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 10, 2023, Eledon Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the period ended June 30, 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: |
August 10, 2023 |
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 2023 Operating and Financial Results
Ninth patient dosed in ongoing Phase 1b trial evaluating tegoprubart in patients undergoing kidney transplantation; updated clinical data expected in the fourth quarter
Raised up to $185 million, including $35 million upfront, from leading investors
Successfully completed a non-human primate study for subcutaneous tegoprubart formulation
IRVINE, Calif., August 10, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its second quarter operating and financial results and reviewed recent business highlights.
“We have now transplanted nine patients in our ongoing Phase 1b kidney transplantation trial and remain highly encouraged by the results to date,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “We believe that tegoprubart could represent a significant advancement in immunosuppressive therapy following kidney transplantation and look forward to presenting updated data from our Phase 1b at a medical conference next quarter. In addition, we have started activating sites in our BESTOW Phase 2 kidney transplantation trial and are progressing towards dosing the first patient.”
Second Quarter 2023 and Recent Corporate Developments
EXHIBIT 99.1
Upcoming Anticipated 2023 Milestones
Second Quarter Financial Results
The company reported a net loss of $9.6 million, or $0.40 per share, for the three months ended June 30, 2023, compared to a net loss of $9.2 million, or $0.65 per share, for the same period in 2022.
Research and development expenses were $7.2 million for the three months ended June 30, 2023, compared to $5.7 million for the comparable period in 2022, an increase of $1.5 million. The increase in research and development spend primarily reflects an increase in clinical development costs, personnel costs and costs related to the production of clinical trial materials.
General and administrative expenses were $3.2 million for the three months ended June 30, 2023, compared to $3.5 million for the comparable period in 2022, a decrease of $0.3 million. The decrease was primarily related to lower professional service costs.
The company had approximately $71.4 million in cash and cash equivalents and short-term investments as of June 30, 2023, compared to $56.4 million in cash and cash equivalents as of December 31, 2022. Cash and cash equivalents and short-term investments at June 30, 2023 included net cash proceeds received from the Securities Purchase Agreement entered into on April 28, 2023.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (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, 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
EXHIBIT 99.1
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-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
Media Contact:
Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com
Source: Eledon Pharmaceuticals
EXHIBIT 99.1
ELEDON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
(Unaudited)
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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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$ |
40,947 |
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$ |
56,409 |
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Short-term investments |
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30,431 |
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— |
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Prepaid expenses and other current assets |
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2,244 |
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3,109 |
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Total current assets |
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73,622 |
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59,518 |
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Operating lease asset, net |
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553 |
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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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224 |
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150 |
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Total assets |
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$ |
106,785 |
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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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$ |
2,197 |
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$ |
2,200 |
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Current operating lease liabilities |
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390 |
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363 |
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Accrued expenses and other liabilities |
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2,313 |
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3,912 |
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Total current liabilities |
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4,900 |
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6,475 |
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Deferred tax liabilities |
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1,752 |
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1,752 |
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Non-current operating lease liabilities |
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184 |
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383 |
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Total liabilities |
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6,836 |
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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 June 30, |
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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, |
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— |
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— |
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Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, |
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23 |
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14 |
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Additional paid-in capital |
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323,142 |
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287,034 |
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Accumulated deficit |
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(223,216 |
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(202,865 |
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Total stockholders’ equity |
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99,949 |
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84,183 |
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Total liabilities and stockholders’ equity |
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$ |
106,785 |
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$ |
92,793 |
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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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2023 |
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2022 |
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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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$ |
7,201 |
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$ |
5,743 |
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$ |
15,314 |
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$ |
12,378 |
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General and administrative |
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3,153 |
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3,540 |
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6,150 |
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6,764 |
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Total operating expenses |
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10,354 |
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9,283 |
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21,464 |
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19,142 |
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Loss from operations |
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(10,354 |
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(9,283 |
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(21,464 |
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(19,142 |
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Other income, net |
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775 |
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36 |
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1,113 |
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31 |
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Net loss and comprehensive loss |
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$ |
(9,579 |
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$ |
(9,247 |
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$ |
(20,351 |
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$ |
(19,111 |
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Net loss per share, basic and diluted |
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$ |
(0.40 |
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$ |
(0.65 |
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$ |
(1.06 |
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$ |
(1.34 |
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Weighted-average common shares outstanding, basic and diluted |
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24,006,549 |
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14,265,905 |
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19,173,080 |
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14,299,969 |
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