UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36620 ELEDON PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 20-1000967 (State or other jurisdiction of incorporation or organization) 19800 MacArthur Blvd., Suite 250 Irvine, California 92612 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SEC ...

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EXHIBIT 99.1 Eledon Pharmaceuticals Reports First Quarter 2024 Operating and Financial Results Completed oversubscribed $50 million private placement First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes Reported updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation Tegoprubart used as part of immunosuppressive trea ...

First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes Company reports updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ:ELDN) today announced that the first participant in an investigator-led clinical trial has rece ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36620 ELEDON PHARMACEUTICALS, INC. Form 10-K (Exact name of registrant as specified in its charter) Delaware 20-1000967 (Stat ...

Enrolled 12 participants in Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney rejection Tegoprubart used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human Additional data from 11 participants in Phase 1b trial in kidney transplantation demonstrated that tegoprubart was generally safe and well tolerated, successfully prevented rejection and permitted above historical average post-transpla ...

Historic kidney xenotransplantation procedure conducted at Massachusetts General Hospital Tegoprubart administration has now been used investigationally to prevent rejection in both kidney and heart pig-to-human xenotransplantations, as well as in human-to-human kidney transplantation Eledon recently presented results from its ongoing Phase 1b kidney transplantation study which demonstrated that tegoprubart was generally safe and well tolerated and successfully prevented rejection with post-transplant kid ...

IRVINE, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ:ELDN) today announced that the Company's Compensation Committee granted 42,500 restricted stock units (RSUs) and stock options to purchase an aggregate of 90,000 common shares, at a per share exercise price of $1.77, the closing price of Eledon's common stock on the grant date, to one employee. The RSUs and stock options were granted as inducements material to the new employee entering employment with Eledon in ...

WASHINGTON, DC 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36620 ELEDON PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) 19900 MacArthur Blvd., Su ...

Company Focus and Development - Eledon Pharmaceuticals is focusing on the development of tegoprubart, an anti-CD40L antibody, to protect transplanted organs and treat amyotrophic lateral sclerosis (ALS) [99]. - The company has prioritized its kidney transplantation programs, discontinuing the islet cell transplantation program and deprioritizing the IgA Nephropathy program as of January 2023 [103]. - Eledon has received regulatory approvals in Canada, the UK, and Australia for a Phase 1b clinical trial of tegoprubart, with the first subject dosed in July 2022 [107]. - A Phase 2 trial of tegoprubart for kidney transplant rejection prevention is set to enroll 120 participants, with patient enrollment expected to begin in Q3 2023 [108]. - ALS has an estimated incidence of 5,000 cases per year in the U.S., with a prevalence of approximately 30,000 cases overall [109]. - Tegoprubart has shown potential therapeutic benefits in ALS models, with a Phase 2a study demonstrating safety and tolerability in 54 subjects [113]. - Eledon entered a collaboration agreement with eGenesis in January 2023 for preclinical xenotransplantation studies using tegoprubart [118]. Financial Performance - The company reported a net loss of $20.4 million for the six months ended June 30, 2023, compared to a net loss of $19.1 million for the same period in 2022 [132]. - Research and development expenses increased by $2.9 million to $15.3 million for the six months ended June 30, 2023, primarily due to higher clinical development expenses [133][128]. - General and administrative expenses decreased by $0.6 million to $6.2 million for the six months ended June 30, 2023, primarily due to lower professional service costs [134]. - Net cash used in operating activities for the six months ended June 30, 2023 was $18.1 million, compared to $14.4 million for the same period in 2022 [145]. - The company reported a net loss of $20.4 million for the six months ended June 30, 2023, partially offset by non-cash items totaling $3.3 million [146]. - Net cash used in investing activities for the six months ended June 30, 2023 was $30.3 million, primarily for purchases of available-for-sale short-term investments [149]. - Net cash provided by financing activities for the six months ended June 30, 2023 was $33.0 million, resulting from the sale of 8.7 million shares of common stock and 6.4 million pre-funded warrants [150]. - The company experienced a net change in cash and cash equivalents of $(15.5) million for the six months ended June 30, 2023 [145]. - The company’s cash flow from operating activities included a decrease in accounts payable and accrued expenses of $1.6 million [146]. Funding and Capital Raising - The company is unable to continue ALS clinical development without additional financing specific to the ALS program [114]. - The company plans to seek additional financing through equity offerings, debt financings, or collaborations to fund ongoing operations and product development [141]. - The company is currently unable to fund the continued clinical development of tegoprubart for ALS without additional financing [138]. - The company may receive up to an additional $105.0 million from the second and third closings of the Private Placement, contingent on achieving specified milestones [120][138]. - As of June 30, 2023, the company had cash and cash equivalents and short-term investments of approximately $71.4 million, with expectations of incurring significant net operating losses for the foreseeable future [137][136]. - The company has no approved products for commercial sale and has never generated revenue from product sales [136]. - The company faces significant uncertainties due to global economic volatility, which could impact its ability to raise necessary capital [122][142]. - The company is subject to risks associated with capital raising, including potential dilution of stockholder ownership interests [143]. - As of June 30, 2023, the company was permitted to sell up to $17.8 million of shares under the ATM Program [144]. - The company has not sold any shares under the ATM program through June 30, 2023 [144]. - The company’s public float must exceed $75.0 million for the ATM Program to allow for additional share sales [144].