Market Newsdesk

• Collaboration with NYS Department of Health’s Wadsworth Center continues for extended six-month term until September 30, 2021
• Project utilizes OpGen’s Acuitas® AMR Gene Panel and Acuitas Lighthouse® Software within digital health and precision medicine platform at multiple healthcare institutions

GAITHERSBURG, Md., April 19, 2021 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN) announced today that its strategic collaboration with the New York State Department of Health (“DOH”) to develop a state-of-the-art solution to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide is being extended beyond the second-year expansion phase by another six months through September 30, 2021.

Having successfully achieved all of the milestones of the first and second year phases for the development of an infectious disease digital health and precision medicine platform that connects healthcare institutions to DOH and uses genomic microbiology for statewide surveillance and control of antimicrobial resistance, OpGen will continue to work together with DOH’s Wadsworth Center and the participating healthcare systems to expand the reach of the platform, increase the volume of testing, and enhance data collection. Due to the COVID-19 pandemic which had slowed down testing throughout much of 2020, the extension and expansion phase allows all stakeholders to generate significantly more data as testing volumes have been increasing substantially from fall of 2020 month by month until the end of March 2021 to date.

The DOH, OpGen, and all stakeholders will continue to work collaboratively to demonstrate that a sustainable, flexible infectious diseases reporting, tracking and surveillance tool for antimicrobial resistance can be applied across New York State. The six-month extension and expansion phase will build on the successes and experience of the first two years while focusing on accomplishing the goal of this visionary effort to improve patient outcomes and save healthcare dollars by integrating real-time epidemiologic surveillance with rapid delivery of antibiotic resistance results to care-givers via web-based and mobile platforms. OpGen is providing its Acuitas® AMR Gene Panel for rapid detection of multidrug-resistant bacterial pathogens along with its Acuitas Lighthouse® Software for high resolution pathogen tracking. The six-month extension and expansion contract includes a quarterly retainer-based project fee as well as volume-dependent per test fees for a total contract value of up to an additional $540,000 to OpGen, which includes unused budget resources from the second-year phase.

“We are excited and grateful that despite the continued COVID-19 pandemic, the Department of Health of New York State and the Wadsworth Center continue to work with us and have expanded their partnership beyond the second year, adding another up to 1,680 AMR Gene Panel tests to be run,” commented Oliver Schacht, CEO of OpGen. “The quick spread of antimicrobial resistant superbugs across healthcare systems is the silent pandemic hidden underneath the current COVID-19 pandemic. We anticipate that with our innovative diagnostic solutions we will be able to proactively identify such pathogens leading to early intervention and lifesaving treatment. This six month extension period gives us the time to also discuss and evaluate potential future forms of collaboration with the NYS DOH across the state.”

The precision medicine solutions provided by OpGen to accomplish the project goals are:

• The OpGen Acuitas AMR Gene Panel, a rapid diagnostics platform capable of detecting and identifying multidrug-resistant bacterial pathogens in under three hours and for use with the Acuitas Lighthouse Software. Together, these products can help to rapidly identify and locate antibiotic resistance threats in healthcare institutions and networks. Both systems are commercially available for Research Use Only (RUO) and the Acuitas AMR Gene Panel for use with bacterial isolates is pending an expected FDA clearance decision as soon as practicable given FDA’s staffing resource constraints.
• The OpGen Acuitas Lighthouse Software includes Acuitas Lighthouse epidemiology dashboards with high-resolution pathogen tracking through healthcare facilities, to cities, regions, as well as the entire state.

Wadsworth Center Deputy Director Dr. Victory Derbyshire said, “Under Governor Cuomo’s leadership New York State continues to lead the nation in addressing the threat of antimicrobial resistance. Working with our private-sector partners, the Wadsworth Center is able to further advance our mission to improve the public health of all New Yorkers.”

About Antimicrobial-resistant Infections

The Centers for Disease Control and Prevention estimates that annually in the United States we face
2.8 million infections with 35,000 deaths and $49 billion in lost productivity – all attributable to antibiotic resistant infections. Among the infectious diseases the parties are working to address are carbapenem-resistant Enterobacteriaceae (CRE) bacteria; they are untreatable and hard-to-treat infections on the rise among patients in medical facilities. CREs have become resistant to all or nearly all the antibiotics we have today. Almost half of hospital patients who get bloodstream infections from CRE bacteria die from the infection. The CDC has classified CRE’s as one of three urgent threats to the public health.

About Wadsworth Center Laboratories

The Wadsworth Center laboratories stand at the forefront of biomedical and environmental sciences and their interplay. The Center serves a vital role in the New York State Department of Health’s efforts to protect and promote the health of New York’s citizens. Building on more than a century of excellence as the state’s public health laboratory, the Center continues as a premier biomedical institute that merges clinical and environmental testing with fundamental, applied and translational research. Today, Wadsworth Center scientists use both classical and contemporary approaches to study environmental and biological questions related to human health and disease. They develop advanced methods to identify microbial or chemical threats; study drug resistance, emerging infections, and environmental exposures; manage the country’s most comprehensive diagnostic and environmental testing laboratory permit program; oversee extramural research programs on stem cells, breast cancer and spinal cord injury; and train the next generation of scientists through undergraduate, graduate, postdoctoral and visiting scientist programs.

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s product portfolio includes Unyvero, Acuitas® AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

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

Forward-Looking Statements

This press release includes statements regarding OpGen’s collaboration with the NYS DOH Wadsworth Center. These statements and other statements regarding OpGen’s future plans and goals constitute “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 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use proceeds from recent financings, including our November 2020 private placement, February 2021 Registered Direct and March 2021 warrant exercise and exchange, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:

Oliver Schacht
President and CEO
[email protected]

OpGen Press Contact:

Matthew Bretzius 
FischTank Marketing and PR
[email protected]

OpGen Investor Contact:

Megan Paul
Edison Group 
[email protected]

VANCOUVER, British Columbia and TORONTO, April 19, 2021 (GLOBE NEWSWIRE) — Clean Power Capital Corp. (CSE: MOVE)(FWB: 2K6)(OTC: MOTNF) (“Clean Power” or the “Company” or “MOVE”) is pleased to announce that it has submitted an initial application to list its common shares (the “Common Shares”) on the NASDAQ Capital Market (“Nasdaq”). The Company previously announced on December 3, 2020 that the Board of the Company had formed a strategic committee to review and develop a strategy to enhance its investor profile through a capital markets strategy focused on the United States. As part of the review, the strategic committee would consider an application to list its common shares on Nasdaq.

Upon consultation with advisors and legal counsel, the Company submitted its initial application to list its Common Shares on Nasdaq. This initiative is aimed to:

• provide additional opportunities to attract institutional and retail investors, allowing the Company to broaden its investor base in the United States and internationally;
• increase the visibility of the Company, its growth strategy, accomplishments and results to date;
• increase liquidity of its Common Shares; and
• raise the Company’s overall profile and ultimately enhance shareholder value.

Raghu Kilambi, the CEO of the Company, stated, “We are excited about the prospect of listing on Nasdaq. The initiative to apply for listing on Nasdaq is a major step in expanding our shareholder base in the United States and having access to one of the largest capital markets in the world.”

The listing of the Company’s Common Shares on Nasdaq remains subject to the review and approval of the initial listing application and the satisfaction of all applicable listing and regulatory requirements.

The Company is also pleased to announce that it will be uplisting its Common Shares to the NEO Exchange (“NEO Exchange”) effective April 26, 2021. Clean Power will continue to trade under the symbol “MOVE” after listing on the NEO Exchange. The Company has arranged for the delisting from the Canadian Securities Exchange (“CSE”), effective the close of trading on April 23, 2021. This transition is not expected to impact current investors’ ability to trade shares of Clean Power.

With the impending graduation from the CSE to the NEO Exchange, the Company is positioning its Common Shares to be traded on a senior exchange in Canada and in the United States, providing exposure to an increased number of retail and institutional investors.

ABOUT CLEAN POWER CAPITAL CORP.

Clean Power is an investment company that specializes in investing into private and public companies opportunistically that may be engaged in a variety of industries, with a current focus in the health and renewable energy industries. In particular, the investment mandate is focused on high return investment opportunities, the ability to achieve a reasonable rate of capital appreciation and to seek liquidity in our investments. A copy of Clean Power’s amended and restated investment policy may be found under the Company’s profile at www.sedar.com.

Learn more about Clean Power by visiting our website at: https://cleanpower.capital/

NEITHER THE CSE, NEO Exchange, NASDAQ NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

PR Contact Vito Palmeri AMW PR
c: 347.471.4488 | o: 212.542.3146
[email protected]

Clean Power Contact
Raghu Kilambi
[email protected]
+1 (604) 687-2038

Notice Regarding Forward Looking Information:

This press release contains “forward-looking statements” or “forward-looking information” (collectively referred to herein as “forward-looking statements”) within the meaning of applicable securities legislation. Such forward-looking statements include, without limitation, forecasts, estimates, expectations and objectives for future operations that are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Clean Power, which includes, without limitation, the potential listing of the Company’s common shares on Nasdaq, the timing thereof, the benefits to be provided to the Company by a Nasdaq listing, the Company’s exposure to more investors and the liquidity of the Company’s securities. Some assumptions include, without limitation, the development of hydrogen powered vehicles by vehicle makers, the adoption of hydrogen powered vehicles by the market, legislation and regulations favoring the use of hydrogen as an alternative energy source, the Company’s ability to build out its planned hydrogen fueling station network, and the Company’s ability to raise sufficient funds to fund its business plan. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur or be achieved. This press release contains forward-looking statements pertaining to, among other things, the timing and ability of the Company to complete any potential investments or acquisitions, if at all, and the timing thereof. Forward-looking information is based on current expectations, estimates and projections that involve a number of risks, which could cause actual results to vary and, in some instances, to differ materially from those anticipated by the Company and described in the forward-looking information contained in this press release.

Although the Company believes that the material factors, expectations and assumptions expressed in such forward-looking statements are reasonable based on information available to it on the date such statements were made, no assurances can be given as to future results, levels of activity and achievements and such statements are not guarantees of future performance.

The forward-looking information contained in this release is expressly qualified by the foregoing cautionary statements and is made as of the date of this release. Except as may be required by applicable securities laws, the Company does not undertake any obligation to publicly update or revise any forward-looking information to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or results, or otherwise.

NEW YORK and CLEVELAND, April 19, 2021 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Dr. Leila Alland and Mr. Donald Wuchterl as new independent members to its Board of Directors.

“Leila and Donald bring a collective wealth of diverse biologics experience to Abeona that spans clinical development and manufacturing of cell therapy and gene therapy products, as we continue to focus on the mission of bringing our novel gene and cell therapies to patients who currently have no approved treatment options,” said Steven H. Rouhandeh, Chairman of Abeona’s Board of Directors. “Their relevant expertise and backgrounds complement those of our current directors, and I look forward to relying on the fresh perspectives of our strengthened and expanded board to help guide Abeona’s corporate strategy and operational execution going forward.”

Dr. Alland, a pediatric hematologist-oncologist and accomplished physician-scientist, has been working in the biopharmaceutical industry since 2001 to bring novel therapies to patients. Dr. Alland is currently Chief Medical Officer of PMV Pharmaceuticals, Inc., a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. Previously, Dr. Alland served as Chief Medical Officer at Affimed, and prior to that she held the same position at Tarveda Therapeutics. Dr. Alland also held leadership positions at AstraZeneca, Bristol-Myers Squibb, Novartis, and Schering-Plough, where she worked on a broad range of oncology products from early to late-stage development and contributed to multiple successful drug approvals.

Dr. Alland obtained her medical degree from New York University School of Medicine, and her B.A. in Biology from the University of Pennsylvania. She completed her residency in Pediatrics at The Children’s Hospital of Philadelphia, and her fellowship in Pediatric Hematology/Oncology at The New York Hospital and Memorial Sloan-Kettering Cancer Center. Earlier in her career, Dr. Alland served as Assistant Professor of Pediatrics at Albert Einstein College of Medicine, where she was awarded the James S. McDonnell Foundation Scholar Award and pursued basic cancer research while also caring for children with cancer and blood disorders. Since 2020, Dr. Alland has served on the Board of Directors of Cytovia Therapeutics, Inc., an immuno-oncology company developing engineered cellular and antibody therapies to treat cancer. Dr. Alland is a member of the Scientific Advisory Council of Columbia University’s Center for Radiological Research and serves as a scientific reviewer for the Cancer Prevention and Research Institute of Texas.

Mr. Wuchterl brings over 29 years of experience in the life sciences industry, with senior roles in operations and Chemistry, Manufacturing, and Controls (CMC). He has significant experience building and leading current Good Manufacturing Practices (cGMP) manufacturing organizations and facilities. Mr. Wuchterl currently serves as Senior Vice President and Chief Manufacturing Officer at T-knife Therapeutics, a next-generation T-cell receptor company developing innovative therapeutics for the benefit of solid tumor patients and their families. Previously, he served as Senior Vice President, Technical Operations & Quality at Audentes Therapeutics (an Astellas Company), a gene therapy company focused on developing and commercializing innovative products for patients living with serious, life-threatening rare neuromuscular diseases. Prior to Audentes, Mr. Wuchterl served as Senior Vice President and Chief Operating Officer at Cytovance Biologics, and held positions of increasing responsibility with Dendreon, Shire HGT, Amgen, Biogen Idec and Roche. Mr. Wuchterl has a B.S. in Business Administration from Colorado Technical University and an M.B.A. from Fitchburg State University.

About Abeona Therapeutics

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

Forward-Looking Statements

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

SHANGHAI, China, April 19, 2021 (GLOBE NEWSWIRE) — BioShin Limited, biopharmaceutical company focused on the discovery, development and commercialization of novel, life-improving treatments for patients with neuro-immune diseases in China and the Asia-Pacific region, today announced the appointment of David Chung as Chief Strategy Officer and Head of Business Development. David will be responsible for driving BioShin Strategy, focusing on expanding the company’s pipeline through innovative partnerships where BioShin will, as needed, partner on the discovery, development and commercialization of novel medicines to the benefit of patients in the Asia-Pacific region. David will report to Karl Lintel, CEO of BioShin.

As a veteran of the pharma and biotech industry, David has over 20 years of experience working with both biotechnology and top Multi-National Companies. Before joining BioShin, David was Vice President of Business Development at Intercept Pharmaceuticals, a public US biotech company. Prior to that, David held various senior roles in Strategy, Corporate Development, and Business Development at Bristol Myers Squibb, Jazz Pharmaceuticals, and Johnson & Johnson. He was also a Vice President, Health Care Analyst at Lehman Brothers.

David holds an MBA from the Massachusetts Institute of Technology and a master’s degree from the Johns Hopkins School of Public Health. David is also a Chartered Financial Analyst.

“We warmly welcome David, and we are more than excited to have him join the BioShin team,” said Karl Lintel, CEO of BioShin. “David brings to BioShin deep experience in Strategy and Business Development. We believe that, under his leadership, we can leverage BioShin as a preferred partner for companies seeking entry into China and other Asia Pacific markets.”

“BioShin is a rapidly growing and innovative biopharmaceutical company,” said David Chung. “I’m very pleased to join a company that combines a strong emphasis on science and innovation with an entrepreneurial culture in the service of addressing unmet medical needs in Asia. Patient needs in China drive everything BioShin does. By providing much-needed treatment options for neuro-immune disorders, BioShin will be at the forefront of the country’s healthcare revolution. I look forward to working with the team to further build out a robust, innovative pipeline that benefits patients.”

About BioShin

Based in Shanghai, BioShin Limited is a biopharmaceutical company focused on the discovery, development and commercialization of novel, life-improving treatments for patients with neuro-immune diseases in China and the Asia-Pacific region. BioShin has a proven and established, late-stage portfolio from its strategic partner, U.S.-based Biohaven Pharmaceuticals Inc. and is poised to quickly launch novel medicines for patients in need. Beyond its current research and development portfolio, BioShin’s strategic vision also includes partnering with biopharmaceutical companies, inside and outside China, that seek to discover, develop, and commercialize assets in the region. By bringing together promising assets and a diverse management team with international expertise, BioShin is growing a nimble organization with an entrepreneurial spirit to serve patients throughout the region. For more information, please visit www.bioshin.com.

Karl Lintel
CEO, BioShin
[email protected]

Media Contact:
CHINA – Zoey Wang
General Manager, BioShin
[email protected] 

NEW YORK, April 19, 2021 (GLOBE NEWSWIRE) — LifeMD, Inc. (“the Company”) (NASDAQ: LFMD), a leading direct-to-patient telehealth company, today announced expected record revenue of $18.2M for Q1’21. The Company had previously guided towards revenue to be greater than $17 million (Link). However, a stronger than expected March resulted in performance exceeding that guidance. The expected quarterly revenue represents an increase of 323% year-over-year and a 41% increase compared to last quarter. Telehealth order volume grew by 373% versus the year-ago quarter, driven by both strong retention and new patient acquisition.

Justin Schreiber, CEO of LifeMD commented, “We are pleased to report another strong quarter, as revenue for Q1‘21 grew by 323% compared to revenue in Q1’20 and more than 40% quarter-over-quarter, driven by a rapidly growing recurring subscriber base and efficient acquisition spending. We onboarded a substantial number of new patients to our platform this quarter at an improved cost per acquisition (“CPA”) when compared to the prior quarter. We are excited to share more detailed metrics on our upcoming earnings call.”

Subscriptions generated 92% of revenue in Q1’21, compared to 75% in Q1’20. The increase in subscription revenue is largely due to increased sales of the company’s Shapiro MD™ hair products for men and women under a new subscription-based program, as well as continued increased subscription sales of the company’s telemedicine brand for men, Rex MD™.

LifeMD CFO, Marc Benathen, commented, “LifeMD continues to realize the significant benefits of our subscription-based business model underscored by strong patient retention and growing levels of patient acquisition. Our team has done a tremendous job of thoroughly monitoring expenses across the full brand portfolio to ensure efficient spending, while achieving a 41% increase in sequential revenue growth. As mentioned, March 2021 was a record month. We look forward to providing a complete financial and operational update on our upcoming earnings call.”

Mr. Schreiber added, “I am very proud of what our management team has accomplished in short order, and with their help, LifeMD is well-positioned to continue achieving revenue growth and further expand its footprint nationwide. In bridging the gap between technology and healthcare, we are also driving innovation, as evidenced by our patients actively choosing to enroll in our subscription-based offerings. We were also able to expand our portfolio of brand offerings at the end of the quarter when we successfully launched NavaMD™, the Company’s teledermatology brand. We are pleased by the early data we are seeing from this newly launched brand. We are also gearing up for the launch of LifeMD’s longitudinal telehealth service as part of a holistic patient-centered business model and comprehensive brand portfolio.”

About LifeMD

LifeMD, Inc. is a leading telehealth company that is transforming the healthcare landscape with direct-to-patient product and service offerings. LifeMD’s telemedicine platform enables virtual access to affordable and convenient medical treatment from licensed providers and, when appropriate, prescription medications and over-the-counter products delivered directly to the patient’s home.  To learn more, go to LifeMD.com. 

Cautionary Note Regarding Forward Looking Statements

This news release includes 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, as amended, regarding, among other things our plans, strategies and prospects — both business and financial. While we believe that our plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, we cannot assure you that we will achieve or realize these plans, intentions or expectations. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Many of the forward-looking statements contained in this news release may be identified by the use of forward-looking words such as “believe,” “expect,” “anticipate,” “should,” “planned,” “will,” “may,” “intend,” “estimated,” and “potential,” among others. Important factors that could cause actual results to differ materially from the forward-looking statements we make in this news release include market conditions and those set forth in reports or documents that we file from time to time with the United States Securities and Exchange Commission. All forward-looking statements attributable to LifeMD, Inc. or a person acting on its behalf are expressly qualified in their entirety by this cautionary language.

Company Contact                                
LifeMD, Inc.        
Marc Benathen, CFO
Email Contact        

Investor Relations Contact

Ashley Robinson
LifeSci Advisors, LLC
[email protected]

HOUSTON, April 19, 2021 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, announced today that all three submitted abstracts detailing research involving seclidemstat were accepted for poster presentations, with one abstract also selected for a poster discussion session, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. ASCO will be held virtually from June 4-8, 2021.

“We are very pleased to report that research involving seclidemstat will be the subject of three poster presentations at the 2021 ASCO Annual Meeting,” stated David Arthur, President and CEO of Salarius Pharmaceuticals. “As previously noted, the full findings from the dose escalation-stage of the Phase 1/2 trial of seclidemstat in patients with relapsed and refractory Ewing sarcoma, including details on safety, dosing, and initial efficacy signal, and preliminary data from the solid tumor trial including FET-translocated sarcomas, also known as Ewing-related sarcomas, will be reported at the conference.”

This year, ASCO received and reviewed more than 5,400 abstracts for the 2021 ASCO Annual Meeting. Information about the meeting may be accessed via the following website: https://meetings.asco.org/am/registration. Per ASCO’s Embargo & Release Information, abstracts will be released to the public on ASCO’s Meeting Library at 5:00 p.m. ET on May 19, 2021.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and Ewing-related sarcomas, also called FET-translocated sarcomas. Seclidemstat has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for the Ewing sarcoma program. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study in advanced solid tumors, including prostate, breast, and ovarian cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.

Forward-Looking Statements 

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” “developing,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: the company’s growth strategy; the value of seclidemstat as a potential treatment for Ewing sarcoma, Ewing-related sarcomas and other cancers; the status and anticipated progress and milestones of the company’s clinical trials in Advanced Solid Tumors and Ewing sarcoma; the expansion of the company’s clinical trials to include Ewing-related sarcomas; the company’s belief as to being well-capitalized through the completion of its clinical trials for seclidemstat and beyond; Salarius’ goal to maximize the potential of seclidemstat; and Salarius developing seclidemstat for several cancers with high unmet medical need. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the sufficiency of the company’s capital resources; the ability of, and need for, the company to raise additional capital to meet the company’s business operational needs and to achieve its business objectives and strategy; the company’s ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of the company to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of results on the company; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2020 and in the company’s annual report on Form 10-K for the year ended December 31, 2020. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward- looking statements to reflect events or circumstances that exist after the date on which they were made.

Contact:

Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA/Miriam Miller (investors)
(212) 375-2664 / 2694
[email protected]
[email protected]

Johanna Bennett (media relations)
(212) 375-2686 
[email protected]

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Seasoned healthcare executive, Brendan Smith, appointed as Chief Financial Officer, bringing

strategic operations and financial leadership —

— Appointments enhance capabilities across pulmonary programs, manufacturing and financial operations with a goal of advancing platform, preclinical and clinical milestones —

LEXINGTON, Mass., April 19, 2021 (GLOBE NEWSWIRE) — Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat or prevent debilitating or life-threatening diseases, today announced several key leadership appointments, including Brendan Smith as Chief Financial Officer, Greg Troiano as Chief Manufacturing Officer, and Jim Sullivan as Senior Vice President, Pulmonary Discovery. These leadership appointments support the Company’s long-term strategic plan, TBIO 2025, that emphasizes several areas for value creation across the Company including adding key in-house quality and manufacturing capabilities, deepening pulmonary expertise and increasing research and development (R&D) investments with a goal of advancing platform innovation and driving multiple programs into the clinic.

“Now is an exciting time for Translate Bio—and there is considerable momentum in the mRNA field. From vaccines to therapeutics, we have seen the substantial role that mRNA can play, and we have outlined key steps as part of TBIO 2025, our 5-year strategic plan, that we believe will enable the advancement of multiple investigational new drug applications (INDs), new pipeline programs and platform innovation,” said Ronald Renaud, chief executive officer of Translate Bio. “Adding key talent across the company to the Translate Bio team is a critical aspect of our plan and I am thrilled to share these important leadership appointments today that we believe will position us well to capture the significant potential of mRNA.”

Brendan Smith, Chief Financial Officer & Corporate Strategy

Mr. Smith was appointed Chief Financial Officer & Corporate Strategy effective April 19, 2021, his first day of employment with Translate Bio. Mr. Smith is an accomplished executive with more than two decades of experience within high-growth biopharma environments where he made significant contributions in various operations and strategy positions. A key area of strength in these roles was providing strategic financial leadership relating to long-term growth planning focused on operational efficiencies, building manufacturing and supply capabilities, and evaluation of business development opportunities and commercial planning assessments. In the role of Chief Financial Officer & Corporate Strategy, Mr. Smith will be responsible for Translate Bio’s finance and accounting, information technology, investor relations, and corporate strategy functions while working with the Company’s leadership team to ensure measured growth while executing on its strategic plan. Previously, as a Partner at Boston Consulting Group, Mr. Smith led integrated biopharma client engagements that included planning and executing on R&D strategy, operations, business development and deal diligence. Prior to that, Mr. Smith was VP, Head of Business Operations for Worldwide R&D at Pfizer where he led financial and headcount planning across discovery and development operations. In addition, as Executive Director, Head of Business Strategy and Operations for Biologics Pharmaceutical Sciences at Pfizer, Mr. Smith led manufacturing and financial operations for the company’s global biologics process development organization. Mr. Smith received a B.S. in Biochemistry from Worcester Polytechnic Institute and an M.B.A. from Harvard Business School.

Greg Troiano, Chief Manufacturing Officer

Mr. Troiano joined Translate Bio as SVP of Technical Operations in May of 2020, and was appointed Chief Manufacturing Officer in March 2021. Mr. Troiano is a seasoned manufacturing operations executive who has led the development of pharmaceutical products from feasibility through commercial production. In the role of CMO, Mr. Troiano will be responsible for strategic oversight of all aspects of cGMP CMC operations, including clinical supply, analytical testing, quality and engineering. Previously, he was VP of Technology and Chief Engineer at Seer, a life sciences and health data company using nanotechnology for proteomics and biomarker discovery. He was also VP of Nanomedicine Development and Manufacturing within Pfizer’s Pharmaceutical Sciences group where he led the development and manufacturing of novel nanoparticle drug products. Over his 20+ year biopharma career, Mr. Troiano supported the technical operations behind the commercialization of Gliadel® Wafer, Nutropin Depot®, Risperdal Consta®, Vivitrol® and Bydureon®. Mr. Troiano received his M.S.E. and B.S. in Biomedical Engineering from The Johns Hopkins University. He is an inventor on more than 20 process and equipment patents/applications and an author on over a dozen scientific publications in drug delivery. He was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

Jim Sullivan, PhD, Senior Vice President, Pulmonary Discovery

Dr. Sullivan joined Translate Bio in January 2021 as Senior Vice President, Pulmonary Discovery. In this role, Dr. Sullivan leads preclinical discovery efforts for all pulmonary programs. Dr. Sullivan’s drug development experience in both basic research and clinical development (early and late stage) will strengthen Translate Bio’s translational research efforts, with a goal of bringing novel mRNA therapeutics to patients. Prior to joining Translate Bio, Dr. Sullivan was most recently at Sana Biotechnology, where he was an Executive Director focused on cell and gene therapy. In this role, Dr. Sullivan was Head of Translational Sciences and a Program Lead for novel treatment modalities for certain inherited diseases. Before Sana, Dr. Sullivan was Director at Vertex where he was an s/NDA team member for several products, including, for cystic fibrosis, Kalydeco®, Orkambi® and Symdeko®, as well as Incivek® for Hepatitis C. Dr. Sullivan was also an IND team member for multiple assets currently in clinical development to treat alpha-1-antitrypsin (AAT) deficiency and the first-ever CRISPR-based gene editing therapeutic product for the treatment of certain hemoglobinopathies. Dr. Sullivan received a B.S. in Biology from Boston College, an M.S. in Environmental Chemistry from University College Dublin, and a Ph.D. in Genome Sciences/Genetics from Boston University. He has authored more than 30 publications in peer-reviewed journals.

About Translate Bio

Translate Bio is a clinical-stage mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, or to prevent infectious diseases by generating protective immunity. Translate Bio is primarily focused on applying its technology to treat pulmonary diseases with a lead pulmonary candidate being evaluated as an inhaled treatment for cystic fibrosis (CF) in a Phase 1/2 clinical trial. Additional pulmonary diseases are being evaluated in discovery-stage research programs that utilize a proprietary lung delivery platform. Translate Bio also believes its technology may apply broadly to a wide range of diseases, including diseases that affect the liver. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or protein degradation. Translate Bio is also pursuing the development of mRNA vaccines for infectious diseases under a collaboration with Sanofi Pasteur. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: Translate Bio’s expectations regarding the anticipated contributions of Mr. Smith, Mr. Troiano and Dr. Sullivan to the leadership team, its strategic plan, TBIO 2025, and the Company’s platform; Translate Bio’s plan to continue to grow the Company; Translate Bio’s belief that its strategic plan, TBIO 2025, will enable the advancement of multiple INDs, broaden its pipeline opportunities and advance platform innovation; and Translate Bio’s plans strategies and prospects for its business, including its lead development programs. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forward,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: the current and potential future impacts of the COVID-19 pandemic on Translate Bio’s business, financial condition, operations and liquidity; Translate Bio’s ability to advance the development of its platform and programs, including without limitation, under the timelines it projects, demonstrate the requisite safety and efficacy of its product candidates and replicate in clinical trials any positive findings from preclinical studies or early-stage clinical trials; the content and timing of decisions made by the U.S. Food and Drug Administration, other regulatory authorities and investigational review boards at clinical trial sites, including decisions as it relates to ongoing and planned clinical trials; Translate Bio’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the availability of significant cash required to fund operations; competitive factors; general economic and market conditions and other important risk factors set forth under the caption “Risk Factors” in Translate Bio’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (“SEC”) on March 1, 2021 and in any other subsequent filings made with the SEC by Translate Bio. Any forward-looking statements contained in this press release speak only as of the date hereof, and Translate Bio specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.