10-Q
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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, 2023

OR

 

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: 001-39655

 

GALECTO, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

37-1957007

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

 

 

Ole Maaloes Vej 3

DK-2200 Copenhagen N

Denmark

N/A

 

 

75 State Street, Suite 100

Boston, MA 02109

02109

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (+45) 70 70 52 10

 

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 $0.00001 per share

 

GLTO

 

The Nasdaq Global Select 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, 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 1, 2023, the registrant had 27,112,697 shares of common stock, $0.00001 par value per share, outstanding.

 

 


 

Table of Contents

 

Page

 

PART I. FINANCIAL INFORMATION

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

4

Condensed Consolidated Balance Sheets

4

Condensed Consolidated Statements of Operations and Comprehensive Loss

5

Condensed Consolidated Statements of Changes in Stockholders’ Equity

6

Condensed Consolidated Statements of Cash Flows

8

Notes to Unaudited Interim Condensed Consolidated Financial Statements

9

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

30

 

 

 

 

PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

34

Item 3.

Defaults Upon Senior Securities

35

Item 4.

Mine Safety Disclosures

35

Item 5.

Other Information

35

Item 6.

Exhibits

36

Signatures

37

 

 

 

 

i


 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report on Form 10-Q. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “project,” “continue,” “potential,” “ongoing,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding:

 

our plans and expectations regarding our strategic alternative review process that we announced in September 2023 and the timing and success of such process, including the completion of a potential transaction;
timing of and costs associated with our restructuring, and the savings benefits we except to receive from the corporate restructuring that we announced in September 2023;
our ability to retain the continued service of our directors, officers, key employees and consultants;
our ability to maintain the listing of our common stock on the Nasdaq Stock Market;
the success, cost and timing of our product development activities and planned initiation and completion of clinical trials of our product candidates, including GB1211 and GB2064;
our ability to obtain regulatory approval for our current or future product candidates that we may identify or develop;
our ability to ensure adequate supply of our current or future product candidates;
our ability to maintain third-party relationships necessary to conduct our business;
our ability to establish an adequate safety or efficacy profile for our current or future product candidates that we may pursue;
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
the rate and degree of market acceptance and clinical utility for our current or future product candidates we may develop;
our estimates about the size of our market opportunity;
our estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
our ability to maintain and establish collaborations;
our financial performance and liquidity;
developments relating to our competitors and our industry, including the impact of government regulation;
our ability to maintain adequate internal controls over financial reporting;
the effects of global economic uncertainty and financial market volatility caused by economic effects of rising inflation and interest rates, geopolitical instability, changes in international trade relationships and conflicts, such as the ongoing conflict between Russia and Ukraine and the current armed conflict in Israel and the Gaza Strip, on any of the foregoing or other aspects of our business or operations; and
other risks and uncertainties, including those listed under the section titled “Risk Factors.”

 

These statements relate to future events or to our future financial performance and 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 these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, the reasons described elsewhere in this Quarterly Report on Form 10-Q and those set forth in Part I, Item 1A - “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. 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 place undue reliance on these forward-looking statements. 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.

 

 

ii


 

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 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. In some cases, we do not expressly refer to the sources from which these data are derived.

 

Except where the context otherwise requires, in this Quarterly Report on Form 10-Q, “we,” “us,” “our,” “Galecto,” and the “Company” refer to Galecto, Inc. and, where appropriate, its consolidated subsidiaries.

 

Trademarks

 

We have applied for various trademarks that we use in connection with the operation of our business. 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. Solely for convenience, the trademarks and trade names in this report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

 

 

iii


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

GALECTO, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

(unaudited)

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

23,078

 

 

$

32,786

 

Marketable securities

 

 

21,100

 

 

 

27,438

 

Prepaid expenses and other current assets

 

 

2,876

 

 

 

3,686

 

Total current assets

 

 

47,054

 

 

 

63,910

 

Marketable securities, non-current

 

 

 

 

 

5,832

 

Operating lease right-of-use asset

 

 

453

 

 

 

810

 

Equipment, net

 

 

125

 

 

 

357

 

Other assets, non-current

 

 

2,417

 

 

 

2,279

 

Total assets

 

$

50,049

 

 

$

73,188

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

4,477

 

 

$

3,350

 

Accrued expenses and other current liabilities

 

 

8,078

 

 

 

7,757

 

Total current liabilities

 

 

12,555

 

 

 

11,107

 

Operating lease liabilities, non-current

 

 

112

 

 

 

328

 

Total liabilities

 

 

12,667

 

 

 

11,435

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, par value of $0.00001 per share; 10,000,000 shares authorized
     at September 30, 2023 and December 31, 2022;
no shares issued or outstanding
    as of September 30, 2023 and December 31, 2022

 

 

 

 

 

 

Common stock, par value of $0.00001 per share; 300,000,000 shares authorized
     at September 30, 2023 and December 31, 2022;
27,112,697 and 25,652,392 shares
     issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

 

 

 

 

Additional paid-in capital

 

 

286,946

 

 

 

279,733

 

Accumulated deficit

 

 

(249,610

)

 

 

(217,736

)

Accumulated other comprehensive loss

 

 

46

 

 

 

(244

)

Total stockholders’ equity

 

 

37,382

 

 

 

61,753

 

Total liabilities and stockholders' equity

 

$

50,049

 

 

$

73,188

 

See accompanying notes to the unaudited interim condensed consolidated financial statements.

 

4


 

Galecto, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

2,551

 

 

$

10,494

 

 

$

21,002

 

 

$

37,436

 

General and administrative

 

 

3,304

 

 

 

3,128

 

 

 

9,504

 

 

 

10,246

 

Restructuring costs

 

 

2,728

 

 

 

 

 

 

2,728

 

 

 

 

Total operating expenses

 

 

8,583

 

 

 

13,622

 

 

 

33,234

 

 

 

47,682

 

Loss from operations

 

 

(8,583

)

 

 

(13,622

)

 

 

(33,234

)

 

 

(47,682

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

473

 

 

 

221

 

 

 

1,349

 

 

 

438

 

Loss on sale of marketable securities

 

 

 

 

 

 

 

 

 

 

 

(70

)

Foreign exchange transaction gain (loss), net

 

 

(26

)

 

 

(329

)

 

 

11

 

 

 

(241

)

Total other income, net

 

 

447

 

 

 

(108

)

 

 

1,360

 

 

 

127

 

Net loss

 

$

(8,136

)

 

$

(13,730

)

 

 

(31,874

)

 

 

(47,555

)

Net loss per common share, basic and diluted

 

$

(0.30

)

 

$

(0.54

)

 

$

(1.21

)

 

$

(1.88

)

Weighted-average number of shares used in computing net loss
   per common share, basic and diluted

 

 

27,104,777

 

 

 

25,491,786

 

 

 

26,391,987

 

 

 

25,342,153

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

Currency translation gain (loss)

 

 

127

 

 

 

(344

)

 

 

117

 

 

 

(1,233

)

Unrealized gain (loss) on marketable securities

 

 

56

 

 

 

(82

)

 

 

173

 

 

 

(442

)

Reclassification adjustment for loss included in net income

 

 

 

 

 

 

 

 

 

 

 

70

 

Other comprehensive gain (loss), net of tax

 

 

183

 

 

 

(426

)

 

 

290

 

 

 

(1,605

)

Total comprehensive loss

 

$

(7,953

)

 

$

(14,156

)

 

$

(31,584

)

 

$

(49,160

)

 

See accompanying notes to the unaudited interim condensed consolidated financial statements.

5


 

Galecto, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

For the Three Months Ended

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated Other
Comprehensive

 

 

Total
Stockholders’

 

September 30, 2023

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at June 30, 2023

 

 

27,021,899

 

 

$

 

 

$

285,311

 

 

$

(241,474

)

 

$

(137

)

 

$

43,700

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,464

 

 

 

 

 

 

 

 

 

1,464

 

Issuance of common stock; net of issuance costs of $0.1 million

 

 

90,798

 

 

 

 

 

 

171

 

 

 

 

 

 

 

 

 

171

 

Other comprehensive gain, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

183

 

 

 

183

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,136

)

 

 

 

 

 

(8,136

)

Balance at September 30, 2023

 

 

27,112,697

 

 

$

 

 

$

286,946

 

 

$

(249,610

)

 

$

46

 

 

$

37,382

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months Ended

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated Other
Comprehensive

 

 

Total
Stockholders’

 

September 30, 2022

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at June 30, 2022

 

 

25,342,138

 

 

$

 

 

$

276,501

 

 

$

(189,937

)

 

$

(1,499

)

 

$

85,065

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,398

 

 

 

 

 

 

 

 

 

1,398

 

Issuance of common stock; net of issuance costs

 

 

238,891

 

 

 

 

 

 

420

 

 

 

 

 

 

 

 

 

420

 

Other comprehensive loss, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(426

)

 

 

(426

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(13,730

)

 

 

 

 

 

(13,730

)

Balance at September 30, 2022

 

 

25,581,029

 

 

$

 

 

$

278,319

 

 

$

(203,667

)

 

$

(1,925

)

 

$

72,727

 

 

See accompanying notes to the unaudited interim condensed consolidated financial statements.

 

 

 

 

6


 

Galecto, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

For the Nine Months Ended

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated Other
Comprehensive

 

 

Total
Stockholders’

 

September 30, 2023

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at December 31, 2022

 

 

25,652,392

 

 

$

 

 

$

279,733

 

 

$

(217,736

)

 

$

(244

)

 

$

61,753

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

4,337

 

 

 

 

 

 

 

 

 

4,337

 

Issuance of common stock; net of issuance costs of $0.2 million

 

 

1,460,305

 

 

 

 

 

 

2,876

 

 

 

 

 

 

 

 

 

2,876

 

Other comprehensive gain, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

290

 

 

 

290

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(31,874

)

 

 

 

 

 

(31,874

)

Balance at September 30, 2023

 

 

27,112,697

 

 

$

 

 

$

286,946

 

 

$

(249,610

)

 

$

46

 

 

$

37,382

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Nine Months Ended

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated Other
Comprehensive

 

 

Total
Stockholders’

 

September 30, 2022

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at December 31, 2021

 

 

25,261,832

 

 

$

 

 

$

273,655

 

 

$

(156,112

)

 

$

(320

)

 

$

117,223

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

4,222

 

 

 

 

 

 

 

 

 

4,222

 

Issuance of common stock; net of issuance costs of $0.2 million

 

 

319,197

 

 

 

 

 

 

442

 

 

 

 

 

 

 

 

 

442

 

Other comprehensive loss, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,605

)

 

 

(1,605

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(47,555

)

 

 

 

 

 

(47,555

)

Balance at September 30, 2022

 

 

25,581,029

 

 

$

 

 

$

278,319

 

 

$

(203,667

)

 

$

(1,925

)

 

$

72,727

 

 

 

 

 

 

 

 

 

 

 

7


 

GALECTO, INC.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(31,874

)

 

$

(47,555

)

Adjustment to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

246

 

 

 

21

 

Stock-based compensation

 

 

4,337

 

 

 

4,222

 

Amortization of premiums and discounts on marketable securities

 

 

(406

)

 

 

447

 

Net loss on sale of marketable securities

 

 

 

 

 

70

 

Amortization of right of use lease asset

 

 

355

 

 

 

305

 

Accretion of lease liability

 

 

40

 

 

 

36

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

812

 

 

 

7,802

 

Other assets, noncurrent

 

 

(141

)

 

 

(785

)

Accounts payable

 

 

1,127

 

 

 

376

 

Accrued expenses and other current liabilities

 

 

445

 

 

 

3,919

 

Operating lease liabilities

 

 

(378

)

 

 

(342

)

Net cash used in operating activities

 

 

(25,437

)

 

 

(31,484

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of marketable securities

 

 

(25,937

)

 

 

(40,656

)

Proceeds from sale of marketable securities

 

 

38,687

 

 

 

38,865

 

Purchases of property and equipment

 

 

 

 

 

(155

)

Net cash provided by (used in) investing activities

 

 

12,750

 

 

 

(1,946

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

2,876

 

 

 

442

 

Net cash provided by financing activities

 

 

2,876

 

 

 

442

 

Net decrease in cash and cash equivalents

 

 

(9,811

)

 

 

(32,988

)

Effect of exchange rate changes on cash and cash equivalents

 

 

103

 

 

 

(1,239

)

Cash and cash equivalents, beginning of period

 

 

32,786

 

 

 

62,563

 

Cash and cash equivalents, end of period

 

$

23,078

 

 

$

28,336

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

Cash paid for taxes

 

$

 

 

$

 

Supplemental disclosures of noncash activities:

 

 

 

 

 

 

Operating lease liabilities arising from obtaining right-of-use assets

 

$

 

 

$

449

 

 

See accompanying notes to the unaudited interim condensed consolidated financial statements.

8


 

GALECTO, INC.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

1. DESCRIPTION OF BUSINESS, ORGANIZATION AND LIQUIDITY

Business and Organization

Galecto, Inc., together with its consolidated subsidiaries (the “Company” or “Galecto”), is a clinical-stage biotechnology company developing novel therapeutics that are designed to target the biological processes that lie at the heart of fibrotic diseases and cancer. The Company’s initial focus is on the development of small molecule inhibitors of galectin-3 and lysyl oxidase-like 2 ("LOXL2”), which play key roles in regulating fibrosis and cancer.

As of September 30, 2023, the Company’s wholly owned subsidiaries were PharmAkea, Inc. or PharmAkea, Galecto Securities Corporation, and Galecto Biotech AB, a Swedish company. Galecto Biotech ApS, a Danish operating company, is a wholly-owned subsidiary of Galecto Biotech AB.

Risks and uncertainties

The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance reporting capabilities.

The Company’s product candidates are in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants.

In September 2023, the Company undertook an organizational restructuring and determined to conduct a comprehensive exploration of strategic alternatives. The restructuring and pursuit of strategic alternatives involves risks. There can be no assurance that the Company’s significantly reduced workforce will be sufficient to pursue the strategic alternatives and the development of the Company’s product candidates. Additionally, availability of suitable third parties with which to conduct contemplated strategic transactions may be limited and whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all is uncertain.

Liquidity and management plans

Since inception, the Company has devoted substantially all its efforts to business planning, research and development,

recruiting management and technical staff and raising capital, and has financed its operations primarily through the issuance of redeemable convertible preferred shares, debt financings, the Company’s initial public offering (“IPO”) and sales of the Company's common stock in "at-the-market" offerings.

As of September 30, 2023, the Company had an accumulated deficit of $249.6 million, from recurring losses since inception in 2011. The Company has incurred recurring losses and has no sales as none of its product candidates have obtained the necessary regulatory approval for commercialization and to be marketed as approved products. The Company expects to continue to incur losses following the Company’s reduced clinical development and corporate general and administrative activities resulting from the restructuring and its exploration of strategic alternatives. The Company had negative cash flows from operating activities during the nine months ended September 30, 2023 and 2022 of $25.4 million and $31.5 million, respectively, and current projections indicate that the Company will have continued negative cash flows for the foreseeable future. Net losses incurred for the three and nine months ended September 30, 2023 were $8.1 million and $31.9 million, respectively. Net losses incurred for the three and nine months ended September 30, 2022 were $13.7 million and $47.6 million, respectively.

9


 

At September 30, 2023, the Company’s cash, cash equivalents and marketable securities amounted to $44.2 million and current assets amounted to $47.1 million and current liabilities amounted to $12.6 million. At December 31, 2022, the Company’s cash, cash equivalents and marketable securities amounted to $66.1 million, current assets amounted to $63.9 million and current liabilities amounted to $11.1 million.

On September 26, 2023, the Company announced a restructuring plan to reduce the Company's operations to preserve financial resources, resulting in a reduction of the Company’s workforce by up to 29 people, or approximately 70% of the Company's existing headcount. As a result, the Company estimates that it will incur approximately $3.4 million in restructuring charges in connection with the restructuring, consisting primarily of cash-based expenses related to employee severance and notice period payments, benefits and related costs. The Company incurred restructuring charges of $2.7 million in the third quarter of 2023 and expects that the execution of the restructuring plan will be substantially complete by the end of the fourth quarter of 2023.

 

Additionally, the Company has initiated a process to evaluate strategic alternatives in order to maximize stockholder value. As part of the strategic review process, the Company is exploring potential strategic alternatives that include, without limitation, an acquisition, merger, business combination or other transactions. The Company is also exploring strategic alternatives related to its product candidates and related assets, including, without limitation, licensing transactions and asset sales. There can be no assurance that the strategic review process will result in the Company pursuing a transaction, or that any transaction, if pursued, will be completed on terms favorable to the Company and its stockholders.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The accompanying interim condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”).

The accompanying interim condensed consolidated financial statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022, and related interim information contained within the notes to the interim condensed consolidated financial statements, are unaudited. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s audited consolidated financial statements and include all adjustments (including normal recurring adjustments) necessary for the fair presentation of the Company’s financial position as of September 30, 2023, results of operations, statement of stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and its cash flows for the nine months ended September 30, 2023 and 2022. All intercompany balances and transactions have been eliminated. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and accompanying notes contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission (“SEC”) on March 9, 2023 ("2022 Consolidated Financial Statements"). The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results expected for the full fiscal year or any interim period.

For the nine months ended September 30, 2023, there have been no changes to the significant accounting policies as disclosed in Note 2 to the 2022 Consolidated Financial Statements.

Recently issued accounting standards

The Company periodically reviews new accounting standards that are issued and has not identified any new standards that it believes merit further discussion or would have a significant impact on its financial statements.

 

10


 

3. INVESTMENTS

Cash in excess of the Company’s immediate requirements is invested in accordance with the Company’s investment policy that primarily seeks to maintain adequate liquidity and preserve capital.

A summary of the Company’s available-for-sale investments as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands):

 

 

At September 30, 2023

 

 

 

Amortized

 

 

Gross Unrealized

 

 

Gross Unrealized

 

 

Fair

 

Marketable securities:

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

Corporate bonds

 

$

21,193

 

 

$

 

 

$

(93

)

 

$

21,100

 

Total

 

$

21,193

 

 

$

 

 

$

(93

)

 

$

21,100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

At December 31, 2022

 

 

 

Amortized

 

 

Gross Unrealized

 

 

Gross Unrealized

 

 

Fair

 

Marketable securities:

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

Corporate bonds

 

$

27,573

 

 

$

 

 

$

(135

)

 

$

27,438

 

Total

 

$

27,573

 

 

$

 

 

$

(135

)

 

$

27,438

 

Marketable securities, noncurrent:

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

$

5,963

 

 

$

 

 

$

(131

)

 

$

5,832

 

Total

 

$

5,963

 

 

$

 

 

$

(131

)

 

$

5,832

 

 

 

4. PROPERTY AND EQUIPMENT, NET

Property and equipment as of September 30, 2023 consisted of the following (in thousands):

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Equipment

 

$

430

 

 

$

419

 

Less: accumulated depreciation

 

 

(305

)

 

 

(62

)

Equipment, net

 

$

125