Galecto Inc
For the period ended Sep 30, 2024. Filed Nov 1, 2024.
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Sep 30, 2024 · Filed Nov 1, 2024
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Notes to Unaudited Interim Condensed Consolidated Financial Statements
Notes to the Condensed Consol idated Financial Statements
- 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 focus is on the development of small molecule inhibitors for the treatment of cancer and severe liver diseases.
As of September 30, 2024, the Company’s wholly owned subsidiaries were PharmAkea, Inc., a Delaware corporation (“PharmAkea”), Galecto Securities Corporation, a Massachusetts corporation, and Galecto Biotech AB, a Swedish company. Galecto Biotech ApS, a Danish operating company, is a wholly-owned subsidiary of Galecto Biotech AB.
Strategic Shift in Business Strategy
In September 2023, the Company undertook an organizational restructuring and determined to conduct a comprehensive exploration of strategic alternatives. In consultation with experienced financial and legal advisors, a comprehensive strategic alternative review process began immediately and evaluated a broad range of options to maximize shareholder value through broad outreach to life sciences companies and a thorough process of evaluation of prospective strategic partners. This review of strategic alternatives resulted in the execution of the Asset Purchase Agreement (as defined below) in October 2024 with Bridge Medicines LLC (“Bridge Medicines”) to acquirethe global rights to Bridge Medicines’ BRM-1420 program, a novel dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (“AML”), and assumed certain of Bridge Medicines’ liabilities associated with the acquired assets (the “Asset Purchase”). For additional details, see Note 14 to the Company’s unaudited interim condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
As a result of the conclusion of the strategic alternatives review process, the Company’s focus is now on the development of GB1211 and the addition of BRM-1420 from Bridge Medicines. As part of the strategic alternative review process, the Company determined not to further advance GB2064, its LOXL-2 inhibitor candidate, at this time.
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.
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 and sales of the Company's common stock in "at-the-market" offerings.
As of September 30, 2024, the Company had an accumulated deficit of$270.8 million from recurring losses since inception in 2011. The Company has incurred recurring losses and has not generated revenue as no products have obtained the necessary regulatory approval in order to market products. The Company expects to continue to incur losses as a result of costs and expenses related to the
Company’s clinical development and corporate general and administrative activities. The Company had negative cash flows from operating activities during the nine months ended September 30, 2024 and 2023 of $13.7 million and $25.4 million, respectively, and current projections indicate that the Company will have continued negative cash flows for the foreseeable future as it continues to fund operating expenses. Net losses incurred for the three and nine months ended September 30, 2024 were$3.9 million and$14.7 million, respectively. Net losses incurred for the three and nine months ended September 30, 2023 were$8.1 million and$31.9 million, respectively.
As of September 30, 2024, the Company’s cash and cash equivalents amounted to$19.7 million, current assets amounted to $21.2 million and current liabilities amounted to $2.4 million. At December 31, 2023, the Company’s cash, cash equivalents and marketable securities amounted to $33.2 million, current assets amounted to $36.8 million and current liabilities amounted to $5.8 million.
In September 2023, the Company announced the Restructuring Plan (as defined below) 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 then existing headcount. In May 2024, the Company's Board of Directors approved an additional reduction ofeight employees in an effort to conserve cash resources. As of June 30, 2024, the Company incurred $4.4 million in charges relating to these reductions in workforce, consisting primarily of cash-based expenses related to employee severance and notice period payments, benefits and related costs. These activities were substantially complete as of June 30, 2024 and the Company didnot incur any restructuring costs for the three months ended September 30, 2024.
Reverse Stock Split
On August 29, 2024, the Company effected a 1-for-25 reverse stock split of its issued and outstanding common stock. Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this reverse stock split. All fractional shares resulting from the reverse stock split were rounded up to the nearest whole number.
- 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, 2024 and for the three and nine months ended September 30, 2024 and 2023, 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, 2024, results of operations, statement of stockholders’ equity for the three and nine months ended September 30, 2024 and 2023 and its cash flows for the nine months ended September 30, 2024 and 2023. 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, 2023, as filed with the Securities and Exchange Commission on March 8, 2024 (the “2023 Consolidated Financial Statements”). The results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results expected for the full fiscal year or any interim period.
For the nine months ended September 30, 2024, there have been no material changes to the significant accounting policies as disclosed in Note 2 to the 2023 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.
- 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.
The Company hadno available-for-sale investments as of September 30, 2024. A summary of the Company’s available-for-sale investments as of December 31, 2023 consisted of the following (in thousands):
| Amortized | Gross Unrealized | Gross Unrealized | Fair | |
|---|---|---|---|---|
| Marketable securities: | Cost | Gains | Losses | Value |
| Corporate bonds | $11,720 | $— | $(34) | $11,686 |
| Total | $11,720 | $— | $(34) | $11,686 |
- PROPERTY AND EQUIPMENT, NET
Property and equipment as of September 30, 2024 consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Equipment | $107 | $107 |
| Less: accumulated depreciation | (45) | (29) |
| Equipment, net | $62 | $78 |
Depreciation expense for the three and nine months ended September 30, 2024 was $6,000 and $16,000, respectively. Depreciation expense for thethree and nine months ended September 30, 2023 was $211,000 and $246,000, respectively.
- FAIR VALUE MEASUREMENTS
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs.
The Company classified its money market funds within Level 1 because their fair values are based on their quoted market prices. The Company classified its debt securities within Level 2 because their fair values are determined using alternative pricing sources or models that utilized market observable inputs.
A summary of the assets that are measured at fair value as of September 30, 2024 and December 31, 2023 is as follows (in thousands):
| Assets: | CarryingValue | Quoted Prices inActive Marketsfor IdenticalAssets(Level 1) | SignificantotherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) |
|---|---|---|---|---|
| Money market funds(1) | $8,856 | $8,856 | $— | $— |
| Debt securities | — | — | — | — |
| Total | $8,856 | $8,856 | $— | $— |
| Assets: | CarryingValue | Quoted Prices inActive Marketsfor IdenticalAssets(Level 1) | SignificantotherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) |
| Money market funds(1) | $13,610 | 13,610 | — | — |
| Debt securities | 11,686 | — | 11,686 | — |
| Total | $25,296 | $13,610 | $11,686 | $— |
(1)
Money market funds with maturities of 90 days or less at the date of purchase are included within cash and cash equivalents in the accompanying condensed consolidated balance sheets and are recognized at fair value.
- PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consist of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Research and development tax credit receivable | $949 | $1,438 |
| Prepaid insurance costs | 89 | 774 |
| Value-added tax refund receivable | 256 | 280 |
| Contract research and development costs | 73 | 1,046 |
| Other | 133 | 85 |
| Total prepaid expenses and other current assets | $1,500 | $3,623 |
- LEASES
The Company has the following operating leases:
| Location | Primary Use | Lease Expiration Date | Renewal Option |
|---|---|---|---|
| Copenhagen, Denmark | Corporate headquarters | November 2024 | None |
The Company has no finance leases and has elected to apply the short-term lease exception to all leases of one year or less. Rent expense for the three and nine months ended September 30, 2024 was $0.05 million and $0.2 million, respectively. Rent expense for thethree and nine months ended September 30, 2023 was $0.2 million and $0.5 million, respectively.
Quantitative information regarding the Company’s leases for thethree and nine months ended September 30, 2024 and 2023 was as follows:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| Lease Cost | 2024 | 2023 | 2024 | 2023 |
| Operating lease cost (in thousands) | $49 | $135 | $192 | $411 |
| Other Information | ||||
| Operating cash flows paid for amounts included in the measurement of lease liabilities (in thousands) | $50 | $121 | $190 | $394 |
| Operating lease liabilities arising from obtaining right-of-use assets (in thousands) | $— | $— | $— | $— |
As of September 30, 2024 and December 31, 2023, the weighted average remaining lease term for operating leases was 0.2 years and 0.9 years, respectively.
As of September 30, 2024 and December 31, 2023, the weighted average discount rate for operating leases was 8% for both periods.
Operating lease liabilities at September 30, 2024 are as follows (in thousands):
| Operating | |
|---|---|
| Future Lease Payments | Leases |
| 2024 (excluding the period ended September 30, 2024) | $33 |
| 2025 | — |
| 2026 | — |
| 2027 | — |
| 2028 | — |
| Total lease payments | 33 |
| Less: imputed interest | (1) |
| Total lease liabilities | $32 |
- ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued expenses and other current liabilities consist of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Employee compensation costs | $809 | $987 |
| Contract research and development costs | 247 | 685 |
| Restructuring costs | 230 | 1,734 |
| Operating lease liabilities, current | 32 | 183 |
| Other liabilities | 620 | 539 |
| Total accrued expenses and other current liabilities | $1,938 | $4,128 |
- COMMITMENTS AND CONTINGENCIES
During the three and nine months ended September 30, 2024, there were no material changes to the Company’s commitments and contingencies as disclosed in Note 9 of the 2023 Consolidated Financial Statements. Further, the Company’s commitments related to lease agreements are disclosed in Note 7 to the Company’s unaudited interim condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
- STOCK-BASED COMPENSATION
Employee Equity Plan
In March 2020, the Company's Board of Directors and stockholders approved the 2020 Stock Option and Grant Plan (“2020 Plan”). Holders of stock options under the 2020 Plan shall be entitled to exercise the vested portion of the stock option during the term of the grant. If a qualified exit, as defined in the 2020 Plan, occurs before the stock option vests, then all of the holders' unvested options shall vest immediately.
In October 2020, the Company's Board of Directors and stockholders approved the 2020 Equity Incentive Plan (“2020 Equity Plan”). Following the adoption of the 2020 Equity Plan, no further options are available to be issued under the 2020 Plan. Stock-based awards granted under the 2020 Equity Plan generally vest over afour-year period and expireten years from the grant date. Shares available for grant under the 2020 Equity Plan will cumulatively increase by 5 percent of the number of shares of common stock issued and outstanding on January 1 steach year until 2030. At September 30, 2024, the Company had 164,785 shares available for future grant under the 2020 Equity Plan.
The following table sets forth the activity for the Company’s stock options during thenine months ended September 30, 2024:
| Number ofOptions | Weighted-averageexerciseprice pershare | Weighted-averageremainingcontractualterm(in years) | Aggregateintrinsicvalue | |
|---|---|---|---|---|
| Outstanding at December 31, 2023 | 275,478 | $114.40 | 6.7 | $— |
| Granted | 4,320 | 12.25 | — | 130 |
| Cancelled | (97,593) | 103.56 | — | — |
| Outstanding at September 30, 2024 | 182,205 | $117.78 | 6.3 | $— |
| Vested and expected to vest at September 30, 2024 | 172,493 | $116.87 | 6.3 | $— |
| Vested and exercisable at September 30, 2024 | 160,204 | $126.10 | 6.0 | $— |
The weighted-average grant date fair value of all stock-based awards granted for the nine months ended September 30, 2024 was $9.47 per share. The intrinsic value at September 30, 2024 and December 31, 2023 was based on the closing price of the Company’s common stock on these dates of $12.15 and $18.00 per share, respectively.
In November 2022, the Company's Board of Directors approved the 2022 Inducement Plan (the “Inducement Plan”), which allows for the grant of equity awards to be made to new employees where the equity award is a material inducement to an employee entering into employment with the Company. The Inducement Plan was adopted by the Company's Board of Directors without stockholder approval pursuant to Nasdaq Listing Rule 5635(c)(4). A total of 10,000 shares of the Company's common stock have been reserved for issuance under the Inducement Plan. As of September 30, 2024, no shares have been issued under the Inducement Plan.
Restricted Stock Units
In January 2024, the Company granted 34,200 restricted stock units (“RSUs”) to its employees under the 2020 Equity Plan. The weighted average grant date fair value of the time-based RSUs was $17.75 for thenine months ended September 30, 2024.The RSUs vest 33% afterone-year from the grant date and 17% everysix-months thereafter, subject to continued service to the Company through the applicable vesting dates. For thethree and nine months ended September 30, 2024, the Company recognized $99,000 and $193,000 expense related to the RSUs, respectively.
The following table sets forth the activity for the Company’s RSUs during thenine months ended September 30, 2024:
| Restricted Stock Units | Weighted-averagegrant date fair value | |
|---|---|---|
| Total nonvested units at December 31, 2023 | — | $— |
| Granted | 34,200 | 17.75 |
| Vested | (6,828) | 17.75 |
| Cancelled | (10,772) | 17.75 |
| Total nonvested units at September 30, 2024 | 16,600 | $17.75 |
Stock-Based Compensation
The grant date fair value of stock-based awards vested during the nine months ended September 30, 2024 and 2023 was $3.0 million and $5.0 million, respectively. Total unrecognized compensation expense related to unvested options granted under the Company’s stock-based compensation plan was $0.8 million at September 30, 2024, which is expected to be recognized over a weighted average period of 1.2 years. The Company recorded stock-based compensation expense related to the issuance of stock as follows (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $70 | $712 | $887 | $2,082 |
| General and administrative | 611 | 752 | 2,044 | 2,255 |
| Total stock-based compensation | $681 | $1,464 | $2,931 | $4,337 |
The Company uses a Black-Scholes option pricing model to determine fair value of its stock options. The Black-Scholes option pricing model includes various assumptions, including the fair value of common stock, expected life of stock options, the expected volatility based on the historical volatility of a publicly traded set of peer companies and the expected risk-free interest rate based on the implied yield on a U.S. Treasury security.
The fair values of the options granted were estimated using the following assumptions:
| Nine Months Ended | ||
|---|---|---|
| September 30, | ||
| 2024 | 2023 | |
| Risk-free interest rate | 4.2% | 3.8% |
| Expected term (in years) | 5.3 | 6.0 |
| Expected volatility | 99.3% | 91.0% |
| Expected dividend yield | — | — |
- RESTRUCTURING ACTIVITIES
In September 2023, the Company’s Board of Directors approved a restructuring plan (the “Restructuring Plan”) to reduce the Company’s operating costs and better align its workforce with the needs of its business. The Restructuring Plan eliminated approximately 70% of the Company’s workforce. In May 2024, the Company's Board of Directors approved an additional reduction ofeight employees in an effort to conserve cash resources (the “May RIF”).
Employees affected by the Restructuring Plan and the May RIF obtained involuntary termination benefits pursuant to a one-time benefit arrangement. For employees who have no requirements to provide future service, the Company recognized the liability for the termination benefits in full at fair value at the time of termination. For employees who are required to render services beyond a minimum retention period to receive their one-time termination benefits, the Company recognized the termination benefits ratably over their future service periods. For the Restructuring Plan, the Company recorded employee termination benefit charges during the year ended December 31, 2023 of $3.4 million and has included such charges as operating expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. For the May RIF, the Company recorded employee termination benefit charges during the three and nine months ended September 30, 2024 of $1.0 million and has included such charges as operating expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.
Restructuring costs pertaining to the Restructuring Plan and the May RIF consist of the following (in thousands):
| Balance at December 31, 2022 | $— |
|---|---|
| Restructuring expenses incurred | 3,448 |
| Payments | (1,593) |
| Non-cash charges | (121) |
| Balance at December 31, 2023 | 1,734 |
| Restructuring expenses incurred | 968 |
| Payments | (2,472) |
| Balance at September 30, 2024 | $230 |
The Company incurred an impairment charge related to a leased facility of $0.03 million during the year ended December 31, 2023 resulting from the Restructuring Plan.
In September 2023, the Board of Directors approved arrangements designed to provide that the Company will have the continued dedication and commitment of its remaining employees, including executives, determined to be key to the Company’s planned go-forward operations. The Board of Directors approved, and management implemented, a retention program for employees remaining with the Company which includes cash retention bonuses totaling $1.2 million for certain retained employees, provided that they remain within the Company through various requisite service periods. As a result, these cash retention bonuses are being accrued over the requisite service period. The Company’s arrangement with its Chief Executive Officer specified that he was only entitled to a cash bonus upon the timely achievement of certain corporate and strategic milestones for the Company, which were not achieved by September 30, 2024. During the period ended September 30, 2024, the Company's retention accrual was $0.2 million. During the year ended December 31, 2023, the Company's retention accrual was $0.4 million.
- INCOME TAXES
As a result of the Company's history of net operating losses ("NOL"), the Company continues to maintain a full valuation allowance against its domestic net deferred tax assets. For the three and nine months ended September 30, 2024, the Company recognized an income tax expense of $0.04 million, primarily due to foreign income tax expense.
- NET LOSS PER SHARE
Basic and diluted net loss per share is calculated as follows (in thousands except share and per share amounts):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Net loss | $(3,883) | $(8,136) | $(14,698) | $(31,874) |
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 1,144,978 | 1,084,191 | 1,104,849 | 1,055,679 |
| Net loss per common share, basic and diluted | $(3.39) | $(7.50) | $(13.30) | $(30.19) |
The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as their effect is anti-dilutive:
| Nine Months EndedSeptember 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options to purchase common stock | 182,206 | 292,010 |
| Restricted stock units | 16,600 | — |
- SUBSEQUENT EVENTS
On October 7, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Bridge Medicines pursuant to which the Company acquired global rights to Bridge Medicines’ BRM-1420 program, a novel dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of AML, and assumed certain of Bridge Medicines’ liabilities associated with the acquired assets (the “Asset Purchase”). As consideration to Bridge Medicines for the Asset Purchase, the Company (a) issued to Bridge Medicines (i)62,594 shares of the Company’s common stock and (ii)160.562 shares of the Company’s newly designated Series A non-voting convertible preferred stock, par value $0.00001 per share (the “Preferred Stock”) and (b) assumed specified liabilities. The closing of the Asset Purchase occurred on October 7, 2024. The total cost of the Asset Purchase was $4.4 million, including the fair value of the common stock, the fair value of the convertible preferred stock, the assumed specified liabilities and transaction costs.
The terms of the Preferred Stock are as set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock. Each share of Preferred Stock is convertible into 1,000 shares of common stock at the election of the holder of such Preferred Stock, subject to, and contingent upon, the approval by the Company’s stockholders to approve, for purposes of the Nasdaq Stock Market Rules, the issuance of the Company’s common stock upon conversion of the Preferred Stock (the “Stockholder Approval”). Furthermore, on the third business day following the Company’s receipt of Stockholder Approval, each outstanding share of Preferred Stock shall, subject to certain beneficial ownership limitations, automatically convert into 1,000 shares of common stock upon the conversion terms set forth in the Certificate of Designation. Except as required by law, the Preferred Stock has no voting rights, provided that the Company shall not, without the affirmative vote or written consent of the holders of majority of then outstanding Preferred Stock, among other things, alter or change adversely the power, preferences or rights given to the Preferred Stock, amend the Certificate of Designation, issue additional shares of Preferred Stock, consummate certain transactions prior to Stockholder Approval, amend or terminate the support agreements entered into by the Company’s directors and officers, or amend or fail to comply with certain provisions of the Purchase Agreement.
Carl Goldfischer, Chairman of the Company’s Board of Directors is also the Executive Chairman of Bridge Medicines.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.