angn-20240630

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_____________________________________________

FORM 10-Q

_____________________________________________


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

For the quarterly period ended June 30, 2024


☐			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 001-39990

Elicio Therapeutics, Inc.

(Exact name of registrant as specified in its charter)


Delaware									11-3430072
(State or other jurisdiction of incorporation or organization)									(I.R.S. Employer Identification No.)

451 D Street, 5th Floor Boston, Massachusetts									02210
(Address of Principal Executive Offices)									(Zip Code)

(857) 209-0050

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, par value $0.01	ELTX	The Nasdaq Global 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 and post 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 ☒

The number of shares of the registrant’s common stock outstanding as of August 9, 2024 was 10,774,574.


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PART I FINANCIAL INFORMATION			Page
Item 1. Financial Statements			5
Condensed Consolidated Balance Sheets (unaudited)			5
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)			6
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ (Deficit) Equity (unaudited)			7
Condensed Consolidated Statements of Cash Flows (unaudited)			9
Notes to Unaudited Interim Condensed Consolidated Financial Statements			10
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations			27
Item 3. Quantitative and Qualitative Disclosures			35
Item 4. Controls and Procedures			35
PART II OTHER INFORMATION
Item 1. Legal Proceedings			37
Item 1A. Risk Factors			38
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			39
Item 3. Defaults Upon Senior Securities			39
Item 4. Mine Safety Disclosures			39
Item 5. Other Information			39
Item 6. Exhibits			40
Signatures			41

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Forward-Looking Statements

This Quarterly Report on Form 10-Q, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical fact, including statements concerning our business strategy and plans, future operating results and financial position, as well as our objectives and expectations for our future operations, are forward-looking statements.

In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

•our financial condition, including our ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, our ability to continue as a going concern and our cash runway;

•the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

•our ability to utilize our platform to develop a pipeline of product candidates to address unmet needs in cancer and infectious disease;

•the timing, progress and results of clinical trials for ELI-002, and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, and the timing, progress and results of our research and development programs;

•the timing, scope and likelihood of regulatory filings and approvals, including timing of Investigational New Drug applications and U.S. Food and Drug Administration (“FDA”) approval of ELI-002 and any future product candidates;

•the timing, scope or likelihood of foreign regulatory filings and approvals;

•our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies;

•our manufacturing, commercialization, and marketing capabilities and strategy;

•the need to hire additional personnel and our ability to attract and retain such personnel;

•the size of the market opportunity for our product candidates, including estimates of the number of patients who suffer from the diseases we are targeting;

•expectations regarding the approval and use of our product candidates in combination with other drugs;

•expectations regarding potential for accelerated approval or other expedited regulatory designation;

•our competitive position and the success of competing therapies that are or may become available;

•our anticipated research and development activities and projected expenditures;

•existing regulations and regulatory developments in the United States, Europe and other jurisdictions;

•the extent to which global economic and political developments, including the ongoing conflict between Ukraine and Russia, the conflicts in the Middle East, geopolitical tensions with China, and other geopolitical events, will affect our business operations, clinical trials, or financial condition;

•our expectations regarding other macroeconomic trends;

•our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering ELI-002, other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;

•our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for clinical trials;

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•our ability to have manufactured sufficient supplies of drug product for clinical testing and commercialization;

•our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

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

•our projected financial performance;

•our anticipated use of proceeds from any financing activities;

•the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our planned operating expenses and capital expenditure requirements; and

•the impact of laws and regulations.

We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss these risks in greater detail in our Annual Report on Form 10-K filed with the SEC on March 29, 2024, as amended, and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. In addition, statements such as “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into or review of all relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely on these statements.

This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business and the markets for certain drugs, including data regarding the estimated size of those markets, their projected growth rates and the incidence of certain medical conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.

In this Quarterly Report on Form 10-Q, unless the context indicates otherwise, the terms “Company,” “we,” “us,” and “our” refer to Elicio Therapeutics, Inc. and our wholly-owned subsidiaries.

Trademarks

This Quarterly Report on Form 10-Q includes trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this Quarterly Report on Form 10-Q are the property of their respective owners. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

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Part I FINANCIAL INFORMATION

Item 1. Financial Statements

ELICIO THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(unaudited)


	June 30, 2024		December 31, 2023
Assets
Current assets
Cash and cash equivalents	$	3,425	$	12,894
Restricted cash, current	396		722
Prepaid expenses and other current assets	2,868		2,732
Total current assets	6,689		16,348
Property and equipment, net	597		717
Operating lease, right-of-use assets	6,142		6,563
Restricted cash, noncurrent	690		685
Other long-term prepaid assets	1,632		2,833
Total assets	$	15,750	$	27,146
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	1,055	$	4,369
Accrued expenses	5,321		3,757


Deferred research obligation	350		694
Operating lease liability, current	854		910
Unvested option exercise liability, current	5		25
Total current liabilities	7,585		9,755
Warrant liability	4,252		11
Operating lease liability, noncurrent	5,565		6,007

Total liabilities	17,402		15,773
Commitments and contingencies - Note 10
Stockholders' (deficit) equity:
Preferred stock, $0.01 par value; 10,000,000 shares authorized at June 30, 2024 and December 31, 2023; no shares issued and outstanding at June 30, 2024 and December 31, 2023	—		—
Common stock, $0.01 par value; 300,000,000 shares authorized at June 30, 2024 and December 31, 2023; 10,273,328 shares and 9,618,178 shares issued at June 30, 2024 and December 31, 2023, respectively; 10,258,873 and 9,603,723 outstanding as of June 30, 2024 and December 31, 2023, respectively	103		96
Treasury stock, at cost, 14,455 shares outstanding as of June 30, 2024 and December 31, 2023	(150)		(150)
Additional paid-in capital	159,892		153,827
Accumulated other comprehensive loss	(238)		(197)
Accumulated deficit	(161,259)		(142,203)
Total stockholders' (deficit) equity	(1,652)		11,373
Total liabilities and stockholders' (deficit) equity	$	15,750	$	27,146

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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ELICIO THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023




Operating expenses:


Research and development	$	8,180	$	4,944	$	15,739	$	10,428
General and administrative	2,744		2,833		5,426		5,154
Total operating expenses	10,924		7,777		21,165		15,582
Loss from operations	(10,924)		(7,777)		(21,165)		(15,582)
Other income (expense)
Change in fair value of warrant liability	3,616		(23)		2,338		(23)
Loss on issuance of pre-funded warrants	—		—		(578)		—
Change in fair value of embedded derivatives	—		321		—		429
Gain on extinguishment of promissory notes payable	—		604		—		604

Gain on sale of equipment	—		—		3		—
Foreign exchange transaction (loss) gain	(9)		(9)		144		(9)
Interest income	137		39		287		51
Interest expense	(49)		(714)		(85)		(1,056)
Total other income (expense), net	3,695		218		2,109		(4)
Net loss	(7,229)		(7,559)		(19,056)		(15,586)
Other comprehensive gain (loss):
Foreign currency translation adjustment	32		(2)		(41)		(2)
Comprehensive loss	$	(7,197)	$	(7,561)	$	(19,097)	$	(15,588)
Net loss per common share, basic and diluted (1)	$	(0.64)	$	(2.61)	$	(1.77)	$	(9.65)
Weighted average common shares and pre-funded warrants outstanding, basic and diluted (1)	11,284,853		2,893,244		10,779,389		1,615,772

(1) As described in Note 2 to these Condensed Consolidated Financial Statements, the Company has revised the net loss per common share and weighted average common shares outstanding for 2023.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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ELICIO THERAPEUTICS, INC.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ (Deficit) Equity

(in thousands, except share amounts)

(unaudited)


	Convertible Preferred Stock			Common Stock			Treasury Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' (Deficit) Equity
	Shares	Amount		Shares	Amount		Shares	Amount
Balance as of December 31, 2023	—	$	—	9,603,723	$	96	(14,455)	$	(150)	$	153,827	$	(197)	$	(142,203)	$	11,373
Issuance of common stock from At-the-Market offering, net of issuance costs of $103	—	—		615,363	6		—	—		5,056		—		—		5,062
Issuance of common stock upon settlement of restricted stock units	—	—		903	—		—	—		11		—		—		11
Stock-based compensation	—	—		—	—		—	—		324		—		—		324
Foreign currency translation adjustment	—	—		—	—		—	—		—		(73)		—		(73)
Net loss	—	—		—	—		—	—		—		—		(11,827)		(11,827)
Balance as of March 31, 2024	—	$	—	10,219,989	$	102	(14,455)	$	(150)	$	159,218	$	(270)	$	(154,030)	$	4,870
Exercise of stock options	—	—		3,391	—		—	—		13		—		—		13
Issuance of common stock upon settlement of restricted stock units	—	—		677	—		—	—		9		—		—		9
Issuance of common stock from At-the-Market offering, net of issuance costs of $6	—	—		34,816	1		—	—		302		—		—		303
Stock-based compensation	—	—		—	—		—	—		350		—		—		350
Foreign currency translation adjustment	—	—		—	—		—	—		—		32		—		32
Net loss	—	—		—	—		—	—		—		—		(7,229)		(7,229)
Balance as of June 30, 2024	—	$	—	10,258,873	$	103	(14,455)	$	(150)	$	159,892	$	(238)	$	(161,259)	$	(1,652)

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	Convertible Preferred Stock			Common Stock			Treasury Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' (Deficit)
	Shares	Amount		Shares	Amount		Shares	Amount
Balance as of December 31, 2022 (1)	4,997,920	$	111,060	320,281	$	3	—	$	—	$	4,860	$	—	$	(107,008)	$	(102,145)
Exercise of stock options	—	—		4,699	—		—	—		40		—		—		40
Issuance of common stock upon settlement of restricted stock units	—	—		2,601	—		—	—		34		—		—		34
Stock-based compensation	—	—		—	—		—	—		224		—		—		224
Net loss	—	—		—	—		—	—		—		—		(8,029)		(8,029)
Balance as of March 31, 2023	4,997,920	111,060		327,581	3		—	—		5,158		—		(115,037)		(109,876)
Exercise of stock options	—	—		4,460	—		—	—		—		—		—		—
Issuance of common stock upon settlement of restricted stock units	—	—		903	—		—	—		11		—		—		11
Conversion of preferred stock	(4,997,920)	(111,060)		4,997,920	50		—	—		111,010		—		—		111,060
Issuance of common stock to Angion stockholders as result of Merger and reset to par of $0.01, net of transaction cost of $2.4 million	—	—		3,012,854	30		—	—		19,709		—		—		19,739
Settlement of promissory notes in connection with the Merger	—	—		—	—		—	—		10,028		—		—		10,028
Issuance of common stock upon accelerated vesting of restricted stock units due to Merger, net of treasury stock	—	—		26,550	1		—	—		26		—		—		27
Return of common stock to pay withholding taxes on restricted stock	—	—		—	—		(14,455)	(150)		—		—		—		(150)
Stock-based compensation	—	—		—	—		—

SEC Form 10-Q filed by Elicio Therapeutics Inc.