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Gossamer Bio Announces Seralutinib Meets Primary Endpoint in Phase 2 TORREY Study in PAH

Gossamer Bio Announces Seralutinib Meets Primary Endpoint in Phase 2 TORREY Study in PAH

– Primary Endpoint, Change in PVR at Week 24, Met with P-Value of 0.0310 –

– Secondary Endpoint, Change in 6MWD, Numerically Favored Seralutinib –

– Statistically Significant Improvements Observed in NT-proBNP and ECHO Measures of Cardiac Structure and Function –

– Consistently Positive Results Seen Across Pre-Specified Sub-Groups, Including Statistically Significant Placebo-Adjusted Improvements of 21% in PVR and 37 Meters in 6MWD in WHO Functional Class III Patients –

– Seralutinib was Well Tolerated and Avoided High Frequency Adverse Events Observed in the Imatinib IMPRES Study –

SAN DIEGO–(BUSINESS WIRE)–
Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced topline results for the TORREY Phase 2 study of seralutinib in patients with pulmonary arterial hypertension (PAH). Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and c-KIT, specifically designed to be delivered via dry powder inhaler for the treatment of pulmonary hypertension.

“We are very pleased to share that seralutinib significantly improved hemodynamic, biomarker, and right heart structural and functional measures in a heavily treated PAH patient population,” said Faheem Hasnain, Co-Founder, Chairman and CEO of Gossamer. “Importantly, these efficacy results were paired with a favorable safety and tolerability profile, something that has challenged past development of tyrosine kinase inhibitors in PAH.”

“Though many PAH therapeutic options have become available over the past two decades, the majority of patients are still falling short of their treatment goals,” said Dr. Raymond Benza, a Professor of Medicine in the Cardiovascular Division at the Ohio State University. “New mechanisms of action are desperately needed, and the strong concordance of the results generated in the TORREY study, particularly the impact seen on cardiac measures of disease progression, suggest that seralutinib could be an important future therapy for patients with PAH.”

“The TORREY results represent a significant step forward in unlocking the promise of safely using tyrosine kinase inhibitors to treat PAH,” said Dr. Ardeschir Ghofrani, Professor of Pulmonary Vascular Research at Justus Liebig University, Giessen, Germany and Head of the Pulmonary Hypertension Division at the University Hospital in Giessen. “The efficacy results generated with seralutinib in the context of a favorable safety and tolerability profile highlight compelling potential differentiation for seralutinib as an anti-proliferative, anti-inflammatory, and anti-fibrotic therapeutic candidate with possible reverse remodeling effects.”

TORREY Study Overview and Baseline Characteristics

The Phase 2 TORREY study enrolled 86 patients with WHO Functional Class (FC) II or III PAH, with 42 randomized to the placebo arm and 44 randomized to the seralutinib arm. The primary endpoint of the study was change from baseline to Week 24 in pulmonary vascular resistance (PVR). The secondary endpoint was change in six-minute walk distance (6MWD) from baseline to Week 24.

Patients remained on their background PAH therapies during the study. At baseline, 57% of patients were on background triple therapy, consisting of three classes of vasodilator treatments. The mean baseline PVR and 6MWD of randomized patients were ~669 dynes*s/cm5 and ~408 meters, respectively. The treatment and placebo arms were generally well balanced, except for baseline WHO Functional Class: 20 FC II and 22 FC III patients were randomized to the placebo arm, while 30 FC II and 14 FC III patients were randomized to the seralutinib arm.

Efficacy Results – PVR and 6WMD

A mean difference in PVR between the placebo and seralutinib arms of -96.1 dynes (p = 0.0310), equating to a placebo-corrected improvement of 14.3%, was observed in the study. An observed mean difference in 6MWD between placebo and seralutinib of 6.5 meters numerically favored the seralutinib arm. Changes in PVR favored seralutinib across all pre-specified patient sub-group analyses, demonstrating consistency in the hemodynamic outcomes observed in the study. Likewise, changes in 6MWD favored seralutinib in the majority of pre-specified sub-groups. Enhanced effects for both PVR and 6MWD were observed in patients with more severe baseline disease, as defined by WHO Functional Class and REVEAL 2.0 Risk Scores. In FC III patients, a 21% reduction in PVR (p = 0.0427) and 37m improvement in 6MWD (p = 0.0476) were observed for the seralutinib arm vs. placebo. In patients with a baseline REVEAL 2.0 Risk Score of 6 or greater, a 23% reduction in PVR (p = 0.0134) and 22m improvement in 6MWD (p = 0.2482) were observed for the seralutinib arm vs. placebo.

Efficacy Results – Exploratory Endpoints

Seralutinib treatment resulted in a statistically significant reduction in NT-proBNP, a biomarker of right heart stress, as early as 12 weeks, increasing to a 408.3 ng/L mean difference from placebo at Week 24 (p = 0.0012). This biomarker change was accompanied by clinically relevant and statistically significant changes for seralutinib vs. placebo in key assessments of right heart structure and function, including right atrium area, right ventricle free wall strain, and pulmonary artery compliance.

Safety and Tolerability Results

Seralutinib was generally well tolerated in the TORREY study, with treatment emergent adverse events (TEAEs) reported in 36 (86%) and 41 (93%) of the patients in the placebo and seralutinib arms, respectively. The vast majority of TEAEs reported in the study were mild to moderate in severity. In the seralutinib arm, there was one serious adverse event (SAE) related to study drug reported, while no SAEs related to study drug were reported in the placebo arm. The most frequently reported TEAE in the study was cough, reported in 16 (38%) and 19 (43%) of the patients in the placebo and seralutinib arms, respectively. Of the 19 patients reporting cough in the seralutinib arm, 17 experienced mild cough, while 2 experienced moderate cough. Of note, the most frequently reported TEAEs in the IMPRES Phase 3 study of imatinib in PAH, including nausea, peripheral edema, diarrhea, and vomiting, were observed at substantially lower frequency in the TORREY study, and reported cases were generally well balanced between the seralutinib and placebo arms. No cases of subdural hematoma were reported in the study.

Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast with Dr. Ardeschir Ghofrani and Dr. Raymond Benza to discuss the Phase 2 TORREY Study topline results today at 8:00 a.m. ET.

The live audio webcast may be accessed through the “Events / Presentations” page in the “Investors” section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Domestic Dial-in Number: 1-866-652-5200

International Dial-in Number: 1-412-317-6060

Conference Reference: Gossamer Bio Call

Live Webcast: https://edge.media-server.com/mmc/p/htbkrajp

A replay of the audio webcast will be available for 30 days on the “Investors” section of the Company’s website, www.gossamerbio.com.

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.

Forward-Looking Statements

Gossamer cautions you that statements contained in this current report regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include: the potential of seralutinib to serve PAH patients and the potential for seralutinib to be differentiated from other PAH therapies. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this current report due to the risks and uncertainties inherent in Gossamer’s business, including, without limitation: topline results Gossamer reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; potential delays in the commencement, enrollment and completion of clinical trials; comparative safety information is not based on a head-to-head comparison and differences exist between study designs and subject characteristics which could confound the results; disruption to Gossamer’s operations from the ongoing COVID-19 pandemic, including clinical trial delays and clinical site staff shortages; Gossamer’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer’s clinical trials and preclinical studies for its product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Gossamer’s ability to obtain and maintain intellectual property protection for its product candidates; Gossamer’s ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; Gossamer may use its capital resources sooner than it expects; and other risks described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

For Investors and Media:

Bryan Giraudo, Chief Operating Officer and Chief Financial Officer

Gossamer Bio Investor Relations

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Science Cardiology Biotechnology Research Pharmaceutical General Health Health Clinical Trials

MEDIA:

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Symbeo, Inc. launches latest solution for today’s AP challenges

New platform for enterprise and mid-market-size organizations drives invoice automation

PORTLAND, Ore., Dec. 06, 2022 (GLOBE NEWSWIRE) — Symbeo, Inc., a CorVel company, has launched a new version of its AP invoicing product that delivers on its promise of automation with reduced invoice processing cycle times, rapid startup, a proven ROI, and digital mailroom services for enterprise and mid-market organizations.

For decades, customers have trusted Symbeo to deliver automation with the blend of people, processes, and technology. Symbeo’s new product is cloud-based and built with powerful optical character recognition (OCR) capabilities and deep learning models, in order to swiftly and accurately extract invoice metadata for header and line item details. It works with attachments and invoices in all formats, including paper-based invoices, phone-captured images, scanned documents, and digital PDFs. End-to-end processing shares data with the customer’s enterprise resource planning (ERP) system, which eliminates redundancy during financial closing processes.

“Customers trust us to help manage their business with the right tools in order to develop a strong cash culture for growth and build toward an autonomous future. Our new product is revolutionary and blends best-in-class emerging technologies with our focused industry expertise. While our customer experience has improved, our commitment to accuracy, touchless automation, and turnaround time are unwavering.” — Tomika A. Russell, President of Symbeo

Symbeo’s latest solution contributes to a modern work environment with automated approvals, centralized controls, and the agility to quickly respond to environmental factors. Customers can grow their business, reduce cycle times, and manage transparency throughout the value chain.

About Symbeo
Symbeo helps businesses everywhere achieve true AP automation. As an industry leader for over 30 years, we remove the manual invoice processing burden with intelligent OCR, AI, and enhanced machine learning solutions that eliminate tedious functions and streamline the P2P ecosystem. In harnessing the power of automation, we create a paperless environment that helps our customers achieve sustainability goals and focus on what matters most. Learn more at symbeo.com or call us today at 888.722.6663.

Press contact: Melissa Storan
CorVel Corp.
[email protected]
www.symbeo.com



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Lucira and Loch Lomond Villa Announce Clinical Study to Tackle Tripledemic With First and Only Combination COVID-19 and Flu OTC Molecular Self-Test

With 99% accuracy and within 30 minutes, institutions will simultaneously and accurately test residents, health workers and visitors for COVID-19 and Flu A/B

  • Lucira COVID-19 & Flu Test is the first and only combination over-the-counter (OTC) self-test with fast, molecular lab-quality results enabling mass testing of symptomatic residents, staff and visitors amid the aggressive COVID-19 and flu season in Canada.
  • Lucira’s 99% accurate, differential molecular test can detect Influenza A/B and all strains of COVID-19 earlier in an infection.
  • On-site assessment (as little as 11-mins for positive status up to 30-min for result confirmation) will minimize result turnaround time and improve resident health management pathways at Loch Lomond Villa.

EMERYVILLE, Calif., Dec. 06, 2022 (GLOBE NEWSWIRE) — Lucira Health, Inc. (Nasdaq: LHDX) (“Lucira Health” or “Lucira”), a medical technology company, and Loch Lomond Villa, one of New Brunswick’s largest long-term health facility operators announced today a clinical study to simultaneously test residents, medical and support staff, and visitors for COVID-19 and Influenza A/B infection with the Lucira COVID-19 & Flu Test.

This pilot will significantly enhance testing and tracking capabilities at Loch Lomond Villa, while allowing medical staff to conduct a comparative and observational study that will help assess the effectiveness of Lucira’s testing platform in managing and minimizing COVID-19 and Influenza A/B outbreaks in long-term care settings. Lucira’s COVID-19 & Flu Test, the first and only 99% accurate molecular self-test, can provide immediate testing and accurate PCR (polymerase chain reaction) test results for all three viruses.

“Effective testing is the first line of defense in managing respiratory outbreaks,” said Loch Lomond Villa Chief Executive Officer, Ms. Cindy Donovan. “The ability of Lucira’s platform to simultaneously test for influenza A/B and COVID-19 has the potential to make a huge difference to our residents and staff. We look forward to analyzing and reporting the results.”

“Lucira’s test means that Canadians no longer need to trade-off speed for accuracy when testing for infection,” said Erik Engelson, President and Chief Executive Officer of Lucira Health. “This is the only portable molecular self-test for COVID-19 and the flu on the market, providing lab-quality test results, at home and work, in hospitals or while travelling.”

The Lucira COVID-19 & Flu Test is also available for direct purchase by Canadians on Lucira’s website: lucirahealth.ca.

About Lucira COVID-19 & Flu Test

The Lucira COVID-19 & Flu Test is a NAAT test utilizing the same platform and device design as Lucira’s COVID-19 Test to provide independent diagnoses for COVID-19, Flu A, and Flu B. The single-use test fits in the palm of your hand, runs on two AA batteries, and with one nasal swab, provides a positive or negative result for COVID-19, Flu A, and Flu B in 30 minutes or less. Each Lucira test is packaged with everything needed to run a single test: the test device, two AA batteries, sample vial, swab, and simple instructions. There is no separate reader or instrument to purchase and maintain.

About Lucira Health

Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. Beyond its already commercialized COVID-19 and COVID-19 & Flu Tests, Lucira is working on new diagnostic tests for respiratory infections and other categories including women’s health and sexually transmitted infections (STIs). For more information, visit www.lucirahealth.com.

About Loch Lomond Villa

Loch Lomond Villa officially opened its doors in 1973, thanks to the vision and support of East Saint Johns Simonds Lions Club, who foresaw the need for a complete life-care centre for the Saint John area senior population. Loch Lomond Villa’s person-centered approach means providing individualized care for all residents and applying the highest standards of care to everything we do. We are focused on the elements of care and support that matter most to residents and their families. In October of 2019, Loch Lomond Villa was awarded Gold Certification for Excellence in Person-Centered Care by Planetree International. This Person-Centered Care Certification recognizes Loch Lomond Villa’s achievement and innovation in the delivery of person-centered care. Loch Lomond Villa is one of only 90 healthcare organizations worldwide to receive the Person-Centered Care Gold Certification since the program’s launch in 2007. Loch Lomond Villa is also accredited through Accreditation Canada with exemplary status.

Media:

English Canada Media: Holly Windler [email protected]– +1 619-929-1275

Québec & Francophone Media: Martin Croteau [email protected] – 418-956-6898

Investor Relations:

Greg Chodaczek [email protected] – 347-620-7010

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5881b5b9-52d8-4c9a-a0f2-32b880928555



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Good Supply Cannabis Brand Launches ‘Peppermint Phatty’

New 510 Thread Vape Cartridge Now Available Across Canada

TORONTO, Dec. 06, 2022 (GLOBE NEWSWIRE) — Tilray Brands, Inc. (“Tilray” or the “Company”) (Nasdaq: TLRY; TSX: TLRY), a leading global cannabis-lifestyle and consumer packaged goods company, announced today the launch of Peppermint Phatty 510 vape, the newest addition to the Good Supply vape lineup.

Just in time for the holidays, Peppermint Phatty is packed with peppermint and vanilla aromas and topped off with a slight cooling sensation. These 1g 510 cartridges deliver our most potent vape yet and provide a refreshing touch with every minty pull.

“With the launch of Peppermint Phatty, our most refreshing tasting vape yet, customers can expect the same features like high quality cartridges and innovative flavour formulations that have made Good Supply so recognizable and respected among Canadian cannabis enthusiasts,” said Michelle Morin, Brand Manager.

Good Supply’s Peppermint Phatty vape is now available across Canada.

About Good Supply

Good Supply is one of Canada’s leading cannabis brands in flower, pre-rolls, vapes, concentrates, and has become a favourite among consumers and budtenders. At Good Supply good is the new great. Rooted in classic strains that punch above their weight, Good Supply has been one of the top-selling brands in the concentrates and pre-roll category within Canada and is known for its innovative take on its products across its expansive portfolio.

To learn more about Good Supply, visit www.goodsupplycannabis.com and follow @goodsupplycannabis.

About Tilray Brands

Tilray Brands, Inc. (Nasdaq: TLRY; TSX: TLRY), is a leading global cannabis-lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people’s lives for the better – one person at a time. Tilray Brands delivers on this mission by inspiring and empowering the worldwide community to live their very best life and providing access to products that meet the needs of their mind, body, and soul while invoking wellbeing. Patients and consumers trust Tilray Brands to deliver a cultivated experience and health and wellbeing through high-quality, differentiated brands and innovative products. A pioneer in cannabis research, cultivation, and distribution, Tilray’s unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on Tilray, visit Tilray Brands, Inc. and follow @tilray on Instagram, Twitter, Facebook, and LinkedIn.

__________
Forward-Looking Statements

Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian securities laws and 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, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ability to commercialize new and innovative products worldwide. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.

Contacts:

Tilray Global:
Kaitlin Macapagal
[email protected]

Investors
Raphael Gross
203-682-8253
[email protected]



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View Announces the Deployment of Smart Building Cloud Across BentallGreenOak’s Canadian Portfolio

MILPITAS, Calif., Dec. 06, 2022 (GLOBE NEWSWIRE) — View, Inc. (Nasdaq: VIEW), a leader in smart building technologies, today announced that BentallGreenOak (“BGO”) has deployed the Smart Building Cloud across 45 properties spanning 12 million square feet in their Canadian portfolio, with plans for future expansion to approximately 115 properties in total. The deployment is part of a deepening partnership between the two companies to accelerate the digital transformation of real estate.

View created the Smart Building Cloud to enable real estate technology teams to rapidly connect, operate, and optimize a portfolio of smart buildings with strong cybersecurity protection and maximum flexibility. The open, secure platform is comprised of modular hardware and software components that enable IT, OT and digital innovation teams to securely consolidate and normalize building data from across their entire portfolio into a cloud-based environment, and drive business outcomes such as reduced energy consumption and more efficient facilities management with pre-configured insights and automation.

BGO initially deployed the cybersecurity solutions in the View Smart Building Cloud to secure its buildings, gain visibility into network activity, and provide third-party vendors with secure, auditable remote access to building networks, devices, and systems, dramatically reducing operational costs. Now the company is expanding this deployment across its portfolio and is taking advantage of additional capabilities including automated device discovery to gain greater visibility into noncompliant devices running on its networks. BGO is also using View’s edge compute capabilities to address more advanced use cases requiring large amounts of data.

“View is on a mission to accelerate the digital transformation of real estate to make buildings healthier, more sustainable, and easier to operate,” said Nitesh Trikha, Chief Product Officer with View. “BGO is a pioneer in the industry, and we’re thrilled to deepen our partnership.”

The Smart Building Cloud can be deployed in both new and existing buildings, and in conjunction with or independently of View Smart Windows, View’s flagship product that uses artificial intelligence to optimize access to natural light and outdoor views while keeping occupants comfortable. Every View Smart Window installation comes with an extensible OT network, which supports a wide variety of smart building devices and applications and serves as the foundation for a complete smart building technology stack.

About View

View delivers optimal human experiences in buildings. We started by revolutionizing something that hadn’t changed for centuries—the simple window—and in so doing, built the only complete, modular, cloud-native platform to deliver on the promise of smart buildings. View Smart Glass and the Smart Building Cloud transform new and existing buildings into responsive environments that continuously adjust to meet human needs for natural light, connection to nature, fresh air, and comfortable temperatures while improving energy efficiency and increasing profits for building owners and their tenants. Today, View’s products are deployed in offices, apartments, life science facilities, airports, hospitals, schools, hotels. Learn more at www.view.com.

About BentallGreenOak

BentallGreenOak is a leading, global real estate investment management advisor and a globally recognized provider of real estate services. BGO serves the interests of more than 750 institutional clients with approximately $78 billion USD of assets under management (as of March 31, 2022) and expertise in the asset management of office, industrial, multi-residential, retail and hospitality property across the globe. BGO has offices in 28 cities across thirteen countries with deep, local knowledge, experience, and extensive networks in the regions where we invest in and manage real estate assets on behalf of our clients in primary, secondary and co-investment markets. BGO is a part of SLC Management, which is the alternatives asset management business of Sun Life.

The assets under management shown above includes real estate equity and mortgage investments managed by the BGO group of companies and their affiliates, and as of 1Q21, includes certain uncalled capital commitments for discretionary capital until they are legally expired and excludes certain uncalled capital commitments where the investor has complete discretion over investment.

For more information, please visit www.bentallgreenoak.com.

Contact:

Deepak Shivaprasad

View, Inc.

408-691-2081

[email protected]



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Sencinet Locks in 5-Year HTS Capacity Commitment on Telesat’s Telstar 19 VANTAGE Satellite

OTTAWA and SÃO PAULO, Brazil, Dec. 06, 2022 (GLOBE NEWSWIRE) — Telesat (NASDAQ and TSX: TSAT), one of the world’s largest and most innovative satellite operators, and Sencinet, a leading integrator of managed services and solutions, today announced Sencinet’s 5-year high-throughput satellite (HTS) capacity commitment to modernize and expand the Petrobras oil and gas connectivity network.

The innovative design of Telesat’s Telstar 19 VANTAGE satellite was a key differentiator in the managed solution that Sencinet designed to win the Petrobras connectivity network contract. A high-power Ku-band spot beam will provide very high throughputs at a lower cost-per-bit in the Brazilian Pre-salt oil region, where the greatest concentration of Petrobras’ data traffic occurs. This, combined with a wide regional Ku-beam on the same satellite will connect refineries and other enterprise locations throughout the country.

“We congratulate Sencinet on winning this competitive procurement and for making Telstar 19 VANTAGE a key component of its solution for Petrobras,” stated Glenn Katz, Telesat’s Chief Commercial Officer. “As valued partners for nearly two decades, Sencinet and Telesat have been collaborating and engineering cutting-edge solutions, creating important operational and commercial advantages for enterprise customers in Brazil.”   

“With an optimal 63°W orbital location over Brazil, Telstar 19 VANTAGE provides Petrobras with unsurpassed performance and efficiency,” stated Jayme Ribeiro, Sencinet’s Executive Director of Sales and Marketing. “Additionally, our state-of-the-art hub investments leveraged in this solution provides growth capabilities for Petrobras as well as other enterprise customers in the region.”

About Telesat

Backed by a legacy of engineering excellence, reliability and industry-leading customer service, Telesat (NASDAQ and TSX: TSAT) is one of the largest and most successful global satellite operators. Telesat works collaboratively with its customers to deliver critical connectivity solutions that tackle the world’s most complex communications challenges, providing powerful advantages that improve their operations and drive profitable growth.

Continuously innovating to meet the connectivity demands of the future, Telesat Lightspeed, the company’s Low Earth Orbit (“LEO”) satellite network, will be the first and only LEO network optimized to meet the rigorous requirements of telecom, government, maritime and aeronautical customers. Telesat Lightspeed will redefine global satellite connectivity with ubiquitous, affordable, high-capacity links with fibre-like speeds. For updates on Telesat, follow us on Twitter @Telesat, LinkedIn, or visit www.telesat.com.

About Sencinet

Sencinet is an integrator of solutions and managed services, which operates in the corporate market of medium and large companies. And it has been designing and delivering mission-critical communications solutions throughout Latin America for decades.

Its portfolio of SDWAN products and services, security, hybrid clouds, satellites and networks are designed to solve the connectivity and security challenges of companies.

These four components allow the design of solutions to the extent that they guarantee the best conditions to allow the digitization of companies, the evolution of corporate networks and Internet and cloud applications, with the highest levels of security. For more information, visit www.sencinet.com.

Media Contacts:

Lynette Simmons
Telesat
+1 613 748 8729
[email protected]

Luciana Faggin
Sencinet
+55 11 99164-5954
[email protected]

Forward-Looking Statements Safe Harbor

This news release contains statements that are not based on historical fact, including financial outlook for 2022 and are “forward-looking statements’’ within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. When used herein, statements which are not historical in nature, or which contain the words “will,” or similar expressions, are forward-looking statements. Actual results may differ materially from the expectations expressed or implied in the forward-looking statements as a result of known and unknown risks and uncertainties. All statements made in this press release are made only as of the date set forth at the beginning of this release. Telesat Corporation undertakes no obligation to update the information made in this release in the event facts or circumstances subsequently change after the date of this press release.

These forward-looking statements are based on Telesat Corporation’s current expectations and are subject to a number of risks, uncertainties and assumptions. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond Telesat Corporation’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. Known risks and uncertainties include but are not limited to: inflation, risks associated with operating satellites and providing satellite services, including satellite construction or launch delays, launch failures, in-orbit failures or impaired satellite performance; the impact of COVID-19 on Telesat Corporation’s business and the economic environment; the ability to deploy successfully an advanced global LEO satellite constellation, and the timing of any such deployment; the availability of government and/or other funding for the LEO satellite constellation; the receipt of proceeds in relation to the re-allocation of C-band spectrum; volatility in exchange rates; the ability to expand Telesat Corporation’s existing satellite utilization; and risks associated with domestic and foreign government regulation. The foregoing list of important factors is not exhaustive. Investors should review the other risk factors discussed in Telesat Corporation’s annual report on Form 20-F for the year ended December 31, 2021, that was filed on March 18, 2022, and the Form 6-K reports filed for the first three, six and nine month periods of 2022, with the United States Securities and Exchange Commission (“SEC”) and the Canadian securities regulatory authorities at the System for Electronic Document Analysis and Retrieval (“SEDAR”), and may be accessed on the SEC’s website at www.sec.gov and SEDAR’s website at www.sedar.com.

 



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OneWater Marine Inc. Completes the Acquisition of Harbor View Marine

Acquisition reinforces geographic positioning in the Florida Gulf Coast Market

BUFORD, Ga., Dec. 06, 2022 (GLOBE NEWSWIRE) — OneWater Marine Inc. (NASDAQ: ONEW) (“OneWater” or “the Company”) announced today that it has completed the previously announced acquisition of Harbor View Marine. The transaction expands the Company’s presence in the Gulf Coast region and enhances new and pre-owned boat sales, finance, and parts and services offerings.

“We are thrilled to welcome Harbor View Marine and their loyal, local following to the OneWater family. The acquisition strengthens our presence in the Gulf Coast market and expands our portfolio with their suite of iconic brands and full-service offerings.” said Austin Singleton, Chief Executive Officer for OneWater.

About OneWater Marine Inc.

OneWater Marine Inc. is one of the largest and fastest-growing premium marine retailers in the United States. OneWater operates a total of 100 retail locations, 12 distribution centers/warehouses and multiple online marketplaces in 20 different states, several of which are in the top twenty states for marine retail expenditures. OneWater offers a broad range of products and services and has diversified revenue streams, which include the sale of new and pre-owned boats, finance and insurance products, parts and accessories, maintenance, repair and other services.

Cautionary Statement Concerning Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including regarding our strategy, future operations, financial position, prospects, plans and objectives of management, growth rate and its expectations regarding future revenue, operating income or loss or earnings or loss per share. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “will be,” “will likely result,” “should,” “expects,” “plans,” “anticipates,” “could,” “would,” “foresees,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “outlook” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. These forward-looking statements are not guarantees of future performance, but are based on management’s current expectations, assumptions and beliefs concerning future developments and their potential effect on us, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. Our expectations expressed or implied in these forward-looking statements may not turn out to be correct.

Important factors, some of which are beyond our control, that could cause actual results to differ materially from our historical results or those expressed or implied by these forward-looking statements include the following: effects of industry wide supply chain challenges and our ability to maintain adequate inventory, changes in demand for our products and services, the seasonality and volatility of the boat industry, our acquisition and business strategies, the inability to comply with the financial and other covenants and metrics in our credit facilities, cash flow and access to capital, effects of the COVID-19 pandemic and related governmental actions or restrictions on the Company’s business, risks related to the ability to realize the anticipated benefits of any proposed or recent acquisitions within the anticipated time frame if at all, including the risk that proposed or recent acquisitions will not be integrated successfully, the timing of development expenditures, and other risks.

More information on these risks and other potential factors that could affect our financial results is included in our filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of our Annual Report on Form 10-K for the fiscal year ended September 30, 2021 and in our subsequently filed Quarterly Reports on Form 10-Q, each of which is on file with the SEC and available from OneWater Marine’s website at www.onewatermarine.com under the “Investors” tab, and in other documents OneWater Marine files with the SEC. Any forward-looking statement speaks only as of the date as of which such statement is made, and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether because of new information, future events, or otherwise.

Investor or Media Contact:

Jack Ezzell
Chief Financial Officer
[email protected]



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BioRestorative Therapies Announces SBIR Phase I Grant to Explore the Therapeutic Effects of ThermoStem® Targeting Polycystic Ovary Syndrome as an Indication

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MELVILLE, N.Y., Dec. 06, 2022 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has been awarded a Small Business Innovation Research (SBIR) Phase I grant from the Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health. This collaborative research will be conducted in partnership with Dr. Sheng Wu, Associate Professor, Center for Metabolic Disease Research at Temple University, School of Medicine, Dr. Wu has received numerous national and international awards such as the Women in Endocrinology Young Investigator Award, Eugenia Rosemberg Abstract Award, Early Investigator Award from the Endocrine Society; Virendra B. Mahesh Award of Excellence in Endocrinology, and Endocrinology and Metabolism Section New Investigator Award from American Physiology Society.

The specific objective of this NIH grant is to enable the development and evaluation of the Company’s ThermoStem® program for the treatment of polycystic ovary syndrome (PCOS). Therapeutic brown adipocyte transplantation is an emerging and novel therapy for PCOS. BRTX has developed proprietary methods for the generation of metabolically active brown adipocytes.

“This new indication will expand BioRestorative’s current discovery pipeline focused on the novel brown fat therapy at the intersection of innate, adaptive metabolic regulation and women’s health. Our industry expertise in brown fat complements world class research conducted by Dr. Wu’s laboratory and thus strengthen our commitment to discover innovative solutions for patients with unmet medical needs.” said Lance Alstodt, CEO of BioRestorative Therapies.

PCOS affects 6-18% of reproductive age females, representing the most common endocrine disease in women and a $4.36 billion healthcare cost annually in the US. PCOS causes gynecological, dermatologic and metabolic comorbidities, and also imposes long-term risks of diabetes mellitus type 2 (T2D), cardiovascular diseases (CVD) and psychiatric problems including severe depression.

PCOS is commonly associated with metabolic disorders, with 50-70% of PCOS patients showing insulin resistance and 10% with T2D, implying a potential causative link between them. Current standard of care includes lifestyle changes and multiple lines of medications with aims to relieve symptoms. Medications usually have moderate success rates, and have limited effects and long-term risks of T2D, CVD and psychiatric problems

“There is a tremendous gap in the understanding of the metabolic dysfunction of PCOS and the underlying mechanisms remain largely incomplete. In addition, the development of more efficient, even personalized therapeutic strategies for the metabolic management of PCOS patients persists as an unmet need. ThermoStem® may provide a therapeutic option,” said Francisco Silva, Vice President of Research and Development of BioRestorative Therapies.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

• Metabolic Program (ThermoStem®): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. 

Forward-Looking Statements

This press release contains “forward-looking statements” 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 such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company’s latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Email: [email protected] 



Posted on

FLJ Group Limited and Quhuo Limited Signed Cooperation Framework Agreement

SHANGHAI, China, Dec. 06, 2022 (GLOBE NEWSWIRE) — FLJ Group Limited (NASDAQ: FLJ) (the “Company”), a leading technology-driven long-term apartment rental platform in China, today signed a cooperation framework agreement (the “Agreement”) with Quhuo Limited (“Quhuo”), a leading gig economy platform focusing on community-centered services in China. Under the Agreement, two parties will establish a continuing, stable and solid joint partnership and work together to provide their respective customers with integrated services across areas such as apartment rental, community service and platform development and expansion.

Leveraging its large apartment network, the Company will provide customized rental apartments (including centralized or dispersed apartments based on Quhuo’s need) to Quhuo’s large workforce to address their housing needs. On the other hand, Quhuo will provide comprehensive value-adding services such as delivery, cleaning and facilities maintenance to the Company’s tenants.

Looking forward, both parties are confident that they will be able to optimize their respective technology-driven and platform-based strength in workforce operational solutions and rental solutions and solidify their leading positions in respective fields. Working closely together, both parties will continue to provide more comprehensive services to their customers and achieve growth mutually.

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements 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 as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company and its subsidiaries’ (collectively, the “Group”) operations and business outlook contain forward-looking statements. Such statements involve certain risks, uncertainties and other factors that could cause actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, but are not limited to the following: the Group’s ability to access financing on favorable terms in a timely manner and maintain and expand its cooperation with financial institutions; the Group’s ability to continue as a going concern in the future or achieve or maintain profitability; the Group’s ability to effectively respond to the challenges and uncertainties resulting from the COVID-19 pandemic and other outbreaks and catastrophes; the Group’s ability to manage its growth; the Group’s ability to integrate strategic investments, acquisitions and new business initiatives; the Group’s ability to control the quality of its operations, including the operation of the rental apartments managed by its own apartment managers or by third-party contractors; the Group’s ability to attract and retain tenants and landlords, including tenants and landlords from its acquired lease contracts; the Group’s ability to resolve disputes with third parties; the Group’s ability to manage its brand and reputation; the Group’s goal and strategies; the Group’s limited operating history; the Group’s ability to compete effectively; and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in the Group’s filings with the U.S. Securities and Exchange Commission. Except as required by law, the Group does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

About FLJ Group Limited

FLJ Group Limited is a leading technology-driven long-term apartment rental platform in China. The Company offers young, emerging urban residents conveniently-located, ready-to-move-in, and affordable branded apartments as well as facilitates a variety of value-added services. The Company leverages advanced IT and mobile technologies to manage rental apartments in various cities in China. Technology is the core of the Company’s business and is applied to its operational process from apartment sourcing, renovation, and tenant acquisition, to property management. The focus on technology enables the Company to operate a large, dispersed, and fast-growing portfolio of apartments with high operational efficiency and deliver a superior user experience.

For investor and media inquiries, please contact:

FLJ Group Limited

E-mail: [email protected]

Christensen

In China
Mr. Rene Vanguestaine
Phone: +86-10-5900-1548
E-mail: [email protected]
In the U.S.
Ms. Linda Bergkamp
Phone: +1-480-614-3004
Email: [email protected]



Posted on

Agios Appoints Tsveta Milanova as Chief Commercial Officer

CAMBRIDGE, Mass., Dec. 06, 2022 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the appointment of Tsveta Milanova to the role of chief commercial officer, effective Jan. 3, 2023. Ms. Milanova will succeed Richa Poddar, who has been with Agios since 2016 and will continue to serve as the company’s chief commercial officer until the end of the year.

“Tsveta brings deep expertise in launching and commercializing medicines in rare disease and hematology, as well as international operations and global market access experience that will be a tremendous asset for Agios as we expand the reach and impact of our rare disease portfolio and work toward approvals in new indications and geographies,” said Brian Goff, chief executive officer at Agios. “Her leadership and strategic insights have contributed to the exponential growth of leading global biopharmaceutical companies and have helped to maximize the positive impact of innovative products for patient communities. I am thrilled she is joining the Agios team and look forward to her contributions to shaping our bright future.”

“I am tremendously grateful to Richa for her work at Agios over the past six years,” continued Mr. Goff. “During her time with the company, she has displayed remarkable versatility, effectively taking on roles in corporate strategy and business development, oncology portfolio management and commercial leadership. She seamlessly led the transition of the company’s oncology assets following the divestiture of our oncology business and has been leading the launch of our first rare disease medicine. She has been instrumental in helping make Agios what it is today.”

Ms. Milanova joins Agios with two decades of experience in commercial leadership and global market access in the biopharmaceutical industry. She spent five years at Alexion in high-impact commercial and market access roles, including senior vice president, head of U.S. commercial; senior vice president, global commercial strategy; and senior vice president, global value, access and policy. Prior to Alexion, she spent more than ten years at Celgene in roles of increasing responsibility in global pricing and market access, most recently as global head, pricing and market access for the hematology and oncology division. She holds a master of science (MSc) degree in international health policy and health economics from the London School of Economics, a master of science (MSc) degree in pharmacy from the Medical University of Sofia, Bulgaria and is a graduate of Harvard’s Advanced Management Program.

“With the approval of its first-in-class PK activator in adults with pyruvate kinase (PK) deficiency in the U.S. and EU, and the ongoing pivotal trials of the same medicine in thalassemia, pediatric PK deficiency and sickle cell disease, Agios has a special opportunity to make a transformative impact in multiple rare blood disorders with profound unmet need,” said Ms. Milanova. “I look forward to working with the Agios team to continue advancing the PK deficiency launch while building and expanding commercial capabilities to support potential expansion into additional indications. PK activation is a promising therapeutic approach for a number of rare hemolytic and acquired anemias, and I am excited to work toward improving the lives of people with these conditions.”

About Agios

Agios is a biopharmaceutical company that is fueled by connections. The Agios team cultivates strong bonds with patient communities, healthcare professionals, partners and colleagues to discover, develop and deliver therapies for rare diseases. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for adults with PK deficiency, the first disease-modifying therapy for this rare, lifelong, debilitating hemolytic anemia. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. In addition to its clinical pipeline, Agios has multiple investigational therapies in preclinical development and deep scientific expertise in classical hematology. For more information, please visit the company’s website at www.agios.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the expected benefits of Ms. Milanova’s appointment and Agios’ strategic plans and focus. The words “anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,” “potential,” “possible,” “strategy,” “will,” “vision,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios’ current expectations and beliefs. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including, without limitation risks and uncertainties related to: the impact of the COVID-19 pandemic on Agios’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of future approved products, and launching, marketing and selling future approved products; Agios’ results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures and competitive factors; Agios’ ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios’ ability to establish and maintain collaborations; the failure of Agios to receive milestone or royalty payments related to the sale of its oncology business, the uncertainty of the timing of any receipt of any such payments, and the uncertainty of the results and effectiveness of the use of proceeds from the transaction with Servier; and general economic and market conditions. These and other risks are described in greater detail under the caption “Risk Factors” included in Agios’ public filings with the Securities and Exchange Commission. While the list of factors presented here is considered representative, this list should not be considered to be a complete statement of all potential risks and uncertainties. Any forward-looking statements contained in this press release are made only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect developments or information obtained after the date hereof and disclaim any obligation to do so other than as may be required by law.

Investor & Media Contact:

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