Market Newsdesk

TORONTO, Dec. 10, 2020 (GLOBE NEWSWIRE) — As the next step in its fast-evolving social impact journey, Green Shield Canada (GSC) is pleased to announce $4 million of funding to six new Community Foundation partnerships. These new partnerships – with Kitchener Waterloo Community Foundation, Ottawa Community Foundation, Foundation of Greater Montreal, Toronto Foundation, Fondation Quebec Philanthrope, and Haida Gwaii Community Foundation – double GSC’s network across Canada to 12 Community Foundations and a total of $10 million of funding.

As with the $6 million that GSC invested in six Community Foundations in 2018 to celebrate the organization’s 60-year history of social impact and charitable giving, this latest funding will be primarily directed to community programs aimed at improving access to oral and mental health care – the two core focus areas of GSC’s Social Impact Program. GSC and Community Foundations will now also consider the impact of COVID-19 and look to bring an equity lens to the granting process.

GSC’s support delivered through Community Foundations has already made a positive impact in the lives of over 15,000 Canadians.

And in recognition of Sherry Peister, GSC’s recently retired Chair of its Board of Directors who lives in Waterloo Region, the $500,000 grant to Kitchener Waterloo Community Foundation is being made in Sherry’s name. This grant is inclusive of a $200,000 permanent endowment fund that will be named the GSC Sherry Peister Community Impact Fund.

Last, as part of its ongoing efforts to help build more equitable and inclusive communities, GSC is making contributions totaling over $200,000 to address the disproportionate impact of COVID-19 on specific segments of the population, and tackle broader gender equality and racial justice issues, including three national funds:

• The Black Opportunity Fund, hosted by the Toronto Foundation
• The Fund for Gender Equality, hosted by Community Foundations of Canada
• The Indigenous Peoples Resilience Fund, hosted by Community Foundations of Canada

“2020 has been an incredibly challenging year and our communities need support, now more than ever,” explains Zahid Salman, GSC’s President and CEO. “Community Foundations have proven themselves as effective partners in identifying local needs and priorities, which is why we’re so excited to expand this partnership and have an even bigger impact in the years to come.”

This announcement follows GSC’s late-November launch of a $6.15 million partnership with the University of Toronto to create a new dental clinic and the largest-ever oral health research program in Canadian history.

For more information:

Deb Quinn
spPR Inc.
[email protected]
647.985.7162

About Green Shield Canada
GSC is Canada’s fourth-largest health and dental benefits provider, and is uniquely structured as a social enterprise with the purpose of making it easier for people to live their healthiest lives. From coast-to-coast, our service delivery includes drug, dental, extended health care, vision, hospital, and travel benefits for groups and individuals, as well as administration and benefits management services. Supported by outcomes-based sustainability strategies, advanced technology, and exceptional customer service, GSC creates innovative programs for nearly four million plan participants nationwide. greenshield.ca

CHICAGO, Dec. 10, 2020 (GLOBE NEWSWIRE) — BLGI, Inc. (OTC: BLGI) (“BLGI” or the “Company”) announced today the introduction of its asset management trading platform that will be white labelled to third party clients.

BLGI Inc. launches “BLGI Markets” platform variant for clients including banks and asset management companies. The “white label” platform offering delivers market data, trading, and asset management technology with BLGI’s unique De-centralized Network Architecture in the clients desired configuration and design.

BLGI Markets (the “Platform/s”) has been designed and built by BLGI’s CEO Lawrence P. Cummins utilizing proprietary De-centralized Cloud Architecture entitled “ DCA™”. “With significantly lower costs of implementation and hosted in the cloud, DCA offers unparalleled reliability with no service outages. We look forward to announcing further white labelled variants of BLGI Markets for our clients as well as deploying DCA into other market sectors”said Lawrence P. Cummins.

BLGI Markets provides real-time market data on company stocks, Forex, Futures, CFD’s EFT’s, Indices, Bitcoin, and Cryptocurrency Markets. 

De-centralized Cloud Architecture – DCA
TM – enables all of BLGI’s proprietary platforms including it BLGI Markets Platform to operate without all information passing through a single point.  This key development from BLGI means that no one party is required to be responsible for all the data and information: All BLGI platforms operate on a peer-to-peer basis with security utilizing 256-bit encryption. 256-bit key to encrypt and decrypt data or files. It is one of the most secure encryption methods after 128- and 192-bit encryption and is used in most modern encryption algorithms protocols. 

BLGI’s Platforms offer unique security, privacy and control over the assets. The Platforms also operate with the utilization of a smart contract. When a transaction initiates on a Platform, a DEX (decentralized exchange), the transaction data is processed on different hard drives and verified to achieve a secure result.

The Company is currently in-build with several asset management clients for white-labelled versions Platforms. BLGI is a leading Data Science innovator building technology for the Internet of Economies and provides Machine Learning and blockchain solutions for Fin-tech, Media, and other market sectors.

About BLGI Inc.
At the core of any data science company is the need to optimize a client’s assets, whether the asset is financial trading data or sensitive health care information. As technology across all asset-driven industries moves toward blockchain and AI infrastructures, many organizations are rushing to adapt to these new technologies. At BLGI, we remove the guesswork from data-driven asset optimization. We deliver high-impact strategies that extend our clients assets’ lives, reduce life-cycle costs, and ensure asset availability. Doing so aids our clients embrace these new emerging technologies and empower them to compete in an ever-changing digital landscape. For additional news and information, please visit BLGI’s website at www.blgi.net or by contacting BLGI as follows:

Contact Information
Lawrence P. Cummins
Tel: +44 (0) 777 037 0114
[email protected]

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, many of which are beyond management control. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. These cautionary statements should not be construed as exhaustive or as any admission to the adequacy of BLGI’s disclosures. BLGI cannot predict or determine after the fact what factors would cause actual results to differ materially from those indicated by the forward-looking statements or other statements. The reader should consider statements that include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plans,” “projects,” “should,” or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. BLGI does not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future events, or otherwise. Additional information respecting factors that could materially affect BLGI and its operations are contained in its annual report on Form 10-K for the year ended April 30, 2019, as filed with the Securities and Exchange Commission.

HOUSTON, Dec. 10, 2020 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with tumors that express human epidermal growth factor 2 (HER2). BPX-603 is Bellicum’s first dual switch GoCAR-T^® product candidate that incorporates the company’s iMC activation and CaspaCIDe^® safety switch technologies.

“Initiation of this Phase 1/2 dose escalation clinical trial for BPX-603 denotes an important achievement for Bellicum and represents our second GoCAR-T program to enter the clinic,” stated Rick Fair, President and CEO. “This program may provide further validation of our technology’s ability to enhance both the efficacy and safety of immune cell therapy against solid tumors. We are excited to advance this potentially life-saving treatment approach into the clinic.”

BPX-603 Phase 1/2 Clinical Trial Design

This Phase 1/2, open-label, multicenter, non-randomized study will investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid. The trial will enroll patients with previously treated, locally advanced or metastatic solid tumors with HER2 amplification or overexpression. The initial dose escalation phase of the trial is designed to evaluate safety and identify the Phase 2 dose of BPX-603 administered with rimiducid at a fixed dose of 0.4 mg/kg per infusion. The Phase 2 portion of the trial will assess the safety, pharmacodynamics, and clinical activity of BPX-603 in various HER2+ solid tumors. Tumor types that may be studied include gastric, breast, ovarian, endometrial, and colorectal.

About BPX-603

HER2 is a validated antigen for cancer therapies and academic CAR-T cell clinical studies have shown evidence of modest antitumor activity. BPX-603 was designed to improve upon these efforts, primarily through incorporation of the inducible co-activation domain MyD88/CD40, or “iMC”. MC signaling is believed to boost effector cell proliferation and survival, enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment, and stimulate the cancer patient’s own immune system. Additionally, Bellicum’s dual-switch technology—which enables the clinician to either activate or eliminate GoCAR-T cells with the administration of small molecules—is designed to enhance real-time control of both efficacy and safety.

About Bellicum Pharmaceuticals

Bellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The company’s next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T cell therapies. Bellicum’s GoCAR-T^® product candidates, BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell products capable of overriding key immune inhibitory mechanisms. More information about Bellicum can be found at www.bellicum.com.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential further validation of our technology’s ability to enhance both the efficacy and safety of immune cell therapy against solid tumors; the potential for this treatment approach to save lives; and the tumor types to be evaluated in the Phase 2 portion of the trial. Various factors may cause differences between Bellicum’s expectations and actual results as discussed in greater detail under the heading “Risk Factors” in Bellicum’s filings with the Securities and Exchange Commission, including without limitation our quarterly report on Form 10-Q for the three months ended September 30, 2020 and our annual report on Form 10-K the year ended December 31, 2019. Any forward-looking statements that Bellicum makes in this press release speak only as of the date of this press release. Bellicum assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Source: Bellicum Pharmaceuticals

Investors:
Robert H. Uhl
Managing Director
Westwicke ICR
858-356-5932
[email protected]

TORONTO, Dec. 10, 2020 (GLOBE NEWSWIRE) — The holiday season is typically a time to celebrate and reconnect with friends and family. This holiday season, however, is going to look a lot different and many Canadians will be turning to the memories of past celebrations for comfort and joy. It’s in this spirit of nostalgia that Kolab Project is introducing a new, multisensory, flavour-first cannabis edible product – Cherry Cola Pop milk chocolates. Kolab Project Cherry Cola Pop combines premium cannabis distillate, creamy milk chocolate, classic cola flavouring and black-cherry popping candy for a unique experience with every bite. Kolab Project Cherry Cola Pop is available to order for provincial wholesalers across Canada, and is available in stores now in Alberta and Saskatchewan. Kolab Project is a cannabis brand owned and operated by Auxly Cannabis Group (TSX.V – XLY) (“Auxly”).

“We created Cherry Cola Pop for the Kolab Project consumer who is looking for a unique experience that has a layer of familiarity,” said Peter Crooks, Chief Product Innovation Office, Auxly. “Popping candy is a throwback and our team was inspired to evoke the sentimentality associated with carbonated confections of the past. The real differentiator for this product is the recruitment of additional senses. The sound of the popping candy brings an auditory element to the tactile sensation of popping on the palette. This has been one of the most fun products to design and develop – it’s quite a technical accomplishment by our team and we’re confident that consumers will deem it well worth the effort. In order to gain the full effect of the popping candy, consumers are encouraged to let the milk chocolate melt in their mouths, and then allow the pressurized carbon dioxide to escape from the candy, which creates the satisfying sizzling pop.”

“Consumers are looking to treat themselves during this time, which typically correlates with a spike in confectionary sales,” said Brad Canario, Brand Director, Auxly. “With Kolab Project Cherry Cola Pop, we wanted to make sure we were launching a new treat for consumers during the most relevant time for indulgence. In a sea of traditional chocolate flavours, we’re delighted to offer something wholly unique in the cannabis edibles market. Kolab Project Cherry Cola Pop is perfect for a trip down memory lane this holiday season.”

Kolab Project Cherry Cola Pop was developed and manufactured in Charlottetown, Prince Edward Island, under the direction of Peter Crooks, Chief Product Innovation Officer at Auxly. Cherry Cola Pop is made with natural cola and cherry flavours, popping candy, a traceable 41% cocoa milk chocolate sourced from Ivory Coast, and 10 mg of high-purity THC. Each batch undergoes rigorous testing to ensure a high-quality, consistent dosage with every use.

About Kolab Project

Kolab Project is a cannabis brand, wholly owned by Auxly Cannabis Group Inc., that aims to connect with those actively in the cannabis category that have an appreciation for the positive impact that art, culture and design have on humanity. Kolab Project cannabis products, available at licensed cannabis retailers across Canada, include premium pre-rolls, vapes and soft chews. Visit us at kolabproject.com.

About Auxly Cannabis Group Inc. (TSX.V: XLY)

Auxly is an international cannabis company dedicated to bringing innovative, effective, and high-quality cannabis products to the medical, wellness and adult-use markets. Auxly’s experienced team of industry first-movers and enterprising visionaries have secured a diversified supply of raw cannabis, strong clinical, scientific, and operating capabilities and leading research and development infrastructure in order to create trusted products and brands in an expanding global market.

Learn more at www.auxly.com and stay up to date at Twitter: @AuxlyGroup; Instagram: @auxlygroup; Facebook: @auxlygroup; LinkedIn: company/auxlygroup/.

For more information please contact:
Scott Campbell, 647-402-4957, [email protected] 

Notice Regarding Forward Looking Information:

This news release contains certain “forward-looking information” within the meaning of applicable Canadian securities law. Forward-looking information is frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or information that certain events or conditions “may” or “will” occur. This information is only a prediction. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking information throughout this news release. Forward-looking information includes, but is not limited to: consumer preferences, political change, future legislative and regulatory developments involving cannabis and cannabis products; and competition and other risks affecting Auxly in particular and the cannabis industry generally.

A number of factors could cause actual results to differ materially from a conclusion, forecast or projection contained in the forward-looking information in this release including, but not limited to whether: there is acceptance and demand for Kolab Project products by consumers and provincial purchasers; and general economic, financial market, regulatory and political conditions in which Auxly operates will remain the same. The forward-looking information contained in this release is expressly qualified by the foregoing cautionary statements and is made as of the date of this release. Except as may be required by applicable securities laws, the Company does not undertake any obligation to publicly update or revise any forward-looking information to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or results, or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/e4938455-c2a2-4cf8-8dac-8163c138e414

https://www.globenewswire.com/NewsRoom/AttachmentNg/908fb3f8-9ac7-48bf-b0b4-0e44160cede8

SAN DIEGO, Dec. 10, 2020 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation in the JMP Securities Hematology Summit. Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat on Tuesday, December 15, 2020 at 11:00 a.m. ET / 8:00 a.m. PT. The virtual forum will be held from December 15-16, 2020.

A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura’s most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. The Company’s pipeline is also highlighted by KO-539, a potent and selective menin inhibitor currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company’s website at www.kuraoncology.com.

Contacts

Company:
Pete De Spain
Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
[email protected]

Investors:
Robert H. Uhl
Managing Director
Westwicke ICR
(858) 356-5932
[email protected]

Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
[email protected]

WASHINGTON, Dec. 10, 2020 (GLOBE NEWSWIRE) — FTI Consulting, Inc. (NYSE: FCN) today announced the appointment of seven professionals to its Health Solutions practice, including Senior Managing Directors James Fisher, Julie Kliger and Kevin McCadden, and Managing Directors Matthew Leshy, Juliana Malhotra, Patterson Shafer and Amy Showalter.

“We are pleased to continue executing on our strategy and commitment to growing our Health Solutions business, and we are excited to welcome these key members to our team” said Charles Overstreet, Global Leader of the Health Solutions practice at FTI Consulting. “Jim, Julie, Kevin, Matt, Juliana, Pat and Amy bring deep industry expertise, know our clients’ businesses and enhance our ability to help them navigate through these turbulent times.”

Based in Brentwood, Tenn., Mr. Fisher is a seasoned healthcare executive with business and information technology experience. He has more than 25 years of experience working with small and large healthcare providers (inpatient and ambulatory) and a variety of adjacent businesses. Mr. Fisher’s healthcare experience includes business transformation leveraging electronic medical records, enterprise resource planning and patient accounting technology solutions. He also has experience with digital transformation, cybersecurity, outsourcing, operational process improvement and physician network optimization.

Based in San Francisco, Ms. Kliger is an experienced clinician, independent consultant and member of a health system Board of Directors. She focuses on designing and deploying domain and organizational digital transformation, business and process model improvements to optimize patient care across the continuum. She works with provider-oriented clients, nonprofit policy organizations and digital health companies.

Based in Boston, Mr. McCadden has more than 25 years of experience in the healthcare industry. He has worked with healthcare facilities across the United States, including academic medical centers, community hospitals, payers, higher education institutions, research institutions and life sciences companies. He specializes in performance improvement, finance, perioperative services, supply chain, revenue cycle, labor productivity and physician practice operations.

Based in Chicago, Mr. Leshy has more than 15 years of experience working for hospitals, large integrated networks, consultancies and managed service providers. He specializes in guiding clients through digital transformation journeys, focusing on the changing environmental landscape, applied technologies and strategic relationships.

Based in Houston, Ms. Malhotra has more than 20 years of experience advising on business strategy, revenue cycle management, supply chain and technology optimization. Her industry experience spans academic medical centers, children’s hospitals, post- and long-term acute care facilities, medical device and equipment manufacturers, and software technology companies.

Based in New York, Mr. Shafer delivers services and solutions to pharmaceutical, biotech and medical device clients. He has more than 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance.

Based in Washington, D.C., Ms. Showalter is a registered nurse with more than 25 years of experience in hospital and healthcare operations. She is a nursing executive leader with particular experience in workforce management. She has worked across the healthcare continuum in inpatient, ambulatory, post-acute and physician services. During her consulting career, Ms. Showalter led diverse cross-functional teams in organizations ranging from complex healthcare systems to critical access and stand-alone hospitals to meet financial and service goals related to patient care.

About FTI Consulting

FTI Consulting, Inc. is a global business advisory firm dedicated to helping organizations manage change, mitigate risk and resolve disputes: financial, legal, operational, political & regulatory, reputational and transactional. With more than 6,200 employees located in 28 countries, FTI Consulting professionals work closely with clients to anticipate, illuminate and overcome complex business challenges and make the most of opportunities. The Company generated $2.35 billion in revenues during fiscal year 2019. For more information, visit www.fticonsulting.com and connect with us on Twitter (@FTIConsulting), Facebook and LinkedIn.

FTI Consulting, Inc.

555 12^th Street NW
Washington, DC 20004
+1.202.312.9100

Investor
Contact
:

Mollie Hawkes
+1.617.747.1791
[email protected]

Media
Contact
:

Matthew Bashalany
+1.617.897.1545
[email protected]

Repeat dosing of 60 mg AB-729 every
8
weeks resulted in
mean
HBsAg declines
of –1.37 log10 (N=6) comparable
to AB-729 dosed every 4 weeks
(
–1.44 log10, N=7, p<0.7)

AB-729 remains generally safe and well tolerated
with no SAEs or treatment discontinuations in any cohort

WARMINSTER, Pa., Dec. 10, 2020 (GLOBE NEWSWIRE) — Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced additional clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound.

William Collier, President and Chief Executive Officer of Arbutus, stated, “Throughout 2020, Arbutus has reported data that demonstrate the robust safety and efficacy of AB-729 in multiple patient cohorts. These data support advancing AB-729 into phase 2a clinical studies in 2021 and further support our confidence in its potential to become a cornerstone drug in future combination regimens to cure chronic hepatitis B.”

Summary of new data

Repeat dosing of AB-729 60 mg every
4
and 8 weeks
results in
comparable
declines in
mean
HBsAg through week
16

Δlog10 HBsAg/(SE) (IU/ mL )	Mean (SE) Week 12	Mean (SE) Week 16	Mean (SE) Week 24
Cohort E Q4W (N=7)	-1.10 (0.15)	-1.44 (0.18)	-1.84 (0.16)
Cohort F Q8W (N=7)	-1.02 (0.11)	-1.37* (0.08)	N/A **

*Mean determined based on N=6 since one subject has not reached week 16.
**Data not yet available since none of the subjects have reached week 24.

Dr. Gaston Picchio, Chief Development Officer of Arbutus, commented, “The mean reduction in HBsAg seen at week 16 in Cohort F suggests that AB-729 could offer patients the advantage of being dosed every 8 weeks versus every 4 weeks. Further dosing should allow us to confirm this finding.”

Dr. Picchio added, “Importantly, safety continues to be unremarkable. We have not seen any related Grade 3/4 AEs or treatment-related discontinuations in any cohorts to date. In Cohort F, two subjects had asymptomatic ALT elevations not considered AEs; one subject with Grade 1 ALT elevations prior to trial entry has had intermittent Grade 2 elevations, while another subject had a transient Grade 1 elevation which resolved with continued treatment.

Further, in Cohort E, the two subjects previously reported with Grade 2 and two subjects with Grade 1 ALT elevations have improved to Grade 1 and Grade 0, respectively, after week 24. All seven subjects in the cohort have consented to continue dosing with AB-729 for an additional 6 months.” 

Summary of clinical trial design 

AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts: 
In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

About AB-729 

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About HBV

Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, please visit www.arbutusbio.com.

Forward-Looking Statements and Information

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about advancing AB-729 into phase 2a clinical studies in 2021; the Company’s suggestion that suggests that AB-729 could offer patients the advantage of being dosed every 8 weeks versus every 4 weeks, which could be confirmed via further dosing; and the potential that AB-729 could be a cornerstone drug in future combination regimens to cure chronic hepatitis B infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ clinical development programs.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information

Investors and Media

William H. Collier
President and CEO
Phone: 267-469-0914
Email: [email protected]

Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: [email protected]

/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS/

• Leveraging the
  successful launch of
  the Company’s
  RHO Phyto
  ™
  branded
  advanced
  medical cannabis
  product line
  in Canada,
  the portfolio of preparations
  ,
  including oil drops, sublingual sprays, capsules and topicals
  ,
  are now
  available
  nationwide in
  Colombia through physician prescription under the Magisterial model

• The medical program
  includes
  Avicanna’s 3
  pillars
  aimed at setting the gold standard for medical cannabis in Colombia and
  other
  Latin America
  n markets
  , including
  M
  edical community education
  ,
  A
  dvanced
  pharmaceutical
  –
  grade
  cannabinoid preparations
  and a
  C
  omprehensive patient support program

• Coinciding with the launch of the medical program, Avicanna is hosting its second Colombian symposium
  Magisterial Formulas: Advances in Cannabinoid Research, Product Offering and Patient Access
  

TORONTO, Dec. 10, 2020 (GLOBE NEWSWIRE) — Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based products announces the launch of its medical cannabis program in Colombia, under compound pharmacy legislation “Formulaciones Magistrales”, in which Avicanna will provide its standardized, industry-leading cannabinoid formulary to patients and the medical community. Additionally, this program includes the education and training of the medical community and a comprehensive patient support program.

Aras Azadian, CEO of Avicanna Inc., commented: “After 2 years of preparation, we are proud to be launching this complete program in a market that is very significant to us and to be doing so with a medical community that we have been working closely with for close to 3 years. We believe that this medical program will set the gold standard for advanced cannabinoid-based medicine in Colombia and will act as a proof of concept for planned expansions into other Latin American markets.”

The pharmaceutical cannabinoid preparations, which require physician prescription, will be commercialized through a range of business models including direct sales to patients, delivery to national pharmacies and delivery to third party medical institutions across Colombia. This comprehensive medical cannabis program is the first of its kind in Colombia to be educating and training third party health care practitioners on the efficacy of advanced cannabinoid-based medicine across various clinical indications and comorbidities and providing appropriate cannabinoid solutions. The target therapeutic areas include neurological disorders such as epilepsy, Parkinson’s disease, multiple sclerosis, psychiatric indications such as PTSD, anxiety, depression as well as chronic pain.

This first complete portfolio of advanced cannabinoid preparations comprises the same scientifically developed formulations as Avicanna’s Canadian RHO Phyto branded dosage forms including topicals, oil drops, sublingual sprays, and capsules in range of CBD only and CBD-THC ratios. The products are subjected to typical pharmaceutical drug development, including stability studies and preclinical analysis where they have demonstrated superior stability and bioavailability in comparison to basic MCT oil formulations. Avicanna continues to advance these formulations through real world evidence trials and further preclinical studies with leading Canadian institutions and clinicians. In addition to its R&D efforts, the Company continues to optimize its current formulas and expand its pipeline of products to include alternative delivery mechanisms. The active pharmaceutical ingredients for this program are sourced from Avicanna’s majority owned subsidiary Santa Marta Golden Hemp S.A.S., where the cannabinoids are extracted from organic and sustainably cultivated plants. The final preparation of these products is completed through Avicanna’s own Good Production Practices (GPP) certified pharmacy lab in Bogota through its wholly owned subsidiary Avicanna LATAM S.A.S. (“Avicanna LATAM”), which is believed to be the first of its kind to be certified for cannabinoid preparations. The education and patient support programs are also managed and operated by Avicanna’s medical team to ensure the services meet Avicanna’s quality standards and complete the full vertical integration.

“At Avicanna, our focus has always been on patients, and today, with the launch of our medical program, patients in Colombia will have access to therapeutic alternatives that may contribute to the control of their comorbidities, improving their quality of life and solving possible unmet medical needs altogether. With that, we have established ourselves as a significant contributor to the health system in Colombia, where we intend to also introduce novel pharmaceutical forms and provide optimal care,” stated Dr. Carlos Maldonado, Senior Vice President, Clinical Development at Avicanna LATAM.

Avicanna’s educational program includes health care practitioner (“HCP”) training packages, educational modules, certifications, medical symposia and real-world evidence trials. The goal of this educational program is to contribute to scientific progress through evidence generation and to equip HCPs to provide patients with optimal care. A timely component of the Company’s educational program, its upcoming event titled Magisterial Formulas: Advances in Cannabinoid Research, Product Offering and Patient Access” on December 10, 2020 at 10am EST, will officially kick off the nation program.

To register for the symposium please visit https://www.bigmarker.com/avicanna-latam-s-a-s/Simposio-de-Avicanna-Colombia-Cannabis-Medicinal

For more information regarding the Magisterial Preparations contact [email protected].

About Avicanna Inc.

Avicanna is a diversified and vertically integrated Canadian biopharmaceutical company focused on the research, development, and commercialization of plant-derived cannabinoid-based products for the global consumer, medical, and pharmaceutical market segments.

Avicanna is an established leader in cannabinoid research and development, which it primarily conducts at its R&D headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto, Canada and in collaboration with leading Canadian academic and medical institutions. In addition to its developing pharmaceutical pipeline, Avicanna’s team of experts have developed and commercialized several industry leading product lines, including:

• Pura H&W™: an advanced and clinically tested line of CBD consumer derma-cosmetic products; and,
• RHO Phyto™: an advanced line of medical cannabis products containing varying ratios of CBD and THC currently available nation-wide across Canada in partnership with Medical Cannabis by Shoppers™, a subsidiary of Shoppers Drug Mart. RHO Phyto is the first strictly medical formulary of advanced “Cannabis 2.0” products, containing oils, sprays, capsules, creams, and gels, all 2 developed with scientific rigour, manufactured under GMP standards and supported by pre-clinical data.

With ongoing clinical trials on its derma-cosmetic (Pura H&W), medical cannabis (RHO Phyto) and a pipeline of pharmaceutical products, Avicanna’s dedication to researching the important role that cannabinoids play in an increasingly wider scope of products has been at the core of the Company’s vision since its inception. Furthermore, Avicanna’s commitment to education is demonstrated through its annual medical symposium, the Avicanna Academy educational platform, and the My Cannabis Clinic patient program through its subsidiary company.

Avicanna manages its own supply chain including cultivation and extraction through its two majority-owned subsidiaries, Sativa Nativa S.A.S. and Santa Marta Golden Hemp S.A.S., both located in Santa Marta, Colombia. Through these sustainable, economical, and industrial scale subsidiaries, Avicanna cultivates, processes, and commercializes a range of cannabis and hemp cultivars dominant in CBD, CBG, THC, and other cannabinoids for use as active pharmaceutical ingredients. Avicanna’s Avesta Genetica program specializes in the development and optimization of rare cultivars for commercial production along with feminized seeds for global export. In June 2020, Avicanna made history with a shipment of hemp seeds to the United States of America by completing the first ever export of hemp seeds from Colombia.

SOURCE Avicanna Inc.

Stay Connected

For more information about Avicanna, visit www.avicanna.com, call 1-647-243-5283, or contact Setu Purohit, President by email at [email protected].

Cautionary Note Regarding Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions, and includes statements with resp
ec
t
to the ability of the
Company to
provide the Colombian population with standardized and advanced medical solutions
, the ability of
the Company and
Avicanna LATAM to
manufacture its line of advanced cannabinoid formulations
to service individual prescriptions issued by qualified medical professionals
,
the Company’s ability to set
the standard in
Colombia and other
Latin America
n countries
by offering products with years of
extensive research and development manufactured with world-class quality standards,
the ability of the unique formulations to
maintain the stability of the cannabinoids over the course of treatment
, the ability of the Company to source the cannabinoids for the manufacture of the medical cannabis products from
Santa Marta Golden Hemp S.A.S.
, the ability of the product formulations to address specific medical conditions, and the ability of
Santa Marta Golden Hemp S.A.S.
to continue to cultivate cannabis
.
Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking
information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those
projected in the forward-looking information. Such risks and uncertainties include, but are not limited to current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company’s annual information form dated April 15, 2020
and final short form prospectus
dated
November 27, 2020
, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at

www.sedar.com

.

The statements in this press release
are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

TORONTO, Dec. 10, 2020 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the Veterans Affairs San Diego Healthcare System (VASDHS) has started recruiting patients for the Phase II trial of its lead drug LSALT peptide, targeting the prevention of acute lung injury, acute kidney injury and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19.

“Acute lung injury and acute kidney injury are among the most serious consequences of COVID-19, and novel medications focused on preventing these organ failures have the potential to be life-saving. We are excited to be part of this research, and to give our Veterans the opportunity to participate in this trial,” said Dr. Mark Hepokoski, M.D. a pulmonary and critical care physician at the VASDHS and site principal investigator for the LSALT Phase II trial.

The VASDHS is the fifth hospital to be activated into the trial, joining sites in Florida and Louisiana, as well as two hospital sites in Turkey. Arch is currently exploring opportunities to add Canadian clinical sites into the trial as the number of hospitalized COVID-19 patients has grown significantly in Alberta and Ontario in recent weeks.

Hospitalizations of COVID-19 patients have been on the increase as infection rates have surged throughout the world. In the last month, California has experienced a spike in COVID-19 infection rates, with daily cases growing from approximately 3,000 cases in early October to over 25,000 daily cases. Infection rates in the U.S. are now at the highest level of the year, with over 200,000 daily cases reported this past week. COVID-19 infection rates in Turkey have similarly spiked to 30,000 daily cases, more than ten times the average daily numbers reported there in July.

About the Phase II trial for
LSALT Peptide

The Phase II trial is an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide (Metablok) as prevention of organ inflammation known to trigger acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2 (COVID-19).

The composite primary endpoint of the Phase II trial reflects the severe effects often experienced by hospitalized COVID-19 patients and deemed appropriate for LSALT peptide’s novel mechanism of action in blocking consequential inflammation in the lungs and kidneys.

Additional information about the Phase II trial can be found at:

https://clinicaltrials.gov/ct2/show/NCT04402957

The Phase II results will be used to design the Phase III trial, including greater patient numbers to more fully evaluate efficacy and safety in COVID-19 patients.

About
COVID
-19

COVID-19 is the disease caused by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. Severe complications from COVID-19 are in large part due to excessive host immune responses to the virus that result in progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care¹. Patients with severe COVID-19 also experience multiple organ dysfunction including acute kidney injury, liver dysfunction, cardiac failure, and blood abnormalities. Currently, no effective antiviral drug or specific treatment exists for SARS-CoV-2 infection. Treatment of severe COVID-19 has been primarily supportive, relying heavily on respiratory, infectious disease and critical care medicine.

Survival rates and health care system capacity could both be improved with new treatments that prevent the severe manifestations of COVID-19, such as worsening lung inflammation (ARDS) and AKI experienced by patients infected with SARS-CoV-2.

¹ J. S. Ayres, Sci. Adv 10.1126/sciadv.abc1518 (2020)

About Arch Biopartners

Arch Biopartners Inc. is a clinical stage company focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact.  Arch is developing a pipeline of new drug candidates that inhibit inflammation in the lungs, liver and kidneys via the dipeptidase-1 (DPEP-1) pathway for multiple medical indications.

For more information on Arch Biopartners, its technologies and other public documents Arch has filed on SEDAR, please visit www.archbiopartners.com

The Company has 60,782,302 common shares outstanding.

Forward-Looking Statements

All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.

The
science and medical
contents of this release have been approved by the Company’s Chief Science Officer

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain Covid-19 (or SARS-2 Coronavirus) at this time

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

For more information, please contact:

Richard Muruve
Chief Executive Officer
Arch Biopartners, Inc. 
647-428-7031
[email protected]

Both
studies
met their primary endpoint of
significantly reducing
annualized relapse rate (
ARR
)
(p<0.005 in each
study
)
with
ublituximab
demonstrating an ARR of <0.10 in
each of the
studies

Relative
reduction
s of approximately
60
%
and
50
%
in
ARR
over teriflunomide were observed in
U
LTIMATE
I
&
II,
respectively

Detailed
data presentation
targeted in 1H 2021 with a
BLA
submission
targeted mid-year 2021

Conference
call to be held today,
Thursday, December 10, 2020
at
8
:
30
AM
ET

NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced positive topline results from two global, active-controlled, Phase 3 studies, called ULTIMATE I & II, evaluating ublituximab, the Company’s investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide in patients with relapsing forms of multiple sclerosis (RMS). Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide.

The ULTIMATE I & II studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the Day 1 infusion (150mg over four hours). The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Further analyses of the ULTIMATE I & II studies including safety and secondary endpoints will be conducted and detailed data will be presented at an upcoming medical congress, targeted in first half of 2021. Additionally, data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in mid-year 2021.

Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and Global Study Chair for the ULTIMATE I & II studies commented, “B-cell targeted therapy with anti-CD20 monoclonal antibodies has dramatically shifted the treatment paradigm for patients with MS and has shown to be very effective in reducing relapses in patients. I am pleased to see such positive results from this important trial exploring a one-hour infusion of ublituximab every six months and believe, if approved, the unique attributes of ublituximab, particularly that it has been glycoengineered for enhanced antibody dependent cellular cytotoxicity, may offer benefits to patients in the RMS treatment paradigm.” Dr. Steinman continued, “MS is a chronic demyelinating disease where having a variety of treatment options within the same class has shown to be important for patients. I look forward to the full data from the ULTIMATE studies to further understand the potential of ublituximab in MS.”

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “We are so pleased to share these positive topline results for our ULTIMATE MS studies. If approved, ublituximab has the potential to offer patients a one-hour infusion, which we believe will be an attractive option for many patients with MS. With more than 1,000,000 Americans estimated to be living with MS today, there continues to be a need for efficacious and convenient treatment options.” Mr. Weiss continued, “We want to thank the patients, caregivers, doctors and research teams who participated in these studies, as well as the TG team for their efforts in helping to achieve this important milestone. We look forward to a detailed presentation of the data at a major medical meeting in the first half of 2021 once the full data are analyzed, as well as completing a BLA submission targeted for mid-next year.”

ABOUT THE ULTIMATE I & II TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The primary endpoint for each study was Annualized Relapse Rate (ARR) following 96 weeks of treatment. Secondary endpoints include total number of T1 gadolinium-enhancing lesions, total number of new and/or enlarging T2 hyperintense lesions, and time to confirmed disability progression (CDP). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

CONFERENCE CALL INFORMATION

The Company will host a conference call today, Thursday December 10, 2020 at 8:30 AM ET to discuss the ULTIMATE I & II Topline Results. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. 

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 www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.^1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.¹

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 developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), 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. Both ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its 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.

Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.   These forward-looking statements include, but may not be limited to, statements anticipating the benefits of ublituximab and projecting publication and regulatory submission timelines. Factors that could cause our actual results to differ materially include the following:  our ability to successfully deliver the complete data set from the ULTIMATE I & II trials and complete a BLA submission on schedule as planned; the risk that safety issues or trends will be observed in the ULTIMATE I & II trials when the full safety dataset is available and analyzed; the risk that secondary endpoints from the ULTIMATE I & II will not be positive; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS or, if approved, that ublituximab will not be commercially successful; other uncertainties inherent in research and development; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in our other filings with the U.S. Securities and Exchange Commission.

Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:

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

<sup>1.

 MS Prevalence. National Multiple Sclerosis Society website. 

https://www.nationalmssociety.org/About-the-Society/MS-Prevalence

. Accessed October 26, 2020.

 2.

 Multiple Sclerosis International Federation, 2013 via
Datamonitor
p. 236.</sup>