Market Newsdesk

NEW YORK, May 04, 2021 (GLOBE NEWSWIRE) — LifeMD, Inc. (“the Company”) (NASDAQ: LFMD) is a rapidly growing direct-to-patient telehealth company that offers cash pay virtual medical treatment, prescription medications and over the counter products to patients across all 50 states. The Company today announced that it will host a conference call to discuss its unaudited financial results for first quarter fiscal 2021, on Thursday, May 13, 2021 after the close of market. The financial results will be issued in a press release prior to the call. LifeMD management will host the conference call followed by a question-and-answer period.

Conference Call:

Date: Thursday, May 13, 2021
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Toll-free dial-in number: 1-866-269-4260
International dial-in number: 1-720-452-9102
Conference ID: 3530318
Webcast: http://public.viavid.com/index.php?id=144808

The conference call will be webcast live and available for replay via a link provided in the Investors section of the company’s website at https://ir.lifemd.com.

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

About LifeMD

LifeMD, Inc. is a rapidly growing direct-to-patient telehealth company that offers cash pay virtual medical treatment, prescription medications and over the counter products to patients across all 50 states. 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 Contacts

Ashley Robinson
LifeSci Advisors, LLC
[email protected]

-Data from studies of novel AAV vectors and AAV immunology and an encore of 12-month safety, efficacy and patient-reported outcomes measurements from the ongoing IGNITE DMD trial of SGT001 to be presented-

CAMBRIDGE, Mass., May 04, 2021 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced the presentation of three abstracts at the upcoming American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting. The abstracts report data from research-stage studies of novel adeno-associated viral (AAV) vectors for muscle gene delivery and mechanisms of immune responses to AAV9, as well as 12-month data from the ongoing IGNITE DMD trial Phase I/II study of SGT-001 microdystrophin gene therapy in patients with Duchenne, which were previously presented at the Muscular Dystrophy Association Virtual Clinical & Scientific Conference in March 2021. The ASGCT Annual Meeting is being held virtually May 11-14, 2021.

Presentation Details


Title: AAV9 Capsid-Anti-AAV9 Antibody Immune Complexes Promote Complement Activation and Cytokine Release In Vitro
Presenter: Qian Chen, Senior Director, R&D, Solid Biosciences
Presentation Type: Digital poster
Abstract Number: 747

Title: Continued In Vitro and In Vivo Characterization of Novel AAV Vectors Engineered for Muscle Gene Delivery
Presenter: Jennifer Green, PhD, Principal Scientist, R&D, Solid Biosciences
Presentation Type: Digital poster
Abstract Number: 319

Title: IGNITE-DMD: Phase I/II Study of Single SGT-001 Microdystrophin Gene Therapy for DMD
Presenter: Carl Morris, PhD, Chief Scientific Officer, Solid Biosciences
Presentation Date & Time: Friday, May 14, 2021, 1:45-2:00 PM ET
Presentation Type: Oral
Abstract Number: 263

Abstracts for the presentations can be viewed online at: https://annualmeeting.asgct.org/

About SGT-001

Solid’s SGT-001 is a novel adeno-associated viral (AAV) vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne. Duchenne is caused by mutations in the dystrophin gene that result in the absence or near absence of dystrophin protein. SGT-001 is a systemically administered candidate that delivers a synthetic dystrophin gene, called microdystrophin, to the body. This microdystrophin encodes for a functional protein surrogate that is expressed in muscles and stabilizes essential associated proteins, including neuronal nitric oxide synthase (nNOS). Data from Solid’s clinical program suggests that SGT-001 has the potential to slow or stop the progression of Duchenne, regardless of genetic mutation or disease stage.

SGT-001 is based on pioneering research in dystrophin biology by Dr. Jeffrey Chamberlain of the University of Washington and Dr. Dongsheng Duan of the University of Missouri. SGT-001 has been granted Rare Pediatric Disease Designation, or RPDD, and Fast Track Designation in the United States and Orphan Drug Designations in both the United States and European Union.

About Solid Biosciences

Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the ability of the Company to continue dosing patients in the IGNITE DMD trial, the implication of interim clinical data, the safety or potential treatment benefits of SGT-001 in patients with DMD, the Company’s expectations for reporting future data from the IGNITE DMD trial, the Company’s regulatory plans and timelines and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company’s ability to or continue IGNITE DMD on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; obtain and maintain the necessary approvals from investigational review boards at IGNITE DMD clinical trial sites and the IGNITE DMD independent data safety monitoring board; enroll patients in IGNITE DMD on the timeline expected; the Company’s dosing strategy; replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development; whether the interim data presented in this release will be predicative of the final results of the trial or will demonstrate a safe or effective treatment benefit of SGT-001; whether the methodologies, assumptions and applications we utilize to assess particular safety or efficacy parameters will yield meaningful statistical results; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; successfully optimize and scale its manufacturing process; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop Duchenne treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-001, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Investor Contact:

David Carey
FINN Partners
212-867-1768
[email protected]

Media Contact:

Erich Sandoval
FINN Partners
917-497-2867
[email protected]

SOUTH SAN FRANCISCO, Calif., May 04, 2021 (GLOBE NEWSWIRE) — VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression, and other central nervous system (“CNS”) disorders, today announced the appointment of Ann Cunningham as its Chief Commercial Officer. Ms. Cunningham has a proven pharmaceutical commercial track record of more than 25 years delivering sales, marketing, and global life cycle product management expertise in roles across several healthcare markets, including neuropsychiatry and other CNS markets that VistaGen is pursuing. She has been serving on VistaGen’s Board of Directors (“Board”) since January 2019 and will remain a member of the Board.

“Since joining our Board, Ann’s commercial insight, expertise and leadership experience has been tremendously helpful in support of our pre-commercial planning for PH94B, with special emphasis on a broad range of anxiety markets in the U.S. With the near term launch of our Phase 3 clinical development program for PH94B, our investigational product focused on the acute treatment of anxiety in adults with social anxiety disorder, Ann’s appointment as our Chief Commercial Officer adds considerable strength to the world-class team we have assembled across all key functional areas necessary to advance our company through the next phases of our growth,” said Shawn Singh, Chief Executive Officer of VistaGen. “Ann’s many notable accomplishments throughout her distinguished career in the pharmaceutical industry include leading campaigns for prominent neuropsychiatric drug treatments in multiple markets where we believe our investigational products, including PH94B, have therapeutic and commercial potential. As we look to transition from clinical development into a commercial growth mode and steadfastly pursue our mission to create life-changing medicines to improve mental health and well-being, Ann’s leadership will make a difference.”

“Serving on the VistaGen Board has allowed me to gain important insight into the ongoing development of VistaGen’s potentially life-changing CNS product candidates. I am thrilled to expand my role, join the team full time, and lead the company’s commercial efforts. The company’s innovative fast-acting, new generation CNS drug candidates have exciting potential in large markets where millions of individuals need novel products that are safe and effective alternatives to current treatments,” said Cunningham. “As VistaGen progresses its late-stage product candidates, I am excited to ensure that the company will be well prepared and strategically positioned to build brand awareness for our lead product candidate, PH94B, and to accelerate its adoption, as well as that of our other pipeline products, once approved, across these large target markets.”

Most recently, Ms. Cunningham served as Managing Partner of i³ Strategy Partners, where she guided pharmaceutical and biotechnology executives in planning and executing successful portfolio strategies and brand launches by evaluating key business questions and unique strategies to unlock the full potential of each organization served. Her experience in the pharmaceutical industry includes multiple instrumental roles, including Vice President, Neurodegenerative Disease and Psychiatry at Teva Pharmaceutical Industries; Senior Director, Global Brand Lead, Rexulti, at Otsuka America Pharmaceutical; and Senior Director, Global Brand Lead and Sales Director in multiple therapeutic areas, including Psychiatry, at Eli Lilly and Company. Ms. Cunningham holds a B.A. in Psychology from Yale University and an M.B.A. from the University of Michigan, Stephen M. Ross School of Business.

About VistaGen

VistaGen Therapeutics is a biopharmaceutical company committed to developing and commercializing innovative medicines with the potential to go beyond the current standard of care for anxiety, depression, and other CNS disorders. Each of VistaGen’s three drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date, and has therapeutic potential in multiple CNS markets. For more information, please visit www.VistaGen.com and connect with VistaGen on Twitter, LinkedIn, and Facebook.

Forward Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by us and our management, are inherently uncertain. Our actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties relating to delays in launching and/or conducting our planned clinical trials, including delays due to the impact of the COVID-19 pandemic; fluctuating costs of materials and other resources required to conduct our planned clinical and non-clinical trials; continued uncertainty with respect to the COVID-19 pandemic; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; adverse healthcare reforms and changes of laws and regulations; manufacturing and marketing risks, including risks related to the COVID-19 pandemic, which may include, but are not limited to, unavailability of or delays in delivery of raw materials for manufacture of our CNS drug candidates and difficulty in initiating or conducting clinical trials; inadequate and/or untimely supply of one or more of our CNS drug candidates to meet demand; entry of competitive products; and other technical and unexpected hurdles in the development, manufacture and commercialization of our CNS drug candidates; and the risks more fully discussed in the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended March 31, 2020, and in our most recent Quarterly Report on Form 10-Q for the quarter ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC’s website at www.sec.gov. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements, other than as may be required by law. If we do update one or more forward-looking statements, no inference should be made that we will make additional updates with respect to those or other forward-looking statements.

VistaGen Company Contacts

Mark McPartland / Mark Flather
VistaGen Therapeutics
Phone: (650) 577-3606
Email: [email protected]

Cambridge, Massachusetts, May 04, 2021 (GLOBE NEWSWIRE) — Students earn lower math and reading scores on standardized tests after their schools switch to a four-day school week, Paul Thompson of Oregon State University reports in a new article for Education Next. As schools across the country grapple with a return to in-person schooling amid pandemic-induced learning loss, the findings offer a cautionary tale—but also reason for hope.

Nationwide, even before the pandemic, some 1,600 schools adopted four-day schedules, most often to cut costs. While these schools extend instructional time during the four days they are open, students still lose about three to four hours of instruction every week compared to students on a five-day schedule. Four-day schools average 148 school days a year, well below the 175-180 average typically provided by a traditional weekly schedule.

“Teachers, students, and families have now experienced radi­cally different learning schedules due to school closures and broad adoption of hybrid schedules, which mimic the part-time nature of the four-day school week. That may stoke interest in a four-day schedule and put pressure on local school boards to consider it. These findings suggest that they proceed with caution,” Thompson writes.

Among the key findings:

• Student achievement. Students earn lower math and reading scores on standardized tests after their schools switch to a four-day schedule. Overall losses are equivalent to nearly one-third the size of the impact of having a larger class size, and equal to losing 40 minutes of reading instruction and about an hour of math instruction each week. The negative effects in math are most prominent in 7th and 8th grades.
• Trends over time. The negative impacts of a four-day schedule grow over time. Four years after switching to shorter school weeks, math and reading scores fall by 8.8 percent and 10.4 percent of a standard deviation, respectively. The lasting impacts of the four-day week are minimal for schools that eventually switch back to a five-day schedule.

Thompson studied the academic performance in reading and math of nearly 700,000 students in Oregon—where approximately one in 10 schools follow a four-day schedule—over a 15-year period. He compared changes in student achievement in districts that shifted from a five-day to a four-day week to achievement changes in districts that did not make the shift.

About the Author: Paul N. Thompson is associate professor of eco­nomics at Oregon State University and a research affiliate at the Institute for Labor Economics.

About Education Next:
Education Next is a scholarly journal committed to careful examination of evidence relating to school reform, published by the Education Next Institute and the Program on Education Policy and Governance at the Harvard Kennedy School. For more information, please visit educationnext.org.

LONDON and REDWOOD CITY, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or “the Company”), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced it will host a virtual R&D day on Thursday, May 13, 2021 to review the Company’s etigilimab (Anti-TIGIT) program, highlighting studies in ovarian cancer including Clear-cell ovarian cancer, Cervical cancer and Sarcoma. The event will feature a panel of key opinion leaders and will include an update on the Company’s ACTIVATE Phase 1b/2 combination study, and a more detailed review of the recently announced agreement with the Cancer Focus Fund, as well as the planned clinical trial in clear-cell ovarian cancer to be led by The University of Texas MD Anderson Cancer Center.

R&D Day Information

Date: Thursday, May 13, 2021

Time: 11:00 a.m. EDT / 4:00 p.m. GMT

Presenters:

• Shannon Westin, MD, MPH, Associate Professor of Gynecologic Oncology and Reproductive Medicine MD Anderson
• Kathleen Moore, MD, MS, Director, Oklahoma TSET Phase I Program, Associate Professor, Section of Gynecologic Oncology
• Priscilla Merriam, MD, Clinical Director, Sarcoma Center, Dana-Farber Cancer Institute
• Denise Scots-Knight, Chief Executive Officer
• John Lewicki, Chief Scientific Officer
• Ann Kapoun, Senior Vice President of Translational Research and Development
• Suba Krishnan, Senior Vice President of Clinical Development

A live audio webcast of the R&D day can be accessed through the Investors section of the Company’s website at www.mereobiopharma.com/investors/results-reports-and-presentations. The event is expected to last approximately two hours. An archived replay of the webcast will be made available on the Company’s website.

About Mereo BioPharma

Mereo BioPharma is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to improve outcomes for oncology and rare diseases. The Company has developed a portfolio of six clinical stage product candidates. Mereo’s lead oncology product candidate, etigilimab (Anti-TIGIT), has recently advanced into an open label Phase 1b/2 basket study evaluating Anti-TIGIT in combination with an anti-PD-1 in a range of tumor types including three rare tumors and a number of gynecological carcinomas including cervical, ovarian and endometrial carcinomas. The Company’s second oncology product, navicixizumab, for the treatment of late line ovarian cancer, has completed a Phase 1 study and has been partnered with OncXerna Therapeutics, Inc., formerly Oncologie, Inc. The Company has two rare disease product candidates: alvelestat for the treatment of severe Alpha-1 antitrypsin deficiency (AATD), which is being investigated in an ongoing Phase 2 proof-of-concept study in the U.S. and Europe, for which the Company expects to report top line data in late 2021, and setrusumab for the treatment of osteogenesis imperfecta (OI). In September 2020, the FDA granted Rare Pediatric Disease designation to setrusumab for the treatment of OI. In December 2020, the Company signed a license and collaboration agreement for setrusumab in OI with Ultragenyx Pharmaceutical Inc.

Forward-Looking Statements

This press release contains “forward-looking statements.” All statements other than statements of historical fact contained in this press release are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements usually relate to future events and anticipated revenues, earnings, cash flows or other aspects of our operations or operating results. Forward-looking statements are often identified by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “estimate,” “outlook” and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company’s current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.

All of the Company’s forward-looking statements involve known and unknown risks and uncertainties some of which are significant or beyond its control and involve assumptions that could cause actual results to differ materially from the Company’s historical experience and its present expectations or projections. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company’s business, including those described in the “Risk Factors” section of its latest Annual Report on Form 20-F, reports on Form 6-K and other documents furnished or filed from time to time by the Company with the SEC. The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law.

THE WOODLANDS, Texas, May 04, 2021 (GLOBE NEWSWIRE) — Country Fresh and Sun Rich USA, two divisions previously part of the Fresh Food Group, will now operate as a standalone company under the Country Fresh name following the completion of the acquisition of Country Fresh and Sun Rich USA assets by a group consisting of Stellex Capital Management, previous management, and Country Fresh’s original founder. The new parent entity will operate under the Country Fresh name and provide Country Fresh and Sun Rich USA brand products. Country Fresh is a premier full-service, fresh food solutions partner for retail, foodservice, club, and convenience stores.

Doug Burris, an experienced food industry executive who served the company from 2005 to 2019 and most recently held the Executive Vice-President title, will serve as CEO. The new enterprise will focus on its core-competencies of producing convenient, ready-to-serve fresh fruit and vegetable products for customers in the United States.

“This is an exciting opportunity to continue building a market-leading business that offers quality, consistency and innovative new products – attributes that has historically differentiated Country Fresh in the market,” said Doug Burris, CEO of Country Fresh. “We have brought together an exceptionally talented team to lead this business into a new era and capture the opportunities before us. Our immediate goal is to strengthen the company’s operations and enhance its fresh food product offerings to create an optimized foundation for increased growth.”

“I am excited to be re-entering this product category,” stated Bryan Herr, Country Fresh’s original founder. “Service to the customer was the core tenant of Country Fresh’s foundation, and this philosophy will guide all priorities at the company moving forward.”

Mr. Herr provided investment alongside Stellex and has assumed the role of Chairman.

Trey Lee, Principal at Stellex, offered further commentary: “Country Fresh was an early pioneer in providing innovative produce solutions to retailers and was instrumental in growing the value-added fresh product category. We are pleased to once again partner with Doug and Bryan to drive renewed focus on product innovation, quality, and service. We want to let Country Fresh’s valued customers know the company has an entirely new balance sheet with significant equity support, and Doug and his team have Stellex’s financial and strategic resources at their disposal.”

About Country Fresh

Country Fresh is a leading provider of fresh-cut fruit, apple slices, vegetable and snacking solutions and ready-to-serve fresh salad kits in a variety of blends, sizes, and packaging options. The company’s all-natural, convenient, and ready-to-eat products are distributed nationwide to a variety of retail and foodservice outlets. State-of-the-art production facilities ensure food safety and the best quality, while minimizing cross-contamination to deliver exciting and healthy convenience food products for a variety of customer dietary considerations and lifestyles. Visit www.freshfoodgroup.com/about-country-fresh/ for more information.

Press Contact:

April Lynch, Lynchpin Strategic Communications
[email protected]
Phone: +1 713-922-1895

CARLSBAD, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI), a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced that it will host a key opinion leader (KOL) webinar event on LB1148, the Company’s lead asset for indications associated with GI Surgery, on Thursday, May 13, 2021 at 1:00pm Eastern Time.

The webinar will feature presentations by KOLs Steven Wexner, M.D., Cleveland Clinic, and Mark A. Talamini, M.D., Northwell Health, who will discuss the current treatment landscape and unmet medical need for two indications associated with postsurgical complications of the GI tract: 1) accelerating the recovery of postoperative bowel function, and 2) reducing post-surgical adhesions. Drs. Wexner and Talamini will be available to answer questions following the formal presentations.

The Palisade Bio management team will also give an update on the GI surgery clinical development activities for LB1148. As an oral broad-spectrum serine protease inhibitor, LB1148 is designed to inhibit activity of potent digestive enzymes that cause tissue damage and inflammation when the intestinal mucosal barrier is compromised during surgery.

In a successfully completed Phase 2 clinical trial in patients undergoing elective cardiac surgery, LB1148 improved the time to return of bowel function, which is frequently a limiting factor for hospital discharge following routine surgery. A second Phase 2 clinical trial is underway in patients undergoing elective GI surgery to evaluate the return of bowel function and prevention of abdominal adhesions. The company plans to initiate a Phase 2/3 clinical trial of LB1148 for the treatment of postoperative GI dysfunction associated with pediatric cardiovascular surgery and report Phase 2 data in GI surgery by year-end 2021.

To register for the webinar, please click HERE.

Dr. Wexner is chair of the department of colorectal surgery and director of the Digestive Disease Institute at Cleveland Clinic Florida in Weston, Fla., and clinical professor, Cleveland Clinic Lerner College of Medicine at Case Western Reserve University.

Dr. Wexner has been a Fellow of the American College of Surgeons (FACS) since 1991 and has served as an ACS Regent since 2012. He is the founding Chair of the ACS Commission on Cancer (CoC) National Accreditation Program for Rectal Cancer, a member of the Executive Committee of the CoC, and served as President of the College’s South Florida Chapter (2000-2004). He also served as an ACS Governor (2000-2006), as Chair of the ACS Advisory Council for Colon and Rectal Surgery, and on both the ACSPA-Surgeons PAC (2005-2011 and 2017-2020), and ACS Foundation Board (2020) among numerous other involvements with the College.

Dr. Wexner is renowned for his work in the field of colon and rectal surgery. He was the first surgeon in North America to popularize the colonic J-pouch for rectal cancer, a procedure which is now an acceptable standard of care for patients with rectal carcinoma. He also developed significant innovations for fecal incontinence and research of laparoscopy for colon and rectal cancer.

Dr. Talamini is vice president of surgical operations and program development for Northwell Health. Dr. Talamini is a graduate of Johns Hopkins University and Johns Hopkins School of Medicine, where he also completed a residency in general surgery. As a faculty member at Hopkins, he developed and established the minimally invasive and robotic surgery programs, and was an NIH funded investigator. He served as Chairman of the Department of Surgery at the University of California San Diego from 2005 to 2013, and was most recently Chairman of the Department of Surgery and Surgeon in Chief at SUNY Stony Brook from 2013 to 2021. As the Chairman, he built strong departments through recruitment of successful faculty surgeons and the development of novel clinical, research, and teaching programs and platforms. Dr. Talamini was president of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in 2008-2009, and serves as editor of Surgical Endoscopy, one of the most widely read and cited international journals in Surgery. He has chaired the FDA Gastroenterology and Urology devices advisory panel, and is currently president of the Foundation for Surgical Fellowships. He has published nearly 300 peer reviewed manuscripts. He obtained his Executive MBA from the Heller Business School at Brandeis University in 2017.

About LB1148

LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to return of normal GI function, and shorten the duration of costly post-surgery hospital stays.

About Palisade Bio, Inc.

Palisade Bio is a late-stage biopharma company advancing therapies that help patients with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio’s innovative lead asset, LB1148, is a Phase 3-ready protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to bowel function and decrease in length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.

Forward Looking Statements

This communication contains “forward-looking” statements, including, without limitation, statements related to anticipated timing for clinical trial initiation and results, and other statements related to Palisade’s development programs. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Palisade’s current expectations. Forward-looking statements involve risks and uncertainties. Palisade’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, related to the Company’s ability to advance its preclinical programs and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio’s (formerly known as Seneca Biopharma, Inc.) Registration Statement on Form S-4 initially filed with the SEC on December 23, 2020, as amended. Palisade expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Palisade’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Palisade Bio Media Relations Contact:

Darren Opland, Ph.D.
LifeSci Communications
[email protected]

Palisade Bio Investor Relations Contact:

Corey Davis, Ph.D.
LifeSci Advisors
[email protected]

Corporate Contact:

Justin Stege, Ph.D.
[email protected]

BURLINGTON, Mass., May 04, 2021 (GLOBE NEWSWIRE) — Cerence Inc. (NASDAQ: CRNC), AI for a world in motion, today announced that it has expanded its Cerence Pay partner ecosystem with the addition of P97 Networks Inc., the leader in cloud-based mobile commerce, in-vehicle payments, and digital marketing solutions. With the integration of P97’s mobility services platform, Cerence Pay will connect drivers to safe, seamless payments through the P97 mobile commerce platform currently available to more than 30% of the retail fuel sites across the US.

Cerence Pay delivers a secure, voice-powered, contactless payment experience in the car that leverages AI to anticipate drivers’ needs and provide a seamless payment transaction from intent to authentication via voice and facial biometrics and through to purchase. Leveraging P97’s mobile commerce platform, integrated with most of the major fuel brands, Cerence Pay enables drivers to find a fueling location, learn about pricing and amenities, choose a pump, and pay – directly from the car and using their voice. Drivers can also add a car wash or coffee or other convenience items from the gas station’s store for pickup or curbside delivery.

“The Cerence Pay partner ecosystem is integral to our delivery of a flexible platform that enables OEMs to create unique branded experiences that meet the needs of their drivers,” said Nils Lenke, VP & GM of Apps, Cerence. “With the addition of P97 to our partner roster, we are further expanding the capabilities of Cerence Pay and the automotive assistant with extensive reach to fueling sites across the US.”

“Voice-powered payments are becoming an increasingly critical element of today’s mobility experience,” said David Nichamoff, Senior Vice President, Innovation & Platforms at P97 Networks. “We are proud to partner with Cerence to bring our gas station commerce services to Cerence Pay, an innovative platform that will transform how drivers think about productivity and safety on the road.”

For more information about P97, visit www.p97.com and follow the company on LinkedIn. To learn more about Cerence, visit www.cerence.com, and follow the company on LinkedIn and Twitter.

About Cerence Inc.

Cerence (NASDAQ: CRNC) is the global industry leader in creating unique, moving experiences for the automotive world. As an innovation partner to the world’s leading automakers, it is helping transform how a car feels, responds and learns. Its track record is built on more than 20 years of knowledge and more than 350 million cars on the road today. Whether it’s connected cars, autonomous driving or e-vehicles, Cerence is mapping the road ahead. For more information, visit www.cerence.com.

About P97 Networks

P97 Networks provides secure, cloud-based in-vehicle payments and digital marketing solutions that transforms mobile commerce for the convenience retail, fuel, and vehicle manufacturing industries. P97’s Mobile Commerce solutions enhance the ability to attract, engage, and retain customers by securely connecting millions of individual mobile phones and connected cars with merchants using identity, geolocation-based software that creates a unique mobile consumer experience. For more information, visit www.p97.com.

Contact Information

Kate Hickman
Cerence Inc.
Tel: 339-215-4583
Email: [email protected]