Anelixis Therapeutics, Inc.

A man-made antibody successfully prevented organ rejection when tested in primates that had undergone a kidney transplant, Duke Health researchers report. The finding clears the way for the new monoclonal antibody to move forward in human clinical trials. A human-made antibody successfully prevented organ rejection when tested in primates that had undergone a kidney transplant, Duke Health researchers report. The finding clears the way for the new monoclonal antibody to move forward in human clinical trials. Results of the study appear online Aug. 30 in the journal Science Translational Medicine. "Current medications to prevent organ rejection are good overall, but they have a lot of side effects," said lead author Imran J. Anwar, M.D., a surgical research fellow in Duke's Department of Surgery. "These therapies suppress the immune system, putting patients at risk of infections and organ damage, and many cause non-immune complications such as diabetes and high blood pressure. "The push over the last 30 to 40 years has been to develop new, less toxic drugs," Anwar said. "We are hopeful this antibody moves us closer to that goal." Anwar and colleagues, including co-senior author Allan Kirk, M.D., Ph.D., chair of the Department of Surgery, focused on a monoclonal antibody identified as AT-1501. It was engineered to minimize the risk of blood clots, which had become problematic for an earlier version of this therapy. In studies using primates that had undergone kidney transplantation, AT-1501 prevented rejection without the need for additional immunosuppressive drugs or promoting blood clots, confirming its immunosuppressive potential. In animals that had undergone islet transplantation, AT-1501 alone did not lead to uniform rejection control, but it was effective in combination with existing immunosuppressive agents. The combination therapies in islet transplantation led to uniform islet graft survival without weight loss or infections that can typically arise. The islet transplants were performed by Norma Kenyon, Ph.D., co-senior author and professor at the University of Miami. "These data support AT-1501 as a safe and effective agent to promote both islet and kidney transplant survival and function and allow us to advance into clinical trials right away," Kirk said. "This less toxic approach has been pursued for over 20 years, and I think we are finally at a turning point. This could be a great advance for people in need of organ transplants." In addition to Kirk and Anwar, study authors include Dora M. Berman, Isabel DeLaura, Qimeng Gao, Melissa A. Willman, Allison Miller, Alan Gill, Cindy Gill, Steve Perrin, Camillo Ricordi, Philip Ruiz, Mingqing Song, Joseph M Ladowski, and Norma S. Kenyon. The study received funding support from the National Institutes of Health (U19-AI051731), the Diabetes Research Institute Foundation, and Anelixis Therapeutics, now Eledon Pharmaceuticals, which is developing AT-1501 for kidney and islet cell transplant.

DUBLIN, July 12, 2022 /PRNewswire/ -- The "Global Hospital Care Partnering 2015-2022: Deal Trends, Players and Financials" report has been added to ResearchAndMarkets.com's offering. Global Hospital Care Partnering 2015 to 2022 provides the full collection of Hospital Care disease deals signed between the world's pharmaceutical and biotechnology companies since 2015. Trends in Hospital Care partnering deals Financial deal terms for headline, upfront and royalty by stage of development Hospital Care partnering agreement structure Hospital Care partnering contract documents Top Hospital Care deals by value Most active Hospital Care dealmakers Most of the deals included within the report occur when a licensee obtains a right or an option right to license a licensor's product or technology. More often these days these deals tend to be multi-component including both a collaborative R&D and a commercialization of outcomes element. The report takes readers through the comprehensive Hospital Care disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Hospital Care deals. The report presents financial deal terms values for Hospital Care deals, where available listing by overall headline values, upfront payments, milestones and royalties enabling readers to analyse and benchmark the value of current deals. Global Hospital Care Partnering 2015 to 2022 includes: Trends in Hospital Care dealmaking in the biopharma industry since 2015 Access to headline, upfront, milestone and royalty data Access to hundreds of Hospital Care deal contract documents Comprehensive access to over 1200 Hospital Care deal records The leading Hospital Care deals by value since 2015 Most active Hospital Care dealmakers since 2015 Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in Hospital Care dealmaking 2.1. Introduction 2.2. Hospital Care partnering over the years 2.3. Hospital Care partnering by deal type 2.4. Hospital Care partnering by industry sector 2.5. Hospital Care partnering by stage of development 2.6. Hospital Care partnering by technology type 2.7. Hospital Care partnering by therapeutic indication Chapter 3 -Financial deal terms for Hospital Care partnering 3.1. Introduction 3.2. Disclosed financials terms for Hospital Care partnering 3.3. Hospital Care partnering headline values 3.4. Hospital Care deal upfront payments 3.5. Hospital Care deal milestone payments 3.6. Hospital Care royalty rates Chapter 4 - Leading Hospital Care deals and dealmakers 4.1. Introduction 4.2. Most active in Hospital Care partnering 4.3. List of most active dealmakers in Hospital Care 4.4. Top Hospital Care deals by value Chapter 5 - Hospital Care contract document directory 5.1. Introduction 5.2. Hospital Care partnering deals where contract document available Chapter 6 - Hospital Care dealmaking by therapeutic target 6.1. Introduction 6.2. Deals by Hospital Care therapeutic target Companies Mentioned 3D-Side 3D Systems 3M 3SBio 4WEB Medical 7 Hills Pharma 7D Surgical 11 Health and Technologies 111 A&E Medical AAP Implantate AG Aatru Medical Abbvie Abiomed Ab Medica Abram Scientific Absolute Antibody AbSorber Acacia Pharma Acacia Research Acare Medical Science Accelus Accenture Access Scientific Accord Healthcare Accuray AccuTec Blades Acelity Acell Acelrx Pharmaceuticals Acentrus Specialty Acerus ActLight Acuity Healthcare Acuna-Fombona AdaptHealth Adaptimmune ADAS 3D Medical Adeor Medical Adhezion Biomedical ADIENNE Pharma & Biotech Admedus Advanced Aesthetic Technologies Advanced Cooling Therapy Advanced Guidance Technologies Advanced IT Concepts Advanced Ultrasound Systems Advantage Medical Advanz Pharma AdventHealth Aerapy Aerobiotix Aesculap Aesthetic Management Partners Aesthetic Medical International Aethlon Medical Aetna Agadia Systems AgeX Therapeutics Agiliti AgNovos Healthcare Aguettant Aidoc Aiforia Technologies AirStrip Technologies AirXpanders Aitrics Akari Therapeutics Akers Biosciences Akumin ALASTIN Skincare Alfasigma Algeos AliMed AliveCor ALK-Abello Allegheny Technologies Allenex Allergan Allergan Aesthetics Alliance Medical Allied Centre for Medical Excellence Alliqua Biomedical Alloksys Life Sciences AlloSource Almirall Alnylam Pharmaceuticals Alpha Imaging Alphamedix Alphatec Spine Altan Pharma Altaris Capital Partners Altasciences Altitude International Alume Biosciences Alvarado Hospital Medical Center Alyzen Medical Physics Amag Pharmaceuticals Ambra Health Ambu Amedica Amedisys Amendia Amend Surgical American Academy of Orthopaedic Surgeons American College of Chest Physicians American Health Imaging American Medical Technologies American Society for Aesthetic Plastic Surgery American Well Amerinet AmerisourceBergen Amgen AMI Amicrobe AMNIOX Amomed Pharma Amplifire Amplyx Pharmaceuticals Ancestry Anelixis Therapeutics Anelto Angiodynamics Angion Biomedica Angsana Molecular & Diagnostics Anika Therapeutics Anita Tecnica ANP Technologies Antares Pharma Anthem Antibe Therapeutics Apex Physics Partners ApiFix Apollo Endosurgery Appalachian Regional Healthcare Apple Applied DNA Sciences Applimotion APR Medtech Aptevo Therapeutics Archer Capital Arch Therapeutics argenx Argon Medical Devices Aridea Solutions Aridis Pharmaceuticals Arjo Arkansas Childrens Hospital Armaghan Salamat Kish Armis Biopharma Armor Arsenal Medical Artegraft Arteriocyte Medical Systems Arthrex Arthrosurface ARxIUM Asahi Kasei Ascendum Ascension Ascension Saint Thomas Asensus Surgical ASICO AskAt Asklepios Group Aspen Surgical Products Assure Astarte Medical Astellas Pharma AstraZeneca Asys Athersys Atlas Lift Tech ATL Technology Atnahs Pharma Atos Medical Atricure For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Continued enrollment in Phase 2 clinical trial of AT-1501 in amyotrophic lateral sclerosis (ALS) First patient to be enrolled in Phase 2 clinical trial of AT-1501 in islet cell transplantation for type 1 diabetes expected in Q2’21 Cash Balance of $114.2 million at December 31, 2020 IRVINE, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc., (“Eledon”) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with an autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), today reported its fourth quarter and full-year 2020 operating and financial results. “2020 was a transformational year highlighted by our acquisition of Anelixis Therapeutics and recent name change to Eledon Pharmaceuticals, reflecting our evolution in therapeutic focus to transplantation, autoimmune diseases and ALS, areas of significant unmet medical need,” stated David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon Pharmaceuticals, Inc. “Our lead asset, AT-1501, has unique attributes that we believe make it a potential best in class molecule as a humanized IgG1 anti-CD40 ligand antibody targeting a well-validated pathway that has shown promise in multiple indications. We are financed to advance up to four Phase 2 clinical trials of AT-1501, covering multiple indications, with data readouts expected to begin in the first half of 2022.” Fourth Quarter 2020 and Recent Corporate Developments Upcoming Anticipated Milestones Financial Results for the Three Months Ended December 31, 2020 The company reported a net loss of $5.9 million, or $2.13 per share, for the three months ended December 31, 2020, compared to a net loss of $4.1 million, or $5.75 per share, for the same period in 2019. Financial Results for the Year Ended December 31, 2020 The company reported a net loss of $22.8 million, or $15.72 per share, for the year ended December 31, 2020, compared to a net loss of $16.0 million, or $24.42 per share, for the year ended December 31, 2019. Financial Liquidity at December 31, 2020 Concurrent with the acquisition of Anelixis Therapeutics in September 2020, the company raised gross proceeds of $108 million through a private placement of shares to a group of premier life science investors, led by BVF Partners L.P., with participation from Cormorant Asset Management, Ecor1 Capital, Logos Capital, Fidelity Management and Research Company, Adage Capital Partners L.P., Woodline Partners LP, Ridgeback Capital, Janus Henderson Investors, and Samsara BioCapital, among others. The company had approximately $114.2 million in cash and cash equivalents as of December 31, 2020, compared to $8.8 million in cash and cash equivalents as of December 31, 2019. The Company believes that it has sufficient financial resources to fund up to four Phase 2 clinical trials with AT-1501 and fund operating activities well into 2023. Conference Call Eledon will hold a conference call today, March 30, 2021 at 4:30 pm Eastern Time to discuss fourth quarter results. The dial-in numbers are 877-407-9039 for domestic callers and 201-689-8470 for international callers. The conference ID is 13717918. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at . The webcast will be archived on the website following the completion of the call. About Eledon Pharmaceuticals and AT-1501 Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for patients living with an autoimmune disease, patients requiring an organ or cell-based transplant, and for patients living with ALS. The company’s lead compound in development is AT-1501, an anti-CD40L antibody with high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential. AT-1501 is a humanized IgG1 antibody engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40 approaches. The CD40L/CD40 pathway is widely recognized for its prominent role in immune regulation. CD40L is primarily expressed on activated CD4+ T cells, platelets and endothelial cells while the CD40 receptor is constitutively expressed on antigen presenting cells such as B cells, macrophages, and dendritic cells. By blocking CD40L and not the CD40 receptor, AT-1501 inhibits both the CD40 and CD11 costimulatory signaling pathways, providing the potential for improved efficacy compared to anti-CD40 receptor approaches. Blocking CD40L also increases polarization of CD4+ lymphocytes to Tregs, a specialized subpopulation of T cells that act to suppress an immune response, thus creating a more tolerogenic environment, which may also play a therapeutic role for autoimmune diseases and in the transplant setting. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at . Follow Eledon Pharmaceuticals on social media: @Eledon_Pharma and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements that involves substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the Company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the Company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at . Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact:Corey Davis, Ph.D.LifeSci Advisors, LLCcdavis@lifesciadvisors.com212.915.2577 Source: Eledon Pharmaceuticals ELEDON PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share data) ELEDON PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data)