Form 10-Q - Quarterly report [Sections 13 or 15(d)]

P0YP0Y15609984741964484.52514.96Entero Therapeutics, 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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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, 2024


☐	TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

From the transition period from to

Commission File Number 001-37853

ENTERO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

46-4993860

(State or other jurisdiction of

incorporation or organization)

(I.R.S Employer

Identification No.)

777 Yamato Road, Suite 502
Boca Raton, Florida		33431
(Address of principal executive offices)		(Zip Code)

(561) 589-7020

(Registrant’s telephone number, including area code)

First Wave BioPharma, Inc.

(Former name, former address and former fiscal year, if changed since last report)

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


Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common stock, par value $0.0001 per share	ENTO	The 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 ☒

There were 4,754,030 shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”), outstanding as of November 8, 2024.

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		Page

PART I. FINANCIAL INFORMATION

Item 1.	Unaudited Condensed Consolidated Financial Statements	1

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	30

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	39

Item 4.	Controls and Procedures	39

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	40

Item 1A.	Risk Factors	40

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	41

Item 3.	Defaults Upon Senior Securities	41

Item 4.	Mine Safety Disclosures	42

Item 5.	Other Information	42

Item 6.	Exhibits	42

SIGNATURES

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Quarterly Report other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important 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.

The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about:

●

our ability to maintain compliance with the applicable listing requirements of The Nasdaq Capital Market;

●

our ability to satisfy our existing payment obligations and other payment obligations as they become due, including those related to the acquisition of First Wave Bio, Inc. and merger with ImmunogenX;

●

statements regarding the impact of geopolitical events, including the war in Ukraine and the Middle East, and their effects on our operations, access to capital, research and development and clinical trials and potential disruption in the operations and business of third-party vendors, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”), other service providers, and collaborators with whom we conduct business;

●

the availability of capital to satisfy our working capital requirements;

●

our current and future capital requirements and our ability to raise additional funds to satisfy our capital needs;

●

the integration and effects of our acquisitions, including the merger with ImmunogenX, and other strategic transactions;

●

the accuracy of our estimates regarding expense, future revenue and capital requirements;

●

our ability to continue operating as a going concern;

●

our plans to develop and commercialize our product candidates, including Adrulipase, Capeserod and Niclosamide;

●

our ability to initiate and complete our clinical trials and to advance our principal product candidates into additional clinical trials, including pivotal clinical trials, and successfully complete such clinical trials;

●

regulatory developments in the U.S. and foreign countries;

●

the performance of our third-party vendor(s), CROs, CDMOs and other third-party non-clinical and clinical development collaborators and regulatory service providers;

●

our ability to obtain and maintain intellectual property protection for our core assets;

●

the size of the potential markets for our product candidates and our ability to serve those markets;

●

the rate and degree of market acceptance of our product candidates for any indication once approved;

●

the success of competing products and product candidates in development by others that are or become available for the indications that we are pursuing;

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●

the loss of key scientific, clinical and nonclinical development, and/or management personnel, internally or from one of our third-party collaborators; and

●

other risks and uncertainties, including those listed under Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K.

Factors that may cause actual results to differ materially from current expectations include, among other things, those set forth in Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K and for the reasons described elsewhere in this Quarterly Report on Form 10-Q. Any forward-looking statement in this Quarterly Report on Form 10-Q reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Given these uncertainties, you should not rely on these forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

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 and consumer products, 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 these 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 and we have not independently verified the data from third party sources. In some cases, we do not expressly refer to the sources from which these data are derived.

In this Quarterly Report on Form 10-Q, unless otherwise stated or as the context otherwise requires, references to “Entero,” the “Company,” “we,” “us,” “our” and similar references are to Entero Therapeutics, Inc. and its subsidiaries on a consolidated basis. References to “FWB” refer to First Wave Bio, Inc. and references to “IMGX” refer to ImmunogenX, LLC, each of which are Entero’s wholly-owned subsidiaries.

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PART I

FINANCIAL INFORMATION

ITEM 1. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

In our opinion, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to present fairly our financial position, results of operations, and cash flows for the interim periods presented. We have consolidated such financial statements in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”). Therefore, such financial statements do not include all disclosures required by accounting principles generally accepted in the United States of America. In preparing these unaudited condensed consolidated financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through the date the unaudited condensed consolidated financial statements were issued by filing with the SEC.

These financial statements should be read in conjunction with our audited financial statements for the year ended December 31, 2023, included in our Annual Report filed on Form 10-K, filed with the SEC on March 29, 2024.

The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the fiscal year ending December 31, 2024.

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets


	September 30,
	2024		December 31,
	(unaudited)		2023
ASSETS

Current Assets:
Cash and cash equivalents	$	366,788	$	3,711,770
Prepaid expenses		305,461		1,244,466
Assets of disposal group held for sale		83,170,009		—
Total Current Assets		83,842,258		4,956,236

Property, equipment, and leasehold improvements, net		—		14,565

Other Assets:
Restricted cash		21,520		21,522
Goodwill		1,684,182		1,684,182
Operating lease right-of-use assets		144,410		195,440
Deposits		128,250		11,250
Total Other Assets		1,978,362		1,912,394
Total Assets	$	85,820,620	$	6,883,195

LIABILITIES, MEZZANINE EQUITY, AND STOCKHOLDERS’ EQUITY

Current Liabilities:
Accounts payable	$	2,214,946	$	554,277
Accrued expenses		219,193		825,290
Accrued dividend payable		1,258,450		1,069,616
Note payable		—		612,784
Operating lease liabilities		79,454		67,111
Other current liabilities		—		4,239
Liabilities of disposal group held for sale		11,918,261		—
Total Current Liabilities		15,690,304		3,133,317
Non-current operating lease liabilities		80,213		146,949
Total Liabilities		15,770,517		3,280,266

Mezzanine Equity:
Series G redeemable preferred stock- Par value $0.0001 per share; 13,000 shares designated; 12,373.226 and 0 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		61,681,100		—
Total Mezzanine Equity		61,681,100		—

Stockholders’ Equity:
Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 4,741,964 and 1,560,998 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		474		156
Series B preferred stock- Par value $0.0001 per share; 5,194.81 shares authorized; 484.52 and 514.96 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		—		—
Series C preferred stock- Par value $0.0001 per share; 75,000 shares authorized; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Series D preferred stock- Par value $0.0001 per share; 150 shares designated; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Series E preferred stock- Par value $0.0001 per share; 150 shares designated; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Series F preferred stock- Par value $0.0001 per share; 7,000 shares designated; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Additional paid-in capital		198,518,268		187,931,445
Accumulated deficit		(190,149,739)		(184,328,672)
Total Stockholders’ Equity		8,369,003		3,602,929
Total Liabilities, Mezzanine Equity and Stockholders’ Equity	$	85,820,620	$	6,883,195

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations (unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development expenses	$	206,999	$	1,011,055	$	882,522	$	3,725,833
General and administrative expenses		1,685,608		2,422,082		13,535,241		7,951,373
Total operating expenses		1,892,607		3,433,137		14,417,763		11,677,206

Loss from operations		(1,892,607)		(3,433,137)		(14,417,763)		(11,677,206)

Other expenses:
Interest income (expense), net		229		(1,021)		675		(13,108)
Other expense, net		(2,874)		—		(7,859)		(3,729)
Total other expenses		(2,645)		(1,021)		(7,184)		(16,837)

Loss before income tax benefit	$	(1,895,252)	$	(3,434,158)	$	(14,424,947)	$	(11,694,043)

Income tax benefit		—		—		10,604,640		—
Net loss from continuing operations	$	(1,895,252)	$	(3,434,158)	$	(3,820,307)	$	(11,694,043)

Loss from discontinued operations		(685,719)		—		(2,000,760)		—
Net loss	$	(2,580,971)	$	(3,434,158)	$	(5,821,067)	$	(11,694,043)

Preferred stock dividends		(84,632)		(49,292)		(150,776)		(231,047)
Net loss applicable to common shareholders	$	(2,665,603)	$	(3,483,450)	$	(5,971,843)	$	(11,925,090)

Weighted average shares outstanding, basic and diluted		4,552,019		378,301		3,005,055		188,175
Loss per share, basic and diluted	$	(0.59)	$	(9.21)	$	(1.99)	$	(63.37)
Loss per share from discontinued operations, basic and diluted	$	(0.15)	$	—	$	(0.67)	$	—

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders’ Equity (unaudited)


	Series G Convertible			Series B Convertible						Additional				Total
	Preferred Stock			Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, July 1, 2024	12,373	$	61,681,100	485	$	—	2,941,108	$	294	$	196,689,069	$	(187,568,768)	$	9,120,595
Issuance of common stock in connection with the exercise of warrants in the July 2024 Inducement Offering, net of offering costs	—		—	—		—	1,762,674		176		1,730,189		—		1,730,365
Deemed dividend of Series B preferred stock	—		—	—		—	—		—		(84,632)		—		(84,632)
Issuance of common stock from RSU vest	—		—	—		—	38,182		4		(4)		—		—
Stock-based compensation	—		—	—		—	—		—		183,646		—		183,646
Net loss	—		—	—		—	—		—		—		(2,580,971)		(2,580,971)
Balance, September 30, 2024	12,373	$	61,681,100	485	$	—	4,741,964	$	474	$	198,518,268	$	(190,149,739)	$	8,369,003


	Series B Convertible						Additional				Total
	Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, July 1, 2023	546	$	—	210,450	$	21	$	177,675,513	$	(176,793,574)	$	881,960
Issuance of common stock, pre-funded warrants and warrants in July 2023 offering, net of issuance costs	—		—	30,500		3		1,833,924		—		1,833,927
Issuance of common stock in connection with the exercise of warrants in the September 2023 Inducement Offering, net of offering costs	—		—	294,101		29		3,706,742		—		3,706,771
Exercise of pre-funded warrants into Common Stock	—		—	133,750		14		253		—		267
Deemed dividend of Series B preferred stock	—		—	—		—		(49,292)		—		(49,292)
Conversion of Series B preferred shares into common stock	(24)		—	22		—		—		—		—
Common stock issued to consultants	—		—	2,500		—		76,000		—		76,000
Issuance of Common Stock from RSU vest	—		—	1,851		—		—		—		—
Stock-based compensation	—		—	—		—		263,330		—		263,330
Net loss	—		—	—		—		—		(3,434,158)		(3,434,158)
Balance, September 30, 2023	522	$	—	673,174	$	67	$	183,506,470	$	(180,227,732)	$	3,278,805

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders’ Equity (unaudited)


	Series G Convertible			Series B Convertible						Additional				Total
	Preferred Stock			Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, January 1, 2024	—	$	—	515	$	—	1,560,998	$	156	$	187,931,445	$	(184,328,672)	$	3,602,929
Issuance of common stock, pre-funded warrants and warrants in registered direct offerings, net of issuance costs	—		—	—		—	448,100		44		4,495,482		—		4,495,526
Issuance of common stock in connection with the exercise of warrants in the July 2024 Inducement Offering, net of offering costs	—		—	—		—	1,762,674		176		1,730,189		—		1,730,365
Issuance of Series G convertible preferred stock upon acquisition of IMGX	11,777		57,790,474	—		—	—		—		—		—		—
Issuance of common stock upon acquisition of IMGX	—		—	—		—	36,830		4		2,300,496		—		2,300,500
Issuance of Series G convertible preferred stock to financial advisors	596		3,890,626	—		—	—		—		—		—		—
Issuance of common stock to financial advisors	—		—	—		—	18,475		2		120,646		—		120,648
Exercise of pre-funded warrants into common stock	—		—	—		—	443,525		45		—		—		45
Deemed dividend of Series B preferred stock	—		—	—		—	—		—		(188,834)		—		(188,834)
Conversion of Series B preferred shares into common stock	—		—	(30)		—	27		—		—		—		—
Common stock issued to consultants	—		—	—		—	350,000		35		1,541,960		—		1,541,995
Issuance of common stock from RSU vest	—		—	—		—	121,335		12		(12)		—		—
Stock-based compensation	—		—	—		—	—		—		586,896		—		586,896
Net loss	—		—	—		—	—		—		—		(5,821,067)		(5,821,067)
Balance, September 30, 2024	12,373	$	61,681,100	485	$	—	4,741,964	$	474	$	198,518,268	$	(190,149,739)	$	8,369,003


	Series B Convertible						Additional				Total
	Preferred Stock			Common Stock			Paid In		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Capital		Deficit		Equity
Balance, January 1, 2023	550	$	—	49,750	$	5	$	171,275,836	$	(168,533,689)	$	2,742,152
Issuance of common stock, pre-funded warrants and warrants in private placement, net of issuance costs	—		—	6,400		1		3,690,972		—		3,690,973
Issuance of Common Stock in connection with the exercise of warrants in the June 2023 Inducement Offering, net of offering costs	—		—	86,216		8		2,239,057		—		2,239,065
Issuance of common stock, pre-funded warrants and warrants in July 2023 offering, net of issuance costs	—		—	30,500		3		1,833,924		—		1,833,927
Issuance of common stock in connection with the exercise of warrants in the September 2023 Inducement Offering, net of offering costs	—		—	294,101		29		3,706,742		—		3,706,771
Exercise of pre-funded warrants into common stock	—		—	199,974		21		636		—		657
Deemed dividend of Series B preferred stock	—		—	—		—		(231,047)		—		(231,047)
Conversion of Series B preferred shares into common stock	(28)		—	26		—		—		—		—
Common stock issued to consultants	—		—	2,500		—		76,000		—		76,000
Issuance of common stock from RSU vest	—		—	3,854		—		—		—		—
Effect of cancelled shares from the 1-for-7 reverse stock split	—		—	(147)		—		—		—		—
Stock-based compensation	—		—	—		—		914,350		—		914,350
Net loss	—		—	—		—		—		(11,694,043)		(11,694,043)
Balance, September 30, 2023	522	$	—	673,174	$	67	$	183,506,470	$	(180,227,732)	$	3,278,805

See accompanying notes to unaudited condensed consolidated financial statements

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ENTERO THERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows (unaudited)


	Nine Months Ended September 30,
	2024		2023
Cash flows from operating activities:
Net loss	$	(5,821,067)	$	(11,694,043)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		48,946		21,955
Amortization of debt discount		5,848		—
Change in right-of-use assets		55,262		47,429
Stock-based compensation		586,896

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