Market Newsdesk

• PC14586 targets p53 Y220C mutants to selectively reactivate p53, restoring the protein’s tumor-suppressing function
• Phase 1/2 study is enrolling patients with advanced solid tumors that have a p53 Y220C mutation

CRANBURY, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced dosing of the first patient in its Phase 1/2 clinical trial evaluating PC14586, the company’s investigational lead compound that targets the Y220C mutant of p53. The trial will enroll up to 130 patients with advanced solid tumors that have the specific p53 Y220C variant.

“This is an important step forward in the battle against the many cancers that are driven by a p53 mutation,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “Initiating our Phase 1/2 study represents a significant milestone for PMV, as PC14586 is our first tumor-agnostic therapy to enter the clinic. By selectively binding to the p53 Y220C mutant, PC14586 is designed to reactivate the tumor suppressing function of p53. We look forward to the opportunity to address the significant unmet need for patients whose cancers have a p53 Y220C mutation as we advance PC14586 in the clinic.”

The multi-center, single-arm Phase 1/2 study will evaluate PC14586 in patients with advanced solid tumors with a p53 Y220C mutation. Phase 1 will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of PC14586. Phase 2 will determine the overall response rate and duration of response of PC14586 at a dose identified in Phase 1.

About p53

p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.  

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice created by the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with advanced solid tumors that have a p53 Y220C mutation identified by next generation sequencing. PC14586 was granted Fast Track Designation by the U.S. Food and Drug Administration in October 2020.

For information on the Phase 1/2 trial, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).

About
PMV Pharma

PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 is mutated in approximately half of all cancer. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus.  PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.

Forward-Looking
Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s future plans or expectations for PC14586, including expectations regarding the timing for patient enrollment and success of its current clinical trial for PC14586. Any forward-looking statements in this statement 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 such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities and planned clinical trials, the Company’s ability to execute on its strategy and operate as an early clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company’s ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 13, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact

For Investors:

Winston Kung
Chief Financial Officer
[email protected]

For Media:

Mariann Caprino
[email protected]
(917) 242-1087 mobile 

– Will substantially extend maturities to 8 to 15 years at fixed rates –

– Leverage-neutral –

MONTREAL, Nov. 23, 2020 (GLOBE NEWSWIRE) — TFI International Inc. (NYSE and TSX: TFII), a North American leader in the transportation and logistics industry, today announced an agreement to issue and sell an aggregate principal amount of US $500 million of senior notes consisting of four tranches in a private placement transaction led by Prudential Private Capital, to entities including but not limited to Guggenheim Investments, MetLife Investment Management, LLC’s clients, Voya Investment Management, LLC and Barings LLC. TFI International intends to use the net proceeds from the issuance of the senior notes primarily to repay existing debt as well as for general corporate purposes, which may include acquisitions. The financing is expected to be leverage-neutral at closing from a net debt perspective.

“Through this transaction we will significantly extend our average debt maturities, with maturities ranging from 8 to 15 years, at attractive, fixed rates of interest,” stated Alain Bédard, Chairman, President and Chief Executive Officer of TFI International. “In addition, this debt financing will help further diversify our capital structure, and we’re very pleased to be working with a world-class group of lenders.”

“We are expanding our relationship with TFI International to support what we view as a winning strategy in the competitive and evolving transportation and logistics industry. Along with a group of other world class investors, we are pleased to be making a significant investment in TFI International and its management team,” said Ashley Dexter, Senior Vice President, Prudential Private Capital.

The four tranches of aggregate principal amount of senior notes will include: (a) US $150 million aggregate principal amount of 3.15% Guaranteed Senior Notes, Series A, due January 5, 2029; (b) US $150 million aggregate principal amount of 3.25% Guaranteed Senior Notes, Series B, due January 5, 2031; (c) US $150 million aggregate principal amount of 3.35% Guaranteed Senior Notes, Series C, due January 5, 2033; and (d) US $50 million aggregate principal amount of 3.50% Guaranteed Senior Notes, Series D, due January 5, 2036.

The private placement of the senior notes is expected to close on or about January 5, 2021, subject to customary conditions. The notes will be senior unsecured obligations issued by TForce Holdings Inc., a wholly-owned subsidiary of TFI International, and unconditionally guaranteed by TFI International and substantially all of its subsidiaries.

The notes will not be registered in the United States under the Securities Act of 1933, as amended, and are being offered and sold in reliance on applicable exemptions from registration.

ABOUT TFI INTERNATIONAL

TFI International Inc. is a North American leader in the transportation and logistics industry, operating across the United States, Canada and Mexico through its subsidiaries. TFI International creates value for shareholders by identifying strategic acquisitions and managing a growing network of wholly-owned operating subsidiaries. Under the TFI International umbrella, companies benefit from financial and operational resources to build their businesses and increase their efficiency. TFI International companies service the following segments:

• Package and Courier;
• Less-Than-Truckload;
• Truckload;
• Logistics.

TFI International Inc. is publicly traded on the New York Stock Exchange and the Toronto Stock Exchange under the symbol TFII. For more information, visit www.tfiintl.com.

ABOUT PRUDENTIAL PRIVATE CAPITAL

For more than 75 years, Prudential Private Capital has been partnering with a wide range of corporations, sponsors, and institutions to provide valuable insights, guidance, and customized capital solutions that enable them to achieve their growth and funding goals. In an industry where capital can seem like a commodity and relationships often fleeting and transactional, we are known for building enduring local partnerships based on a steady and patient commitment to our partners’ long-term capital needs. With regional teams in 14 offices around the world, we manage a portfolio of $97.5 billion (as of 9/30/20). For more information about Prudential Private Capital, please visit https://prudentialprivatecapital.com.

CAUTION CONCERNING FORWARD-LOOKING STATEMENTS

Certain statements included in this press release may be “forward-looking information” within the meaning of applicable Canadian securities laws, section 27A of the United States Securities Act of 1933, as amended, and section 21E of the United States Securities Exchange Act of 1934, as amended, and such statements are subject to the safe harbor created by those sections and by the United States Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the private placement of senior notes and the anticipated closing thereof. This forward-looking information is identified by the use of terms and phrases such as “may”, “might”, “expect”, “intend”, “estimate”, “anticipate”, “plan”, “foresee”, “believe”, “to its knowledge”, “could”, “design”, “forecast”, “goal”, “hope”, “intend”, “likely”, “predict”, “project”, “seek”, “should”, “target”, “will”, “would” or “continue”, and the negative of these terms and similar terminology, including references to assumptions, although not all forward-looking information contains these terms and phrases. Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond TFI International’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. Completion of the private placement of senior notes and the use of the net proceeds thereof referred to in this press release are subject to numerous factors, many of which are beyond TFI International’s control, including but not limited to, the failure to fulfill customary closing conditions and other important factors disclosed previously and from time to time in TFI International’s filings with the securities regulatory authorities in each of the provinces of Canada and the SEC. The forward-looking information contained in this press release represents TFI International’s expectations as of the date of this press release (or as of the date they are otherwise stated to be made), and are subject to change after such date. However, TFI International does not undertake to update or amend such forward-looking information whether as a result of new information, future events or otherwise, except as may be required by applicable law.

For further information:

Alain Bédard
Chairman, President and CEO
TFI International Inc.
647-729-4079
[email protected] 

WATERTOWN, Mass., Nov. 23, 2020 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body’s own natural protein degradation system, today announced Nello Mainolfi, Co-Founder, President and CEO and Jared Gollob, Chief Medical Officer of Kymera Therapeutics, will present at the Piper Sandler 32nd Annual Healthcare Conference being held virtually from December 1 to December 3, 2020.

A webcast of the pre-recorded fireside chat presentation has been made available ahead of the conference and can be accessed by clicking here and found under “Events and Presentations” in the Investors section of the Company’s website at www.kymeratx.com. The webcast will remain available for 90 days.

About Kymera Therapeutics

Kymera Therapeutics is a biopharmaceutical company focused on a transformative new approach to address previously intractable disease targets. Kymera is advancing the field of targeted protein degradation, accessing the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. Kymera’s Pegasus targeted protein degradation platform harnesses the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on un-drugged nodes in validated pathways currently inaccessible with conventional therapeutics. Kymera is accelerating drug discovery with an unmatched ability to target and degrade the most intractable of proteins, and advance new treatment options for patients. Kymera’s initial programs target IRAK4, IRAKIMiD and STAT3 within the IL-1R/TLR or JAK/STAT pathways, providing the opportunity to treat a broad range of immune-inflammatory diseases, hematologic malignancies and solid tumors. For more information, visit www.kymeratx.com.

Contact:

[email protected]
Bruce Jacobs
Chief Financial Officer
+1 857.285.5300

Christopher F. Brinzey
Westwicke, an ICR Company for Kymera Therapeutics
[email protected]
+1 339.970.2843

[email protected]

Lissette L. Steele
Verge Scientific Communications for Kymera Therapeutics
[email protected]
+1 202.930.4762

PLEASANTON, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — Natus Medical Incorporated (NASDAQ:NTUS) (the “Company” or “Natus”), a leading provider of medical device solutions focused on the diagnosis and treatment of central nervous and sensory system disorders for patients of all ages, today announced the acquisition of Babybe GmbH and its patented remote mother to baby communication technology. The Babybe technology will add to Natus’s market leading Newborn Care portfolio of products.

Babybe offers an innovative new way to remotely connect a mother and her baby in the neonatal intensive care unit (NICU). With this technology, mother and baby are connected in real time through heartbeat, breathing and vocal sounds using an active mattress system.

Clinical studies are currently underway to assess how the mother and baby connection impacts weight gain, apnea and neuro-development in premature newborns who are isolated in the NICU.

“We are very excited about this technology. It complements NICVIEW, our remote video streaming service for NICU babies and offers mothers an additional level of remote interaction with babies isolated in the NICU,” said Jonathan Kennedy, President and Chief Executive Officer of Natus. “With 10% of all births world-wide or 15 million babies per year born prematurely, there is significant market opportunity for this product and we believe in the potential benefits this product can have in connecting baby and mother during the most critical period in the baby’s life,” Mr. Kennedy continued.

Natus expects the Babybe product to be available in commercial quantities in early 2022.

About
Natus
Medical Incorporated

Natus is a leading provider of medical device solutions focused on the diagnosis and treatment of central nervous and sensory system disorders for patients of all ages.

Additional information about Natus Medical can be found at www.natus.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “will”, “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. These statements relate to current estimates and assumptions of our management as of the date of this press release and involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements are only predictions and the actual events or results may differ materially. Natus cannot provide any assurance that its future results or the results implied by the forward-looking statements will meet expectations. A list of the Company’s risk factors are identified under the heading Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2020, June 30, 2020, September 30, 2020. Natus disclaims any obligation to update information contained in any forward looking statement, except as required by law.

Contacts:

Natus Medical Incorporated
Drew Davies
Executive Vice President and Chief Financial Officer
(925) 223-6700
[email protected]   

FOSTER CITY, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — GridGain Systems, provider of enterprise-grade in-memory computing solutions based on Apache^® Ignite^®, today discussed new resources to help organizations accelerate their digital transformations using digital integration hubs (DIHs) to power real-time business processes such as those powered by 360-degree customer views. GridGain has posted a variety of new resources on its website and announced a new webinar on how to create an effective DIH data synchronization layer called “How to Deploy Change Data Capture Using Debezium in Apache Ignite and GridGain,” which will be presented on Wednesday, December 2, 2020, at 9:00 a.m. PST / 12:00 p.m. EST.

A digital integration hub (or smart operational datastore, smart data hub or API platform) is rapidly becoming a foundational data center technology for enabling multiple business applications to access aggregated data from multiple source systems in real-time. A DIH aggregates defined subsets of data from multiple on-premises and cloud-based systems, including data warehouses, data lakes, on-premises business applications, SaaS applications and streaming data feeds. The data in the hub is then available for use by one or more business applications. IMDGs provide extremely high performance by caching the relevant data in memory and parallel processing queries from the connected business applications.

“A DIH powered by an in-memory computing platform is now the most popular approach to enabling real-time business processes that require 360-degree access to data from multiple, disparate data sources,” said Terry Erisman, Executive Vice President of Corporate Development at GridGain Systems. “Resources available for free on the GridGain website offer a training manual for developers to understand DIH use cases, architectures, and implementation strategies, including how to include mainframe data in a DIH and how to ensure the data in the DIH remains in sync with the source datastores.”

Compl
imentary Webinar

In “How to Deploy Change Data Capture Using Debezium in Apache Ignite and GridGain,” Evgenii Zhuravlev, GridGain Customer Solutions Team Lead, will explain how Kafka with Debezium and GridGain connectors enables change data capture (CDC)-based synchronization between third-party databases and GridGain clusters. Synchronization utilizing CDC eliminates the need for coding, requiring only the preparation of configuration files for each of the points. Developers and architects relying on legacy systems can deploy this solution to boost the performance of applications or enable applications to access data from multiple data silos and store it in one place. Webinar attendees will learn how to deploy such an architecture by configuring a Debezium Connector and a GridGain Certified Kafka Connector.

What: “How to Deploy Change Data Capture Using Debezium in Apache Ignite and GridGain” webinar
When: Wednesday, December 2, 2020, at 9:00 a.m. PST / 12:00 p.m. EST
Register: Sign up for the webinar on the GridGain website.

GridGain
Conference Recordings and Webinars

Additional GridGain resources that describe how enterprises are leveraging digital integration hubs to accelerate digital transformation include:

• In-Memory Computing Summit (IMCS) 2020 keynotes and breakout sessions, including:
    ° “The Future of In-Memory Computing” by Terry Erisman, EVP of Corporate Development, GridGain Systems
    ° “Real World Transformation with Z Digital Integration Hub” by Mythili Venkatakrishnan, Distinguished Engineer at IBM, and Sean Ashley, Assistant Vice President, Consumer Business and Digital Technology, M&T Bank
    ° “An Innovative Approach to Progressive Core Modernization in Banking” by Venkataraman Balasubramanian, Chief Technology Officer at Zafin, and Mythili Venkatakrishnan, Distinguished Engineer at IBM

• A webinar recording on DIH entitled “How to Drive Superior Customer Experiences at Massive Scale with In-Memory Computing” by Tech Mahindra’s Stalin Rajkumar, Global Practice Head – Digital Process Transformation, and Jayanarayan Mehanathan, Senior Solution Architect, along with GridGain’s Terry Erisman, EVP of Corporate Development, and Nikita Ivanov, CTO
• An application note titled “Powering Your Digital Transformation with a Digital Integration Hub”
• A blog post titled “GridGain’s Digital Integration Hub for Next Gen Telcos” by Lalit Ahuja, Vice President of Solutions & Services at GridGain

Additional Resources

To learn more about the GridGain in-memory computing platform:  

• Read the “Introducing the GridGain In-Memory Computing Platform” white paper
• Gain knowledge from the GridGain Developer Portal and GridGain webinars
• See how GridGain helps CTOs & CIOs, Architects, Business Decision Makers and Developers
• Read GridGain customer success stories and industry use cases

About GridGain Systems

GridGain Systems is revolutionizing real-time data access and processing by offering an in-memory computing platform built on Apache^® Ignite^®. Common use cases for the GridGain platform include application acceleration and as a digital integration hub for real-time data access across data sources and applications. GridGain solutions are used by global enterprises in financial services, software, e-commerce, retail, online business services, healthcare, telecom, transportation and other major sectors, with a client list that includes ING, Raymond James, American Express, Société Générale, Finastra, IHS Markit, ServiceNow, Marketo, RingCentral, American Airlines, Agilent, and UnitedHealthcare. GridGain delivers unprecedented speed, massive scalability, and real-time data access for both legacy and greenfield applications. Deployed on a distributed cluster of commodity servers, GridGain software can reside between the application and data layers (RDBMS, NoSQL and Apache^® Hadoop^®), requiring no rip-and-replace of the existing databases, or it can be deployed as an in-memory database. For more information, visit gridgain.com.

CONTACT:

Terry Erisman
GridGain Systems
[email protected]
(650) 241-2281

GridGain is a trademark or registered trademark of GridGain Systems, Inc. Apache, Apache Hadoop, Hadoop, Apache Ignite, Ignite, Apache Kafka, Kafka, Apache Spark, and Spark are trademarks of The Apache Software Foundation. All other product and company names herein may be trademarks of their registered owners.

VANCOUVER, British Columbia, Nov. 23, 2020 (GLOBE NEWSWIRE) — SHARC International Systems Inc. (CSE:SHRC) (FSE:IWIA) (OTCQB:INTWF) (the “Company” or “SHARC Energy”) has been selected to be part of a Canadian government Clean Tech Accelerator program that will market Canada’s leading clean-technology companies to global markets.

Only nine Canadian companies were selected for a five-month Canadian Technology Accelerator (“CTA”) program, which will focus on business opportunities in Southeast Asia through a series of virtual meetings.

Led by the Canadian Trade Office in Singapore, the CTA program allows chosen companies to access potential investments, pilot projects, partnerships and long-term sales in Singapore, Vietnam, Malaysia, and the Philippines, four of the ten Association of Southeast Asian Nations (“ASEAN”) countries.

According to a report published by the International Energy Agency (“IEA”), the ASEAN region is one of the world’s hottest areas, which caused a demand growth for space cooling of 7.5 times over the last 30 years. The temperature in this region keeps rising, as well as household income, leading to an increase in energy consumption and peak electricity demand. By 2040, cooling will account for 30% of peak electricity demand in ASEAN countries, and an additional 200 GW energy capacity will be required to meet the growing energy demand from ACs. These market trends support the adoption of high-efficient cooling technologies, making SHARC Systems a good fit. Our SHARC Systems can provide a super-efficient and climate-friendly district cooling solution through wastewater thermal energy exchange, and a process called heat rejection, as well as district heating and hot water production.

“We are honoured to have been chosen by the Canadian Technology Accelerator to bring our technology to global markets,” said Hanspaul Pannu, SHARC Energy’s CFO. “By recovering or rejecting the thermal energy from the wastewater we send down the drain every day, our made-in-Canada technology will have a significant role in reducing a building’s energy costs and its carbon footprint.”

SHARC Energy’s wastewater energy recovery technology — which exchanges the thermal energy from wastewater that is sent down the drain and turns it into heating and cooling — is already being used in Canada, the United States, Australia and the United Kingdom. Designed for both individual buildings and district energy systems, SHARC Energy’s technology is highly scalable and is being applied to both new and retrofitted buildings. “The nine companies taking part in the Southeast Asia program clearly demonstrate Canada’s leadership position in the cleantech sectors,” said Tegan Watson, Trade Commissioner, Canadian Technology Accelerator, Singapore. “It’s an exciting time to showcase Canadian innovation and know-how.”

Since 2013, the CTA program has supported the international scale-up of high-growth, high-potential Canadian firms in the sectors of cleantech, as well as life sciences and digital and information communication technologies. To date the CTA program has had 574 participants, collectively garnering $646 million in capital, $238 million in revenue and created 1,128 strategic partnerships and 2,529 new jobs.

“We’re seeing significant growth in the Southeast Asian cleantech sector and that includes growth in demand for circular economy and energy efficiency technologies,” said Lynn McDonald, Canadian High Commissioner in Singapore. “There’s a great opportunity for Canadian innovation to address some of the region’s most pressing environmental issues.”

The CTA program has also partnered with industry-leading organizations at the forefront of cleantech innovation. The nine companies in this year’s program will benefit from the expertise of New Energy Nexus, SecondMuse and the EcoLabs Centre of Innovation for Energy. New Energy Nexus is an international non-profit that supports clean energy entrepreneurs with funds, accelerators, and networks. SecondMuse is an impact and innovation company that builds resilient economies by supporting entrepreneurs and the ecosystems around them. The EcoLabs Centre of Innovation for Energy is designed to build and accelerate deep-tech energy innovation capabilities in Singapore to support the nation’s energy transition.

About SHARC International Systems

SHARC International Systems Inc. is a world leader in thermal heat recovery. SHARC systems recycle thermal energy from wastewater, generating one of the most energy efficient and economical systems for heating, cooling & hot water preheating for commercial, residential and industrial buildings, reducing their carbon footprint. SHARC is publicly traded in Canada (CSE: SHRC), the United States (OTCQB: INTWF) and Germany (Frankfurt: IWIA).

Further information about the Company is available on our website at www.SHARCenergy.com or SEDAR at www.sedar.com.

ON BEHALF OF THE BOARD

“Lynn Mueller”

Chairman and Chief Executive Officer

For
investor inquiries
, please contact:

Jason Shepherd
Investor Relations
SHARC International Systems Inc.
Telephone: (250) 212-2122
Email: [email protected]

For media inquiries, please contact

Mike Tanyi
Director of Marketing and IT 
SHARC International Systems Inc. 
Telephone: (250) 212-2122 
Email: [email protected]

The Canadian Securities Exchange does not accept responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

Certain statements contained in this news release may constitute forward-looking information. Forward-looking information is often, but not always, identified by the use of words such as “anticipate”, “plan”, “estimate”, “expect”, “may”, “will”, “intend”, “should”, and similar expressions. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. SHARC
Energy
‘s actual results could differ materially from those anticipated in this forward-looking information as a result of regulatory decisions, competitive factors in the industries in which the Company operates, prevailing economic conditions, and other factors, many of which are beyond the control of the Company. SHARC
Energy
believes that the expectations reflected in the forward-looking information are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking information should not be unduly relied upon. Any forward-looking information contained in this news release represents the Company’s expectations as of the date hereof, and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward-looking information whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/87efcf37-a84a-4b02-8720-740680631c09

NEWARK, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — Teneobio, Inc., a clinical stage next generation, multi-specific antibody therapeutics company, announced today that in 2020, Poseida exercised four options to commercial licenses for Teneobio human heavy chain only domain antibodies, UniDabs®, to develop novel CAR T therapies. Poseida will apply licensed UniDab binders, which possess significant advantages over traditional single chain variable antibody fragment (scFv) binders, to develop its next generation CAR-T therapies. Targets were not disclosed.

This announcement follows the expansion of a commercial license agreement between the companies that was announced in August of 2018. Under the terms of that agreement, Teneobio would generate multiple UniDab product candidates using its proprietary UniRat® transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. Poseida would have exclusive global licensing rights for the clinical development and commercialization of specific UniDabs for CAR cell therapies.

Teneobio Inc. receives commercial licensing fees for these milestones and is eligible to receive future research, development and regulatory milestone payments per UniDab candidate, with total potential earnings of over $250 million for CAR-T therapies developed by Poseida. Teneobio would also receive royalties on worldwide net sales of each CAR-T therapy.

“We are excited that Poseida has exercised multiple commercial license options on UniDabs to create the next generation of cell therapies,” said Omid Vafa, CBO of Teneobio. “UniDabs have been preclinically and clinically validated as excellent human single domain antibody targeting moieties of CAR T-cells. They have demonstrated both in vivo specificity and robust efficacy. Their advantageous smaller in size, and superior developability relative to standard scFv’s make them ideal for CAR T-cell products.”

Eric Ostertag, CEO of Poseida, added, “We have evaluated a large number of binding technologies for use in our CAR-T platforms and view single domain antibodies as one of the most superior. In our view, the fact that Teneobio’s VH binders are fully human makes them a better option than camelid VHH single domain antibodies.”

About Teneobio, Inc.

Teneobio, Inc. is a clinical stage biotechnology company developing a new class of biologics, Human Heavy-Chain Antibodies (UniAb^®), for the treatments of cancer, autoimmunity, and infectious diseases. Teneobio’s discovery platform, TeneoSeek, comprises genetically engineered animals (UniRat^® and OmniFlic^®), next-generation sequencing, bioinformatics and high-throughput vector assembly technologies. TeneoSeek rapidly identifies large numbers of unique binding molecules specific for therapeutic targets of interest. Versatile antibody variable domains (UniDab^®) derived from UniAb^® can be assembled into multi-specific and multivalent therapeutic proteins, surpassing limitations of conventional antibody therapeutics. Teneobio’s “plug-and-play” T-cell engaging platform includes a diverse set of anti-CD3 antibodies for therapeutics with optimal efficacy and reduced toxicity.

Teneobio partners include AbbVie, Janssen, GSK, Kite, Poseida, Intellia, and ArsenalBio.  For more information, please visit www.teneobio.com.

Company Inquiries for Teneobio, Inc.

Omid Vafa, Chief Business Officer
[email protected]

WORCESTER, Mass. and MUNICH, Germany, Nov. 23, 2020 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, and Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing service provider for the cell and gene therapy industry, today announced that they have signed an agreement to enable technology transfer and GMP clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for the treatment of X-linked severe combined immunodeficiency (“XSCID”), also known as bubble boy disease, in Europe.

Under the terms of the agreement, Minaris will perform technology transfer of the manufacturing and analytical processes, as well as their adoption to the European regulatory environment, for the GMP-compliant manufacturing of the drug product at its site in Ottobrunn, Germany, with the goal of supplying clinical trials in Europe.

“We look forward to a productive and successful partnership with Mustang where Minaris will be able to support them with our extensive experience in the clinical and commercial manufacturing of autologous gene therapies,” said Dusan Kosijer, Managing Director of Minaris. “We are eager to work together with Mustang in the fight against this devastating disease.”

“This agreement with Minaris is an important step in supporting expansion of our MB-107 pivotal clinical trial into Europe,” said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. “We look forward to working with Minaris to grow our geographic footprint and bring this potential life-saving therapy to XSCID patients in need internationally.”

MB-107 is currently being assessed in a Phase 1/2 clinical trial for XSCID in newly diagnosed infants under the age of two at St. Jude Children’s Research Hospital, UCSF Benioff Children’s Hospital in San Francisco and Seattle Children’s Hospital. Mustang submitted an investigational new drug application (“IND”) to the FDA to initiate a pivotal multi-center Phase 2 clinical trial of MB-107 in this same patient population. The trial is expected to enroll 10 patients who, together with 15 patients enrolled in the current multi-center trial led by St. Jude, will be compared with 25 matched historical control patients who have undergone hematopoietic stem cell transplantation. The primary efficacy endpoint will be event-free survival. The initiation of this trial is expected soon. Mustang is targeting topline data from this trial in the second half of 2022.

The FDA granted Rare Pediatric Disease, Orphan Drug and Regenerative Medicine Advanced Therapy Designations to MB-107 for the treatment of XSCID in newly diagnosed infants.

About X-linked Severe Combined Immunodeficiency (“XSCID”)

X-linked severe combined immunodeficiency is a rare genetic disorder that occurs in approximately 1 per 225,000 births. It is characterized by the absence or lack of function of key immune cells, resulting in a severely compromised immune system and death by one year of age if untreated. Patients with XSCID have no T-cells or natural killer cells. Although their B-cells are normal in number, they are not functional. As a result, XSCID patients are usually affected by severe bacterial, viral or fungal infections early in life and often present with interstitial lung disease, chronic diarrhea and failure to thrive.

The specific genetic disorder that causes XSCID is a mutation in the gene coding for the common gamma chain (“γc”), a protein that is shared by the receptors for at least six interleukins. These interleukins and their receptors are critical for the development and differentiation of immune cells. The gene coding for γc is known as IL-2 receptor gamma, or IL2RG. Because IL2RG is located on the X-chromosome, XSCID is inherited in an X-linked recessive pattern, resulting in almost all patients being male.

About Mustang Bio

Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of chimeric antigen receptor T cell (CAR T) therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.mustangbio.com.

About Minaris Regenerative Medicine

Minaris Regenerative Medicine is a global contract development and manufacturing organization (CDMO) for cell and gene therapies. We offer our clients high value clinical and commercial manufacturing services, development solutions, and technologies. We are pioneers in the field with more than 20 years’ experience providing outstanding quality and reliability. Our facilities in the US, Europe, and Asia allow us to supply patients worldwide with life-changing therapies. Minaris Regenerative Medicine is wholly owned by Showa Denko Materials Co., Ltd. For more information, please visit www.rm.minaris.com.

Forward‐Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Minaris Regenerative Medicine Contact:

Luc St-Onge, Ph.D.
Global Head of Sales and Marketing
Minaris Regenerative Medicine GmbH

E-Mail: [email protected]
Phone: +49 (0)89 700 9608-0

Mustang Bio Contacts:

Jaclyn Jaffe and William Begien
Mustang Bio, Inc.
(781) 652-4500
[email protected]

Investor Relations Contact:
Daniel Ferry
LifeSci Advisors, LLC
(617) 430-7576
[email protected]

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
[email protected]

MALVERN, Pa., Nov. 23, 2020 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, (“Baudax Bio” or the “Company”) today announced that it has entered into a definitive agreement with a healthcare-focused institutional investor for the purchase and sale of an aggregate of 10,126,583 shares of common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to an aggregate of 10,126,583 shares of common stock at a purchase price of $1.185 per share (or $1.175 per prefunded warrant) and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.20 per share, are exercisable immediately, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about November 25, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Baudax Bio from the offering are expected to be approximately $12 million. In addition, in the event the warrants are exercised in full for cash, Baudax Bio expects to receive approximately $12.15 million in additional gross proceeds. However, there is no assurance that all or any portion of the warrants will be exercised prior to their expiration. Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

The securities described above are being offered by Baudax Bio pursuant to a “shelf” registration statement on Form S-3 (File No. 333-243488) filed with the Securities and Exchange Commission (SEC) on August 10, 2020 and declared effective on October 2, 2020. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About ANJESO®

ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio’s first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio’s ability to maintain regulatory approval for ANJESO, Baudax Bio’s ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio’s ability and that of Baudax Bio’s third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio’s ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio’s ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio’s estimates of the potential market for ANJESO, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:   

Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected] 
[email protected]   

Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected] 

SAINT PETERSBURG, FL, Nov. 23, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Energy and Water Development Corp. (OTC: EAWD) announces that it signed a Letter of Intent (LOI) to acquire a prolific 16,000 sq. ft. area near the Port of Hamburg to become its new branch in Hamburg, Germany. The property’s location is ideal as a key transportation hub. The German property is situated in a region where EAWD has a comparative advantage of engineering resources and expertise readily available to rapidly build its first CO2-free Assembling Manufactory.

EAWD recently signed several sales agreements to deliver Solar Powered Atmosphere Water Generation Systems (SPAWGs). This European CO2-free assembling manufactory is anticipated to satisfy yearly production of at least 3000 SPAWGs for worldwide export. The technological innovation of these systems is extraordinary and game changing in that they generate their own energy and water supply. 

CEO Ralph Hofmeier stated, “Despite challenges to accelerate our timeline to deliver meaningful progress due to Covid-19, we are now on a direct trajectory for sustainable production at an ideal site. We remain excited about our prospects and plans to deliver efficient CO2 Free production of the innovative, industrial size Solar Powered Atmosphere Water Generation Systems.” 

About Energy and Water Development Corp.

Energy and Water Development Corp. (“EAWD”) is a green-tech engineering solutions company focused on delivering water and energy to extreme environments. The Company offers design, construction, maintenance, and specialty consulting services to private companies, government entities and non-government organizations (NGOs).  EAWD builds water and energy systems out of already-existing, proven technologies, utilizing their technical know-how to customize solutions to their clients’ needs. Website: www.eawctechnologies.com

Forward-Looking Statements

This press release may contain forward-looking statements. The words “believe,” “expect,” “should,” “intend,” “estimate,” “projects,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based upon the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Among the important factors that could cause actual results to differ significantly from those expressed or implied by such forward-looking statements are risks that are detailed in the Company’s filings.

Contact Information:

Energy and Water Development Corp. 
Irma Velazquez, Chief Operating Officer 
Email: [email protected]
Tel. +1 347 871 8927