Market Newsdesk

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Full Circle TMS, a supplier of transportation management software (TMS) for carriers and brokers in the expedite, hot-shot and truckload market, has natively integrated FourKites’ market-leading global, multimodal real-time transportation visibility platform into the Enterprise version of their TMS. This new integration delivers third-party logistics providers, brokers and shippers real-time, accurate data on shipment transit times, location, and status.

Growing supply-chain complexity has increased the need for improved visibility on shipments. With this integration, Enterprise TMS users, which include hundreds of expedite, hot-shot and truckload carriers and brokers, can easily send updated shipment status information via FourKites to shippers from within the Full Circle TMS platform. The integration allows them to improve tracking and exception management, reduce costs associated with missing delivery windows, and provide world-class tracking experiences to their shipping customers.

“Our TMS subscribers constantly must give their customers accurate and timely information about the status of their time critical shipments,” said Stuart Sutton, President & CEO of Full Circle TMS. “Our integration with FourKites provides tremendous value to our Enterprise TMS customers. Shipment information, like vehicle position, arrivals, departures and supporting documentation seamlessly flow from the integrated driver productivity app, Circle Mobile, through the TMS out to the shipper in real time. With FourKites, shippers and logistics providers can quickly activate tracking, notifications for exceptions, and get precise ETAs. This integration enhances our Enterprise TMS offering which is a clear win for our subscribers who can expand their market to a whole new set of shippers.”

FourKites’ integration with Full Circle TMS Enterprise level software provides users with instant and normalized carrier data, including transit times, location and status of shipments, directly from capacity providers within the FourKites network.

“We love how Full Circle TMS makes it easy for us to provide real-time shipment transparency and visibility to our shippers,” says Jim Noble, Chief Operating Officer of Issa Logistics. “The TMS has all sorts of visibility integrations for shippers, and the FourKites integration is just another way the ingenious minds at Full Circle TMS keep our company on the leading edge of technology. Now, if a shipper says they will only give me business if I integrate with FourKites, I can easily say YES!”

“With the constant pressure on global supply chains for real-time data, carriers of all sizes are fielding customer demands for more transparency throughout the lifecycle of a shipment,” said Mathew Elenjickal, Founder and CEO of FourKites. “Together with shipment information from Full Circle TMS, our predictive visibility platform leverages machine learning and advanced analytics to provide supply chain professionals with the real-time data needed to make informed, trusted decisions, and to remain agile in the face of any circumstance.”

About Full Circle TMS

Full Circle TMS (www.fullcircletms.com) is web-based, transportation management software (TMS) including customer relationship management, compliance management, order entry (including EDI), rating, planning, dispatch operations, integrated driver mobile app, customer portal, driver portal, carrier portal, fleet management, driver planning, load board, bid board, business process automation with visual workflow, document management and integrations to many 3^rd party applications, all in one integrated system. The TMS is designed to improve the productivity and profitability of transportation companies and grow their businesses. To learn more, visit www.FullCircleTMS.com.

About FourKites

FourKites is the largest predictive supply chain visibility platform, delivering real-time visibility and predictive analytics for the broadest network of Global 1000 companies and third-party logistics firms. Using a proprietary algorithm to calculate shipment arrival times, FourKites enables customers to lower operating costs, improve on-time performance and strengthen end-customer relationships. With a network that spans millions of GPS/ELD devices in 80+ countries, FourKites has 1 million loads and over $100 billion in freight under management at any given time. The platform covers all modes, including truckload, LTL, ocean, rail, air, intermodal, parcel and courier, and extends real-time, in-transit visibility into the yard. FourKites is optimized for mobile and equipped with market-leading end-to-end security. To learn more, visit https://www.FourKites.com/.

About Issa Logistics

Issa Logistics is a family-owned logistics company built on three core pillars: quality, safety, and exceptional customer service. Providing top-quality service to our customers is a privilege, and their continued support and satisfaction ensures our success. To learn more, visit https://issalogistics.net.

Media Contact: 
Marianna Vyridi 
Big Valley Marketing for FourKites 
(650) 468-3263 
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f9876432-c55f-4872-8f04-df2fee870ae9

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that preclinical data for CK-3773274 (CK-274) and CK-3772271 (CK-271) were shared in poster presentations at the American Heart Association (AHA) Scientific Sessions 2020. CK-274 reduced contractility and left ventricular outflow tract (LVOT) peak pressure gradient in cats with naturally occurring hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction (LVOTO). In the Dahl/Salt sensitive rat model of heart failure with preserved ejection fraction (HFpEF), CK-271 attenuated the development of fibrosis and diastolic dysfunction.

“We’re pleased to share preclinical data that builds on the growing body of evidence for our pipeline of cardiac myosin inhibitors,” said Brad Morgan, Ph.D., Cytokinetics’ Senior Vice President, Research and Non-Clinical Development. “Collectively, these data demonstrate the potential of this mechanism of action to reduce or arrest the development of cardiac hypercontractility in animal models which may support application in patients with diseases of hypercontractility including HCM and HFpEF.”

Previous preclinical data has shown that CK-274 produces exposure related effects on cardiac contractility in healthy animals and mouse models of HCM. New preclinical data demonstrated dose-related changes in left ventricular (LV) systolic function and reductions in LVOT peak pressure gradient in cats with naturally occurring HCM and LVOTO due to the A31P mutation in cardiac myosin binding protein C (cMyBP-C). Treatment with CK-274 (1 mg/kg) reduced mean left ventricular (LV) fractional shortening at 6, 24, and 48 hours post-treatment (mean reduction 13.6%, p = 0.03; 15.4%, p = 0.01; 11.6%, p = 0.02, respectively). In addition to lowering the hypercontractility in cats with naturally occurring HCM and LVOTO, CK-274 reduced the left ventricular outflow tract peak pressure gradient in concentration related manner (median pressure gradient at baseline 27.1 mmHg [interquartile range {IQR} 18.3–33.3] vs 24 hours post-drug, 7.3 mmHg [IQR 14.2–19.7], p= 0.01). CK-274 was well tolerated and no changes in heart rate were observed for any treatment group over time.

A preclinical study of CK-271 demonstrated that treatment with this novel small molecule cardiac myosin inhibitor attenuated the development of fibrosis and diastolic dysfunction in an animal model of HFpEF. Previous studies have shown that CK-271 reduces cardiac myosin ATPase activity in vitro and cardiac contractility in vivo in healthy rats and dogs. In this study of the Dahl/Salt Sensitive rat hypertension model of HFpEF, six weeks of treatment with CK-271 reduced fractional shortening (HS: 53.8 ±1.4 vs HS + CK-271: 42.7 ±1.0%, p< 0.0001) and reduced high salt diet-induced diastolic dysfunction, including reductions in isovolumic relaxation time (IVRT) (HS: 22.8 ±0.6 vs HS + CK-271: 19.5 ±0.5 ms, p< 0.0001) and left atrial area (HS: 42.5 ±2.2 vs HS + CK-271: 35.4 ±0.8 mm2, p< 0.0001). CK-271 also reduced the development of cardiac fibrosis induced by a high salt diet (HS: 5.0 ±0.6 vs HS + CK-271: 3.5 ±0.3%, p< 0.05). These results suggest that cardiac myosin inhibition may be a novel approach to mitigate the development of HFpEF.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtivmecarbil, a novel cardiac muscle activator. Omecamtivmecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF, of which topline results were recently reported, and METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide license to develop and commercialize omecamtivmecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3 pending ongoing regulatory interactions. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (not including FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the timing, design and results of Cytokinetics’ preclinical trials of CK-274 or CK-271; the potential benefits of CK-274 or CK-271; Cytokinetics’ and its partners’ research and development activities; the timing of enrollment of patients in Cytokinetics’ and its partners’ clinical trials; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Cytokinetics’ partners decisions with respect to research and development activities; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757 

MONTREAL, Nov. 16, 2020 (GLOBE NEWSWIRE) — Nuvei Corporation (“Nuvei” or the “Company”) (TSX: NVEI and NVEI.U), the global payment technology partner of thriving brands, today announced that the Company will be participating in the following virtual investor conferences.

• On Monday, November 16, 2020, members of the Company’s management team will be participating in a fireside chat at the TD Securities Technology Virtual Conference. The fireside chat will begin at 11:10AM ET.
• On Wednesday, November 18, 2020, members of the Company’s management team will be participating in a fireside chat at Citi’s 2020 Financial Technology Virtual Conference. The fireside chat will begin at 8:15AM ET.

Live webcasts, as well as replays, will be available from the Company’s investor relations website at https://investors.nuvei.com under the “Events & Presentations” section.

About
Nuvei

We are Nuvei, the payment technology partner of thriving brands. We provide the intelligence and technology businesses need to succeed locally and globally, through one integration – propelling them further, faster. Uniting payment technology and consulting, we help businesses remove payment barriers, optimize operating costs and increase acceptance rates. Our proprietary platform offers direct connections to all major payment card schemes worldwide, supports 450 local and alternative payment methods and nearly 150 currencies. Our purpose is to make our world a local marketplace. For more information, visit www.nuvei.com.

Contact:

Investor Relations
[email protected]

Public Relations
[email protected]

 

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new findings from analyses of claims data and electronic health records related to heart failure and hypertrophic cardiomyopathy (HCM) were shared in three poster presentations at the American Heart Association (AHA) Scientific Sessions 2020. Two posters related to heart failure included one detailing analyses of outcomes highlighting the high unmet need in these patients with reduced ejection fraction (HFrEF) and a worsening heart failure event, and another one presenting data on spending for hospitalized Medicare patients with heart failure underscoring the high costs of their healthcare. An additional poster presented demographics and clinical characteristics of patients with HCM.

“These presentations and analyses related to heart failure underscore the growing economic burden of this disease which, despite standard of care, is accompanied by a high risk of hospitalization and cardiovascular death,” said Robert I. Blum, President and Chief Executive Officer of Cytokinetics. “Furthermore, the analyses of patients with HCM adds to our understanding of this complex disease as we continue to advance and refine our clinical development program for CK-274, our next-in-class cardiac myosin inhibitor.”

Findings
in Heart Failure Detail High Risk Population
and
High Spending
Among Hospitalized
Patients

The first analysis, conducted in collaboration with Duke Clinical Research Institute, characterized outcomes of patients with HFrEF and a recent worsening heart failure event (WHF), defined as an emergency department visit or hospitalization with heart failure as the primary discharge diagnosis within 12 months prior to their index echocardiogram. A total of 3,867 patients aged 18-85 with chronic symptomatic HFrEF were identified via electronic health records from the Duke University Health System between January 2008 to December 2018. 1,668 (43.1%) had a WHF event in the year prior to index echocardiogram. Patients with a recent WHF event had more comorbidities, including the presence of renal disease (40.5% vs. 26.7%; p<0.001) as well as higher rates of mortality (hazard ratio 1.59; p<0.001), all-cause hospitalization (hazard ratio 1.51; p<0.001), and heart failure hospitalization (hazard ratio 1.85; p<0.001). Patients with a recent WHF event also had lower ejection fraction (EF) (63.5% with EF <25% vs. 48.4%; p<0.001) and higher NT-proBNP (3864 vs. 2443; p<0.001). Use of heart failure medication was statistically significantly higher in those with a recent WHF event (% on ACE-I, ARB, ARNI/Beta-Blocker/Mineralocorticoid antagonist was 87/76/53 for the WHF group and 78/71/35 for non-WHF). These results suggest that despite broad use of heart failure medication in patients who experienced a worsening heart failure event, a significant unmet need remains for new therapies.

The second analysis, conducted in collaboration with Yale University School of Medicine, examined payments spanning the index hospitalization through 30-days post-discharge for Medicare beneficiaries with heart failure (HF). Using Medicare fee-for-service administrative claims data, patients hospitalized with HF from 2016-2018 were identified with the following primary discharge diagnoses (ICD-10 codes): systolic HF (50.2 and 50.4), diastolic HF (50.3), hypertensive heart disease (HHD) with HF (I11), and HHD with HF and chronic kidney disease (CKD) (I13). Of the 935,962 patients hospitalized with HF included in the analysis, 365,274 (39.0%) were hospitalized with HHD with HF and CKD, 226,929 (24.2%) with HHD with HF, 165,156 (17.6%) with diastolic HF, and 178,603 (19.1%) with systolic HF. Over time, there was a substantial increase in hospital admissions with a primary diagnosis of HHD with HF with or without CKD. Payments varied across HF diagnosis, with the highest payments for patients with HHD with HF and CKD. The total estimated mean Medicare 30-day payments for HF care were approximately $16.5 billion over the 3-year study period, with little change in spending year to year. These results underscore the high cost of heart failure related health care, especially for hospitalizations.

Demographics and Clinical Characteristics of
Patients with Obstructive
HCM

In a retrospective analysis of demographics and clinical characteristics of adult patients with obstructive HCM (oHCM), patients were identified from electronic health records from 39 Integrated Delivery Networks (IDN) in the IBM Explorys database from 2010 through 2018. Of 8,792 patients, 53.0% were female, and 81.2% Caucasian (mean index age: 61.8 years). Primary insurance type was private (58.9%) and 54.9% of patients lived in the Midwest. Mean BMI at index was 30.4 and 30.9% were nondrinkers. The mean Quan-Charlson Comorbidity Index was 6.35% with the most common comorbidities being congestive heart failure (31.9%), chronic pulmonary disease (20.1%), and diabetes without chronic complications (16.9%). Cardiovascular (CV) drug rates included beta blockers (80.5%), calcium channel blockers (46.0%), ACE inhibitors (27.7%), ARBs (18.8%), disopyramide (2.4%) and amiodarone (13.0%). Surgical procedure rates included septal myectomy (22%), ablation (19.8%), implantable cardioverter defibrillator (11.2%), and heart transplantation (0.3%). Major residual side effects subsequent to surgical procedures included atrial fibrillation (31.4%) and reintervention (15.6%). Common reintervention procedures included ablation and septal myectomy. The results from this analysis of a large, diverse, national sample of patients with obstructive HCM may be used to compare the characteristics of patients with obstructive HCM in the general population and those treated in centers of excellence.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF, of which topline results were recently reported, and METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3 pending ongoing regulatory interactions. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (not including FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the GALACTIC-HF clinical trial, including the results thereof; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the timing and likelihood of regulatory approval for omecamtiv mecarbil, Cytokinetics’ and its partners’ research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ other drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen’s decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757

• Biogen
  earns
  top scores
  on areas including
  access to medicine, talent attraction,
  innovation management
  and climate
  performance and
  reporting
  
• In 2013
  Biogen
  became
  the 1
  
  ^st
  
  U.S. biotech company to appear on the DJSI World
  Index
• 2020 marks the 8
  
  ^th
  
  consecutive year that Biogen was listed among top performers
  

CAMBRIDGE, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced that it has been ranked the number one biotechnology company on the Dow Jones Sustainability World Index (DJSI World Index) for the fifth time, more than any other biotechnology company. The DJSI World Index recognizes the top 10 percent of companies in the S&P Global Broad Market Index for performance on environmental, social and governance (ESG) issues, which S&P Global considers key to generating long-term stakeholder value.

Of the 318 companies named to DJSI World Index, Biogen led the biotechnology industry with the top scores in areas such as strategies to improve access to medicine and cost burden, innovation management, talent attraction, climate performance and reporting. In 2013 Biogen was the first U.S.-based biotech company to appear on DJSI World Index, and 2020 marks the eighth consecutive year that Biogen was listed among top corporate performers.

“At Biogen, we believe that responsible corporate leadership is a defining part of our culture and our ongoing business success. We are proud to top the DJSI World Index for the fifth time, an achievement that reflects Biogen’s longstanding commitment to making advances in climate, health, equity and other urgent issues of our time while pioneering neuroscience,” said Michel Vounatsos, Chief Executive Officer of Biogen.

The DJSI World Index ranking results from Biogen’s outstanding performance on multiple dimensions of corporate responsibility, including an ongoing focus on health equity and access; ethical marketing practices; and human capital development with a focus on diversity, equity and inclusion. It also reflects Biogen’s emphasis on transparency and expanded public reporting on emerging risks, employee benefits and philanthropic contributions, among other issues.

“We congratulate Biogen for being included in the DJSI World Index. A DJSI distinction is a reflection of being a sustainability leader in your industry,” said Manjit Jus, Global Head of ESG Research and Data, S&P Global. “With a record number of companies participating in the 2020 Corporate Sustainability Assessment and more stringent rules for inclusion this year, this sets your company apart and rewards your continued commitment to people and planet.”

To bolster its ESG commitments, Biogen recently launched Healthy Climate, Healthy Lives^TM, a 20-year initiative to eliminate fossil fuels across its operations and collaborate with renowned institutions to advance human health. The program includes research into the potential link between dementia and air pollution.

Details on Biogen’s ESG commitments can be found in its 2019 Year In Review, which is based on internationally recognized Global Reporting Initiative (GRI) G4 Guidelines.

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.

We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook,YouTube.

Biogen Safe Harbor

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about our strategy and plans; and our ability to achieve our ESG goals, commitments and targets. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation the risks of unexpected hurdles, costs or delays; uncertainty of success in the execution of our strategy and plans; the direct and indirect impact of the ongoing COVID-19 pandemic on our business, results of operations and financial condition; and the risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

MEDIA CONTACT : David Caouette + 1 617 679 4945 [email protected]

INVESTOR CONTACT: Joe Mara +1 781 464 2442 [email protected]

VANCOUVER, British Columbia, Nov. 16, 2020 (GLOBE NEWSWIRE) — NexTech AR Solutions (NexTech) (OTCQB: NEXCF) (CSE: NTAR) (FSE: N29), an emerging leader in augmented reality for eCommerce, AR learning applications, AR-enhanced video conferencing and virtual events today announced that President Paul Duffy will deliver a presentation on leveraging the power of AR for virtual experiences during techsytalk Global. Duffy’s presentation will take place on November 18 at 11:40am ET. NexTech is also serving as a Gold Sponsor of the event which runs from November 17-18, 2020.

Tickets for techsytalk Global can be purchased here.

techsytalk Global anticipates an international audience of more than 2,000 attendees from the corporate, association and independent event planning industries. In his presentation, Duffy will highlight how AR is making the difference in the way event managers can immerse attendees in virtual environments and share creative ideas to increase engagement, sponsor ROI and fun during virtual events using AR.

The techsytalk brand was founded by event planners with over a decade of experience planning meetings, conferences, and corporate events in both live and virtual settings. techsytalk’s live event offers event planners a setting in which they can discuss the discovery and implementation of novel event solutions and ideas. As the industry and event professionals face a rapidly changing event landscape amid the COVID-19 pandemic, techsytalk made the decision to re-launch the signature event as a global, virtual experience in 2020.

“I spend every day planning events for clients and working with various teams to better understand the challenges that event planners have with technology. When we decided to reimagine techsytalk Global as a virtual event it was because we really saw the power in the various platforms that were available to planners, many of which they just aren’t aware of,” said Liz King Caruso, CEO of techsytalk & Liz King Events. “NexTech is an example of a really powerful company doing interesting and innovative things for the event industry. We love the possibilities for AR and VR in our digital-first world and believe Paul’s presentation during techsytalk Global will enable attendees to embrace these technologies and their implications for our events.”

“I’m thrilled to be highlighting the power of AR for virtual events during techsytalk Global 2020. This event has an impressive history within the event management industry and has the unique advantage of being crafted by event professionals for event professionals.” said Paul Duffy, President of NexTech AR, “Attendees understand the challenges that come with transforming events, conferences and meetings into virtual experiences. At NexTech, we firmly believe that virtual events are here to stay, and AR-driven applications should be considered by any event managers looking to boost attendance, engagement and take their experience to the next level.”

To learn more about NexTech AR, please visit www.nextechar.com

About techsytalk

techsytalk was founded by event planners with over a decade of experience planning meetings, conferences, and other corporate events in both live and virtual settings. techsytalk LIVE Global promises to be a resource to facilitate the evolution of the events and meeting industry in an increasingly tech-centric world.

About NexTech AR

NexTech is one of the leaders in the rapidly growing Augmented Reality market estimated to grow from USD $10.7B in 2019 and projected to reach USD $72.7B by 2024 according to Markets & Markets Research; it is expected to grow at a CAGR of 46.6% from 2019 to 2024.

The company is pursuing four verticals:

InfernoAR:
An advanced Augmented Reality and Video Learning Experience Platform for Events, is a SaaS video platform that integrates Interactive Video, Artificial Intelligence and Augmented Reality in one secure platform to allow enterprises the ability to create the world’s most engaging virtual event management and learning experiences. Automated closed captions and translations to over 64 languages. According to Grandview Research the global virtual events market in 2020 is $90B and expected to reach more than $400B by 2027, growing at a 23% CAGR. With NexTech’s InfernoAR platform having augmented reality, AI, end-to-end encryption and built in language translation for 64 languages, the company is well positioned to rapidly take market share as the growth accelerates globally.

ARitize™ For eCommerce:
The company launched its SaaS platform for webAR in eCommerce early in 2019. NexTech has a ​‘full funnel’ end-to-end eCommerce solution for the AR industry including its Aritize360 app for 3D product capture, 3D/AR ads, its ARitize white label app it’s ‘Try it On’ technology for online apparel, 3D and 360-degree product views, and ‘one click buy’.

ARitize™ 3D/AR Advertising Plat


form:
Launched in Q1 2020 the ad platform will be the industry’s first end-to-end solution whereby the company will leverage its 3D asset creation into 3D/AR ads. In 2019, according to IDC, global advertising spend will be about $725 billion.

ARitize™ Holl


ywood Studios
: The studio is in development producing immersive content using 360 video, and augmented reality as the primary display platform.

To learn more, please follow us on Twitter, YouTube, Instagram, LinkedIn, and Facebook, or visit our website: https://www.nextechar.com.

On behalf of the Board of NexTech AR Solutions Corp.

“Evan Gappelberg”
CEO and Director

For further information, please contact:

Evan Gappelberg
Chief Executive Officer
[email protected]   

The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

Certain in
formation contained herein may constitute “forward-looking information” under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “will be”, “looking forward” or varia
tions of such words and phrases or statements that certain actions, events or results “will” occur. Forward-looking statements regarding the Company increasing investors awareness are based on the Company’s estimates and are subject to known and unknown ri
sks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of NexTech to be materially different from those expressed or implied by such forward-looking statements or forward-looking information,
including capital expenditures and other costs.  There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should n
ot place undue reliance on forward-looking statements and forward-looking information. NexTech will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securit
ies laws. 

Stockholders
Approve RareGen
Acquisition

Merger Expected to
Close on
or
A
bout
November
18
, 2020

RESEARCH TRIANGLE PARK, N.C., Nov. 16, 2020 (GLOBE NEWSWIRE) — Liquidia Technologies, Inc. (NASDAQ: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT® technology, today announced that its stockholders voted to adopt and approve the previously announced merger agreement, dated as of June 29, 2020, among the Company, RareGen, LLC (“RareGen”), Liquidia Corporation (“Liquidia Corporation”), Gemini Merger Sub I, Inc. (“Liquidia Merger Sub”), Gemini Merger Sub II, LLC and PBM RG Holdings, LLC (the “Merger Agreement”), including the merger of the Company with and into Liquidia Merger Sub (the “Liquidia Merger”), with the Company and RareGen surviving as wholly owned subsidiaries of Liquidia Corporation post-merger, at a special meeting of stockholders held on November 13, 2020. In addition, Liquidia stockholders voted to approve all other matters related to the Merger Agreement and the Liquidia Merger.

At the close of business on September 14, 2020, the record date for the special meeting, there were 37,752,027 shares of Company common stock outstanding. Approximately 71 percent of the shares outstanding as of September 14, 2020 voted to adopt and approve the Merger Agreement. Further, among other proposals, stockholders voted to approve the Liquidia Corporation 2020 Long-Term Incentive Plan and the Liquidia Corporation 2020 Employee Stock Purchase Plan, both of which will be effective upon completion of the merger.

The closing of the merger transaction is expected to occur on or about November 18, 2020, subject to the satisfaction of the closing conditions set forth in the Merger Agreement.

About Liquidia

Liquidia is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT® technology to transform the lives of patients. PRINT is a particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Currently, Liquidia is focused on the development of two product candidates for which it holds worldwide commercial rights: LIQ861 for the treatment of pulmonary arterial hypertension (PAH) and LIQ865 for the treatment of local post-operative pain. Liquidia is headquartered in Research Triangle Park, NC. For more information, please visit www.liquidia.com.

About RareGen

RareGen, LLC is a portfolio company of PBM Capital Group, a healthcare investment firm. RareGen provides strategy, investment, and commercialization for rare disease pharmaceutical products. RareGen has a national sales force focused on cardiology and pulmonology specialties.

Important Information About the Transaction and Where to Find It

In connection with the proposed merger transaction, the Company and Liquidia Corporation have filed documents with the SEC, including the filing by Liquidia Corporation of a registration statement on Form S-4, which was declared effective on September 16, 2020, and a final proxy statement/prospectus (including the supplements thereto), and the Company mailed a proxy statement (and supplements thereto) regarding the proposed merger transaction to its stockholders that also constitutes a prospectus of the Company. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document which the Company or Liquidia Corporation have filed with the SEC. Investors and security holders of the Company and RareGen are urged to read the registration statement, the proxy statement/prospectus and any other relevant documents, as well as any amendments or supplements to these documents, carefully and in their entirety because they will contain important information. Investors and security holders may obtain free copies of the registration statement and the proxy statement/prospectus and other documents filed with the SEC by the Company through the website maintained by the SEC at www.sec.gov or by contacting the investor relations department of the Company at the following:

Liquidia Technologies, Inc.
Jason Adair
Investor Relations
(919) 328-4350
[email protected]

Participants in the Solicitation

The Company, RareGen and certain of their respective directors, executive officers and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction and related matters. Information regarding the Company’s directors and executive officers, including a description of their direct interests, by security holdings or otherwise, is contained in the Company’s Form 10-K for the year ended December 31, 2019 and its proxy statement filed on April 28, 2020, which are filed with the SEC. Additional information is available in the registration statement on Form S-4 and the proxy statement/prospectus (as supplemented).

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote of approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Cautionary Statements Regarding Forward Looking Statements 

This communication contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. In this context, forward-looking statements often address expected future business and financial performance and financial condition, and often contain words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “see,” “will,” “would,” “target,” similar expressions, and variations or negatives of these words. Forward-looking statements by their nature address matters that are, to different degrees, uncertain, such as statements about the potential timing or consummation of the proposed merger transaction or the anticipated benefits thereof, including, without limitation, future financial and operating results. The Company cautions readers that these and other forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed in any forward-looking statements. Important risk factors that may cause such a difference include, but are not limited to risks and uncertainties related to (i) the risk that a condition to closing of the merger transaction may not be satisfied, (ii) the ability of the Company and RareGen to integrate their businesses successfully and to achieve anticipated cost savings and other synergies, (iii) the possibility that other anticipated benefits of the proposed merger transaction will not be realized, including without limitation, anticipated revenues, expenses, earnings and other financial results, and growth and expansion of the new combined company’s operations, and the anticipated tax treatment, (iv) potential litigation relating to the proposed merger transaction that has and could be instituted against the Company, RareGen or their respective officers or directors, (v) possible disruptions from the proposed merger transaction that could harm the Company’s or RareGen’s business, including current plans and operations, (vi) the ability of the Company or RareGen to retain, attract and hire key personnel, (vii) potential adverse reactions or changes to relationships with employees, customers, suppliers, licensees, collaborators, business partners or other parties resulting from the announcement or completion of the merger transaction, (viii) potential business uncertainty, including changes to existing business relationships, during the pendency of the merger transaction that could affect the Company’s and/or RareGen’s financial performance, (ix) certain restrictions during the pendency of the merger transaction that may impact the Company’s or RareGen’s ability to pursue certain business opportunities or strategic transactions, (x) continued availability of capital and financing and rating agency actions, (xi) legislative, regulatory and economic developments and (xii) unpredictability and severity of catastrophic events, including, but not limited to, global pandemics such as coronavirus, acts of terrorism or outbreak of war or hostilities, as well as management’s response to any of the aforementioned factors. These risks, as well as other risks associated with the proposed merger transaction, as more fully discussed in the proxy statement/prospectus in connection with the proposed merger transaction, which was declared effective on September 16, 2020, as subsequently supplemented. While the list of factors presented here is, and the list of factors to be presented in the registration statement on Form S-4 are, considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on the Company’s or RareGen’s consolidated financial condition, results of operations, credit rating or liquidity. Neither the Company nor RareGen assumes any obligation to provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by securities and other applicable laws.

Contact Information

Media:
Michael Parks
Corporate Communications
484.356.7105
[email protected]

Investors:
Jason Adair
Vice President, Corporate Development and Strategy
919.328.4400
[email protected]

SALT LAKE CITY, Nov. 16, 2020 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, announced today the expansion of Myriad myChoice^® tumor testing in several European markets and China.

Myriad myChoice CDx is the industry’s most clinically-validated genomic instability test. The test enables physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in potentially increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors, including Lynparza (olaparib). A biomarker subgroup analysis of the PAOLA-1 Phase III trial (Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer, 2019) of Lynparza included patients with advanced ovarian cancer and homologous recombination deficient (HRD)-positive tumors as detected by the myChoice test, including those with BRCA gene mutations. The trial showed that Lynparza in combination with bevacizumab maintenance treatment improved progression-free survival to a median of 37.2 months versus 17.7 months for bevacizumab alone in patients with HRD-positive advanced ovarian cancer. Recently, the European Commission authorized use of Lynparza for the first-line maintenance treatment with bevacizumab of patients with HRD-positive advanced ovarian cancer. Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and Merck.

As part of the expansion in Europe, Myriad will license and provide technological support to leading pathology institutes in Germany and France. Additionally, Myriad will support European customers by performing testing out of its clinical laboratory at the company’s global headquarters in Salt Lake City. Also, the institutes in Europe will perform the tests with Myriad’s myChoice CDx PLUS assay. Myriad myChoice CDx PLUS is CE-marked in accordance with the In-Vitro Diagnostic Devices Directive (98/79/EC). 

Another collaboration in China provides that Myriad will partner with Burning Rock Biotech, a leader in next generation sequencing technology for precision oncology, to provide myChoice for HRD testing in Phase III clinical studies and clinics throughout China. Myriad will provide Burning Rock with access to its proprietary myChoice technology. The partnership with Burning Rock expands global access to myChoice and positions the test as a preferred developmental companion diagnostic in this important drug development category.

“These new strategic partnerships with leading companies dedicated to advancing the power of precision medicine, reinforce Myriad’s commitment to expanding access to genetic insights for more patients than ever before,” said Nicole Lambert, president of Myriad Genetic Laboratories. “Through close collaboration with innovative laboratories in Europe and with Burning Rock in China, we are bringing the clinical benefits of myChoice testing to additional markets and patients, advancing personalized treatment for patients around the world.”

In August 2020, myChoice was exclusively cited and the only named commercial companion diagnostic by the American Society of Clinical Oncology in new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology.

About Myriad myChoice

Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: https://myriad-oncology.com/mychoice-cdx/

About Myriad Genetics

Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Company’s new international collaborations on the myChoice^® CDx test, including offering the test to European patients, and partnering with pathology institutes in Europe and Burning Rock in China; and the Company’s strategic directives under the caption “About Myriad Genetics.”  These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements.  These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements;  the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.  All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Media Contact:
Jared Maxwell          
(801) 505-5027        
[email protected]

Investor Contact:
Scott Gleason
(801) 584-1143
[email protected] 

ALPHARETTA, Ga., Nov. 16, 2020 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting.

Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data described in this paper demonstrate that suprachoroidal injection was well accepted by physician-investigators, and that the device and procedure may accommodate a wide range of anatomic and demographic variables. These data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapies.

“Reflecting on the past year, I am grateful to our team and the numerous physicians and researchers who have delivered 33 presentations on our assets and suprachoroidal space (SCS^®) injection platform during 2020,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “In addition to our conference presentations, we have placed four publications in peer reviewed journals to further educate the medical community on our clinical progress. This coverage and attention on our programs have established Clearside as the leader in suprachoroidal delivery. We look forward to continuing to advance our suprachoroidal delivery programs with data expected in 2021 from our CLS-AX (axitinib injectable suspension) Phase 1/2a clinical trial, and our integrin inhibitor preclinical studies.”

Dr. Ciulla continued, “In addition to our internal progress, we are pleased with the advancements of our clinical development partners. This weekend at the AAO conference, suprachoroidal delivery was featured by our gene therapy partner, REGENXBIO, as well as in a late breaking presentation from Aura Biosciences in choroidal melanoma. Both of these companies are using our SCS Microinjector^® to deliver their assets into the suprachoroidal space.”

Title: Suprachoroidal
CLS-AX (axitinib injectable suspension),
as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (
nAMD
)

Authors: Robert Bhisitkul; Viral Kansara; Thomas Ciulla
Conclusions:
CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection. Axitinib has intrinsic high potency and pan-VEGF inhibition through receptor blockade. In pharmacokinetic studies, CLS-AX demonstrated prolonged duration. The U.S. Food and Drug Administration has accepted Clearside’s Investigational New Drug Application and a Phase 1/2a clinical trial in wet age-related macular degeneration (wet AMD) is expected to initiate by the end of 2020.

Title:
Systemic Therapy and Efficacy of CLS-TA
:
Results from the Phase 3 PEACHTREE Clinical Trial

Authors: Quan Nguyen; Thomas Ciulla
Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. The visual acuity and macular edema improvements associated with suprachoroidally injected CLS-TA versus the control in treating macular edema associated with noninfectious uveitis, was noted regardless of administration of systemic therapy at baseline.

About Clearside’s Suprachoroidal Space (SCS

^®

) Injection Platform

Clearside’s patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s proprietary SCS Microinjector^® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. Clearside’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.

About
CLS-AX (axitinib injectable suspension)

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

About
XIPERE
™
(triamcinolone acetonide suprachoroidal injectable suspension)

XIPERE^TM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (“Bausch Health”) (NYSE/TSX: BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health’s affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

About Clearside Biomedical

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector^® targets the suprachoroidal space (SCS^®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of initiation of and data from the Phase 1/2a clinical trial for CLS-AX in wet AMD, as well as the timing of data from preclinical studies in Clearside’s integrin inhibitor program. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor and Media
Contact
s
:

Jenny Kobin
Remy Bernarda
[email protected]
(678) 430-8206

Source: Clearside Biomedical, Inc.

BARRIE, Ontario, Nov. 16, 2020 (GLOBE NEWSWIRE) — MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in specialized, research-driven cannabis extraction, distillation and derivative products today announced its financial results for the three and nine months ended September 30, 2020 and outlined its plan to accelerate growth and improve profitability.

“MediPharm Labs has created a strong and capable platform to pursue global leadership of medical, wellness and adult-use markets for cannabis,” said Pat McCutcheon, CEO, MediPharm Labs. “We have identified business strengths that can be exploited including significant technical depth, global GMP supply-chain capabilities, high-potential customer agreements including a significant exclusive multi-year contract with European pharmaceutical leader STADA, and a strong cash position.”

“Economic conditions including the oversupply in the Canadian bulk crude resin and distillate markets, along with the impact of COVID 19, continue to challenge the industry,” added Mr. McCutcheon. “We are now focused on doing more to drive profitable revenue and address weaknesses including reducing our cost structure. We have taken immediate steps to improve our costs and organizational alignment against which we have put an action plan in place that will create value and enable us to achieve our potential.”

The immediate action plan to create value consists of the following elements:

• Improve financial management to reduce and better align costs with the timing of sales generation
• Enhance marketing and sales with focus on accelerating research and development and new product commercialization for B2B and B2C operations
• Transition from B2B wholesale concentrate market, due to oversupply in Canada, to white label contract manufacturing
• Reduced headcount for an annualized savings of $3 million to meet needs of current environment
• Undertook an independent operational review to identify areas for improvement and opportunities to restore growth to help drive significant improvement in cash flows and margins

These actions, some of which were taken late in the third quarter, and others subsequent to the quarter end, will prepare MediPharm Labs for significant performance improvements in 2021 as revenue under new customer agreements ramps up.

Q3
2020
FINANCIAL SUMMARY

• Cash and equivalents balance at September 30, 2020, was $36.5 million; finalized settlement of the second tranche of the convertible debenture.

• Revenue was $4.9 million, compared to $13.9 million in Q2 2020. Reflects lower bulk extract volumes and average selling prices, partially offset by growth in formulated finished goods sales, up 30% to provincial distributors throughout Canada, and sales from MediPharm Labs Australia.
• Finished product shipments grew to comprise 57% of Q3 revenue up from 16% in Q2 2020.
• Commercialized SKUs grew 13% from Q2. Increased development activities for continued growth.
• International revenue grew to $0.7 million as sales of GMP-certified formulated products under agreements with customers in Australia, New Zealand and the U.K. ramped up.
• Gross profit was ($10.6 million) and gross margin was (214%) compared to gross profit of $2.2 million and gross margin of 16% in Q2 2020, primarily due to a $6.3 million non-cash write down of inventory to net realizable value and a $1.5 million write down of non-current deposits given to vendors for capital expenditures.
• Negative Adjusted EBITDA⁽¹⁾ was $7.3 million.
• Net loss before tax was $15.4 million, compared to a net loss of $3.8 million in Q2 2020.

Q3 2020 FINANCIAL SUMMARY TABLE

	Three months ended
	September 30, 2020	June 30, 2020	March 31, 2020	December 31, 2019	September 30, 2019
Revenue	4,947	13,918	11,089	32,444	43,386
Gross profit	( 10,588 )	2,212	(10,882)	9,987	14,754
Gross margin %	( 214 %)	16 %	(98 %)	31 %	34 %
Net (loss)/income before tax	( 15,422 )	(3,775)	(22,029)	(2,401)	5,395
Adjusted EBITDA (1)	(7,26 2 )	(2,180)	(5,657)	2,661	10,066
Adjusted EBITDA margin %	(147 %)	(16 %)	(51 %)	8%	23 %
(1)   See Non-IFRS Measures section of this news release.

LOOKING FORWARD: GROWTH AND IMPROVEMENT CATALYSTS

Refining Processes,
Leveraging SAP and
Reducing Costs: During and subsequent to the third quarter, production processes were refined, the workforce was streamlined by 20% representing $3 million annualized cost reductions, and strict spending disciplines were implemented. Along with other cost containment measures in Q4, these actions will provide benefits as revenue ramps up. The Company is also realizing increasing advantages from the recent implementation of its SAP resource planning system.

STADA
Pharmaceutical Partnership
and
30 Supply Contracts
to
Drive
Revenue
: The Company now has more than 30 supply agreements with customers in eight countries, including its first major collaboration with a leading European consumer healthcare and generics company. Under its agreement with STADA, MediPharm Labs will export GMP-certified finished product and cannabis API for Germany with a plan to expand to other promising European markets over time. This agreement, the first of its kind in the cannabis industry, further strengthened the Company’s reputation as a specialist pharmaceutical manufacturer of cannabis API and finished products. In addition, the Company has formed its first alliances in the large and growing Latin American market for medical cannabis and has continued to build out its MediPharm Labs Australia customer base.

Gathering Speed with Finished Goods Production
and

LABS Cannabis

Brand
: In Q3, MediPharm Labs finished goods sales to provincial retailers grew 30% despite modest month over month sales growth of adult-use cannabis channels in Canada. To enhance its prospects domestically, the Company continues to shift its focus toward white label contract manufacturing and producing finished goods gaining market share with its growing product line up. In late October, MediPharm Labs was first to market with a consumer sized 99% Pure CBD Isolate Crystal on the launch of LABS Cannabis CBD Isolate, which serves a broad range of wellness consumers and patients. More new products will follow.

Expanding Production Capabilities: The Company remains focused on global medical and wellness markets and to enhance and diversify its channels. As such, the Company continues to expand its production capabilities and contract manufacturing operations. During the quarter, SKUs increased 10% from Q2, and included tincture bottles, topicals, isolate, sublingual sprays and various formulations for edibles and beverages.

Contributing to Clinical Research: Subsequent to quarter end, the Company initiated a clinical trial to research and evaluate the effectiveness of MediPharm Labs’ proprietary cannabis-derived medical products and formulations on the treatment of end-stage renal disease or chronic kidney disease. The Company expects to expand its portfolio of clinical trials in the coming quarters.

REVENUE EXPECTATIONS

Based on agreed customer production schedules, the Company expects revenue from its portfolio of domestic and international sales agreements will grow beginning early in 2021 and will be complemented by new sales of LABS Cannabis products.

GOVERNANCE AND LEADERSHIP CHANGES

Subsequent to quarter end, the Company announced the departures of Robert Kwon, Chief Financial Officer and the Company’s Chief Marketing Officer. A search process has been initiated for a new CFO while the role of Chief Marketing Officer will not be directly filled and but will be covered by the Company’s new VP of Sales.

As part of a broader plan to strengthen the skills and independence of the Company’s Board of Directors, MediPharm Labs welcomed Shelley Martin, the retired President and Chief Executive Officer of Nestlé Canada Inc., Chris Taves, the COO of BMO Capital Markets, and Chris Halyk, the former President of Janssen Inc. (Canada) as Directors this year. The Company’s Board of Directors is now comprised of 7 Directors, 5 of whom are independent.

Q3 2020 FINANCIAL RESULTS CONFERENCE CALL DETAILS

MediPharm Labs executive management team will host a conference call and audio webcast to discuss the results and outlook for its third quarter ended September 30, 2020 on Monday November 16, 2020, at 8:30 a.m. eastern time.

Audio Conference Call Dial
In
Details:

Date:	Monday, November 16, 2020
Time:	8:30 a.m. Eastern Time
Dial In:	Toll-free number: +1-833-502-0471 / International number: +1-236-714-2179
Conference ID:	7656805
Audio Webcast:	WEBCAST or https://ir.medipharmlabs.com/news-events in the Events section
Replay:	+1-800-585-8367/ International +1-416-621-4642 Conference ID: 7656805
	until November 23, 2020 11:59 p.m.

NON-IFRS MEASURES

Adjusted EBITDA is not a recognized performance measure under IFRS, does not have a standardized meaning and therefore may not be comparable to similar measures presented by other issuers. Adjusted EBITDA is included as a supplemental disclosure because Management believes that such measurement provides a better assessment of the Company’s operations on a continuing basis by eliminating certain non-cash charges and charges or gains that are nonrecurring. Adjusted EBITDA is defined as net loss excluding interest, taxes, depreciation and amortization, share-based compensation, non-cash, non-recurring expense and one-time inventory write downs. Adjusted EBITDA has limitations as an analytical tool as it does not include depreciation and amortization expense, interest income and expense, taxes, share-based compensation and transaction fees. Because of these limitations, Adjusted EBITDA should not be considered as the sole measure of the Company’s performance and should not be considered in isolation from, or as a substitute for, analysis of the Company’s results as reported under IFRS. The most directly comparable measure to Adjusted EBITDA calculated in accordance with IFRS is operating income (loss). The above is a reconciliation of the Company’s operating loss to Adjusted EBITDA. See “Reconciliation of non-IFRS measures” in the Company’s Management’s Discussion and Analysis for the period ended September 30, 2020 for additional information.

About MediPharm Labs

Founded in 2015, MediPharm Labs specializes in the production of purified, pharmaceutical-quality cannabis oil and concentrates and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. As a global leader, MediPharm Labs has completed commercial exports to Australia and has fully commercialized its wholly-owned Australian extraction facility. MediPharm Labs Australia was established in 2017.

For further information, please contact:

Laura Lepore, VP, Investor Relations
Telephone: 705-719-7425 ext 1525
Email: [email protected]     
Website: www.medipharmlabs.com    

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION:

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, doing more to drive profitable revenue and reduce costs; exploiting business strengths; putting an action plan in place that will create value and will enable the Company to achieve its potential; improving financial management; accelerating research and development and new product commercialization for B2B and B2C operation; enhancing marketing and sales; exiting the B2B wholesale concentrate market; significant performance improvements in 2021 as revenue under new customer agreements ramps up; revenues ramping up; the launch of new products; and revenue growth beginning in early 2021 and being complemented by new sales of LABS Cannabis products. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.