Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results
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
“Eledon continues to execute on time and as promised towards our goal of extending the functional life of transplanted organs,” said
“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
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 , atMassachusetts 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 inPhiladelphia, PA inNovember 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 theJuvenile Diabetes Research Foundation (JDRF) andThe 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 ofAllan Kirk , M.D., Ph.D. andJames 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
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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:
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com
Source: Eledon Pharmaceuticals
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands, except share and per share data) | ||||||||
| 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 | ||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (In thousands, except share and per share data) | ||||||||
| Year Ended |
||||||||
| 2023 | 2022 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 30,312 | $ | 27,080 | ||||
| General and administrative | 12,688 | 12,700 | ||||||
| — | 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 | ||||||
Source: Eledon Pharmaceuticals, Inc.