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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2025
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Lantern
Pharma Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-39318 |
|
46-3973463 |
(State
or Other Jurisdiction |
|
(Commission |
|
(IRS
Employer |
of
Incorporation) |
|
File
Number) |
|
Identification
No.) |
1920
McKinney Avenue, 7th Floor Dallas, Texas |
|
75201 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(972)
277-1136
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act: Common Stock
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, $0.0001 par value |
|
LTRN |
|
The
Nasdaq Stock Market |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
|
Accelerated
filer |
☐ |
|
Non-accelerated
filer |
☒ |
|
Smaller
reporting company |
☒ |
|
Emerging
growth company |
☒ |
|
|
|
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 8, 2025 the registrant had 10,799,417
shares of common stock, $0.0001
par value per share outstanding.
Table
of Contents
|
|
|
Page |
|
|
|
|
|
Forward Looking Statements |
|
ii |
|
|
|
|
PART I – FINANCIAL INFORMATION |
|
|
|
|
|
|
Item
1. |
Financial Statements. |
|
1 |
|
Condensed Consolidated Balance Sheets as of June 30, 2025 (unaudited) and December 31, 2024 |
|
1 |
|
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024 (unaudited) |
|
2 |
|
Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2025 and 2024 (unaudited) |
|
3 |
|
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2025 and 2024 (unaudited) |
|
4 |
|
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024 (unaudited) |
|
5 |
|
Notes to Condensed Consolidated Financial Statements (unaudited) |
|
6 |
Item
2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
|
16 |
Item
3. |
Quantitative and Qualitative Disclosures About Market Risk. |
|
22 |
Item
4. |
Controls and Procedures. |
|
22 |
|
|
|
|
PART II – OTHER INFORMATION |
|
|
|
|
|
|
Item
1A. |
Risk Factors. |
|
23 |
Item
6. |
Exhibits. |
|
23 |
Signatures |
|
24 |
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking
statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities
Exchange Act of 1934, as amended, and other federal securities laws. All statements, other than statements of historical fact, contained
in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future preclinical studies and clinical trials, future
expectations for existing preclinical studies and clinical trials, future financial position, projected costs, prospects, plans and objectives
of management, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,”
“could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,”
“plan,” “potential,” “predict,” “project,” “target,” “model”,
“objective”, “aim,” “upcoming”, “should,” ‘will” “would,” or
the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these words. Forward-looking statements reflect our current views with respect to future events and are based on assumptions
and subject to risks and uncertainties.
The
forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements relating to:
|
● |
our
ability to secure sufficient funding and alternative sources of funding to support our existing
and proposed preclinical studies and clinical trials;
|
|
● |
the
potential advantages of our RADR® platform in identifying drug candidates
and patient populations that are likely to respond to a drug candidate;
|
|
● |
our
strategic plans to advance the development of any of our drug candidates; |
|
|
|
|
● |
our
strategic plans to expand the number of data points that our RADR® platform can access and analyze; |
|
|
|
|
● |
our
research and development efforts of our internal drug discovery and development programs and antibody drug conjugate (ADC) development
program and the utilization of our RADR® platform to streamline the drug development process; |
|
|
|
|
● |
the
initiation, timing, progress, and results of our preclinical studies or clinical trials for any of our drug candidates; |
|
|
|
|
● |
our
intention to leverage artificial intelligence, machine learning and biomarker data to streamline the drug development process and
to identify patient populations that would likely respond to a drug candidate; |
|
|
|
|
● |
our
plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves
or in collaboration with others; |
|
|
|
|
● |
our
expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our existing cash, cash
equivalents, and marketable securities; |
|
|
|
|
● |
our
estimates regarding the potential market opportunity for our drug candidates we or any of our collaborators may in the future develop; |
|
|
|
|
● |
our
anticipated growth strategies and our ability to manage the potential expansion of our business operations effectively; |
|
|
|
|
● |
our
expectations related to future expenses and expenditures; |
|
|
|
|
● |
our
ability to keep up with rapidly changing technologies and evolving industry standards, including our ability to achieve technological
advances; |
|
● |
our
ability to source our needs for skilled labor in the fields of artificial intelligence, genomics, biology, oncology and drug development;
and |
|
|
|
|
● |
the
impact of government laws and regulations on the development and commercialization of our drug candidates and ADC development program. |
We
may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations
disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this
Quarterly Report on Form 10-Q and in the Risk Factors section of our Annual Report on Form 10-K (“2024 Form 10-K”), for the
year ended December 31, 2024 filed with the Securities and Exchange Commission, or the SEC, on March 27, 2025, and have identified other
factors such as the results of our clinical trials, and the impact of competition, that we believe could cause actual results or events
to differ materially from the forward-statements that we make. Furthermore, we operate in a competitive and rapidly changing environment.
New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could
have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q.
You
should read this Quarterly Report on Form 10-Q and the documents that we file with the SEC with the understanding that our actual future
results may be materially different from what we expect. These forward-looking statements are based on management’s current expectations.
These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors
that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Factors that may cause actual results to differ materially from current expectations
include, among other things, those listed elsewhere in this Quarterly Report on Form 10-Q and those listed under the Risk Factors section
of our 2024 Form 10-K. You may access our 2024 Form 10-K under the investor SEC filings tab of our website at www.lanternpharma.com or
on the SEC’s website at www.sec.gov. Given these uncertainties, you should not rely on these forward-looking statements as predictions
of future events. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly
Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future
events or otherwise, except as required by applicable law.
In
addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These
statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such
information forms a reasonable basis for such statements, such information may be limited or incomplete. Our statements should not be
read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These
statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
Unless
the context requires otherwise, references to the “Company,” “Lantern,” “we,” “us,” and
“our” in this Quarterly Report on Form 10-Q refer to Lantern Pharma Inc., a Delaware corporation, and, where appropriate,
its wholly-owned subsidiaries.
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements.
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
| |
June 30, 2025 | | |
December 31, 2024 | |
| |
| (Unaudited) | | |
| | |
CURRENT ASSETS | |
| | | |
| | |
Cash and cash equivalents | |
$ | 6,061,408 | | |
$ | 7,511,079 | |
Marketable securities | |
| 9,840,366 | | |
| 16,501,984 | |
Prepaid expenses & other current assets | |
| 1,299,016 | | |
| 1,234,566 | |
Total current assets | |
| 17,200,790 | | |
| 25,247,629 | |
| |
| | | |
| | |
Property and equipment, net | |
| 39,524 | | |
| 47,440 | |
Operating lease right-of-use assets | |
| 143,240 | | |
| 239,985 | |
Other assets | |
| 36,738 | | |
| 36,738 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 17,420,292 | | |
$ | 25,571,792 | |
| |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 4,752,848 | | |
$ | 4,140,361 | |
Operating lease liabilities, current | |
| 131,515 | | |
| 190,814 | |
Total current liabilities | |
| 4,884,363 | | |
| 4,331,175 | |
| |
| | | |
| | |
Operating lease liabilities, net of current portion | |
| 13,524 | | |
| 52,843 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 4,897,887 | | |
| 4,384,018 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES (NOTE 4) | |
| | | |
| | |
| |
| | | |
| | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Preferred Stock (1,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (Zero shares issued and outstanding at June 30, 2025 and December 31, 2024) | |
| - | | |
| - | |
Common Stock (25,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (10,784,725 shares issued and outstanding at June 30, 2025 and December 31, 2024) | |
| 1,078 | | |
| 1,078 | |
Additional paid-in capital | |
| 97,366,699 | | |
| 97,058,323 | |
Accumulated other comprehensive income | |
| 48,043 | | |
| 153,990 | |
Accumulated deficit | |
| (84,893,415 | ) | |
| (76,025,617 | ) |
Total stockholders’ equity | |
| 12,522,405 | | |
| 21,187,774 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 17,420,292 | | |
$ | 25,571,792 | |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations (Unaudited)
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 1,583,521 | | |
$ | 1,519,724 | | |
$ | 3,093,598 | | |
$ | 3,000,939 | |
Research and development | |
| 3,068,379 | | |
| 3,888,737 | | |
| 6,332,334 | | |
| 8,139,523 | |
Total operating expenses | |
| 4,651,900 | | |
| 5,408,461 | | |
| 9,425,932 | | |
| 11,140,462 | |
Loss from operations | |
| (4,651,900 | ) | |
| (5,408,461 | ) | |
| (9,425,932 | ) | |
| (11,140,462 | ) |
Interest income | |
| 114,745 | | |
| 188,660 | | |
| 264,535 | | |
| 389,610 | |
Other income, net | |
| 206,140 | | |
| 260,295 | | |
| 293,599 | | |
| 350,536 | |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (4,331,015 | ) | |
$ | (4,959,506 | ) | |
$ | (8,867,798 | ) | |
$ | (10,400,316 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share of common shares, basic and diluted | |
$ | (0.40 | ) | |
$ | (0.46 | ) | |
$ | (0.82 | ) | |
$ | (0.97 | ) |
Weighted-average number of common shares outstanding, basic and diluted | |
| 10,784,725 | | |
| 10,758,805 | | |
| 10,784,725 | | |
| 10,750,801 | |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Comprehensive Loss (Unaudited)
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
| | |
| | |
| | |
| |
NET LOSS | |
$ | (4,331,015 | ) | |
$ | (4,959,506 | ) | |
$ | (8,867,798 | ) | |
$ | (10,400,316 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive (loss) income | |
| | | |
| | | |
| | | |
| | |
Unrealized (loss) gain on available-for-sale securities | |
| (468 | ) | |
| 26,483 | | |
| (8,670 | ) | |
| 70,429 | |
Unrealized (loss) gain on foreign currency translation | |
| (83,223 | ) | |
| (34,928 | ) | |
| (97,277 | ) | |
| 30,446 | |
Other comprehensive (loss) income | |
| (83,691 | ) | |
| (8,445 | ) | |
| (105,947 | ) | |
| 100,875 | |
Comprehensive loss | |
$ | (4,414,706 | ) | |
$ | (4,967,951 | ) | |
$ | (8,973,745 | ) | |
$ | (10,299,441 | ) |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Stockholders’ Equity (Unaudited)
| |
Preferred Stock Number of | | |
Preferred Stock | | |
Common Stock Number of | | |
Common Stock | | |
Additional Paid-in- | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Loss | | |
Deficit | | |
Equity | |
Three and Six Months Ended June 30, 2024 |
Balance, December 31, 2023 | |
| - | | |
$ | - | | |
| 10,721,192 | | |
$ | 1,072 | | |
$ | 96,258,726 | | |
$ | (107,460 | ) | |
$ | (55,244,404 | ) | |
$ | 40,907,934 | |
Common stock issued from warrant exercises | |
| - | | |
| - | | |
| 37,613 | | |
| 4 | | |
| 54,712 | | |
| - | | |
| - | | |
| 54,716 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 134,057 | | |
| - | | |
| - | | |
| 134,057 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,440,810 | ) | |
| (5,440,810 | ) |
Other comprehensive income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 109,320 | | |
| - | | |
| 109,320 | |
Balance, March 31, 2024 | |
| - | | |
| - | | |
| 10,758,805 | | |
| 1,076 | | |
| 96,447,495 | | |
| 1,860 | | |
| (60,685,214 | ) | |
| 35,765,217 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 134,171 | | |
| - | | |
| - | | |
| 134,171 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,959,506 | ) | |
| (4,959,506 | ) |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,445 | ) | |
| - | | |
| (8,445 | ) |
Balance, June 30, 2024 | |
| - | | |
$ | - | | |
| 10,758,805 | | |
$ | 1,076 | | |
$ | 96,581,666 | | |
$ | (6,585 | ) | |
$ | (65,644,720 | ) | |
$ | 30,931,437 | |
| |
Preferred Stock Number of | | |
Preferred Stock | | |
Common Stock Number of | | |
Common Stock | | |
Additional Paid-in- | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Income | | |
Deficit | | |
Equity | |
Three and Six Months Ended June 30, 2025 |
Balance, December 31, 2024 | |
| - | | |
$ | - | | |
| 10,784,725 | | |
$ | 1,078 | | |
$ | 97,058,323 | | |
$ | 153,990 | | |
$ | (76,025,617 | ) | |
$ | 21,187,774 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| | | |
| 147,750 | | |
| - | | |
| - | | |
| 147,750 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| | | |
| - | | |
| - | | |
| (4,536,783 | ) | |
| (4,536,783 | ) |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (22,256 | ) | |
| - | | |
| (22,256 | ) |
Balance, March 31, 2025 | |
| - | | |
| - | | |
| 10,784,725 | | |
| 1,078 | | |
| 97,206,073 | | |
| 131,734 | | |
| (80,562,400 | ) | |
| 16,776,485 | |
Balance | |
| - | | |
| - | | |
| 10,784,725 | | |
| 1,078 | | |
| 97,206,073 | | |
| 131,734 | | |
| (80,562,400 | ) | |
| 16,776,485 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 160,626 | | |
| - | | |
| - | | |
| 160,626 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,331,015 | ) | |
| (4,331,015 | ) |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (83,691 | ) | |
| - | | |
| (83,691 | ) |
Balance, June 30, 2025 | |
| - | | |
$ | - | | |
| 10,784,725 | | |
$ | 1,078 | | |
$ | 97,366,699 | | |
$ | 48,043 | | |
$ | (84,893,415 | ) | |
$ | 12,522,405 | |
Balance | |
| - | | |
$ | - | | |
| 10,784,725 | | |
$ | 1,078 | | |
$ | 97,366,699 | | |
$ | 48,043 | | |
$ | (84,893,415 | ) | |
$ | 12,522,405 | |
See
accompanying Notes to Condensed Consolidated Financial Statements
Lantern
Pharma Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows (Unaudited)
| |
2025 | | |
2024 | |
| |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (8,867,798 | ) | |
$ | (10,400,316 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 9,075 | | |
| 8,319 | |
Changes in operating right-of-use assets | |
| 96,745 | | |
| 83,092 | |
Stock-based compensation | |
| 308,376 | | |
| 268,228 | |
Accretion of discounts on available for sale debt securities, net | |
| (132,925 | ) | |
| (93,166 | ) |
Foreign currency remeasurement (gain) loss | |
| (129,565 | ) | |
| 50,778 | |
Realized gain on available for sale debt securities | |
| (22,634 | ) | |
| (7,088 | ) |
Realized loss on equity securities | |
| 142,248 | | |
| - | |
Unrealized (gain) loss on equity securities | |
| (167,389 | ) | |
| 1,799 | |
Changes in assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| (62,133 | ) | |
| (12,932 | ) |
Accounts payable and accrued expenses | |
| 611,731 | | |
| 1,931,888 | |
Operating lease liabilities | |
| (98,618 | ) | |
| (83,617 | ) |
Other assets | |
| - | | |
| (6,146 | ) |
Net cash flows used in operating activities | |
| (8,312,887 | ) | |
| (8,259,161 | ) |
| |
| | | |
| | |
INVESTING ACTIVITIES | |
| | | |
| | |
Purchase of property and equipment | |
| (1,159 | ) | |
| (6,484 | ) |
Sales of marketable securities | |
| 15,274,344 | | |
| 13,608,333 | |
Net cash flows provided by (used in) investing activities | |
| 6,832,489 | | |
| (758,231 | ) |
| |
| | | |
| | |
FINANCING ACTIVITIES | |
| | | |
| | |
Proceeds from warrant exercises | |
| - | | |
| 54,716 | |
Net cash flows provided by financing activities | |
| - | | |
| 54,716 | |
| |
| | | |
| | |
Effect of foreign exchange rates on cash | |
| 30,727 | | |
| 1,492 | |
| |
| | | |
| | |
CHANGE IN CASH AND CASH EQUIVALENTS FOR THE PERIOD | |
| (1,449,671 | ) | |
| (8,961,184 | ) |
| |
| | | |
| | |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | |
| 7,511,079 | | |
| 21,937,749 | |
| |
| | | |
| | |
CASH AND CASH EQUIVALENTS, END OF PERIOD | |
$ | 6,061,408 | | |
$ | 12,976,565 | |
| |
| | | |
| | |
Non-cash investing and financing activities | |
| | | |
| | |
Operating lease right-of-use asset acquired through operating lease liability | |
$ | - | | |
$ | 198,405 | |
Removal of operating lease right-of-use assets and related operating lease liabilities upon early termination of leases | |
| - | | |
| 130,563 | |
See
accompanying Notes to Condensed Consolidated Financial Statements
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note
1. Organization, Principal Activities, and Basis of Presentation
Lantern
Pharma Inc., and Subsidiaries (the “Company”) is an artificial intelligence (A.I.) focused company dedicated to developing
cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development. The Company’s development
portfolio includes three clinical stage oncology focused product candidates and consists of small molecule drug candidates that others
have tried, but failed, to develop into an approved commercialized drug, as well as new compounds that it is developing with the assistance
of its A.I. platform and its biomarker driven approach. The Company’s A.I. platform, known as RADR®, uses big data
analytics (combining molecular data, drug efficacy data, data from historical studies, data from scientific literature, phenotypic data
from trials and publications, and mechanistic pathway data) and machine learning. The Company’s data-driven, genomically-targeted
and biomarker-driven approach allows it to pursue a transformational drug development strategy that identifies, rescues or develops,
and advances potential small molecule drug candidates.
Lantern
Pharma Inc. was incorporated under the laws of the state of Texas on November 7, 2013, and thereafter reincorporated in the state of
Delaware on January 15, 2020. The Company’s principal operations are located in Texas. The Company formed a wholly owned subsidiary,
Lantern Pharma Limited, in the United Kingdom in July 2017 and a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia
in September 2021. In January 2023, the Company formed a wholly owned subsidiary, Starlight Therapeutics Inc. (“Starlight”),
to continue with advancing the development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications.
Since
inception, the Company has devoted substantially all its activity to advancing research and development, including efforts in connection
with preclinical studies, clinical trials and development of its RADR® platform. This now includes three lead drug candidates
and an Antibody Drug Conjugate (ADC) program directed towards 11 disclosed therapeutic targets:
|
● |
LP-300
(Tavocept), which we are advancing in a Phase 2 clinical trial, the Harmonic™ trial, focused on never smokers with
advanced non-small cell lung cancer; |
|
|
|
|
● |
LP-184,
which we are advancing in a Phase 1 clinical trial and has potential for treatment of solid tumors including breast, pancreatic,
bladder, and lung cancers, and glioblastoma and other CNS cancers. Following the formation of Starlight, the Company now refers to
the molecule LP-184, as it is developed in CNS indications, as “STAR-001”; |
|
|
|
|
● |
LP-284,
the stereoisomer (enantiomer) of LP-184, is advancing in a Phase 1 clinical trial, and has shown promising in-vitro and in
vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184; and |
|
|
|
|
● |
Our
ADC program is focused on developing highly specific ADCs with highly potent drug payloads. |
The
Company’s fiscal year ends on December 31 of each calendar year. The accompanying interim condensed consolidated financial statements
are unaudited and have been prepared on substantially the same basis as the Company’s annual consolidated financial statements
for the fiscal year ended December 31, 2024. In the opinion of the Company’s management, these interim condensed consolidated financial
statements reflect all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the
Company’s financial position, results of operations and cash flows for the periods presented. The preparation of financial statements
in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management
to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting
periods. Actual results could differ from these estimates.
The
December 31, 2024 year-end condensed consolidated balance sheet data in the accompanying interim condensed consolidated financial statements
was derived from audited consolidated financial statements. These condensed consolidated financial statements and notes do not include
all disclosures required by GAAP and should be read in conjunction with the Company’s audited consolidated financial statements
as of and for the year ended December 31, 2024 and the notes thereto included in the Company’s Annual Report on Form 10-K, dated
March 27, 2025, on file with the Securities and Exchange Commission.
The
results of operations and cash flows for the interim periods included in these condensed consolidated financial statements are not necessarily
indicative of the results to be expected for any future period or the entire fiscal year.
Any
reference in these notes to applicable guidance refers to Accounting Standards Codification (“ASC”) and Accounting Standards
Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). To date, the Company has operated its business
as one segment.
Note
2. Liquidity and Going Concern
The
Company incurred a net loss of approximately $8,868,000
and $10,400,000
during the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, the Company had working capital of
approximately $12,316,000. The
Company plans to pursue periodic capital raises and also plans to apply for grant funding in the future to assist in supporting its
capital needs. In July 2025, the Company entered into an ATM Sales Agreement, with ThinkEquity, LLC, as sales agent, pursuant to
which the Company may offer and sell up to $15,530,000
of its common stock from time to time, in an “at-the-market” offering to or through its sales agent. We may also explore the possibility of entering into commercial credit facilities as an additional source of liquidity. We
believe that our existing cash, cash equivalents, and marketable securities as of June 30, 2025, and our anticipated expenditures
and capital commitments, will enable us to fund our operating expenses and capital expenditure requirements at least into June
2026. We will need substantial additional funding in the near future, and if we are unable to raise capital when needed, we could be
forced to delay, reduce or eliminate our drug development programs or commercialization efforts.
The Company’s ability to continue as a going concern is highly contingent on the ability to raise additional
capital for ongoing research and development and clinical trials as the Company expects to continue incurring losses for the foreseeable
future. The financial statements contained in this Quarterly
Report on Form 10-Q have been prepared assuming that the Company will continue as a going concern, and do not include any adjustments
that may be necessary should the Company be unable to continue as a going concern. The Company has incurred, and it anticipates it will
continue to incur, losses and generate negative operating cash flows and as such will require substantial additional funding in the near
future to continue its research and development activities. These factors raise substantial doubt about the Company’s ability to
continue as a going concern in the absence of obtaining substantial additional funding. While the Company plans to pursue periodic capital
raises, including potential sales under the ATM Sales Agreement, no assurance can be given that sufficient funding will be available when
needed to allow the Company to continue as a going concern.
Note
3. Summary of Significant Accounting Policies
Use
of Estimates and Assumptions
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. The significant areas of estimation include determining research
and development accruals, the inputs in determining the fair value of equity-based awards and warrants issued, the inputs in determining
present value of lease payments, and determining the fair value of marketable securities. Actual results could differ from those estimates.
Income
Taxes
Due
to the Company’s current and prior operating losses, the Company has no corporate income tax liabilities as of June 30, 2025 and
December 31, 2024. Because of its history of losses, the Company believes it is more-likely-than-not that all of the Company’s
deferred tax assets will not be realized as of June 30, 2025 and December 31, 2024. Therefore, the Company has recorded a full valuation
allowance on its deferred tax assets.
On July 4, 2025, H.R. 1, commonly known as the One Big Beautiful Bill Act (the “OBBB”), was signed into
law. This includes significant changes to the federal corporate tax provisions and extends certain otherwise expiring provisions of the
2017 Tax Cuts and Jobs Act. Among other things, the legislation reinstates expensing for domestic research and experimental expenditures,
imposes new limitations on interest expense deductibility, and expands disallowed deductions for certain employee remuneration. FASB ASC
740 Income Taxes requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period
in which the relevant legislation is enacted. The OBBB was passed after the three-month period covered by this Quarterly Report on Form
10-Q and may affect the Company’s gross tax assets and liabilities in future periods. As of the date of this Quarterly Report on
Form 10-Q, the Company is continuing to assess the potential impact of the OBBB.
Foreign
Currency
We
translate the financial statements of our Australian subsidiary, which has a functional currency of the Australian dollar, to U.S. dollars
using month-end exchange rates for assets and liabilities and average exchange rates for income and expenses. Translation gains and losses
are recorded in accumulated other comprehensive income (loss) as a component of stockholders’ equity. Gains and losses resulting
from foreign currency transactions that are denominated in currencies other than our functional currency (U.S. dollar) are included within
other income, net on the condensed consolidated statements of operations.
Risks
and Uncertainties
The
Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. Operations
are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and other risks, including
the potential risk of business failure.
Our
marketable securities may be impacted by various risks related to interest rates, market conditions and credit risk. Our marketable securities
have had and may in the future have their market value fluctuate due to rises or falls in interest rates. While we believe our cash,
cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that in the future our
investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of cash and cash equivalents
at one or more financial institutions that are federally insured. Interest bearing and non-interest bearing accounts we hold at these
banking institutions are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 per depositor, per
FDIC-insured bank, per ownership category. From time to time, some of our cash balances held at banking institutions may be in excess
of FDIC coverage.
We
currently rely on foreign third-party manufacturers and service providers in connection with certain aspects of our clinical operations.
The U.S. government and persons involved in the Trump administration have made statements and taken certain actions that have led to,
and may continue to lead to, changes to U.S. and international trade policies. If maintained, tariffs and the potential escalation of
trade disputes with foreign countries could pose a significant risk to our business and could result in higher operating expenses. U.S.
policies on tariffs and international trade could also result in fluctuations in interest rates, which could have a negative impact on
general economic conditions, on the industry sector in which we operate, and on our business.
Research
and Development
Research
and development costs are expensed as incurred. These expenses primarily consist of payroll, contractor expenses, research study expenses,
costs for manufacturing and supplies, clinical site costs and other costs for the conduct of clinical trials, costs for technical infrastructure
on the cloud for the purposes of developing the Company’s RADR® platform, and other costs for identifying, developing,
and testing drug candidates. Development costs incurred by third parties are expensed as the work is performed. Costs to acquire technologies,
including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.
Cash
and Cash Equivalents
The
Company considers money market funds and other highly liquid instruments with an original maturity of 3 months or less to be cash equivalents.
Cash equivalents at June 30, 2025 and December 31, 2024 were approximately $4,617,000 and $6,619,000, respectively, and are included
along with cash under the caption cash and cash equivalents on the Company’s condensed consolidated balance sheets.
Leases
The
Company determines whether an arrangement contains a lease at inception. Operating leases are included in operating lease right-of-use
(“ROU”) assets, current portion of operating lease liabilities, and net of current portion of operating lease liabilities
on our condensed consolidated balance sheets. Lease ROU assets represent the Company’s right to use an underlying asset for the
lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Lease ROU assets and lease liabilities
are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company’s
leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement
date in determining the present value of lease payments. The Company does not include options to extend or terminate the lease term unless
it is reasonably certain that the Company will exercise any such options. Rent expense is recognized under the operating leases on a
straight-line basis. The Company does not recognize right-of-use assets or lease liabilities for short-term leases, which have a lease
term of twelve months or less, and instead will recognize lease payments as expense on a straight-line basis over the lease term.
Marketable
Securities
The
Company’s marketable securities consist of government and agency securities, corporate bonds, mutual funds and common stock. We
classify our marketable securities as available-for-sale at the time of purchase and reevaluate such classification as of each balance
sheet date. We may sell these securities at any time for use in current operations even if they have not yet reached maturity. As a result,
we classify our investments, including securities with maturities beyond twelve months, as current assets in the accompanying condensed
consolidated balance sheets.
Available-for-sale
debt securities are recorded at fair value each reporting period. Unrealized gains and losses on available-for-sale debt securities are
excluded from earnings and recorded as a separate component within accumulated other comprehensive income (loss) on the condensed consolidated
balance sheets until realized. Interest is reported within interest income on the condensed consolidated statements of operations. We
evaluate our available-for-sale debt securities to assess whether the amortized cost basis is in excess of estimated fair value and determine
what amount of that difference, if any, is caused by expected credit losses. Allowance for credit losses are recognized as a charge in
other income, net on the condensed consolidated statements of operations, and any remaining unrealized losses are included in accumulated
other comprehensive income (loss) on the condensed consolidated balance sheets. The allowance for credit losses is zero at June 30, 2025
and December 31, 2024, and there were no credit losses recorded during the three and six months ended June 30, 2025 and 2024.
Equity
securities, which are composed of mutual funds and common stock, are recorded at fair value each reporting period, with changes in fair
value of these investments, as well as dividends earned, recorded within other income, net on the condensed consolidated statements of
operations.
We
determine realized gains and losses on the sale of marketable securities based on the specific identification method and record such
gains and losses within other income, net on the condensed consolidated statements of operations.
Recent
Accounting Pronouncements
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which will require
public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation table, as well as disclosure
of income taxes paid disaggregated by jurisdiction. The standard is effective for our 2025 annual period and can be applied either prospectively
or retrospectively. We are currently assessing the effect that the updated standard will have on our financial statement disclosures.
In
November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic
220-40): Disaggregation of Income Statement Expenses, requiring public business entities to provide disaggregated disclosures of
relevant income statement expenses. The amendments aim to improve financial reporting by enhancing transparency in the notes to financial
statements, specifically regarding expense categories. The amendments in this update are effective for annual reporting periods beginning
after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The Company is assessing the effect of this
update on its condensed consolidated financial statements and related disclosures.
Note
4. Commitments and Contingencies
General
The
Company has entered into, and expects to enter into from time to time in the future, license agreements, strategic alliance agreements,
assignment agreements, research service agreements, and similar agreements related to the advancement of its product candidates and research
and development efforts. Significant agreements (collectively, the “License, Strategic Alliance, and Research Agreements”)
are described in detail in the Company’s 2024 Form 10-K. While specific amounts will fluctuate from quarter to quarter based on
clinical trials progress, advancement and completion of research studies and manufacturing projects, and other factors, the Company believes
its overall activities regarding License, Strategic Alliance, and Research Agreements are materially consistent with those described
in the 2024 Form 10-K, as supplemented by the discussion in the following paragraph.
As
described in the 2024 Form 10-K, the Company has previously entered into a work order with Fortrea Inc. (“Fortrea”) to provide
contract research organization (CRO) services in connection with the Company’s Phase 2 clinical trial for LP-300. While there has
not yet been a formal amendment or contract termination, in July 2025, the Company and Fortrea determined that the CRO services being
performed by Fortrea for the LP-300 Phase 2 clinical trial would be transitioned to other service providers.
In
addition to the specific agreements described in the 2024 Form 10-K and the Fortrea work order matters described above, the Company has
entered into, and will in the future enter into, other research and service provider agreements for the advancement of its product candidates
and research and development efforts. The Company expects to pay additional amounts in future periods in connection with existing and
future research and service provider agreements.
Set
forth below are the approximate amounts expensed for License, Strategic Alliance, and Research Agreements during the three and six months
ended June 30, 2025 and 2024, respectively. These expensed amounts are included under research and development expenses in the accompanying
condensed consolidated statements of operations, and also include estimated accruals in connection with the transition of Fortrea’s services.
Schedule of Research and Development
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Amount Expensed for License, Strategic Alliance, and Research Agreements | |
$ | 1,133,000 | | |
$ | 1,639,000 | | |
$ | 2,314,000 | | |
$ | 3,741,000 | |
Set
forth below at June 30, 2025 and December 31, 2024, respectively, are (1) the approximate amounts accrued and payable under License,
Strategic Alliance, and Research Agreements, and (2) the approximate amount of prepaid expenses and other current assets under License,
Strategic Alliance, and Research Agreements. These amounts are included in the accompanying condensed consolidated balance sheets.
Schedule of Accounts Payable and Accrued Liabilities
| |
June 30, 2025 | | |
December 31, 2024 | |
| |
| | |
| |
Amount accrued and payable under License, Strategic Alliance, and Research Agreements | |
$ | 1,382,000 | | |
$ | 1,725,000 | |
| |
| | | |
| | |
Prepaid expenses and other current assets under License, Strategic Alliance, and Research Agreements | |
$ | 368,000 | | |
$ | 490,000 | |
Actuate
Therapeutics
In
May 2021, the Company entered into a Collaboration Agreement with Actuate Therapeutics, Inc. (“Actuate”), a clinical stage
private biopharmaceutical company focused on the development of compounds for use in the treatment of cancer, and inflammatory diseases
leading to fibrosis. Pursuant to the agreement, the Company and Actuate have collaborated on utilization of the Company’s RADR®
platform to develop novel biomarker derived signatures for use with one of Actuate’s product candidates. As part of the collaboration,
the Company received 25,000 restricted shares of Actuate stock, subject to meeting certain conditions of the collaboration, as well as
the potential to receive additional Actuate stock if results from the collaboration are utilized in future development efforts. In 2023,
the term of the Collaboration Agreement was extended to continue until March 31, 2024. The Company is currently evaluating the possibility
of further collaborations with Actuate. Certain affiliates of Bios Partners beneficially own greater than 10% of the Company’s
common stock and also hold substantial beneficial ownership interests in Actuate. Through June 30, 2025, no revenues have been recognized
under the Collaboration Agreement.
In
August 2024, Actuate announced the closing of its initial public offering (“IPO”), which also included a reverse stock split.
Following the reverse stock split and the IPO, the Company holds 13,889 shares of common stock, which can be sold by the Company without
restriction in accordance with Rule 144 of the Securities Act of 1933. At June 30, 2025 and December 31, 2024, the Actuate common stock
held by the Company had a fair value of approximately $85,000 and $111,000, respectively, which amounts were included in the caption
marketable securities on the Company’s condensed consolidated balance sheets.
Note
5. Leases
The
following provides balance sheet information related to leases as of June 30, 2025 and December 31, 2024:
Schedule of Balance Sheet Information Related to Leases
| |
June 30, 2025 | | |
December 31, 2024 | |
Assets | |
| | | |
| | |
Operating lease, right-of-use asset, net | |
$ | 143,240 | | |
$ | 239,985 | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 131,515 | | |
$ | 190,814 | |
Operating lease liabilities, net of current portion | |
| 13,524 | | |
| 52,843 | |
Total operating lease liabilities | |
$ | 145,039 | | |
$ | 243,657 | |
At
June 30, 2025, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
Schedule of Future Estimated Minimum Lease Payments Under Non-cancelable Operating Leases
| |
| | |
2025 (remaining six months) | |
$ | 97,057 | |
2026 | |
| 54,744 | |
Total minimum lease payments | |
| 151,801 | |
Less amount representing interest | |
| 6,762 | |
Present value of future minimum lease payments | |
| 145,039 | |
Less current portion of operating lease liabilities | |
| 131,515 | |
Operating lease liabilities, net of current portion | |
$ | 13,524 | |
The
Company leases office space in the Dallas, Texas and Atlanta, Georgia metropolitan areas under non-cancellable operating leases. In January
2023, the Company renewed its existing lease in the Atlanta area for an additional two years (“Colony Square Lease”). Effective
August 31, 2024, the Colony Square Lease was terminated in conjunction with a new lease with the same landlord. The new lease began September
1, 2024 for a period of 24 months, requires payments of approximately $6,800 per month, and is subject to automatic renewal on a month-to-month
basis unless the Company provides three-months written notice to the landlord. The exercise of lease renewal options is at the Company’s
sole discretion and is assessed as to whether to include any renewals in the lease term at inception.
In
January 2023, the Company also entered into two new leases in the Dallas area that commenced in March 2023 and May 2023, respectively
(“Legacy West Leases”). Effective April 30, 2024, the Legacy West Leases were terminated in conjunction with a new lease
with the same landlord. The new lease began May 1, 2024 for a period of 19 months, requires payments of approximately $11,200 per month,
and is subject to automatic renewal on a month-to-month basis unless the Company provides three-months written notice to the landlord.
The exercise of lease renewal options is at the Company’s sole discretion and is assessed as to whether to include any renewals
in the lease term at inception.
The
following table provides a reconciliation for our operating right-of-use assets and operating lease liabilities:
Schedule of Reconciliation of Right-of-Use Assets and lease Liabilities
| |
Operating | | |
Operating | |
| |
Right-of- Use | | |
Lease | |
| |
Assets | | |
Liabilities | |
Balance at December 31, 2024 | |
$ | 239,985 | | |
$ | 243,657 | |
Amortizations and reductions | |
| (96,745 | ) | |
| (98,618 | ) |
Balance at June 30, 2025 | |
$ | 143,240 | | |
$ | 145,039 | |
Other
supplemental information related to operating leases is as follows:
Schedule of Other Supplemental Information Related to Operating Leases
| |
2025 | | |
2024 | |
| |
As of June 30, | |
| |
2025 | | |
2024 | |
Weighted average remaining term of operating leases (in years) | |
| 0.89 | | |
| 1.31 | |
Weighted average discount rate of operating leases | |
| 9.50 | % | |
| 9.03 | % |
The
Company also leased office space in Dallas, Texas under month-to-month lease arrangements during the three and six months ended June
30, 2025 and 2024. In April 2023, the Company entered into a 2two-year lease for material storage and handling, which the Company is in
the process of extending. The lease is cancellable with 45-days’ written notice. Under these short-term leases, the Company elected
the short-term lease measurement and recognition exemption under ASC 842 and recorded rent expense as incurred.
The
components of lease expense were approximately as follows for the three and six months ended June 30, 2025 and 2024:
Schedule of Lease Expense
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Operating lease cost | |
$ | 53,000 | | |
$ | 45,000 | | |
$ | 106,000 | | |
$ | 90,000 | |
Short-term lease cost | |
| 4,800 | | |
| 4,800 | | |
| 9,600 | | |
| 9,300 | |
Lease expense | |
$ | 57,800 | | |
$ | 49,800 | | |
$ | 115,600 | | |
$ | 99,300 | |
During
the six months ended June 30, 2025 and 2024, cash used in operating activities associated with operating leases was approximately $108,000
and $91,000, respectively.
Note
6. Stockholders’ Equity
Common
Stock
As
of June 30, 2025 and December 31, 2024, the Company had 25,000,000 authorized shares of Common Stock, of which 10,784,725 shares were
issued and outstanding.
In July 2025, the Company entered into an ATM Sales Agreement, with ThinkEquity, LLC, as sales agent (the “Sales
Agent”), pursuant to which the Company may offer and sell up to $15,530,000 of shares (“Placement Shares”) of its common
stock from time to time, in an “at-the-market” offering to or through the Sales agent. The Company will pay the Sales Agent
a commission of 3.0% of the aggregate gross proceeds from the sale of the Placement Shares pursuant to the ATM Sales Agreement. The ATM
Sales Agreement contains customary representations, warranties and agreements of the Company, conditions to closing, indemnification rights
and obligations of the parties, and termination provisions. Through August 12, 2025, the Company has sold a total of 15,185 shares of Common Stock under the ATM Sales Agreement
for aggregate gross proceeds of approximately $80,000.
Warrants
There
were no warrant exercises during the three months ended June 30, 2025 and 2024, or during the six months ended June 30, 2025. During
the six months ended June 30, 2024, the Company issued 20,132 shares of common stock relating to the cashless exercise of 79,021 warrants
that were expiring. The Company also issued 17,481 shares of common stock for aggregate proceeds of $54,716, relating to the exercise
of warrants that were expiring during the six months ended June 30, 2024. During the three and six months ended June 30, 2025, warrants
to purchase 70,000 shares expired unexercised, and there are no outstanding warrants as of June 30, 2025.
Options
A
summary of stock option activity under the Lantern Pharma Inc. 2018 Equity Incentive Plan, as amended and restated, during the six months
ended June 30, 2025 is presented below:
Schedule of Stock Option Activity
| |
Options Outstanding | |
| |
Number of Shares | | |
Weighted- Average Exercise
Price Per Share | |
Outstanding December 31, 2024 | |
| 1,245,694 | | |
$ | 5.72 | |
Cancelled or expired | |
| (5,928 | ) | |
| 6.16 | |
Outstanding June 30, 2025 | |
| 1,239,766 | | |
$ | 5.72 | |
Options
were exercisable for 1,057,353 shares of common stock at June 30, 2025 at a weighted average exercise price of $5.95 per share.
Stock-based
compensation was as follows for the three and six months ended June 30, 2025 and 2024:
Schedule of Stock-based Compensation
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
General and administrative | |
$ | 65,791 | | |
$ | 56,051 | | |
$ | 139,544 | | |
$ | 112,296 | |
Research and development | |
| 94,835 | | |
| 78,120 | | |
| 168,832 | | |
| 155,932 | |
Total stock-based compensation | |
$ | 160,626 | | |
$ | 134,171 | | |
$ | 308,376 | | |
$ | 268,228 | |
Note
7. Marketable Securities
At
June 30, 2025, debt and equity securities consisted of the following:
Schedule of Marketable of Securities
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
Aggregate | |
| |
Cost | | |
Gains | | |
Losses | | |
Fair Value | |
Government and agency debt securities | |
$ | 9,951,518 | | |
$ | 475 | | |
$ | (453 | ) | |
$ | 9,951,540 | |
Equity securities | |
| | | |
| | | |
| | | |
| 4,505,440 | |
| |
| | | |
| | | |
| | | |
$ | 14,456,980 | |
| |
| | | |
| | | |
| | | |
| | |
Included in cash and cash equivalents | |
| | | |
| | | |
| | | |
$ | 4,616,614 | |
Included in marketable securities | |
| | | |
| | | |
| | | |
$ | 9,840,366 | |
The
contractual maturities of the Company’s debt securities, including approximately $3,990,000 classified in cash and cash equivalents,
are as follows:
Schedule of Contractual Maturities Investments of Marketable Securities
| |
As of | |
| |
June 30, 2025 | |
Due within one year | |
$ | 9,951,540 | |
The
following table presents gross unrealized losses and fair values for those marketable securities that were in an unrealized loss position
as of June 30, 2025, aggregated by investment category and the length of time that individual securities have been in a continuous loss
position:
Schedule of Gross Unrealized Losses and Fair Values for Marketable Securities
| |
As of June 30, 2025 | |
| |
Less than 12 months | | |
More than 12 months | |
| |
Fair Value | | |
Unrealized Loss | | |
Fair Value | | |
Unrealized Loss | |
Government and agency debt securities | |
$ | 3,970,755 | | |
$ | (453 | ) | |
$ | - | | |
$ | - | |
We
do not believe the unrealized losses on debt securities represent credit losses based on our evaluation of available evidence as of June
30, 2025, which includes an assessment of whether it is more likely than not we will be required to sell the investment before recovery
of the investment’s amortized cost basis.
Note
8. Fair Value Measurements
We
determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use
of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would
be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous
market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions
that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the
hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes
the inputs into three levels that may be used to measure fair value:
Level
1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
Level
2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability,
either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level
3 - Inputs are unobservable inputs based on our assumptions.
Financial
Assets
When
available, our marketable securities are valued using quoted prices for identical instruments in active markets. If we are unable to
value our marketable securities using quoted prices for identical instruments in active markets, we value our investments using broker
reports that utilize quoted market prices for comparable instruments. As of June 30, 2025, our available-for-sale debt securities were
valued through use of quoted prices for comparable instruments in active markets and are classified as Level 2, and our money markets,
common stock and mutual funds were valued using quoted prices in active markets for identical assets and are classified as Level 1.
Based
on our valuation of our marketable securities, we concluded that they are classified in either Level 1 or Level 2, and we have no financial
assets measured using Level 3 inputs. The following table presents information about our assets that are measured at fair value on a
recurring basis using the above input categories.
Schedule of Assets are Measured at Fair Value on Recurring Basis
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
Fair Value Measurements as of June 30, 2025 | |
Description | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Government and agency debt securities | |
$ | 9,951,540 | | |
$ | - | | |
$ | 9,951,540 | | |
$ | - | |
Money markets | |
| 626,569 | | |
| 626,569 | | |
| - | | |
| - | |
Mutual funds – fixed income | |
| 2,922,809 | | |
| 2,922,809 | | |
| - | | |
| - | |
Mutual funds – alternative investments | |
| 871,200 | | |
| 871,200 | | |
| - | | |
| - | |
Common stock | |
| 84,862 | | |
| 84,862 | | |
| - | | |
| - | |
Fair
value recurring basis | |
$ | 14,456,980 | | |
$ | 4,505,440 | | |
$ | 9,951,540 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Included in cash and cash equivalents | |
$ | 4,616,614 | | |
| | | |
| | | |
| | |
Included in marketable securities | |
$ | 9,840,366 | | |
| | | |
| | | |
| | |
Note
9. Loss Per Share of Common Shares
Basic
loss per share is derived by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock
outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities,
such as warrants and stock options, which would result in the issuance of incremental shares of common stock unless such effect is anti-dilutive.
In calculating the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remained
the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation. Potentially
dilutive securities outstanding that have been excluded from diluted loss per share due to being anti-dilutive include the following:
Schedule of Anti-dilutive Securities Outstanding Diluted Loss Per Share
| |
2025 | | |
2024 | |
| |
Outstanding at June 30, | |
| |
2025 | | |
2024 | |
Warrants to purchase common stock | |
| - | | |
| 81,496 | |
Stock options | |
| 1,239,766 | | |
| 1,063,548 | |
Anti-dilutive
securities | |
| 1,239,766 | | |
| 1,145,044 | |
Note
10. Segment Reporting
The
Company operates as one operating segment. The Company’s chief operating decision maker (“CODM”) is its chief executive
officer, who reviews financial information presented on a condensed consolidated basis. The CODM uses expected research and development
study and material costs; cash, cash equivalents and marketable securities balances; operating losses; and budget projections to assess
financial performance and allocate resources. During the six months ended June 30, 2025 and 2024, research and development study and
material costs, which include clinical trial and product candidate manufacturing costs, were approximately $4,072,000 and $5,848,000,
respectively. During the three months ended June 30, 2025 and 2024, research and development study and material costs, which include
clinical trial and product candidate manufacturing costs, were approximately $1,946,000 and $2,730,000, respectively. These financial
metrics are used by the CODM to make key operating decisions, such as which research and development studies to commence, extend or discontinue.
See the condensed consolidated balance sheets as of June 30, 2025 and December 31, 2024, as well as the condensed consolidated statements
of operations for the three and six months ended June 30, 2025 and 2024.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You
should read the following discussion and analysis of our financial condition and plan of operations together with our condensed consolidated
financial statements and the related notes appearing elsewhere in this Quarterly Report. In addition to historical information, this
discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may
differ materially from the plans, intentions, expectations and other forward-looking statements included in the discussion below. Factors
that could cause or contribute to such differences include, but are not limited to, those identified below, and those factors discussed
in the Risk Factors section of our 2024 Form 10-K on file with the SEC.
Overview
We
are an artificial intelligence (A.I.) focused company dedicated to developing cancer therapies and transforming the cost, pace, and timeline
of oncology drug discovery and development. Our development portfolio includes three clinical stage oncology focused product candidates
and consists of small molecules that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds
that we are developing with the assistance of our proprietary A.I. platform and our biomarker driven approach. Our A.I. platform, known
as RADR®, currently includes over 200 billion data points, and uses big data analytics (combining molecular data, drug efficacy data,
data from historical studies, data from scientific literature, phenotypic data from trials and publications, and mechanistic pathway
data) and machine learning to rapidly uncover biologically relevant genomic signatures correlated to drug response, and then identify
the cancer patients that we believe may benefit most from our compounds. This data-driven, genomically-targeted and biomarker-driven
approach allows us to pursue a transformational drug development strategy that identifies, rescues or develops, and advances potential
small molecule drug candidates at what we believe is a fraction of the time and cost associated with traditional cancer drug development.
We
have active clinical programs for our three lead small molecule drug candidates: LP-300, LP-184, and LP-284. These programs are focused
on multiple important cancer indications, including both solid tumors and blood cancers. We have established a wholly-owned subsidiary,
Starlight Therapeutics, to focus exclusively on the clinical development of our promising opportunities for central nervous system (“CNS”)
and brain cancers, many of which have no effective treatment options. We are also advancing an antibody-drug conjugate (“ADC”)
program focused on developing highly specific ADCs with highly potent drug-payloads.
Our
strategy is to both develop new drug candidates using our RADR® platform, and other machine learning driven methodologies,
and to pursue the development of drug candidates that have undergone previous clinical trial testing or that may have been halted in
development or deprioritized because of insufficient clinical trial efficacy (i.e., a meaningful treatment benefit relevant for the disease
or condition under study as measured against the comparator treatment used in the relevant clinical testing) or for strategic reasons
by the owner or development team responsible for the compound. Importantly, these historical drug candidates appear to have been well-tolerated
in many instances, and often have considerable data from previous toxicity, tolerability and ADME (absorption, distribution, metabolism,
and excretion) studies that have been completed. Additionally, these drug candidates may also have a body of existing data supporting
the potential mechanism(s) by which they achieve their intended biologic effect, but often require more targeted trials in a stratified
group of patients to demonstrate statistically meaningful results. Our dual approach to both develop de-novo, biomarker-guided drug candidates
and “rescue” historical drug-candidates by leveraging A.I., recent advances in genomics, computational biology and cloud
computing is emblematic of a new era in drug development that is being driven by data-intensive approaches meant to de-risk development
and accelerate the clinical trial process. In this context, we intend to create a diverse portfolio of oncology drug candidates for further
development towards regulatory and marketing approval with the objective of establishing a leading A.I.-driven methodology for treating
the right patient with the right oncology therapy.
A
key component of our strategy is to target specific cancer patient populations and treatment indications identified by leveraging our
RADR® platform, a proprietary A.I. enabled engine created and owned by us. We believe the combination of our therapeutic area expertise,
our A.I. expertise, and our ability to identify and develop promising drug candidates through our collaborative relationships with research
institutions in selected areas of oncology gives us a significant competitive advantage. Our RADR® platform has been developed
and refined over the last several years and integrates billions of data points immediately relevant for oncology drug development and
patient response prediction using artificial intelligence and proprietary machine learning algorithms. By identifying clinical candidates,
together with relevant genomic and phenotypic data, we believe our approach will help us design more efficient pre-clinical studies,
and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. Although
we have not yet applied for or received regulatory or marketing approval for any of our drug candidates, we believe our RADR®
platform has the ability to reduce the cost and time to bring drug candidates to specifically targeted patient groups. We believe we
have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that leverages
artificial intelligence along with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic areas
to address today’s treatment needs.
Our
current portfolio consists of three lead drug candidates that are in clinical phases (known as LP-300, LP-184 and LP-284) and an Antibody
Drug Conjugate (ADC) program that is in preclinical research optimization. In January 2023, we formed a wholly owned subsidiary, Starlight
Therapeutics Inc. (“Starlight”), to develop drug candidate LP-184’s central nervous system (CNS) and brain cancer indications
– including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers. Following the formation
of Starlight, we may also refer to the molecule LP-184, as it is developed in CNS indications, as “STAR-001”. All of these
drug candidates and our ADC program are leveraging precision oncology, A.I. and genomic driven approaches to accelerate and direct development
efforts.
We
are conducting a targeted phase 2 trial (the Harmonic™ trial) for LP-300 in never smoking
patients with advanced non-small cell lung cancer (“NSCLC”) in combination with chemotherapy, under an existing investigational
new drug application. Our candidate LP-184 has shown promising in-vitro and in
vivo anticancer activity in multiple solid tumor indications (including pancreatic, glioblastoma
and triple negative breast cancer), and it is advancing in a Phase 1A clinical trial that is nearing completion. Our candidate LP-284
has shown promising in-vitro and in vivo anticancer
activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184. LP-284 is advancing in a Phase
1A clinical trial.
Our
ADC program has also continued to advance. During 2024 and the first half of 2025, we continued to progress the application of our RADR®
A.I. platform to advance and refine an A.I. powered module focused on improving the precision, cost and timelines of ADC development
for cancer. In 2023, we entered into a research collaboration with Bielefeld University in Germany
focused on development of ADCs utilizing cryptophycin as the ADC drug-payload. Cryptophycins are promising antitumor molecules that have
demonstrated potency at ultra-low, picomolar, concentrations. In a broad range of preclinical studies, the cryptophycin-ADC synthesized
as part of the Bielefeld collaboration demonstrated promising picomolar level potency and
anti-tumor activity in multiple solid tumor cell lines, including breast, bladder, colorectal, gastric, pancreatic and ovarian.
In
addition to our lead drug candidates and ADC program, we also have an additional drug candidate, LP-100, that we believe has potential
for future development in combination with the class of anticancer agents known as PARP inhibitors (PARPi). For LP-100, as well as our
lead drug candidate LP-300, we are leveraging data from prior preclinical studies and clinical trials, along with insights generated
from our A.I. platform, to target the types of tumors and patient groups we believe will be most responsive to the drug. Both LP-100
and LP-300 showed promise in important patient subgroups, but failed pivotal Phase 3 trials when the overall results did not meet the
predefined clinical endpoints. We believe that this was due to a lack of biomarker-driven patient stratification.
LP-300
has been studied in multiple randomized, controlled, multi-center non-small cell lung cancer, or NSCLC, trials that included administration
of either paclitaxel and cisplatin and/or docetaxel and cisplatin. LP-100 has previously been in a genomic signature guided phase 2 clinical
trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC). 9 patients (out of a targeted enrollment
of 27) were treated in the trial. The median overall survival (OS) for the initial group of 9 patients was approximately 12.5 months,
which is an improvement over other similar fourth-line treatment regimens for mCRPC. Based on our evaluation of the synergies of LP-100
with PARP inhibitors, the decision was made in the first quarter of 2023 to close the phase 2 clinical trial in Denmark, to allow the
focus of LP-100-directed resources on positioning the molecule for development in earlier lines of therapy with potentially larger market
opportunities. LP-100 was previously out-licensed by us to Allarity Therapeutics A/S. In July 2021, we entered into an Asset Purchase
Agreement to reacquire global development and commercialization rights for LP-100 from Allarity.
Our
development strategy is to pursue an increasing number of oncology focused, molecularly targeted therapies where artificial intelligence
and genomic data can help us provide biological insights, reduce the risk associated with development efforts and help clarify potential
patient response. We plan on strategically evaluating these on a program-by-program basis as they advance into clinical development,
either to be done entirely by us, or with licensing partners, to maximize the commercial opportunity and reduce the time it takes to
bring the right drug to the right patient.
To
date, except for a prior research grant, we have not generated any revenue, we have incurred net losses and our operations have been
financed primarily by sales of our equity securities. Our net losses were approximately $8,868,000 and $10,400,000 for the six months
ended June 30, 2025 and 2024, respectively.
Our
net losses have primarily resulted from costs incurred in licensing and developing the drug candidates in our pipeline, planning, preparing
and conducting preclinical studies and clinical testing, and general and administrative activities associated with our operations. We
expect to continue to incur significant expenses and corresponding operating losses for the foreseeable future as we continue to develop
our pipeline. Our costs may further increase as we conduct additional preclinical studies and clinical trials and potentially seek regulatory
clearance for and prepare to commercialize our drug candidates. We expect to incur significant expenses to continue to build the infrastructure
necessary to support our expanded operations, preclinical studies, clinical trials, and commercialization, including manufacturing, marketing,
sales and distribution functions. We have experienced and will continue to experience substantial costs associated with operating as
a public company.
Components
of Our Results of Operations
Revenues
We
did not recognize revenues for the three and six-month periods ended June 30, 2025 and 2024.
Expenses
Our
research and development expenses by project category for the three and six months ended June 30, 2025 are as follows:
| |
Three Months | | |
Six Months | |
| |
Ended June 30, 2025 | | |
Ended June 30, 2025 | |
LP-300 | |
$ | 1,164,748 | | |
$ | 2,172,656 | |
LP-184 | |
| 1,272,370 | | |
| 2,633,833 | |
LP-284 | |
| 275,957 | | |
| 732,428 | |
LP-100 | |
| 31,250 | | |
| 60,650 | |
ADC Program | |
| 7,999 | | |
| 14,376 | |
RADR® Platform | |
| 263,564 | | |
| 517,143 | |
Other | |
| 52,491 | | |
| 201,248 | |
Total research and development expenses | |
$ | 3,068,379 | | |
$ | 6,332,334 | |
We
expect that our research and development expenses will fluctuate from quarter to quarter and year to year. We expect that our research
and development expenses will increase substantially over time based on the progress of our clinical trials for LP-300, LP-184 and LP-284,
and other programs and drug candidates. We expect to make substantial expenditures associated with research and service provider agreements
for the advancement of our drug candidates and research and development efforts.
Because
of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion
costs of these or other current or future clinical trials of LP-300, LP-184, LP-284 or our other drug candidates. We may never succeed
in achieving regulatory approval for LP-300, LP-184, LP-284, or any of our other drug candidates. The duration, costs and timing of clinical
trials and development of our drug candidates will depend on a variety of factors, including the uncertainties of future clinical and
preclinical studies, uncertainties in clinical trial enrollment rates, significant and changing government regulation, and geopolitical
risk, including in Taiwan where we are pursuing clinical testing of LP-300. In addition, the probability of success for each drug candidate
will depend on numerous factors, including competition, manufacturing capability and commercial viability.
General
and Administrative
General
and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, corporate
development and administrative support functions, including stock-based compensation expenses and benefits. Other significant general
and administrative expenses include accounting and legal services, insurance, the cost of various consultants, occupancy costs, investor
relations and information systems costs.
We
expect fluctuating and increased administrative costs over time resulting from our existing and anticipated clinical trials and the potential
commercialization of our drug candidates. We believe that these increases will likely include increased costs for hiring additional administrative
personnel to support future market research and future product commercialization efforts and increased fees for outside consultants,
attorneys and accountants.
Summary
Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024 (unaudited)
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 1,583,521 | | |
$ | 1,519,724 | | |
$ | 3,093,598 | | |
$ | 3,000,939 | |
Research and development | |
| 3,068,379 | | |
| 3,888,737 | | |
| 6,332,334 | | |
| 8,139,523 | |
Total operating expenses | |
| 4,651,900 | | |
| 5,408,461 | | |
| 9,425,932 | | |
| 11,140,462 | |
Loss from operations | |
| (4,651,900 | ) | |
| (5,408,461 | ) | |
| (9,425,932 | ) | |
| (11,140,462 | ) |
Interest income | |
| 114,745 | | |
| 188,660 | | |
| 264,535 | | |
| 389,610 | |
Other income, net | |
| 206,140 | | |
| 260,295 | | |
| 293,599 | | |
| 350,536 | |
NET LOSS | |
$ | (4,331,015 | ) | |
$ | (4,959,506 | ) | |
$ | (8,867,798 | ) | |
$ | (10,400,316 | ) |
Comparison
of the Three Months Ended June 30, 2025 and 2024
General
and Administrative Expenses
General
and administrative expenses increased approximately $64,000, or 4%, from approximately $1,520,000 for the three months ended June 30,
2024 to approximately $1,584,000 for the three months ended June 30, 2025. The increase was primarily attributable to increases in other
professional fees of approximately $75,000, increases in patent costs of approximately $29,000, increases in payroll and compensation
expenses of approximately $11,000, and increases in corporate insurance expense of approximately $10,000. This was partially offset by
decreases in business development expenses of approximately $51,000 and decreases in office and administrative fees of approximately
$8,000.
Research
and Development Expenses
Research
and development expenses decreased approximately $821,000, or 21%, from approximately $3,889,000 for the three months ended June 30,
2024 to approximately $3,068,000 for the three months ended June 30, 2025. The decrease was primarily attributable to decreases in research
studies of approximately $777,000, decreases in consulting expenses of approximately $53,000 and decreases in payroll and
compensation expenses of approximately $15,000. This was partially offset by increases in licensing expenses of approximately
$31,000.
Interest
and Other Income, Net
Interest
income decreased approximately $74,000, or 39%, from approximately $189,000 for the three months ended June 30, 2024 to approximately
$115,000 for the three months ended June 30, 2025. Other income, net decreased approximately $54,000 from a gain of approximately $260,000
for the three months ended June 30, 2024 to a gain of approximately $206,000 for the three months ended June 30, 2025. This decrease
was primarily attributable to decreases in dividend income of approximately $156,000, offset in part by increases in foreign currency
gains of approximately $64,000, increases in investment income of approximately $32,000, and increases of approximately $6,000 in research
and development tax incentives related to our Australia subsidiary.
Comparison
of the Six Months Ended June 30, 2025 and 2024
General
and Administrative Expenses
General
and administrative expenses increased approximately $93,000, or 3%, from approximately $3,001,000 for the six months ended June 30, 2024
to approximately $3,094,000 for the six months ended June 30, 2025. The increase was primarily attributable to increases in other professional
fees of approximately $202,000, increases in payroll and compensation expenses of approximately $45,000, increases in corporate insurance
expense of approximately $25,000, increases in patent and legal expenses of approximately $17,000, and increases in rent expense of approximately
$14,000. This was partially offset by decreases in business development expenses of approximately $188,000 and decreases in travel expenses
of approximately $19,000.
Research
and Development Expenses
Research
and development expenses decreased approximately $1,807,000, or 22%, from approximately $8,140,000 for the six months ended June 30,
2024 to approximately $6,332,000 for the six months ended June 30, 2025. The decrease was primarily attributable to decreases in
research studies of approximately $1,789,000, decreases in payroll and compensation expenses of approximately $70,000 and decreases
in consulting expenses of approximately $25,000. This was partially offset by increases in licensing expenses of approximately
$62,000 and increases in research materials expenses of approximately $14,000.
Interest
and Other Income, Net
Interest
income decreased approximately $125,000 from approximately $390,000 for the six months ended June 30, 2024 to approximately $265,000
for the six months ended June 30, 2025. Other income, net decreased approximately $57,000 from a gain of approximately $351,000 for the
six months ended June 30, 2024 to a gain of approximately $294,000 for the six months ended June 30, 2025. This decrease was primarily
attributable to decreases in dividend income of approximately $298,000, which were partially offset by increases of approximately $180,000
in foreign currency gains, and increases in investment income of approximately $59,000.
Cash
Flows
The
following table summarizes our cash flow for the periods indicated:
| |
For the Six Months ended June 30, | |
| |
2025 | | |
2024 | |
| |
(Unaudited) | |
Net cash flows used in operating activities | |
$ | (8,312,887 | ) | |
$ | (8,259,161 | ) |
Net cash flows provided by (used in) investing activities | |
| 6,832,489 | | |
| (758,231 | ) |
Net cash flows provided by financing activities | |
| - | | |
| 54,716 | |
Effect of foreign exchange rates on cash | |
| 30,727 | | |
| 1,492 | |
Net decrease in cash and cash equivalents | |
$ | (1,449,671 | ) | |
$ | (8,961,184 | ) |
Operating
Activities
For the six months ended June 30, 2025, net cash used in operating activities
was approximately $8,313,000 compared to approximately $8,259,000 for the six months ended June 30, 2024. The increase in net cash used
in operating activities was primarily due to a smaller increase in accounts payable and accrued expenses during the six months ended June
30, 2025 when compared to the six months ended June 30, 2024, resulting in an increased use of cash, and was offset in part by a decrease
in the net loss for the six months ended June 30, 2025 compared to the net loss for the six months ended June 30, 2024.
Investing
Activities
For
the six months ended June 30, 2025, net cash provided by investing activities was approximately $6,832,000 compared to $758,000 of net
cash used in investing activities for the six months ended June 30, 2024. The increase in cash provided by investing activities is primarily
related to an increase in net redemptions of investments in marketable securities during the six months ended June 30, 2025, as compared
to the six months ended June 30, 2024.
Financing
Activities
No
financing activities took place during the six months ended June 30, 2025. Net cash provided by financing activities was approximately
$55,000 during the six months ended June 30, 2024, which is attributable to proceeds from warrant exercises.
Operating
Capital and Capital Expenditure Requirements
As
of June 30, 2025, we had total assets of approximately $17.4 million and working capital of approximately $12.3 million. As of June
30, 2025, our liquidity included approximately $15.9 million of cash, cash equivalents and marketable securities. We plan to pursue
periodic capital raises and also plan to apply for grant funding in the future to assist in supporting our capital needs. In July
2025, we entered into an ATM Sales Agreement with ThinkEquity, LLC, as sales agent, pursuant to which we may offer and sell up to
$15,530,000 of our common stock from time to time, in an “at-the-market” offering to or through our sales agent. We may also explore the possibility of entering into commercial credit facilities as an additional source of
liquidity. We believe that our existing cash, cash equivalents, and marketable securities as of June 30, 2025, and our anticipated
expenditures and capital commitments, will enable us to fund our operating expenses and capital expenditure requirements at
least into June 2026. We will need substantial additional funding in the near future, and if we are unable to raise capital when needed,
we could be forced to delay, reduce or eliminate our drug development programs or commercialization efforts.
Our
ability to continue as a going concern is highly contingent on the ability to raise additional capital for ongoing research and development
and clinical trials as we expect to continue incurring losses for the foreseeable future. The financial statements contained in this
Quarterly Report on Form 10-Q have been prepared assuming that we will continue as a going concern, and do not include any adjustments
that may be necessary should we be unable to continue as a going concern. We have incurred, and anticipate we will continue to incur,
losses and generate negative operating cash flows and as such will require substantial additional funding in the near future to continue
our research and development activities. These factors raise substantial doubt about our ability to continue as a going concern in the
absence of obtaining substantial additional funding. While we plan to pursue periodic capital raises, including potential sales under
the ATM Sales Agreement, no assurance can be given that sufficient funding will be available when needed to allow us to continue as a
going concern.
We
expect to incur significant, fluctuating and often increasing operating losses at least for the next several years as we continue our
clinical development of LP-300, LP-184 and LP-284, pursue development of our other drug candidates and programs, and seek potential future
marketing approval for our drug candidates, which could be several years in the future, if at all. We do not expect to generate revenue,
other than possible license and grant revenue, unless and until we successfully complete development and obtain regulatory approval for
our therapeutic candidates. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing
of our existing and planned clinical trials and our expenditures on other research and development activities.
We
have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our
available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development
and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. We
anticipate that our expenses will increase substantially as we:
|
● |
continue
the development, including preclinical studies and clinical trials, of our drug candidates; |
|
|
|
|
● |
initiate
preclinical studies and clinical trials for any additional indications for our current drug candidates and any future drug candidates
that we may pursue; |
|
|
|
|
● |
continue
to build our portfolio of drug candidates through the acquisition or in-license of additional drug candidates or technologies; |
|
|
|
|
● |
continue
to develop, maintain, expand and protect our intellectual property portfolio; |
|
|
|
|
● |
pursue
regulatory approvals for those of our current and future drug candidates that successfully complete clinical trials; |
|
|
|
|
● |
ultimately
establish a sales, marketing, distribution and other commercial infrastructure to commercialize any drug candidate for which we may
obtain marketing approval; |
|
|
|
|
● |
hire
additional clinical, regulatory, scientific and accounting personnel; |
|
|
|
|
● |
incur
additional legal, accounting and other expenses in operating as a public company; and |
|
|
|
|
● |
continue
to develop, maintain, and expand our RADR® platform. |
We
expect that we will need to obtain substantial additional funding in order to complete our clinical trials. To the extent that we raise
additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interests of our
existing stockholders may be materially diluted and the terms of these securities could include liquidation or other preferences that
could adversely affect the rights of our existing stockholders. In addition, debt financing, if available, would result in increased
fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions,
such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct
our business. If we are unable to raise capital when needed or on attractive terms, we could be forced to significantly delay, scale
back or discontinue the development or commercialization of LP-300, LP-184, LP-284, and/or our other drug candidates and programs, seek
collaborators at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available,
and relinquish or license, potentially on unfavorable terms, our rights to LP-300, LP-184, LP-284, and/or other drug candidates and programs
that we otherwise would seek to develop or commercialize ourselves.
Critical
Accounting Estimates
There
have been no changes to our critical accounting estimates during the six months ended June 30, 2025.
Quantitative
and Qualitative Disclosure About Market Risk
Our
primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates.
Fixed rate securities may have their market value adversely affected due to a rise in interest rates. Accordingly, our future investment
income may fluctuate as a result of changes in interest rates, or we may suffer losses in principal if we are forced to sell securities
that decline in market value as a result of changes in interest rates.
Historically,
we have raised capital through the issuance of equity securities. We had no long-term debt outstanding as of June 30, 2025 and December
31, 2024.
We
do not believe that our cash and cash equivalents have significant risk of default or illiquidity. Our cash and cash equivalents consist
primarily of cash and money market funds. Our exposure to market risk relating to cash and cash equivalents due to changes in interest
rates is limited because our cash and cash equivalents have a short-term maturity and are used primarily for working capital purposes.
Our marketable securities have had and may in the future have their market value adversely affected due to rises in interest rates. While
we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that
in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of
cash and cash equivalents at one or more financial institutions that from time to time may be in excess of federally insured limits.
Interest bearing and non-interest bearing accounts we hold at banking institutions are guaranteed by the Federal Deposit Insurance Corporation
(“FDIC”) up to $250,000. From time to time, some of our cash balances held at banking institutions may be in excess of FDIC
coverage. We consider this to be a normal business risk.
We
formed a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia in September 2021 and experienced foreign currency gains
of approximately $130,000 for the six months ended June 30, 2025 and foreign currency losses of approximately $51,000 for the six months
ended June 30, 2024 in connection with this subsidiary. We will remain subject to the risk of foreign currency losses in future periods,
although we do not expect the impact of any foreign currency losses to be material. We do not participate in any foreign currency hedging
activities, and we do not have any other derivative financial instruments.
Inflation
generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect
on our results of operations during the periods presented. Inflation could have a greater impact on our future results of operations
if it remains at current levels or increases.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
As
a Smaller Reporting Company we are exempt from the requirements of Item 3.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures.
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal
financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. The term
“disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934,
as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required
to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported,
within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal
financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management
necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based
on such evaluation of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer and Chief Financial Officer
have concluded that, as of such date, our disclosure controls and procedures, as defined above, were effective at the reasonable assurance
level.
Changes
in Internal Control Over Financial Reporting.
There
were no changes in our internal control over financial reporting that occurred during the three months ended June 30, 2025 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent
Limitations on Effectiveness of Controls.
Our
management, including our principal executive officer and principal financial officer, do not expect that our disclosure controls or
our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design
of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative
to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance
that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments
in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented
by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any
system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance
that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate
because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations
in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART
II – OTHER INFORMATION
Item
1A. Risk Factors.
As
a Smaller Reporting Company we are exempted from the requirements of Item 1A.
Item
6. Exhibits.
Exhibit
No. |
|
Exhibit
Description |
|
Method
of Filing |
3.1 |
|
Amended and Restated Certificate of Incorporation |
|
Incorporated
by reference from the Registrant’s Current Report on Form 8-K filed June 17, 2020 |
|
|
|
|
|
3.2 |
|
By-Laws |
|
Incorporated
by reference from the Registrant’s Registration Statement on Form S-1 filed April 16, 2020 |
|
|
|
|
|
3.3 |
|
Amendment No. 1 to By-Laws |
|
Incorporated
by reference from the Registrant’s Current Report on Form 8-K filed May 24, 2024 |
|
|
|
|
|
3.4 |
|
Amendment No. 2 to By-Laws |
|
Incorporated
by reference from Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed July 29, 2025 |
|
|
|
|
|
10.1 |
|
Amendment to Second Amended and Restated Lantern Pharma Inc. 2018 Equity Incentive Plan, as amended |
|
Incorporated
by reference from Exhibit A to Registrant’s Definitive Proxy Statement filed April 29, 2024 |
|
|
|
|
|
10.2 |
|
ATM Sales Agreement, dated July 3, 2025, by and between Lantern Pharma Inc. and ThinkEquity LLC |
|
Incorporated by reference
from Exhibit 1.1 to the Registrant’s Current Report on Form 8-K filed July 3, 2025 |
|
|
|
|
|
31.1 |
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
Filed
electronically herewith |
|
|
|
|
|
31.2 |
|
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
Filed
electronically herewith |
|
|
|
|
|
32.1 |
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
Furnished
electronically herewith |
|
|
|
|
|
32.2 |
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
Furnished
electronically herewith |
|
|
|
|
|
101.INS |
|
Inline
XBRL Instance Document. |
|
Filed
electronically herewith |
|
|
|
|
|
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document. |
|
Filed
electronically herewith |
|
|
|
|
|
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document. |
|
Filed
electronically herewith |
|
|
|
|
|
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document. |
|
Filed
electronically herewith |
|
|
|
|
|
101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document. |
|
Filed
electronically herewith |
|
|
|
|
|
101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document. |
|
Filed
electronically herewith |
|
|
|
|
|
104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
|
Filed
electronically herewith |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
Lantern
Pharma Inc., |
|
|
|
A
Delaware Corporation |
|
|
|
Dated:
August 13, 2025 |
By:
|
/s/
Panna Sharma |
|
|
Panna
Sharma, Chief Executive Officer |
|
|
|
Dated:
August 13, 2025 |
By: |
/s/
David R. Margrave |
|
|
David
R. Margrave, Chief Financial Officer |