Eledon Pharmaceuticals, Inc. [ELDN] Filings

10-Q 1 eldn-20220930.htm 10-Q 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-36620

ELEDON PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)


Delaware		20-1000967
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

19900 MacArthur Blvd., Suite 550 Irvine, California		92612
(Address of principal executive offices)		(Zip Code)

(949) 238-8090

Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value

ELDN

Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

As of November 10, 2022, there were 13,756,788 shares of the Registrant’s common stock outstanding.

CONFIDENTIAL

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995, which statements involve substantial risks and uncertainties. Any statements in this Quarterly Report on Form 10-Q about the Company’s future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, the review of strategic alternatives and the outcome of such review and other statements containing words such as “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “could,” “may,” and similar expressions, constitute forward-looking statements, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding:

•

our product development plans, expectations for and the timing of commencement, enrollment, completion, data, and release of results of clinical trials for our product candidates;

•

our estimates regarding expenses, capital requirements and needs for additional financing;

•

our strategies with respect to our preclinical and clinical development programs;

•

our plans, strategy and timing to obtain and maintain regulatory approvals of our product candidates; and

•

expectations about our future financial performance or condition.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors listed under “Risk Factor Summary” below. 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 described in greater detail in Part II, Item 1A. Risk Factors in this Quarterly Report on Form 10-Q.

Any forward-looking statements contained in this Quarterly Report on Form 10-Q speak only as of the date hereof and not as 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.

The market data and certain other statistical information used in this Quarterly Report are based on independent industry publications, governmental publications, reports by market research firms or other independent sources. Some data are also based on our good faith estimates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information.

RISK FACTOR SUMMARY

The following summarizes the principal factors that make an investment in the Company speculative or risky, all of which are more fully described in Part II, Item 1A, Risk Factors in this Quarterly Report on Form 10-Q. This summary should be read in conjunction with the Risk Factors section and should not be relied upon as an exhaustive summary of the material risks facing our business. The occurrence of any of these risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. You should consider all of the risk factors described in our public filings when evaluating our business.

•

Our short operating history and the acquisition of Anelixis Therapeutics, Inc. in September 2020 may make it difficult to evaluate the success of our business to date and to assess our future viability.

•

We have incurred significant operating losses since our inception and expect that we will continue to incur losses over the next several years and may never achieve or maintain profitability.

•

Our product candidates are in the early stages of clinical development and may not be successfully developed. If we are unable to successfully develop and commercialize these or any other product candidate, or if we experience significant delays in doing so, our business will be materially harmed.

•

The ongoing COVID-19 pandemic and actions taken in response to it may result in additional disruptions to our business operations, which could have a material adverse effect on our business.

•

Unfavorable global economic conditions could have a material adverse effect on our business.

•

Drug development involves a lengthy and expensive process with an uncertain outcome, including failure to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the formulation and commercialization of our product candidates.

•

The results of nonclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials, and there is a risk that additional nonclinical and/or clinical safety studies will be required by the U.S. Food and Drug Administration or similar regulatory authorities outside the United States or that subsequent studies will not match results seen in prior studies.

•

Delays or difficulties in the enrollment of patients in clinical trials could delay or prevent our receipt of necessary regulatory approvals and increase expenses for the development of our product candidates.

•

If serious adverse events or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of some of our product candidates.

•

We will require additional funding to be able to complete the development of our lead drug candidate. If we are unable to raise capital when needed, we may be forced to significantly alter our business strategy, substantially curtail our current operations, or liquidate and cease operations altogether.

•

Our future success depends on our ability to retain executives and key employees and to attract, retain and motivate qualified personnel in the future.

•

If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, or the approvals may be for a narrow indication, we may not be able to commercialize our product candidates, and our ability to generate revenue may be materially impaired.

•

Legislation regulating the pharmaceutical and healthcare industries may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.

•

Our internal computer systems, or those of our third-party collaborators, service providers, contractors or consultants, may fail or suffer security breaches, disruptions, or incidents, which could result in a material disruption of our development programs or loss of data or compromise the privacy, security, integrity or confidentiality of sensitive information related to our business and have a material adverse effect on our reputation, business, financial condition or results of operations.

•

Even if any of our product candidates receives marketing approval, we may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success.

•

If our current product candidates, or a future product candidate receives marketing approval and we, or others, later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, the ability to market the product could be compromised.

•

We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.

•

The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.

•

Our reliance on third parties for the manufacture of our product candidates for nonclinical and clinical trials, and for eventual commercialization, increases the risk that we will not have sufficient quantities of our product candidates or products at an acceptable cost and quality, which could delay, prevent or impair our development or commercialization efforts.

•

We depend on contract research organizations (“CROs”) and other contracted third parties to perform nonclinical and clinical testing and certain other research and development activities. As a result, the outcomes of the activities performed by these organizations will be, to a certain extent, beyond our control.

•

If we are unable to obtain and maintain intellectual property protection for our technology and products or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.

•

Our stock price could be volatile, and the market price of our common stock may drop unexpectedly.

•

If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.

•

Provisions in our corporate charter and under Delaware law could make an acquisition of the Company more difficult and may prevent attempts by our stockholders to replace or remove our current management.

ELEDON PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2022

Table of Contents


		Page

PART I.	FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements - Unaudited	6

	Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021	6

	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021	7

	Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and 2021	8

	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021	9

	Notes to Condensed Consolidated Financial Statements	10

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28

Item 4.	Controls and Procedures	28

PART II.	OTHER INFORMATION

Item 1.	Legal Proceedings	29

Item 1A.	Risk Factors	29

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	49

Item 3.	Defaults Upon Senior Securities	49

Item 4.	Mine Safety Disclosures	50

Item 5.	Other Information	50

Item 6.	Exhibits	51

Signatures		52

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

ELEDON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

(Unaudited)


	September 30, 2022			December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents	$	65,889		$	84,833
Prepaid expenses and other current assets		1,676			3,513
Total current assets		67,565			88,346
Operating lease asset, net		832			768
Goodwill		48,648			48,648
In-process research and development		32,386			32,386
Other assets		155			400
Total assets	$	149,586		$	170,548
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	3,859		$	1,813
Current operating lease liability		378			369
Accrued expenses and other liabilities		2,043			2,219
Total current liabilities		6,280			4,401
Deferred tax liability		1,752			1,752
Non-current operating lease liability		461			400
Total liabilities		8,493			6,553

Commitments and contingencies (Note 5)

Stockholders’ equity:
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 September 30, 2022 and December 31, 2021, respectively		—			—
Series X non-voting convertible preferred stock, $0.001 par value, 10,000 shares authorized; 6,204 shares issued and outstanding at September 30, 2022 and December 31, 2021		—			—
Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2022 and December 31, 2021; 13,756,788 and 14,306,788 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		14			14
Additional paid-in capital		285,560			278,880
Accumulated deficit		(144,481	)		(114,899	)
Total stockholders’ equity		141,093			163,995
Total liabilities and stockholders’ equity	$	149,586		$	170,548

See accompanying notes to unaudited condensed consolidated financial statements.

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 September 30,						For the Nine Months Ended September 30,
	2022			2021			2022			2021
Operating expenses
Research and development	$	7,452		$	7,658		$	19,830		$	17,553
General and administrative		3,146			2,848			9,910			9,929
Total operating expenses		10,598			10,506			29,740			27,482
Loss from operations		(10,598	)		(10,506	)		(29,740	)		(27,482	)
Other income, net		127			3			158			7
Loss before income tax benefit		(10,471	)		(10,503	)		(29,582	)		(27,475	)
Income tax benefit		—			686			—			1,775
Net loss and comprehensive loss	$	(10,471	)	$	(9,817	)	$	(29,582	)	$	(25,700	)
Net loss per share, basic and diluted	$	(0.73	)	$	(0.66	)	$	(2.07	)	$	(1.73	)
Weighted-average common shares outstanding, basic and diluted		14,265,905			14,815,852			14,289,729			14,820,822

See accompanying notes to unaudited condensed consolidated financial statements.

ELEDON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share data)

(Unaudited)



	Series X1 Non-Voting Convertible Preferred Stock				Series X Non-Voting Convertible Preferred Stock				Common Stock						Additional Paid-In		Accumulated
	Shares		Amount		Shares		Amount		Shares			Amount			Capital		Deficit			Total
Balance as of December 31, 2021		108,070	$	—		6,204	$	—		14,306,788		$	14		$	278,880	$	(114,899	)	$	163,995
Cancellation of common stock in connection with exchange for X1 non-voting convertible preferred stock		9,900		—		—		—		(550,000	)		—			1		—			1
Stock-based compensation		—		—		—		—		—			—			6,679		—			6,679
Net loss and other comprehensive loss		—		—		—		—		—			—			—		(29,582	)		(29,582	)
Balance as of September 30, 2022		117,970	$	—		6,204	$	—		13,756,788		$	14		$	285,560	$	(144,481	)	$	141,093

Balance as of June 30, 2022		117,970	$	—		6,204	$	—		13,756,788		$	14		$	283,375	$	(134,010	)	$	149,379
Stock-based compensation		—		—		—		—		—			—			2,185		—			2,185
Net loss and other comprehensive loss		—		—		—		—		—			—			—		(10,471	)		(10,471	)
Balance as of September 30, 2022		117,970	$	—		6,204	$	—		13,756,788		$	14		$	285,560	$	(144,481	)	$	141,093

Balance as of December 31, 2020		108,070	$	—		—	$	—		15,160,397		$	15		$	270,974	$	(80,393	)	$	190,596
Cancellation of common stock in connection with exchange for X non-voting convertible preferred stock		—		—		6,204		—		(344,666	)		—			—		—			—
Cancellation of common stock in connection with exchange for warrants		—		—		—		—		(509,117	)		(1	)		1		—			—
Stock-based compensation		—		—		—		—		—			—			5,851		—			5,851
Stock options exercised		—		—		—		—		174			—			1		—			1
Net loss and other comprehensive loss		—		—		—		—		—			—			—		(25,700	)		(25,700	)
Balance as of September 30, 2021		108,070	$	—		6,204	$	—		14,306,788		$	14		$	276,827	$	(106,093	)	$	170,748

Balance as of June 30, 2021		108,070	$	—		6,204	$	—		14,306,614		$	14		$	274,783	$	(96,276	)	$	178,521
Stock-based compensation		—		—		—		—		—			—			2,043		—			2,043
Stock options exercised		—		—		—		—		174			—			1		—			1
Net loss and other comprehensive loss		—		—		—		—		—			—			—		(9,817	)		(9,817	)
Balance as of September 30, 2021		108,070	$	—		6,204	$	—		14,306,788		$	14		$	276,827	$	(106,093	)	$	170,748

See accompanying notes to unaudited condensed consolidated financial statements.

ELEDON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)


	For the Nine Months Ended September 30,
	2022			2021
Operating activities
Net loss	$	(29,582	)	$	(25,700	)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of operating lease asset		280			134
Stock-based compensation		6,679			5,851
Deferred tax liabilities		—			(1,775	)
Changes in operating assets and liabilities:
Prepaid expenses and other assets		2,082			(55	)
Accounts payable and accrued expenses		1,871			1,980
Operating lease liability		(274	)		(140	)
Net cash used in operating activities		(18,944	)		(19,705	)
Financing activities
Proceeds from exercise of stock options		—			1
Offering costs in connection with PIPE transaction		—			(450	)
Net cash used in financing activities		—			(449	)
Net change in cash and cash equivalents		(18,944	)		(20,154	)
Cash and cash equivalents at beginning of period		84,833			114,195
Cash and cash equivalents at end of period	$	65,889		$	94,041

Eledon Pharmaceuticals, Inc. [ELDN] Filings
10-Q	[2022-11-14]
10-Q	[2022-08-11]
10-Q	[2022-05-12]
10-K	[2022-03-24]
10-Q	[2021-11-12]
10-Q	[2021-08-12]
10-Q	[2021-05-14]
10-K	[2021-03-31]
10-Q	[2020-11-16]
10-Q	[2020-08-14]
10-Q	[2020-05-15]
S-1	[2020-03-25]
10-K	[2020-03-17]
10-Q	[2019-11-13]
10-Q	[2019-08-13]
S-1	[2019-06-07]
10-Q	[2019-05-14]
10-K	[2019-03-28]
10-Q	[2018-11-13]
10-Q	[2018-08-07]
S-1	[2018-08-01]
10-Q	[2018-05-11]
10-K	[2018-04-02]
10-Q	[2017-11-08]
10-Q	[2017-08-09]
10-Q	[2017-05-03]
10-K	[2017-03-03]
10-Q	[2016-11-03]
10-Q	[2016-08-04]
10-Q	[2016-05-10]
10-K	[2016-03-10]
10-Q	[2015-11-10]
10-Q	[2015-08-12]
10-Q	[2015-05-12]
10-K	[2015-03-26]
10-Q	[2014-11-13]
S-1	[2014-08-11]