UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Emerging growth company ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 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 20-10 ...

Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Paul Little – Chief Financial Officer David-Alexandre Gros – Chief Executive Officer Steve Perrin – President and Chief Scientific Officer Jeff Bornstein – Chief Medical Officer Conference Call Participants Pete Stavropoulos – Cantor Fitzgerald Nat Charoensook – SVB Matt Kaplan – Ladenburg Thalmann Operator Greetings, and welcome to Eledon Pharmaceuticals First Quarter Financial Results C ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%2E%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements](index=6&type=section&id=Item%201.%2E%20Condensed%20Consolidated%20Financial%20Statements) 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](index=6&type=page&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=7&type=page&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=8&type=page&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) 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](index=9&type=page&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=10&type=page&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) 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](index=31&type=chunk) - 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](index=38&type=chunk)[39](index=39&type=chunk) - 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](index=76&type=chunk)[77](index=77&type=chunk) - 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](index=87&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=20&type=page&id=Overview%20of%20Business%20and%20Clinical%20Pipeline) 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](index=99&type=chunk)[103](index=103&type=chunk) - As of March 31, 2022, all **54 subjects** in the Phase 2a ALS study were enrolled and had completed participation in the trial[108](index=108&type=chunk) - 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](index=103&type=chunk)[111](index=111&type=chunk)[115](index=115&type=chunk)[119](index=119&type=chunk) [Results of Operations](index=24&type=page&id=Results%20of%20Operations) 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](index=124&type=chunk) [Liquidity and Capital Resources](index=24&type=page&id=Liquidity%20and%20Capital%20Resources) 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](index=128&type=chunk)[130](index=130&type=chunk) - 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](index=132&type=chunk) 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](index=26&type=section&id=Item%203.%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=140&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%2E%20Controls%20and%20Procedures) 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](index=142&type=chunk) - 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](index=143&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%2E%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%2E%20Legal%20Proceedings) 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](index=84&type=chunk)[145](index=145&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%2E%20Risk%20Factors) 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](index=28&type=page&id=Risks%20Related%20to%20Our%20Operations) 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](index=148&type=chunk)[151](index=151&type=chunk) - 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](index=155&type=chunk)[167](index=167&type=chunk) - 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](index=183&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=35&type=page&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Legal%20Compliance) 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](index=188&type=chunk) - 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](index=193&type=chunk) - 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](index=207&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=39&type=page&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) 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](index=214&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies developing similar or alternative therapies, including **Novartis**, **Boehringer Ingelheim**, **AbbVie**, and **Sanofi**[221](index=221&type=chunk)[222](index=222&type=chunk) - The availability and extent of reimbursement from government and private payers are uncertain and could limit the ability to market products profitably[229](index=229&type=chunk) [Risks Related to Our Dependence on Third Parties](index=42&type=page&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) 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](index=237&type=chunk)[238](index=238&type=chunk) - 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](index=247&type=chunk) [Risks Related to Our Intellectual Property](index=44&type=page&id=Risks%20Related%20to%20Our%20Intellectual%20Property) 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](index=248&type=chunk)[249](index=249&type=chunk) - 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](index=256&type=chunk)[257](index=257&type=chunk) - The company relies on trade secrets and confidentiality agreements, which may be breached, and protecting them can be difficult and expensive[263](index=263&type=chunk) [Risks Related to Our Common Stock](index=46&type=page&id=Risks%20Related%20to%20Our%20Common%20Stock) 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](index=265&type=chunk) - 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](index=276&type=chunk) - 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](index=273&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%2E%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Not applicable for this reporting period - Not applicable[277](index=277&type=chunk) [Item 3. Defaults Upon Senior Securities](index=48&type=section&id=Item%203.%2E%20Defaults%20Upon%20Senior%20Securities) None - None[278](index=278&type=chunk) [Item 4. Mine Safety Disclosures](index=48&type=section&id=Item%204.%2E%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[279](index=279&type=chunk) [Item 5. Other Information](index=48&type=section&id=Item%205.%2E%20Other%20Information) None - None[279](index=279&type=chunk) [Item 6. Exhibits](index=48&type=section&id=Item%206.%2E%20Exhibits) 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](index=279&type=chunk)[281](index=281&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (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, 2021 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 jurisdi ...

Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) Q3 2021 Earnings Conference Call November 11, 2021 4:30 PM ET Company Participants Paul Little - Chief Financial Officer David-Alexandre Gros - Chief Executive Officer Steven Perrin - President & Chief Scientific Officer Jeff Bornstein - Chief Medical Officer Conference Call Participants Alethia Young - Cantor Fitzgerald Thomas Smith - SVB leerink Raymond Wu - Ladenburg Thalmann Rami Katkhuda - LifeSci Capital Operator Hello and welcome to the Eledon Pharmaceutica ...

Product Development - Eledon Pharmaceuticals is focused on developing AT-1501, an anti-CD40L antibody, targeting conditions such as ALS, kidney allograft rejection, islet cell allograft rejection, and IgA Nephropathy [126][129]. - The company acquired Anelixis Therapeutics in September 2020, which owned the intellectual property for AT-1501, to enhance its clinical and commercial value [127][131]. - AT-1501 has shown a half-life of up to 26 days and demonstrated low anti-drug antibody responses in Phase 1 studies [128]. - A Phase 2a clinical trial for AT-1501 in ALS began in October 2020, with plans to enroll approximately 54 subjects across 13 sites in the U.S. and Canada [135]. - In July 2021, Eledon received clearance from Health Canada to initiate a Phase 1b trial of AT-1501 for kidney transplantation, aiming to replace tacrolimus in immunosuppressive regimens [141]. - The company also received clearance in November 2020 for a Phase 2 trial of AT-1501 in islet cell transplantation for type 1 diabetes [142]. - Eledon aims to mitigate the adverse effects associated with current immunosuppressive therapies, potentially improving long-term graft survival in transplant patients [139][140]. - Eledon reported that approximately 30%-40% of IgA Nephropathy patients may reach end-stage renal disease, highlighting the need for effective treatments [145]. Financial Performance - Research and development expenses increased by $7.0 million to $7.7 million for the three months ended September 30, 2021, compared to $0.6 million for the same period in 2020 [152]. - General and administrative expenses decreased by $0.9 million to $2.8 million for the three months ended September 30, 2021, compared to $3.7 million for the same period in 2020 [153]. - Total operating expenses for the nine months ended September 30, 2021, were $27.5 million, an increase of $15.4 million compared to $12.1 million for the same period in 2020 [162]. - The net loss for the nine months ended September 30, 2021, was $25.7 million, compared to a net loss of $16.9 million for the same period in 2020, representing an increase of $8.8 million [162]. - Cash and cash equivalents as of September 30, 2021, were $94.0 million, consisting of readily available cash in bank accounts [167]. - The company recognized an income tax benefit of $0.7 million for the three months ended September 30, 2021, due to changes in deferred tax liabilities related to the Anelixis acquisition [157]. - The company incurred no restructuring expenses for the three months ended September 30, 2021, compared to $1.8 million for the same period in 2020 [154]. - The company plans to continue funding losses from operations and capital needs through cash on hand and future equity or debt financings [171]. - Net cash used in operating activities for the nine months ended September 30, 2021, was $19.7 million, compared to $5.8 million for the same period in 2020 [173]. - The company expects to incur substantial expenditures for the development and potential commercialization of its product candidates in the foreseeable future [172]. - Net cash used in operating activities for the nine months ended September 30, 2021 was $25.7 million, compared to $16.9 million for the same period in 2020 [174][175]. - Non-cash items for the nine months ended September 30, 2021 included stock-based compensation of $5.9 million and amortization of operating lease assets of $0.1 million [174]. - Cash used in operating activities for the nine months ended September 30, 2021 reflected a net increase in cash from changes in operating assets and liabilities of $1.8 million, primarily due to an increase in accounts payable and accrued expenses of $2.0 million [174]. - There was no cash provided by or used in the Company's investing activities for the nine months ended September 30, 2021 [176]. - Net cash used in financing activities for the nine months ended September 30, 2021 was $0.5 million related to offering costs accrued in connection with the sale of common stock [177]. - In contrast, net cash provided by financing activities for the nine months ended September 30, 2020 was $95.2 million from the sale of Series X1 preferred stock [178]. Operational Challenges - The COVID-19 pandemic has caused delays in studies and data collection, impacting the company's operations and financial condition [148]. - The company has suspended development of its legacy ENT assets following a failed clinical trial, focusing resources on the development of AT-1501 [131]. Regulatory and Compliance - The Company did not have any off-balance sheet arrangements as defined by SEC rules [181]. - The Company is designated as a Smaller Reporting Company and is not required to provide certain disclosures under Regulation S-K [180][182].

Financial Data and Key Metrics Changes - The company reported a net loss of $7.4 million or $0.50 per share for Q2 2021, compared to a net loss of $2.6 million or $2.74 per share for the same period in 2020 [56] - Research and development expenses increased to $4.2 million in Q2 2021 from $800,000 in Q2 2020, primarily due to clinical and CMC activities related to AT-1501 [57] - General and administrative expenses rose to $3.7 million in Q2 2021 from $1.3 million in Q2 2020, reflecting increased personnel and stock-based compensation costs [58] - For the six months ended June 30, 2021, the company reported a net loss of $15.9 million or $1.07 per share, compared to a net loss of $10.8 million or $11.31 per share for the same period in 2020 [59] - Cash and cash equivalents stood at $101.1 million as of June 30, 2021, down from $108.6 million as of March 31, 2021, with expectations to fund operations well into 2023 [61] Business Line Data and Key Metrics Changes - The lead molecule AT-1501 is being advanced in multiple clinical trials targeting ALS, kidney transplantation, autoimmune nephritis (IgA nephropathy), and islet cell transplantation for Type 1 diabetes [6][11] - The ALS Phase 2 biomarker study is progressing as planned, with top-line data expected in the first half of 2022 [7][20] - A no objection letter from Health Canada was received for a clinical trial evaluating AT-1501 in kidney transplantation, expected to start in Q4 2021 [11][25] Market Data and Key Metrics Changes - The company is focusing on the U.S. and Canadian markets for its clinical trials, with plans to potentially expand to Europe as COVID-19 conditions improve [66][54] - The ongoing COVID-19 pandemic has significantly impacted the ability to conduct islet cell transplants in Canada, affecting patient enrollment [51][52] Company Strategy and Development Direction - The company aims to advance AT-1501 through four clinical trials, focusing on indications with limited treatment options [6] - A strategic review of legacy assets led to the termination of license agreements associated with Otitis Media, with no financial impact [62] - The company plans to present non-human primate data at the International Pancreas and Islet Cell Transplantation World Congress in October 2021 [63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of AT-1501 as a therapeutic option for various serious conditions, highlighting the importance of upcoming clinical milestones [5][63] - The company is working to address challenges in patient recruitment and trial initiation due to COVID-19, with a focus on expediting the development pathway [54][98] Other Important Information - The company is collaborating with an academic partner for the non-human primate study required by the FDA for renal transplantation [10][28] - The Phase 2 study for IgA nephropathy is expected to provide insights into the drug's mechanism and its potential impact on other autoimmune nephritis conditions [81][89] Q&A Session Summary Question: When might the first patient be enrolled in the islet cell transplantation program? - Management is looking to enroll the first patient as soon as possible, currently focused on Canada, with potential for additional countries as COVID-19 conditions improve [66] Question: What is the timeline for starting a U.S.-focused study for renal transplantation? - The timeline depends on the data from the Canadian study, with discussions with the FDA anticipated in the second half of next year [76][77] Question: Can you provide more details on the Phase 2 study for IgA nephropathy? - Specific details on trial design will be provided once discussions with regulatory bodies are completed [79] Question: What should be expected in the upcoming presentation at the Islet Transplant World Congress? - The presentation will focus on data generated from non-human primate studies related to islet cell transplants [90] Question: How does AT-1501 differentiate from other therapies in development for IgA nephropathy? - AT-1501 may have a broader impact on multiple pathological processes compared to other therapies targeting specific aspects of antibody formation [96][97]

**Part I: Financial Information** This part details the company's financial statements, management's discussion and analysis, market risk disclosures, and internal controls [**Item 1. Financial Statements**](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20-%20Unaudited) This section presents the company's consolidated financial statements, showing a net loss increase and detailing cash position and accumulated deficit [**Condensed Consolidated Balance Sheets**](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $101,133 | $114,195 | | Total current assets | $102,582 | $115,630 | | Goodwill | $48,648 | $48,648 | | In-process research and development | $32,386 | $32,386 | | **Total assets** | **$184,305** | **$197,185** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $2,677 | $2,483 | | Total liabilities | $5,784 | $6,589 | | Total stockholders' equity | $178,521 | $190,596 | | **Total liabilities and stockholders' equity** | **$184,305** | **$197,185** | [**Condensed Consolidated Statements of Operations and Comprehensive Loss**](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's revenues, expenses, and net loss for the reported periods Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | :--- | :--- | | | **2021** | **2020** | **2021** | **2020** | | Research and development | $4,242 | $832 | $9,895 | $2,480 | | General and administrative | $3,729 | $1,269 | $7,081 | $2,999 | | Total operating expenses | $7,971 | $2,591 | $16,976 | $5,969 | | Loss from operations | $(7,971) | $(2,591) | $(16,976) | $(5,969) | | **Net loss** | **$(7,384)** | **$(2,586)** | **$(15,883)** | **$(10,763)** | | Net loss per share, basic and diluted | $(0.50) | $(2.74) | $(1.07) | $(11.31) | [**Condensed Consolidated Statements of Cash Flows**](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,612) | $(5,218) | | Net cash (used in) provided by financing activities | $(450) | $5,191 | | Net change in cash and cash equivalents | $(13,062) | $(27) | | Cash and cash equivalents at beginning of period | $114,195 | $8,791 | | **Cash and cash equivalents at end of period** | **$101,133** | **$8,764** | [**Notes to Condensed Consolidated Financial Statements**](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of accounting policies, significant transactions, and financial commitments - The company is a clinical-stage biopharmaceutical firm focused on developing AT-1501, an anti-CD40L antibody, for autoimmune diseases, organ/cell transplantation, and ALS. This focus follows the acquisition of Anelixis Therapeutics, Inc. in September 2020[36](index=36&type=chunk) - Management performed an analysis and concluded that the company's cash and cash equivalents of **$101.1 million** as of June 30, 2021, are **sufficient to meet its anticipated cash needs for at least the next 12 months**[43](index=43&type=chunk)[44](index=44&type=chunk) - The company has a license agreement with ALSTDI for AT-1501, which requires up to **$6.0 million** in remaining milestone payments for the first product, plus potential sales-based milestones and low single-digit royalties[79](index=79&type=chunk) - The acquisition of Anelixis was accounted for as a business combination, with total purchase consideration valued at **$86.8 million**. This resulted in the recognition of **$32.4 million** in In-Process Research and Development (IPR&D) and **$48.6 million** in goodwill[103](index=103&type=chunk)[106](index=106&type=chunk)[110](index=110&type=chunk) [**Item 2. MD&A of Financial Condition and Results of Operations**](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses the company's financial performance, liquidity, and clinical development progress for AT-1501 [**Business Overview and Clinical Pipeline**](index=24&type=section&id=Business%20Overview%20and%20Clinical%20Pipeline) This section outlines the company's strategic focus on developing AT-1501 for various indications and its clinical trial progress - The company's lead compound is AT-1501, an anti-CD40L antibody engineered to improve safety and provide dosing advantages over other anti-CD40 approaches[119](index=119&type=chunk) - Eledon is pursuing up to four indications for AT-1501: kidney allograft rejection, islet cell allograft rejection, autoimmune nephritis, and ALS[123](index=123&type=chunk) - A Phase 2a clinical trial of AT-1501 in ALS was initiated in October 2020, and clearance was received from Health Canada in November 2020 to start a Phase 2 trial in islet cell transplantation[123](index=123&type=chunk)[130](index=130&type=chunk) [**Results of Operations**](index=28&type=section&id=Results%20of%20Operations) This section analyzes the significant increase in operating expenses, primarily driven by higher R&D and G&A costs Comparison of Operating Expenses (in thousands) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | :--- | :--- | | | **2021** | **2020** | **2021** | **2020** | | Research and development | $4,242 | $832 | $9,895 | $2,480 | | General and administrative | $3,729 | $1,269 | $7,081 | $2,999 | | **Total operating expenses** | **$7,971** | **$2,591** | **$16,976** | **$5,969** | - R&D expenses for Q2 2021 increased by **$3.4 million** year-over-year, mainly due to costs for clinical trial materials, clinical studies for AT-1501, and increased personnel and stock compensation costs[145](index=145&type=chunk) - G&A expenses for Q2 2021 increased by **$2.5 million** year-over-year, primarily from higher stock-based compensation, personnel costs due to increased headcount, legal fees, and insurance premiums[146](index=146&type=chunk) [**Liquidity and Capital Resources**](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's cash position, funding sources, and future capital requirements for clinical development - The company had cash and cash equivalents of **$101.1 million** as of June 30, 2021[159](index=159&type=chunk) - The company expects to continue incurring net operating losses and will require additional financing to advance its product candidates through clinical development and potential commercialization[160](index=160&type=chunk)[161](index=161&type=chunk) Summary of Net Cash Flow (in thousands) | | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,612) | $(5,218) | | Net cash (used in) provided by financing activities | $(450) | $5,191 | | **Net change in cash and cash equivalents** | **$(13,062)** | **$(27)** | [**Item 3. Quantitative and Qualitative Disclosures About Market Risk**](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the company, as a Smaller Reporting Company, is exempt from providing market risk disclosures - The company is designated as a Smaller Reporting Company and is **not required to provide disclosures about market risk**[172](index=172&type=chunk) [**Item 4. Controls and Procedures**](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures and reports no material changes - Management concluded that the company's disclosure controls and procedures were **effective as of June 30, 2021**[174](index=174&type=chunk) - **No material changes were made** to the company's internal control over financial reporting during the quarter ended June 30, 2021[175](index=175&type=chunk) **Part II: Other Information** This part covers legal proceedings, risk factors, and other required disclosures [**Item 1. Legal Proceedings**](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently involved in any material legal proceedings - The company is **not currently a party to any material legal proceedings**[83](index=83&type=chunk)[177](index=177&type=chunk) [**Item 1A. Risk Factors**](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks across operations, regulatory compliance, commercialization, third-party reliance, intellectual property, and common stock [**Risks Related to Operations**](index=33&type=section&id=Risks%20Related%20to%20Our%20Operations) This section details operational risks, including the company's limited operating history, history of losses, and dependence on its lead product - The company has a short operating history and incurred a net loss of **$15.9 million** for the six months ended June 30, 2021, with an accumulated deficit of **$96.3 million**. It **may never achieve profitability**[179](index=179&type=chunk)[180](index=180&type=chunk) - The business is substantially dependent on the successful development and commercialization of its early-stage product candidate, AT-1501, which faces a **high risk of failure**[184](index=184&type=chunk) - The COVID-19 pandemic has caused and may continue to cause disruptions, including delays in clinical studies, data collection, and manufacturing[189](index=189&type=chunk) - The company **will require additional funding** to complete the development of its lead drug candidate and may be forced to curtail operations or cease altogether if unable to raise capital[204](index=204&type=chunk) [**Risks Related to Regulatory Approval and Compliance**](index=39&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) This section addresses risks associated with obtaining regulatory approvals, post-marketing compliance, and cybersecurity vulnerabilities - Obtaining regulatory approval from the FDA and other authorities is an expensive, lengthy, and uncertain process. Failure to obtain approval for AT-1501 would prevent its commercialization[209](index=209&type=chunk) - Any approved product will be subject to extensive post-marketing regulations, and failure to comply could result in restrictions, withdrawal from the market, or penalties[214](index=214&type=chunk) - Business operations are subject to anti-kickback, fraud, and abuse laws, which could expose the company to criminal sanctions, civil penalties, and reputational harm[222](index=222&type=chunk) - Internal and third-party IT systems are vulnerable to security breaches, which could disrupt development programs and compromise sensitive data, leading to significant financial and legal harm[227](index=227&type=chunk) [**Risks Related to Commercialization**](index=43&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) This section discusses challenges in achieving market acceptance, building sales capabilities, facing competition, and securing adequate reimbursement - Even if approved, product candidates may fail to achieve market acceptance from physicians, patients, and payers, which is necessary for commercial success[233](index=233&type=chunk) - The company currently has no marketing or sales force and will need to build these capabilities or partner with third parties to commercialize its products[239](index=239&type=chunk) - The company faces **substantial competition** from major pharmaceutical and biotechnology companies with greater resources, including Novartis, Abbvie, Sanofi, and Bristol Myers Squibb, who are developing similar therapeutics[240](index=240&type=chunk)[241](index=241&type=chunk) - Failure to obtain or maintain adequate insurance coverage and reimbursement from government and private payers could limit the ability to market products and generate revenue[249](index=249&type=chunk) [**Risks Related to Dependence on Third Parties**](index=47&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This section highlights risks stemming from reliance on third parties for manufacturing, clinical testing, and regulatory submissions - The company relies on third parties for the manufacturing of its product candidates, which increases the risk of insufficient quantities, unacceptable cost or quality, and potential delays in development or commercialization[256](index=256&type=chunk) - Reliance on third-party manufacturers entails risks such as regulatory compliance failures, breach of agreements, and misappropriation of proprietary information[261](index=261&type=chunk) - The company depends on CROs and other contractors for research, clinical testing, and regulatory submissions, making its success partially dependent on their performance[265](index=265&type=chunk) [**Risks Related to Intellectual Property**](index=49&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section covers risks concerning patent protection, potential litigation, and the ability to safeguard trade secrets - The company's success depends on its ability to obtain and maintain patent protection for its technology and products, a process that is expensive, time-consuming, and uncertain[268](index=268&type=chunk)[269](index=269&type=chunk) - The company may become involved in expensive and time-consuming lawsuits to protect or enforce its patents, or defend against infringement claims from others[275](index=275&type=chunk)[276](index=276&type=chunk) - The company relies on trade secrets and proprietary know-how, and if it is unable to protect their confidentiality, its business and competitive position could be harmed[282](index=282&type=chunk) [**Risks Related to Common Stock**](index=51&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) This section addresses risks related to stock price volatility, internal control effectiveness, potential acquisition difficulties, and dividend policy - The company's stock price is expected to be volatile due to factors common in the biopharmaceutical industry, such as clinical trial results and regulatory decisions[284](index=284&type=chunk) - Failure to maintain effective internal control over financial reporting could harm operating results and the ability to operate the business[288](index=288&type=chunk) - Provisions in the company's corporate charter and Delaware law could make an acquisition more difficult and prevent attempts by stockholders to replace management[291](index=291&type=chunk) - The company **does not expect to pay any cash dividends in the foreseeable future**[294](index=294&type=chunk) [**Item 2-6. Other Required Disclosures**](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms the absence of unregistered equity sales, senior security defaults, or mine safety disclosures - The company reported **no unregistered sales of equity securities, defaults upon senior securities, or mine safety issues** during the reporting period[295](index=295&type=chunk)[296](index=296&type=chunk)[297](index=297&type=chunk)

Eledon Pharmaceuticals (NASDAQ:ELDN) Q1 2021 Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants Jon Kuwahara - Senior Vice President of Finance David-Alexandre Gros - Chief Executive Officer Steve Perrin - President & Chief Scientific Officer Paul Little - Chief Financial Officer Conference Call Participants Li Watsek - Cantor Rami Katkhuda - LifeSci Capital Thomas Smith - SVB Leerink Matthew Kaplan - Ladenburg Thalmann Vernon Bernardino - H.C. Wainwright Operator Greetings, all, and welc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 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 jur ...