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 March 31, 2023

☐	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: 001-40237

GAIN THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Delaware		85-1726310
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

4800 Montgomery Lane, Suite 220
Bethesda, Maryland		20814
(Address of principal executive offices)		(Zip Code)

(301) 500-1556

(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 $0.0001 per share	GANX	Nasdaq Stock Market LLC

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

As of April 30, 2023, the registrant had 12,328,846 shares of common stock outstanding.

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TABLE OF CONTENTS


PART I	FINANCIAL INFORMATION	5

Item 1	Condensed Consolidated Financial Statements	5

	Condensed Consolidated Balance Sheets (Unaudited)	5

	Condensed Consolidated Statements of Operations (Unaudited)	6

	Condensed Consolidated Statements of Comprehensive (Loss) (Unaudited)	7

	Condensed Consolidated Statement of Stockholders’ Equity (Unaudited)	8

	Condensed Consolidated Statements of Cash Flows (Unaudited)	10

	Notes to Condensed Consolidated Financial Statements (Unaudited)	11

Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	29

Item 3	Quantitative and Qualitative Disclosures About Market Risk	37

Item 4	Controls and Procedures	37

PART II	OTHER INFORMATION	38

Item 1	Legal Proceedings	38

Item 1A	Risk Factors	38

Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	76

Item 3	Defaults Upon Senior Securities.	76

Item 4	Mine Safety Disclosures	76

Item 5	Other Information	76

Item 6	Exhibits	77

Signatures		78

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and are often characterized by the use of words such as “aim”, “believe,” “can,” “could,” “potential,” “plan,” “predict,” “goals,” “seek,” “should,” “may,” “may have,” “would,” “estimate,” “continue,” “anticipate,” “intend,” “expect” or the negative of these terms, other comparable terminology or by discussions of strategy, plans or intentions. These include, but are not limited to, statements about:

●

the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs;

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the success of our efforts to expand our pipeline of product candidates and develop marketable products through the use of our in-licensed Site-Directed Enzyme Enhancement Therapy, or SEE-Tx®, platform;

●

our ability to develop, obtain regulatory approval for and commercialize our current and future product candidates;

●

our expectations regarding collaborations and other agreements with third parties and their potential benefits;

●

the timing of investigational new drug, or IND, submissions, initiation of preclinical studies and clinical trials, and timing of expected clinical results for our product candidates;

●

our success in early preclinical studies, which may not be indicative of results obtained in later studies or clinical trials;

●

the potential benefits of our product candidates;

●

our ability to identify patients with the diseases treated by our product candidates, and to enroll healthy volunteers and patients in clinical trials;

●

our ability to obtain, maintain and protect our intellectual property;

●

our reliance upon intellectual property licensed from third parties, including the license to use the SEE-Tx® platform;

●

our ability to identify, recruit and retain key personnel;

●

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, including our anticipated cash runway;

●

our financial performance;

●

developments or projections relating to our competitors or our industry;

●

the impact of laws and regulations;

●

our expectations regarding government and third-party payor coverage and reimbursement;

●

our expectations regarding the time during which we will be an emerging growth company under the JOBS Act;

●

the impact of worsening macroeconomic conditions, including heightened global inflation, actions taken by central banks to counter inflation, liquidity concerns at and failures of banks and other financial

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institutions, capital market instability, exchange rate fluctuations, supply chain disruptions and increases in commodity, energy and fuel prices;

●

the impacts of the COVID-19 pandemic (or other pandemics or endemics) including on our operations, access to capital, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers, and collaborators with whom we conduct business;

●

the impact of other global events, including political instability, natural disaster, events of terrorism and wars, including the war between Ukraine and Russia, and the corresponding tensions created from such conflict between Russia, the United States and countries in Europe as well as other countries such as China; and

●

other factors and assumptions described in this Quarterly Report.

You should read this Quarterly Report with the understanding that such forward-looking statements involve known and unknown risks, expectations, uncertainties, assumptions, estimates and projections about our company and other important factors that could cause our actual results, performance or achievements, actual industry results, or other actual results or events to differ materially from historical results, from any plans, intentions, or expectations disclosed in such forward-looking statements or from any future results, performance, achievements or other events expressed, suggested or implied by such forward-looking statements. Therefore, you should not rely on any forward-looking information or statements as predictors of future results or events. Factors that could cause or contribute to such differences in results and events include, without limitation, those specifically addressed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” in this Quarterly Report and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (“Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on March 23, 2023. The effect of these factors is difficult to predict. In addition, factors other than these could also adversely affect our results, and the reader should not consider these factors to be a complete set of all potential risks or uncertainties. New factors emerge from time to time, and management cannot assess the impact of any such factor on our business or the extent to which any factor, or combination of factors, may cause results or events to differ materially from those contained in any forward-looking statement.

Any forward-looking statements included herein speak only as of the date of this Quarterly Report, and we undertake no obligation to update any forward-looking information or statements for any reason after the date of this Quarterly Report to conform these statements to actual results or changes in expectations, except as required by law. All forward-looking statements attributable to us are expressly qualified by the foregoing cautionary statements.

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Item 1. Financial Statements.

PART I—FINANCIAL INFORMATION

GAIN THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)


	March 31,		December 31,
	2023		2022
Assets
Current assets:
Cash and cash equivalents	$	5,988,202	$	7,311,611
Marketable securities - current		11,827,528		12,826,954
Tax credits		137,383		103,877
Prepaid expenses and other current assets		1,368,871		848,854
Total current assets	$	19,321,984	$	21,091,296

Non-current assets:
Marketable securities - non current	$	988,388	$	1,941,488
Property and equipment, net		144,636		144,379
Internal-use software		208,913		213,967
Operating lease - right of use assets		609,877		659,933
Restricted cash		31,122		30,818
Long-term deposits and other non-current assets		17,655		17,506
Total non-current assets		2,000,591		3,008,091
Total assets	$	21,322,575	$	24,099,387

Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	2,213,489	$	1,626,100
Operating lease liability - current		232,507		229,080
Other current liabilities		2,599,763		2,106,756
Deferred income		—		55,180
Loans - current		109,200		108,135
Total current liabilities	$	5,154,959	$	4,125,251

Non-current liabilities:
Defined benefit pension plan	$	164,568	$	157,580
Operating lease liability - non-current		385,922		441,784
Loans - non-current		478,296		495,258
Total non-current liabilities		1,028,786		1,094,622
Total liabilities	$	6,183,745	$	5,219,873

Stockholders’ equity
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; nil shares issued and outstanding as of March 31, 2023 and December 31, 2022.		—		—
Common stock, $0.0001 par value: 50,000,000 shares authorized; 12,087,142 issued and outstanding as of March 31, 2023; 11,883,368 issued and outstanding as of December 31, 2022.		1,209		1,189
Additional paid-in capital		58,694,827		57,358,895
Accumulated other comprehensive income		96,310		35,627
Accumulated deficit		(38,516,197)		(20,925,459)
Loss for the period		(5,137,319)		(17,590,738)
Total stockholders’ equity		15,138,830		18,879,514
Total liabilities and stockholders’ equity	$	21,322,575	$	24,099,387