NurExone Presenting Novel Regulatory Pathways for Exosomes Therapies at Global Summit

TORONTO and HAIFA, Israel, March 01, 2024 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, is pleased to announce that Dr. Ina Sarel, the Head of CMC, Quality and Regulatory Affairs at NurExone, will be leading a workshop at the upcoming Exosome Characterization & Analytical Development Summit. Dr. Sarel will be sharing with her expert colleagues insight and information on the topic of “Regulatory Challenges in the Development of an Extracellular Vesicles (EVs) – Based Clinical Product.”

Dr. Sarel joins a prestigious lineup of speakers including representatives from leading exosome companies, e.g. AbbVie, RION Therapeutics, Aegle Therapeutics and universities, e.g. Harvard Medical school. With her experience in regulatory affairs and her deep understanding of the exosome field, Dr. Sarel is well-positioned to provide perspective on how to navigate the complex regulatory landscape and ensure the successful development of exosome-based therapeutics.

Dr. Sarel who led the activities that resulted in the grant of Orphan Drug Designation for ExoPTEN, an exosome-therapy being developed by the Company, stated “NurExone is developing a platform for using exosomes to create wide range of nanodrugs including our first drug – ExoPTEN, for treating patients with acute spinal cord injury. We are proud to share our development outcomes together with our regulatory expertise and are committed to advancing the field of exosome therapeutics for clinical use.”

The Exosome Characterization & Analytical Development Summit is a premier event that brings together experts from academia and industry to discuss the latest advancements in exosome characterization and analytical development. The summit will take place on April 23-25, 2024 in Boston, MA. To learn more about the summit and to register, please visit the Conference Website.

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation bythe FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Thesis Capital Inc.
Investment Relation – Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com

Dr. Eva Reuter
Investment Relation – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements about the Company’s future plans and intellectual property, the scientific and development and commercial activities to be carried out by the company, the efficient loading of exosomes, future potential manufacturing, clinical, licensing and marketing activities and the treatment of certain conditions. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. Certain assumptions include the ability of the Company to commercialize its intellectual property internally and through licensing and that the Company has the appropriate team in order to realize commercialization. Risks and uncertainties include, but are not limited to, risks related to the Company’s early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company’s intellectual property and dependence on the Company’s strategic partners. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

FogPharma Announces $145 Million Financing to Support Ongoing Clinical Development of FOG-001 and Accelerate Helicon Peptide Portfolio

Financing led by Nextech Invest and joined by new investors RA Capital Management, Rock Springs Capital, General Catalyst, Marshall Wace, Samsara Biocapital, Foresite Capital, Symbiosis, Catalio Capital Management, Sixty Degree Capital and Alex Gorsky

CAMBRIDGE, Mass.–(BUSINESS WIRE)–FogPharma®, a clinical-stage biopharmaceutical company dedicated to delivering a new class of therapies that go beyond the limits of currently available medicines using its Helicon™ peptide platform, today announced the successful closing of a $145 million Series E financing round. The financing was led by Nextech Invest with participation from other new investors including RA Capital Management, Rock Springs Capital, General Catalyst, Marshall Wace, Samsara Biocapital, Foresite Capital, Symbiosis, Catalio Capital Management, Sixty Degree Capital and former chairman and CEO of Johnson & Johnson, Alex Gorsky.

There was strong support by existing investors, including ARCH Venture Partners, Fidelity Management & Research Company, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Farallon Capital Management, venBio Partners, Invus and Milky Way Investments. Alexis Borisy, an accomplished investor and entrepreneur, also joined the company’s board of directors in the position designated to Nextech.

The financing will fund the ongoing clinical development of FOG-001, the company’s first-in-class intracellular TCF-blocking β-catenin inhibitor currently being evaluated in a Phase 1/2 study in solid tumors. The round will also accelerate the development of its robust portfolio of unique discovery programs, deepen its data science capabilities and strengthen its core Helicon therapeutics platform.

FOG-001 is a Helicon designed to block the key oncogenic step in the Wnt/β-catenin signaling pathway, one of the most frequently activated pathways in a variety of cancers. Mutations in the pathway are particularly prevalent in colorectal cancer, the second leading cause of all global cancer deaths, with an estimated two million new cases per year, according to the World Health Organization. Despite significant biological validation of the β-catenin:TCF interaction as a cancer driver, no existing treatment has been able to disrupt it due to its inaccessibility to antibody and traditional small molecule medicines.

“Millions of colorectal cancer patients have been told by their oncologists that no more can be done for them. We believe FOG-001 may represent the long-awaited major technological breakthrough needed to address one of the most common yet unaddressed oncogenic signaling pathways,” said Mathai Mammen, M.D., Ph.D., FogPharma’s chairman, president and chief executive officer. “This financing will allow us to execute on our expanded clinical development and commercialization strategy to deliver FOG-001 to patients, while simultaneously strengthening our discovery efforts against other compelling intracellular targets that drive a range of diseases.”

FOG-001 is the first of several wholly-owned programs generated by FogPharma’s Helicon platform being advanced to address biologically validated disease-driving intracellular targets by modulating protein-protein and protein-DNA interactions inside the cell. FogPharma’s Helicon platform combines ultra-diverse and tunable stabilized helical peptides with custom-built computational physics and artificial intelligence (AI) techniques to enable the discovery and development of novel programs across a vast array of intracellular targets that have never before been drugged.

“We are excited by the tremendous potential of FOG-001 to meaningfully change the therapeutic landscape through a novel approach, and are equally impressed by FogPharma’s robust pipeline of programs for significant drivers of cancer,” said Nextech Managing Partner Thilo Schroeder, Ph.D. “The company’s rapid progress across its growing pipeline demonstrates FogPharma’s team is enabled to deliver on the vast potential of its Helicon therapeutics platform.”

The financing follows a period of rapid growth for the company as its leadership team has expanded with industry veterans with track records in clinical, commercial and data science execution. This includes the company’s Chairman, President and Chief Executive Officer Mathai Mammen, M.D., Ph.D.; healthcare data science pioneer and Chief Data Officer Brandon Allgood, Ph.D.; Chief Technical Operations Officer Rohin Mhatre, Ph.D.; and Chief Business Officer Gregory Miller, MPH, MBA.

About FogPharma®

FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell. FOG-001, the company’s first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass. For more information, please visit: www.fogpharma.com.

Contacts

Media
Ten Bridge Communications

Rebecca Spalding

rebecca@tenbridgecommunications.com

MaaT Pharma Announces Positive Review from the DSMB on the Ongoing Phase 1 Clinical Trial Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS)

  • Independent Data Safety and Monitoring Board (DSMB) recommended that the trial proceeds as planned without modifications.
  • MaaT033 has shown a good safety profile and was generally well tolerated in the first 8 patients with ALS treated with MaaT033 used in a chronic setting.
  • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today announced that the DSMB reviewed safety data in the first 8 patients with Amyotrophic Lateral Sclerosis (ALS) treated with MaaT033 in the IASO clinical trial. The DSMB recommended that the trial continue without modifications.

    The DSMB, composed of 4 independent experts, including an ALS patient association representative, concluded that safety was good. More precisely, it should be noted that no serious or severe adverse events were observed, and no infectious events could be related to MaaT033. The preliminary results reinforce confidence in the safety of MaaT033, a drug candidate produced by combining the microbiota from multiple donors using a “pooling” process.

    MaaT033 is currently evaluated, in a chronic setting, in a Phase 1b pilot study (NCT05889572) in ALS (also known as Lou Gehrig’s disease in the US and Charcot’s disease in French-speaking countries). The Company has developed the clinical trial with the French academic experts FILSLAN/ ACT4ALS-MND and in collaboration with the French patients’ association Tous en Selles contre la SLA. Data readout is now expected in early H2 2024. MaaT033 is also being evaluated in the Phase 2b trial PHOEBUS (NCT05762211), the largest one to date in Europe for a microbiome therapy in oncology, dedicated to improving survival of patients with blood cancers receiving allogeneic hematopoietic stem cell transplantation (HSCT).

    About MaaT033

    MaaT033, a donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

    About MaaT Pharma

    MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma launched, in March 2022, an open-label, single arm, phase 3 clinical trial in patients with acute GvHD (aGvHD), following the achievement of its proof of concept in a phase 2 trial. Its powerful discovery and analysis platform, gutPrint®, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice. MaaT Pharma is listed on Euronext Paris (ticker: MAAT).

    Forward-looking Statements

    All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

    Contacts

    MaaT Pharma – Investor Relations
    Guilhaume DEBROAS, Ph.D.

    Head of Investor Relations

    +33 6 16 48 92 50

    invest@maat-pharma.com

    MaaT Pharma – Media Relations
    Pauline RICHAUD

    Senior PR & Corporate Communications Manager

    +33 6 14 06 45 92

    media@maat-pharma.com

    Trophic Communications
    Stephanie MAY or

    Priscillia PERRIN

    +49 171 185 56 82

    maat@trophic.eu

    Animal Biosciences Announces New Canine Clinical Research Evaluating Reversal of Age-Related Signs in Dogs

    After five years of development, positive results are seen in old dogs in a rigorous placebo-controlled trial performed at a leading vet school

    BOSTON–(BUSINESS WIRE)–Animal Biosciences, Inc., a company aiming to extend the lifespan of pets, today announced new clinical research published to the preprint server BioRxiv that tested the effects of their “LeapYears” supplement designed to extend healthspan in dogs.

    After five years of development and testing in dogs, leveraging discoveries made at Harvard Medical School, the study shows the first clinical evidence that it is possible to reverse age-related decline in dogs.

    The supplement, formulated as a soft chew, is a combination of an “NAD booster” to mimic fasting, and a molecule that kills “zombie” senescent cells that cause aging. The combination was developed because the effects in vivo were better than the single molecules alone.

    The double-blind clinical study conducted at North Carolina State University Veterinary College, in collaboration with Dr. Natasha Olby, a Professor of Neurology and Neurosurgery, has confirmed the effects of the supplement to significantly improve cognitive function. The formulation may have broader effects on frailty, activity, and happiness, as assessed by owners.

    “The outcomes of the clinical trial, especially the enhancements in cognition, are encouraging and represent a unique achievement,” Dr. Olby noted. “This rigorous study, which acknowledges the difficulties aging pets and their owners encounter, shows dedication to scientific methods aimed at improving the quality of life for our canine companions.”

    Aging has been defined as the chronic dysregulation of gene expression networks over time leading to subsequent deteriorated tissue and organ function causing age-related functional decline. In senior dogs, as in humans, this age-related decline can manifest as cognitive decline, increased frailty and lower engagement. The results of the trial showed positive impacts in all these areas of decline.

    Dr. David A. Sinclair, AO, PhD, Professor of Genetics at Harvard Medical School and co-founder of Animal Biosciences stated, “I am very proud of the teams at NCSU and Animal Biosciences, who, after years of collaborative research and a clinical trial, have developed the first supplement proven to reverse aging in dogs.”

    Animal Biosciences Inc. is a Boston-based animal health company focused on delaying aging and extending the healthy lifespan of companion animals. Co-founded in 2017 by well-known longevity pioneer, Professor David A. Sinclair of Harvard Medical School, and his brother, Nick Sinclair, CEO, a dedicated dog-lover with experience in the pharmaceutical and food industries, Animal Biosciences is adapting small molecule-based therapies from human health specifically for companion animals and testing them in rigorous clinical trials. The company has a pipeline of additional small molecules and therapies targeting aging in companion animals.

    Contacts

    arianna@gcw.agency
    Phone: 646-964-4446

    Atara Biotherapeutics Receives FDA Clearance of IND Application in Lupus Nephritis for ATA3219, an Allogeneic CAR T Therapy

    Second IND Clearance for ATA3219 Following Non-Hodgkin’s Lymphoma (NHL) and First in an Autoimmune Disease Indication

    Initial Clinical Data in NHL Anticipated in H2 2024 and for Lupus Nephritis in H1 2025

    THOUSAND OAKS, Calif.–(BUSINESS WIRE)–$ATRA #CARTAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for ATA3219, an allogeneic, anti-CD19 chimeric antigen receptor (CAR) T-cell monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]).

    Expanding upon an extensive clinical experience encompassing the treatment of over 600 patients using our allogeneic T-cell platform in both oncology and autoimmune diseases, we are excited to clinically evaluate the potential of our differentiated allogeneic CAR T-cell approach. We are eager to address the significant unmet need in lupus nephritis as we initiate our Phase 1 trial,” said Pascal Touchon, President and Chief Executive Officer of Atara. “We look forward to bringing the promise and accessibility of a potentially curative off-the-shelf cell therapy option to patients with severe autoimmune diseases, potentially eliminating the burdens of autologous CAR T therapies like costly infrastructure and treatment delays.”

    The multi-center, Phase 1, open-label, single-arm, dose-escalation study will evaluate the safety and preliminary efficacy of ATA3219 in subjects with LN. Subjects will receive lymphodepletion treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells. ATA3219 is designed to be given as a one-time infusion and followed for safety and efficacy. Each dose level is designed to enroll 3-6 patients, with the first subject expected to be enrolled in the second half of 2024.

    Existing therapeutic agents for lupus nephritis yield suboptimal responses and have limitations due to their requirement for ongoing administration, susceptibility to treatment failures, and limited accessibility to inflamed tissues resulting in incomplete depletion of B cells,” said Rajani Dinavahi, Chief Medical Officer at Atara. “CAR T cells can naturally infiltrate deep into target tissues to mediate B-cell depletion and produce durable responses. Building on the encouraging academic data in lupus nephritis with autologous CD19 CAR T, ATA3219 is an off-the-shelf therapy that could significantly reduce constraints for patients and physicians like leukapheresis and long waiting times, therefore potentially improving access to a large population of patients.”

    Proof of concept for a CD19 CAR T approach in autoimmune disease was first demonstrated in early academic results from an investigator-sponsored study showing 100% (8/8) of LN patients rapidly attaining drug-free, durable remission with an autologous CD19-targeted CAR T therapy. The therapy eliminated the pathogenic, autoreactive B cells and allowed healthy B cells to return after treatment, enabling the patients’ immune system to function normally again with associated improvement of clinical symptoms.1 These early proof of concept clinical data with CD19 targeted CAR T support further development of CAR T for LN with differentiated and off-the-shelf allogeneic approaches.

    The ATA3219 IND submission included in vitro data reflecting the CD19 antigen-specific functional activity of ATA3219 and CAR-mediated activity against B cells from SLE patients. ATA3219 led to robust CD19-specific B-cell depletion compared to controls.

    LN is a serious and most common complication of SLE, a chronic multisystem autoimmune disease. The prevalence of SLE in the U.S. is 73 per 100,000 people, afflicting more than 200,000 U.S. patients alone, and occurs in women much more commonly than men. Up to 60% of adult patients with SLE develop renal disease during the course of their illness, and up to 70% of patients with LN are refractory to standard immunosuppressive therapies. Despite recent advances in treatment strategies, the response rate using existing therapies remains low, with significant risk of long-term morbidity and mortality associated with refractory LN.

    About ATA3219

    ATA3219 combines the natural biology of unedited T cells with the benefits of an allogeneic therapy. It consists of allogeneic Epstein-Barr virus (EBV)-sensitized T cells that express a CD19 CAR construct for the treatment of CD19+ relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin’s lymphoma and B-cell mediated autoimmune diseases including systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]). ATA3219 has been optimized to offer a potential best-in-class profile, featuring off-the-shelf availability. It incorporates multiple clinically validated technologies including a modified CD3ζ signaling domain (1XX) that optimizes expansion and mitigates exhaustion, enrichment during manufacturing for a less differentiated phenotype for robust expansion and persistence and retains the endogenous T-cell receptor without gene editing as a key survival signal for T cells contributing to persistence.

    Next-Generation Allogeneic CAR T Approach

    Atara is focused on applying Epstein-Barr virus (EBV) T-cell biology, featuring experience in over 600 patients treated with allogeneic EBV T cells, and novel chimeric antigen receptor (CAR) technologies to meet the current limitations of autologous and allogeneic CAR therapies head-on by advancing a potential best-in-class CAR T pipeline in oncology and autoimmune disease. Unlike gene-edited approaches aimed at inactivating T-cell receptor (TCR) function to reduce the risk for graft-vs-host disease, Atara’s allogeneic platform maintains expression of the native EBV TCR that promote in vivo functional persistence while also demonstrating inherently low alloreactivity due to their recognition of defined viral antigens and partial human leukocyte antigen (HLA) matching. A molecular toolkit of clinically-validated technologies—including the 1XX costimulatory domain designed for better cell fitness and less exhaustion while maintaining stemness—offers a differentiated approach to addressing significant unmet need with the next generation CAR T.

    About Atara Biotherapeutics, Inc.

    Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn.

    Forward-Looking Statements

    This press release contains or may imply “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. For example, forward-looking statements include statements regarding the development, data, timing and progress, as applicable, of: (1) the ATA3219 program; (2) the potential characteristics and benefits of ATA3219; (3) the Company’s planned clinical study of ATA3219 to treat lupus nephritis, including the timing and enrollment thereof. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic and the wars in Ukraine and the Middle East, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in Southern California and Denver and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara’s cash resources and need for additional capital; and other risks and uncertainties affecting Atara’s and its development programs, including those discussed in Atara’s filings with the Securities and Exchange Commission , including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

    1Mueller, F., et al. CD19-Targeted CAR-T Cells in Refractory Systemic Autoimmune Diseases: A Monocentric Experience from the First Fifteen Patients. Blood 2023; 142 (Supplement 1): 220.

    Contacts

    Investor and Media Relations:
    Jason Awe, Ph.D.

    Senior Director, Corporate Communications & Investor Relations

    (805) 217-2287

    jawe@atarabio.com

    Orbis Medicines Launches with €26 Million Seed Financing to Transform Macrocycle Drug Development through Next-Generation Orally Dosable ‘nCycles’

    Financing led by Novo Holdings and Forbion

    Orbis’ platform is first to systematically explore macrocycle chemical space using unique combination of high-throughput chemical synthesis and large-scale assaying, supported by machine learning

    Pipeline to initially focus on high-value oral alternatives to blockbuster biologic drugs and opening new targets to therapeutic intervention

    COPENHAGEN, Denmark–(BUSINESS WIRE)–Orbis Medicines, a leader in oral macrocycle drug discovery, today announces its launch with a 26 million financing led by global life sciences investor Novo Holdings and European life sciences venture firm Forbion. The funding will support Orbis’ expansion and advancement of its portfolio of next-generation macrocycle drugs it calls ‘nCycles’. Macrocycles are a large and diverse family of compounds with highly desirable therapeutic properties, defined by the presence of a cyclic structure. nCycles are systematically designed by Orbis’ nGen1 platform to be orally bioavailable and membrane permeable, solving decades-long challenges in macrocycle drug design.

    The Orbis pipeline includes programs against targets validated by blockbuster biologic drugs, with the goal of providing oral alternatives that will enable the treatment of many more patients. In addition, Orbis is developing a pipeline of nCycles for other attractive target classes, both intra- and extra-cellular. Oral macrocycle drugs can potentially address a very wide range of diseases based on their ability to target a majority of the potential molecular targets in the body.

    “After decades of challenging de novo synthesis, the universe of potential macrocycle targets is now available for exploration. Not only can Orbis reach a wealth of new targets, both inside and outside cells, but we can do this while preserving an oral format to pioneer a new therapeutic class of oral macrocycles. It’s a milestone for drug development,” said Morten Døssing, Chair of the Orbis Board and Partner at Novo Holdings. “We believe Orbis has the premier chemistry-led approach in the field, which gives us a distinct data advantage. We can generate hundreds of thousands of diverse compounds in record time and immediately apply a range of functional assays in a high-throughput fashion to each individual compound to home in on winners. Establishing this robust, reliable engine for candidate design was crucial for us as we look to bring macrocycle drugs to major patient populations.”

    Orbis was founded in 2021 by the Seeds Investment team of Novo Holdings, with Mr. Døssing as Executive Chair and João Ribas as interim CBO establishing the company’s team and building its corporate strategy. The scientific foundation of Orbis was developed by Prof. Christian Heinis and Sevan Habeshian at the Swiss Federal Institute of Technology in Lausanne (EPFL).

    “The broad potential of oral macrocycle drugs to address challenging targets untouchable by small molecules, coupled with recent momentum in the field, makes this an incredibly exciting development,” said Marco Boorsma, Ph.D., General Partner at Forbion. “With a compelling AI-enabled platform technology, scientific expertise and a clear strategy for growth, Orbis is attracting strong interest for its approach to finally delivering on the promise of this class for medicine. We believe Orbis’ combinatorial approach and ability to continuously generate big data from real compounds gives them an undeniable opportunity to unlock the potential of orally available macrocycle drugs for significantly larger patient populations.”

    The chemical methods by which Orbis rapidly generates vast libraries of diverse macrocycle compounds ready for immediate assay were previously published in Nature Communications. Authors of the paper, which included Orbis’ founders Professor Heinis and Dr. Habeshian, detail how the methods draw on a large range of components to build compounds, including both natural and synthetic amino acids, creating an extremely large chemical space for exploration. Additionally, research recently published in Nature Chemical Biology demonstrates nGen’s ability to deliver nCycles that are orally bioavailable, marking a new era for macrocycle drug discovery.

    About Orbis Medicines

    Orbis Medicines is a biotechnology company focused on pioneering a new era for oral macrocycle drug discovery. Macrocycles are a large and diverse family of compounds with highly desirable therapeutic properties, defined by the presence of a cyclic structure. Orbis’ nGen platform is designed to systematically explore the macrocycle chemical space using a highly automated chemistry platform and deliver oral macrocycle drug candidates – nCycles – suitable for both intra- and extracellular targets. Orbis’ programs are focused on high-value oral alternatives to blockbuster biologic drugs and targets challenging for established modalities. Orbis was founded by Novo Holdings. For more information, please visit: www.orbismedicines.com

    1About nGen

    nGen is Orbis’ technology platform for generating oral macrocycle drug candidates, which it calls nCycles. It consists of multiple proprietary integrated elements starting with hit finding libraries of 100 billion compounds. Hits identified are progressed using Orbis’ highly automated chemistry-based platform that rapidly creates and tests hundreds of thousands of individual analogues with a full suite of assays to identify the most desirable ones. The scale and quality of the data produced from these real compounds, paired with machine learning, creates an industry-leading platform that de-risks and accelerates development. Recently published research in Nature Chemical Biology demonstrates nGen’s ability to deliver nCycles that are orally bioavailable, marking a new era for macrocycle drug discovery.

    About Novo Holdings A/S

    Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

    Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novozymes A/S and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2022, Novo Holdings had total assets of EUR 108 billion. www.novoholdings.dk

    About Forbion

    Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies that are active in the biopharmaceutical space, managing €3 billion across multiple fund strategies that cover all stages of biopharmaceutical drug development. The firm’s current team consists of more than 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in over 100 companies across 8 funds. Forbion’s record of sourcing, building and guiding life sciences companies has resulted in many breakthrough therapies and valuable exits. In addition to its financial return objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. More information can be found at www.forbion.com

    Contacts

    Media:
    Kit Rodophele

    Ten Bridge Communications

    617-999-9620

    krodophele@tenbridgecommunications.com

    Promising Results: TGR-63 Enhances Memory in Alzheimer’s Mouse Model

    IGC Pharma today announced the results of preclinical studies investigating its drug candidate TGR-63 as a treatment for Alzheimer’s disease. The data demonstrated enhanced memory function in an Alzheimer’s mouse model, including improved memory acquisition, consolidation, and retrieval.

    TGR-63 is a therapeutic candidate designed to disrupt the structure of the amyloid-β (Aβ) peptide, mitigating symptoms such as memory loss and disrupted learning ability, signs of cognitive impairment. TGR-63 targets a critical neuropathological hallmark of Alzheimer’s Disease by addressing the misfolding and aggregation of Aβ peptides, specifically the toxic Aβ42 aggregation species associated with neuronal toxicity and cognitive decline. The cognitive impact of TGR-63 was assessed using two renowned behavioral tests, the Novel Object Recognition (“NOR”) Test and the Morris Water Maze (“MWM”), conducted on APP/PS1 genetically modified Alzheimer’s mice.

    Ram Mukunda, CEO, commented, “These results underscore the efficacy of TGR-63 in enhancing spatial memory function in an Alzheimer’s disease model, offering promising implications for potential therapeutic interventions in Alzheimer’s and related neurodegenerative conditions. The improvements in memory acquisition, consolidation, spatial memory formation, and retrieval highlight its potential in addressing cognitive impairment in Alzheimer’s Disease. We are optimistic about TGR-63’s potential and anticipate advancing it towards a Phase 1 trial, enriching our clinical portfolio.”

    The NOR Test, a cornerstone of preclinical research, evaluates recognition memory, a component of declarative memory responsible for recognizing previously encountered stimuli. Widely applicable across neuropharmacology and neurobiology, this test provides crucial insights into memory function and potential interventions for memory-related disorders such as Alzheimer’s. During the NOR Test, Alzheimer’s mice displayed a significantly diminished Discrimination Index (“DI”) compared to normal mice, indicating impaired long-term memory. TGR-63-treated Alzheimer’s mice showed a 51% improvement in DI, signifying promising therapeutic efficacy. After 48 hours, while untreated Alzheimer’s mice experienced a 100% decline in memory, those treated with TGR-63 demonstrated an 86% increase in DI, suggesting robust long-term potentiation (“LTP”) formation and successful memory retrieval.

    The Morris Water Maze (“MWM”) is a pivotal tool in cognitive research, offering deep insights into spatial learning and memory processes. In this test, mice are trained to find a hidden platform in a pool over four days. Particularly crucial in neurodegenerative diseases like Alzheimer’s, the MWM allows researchers to explore spatial navigation and memory formation mechanisms. Over four days of training, TGR-63-treated mice exhibited a statistically significant reduction in the time required to locate the hidden platform, reflecting improved spatial memory acquisition. Additionally, when the platform was removed, the untreated AD mice spent 87% of their time away from the target area, while TGR-63-treated mice spent only 66% of their time away. TGR-63-treated mice also spent more time in the target area, showing improved spatial memory retrieval.

    IGC Pharma is currently underway with a Phase 2b trial in the United States and Canada evaluating IGC-AD1 for agitation in Alzheimer’s. The trial encompasses 146 patients, with half assigned to the treated group receiving IGC-AD1, while the other half, the control group, receiving a placebo.

    About IGC Pharma Inc. (dba IGC):

    IGC Pharma is pursuing innovative solutions to fight Alzheimer’s disease and related challenges. IGC Pharma’s portfolio comprises five assets, all with a singular mission – to transform the landscape of Alzheimer’s treatment. IGC-AD1 and LMP target neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently in a Phase 2b clinical trial for agitation in dementia due to Alzheimer’s (clinicaltrials.gov, NCT05543681). TGR-63 targets Aβ plaque to disrupt the progression of Alzheimer’s disease. IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s. IGC-1C targets tau and neurofibrillary tangles in a forward-thinking approach to Alzheimer’s therapy. In parallel, IGC Pharma is at the forefront of Generative AI development, with projects including clinical trials, early detection of Alzheimer’s, and drug interactions with cannabinoids.

    Forward-Looking Statements:

    This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission (“SEC”) filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, and Quarterly Report on Form 10-Q filed with the SEC on February 14, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.

    Contacts

    Investors
    IMS Investor Relations

    Rosalyn Christian

    igc@imsinvestorrelations.com
    (203) 972-9200

    Media
    JVPRNY

    Janet Vasquez

    jvasquez@jvprny.com
    (212) 645-5498

    VERAXA Biotech AG acquires Synimmune GmbH to expand cancer pipeline

    Zurich, 29th of December 2023: VERAXA Biotech AG, a pioneering company in the development of superior antibody-based cancer therapies and a portfolio company of Xlife Sciences AG (SIX: XLS), is proud to announce the acquisition of Synimmune GmbH and its innovative Phase I antibody (FLYSYN) for the treatment of Acute Myeloid Leukemia (AML). This marks a major milestone in the company’s history and with the expansion of VERAXA’s cancer pipeline it is hope for patients battling AML – one of the most common types of acute leukemia in adults.

    The FLYSYN antibody was acquired by VERAXA Biotech AG from Xlife Sciences AG portfolio company Synimmune GmbH via a share deal. The deal included an upfront payment as well as several milestones and will reach a total deal value of up to 32 million EUR. With this clinical asset, VERAXA strengthens its internal cancer pipeline of innovative antibodies and antibody-drug conjugates (ADCs).

    AML, characterized by its prevalence in individuals over the age of 68 and accounting for approximately 1% of all cancer occurrences, has long presented a challenge in the medical community, particularly for those under 45 where it is less common. The successful First-in-Man multicenter clinical study of FLYSYN focused on patients with AML who had measurable residual disease (MRD). The introduction of FLYSYN, is a testament to VERAXA Biotech AG’s commitment to advancing healthcare and providing innovative solutions for serious health conditions.

    Oliver R. Baumann, CEO of Xlife Sciences AG comments: «Securing the innovative Phase I antibody, FLYSYN, for Acute Myeloid Leukemia (AML) treatment marks a significant step forward. This milestone reflects our commitment to advancing healthcare and sets the stage for a promising future in reshaping AML treatment. »

    Dr. Christoph Antz, CEO of VERAXA Biotech AG, stated: «With FLYSYN, we are one step closer to offering better, more effective treatments for those affected by Acute Myeloid Leukemia. »

    As we continue to navigate the complexities of AML treatment, VERAXA Biotech AG remains steadfast in its mission to transform the landscape of medical care. For more information about VERAXA Biotech AG and our work in AML treatment, please visit www.veraxa.com.

     

    Financial calendar

    Annual Report 2023 23 April 2024
    Annual Shareholders Meeting 2024 20 June 2024
    Half-Year Report 2024 19 September 2024

    Contact 
    Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch
    Information related to VERAXA Biotech AG: Dr. Christoph Antz, antz@veraxa.com

    Xlife Sciences AG 
    Talacker 35, 
    8001 Zurich, Switzerland,
    Phone +41 44 385 84 60
    info@xlifesciences.ch, www.xlifesciences.ch 
    Commercial Register Zurich CHE-330.279.788 
    Stock Exchange: SIX Swiss Exchange


    End of Inside Information


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    A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

    A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

    CASTEL SAN PIETRO, 14 December 2023 – Medacta Group SA (“Medacta”, SIX:MOVE), a Swiss company specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgeries, announces the publication of a new study in the European Spine Journal which demonstrates that NextAR Spine seamlessly integrates into the OR workflow, enabling the surgeon to enhance efficiency, accuracy, and versatility in spine surgery.

    “Precision and accuracy in spine surgery is critical. As stated in our recent study, NextAR, the new AR-assisted navigation system, greatly simplifies pedicle screw placement, ensuring effectiveness and accuracy. It’s a reliable tool, straightforward to use, and it elevates our ability to provide safe and precise navigation for various spinal conditions,” says Professor Dr. med. Bernhard Meyer, Director of the Neurosurgical Clinic and Policlinic at the University Hospital Rechts der Isar, Munich.

    The study “Evaluating a cutting‑edge augmented reality‑supported navigation system for spinal instrumentation”1 led by Prof. Dr. med. Bernhard Meyer, evaluates the efficiency, accuracy, and versatility of NextAR Spine, a navigation system that incorporates augmented reality to provide unique real-time surgical guidance, superimposed onto the operative field, enhancing precision and enabling data-driven decision-making in the placement of pedicle screws, and addressing different types of spine indications, such as trauma, degeneration, infection, and tumor.

    The placement of pedicle screws has been achieved with precision using both open and percutaneous approaches in both long and short constructs, indicating a lower intraoperative revision rate (1.7%)1 compared to the rate documented in the scientific literature with other navigation systems (3.4% by Ille at al2; 4.7% by Ryang at al3). This further highlights that NextAR Spine proves to be a reliable and safe tool for 3D imaging-based pedicle screw placement while requiring minimal setup during surgery, in line with Medacta’s philosophy of healthcare sustainability. The setup is reduced to a minimum by integrating the cameras into the surgical instruments and establishing a flexible platform which includes the preoperative planning.

    The NextAR platform is offered as a hardware system with limited capital investment and single-use instrumentation at a low cost per case and offers the ability to host software for multiple applications (NextAR Knee, NextAR Shoulder, NextAR Spine, and Hip applications). The platform represents an optimal solution worldwide, particularly for US Ambulatory Surgery Centers (ASCs).

    The NextAR surgical platform is part of Medacta’s MySolutions Personalized Ecosystem, a network of advanced digital solutions designed to improve patient outcomes and healthcare efficiency. MySolutions embodies Medacta’s holistic approach to personalized medicine, aiming at bringing value to every step of the patient’s journey, from preoperative through postoperative care.

    NextAR is also supported by the comprehensive, tailored educational offerings provided by the M.O.R.E. Institute. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on spine procedures and products with personalized high-level educational pathways. With Medacta, the surgeon is never alone.

    REFERENCES
    [1] Schwendner M, Ille S, Wostrack M, Meyer B. Evaluating a cutting-edge augmented reality-supported navigation system for spinal instrumentation. Eur Spine J. 2023 Nov 14. doi: 10.1007/s00586-023-08011-w. Epub ahead of print. PMID: 37962688.
    [2] Ille S, Baumgart L, Obermueller T, Meyer B, Krieg SM (2021) Clinical efficiency of operating room-based sliding gantry CT as compared to mobile cone-beam CT-based navigated pedicle screw placement in 853 patients and 6733 screws. Eur Spine J 30(12):3720–3730. https:// doi. org/ 10. 1007/ s00586- 021- 06981-3
    [3] Ryang YM, Villard J, Obermuller T et al (2015) Learning curve of 3D fluoroscopy image-guided pedicle screw placement in the thoracolumbar spine. Spine J 15(3):467–476. https:// doi. org/ 10. 1016/j. spinee. 2014. 10. 003    
     

    Contact

    Medacta International SA
    Gianluca Olgiati     
    Senior Director Global Marketing  
    Phone: +41 91 696 60 60
    media@medacta.ch

     

    About Medacta

    Medacta is an international company specializing in the design, production, and distribution of innovative orthopaedic products, as well as in the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in joint replacement, spine surgery, and sports medicine. Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Medacta’s innovation, forged by close collaboration with surgeon experts globally, began with minimally invasive surgical techniques and has evolved into personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 50 countries. Follow us on Medacta TV, YouTube, LinkedIn, and X.

     

     

     


    Additional features:

    File: MEDIA RELEASE – A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application


    End of Media Release


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    Tryp Therapeutics Inc. Announces Signing of Definitive Agreement with Exopharm Limited

    , 12/11/2023 / 04:00, EST/EDT – EQS Newswire – Tryp Therapeutics Inc. (Regulated Unofficial Market in Berlin, Frankfurt, Munich, Stuttgart, Tradegate Exchange; Canadian Stock Exchange, Nasdaq OTC)

    KELOWNA, BC / ACCESSWIRE / December 11, 2023 / Tryp Therapeutics Inc. (“Tryp” or the “Company“) (CSE:TRYP), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs, is pleased to announce that the Company has entered into an arrangement agreement (the “Arrangement Agreement“) with Exopharm Limited ACN 163 765 991 (“Exopharm” or the “Purchaser“) dated as of December 8, 2023, pursuant to which Exopharm has agreed to acquire all of the issued and outstanding common shares in the capital of Tryp (the “Tryp Shares“) in consideration of the issuance of 4.52 ordinary shares in the capital of Exopharm (the “Exopharm Shares“) for each one (1) Tryp Share. The arm’s length transaction will be completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) (the “Arrangement“).

    Key Transaction Highlights

    • The purchase price of CAD$0.08 represents a 78% premium to the closing price of $0.045 and a 112% premium to the 20-day volume weighted price of $0.0378 per Tryp Share on December 8, 2023
    • Tryp shareholders expected to receive 4.52 Exopharm Shares for each one (1) Tryp Share held, representing an aggregate transaction value of approximately $12.8 million.
    • Both the Board and the Special Committee unanimously recommend that Tryp securityholders vote in favor of the Arrangement.
    • The majority of the directors of the combined entity to be appointed by Tryp.
    • Tryp’s clinical programs and development strategy will remain as the foundation of the combined entity.
    • The combined entity is expected to relist on the Australian Securities Exchange (the “ASX“) in Q1 2024 subject to, among other conditions, receipt of the requisite approval of Exopharm shareholders and raising a minimum of AUD$6,000,000 under a public offering.
    • The Arrangement is subject to customary closing conditions, including approvals from Tryp securityholders and Exopharm shareholders, from the ASX and the Supreme Court of British Columbia (the “Court“).

    Jason Carroll, Chief Executive officer of Tryp, said “joining forces with Exopharm heralds a new era for Tryp, where we expect our combined strength and shared vision to elevate us to the prominent platform of the ASX. With enhanced access to capital and the evolving landscape of the Therapeutic Goods Administration (TGA) regulations in Australia for select psychedelics, we see even more paths forward to innovate and grow. I am thrilled to emphasize that our ongoing clinical commitments and our TRP-8803 R&D program remain unchanged and will be pursued with the same vigor and dedication. It is not expected that Exopharm’s current R&D program will be pursued following completion of the transaction. With this merger, we’re even better positioned to serve our stakeholders.”

    The Arrangement Agreement is the culmination of an extensive and robust review of strategic alternatives available to maximize shareholder value that was conducted by the Company’s board of directors (the “Board“) and a special committee of the Board (the “Special Committee“).

    Pursuant to the terms and conditions of the Arrangement Agreement, Exopharm has agreed to acquire 100% of the issued and outstanding Tryp Shares in consideration of 4.52 Exopharm Shares per one (1) Tryp Share. The consideration reflects a 78% premium to the closing price of the Shares on the Canadian Securities Exchange (the “CSE“) of $0.045 on December 8, 2023, the last trading day of the Tryp Shares prior to the announcement of the Arrangement. Pursuant to the Arrangement Agreement, holders of convertible securities of Tryp, including stock options, common share purchase warrants, secured convertible debentures and unsecured convertible notes (collectively, the “Tryp Convertible Securities“) will receive replacement securities of Exopharm having substantially similar economic terms in accordance with the rules of the ASX.

    The Board, after receiving the recommendation of the Special Committee, has determined that the Arrangement, including the transactions contemplated thereunder, is fair to holders of Tryp securities and is in the best interests of the Company. Accordingly, the Board approved the Arrangement Agreement and recommends that securityholders vote their securities in favour of the Arrangement.

    Each of the directors and executive officers of Tryp have entered into voting and support agreements with the Purchaser and have agreed to, among other things, vote their securities in favour of the Arrangement.

    The Arrangement Agreement

    Pursuant to the Arrangement, each Tryp Share outstanding immediately prior to the effective time of the Arrangement will be transferred to and purchased by the Purchaser in consideration of 4.52 Exopharm Shares and each Tryp Convertible Security outstanding immediately prior to the effective time of the Arrangement will be exchanged for securities of Exopharm having substantially similar economic terms, in accordance with the rules of the ASX.

    The Arrangement is subject to a number of closing conditions, including: the approval of the Court; the approval of the ASX and all other applicable third party and regulatory consents for the Arrangement; the Company obtaining the requisite approval of its securityholders; Exopharm obtaining the requisite approval of its shareholders; no more than 10% of the Company’s shareholders exercising their rights of dissent in connection with the Arrangement, and the satisfaction of certain other closing conditions customary for a transaction of this nature.

    The Arrangement Agreement includes customary provisions, including non-solicitation, right to match, and fiduciary out provisions, as well as certain representations, covenants and conditions which are customary for a transaction of this nature. The Arrangement Agreement provides for a termination fee payable by either party in certain circumstances in the event the Arrangement does not close.

    Further information regarding the Arrangement will be contained in a management information circular that Tryp will prepare, file and mail to the Tryp securityholders (the “Circular“) in connection with an annual and special meeting of the Tryp securityholders to be held to consider the Arrangement (the “Meeting“). All securityholders are urged to read the Circular once available as it will contain important additional important information concerning the Arrangement. The Arrangement Agreement will also be filed on SEDAR+.

    Only the holders of Tryp Shares, Tryp option holders and Tryp warrant holders at the close of business on the record date will be entitled to vote at the Meeting. The Arrangement will require the approval of (i) at least 66⅔% of the votes cast by Tryp shareholders; and (ii) at least 66⅔% of the votes cast by holders of Tryp Convertible Securities, voting as a class.

    Advisors and Counsel

    Pushor Mitchell LLP is acting as legal counsel to Tryp in Canada and K&L Gates LLP is acting as legal counsel to Tryp in Australia in connection with the Arrangement.

    Osler, Hoskin & Harcourt LLP is acting as legal counsel to Exopharm in Canada and Hamilton Locke Pty Ltd is acting as legal counsel to Exopharm in Australia.

    ACNS Capital Markets Pty Ltd trading as Alto Capital acted as Tryp’s advisor to Tryp’s recently closed private placement of unsecured convertible notes which raised approximately AUD$3,390,000, and is acting Exopharm’s corporate advisor in connection with the Arrangements.

    About Tryp

    Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp’s lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has completed a Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%. The Company has also started a Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and is preparing to initiate a Phase 2a clinical trial (IND has been cleared to proceed) with Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from IBS. Each of the studies are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety and patient experience. For more information, please visit www.tryptherapeutics.com.

    About Exopharm

    Exopharm (EX1) is a leader in advancing and manufacturing technologies for exosome-based medicines using exosomes or extracellular vesicles (EVs) as a chassis for improved and non- viral drug-delivery.
    Exosomes can be loaded with a variety of active pharmaceutical ingredients (APIs) and can be targeted to selected cell-types and tissue types, improving the safety-profile of the APIs and providing better treatments. Exosomes can be used to deliver small molecule drugs, mRNA, DNA and other types of APIs. Currently Exopharm is executing a strategy to maximize the significant value of the company’s IP position in the exosome field.

    The Exopharm Shares to be issued under the Arrangement have not been and will not be registered under the U.S. Securities Act of 1933 and may not be offered or sold in the United States absent registration or applicable exemption from registration requirements. It is anticipated that any securities to be issued under the Arrangement will be offered and issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933 provided by Section 3(a)(10) thereof.

    Completion of the Arrangement is subject to a number of conditions, including but not limited to, all requisite regulatory, court and exchange approvals, the approval of the Court as well as the approvals of the securityholders of Tryp and shareholders of Exopharm. The Arrangement cannot close until the required approvals are obtained. There can be no assurance that the Arrangement will be completed as proposed or at all.

    Investors are cautioned that, except as disclosed in the Circular to be prepared in connection with the Arrangement, any information released or received with respect to the Arrangement may not be accurate or complete and should not be relied upon. Trading in the securities of the Company should be considered highly speculative.

    Neither the CSE nor the Market Regulator (as that term is defined in the policies of the CSE) has in any way passed upon the merits of the Arrangement and associated transactions and neither of the foregoing entities accepts responsibility for the adequacy or accuracy of this release or has in any way approved or disapproved of the contents of this press release.

    This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

    Investor & Media Contact

    Peter Molloy
    Chief Business Officer
    Tryp Therapeutics Inc.
    pmolloy@tryptherapeutics.com

    Forward-looking Statements:

    Certain information in this news release is considered forward-looking within the meaning of certain securities laws and is subject to important risks, uncertainties and assumptions. This forward-looking information includes, among other things, information with respect to the Company’s beliefs, plans, expectations, anticipations, estimates and intentions. The words “may”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “anticipate”, “estimate”, “expect”, “intend”, “plan”, “target” and similar words and expressions are used to identify forward-looking information. Forward-looking information in this news release relates to, among other things: anticipated benefits of the Arrangement to securityholders; the timing and receipt of required securityholder, Court, and regulatory approvals for the Arrangement; the ability of Exopharm to complete a prospectus offering and the amount to be raised thereunder, the composition of the board of directors of the combined entity, the ability of the Company and Exopharm to satisfy the other conditions to, and to complete, the Arrangement.

    These statements reflect the Company’s current views with respect to future events and are necessarily based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant uncertainties and contingencies. Many factors, both known and unknown could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements or information and the Company has made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation, the satisfaction or waiver of all applicable conditions to closing of the Arrangement including, without limitation, receipt of all necessary securityholder, court and regulatory approvals or consents and lack of material changes with respect to the Company and its business, all as more particularly set forth in the Arrangement Agreement. In respect of the forward-looking statements and information concerning the anticipated completion of the proposed Arrangement and the anticipated timing for completion of the Arrangement, the Company has made certain assumptions that management believes are reasonable at this time, including assumptions as to the time required to prepare and mail Meeting materials and the satisfaction of all closing conditions. These dates may change for a number of reasons, including unforeseen delays in preparing Meeting materials; inability to secure necessary securityholder, court and regulatory approvals in the time anticipated or the need for additional time to satisfy the other conditions to the completion of the Arrangement. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release concerning these times. In addition, in the event the Arrangement Agreement is terminated in certain circumstances, the Company may be required to pay a termination fee to the Purchaser, the result of which could have a material adverse effect on the Company’s financial position and results of operations and its ability to fund growth prospects and current operations.

    The forward-looking information in this news release describes the Company’s expectations as of the date of this news release. Readers are cautioned against attributing undue certainty to forward-looking statements or information. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update these forward-looking statements or information to reflect changes in assumptions or changes in circumstances or any other events affecting such statements or information, other than as required by applicable law.

    SOURCE: Tryp Therapeutics

    12/11/2023 EQS Newswire / EQS Group AG

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