Eledon Pharmaceuticals(ELDN) - 2022 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements For the first quarter of 2022, Eledon Pharmaceuticals reported a net loss of $9.9 million and ended the period with $76.7 million in cash and cash equivalents Condensed Consolidated Balance Sheets As of March 31, 2022, total assets were $161.4 million, a decrease from $170.5 million at year-end 2021, mainly due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $76,677 | $84,833 | | Total current assets | $79,325 | $88,346 | | Goodwill | $48,648 | $48,648 | | In-process research and development | $32,386 | $32,386 | | Total assets | $161,378 | $170,548 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $2,958 | $4,401 | | Total liabilities | $5,060 | $6,553 | | Accumulated deficit | $(124,763) | $(114,899) | | Total stockholders' equity | $156,318 | $163,995 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended March 31, 2022, the company reported a net loss of $9.9 million, or $0.69 per share, primarily due to higher research and development expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $6,635 | $5,653 | | General and administrative | $3,224 | $3,352 | | Total operating expenses | $9,859 | $9,005 | | Loss from operations | $(9,859) | $(9,005) | | Net loss and comprehensive loss | $(9,864) | $(8,499) | | Net loss per share, basic and diluted | $(0.69) | $(0.57) | Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity decreased from $164.0 million at year-end 2021 to $156.3 million as of March 31, 2022, mainly due to the net loss, partially offset by stock-based compensation Changes in Stockholders' Equity for Q1 2022 (in thousands) | Description | Amount | | :--- | :--- | | Balance as of December 31, 2021 | $163,995 | | Stock-based compensation | $2,186 | | Net loss and other comprehensive loss | $(9,864) | | Balance as of March 31, 2022 | $156,318 | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $8.2 million for Q1 2022, an increase from the prior-year period, with no financing or investing activities Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,156) | $(5,166) | | Net cash used in financing activities | — | $(450) | | Net change in cash and cash equivalents | $(8,156) | $(5,616) | | Cash and cash equivalents at end of period | $76,677 | $108,579 | Notes to Condensed Consolidated Financial Statements The notes detail the company's business focus on tegoprubart, confirm sufficient cash for 12 months, and outline key commitments and equity programs - The company is a clinical-stage biopharmaceutical firm focused on developing its lead compound, tegoprubart, an anti-CD40L antibody, for autoimmune diseases, organ/cell transplants, and ALS[31] - Management concluded that the company's cash and cash equivalents of $76.7 million as of March 31, 2022, are sufficient to meet anticipated cash needs for at least the next 12 months[38][39] - The company has an agreement with ALS TDI requiring up to $6.0 million in remaining milestone payments for the first licensed product and potential future royalties[76][77] - The company has an "at the market" (ATM) equity program to sell up to $75 million in common stock, but is currently limited to selling up to $16.4 million under SEC "baby shelf rules"[87] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's focus on advancing its lead compound, tegoprubart, through clinical trials for four indications, reporting a net loss of $9.9 million for Q1 2022 Overview of Business and Clinical Pipeline Eledon is a clinical-stage biopharmaceutical company developing tegoprubart for multiple indications, having completed enrollment in its Phase 2a ALS trial and received clearances for other trials - The company's lead compound is tegoprubart, an anti-CD40L antibody being developed for up to four indications: ALS, kidney allograft rejection, islet cell allograft rejection, and IgA Nephropathy (IgAN)[99][103] - As of March 31, 2022, all 54 subjects in the Phase 2a ALS study were enrolled and had completed participation in the trial[108] - The company has received regulatory clearances to initiate clinical trials for its other pipeline indications, including a Phase 1b in kidney transplant, a Phase 2a in islet cell transplant, and a Phase 2a in IgAN across various international jurisdictions[103][111][115][119] Results of Operations Comparing Q1 2022 to Q1 2021, the net loss increased by $1.4 million to $9.9 million, driven by a $1.0 million rise in research and development expenses Comparison of Operating Results (in thousands) | Line Item | Q1 2022 | Q1 2021 | $ Variance | | :--- | :--- | :--- | :--- | | Research and development | $6,635 | $5,653 | $982 | | General and administrative | $3,224 | $3,352 | $(128) | | Total operating expenses | $9,859 | $9,005 | $854 | | Net loss | $(9,864) | $(8,499) | $(1,365) | - The $1.0 million increase in R&D expenses was mainly due to higher clinical development costs with external CROs as the tegoprubart program advanced[124] Liquidity and Capital Resources As of March 31, 2022, the company had $76.7 million in cash, sufficient for 12 months, but anticipates needing additional capital for future development and operations - The company had cash and cash equivalents of $76.7 million as of March 31, 2022, which is believed to be sufficient to meet projected operating requirements for at least the next 12 months[128][130] - The company will require additional financing to advance its drug products through clinical development, obtain regulatory approval, and fund operations for the foreseeable future[132] Net Cash Flow Activity (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,156) | $(5,166) | | Net cash used in financing activities | — | $(450) | Item 3. Quantitative and Qualitative Disclosures About Market Risk As a Smaller Reporting Company, Eledon Pharmaceuticals is not required to provide the disclosures for this item - The Company is designated a Smaller Reporting Company and is not required to provide the disclosure required by this Item[140] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes in internal control over financial reporting - Based on an evaluation as of March 31, 2022, management concluded that the company's disclosure controls and procedures were effective[142] - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[143] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[84][145] Item 1A. Risk Factors The company outlines significant risks to its business, including those related to operations, regulatory hurdles, commercialization challenges, dependence on third parties, intellectual property, and stock volatility Risks Related to Our Operations Operational risks include the company's short operating history, significant recurring net losses, the early and high-risk stage of clinical candidates, and the need for substantial additional funding - The company has a short operating history and has incurred significant operating losses since inception, with a net loss of $9.9 million for Q1 2022 and an accumulated deficit of $124.8 million[148][151] - Product candidates are in early stages of clinical development, a lengthy and expensive process with an uncertain outcome and a high risk of failure[155][167] - The company will require additional funding to complete the development of its lead drug candidate and may be forced to alter its business strategy or cease operations if unable to raise capital[183] Risks Related to Regulatory Approval and Legal Compliance The company faces risks of not obtaining or experiencing delays in regulatory approvals, extensive post-marketing regulations, and potential security breaches of its IT systems - Failure to obtain marketing approval for a product candidate from the FDA and other global regulatory authorities will prevent commercialization[188] - Approved products will be subject to extensive post-marketing requirements, and failure to comply can result in restrictions, withdrawal from the market, or penalties[193] - Internal computer systems are vulnerable to security breaches, which could disrupt development programs and compromise sensitive data, leading to significant financial and legal harm[207] Risks Related to the Commercialization of Our Product Candidates Even if approved, product candidates may fail to achieve market acceptance, face substantial competition, and require securing adequate insurance coverage and reimbursement - There is a risk of failing to achieve market acceptance from physicians, patients, and payers, which is necessary for commercial success[214] - The company faces substantial competition from major pharmaceutical and biotechnology companies developing similar or alternative therapies, including Novartis, Boehringer Ingelheim, AbbVie, and Sanofi[221][222] - The availability and extent of reimbursement from government and private payers are uncertain and could limit the ability to market products profitably[229] Risks Related to Our Dependence on Third Parties The company relies heavily on third-party contract manufacturing organizations (CMOs) for supply and contract research organizations (CROs) for clinical trials, creating risks related to control and supply chain - The company relies on third parties to manufacture, package, and distribute clinical supplies and does not have its own manufacturing facilities, increasing risks of supply disruption and cost issues[237][238] - Success is partially dependent on the performance of CROs and other contractors for research, development, and clinical testing activities, which are not fully within the company's control[247] Risks Related to Our Intellectual Property The company's success depends on obtaining and maintaining patent protection, which is uncertain and may involve expensive litigation, and relies on license agreements and trade secrets - The company's success depends on its ability to obtain and maintain patent protection, but the patent process is expensive, time-consuming, and highly uncertain[248][249] - The company may become involved in lawsuits to protect its patents or defend against infringement claims from third parties, which could be costly and unsuccessful[256][257] - The company relies on trade secrets and confidentiality agreements, which may be breached, and protecting them can be difficult and expensive[263] Risks Related to Our Common Stock The company's stock price is expected to be volatile, it does not anticipate paying dividends, and corporate provisions may discourage acquisitions - The market price of the company's common stock is expected to be volatile and subject to significant fluctuations[265] - The company does not expect to pay any cash dividends in the foreseeable future, so capital appreciation will be the sole source of gain for stockholders[276] - Provisions in the company's charter and bylaws may discourage or prevent a merger or acquisition, potentially limiting the price investors might pay for shares[273] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Not applicable for this reporting period - Not applicable[277] Item 3. Defaults Upon Senior Securities None - None[278] Item 4. Mine Safety Disclosures Not applicable - Not applicable[279] Item 5. Other Information None - None[279] Item 6. Exhibits This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer - The Exhibit Index lists all documents filed or furnished as part of the Form 10-Q, including officer certifications pursuant to the Sarbanes-Oxley Act[279][281]