Market Newsdesk

LAS VEGAS, Aug. 04, 2021 (GLOBE NEWSWIRE) — Live Ventures Incorporated (Nasdaq: LIVE), a diversified holding company, announced that after a nearly four-year investigation, the SEC has filed charges against the company. The company categorically denies all charges and will vigorously defend itself. 

The company asserts that the SEC’s pursuit of this matter will not result in any benefit to investors and instead will only serve as a distraction from core business.

Live Ventures has enlisted the representation of highly experienced and respected attorney John Hueston of the law firm Hueston Hennigan. Mr. Hueston’s biography can be found here: https://www.hueston.com/attorney/john-c-hueston/.

The company looks forward to its day in court and vindication at trial.

About Live Ventures

Live Ventures Incorporated (Nasdaq: LIVE) (“Live Ventures” or the “Company”) is a rapidly growing, diversified holding company with a strategic focus on value-oriented acquisitions of domestic middle-market companies. Live Venture’s acquisition strategy is sector agnostic, focuses on well-run, closely held businesses with a demonstrated track record of earnings growth and cash flow generation. The Company looks for opportunities to partner with management to build increased shareholder value through a disciplined buy-build-hold long-term focused strategy. Live Ventures was founded in 1968 and refocused in 2011 under our CEO and strategic investor, Jon Isaac. The Company’s current portfolio of diversified operating subsidiaries includes companies in the textile, flooring, tools, steel, entertainment, and financial services industries.

About Our Main Operating Subsidiaries

Marquis Industries

Based in Chatsworth, GA, and acquired by Live Ventures in 2015, Marquis Industries (“Marquis”) is a leading manufacturer of residential and commercial carpets sold primarily in North America and focused on residential, niche commercial, and hospitality end-markets. In addition to a diverse offering of carpeting products, Marquis Industries also designs, sources, and sells hard-surface flooring products.

Vintage Stock

Based in Joplin, MO and acquired by Live Ventures in 2016, Vintage Stock Inc. (“Vintage Stock”) is an award-winning entertainment retailer that sells new and pre-owned movies, classic and current generation video games and systems, music on CD & LP, collectible comics, books, toys, and more through a unique buy-sell-trade model. Vintage Stock sells through its 60+ retail stores and its website, allowing the company to ship product worldwide directly to the customer’s doorstep.

Precision Marshall

Based in Washington, PA and acquired by Live Ventures in 2020, Precision Industries, Inc. (“Precision Marshall”) is a leading manufacturer of premium steel tools and specialty alloys. Precision Marshall manufactures pre-finished decarb-free tool and die steel. For over 70 years, Precision Marshall has been known by steel distributors for its quick and accurate service and has led the industry with exemplary availability and value-added processing.

Salomon Whitney

Based in Melville, NY, and acquired by Live Ventures in 2021, Salomon Whitney LLC (“SW”) is a licensed broker-dealer and investment bank that offers clients a broad range of products and services, including broker retailing of corporate equity and debt securities, private placement of securities, corporate finance consulting regarding mergers and acquisition and broker retailing of U.S. government and municipal securities.

Contact:

Live Ventures Incorporated
Tim Matula, Investor Relations
(425) 836-9035
[email protected]
http://liveventures.com
Source: Live Ventures Incorporated

Approximately 98% of Voting Shareholders Approve Change to Governing Provisions

Board Elects for Trust to be Treated as Corporation for Tax Purposes Effective September 1, 2021

WESTPORT, Conn., Aug. 04, 2021 (GLOBE NEWSWIRE) — Compass Diversified (NYSE: CODI) (“CODI” or the “Company”), an owner of leading middle market businesses, today announced that, on August 3, 2021, its shareholders voted to approve amendments (the “Amendment”) to the governing documents of Compass Diversified Holdings (the “Trust”) to allow the Board of Directors (the “Board”) to cause the Trust to “check-the-box” to elect to be treated as a corporation for U.S. federal income tax purposes. CODI also announced that, following the shareholder vote, the Board has resolved to cause the Trust to elect to be treated as a corporation for U.S. federal income tax purposes. Such election will be effective September 1, 2021.

“We thank our shareholders for their support of this important change, which we believe presents a significant opportunity to unlock value for our current and future shareholders,” said Elias Sabo, CEO of CODI. “The simplification of our tax structure is a continuation of our efforts to find more efficient ways to lower our cost of capital following the strengthening of our capital structure earlier this year. In addition, we believe that electing to be treated as a corporation for tax purposes will allow CODI to expand its shareholder base and improve the likelihood of our stock’s inclusion within stock indices. With this momentum, we look forward to building on our already strong foundation and 15-plus years of success as a public company as we continue to leverage our permanent capital structure to our advantage and opportunistically acquire and manage leading businesses to deliver long term value for our shareholders.”

CODI expects that being treated as a corporation for U.S. federal income tax purposes will:

• Increase share liquidity with broadened pool of investors;
• Reduce weighted average cost of capital;
• Create more flexibility in investment decisions;
• Improve the likelihood of CODI’s stock’s inclusion within stock indices;
• Improve the Company’s profile with ratings agencies; and
• Reduce administrative cost.

Approximately 98% of shares voted were in favor of the Amendment, which constitutes over 57% of the outstanding shares entitled to vote. The final vote results, as certified by the independent Inspector of Election, have been filed on Form 8-K with the U.S. Securities and Exchange Commission.

On August 3, 2021, in order to offset a portion of the tax liability to the shareholders as result of the election to cause the Trust to be treated as a corporation for U.S. federal income tax purposes, the Board declared a special cash distribution of $0.88 per share on the Trust’s common shares (the “Common Shares”). The distribution on the Common Shares is payable on September 7, 2021 to all holders of record of Common Shares as of the close of business on August 31, 2021.

About Compass Diversified (“CODI”)

CODI owns and manages a diverse set of highly defensible North American middle market businesses. Each of its current subsidiaries is a leader in its niche market.

Leveraging its permanent capital base, long-term disciplined approach and actionable expertise, CODI maintains controlling ownership interests in each of its subsidiaries, maximizing its ability to impact long-term cash flow generation and value creation. CODI provides both debt and equity capital for its subsidiaries, contributing to their financial and operating flexibility. CODI utilizes the cash flows generated by its subsidiaries to invest in its long-term growth and has consistently generated strong returns through its culture of transparency, alignment and accountability.

Our nine majority-owned subsidiaries are engaged in the following lines of business:

• The design and marketing of purpose-built technical apparel and gear serving a wide range of global customers (5.11);
• The manufacture of quick-turn, small-run and production rigid printed circuit boards (Advanced Circuits);
• The design and manufacture of custom packaging, insulation and componentry (Altor Solutions);
• The manufacture of engineered magnetic solutions for a wide range of specialty applications and end-markets (Arnold Magnetic Technologies);
• The design and marketing of dial-based closure systems that deliver performance fit across footwear, headwear and medical bracing products (BOA Technology);
• The design and marketing of wearable baby carriers, strollers and related products (Ergobaby);
• The design and manufacture of baseball and softball equipment and apparel (Marucci Sports);
• The manufacture and marketing of portable food warming systems used in the foodservice industry, creative indoor and outdoor lighting, and home fragrance solutions for the consumer markets (Sterno); and
• The design, manufacture and marketing of airguns, archery products, optics and related accessories (Velocity Outdoor).

Forward Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements with regard to the expectations related to the anticipated timing and impact of the tax election. Words such as “believes,” “expects,” “anticipates,” “intends,” “projects,” “assuming,” and “future” or similar expressions, are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions. Certain factors could cause actual results to differ materially from those projected in these forward-looking statements, including, but not limited to, the factors enumerated in the Form 10-K filed by CODI with the SEC for the year ended December 31, 2020, the proxy statement filed by CODI with the SEC on June 23, 2021 and other filings with the SEC. Except as required by law, CODI undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations: The IGB Group Leon Berman 212-477-8438 [email protected]

Media Contact: Joele Frank, Wilkinson Brimmer Katcher Jon Keehner / Kate Thompson / Lyle Weston 212-355-4449

Data Led to Multi-Center Study
In
Progress At Three Leading Hospitals

Oak Ridge, TN, Aug. 04, 2021 (GLOBE NEWSWIRE) — Daxor
Corpo
ration
(NYSE MKT: DXR), the global leader in blood volume measurement technology, today announces new data published in the journal Critical Care showing Daxor’s unique BVA-100 diagnostic blood test provides insights into the pathophysiology of volume derangements and capillary distress in critically ill COVID-19 patients enabling improved care.

The Research Letter titled “Blood volume and albumin transudation in critically-ill COVID-19 patients” studied the abnormal blood volume profiles in mechanically ventilated patients admitted to the ICU at a leading medical center in New York. The data shows that COVID-19 patients suffer from significant capillary damage and blood volume deficits that care teams became aware of through the use of the Daxor BVA-100 blood test.

Dr. Jan Bakker, the author of the research letter, stated “Fluid resuscitation in COVID-19 patients could benefit from knowing the blood volume and capillary leak rate of patients as they are subject to significant leak and related hypovolemia.” Dr. Bakker noted that he has initiated a multi-center prospective study utilizing the BVA-100 blood test to understand fluid imbalances in COVID-19 patients as a result of this initial research. The study has passed the half-way mark of enrollment at Wake Forest School of Medicine, Oregon Health & Science University and NYU Langone Health (NCT04517695).

“Having this preliminary data published in such a prestigious medical journal as Critical Care highlights the importance of Daxor’s BVA technology in helping clinicians understand COVID-based volume derangements to improve care and outcomes,” said Michael Feldschuh, CEO and President of Daxor. “Daxor’s BVA test is the first and only diagnostic test cleared by FDA that offers insights into patients’ blood volume with a 98% accurate measure of plasma and red cell volume. Prior research in the area of critical care has shown that BVA can dramatically improve fluid management and reduce mortality in the ICU. We look forward to the results of the ongoing trial given this promising research letter from Dr. Bakker.”

About Daxor Corporation

Daxor Corporation (NYSE: DXR) is the global leader in blood volume measurement technology focused on blood volume testing innovation (organized as an investment company with fully-owned innovative medical instrumentation and biotechnology operations). We developed and market the BVA-100^® (Blood Volume Analyzer), the first diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms. The BVA technology enhances hospital performance metrics in a broad range of surgical and medical conditions, including heart failure and critical care, by informing treatment strategies, resulting in significantly improved multiple measures of patient outcomes. Daxor’s mission is to advance healthcare by enabling optimal fluid management with blood volume analysis. Daxor’s vision is optimal blood volume for all. For more information, please visit our website at Daxor.com.

Forward-Looking Statements

Certain statements in this release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the impact of hiring sales staff and expansion of our distribution channels. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, FDA regulatory actions, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and additional other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Daxor does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

Bret Shapiro
Sr. Managing Partner, CORE IR
516-222-2560
[email protected]

• BOAT is the only pure-play maritime shipping company ETF in the United States

• BOAT gives investors exposure to global maritime shipping stocks

• BOAT allows you to invest in the potential growth in shipping and the global economic recovery
  

MIDDLETOWN, Del., Aug. 04, 2021 (GLOBE NEWSWIRE) — SonicShares™ announced the launch today of the SonicShares™ Global Shipping ETF (NYSE Arca: BOAT), which seeks to track the Solactive Global Shipping Index (the “Index”). BOAT provides investors with pure play exposure to a portfolio of global companies engaged in maritime shipping.

It is difficult to overstate how important shipping is to international trade and the global economy as around 90% of the world’s trade is carried by sea.¹   Without shipping, the bulk transport of raw materials and the import/export of food and manufactured goods would simply be impossible.²   The recent Suez Canal blockage and the current supply chain crisis triggered by a shortage of shipping containers highlights the critical role shipping plays in the manufacturing, distribution and retail sectors. With the economy’s continued reliance on world trade, just-in-time manufacturing and inventory management, we believe our dependence on maritime shipping will continue and that can be good news for shipping industry investors.

“Shipping tends to be an unseen activity for most of us, but about 90 percent of what’s in our homes was shipped here from overseas,” said Paul Somma, the Founder of SonicShares. “It’s one of the many reasons why shipping is considered both the backbone and bellwether of the global economy. BOAT allows investors to participate in the potential growth in shipping, which also means investing in the global economic recovery.”

BOAT’s portfolio of over 50 global maritime shipping stocks gives investors an investment vehicle that can directly benefit from the expected ongoing demand for global shipping services. In addition to its potential for quarterly income, BOAT allows investors to express a bullish view not only on the global maritime shipping industry, but also on the anticipated recovery of the global economy that shipping sustains.

SonicShares partnered with Tidal ETF Services to bring BOAT to market. BOAT is SonicShares’ second ETF offering, joining the recently launched SonicShares™ Airlines, Hotels, Cruise Lines ETF (NYSE Arca: TRYP). TRYP, which debuted in May of this year, is designed for investors looking to take advantage of the global reopening and resulting travel recovery.

For more information on BOAT, please visit: www.sonicshares.com/BOAT

About SonicShares™

SonicShares™ is rooted in over a decade of experience developing and pioneering exchange-traded products. SonicShares™ leverages this experience to recognize dominant, large scale trends and, in turn, develops thematic ETFs that seek to provide exposure to companies and sectors that will benefit from such trends. To learn more about SonicShares™, please visit www.sonicshares.com.

Investors should consider the investment objectives, risks, charges and expenses carefully before investing. For a prospectus or summary prospectus with this and other information about the Fund, 



click here



. Read the prospectus or summary prospectus carefully before investing.

Fund Risks:  An investment in the Fund is subject to numerous risks including the possible loss of principal. There can be no assurance that the Fund will achieve its investment objective.  Equity securities, such as common stocks, are subject to market, economic and business risks that may cause their prices to fluctuate. As with all ETFs, Fund shares may be bought and sold in the secondary market at market prices. The market price normally should approximate the Fund’s net asset value per share (NAV), but the market price sometimes may be higher or lower than the NAV. The Fund is new with a limited operating history. There are a limited number of financial institutions authorized to buy and sell shares directly with the Fund, and there may be a limited number of other liquidity providers in the marketplace. There is no assurance that Fund shares will trade at any volume, or at all, on any stock exchange. Low trading activity may result in shares trading at a material discount to NAV. Please see the prospectus and summary prospectus  for a complete description of principal risks.

The Fund’s investments will be concentrated in an industry or group of industries to the extent the Index is so concentrated. In such event, the value of Shares may rise and fall more than the value of shares that invest in securities of companies in a broader range of industries.  Investments in securities or other instruments of foreign securities involve certain risks not involved in domestic investments and may experience more rapid and extreme changes in value than investments in securities of U.S. companies.

Companies in the transportation industry, including companies engaged in the water transportation industry, may be adversely affected by economic changes, increases in fuel, operating and insurance costs and adverse labor relations.

The fund is distributed by Foreside Fund Services, LLC.

Opinions expressed herein are subject to change and should not be considered investment advice.  

Solactive Global Shipping Index – The Index is a rules-based index that seeks to provide exposure to a global portfolio of companies identified as being engaged in the water transportation industry. It is not possible to invest directly in the Index.

The “SonicShares” mark and the SonicShares logo are trademarks of Lucania Investments LLC (the “Licensor”). The Licensor and its affiliates are not affiliated with the Fund’s Adviser, any Sub-Adviser, Index Provider, Trust, administrator, custodian, transfer agent, distributor, or any of their respective affiliates. The Licensor and its affiliates have no role in the administration or operation of the Fund, nor do they make investment decisions, provide investment advice, or otherwise act in the capacity of an investment adviser to the Fund. The Fund is not sold by the Licensor or any of its affiliates. The Licensor and its affiliates make no representation, condition or warranty, express or implied, to the owners of the Fund or any member of the public regarding the advisability of investing in securities generally or in the Fund particularly.

¹     Organisation for Economic Co-operation and Development: https://www.oecd.org/ocean/topics/ocean-shipping/
²     Maritime Industry Foundation: https://www.maritimeinfo.org/en/Why-Maritime/Shipping-Facts

Contacts
Leann Gaines
[email protected]
847.309.5497

HOUSTON, Aug. 04, 2021 (GLOBE NEWSWIRE) — Sharps Compliance Corp. (Nasdaq: SMED) announced today that it will release its fourth quarter 2021 results for the period ended June 30, 2021, before the opening of the financial markets on Wednesday, August 18, 2021. A conference call and webcast will follow at 11:00 a.m. ET, in which management will discuss the Company’s financial results, key market initiatives and business strategy.

The Sharps conference call can be accessed by domestic callers by dialing (877) 407-0782. International callers may access the call by dialing (201) 689-8567. The webcast can be monitored at www.sharpsinc.com.

A telephonic replay will be available through September 17, 2021. To listen to the replay, domestic callers should dial (877) 481-4010 and international callers should dial (919) 882-2331 and enter replay ID number 42199. Transcript will also be posted to the Sharps website, once available.

About Sharps Compliance Corp.

Headquartered in Houston, Texas, Sharps Compliance (NASDAQ: SMED) is a leading business-to-business services provider to the healthcare, long-term care and retail pharmacy markets. Sharps Compliance offers comprehensive solutions for the management of regulated medical waste, hazardous waste and unused medications. For more information, visit: www.sharpsinc.com.

Safe Harbor Statement

The information made available in this news release contains certain forward-looking statements relating to the Company that are based on the beliefs of the Company’s management as well as assumptions made by and information currently available to the Company’s management. When used in this document, the words “may,” “position,” “plan,” “potential,” “continue,” “anticipate,” “believe,” “expect,” “estimate,” “project,” and “intend” and words or phrases of similar import, as they relate to the Company or its subsidiaries or Company management, are intended to identify forward-looking statements. Such statements reflect the known and unknown risks, uncertainties and assumptions related to certain factors including, without limitation, competitive factors, general economic conditions, customer relations, relationships with vendors, governmental regulation and supervision, seasonality, distribution networks, product introductions and acceptance, technological change, changes in industry practices, onetime events and other factors described herein including the impact of the coronavirus COVID-19 (“COVID-19”) pandemic on our operations and financial results. Based upon changing conditions, should any one or more of these risks or uncertainties materialize, or should any underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated, expected or intended. Consequently, no forward-looking statements can be guaranteed. When considering these forward-looking statements, you should keep in mind the risk factors and other cautionary statements in the Company’s Quarterly Report on Form 10-Q or refer to our Annual Report on Form 10-K. Actual results may vary materially. You are cautioned not to place undue reliance on any forward-looking statements. You should also understand that it is not possible to predict or identify all such factors and as such should not consider the preceding list or the risk factors to be a complete list of all potential risks and uncertainties. The Company does not intend to update these forward-looking statements.

For more information contact:

Diana P. Diaz Sharps Compliance Corp. Vice President and Chief Financial Officer Phone: (713) 660-3547 Email: [email protected]

John Nesbett/Jennifer Belodeau IMS Investor Relations Phone: (203) 972-9200 Email: [email protected]

SAN CARLOS, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) — ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 41st Annual Growth Conference on Wednesday, August 11 at 5:00 p.m. ET.

A live audio webcast of the presentation can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. A replay of the webcast will be available on the Company’s website for two weeks following the live presentation.

About ChemoCentryx

ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis and is in late stage clinical development for the treatment of severe Hidradenitis Suppurativa and C3 glomerulopathy (C3G).

ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.

Contacts:

Susan M. Kanaya
Executive Vice President,
Chief Financial and Administrative Officer
[email protected]

Media:
Stephanie Tomei
408.234.1279
[email protected]

Investors:
Lee Roth, Burns McClellan
212.213.0006
[email protected]

Study finds no in-vitro pharmacological difference in the antiproliferative, anti-inflammatory, or permeability effects of purified natural versus synthetic CBD

Study further validates Artelo’s strategy to develop a synthetic CBD-cocrystal with enhanced pharmaceutical properties as well as synergistic use of the coformer TMP

SOLANA BEACH, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) — Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that target lipid signaling pathways, including the endocannabinoid system, today announced the publication of study results in Medical Cannabis and Cannabinoids, a peer-reviewed journal. The study and related article, entitled “The Pharmacological Effects of Plant-Derived versus Synthetic Cannabidiol in Human Cell Lines,” compared the in vitro effects of purified natural and synthetic forms of Cannabidiol (CBD) to establish any pharmacological differences in human cell lines. The study found no in-vitro pharmacological difference in the antiproliferative, anti-inflammatory, or permeability effects of purified natural versus synthetic CBD.

Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences, commented, “Since this study did not find pharmacologic differences among the CBD compositions, we believe that it is the biopharmaceutical properties that have the greatest potential to differentiate CBD products. Our CBD cocrystal should contribute to improved consistency, absorption, bioavailability, processability and stability. These properties, in turn, may lead to a product candidate with better efficacy and safety.”

“Importantly, our patented cocrystal is comprised of both CBD and tetramethylpyrazine (TMP), each of which has have demonstrated anti-cancer properties in-vitro and in-vivo. However, individually, both of these compounds suffer from poor oral bioavailability. A recent study confirmed that when combined, there were synergistic and additive interactions between CBD and TMP in their ability to prevent cancer cell growth and to kill cancer cells. For this reason, we believe ART12.11 represents an attractive drug candidate targeting large indications, such as cancer, PTSD, inflammatory bowel disease and more. In addition, our recently issued composition of matter patents could form the basis for market exclusivity through the end of 2038.”

The company-sponsored study was led by Prof. Saoirse O’Sullivan, scientific advisor to Artelo Biosciences and former Professor of Pharmacology at the University of Nottingham, UK.

About Medical Cannabis and Cannabinoids

Medical Cannabis and Cannabinoids is a peer-reviewed journal offering an international forum to present and discuss recent advances in the rapidly developing and challenging field of the medical use of cannabis and cannabinoids. It seeks to bridge the gap between empirical and evidence-based clinical medicine by covering current basic and applied as well as translational research topics. In addition to original papers, reviews, and mini-reviews, this journal features short communications, case reports, technical notes, letters, and conference proceedings.

About Artelo Biosciences

Artelo Biosciences, Inc. is a clinical stage biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that target lipid signaling pathways, including the endocannabinoid system. Artelo is rapidly advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, PTSD, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the San Diego-based company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio.

Investor Relations Contact:

Crescendo Communications, LLC
Tel: 212-671-1020
Email: [email protected]

Processa’s
Phase 1b
open label, multicenter
trial is currently enrolling patients
who have advanced, relapsed GI cancer
that are refractory or intolerant
to other therapies
and
are candidates for fluoropyrimidine monotherapy.

HANOVER, MD., Aug. 04, 2021 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition, announced today it has dosed the first patient in its Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors. Detailed information on the trial can be located at https://clinicaltrials.gov/ct2/show/NCT04861987

“We believe that the irreversible inhibitor effects of PCS6422 on the dihydropyrimidine dehydrogenase enzyme may significantly improve exposure to the cancer killing 5-FU metabolites while reducing the 5-FU metabolites, like α-fluoro-β-alanine, related to dose limiting side effects such as hand foot syndrome. The dosing of the first patient in our Phase 1b trial represents an important step to explore PCS6422’s potential as a disease modifying therapy for capecitabine,” said Dr. Sian Bigora, Chief Development Officer. “By the end of 2021, we expect to have interim results evaluating the positive effect that PCS6422 has on capecitabine while in 2022 we anticipate being able to define a new maximum tolerated dose and potential biomarkers for the PCS6422 – capecitabine combination which will help us to define the pivotal Phase 3 study design needed for FDA approval.”

Dr. David Young, Chief Executive Officer, added, “The Processa strategy is to design and develop our pipeline of drugs to improve a patient’s benefit-risk profile compared to existing therapy. PCS6422 is a prime example of the drugs in our pipeline and being able to enroll our first patient into this study is the first of many steps that we expect to achieve over the next 6-18 months.”

The present site Principal Investigators are Dr. Jean Grem, Dr. Patrick Boland, Dr. Olivier Rixe, Dr. Sanjay Goel and Dr. Alexander Spira. The first patient was dosed by Dr. Olivier Rixe at Quantum Santa Fe.

About
Processa
Pharmaceuticals, Inc.

Our mission is to develop drug products that improve the survival and/or quality of life for patients with high unmet medical need conditions. We are a development company, not a discovery company, that seeks to identify and develop drugs for patients who need better treatment options than presently exist for their medical condition. To increase the probability of development success, our pipeline only includes drugs which have previously demonstrated some efficacy in the targeted population or a drug with very similar pharmacological properties has been shown to be effective in the population.

We currently have three drugs in various stages of clinical development: PCS499 for Ulcerative Necrobiosis in Phase 2B; PCS3117 for metastatic pancreatic cancer and non-small cell lung cancer in Phase 2B; and PCS6422 for metastatic colorectal cancer and breast cancer in Phase 1B. The PCS12852 IND for the treatment of gastroparesis will be submitted in 3Q2021.

Members of the Processa development team throughout their careers have been involved with more than 30 FDA drug approvals (including drug products targeted to orphan disease conditions), more than 100 FDA meetings, and two FDA regulatory science contracts. For more information, visit the company’s website at www.ProcessaPharma.com .

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the registration statement relating to the securities being sold in this offering, which identifies important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

For More Information:
Michael Floyd
[email protected]
301-651-4256

James Carbonara
Hayden IR
(646) 755-7412
[email protected]

– 

Limb-girdle muscular dystrophy type 2A is the most common form of LGMD, accounting for a third of LGMD diagnoses

– 

Sarepta’s unrivaled portfolio of investigational


gene therapies for LGMD offers the potential to address six LGMD subtypes, which together represent more than 70% of all known LGMDs

CAMBRIDGE, Mass., Aug. 04, 2021 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that upon completion of a number of preclinical and safety studies, it had executed an exclusive license agreement for an investigational gene therapy candidate, calpain 3 (CAPN-3), to treat Limb-girdle muscular dystrophy type 2A (LGMD2A), developed by the Abigail Wexner Research Institute at Nationwide Children’s Hospital (Nationwide Children’s).

LGMDs represent a group of distinct genetic neuromuscular diseases with a generally common set of symptoms, including progressive, debilitating weakness and wasting that begins in muscles around the hips and shoulders before progressing to muscles in the arms and legs. Many LGMD sub-types are significantly life-limiting and often life-ending diseases. Also known as calpainopathy, LGMD2A is caused by mutations in the CAPN-3 gene and is the most common type of LGMD, accounting for almost a third of cases.

“Treatment plans for LGMD2A are currently limited to physical therapy, assistive devices and surgery for complications. We’re excited about the opportunity to transform patient care for this significantly life-limiting disease by advancing the CAPN-3 program following extensive pre-clinical work by the team at Nationwide Children’s. Preclinical research conducted to date has provided early proof of concept for CAPN-3 in LGMD2A and supports further advancement,” said Louise Rodino-Klapac, Sarepta’s executive vice president and chief scientific officer. “We intend to build off the knowledge we have gained from our lead investigational gene transfer programs for Duchenne muscular dystrophy and LGMD2E, as the CAPN-3 program also uses the AAVrh74 vector to address another well-characterized genetic disease. Sarepta’s commitment and research investment in LGMD is unparalleled and we continue to work towards advancing all of our LGMD programs as quickly as possible.”

Like SRP-9001, Sarepta’s lead investigational gene transfer therapy for Duchenne muscular dystrophy, and the Company’s five other LGMD programs, the LGMD2A program uses the AAVrh74 vector, designed to systematically and robustly deliver treatment to skeletal muscle, including the diaphragm, making it an ideal candidate to treat muscle disease.

The preclinical work on the CAPN-3 program in LGMD2A has been led by Zarife Sahenk, M.D., Ph.D., attending neurologist at Nationwide Children’s, Director of Clinical and Experimental Neuromuscular Pathology at The Research Institute at Nationwide Children’s and Professor of Pediatrics, Pathology and Neurology at The Ohio State University College of Medicine.

About Limb-girdle Muscular Dystrophy


Limb-girdle muscular dystrophies are genetic diseases that cause progressive, debilitating weakness and wasting that begins in muscles around the hips and shoulders before progressing to muscles in the arms and legs. Sarepta’s six LGMD gene therapy programs in development include LGMD2E, LGMD2D, LGMD2C, LGMD2B, LGMD2L and LGMD2A, which together represent more than 70 percent of known LGMD cases.

About Sarepta Therapeutics


Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Internet Posting of Information


We routinely post information that may be important to investors in the ‘For Investors’ section of our website at 


www.sarepta.com


. We encourage investors and potential investors to consult our website regularly for important information about us.

Forward-Looking Statements


This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the potential benefits of the licensing agreement; the design of the AAVrh74 vector to systematically and robustly deliver treatment to skeletal muscle, including the diaphragm, making it an ideal candidate to treat muscle disease; the potential of our portfolio of investigational gene therapies for LGMD to address six LGMD subtypes, which together represent more than 70% of all known LGMDs; and our plan to continue to advance all of our LGMD programs as quickly as possible.

These forward-looking statements involve risks and uncertainties, many of which are beyond our control. Known risk factors include, among others: the expected benefits and opportunities related to the licensing agreement may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development. In particular, activities under the license may not result in any viable treatments suitable for commercialization due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement; success in preclinical trials does not ensure that later clinical trials will be successful; Sarepta may not be able to execute on its business plans and goals, including meeting its expected or planned regulatory milestones and timelines, clinical development plans, and bringing its product candidates to market, due to a variety of reasons, many of which may be outside of Sarepta’s control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover Sarepta’s product candidates and the COVID-19 pandemic; even if Sarepta’s programs result in new commercialized products, Sarepta may not achieve the expected revenues from the sale of such products; if the actual number of patients living with LGMD2A is smaller than estimated, Sarepta’s revenue and ability to achieve profitability may be adversely affected; and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K for the year ended December 31, 2020, and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Source: Sarepta Therapeutics, Inc.

Investor Contact:


Ian Estepan, 617-274-4052
[email protected]

Media Contact:


Tracy Sorrentino, 617-301-8566
[email protected]

– Partnership enables LifeMD to offer best-in-class, personalized medical care by providing providers on the platform a deeper understanding of their patients’ medical histories –

NEW YORK, Aug. 04, 2021 (GLOBE NEWSWIRE) — LifeMD, Inc. (“the Company”) (NASDAQ: LFMD), a leading direct-to-patient telehealth company, today announced a partnership with Particle Health, a state-of-the-art, digital health company with a HIPAA-compliant technology platform that converts electronic medical records (EMR) data into a user-friendly FHIR format. With Particle Health’s platform, and patient consent, licensed medical providers on the upcoming LifeMD platform gain instant access to comprehensive patient health records from a database covering over 90% of the US population, therefore enabling best-in-class, personalized care through a deeper understanding of their patients’ medical histories.

“Particle Health has re-envisioned access to medical records by integrating their technology platform into our system. Thanks to the vital medical data delivered by Particle Health’s secure technology platform, LifeMD will launch with the capability to provide comprehensive personalized medical care without all the noise and complication associated with traditional healthcare data on legacy systems,” said Justin Schreiber, Chairman and CEO of LifeMD.

Troy Bannister, CEO and Chairman of Particle Health added, “We have been working to establish a unique set of data partners to further our mission of providing diverse and actionable data to catalyze change in our healthcare system. With an evolutionary approach to healthcare delivery and leading position as a telehealth company, LifeMD is a natural partner for us. We look forward to working with them to deliver on the promise for a more simplified, affordable, and improved experience that patients nationwide deserve.”

Corey Deutsch, CBO of LifeMD added, “At its core, LifeMD believes that the future of healthcare should, and will, be personalized based on an individual’s medical history. This integration represents a critical step towards personalized care and will drive the success of the upcoming launch of the LifeMD primary care platform. This partnership furthers LifeMD’s comprehensive approach to primary care and will enable LifeMD’s affiliated providers to serve patients across the healthcare spectrum. By providing physicians on the LifeMD platform greater insight into their patients, Particle Health has created a better pathway towards building long-term relationships with patients that will help to improve their health outcomes.”

About Particle Health

Founded in 2018, Particle Health enables healthcare companies by offering simple, secure access to vital medical data. The company is focused on breaking down data silos that stunt innovation by building developer-friendly environments. Particle’s modern APIs dismantle the complexities of traditional integrations and make siloed medical records available for care providers and modern healthcare companies across the country.

About LifeMD

LifeMD, Inc. is a rapidly growing, direct-to-patient, telehealth company offering cash-pay virtual medical care from licensed providers across all 50 states. LifeMD’s telemedicine platform enables virtual access to affordable and convenient medical treatment and, when appropriate, prescription medications and over-the-counter products delivered directly to the patient’s home.  To learn more, visit www.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 protected]

Investor Relations Contact

Ashley Robinson
LifeSci Advisors, LLC
[email protected]