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, 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 | --- | |------------------------------------------------------------------------------------------------------------------ ...

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]

Drug Development and Clinical Trials - Eledon Pharmaceuticals is focused on developing AT-1501, an anti-CD40L antibody, for autoimmune diseases and ALS, with a strong emphasis on safety and pharmacokinetic advantages [119]. - The company acquired Anelixis Therapeutics in September 2020 to enhance the clinical and commercial value of AT-1501 [120]. - AT-1501 has shown a safety profile comparable to placebo in a Phase 1 study, with a half-life of up to 26 days and low anti-drug antibody responses [122]. - Eledon plans to develop AT-1501 for four indications: kidney allograft rejection, islet cell allograft rejection, autoimmune nephritis, and ALS [123]. - The company received clearance from Health Canada to initiate a Phase 2 clinical trial of AT-1501 in islet cell transplantation for type 1 diabetes in November 2020 [130]. - Eledon initiated a Phase 2a study of AT-1501 in ALS in October 2020, planning to enroll approximately 54 subjects across 13 treatment sites [140]. Financial Performance and Expenses - Research and development expenses increased by $3.4 million to $4.2 million for the three months ended June 30, 2021, compared to $832,000 for the same period in 2020 [145]. - General and administrative expenses rose by $2.5 million to $3.7 million for the three months ended June 30, 2021, compared to $1.3 million for the same period in 2020 [146]. - Total operating expenses for the three months ended June 30, 2021, were $7.971 million, an increase of $5.38 million from $2.591 million in the same period of 2020 [144]. - The net loss for the three months ended June 30, 2021, was $7.384 million, compared to a net loss of $2.586 million for the same period in 2020, reflecting an increase of $4.798 million [144]. - For the six months ended June 30, 2021, research and development expenses increased by $7.4 million to $9.9 million, compared to $2.5 million for the same period in 2020 [152]. - General and administrative expenses for the six months ended June 30, 2021, increased by $4.1 million to $7.1 million, compared to $3.0 million for the same period in 2020 [153]. - The net loss for the six months ended June 30, 2021, was $15.883 million, compared to a net loss of $10.763 million for the same period in 2020, reflecting an increase of $5.120 million [151]. - As of June 30, 2021, the company had cash and cash equivalents of $101.1 million [159]. - Net cash used in operating activities for the six months ended June 30, 2021, was $12.612 million, compared to $5.218 million for the same period in 2020 [165]. - Net cash provided by financing activities for the six months ended June 30, 2020 was $5.2 million from the exercise of warrants by stockholders to purchase approximately 6.9 million shares of common stock [169]. Challenges and Market Conditions - The COVID-19 pandemic has caused delays in studies and data collection, impacting the company's operations and financial condition [141]. - The company is facing challenges in funding due to volatility in financial markets exacerbated by the COVID-19 pandemic [141]. - The company expects to continue incurring net operating losses and will require additional financing to advance its product candidates through clinical development [161]. Regulatory and Reporting Status - The company does not have any off-balance sheet arrangements as defined by SEC rules and regulations [171]. - The company is designated as a Smaller Reporting Company and is not required to provide certain disclosures under Regulation S-K [170]. - The company has no contractual obligations and commitments that require disclosure under Regulation S-K [172]. - There are no quantitative and qualitative disclosures about market risk required for the company as a Smaller Reporting Company [172].

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 ...

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, 2020 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 ...

Novus Therapeutics, Inc. (NVUS) Q3 2020 Earnings Conference Call November 16, 2020 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 Conference Call Participants Operator Good day and welcome to the Novus Therapeutics Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal pre ...