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 August 11, 2022, Eledon Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the period ended June 30, 2022. 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: |
August 11, 2022 |
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 Second Quarter 2022 Operating and Financial Results
Received FDA clearance of IND application for Phase 2 trial evaluating tegoprubart for the prevention of rejection in kidney transplant recipients
First patient dosed in Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplant recipients in Canada, the United Kingdom and Australia
Reported positive topline results from Phase 2a trial of tegoprubart demonstrating safety, target engagement, and biomarker response in patients living with amyotrophic lateral sclerosis (ALS)
Tegoprubart received Orphan Drug Designation from the U.S. FDA for the prevention of allograft rejection in pancreatic islet cell transplantation
Conference call today at 4:30 PM ET
IRVINE, Calif., August 11, 2022 — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its second quarter 2022 operating and financial results and reviewed recent business highlights.
“This quarter was marked by significant clinical and regulatory progress across all four tegoprubart development programs, reinforcing our confidence in tegoprubart’s broad therapeutic potential and setting the stage for the next 12 months,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We enrolled the first patient in our ex-US open-label kidney transplantation study and multiple patients in our IgAN study. In addition, the FDA gave us clearance to proceed with a kidney transplant study to evaluate whether tegoprubart is superior to the standard of care with tacrolimus. Finally, our recent positive topline Phase 2a data in ALS demonstrated dose dependent target engagement and reductions in critical pro-inflammatory biomarkers associated with ALS as well as biomarkers associated with IgAN and kidney allograft transplant rejection. We now anticipate sharing initial data from the Phase 1b kidney transplant study, the IgAN study, and the islet cell study in the first quarter of 2023, as
Exhibit 99.1
well as providing additional guidance on timing for the new Phase 2 kidney transplant study and next steps in ALS.”
Second Quarter 2022 and Recent Corporate Developments
Upcoming Anticipated Milestones
Financial Results for the Three Months Ended June 30, 2022
The company reported a net loss of $9.2 million, or $0.65 per share, for the three months ended June 30, 2022, compared to a net loss of $7.4 million, or $0.50 per share, for the same period in 2021.
Exhibit 99.1
Conference Call
Eledon will hold a conference call today, August 11, 2022, at 4:30 pm Eastern Time to discuss second quarter 2022 results. The dial-in numbers are 877-300-8521 for domestic callers and 412-317-6026 for international callers. The conference ID is 10169199. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)
Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40 Ligand (CD40L, also called CD154) pathway to develop potential treatments for persons requiring an organ or cell-based transplant, living with autoimmune disease, or living with ALS. The company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, Calif. 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 sites, 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-Q, 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
Source: Eledon Pharmaceuticals
Exhibit 99.1
ELEDON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
(Unaudited)
Exhibit 99.1
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June 30, |
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December 31, |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
70,460 |
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$ |
84,833 |
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Prepaid expenses and other current assets |
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2,328 |
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3,513 |
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Total current assets |
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72,788 |
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88,346 |
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Operating lease asset, net |
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581 |
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768 |
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Goodwill |
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48,648 |
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48,648 |
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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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303 |
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400 |
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Total assets |
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$ |
154,706 |
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$ |
170,548 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,318 |
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$ |
1,813 |
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Current operating lease liability |
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287 |
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369 |
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Accrued expenses and other liabilities |
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1,671 |
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2,219 |
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Total current liabilities |
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3,276 |
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4,401 |
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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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299 |
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400 |
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Total liabilities |
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5,327 |
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6,553 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Series X1 non-voting convertible preferred stock, $0.001 par value, 515,000 shares authorized; 117,970 and 108,070 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively |
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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 shares authorized; 6,204 shares issued and outstanding at June 30, 2022 and December 31, 2021 |
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— |
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— |
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Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 13,756,788 and 14,306,788 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively |
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14 |
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14 |
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Additional paid-in capital |
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283,375 |
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278,880 |
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Accumulated deficit |
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(134,010 |
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(114,899 |
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Total stockholders’ equity |
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149,379 |
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163,995 |
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Total liabilities and stockholders’ equity |
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$ |
154,706 |
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$ |
170,548 |
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Exhibit 99.1
ELEDON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited)
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For the Three Months |
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For the Six Months |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses |
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Research and development |
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$ |
5,743 |
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$ |
4,242 |
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$ |
12,378 |
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$ |
9,895 |
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General and administrative |
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3,540 |
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3,729 |
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6,764 |
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7,081 |
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Total operating expenses |
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9,283 |
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7,971 |
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19,142 |
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16,976 |
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Loss from operations |
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(9,283 |
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(7,971 |
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(19,142 |
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(16,976 |
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Other income/(expense), net |
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36 |
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(1 |
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31 |
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4 |
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Loss before income tax benefit |
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(9,247 |
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(7,972 |
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(19,111 |
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(16,972 |
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Income tax benefit |
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— |
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588 |
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— |
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1,089 |
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Net loss and comprehensive loss |
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$ |
(9,247 |
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$ |
(7,384 |
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$ |
(19,111 |
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$ |
(15,883 |
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Net loss per share, basic and diluted |
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$ |
(0.65 |
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$ |
(0.50 |
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$ |
(1.34 |
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$ |
(1.07 |
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Weighted-average common shares outstanding, basic and diluted |
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14,265,905 |
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14,815,731 |
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14,299,969 |
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14,823,348 |
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