Bright Mountain Media Reports Record Third Quarter 2020 Financial Results

Source: Bright Mountain Media, Inc. 11/25/2020

Bright Mountain Media, Inc. (OTCQB: BMTM), an end-to-end digital media and advertising services platform, has provided its financial results for the third quarter ended September 30, 2020.

Management Commentary

“The third quarter of 2020 was highlighted by our continued revenue growth - a testament to the successful execution of our rollup strategy - with the goal of creating an industry leading digital media and advertising services platform,” said Kip Speyer, Chairman and Chief Executive Officer of Bright Mountain Media. “We continue to integrate Wild Sky Media post-acquisition and have been satisfied with the immense contributions their team has made to the broader organization thus far, expanding our reach into exciting new demographics through a diverse website portfolio.

“We are also exploring further potential acquisitions in what is shaping up to be a buyers market. Bright Mountain maintains a robust pipeline of potential acquisition candidates, though we will remain highly selective to ensure any target is accretive, reasonably valued and complementary to our core business.

“2020 has been a year of growth for Bright Mountain Media and I look forward to what 2021 holds. With a robust acquisition pipeline, a growing core business and a potential uplisting on the horizon – we are well positioned to create sustainable value for our shareholders over the long-term,” concluded Speyer.

Third Quarter 2020 Financial Summary

• Total revenue for the third quarter of 2020 grew 132% to $4.9 million, compared to revenue of $2.1 million in the same year-ago quarter. The increase in revenue was largely due to the acquisition of Wild Sky Media, in spite of the negative influence of COVID-19 on the digital advertising market.

• Selling, general and administrative expenses for the third quarter of 2020 were $5.5 million, compared to $2.7 million in the same year-ago quarter. The increase in selling, general and administrative expenses was due to the acquisitions of MediaHouse and Wild Sky which are not reflected in the prior period expenses

• Net loss for the third quarter of 2020 was $56.6 million, compared to a net loss of $2.0 million in the same year-ago quarter. The increase in net loss was primarily non-cash, related to the impairment of goodwill from previous acquisitions.

• Cash, cash equivalents and short-term deposits increased to $1.1 million as of September 30, 2020, compared with $1.0 million as of December 31, 2019.

• Cash used in operations for the second quarter of 2020 was $2.1 million, compared with cash used in operations of $0.4 million in the same year-ago quarter.
  

About Bright Mountain Media

Bright Mountain Media, Inc. (OTCQB: BMTM) is an end-to-end digital media and advertising services platform, efficiently connecting brands with targeted consumer demographics. Through the removal of middlemen in the advertising services process, Bright Mountain Media efficiently connects brands with targeted consumer demographics while maximizing revenue to publishers. Bright Mountain Media’s assets include Bright Mountain, LLC, MediaHouse (f/k/a NDN), Oceanside (f/k/a S&W Media), and Wild Sky Media including 24 owned and/or managed websites and 15 CTV apps. For more information, please visit www.brightmountainmedia.com.

Update: Bright Mountain Media Appoints Pamela J. Parizek to the Board of Directors

 

Source: Bright Mountain Media, Inc. 10/23/2020

Renowned Industry Thought Leader Brings 30+ Years of Financial Reporting and Regulatory Compliance Experience to the Company’s Board of Directors

Bright Mountain Media, Inc. (OTCQB: BMTM), an end-to-end digital media and advertising services platform, today announced that Pamela J. Parizek, renowned financial reporting and compliance executive and industry thought leader, has been appointed to the Company’s Board of Directors effective immediately.

Ms. Parizek brings with her over 30 years of experience in strategic advisory, compliance, accounting and financial reporting. A Certified Public Accountant, she currently serves as Chair of the Board of Directors of The Foundation for a Smoke-Free World, while concurrently serving on the Board of Trustees of the National Museum of Women in the Arts.

Previously, Ms. Parizek served in the enforcement division of the U.S. Securities and Exchange Commission, led the Washington, DC forensics practice of KPMG and conducted sensitive investigations for Kroll, a business intelligence firm. Ms. Parizek graduated from Harvard College and obtained a J.D. from the Northwestern University School of Law.

“I am pleased to appoint Pamela to our Board of Directors, as she brings decades of invaluable advisory experience to further strengthen our competency in financial reporting and regulatory compliance,” said Kip Speyer, Chairman & Chief Executive Officer of Bright Mountain Media. “Her unique financial insights will help us continue to expand the breadth and depth of our reach as a Company, positioning us to continue to create value for our shareholders.”

“Bright Mountain Media is building a solid digital media company and is well positioned to grow revenues through 2020 and beyond. I look forward to working with Kip Speyer and the Bright Mountain Media Board of Directors,” added Pamela J. Parizek.

About Bright Mountain Media

Bright Mountain Media, Inc. (OTCQB: BMTM) is an end-to-end digital media and advertising services platform, efficiently connecting brands with targeted consumer demographics. Through the removal of middlemen in the advertising services process, Bright Mountain Media efficiently connects brands with targeted consumer demographics while maximizing revenue to publishers. Bright Mountain Media’s assets include Bright Mountain, LLC, MediaHouse (f/k/a NDN), Oceanside (f/k/a S&W Media), and Wild Sky Media including 24 owned and/or managed websites and 15 CTV apps. For more information, please visit www.brightmountainmedia.com.

Genprex Strengthens Scientific Advisory Board with Appointment of Lead Researcher of University of Pittsburgh, George K. Gittes, MD

Source: Genprex, Inc. 11/10/2020

Inventor of the Company’s licensed diabetes gene therapy technology to provide leadership, strategy for diabetes program

Dr. Gittes was recipient of a $2.59 million grant from the National Institutes of Health (“NIH”) National Institute of Diabetes and Digestive and Kidney Diseases for his groundbreaking gene therapy research 

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the addition of George K. Gittes, MD to its Scientific Advisory Board (SAB). Dr. Gittes is the inventor of the Company’s licensed diabetes gene therapy technology that is currently in development, and serves as the Chief of Pediatric Surgery and Surgeon-in-Chief Emeritus at the UPMC Children’s Hospital of Pittsburgh. 

In February 2020, Genprex signed an exclusive license agreement with the University of Pittsburgh for Dr. Gittes’ diabetes gene therapy technology. Type 1 and Type 2 diabetes together affect approximately 30.3 million people in the U.S., or about 9 percent of the U.S. population. By replacing or repairing damaged or missing genes, gene therapy offers a potential cure for patients suffering from diabetes, as opposed to merely treating symptoms.

As a member of Genprex’s SAB, Dr. Gittes will leverage his highly impressive expertise to provide strategic support and drive strategy for the Company’s diabetes clinical development program.

“We are delighted to have Dr. Gittes join our Scientific Advisory Board as Genprex continues to advance its diabetes program,” said Rodney Varner, Genprex’s President and Chief Executive Officer. “It is imperative that we rely on the guidance and direction of esteemed individuals with a wealth of expertise in research and gene therapy, and I expect that Genprex will benefit greatly from Dr. Gittes’ experience. He will play an instrumental role in our efforts to bring new hope to patients who suffer from the devastating complications of this chronic illness.”

In addition to his role as Chief of Pediatric Surgery and Surgeon-in-Chief Emeritus at UPMC Children’s Hospital of Pittsburgh, one of the busiest pediatric surgical programs in the U.S., he was appointed Director of the Richard King Mellon Foundation Institute for Pediatric Research and Co-Scientific director at UPMC Children's Hospital in 2018. Prior to UPMC, Dr. Gittes served as the Director of Surgical Research at Children’s Mercy Hospital in Kansas City and held the Thomas M. Holder and Keith W. Ashcraft Chair in Pediatric Surgical Research. During his time in Kansas City, he also was elected to the position of President of the Society of University of Surgeons.

He is an active member of numerous professional and scientific society memberships, including the American Society of Clinical Investigators, the American Surgical Association, the American Diabetes Association and the Association of American Physicians. His research has been published in several peer-reviewed scientific publications, and he is the recipient of several research grants, including a recent $2.59 million grant awarded by the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases to assist his ongoing preclinical research for important proof-of-principle non-human primate studies of his diabetes gene therapy.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ immunogene therapy drug (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

 

 

Genprex Unveils New Branding for Upcoming Combination Clinical Trials in Non-Small Cell Lung Cancer

 

Source: Genprex, Inc. 10/30/2020

New branding will support upcoming combination clinical trials, including the Company’s trial combining REQORSA™ immunogene therapy drug with AstraZeneca’s Tagrisso^®, which received FDA Fast Track Designation earlier in 2020

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the launch of new branding for its upcoming oncology clinical trials combining its lead drug candidate, REQORSA™ (quaratusugene ozeplasmid), with AstraZeneca’s Tagrisso^® (osimertinib), which received U.S. Food and Drug Administration (FDA) Fast Track Designation earlier this year, and for the combination of REQORSA with Merck’s Keytruda^® (pembrolizumab), for the treatment of non-small cell lung cancer (NSCLC).  

These trials will use the trial brand “Acclaim,” which the Company believes evokes its enthusiasm and the hope these trials represent for NSCLC patients and the oncology community. Acclaim-1 will be used to identify the REQORSA and Tagrisso combination clinical trial, and Acclaim-2 will be used to identify the REQORSA and Keytruda combination clinical trial.

“We are enthusiastically preparing for our upcoming clinical trials and are excited to launch the adoption of this branding,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We believe the Acclaim brand communicates our passion for providing hope to NSCLC patients for important new treatment options in the fight against this devastating disease and aligns us with the clinical, medical and patient communities.”

The trial brand was developed in order to encourage early exposure of the Company’s clinical programs to the broad audience that Genprex’s business addresses, including patients, healthcare practitioners, clinical investigators, investors, employees and others. Genprex plans to initiate the Acclaim-1 clinical trial and the Acclaim 2 clinical trial in the first-half of 2021. Acclaim-1 is a Phase 1/2 clinical trial using a combination of REQORSA with Tagrisso in patients with late stage NSCLC with mutated epidermal growth factor receptors (“EGFRs”) whose disease progressed after treatment with Tagrisso. Acclaim-2 is a Phase 1/2 clinical trial using a combination of REQORSA with Keytruda in NSCLC patients who are low expressors (1 to 49%) of the protein, programmed death-ligand 1 (PD-L1).

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing potentially life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso^®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Genprex Receives Conditional FDA Acceptance of Proprietary Name REQORSA™ for Lead Drug Candidate for Treatment of Non-Small Cell Lung Cancer

 

Source: Genprex, Inc. 10/29/2020

Approval of new name marks important branding milestone and aligns with the program’s overall progress

REQORSA immunogene therapy uses the company’s unique, proprietary ONCOPREX™ nanoparticle delivery system to deliver cancer-fighting genes

FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® for the treatment of non-small cell lung cancer earlier this year

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name REQORSA™ for its lead drug candidate in development for the treatment of non-small cell lung cancer, known previously by the laboratory designation GPX-001.

The name REQORSA (pronounced “re-KORE-suh”), was developed in accordance with FDA’s guidance for the submission and evaluation of proprietary names. The Company selected the name based on comprehensive and disciplined review of name candidates, including a research study of healthcare practitioners across the U.S. to ensure accurate prescription and safety interpretation of the name.

“We are very pleased to receive FDA’s conditional acceptance of our proprietary name, REQORSA, which is a necessary step toward being able to market our lead drug candidate for non-small cell lung cancer,” said Rodney Varner, President and Chief Executive Officer of Genprex. “This name approval also marks an important milestone in our overall branding strategy, giving us a unique, easily understood name people can associate with the Genprex brand and mission.”

Genprex will resubmit its proprietary name for FDA final review upon completion of all required clinical trials and prior to the submission of a Biologics License Application. Final approval of the REQORSA brand name is conditional on FDA approval of the product candidate.

REQORSA uses the company’s unique, proprietary ONCOPREX® nanoparticle delivery system, which delivers cancer-fighting genes by encapsulating them into nanoparticles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. In January 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® for the treatment of non-small cell lung cancer.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ immunogene therapy drug (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

 

Genprex Promotes Eric Chapdelaine to Vice President of Manufacturing

 

Source: Genprex, Inc. 10/26/2020

Promotion follows the Company’s achievement of key manufacturing milestones to support upcoming clinical trials

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today the promotion of Eric Chapdelaine to Vice President of Manufacturing. Mr. Chapdelaine’s promotion is a result of the Company’s achievement of key manufacturing milestones to support upcoming clinical trials of the Company’s lead drug candidate, GPX-001 (quaratusugene ozeplasmid). Upcoming trials include a Phase I/II trial combining GPX-001 with AstraZeneca’s Tagrisso® (osimertinib) in non-small cell lung cancer (NSCLC) patients who progressed on Tagrisso, which received U.S. Food and Drug Administration (FDA) Fast Track Designation in January 2020. 

“The appointment of Eric to our senior team is a hallmark of our manufacturing achievements and highlights the progress we have made in scaling up our manufacturing to commercial scale, which will further supply our upcoming clinical trials,” said Michael Redman, Genprex’s Executive Vice President and Chief Operating Officer.

In June of 2020, Genprex announced the expansion of its commercial development program for the manufacture of TUSC2 (Tumor Supressor Candidate 2) plasmid DNA, the active agent in GPX-001. The program expansion provides for full commercial scale plasmid DNA manufacturing with a key manufacturing partner. This relationship is supporting the manufacture of the drug product, GPX-001, to supply the Company’s upcoming clinical trials in which GPX-001 is combined with Tagrisso and Keytruda® (marketed by Merck), respectively.

Mr. Chapdelaine has more than 15 years of experience in the pharmaceutical and biotech industries. He joined Genprex in 2019 as Senior Director of Pharmaceutical Sciences and Manufacturing, where he has been responsible for leading the Company’s Manufacturing Operations and Supply Chain functions. Prior to joining Genprex, Mr. Chapdelaine was Director of Quality Control and Analytical Development at Cognate BioServices, responsible for management and oversight of a large Quality Control and Analytical Development staff and multiple laboratories in a Cell and Gene Therapy CDMO facility. Prior to Cognate, he served as Quality Control Manager of Specifications at Alnylam Pharmaceuticals, where he led as Specification Committee Chairperson and authored CMC-related sections of regulatory filings for the first ever approved RNAi therapeutic for commercial use. Mr. Chapdelaine spent the prior six years at Sanofi Genzyme.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Genprex Names Seasoned IP Executive, Thomas C. Gallagher, as Senior Vice President of Intellectual Property and Licensing

Source: Genprex, Inc. 9/21/2020

 Gallagher’s appointment demonstrates the Company’s commitment to building a world-class intellectual property portfolio

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced it has named Thomas C. Gallagher, Esq. as the Company’s Senior Vice President of Intellectual Property and Licensing. Mr. Gallagher has extensive experience in the area of biotechnology intellectual property (IP) law, business development, and licensing transactions with industry and academic institutions.

“Mr. Gallagher will play a critical role in advancing our expanding intellectual property estate by spearheading IP strategy, which is an important element of the Company’s overall success and value creation. A seasoned biotech executive, he will provide significant support as we execute on broadening our research and development programs, explore opportunities for partnerships on our existing programs, and opportunistically acquire new technologies to further expand our pipeline,” said Rodney Varner, President and Chief Executive Officer of Genprex.

Mr. Gallagher has more than 20 years of experience as an intellectual property attorney. Prior to joining Genprex, he served as Principal at the Fenagh Group, an IP and licensing consultancy providing clients in the healthcare sector guidance on all aspects of patent and trademark portfolio management, intellectual property due diligence, freedom-to-operate analysis and related transactional work. He has also served as Senior Vice President of Intellectual Property and Licensing at Kadmon Corporation, LLC, a biopharmaceutical company based in Manhattan. Prior to joining Kadmon, he served as in-house IP counsel at Neostem Inc. (now Caladrius Biosciences, Inc.), a company focused on stem cell biology. Previously, he held several positions at ImClone Systems Incorporated, most recently as Vice President of Intellectual Property and Licensing. While at ImClone, he was responsible for all aspects of intellectual property and led the IP function in multiple due diligence undertakings by major pharmaceutical companies, which resulted in a $2 billion strategic investment, the highest-valued biotech deal ever at the time, and the eventual sale of the company to Eli Lilly and Company for $6.5 billion.

Mr. Gallagher is experienced in both patent prosecution and litigation, as well as intellectual property issues relating to business development and licensing matters. His patent litigation experience includes European litigation and opposition proceedings. In addition to a law degree, Mr. Gallagher holds a Master’s degree in molecular biology. Before becoming an attorney, Mr. Gallagher worked as a molecular biologist in France, Spain and the United States.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

 

Operational Update

Source: Western Magnesium Corporation 9/22/2020

Western Magnesium Corporation (TSXV: WMG; Frankfurt-M1V; OTCQB:  MLYF) (“Western Magnesium” or the “Company”).

Western Magnesium provides an update on the organization of the plant!

These are the foundational steps that Paul Sauvé, Sr Vice-President of Operations, and his technical team are taking to construct a well-designed, safe, and flexible plant. Equally important, the plan will ensure all design, construction and build-out will be in accordance with federal and local codes and standards.

To that effect, the following is taking place:

• the technical staff has started to work on the design of the space to comply with city code requirements.
• the design towards installation of structural steel is underway;
• our mechanical engineering drawings and models are in the final stage of review;
• initial facility construction is beginning in preparation for the equipment delivery;
• various suppliers and service providers have been granted access to the site to begin their evaluations to ensure a safe & expedient completion of the pilot plant.

Western Magnesium also thanks shareholders that asked us some great clarifying questions about our pilot plant. The commercial pilot plant is a smaller-scale version of the full-scale production system. The plant is going to test and validate our production technology before commercialization and will demonstrate its efficiency and effectiveness in producing magnesium metal. At the same time, Mr. Sauve and his team will look to optimize the process flowsheet to meet production deliverables. With commercialization as the end goal, the pilot plant will exhibit scale up efficiency, technical process validation, eco-friendly efficacy, and production of full magnesium metal.

About Western Magnesium

Western Magnesium’s goal is to be a low-cost producer of green, primary magnesium metal, a strategic commodity prized for its strength and lightweight qualities. Unlike outdated and costly production processes, Western Magnesium looks to use a continuous silicothermic process to produce magnesium, which significantly reduces manufacturing and energy costs relative to current methods and processes, while being environmentally friendly.

 

Western Magnesium Announces Non-Brokered Private Placement

 

Source: Western Magnesium Corporation 9/10/2020 

Western Magnesium Corporation (TSXV:WMG; Frankfurt-M1V; OTCQB:MLYF) (“Western Magnesium” or the “Company”) is pleased to announce that it intends to raise up to CDN $7,000,000 by way of a non-brokered private placement (the “Offering”) of Units (“Units”) of the Company at a price of CDN $0.13 per Unit.

The Offering

The maximum Offering is for gross proceeds of up to CDN $7,000,000. Each Unit will consist of one common share in the capital of Western Magnesium Corporation (the “Common Shares”) and one Common Share Purchase Warrant (the “Warrants”). Each Warrant will be exercisable into one Common Share for a period of one year at a price of $0.19/share.

The completion of the private placement and payment of any commission and fees remains subject to the receipt of all necessary approvals, including the approval of the TSX Venture Exchange.  The securities issued will be subject to a statutory hold period in Canada for a period of four months and one day from the Closing Date. The securities have not been registered with the SEC and are also subject to a statutory one-year hold period in compliance with Regulation S of the Securities Act of 1933 as amended.  The Regulation S hold period supersedes the TSX Venture Exchange hold period. Proceeds of the private placement will be used for working capital and to complete our commercialized pilot plant.

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

About Western Magnesium

Western Magnesium’s goal is to be a low-cost producer of green, primary magnesium metal, a strategic commodity prized for its strength and lightweight qualities. Unlike outdated and costly production processes, Western Magnesium looks to use a continuous silicothermic process to produce magnesium, which significantly reduces manufacturing and energy costs relative to current methods and processes, while being environmentally friendly.

 

Western Magnesium Obtains Pilot Plant Location

 

Source: Western Magnesium Corporation 9/1/2020

Western Magnesium Corporation (TSXV:WMG) (FrankfurtM1V) (OTC:MLYF) (“Western Magnesium” or the “Company”) is very pleased to announce that it has finalized and obtained a location for its commercial pilot plant.

The plant will be in the lower mainland with close proximity to the downtown core, major transportation routes and the airport. The building itself is new and meets all the specifications and zoning needed to build the entire plant. The technical team is excited about the environment and are now going through their last stages of preparation to start moving into the new facility. Mr. Paul Sauve says, “This is an excellent facility that will provide all the required amenities necessary for a successful pilot plant campaign.”

Mr. Sam Ataya commented, “This is a great achievement for Western Magnesium as it has met one of its important milestones in Phase 2 as it continues to move forward towards production of magnesium metal by the end of the year, into the New Year. This critical step not only gets us closer to production, but also gets us closer to end-user testing and certification and being a supplier to the various industries that require magnesium such as the automotive, aerospace, government and eco-friendly industries. This commercialized pilot plant will lay the foundation for all the commercialized plants to follow across Canada and the United States.”

About Western Magnesium

Western Magnesium’s goal is to be a low-cost producer of green, primary magnesium metal, a strategic commodity prized for its strength and lightweight qualities. Unlike outdated and costly production processes, Western Magnesium looks to use a continuous silicothermic process to produce magnesium, which significantly reduces manufacturing and energy costs relative to current methods and processes, while being environmentally friendly.

Potable Water in Buildings Unoccupied During COVID-19 Pandemic Contains Far More Bacteria than in Occupied Buildings; Legionella does not Predominate

Source: Nephros, Inc. 7/22/2020

 Nephros SequaPath™, a new microbial screening system, used to evaluate 88 building water samples across four US geographic regions

Findings confirm importance of assessing microbial community structure before re‑occupancy. Testing solely for Legionella is not supported by the data.

Nephros, Inc. (Nasdaq:NEPH), a commercial-stage company that develops and sells water purification products and pathogen detection systems to the medical and commercial markets, today announced the results of a study of water in buildings affected by recent COVID-19-related shutdowns.

The manuscript describing the study is available on bioRxiv. The research team collected 88 water samples from a diverse group of buildings in four geographic regions, some of which have been unoccupied during the COVID-19 pandemic. The microbial community structure of each of the samples was analyzed using the Nephros SequaPath microbial screening system. Key takeaways from the study include:

• Bacterial counts in stagnant water samples from unoccupied/under-occupied buildings were as much as 1,400 times higher than in buildings with normal occupancy and water usage.
• More than 50 genera (families) of bacteria known to have at least some pathogenic (i.e., disease-causing) members were detected in approximately 60% of unoccupied building samples, compared with 35% in occupied building samples.
• Many of the bacterial genera that were detected are not typically considered in water safety testing programs. Recent guidance about water safety testing prior to re-occupancy focuses almost solely on Legionella. In this study, however, Legionella was found in only about 10% of the samples and, in samples where Legionella was identified, it was not predominant.

Many office buildings and other facilities across the country have been unoccupied and under-used during the COVID-19 pandemic. When buildings are unoccupied, water in building piping systems becomes stagnant. The level of chlorine in the water (a disinfectant used to inhibit microbial growth), decreases over time and is rarely present in stagnant water. This results in conditions known to support growth of bacteria, including many known to cause disease.

“As we return to our normal routines, health and safety is surely our number one priority,” commented Kimothy L. Smith, DVM, PhD, Nephros Vice President of Pathogen Detection Systems. “This study confirms that, following a long period of under-use, water systems in the majority of unoccupied buildings across the country may be colonized by pathogens, many of which are not considered by most published guidance. In fact, the Legionella-centric approach that is most frequently taken is not supported by the data from this study. Negative results from water tested only for Legionella are not sufficient to declare the building safe for re-occupancy, and may put people in harm’s way by creating a false sense of security. This study highlights the need for screening of the microbial community structure as an important first step in identifying pathogens of concern and determining risk-mitigation measures.”

Daron Evans, President and CEO of Nephros, commented, “Legionnaires disease, caused by Legionella, is the only reportable, plumbing-associated waterborne disease. Guidance for building water health, including microbial testing, has focused almost exclusively on Legionella. However, in the last few years, thought leaders in water and public health have expanded their scope to include other clinically significant plumbing-associated pathogens. Important new standards, such as ASHRAE 514, are addressing multiple pathogens associated with building water systems. At the cutting edge of this new, evolving approach, Nephros has developed its SequaPath and PluraPath™ systems. With streamlined 16S rRNA gene sequencing technology, SequaPath is able to test for over 20,000 different bacterial genera in near-real time, providing a simple yet powerful tool for screening the microbial community structure of water samples from buildings. The water can then be further analyzed for multiple pathogenic species of concern in SequaPath-identified genera using Nephros PluraPath, a robust qPCR-based platform. SequaPath and PluraPath systems and services are available from Nephros and our partner network.”

The authors of the study are Kimothy L. Smith, DVM, PhD, (Nephros) and Howard Shuman, PhD (University of Chicago and Manhattan College), and Douglas Findeisen (Building Water Sampling Services, LLC).

Disclosure:
Nephros provided financial support for the study.

Links:

• A pre-print of the study is here.
• A blog post about the study is here.
• More information about Nephros SequaPath system is here.

About Nephros:
Nephros is a commercial-stage company that develops and markets high-performance water purification products and pathogen detection systems for medical and commercial markets.

Nephros ultrafilters are used in hospitals, medical clinics, and commercial facilities to retain bacteria and viruses from water, providing barriers that aid in infection control for showers, sinks, and ice machines. Nephros ultrafilters are also used in dialysis centers to aid in the removal of endotoxins and other biological contaminants from water and bicarbonate concentrate in hemodialysis machines.

Nephros pathogen detection systems, including the PluraPath and SequaPath systems, provide near-real time information on bacterial genera, waterborne bacteria, and viruses to medical and water safety professionals. These products integrate Nephros ultrafilters with DNA sequencing and quantitative polymerase chain reaction (qPCR) technology.

Nephros commercial filters, including AETHER™ brand filters, improve the taste and odor of water, and reduce scale build-up in downstream equipment. Nephros and AETHER products are used in the health care, food service, hospitality, and convenience store markets.

For more information about Nephros, please visit its website at www.nephros.com.

Nephros Names Andy Astor President and Chief Executive Officer

Source: Nephros, Inc. 8/14/2020

 Daron Evans to Remain Senior Science Advisor and CEO of Specialty Renal Products

Nephros, Inc. (Nasdaq:NEPH), a commercial-stage company that develops and sells water purification products and pathogen detection systems to the medical and commercial markets, today announced that Andy Astor, currently the company’s Chief Operating Officer and Chief Financial Officer, has been named President and CEO, effective August 24, 2020. Mr. Astor was also elected to Nephros’s board of directors.

Daron Evans, Nephros’s current President and CEO, will remain with the company as a special advisor focused on the pathogen detection and dialysis businesses. Mr. Evans will also continue as CEO of Specialty Renal Products (“SRP”), a Nephros subsidiary. As part of the transition, Mr. Evans will step down from Nephros’s board of directors.

“I am very pleased to announce Andy’s promotion to President and CEO,” said Mr. Evans. “Since joining the company in 2017, Andy has been instrumental to our success in growing revenues four-fold. Driven by an intense focus on serving our customers and strategic partners, Andy has led the development of operational and financial systems, built strong relationships with the investor community, raised the capital we needed, spearheaded the acquisition of the Aether™ filter brand, driven high-talent recruitment, and built a strong team-based organization and culture.”

Mr. Evans continued, “Going forward, Andy and I will continue to partner closely to build on this foundation and to drive the success of both Nephros and SRP. Although I have decided to transition to a reduced time commitment for personal reasons, I have had the privilege to lead the company for over five years, and I remain fully committed to Nephros’ success.”

“We congratulate Andy on this promotion, and it is a pleasure to welcome him to the board of directors,” said Paul Mieyal of Wexford Capital and board member of Nephros. “Over the past three years, he has demonstrated a deep commitment to the company, along with the acumen required to lead Nephros from early-stage to commercial-stage and beyond.”

“It is an honor to be asked to lead this organization,” said Andy Astor. “We have built a strong growth platform for the future, including deep relationships with many of the country’s leading water quality professionals. With more than 1,100 active customer sites using Nephros products to protect people from waterborne pathogens with our filtration and detection solutions, I am very pleased to take on this leadership role as we continue the company’s momentum and progress.”

About Nephros:
Nephros is a commercial-stage company that develops and markets high-performance water purification products and pathogen detection systems for medical and commercial markets.

Nephros ultrafilters are used in hospitals, medical clinics, and commercial facilities to retain bacteria and viruses from water, providing barriers that aid in infection control for showers, sinks, and ice machines. Nephros ultrafilters are also used in dialysis centers to aid in the removal of endotoxins and other biological contaminants from water and bicarbonate concentrate in hemodialysis machines.

Nephros pathogen detection systems, including the PluraPath and SequaPath systems, provide near-real time information on bacterial genera, waterborne bacteria, and viruses to medical and water safety professionals. These products integrate Nephros ultrafilters with DNA sequencing and quantitative polymerase chain reaction (qPCR) technology.

Nephros commercial filters, including AETHER™ brand filters, improve the taste and odor of water, and reduce scale build-up in downstream equipment. Nephros and AETHER products are used in the health care, food service, hospitality, and convenience store markets.

For more information about Nephros, please visit its website at www.nephros.com.

Nephros Reports Second Quarter Financial Results

 Source:  Nephros, Inc. 8/5/2020

Nephros, Inc. (Nasdaq:NEPH), a commercial-stage company that develops and sells high performance water purification products and pathogen detection systems to the medical and commercial markets, today announced financial results for the three months ended June 30, 2020.

Financial Highlights

Water Filtration Business Segment Highlights

• Net revenue was $1.6 million, down 32% compared with $2.3 million in 2019
• Net loss was $0.9 million, compared with $0.3 million in 2019
• Adjusted EBITDA was ($0.7 million), compared with breakeven in 2019

Consolidated Highlights

• Net revenue was $1.6 million, down 32% compared with $2.3 million in 2019
• Net loss was $1.7 million, compared with $0.9 million in 2019
• Adjusted EBITDA was ($1.4 million) compared with ($0.5 million) in 2019

“While COVID-19 broke our streak of 15 quarters of year-over-year growth, we remain optimistic about our growth prospects,” said Daron Evans, President and CEO. “We have already seen some strengthening of the market in early Q3, and we hope to see a return to revenue growth soon, as the pandemic evolves from an all-hands-on-deck emergency to a ‘new normal’ background issue.”

Mr. Evans continued, “During the relatively slower second quarter, our team focused on building new capabilities, including the acceleration and release of our SequaPath™ product and our recently published study of water in buildings affected by COVID-19-related shutdowns. In the near future, we will also release DialyPath™, our real-time test for dialysis clinics that will detect and quantify endotoxin-producing Gram-negative bacteria.”

Consolidated Financial Performance for the Quarter Ended June 30, 2020

Net revenue for the quarter ended June 30, 2020 was $1.6 million, compared with $2.3 million in 2019, a decrease of 32%.

Net loss for the quarter ended June 30, 2020 was $1.7 million, compared with a net loss of $0.9 million in 2019 an increase of 76%.

Adjusted EBITDA for the quarter ended June 30, 2020 was ($1.4 million), compared with ($0.5 million) in 2019.

Cost of goods sold for the quarter ended June 30, 2020 was $0.7 million, compared with $0.9 million in 2019, a decrease of 28%. Gross margins for the quarter ended June 30, 2020 were 57%, compared with 59% in 2019. Management expects future gross margins to continue in the range of 55% to 60%.

Research and development expenses for the quarter ended June 30, 2020 were $0.84 million, compared with $0.80 million in 2019, an increase of 5%.

Depreciation and amortization expenses for the quarter ended June 30, 2020 were approximately $47,000, compared with approximately $48,000 in 2019, a decrease of 2%.

Selling, general and administrative expenses for the quarter ended June 30, 2020 were $1.6 million, compared with $1.4 million in 2019, an increase of 15%.

As of June 30, 2020, Nephros had cash and cash equivalents of $7.0 million.

Adjusted EBITDA Definition and Reconciliation to GAAP Financial Measures

Adjusted EBITDA is calculated by taking net (loss) income calculated in accordance with generally accepted accounting principles (“GAAP”) and excluding all interest-related expenses and income, tax-related expenses and income, non-recurring expenses and income, and non-cash items, including depreciation and amortization and non-cash compensation. The following table presents a reconciliation of Adjusted EBITDA to net (loss) income, the most directly comparable GAAP financial measure, for the second quarter of the 2020 and 2019 fiscal years for both Nephros (on a consolidated basis) and the Water Filtration Business Segment:

	3 Months Ended Jun 30,
Water Filtration Business Segment	2020	2019
Net loss	(911)	(408)
Adjustments:
Depreciation of property and equipment	6	8
Amortization of other assets	45	44
Interest expense	30	46
Noncash interest expense	-	-
Interest income	(4)	-
Change in fair value of contingent consideration	-	(9)
Noncash compensation	166	150
Other noncash items	12	31
Nonrecurring: Biocon & Pathogen Detection	-	150
Adjusted EBITDA	(656)	12

	3 Months Ended Jun 30,
Consolidated Results	2020	2019
Net loss	(1,657)	(942)
Adjustments:
Depreciation of property and equipment	6	8
Amortization of other assets	45	44
Interest expense	30	46
Noncash interest expense	-	-
Interest Income	(4)	-
Change in fair value of contingent consideration	-	(9)
Noncash compensation	179	150
Other noncash items	12	31
Nonrecurring: Biocon & Pathogen Detection	-	150
Adjusted EBITDA	(1,389)	(522)

Nephros believes that Adjusted EBITDA provides useful information to management and investors regarding certain financial and business trends relating to Nephros’s financial condition and results of operations. Management does not consider Adjusted EBITDA in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of Adjusted EBITDA is that it excludes significant expenses and income that are required by GAAP to be recognized in Nephros’s consolidated financial statements.  In addition, Adjusted EBITDA is subject to inherent limitations as it reflects the exercise of judgments by management about which expenses and income are excluded or included in determining Adjusted EBITDA. In order to compensate for these limitations, management presents Adjusted EBITDA in connection with net (loss) income, the most directly comparable GAAP financial measure. Nephros urges investors to review the reconciliation of Adjusted EBITDA to net (loss) income and not to rely on any single financial measure to evaluate the business.

Conference Call Today at 4:30 p.m. ET

Nephros will host a conference call today at 4:30 PM Eastern Time, during which management will discuss Nephros’s financial results and provide a general business overview.

Participants may dial into the following number to access the call: 1-844-808-7106.International callers may use 1-412-317-5285. Please ask to be joined into the Nephros conference call. A replay of the call can be accessed until August 12, 2020 at 1-877-344-7529or 1-412-317-0088for international callers and entering replay access code: 10144283. An audio archive of the call will be available shortly after the call on the Nephros investor relations page at https://investors.nephros.com/events/.

About Nephros

Nephros is a commercial-stagecompany that develops and markets high-performance water purification products and pathogen detection systems for medical and commercial markets.

Nephros ultrafilters are used in hospitals, medical clinics, and commercial facilities to retain bacteria and viruses from water, providing barriers that aid in infection control for showers, sinks, and ice machines. Nephros ultrafilters are also used in dialysis centers to aid in the removal of endotoxins and other biological contaminants from water and bicarbonate concentrate in hemodialysis machines. 

Nephros pathogen detection systems, including thePluraPathand SequaPathsystems, provide near-real time information on bacterial genera, waterborne bacteria, and viruses to medical and water safety professionals. These products integrate Nephros ultrafilters with DNA sequencing and quantitative polymerase chain reaction (qPCR) technology.

Nephros commercial filters, including AETHER™ brand filters, improve the taste and odor of water, and reduce scale build-up in downstream equipment. Nephros and AETHER products are used in the health care, food service, hospitality, and convenience store markets.

For more information about Nephros, please visit its website at www.nephros.com.

Soligenix Announces Publication Demonstrating Thermostabilization of Filovirus Vaccine Antigens

 

Source: Soligenix, Inc. 9/15/2020

- Protein antigen stability after lyophilization demonstrated

- Key analytical assays identified

Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization.  The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, "Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays" and has been accepted for publication in the Journal of Pharmaceutical Sciences. A copy of manuscript has been made available here.

Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM and Hawaii Biotech Inc. (HBI), as well as work conducted by Theodore Randolph, PhD, Professor, Center for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering at the University of Colorado, Boulder have demonstrated the feasibility of developing heat stable subunit protein vaccine formulations for filovirus vaccines.  Protective efficacy has been demonstrated in non-human primates against infection with Ebola virus, Sudan virus, and Marburg virus.  Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).  These most recent results demonstrate the thermostabilization of three virus glycoproteins (from Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus), and the identification of key stability-indicating assays to further support mono-, bi- and tri-valent vaccine formulations. 

"Filoviruses are endemic in areas of the world where the power supply can be uncertain, making a thermostable vaccine particularly valuable," stated Dr. Lehrer, "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the applicability of thermostabilization and the potential for a broadly applicable and easily distributed vaccine.  With Marburg virus continuing to be an unmet medical need of priority to the US government, we are now focusing and accelerating evaluations of the Marburg virus vaccine specifically."

"The continued advances in the filovirus program demonstrates the program's maturity and overall developability," noted Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix.  "The compatibility with thermostabilization, and the identification of key stability indicating assays, are both hallmarks of a potentially broadly applicable vaccine platform.  Using this platform, we also continue to accelerate our joint COVID-19 vaccine effort, called CiVax™, with Dr. Lehrer and look forward to further developments for both programs."

About Filovirus Infection

Ebola Virus Disease is caused by one of six species of Ebolavirus, four of which are known to cause disease in humans, including its best-known member, Zaire ebolavirus (Ebola virus).  All species of ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburg virus.  Filoviruses are believed to be harbored in various animal species in Africa, particularly bats, although the specific reservoir host for many of these viruses is still unknown.  There have been several known Ebola and Marburg virus disease outbreaks since 1967, with the largest outbreak starting in 2014 in Western Africa, and involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of over 11,000 people according to the Centers for Disease Control and Prevention (CDC), including some cases in Europe and the United States.

Transmission of filoviruses requires direct contact with bodily fluids from an infected person or contact with infected animals.  The mortality rate from filovirus infections are extremely high, and can sometimes be affected by the quality of supportive care available with a focus on early initiation of treatment.  Resolution of the disease largely depends on the patient's own immune system.  There is no approved treatment for Ebola or Marburg although research into both has accelerated since the onset of the 2014 outbreak and significant progress has been made in advanced clinical testing of immunotherapeutics for Zaire ebolavirus. There is an approved vaccine, requiring storage at less than -60°C for Ebola virus (Zaire ebolavirus), but no protection is yet available for Marburg virus (Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).

About John A. Burns School of Medicine, University of Hawai'i at Manoa

The University of Hawai'i at Manoa is one of the most ethnically diverse institutions of higher education.  Hawai'i's cultural diversity and geographical setting affords the JABSOM a unique research environment to excel in health disparity research.  JABSOM faculty bring external funding of about $40 million annually into Hawai'i.

About Hawaii Biotech, Inc.

Hawaii Biotech (HBI) is a privately held biotechnology company focused on the development of prophylactic vaccines for established and emerging infectious diseases and anti-toxin drugs for biological threats.  HBI has developed proprietary expertise in the production of recombinant proteins that have application to the manufacture of safe and effective vaccines, diagnostic kits, and as research tools.  HBI completed successful first-in-human Phase 1 clinical studies with both West Nile virus and dengue vaccines in healthy human subjects.  HBI has developed a product pipeline of recombinant subunit vaccines, including vaccine candidates for West Nile virus, tick-borne flavivirus, malaria, Crimean-Congo hemorrhagic fever, and Ebola.  The company is also continuing the development of small molecule anti-toxin drugs for anthrax and botulism. HBI, founded in Hawaii in 1982, is headquartered in Honolulu.  For more information, please visit: www.hibiotech.com.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses. The development of our vaccine programs incorporates the use of  our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the Defense Threat Reduction Agency (DTRA).

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.