EX-99.1 2 eldn-ex99_1.htm EX-99.1 EX-99.1

EXHIBIT 99.1

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Eledon Pharmaceuticals Reports First Quarter 2024 Operating and Financial Results

 

Completed oversubscribed $50 million private placement

First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes

Reported updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation

Tegoprubart used as part of immunosuppressive treatment following the first-ever kidney xenotransplant

IRVINE, Calif., May 9, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2024 operating and financial results and reviewed recent business highlights.

“We are pleased with the significant progress made so far this year in the development of tegoprubart for use both in kidney transplantation and in the emerging fields of xenotransplantation and islet cell transplantation. This progress reinforces tegoprubart’s potential to become the first-line immunosuppressive treatment option of choice for a broad range of transplant procedures,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon.

First Quarter 2024 and Recent Corporate Developments

First participant in an investigator-led clinical trial has received an islet cell transplant and is being treated with a novel immunosuppression regimen including tegoprubart, the company’s novel anti-CD40L antibody, which is in development for the prevention of pancreatic islet cell transplant rejection in patients with type 1 diabetes. The study is being conducted by the research team at the University of Chicago’s Pancreatic and Islet Transplant Program in collaboration with Eledon, the Juvenile Diabetes Research Foundation, and The Cure Alliance.
Announced the use of tegoprubart as part of the immunosuppressive treatment regimen used following the first-ever kidney xenotransplant procedure of a genetically modified kidney from a pig to a human.
Enrolled the 12th participant in March 2024 in the ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
Completed a private placement financing for total gross proceeds of $50.0 million, before deducting any offering related expenses, to a select group of institutional and accredited investors at a price per share of $2.37.

 

 


EXHIBIT 99.1

Anticipated 2024 Milestones

June 2024: Report updated interim clinical data from the ongoing Phase 1b trial and open-label extension study of tegoprubart in kidney transplantation at the American Transplant Congress in Philadelphia, PA.
End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.

First Quarter 2024 Financial Results

The Company reported a net loss of $10.3 million, or $0.34 per share, for the three months ended March 31, 2024, compared to a net loss of $10.8 million, or $0.75 per share, for the same period in 2023.

Research and development expenses were $7.4 million for the three months ended March 31, 2024, compared to $8.1 million for the comparable period in 2023, a decrease of $0.7 million.

General and administrative expenses were $3.5 million for the three months ended March 31, 2024, compared to $3.0 million for the comparable period in 2023, an increase of $0.5 million.

Eledon ended the first quarter with approximately $42.9 million in cash, cash equivalents and short-term investments, which excludes the $50.0 million in gross proceeds received in the recently completed private placement.

 

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,”


EXHIBIT 99.1

“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.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

(Unaudited)

 

 

 

 

March 31,
2024

 

 

December 31,
2023

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

5,655

 

 

$

4,612

 

Short-term investments

 

 

37,207

 

 

 

46,490

 

Prepaid expenses and other current assets

 

 

5,115

 

 

 

5,027

 

Total current assets

 

 

47,977

 

 

 

56,129

 

Operating lease asset, net

 

 

270

 

 

 

365

 

In-process research and development

 

 

32,386

 

 

 

32,386

 

Other assets

 

 

185

 

 

 

186

 

Total assets

 

$

80,818

 

 

$

89,066

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,864

 

 

$

967

 

Current operating lease liabilities

 

 

284

 

 

 

383

 

Accrued expenses and other liabilities

 

 

2,099

 

 

 

2,545

 

Total current liabilities

 

 

4,247

 

 

 

3,895

 

Deferred tax liabilities

 

 

1,752

 

 

 

1,752

 

Total liabilities

 

 

5,999

 

 

 

5,647

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value, 5,000,000 shares authorized at March 31,
    2024 and December 31, 2023:

 

 

 

 

 

 

Series X1 non-voting convertible preferred stock, $0.001 par value,
   515,000 shares designated; 110,086 shares issued and outstanding
   at March 31, 2024 and December 31, 2023

 

 

 

 

 

 

Series X non-voting convertible preferred stock, $0.001 par value,
   10,000 shares designated; 4,422 shares issued and outstanding
   at March 31, 2024 and December 31, 2023

 

 

 

 

 

 

Common stock, $0.001 par value, 200,000,000 shares authorized at March 31,
    2024 and December 31, 2023; 24,813,130 and 24,213,130 shares issued and
    outstanding at March 31, 2024 and December 31, 2023, respectively

 

 

25

 

 

 

24

 

Additional paid-in capital

 

 

328,280

 

 

 

326,586

 

Accumulated deficit

 

 

(253,486

)

 

 

(243,191

)

Total stockholders’ equity

 

 

74,819

 

 

 

83,419

 

Total liabilities and stockholders’ equity

 

$

80,818

 

 

$

89,066

 

 

 


EXHIBIT 99.1

ELEDON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

For the Three Months
Ended March 31,

 

 

 

2024

 

 

2023

 

Operating expenses

 

 

 

 

 

 

Research and development

 

$

7,410

 

 

$

8,113

 

General and administrative

 

 

3,459

 

 

 

2,997

 

Total operating expenses

 

 

10,869

 

 

 

11,110

 

Loss from operations

 

 

(10,869

)

 

 

(11,110

)

Other income, net

 

 

574

 

 

 

338

 

Net loss and comprehensive loss

 

$

(10,295

)

 

$

(10,772

)

Net loss per share, basic and diluted

 

$

(0.34

)

 

$

(0.75

)

Weighted-average common shares outstanding, basic and diluted

 

 

29,989,400

 

 

 

14,285,905