UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
|
Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
For the quarterly period ended June 30, 2024
|
Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
For the transition period from to
Commission File No. 001-31791
|
|
|
|
(State or other jurisdiction of incorporation)
|
(I.R.S. Employer Identification No.)
|
|
|
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
(678 ) 620 -3186
(Registrant’s Telephone Number, Including Area Code)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
|
|
|
|
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, or 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
|
☐ |
|
|
☒ |
Smaller reporting company
|
|
|
Emerging growth company
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
The number of shares outstanding of the registrant’s common stock as of August 9, 2024 was 62,278,125 .
| PART I — FINANCIAL INFORMATION | PAGE |
|
|
ITEM 1.
|
Unaudited Condensed Consolidated Financial Statements (unaudited)
|
|
|
|
3
|
|
|
|
4
|
|
|
|
5
|
|
|
|
6
|
|
|
|
|
|
|
|
8
|
|
|
ITEM 2.
|
17
|
|
|
ITEM 3.
|
24
|
|
|
ITEM 4.
|
25
|
|
| PART II — OTHER INFORMATION | ||
|
ITEM 1.
|
25
|
|
|
ITEM 1A.
|
25
|
|
|
ITEM 2.
|
25
|
|
|
ITEM 3.
|
25
|
|
|
ITEM 4.
|
25
|
|
|
ITEM 5.
|
25
|
|
|
ITEM 6.
|
25
|
|
|
27
|
||
GALECTIN THERAPEUTICS INC.
|
|
June 30,
2024 |
December 31,
2023 |
||||||
|
|
(in thousands)
|
|||||||
|
ASSETS
|
||||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
|
$
|
|
||||
|
Prepaid expenses and other current assets
|
|
|
||||||
|
Total current assets
|
|
|
||||||
|
Other assets
|
|
|
||||||
|
Total assets
|
$
|
|
$
|
|
||||
|
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
|
$
|
|
||||
|
Accrued expenses and other
|
|
|
||||||
|
Accrued dividends payable
|
|
|
||||||
|
Total current liabilities
|
|
|
||||||
|
Convertible notes payable and accrued interest, net of discounts – related party (Note 3)
|
|
|
||||||
| Derivative liabilities (Note 4) |
|
|
||||||
|
Borrowing and accrued interest under convertible line of credit, net of debt discount – related party (Notes 9 and 10)
|
||||||||
|
Other liabilities
|
|
|
||||||
|
Total liabilities
|
|
|
||||||
|
Commitments and contingencies (Note 11)
|
||||||||
|
Series C super dividend redeemable convertible preferred stock;
|
|
|
||||||
|
Stockholders’ equity (deficit):
|
||||||||
|
Undesignated stock, $
|
|
|
||||||
|
Series A 12% convertible preferred stock;
|
|
|
||||||
|
Common stock, $
|
|
|
||||||
|
Additional paid-in capital
|
|
|
||||||
|
Retained deficit
|
(
|
)
|
(
|
)
|
||||
|
Total stockholders’ equity (deficit)
|
(
|
)
|
(
|
)
|
||||
|
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)
|
$
|
|
$
|
|
||||
See notes to unaudited condensed consolidated financial statements.
GALECTIN THERAPEUTICS INC.
|
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
||||||||||||||
|
|
2024
|
2023
|
2024
|
2023
|
||||||||||||
|
|
(in thousands, except per share
data)
|
(in thousands, except per share
data)
|
||||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
General and administrative
|
|
|
|
|
||||||||||||
|
Total operating expenses
|
|
|
|
|
||||||||||||
|
Total operating loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Other income (expense):
|
||||||||||||||||
|
Interest income
|
|
|
|
|
||||||||||||
|
Interest expense
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Change in fair value of derivative
|
|
|
(
|
)
|
(
|
)
|
||||||||||
|
Total other income (expense)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||
|
Preferred stock dividends
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Net loss applicable to common stockholders
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||
|
Net loss per common share — basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||
|
Weighted average common shares outstanding — basic and diluted
|
|
|
|
|
||||||||||||
See notes to unaudited condensed consolidated financial statements.
GALECTIN THERAPEUTICS INC.
|
|
Six Months Ended
June 30, |
|||||||
|
|
2024
|
2023
|
||||||
|
|
(in thousands)
|
|||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
|
Adjustments to reconcile net loss to net cash flows from operating activities:
|
||||||||
|
Stock-based compensation expense
|
|
|
||||||
|
Amortization of right to use lease asset
|
|
|
||||||
|
Non-cash interest expense
|
|
|
||||||
|
Change in fair value of derivative liabilities
|
|
|
||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Prepaid expenses and other assets
|
|
|
||||||
|
Accounts payable, accrued expenses and other liabilities
|
(
|
)
|
(
|
)
|
||||
|
Accrued interest on convertible debt - related party
|
||||||||
|
Net cash from operating activities
|
(
|
)
|
(
|
)
|
||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Net proceeds from convertible line of credit – related party
|
||||||||
| Net proceeds from exercise of common stock warrants |
||||||||
|
Net cash flows from financing activities
|
|
|
||||||
|
NET DECREASE IN CASH AND CASH EQUIVALENTS
|
(
|
)
|
(
|
)
|
||||
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
||||||
|
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
|
$
|
|
||||
|
NONCASH FINANCING ACTIVITIES:
|
||||||||
|
Payment of preferred stock dividends in common stock
|
$ | $ | ||||||
|
Reclassification of accrued bonus to additional paid in capital
|
|
|
||||||
|
Common stock purchase warrants issued in connection with related party line of credit
|
||||||||
See notes to unaudited condensed consolidated financial statements.
GALECTIN THERAPEUTICS INC.
STOCKHOLDERS’ EQUITY (DEFICIT) (UNAUDITED)
(amounts in thousands except share data)
|
|
Series C Super
Dividend Redeemable Convertible Preferred Stock |
|||||||
|
|
Number of
Shares |
Amount
|
||||||
|
Balance at December 31, 2022
|
|
$
|
|
|||||
|
Balance at June 30, 2023
|
|
$
|
|
|||||
|
Balance at December 31, 2023
|
|
$
|
|
|||||
|
Balance at June 30, 2024
|
|
$
|
|
|||||
|
|
Series A 12%
Convertible Preferred Stock |
Common Stock
|
||||||||||||||||||||||||||
|
|
Number
of Shares |
Amount
|
Number
of Shares |
Amount
|
Additional
Paid-In
Capital |
Retained
Deficit |
Total
Stockholders’ Equity (Deficit) |
|||||||||||||||||||||
|
Balance at March 31, 2023
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
|
Series A 12% convertible preferred stock dividend
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Series C super dividend redeemable convertible preferred
stock dividend
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Common stock purchase warrants issued in connection
with related party line of credit
|
||||||||||||||||||||||||||||
|
Stock-based compensation expense
|
|
|
||||||||||||||||||||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Balance at June 30, 2023
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
|
Balance at March 31, 2024
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
|
Series A 12% convertible preferred stock dividend
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Series C super dividend redeemable convertible preferred
stock dividend |
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Common stock purchase warrants issued in connection
with related party line of credit
|
||||||||||||||||||||||||||||
| Exercise of common stock options |
||||||||||||||||||||||||||||
| Exercise of common stock purchase warrants | ||||||||||||||||||||||||||||
|
Stock-based compensation expense
|
|
|
||||||||||||||||||||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Balance at June 30, 2024
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
See notes to unaudited condensed consolidated financial statements.
GALECTIN THERAPEUTICS INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) — (Continued)
For the Six Months Ended June 30, 2023 and 2024
(amounts in thousands except share data)
|
|
Series A 12%
Convertible Preferred Stock |
Common Stock
|
||||||||||||||||||||||||||
|
|
Number
of Shares |
Amount
|
Number
of Shares |
Amount
|
Additional
Paid-In
Capital |
Retained
Deficit |
Total
Stockholders’ Equity (Deficit) |
|||||||||||||||||||||
|
Balance at December 31, 2022
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
|
Series A 12% convertible preferred stock dividend
|
|
|
(
|
)
|
||||||||||||||||||||||||
|
Series C super dividend redeemable convertible preferred
stock dividend
|
|
|
(
|
)
|
( |
) | ||||||||||||||||||||||
|
Common stock purchase warrants issued in connection with related party line of credit
|
||||||||||||||||||||||||||||
|
Stock-based compensation expense
|
|
|
|
|||||||||||||||||||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Balance at June 30, 2023
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
|
Balance at December 31, 2023
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
|
Series A 12% convertible preferred stock dividend
|
|
|
(
|
)
|
||||||||||||||||||||||||
|
Series C super dividend redeemable convertible preferred stock dividend
|
|
|
(
|
)
|
||||||||||||||||||||||||
|
Exercise of common stock options
|
||||||||||||||||||||||||||||
|
Exercise of common stock purchase warrants
|
||||||||||||||||||||||||||||
|
Common stock purchase warrants issued in connection with related party line of credit
|
||||||||||||||||||||||||||||
|
Stock-based compensation expense, net of shares forfeited to cover tax withholding
|
|
|
|
|||||||||||||||||||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||||
|
Balance at June 30, 2024
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||||||
See notes to consolidated financial statements.
GALECTIN THERAPEUTICS INC.
1. Basis of Presentation, Liquidity and Going Concern
Galectin Therapeutics Inc. and subsidiaries (the “Company”) is a clinical stage biopharmaceutical company that is applying its leadership in galectin science and drug
development to create new therapies for fibrotic disease and cancer. These candidates are based on the Company’s targeting of galectin proteins which are key mediators of biologic and pathologic function. These compounds also may have application
for drugs to treat other diseases and chronic health conditions.
The unaudited condensed consolidated financial statements as reported in this Quarterly Report on Form 10-Q reflect all adjustments which are, in the opinion of
management, necessary to present fairly the financial position of the Company as of June 30, 2024 and the results of its operations for the three and six months ended June 30, 2024 and 2023 and its cash flows for the six months ended June 30,
2024 and 2023. All adjustments made to the interim financial statements include all those of a normal and recurring nature. Amounts presented in the condensed consolidated balance sheet as of December 31, 2023 are derived from the Company’s
audited consolidated financial statements as of that date, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. The Company
considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure.
Subsequent events have been evaluated through the date these financial statements are available to be issued. The results for interim periods are not necessarily indicative of results that may be expected for any other interim period or for the
full year. The unaudited condensed consolidated financial statements of the Company should be read in conjunction with its Annual Report on Form 10-K for the year ended December 31, 2023.
The Company has
operated at a loss since its inception and has had no revenues. The Company anticipates that losses will continue for the foreseeable future. At June 30, 2024, the company had $25,598 ,000 of unrestricted cash and cash equivalents available to fund future operations. In July 2022, the Company entered into a $60 million unsecured line of credit financing, which has been fully drawn at June 30, 2024, with its chairman, Richard E. Uihlein (See Note 9). Additionally, on March 29,
2024, the Company entered into a supplemental unsecured $10 million line of credit financing also provided by our chairman (See Note
10). The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations approximately through May 15, 2025. These factors raise substantial doubt about the Company’s ability to
continue as a going concern for a period of 12 months from the issuance date of these financial statements. The ability of the Company to continue as a going concern is likely dependent on the results of the Interim Analysis of the Company’s
NAVIGATE clinical trial expected in December 2024 and its ability to raise capital; however, the Company’s cash position may not be sufficient to support its daily operations in May 2025. To meet its future capital needs, the Company intends to
raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions. However, there can be no assurance that the Company will be able to complete any such transactions on acceptable terms or
otherwise. The inability of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition. The Company has the ability to
delay certain research activities and related clinical expenses if necessary due to liquidity concerns until a date when those concerns are relieved.
The Company was founded
in July 2000, was incorporated in the State of Nevada in January 2001 under the name “Pro-Pharmaceuticals, Inc.,” and changed its name to “Galectin Therapeutics Inc.” on May 26, 2011.
2. Accrued Expenses and Other
Accrued expenses consist of the following:
|
|
June 30,
2024 |
December 31,
2023 |
||||||
|
|
(in thousands)
|
|||||||
|
Legal and accounting fees
|
$
|
|
$
|
|
||||
|
Accrued compensation
|
|
|
||||||
|
Lease liability
|
|
|
||||||
|
Accrued research and development costs and other
|
|
|
||||||
|
|
$
|
|
$
|
|
||||
Research and development expenses, including personnel costs, allocated facility costs, lab supplies, outside services, contract laboratory costs related to
manufacturing drug product, clinical trials and preclinical studies are charged to research and development expense as incurred. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research
and development activities as expense when the service has been performed or when the goods have been received. Our current NAVIGATE clinical trial is being supported by third-party contract research organizations, or CROs, and other vendors. We
accrue expenses for clinical trial activities performed by CROs based upon the estimated amount of work completed on each trial. For clinical trial expenses and related expenses associated with the conduct of clinical trials, the significant
factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients have been enrolled in the trial. We monitor patient enrollment levels and related activities
to the extent possible through internal reviews, review of contractual terms and correspondence with CROs. We base our estimates on the best information available at the time. We monitor patient enrollment levels and related activities to the
extent possible through discussions with CRO personnel and based our estimates of clinical trial costs on the best information available at the time. However, additional information may become available to us which will allow us to make a more
accurate estimate in future periods. In that event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain.
3. Convertible Notes Payable – Related Party
On April 16, 2021, the Company and Richard
E. Uihlein entered into a debt financing arrangement whereby Mr. Uihlein loaned $10,000,000 to the Company. In consideration for the
loan, the Company issued a convertible promissory note (the “April 2021 Note”) in the principal amount of ten million dollars.
The April 2021 Note has a maturity date of April 16, 2025 , is
prepayable at the option of the Company in whole or in part at any time and is convertible into the Company’s common stock at a conversion price equal to $5.00 per share at the option of the noteholder. The April 2021 Note bears interest at the rate of two percent (2 %) per annum, compounded annually with an effective interest rate of approximately 3 %.
For the three months ended June 30, 2024 and 2023, approximately $53,000 and $52,000 , respectively, of interest expense was
accrued and included with the principal in the financial statements. For the six months ended June 30, 2024 and 2023, approximately $104,000
and $102,000 , respectively, of interest expense was accrued and included with the principal in the financial statements.
The April 2021 Note also includes a contingent interest component that requires the Company to pay additional interest at a rate of two and one-half percent (2.5 %) per quarter (10 % per annum)
(the “Additional Interest”) beginning on the date of issuance of this Note and ending on the maturity date, provided however, that such payment is only required if and only if the noteholder elects to convert the entire balance of the April
2021 Note into the Company’s common stock on or prior to maturity. As the contingent event is not based on creditworthiness, such feature is not clearly and closely related to the host instrument and accordingly must be bifurcated and
recognized as a derivative liability and a debt discount on the April 2021 Note at its inception. The fair value of the contingent interest derivative liability was $420,000 at note inception (April 16, 2021). The fair value of the contingent interest derivative liability was $789,000
and $366,000 at June 30, 2024 and December 31, 2023, respectively, and is recognized as a derivative liability in the consolidated
balance sheet. The change in the fair value of the derivative liability for the three months ended June 30, 2024 and 2023 of $(89,000 ) and $(221,000 ),
respectively, was charged to other expense/(income) for the three months ended June 30, 2024 and 2023. The change in the fair value of the derivative liability for the six months ended June 30, 2024 and 2023 of $358,000 and $117,000 , respectively,
was charged to other expense/(income) for the six months ended June 30, 2023 and 2022. The amortization of the original $420,000
debt discount of $26,000 and $26,000
was recorded as additional interest expense for the three months ended June 30, 2024 and 2023, respectively. The amortization of the original $420,000
debt discount of $52,000 and $52,000
was recorded as additional interest expense for the six months ended June 30, 2024 and 2023, respectively.
On May 14, 2024, Mr. Uihlein, as holder of the
April 2021 Note irrevocably elected to convert the entire principal amount of such note, plus accrued and unpaid interest, into shares of common stock of the Company at a price of $5.00 per share, effective as of April 16, 2025 , which is the maturity date
of the April 2021 Note. The April 2021 Note will remain outstanding and accrue interest until maturity and no shares of common
stock will be issued as a result of this election until April 16, 2025.
The September 2021 Note has a maturity date of September 17, 2025 ,
is prepayable at the option of the Company in whole or in part at any time and is convertible into the Company’s common stock at a conversion price equal to $8.64 per share at the option of the noteholder. The September 2021 Note bears interest at the rate of two percent (2 %) per annum, compounded annually with an effective interest rate of approximately 3 %.
For the three months ended June 30, 2024 and 2023, approximately $52,000 and $51,000 , respectively, of interest expense was
accrued and included with the principal in the financial statements. For the six months ended June 30, 2024 and 2023, approximately $104,000
and $101,000 , respectively, of interest expense was accrued and included with the principal in the financial statements.
The September 2021 Note also includes a contingent interest component that requires the Company to pay additional interest at a rate of two and one-half percent (2.5 %) per quarter (10 % per annum)
(the “Additional Interest”) beginning on the date of issuance of this Note and ending on the maturity date, provided however, that such payment is only required if and only if the noteholder elects to convert the entire balance of the September
2021 Note into the Company’s common stock on or prior to maturity. As the contingent event is not based on creditworthiness, such feature is not clearly and closely related to the host instrument and accordingly must be bifurcated and
recognized as a derivative liability and a debt discount on the September Note at its inception. The fair value of the contingent interest derivative liability was $433,000 at note inception (September 17, 2021). The fair value of the contingent interest derivative liability was $309,000
and $169,000 and June 30, 2024 and December 31, 2023, respectively, and is recognized as a derivative liability in the consolidated
balance sheet. The change in the fair value of the derivative liability for three months ended June 30, 2024 and 2023 of $2,000 and ($116,000 ), respectively,
was recorded to other expense/(income) for three months ended June 30, 2024 and 2023. The change in the fair value of the derivative liability for six months ended June 30, 2024 and 2023 of $140,000 and $50,000 , respectively, was recorded to other
expense/(income) for six months ended June 30, 2024 and 2023. The amortization of the original $433,000 debt discount of $27,000 and $27,000 was recorded as
additional interest expense for the three months ended June 30, 2024 and 2023. The amortization of the original $433,000 debt
discount of $54,000 and $54,000
was recorded as additional interest expense for the six months ended June 30, 2024 and 2023.
On December 20, 2021, the second of the two promissory notes under the Loan Agreement was executed and delivered, (the “December 2021 Note”) to evidence the second loan in the principal
amount of $10,000,000 . The December 2021 Note has a maturity date of December 20, 2025 , is prepayable at the option of the Company in whole or in part at any time and is convertible into the Company’s common stock at a conversion price equal
to $5.43 per share at the option of the noteholder. The December Note bears interest at the rate of two percent (2 %) per annum, compounded annually with an effective interest rate of approximately 3 %. For three months ended June 30, 2024 and 2023,
approximately $52,000 and $51,000 ,
respectively, of interest expense was accrued and included with the principal in the financial statements. For six months ended June 30, 2024 and 2023, approximately $104,000 and $101,000 , respectively, of interest expense was
accrued and included with the principal in the financial statements.
The December 2021 Note also includes a contingent interest component
that requires the Company to pay additional interest at a rate of two and one-half percent (2.5 %) per quarter (10 % per annum) (the “Additional Interest”) beginning on the date of issuance of this Note and ending on the maturity date, provided however, that
such payment is only required if and only if the noteholder elects to convert the entire balance of the December 2021 Note into the Company’s common stock on or prior to maturity. As the contingent event is not based on creditworthiness, such
feature is not clearly and closely related to the host instrument and accordingly must be bifurcated and recognized as a derivative liability and a debt discount on the December Note at its inception. The fair value of the contingent interest
derivative liability was $415,000 at note inception (December 20, 2021). The fair value of the contingent interest derivative
liability was $666,000 and $404,000
at June 30, 2024 and December 31, 2023, respectively, and is recognized as a derivative liability in the consolidated balance sheet. The change in the fair value of the derivative liability for three months ended June 30, 2024 and 2023 of $(21,000 )
and ($152,000 ), respectively was recorded to other expense/(income) for three months ended June 30, 2024 and 2023. The change in
the fair value of the derivative liability for six months ended June 30, 2024 and 2023 of $262,000 and $112,000 , respectively was recorded to other expense/(income) for six months ended June 30, 2024 and 2023. The amortization of the original $415,000 debt discount of $26,000
and $26,000 was recorded as additional interest expense for three months ended June 30, 2024 and 2023, respectively. The
amortization of the original $415,000 debt discount of $52,000 and $52,000 was recorded as additional interest
expense for six months ended June 30, 2024 and 2023, respectively.
The Company’s contractual cash obligations related to the outstanding convertible notes payable is a repayment of the September 2021 Note of the $10,000,000 plus accrued interest on September 17, 2025 and a repayment of the December 2021 Note of the $10,000,000 plus accrued interest on December 30, 2025, unless converted at the option of the noteholder.
4. Fair Value of Financial Instruments
The Company has certain financial assets
and liabilities recorded at fair value. Fair values determined by Level 1 inputs utilize observable data such as quoted prices in active markets. Fair values determined by Level 2 inputs utilize data points other than quoted prices in active
markets that are observable either directly or indirectly. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, which require the reporting entity to develop its own assumptions.
The carrying amounts reflected in the consolidated balance sheets for cash equivalents, accounts payable and accrued expenses approximate their carrying value due to their short-term nature. There were no
Level 3 assets and liabilities measured
and recorded at fair value on a recurring basis at June 30, 2024 and December 31, 2023 were as follows:
|
June 30,
2024
|
December 31,
2023
|
|||||||
|
Derivative Liability – Contingent Interest April Note
|
$
|
|
$
|
|
||||
| Derivative Liability – Contingent Interest September Note | $ | $ | ||||||
| Derivative Liability – Contingent Interest December Note | $ | $ | ||||||
The April Note derivative liability – contingent interest
was valued using a Monte Carlo Geometric Brownian Stock Path Model. The key assumptions used in the model at June 30, 2024 and December 31, 2023 are as follows:
| |
June 30,
2024
|
December 31,
2023
|
||||||
|
Stock Price
|
$
|
|
$
|
|
||||
|
Conversion Price of conversion feature
|
$
|
|
$
|
|
||||
|
Term
|
|
|
||||||
|
Risk Free Interest Rate
|
|
%
|
|
%
|
||||
|
Credit Adjusted Discount Rate
|
|
%
|
|
%
|
||||
|
Volatility
|
|
%
|
|
%
|
||||
|
Dividend Rate
|
|
% |
|
% |
||||
The roll forward of the April Note derivative liability –
contingent interest is as follows for the six months ended June 30, 2024 and 2023:
|
Balance – December 31, 2023
|
$
|
|
||
|
Fair Value Adjustment
|
|
|||
|
Balance – June 30, 2024
|
$
|
|
||
| Balance – December 31, 2022 |
$ |
|||
| Fair Value Adjustment | ||||
|
Balance – June 30, 2023
|
$ |
The September Note derivative
liability – contingent interest was valued using a Monte Carlo Geometric Brownian Stock Path Model. The key assumptions used in the model at June 30, 2024 and December 31, 2023 are as follows:
|
June 30,
2024
|
December 31,
2023
|
|||||||
|
Stock Price
|
$
|
|
$
|
|
||||
|
Conversion Price of conversion feature
|
$
|
|
$
|
|
||||
|
Term
|
|
|
||||||
|
Risk Free Interest Rate
|
|
%
|
|
%
|
||||
|
Credit Adjusted Discount Rate
|
|
%
|
|
%
|
||||
|
Volatility
|
|
%
|
|
%
|
||||
|
Dividend Rate
|
|
% |
|
% | ||||
The roll forward of the September
Note derivative liability – contingent interest is as follows:
|
Balance – December 31, 2023
|
$ | |||
|
Fair Value Adjustment
|
||||
|
Balance – June 30, 2024
|
$ | |||
|
Balance – December 31, 2022
|
||||
| Fair Value Adjustment | ||||
| Balance – June 30, 2023 | $ |
The December Note derivative liability – contingent
interest was valued using a Monte Carlo Geometric Brownian Stock Path Model. The key assumptions used in the model at June 30, 2024 and December 31, 2023 are as follows:
|
June 30,
2024
|
December 31,
2023
|
|||||||
|
Stock Price
|
$
|
|
$
|
|
||||
|
Conversion Price of conversion feature
|
$
|
|
$
|
|
||||
|
Term
|
|
|
||||||
|
Risk Free Interest Rate
|
|
%
|
|
%
|
||||
|
Credit Adjusted Discount Rate
|
|
%
|
|
%
|
||||
|
Volatility
|
|
%
|
|
%
|
||||
|
Dividend Rate
|
|
% |
|
% | ||||
The roll forward
of the December Note derivative liability – contingent interest is as follows:
|
Balance – December 31, 2023
|
$
|
|
||
|
Fair Value Adjustment
|
|
|||
|
Balance – June 30, 2024
|
$
|
|
||
| Balance – December 31, 2022 |
$ | |||
|
Fair Value Adjustment
|
|
|||
|
Balance – June 30, 2023
|
$
|
|
5. Stock-Based Compensation
Following is the stock-based compensation expense related to common stock options, restricted common stock, common stock warrants and deferred stock units:
|
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
||||||||||||||
|
|
2024
|
2023
|
2024
|
2023
|
||||||||||||
|
|
in thousands
|
|||||||||||||||
|
Research and development
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
General and administrative
|
|
|
|
|
||||||||||||
|
Total stock-based compensation expense
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
The following table summarizes the stock option activity in the Company’s equity incentive plans, including non-plan grants to Company executives, from December 31, 2023
through June 30, 2024:
|
|
Shares
|
Weighted
Average Exercise Price |
||||||
|
Outstanding, December 31, 2023
|
|
$
|
|
|||||
|
Granted
|
|
|
||||||
|
Exercised
|
( |
) |
(
|
)
|
||||
|
Options forfeited/cancelled
|
(
|
)
|
(
|
)
|
||||
|
Outstanding, June 30, 2024
|
|
$
|
|
|||||
As of June 30, 2024, there was $1,568,000 of unrecognized
compensation related to 2,574,753 unvested options, which is expected to be recognized over a weighted–average period of approximately 1 year. The weighted-average grant date fair value for options granted during the six months ended June 30, 2024 was $1.23 . The Company granted 1,273,000 stock
options during the six months ended June 30, 2024.
The fair value of all other options granted is determined using the Black-Scholes option-pricing model. The following weighted average assumptions were used:
|
|
Six
Months Ended
June 30, |
Six
Months Ended June 30, |
||||||
|
|
2024
|
2023
|
||||||
|
Risk-free interest rate
|
|
%
|
|
%
|
||||
|
Expected life of the options
|
|
|
||||||
|
Expected volatility of the underlying stock
|
|
%
|
|
%
|
||||
|
Expected dividend rate
|
|
% |
|
% | ||||
In January 2024, the Company’s board chairman
elected to take restricted stock grants in lieu of cash retainers for 2024. A total of 23,256 shares of restricted stock valued at
approximately $40,000 is being amortized to expense on a straight-line basis until December 31, 2024 when the stock vests in full. In
January 2023, the Company’s board chairman elected to take restricted stock grants in lieu of cash retainers for 2023. A total of 36,036
shares of restricted stock valued at approximately $40,000 was being amortized to expense on a straight-line basis until December 31,
2023 when the stock vested in full.
During the
six months ended June 30, 2024, the Company issued 408,000 restricted stock units to its employees valued at $734,000 at the date of grant. These restricted stock units will vest 100 % if the Company publicly presents the results of the Interim Analysis of its NAVIGATE clinical trial on or before December 31, 2024. The Company believes that is probable that the
vesting condition will be met and is amortizing the restricted stock unit expense ratably in 2024. The amount of expense recorded during the three and six months ended June 30, 2024 was $196,000 and $324,000 respectively.
In September 2020, the Company entered into an employment agreement with its new Chief Executive Officer whereby 20 % of his base salary and performance bonuses will be paid in cash, and 80 %
will be paid in the form of deferred stock units (“DSUs”) through December 31, 2022 in accordance with the terms and subject to the provisions set forth in the DSU Agreement. DSUs credited to Mr. Lewis as of any date shall be fully vested and
nonforfeitable at all times. Pursuant to an amendment to the DSU Agreement in July 2022, the Company shall issue the shares earned through December 31, 2022 underlying the outstanding whole number of DSUs credited to Mr. Lewis as follows: twenty five percent shall be issued on March 1, 2023, fifty percent shall be issued on March 1, 2024 and twenty five percent shall be issued on September 1, 2028. Additionally,
a 2023 DSU Agreement was executed in July 2022, whereby Mr. Lewis would continue to receive 20 % of salary in cash and 80 % in DSUs through December 31, 2023. The shares under the 2023 DSU Agreement are to be issued fifty percent on March 1, 2025 and fifty percent on January 5, 2026.
For the three months ended March 31, 2023, approximately $112,000
of his compensation was recorded as stock compensation expense representing 72,440 shares of common stock to be issued under the DSU
agreement with a weighted average grant date fair value of $1.55 per share.
On March 1, 2024, fifty percent of the DSU’s were issued
to Mr. Lewis in accordance with the DSU Agreement. A total of 367,800 shares were due to be issued; however, 153,288 shares were withheld to cover income tax withholding of $300,445 resulting in 214,512 shares actually issued. On March 1, 2023, twenty five percent of the DSU’s were issued to Mr. Lewis in accordance with the DSU Agreement. A total of 183,900 shares were due to be issued; however, 75,529 shares
were withheld to cover income tax withholding of $156,345 resulting in 108,371 shares actually issued.
Also, Mr. Lewis’ bonus for the year ended December 31, 2022 of $210,000
(which was included in accrued compensation at December 31, 2022) was approved in January 2023 and represents 143,836 shares of common
stock to be issued under the DSU agreement with a grant date fair value of $1.46 per share. The $210,000 was reclassified from accrued compensation to additional paid in capital in January 2023.
There is no unrecognized compensation expense related to
the DSUs.
6. Common Stock Warrants
The following table summarizes the common stock warrant activity from December 31, 2023 through June 30, 2024:
|
|
Shares
|
Weighted Average
Exercise Price |
||||||
|
Outstanding, December 31, 2023
|
|
$
|
|
|||||
|
Granted
|
|
|
||||||
|
Exercised
|
(
|
)
|
|
|||||
|
Forfeited/cancelled
|
(
|
)
|
|
|||||
|
Outstanding, June 30, 2024
|
|
$
|
|
|||||
The weighted average expiration of the warrants outstanding as of June 30, 2024 is 2.4
years.
7. Loss Per Share
Basic net loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common shares outstanding
during the period. Diluted net loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common shares and other potential common shares then outstanding. Potential common shares
consist of common shares issuable upon the assumed exercise of in-the-money stock options and warrants and potential common shares related to the conversion of the preferred stock. The computation of diluted net loss per share does not assume the
issuance of common shares that have an anti-dilutive effect on net loss per share.
Dilutive shares which could exist pursuant to the exercise of outstanding stock instruments and which were not included in the calculation because their affect would
have been anti-dilutive are as follows:
|
|
June 30,
2024
|
June 30,
2023
|
||||||
| (shares) |
(shares) |
|||||||
|
Warrants to purchase shares of common stock
|
|
|
||||||
|
Options to purchase shares of common stock
|
|
|
||||||
| Restricted stock units |
||||||||
|
Shares of common stock issuable upon conversion of convertible notes payable – related party
|
|
|
||||||
| Shares of common stock issuable upon conversion of convertible line of credit – related party |
||||||||
|
Shares of common stock issuable upon conversion of preferred stock
|
|
|
||||||
|
|
|
|
||||||
8. Common Stock
2020 At Market Issuance of Common Stock
On May 11, 2020, the Company entered into an At Market Issuance Sales Agreement (the “2020
At Market Agreement”) with a sales agent under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $40.0 million from time to time through the sales agent. Sales of the Company’s common stock through the sales agent, if any, will be made by any method that is deemed an “at the market” offering as defined by the
U.S. Securities and Exchange Commission. The Company will pay to the sales agent a commission rate equal to 3.0 % of the gross proceeds
from the sale of any shares of common stock sold through the sales agent under the 2020 At Market Agreement. During the six months ended June 30, 2024 and 2023, there were no
For each of the six months ended June 30, 2024 and 2023, the Company issued a total of 29,950 and 30,200 shares of common stock, respectively, for
dividends on Series A and Series C Preferred Stock.
9. Convertible Line of Credit – Related Party
On July 25, 2022, the Company and Richard E. Uihlein (the “Lender”) entered into a Line of Credit Letter Agreement (the “Credit Agreement”),
pursuant to which the Lender shall provide the Company a line of credit of up to $60.0 million (the “Line of Credit”) to finance the
Company’s working capital needs. The Company may draw upon the Line of Credit through July 31, 2024.
Each advance made pursuant to the Credit Agreement shall be evidenced by an unsecured, convertible promissory note (individually, a “Promissory
Note,” and collectively, the “Promissory Notes”), and bear interest at the Applicable Federal Rate for short term loans, plus two (2 %)
percent. Principal and interest on the Promissory Notes are due on or before January 31, 2026 . Only with the consent of the Lender, may
the Promissory Notes be prepaid, in whole or in part, at any time without premium or penalty, but with interest on the amount or amounts prepaid.
At the election of Lender, the principal and accrued interest on Promissory Note(s) may be converted into the number of shares of the Company’s
Common Stock equal to the amount of principal and accrued interest on such Promissory Note divided by the price equal to the closing price of the Common Stock on the date of such Promissory Note, but in no event less than $3.00 per share.
In connection with the Credit Agreement, the Company agreed to issue the Lender warrants to purchase up to an aggregate of 1,700,000 shares of the Company’s common stock, par value $0.001
per share (collectively, the “Warrants”). Upon execution of the Credit Agreement, the Company issued the Lender a Warrant to purchase up to 500,000
shares of Company’s Common Stock at an exercise price of $5.00 per share, which Warrant is exercisable upon issuance. Further, pursuant to
the Credit Agreement, the Company shall issue to the Lender additional Warrants to purchase up to the remaining 1,200,000 shares of the
Company’s common stock, ratably, upon borrowings under the Credit Agreement, with exercise prices equal to 150 % of the closing price of
the Company’s common Stock on the date of the Promissory Note evidencing such draw, but in no event more than $10.00 per share nor less
than $3.00 per share. The Warrants expire on July 31, 2029 .
The fair value of the 500,000
warrants vested at closing on July 25, 2022 was $738,000 at the date of issuance based on the following assumptions: an expected life of 7 years , volatility of 92 %, risk free
interest rate of 3.19 % and zero
dividends. The fair value of the vested warrants was recorded in other assets (non-current) as a deferred financing cost and will be amortized on a straight-line basis from July 25, 2022 through January 31, 2026. Amortization for the three months
ended June 30, 2024 and 2023 of $52,000 and $52,000 ,
respectively, was recorded as interest expense. Amortization for the six months ended June 30, 2024 and 2023 of $104,000 and $104,000 , respectively, was recorded as interest expense.
On December 19, 2022, the Company executed a $10
million Promissory Note under the Line of Credit. The interest rate on this draw is 6.46 % (Applicable Federal Rate for short term loans on
date of draw of 4.46 % plus 2 %).
The effective interest rate is approximately 7.1 %. Accrued interest on this draw was $1,038,000 and $349,000 at June 30, 2024 and 2023, respectively. The
principal and accrued interest is convertible at the option of the Lender at $3.00 per share. In accordance with the Credit Agreement, the
Company issued the Lender a Warrant to purchase up to 200,000 shares of Company’s Common Stock at an exercise price of $3.00 per share, which Warrant is exercisable upon issuance.
The fair value of the 200,000 warrants vested at closing on December 19, 2022 was $160,780 at the
date of issuance based on the following assumptions: an expected life of 7 years , volatility of 91 %, risk free interest rate of 4.06 %
and zero dividends. The proceeds were allocated between the Promissory Note and the warrants issued, and the amount allocated to the
warrants was recorded as a debt discount netted against principal to be amortized on a straight-line basis, which is not materially different than the effective interest method, from December 19, 2022 through January 31, 2026. Amortization for the
six months ended June 30, 2024 and 2023 of $26,000
On March 31, 2023, the Company executed an additional $10
million Promissory Note under the Line of Credit. The interest rate on this draw is 6.41 % (Applicable Federal Rate for short term loans on
date of draw of 4.41 % plus 2 %).
The effective interest rate is approximately 7.1 %. Accrued interest on this draw was $832,000 and $161,000 at June 30, 2024 and 2023, respectively. The
principal and accrued interest is convertible at the option of the Lender at $3.00 per share. In accordance with the Credit Agreement, the
Company issued the Lender a Warrant to purchase up to 200,000 shares of Company’s Common Stock at an exercise price of $3.26 per share, which Warrant is exercisable upon issuance.
The fair value of the 200,000 warrants vested at closing on March 31, 2023 was $296,680
at the date of issuance based on the following assumptions: an expected life of 6.33 years, volatility of 88 %, risk free interest rate of 3.94 % and
zero dividends. The proceeds were allocated between the Promissory Note and the warrants issued, and the amount allocated to the warrants
was recorded as a debt discount netted against principal to be amortized on a straight-line basis, which is not materially different than the effective interest method, from March 31, 2023 through January 31, 2026. Amortization for the six months
ended June 30, 2024 and 2023 of $52,000 and $26,000 ,
respectively, and was recorded as interest expense.
On June 30, 2023, the Company executed an
additional $10 million Promissory Note under the Line of Credit. The interest rate on this draw is 6.34 % (Applicable Federal Rate for short term loans on date of draw of 4.34 % plus 2 %). The effective interest rate is approximately 7.1 %. Accrued interest on this draw was $653,000 and $0 at June 30, 2024 and 2023, respectively. The principal and accrued interest is convertible at the option of the Lender at $3.00 per share. In accordance with the Credit Agreement, the Company issued the Lender a Warrant to purchase up to 200,000 shares of Company’s Common Stock at an exercise price of $3.00 per share, which Warrant is exercisable upon issuance.
The fair value of the 200,000 warrants vested at closing on June
30, 2023 was $179,920 at the date of issuance based on the following assumptions: an expected life of 6.08 years, volatility of 85 %, risk free
interest rate of 3.59 % and zero
dividends. The proceeds were allocated between the Promissory Note and the warrants issued, and the amount allocated to the warrants was recorded as a debt discount netted against principal amortized on a straight-line basis, which is not
materially different than the effective interest method, from June 30, 2023 through January 31, 2026. Amortization for the six months ended June 30, 2024 and 2023 of $34,000 and $0 , respectively, and was recorded as interest expense.
On December 29, 2023, the Company executed an additional $10 million Promissory Note under the Line of Credit. The interest rate on this draw is 7.13 %
(Applicable Federal Rate for short term loans on date of draw of 5.13 % plus 2 %). The effective interest rate is approximately 7.5 %. Accrued interest on this
draw was $362,000 June 30, 2024. The principal and accrued interest is convertible at the option of the Lender at $3.00 per share. In accordance with the Credit Agreement, the Company issued the Lender a Warrant to purchase up to 200,000 shares of Company’s Common Stock at an exercise price of $3.00 per share, which Warrant is exercisable upon issuance.
The fair value of the 200,000
warrants vested at closing on December 31, 2023 was $193,745 at the date of issuance based on the following assumptions: an expected life
of 5.7 years, volatility of 79 %,
risk free interest rate of 4.49 % and zero
dividends. The proceeds were allocated between the Promissory Note and the warrants issued, and the amount allocated to the warrants was recorded as a debt discount netted against principal amortized on a straight-line basis, which is not materially
different than the effective interest method, from December 29, 2023 through January 31, 2026. Amortization for the six months ended June 30, 2024 of $47,000
and was recorded as interest expense.
On March 29, 2024, the Company executed an additional $10 million Promissory Note under the
Line of Credit. The interest rate on this draw is 6.62 % (Applicable Federal Rate for short term loans on date of draw of 4.62 % plus 2 %). The effective interest
rate is approximately 7.1 %. Accrued interest on this draw was $166,000 June 30, 2024. The principal and accrued interest is convertible at the option of the Lender at $3.00 per share. In accordance with the Credit Agreement, the Company issued the Lender a Warrant to purchase up to 200,000 shares of Company’s Common Stock at an exercise price of $3.59 per
share, which Warrant is exercisable upon issuance.
The fair value of the 200,000 warrants vested at
closing on March 29, 2024, was $277,389 at the date of issuance based on the following assumptions: an expected life of 5.33 years, volatility of 75 %, risk free
interest rate of 4.19 % and zero
dividends. The proceeds were allocated between the Promissory Note and the warrants issued, and the amount allocated to the warrants was recorded as a debt discount netted against principal amortized on a straight-line basis, which is not
materially different than the effective interest method, from March 29, 2024 through January 31, 2026. Amortization for the six months ended June 30, 2024 of $38,000 and was recorded as interest expense.
On June 28, 2024, the Company executed an additional $10
million Promissory Note under the Line of Credit. The interest rate on this draw is 7.01 % (Applicable Federal Rate for short term loans
on date of draw of 5.01 % plus 2 %).
The effective interest rate is approximately 7.4 %. The principal and accrued interest is convertible at the option of the Lender at $3.00 per share. In accordance with the Credit Agreement, the Company issued the Lender a Warrant to purchase up to 200,000 shares of Company’s Common Stock at an exercise price of $3.39 per share, which Warrant is exercisable upon issuance.
The fair value of the 200,000 warrants vested at
closing on June 28, 2024, was $260,000 at the date of issuance based on the following assumptions: an expected life of 5.03 years, volatility of 77 %, risk free
interest rate of 4.29 % and zero
dividends. The proceeds were allocated between the Promissory Note and the warrants issued, and the amount allocated to the warrants was recorded as a debt discount netted against principal amortized on a straight-line basis, which is not
materially different than the effective interest method, from June 28, 2024 through January 31, 2026.
The fair value of warrants that vest in the future based on borrowings will be computed when those borrowings occur and amortized over the remaining period
through January 31, 2026.
10. Supplemental Convertible Line of Credit – Related Party
On March 29, 2024, the Company and Richard E. Uihlein (the “Lender”) entered into a Supplemental Line of Credit Letter Agreement (the “Supplemental Credit Agreement”), pursuant to which the Lender shall provide the Company a
line of credit of up to $10.0 million (the “Supplemental Line of Credit”) to finance the Company’s working capital needs. The Company may
draw upon the Supplemental Line of Credit through March 31, 2025.
Each advance made pursuant to the Supplemental Credit Agreement shall be evidenced by an unsecured, convertible promissory note (individually, a “Promissory Note,” and collectively, the “Promissory Notes”), and bear interest
at the Applicable Federal Rate for short term loans, plus two (2 %) percent. Principal and interest on the Promissory Notes are due on or
before March 31, 2026 . Only with the consent of the Lender, may the Promissory Notes be prepaid, in whole or in part, at any time
without premium or penalty, but with interest on the amount or amounts prepaid.
At the election of Lender, the principal and accrued interest on Promissory Note(s) may be converted into the number of shares of the Company’s Common Stock equal to the amount of principal and accrued interest on such
Promissory Note divided by the price equal to the closing price of the Common Stock on the date of such Promissory Note, but in no event less than $3.00
per share.
In connection with the Supplemental Credit Agreement, the Company agreed to issue the Lender warrants to purchase up to an aggregate of 200,000 shares of the Company’s common stock, par value $0.001 per share (collectively, the
“Warrants”). The Company shall issue to the Lender Warrants ratably, upon borrowings under the Supplemental Line of Credit, with exercise prices equal to 150 %
of the closing price of the Company’s common Stock on the date of the Promissory Note evidencing such draw, but in no event more than $10.00
per share nor less than $3.00 per share. The Warrants expire on July 31, 2029 .
11. Commitments and Contingencies
Other Legal Proceedings
The Company records accruals for such contingencies to the extent that the Company concludes that their occurrence is probable, and the related damages are
estimable. There are no significant pending legal proceedings.
Clinical Trial and Research Commitments
The Company has entered into agreements with contractors for research and development activities to further its product candidates. The contracts generally may be
canceled at any time by providing thirty days ’ notice.
12. Leases
The Company has one operating lease for its office
space which was amended effective March 1, 2022 for a term of 38 months with no residual value guarantees or material restrictive
covenants. The amended lease provided for free rent for the first of the lease and continues the security
deposit of $6,000 . In addition to base rental payments included in the contractual obligations table above, the Company is responsible
for our pro-rata share of the operating expenses for the building. Our lease cost for the six-month periods ended June 30, 2024 and 2023 was approximately $26,000 35,000 and is included in . Also, at June 30,
2024, current lease liability of $44,000 is included in .
Maturity of operating lease as of June 30, 2024 in thousands:
|
2024
|
|
|
||
| 2025 |
||||
|
Total
|
|
|||
|
Less imputed interest
|
|
|||
|
Present value of lease liability
|
$
|
|
The
discount rate used in calculating the present value of the lease payments was 11 %.
13. Galectin Sciences LLC
In January 2014, we created Galectin Sciences, LLC (the “LLC” or “Investee”), a collaborative joint venture co-owned by SBH Sciences, Inc. (“SBH”),
to research and develop small organic molecule inhibitors of galectin-3 for oral administration. The LLC was initially capitalized with a $400,000
cash investment to fund future research and development activities, which was provided by the Company, and specific in-process research and development (“IPR&D”) contributed by SBH. The estimated fair value of the IPR&D contributed by
SBH, on the date of contribution, was $400,000 . Initially, the Company and SBH each had a 50 % equity ownership interest in the LLC, with neither party having control over the LLC. Accordingly, from inception through the fourth quarter of 2014, the Company
accounted for its investment in the LLC using the equity method of accounting. Under the equity method of accounting, the Company’s investment was initially recorded at cost with subsequent adjustments to the carrying value to recognize
additional investments in or distributions from the Investee, as well as the Company’s share of the Investee’s earnings, losses and/or changes in capital. The estimated fair value of the IPR&D contributed to the LLC was immediately expensed
upon contribution as there was no alternative future use available at the point of contribution. The operating agreement provides that if either party does not desire to contribute its equal share of funding required after the initial
capitalization, then the other party, providing all of the funding, will have its ownership share increased in proportion to the total amount contributed from inception. In the fourth quarter of 2014, after the LLC had expended the $400,000 in cash, SBH decided not to contribute its share of the funding required. Cumulatively, the Company has contributed a total of $4,013,000 , including $233,000 for the
six months ended June 30, 2024, for expenses of the LLC. Since the end of 2014, SBH has contributed $711,000 for expenses in the LLC.
As of June 30, 2024, the Company’s ownership percentage in the LLC was 85 %. The Company accounts for the interest in the LLC as a
consolidated, less than wholly owned subsidiary. Because the LLC’s equity is immaterial, the value of the non-controlling interest is also deemed to be immaterial.
In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements as defined under
Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created therein for forward-looking statements. Such statements include, but are not limited to, statements concerning our anticipated operating
results, research and development, clinical trials, regulatory proceedings, and financial resources, and can be identified by use of words such as, for example, “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” and
“would,” “should,” “could” or “may.” All statements, other than statements of historical facts, included herein that address activities, events, or developments that the Company expects or anticipates will or may occur in the future, are
forward-looking statements, including statements regarding: plans and expectations regarding clinical trials; plans and expectations regarding regulatory approvals; our strategy and expectations for clinical development and commercialization of
our products; potential strategic partnerships; expectations regarding the effectiveness of our products; plans for research and development and related costs; statements about accounting assumptions and estimates; expectations regarding
liquidity and the sufficiency of cash to fund currently planned operations through at least May 15, 2025; our commitments and contingencies; and our market risk exposure. Forward-looking statements are based on current expectations, estimates and
projections about the industry and markets in which Galectin Therapeutics operates, and management’s beliefs and assumptions. These statements are not guarantees of future performance and involve certain known and unknown risks and uncertainties
that could cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties are related to and include, without limitation,
| • |
our early stage of development,
|
| • |
we have incurred significant operating losses since our inception and cannot assure you that we will generate revenue or profit,
|
| • |
our dependence on additional outside capital,
|
| • |
we may be unable to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates,
|
| • |
uncertainties related to any litigation,
|
| • |
uncertainties related to our technology and clinical trials, including expected dates of availability of clinical data,
|
| • |
we may be unable to demonstrate the efficacy and safety of our developmental product candidates in human trials,
|
| • |
we may be unable to improve upon, protect and/or enforce our intellectual property,
|
| • |
we are subject to extensive and costly regulation by the U.S. Food and Drug Administration (FDA) and by foreign regulatory authorities, which must approve our product candidates in development and could restrict the sales and marketing
and pricing of such products,
|
| • |
competition and stock price volatility in the biotechnology industry,
|
| • |
limited trading volume for our stock, concentration of ownership of our stock, and other risks detailed herein and from time to time in our SEC reports, and
|
| • |
the impact resulting from a pandemic or the reemergence of COVID-19, which delayed our clinical trial and development efforts, as well as the impact that such a pandemic has on the volatility of the capital market and our ability to
access the capital market and,
|
| • |
other risks detailed herein and from time to time in our SEC reports, including our Annual Report on Form 10-K filed with the SEC for the fiscal year ended December 31, 2023, and our subsequent SEC filings.
|
The following discussion should be read in conjunction with the accompanying consolidated financial statements and notes thereto of Galectin Therapeutics appearing elsewhere
herein.
Overview
We are a clinical stage biopharmaceutical company engaged in drug research and development to create new therapies for fibrotic disease, cancer and selected other diseases.
Our drug candidates are based on our method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. We use naturally occurring, readily-available plant products as starting material in manufacturing processes
to create proprietary, patented complex carbohydrates with specific molecular weights and other pharmaceutical properties. These complex carbohydrate molecules are appropriately formulated into acceptable pharmaceutical formulations. Using these
unique carbohydrate-based candidate compounds that largely bind and inhibit galectin proteins, particularly galectin-3, we are undertaking the focused pursuit of therapies for indications where galectin proteins have a demonstrated role in the
pathogenesis of a given disease. We focus on diseases with serious, life- threatening consequences and those where current treatment options are limited specifically in MASH (metabolic dysfunction-associated steatohepatitis) (formerly known as
non-alcoholic steatohepatitis or NASH) with cirrhosis and certain cancer indications. Our strategy is to establish and implement clinical development programs that add value to our business in the shortest period of time possible and to seek
strategic partners when one of our programs becomes advanced and requires significant additional resources.
Our lead galectin-3 inhibitor is belapectin (GR-MD-02), which has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to
decrease portal hypertension and prevent its complication: the development of esophageal varices. Belapectin has the potential to treat many diseases due to galectin-3’s involvement in multiple key biological pathways such as fibrosis, immune
cell function and immunity, cell differentiation, cell growth, and apoptosis (cell death). The importance of galectin-3 in the fibrotic process is supported by experimental evidence. Animals with the galectin-3 gene “knocked-out” can no longer
develop fibrosis in response to experimental stimuli compared to animals with an intact galectin-3 gene. We are using our galectin-3 inhibitor to treat advanced liver fibrosis and liver cirrhosis in NASH patients. We have completed two Phase 1
clinical studies, a Phase 2 clinical study in MASH patients with advanced fibrosis (NASH-FX) and a second Phase 2b clinical trial in NASH patients with compensated cirrhosis and portal hypertension (NASH-CX).
In February 2023, we completed randomizations totaling 357 patients in a large, global Phase 2b/3 clinical trial, the NAVIGATE trial. Our study protocol was filed with the FDA on April 30,
2020, for a seamless adaptively-designed Phase 2b/3 clinical study evaluating the safety and efficacy of our galectin-3 inhibitor, belapectin, for the prevention of esophageal varices in patients with MASH cirrhosis (Further details are available
at www.clinicaltrials.gov under study NCT04365868. In September 2020, the Company received a letter from the FDA providing comments, asking questions and providing guidance on various aspects of the ongoing NAVIGATE trial. These comments were
addressed, and the study proceeded accordingly. An interim analysis of NAVIGATE is expected late in the fourth quarter of 2024.
Additionally, a study protocol entitled “A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With
Varying Degrees of Hepatic Impairment” has been filed with the FDA to examine the effects of the drug in subjects with normal hepatic function and subjects with varying degrees of hepatic impairment (study details are listed under study
NCT04332432 on www.clinicaltrials.gov); this study became fully enrolled in February 2022 and favorable results were reported in 2023.
We endeavor to leverage our scientific and product development expertise as well as established relationships with outside sources to achieve cost-effective and efficient
drug development. These outside sources, amongst others, provide us with expertise in preclinical models, pharmaceutical development, toxicology, clinical trial operations, pharmaceutical manufacturing, including physical and chemical drug
characterization, and commercial development. We also have established through our majority-owned joint venture subsidiary, Galectin Sciences LLC, a discovery program developing small molecules that inhibit galectin-3 and may afford alternative
drug delivery (e.g., oral) and as a result expand the potential uses of galectin-3 inhibitor beyond belapectin. Three chemical series of composition of matter patents have been filed.
We are also pursuing a development pathway to clinical enhancement and commercialization for our lead compounds in immuno-oncology following our previous successful
collaboration with Providence Portland Cancer Center. In 2022, we filed a new IND with FDA for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint (PD-1) inhibitor and received a Study May Proceed letter.
The proposed phase 2 trial commencement is dependent on timing of financing.
All of our proposed products are presently in development, including pre-clinical and clinical trials.
Our Drug Development Programs
Galectins are a class of proteins that are made by many cells in the body, but predominantly in cells of the immune system. As a group, these proteins are able to bind to sugar molecules that
are attached to other proteins, called glycoproteins that are responsible for various functions within the body, most notably inflammation and fibrosis. Galectins, in particular galectin-3, act as a molecular glue, bringing together molecules
that have sugars on them. Galectin-3, is known to be markedly increased in a number of significant diseases including inflammatory diseases leading to organs scarring (e.g. liver, lung, kidney, and heart) and cancers. The increase in galectin-3,
by creating the so-called galectin-3 fibrosome, promotes the progression of multiple diseases. Published data substantiating the importance of galectin-3 in the fibrotic process arises from gene knockout experiments in animal studies. For
instance, mice genetically altered to eliminate the galectin-3 gene, and thus unable to produce galectin-3, do not develop liver fibrosis in response to toxic insult to the liver.
We have one new proprietary chemical entity (NCE) in development, belapectin, which has shown promise in preclinical and clinical studies for the treatment of liver fibrosis, severe skin
disease, and cancer (melanoma and head and neck squamous cell carcinoma). Currently, we are focusing on development of belapectin for the treatment of NASH cirrhosis and head and neck cancer. Belapectin is a proprietary, patented compound derived
from natural, plant-based, starting materials, which following chemical processing, exhibits the properties of binding to and inhibiting galectin-3.