for the treatment of frontotemporal dementia (FTD). PR006 is an investigational AAV9 gene therapy delivering the GRN gene and is being developed as a potential therapy for patients with frontotemporal dementia with GRN mutations (FTD-GRN).

“The European Commission’s decision to grant orphan designation for PR006 is an important step in helping to advance this potential therapeutic option for patients with frontotemporal dementia with GRN mutations,” said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. “We are excited to progress clinical development of PR006 as part of our mission to deliver a potentially disease-modifying gene therapy to these patients as quickly as possible.”

The Company expects to initiate enrollment in the Phase 1/2 PROCLAIM trial of PR006 in the fourth quarter of 2020, and it currently anticipates it will provide a biomarker and safety analysis on a subset of patients in the PROCLAIM trial in 2021.

The U.S. Food and Drug Administration has also granted Orphan Drug designation for PR006 for the treatment of FTD and Fast Track designation for FTD-GRN.

About European Commission Orphan Designation

Orphan designation is granted by the European Commission to encourage development of medicines intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the European Union. Orphan designation by the European Commission provides companies with certain benefits and incentives, including protocol assistance, reduced regulatory fees and 10 years of market exclusivity following regulatory approval.

About Prevail Therapeutics

Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson’s with GBA and OrbiMed, and is headquartered in New York, NY.

Forward-Looking Statements Related to Prevail

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning Prevail’s mission to deliver a potentially disease-modifying gene therapy to patients with FTD-GRN as quickly as possible; the potential benefits of orphan designation by the European Commission; and the anticipated timing of enrollment and of reporting of interim data on a subset of patients from the PROCLAIM trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail’s novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail’s gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail’s filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” sections of the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media Contact:

Lisa Qu
Ten Bridge Communications
[email protected]
678-662-9166

Investor Contact:

[email protected]

CAMBRIDGE, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the launch of Anemia ID, a program providing no-cost genetic testing for patients with suspected hereditary anemias. The next-generation sequencing panel consists of more than 50 genes and disorders that are known to cause hereditary anemias, including pyruvate kinase deficiency. Patients with hereditary anemia can face a difficult path to a proper diagnosis, and access to comprehensive diagnostic testing is a common barrier to diagnosis. Receiving an accurate diagnosis enables patients and their physicians to better understand their condition and informs disease management decisions.

“Differentiating among hereditary anemias is extremely challenging, given the wide range of disorders and unspecified or overlapping phenotypes. Having a specific diagnosis is extremely helpful, allowing us to tailor the treatment and management approach to the particular anemia,” said Dr. Geetha Puthenveetil, a pediatric hematologist at Children’s Hospital of Orange County. “Genetic testing, such as the Anemia ID program, is one of the most useful tools we can employ when treating patients with hereditary anemias. Using a simple saliva or blood sample, Anemia ID offers a non-invasive, convenient and no-cost path to diagnosis.”

“We launched the Anemia ID program as a result of our continuing commitment to the hematology communities we serve,” said Jackie Fouse, Ph.D., chief executive officer of Agios. “Anemia ID enables patients and physicians in the hereditary anemia community to receive a no-cost, rapid diagnosis, with the goal of enabling more informed decisions that may mitigate disease impact on quality of life and open up new treatment opportunities for patients.”

Agios launched the Anemia ID program, in partnership with PerkinElmer Genomics, in response to feedback from patients, advocates and physicians about the need for improved diagnosis to inform disease management decisions. Agios plans to work with physicians across the country to educate about the availability of the test. Participating physicians will order a test kit from PerkinElmer Genomics, collect a single blood or saliva sample from the patient and return the kit to PerkinElmer Genomics, which will perform the molecular analysis and provide the clinical interpretation. While genetic testing alone cannot provide a definitive diagnosis, it is used in conjunction with additional clinical data or testing to diagnose the underlying cause of the patient’s anemia. Eligible patients will receive the Anemia ID genetic test at no cost, subject to the program’s terms and conditions.

About Anemia ID
Genetic Testing Program for Hereditary Anemias

Agios Pharmaceuticals, in partnership with PerkinElmer Genomics, launched the Anemia ID program to offer no-cost genetic testing to eligible patients in the U.S with suspected hereditary anemias, a group of highly heterogeneous disorders that occur infrequently across the general population.

The goal of the Anemia ID program is to provide a diagnosis confirming the underlying cause(s) of a patient’s hereditary anemia, support the development of an effective management plan, inform genetic counseling discussions and enable the identification of appropriate treatment options or clinical trials. The next-generation sequencing panel uses a single blood or saliva sample to test for more than 50 mutated genes and disorders, including congenital dyserythropoietic anemias, Diamond-Blackfan anemia, enzymopathies (red blood cell enzyme disorders) including pyruvate kinase deficiency, membranopathies (red blood cell membrane disorders) and other disorders with overlapping clinical features.

All testing provided to patients through Anemia ID is paid for by Agios Pharmaceuticals. While Agios provides financial support for this program, all tests and services are performed by PerkinElmer Genomics. Agios receives contact information for healthcare professionals who submit tests under this program and limited de-identified aggregate data.

To learn more about the program, please visit www.AnemiaID.com.

About Agios

Agios is focused on discovering and developing novel investigational medicines to treat malignant hematology, solid tumors and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across these three therapeutic areas, Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. For more information, please visit the company’s website at www.agios.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of the Anemia ID program; and the benefit of Agios’ strategic plans and focus. The words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook,” “goal”, “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios’ current expectations and beliefs. For example, a positive opinion on Agios’ application for orphan drug designation for mitapivat is not a guarantee of approval. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including: risks and uncertainties related to the impact of the COVID-19 pandemic to Agios’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products; the results of Agios’ clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios’ ability to obtain and maintain requisite regulatory approvals and to enroll patients and conduct its current and future clinical trials; unplanned cash requirements and expenditures; competitive factors; Agios’ ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios’ ability to maintain key collaborations; and general economic, market and global health conditions. These and other risks are described in greater detail under the caption “Risk Factors” included in Agios’ public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Agios expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Investors:

Holly Manning, 617-844-6630
Director, Investor Relations
[email protected]

Media:

Jessica Rennekamp, 857-209-3286
Associate Director, Corporate Communications
[email protected]

BETHLEHEM, Pa., Nov. 30, 2020 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in the fight against HIV, today announced its plans to commemorate World AIDS Day. On Tuesday, Dec. 1st, OraSure will ring the closing bell for the NASDAQ Stock Market, in a virtual ceremony that will be livestreamed.

“A year ago, on World AIDS Day 2019, it appeared that eliminating the HIV epidemic was within our grasp. Today, we’re in a far different place as COVID-19 has disrupted the delivery of testing, services and care, reversing many of the gains we’ve made,” said OraSure President and CEO, Stephen S. Tang, Ph.D. “Today, on World AIDS Day 2020, it’s time to put a stake in the ground: We cannot let the HIV epidemic take a back seat to COVID-19. At OraSure, we are proud of the ways in which we are meeting the global need for HIV diagnostics, and we are committed to doing the same for COVID-19.”

To commemorate World AIDS Day globally, OraSure also partnered with the MTV Staying Alive Foundation on a video campaign, based around an African television series MTV Shuga, which encourages young adults to take an HIV self-test. Furthermore, in Kenya, the Ministry of Health has partnered with OraSure to pilot electronic vending machines for HIV self-test kits. The machines will launch on World AIDS Day. The widely used OraQuick^® HIV Self-Test was the first WHO-prequalified HIV self-test in Sub-Saharan Africa.

To watch the livestream feed of the NASDAQ Closing Bell Ceremony, go to https://livestream.com/accounts/27896496/events/9408209 by 3:45 p.m. ET.

About OraSure Technologies HIV Tests

The OraQuick^® In-Home HIV Test is the first and only oral fluid rapid over-the-counter (OTC) HIV test approved in the U.S. The OraQuick^® In-Home HIV Test can detect antibodies to both HIV-1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes. It is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale to the consumer market.

The OraQuick^® HIV Self-Test (HIVST) is a rapid, point-of-care test that allows an individual to detect antibodies to both HIV-1 and HIV-2 with a simple oral swab and provides a result in as little as 20 minutes in the privacy of an individual’s home, at outreach testing settings, in the pharmacy or at community based screening events. Based on the same OraQuick^® platform that is used for the FDA-approved OraQuick^® In-Home HIV Test and the WHO Prequalified OraQuick^® Rapid HIV-1/2 Antibody Test used by health care professionals worldwide, the platform has been used to test millions in international markets.

The OraQuick ADVANCE^® Rapid HIV-1/2 Antibody Test is the first FDA approved, CLIA-waived, rapid point-of care test that can detect antibodies to both HIV-1 and HIV-2 with greater than 99 percent accuracy in as little as 20 minutes, using an oral fluid, finger-stick or venipuncture whole blood, or plasma sample.

UrSure, a wholly-owned subsidiary of OraSure, offers diagnostic tests that measure adherence to HIV medications, including pre-exposure prophylaxis or PrEP, the daily medication to prevent HIV. This includes laboratory-based tests that can measure levels of the medication in a patient’s urine or blood, as well as several additional point of care products in development.

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, CoreBiome (now operating under the Diversigen brand), UrSure and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Company contacts:

Sam Martin
Argot Partners
212-600-1902
[email protected]

Jeanne Mell
VP Corporate Communications
484-353-1575
[email protected]
www.orasure.com

GUANGZHOU, China, Nov. 30, 2020 (GLOBE NEWSWIRE) — JOYY Inc. (NASDAQ: YY), a global video-based social media platform (“JOYY” or the “Company”), today announced that it will hold its 2020 annual general meeting of shareholders at Gallery 303, 3/F, Rosewood Guangzhou, 6 East Zhujiang Road, Tianhe District, Guangzhou 510623, People’s Republic of China on December 18, 2020 at 2:00 p.m. (local time).

No proposal will be submitted for shareholder approval at the annual general meeting. Instead, the annual general meeting will serve as an open forum for shareholders of record and beneficial owners of the Company’s American depositary shares (“ADSs”) to discuss Company affairs with the management.

The board of directors of the Company has fixed the close of business on November 30, 2020 as the record date (the “Record Date”) for determining the shareholders entitled to receive notice of the annual general meeting or any adjourned or postponed meeting thereof.

Holders of record of the Company’s common shares at the close of business on the Record Date are entitled to attend the annual general meeting and any adjournment or postponement thereof in person. Beneficial owners of the Company’s ADSs are welcome to attend the annual general meeting in person.

The Company has filed its annual report on Form 20-F (the “Annual Report”), which includes the Company’s audited financial statements for the fiscal year ended December 31, 2019, with the U.S. Securities and Exchange Commission (the “SEC”). The Company’s Annual Report can be accessed on the investor relations section of its website at http://ir.yy.com/, as well as on the SEC’s website at http://www.sec.gov/.

Holders of the Company’s common shares or ADSs may obtain a hard copy of the Annual Report free of charge by contacting JOYY Inc. at [email protected] or by writing to JOYY Inc. at Building B-1, North Block of Wanda Plaza, No. 79 Wanbo Er Road, Nancun Town, Panyu District, Guangzhou 511442, the People’s Republic of China, telephone: +86 (20) 8212-0000.

About JOYY Inc.

JOYY Inc. is a global social media platform. The Company’s highly engaged users contribute to a vibrant social community by creating, sharing, and enjoying a vast range of entertainment content and activities. JOYY enables users to interact with each other in real time through online live media and offers users a uniquely engaging and immersive entertainment experience. JOYY owns BIGO, a fast-growing global tech company headquartered in Singapore. BIGO owns several popular video based social platforms including BIGO live, a leading global live streaming platform outside China; Likee, a leading global short-form video social platform; and video communication service and others. JOYY has created an online community for global video and live streaming users. JOYY Inc. was listed on the NASDAQ in November 2012.

Investor Relations Contact

JOYY Inc.
Jane Xie/Maggie Yan
Tel: +86 (20) 8212-0000
Email: [email protected] 

ICR, Inc.
Jack Wang
Tel: +1 (646) 915-1611
Email: [email protected]  

NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the 3rd Annual Evercore ISI HealthCONx Conference. The fireside chat is scheduled to take place on Tuesday, December 1, 2020 at 10:05 AM ET.

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as “U2”, targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS). Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

CONTACT:

Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: [email protected]

–75% IMPROVEMENT BY DAY 2 ON ARTIVEDA™

AGOURA HILLS, California, Nov. 30, 2020 (GLOBE NEWSWIRE) — Mateon Therapeutics, Inc. (OTCQB: MATN) (“Mateon”), a leading developer of TGF-β therapeutics for oncology and COVID-19, provided development update for ARTIVeda^TM/ArtiShield^TM against COVID-19. ARTIVeda^TM is Mateon’s lead Ayurvedic drug against COVID-19 in India and ArtiShield^TM is for Rest-of-World.

• The India arm of ARTI-19 global study is on track to complete enrollment of the first 120 cohort by Dec 15, 2020, of which 78 patients have already been randomized.
• Interim analysis of the first 32 pts (8 WHO scale 2 and 24 WHO scale 4 on randomization) was performed.
• Statistical significant Time dependent improvement in WHO scale following treatment with ARTIVeda^TM+SOC versus SOC alone was observed.
• 75% of WHO scale 4 patients exhibited a drop to WHO scale 3 on Day Two of treatment with ARTIVeda^TM. Note: WHO scale 3 does not require hospitalization.
• 40% of WHO scale 4 patients exhibited a drop to WHO scale 1 on day 5 of treatment with ARTIVeda^TM. Note: WHO scale 1 is asymptomatic.

ARTI-19 in India is being conducted by Windlas Biotech Private Limited, as part of Mateon’s global effort in deploying ARTIVeda^TM/ArtiShield^TM across India, Africa, and Latin America. Windlas promotes more than 120 chronic and acute care branded products (allopathic, nutraceutical and Ayush formulations) through its “affordable generics platform” spanning over 950 wholesalers across India. Windlas branded medicines and wellness products are sold in several markets across the globe like Sri Lanka, Vietnam, Thailand, Myanmar etc.

Saran Saund, Chief Business Officer and GM of AI division of Mateon, commented, “I am pleased that ARTI-19 is progressing well and yielding early data supportive of a therapeutic potential of ARTIVeda^TM against COVID-19. A cost-effective treatment that is also prophylactic is needed to achieve complete control of the pandemic as essential backstop to manage illness resulting from imperfections in vaccine effectiveness and uptake.”

Dr. Vuong Trieu, CEO of Mateon commented, “The early data of ARTI-19 is supportive of our concept that COVID-19 is caused by a TGF-β surge which leads to multitude of symptoms including respiratory failure, lung fibrosis, and long-term damages observed among long-haulers. ARTIVeda^TM and OT-101 are inhibitors of TGF-β and are being evaluated across multiple clinical trials against COVID-19.”

About ARTI-19 India

The ARTI-19 trial is registered under the Clinical Trials Registry India (CTRI) with three active sites and additional sites to be added as the trial progresses and expands. ARTI-19 trial registration information can be found at: CTRI/2020/09/028044. Phase IV study to evaluate the safety and efficacy of ArtiShield^TM on COVID-19 subjects as Interventional. http://ctri.nic.in/Clinicaltrials/advsearch.php. Site specific information is: 1) Government Medical College & Government General Hospital, Srikakulam, ANDHRA PRADESH. 2) Rajarshi Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital, MAHARASHTRA. And 3) Seven Star Hospital, MAHARASHTRA. This trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. Oral administration of Artemisia absinthium Powder 500mg capsule/day for 5 days with SOC per cycle with the option to repeat as needed until disease is resolved or subject is discharged, up to a total of consecutive 3 cycles (“5 days treatment, 5 days off”). SOC is standard-of-care as per Clinical Management Protocol: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division). Safety is defined as: 1) Adverse events (AEs) during the study and 2) Serious adverse events (SAEs) during the study. Efficacy is defined as: 1) Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale and 2) Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms.

About ARTIVeda^™ and ArtiShield^TM

The product, ARTIVeda^TM, is a formulated plant extract of the indigenous plant Artemisia, known in Sanskrit texts as Damanaka. ARTIVeda^TM is the first Ayurvedic drug against COVID-19 through TGF-β inhibition. ARTIVeda^TM is expected to be effective through the entire infection cycle. The active component of ARTIVeda^TM has been identified as artemisinin. Through proprietary GMP quality extraction and manufacturing processes, the Artemisia extract was rendered active against SARS-CoV-2 with robust Safety Index (SI) greater than 100 (ratio of nonspecific cell kill versus viral kill). Other extracts have SI <10. Testing was performed at the US NIAID core viral laboratory. The product is protected by a patent portfolio of over 15 international patents by Mateon’s R&D. The mechanism of action against COVID-19 has been confirmed in 5 key peer reviewed international scientific/medical publications. ARTIVeda™ is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. A phase IV trial looking at ARTIVeda™ in COVID-19 is ongoing in India and globally. The US name for this drug product is ArtiShield^TM. We are looking to leverage ex-US data for the commercialization of ArtiShield^TM in the US. We are expecting ArtiShield^TM to be cost effective prophylactic suitable for global deployment.

About Mateon Therapeutics

Mateon was created by the recent reverse merger with Oncotelic, which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Mateon/Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has activity against SARS-CoV-2. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503). For more information, please visit www.oncotelic.com and www.mateon.com.

Mateon’s Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe”, “quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”, “impact potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company’s annual report on Form 10-K filed with the SEC on April 10, 2019 and in the company’s other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.

Contact Information:
For Mateon Therapeutics, Inc.:
Amit Shah
[email protected]

Attachment

• Mateon Therapeutics, Inc

RESEARCH TRIANGLE PARK, N.C., Nov. 30, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the journal Allergy has published data from the APeX-J trial, a randomized, placebo-controlled trial conducted in Japan evaluating oral, once-daily berotralstat for the prophylactic treatment of hereditary angioedema (HAE).

The APeX-J trial met its primary endpoint of a reduction in the rate of HAE attacks for berotralstat 150 mg compared to placebo during the 24-week period (p=0.003). Berotralstat was safe and generally well-tolerated in the trial.

These results are consistent with the global phase 3 APeX-2 trial, where berotralstat 150 mg also reduced the rate of HAE attacks compared to placebo (p<0.001) and was safe and generally well-tolerated.

“APeX-J is the first placebo-controlled trial of an HAE medicine conducted in Japan and the berotralstat data are very exciting for patients, who currently have no approved prophylactic treatment options. Based on the safety and efficacy profile, I believe berotralstat, if approved, would be an important advancement in HAE management for Japanese patients,” said Dr. Isao Ohsawa, president of Saiyu Soka hospital and principal investigator of the APeX-J trial. 

Dr. Ohsawa and the study authors note that HAE is estimated to affect 2,500 patients in Japan and the recognition of HAE by physicians is low. Although two on-demand treatments are approved, no therapies are currently approved for long-term prophylaxis in Japan.

“Berotralstat would be the first approved prophylactic therapy for HAE patients in Japan and we believe there is a significant opportunity for berotralstat to accelerate the diagnosis of HAE patients and dramatically improve the quality of life for patients,” said Jon Stonehouse, president and chief executive officer of BioCryst.

A new drug application (JNDA) is under review in Japan for approval of oral, once-daily berotralstat for the prophylactic treatment of HAE. Berotralstat is being reviewed under Sakigake designation and the company expects a decision on approval in December 2020.

Torii Pharmaceutical, Co., Ltd. is BioCryst’s commercial partner in Japan for berotralstat.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO^™ (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB^® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.

Fo
rward-Looking Statements

This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements are identified by use of terms such as “believe,” “will,” “would,” “expect,” and similar words, although some forward-looking statements may be expressed differently. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; developing and commercializing ORLADEYO or any HAE product candidate may take longer or may be more expensive than planned; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on product candidates, may impose a clinical hold with respect to such product candidates, or may withhold or delay market approval for product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst’s ability to successfully commercialize its product candidates, manage its growth, and compete effectively; and risks related to the international expansion of BioCryst’s business.  Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements.

BCRXW

Contact


s


:


John Bluth
+1 919 859 7910
[email protected]

Catherine Collier Kyroulis
+1 917 886 5586
[email protected]

 

• Formerly CB2 Insights, the Company enters a new chapter as it completes its rebranding to Skylight Health Group effective Monday, November 30, 2020.
• Skylight Health is a national US provider of multi-disciplinary services with 30+ physical clinics across 14 states and a proprietary virtual telehealth and electronic medical record platform.
• The Company uses a hybrid approach of in-clinic and virtual services to deliver quality primary care, sub-specialty and allied health services to patients covered by most US health insurance plans.
• The Company is focused on robust expansion throughout the US adding new states by way of strategic acquisitions and organic growth of services to existing patients.
• The company has a strong base of operation with positive cash flow with no long-term debt and cash balance of $10.3MM.
• Led by management with 50+ years of collective practice management expertise

TORONTO, Nov. 30, 2020 (GLOBE NEWSWIRE) —  Skylight Health Group Inc. (formerly CB2 Insights) (CSE:SHG; OTCQB: CBIIF) (“Skylight Health” or the “Company”), one of the largest multi-specialty healthcare services in the United States, today announces its rebranding and corporate plan to address massive gaps and opportunities in the US trillion-dollar healthcare market. To view the new brand and learn more, visit the new website www.skylighthealthgroup.com.

Prad Sekar, Chief Executive Officer of Skylight Health Group stated “For the past 25 years, my co-founder Kash Qureshi and I have built successful and profitable healthcare operations. We are now on a path to becomingone of the largest multi-specialty healthcare system in the US. By providing a broad rangeof services that are not traditionally found under one clinic group, we are able to provide services both physically and virtually and we do so at a substantially lower cost to the patient. We bring the focus back to the patient. Whether it is providing insurable services to patients with insurance or subscription services for the uninsured or underinsured, patients are able to have greater accessibility and greater affordability in an otherwise fragmented and complex industry.”

The US healthcare market represents a multi-trillion-dollar opportunity ripe for disruption. Skylight has a hybrid approach to healthcare delivery. In-clinic services to support patient needs where standards of care require the physical presence of a health care provider; and virtual telemedicine to support patients who may not need to travel or further expose themselves by receiving the same quality of care from the comfort of their home. With a multi-disciplinary approach, the Company brings primary care, sub-specialty, allied health & wellness and laboratory/diagnostic services under one roof.

Skylight operates both an organic growth strategy, implementing new services to broaden the offerings available within each clinic. The Company’s clinic network will offer primary care services. Additional services will be based on each population set in each region and will complement the healthcare needs of patients.

The Company also employs a growth-by-acquisition strategy. Acquisitions are attractively priced between 3 to 7 times EBITDA or in some cases, less than 1 times revenue. The Company has already demonstrated its ability to target, qualify and acquire with its two most recent transactions in October and November 2020 and a third deal already announced and set to close early 2021. On an aggregate basis, the three transactions will add an incremental expected $5 million to the current run rate. The Company is on track to achieve a $20 million run rate by the end of 2020. At any given time, there are more than 200 potential acquisition opportunities in the market throughout the US that are seen as an ideal addition to Skylight Health. The Company believes this pathway to growth will continue to result in growth opportunities that are accretive to its core clinical offerings and add immediate revenue and positive EBITDA.

The Company looks forward to providing further updates about its strategy and outlook for 2021 during its scheduled Q3 2020 earnings call on Tuesday, December 1, 2020. For dial in details, clickhere.

Under its existing stock option plan, the company has granted certain consultants 2,050,000 stock options. The Company has engaged Winning Media (“ WM ”) to provide strategic digital media services, marketing, and data analytics services (the “ Services ”).The Company has agreed to pay WM $250,000 USD in consideration for the Services to be provided for a 6-month term. WM will not receive any securities of the Company as compensation for the Services. The Company has signed an agreement with Octagon Media Corp./Wall Street Reporter (“ Octagon ”) for an investor marketing program, which includes digital media and investor awareness. The Company has agreed to pay Octagon $125,000 USD in consideration for providing the marketing program for a 6-month term. Octagon will receive options within the existing stock option plan of the Company of 500,000 options at $0.60 for a 1-year period.

About
Skylight Health Group

Skylight Health Group (CSE:SHG OTCQB:CBIIF) is a healthcare services and technology company, working to positively impact patient health outcomes. The Company operates a US multi-state health network that comprises of physical multi-disciplinary medical clinics providing a range of services from primary care, sub-specialty, allied health and laboratory/diagnostic testing. The Company owns and operates a proprietary electronic health record system that supports the delivery of care to patients via telemedicine and other remote monitoring system integrations. healthcare services. With a patient roster of over 120,000 patients, the Company’s operations spread across 14 states and continues to expand in services and locations both organically and by way of strategic acquisitions.

The Company primarily operates a traditional insurable fee-for-service model contracting with Medicare, Medicaid and other Commercial Payors. The Company also offers a disruptive subscription-based telemedicine service for the un/under-insured population who have limited access to urgent care due to cost.

For more information, please visit www.skylighthealthgroup.com or contact:

Investor Relations

Jonathan L. Robinson CFA
Oak Hill Financial
[email protected]
416-669-1001

Forward Looking Statements

Statements in this news release that are forward-looking statements are subject to various risks and uncertainties concerning the specific factors disclosed here and elsewhere in
Skylight Health
’s filings with Canadian securities regulators. When used in this news release, words such as “will, could, plan, estimate, expect, intend, may, potential, believe, should,” and similar expressions, are forward-looking statements.

Forward-looking statements may include, without limitation, statements regarding the Company’s unaudited financial results and projected growth.

Although
Skylight Health
as attempted to identify important factors that could cause actual results, performance or achievements to
differ materially from those contained in the forward-looking statements, there can be other factors that cause results, performance or achievements not to be as anticipated, estimated or intended, including, but not limited to: dependence on obtaining regulatory approvals; investing in target companies or projects which have limited or no operating history and are subject to inconsistent legislation and regulation; change in laws; reliance on management; requirements for additional financing; competition; hindering market growth and state adoption due to inconsistent public opinion and perception of the medical-use and recreational-use marijuana industry and; regulatory or political change.

There can be no assurance that such information will prove to be accurate or that management’s expectations or estimates of future developments, circumstances or results will materialize. As a result of these risks and uncertainties, the results or events predicted in these forward-looking statements may differ materially from actual results or events.

Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release are made as of the date of this release.
Skylight Health
disclaims any intention or obligation to update or revise such information, except as required by applicable law, and
Skylight Health
does not assume any liability for disclosure relating to any other company mentioned herein.

No securities regulator or exchange has reviewed, approved, disapproved, or accepts responsibility for the content of this news release.