Diabetes Mellitus, Type 2

HOUSTON, March 19, 2024 /PRNewswire/ -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the progress of a clinical program under development using a fibroblast-based pancreatic beta cell spheroid that secretes insulin in vitro upon glucose stimulation. The development and reproducibility of this work demonstrates that an organoid composed of fibroblasts, beta cells and other components can successfully and durably secrete insulin. "This early proof of concept is encouraging and may lead to a new and durable potential allogeneic treatment option for people with insulin-dependent diabetes," said Hamid Khoja, Ph.D., Chief Scientific Officer. "We look forward to confirming these early results and in vivo utility. We will then determine whether to designate the program as an early phase pre-clinical project for developing a minimally invasive therapeutic for type 1 diabetes." About Diabetes Diabetes mellitus is a chronic heterogeneous metabolic disease characterized by elevated blood glucose levels due to abnormalities in either insulin production or insulin action that impacts more than 37 million people in the United States and over 500 million people worldwide. Type 1 diabetes, an autoimmune disorder in which the immune system destroys the pancreatic beta cells that produce insulin, accounts for 10% of diabetes cases worldwide, and type 2 diabetes, in which the body does not respond to insulin, accounts for the remaining 90% of diabetes cases. With such a high and growing prevalence of the disease, over 200 million individuals are dependent on consistent and often daily insulin therapy for their health. To date, durable, long-term, and economical treatment options are not available. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential of organoids composed of fibroblasts, beta cells and other components to successfully and durably secrete insulin and to treat insulin-dependent diabetes, and our expectations regarding plans for our current and future product candidates and programs. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, . These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) the ability of FibroBiologics to continue to meet Nasdaq listing requirements; (b) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (c) the ability to effectively manage the business as a result of the super-voting proxy given to the Board of Directors; (d) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; and (e) the unpredictable relationship between R&D and preclinical results and clinical study results. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations.  About FibroBiologics Based in Houston, FibroBiologics is a cell therapy and regenerative medicine company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 150+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit . Investor Relations: Nic Johnson or Harrison Seidner, Ph.D. Russo Partners (646) 942-5599 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected] General Inquiries: [email protected] Logo -

Lubbock–area surgery center remains one of only two dozen in the country to meet all criteria to achieve accreditation from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program®, demonstrating the highest standards for patient safety and quality LUBBOCK, Texas, March 19, 2024 /PRNewswire/ -- Covenant High Plains Surgery Center announced today that its ambulatory surgery center (ASC) has been reaccredited by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP®), a joint Quality Program of the American College of Surgeons (ACS) and the American Society for Metabolic and Bariatric Surgery (ASMBS). MBSAQIP Accreditation is normally the domain of hospital programs, and fewer than two dozen surgery centers in the nation have merited this designation. Dr. Adam Purtell, Metabolic and Bariatric Surgery Director at Covenant High Plains Surgery Center (CHPSC), made the announcement, noting that West Texas and Eastern New Mexico patients seeking outpatient, surgical treatment for obesity and its related conditions will continue to have a high-quality, cost-effective choice for receiving care at a nationally accredited program that meets the highest standards for patient safety and quality. The MBSAQIP Standards, Optimal Resources for Metabolic and Bariatric Surgery, ensure that metabolic and bariatric patients receive multidisciplinary medical care, which improves patient outcomes and long-term success. MBSAQIP-accredited surgery centers offer preoperative and postoperative care designed specifically for patients with obesity. "We are excited about the opportunity to continue to offer Lubbock and the West Texas community an excellent Bariatric surgery experience in the only MBSAQIP-accredited ambulatory surgery center in the region," said Dr. Purtell. "Our fellowship-trained Bariatric surgeons provide tremendous quality and outcomes at affordable cost. The accreditation also allows many insured patients with bariatric benefits the opportunity to change their lives as well, with long term weight loss and improvement of medical conditions." CHPSC's commitment to quality care begins with its expertly trained staff and the leadership of an experienced bariatric surgeon. The program is tasked with continuous review of surgical data as they continue improving the structure and outcomes expertise necessary to provide safe, efficacious, and high-quality care to all metabolic and bariatric patients. To earn MBSAQIP Accreditation, CHPSC met essential criteria for staffing, training, facility infrastructure and patient care pathways, ensuring its ability to support patients with obesity. The center also participates in a national data registry that yields semiannual reports on the quality of its surgical outcomes and identifying opportunities for quality improvement. The MBSAQIP Standards, Optimal Resources for Metabolic and Bariatric Surgery, are published by the ACS and the ASMBS. After applying for MBSAQIP accreditation, centers undergo an extensive site visit by an experienced bariatric surgeon who reviews the center's structure, processes, and clinical outcomes data. Centers that earn accreditation are awarded a specific designation level, depending on how many patients it serves annually, critical care capabilities, the types of procedures provided, and whether it provides care to patients under the age of 18. The Centers for Disease Control and Prevention (CDC) estimates about 93 million adults in the United States are affected by obesity and that number continues to increase. The disease of obesity increases the risks of morbidity and mortality because of the diseases and conditions that are commonly associated with it, such as type II diabetes, hypertension, cardiovascular disease, and cancer, among other health risks. Metabolic and bariatric surgery has proven to be effective in the reduction of comorbid conditions related to obesity.* Working together, the ACS and the ASMBS have developed accreditation standards for metabolic and bariatric surgery to assist patients with obesity in identifying centers that provide optimal patient care. "We are proud to provide this level of care in an ambulatory surgery setting to patients in West Texas," stated CHPSC Administrator Alfonso del Granado, a bariatric patient himself who supports his organization's dedication to excellence. "Too many patients are not able to afford the treatment options available at large hospital programs or have to compromise by seeking care at non-accredited centers. With this reaccreditation, we are demonstrating our commitment to offer patients the highest standards of care." About Covenant High Plains Surgery Center, LLC Covenant High Plains Surgery Center (CHPSC) operates two freestanding, independent multispecialty ambulatory surgery centers (ASCs) in Lubbock, Texas with joint-venture partners Covenant Health System and National Cardiovascular Partners (NCP). Fully accredited by the Accreditation Association for Ambulatory Health Care and the American Society for Metabolic and Bariatric Surgery, CHPSC runs 14 operating and procedure rooms with more than a hundred physicians on staff. CHPSC features robotic general surgery, urology, and total joint replacement programs, as well as advanced surgical treatment options in bariatrics, ENT, general surgery, GI, gynecology, interventional pain, neuro & spine surgery, ophthalmology, orthopedics, maxillofacial, plastic & reconstructive surgery, podiatry, and urology to patients from Texas, New Mexico, and Oklahoma. For more information, visit . About the American College of Surgeons The American College of Surgeons (ACS) is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical education and practice and to improve the quality of care for surgical patients. Its achievements have placed it at the forefront of American surgery and have made the College an important advocate for all surgical patients. The College has more than 82,000 members and is the largest organization of surgeons in the world. About the American Society for Metabolic and Bariatric Surgery The American Society for Metabolic and Bariatric Surgery (ASMBS) is the largest organization for metabolic and bariatric surgeons in the world, with more than 4,200 members. It is a not-for-profit organization that works to advance the science of metabolic and bariatric surgery. The ASMBS is committed to educating medical professionals and the lay public about metabolic and bariatric surgery, including the associated risks and benefits, as a treatment option for obesity. *Buchwald H, Avidor Y, Braunwald E, et al. Bariatric Surgery: A Systematic Review and Meta-analysis. JAMA. 2004;292(14):1724-1737. DOI:10.1001/jama.292.14.1724. SOURCE Covenant High Plains Surgery Center

AUSTIN, Texas, March 19, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that it has entered into definitive agreements for the sale and issuance of 1,542,112 shares of common stock (or prefunded warrants in lieu thereof) of the Company and warrants to purchase up to 1,542,112 shares of common stock at a combined offering price of $4.215 per share of common stock (or per prefunded warrant in lieu thereof) and accompanying warrant, in a registered direct offering priced at-the-market under the Nasdaq rules. The warrants have an exercise price of $4.09 per share, will be exercisable on the date of issuance, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about March 21, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to Genprex from this offering are expected to be approximately $6.5 million, before deducting the placement agent's fees and other offering expenses. Genprex intends to use the net proceeds from this offering for working capital and general corporate purposes. A "shelf" registration statement (File Number 333-271386) relating to the offered securities was filed with the Securities and Exchange Commission ("SEC") on April 21, 2023 and was declared effective on June 9, 2023. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com. The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 194,248 shares of the Company's common stock that were previously issued to investors in March 2023 and July 2023, with exercise prices of $44.00 and $35.40 per share and expiration dates of March 1, 2028 and July 21, 2028 for $0.125 per amended warrant, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $4.09 per share and an expiration date of five years from the closing of the offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Genprex, Inc. Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. For more information, please visit the Company's web site at or follow Genprex on Twitter, Facebook and LinkedIn. Forward Looking Statements This press release contains certain 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 Private Securities Litigation Reform Act, as amended, including those relating to the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering, the intended use of proceeds from the registered direct offering and other statement that are predictive in nature. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any results, performance or achievements expressed or implied by the forward-looking statements. Such factors include the risk factors set forth in the Company's filings with the SEC, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2022, its periodic reports on Form 10-Q, and its Current Reports on Form 8-K filed in 2023 and 2024, as well as the risks identified in the shelf registration statement and the prospectus supplement relating to the offering. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. Genprex undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Genprex, Inc. (877) 774-GNPX (4679) GNPX Investor Relations investors@genprex.com GNPX Media Contact Kalyn Dabbs media@genprex.com Company Codes: NASDAQ-NMS:GNPX