Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results
- Enrollment of 12 participants in Phase 2 BESTOW trial for tegoprubart in kidney transplantation
- Positive Phase 1b data demonstrating safety, efficacy, and improved kidney function
- Financial improvement with a reduced net loss in Q4 2023 and full year 2023
- Net loss reported in Q4 2023 and full year 2023
- Increase in general and administrative expenses in Q4 2023 compared to the same period in 2022
The enrollment of participants in the Phase 2 BESTOW trial and the reported data from the Phase 1b trial of tegoprubart represent significant milestones for Eledon Pharmaceuticals. The successful prevention of rejection and the demonstration of safety and tolerability are key factors in the development of new immunosuppressive drugs. The reported eGFR rates above 70 mL/min/1.73m² are indicative of healthy kidney function post-transplant, suggesting tegoprubart's potential efficacy.
Furthermore, the inclusion of tegoprubart in the groundbreaking pig-to-human kidney xenotransplant is a testament to its perceived potential in the field of transplantation medicine. The long-term effectiveness data to be collected from the open-label extension study will be critical in understanding the durability of tegoprubart's benefits. The partnership with the University of Chicago and funding from JDRF and The Cure Alliance for a study in pancreatic islet cell transplantation could pave the way for tegoprubart's application in other types of organ transplants, potentially expanding its market use.
The financial results of Eledon Pharmaceuticals show a net loss decrease from the previous year, which could be interpreted as a positive signal for investors, especially considering the exclusion of the non-cash goodwill impairment charge. A careful analysis of the R&D expenses reveals a moderate increase, which is expected during the active phases of clinical trials. The cash and cash equivalents position, along with short-term investments, provides insight into the company's runway and its ability to fund ongoing research without immediate additional financing.
Investors will be attentive to the upcoming interim clinical data reports, as these will provide further evidence of tegoprubart's efficacy and safety. Positive results could potentially influence the company's stock value. However, it is also important to consider the inherent risks of investing in biotech companies, particularly those in the clinical trial stage, where outcomes are uncertain and regulatory approvals are pending.
The demand for effective immunosuppressive therapies in organ transplantation is significant, with a constant need for improved treatments that can reduce the risk of rejection while minimizing side effects. Eledon Pharmaceuticals' focus on tegoprubart and its application in kidney transplantation and potentially in pancreatic islet cell transplantation for type 1 diabetes patients addresses a critical market need. The successful development of such a drug could disrupt the current standard of care and offer substantial market opportunities.
Moreover, the involvement in xenotransplantation procedures could open new avenues for organ availability, addressing the organ shortage crisis. This innovative approach, if successful, may create a new niche market for Eledon. The anticipation of the Phase 2 BESTOW trial completion and the dosing of the first participant in the pancreatic islet cell transplantation study are events that could influence market perception and the company's strategic positioning in the transplantation field.
Enrolled 12 participants in Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney rejection
Tegoprubart used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human
Additional data from 11 participants in Phase 1b trial in kidney transplantation demonstrated that tegoprubart was generally safe and well tolerated, successfully prevented rejection and permitted above historical average post-transplant kidney function
IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.
“Eledon continues to execute on time and as promised towards our goal of extending the functional life of transplanted organs,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Our latest Phase 1b data further support the potential of tegoprubart to significantly reduce the risk of rejection as well as harmful side effects associated with current standard of care in immunosuppression. In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures. As we advance our clinical program to assess the use of tegoprubart in kidney transplant procedures, we remain committed to supporting groundbreaking advancements that can lead to broader organ availability for patients around the world.”
“Looking ahead, we anticipate completing enrollment of our Phase 2 BESTOW study by the end of the year as we also continue to enroll participants in the second cohort of our Phase 1b study and open-label extension study designed to provide additional insights into tegoprubart’s long-term effectiveness,” continued Dr. Gros. “We look forward to providing updated interim clinical data from both the Phase 1b and open-label studies in the second quarter of this year.”
Fourth Quarter 2023 and Recent Corporate Developments
- Announced the use of tegoprubart as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
- Announced 12th participant enrolled in the Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
- Reported updated safety and efficacy data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplant. Data from 11 participants demonstrated that tegoprubart was generally safe and well-tolerated in patients undergoing kidney transplantation, with aggregate mean estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m² at all reported time points after 90 days post-transplant. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
- Amended Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
- Enrolled first patient in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study. The participant completed the Phase 1b study with an eGFR of 91 at one year (day 374).
- Partnered with the University of Chicago Transplantation Institute to secure financing from the Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance to fund an investigator sponsored study in pancreatic islet cell transplantation in participants with type 1 diabetes. Tegoprubart treatment will be evaluated for the prevention of transplant rejection.
- Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer and strengthened board of directors with appointment of Allan Kirk, M.D., Ph.D. and James Robinson.
Anticipated 2024 Milestones
- Second quarter 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
- End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
- 2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute.
Fourth Quarter 2023 Financial Results
The Company reported a net loss of
Research and development expenses were
General and administrative expenses were
Full Year 2023 Financial Results
The Company reported a net loss of
Research and development expenses were
General and administrative expenses were
The Company ended the year with approximately
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Qs, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com
Source: Eledon Pharmaceuticals
| ELEDON PHARMACEUTICALS, INC. | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands, except share and per share data) | ||||||||
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,612 | $ | 56,409 | ||||
| Short-term investments | 46,490 | — | ||||||
| Prepaid expenses and other current assets | 5,027 | 3,109 | ||||||
| Total current assets | 56,129 | 59,518 | ||||||
| Operating lease asset, net | 365 | 739 | ||||||
| In-process research and development | 32,386 | 32,386 | ||||||
| Other assets | 186 | 150 | ||||||
| Total assets | $ | 89,066 | $ | 92,793 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 967 | $ | 2,200 | ||||
| Current operating lease liability | 383 | 363 | ||||||
| Accrued expenses and other liabilities | 2,545 | 3,912 | ||||||
| Total current liabilities | 3,895 | 6,475 | ||||||
| Deferred tax liability | 1,752 | 1,752 | ||||||
| Non-current operating lease liability | — | 383 | ||||||
| Total liabilities | 5,647 | 8,610 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, 2023 and 2022: | ||||||||
| Series X¹ non-voting convertible preferred stock, | — | — | ||||||
| Series X non-voting convertible preferred stock, | — | — | ||||||
| Common stock, | 24 | 14 | ||||||
| Additional paid-in capital | 326,586 | 287,034 | ||||||
| Accumulated deficit | (243,191 | ) | (202,865 | ) | ||||
| Total stockholders’ equity | 83,419 | 84,183 | ||||||
| Total liabilities and stockholders’ equity | $ | 89,066 | $ | 92,793 | ||||
| ELEDON PHARMACEUTICALS, INC. | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (In thousands, except share and per share data) | ||||||||
| Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 30,312 | $ | 27,080 | ||||
| General and administrative | 12,688 | 12,700 | ||||||
| Goodwill impairment | — | 48,648 | ||||||
| Total operating expenses | 43,000 | 88,428 | ||||||
| Loss from operations | (43,000 | ) | (88,428 | ) | ||||
| Other income, net | 2,674 | 462 | ||||||
| Loss before income taxes | (40,326 | ) | (87,966 | ) | ||||
| Income taxes | — | — | ||||||
| Net loss and comprehensive loss | $ | (40,326 | ) | $ | (87,966 | ) | ||
| Net loss per share, basic and diluted | $ | (1.64 | ) | $ | (6.16 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 24,619,197 | 14,285,254 | ||||||
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