UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 28, 2024, Eledon Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2023. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is furnished to comply with Item 2.02 of Form 8-K, and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. |
Description |
99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Eledon Pharmaceuticals, Inc. |
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Date: |
March 28, 2024 |
By: |
/s/ David-Alexandre C. Gros, M.D. |
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Name: David-Alexandre C. Gros, M.D. |
EXHIBIT 99.1
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
IRVINE, Calif., Mar. 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
EXHIBIT 99.1
Anticipated 2024 Milestones
Fourth Quarter 2023 Financial Results
EXHIBIT 99.1
The Company reported a net loss of $9.6 million, or $0.32 per share, for the three months ended December 31, 2023, compared to a net loss of $58.4 million, or $4.09 per share, for the same period in 2022. The net loss for the three months ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $9.7 million, or $0.68 per share.
Research and development expenses were $7.1 million for the three months ended December 31, 2023, compared to $7.3 million for the comparable period in 2022, a decrease of $0.2 million.
General and administrative expenses were $3.3 million for the three months ended December 31, 2023, compared to $2.8 million for the comparable period in 2022, an increase of $0.5 million.
Full Year 2023 Financial Results
The Company reported a net loss of $40.3 million, or $1.64 per share, for the year ended December 31, 2023, compared to a net loss of $88.0 million, or $6.16 per share, in 2022. The net loss for the year ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $39.3 million, or $2.75 per share.
Research and development expenses were $30.3 million for the year ended December 31, 2023, compared to $27.1 million for the year ended December 31, 2022, an increase of $3.2 million.
General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.
The Company ended the year with approximately $51.1 million in cash and cash equivalents and short-term investments, compared to $56.4 million in cash and cash equivalents as of December 31, 2022.
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
EXHIBIT 99.1
“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
EXHIBIT 99.1
ELEDON PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
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December 31, |
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2023 |
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2022 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
4,612 |
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$ |
56,409 |
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Short-term investments |
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46,490 |
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— |
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Prepaid expenses and other current assets |
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5,027 |
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3,109 |
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Total current assets |
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56,129 |
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59,518 |
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Operating lease asset, net |
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365 |
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739 |
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In-process research and development |
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32,386 |
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32,386 |
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Other assets |
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186 |
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150 |
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Total assets |
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$ |
89,066 |
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$ |
92,793 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
967 |
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$ |
2,200 |
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Current operating lease liability |
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383 |
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363 |
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Accrued expenses and other liabilities |
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2,545 |
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3,912 |
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Total current liabilities |
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3,895 |
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6,475 |
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Deferred tax liability |
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1,752 |
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1,752 |
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Non-current operating lease liability |
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— |
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383 |
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Total liabilities |
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5,647 |
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8,610 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, $0.001 par value, 5,000,000 shares authorized at December 31, |
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Series X1 non-voting convertible preferred stock, $0.001 par value, |
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— |
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— |
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Series X non-voting convertible preferred stock, $0.001 par value, 10,000 |
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— |
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— |
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Common stock, $0.001 par value, 200,000,000 shares authorized at |
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24 |
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14 |
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Additional paid-in capital |
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326,586 |
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287,034 |
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Accumulated deficit |
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(243,191 |
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(202,865 |
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Total stockholders’ equity |
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83,419 |
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84,183 |
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Total liabilities and stockholders’ equity |
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$ |
89,066 |
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$ |
92,793 |
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EXHIBIT 99.1
ELEDON PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
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Year Ended |
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2023 |
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2022 |
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Operating expenses |
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Research and development |
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$ |
30,312 |
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$ |
27,080 |
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General and administrative |
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12,688 |
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12,700 |
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Goodwill impairment |
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— |
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48,648 |
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Total operating expenses |
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43,000 |
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88,428 |
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Loss from operations |
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(43,000 |
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(88,428 |
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Other income, net |
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2,674 |
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462 |
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Loss before income taxes |
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(40,326 |
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(87,966 |
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Income taxes |
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— |
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— |
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Net loss and comprehensive loss |
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$ |
(40,326 |
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$ |
(87,966 |
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Net loss per share, basic and diluted |
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$ |
(1.64 |
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$ |
(6.16 |
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Weighted-average common shares outstanding, basic and diluted |
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24,619,197 |
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14,285,254 |
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