Moderna Highlights Advances in Platform Science and Innovative Vaccine Research at Fourth Annual Science Day – Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced new research being highlighted as part of the Companys fourth annual Science Day. Modernas Science Day is designed to provide insight into the continued diverse efforts underway at Moderna to better understand how to use mRNA as medicines and vaccines and underscores the Companys continued commitment to basic science and innovation.

Science Day gives us an opportunity to provide insights into the advancements in our platform science and our further understanding of how to use mRNA as both a vaccine and a medicine. Our investments in basic science continue to result in major steps forward in our platforms capabilities, and these have allowed us to open new therapeutic areas and new scientific directions, said Stephen Hoge, M.D., President of Moderna. Our investments in platform research along with our digital backbone and manufacturing plants have enabled us to create first-in-class mRNA medicines and vaccines. Today, we're excited to highlight our work to identify and address SARS-CoV-2 variants of concern, optimize our proprietary lipid nanoparticle (LNP) technology, and deliver mRNA to hematopoietic stem cells.

Moderna currently has 24 mRNA development programs in its portfolio with 14 having entered clinical studies. The Companys updated pipeline can be found at http://www.modernatx.com/pipeline. Moderna and collaborators have published more than 65 peer-reviewed papers.

At this years Science Day, Moderna will present new platform science and preclinical research, including:

mRNA Delivery to Hematopoietic Stem and Progenitor Cells (HSPC)

Of the nearly 30 trillion cells in the body, approximately 90% are of hematopoietic origin. Hematopoietic lineages originating in the bone marrow are intimately involved in maintaining homeostasis and human health. Nonetheless, there are hundreds of hematologic or immune-related disorders caused or exacerbated by cells of the hematopoietic lineage. In a disease setting, cells of hematopoietic origin interact with host tissues to drive chronic inflammatory and immune disorders. Because some hematopoietic stem and progenitor cells (HSPC) have self-renewal and pluripotent properties, targeting HSPC has the potential to modulate underlying chronic inflammation and immune-related disorders.

Advances in lipid nanoparticle (LNP) technology has allowed for delivery to the bone marrow following systemic LNP administration in vivo. This achievement has enabled Moderna scientists to deliver mRNA directly to bone marrow HSPC in vivo, leading to HSPC transfection and long-term modulation of all hematopoietic lineages. This represents a major milestone in impacting chronic inflammatory and immune related disease.

mRNA Engineering: Optimizing Ribosome Load

The ribosome plays a central role in orchestrating the life of mRNA inside the cell. Understanding how to modulate translation by changing mRNA sequence could enable a powerful lever to control the performance of an mRNA drug. To develop such a lever, the Moderna's scientists strove to characterize mechanistically how differences in translation drive differences in protein expression. In this research, an unexpected relationship emerged where mRNAs with low translation initiation rates conferred the highest and most durable levels of protein expression. By understanding the mechanisms that drive this behavior, the Company is taking mRNA design from a guess-and-check discipline into an engineering discipline. With tools in place, and more under development, Moderna is improving its ability to make an mRNA that generates the right amount of the right protein, for the right amount of time, in the right cell type. As Moderna builds these levers into its mRNA drugs, the Company believes it will be able to target more indications with more precision.

Addressing SARS-CoV-2 Variants of Concern

One part of the Companys strategy to remain ahead of the SARS-CoV-2 virus is to closely monitor and address emerging variants of concern and waning immunity. Moderna is using artificial intelligence (AI) and machine learning to predict escape risk. This involves developing statistical models to understand and predict escape risk, including identifying breakthrough sequences from clinical trials and real-world data, examining spike protein biophysical and pseudovirus neutralization data, studying spike mutations and lineage info, and time tracking.

Science Day Webcast Information

Moderna will host its annual Science Day for analysts and investors at 8:00 a.m. ET on Thursday, May 27. A live webcast will be available under Events and Presentations in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Modernas website for one year following the presentation.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Modernas capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Modernas mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 14 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit http://www.modernatx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential for delivery of mRNA to hematopoietic stem and progenitor cells (HSPC) in vivo; methods of detecting and interrogating HSPC in vivo; the potential for delivering LNPs to hematopoietic stem cells in vivo; the ability to optimize codons and mRNA structures to increase total protein outputs; the potential for the Company to develop processes for controlling protein expression by modifying ribosomal loads; the Companys ability to engineer LNPs capable of accessing difficult-to-transfect primary cells with efficient endosomal escape and high functional mRNA delivery; the Companys strategy for combatting COVID-19, including processes for monitoring emerging variants and waning immunity; and strategies for modeling viral escape. In some cases, forward-looking statements can be identified by terminology such as will, may, should, could, expects, intends, plans, aims, anticipates, believes, estimates, predicts, potential, continue, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Modernas control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Companys regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading Risk Factors in Modernas most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SECs website at http://www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Modernas current expectations and speak only as of the date hereof.

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Moderna Highlights Advances in Platform Science and Innovative Vaccine Research at Fourth Annual Science Day - Business Wire

TScan Therapeutics Adds to Executive Leadership Team and Board of Directors – BioSpace

Bill Desmarais, Ph.D., MBA, named Chief Business Officer, bringing more than 20 years of business development and partnering experience

Oncology drug development veteran Gabriela Gruia, M.D., appointed to Board of Directors

Timothy Barberich named Chair of Board of Directors

WALTHAM, Mass.--(BUSINESS WIRE)-- TScan Therapeutics, Inc. (TScan), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the appointments of Bill Desmarais, Ph.D., MBA, as Chief Business Officer, and Gabriela Gruia, M.D., to its Board of Directors. Dr. Desmarais brings more than 20 years of business development, partnering, and research experience to TScan, including his most recent role as Vice President of Business Development of Momenta Pharmaceuticals, where he spearheaded the Companys partnering strategy that led to Momentas $6.5 billion acquisition by Johnson & Johnson. Dr. Gruia is a seasoned oncology drug development executive with more than 25 years of global regulatory and research experience, including at Novartis as Global Head of Drug Regulatory, Oncology. The Company also named Timothy Barberich, the founder and former Chair and CEO of Sepracor Inc. and member of TScans Board, as Chair of the Board of Directors.

We are thrilled to welcome Bill and Gabriela to the TScan team as we continue to advance our pipeline of TCR-T therapies to the clinic for cancers with significant unmet need, said David Southwell, Chief Executive Officer and President at TScan. Bills proven track record of securing key corporate partnerships and licensing collaborations throughout his 20-year career at leading biopharmaceutical companies will be invaluable to TScan as we look to maximize the full potential of our discovery platform in oncology and in other therapeutic areas, including autoimmune disorders and infectious diseases. Gabriela is an accomplished oncology drug developer that spearheaded the worldwide regulatory approval of 12 novel therapeutics throughout her 16-year career at Novartis. We look forward to working with her on our Board. Additionally, we are pleased to have Tim Barberichs leadership as Chair of TScans Board as we continue to progress our programs.

I look forward to leading TScans efforts to work with strategic partners to further unlock the potential of our target discovery platform across the domains of oncology, autoimmune and infectious disease, said Dr. Desmarais.

TScan has a strong commitment to improving the lives of cancer patients. I am honored to join TScans Board of Directors and believe my oncology drug development and regulatory expertise will be beneficial in helping advance TScans pipeline of TCR-T therapies through the clinic, said Dr. Gruia.

Prior to joining TScan, Dr. Desmarais served as Vice President of Business Development of Momenta Pharmaceuticals. Before Momenta, Dr. Desmarais spent 11 years in roles of increasing responsibility within business development and research and development at Eli Lilly & Co. At Lilly, Dr. Desmarais oversaw regional licensing, promotion and distribution, and co-marketing deals in South Korea, Latin America, Russia, and Japan, assisted in drug repositioning efforts and academic collaborations, and managed the scientific pre-due diligence process for potential partnering opportunities. He received his Ph.D. in Biophysics and Structural Biology from Brandeis University, an MBA from Massachusetts Institute of Technology and a B.S. in Cell and Developmental Biology from Purdue University.

Dr. Gruia most recently served as Chief Development Officer at Ichnos Sciences, where she oversaw regulatory sciences, clinical operations, drug safety, clinical pharmacology, biostatistics and clinical outsourcing. Prior to joining Ichnos, Dr. Gruia spent 16 years at Novartis where she served in several senior roles of increasing responsibility, including Senior Vice President and Global Head of Drug Regulatory Affairs Oncology and Head of Medical Writing and Submissions. At Novartis, Dr. Gruia led the world class oncology regulatory affairs organization of approximately 120 associates and managed all regulatory activities in close partnership with research collaborators, preclinical development, the development organization and senior management. Previously, Dr. Gruia held oncology research and development roles at Pfizer, Pharmacia, Aventis and Rhone Poulenc Rorer. Dr. Gruia received her doctorate in medicine from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from Rene Huguenin/Curie Institute Cancer Center in Paris, France. She received her training in oncology and hematology from Rene Descartes University in Paris, France.

Mr. Barberich is founder and former Chair and CEO of Sepracor Inc., a research-based pharmaceutical company which was acquired by Dainippon Sumitomo Pharma Co., Ltd. in 2009 and is now known as Sunovion Pharmaceuticals. Mr. Barberich served as CEO of Sepracor from 1984 to 2007 and as Chair of the Board from 1990 to 2009. Prior to founding Sepracor, Mr. Barberich spent 10 years as a senior executive at Millipore Corporation. He holds a B.S. in chemistry from Kings College.

About TScan Therapeutics

TScan is a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer. The companys lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual leukemia and prevent relapse after hematopoietic stem cell transplantation. The company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors.

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TScan Therapeutics Adds to Executive Leadership Team and Board of Directors - BioSpace

GPB Scientific Announces Additional Growth Financing to Support Commercialization of Curate Cell Processing System for Next-Generation Cell & Gene…

- Syndicate includes existing investors Vensana Capital and Amgen Ventures joined by new healthcare investor

- Amgen Vice President of Research Philip Tagari, joins companys board of directors

CARLSBAD, Calif.--(BUSINESS WIRE)-- GPB Scientific, Inc., a developer of transformative cell processing technology for next generation cell and gene therapies, today announced raising an additional $18 million in capital as part of a previously announced financing, including commitments from existing investors Vensana Capital and Amgen Ventures, and from a new undisclosed healthcare investor. This financing will support expanded placements of GPBs Curate Cell Processing System into partner facilities to enable optimized development and manufacturing in CAR-T and TCR programs, as well as development of the platforms utility in additional types of cell and gene therapy applications.

Conventional bioprocessing solutions for cell and gene therapies are challenged by cost, turnaround time, and scalability as well as suboptimal clinical performance characterized by limitations on cell therapy persistence, potency, adverse events, and applicability to various tumor types. The Curate system utilizes GPBs proprietary Deterministic Cell Separation technology to deliver unmatched recovery, purity, and cell health impacting each of these challenges in bioprocessing for cell and gene therapies. In its first application, the Curate system has been optimized for T-cell isolation and associated downstream handling activities such as washing, concentrating, and exchanges in centralized and decentralized workflows. Additional applications will include optimization for stem cells and other cell types. Early data on GPB Scientifics Deterministic Cell Separation process confirm substantial improvements in cost, target cell harvest time, and cell quality which enable the pursuit of advanced objectives across operational, clinical, and business-related areas of interest for therapy developers.

In parallel with GPBs progress on the development of the Curate platform, Phillip Tagari, Amgens Vice President of Research, has joined GPB Scientifics Board of Directors. He commented, "The Curate system is poised to be transformative for cell and gene therapies. As the industry works to implement reliable, efficient, and cost-effective systems for the global deployment of these breakthrough medical treatments, GPB has devised an elegant yet powerful solution for cell separation, washing and concentration. The broad potential of this innovation aligns with Amgen's mission to partner with innovators in the fight against serious illness."

"In order for cell and gene therapies to achieve their full potential, promising outcomes in hematological cancers that supported recent FDA approvals must be followed by improvements in manufacturing cost reductions, scalability and turnaround time for patients. Moreover, we hope to see continued advances in clinical impact against solid tumors and other indications for cell therapies. These advances will require creativity and execution from the drug developers, but in almost every case, can be aided by bioprocessing enhancements that yield more and healthier cells that are collected more efficiently, said Justin Klein, M.D., co-founder and managing partner at Vensana Capital. "In a field where the process is the product, we believe GPB Scientifics Curate Cell Processing System can confer a significant competitive advantage for cell and gene therapy companies and a much needed solution to scaling production to meet global demand."

"We are pleased to see that our progress over the past year has been recognized by our existing partners and by new, important sponsors that share our vision for advancing therapies, said Mike Grisham, CEO of GPB Scientific. Our groundbreaking cell processing capabilities will enable next-generation medicines that are more consistently produced, at lower cost, for more patients and for additional conditions. We are proud to expand our efforts with this increased funding to deliver on our promise and to play our part in the enabling the development of new treatments for intractable disease.

About GBP Scientific

GPB Scientific is a pioneering biomedical company realizing the promise of its Curate Cell Processing System. The Curate solution applies Deterministic Cell Separation (DCS) technology, through a benchtop system and single-use cartridges that are currently optimized for T-cells. Designed with both manufacturing and clinical potential at the forefront, Curate delivers the scale and performance required to advance CAR-T and TCR applications beyond their limitations today. GPB works with leading biopharma and biotech companies, cancer centers, research institutes, and universities to advance the technology within and beyond this space, with future releases targeting additional cell types, use cases, disease states, and workflow paradigms.

Learn more at http://www.gpbscientific.com or contact inquiries@gpbscientific.com

About Vensana Capital

Vensana Capital is a venture capital and growth equity investment firm dedicated to partnering with entrepreneurs who seek to transform healthcare with breakthrough innovations in medical technology. Launched in 2019, Vensana is actively investing in late development and commercial stage companies across the medtech sector, including medical devices, diagnostics, drug delivery, digital health, and tech-enabled services. Vensanas investment team has a history of successfully partnering with management teams behind industry-leading companies including Cameron Health, CardiAQ, Cartiva, CV Ingenuity, Epix Therapeutics, Inari Medical, Intact Vascular, Lutonix, Neuwave Medical, Sequent Medical, Topera, Ulthera, Veran Medical Technologies, and Vertiflex. Learn more at http://www.vensanacap.com

About Amgen Ventures

Established in 2004 as Amgen's corporate venture capital arm, Amgen Ventures identifies and invests in emerging companies and technologies to advance promising new medicines and solutions to healthcare's biggest challenges. Amgen Ventures has committed $625M to invest in biotechs focused on human therapeutics and drug discovery as well as MedTech, such as digital health platforms, data analytics, and value-based approaches.

Learn more at http://www.amgenbd.com

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GPB Scientific Announces Additional Growth Financing to Support Commercialization of Curate Cell Processing System for Next-Generation Cell & Gene...

Bone Therapeutics Provides First Quarter 2021 Business Update – GlobeNewswire

REGULATED INFORMATION

Strong clinical progress especially in JTA-004 Phase III study thanks to high patient compliance and retention

Process development partnership and appointment of cell therapy expert Anthony Ting as CSO to further strengthen product pipeline

Gosselies, Belgium, 26May 2021, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its business update for the first quarter, ended 31 March 2021.

Bone Therapeutics has continued the strong momentum into 2021, said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. Bone Therapeutics mid-late stage clinical programs continue to advance largely on schedule, including the Phase IIb trial of the allogenic cell therapy platform ALLOB in difficult-to-heal tibial fractures and the Phase III trial of the enhanced viscosupplement JTA-004 in knee osteoarthritic pain. Alongside this, Bone Therapeutics has strengthened its manufacturing and R&D capabilities by signing a process development partnership with Rigenerand. It has also appointed the industry veteran Tony Ting as our new Chief Scientific Officer. Building on these achievements, Bone Therapeutics will be able to continue significant clinical and commercial advancements as we move towards the topline data of our JTA-004 Phase III study; a potential key inflection point for Bone Therapeutics.

Operational highlights

Financial highlights

Outlook for the remainder of 2021

(1) Unaudited number

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SA Miguel Forte, MD, PhD, Chief Executive Officer Jean-Luc Vandebroek, Chief Financial Officer Tel: +32 (0)71 12 10 00 investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries: Bepublic Catherine Haquenne Tel: +32 (0)497 75 63 56 catherine@bepublic.be

International Media Enquiries: Image Box Communications Neil Hunter / Michelle Boxall Tel: +44 (0)20 8943 4685 neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries: NewCap Investor Relations & Financial Communications Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouill Tel: +33 (0)1 44 71 94 94 bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics Provides First Quarter 2021 Business Update - GlobeNewswire

Merakris Therapeutics, Inc. Announces FDA Clearance for – GlobeNewswire

RESEARCH TRIANGLE PARK, N.C., May 25, 2021 (GLOBE NEWSWIRE) -- Merakris Therapeutics, Inc. (Merakris) announced that it has received U.S. Food and Drug Administration (FDA) clearance for a Phase II clinical trial involving its investigational new drug (IND), Dermacyte Amniotic Wound Care Liquid. The study will address the frequency of administration, safety and efficacy of Dermacyte Liquid in treating non-healing venous stasis ulcers (VSUs).

Merakris is a Research Triangle Park-based biotechnology business dedicated to the research, development and marketing of regenerative healthcare products.

The company initially met with the FDA in 2020 to discuss the clinical trial and IND filing, according to CEO Chris Broderick. He said the team at Merakris which includes experts in regulatory affairs, Good Clinical Practices, clinical data management, and clinical trial design and oversight will manage the study. It will work with a Good Manufacturing Practice (GMP) laboratory partner to ensure that the investigational product is manufactured in accordance with all FDA requirements.

We are excited about the potential benefits Dermacyte Liquid offers to patients in terms of healing difficult-to-treat venous leg ulcers caused by venous reflux disease, Broderick stated. And we look forward to more closely assessing the safety and efficacy of this product in our upcoming clinical trial.

Dermacyte Amniotic Wound Care Liquid is an acellular, sterile-filtered human amniotic fluid allograft. Merakris lead scientist has shown that the product stimulates skin cell migration and activates the gene expression pathways required to promote wound healing. If approved, it will be the first subcutaneous (below the skin) biologic indicated for VSUs.

The global market for the treatment of venous leg ulcers was valued at $2.95 billion in 2018 and is forecasted to reach $4.84 billion by 2026, Merakris reported. An estimated 500,000-600,000 people suffer from VSUs in the U.S. alone. Topical cellular/biological skin graft substitutes are often used as advanced skin graft substitutes to treat VSUs.

Dermacyte Liquid contains the natural biomolecules present in amniotic tissues and fluids. In a discovery-based translational research project, the company has isolated various components of Dermacyte Liquid and is studying how it affects the stages of wound healing. The data from the project suggest that these components may allow us to usher in a new era of precision wound healing, based on a patients personal wound profile, Broderick pointed out.

He said the company has filed patents covering Dermacyte Liquid and its unique mode of action and plans to conduct additional pre-clinical and clinical studies to evaluate the products safety and efficacy in cutaneous wound healing.

MerakrisTherapeutics, founded in 2016, is pioneering the use of commercially scalable stem cell-derived biotherapeutic technologies to promote the healing of damaged tissue. Its mission is to improve global patient care and outcomes through regenerative biotechnologies. The companys products include:

The company also is investigating other novel biotechnology solutions to promote wound healing and skin rejuvenation.

About the Dermacyte Liquid Phase II Clinical Trial Dermacyte Liquid will be evaluated in a Phase II clinical trial entitled, A Two-Part, Randomized Study of Dermacyte Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers. The clinical trial has been designed to include an initial open-label study group (Part 1) followed by a randomized, double-blind, placebo-controlled study group (Part 2) in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of the biological drug product.

The run-in phase of the study (Part 1) will enroll 10 eligible subjects. In Part 1, patients will be randomized 1:1 to receive active Dermacyte once weekly or once every two weeks with standard of care. The data from Part 1 will be reviewed to determine the administration frequency of the study product (once weekly or once every two weeks) in Part 2 of the Study.

In Part 2, approximately 30 subjects will be randomized 1:1 to receive Dermacyte Liquid or placebo with standard of care. Subjects will be followed for 12 weeks.

Subjects will receive localized subcutaneous injection of Dermacyte Liquid or placebo into and/or around the wound bed during clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area (L X W) from Baseline. Overall change in patient reported pain scores from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Merakris management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole.

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Merakris Therapeutics, Inc. Announces FDA Clearance for - GlobeNewswire