Market Newsdesk

NEW YORK and CLEVELAND, Jan. 25, 2021 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the company held a successful Type B meeting with the U.S. Food and Drug Administration (FDA) to align with the Agency on the company’s proposal regarding co-primary endpoints for the pivotal Phase 3 VIITAL™ study of EB-101 in recessive dystrophic epidermolysis bullosa (RDEB). Following the meeting, Abeona is proceeding with its plan to enroll between 10 to 15 patients with RDEB, comprising approximately 35 large chronic wound sites treated in total.

“We appreciate the clarity provided by the FDA and we are pleased to be aligned with the Agency on the co-primary endpoints for the Phase 3 VIITAL™ study,” said Michael Amoroso, Principal Executive and Chief Operating Officer of Abeona. “Following the successful completion of the FDA meeting, we continue with all necessary steps to enroll our next patient in the VIITAL™ study and aim to complete enrollment in 2021.”

The co-primary endpoints of the study are: 1) the proportion of RDEB wound sites with greater than or equal to 50% healing from baseline, comparing treated with untreated wound sites at Week 24 (Month 6) as determined by direct investigator assessment; and 2) pain reduction associated with wound dressing change assessed by the mean differences in scores of the Wong-Baker FACES scale between treated and untreated wounds at Week 24 (Month 6).

As previously announced, data from a Phase 1/2a clinical trial presented at the 2020 Society for Pediatric Dermatology Annual Meeting showed that wound healing of 50% or greater following EB-101 treatment in patients with RDEB was associated with no pain at treated sites at three-, four- and five-years post-treatment, compared with presence of pain in 53% of wound sites at baseline.

Jodie Gillon, Vice President and Chief Patient Officer of Abeona commented, “We greatly appreciate the level of clarity we received from the FDA as we continue to work with our clinical study partners at Stanford University Medical Center and patient advocacy groups to enroll additional patients in the VIITAL™ study.”

Investigators at Stanford University Medical Center are currently enrolling eligible patients into the VIITAL™ study. Additional information about the trial, including eligibility criteria, is available at https://www.abeonatherapeutics.com/clinical-trials/rdeb and https://clinicaltrials.gov/ (Identifier: NCT04227106).

About Recessive Dystrophic Epidermolysis Bullosa

Recessive dystrophic epidermolysis bullosa (RDEB) is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning type VII collagen which is necessary to anchor the dermal and epidermal layers of the skin. There is currently no approved treatment for RDEB.

About EB-101

EB-101 is an autologous, gene-corrected cell therapy currently being investigated in the pivotal Phase 3 VIITAL™ study for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. The EB-101 VIITAL™ study is a randomized clinical trial enrolling 10 to 15 RDEB patients with approximately 30 large, chronic wound sites treated in total. Treatment with EB-101 involves using gene transfer to deliver COL7A1 genes into a patient’s own skin cells (keratinocytes and its progenitors) and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. Abeona produces EB-101 for the VIITAL™ study at its fully-functional gene and cell therapy manufacturing facility in Cleveland, OH. In a Phase 1/2a clinical trial, EB-101 provided durable wound healing for RDEB patients lasting 2+ to 5+ years, including for the largest, most challenging wounds that affect the majority of the RDEB population.

About Abeona Therapeutics

Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona’s clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company’s portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical needs. Abeona’s novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona’s fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and commercial production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com.

Forward-Looking Statements

This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. These statements include statements about the Company’s aim to complete enrollment of patients in our VIITAL study in 2021. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “estimate,” “expect,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, the outcome of our announced strategic review, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the financial markets and global economic conditions, risks associated with data analysis and reporting, and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q and other periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
+1 (646) 813-4709
[email protected]

2021 objectives leverage positive momentum in Arbutus’ Hepatitis B research and development programs

WARMINSTER, Pa., Jan. 25, 2021 (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 its 2021 corporate objectives and provided a financial update.

William Collier, President and CEO, stated, “We begin 2021 on solid footing from both a pipeline and financial perspective. Our lead clinical asset, AB-729, continues to demonstrate positive data in an ongoing Phase 1a/b clinical trial and we look forward to initiating several Phase 2a clinical trials in 2021. We believe AB-729 could become a cornerstone drug in future combination regimens to cure chronic hepatitis B.” Mr. Collier added, “AB-836, our oral capsid inhibitor, is expected to enter a Phase 1a/1b clinical trial in the first half of this year.”

Summary of 2021 Corporate Objectives:

• Provide additional data from ongoing cohorts of the Phase 1a/1b clinical trial of AB-729 in the first half of 2021 (except for initial data from the 90 mg every 12 week cohort which is expected in the second half of 2021).
• Initiate a Phase 2a combination clinical trial to evaluate AB-729 in combination with Assembly Biosciences’ lead core/capsid inhibitor candidate vebicorvir (VBR) and a nucleos(t)ide reverse transcriptase inhibitor (NrtI) for the treatment of subjects with chronic HBV infection in the first half of 2021.
• Initiate two Phase 2a combination clinical trials in HBV subjects, both including AB-729 with one or more approved or investigational agents, in the second half of 2021.
• Initiate a Phase 1a/1b clinical trial of AB-836, our next-generation oral capsid inhibitor, in the first half of 2021.
• The company expects to continue to advance its research in the oral PD-L1 inhibitor, RNA-destabilizer and coronavirus programs.

Financial Update:

• Arbutus had approximately $123.3 million (unaudited) in cash, cash equivalents and investments as of December 31, 2020. The preliminary cash, cash equivalents and investments as of December 31, 2020 were calculated prior to the completion of a review by Arbutus’ independent registered public accounting firm and are therefore subject to adjustment.
• We expect our net cash burn to range from $70 to $75 million in 2021 and therefore our cash runway extends to mid-2022.

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. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About AB-836

AB-836 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleos(t)ide analogues that work by inhibiting the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by preventing the assembly of functional viral capsids. They also have been shown to inhibit the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA (cccDNA), the genetic reservoir which the virus uses to replicate itself.

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, 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 the expected receipt of additional data from ongoing cohorts of the Phase 1a/1b clinical trial of AB-729 in the first half of 2021 (except for initial data from the 90 mg every 12 week cohort which is expected in the second half of 2021); the expected initiation, in the first half of 2021, of a Phase 2a combination clinical trial to evaluate AB-729 in combination with Assembly Biosciences’ lead core/capsid inhibitor candidate vebicorvir (VBR) and an NrtI for the treatment of subjects with chronic HBV infection; the expected initiation, in the second half of 2021, of two Phase 2a combination clinical trials in HBV subjects, both including AB-729 with one or more approved or investigational agents; the expected initiation, in the first half of 2021, of a Phase 1a/1b clinical trial of AB-836; the expected continued advancement of our research in the oral PD-LE inhibitor RNA-destabilizer and coronavirus programs; our preliminary financial information as of December 31, 2020; and our expected net cash burn for 2021 and expected cash runway into mid-2022.

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; and the potential for our preliminary financial information to change in connection with the finalization of our financial results for the fourth quarter of 2020.

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]

 

TORONTO, Jan. 25, 2021 (GLOBE NEWSWIRE) — VitalHub Corp. (the “Company” or “VitalHub”) (TSXV: VHI) is pleased to announce a material licensing transaction comprising an expansion of recently-acquired subsidiary Intouch With Health’s (“Intouch”) digital health platform installation at Rotherham Foundation NHS Trust (the “Trust”).

The Rotherham NHS Foundation Trust has chosen to work with the Company to support the digital transformation of the Trust’s outpatient department and to help deliver an improved hospital experience for patients. The Trust, which manages more than 250,000 outpatient appointments every year, will deploy several digital solutions from Intouch to help overhaul the way outpatient journeys are managed for both patients and staff.

Prior to the expansion contract, the Trust had been utilizing Intouch with Health’s Flow Manager solution. Upon the success of this implementation, the Trust has now committed to extend their initial contract, increasing their adoption of the Intouch platform with the introduction of new patient-facing technology to include digital patient check-in kiosks to reduce reception queue backlog, and deploying digital patient calling screens in patient waiting areas, to enable more streamlined patient communication, in-clinic. In each case, the additional implementations contribute to the overall robustness of the Intouch’s patient visibility and operational management solutions, enabling more effective utilization of resources and improved to overall care delivery and patient experience.

The Company will be implementing these modules at Greenoaks, Rotherham Community Health Centre, and the Early Pregnancy Assessment Unit. These modules will also go-live at the Trust’s satellite site, Rotherham Community Health Centre (RCHC), which has also been refurbished to support the move for all their Ophthalmology services, allowing patients to check themselves in using VitalHub’s solution.

Central to the new technology will be the introduction of Intouch’s Flow Manager digital dashboard; a central digital hub accessible by staff that allows them to monitor the progress of each visiting patient and their location in the department throughout the duration of their appointment.

The deal comes at a crucial time for the Trust, as their need to digitally transform its outpatient department has never been greater. Increasing demands on hospital services are requiring Trusts to improve the way that outpatient journeys are managed for both patients and staff in order to increase operational efficiency; enhancing patient care and enriching patient experience. The solutions which they will implement are aimed at helping to deliver an improved hospital experience for patients whilst alleviating pressure on administrators and clinical staff.

“Flow Manager will allow our staff to manage each stage of the patient journey from a single location,” said Charlotte Smith, Project Manager at The Rotherham NHS Foundation Trust. “Giving patients the ability to self-check-in for their outpatient appointment […] will help deliver a much-improved experience for all patients when they arrive at hospital. Clearly there are multiple benefits of this platform for both patients and staff, but one of the most important benefit of the Intouch Platform is the integration it provides with our Trust EPR. Joining-up systems and processes across the Trust is key to continuing to improve the patient experience and alleviate pressure on staff.”

“This deal contributes to our continued and increased expansion within the NHS and across the UK marketplace. Our continued growth and deep market penetration in this segment is indicative of the value our customers derive from our products, and the demand existing in the market for such solutions,” said Dan Matlow, CEO of VitalHub Corp. “The Company is committed to providing unrivaled patient flow and operational visibility solutions to healthcare systems on a global basis, especially during a time when minimizing the number of patients physically present in the hospital is vital. We look forward to ongoing strength in our growth as we continue this commitment toward maximizing health system efficiencies, thereby benefiting healthcare organizations, clinicians, striving to achieve improvements in care delivery and outcomes for patients.”

ABOUT ROTHERHAM NHS FOUNDATION TRUST

Awarded Foundation Trust status in 2005, The Rotherham NHS Foundation Trust provides a wide range of health services to the people of Rotherham (population approximately 252,000) and to an increasing number of patients from further afield. The Trust was developed from the Rotherham General Hospitals NHS Trust. One of the first 35 Trusts in England and Wales to achieve NHS Foundation Trust status, it has developed a reputation as a thriving and successful organisation achieving recognition at local, regional and national levels.

The Rotherham NHS Foundation Trust is an innovative, high performing organisation which continues to develop and grow at pace. One of the most forward-thinking trusts in the UK, they are at the leading edge of health service reform and achieving outstanding results. The trust operates five sites: Rotherham Hospital, Rotherham Community Health Centre, BreathingSpace, Park Rehabilitations Centre, and Kimberworth Place.

ABOUT VITALHUB

Software for Health and Human Services providers designed to simplify the user experience & optimize outcomes.

VitalHub provides technology to Health and Human Services providers including; Hospitals, Regional Health Authorities, Mental Health, Long Term Care, Home Health, Community and Social Services. VitalHub solutions span the categories of Electronic Health Record (EHR), Case Management, Care Coordination, Patient Flow & Operational Visibility, and DOCit Mobile Apps.

The Company has a robust two-pronged growth strategy, targeting organic growth opportunities within its product suite, and pursuing an aggressive M&A plan. Currently, VitalHub serves 275+ clients across Canada, USA, UK, Australia, Qatar, and Latvia. VitalHub is based in Toronto, Canada, with an offshore development hub in Sri Lanka. The Company is publicly traded on the TSX Venture Exchange under the symbol “VHI”.

CAUTIONARY STATEMENT

This press release includes forward-looking statements regarding the Corporation and its business, which may include, but is not limited to, statements with respect to the appointment of a new directors. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity and are based on assumptions and subject to risks and uncertainties. Although the management of each entity believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding the technology industry, failure to obtain regulatory or shareholder approvals, market conditions, economic factors, the equity markets generally and risks associated with growth and competition. Although the Corporation has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Corporation undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

CONTACT INFORMATION

Dan Matlow
Chief Executive Officer, Director
(416) 727-9061
[email protected]

• Completion of Phase 1 Testing Demonstrates 91% Sensitivity and 85% Specificity
• Further Optimization Studies are Currently Being Performed and are Expected to Continue to Improve Results and Match WHO Standards
• Next Steps are Completion of Regulatory Approvals and Moving the Technology to Market as Soon as Possible

ZURICH, Switzerland, Jan. 25, 2021 (GLOBE NEWSWIRE) —  Achiko AG (SWX: ACHI, ISIN CH0522213468) along with Regenacellx.sl, announces the completion of their Phase 1 study, for the group’s patent pending, nanoparticulate DNA aptamer conjugate and diagnostic testing technology, Project Gumnuts. Following a successful in vitro study conducted in 2020 by the University of Rovira, Tarragona, Spain, the current series of studies in Spain and Indonesia were conducted by IS Global (The Barcelona Institute for Global Health), and both Riau University and Madani Pekanbaru City District Hospital, respectively.

The study conducted in Barcelona involved translating the Rovira laboratory protocol into a clinical setting using the original prototype materials. A sample of 82 participants collected over 3 months and across a range of scenarios was compared and cross-referenced against positive and negative results obtained through RT-PCR. An initial manual read yielded a result of 80% sensitivity and 63% specificity. Subsequent application of software and machine learning yielded a result of 91% sensitivity and 85% specificity.

“We are encouraged by the progress of Project Gumnuts in the field,” said Dr Michael Edel of Regenacellx.sl and Inventor of Project Gumnuts. “The chemistry offers possible advantages over other approaches especially in the areas of consumer experience, stability and cost and we’re looking forward to the further development of the technology.”

The ongoing studies in Pekanbaru, Indonesia are being conducted with both the original prototype conjugate (Barcelona study) and additionally with a new conjugate with applied improvements. To date, over 250 patient tests have been compared with results obtained through nasopharyngeal swabs with 20 to 30 more being performed each week. Using prototyping materials, the Indonesian team has successfully replicated results from Spain in the field in Pekanbaru: test results from 64 participants initially yielded 82% sensitivity and 63% specificity rates. After conducting further testing using improved pre-production materials, and further improvements in software and machine learning, is yielding additional results such as bringing testing time under 15 minutes, and further improvements in sensitivity and specificity. The Company expects further gains to be made in ensuing months.

“We’re now moving quickly to get the technology into test kits and into and through approvals, and we believe that given the progress beyond the initial prototypes, we’ll be able to deliver test kits which pass the WHO guidelines for sensitivity and specificity,” said Steven Goh, CEO of Achiko AG.

“We believe that as testing moves from point of care to point of need, the presence of the right testing technologies with the right consumer experience, available in large quantities and at the right price point, to customers at the right time, will contribute to successfully responding to and overcoming the impact of Covid-19 on society and do good in this world. That is what we’re here for.”

ABOUT ACHIKO AG

We harness ground-breaking science with innovative technology to create solutions that provide a great user experience for patients, physicians, and governing bodies alike, leading ultimately to the transformation of the healthcare industry. 

The current development of our patent pending diagnostic testing kit for Covid-19 (Project Gumnuts) provides an easy and effective way that enables people to obtain the information they need and require. Complemented by our mobile check-in app (Teman Sehat), we empower users to manage their diagnostic experiences on their own terms, safeguard their privacy, share experiences, obtain passport verification and find community.

Achiko holds exclusive commercialization rights to the technology underlying Project Gumnuts from Regenacellex.SL. It may be used to detect all types of Covid-19, but also many other pathogens. Achiko is looking forward to the completion of regulatory approval and getting the technology to market as quickly as possible, applying it in an array of test kits and other assay formats.

Headquartered in Zurich, we have offices in Hong Kong, Jakarta, Singapore, and Seoul. For more information, visit www.achiko.com

ABOUT REGENACELLX.SL

We are a regenerative medicine company working with expert clinicians and scientists in the field of stem cells and small chemicals to advance cell replacement strategies to regenerate damaged tissues of the human body. In response to the global Covid-19 pandemic, we are developing next stage technology in the testing and diagnosis of pathogens as simple kits for home use or point of care (PoC) for a range of human diseases including Covid-19. For more information, visit www.regenacellx.com/

Media contacts:

ACHIKO AG

Investor Relations
E: [email protected]

SWITZERLAND

Marcus Balogh
Farner Consulting Ltd.
E: [email protected]
T: +41 44 266 67 67

GERMANY AND AUSTRIA

Axel Mühlhaus / Dr Sönke Knop
edicto GmbH
E: [email protected]
T: +49 69 90 55 05-51

DISCLAIMER

This communication expressly or implicitly contains certain forward-looking statements concerning Achiko AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Achiko AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Achiko AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Study results expected to be presented in mid-2021

ATLANTA, Jan. 25, 2021 (GLOBE NEWSWIRE) — Antios Therapeutics, Inc. (“Antios”) today announced that it has completed the Phase 1b clinical trial of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN), in patients with chronic hepatitis B virus (HBV) infection. The Company expects to present the results of this study at an upcoming major medical conference in mid-2021.

“Despite the availability of a vaccine, HBV remains a serious global public health problem with more than 250 million people worldwide living with chronic infection,” said Gregory Mayes, chief executive officer of Antios. “Life-long treatment with nucleoside analogues can control the infection by suppressing viral replication, but it rapidly rebounds in most patients when medication is stopped. ATI-2173’s unique mechanism of action positions it as a promising clinical candidate and potential backbone treatment in a functional curative regimen for chronic HBV infection. We look forward to presenting the data to the scientific community at an upcoming medical conference.”

The placebo-controlled Phase 1b trial evaluated the safety, tolerability, pharmacokinetics, and measurable reductions in HBV viral load of multiple oral doses of ATI-2173 in 24 patients with chronic HBV infection. The patients were randomized 6:2 to three dose cohorts: 10 mg, 25 mg or 50 mg of ATI-2173 or placebo, dosed orally, once-daily for 28 days. All doses were generally well tolerated with no apparent dose relationship for occurrence of adverse events, and no serious adverse events were observed. Based on the potent viral response observed, the 25 and 50 mg doses have been selected for the next clinical study that is expected to start in early 2021. More information on the trial can be found at https://clinicaltrials.gov/ct2/show/NCT04248426?term=ATI-2173&draw=2&rank=1.

About ATI-2173

ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.

About Antios Therapeutics Inc.

Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.

CONTACTS:

Investors:

Lee Roth
Burns McClellan
[email protected]
+1 (212) 213-0006

Media:

Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan
[email protected] / [email protected]
+1 (212) 300-8315 / +1 (212) 300-8364

NEW YORK, Jan. 25, 2021 (GLOBE NEWSWIRE) — AMC Networks Inc. (“AMC Networks” or the “Company”) (Nasdaq:AMCX) today announced a proposed public offering of $500 million in aggregate principal amount of Senior Notes due 2029 (the “Senior Notes”).

AMC Networks intends to use the proceeds of the offering to redeem (i) the remaining $400 million principal amount of the Company’s 4.75% Senior Notes due December 2022 (the “2022 Notes”) at a redemption price of 100.000% and (ii) $100 million principal amount of the Company’s 5.00% Senior Notes due April 2024 (the “2024 Notes”) at a redemption price of 102.500%. This press release shall not constitute a notice of redemption with respect to the 2022 Notes or the 2024 Notes.

AMC Networks today filed a preliminary prospectus supplement with the United States Securities and Exchange Commission (the “SEC”), filed as part of an effective shelf registration statement filed with the SEC on Form S-3 under the registration statement, pursuant to which AMC Networks proposes to offer and sell the Senior Notes. The preliminary prospectus supplement and accompanying prospectus describe the terms of the offering. J.P. Morgan Securities LLC, BofA Securities, Inc., Citigroup Global Markets Inc., Mizuho Securities USA LLC, Truist Securities, Inc., Wells Fargo Securities, LLC, BNP Paribas Securities Corp., Fifth Third Securities, Inc., Morgan Stanley & Co. LLC, Scotia Capital (USA) Inc., U.S. Bancorp Investments, Inc. and Barclays Capital Inc. will act as joint book-running managers for the offering.

Before you invest, you should read the registration statement, the prospectus, the prospectus supplement and other documents filed with the SEC and incorporated by reference therein for more complete information about AMC Networks and the offering. You may get these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and accompanying prospectus for the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling +1 (866) 803-9204.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. The offering of these securities will be made only by means of the prospectus supplement and the accompanying prospectus.

AMC Networks is a global entertainment company known for its popular and critically-acclaimed content. Its portfolio of brands includes AMC, BBC AMERICA (operated through a joint venture with BBC Studios), IFC, SundanceTV, WE tv, IFC Films, and a number of fast-growing streaming services, including the AMC+ premium streaming bundle, Acorn TV, Shudder, Sundance Now and ALLBLK (formerly branded “UMC”). AMC Studios, the Company’s in-house studio, production and distribution operation, is behind award-winning owned series and franchises, including The Walking Dead, the highest-rated series in cable history. The Company also operates AMC Networks International, its international programming business, and Levity Entertainment Group, its production services and comedy venues business.  

This press release may contain statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that any such forward-looking statements are not guarantees of future performance or results and involve risks and uncertainties, and that actual results or developments may differ materially from those in the forward-looking statements as a result of various factors, including financial community and rating agency perceptions of the Company and its business, operations, financial condition and the industries in which it operates and the factors described in the Company’s filings with the SEC, including the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained therein. The Company disclaims any obligation to update any forward-looking statements contained herein.

Contacts:
Nicholas Seibert
Corporate Development and Investor Relations
646-740-5749
[email protected]

Georgia Juvelis
Corporate Communications
917-542-6390
[email protected]

VANCOUVER, British Columbia, Jan. 25, 2021 (GLOBE NEWSWIRE) — TELUS Corporation (TSX: T; NYSE: TU) announced today that its subsidiary, TELUS International (Cda) Inc. (TELUS International), has disclosed its preliminary and unaudited estimates of selected results for the three months and full year ended December 31, 2020. TELUS International has disclosed these preliminary results in connection with its previously announced initial public offering. The preliminary results are presented below.

The following information reflects preliminary estimates with respect to such results based on currently available information, is not a comprehensive statement of TELUS International’s financial results and is subject to completion of its financial closing procedures.

TELUS International’s financial closing procedures are not yet complete and, as a result, its actual results may change as a result of such financial closing procedures, final adjustments, management’s review of results, and other developments that may arise between now and the time the financial results are finalized, and results could be outside of the ranges set forth below. These estimates should not be viewed as a substitute for TELUS International’s consolidated financial statements prepared in accordance with IFRS which will be available at a later date.

Selected Financial Information (US $ millions):

	Three Months Ended December 31						Full Year Ended December 31
	2020 Estimated Range				2019 Actual		2020 Estimated Range				2019 Actual
Revenues arising from contracts with customers	$430		$445		$272.5		$1,569		$1,584		$1,019.6
Net Income	$13		$20		$27.3		$95		$102		$69.0
TI Adjusted EBITDA1	$122		$130		$63.7		$384		$392		$225.6

(1) TELUS International Adjusted EBITDA is a non-GAAP financial measure. The most comparable GAAP measure is net income and a reconciliation to net income is presented below.

	Three Months Ended December 31			Full Year Ended December 31
	2020 Estimated Range		2019 Actual	2020 Estimated Range		2019 Actual
Net Income	$20	$13	$27.3	$102	$95	$69.0
Add back (deduct):
Changes in business combination related provisions	–	–	(12.1)	(73)	(73)	(14.6)
Interest expense	10	12	8.3	44	46	36.3
Foreign exchange	(3)	(6)	(0.3)	(1)	(4)	(2.6)
Income taxes	11	18	7.7	46	53	26.0
Depreciation and amortization	49	50	24.7	181	182	92.2
Sharebased compensation expense	11	17	6.0	28	34	13.2
Restructuring and other costs	24	26	2.1	57	59	6.1
TI Adjusted EBITDA	$ 122	$ 130	$ 63.7	$ 384	$ 392	$ 225.6

About TELUS

TELUS (TSX: T, NYSE: TU) is a dynamic, world-leading communications and information technology company with $15.3 billion in annual revenue and 15.7 million customer connections spanning wireless, data, IP, voice, television, entertainment, video and security. We leverage our global-leading technology to enable remarkable human outcomes. Our longstanding commitment to putting our customers first fuels every aspect of our business, making us a distinct leader in customer service excellence and loyalty. TELUS Health is Canada’s largest healthcare IT provider. TELUS International is a leading digital customer experience innovator that designs, builds and delivers next-generation solutions for global and disruptive brands. Their services support the full lifecycle of their clients’ digital transformation journeys and enable clients to more quickly embrace next-generation digital technologies to deliver better business outcomes.

Driven by our passionate social purpose to connect all Canadians for good, our deeply meaningful and enduring philosophy to give where we live has inspired our team members and retirees to contribute more than $700 million and 1.3 million days of service since 2000. This unprecedented generosity and unparalleled volunteerism have made TELUS the most giving company in the world.

For more information about TELUS, please visit telus.com, follow us @TELUSNews on Twitter and @Darren_Entwistle on Instagram.

Investor Relations

Ian McMillan
(604) 695-4539
[email protected]

Media Relations

Steve Beisswanger
(514) 865-2787
[email protected]

VANCOUVER, British Columbia, Jan. 25, 2021 (GLOBE NEWSWIRE) — TELUS International, a subsidiary of TELUS Corporation (TSX: T; NYSE: TU), today announced it has launched a roadshow for the initial public offering (IPO) of its subordinate voting shares.

TELUS International is offering 33.33 million of its subordinate voting shares in the IPO, including 21.93 million from treasury and 11.40 million from TELUS Corporation (TELUS) and Baring Private Equity Asia, its selling shareholders. The underwriters will also have a 30-day option to purchase up to 5.0 million additional subordinate voting shares at the IPO price, less underwriting discounts and commissions. The IPO price is currently expected to be between US$23 and US$25 per share. TELUS International will list its subordinate voting shares on the New York Stock Exchange and Toronto Stock Exchange under the ticker symbol “TIXT”.

Following the IPO, TELUS is expected to hold approximately 66.6% of the combined voting power of TELUS International (68.0% if the underwriters’ over-allotment option is exercised in full) and Baring Private Equity Asia is expected to hold approximately 31.5% of the combined voting power of TELUS International (29.9% if the underwriters’ over-allotment option is exercised in full).

J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC will act as joint lead book-running managers for the IPO. Barclays, BofA Securities and CIBC Capital Markets will act as book-running managers.

The IPO will be made only by means of a prospectus. When available, a copy of the preliminary prospectus related to the offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Barclays, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by calling (888) 603-5847, or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or CIBC Capital Markets, 22 Front Street West, Mailroom, Toronto, ON, M5J 2W5, by telephone at (416) 956-3636, or by email at [email protected].

The prospectus relating to the proposed IPO of subordinate voting shares has been filed with the SEC but has not yet become effective. The preliminary prospectus contains important information relating to the subordinate voting shares and is still subject to completion or amendment. The subordinate voting shares may not be sold nor may offers to buy be accepted prior to the time the prospectus becomes effective and a receipt for the final prospectus has been issued by the Canadian regulatory authorities.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities of TELUS International, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. The IPO is subject to market conditions, and there can be no assurance as to whether or when the IPO may be completed, or as to the actual size or terms of the IPO.

About TELUS

TELUS (TSX: T, NYSE: TU) is a dynamic, world-leading communications and information technology company with $15.3 billion in annual revenue and 15.7 million customer connections spanning wireless, data, IP, voice, television, entertainment, video and security. We leverage our global-leading technology to enable remarkable human outcomes. Our longstanding commitment to putting our customers first fuels every aspect of our business, making us a distinct leader in customer service excellence and loyalty. TELUS Health is Canada’s largest healthcare IT provider. TELUS International is a leading digital customer experience innovator that designs, builds and delivers next-generation solutions for global and disruptive brands. Their services support the full lifecycle of their clients’ digital transformation journeys and enable clients to more quickly embrace next-generation digital technologies to deliver better business outcomes.

Driven by our passionate social purpose to connect all Canadians for good, our deeply meaningful and enduring philosophy to give where we live has inspired our team members and retirees to contribute more than $700 million and 1.3 million days of service since 2000. This unprecedented generosity and unparalleled volunteerism have made TELUS the most giving company in the world.

For more information about TELUS, please visit telus.com, follow us @TELUSNews on Twitter and @Darren_Entwistle on Instagram.

About TELUS International

TELUS International designs, builds and delivers next-generation digital solutions to enhance the customer experience (CX) for global and disruptive brands. The company’s services support the full lifecycle of its clients’ digital transformation journeys and enable them to more quickly embrace next-generation digital technologies to deliver better business outcomes. TELUS International’s integrated solutions and capabilities span digital strategy, innovation, consulting and design, digital transformation and IT lifecycle solutions, and omnichannel CX solutions that include content moderation, trust and safety solutions and other managed solutions. Fueling all stages of company growth, TELUS International partners with brands across high growth industry verticals, including tech and games, communications and media, eCommerce and fintech, healthcare, and travel and hospitality. Learn more at: telusinternational.com. 

Investor Relations

Ian McMillan
(604) 695-4539
[email protected]

Media Relations

Steve Beisswanger
(514) 865-2787
[email protected]