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 ...

Core Viewpoint - Eledon Pharmaceuticals, Inc. (ELDN) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Eledon Pharmaceuticals for the fiscal year ending December 2024 is projected at -$1.16 per share, reflecting a 29.3% change from the previous year's reported number [9]. - Over the past three months, the Zacks Consensus Estimate for Eledon has increased by 14.6%, indicating a positive shift in analysts' expectations [9]. Zacks Rating System - The Zacks rating system is based solely on a company's changing earnings picture, which is tracked through EPS estimates from sell-side analysts [2]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has shown an impressive track record, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. - Eledon Pharmaceuticals' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for stock price appreciation in the near term [12]. Market Influence - Changes in earnings estimates are strongly correlated with stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [5]. - Rising earnings estimates and the subsequent rating upgrade for Eledon imply an improvement in the company's underlying business, which could lead to higher stock prices as investors respond positively [6].

Financial Performance - Eledon Pharmaceuticals reported a net loss of $10.3 million, or $0.34 per share, for Q1 2024, compared to a net loss of $10.8 million, or $0.75 per share, in Q1 2023[4]. - Research and development expenses decreased to $7.4 million in Q1 2024 from $8.1 million in the same period in 2023, a reduction of approximately 8.6%[4]. - General and administrative expenses increased to $3.5 million in Q1 2024 from $3.0 million in Q1 2023, an increase of approximately 16.7%[5]. - Total current assets decreased to $47.977 million as of March 31, 2024, from $56.129 million as of December 31, 2023[12]. - Total stockholders' equity decreased to $74.819 million as of March 31, 2024, from $83.419 million as of December 31, 2023[12]. Cash and Investments - Eledon ended Q1 2024 with approximately $42.9 million in cash, cash equivalents, and short-term investments, excluding the $50 million raised in a recent private placement[5]. - The company completed an oversubscribed private placement raising $50 million at a price per share of $2.37[3]. Clinical Trials and Research - The first participant in a clinical trial for islet cell transplantation using tegoprubart has been dosed, marking a significant milestone in the study[3]. - Eledon enrolled the 12th participant in the ongoing Phase 2 BESTOW trial, which compares tegoprubart with tacrolimus for kidney transplantation[3]. - The company anticipates reporting updated interim clinical data from the ongoing Phase 1b trial at the American Transplant Congress in June 2024[8].

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 ...

Financial Performance - The company incurred a net loss of $40.3 million for the year ended December 31, 2023, with an accumulated deficit of $243.2 million[141]. - The company expects to continue incurring significant operating losses over the next several years and may never achieve profitability[141]. - The company faces uncertainties regarding its financial condition and ability to raise sufficient capital for ongoing operations[44]. - The market price of the company's common stock is expected to be volatile, influenced by various factors typical of early-stage pharmaceutical companies[247]. - The company may experience fluctuations in financial results from period to period[44]. Capital and Financing - As of December 31, 2023, the company had cash and cash equivalents of $51.1 million and working capital of $52.2 million[141]. - The company may need to raise additional capital to finance future operations, which could dilute the ownership interest of common stockholders[142]. - The company has financed operations primarily through the sale of preferred and common stock, and the sale of warrants[141]. - The company may receive up to an additional $105.0 million in tranche financing, contingent on achieving specified clinical development milestones[145]. - An additional $45.5 million may be obtained assuming the exercise of all Common Warrants issued in the initial closing of the Private Placement[145]. Product Development and Regulatory Risks - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[141]. - The company is unable to continue clinical development of its lead drug candidate without additional financing[145]. - The company may experience delays in clinical trials due to various factors, including regulatory approval processes and recruitment challenges[160]. - The regulatory approval process is expensive and can take several years, with substantial discretion from authorities that may delay or prevent approval[178]. - The company has not received marketing approval for any of its product candidates from regulatory authorities in any country, which may materially impair its ability to generate revenue[175]. Competition and Market Challenges - The company faces substantial competition from larger pharmaceutical and biotechnology companies, including Novartis, Sanofi, and Amgen, which have significantly greater resources[206]. - If approved, the product tegoprubart is expected to face competition from numerous FDA-approved therapeutics for transplant rejection, including PROGRAF® and CELLCEPT®[207]. - The commercial opportunity for the company could be reduced if competitors develop safer, more effective, or less expensive products[209]. - The insurance coverage and reimbursement status for newly-approved products remains uncertain, which could limit the company's ability to market its products[212]. Operational and Compliance Risks - The company faces significant risks related to compliance with healthcare laws, which could expose it to civil penalties and reputational harm[187]. - The company must comply with extensive post-marketing regulatory requirements, which could include penalties for non-compliance[179]. - The company may face significant costs related to ensuring compliance with applicable healthcare laws and regulations[188]. - The company currently holds $10.0 million in product liability insurance coverage, which may not be adequate to cover all potential liabilities[219]. - The company may incur substantial costs to comply with environmental, health, and safety laws, which could adversely affect its business[199]. Human Resources and Management - The company is highly dependent on key personnel, and the loss of executives could impede its development and commercialization objectives[173]. - Recruiting and retaining qualified personnel is critical, with intense competition for talent in the pharmaceutical and biotechnology sectors[174]. - The company depends on CROs and other contracted third parties for nonclinical and clinical testing, which may impact the pace of clinical development if these parties do not perform adequately[229][230]. Supply Chain and Manufacturing Risks - The company is reliant on third parties for the manufacture of its product candidates, increasing the risk of supply issues[220]. - The reliance on third-party manufacturers may adversely affect future profit margins and the timely commercialization of products[228]. - There are no long-term agreements with current suppliers, which may lead to delays and increased costs if alternative manufacturers need to be identified[223][226]. - The company does not have arrangements for redundant supply, increasing vulnerability to potential disruptions in the supply chain[223]. Legal and Litigation Risks - The company may face claims of misappropriation of trade secrets from former employers of personnel, which could lead to litigation and loss of valuable intellectual property rights[246]. - The company may face substantial costs and management distractions from potential class action securities litigation due to market volatility[250]. Strategic and Growth Considerations - The company does not expect to pay any cash dividends in the foreseeable future, focusing instead on retaining earnings for business development[258]. - Internal control over financial reporting is crucial, and failure to maintain it could adversely affect financial reporting accuracy and stock price[252]. - The company has provisions in its corporate charter that may make acquisitions more difficult, potentially limiting stockholder benefits[254]. - The company anticipates that as it grows, it will incur additional costs related to compliance with the Sarbanes-Oxley Act[252].

Financial Performance - Eledon Pharmaceuticals reported a net loss of $9.6 million, or $0.32 per share, for Q4 2023, a significant decrease from a net loss of $58.4 million, or $4.09 per share, in Q4 2022[7]. - For the full year 2023, the company reported a net loss of $40.3 million, or $1.64 per share, compared to a net loss of $88.0 million, or $6.16 per share, in 2022[9]. - Total operating expenses for the year ended December 31, 2023, were $43.0 million, a decrease from $88.4 million in 2022, primarily due to the absence of a goodwill impairment charge[18]. Research and Development - Research and development expenses for Q4 2023 were $7.1 million, slightly down from $7.3 million in Q4 2022, while general and administrative expenses increased to $3.3 million from $2.8 million[8]. - Eledon enrolled 12 participants in the Phase 2 BESTOW trial evaluating tegoprubart for kidney transplantation, with the trial expected to complete enrollment by the end of 2024[3][4]. - Data from 11 participants in the Phase 1b trial showed that tegoprubart was generally safe and well-tolerated, with an estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m² at all reported time points after 90 days post-transplant[6]. - The company amended the Phase 1b trial protocol to allow enrollment of up to 24 participants undergoing kidney transplantation[6]. - Eledon partnered with the University of Chicago Transplantation Institute to fund a study in pancreatic islet cell transplantation for type 1 diabetes, evaluating tegoprubart for transplant rejection prevention[6]. - The company anticipates reporting updated interim clinical data from the ongoing Phase 1b trial in the second quarter of 2024[6]. Cash Position - The company ended 2023 with approximately $51.1 million in cash and cash equivalents, down from $56.4 million at the end of 2022[11].

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 ...

Drug Development and Clinical Trials - Eledon Pharmaceuticals is focusing on the development of tegoprubart, an anti-CD40L antibody, to protect transplanted organs and treat amyotrophic lateral sclerosis (ALS) [102]. - In January 2023, the company decided to prioritize resources on kidney transplantation programs, discontinuing the islet cell transplantation program and deprioritizing the IgA Nephropathy program [106]. - The Phase 1b clinical trial of tegoprubart for kidney transplantation has shown that it is generally safe and well-tolerated, with no cases of hyperglycemia or new onset diabetes reported [110]. - Interim results from the Phase 1b trial indicated that the aggregate mean estimated glomerular filtration rate (eGFR) was above 70 mL/min/1.73m² at all reported time points after day 90, compared to historical averages in the low 50 mL/min/1.73m² range [110]. - The Phase 2 BESTOW trial, initiated in August 2023, aims to enroll 120 participants to evaluate the safety and efficacy of tegoprubart compared to tacrolimus, with the primary objective being eGFR at 12 months post-transplant [111]. - Eledon has received regulatory approvals in Canada, the UK, and Australia for the Phase 1b clinical trial of tegoprubart in kidney transplantation [110]. - The company reported that tegoprubart demonstrated low anti-drug antibody responses and a half-life of up to 26 days in previous studies [116]. - Eledon is unable to continue clinical development of tegoprubart for ALS without additional financing, highlighting the need for funding to progress this program [118]. - The IgA Nephropathy program has been deprioritized, with all related clinical activities and spending to be discontinued in Q4 2023 [122]. - A collaboration agreement with eGenesis was established in January 2023 for preclinical xenotransplantation studies involving tegoprubart [123]. Financial Performance and Funding - The company reported a net loss of $10.3 million for the three months ended September 30, 2023, compared to a net loss of $10.5 million for the same period in 2022, reflecting a $0.1 million improvement [131]. - As of September 30, 2023, the company had cash and cash equivalents and short-term investments of approximately $59.6 million, with significant reliance on future capital raises to fund operations [140]. - The company expects to incur additional losses and requires further financing to advance drug products through clinical development and commercialization efforts [144]. - The company anticipates an increase in operating expenses as it expands its clinical program for tegoprubart and seeks marketing approval for its product candidates [143]. - The company entered into a Securities Purchase Agreement to issue a total of 60,606,072 shares of common stock and warrants in three closings, with the first closing generating $35.0 million in net proceeds [124][125]. - The second and third closings of the Securities Purchase Agreement are contingent upon achieving specified clinical development milestones and share price conditions [128]. - General and administrative expenses rose to $3.3 million for the three months ended September 30, 2023, driven by increased employee compensation [133]. - Other income increased significantly to $849,000 for the three months ended September 30, 2023, primarily due to higher interest income from cash and short-term investments [134]. - For the nine months ended September 30, 2023, the company reported a net cash used in operating activities of $30.4 million, compared to $18.9 million for the same period in 2022 [150][151]. - The company's net cash used in investing activities for the nine months ended September 30, 2023, was $55.4 million, primarily due to the purchase of $60.4 million in short-term investments [152]. - Financing activities provided net cash of $33.0 million for the nine months ended September 30, 2023, from the sale of 8.7 million shares of common stock and 6.4 million pre-funded warrants [153]. - The company experienced a net loss of $30.7 million for the nine months ended September 30, 2023, which included $4.8 million in stock-based compensation [150]. - The company's net change in cash and cash equivalents for the nine months ended September 30, 2023, was a decrease of $52.7 million [148]. - The company’s public float must exceed $75.0 million for it to sell more shares under the Form S-3 registration statement [147]. - The company’s cash flow from financing activities was the only positive cash flow category for the nine months ended September 30, 2023 [153]. - The company is subject to "baby shelf" rules until its public float exceeds $75.0 million, limiting its ability to raise additional capital through equity sales [147]. - The company faces uncertainties due to global economic volatility, which could impact its ability to secure necessary financing [127].

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].