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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: March 31, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File Number: 001-41575
Lipella
Pharmaceuticals Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
20-2388040 |
(State or other jurisdiction
of
incorporation or organization) |
|
(I.R.S. Employer
Identification No.) |
7800
Susquehanna St., Suite 505 |
Pittsburgh,
PA 15208 |
(Address
of principal executive offices) (Zip Code) |
|
(412)
901-0315 |
(Registrant’s
telephone number, including area code) |
Securities
registered pursuant to Section 12(b) of the Act
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of exchange on which
registered |
Common Stock, par
value $0.0001 per share |
|
LIPO |
|
The Nasdaq Stock
Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or 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 May 8, there were 7,605,636 shares of common stock, par value $0.0001 per share, of the registrant outstanding.
Lipella
Pharmaceuticals Inc.
Form
10-Q
March
31, 2024
Table
of Contents
References
in this Quarterly Report on Form 10-Q to the “Company,” “Lipella,” “we,” “us,”
or “our” mean Lipella Pharmaceuticals Inc. unless otherwise expressly stated or the context indicates otherwise.
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements.
Lipella
Pharmaceuticals Inc.
CONDENSED
BALANCE SHEETS
| |
March 31, 2024
(Unaudited)
| | |
December 31, 2023 | |
Assets | |
| | |
| |
Current Assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 2,105,299 | | |
$ | 3,293,738 | |
Grants receivable | |
| 68,934 | | |
| 32,286 | |
Prepaid expenses | |
| 836,857 | | |
| 103,256 | |
Total Current Assets | |
| 3,011,090 | | |
| 3,429,280 | |
Property and Equipment | |
| | | |
| | |
Furniture, fixtures and equipment | |
| 140,294 | | |
| 140,294 | |
Furniture, fixtures and equipment (Accumulated Depreciation) | |
| (128,265 | ) | |
| (127,544 | ) |
Furniture and fixtures, net | |
| 12,029 | | |
| 12,750 | |
Other Assets | |
| | | |
| | |
Operating lease right of use asset | |
| 114,038 | | |
| 135,144 | |
Total Assets | |
$ | 3,137,157 | | |
$ | 3,577,174 | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 293,835 | | |
$ | 138,016 | |
Accrued expenses | |
| 84,929 | | |
| 77,280 | |
Operating lease liability | |
| 91,705 | | |
| 89,223 | |
Payroll liability | |
| 81,412 | | |
| 80,836 | |
Total Current Liabilities | |
| 551,881 | | |
| 385,355 | |
Operating lease liability, net of current portion | |
| 23,997 | | |
| 47,371 | |
Total Liabilities | |
$ | 575,878 | | |
$ | 432,726 | |
Stockholders’ equity: | |
| | | |
| | |
Convertible preferred stock, $0.0001
par value; 20,000,000
shares authorized; -0-
shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | |
$ | — | | |
$ | — | |
Common stock, $0.0001
par value; 200,000,000
shares authorized, 7,039,846
and 6,053,956 shares issued and outstanding at March 31, 2024 and
at December 31, 2023, respectively | |
| 704 | | |
| 605 | |
Additional paid-in capital | |
| 14,076,227 | | |
| 13,467,686 | |
Accumulated deficit | |
| (11,515,652 | ) | |
| (10,323,843 | ) |
Total stockholders’ equity | |
| 2,561,279 | | |
| 3,144,448 | |
Total liabilities and stockholders’ equity | |
$ | 3,137,157 | | |
$ | 3,577,174 | |
The
accompanying notes are an integral part of these condensed financial statements.
Lipella
Pharmaceuticals Inc.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
| |
|
|
|
| |
| |
For the three months ended | |
| |
March 31,
2024 | | |
March 31,
2023 | |
Grant revenues | |
$ | 145,880 | | |
$ | 118,048 | |
Total revenues | |
| 145,880 | | |
| 118,048 | |
| |
| | | |
| | |
Cost and expenses | |
| | | |
| | |
Research and development | |
| 842,600 | | |
| 693,730 | |
General and administrative | |
| 520,926 | | |
| 508,750 | |
Total costs and expenses | |
| 1,363,526 | | |
| 1,202,480 | |
Loss from operations | |
| (1,217,646 | ) | |
| (1,084,432 | ) |
| |
| | | |
| | |
Other income (expense) | |
| | | |
| | |
Interest income, net | |
| 25,837 | | |
| 22,001 | |
Interest expense related party | |
| — | | |
| (5,394 | ) |
Total other income
(expense) | |
| 25,837 | | |
| 16,607 | |
Provision for income taxes | |
| — | | |
| — | |
Net Loss | |
$ | (1,191,809 | ) | |
$ | (1,067,825 | ) |
| |
| | | |
| | |
Loss per common share | |
| | | |
| | |
Basic | |
| (0.16 | ) | |
| (0.19 | ) |
Dilutive | |
| (0.16 | ) | |
| (0.19 | ) |
| |
| | | |
| | |
Weighted-average of common shares
outstanding: | |
| | | |
| | |
Basic | |
| 7,292,396 | | |
| 5,743,945 | |
Dilutive | |
| 7,292,396 | | |
| 5,743,945 | |
The
accompanying notes are an integral part of these condensed financial statements.
Lipella
Pharmaceuticals Inc.
CONDENSED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
| |
|
|
|
| | |
| | |
| | |
| |
| |
| | |
Additional | | |
| | |
| |
| |
Common Stock | | |
paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
Deficit | | |
Total | |
Balances, December 31, 2022 | |
| 5,743,945 | | |
$ | 574 | | |
$ | 10,379,900 | | |
$ | (5,704,878 | ) | |
$ | 4,675,596 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (1,067,825 | ) | |
| (1,067,825 | ) |
Stock-based compensation | |
| — | | |
| — | | |
| 208,639 | | |
| — | | |
| 208,639 | |
Balances, March 31, 2023 | |
| 5,743,945 | | |
| 574 | | |
| 10,588,539 | | |
| (6,772,703 | ) | |
| 3,816,410 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, December 31, 2023 | |
| 6,053,956 | | |
| 605 | | |
| 13,467,686 | | |
| (10,323,843 | ) | |
| 3,144,448 | |
Net loss | |
| — | | |
| | | |
| — | | |
| (1,191,809 | ) | |
| (1,191,809 | ) |
Share based compensation | |
| — | | |
| | | |
| 208,640 | | |
| — | | |
| 208,640 | |
Warrants converted to Common Stock | |
| 500,000 | | |
| 50 | | |
| (50 | ) | |
| — | | |
| — | |
Issuance of Common Stock | |
| 289,812 | | |
| 29 | | |
| 199,971 | | |
| — | | |
| 200,000 | |
Shares issued for services | |
| 196,078 | | |
| 20 | | |
| 199,980 | | |
| — | | |
| 200,000 | |
Balances, March 31, 2024 | |
| 7,039,846 | | |
| 704 | | |
| 14,076,227 | | |
| (11,515,652 | ) | |
| 2,561,279 | |
The
accompanying notes are an integral part of these condensed financial statements.
Lipella
Pharmaceuticals Inc.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
| |
|
|
|
| |
| |
For the three months ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
Cash flow from operating activities: | |
| | | |
| | |
Net loss | |
$ | (1,191,809 | ) | |
$ | (1,067,825 | ) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 72 | | |
| — | |
Shares issued for services | |
| 200,000 | | |
| — | |
Non-cash stock option expense | |
| 208,640 | | |
| 208,639 | |
Interest expense related party net (non-cash) | |
| — | | |
| 5,394 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Operating right of use asset | |
| 214 | | |
| (34 | ) |
Grants receivable | |
| (36,648 | ) | |
| 29,688 | |
Prepaid expense | |
| (733,601 | ) | |
| 188,605 | |
Accounts payable | |
| 155,819 | | |
| (235,437 | ) |
Accrued expenses | |
| 7,649 | | |
| (208,017 | ) |
Payroll liability | |
| 576 | | |
| 997 | |
Net cash used in operating activities | |
| (1,388,439 | ) | |
| (1,077,990 | ) |
Cash flow from investing activities: | |
| — | | |
| — | |
Cash flow from financing activities: | |
| | | |
| | |
Proceeds from issuance of common stock, net of issuance costs | |
| 200,000 | | |
| — | |
Repayment of notes payable | |
| — | | |
| (25,000 | ) |
Net cash (used in) provided
by financing activities | |
| 200,000 | | |
| (25,000 | ) |
Net decrease in cash, cash equivalents | |
| (1,188,439 | ) | |
| (1,102,990 | ) |
Cash, and cash equivalents at beginning of period | |
| 3,293,738 | | |
| 5,121,743 | |
Cash, and cash equivalents at end of period | |
| 2,105,299 | | |
$ | 4,018,753 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Interest paid | |
$ | 6,234 | | |
$ | — | |
Income taxes paid | |
$ | — | | |
$ | — | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Issuance of common stock for forgiveness of related party note | |
$ | — | | |
$ | — | |
Issuance of common stock options for
consulting services | |
$ | — | | |
$ | — | |
The
accompanying notes are an integral part of these condensed financial statements.
Lipella
Pharmaceuticals Inc.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note
1. Description of Business and Basis of Presentation
Nature
of Business
Lipella
Pharmaceuticals Inc. (the “Company”, “we”, “us” or “our”) is a clinical-stage
biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing
these reformulations for new applications. Our operations consist of research, preclinical development and clinical development
activities, and our most advanced program is in Phase 2 clinical development. Since our inception in 2005, we have historically
financed our operations through a combination of federal grant revenue, licensing revenue, manufacturing revenue, as well as equity
and debt financing. On December 19, 2022, a reverse stock split (hereafter, the “Stock Split”) was effected, with
a 2.5 to 1 share conversion ratio for all shares of common stock, par value $0.0001 per share (“Common Stock”), outstanding.
The Company’s outstanding share and per share amounts in these financial statements have been adjusted to give effect to
the Stock Split, for all periods presented. For more information, see Note 11, “Common Stock.”
Basis
of Presentation
The
Company’s unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP
as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of
the Financial Accounting Standards Board (“FASB”).
In
the opinion of management, the accompanying unaudited condensed financial statements include all adjustments, consisting of normal
recurring adjustments, which are necessary to present fairly the Company’s financial position, results of operations, and
cash flows. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal
year. Certain information and footnote disclosure normally included in the financial statements prepared in accordance with GAAP
have been condensed or omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and
Exchange Commission (“SEC”). The unaudited condensed interim financial statements should be read in conjunction with
the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31,
2023 that was filed with the SEC on February 27, 2024 (our “Annual Report”).
Note
2. Going Concern
The
accompanying condensed financial statements have been prepared in conformity with GAAP, which contemplate continuation of the
Company as a going concern. The Company has not established a source of revenues sufficient to cover its operating costs and will
require significant additional capital to continue its research and development programs, including progressing clinical product
candidates to commercialization and preparing for commercial-scale manufacturing and sales.
The
Company’s net loss for the three months ended March 31, 2024 and fiscal year ended December 31, 2023 was $1,191,809 and
$4,618,965, respectively. Since inception, the Company has incurred historical losses and has an accumulated deficit of $11,515,652
at March 31, 2024 and $10,323,843 at December 31, 2023, respectively. At March 31, 2024, the Company had available cash and cash
equivalents of $2,105,299 and net working capital of $2,459,209. The Company anticipates operating losses to continue for the
foreseeable future due to, among other things, costs related to: research, development of product candidates, conducting preclinical
studies and clinical trials, and administrative organization. These funds, and our funds available under existing government contracts,
may not be sufficient to enable us to meet our obligations as they come due at least for the next twelve months from the issuance
date of these financial statements.
If
we are unable to obtain additional capital (which is not assured at this time), our long-term business plan may not be accomplished,
and we may be forced to curtail or cease operations. These factors individually and collectively raise substantial doubt about
our ability to continue as a going concern. The accompanying unaudited condensed financial statements do not include any adjustments
that may result from this uncertainty.
Note
3. Summary of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,”
in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024. There have been no material changes
to the significant accounting policies during the three-month period ended March 31, 2024, except for items mentioned below.
Use
of Estimates
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 these financial
statements. Actual results could differ from those estimates.
Adoption
of New Accounting Pronouncements
During
the three months ended March 31, 2024, no new accounting pronouncement was issued or became effective, that had or is expected
to have, a material impact on our Financial Statements.
Concentration
of Credit Risk
The
Company’s grant revenues and grant receivables are from the National Institute of Health (the “NIH”). The NIH
is an agency of the United States Department of Health & Human Services, and the Company believes amounts are fully collectible
from this agency. Contract revenues were $145,880 for the three months ended March 31, 2024, and $118,048 for the three months
ended March 31, 2024.
Earnings
Per Share
Basic
net loss per share of Common Stock is computed by dividing the net loss for the period by the weighted-average number of shares
of Common Stock outstanding during the period. Diluted net loss per common share is computed giving effect to all dilutive Common
Stock equivalents, consisting of stock options and warrants. Diluted net loss per share of Common Stock for the three months ended
March 31, 2024 and 2023 is the same as basic net loss per share, as the Common Stock equivalents were anti-dilutive due to the
net loss.
At
March 31, 2024 and 2023 the Common Stock equivalent shares were, as follows:
| |
| | |
| |
| |
March 31, | |
| |
2024 | | |
2023 | |
Shares of Common Stock issuable under equity incentive plans outstanding | |
| 2,893,000 | | |
| 2,054,000 | |
Shares of Common Stock issuable upon exercise of warrants | |
| 2,124,257 | | |
| 143,994 | |
Shares of Common Stock issuable upon conversion of Series A Preferred Stock | |
| — | | |
| — | |
Common Stock equivalent shares excluded from diluted net loss per share | |
| 5,017,257 | | |
| 2,197,994 | |
Note
4. Fair Value Measurements and Marketable Debt Securities
In
accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”), the Company measures
its assets and liabilities at fair value. We apply the three-level valuation hierarchy as described in ASC 820, which is based
upon the transparency of input as of the measurement date. The three levels of inputs as defined are:
Level
1 - Inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level
2 - Inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs
that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial
instruments.
Level
3 - Inputs to the valuation methodology are unobservable and significant to the fair value measurement.
At
March 31, 2024 and December 31, 2023, the Company’s financial instruments consist primarily of: cash and cash equivalents,
accounts payable and accrued liabilities. For cash equivalents, accounts payable and accrued liabilities, the carrying amounts
of these financial instruments as of March 31, 2024 and December 31, 2023 were considered representative of their fair values
due to their short term to maturity.
The
Company held no marketable securities at March 31, 2024 and December 31, 2023. For cash equivalents at March 31, 2024 and December
31, 2023, the fair value input levels are summarized below:
March 31, 2024 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Cash Equivalents (maturity less than 90 days) | |
| | | |
| | | |
| | | |
| | |
Commercial Paper | |
$ | — | | |
| — | | |
| — | | |
$ | — | |
U.S. Government | |
| — | | |
| — | | |
| — | | |
| — | |
Money market funds | |
| 1,975,063 | | |
| — | | |
| — | | |
| 1,975,063 | |
Total Cash equivalents | |
| 1,975,063 | | |
| | | |
| | | |
| 1,975,063 | |
| |
| | | |
| | | |
| | | |
| | |
Marketable Securities | |
| — | | |
| — | | |
| — | | |
| — | |
Total Cash Equivalents and Marketable Securities | |
$ | 1,975,063 | | |
$ | — | | |
$ | — | | |
$ | 1,975,063 | |
December 31, 2023 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Cash Equivalents (maturity less than 90 days) | |
| | | |
| | | |
| | | |
| | |
Commercial Paper | |
$ | — | | |
| — | | |
| — | | |
$ | — | |
U.S. Government | |
| — | | |
| — | | |
| — | | |
| — | |
Money market funds | |
| 3,052,648 | | |
| — | | |
| — | | |
| 3,052,648 | |
Total Cash equivalents | |
| 3,052,648 | | |
| | | |
| | | |
| 3,052,648 | |
| |
| | | |
| | | |
| | | |
| | |
Marketable Securities | |
| — | | |
| — | | |
| — | | |
| — | |
Total Cash Equivalents and Marketable Securities | |
$ | 3,052,648 | | |
$ | — | | |
$ | — | | |
$ | 3,052,648 | |
Note
5. Prepaid Expenses
At
March 31, 2024, prepaid expenses consisted primarily of prepaid insurance of $85,891, prepaid costs of issuance of $112,548, an advance deposit with our clinical trial management partner of $372,208, and
$266,210 in other prepaid expenses related primarily to professional services. At December 31, 2023, prepaid expenses consisted
of $88,554 of prepaid insurance, and $14,702 of prepaid expenses.
Note
6. Accrued Expenses
At
March 31, 2024, accrued expenses were $84,929, consisting of $19,575 of accrued clinical expenses and $65,354 of unbilled
legal expenses. At December 31, 2023, accrued expenses totaled $77,280 and consisted of $19,575 in clinical expenses, $52,050
in franchise tax expense, and $5,655 in unbilled professional services expenses.
Note
7. Notes Payable – Related Party
There
were no notes payable outstanding at March 31, 2024 or December 31, 2023.
Note
8. Letter of Credit
The
Company has a letter of credit with a bank for an aggregate available amount of $50,000 due upon demand. The letter of credit
is collateralized by substantially all of the Company’s assets and personally guaranteed by Dr. Jonathan Kaufman, the Company’s
Chief Executive Officer. The outstanding advances under the line of credit bear interest at the lending bank’s prime rate
plus 3.10%. The outstanding balance was $0 at March 31, 2024 and December 31, 2023, respectively.
Note
9. Stock Options
The
Company has two stock incentive plans (each, a “Stock Option Plan” and collectively, the “Stock Option
Plans”), each of which provides for the grant of both incentive stock options and non-qualified stock options. Under
the terms of the Stock Option Plans, the maximum number of shares of Common Stock for which incentive and/or non-qualified
stock options may be issued is 3,078,000 shares. This number comprises 1,078,000 stock options already issued and outstanding
(non-expired) from the 2008 stock option plan, and 2,400,000 shares of Common Stock underlying option awards that may be
issuable under the 2020 stock option plan. Incentive stock options are granted with an exercise price determined by the
Company’s board of directors (the “Board”). The terms of the vesting of such options, including
termination, are as set forth in the Stock Option Plans and their respective award agreements. Such stock options generally
expire 10 years from the date of the grant. Subject to certain exceptions for grants made to employees who are large
stockholders, stock options granted under the Stock Option Plans have an exercise price not less than the fair market value
of the underlying Common Stock on the date of such grant. If an employee leaves the Company prior to fully vesting their
option awards and the remaining unvested portion is considered forfeited, the earlier recognition of the unvested shares is
reversed during the period of forfeiture. As of March 31, 2024, there were $540,759 in unrecognized compensation costs
related to non-vested share-based compensation arrangements granted to be recognized over the remaining vesting period of
less than one year.
The
Company recognized $208,640 of compensation costs for the three months ended March 31, 2024 and $208,639 for the three months
ended March 31, 2023 related to the vesting of stock options.
The
following is an analysis of options to purchase shares of Common Stock issued and outstanding as of March 31, 2024 and December
31, 2023:
|
|
Shares |
|
|
Weighted
Average
Exercise
Price Per
Share ($) |
|
|
Weighted
Average
Remaining
Contractual
Term
(in Years) |
|
|
Aggregate
intrinsic
value ($) |
|
Outstanding as of December
31, 2022 |
|
|
2,054,000 |
|
|
|
2.84 |
|
|
|
5.51 |
|
|
|
605,687 |
|
Granted |
|
|
424,000 |
|
|
|
2.19 |
|
|
|
9.96 |
|
|
|
|
|
Expired |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(25,000 |
) |
|
|
2.19 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of December 31, 2023 |
|
|
2,453,000 |
|
|
|
2.73 |
|
|
|
5.19 |
|
|
$ |
— |
|
Granted |
|
|
440,000 |
|
|
|
0.77 |
|
|
|
9.96 |
|
|
|
|
|
Expired |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2024 |
|
|
2,893,000 |
|
|
|
2.73 |
|
|
|
4.94 |
|
|
$ |
— |
|
Vested as of March 31, 2024 |
|
|
2,346,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of March 31, 2024 |
|
|
2,346,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of December 31, 2023 |
|
|
2,272,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
A
summary of status of the Company’s non-vested stock options (exercisable for shares of Common Stock on a one-to-one basis)
as of, and changes during, the three months ended March 31, 2024 and 2023 is presented below:
|
|
Number
of
Stock Options |
|
|
Weighted-
Average Fair
Value Grant
Date |
|
Nonvested at December 31,
2022 |
|
|
434,667 |
|
|
$ |
2.82 |
|
Granted |
|
|
— |
|
|
|
2.84 |
|
Vested |
|
|
(74,000 |
) |
|
|
2.83 |
|
Expired |
|
|
— |
|
|
|
0.00 |
|
Nonvested at March 31, 2023 |
|
|
360,667 |
|
|
$ |
2.82 |
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2023 |
|
|
180,667 |
|
|
$ |
2.81 |
|
Granted |
|
|
440,000 |
|
|
|
0.55 |
|
Vested |
|
|
(74,000 |
) |
|
|
1.13 |
|
Expired |
|
|
— |
|
|
|
— |
|
Nonvested at March 31, 2024 |
|
|
546,667 |
|
|
$ |
0.66 |
|
There
were no options granted in the three months ended March 31, 2023. In the three months ended March 31, 2024, the Company granted
options as described below.
Stock
Option Grants - On March 15, 2024, the Company granted 440,000 stock options at a $0.77 strike price, vesting as follows:
one third of such grant vests on April 1, 2024, one third of such grant vests on July 1, 2024, and one third of such grant vests
on October 1, 2024.
The
weighted-average fair value of stock options on the date of grant and the assumptions used to estimate the fair value of stock
options granted during the three months ended March 31, 2024 using the Black-Scholes option-pricing model are as follows:
Three months ended March 31, 2024 | |
2024 | | |
2023 | |
Weighted-average fair value of options granted | |
$ | 0.55 | | |
| — | |
Expected volatility | |
| 86.17 | % | |
| — | % |
Expected life (in years) | |
| 5.17 | | |
| — | |
Risk-free interest rate (range) | |
| 4.33 | % | |
| — | % |
Expected dividend yield | |
$ | — | | |
| — | |
Note
10. Preferred Stock
The
Company’s Series A Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”),
ranks prior, with respect to dividend rights and rights upon a liquidation event, to all Common Stock and any other series of
preferred stock which is junior to Series A Preferred Stock. Upon any matter submitted to the shareholders of the Company for
a vote, each holder of Series A Preferred Stock is entitled to the number of votes as is equal to the number of shares of Common
Stock into which such shares of Series A Preferred Stock are convertible at the time of such vote. The Series A Preferred Stock
is not entitled to any mandatory dividends.
The
Company issued 1,592,447 shares of Series A Preferred Stock at $0.60 per share over a period beginning September 2008 through
June 2013, for gross proceeds of $833,188. The implied price of the Series A Preferred Stock issuance, $0.5232 per share, is $0.0768
per share less than the $0.60 offering price. This difference is associated with the conversion terms of three debt instruments
issued from June 2006 through April 2008 that had a total face value of $351,500, and converted into a total of 789,634 of the
1,592,447 shares, which imputes the additional $122,280 to interest and/or conversion discounts. In addition, $351,500 in face
value of the debt instruments had associated warrants. All consideration upon the issuance of convertible debt plus warrants was
imputed to the debt component leaving the associated warrants having no value. All note-associated warrants have expired.
In
the year ended December 31, 2022, all 1,592,447 outstanding shares of Series A Preferred Stock were converted to Common Stock
on a 1:1 basis. After giving effect to the Stock Split, this conversion resulted in 636,979 shares of Common Stock. There were
no shares of Series A Preferred Stock outstanding at December 31, 2023 or March 31, 2024.
Note
11. Common Stock
The
Company’s second amended and restated certificate of incorporation, as amended, authorizes the issuance of 200,000,000 shares
of Common Stock. On December 19, 2022, the Company effected the Stock Split, at a 2.5 for 1 ratio for all shares of Common Stock
outstanding. The Company’s outstanding share and per share amounts in these unaudited condensed financial statements have
been adjusted to give effect to the Stock Split, for all periods presented. There were 7,039,846 shares of Common Stock outstanding
as of March 31, 2024 and 6,053,956 shares outstanding as of December 31, 2023.
During
the year ended December 31, 2022, the Company issued 22,950 shares of Common Stock in forgiveness of two related party notes.
The aggregate principal and interest of the notes was $138,810. On December 22, 2022, we completed an initial public offering
(“IPO”) and listing on the Nasdaq Capital Market (“Nasdaq”) of our Common Stock at a price to the public
of $5.75 per share, which resulted in the issuance of an additional 1,217,391 shares of Common Stock. The aggregate net proceeds
from the IPO were approximately $5,000,000, after deducting underwriting discounts and commissions of $630,000 and offering expenses
of approximately $1,160,000.
On
September 15, 2023, the Company issued 60,000 shares of Common Stock in exchange for services rendered by a third party.
On
November 28, 2023, we issued 250,000 shares of Common Stock for the exercise of the same number of pre-funded warrants. See Note
12 for details of the pre-funded warrants. During the year end December 31, 2023, the Company also issued 60,000 shares of Common
Stock in exchange for services rendered by a third party.
On
February 2, 2024, we issued 196,078 shares of Common Stock in exchange for services rendered by a third party. On March 4, 2024,
500,000 shares of Common Stock were issued for the exercise of the same number of pre-funded warrants. On March 13, 2024, the Company entered into Affiliate Stock Purchase Agreements with each of Jonathan H. Kaufman, the Company's Chief Executive Officer and Chairman of its board of directors, and Michael B. Chancellor, the Company's Chief Medical Officer and a member of its board of directors, pursuant to which each of Drs. Kaufman and Chancellor purchased $100,000 of shares of common stock of the Company, in cash from the Company at $0.6901 per share, based on the official closing price of The Nasdaq Stock Market LLC for the Common Stock on March 13, 2024, resulting in the issuance of 144,906 shares of Common Stock to each of Drs. Kaufman and Chancellor.
The
Common Stock is subject to and qualified by the rights of the Series A Preferred Stock. Upon the dissolution or liquidation of
the Company, the holders of Common Stock will be entitled to receive all assets of the Company available for distribution to its
stockholders, subject to any preferential rights of any then outstanding Series A Preferred Stock.
Note
12. Warrants
No
warrants were issued in the three months ended March 31, 2024. On October 23, 2023, the Company entered into a securities purchase
agreement (the “Purchase Agreement”) with an institutional investor for the issuance and sale in a private placement
(the “Private Placement”) of pre-funded common stock purchase warrants (“Pre-Funded Warrants”) to purchase
up to 1,315,790 shares of Common Stock, with an exercise price of $0.001 per share, and common stock purchase warrants (the “Warrants”)
to purchase up to 1,315,790 shares of Common Stock, with an exercise price of $1.40 per share. The gross proceeds to the Company
from the Private Placement were approximately $2.0 million, before deducting placement agent fees and expenses and offering expenses
payable by the Company. The Warrants and the Pre-Funded Warrants are immediately exercisable for three years from issuance and
are subject to 4.99% and 9.99% beneficial ownership limitations (as applicable). The combined purchase price for one Pre-Funded
Warrant and one accompanying Warrant was $1.519. The closing of the Private Placement contemplated by the Purchase Agreement occurred
on October 25, 2023. The Company had no warrant liabilities at March 31, 2024 and December 31, 2023.
Note
13. Commitment and Contingencies
Operating
Leases
Operating
leases are recorded as ROU assets and lease liabilities on the balance sheet. ROU assets represent our right to use the leased
assets for the lease term, and lease liabilities represent our obligation to make lease payments. Operating lease ROU assets and
liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the
Company’s leases do not provide an implicit rate, the Company uses its estimated incremental borrowing rate at the commencement
date to determine the present value of lease payments. The operating lease ROU assets also include any lease payments made and
exclude lease incentives.
The
Company entered into a lease agreement beginning July 1, 2020, for the Company’s principal headquarters on the fifth floor
of 7800 Susquehanna Street, Pittsburgh, Pennsylvania, which includes office space and sterile manufacturing operations (the “Lease”).
The Lease has a five-year term and includes an option for renewal, which is not reasonably certain and is excluded from the right
of use calculation. On July 26, 2023, the Company entered a second lease for additional space on the fourth floor of the same
building (the “Fourth Floor Lease”), commencing August 1, 2023 and co-terminating with the existing Lease on June
30, 2025. Subsequently effective January 1, 2024, the Company terminated the Fourth Floor Lease early at no penalty upon mutual
agreement with the landlord and replaced it with a lease of additional space that had become available immediately adjacent to
our existing offices (the “Suite 504 Lease”, and together with the “Lease”, “the Leases”).
The Suite 504 Lease term co-terminates with the Lease. Future minimum rent payments under the Leases as of March 31,
2024 are as follows:
Year ending | |
| |
2024 (nine months remaining) | |
$ | 72,316 | |
2025 | |
$ | 48,519 | |
Total minimum lease payments | |
$ | 120,835 | |
Less: amount representing interest | |
$ | (5,133 | ) |
Present value of minimum lease payments | |
$ | 115,702 | |
The
Leases are accounted for as a ROU asset and liability. As of March 31, 2024, the Company had $114,038 of an operating lease ROU
asset, and $91,705 and 23,997 of current and non-current lease liabilities, respectively, recorded on the balance sheets. As of
December 31, 2023, the Company had an ROU asset of $135,144 and current and non-current operating lease liabilities of $89,223
and $47,371, respectively. The lease expense for the three months ended March 31, 2024 and March 31, 2023 was $24,438 and $16,368,
respectively. Cash paid for the amounts included in the measurement of lease liabilities for the three months ended March 31,
2024 and 2023 was $23,797 and $16,402, respectively. The payments are included in the operating activities in the accompanying
statement of cash flows. The discount rates used for our right-of-use leases range from 6.25% to 7.25%.
Contract
Commitments
The
Company enters into contracts in the normal course of business with contract research organizations (“CROs”), contract
manufacturing organizations, universities, and other third parties for preclinical research studies, clinical trials and
testing and manufacturing services. These contracts generally do not contain minimum purchase commitments and are cancelable by
us upon prior written notice although, purchase orders for clinical materials are generally non-cancelable. Payments due upon
cancellation consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our
service providers, up to the date of cancellation or upon the completion of a manufacturing run.
Note
14. Income Taxes
The
provision for income taxes for the three months ended March 31, 2024 and 2023 was $0, resulting in an effective income tax rate
of 0% for each period. The Company’s effective tax rate for the three months ended March 31, 2024 and 2023 was primarily
due to the full valuation allowance against the Company’s net deferred tax assets.
The
Company regularly evaluates the realizability of its deferred tax assets and establishes a valuation allowance if it is more likely
than not that some or all of the deferred tax assets will not be utilized. Because of our cumulative losses, substantially all
of the deferred tax assets have been fully offset by a valuation allowance as of March 31, 2024 and December 31, 2023. We have
not paid income taxes for the year ended December 31, 2023. The income tax provision attributable to loss before income tax benefit for the three months ended March 31, 2024 differed from the amounts computed by applying the U.S. federal statutory rate of 21% as a result of the following:
Schedule of income tax provision attributable to loss before income tax benefit
| |
| | |
Statutory federal income tax rate | |
| 21.00 | % |
State taxes, net of federal benefit | |
| 7.11 | % |
Change in valuation allowance | |
| -28.11 | % |
Effective tax rate | |
| 0.00 | % |
The
Company’s 2019 through 2023 tax years remain subject to examination by the Internal Revenue Service for federal tax purposes
and the Commonwealth of Pennsylvania for state tax purposes.
Note
15. Subsequent Events
Subsequent
events have been evaluated through the date on which the unaudited condensed financial statements were issued.
On
April 10, 2024, the Company eliminated the Series A Preferred Stock, of which there were no shares outstanding.
On
May 3, 2024, the Company issued 565,790 shares of Common Stock in conversion of the same number of pre-funded warrants.
Notice of Failure to Satisfy Nasdaq Minimum
Bid Price Requirement
As disclosed in our
Current Report on Form 8-K filed with the SEC on April 19, 2024, on April 17, 2024, we received a written notification (the “Nasdaq
Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that, based upon the closing bid price of
the Common Stock for the last 30 consecutive business days, the Company was not in compliance with the requirement to maintain
a minimum bid price of $1.00 per share of its Common Stock, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum
Bid Price Requirement”). The Nasdaq Letter had no immediate effect on the listing of the Common Stock, which continues to
trade on the Nasdaq Capital Market under the symbol “LIPO” at this time.
Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until October 14, 2024, to regain
compliance with the Minimum Bid Price Requirement. If at any time before October 14, 2024, the bid price of the Common Stock
closes at $1.00
per share or more for a minimum of 10
consecutive business days, the Nasdaq staff will provide written confirmation that the Company has regained compliance with
the Minimum Bid Price Requirement and the matter will be closed.
If
the Company does not regain compliance with the Minimum Bid Price Requirement, the Company may be eligible for an additional
180-calendar day grace period. To qualify, the Company will be required to meet the continued listing requirement for market
value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of
the Minimum Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the
second compliance period. If the Company does not regain compliance with the Minimum Bid Price Requirement by October 14,
2024, and is otherwise not eligible for such additional 180-day grace period to regain such compliance, the Nasdaq staff will
provide written notice to the Company that the Common Stock will be subject to delisting. At that time, the Company may
appeal any such delisting determination to a Nasdaq hearings panel.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations for the three and three months ended March
31, 2024 should be read together with our unaudited condensed financial statements and related notes included in Item 1 of Part
I of this Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 (this “Form 10-Q”), as well
as the audited financial statements, the related notes thereto and management’s discussion and analysis of financial condition
and results of operations for the year ended December 31, 2023 contained in our Annual Report on Form 10-K for the year ended
December 31, 2023, that was filed with the SEC on February 27, 2024 (our “Annual Report”), and all risk factors disclosed
herein and therein. Such discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act
of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), as well as information relating to our business that reflect our management’s current views,
expectations and assumptions concerning our business, strategies, products, future results and events and financial performance,
which are subject to risks and uncertainties that may cause our, or our industry’s, actual results, levels of activity,
performance or achievements to be materially different from any future results, levels of activity, performance or achievements
expressed or implied by such forward-looking statements. Such forward-looking statements speak only as of the date of this Form
10-Q. Although we believe that the expectations reflected in such forward-looking statements are reasonable, we cannot guarantee
future results, levels of activity or achievements or that our underlying assumptions will prove to be correct. Except as required
by applicable law, including the securities laws of the United States, we expressly disclaim any obligation or undertaking to
disseminate any update or revisions to any such forward-looking statement to reflect any change in our expectations with regard
thereto or to conform such forward-looking statements to actual results. Statements made in this Form 10-Q, other than statements
of historical fact, addressing operating performance, events, or developments which our management expects or anticipates will
or may occur in the future, and also statements related to expected or anticipated growth, revenues, profitability, new products,
adequacy of funds from operations, statements expressing general optimism about future operating results, and other non-historical
information, are forward-looking statements. In particular, the words “may,” “will,” “expects,”
“anticipates,” “aims,” “potential,” “future,” “intends,” “plans,”
believes,” “estimates,” “continue,” “likely to,” and variations of such words and similar
expressions identify forward-looking statements, but such words are not the exclusive means of identifying such forward-looking
statements, and their absence does not necessarily mean that such statement is not forward-looking.
Overview
We
are a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic
drugs and optimizing these reformulations for new applications. We believe that this strategy combines many of the cost efficiencies
and risk abatements derived from using existing generic drugs with potential patent protections for our proprietary formulations;
this strategy allows us to expedite, protect, and monetize our product candidates. Additionally, we maintain a therapeutic focus
on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. We believe
that this focus can potentially help reduce the cost, time and risk associated with obtaining marketing approval.
LP-10
is the development name of our reformulation of tacrolimus (an approved generic active agent) specifically optimized for topical
deposition to the internal surface of the urinary bladder lumen using a proprietary drug delivery platform that we have developed
and that we refer to as our metastable liposome drug delivery platform (our “Platform”). We are developing LP-10 and
our Platform to be, to our knowledge, the first drug candidate and drug delivery technology that could be successful in treating
cancer survivors who acquire hemorrhagic cystitis. We have received U.S. Food and Drug Administration (“FDA”) “orphan
drug” designation covering LP-10 and plan to apply for additional regulatory designations in the event we achieve qualifying
results in the current phase 2a clinical trial for LP-10. Market data exclusivity may be available in the U.S. and other jurisdictions
in which regulatory approval is obtained for the Company’s product, regardless of patent status.
The
safety and efficacy of LP-10 was evaluated in a 13-subject, open-label, multi-center, dose-escalation, phase 2a clinical trial
in patients experiencing complications associated with a rare but highly morbid disease called “radiation-induced hemorrhagic
cystitis” or “radiation cystitis.” This phase 2a clinical trial commenced on February 15, 2021, and we reported
the trial’s summary results in the first quarter of 2023. We met with the FDA in the fourth quarter of 2023 regarding the
LP-10 clinical trial results, and expect to receive their response to our proposed phase 2b trial design in the second quarter
of 2024. There is currently no FDA approved drug therapy available for radiation cystitis patients, who are all cancer survivors
who received pelvic radiation therapy to treat solid pelvic tumors, including prostate and ovarian cancers, and who are now dealing
with therapy-associated complications, including urinary bleeding (a radiation cystitis symptom). LP-10’s active ingredient,
tacrolimus, which has a well-known pharmacology and toxicology, addresses a reduction (or cessation) of uncontrolled urinary bleeding.
In
the fourth quarter of 2023, we received IND approval from the FDA for LP-310, our product for the treatment of oral lichen planus
(“OLP”). We have begun the clinical trial process for LP-310, and expect to initiate the first clinical site in the
second quarter of 2024 and treat the first patient by the third quarter of 2024. OLP is a chronic, T-cell-mediated, autoimmune
oral mucosal disease, and LP-310 contains tacrolimus which inhibits T-lymphocyte activation. To date, upon review of relevant
FDA public data resources on approved drugs and biologics, we are not aware of any other liposomal products developed to treat
such disease.
In
the first quarter of 2024, we received IND approval from the FDA for LP-410, our phase-1/2a product, for the treatment of oral
graft-versus-host disease (“GVHD”). LP-410 is an oral rinse, similar to LP-310, but will have a different containment
system. Hematopoietic cell transplantation (“HCT”) is used to treat a wide range of malignancies, hematologic and
immune deficiency states, and autoimmune diseases. GVHD is a clinical syndrome where donor-derived immunocompetent T-cells react
against patient tissues directly or through exaggerated inflammatory responses following HCT. Lipella has developed LP-410 for
the topical delivery directly to the mouth surface. LP-410 targets the underlying mechanisms of oral GVHD, potentially providing
a safe and effective treatment option for affected individuals. Lipella received “orphan drug” designation approval
on November 11, 2023 for tacrolimus for the treatment of oral GVHD. An IND application for LP-410’s treatment of oral GVHD
was submitted to the FDA on January 30, 2024.
Since
our inception in 2005, we have focused primarily on business planning and progressing our lead product candidates, including progressing
LP-10 through clinical development, raising capital, organizing and staffing the Company. On December 22, 2022, we completed our
initial public offering (the “IPO”) and issued an aggregate of 1,217,391 shares of Common Stock at a price of $5.75
per share. The aggregate net proceeds from the IPO were approximately $5.0 million after deducting underwriting discounts and
commissions of approximately $630,000 and offering expenses of approximately $1.16 million.
Recent
Developments
On
April 3, 2024, the FDA granted a Type C meeting request to discuss the Company’s proposed Phase-2b clinical trial design
for the evaluation of LP-10. Lipella expects to meet with the FDA on May 21, 2024.
Results
of Operations
Comparison
of the Three Months Ended March 31, 2024 and 2023
The
following table summarizes our results of operations for the three months ended March 31, 2024 and 2023 (in thousands):
| |
For the three months ended | | |
| |
| |
March 31, | | |
Increase | |
| |
2024 | | |
2023 | | |
(Decrease) | |
(in thousands) | |
| | |
| | |
| |
Revenue | |
$ | 146 | | |
| 118 | | |
$ | 28 | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development (“R&D”) | |
| 843 | | |
| 694 | | |
| 149 | |
General and administrative | |
| 521 | | |
| 509 | | |
| 12 | |
Total operating expenses | |
| 1,363 | | |
| 1,202 | | |
| 161 | |
Loss from operations | |
| (1,218 | ) | |
| (1,084 | ) | |
| (134 | ) |
Other income | |
| 26 | | |
| 16 | | |
| 10 | |
Net loss | |
$ | (1,192 | ) | |
$ | (1,068 | ) | |
$ | (124 | ) |
Grants
and Other Revenue
We
have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for several
years. For the three months ended March 31, 2024 and 2023, we recognized revenue from a grant awarded by the National Institutes
of Health (“NIH”) in September of 2022 (the “2022 NIH Grant”), which was an award of an aggregate of $673,000.
NIH approved an additional year of funding under the 2022 NIH Grant in June 2023, increasing the total funding provided under
the 2022 NIH Grant to $1,353,000.
We
recognize revenue from grants when the related costs are incurred and the right to payment is realized. For the three months ended
March 31, 2024, we earned $146,000 in connection with the 2022 NIH Grant, recognized as revenue, compared with $118,000 revenue
in the three months ended March 31, 2023. The increase in annual grant revenue from 2023 to 2024 is related to the award and the
extension of the 2022 NIH Grant.
Operating
Expenses
Our
operating expenses consist of (i) R&D expenses and (ii) general and administrative expenses.
Research
and Development Expenses
R&D
costs primarily consist of direct costs associated with consultants and materials, biologic storage, third party CRO costs and
contract development and manufacturing expenses, salaries and other personnel-related expenses. R&D costs are expensed as
incurred. More specifically, these costs include:
|
● |
costs of funding
research performed by third parties that conduct research and development and nonclinical and clinical activities on our behalf; |
|
● |
costs of manufacturing
drug supply and drug product; |
|
● |
costs of conducting
nonclinical studies and clinical trials of our product candidates; |
|
● |
consulting and professional
fees related to research and development activities, including equity-based compensation to non-employees; |
|
● |
costs related to
compliance with clinical regulatory requirements; and |
|
● |
employee-related
expenses, including salaries, benefits and stock-based compensation expense for our research and development personnel. |
Costs
for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data, such
as information provided to us by our vendors, and analyzing the progress of our nonclinical and clinical studies or other services
performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting
period. Advance payments that we make for goods or services to be received in the future for use in R&D activities are recorded
as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed,
or until it is no longer expected that the goods will be delivered or the services rendered.
We
expect that our R&D expenses will increase substantially in connection with our clinical development activities for our LP-10
and LP-310 programs. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will
be necessary to complete the clinical development of, or obtain regulatory approval for, any of our current or future product
candidates. This is due to the numerous risks and uncertainties associated with product development and commercialization, including
the specific factors set forth in the section of our Annual Report titled “Risk Factors.” If any events described
in the applicable risk factors included in the section of our Annual Report titled “Risk Factors” occur, then the
costs and timing associated with the development of any of our product candidates could significantly change. We may never succeed
in obtaining regulatory approval for, of commercialization of, LP-10, LP-310, or any of our other product candidates.
R&D
expenses increased by approximately $149,000, from $694,000 for the three months ended March 31, 2023 to $843,000 for the three
months ended March 31, 2024. The increase in R&D expenses was primarily attributable to an increase in outside services of
$58,000 for clinical study trials. Indirect costs related to operational overhead and employee benefits increased $105,000, and
legal patent costs decreased $8,000.
General
and Administrative Expenses
General
and administrative expenses consist primarily of management and business consultants and other related costs, including stock-based
compensation. General and administrative expenses also include board of directors’ expenses and professional fees for legal,
patent, consulting, accounting, auditing, tax services and insurance costs.
General
and administrative expenses were $521,00 for the three months ended March 31, 2024, compared to $509,000 for the three months
ended March 31, 2023, an increase of $12,000. These increases were primarily related to payment of salaries and outside services,
including investor relations expense.
Net
Other Income (Expense)
Net
other income for the three months ended March 31, 2024 was $26,000, as compared to $16,000 for the three months ended March 31,
2023. There was a $3,000 increase in interest income on the Company’s short term investment portfolio. It was offset by
a reduction in interest expense of $5,000. Interest expense on related party notes decreased during the three months ended March
31, 2024, as the Company had no outstanding debt during such period, as compared to the same period for the prior year, when the
Company had $250,000 of notes outstanding. See Note 7 of the notes to our financial statements in our Annual Report for details
of such related party notes and accrued interest at the prior period.
Liquidity
and Capital Resources
Sources
of Liquidity
We
have not yet commercialized any products, and we do not expect to generate revenue from sales of any product candidates for several
years, if at all. Cash and cash equivalents totaled $2.1 million as of March 31, 2024. We consider all highly liquid investments
that mature in 90 days or less when purchased to be cash equivalents.
We
have incurred operating losses and experienced negative operating cash flows for the three months ended March 31, 2024 and the
year ended December 31, 2023, and we anticipate that we will continue to incur losses for the foreseeable future. Our net loss
totaled $1,191,809 and $1,067,825 for the three months ended March 31, 2024 and 2023 respectively, and $4,618,965 for the
year ended December 31, 2023.
Historically,
we have financed our operations through a combination of grant revenue and equity financing, however our goals for the foreseeable
future will likely require significant equity financing. Our ability to achieve significant profitability depends on our ability
to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, LP-10 and/or our
other product candidates, which may not occur for several years, if ever. The net losses we incur may fluctuate significantly
from quarter to quarter.
Cash
Flows
The
following table provides information regarding our cash flows for each of the periods presented (in thousands):
|
|
For
the three months ended |
|
|
|
March
31, |
|
Dollars
in thousands |
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Net
cash (used) provided in operating activities |
|
$ |
(1,388 |
) |
|
|
(1,078 |
) |
Net cash provided
in financing activities |
|
|
200 |
|
|
|
(25 |
) |
Net
increase(decrease) in cash and cash equivalents |
|
$ |
(1,188 |
) |
|
|
(1,103 |
) |
Net
Cash (Used) Provided in Operating Activities
Net
cash used in operating activities for the three months ended March 31, 2024 was approximately $1,388,000. This comprised a net
loss for the period of approximately $1,192,000, and decreased operating liabilities of $164,000, offset by increases in the following
assets: grants receivable of $37,000 and prepaid expenses (primarily insurance policies and clinical trial operations services)
of $733,000. There were also noncash adjustments to net loss of $208,000 in stock option expense and $200,000 in shares of Common
Stock issued for services.
Net
cash used in operating activities for the three months ended March 31, 2023 was approximately $1,078,000. This comprised a net
loss for the period of approximately $1,068,000, and decreased prepaid expenses of $189,000, partially offset by changes in operating
assets and liabilities of $443,000 and noncash adjustments to net loss of $209,000 in stock option expense and $5,000
in non-cash interest expense.
Net
Cash Used in Financing Activities
Net
cash provided by financing activities for the three months ended March 31, 2024 was $200,000, received for the issuance of Common
Stock. Net cash used in financing activities for the three months ended March 31, 2023 was $25,000 in cash, which was used to
repay a $25,000 line of credit.
Funding
Requirements
We
expect our expenses to increase substantially in connection with our ongoing R&D activities, particularly as we continue R&D,
advance clinical trials of LP-10 and advance the preclinical development of our other programs, including LP-310. In addition,
we expect to incur additional costs associated with operating as a public company. As a result, we expect to incur substantial
operating losses and negative operating cash flows for the foreseeable future.
Based
on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our operations
and capital expenses through the end of 2024. However, we have based this estimate on assumptions that may prove to
be wrong, and we could exhaust our capital resources sooner than we expect.
Because
of the numerous risks and uncertainties associated with research, development and commercialization of LP-10, LP-310 and our other
and future product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding
requirements will depend on, and could increase significantly as a result of, many factors, including, but not limited to, those
referenced above in “— Results of Operations — Operating Expenses — Research and Development Expenses”.
Going
Concern
The
unaudited condensed financial statements of the Company have been prepared on a going concern basis, which contemplates the realization
of assets and the discharge of liabilities in the normal course of business. We have generated losses from operations since inception.
The Company expects operating losses to continue in the foreseeable future because of additional costs and expenses related to
research and development activities, plans to expand its product portfolio, and increasing its market share. The Company’s
ability to transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support its
cost structure. The timing and amount of our actual expenditures will be based on many factors, including cash flows from operations
and the anticipated growth of our business.
Management
of the Company may raise additional funds through the issuance of equity securities or debt. There can be no assurance that such
financing will be available at terms acceptable to the Company, if at all. Failure to generate sufficient cash flows from operations
and raise additional capital could have a material adverse effect on the Company’s ability to achieve its intended business
objectives. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying
unaudited condensed financial statements do not include any adjustments that might be necessary if the Company is unable to continue
as a going concern.
Off-Balance
Sheet Arrangements
We
did not have during the three months ended March 31, 2024, or the year ended December 31, 2023, and we do not currently have,
any off-balance sheet arrangements, as defined under applicable SEC rules.
Contractual
Obligations
We
did not have during the three months ended March 31, 2024 or the year ended December 31, 2023, and we do not currently have, any
material contractual obligations, such as license agreements or similar arrangements, other than as described below and in the
financial notes to our unaudited condensed financial statements included in this Form 10-Q and in our Annual Report.
Employment
Agreements
We
are party to employment agreements with each of Drs. Kaufman and Chancellor and Mr. Johnston, executive officers of the Company,
the material terms of each of which are described in the section entitled “Executive Compensation – Executive Employment
Agreements” of our Annual Report, which descriptions are supplemented by the disclosure of the August 2023 amendments
to our agreements with Drs. Kaufman and Chancellor contained in our Current Report on Form 8-K filed with the SEC on August 8,
2023, and as described in our Annual Report.
Lease
Agreement
We
are party to a lease agreement, dated June 1, 2019, with Bridgeway Development Corporation (“Bridgeway”), as amended,
for the lease of 2,690 square feet of office and lab and manufacturing space in Pittsburgh, Pennsylvania commencing on July 1,
2020 (the “Lease”). The Lease term expires on June 30, 2025 and we have the right to exercise a one-time option to
extend the Lease term for an additional five-year term. The annual base rent under the Lease is approximately $66,000. On July
26, 2023, the Company entered into a second lease for additional space on the fourth floor of the same building (the “Fourth
Floor Lease,” and together with the Lease, the “Leases”), commencing August 1, 2023 and co-terminating with
the Lease on June 30, 2025. Annual rent under the Fourth Floor Lease was approximately $28,000. As space became available in the
immediate proximity to our existing offices at the beginning of 2024, we terminated the Fourth Floor Lease upon mutual agreement
with the landlord and replaced it with a lease for Suite 504 (“the Suite 504 Lease”). The Suite 504 Lease is effective
January 1, 2024 and the term co-terminates with the Lease. The annual base rent for the current year for the Suite 504 Lease is
approximately $29,000. See Note 13 of the notes to our unaudited condensed financial statements included in this Form 10-Q.
Service
Agreements
We enter into service agreements in the
normal course of business with CROs and for clinical trials, preclinical research studies and testing, manufacturing, and other
services and products for operating purposes. These contracts do not contain any minimum purchase commitments. Certain agreements
provide for termination rights subject to termination fees or wind down costs. Under such agreements, we are contractually obligated
to make certain payments to vendors, mainly to reimburse them for their unrecoverable outlays incurred prior to cancellation.
The exact amounts of such obligations are dependent on the timing of termination, and the exact terms of the relevant agreement
and cannot be reasonably estimated. The expense we incurred pursuant to these agreements for the three months ended March 31,
2024 was approximately $204,000, which was consistent with the approximately $204,000 expense incurred for the three months ended
March 31, 2023. The spending was primarily attributable to expenses relating to our ongoing research and development work, and
costs related to our clinical trials for LP-10.
Critical
Accounting Policies and Significant Judgments and Estimates
This
management’s discussion and analysis is based on our unaudited condensed financial statements, which have been prepared
in accordance with GAAP. The preparation of these financial statements requires us to make judgments and estimates that affect
the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the unaudited
condensed financial statements and the reported amounts of expenses during the reported periods. We base our estimates on historical
experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances. Actual
results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments
and estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates, if any,
will be reflected in the financial statements prospectively from the date of change in estimates.
While
our accounting policies are described in more detail in the notes to our financial statements included in our Annual Report, we
believe the following accounting policies used in the preparation of our financial statements require the most significant judgments
and estimates. See Note 3 of the notes to our financial statements in our Annual Report for a description of our other significant
accounting policies.
Accrued
Expenses
As
part of the process of preparing our financial statements, we are required to estimate our accrued third-party R&D expenses
as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel
to identify services that have been performed on our behalf, and estimating the level of service performed and the associated
cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our
service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates
of our accrued expenses as of each balance sheet date based on facts and circumstances known to us at that time. We periodically
confirm the accuracy of our estimates with the service providers and make adjustments if necessary. The significant estimates
in our accrued R&D expenses include the costs incurred for services performed by our vendors in connection with R&D activities
for which we have not yet been invoiced.
We
base our expenses related to R&D activities on our estimates of the services received and efforts expended pursuant to quotes
and contracts with vendors that conduct R&D activities on our behalf. The financial terms of these agreements are subject
to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments
made to our vendors will exceed the level of services provided and result in a prepayment of the R&D expense. In accruing
service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each
period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual
or prepaid balance accordingly. Non-refundable advance payments for goods and services that will be used in future R&D activities
are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
Although
we do not expect our estimates to be materially different from amounts incurred, if our estimates of the status and timing of
services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that
are too high or too low in any particular period. To date, there have been no material differences between our estimates of such
expenses and the amounts incurred.
Stock-Based
Compensation
We
measure stock-based compensation based on the grant date fair value of the stock-based awards and recognize stock-based compensation
expense on a straight-line basis over the requisite service period of the awards, which is generally the vesting period of the
respective award. For non-employee awards, compensation expense is recognized as the services are provided, which is generally
ratably over the vesting period. We account for forfeitures as they occur. On January 1, 2018, we adopted, using the modified
retroactive approach, the guidance of Accounting Standard Update 2018-07, Compensation — Stock Compensation (Topic 718)
— Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), and account for awards to
non-employees using the grant date fair value without subsequent periodic remeasurement. The adoption of ASU 2018-07 did not have
a material effect on our financial statements.
We
classify stock-based compensation expense in our statements of operations in the same manner in which the award recipient’s
salary and related costs are classified or in which the award recipient’s service payments are classified. In future periods,
we expect stock-based compensation expense to increase, due in part to our existing unrecognized stock-based compensation expense
and as we grant additional stock-based awards to continue to attract and retain our employees.
We
determine the fair value of restricted Common Stock awards granted based on the fair value of our Common Stock. We have historically
determined the fair value of the underlying Common Stock based on input from management and the board of directors and the Company’s
enterprise value determined utilizing various methods, including the “back-solve” method. The total enterprise value,
determined from the back-solve method, is historically then allocated to the various outstanding equity instruments, including
the underlying Common Stock, utilizing the option pricing method (“OPM”) or a hybrid of the probability-weighted expected
return method (“PWERM”) and the OPM.
The
fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires
inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option,
the risk-free interest rate for a period that approximates the expected term of the option, and our expected dividend yield. As
the public market for our Common Stock has been limited and prior to the IPO there was no such public market, we have historically
determined the volatility for awards granted based on an analysis of reported data for a group of guideline companies that issued
options with substantially similar terms. The expected volatility has been determined using a weighted-average of the historical
volatility measures of this group of guideline companies along with our own. We expect to continue estimating expected volatility
based on the group of guideline companies until we have adequate historical data regarding the volatility of our own traded stock
price. The expected term of our stock options granted to employees and non-employees has been determined utilizing the “simplified”
method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference
to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected
term of the award. We have not paid, and do not anticipate paying, dividends on our Common Stock; therefore, the expected dividend
yield is assumed to be zero.
As
there was no public market for our Common Stock prior to the IPO, the estimated fair value of our Common Stock prior to our IPO
had been approved by our board of directors, with input from management, as of the date of each award grant, considering our most
recently available independent third-party valuations of our Common Stock and any additional objective and subjective factors
that we believed were relevant and which may have changed from the date of the most recent valuation through the date of each
award grant. We estimated the value of our equity using the market approach and a precedent transaction method which “back-solves”
the equity value that yielded a specific value for our Series A Stock. We allocated the equity value to our Common Stock and shares
of our Series A Stock using either an OPM or a hybrid method, which is a hybrid between the OPM and the PWERM. The hybrid method
we utilized estimated the probability-weighted value across multiple scenarios but used the OPM to estimate the allocation of
value within at least one of the scenarios. In addition to the OPM, the hybrid method considered the IPO scenario in which the
shares of our Series A Preferred Stock converted to Common Stock. The future value of the Common Stock in the IPO scenario was
discounted back to the valuation date at an appropriate risk adjusted discount rate. In the hybrid method, the present value indicated
for each scenario was probability weighted to arrive at an indication of value for our Common Stock.
In
addition to considering the results of the valuations, management considered various objective and subjective factors to determine
the fair value of our Common Stock as of each grant date, which may be a date later than the most recent third-party valuation
date, including:
|
● |
the prices of our
Series A Preferred Stock sold to or exchanged between outside investors in arm’s length transactions, if any, and the
rights, preferences and privileges of our Series A Preferred Stock as compared to those of our Common Stock, including the
liquidation preferences of our Series A Preferred Stock; |
|
● |
the progress of
our R&D efforts, including the status of preclinical studies; |
|
● |
the lack of liquidity
of our equity as a private company; |
|
● |
our stage of development
and business strategy and the material risks related to our business and industry; |
|
● |
the achievement
of enterprise milestones; |
|
● |
the valuation of
publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions
of peer companies; |
|
● |
any external market
conditions affecting the biotechnology industry, and trends within the biotechnology industry; |
|
● |
the likelihood of
achieving a liquidity event for the holders of our Series A Preferred Stock and Common Stock, such as an IPO, or a sale of
the Company, given prevailing market conditions; and |
|
● |
the analysis of
IPOs and the market performance of similar companies in the biopharmaceutical industry. |
There
are significant judgments and estimates inherent in these valuations. These judgments and estimates included assumptions regarding
our future operating performance, the stage of development of our programs, the timing of a potential offering, or other liquidity
event, and the determination of the appropriate valuation methodology at each valuation date. The assumptions underlying these
valuations represented management’s best estimates, which involve inherent uncertainties and the application of management
judgment. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our
stock-based compensation expense could be materially different. Subsequent to the completion of the IPO, the fair value of our
Common Stock is determined based on the market price of our Common Stock on Nasdaq.
With
respect to stock options granted during the three months ended March 31, 2024 and 2023, the following table sets forth by grant
date the (i) number of shares of our Common Stock issuable upon exercise of such stock options, (ii) per share exercise price
of such options and (iii) estimated fair value per share of our Common Stock on each such date. We did not grant any shares of
restricted Common Stock during this period.
Grant
date |
|
Number
of shares of Common
Stock issuable upon exercise of
stock options granted |
|
|
Exercise
price per
share of Common
Stock |
|
|
Estimated
fair value per
share of Common Stock
at grant date |
|
03/15/24 |
|
|
440,000 |
|
|
$ |
0.77 |
|
|
$ |
0.55 |
|
The
per share values at each such grant date, which we applied to determine the per share estimated fair value of the respective awards
for accounting purposes, were based upon the calculations described above used to determine the fair value of our Common Stock
as of each grant date.
Emerging
Growth Company Status
In
April 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107 of the JOBS
Act provides that an “emerging growth company” may take advantage of the extended transition period provided in Section
7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Therefore, an emerging growth company
can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have
irrevocably elected to avail ourselves of this extended transition period and, as a result, we will not be required to adopt new
or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
In
addition, as an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are
otherwise applicable generally to public companies. These provisions include, among other things:
|
● |
reduced disclosure
about the compensation paid to our executive officers; |
|
|
|
|
● |
not being required
to submit to our stockholders’ advisory votes on executive compensation or golden parachute arrangements; |
|
|
|
|
● |
an exemption from
the auditor attestation requirement in the pursuant to the Sarbanes-Oxley Act of 2002; and |
|
|
|
|
● |
an exemption from
compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm
rotation. |
We
may take advantage of these exemptions until such time that we are no longer an emerging growth company. We would cease to be
an emerging growth company upon the earliest of
|
● |
the last day of
the fiscal year on which we have $1.235 billion or more in annual revenue; |
|
|
|
|
● |
the date on which
we become a “large accelerated filer” (i.e., as of our fiscal year end, the total market value of our common equity
securities held by non-affiliates is $700 million or more as of June 30); |
|
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|
|
● |
the date on which
we issue more than $1.0 billion of non-convertible debt over a three-year period; or |
|
|
|
|
● |
the last day of
our fiscal year following the fifth anniversary of the date of the completion of the IPO. |
We
may choose to take advantage of some but not all of these exemptions.
Recent
Accounting Pronouncements
We
have reviewed all recently issued accounting pronouncements and have determined that, other than as disclosed in Note 3 to our
unaudited condensed financial statements included in this Report, such standards will not have a material impact on our financial
statements or do not otherwise apply to our operations.
Item
3. Quantitative and Qualitative Disclosures about Market Risk.
As
a smaller reporting company, as defined in Item 10(f)(1) of Regulation S-K, we are not required to provide the information required
by this Item.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer,
the Company conducted an evaluation of the effectiveness of its disclosure controls and procedures (as such term is defined in
Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this report. Disclosure controls and
procedures are designed to ensure that information required to be disclosed in the reports the Company 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 and that such information is accumulated and communicated to management, including the Chief Executive Officer and Chief
Financial Officer, to allow timely decisions regarding required disclosure. Based on this evaluation, the Company’s management,
including the Chief Executive Officer and Chief Financial Officer, concluded that its disclosure controls and procedures were
effective as of March 31, 2024.
Changes
in Internal Controls
There
were no changes in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f))
that occurred during the three months ended March 31, 2024, that have materially affected or are reasonably likely to materially
affect our internal control over financial reporting.
Limitations
of the Effectiveness of Controls
Our
management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and
procedures 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, but are not limited to,
the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple errors. 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 control. 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.
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
1. Legal Proceedings.
From
time to time, we may become subject to legal proceedings, claims or litigation arising in the ordinary course of business. We
are not presently a party to any legal proceedings that in the opinion of our management, if determined adversely to us, would
individually or taken together have a material adverse effect on our business, operating results, financial condition or cash
flows.
Item
1A. Risk Factors.
Our
business, financial condition and operating results are subject to a number of risk factors, both those that are known to us and
identified below and others that may arise from time to time. These risks and uncertainties are not the only ones that we face
and additional risks and uncertainties not presently known to us or that we currently consider immaterial may also impair our
business operations. These risk factors could cause our actual results to differ materially from those suggested by forward-looking
statements in this Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 (this “Report”) and
elsewhere, and may adversely affect our business, financial condition or operating results. If any of these risk factors should
occur, moreover, the trading price of our Common Stock could decline, and investors in our Common Stock could lose all or
part of their investment. These risk factors, along with other information contained in this Report, should be carefully considered
in evaluating our prospects.
We
have been notified by The Nasdaq Stock Market LLC (“Nasdaq”) of our failure to comply with certain continued listing
requirements and, if we are unable to regain compliance with all applicable continued listing requirements and standards of Nasdaq,
our Common Stock could be delisted from Nasdaq.
Our
Common Stock is currently listed on the Nasdaq Capital Market. In order to maintain that listing, we must satisfy minimum financial
and other continued listing requirements and standards, including those regarding director independence and independent committee
requirements, minimum stockholders’ equity, minimum share price, and certain corporate governance requirements.
As
disclosed in our Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on April 19, 2024, on
April 17, 2024, we received a written notification from Nasdaq’s Listing Qualifications Department notifying us that we
were not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth
under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”), because the closing bid price of our Common
Stock was below $1.00 per share for the previous thirty (30) consecutive business days. We were granted 180 calendar days, or
until October 14, 2024, to regain compliance with the Minimum Bid Price Requirement. In the event we do not regain compliance
with the Minimum Bid Price Requirement by October 14, 2024, we may be eligible for an additional 180-calendar day grace period.
To qualify, we will be required to meet the continued listing requirement for market value of publicly held shares and all other
listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and will need to provide
written notice to Nasdaq of our intent to regain compliance with such requirement during such second compliance period. If we
do not regain compliance within the allotted compliance period(s), including any extensions that may be granted, Nasdaq will provide
notice that our Common Stock will be subject to delisting from the Nasdaq Capital Market. At that time, we may appeal Nasdaq’s
determination to a hearings panel.
We
intend to monitor the closing bid price of our Common Stock and assess potential actions, including effecting a reverse stock
split, to regain compliance, but there is no assurance that we will be able to regain compliance, including under the specified
grace period or any extensions thereof. Even if we were to regain compliance with the deficiency noted above, we may, again, in
the future fall out of compliance with such standards. A delisting of our Common Stock could have an adverse effect on the market
price of, and the efficiency of the trading market for, our Common Stock, not only in terms of the number of shares that can be
bought and sold at a given price, but also through delays in the timing of transactions and less coverage of us by securities
analysts, if any.
There
can be no assurances that we will be able to regain compliance with the Minimum Bid Price Requirement or if we do later regain
compliance with the Minimum Bid Price Requirement, that we will be able to continue to comply with all applicable Nasdaq listing
requirements now or in the future. If we are unable to maintain compliance with these Nasdaq requirements, our Common Stock will
be delisted from the Nasdaq Capital Market.
In
the event that our Common Stock is delisted from the Nasdaq Capital Market, as a result of our failure to comply with the Minimum
Bid Price Requirement, or due to our failure to continue to comply with any other requirement for continued listing on the Nasdaq
Capital Market, and is not eligible for listing on another exchange, trading in the shares of our Common Stock could be conducted
in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Market
or another over-the-counter market operated by the OTC Markets Group Inc. In such event, it could become more difficult to dispose
of, or obtain accurate price quotations for, our Common Stock, and it would likely be more difficult to obtain coverage by securities
analysts and the news media, which could cause the price of our Common Stock to decline further. Also, it may be difficult for
us to raise additional capital if we are not listed on a national exchange.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
|
(a) |
On February 2, 2024,
the Company issued 196,078 shares of Common Stock to a consultant pursuant to that certain consulting services agreement,
dated as of January 24, 2024 (the “Consulting Agreement”), as consideration for certain services provided to the
Company pursuant to the Consulting Agreement. The shares were issued pursuant to an exemption from registration under Section
4(a)(2) of the Securities Act. |
|
(b) |
On March 13, 2024,
the Company entered into Affiliate Stock Purchase Agreements (the “Affiliate Stock Purchase Agreements”) with
each of Drs. Kaufman and Chancellor, pursuant to which each purchased $100,000 of shares of Common Stock in cash from the
Company at $0.6901 per share, resulting in the issuance of 144,906 shares of Common Stock to each of them. The shares were
issued pursuant to an exemption from registration under Section 4(a)(2) of the Securities Act.. |
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
On
January 1, 2024, as space became available in the immediate proximity to the Company’s existing offices covered by the Lease
at the beginning of 2024, we terminated the Fourth Floor Lease upon mutual agreement with Bridgeway and replaced it with the Suite
504 Lease, which co-terminates with the Lease on June 30, 2025. Annual rent under the Suite 504 Lease is approximately $29,000.
The Company agreed to use such space for office, manufacturing and assembly work and it will be used in addition to Company’s
current leased space. The Suite 504 Lease contains customary events of default and various other rights and obligations for leases
of this sort, including but not limited to provisions related to termination, liens, insurance, assignment and subleasing, fixtures
and alterations, and indemnities. The foregoing description of the Suite 504 Lease is only a summary and is qualified in its entirety
by reference to the full text of the Suite 504 Lease, a copy of which is attached as Exhibit 10.1 to this Form 10-Q and incorporated
herein by reference.
Item
6. Exhibits.
In
accordance with SEC Release 33-8238, Exhibits 32.1 and 32.2 are being furnished and not filed.
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.
|
Lipella Pharmaceuticals Inc. |
|
|
|
Date: May 9, 2024 |
By: |
/s/ Jonathan
Kaufman |
|
|
Jonathan Kaufman |
|
|
President and Chief Executive Officer |
|
|
(Duly Authorized Officer and Principal Executive
Officer) |
|
|
|
Date: May 9, 2024 |
By: |
/s/ Douglas
Johnston |
|
|
Douglas Johnston |
|
|
Chief Financial Officer |
|
|
(Duly Authorized Officer and Principal Financial
and Accounting Officer) |
Exhibit 10.1
LEASE AGREEMENT
PART I - BASIC LEASE INFORMATION
This Lease Agreement (“Lease”)
is made and executed this 28th day of December 2023, by and between Bridgeway Development Corporation (“Landlord”)
and Lipella Pharmaceuticals Inc. (“Tenant”).
This Lease consists of the following
two parts: Part I which sets forth terms defined in this Lease (and certain obligations under the Lease) and which is sometimes
referred to as the “Basic Lease Information”, and Part II which provides the terms and conditions of this Lease and
which is sometimes referred to as the “Lease Terms and Conditions”. Part I and Part II collectively, are referred to
as this “Lease.” Capitalized terms not otherwise defined in this Part I - Basic Lease Information shall have the meaning
provided in Part II of the Lease.
1. |
Landlord: |
Bridgeway Development Corporation |
|
|
|
2. |
Tenant: |
Lipella Pharmaceuticals Inc. |
|
|
|
3. |
Permitted Use: |
Office, manufacturing and assembly |
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|
4. |
Premises: |
The Premises identified as Suite 504 consists of approximately 1,964 square feet of floor area located on the fifth floor of the 5 story building located at 7800 Susquehanna Street, Pittsburgh PA 15208 along with the common access to Dock Door 10, the two existing freight elevators, passenger elevator, stairwell access, and bathrooms on the fourth floor. |
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5. |
5th Floor Common Area: |
Bathrooms, elevators, stairwells and common hallway consisting of approximately 3,954 square feet. |
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6. |
5th Floor Gross Floor Area: |
23,920 square feet. |
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7. |
5th Floor Premises: |
1,964 square feet as shown on Exhibit “A-1”. |
|
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8. |
5th Floor Rentable Area: |
1,964
square feet plus Tenant’s prorata share of the 5th Floor Common Area (9.84%) or 389 square feet. Total Rentable Square Feet is 2,353 square feet. |
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11. |
Term: |
18 months |
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12. |
Term Commencement: |
January 1, 2024 |
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13. |
Rent Commencement: |
January 1, 2024 |
14. |
Expiration of Term: |
June 30, 2025 |
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15. |
Option to Extend Term: |
Five years |
|
|
|
16. |
Annual/Monthly Rent: |
|
TERM |
RENT/SF |
ANNUAL |
MONTHLY |
|
|
RENT |
RENT |
1/1/24 -6/30/24 |
$12.00 |
$28,236.00 |
$2,353.00 |
|
|
|
|
7/1/24 -6/30/25 |
$12.50 |
$29,412.50 |
$2,451.04 |
|
|
|
|
OPTION RENT |
|
|
|
|
|
|
|
7/1/25 -6/30/26 |
$13.00 |
$30,589.00 |
$2,549.08 |
|
|
|
|
7/1/26 – 6/30/27 |
$13.50 |
$31,756.50 |
$2,647.13 |
|
|
|
|
7/1/26 - 6/30/28 |
$14.00 |
$32,942.00 |
$2,745.17 |
|
|
|
|
7/1/26 - 6/30/29 |
$14.50 |
$34,118.50 |
$2,843.21 |
|
|
|
|
7/1/26 - 6/30/30 |
$15.00 |
$35,295.00 |
$2,941.25 |
|
|
|
|
17. |
Additional Rent: |
All amounts and charges required to be paid by Tenant hereunder (other than Base Rent), including without limitation the Insurance requirements as described more particularly in Section 12 and 13 of Part II of this Lease. |
|
|
|
18. |
Rent: |
Includes both Base Rent and Additional Rent to be paid by Tenant |
|
|
|
19. |
Landlord’s Address: |
Bridgeway Development Corporation
310 Grant Street, Suite 2800
Pittsburgh, PA 15219 |
|
|
|
20. |
Tenant’s Address: |
Lipella Pharmaceuticals Inc.
7800 Susquehanna Street, Suite 505
Pittsburgh PA 15208
Attn: Jonathan Kaufman |
IN WITNESS WHEREOF, and intending to be
legally bound, Landlord and Tenant have caused the Part I of the Lease to be signed by their dully authorized officers and agents
under seal, as of the date set forth above.
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LANDLORD: |
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|
|
|
|
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|
Bridgeway Development Corporation |
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DATE: |
Jan
3, 2024 |
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By: |
/s/
Thomas J. Bogdewic |
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|
Name: |
Thomas J. Bogdewic |
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|
|
Title: |
President |
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|
|
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TENANT: |
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Lipella Pharmaceuticals Inc. |
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|
|
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|
DATE: |
Jan
3, 2024 |
|
By: |
/s/ Jonathan
Kaufman |
|
|
|
Name: Jonathan Kaufman |
|
|
|
|
|
LEASE AGREEMENT
PART II - LEASE TERMS AND CONDITIONS
1.
LEASE OF PREMISES. Landlord hereby leases to Tenant, and Tenant accepts such lease from Landlord, under the terms and conditions
set forth in this Lease, the Premises which are identified in the Basic Lease Information.
2.
CONDITION OF PREMISES. The Premises shall be delivered by Landlord to Tenant, and Tenant hereby accepts the Premises, in
an “AS-IS” “WHERE IS” condition and acknowledges that Landlord has no obligation to alter, improve, decorate
or otherwise prepare the Premises for Tenant’s occupancy. Tenant acknowledges that neither Landlord nor any agents of Landlord
have made any representations, warranties or covenants or either express or implied, with respect to the Premises or the condition
thereof except the Landlord improvements described in Section 7.
3. TERM. Tenant shall have and hold the Premises for the Term set forth in Basic Lease Information, beginning on the Commencement
Date and ending at 11:59 p.m. on the Expiration Date, both as specified in the Basic Lease Information. If the Term shall commence
or expire on a day which is other than the first day of a calendar month, Rent (as hereafter defined) for such month shall be pro-rated
based on a thirty (30) day month.
4.1 Amount: TENANT SHALL, BY
EVEN DATE HEREWITH, PAY TO LESSOR AND SHALL KEEP ON DEPOSIT WITH LESSOR THE SUM OF $00.00 AS A SECURITY DEPOSIT FOR THE PAYMENT
OF DAMAGES TO THE LEASED PREMISES OR DEFAULT IN RENT.
4.2 Maintenance at Original Amount:
If the whole or any part of said Security Deposit is so applied or retained, Tenant shall upon demand immediately deposit with
Lessor the amount so applied or retained to the end that Tenant shall at all times have and maintain on deposit with Lessor the
full amount of said Security Deposit as aforesaid. Said amount, if not expended by Lessor as herein provided, shall, upon the expiration
of this Lease Agreement or any renewal, be returnable to Tenant with any unpaid interest due thereon. IT IS UNDERSTOOD, HOWEVER,
THAT THE SECURITY DEPOSIT IS NOT TO BE CONSIDERED AS THE LAST MONTHLY RENTAL INSTALLMENT UNDER THIS LEASE AGREEMENT AND SHALL NOT
BE SO APPLIED EXCEPT UPON THE APPROVAL OF LESSOR. Security deposit shall be placed in an interest bearing account and if not expended
by Lessor pursuant hereto, shall be paid to Tenant at the end of the Lease.
4.3 Forwarding Address:
TENANT SHALL PROVIDE LESSOR IN WRITING WITH A FORWARDING ADDRESS UPON TERMINATION OF THIS LEASE AGREEMENT OR UPON SURRENDER AND
ACCEPTANCE BY LESSOR OF THE LEASED PREMISES AS PROVIDED FOR IN SECTION 512 OF THE LESSOR AND TENANT ACT OF 1951, 68 P.S. 250.512.
FAILURE TO DO SO, SHALL NOT RELIEVE LANDLORD FROM THE OBLIGATION TO RETURN THE SECURITY DEPOSIT SO LONG AS LANDLORD CAN REASONABLY
ASCERTAIN TENANT’S ADDRESS.
5. RENT.
5.1 Base Rent. The annual base
rent (“Base Rent”) for the Premises shall be as set forth in the Basic Lease Information. Tenant shall pay Base Rent
in the monthly installments set forth in the Basic Lease Information, in advance, on the first day of each calendar month during
the Term; provided, however, that Base Rent for the first month of the Term shall be paid upon the signing of this Lease.
5.2 Additional Rent. In addition
to Base Rent, Tenant shall pay all sums of money or other charges required to be paid by Tenant under this Lease as additional
rent (“Additional Rent”), whether or not same are expressly designated in this Lease as Additional Rent. All Additional
Rent shall be due and payable with each monthly installment of Base Rent unless otherwise provided herein.
5.3 Manner of Payment. Base Rent and
Additional Rent (together, “Rent”) payable under this Lease shall be paid in lawful money of the United States of America
without prior notice or demand therefore, and without deduction, defense, counterclaim, setoff or abatement whatsoever. Rent shall
be paid to Landlord at the address designated for Rent in the Basic Lease Information or such other address as Landlord may notify
Tenant in accordance with the procedure for notice set forth in this Lease.
5.4 Interest on Delinquent Payments.
If any payment of Rent is not paid within ten (10) business days of its due date, Tenant shall pay interest on such delinquent
payment, from the original due date of such delinquent payment until paid in full, at an interest rate (“Interest Rate”)
equal to the lesser of (a) five percent (5%) per month, or (b) the maximum rate permitted by applicable law, until such amounts
are paid in full. This Section shall not relieve Tenant from its obligation to pay Rent at the times and in the manners herein
specified. Acceptance by Landlord of interest shall not constitute a waiver of Tenant’s default with respect to said delinquent
payment, nor prevent Landlord from exercising any other rights or remedies available to Landlord. Interest at the Interest Rate
also shall accrue on any judgment obtained in connection with enforcement of this Lease.
6. TAXES,
UTILITY CHARGES AND OTHER RESPONSIBILITIES.
6.1 It is the intent of the Landlord
and Tenant that all costs of owning and operating the Premises as described herein during the term hereof shall be paid by Tenant
as Additional Rent hereunder, excluding, however, any other payments Landlord agrees to pay as described herein.
6.2 Utility
Charges. Tenant shall contract for telephone and internet services directly with Verizon or Comcast and contract directly for
electric service with Duquesne Light. Gas, water and sewage is paid by the Landlord.
6.3 Availability of Utilities and
Services. Landlord represents that Landlord will make available, at Landlord’s expense electric, gas, telephone, water
and sanitary sewage service at the Leased Premises on or prior to commencement of the Lease. Tenant acknowledges that Landlord
is not responsible to Tenant for any disruption or inadequacy of utilities services during the Term except to the extent caused
solely by the gross negligence or wilful misconduct of Landlord, its employees or agents. In this regard, Landlord does not warrant
that any services supplied to the Premises will not be interrupted. Services may be interrupted because of accidents, repairs,
alterations, improvements, or any reason beyond the reasonable control of Landlord. Any such interruption shall not make Landlord
liable to Tenant for damages, nor constitute a constructive eviction or entitle Tenant to rent abatement unless same shall have
been caused solely by the gross negligence or wilful misconduct of Landlord, its employees or agents.
| 7. | STRUCTURAL REPLACEMENTS, MAINTENANCE AND SNOW REMOVAL. |
a. Landlord, at Landlord’s expense,
shall perform all replacements and repairs necessary to maintain the roof, load bearing walls, and the foundation of the building
located on the Premises in good condition (“Structural Work”) so long as such Structural Work is not necessitated by
Tenant’s negligence. Landlord shall maintain the parking area and access to the Premises in good condition and shall be responsible
for removal of snow and debris from the parking lot. If an emergency exists, in Tenant’s reasonable commercial judgment with
regard to Structural Work, Tenant is authorized to take such minimal corrective action as is necessary abate the emergency at Landlord’s
expense.
b. Tenant’s General Obligations.
Subject to the foregoing, Tenant, at Tenant’s expense, shall perform all repairs, maintenance and replacements necessary
to maintain the Premises and every part thereof in a good and proper working condition, including without limitation repairs, maintenance
and replacements of windows (damaged by Tenant), doors, overhead doors, floors, other structural elements installed by Tenant,
HVAC equipment and systems, waste disposal and plumbing systems and fixtures, telephone and cable service and fixtures, interior
gas and electric service and fixtures, and all other mechanical elements and building systems serving the interior of the Premises
and installed by Tenant as part of Tenant’s build-out of the Premises.
c. Clean Condition. Tenant,
at Tenant’s expense, shall keep the Premises in a clean, sanitary, orderly and safe condition to the reasonable satisfaction
of Landlord and in accordance with any reasonable rules and regulations from time to time in effect during the Term of this Lease.
Tenant shall provide such reasonable pest extermination measures as is necessary to maintain the Premises free from insects, vermin
and any other pests. Landlord shall deliver possession of the Premises in a clean, sanitary, and safe condition at the time of
execution hereof.
8. ALTERATIONS.
8.1 Consent Required. Except
as hereafter provided in Section 8.2 or as required pursuant to Section 7 above, Tenant shall make no alterations, additions or
improvements (“Tenant Alterations”) to the Premises without the consent of Landlord, which consent shall not be unreasonably
withheld. Landlord may impose such reasonable conditions as part of its consent as Landlord deems appropriate, taking into consideration
the nature of the proposed Tenant Alteration, including, without limitation, requiring Tenant to furnish Landlord with security
for the payment of all costs to be incurred in connection with such work, insurance, and copies of the plans, specification and
permits necessary for such work. Landlord has approved initial Tenant Alterations and these plans and specs have been signed by
and between Landlord and Tenant (the “Initial Tenant Alterations”).
8.2 Permitted Tenant Alterations.
Landlord’s consent shall not be required for Tenant Alterations (“Permitted Tenant Alterations”) which satisfy
each of the following conditions: (i) do not adversely impact the structural integrity of the Premises or the systems serving the
Premises or their operation, (ii) are not visible from the exterior of the Premises and (iii) cost $ 10,000 or less in the aggregate
to complete. Tenant shall not be obligated to remove Permitted Tenant Alterations upon the termination of this Lease, including
Initial Tenant Alterations, but shall remove trade fixtures, furniture, and shelving and like items. Tenant is permitted to install
signage for way finding at the building exterior (location mutually agreed to by Landlord and Tenant) and stairwells.
9. GENERAL
CONSTRUCTION/MAINTENANCE PROCEDURES.
9.1 Quality of Performance. All undertakings
under Sections 7, 8 and 11 hereof shall be performed in a good and workmanlike manner, using only materials of at least the same
quality and integrity as that being repaired, replaced or altered, and performed and furnished in compliance with all applicable
laws, regulations, ordinances and requirements of all duly constituted authorities or governmental bodies having jurisdiction over
the Premises and of the requirements of any board of underwriters having jurisdiction thereof.
9.2 Prior Plan Approval. With
respect to Structural Work and Tenant Alterations other than the Permitted Tenant Alterations, no work shall be performed until
the plans therefore have been approved by Landlord, which approval shall not be unreasonably withheld or delayed and shall be deemed
approved unless Landlord objects in writing to the proposed plans (stating therein with reasonable specificity the reasons for
Landlord’s objection) within ten (10) business days after delivery to Landlord of a complete set of the plans therefor. In
connection with such approval, Landlord reserves the right to require the filing of a mechanic’s lien waiver by each contractor
performing such Structural Work or Tenant Alterations, or requiring that each such contractor post a mechanic’s or materialmen’s
lien bond, performance and/or completion bond. With respect to Permitted Tenant Alterations for which a building permit is required,
no work shall be performed until Tenant provides notice to Landlord that Tenant will be undertaking such Permitted Tenant Alteration,
which notice describes in reasonable detail the scope of the Permitted Tenant Alteration. Tenant’s delivery to Landlord of
a copy of Tenant’s application for a building permit shall be deemed to satisfy the foregoing description of the scope of
the Permitted Tenant Alteration. Where applicable given the nature of the Tenant’s Work, Tenant shall provide copies of as-built
plans and specifications for all Tenant’s Work to Landlord within a reasonable time of completion of the Tenant’s Work.
9.3 Contractors. Each contractor
shall carry contractor’s liability insurance which covers Landlord as additional insured, covering bodily injury in such
amounts as may be customary and appropriate for the Tenant’s Work undertaken, as reasonably determined by Landlord. Tenant
shall provide proof of such insurance acceptable to Landlord prior to commencement of any Tenant’s Work on the Premises.
9.4 Mechanic’s Liens.
Tenant shall pay all sums of money due for labor, services, materials, supplies and equipment furnished at Tenant's request with
respect to the Premises. If a mechanic's, materialman's or other lien (or notice of intent to file such a lien) is filed or recorded
against the Premises, or Landlord's interest in the same, based upon labor, services materials, supplies equipment or the like
ordered, or alleged to have been ordered by Tenant, and said lien constitutes an encumbrance upon the fee or other title of the
Premises, or Landlord's interest therein, Tenant shall indemnify Landlord or any of Landlord’s lenders against any mechanics
liens from all contractors and Tenant shall cause such lien to be discharged of record within ten (10) days of filing such lien.
If such lien is not discharged within said ten (10) day period, Landlord shall have the right to cause such discharge by payment
to the lienor, deposit of substitute security with a court having jurisdiction, bonding, or such other means chosen by Landlord;
the entire cost of said discharge, including monies paid to the lienor, into court, as security with a bondsman or otherwise, and
costs of effecting same, including the fees of Landlord's attorney, shall be paid to Landlord by Tenant upon demand. Tenant shall,
upon request, furnish Landlord with contractor's affidavits, full and final waivers of right to lien and receipted bills covering
all labor and materials expended and used in or about the Demised Premises by or at the request of Tenant.
9.5 Landlord’s Approval and Review
Reimbursement. By approving any request for Tenant’s Work (including the plans therefor), Landlord does not expressly
or implicitly covenant or warrant that the Tenant’s Work or the plans and specifications therefore are accurate, safe or
sufficient, or that the same comply with any applicable laws, ordinances, building codes, zoning requirements and like regulations,
nor shall Landlord’s approval of any contractor be deemed any endorsement of the qualifications of such contractor. Tenant
shall be solely responsible for determining the adequacy and sufficiency of the foregoing and for obtaining all necessary permits
and governmental approvals, including a Certificate of Occupancy upon completion of the Tenant’s Work, if and when required
by the municipality in which the Premises are located. Tenant shall reimburse Landlord for Landlord’s expenses incurred (including
any engineering, architectural or legal fees) in connection with reviewing any request for consent to Tenant’s Work except
Initial Tenant Alterations.
10. SIGNS
AND APPEARANCE OF PREMISES.
Subject to applicable zoning requirements,
Tenant, at its expense, may install and maintain one outside identification sign, which shall be of an appearance that is mutually
acceptable to Landlord and Tenant. Tenant shall obtain at its expense all necessary permits or governmental approvals for such
sign.
| 11. | USE
AND COMPLIANCE WITH LAWS. |
11.1 Permitted
Use. Tenant shall use the Premises only for the Permitted Use set forth in the Basic Lease Information and uses incidental
thereto. Tenant shall not permit the Premises to be used for any illegal purpose or in any manner which would tend to damage any
portion thereof.
11.2 Insurance
Risks. Tenant shall not conduct any activity or permit any activity to be conducted or place any equipment in or about the
Premises which would in any way increase the rate of fire insurance or other insurance on the Premises.
11.3 Compliance
with Applicable Laws. Tenant shall comply with all applicable laws, regulations, ordinances, and directives of the Federal
Government, state and municipality in which the Premises are located as well as all judicial orders and the requirements of any
Board of Fire Underwriters (or any other body exercising similar functions) as are in effect during the Term of this Lease, including
without limitation, those relating to Hazardous Materials (hereafter defined), those otherwise relating to occupational safety
and health, and the Americans With Disabilities Act of 1990, as amended from time to time, and all regulations or judicial interpretations
of the requirements thereof. Tenant, at Tenant’s sole expense, shall perform any act or obligation arising from or as is
necessary to achieve such compliance except Structural Work. At all times during this Lease, Tenant shall maintain and comply
with all permits, licenses or other authorizations required by any governmental authority or agency for Tenant’s occupancy
or operations at the Premises.
a. Tenant
shall comply with all applicable environmental laws, orders, regulations, ordinances and directives now existing or hereafter
enacted (“Environmental Laws”) and, at Tenant’s sole cost and expense, shall perform any act or obligation arising
from or as is necessary to achieve such compliance arising from its use of the Premises. Landlord shall, at its sole cost and
expense, perform any act or obligation in order to comply with all Environmental Laws except those which are Tenant’s obligation
hereunder.
b. Tenant
shall not cause or permit any portion of the Premises to be used for the production, storage, deposit or disposal of Hazardous
Materials, nor shall Tenant permit Hazardous Materials ever to be placed or located upon the Premises. Notwithstanding the above
prohibition, Tenant acknowledges that it stores Hazardous Materials (thinners, lacquers, glues, varnishes, etc.) including the
listed petrochemicals and finishes containing urea formaldehyde and covenants that same are at all times used, kept and stored
in full compliance with the Environmental Laws including the storing of the Hazardous Materials in code-compliant flammable cabinets.
As used herein, “Hazardous Materials” means all substances or pollutants which are declared to be or regulated as
hazardous, toxic, dangerous or polluting substances under the Environmental Laws at any time during the Term of this Lease, including,
without limitation, asbestos, polychlorinated biphenyles (PCBs), urea formaldehyde, foam insulation, and petroleum products and
by-products.
c. Tenant
shall promptly notify Landlord of any actual or threatened lien against the Premises of which Tenant becomes aware pursuant to
any of the Environmental Laws. Tenant, at Tenant’s sole cost and expense, shall promptly discharge and remove any lien arising
from Tenant’s violation of any of the Environmental Laws, such action to be completed within thirty (30) days after Tenant
first receives notice of such lien or violation or such shorter period of time if required (1) by the governmental agency enforcing
the correction of such violation, or (2) to prevent the holder of any such lien from forcing the sale of the Premises.
11.6 Landlord’s
Inquiries and Inspection. Tenant shall promptly and accurately respond in writing to all inquiries made by Landlord (including
without limitation requests for documents) pertaining to Tenant’s obligations under this Lease or use of the Premises. Landlord
and any authorized agent or contractor hired by Landlord may enter the Premises at any time and from time to time for purposes
of inspecting same and conducting tests thereupon as Landlord deems reasonably necessary to determine that Tenant is in compliance
with this Lease, but Landlord shall not be obligated to do so. Unless an emergency exists, as determined by Landlord in its sole
discretion, Landlord shall notify Tenant at least one day in advance of any such inspection or testing and, to the extent practicable,
shall conduct any such inspection or testing in such manner so as to minimize unreasonable interference with Tenant’s business.
The costs of such investigation and inspection shall be paid by Landlord unless it is determined that Tenant is in noncompliance
with this Lease, in which case such costs shall be paid solely by Tenant as Additional Rent within ten (10) business days of Landlord’s
demand therefore after which time interest at the Interest Rate shall be applied.
11.7 Notice
of Violations. Tenant shall promptly notify Landlord of any violation of any applicable law which is alleged to have been
committed at the Premises and shall forward to Landlord copies of any written communications, complaints, citations or other notices
relating to the condition of the Premises or compliance with applicable laws (“Action Notice”). Tenant promptly shall
respond to any Action Notice, cure any violation of applicable laws caused by Tenant and have dismissed any legal action commenced
against Tenant or the Premises arising from its activities to the satisfaction of Landlord. Prior to undertaking same, however,
Tenant shall propose to Landlord its intended course of action and proceed only with Landlord’s approval of same, which
shall not be deemed to be Landlord’s guarantee that such action is appropriate nor impose any liability on same for Landlord
and which shall not be unreasonably withheld. In no event, however, shall any curative action be undertaken by Tenant without
Landlord’s consent unless same (a) strictly comply with the most stringent relevant criteria for protection of human health,
the environment or groundwater quality; or (b) requires no recorded notice or continued institutional control or monitoring.
11.8 Indemnification.
Except to the extent covered by insurance and in amplification of Tenant’s obligations under Section 15 and not in
limitation thereof, Tenant shall indemnify, defend (with legal counsel selected by Landlord) and hold harmless Landlord and
Landlord’s Affiliates (hereafter defined) from and against any and all claims, legal or equitable, damages for personal
injury (including death) or harm to Premises (real or personal), liabilities, penalties, fines and costs (including without
limitation, investigation and remediation costs, sums paid in private rights of action or in settlement of claims, legal
fees, consultant fees and expert fees)
and damages in the nature of loss of use of the Premises, arising out of or in any way connected to any condition caused or created
by Tenant’s failure to comply with its obligations under this Section 11.
11.9 Survival.
The provisions of this Section 11 shall survive the scheduled expiration or earlier termination of this Lease, and, in addition
to performance of the obligations hereby required, Tenant shall continue to pay rent, even though this Lease may have been terminated,
until Tenant has completed the performance of all of its obligations hereunder.
12.1 Landlord’s
Insurance. Landlord shall provide insurance coverage of the Premises, exclusive of Tenant’s leasehold improvements therein
(i.e., standard fire and hazard insurance with approved standard extended coverage endorsement), in commercially reasonable amounts
and with commercially reasonable deductibles. Landlord shall also maintain comprehensive general liability insurance during the
Term with a recognized responsible insurance carrier with limits of coverage of not less than One Million and No/Dollars ($1,000,000.00)
combined single limit.
12.2. Tenant’s
Insurance. a. Liability. Tenant agrees to place and maintain, at Tenant’s own expense, comprehensive general
liability insurance, with respect to Tenant’s use and occupancy of the Premises with limits of coverage not less than One
Million and No/Dollars ($1,000,000.00) combined single limit. Tenant shall carry its own insurance on the contents, i.e., personal
property, equipment, fixtures, etc., located in the Premises as well as on any non-building-standard improvements in an amount
to cover one hundred (100%) percent of the replacement cost of the property and fixtures, subject to a deductible not exceeding
Five Thousand and No/Dollars ($5,000.00).
b. Worker’s
Compensation/Employer’s Liability. Tenant shall carry worker’s compensation insurance containing statutory limits
covering Tenant’s employees and business operations in the Premises, as well as employer’s liability insurance providing
coverage of not less than Five Hundred Thousand Dollars ($500,000.00).
c. Automobile.
Tenant shall carry Automobile Liability Coverage with limits of coverage not less than One Million and No/Dollars ($1,000,000)
each occurrence combined single limit for all owned, non-owned and hired vehicles.
d. Form
of Insurance. All insurance policies obtained by Tenant pursuant to this Section 12.2 shall be issued by companies with a
rating of “A” by AM Best and which are qualified to do business in the Commonwealth of Pennsylvania. Additionally,
each such insurance policy carried by Tenant pursuant to the terms hereof, shall provide for a waiver of recovery against Landlord
by way of subrogation pursuant to Section 12.2(e.) of this Lease. All policies required hereby (exclusive of the worker’s
compensation policy) shall name Landlord, and such other parties as Landlord shall specify as additional insureds and shall further
specify that Landlord shall receive thirty (30) days prior written notice of any proposed cancellation, non-renewal of, or material
change in any such policy. Originals, certified policy copies or certificates, as
Landlord shall elect, of all policies of insurance obtained by Tenant shall be provided to Landlord to evidence compliance with
this Section.
e. Waiver
of Subrogation. Tenant hereby waives, and shall cause its insurers to waive, any and every claim for recovery from Landlord
for any and all loss of or damage to the Premises or to the contents thereof, which loss or damage is covered by insurance policies
or would have been covered by policies required by this Lease.
12.3. Mutual
Release. Notwithstanding anything in this Lease to the contrary, Landlord and Tenant hereby release the other from any and
all liability or responsibility to the other or anyone claiming through or under them by way of subrogation or otherwise for any
loss or damage to insurable tangible property, even if such loss or damage shall have been caused by the fault or negligence of
the other party, or anyone for whom such party may be responsible, provided, however, that this release shall be applicable and
in force and effect only with respect to any loss or damage occurring during such time as the policy or policies of insurance
covering said loss shall contain a clause or endorsement to the effect that this release shall not adversely affect or impair
said insurance or prejudice the right of the insured to recover thereunder. Landlord and Tenant shall each have such clause in
its fire and extended coverage insurance policies if available without extra charge, and if there be a charge, shall notify the
other such party and, in such event, shall have the clause if the other party agrees to pay such extra charge. In the absence
of any such notice, it shall be presumed for purposes of this subsection that the insurance of such party contains the foregoing
clause or endorsement without additional charge.
a. In
case of damage to the Premises by a risk insured against pursuant to Section 12 hereof and self insurance, Landlord shall repair
the Premises to substantially the condition which existed prior to such damage, with reasonable dispatch after receiving from
Tenant written notice that damage has occurred, but without obligation to do so until Landlord has received confirmation from
the insurance carrier and all mortgagees holding mortgages on the Premises that adequate insurance proceeds will be available
for repair or reconstruction. If Landlord does not receive confirmation from the insurance carrier and any self-insurance and
any mortgagee and Landlord does not voluntarily repair the Premises, then Landlord or Tenant may terminate this Lease.
b. If
damage to the Premises reduces usable space to less than 50%, then either party may terminate this Lease in the manner herein
provided, in which event all Rent shall abate and this Lease terminate as of the date said damage occurred. Tenant shall notify
Landlord in writing of its decision to terminate this Lease within thirty (30) days after the occurrence (“Tenant’s
Notice Period”). Tenant’s failure to terminate this Lease by written notice of termination delivered to Landlord within
Tenant’s Notice Period shall be conclusively construed as Tenant’s agreement for this Lease to continue; subject,
however, to Landlord’s right to
terminate this Lease by written notice delivered to Tenant within thirty (30) days after the occurrence. If neither party terminates
this Lease, then Landlord shall commence restoration.
13.3 Mortgagee’s
Right. If the holder of any indebtedness secured by a mortgage covering the Premises requires that the insurance proceeds
be applied to such indebtedness, and Landlord does not repair, then Landlord or Tenant shall have the right to terminate this
Lease by written notice of termination delivered to Tenant within thirty (30) days after such requirement has been made in writing
upon Landlord, unless Tenant decides to repair the Premises on its own. In such case, this Lease shall terminate as of the date
specified in the notice to the other party.
13.4 Damage
Near End of Term. Notwithstanding any provision of this Lease to the contrary, Landlord shall not have any obligation whatsoever
to repair, reconstruct or restore the Premises when the damage or destruction occurs during the last year of the Term of this
Lease (including any exercised renewal thereof). In such event, Landlord shall have the option to terminate this Lease in which
case Rent shall abate as of the date said damage occurred.
14.1 Termination
Rights. If such portion of the Premises is condemned or taken by any governmental body or by any other body or agency possessing
the power of condemnation as, in the reasonable determination of Landlord; substantially impairs the use or occupancy by Tenant
of the Premises or Landlord’s ability to perform its obligations under this Lease (“Taking”), then either party
shall have the right to terminate this Lease effective as of the date that possession is required to be surrendered to said authority.
If Landlord determines that a Taking is to occur, then Landlord shall so notify Tenant in writing. Either party shall then have
the right to terminate this Lease by written notice delivered to the other within thirty (30) days after delivery of Landlord’s
notice to Tenant of a Taking. The failure of Tenant or Landlord to deliver termination notice within the time limit set forth
above shall be conclusively construed as such party’s agreement for this Lease to continue.
14.2 Repair
and Rent Adjustment. If a Taking is not to occur or if neither party terminates this Lease under subsection 14.1 above, Landlord
shall promptly restore the Premises to substantially the same condition prior to such condemnation (less the portion thereof lost
in such condemnation), Base Rent shall be proportionately reduced by the portion of the Premises of which Tenant shall have been
deprived on account of said condemnation, such adjustment to be effective as of the date possession is required to be surrendered
to the condemning authority.
14.3 Temporary
Condemnation. If such condemnation or taking is for temporary use only, this Lease shall continue in full force and effect,
and Tenant shall continue to comply with all of the provisions hereof, except as such compliance shall be rendered impossible
or impracticable by reason of such temporary taking. Rent shall abate during the course of a temporary taking of the Premises
or a portion thereof to the extent and for the period of time that the Premises or portion thereof so taken shall have been rendered
untenantable.
14.4 Condemnation
Awards. Tenant shall not be entitled to receive any part of any award or awards that may be made to or received by Landlord
relating to loss of the Premises or any part thereof, and Tenant hereby assigns to Landlord any share of such award as may be
granted to Tenant. Notwithstanding the foregoing, Tenant, at its sole cost and expense, may pursue independent proceedings against
the public authority exercising the power of condemnation to prove and establish any damage Tenant may have sustained relating
to Tenant’s business and relocation expenses, provided any such compensation does not diminish Landlord’s award.
14.5 Mortgagee’s
Rights. If the holder of any indebtedness secured by a mortgage covering the Premises requires that the condemnation proceeds
be applied to such indebtedness, then Landlord shall have the right to terminate this Lease by written notice of termination delivered
to Tenant within thirty (30) days after such requirement has been made in writing upon Landlord. In such case, this Lease shall
terminate as of the date specified in Landlord’s notice to Tenant.
| 15. | NONLIABILITIES
AND INDEMNIFICATION OF LANDLORD. |
15.1 Release.
Tenant hereby agrees that Landlord and Landlord’s Affiliates shall not be liable to Tenant and hereby releases Landlord
and Landlord’s Affiliates for all liability to Tenant for injury to any person (including bodily damage or death) or damage
to any Premises (including real or personal Premises, whether by theft or any other casualty) happening in any manner in, on or
about the Premises from any cause whatsoever, unless caused solely by the gross negligence or willful misconduct of Landlord or
Landlord’s Affiliates, but neither Landlord nor Landlord’s Affiliates shall be liable to Tenant for any such damage
or loss to the extent that Tenant is compensated therefor by Tenant’s insurance or would have been compensated therefor
under policies which Tenant is required to carry under this Lease. In no event, however, shall Landlord or Landlord’s Affiliates
be liable for consequential damages. Tenant agrees to the foregoing and makes the foregoing release on behalf of Tenant and any
party claiming a right or interest through Tenant, including without limitation Tenant’s agents, contractors, subcontractors,
employees, licensees, or invitees (collectively, “Tenant’s Agents”).
15.2 Indemnification.
Except to the extent covered by insurance, Tenant shall indemnify, defend (with legal counsel selected by Tenant) and hold
harmless Landlord and Landlord’s Affiliates from and against liability whatsoever which may be imposed upon, incurred
by, or asserted against Landlord and/or Landlord’s Affiliates by reason of any of the following which shall occur
during the Term of this Lease: (a) use of the Premises by Tenant or Tenant’s Agents; (b) any Tenant’s Work done
in, on or about the Premises (including without limitation as a result of defect in design, material, workmanship or
mechanic’s liens) made by, or at the direction of Tenant or Tenant’s Agents; (c) any accident, injury or damage
to persons (including bodily injury and death) or Premises (real or personal) occurring in, or about the Premises, but not if
caused solely by the gross negligence or willful misconduct of Landlord and/or Landlord’s Affiliates; and (d) any
failure on the part of Tenant to perform or comply with any provision of this Lease. Without limiting the generality of the
foregoing, Tenant’s obligations hereunder shall include all damages, obligations, penalties, lines, liens, claims,
reasonable fees for legal counsel selected by Tenant, investigation costs, remediation costs and all other reasonable costs
and expenses incurred by Landlord or Landlord’s Affiliates. Tenant shall
not settle or compromise any such liability for which indemnification is sought hereunder without first obtaining Landlord’s
prior written consent, which shall not be unreasonably withheld. Landlord shall indemnify, defend and hold Tenant harmless from
and against any liability whatsoever which may be imposed during the term of the Lease for personal injury or death or loss or
damage to any of Tenant’s alterations or trade fixtures, equipment, furniture, inventory and personal property arising out
of or resulting from any failure on the part of Landlord to perform or comply with any provision of the Lease.
15.3 Limitation
on Landlord’s Liability; Landlord’s Affiliates. The liability of Landlord and/or Landlord’s Affiliates to
Tenant or anyone claiming by or through Tenant shall be limited to Landlord’s interest in the Premises. The foregoing shall
be absolute and without exception whatsoever. When used in this Lease, the term Landlord’s Affiliates shall mean any entity
affiliated with Landlord through common ownership, Landlord’s property manager and their respective, officers, directors,
equity members, employees, agents, contractors and subcontractors.
15.4 Survival.
This Section 15 shall survive the termination of this Lease with respect to any damage, injury, death or claim occurring before
such termination, irrespective of when such claim is presented.
| 16. | ASSIGNMENT
AND SUBLEASING. |
a. Tenant
shall not sell, assign, transfer, mortgage or pledge the Premises, or any part thereof, nor permit occupancy of the Premises by
any party other than Tenant without Landlord’s prior written consent, which Landlord may withhold in its sole discretion.
Consent to one or more assignments shall not destroy or waive this provision. For purposes of this Lease, any merger, consolidation,
or sale or transfer of a controlling interest in Tenant (being 51% or more, whether accomplished in a single transaction or in
a series of transactions) or a sale of substantially all of the assets of Tenant shall be deemed an assignment of this Lease.
All of the foregoing events described in this Section shall be deemed to be a “Transfer.”
b. If
Landlord’s consent is required, Tenant shall deliver to Landlord its request in writing along with notice as to (1) the
identity, business and financial condition of the proposed assignee, (2) the terms and conditions of the proposed assignment,
and (3) the nature of the use of the Premises proposed by such assignee or. Tenant shall deliver such further information as Landlord
may request to make its decision.
c. If
Landlord consents to any Transfer, Landlord shall be provided with a written agreement evidencing same which is acceptable
in form and content to Landlord and by which the transferee assumes all obligations of Tenant hereunder. At Landlord’s
option, upon any Transfer, (1) any amounts to be paid to Tenant in excess of Rent due hereunder shall be paid to Landlord
without Landlord’s application of same to Rent, and (2) the transferee shall remit directly to Landlord all rental
amounts due or any consideration paid to Tenant on account of such Transfer when and as due to be paid to Tenant. The
foregoing shall apply to any Transfer,
even if Landlord has not consented thereto, but application thereof by Landlord shall not be deemed to release Tenant of liability
for failure to obtain Landlord’s consent or otherwise be deemed to prejudice Landlord’s rights hereunder.
d. No
Transfer shall relieve Tenant of any obligation under this Lease, and any purported Transfer undertaken without Landlord’s
consent shall be void at Landlord’s option and constitute an Event of Default hereunder. Landlord’s consent to any
Transfer shall not constitute a waiver of the necessity of such consent to any subsequent Transfer.
e. The
prohibitions in this Lease against assignment by Tenant shall be construed to include assignments by operation of law or by voluntary
assignment or for the benefit of creditors or which might otherwise be affected or accomplished by bankruptcy, receivership, attachment,
execution or other judicial process or proceeding. If any such assignment shall be made or deemed made by Tenant, or if a voluntary
of involuntary petition in bankruptcy or for reorganization, or for an arrangement shall be filed by or against Tenant, or if
Tenant shall be adjudicated a bankrupt or insolvent, or if a receiver is appointed for Tenant or for all or a substantial part
of its Premises, or if any such assignment or transfer operation or law shall occur, then and in any such event, Landlord shall
have the option to immediately terminate this Lease by written notice to Tenant.
f. Tenant
shall pay all of Landlord’s cost and expenses (including reasonable fees for legal counsel) in connection with any request
for Landlord’s consent required hereby.
16.2 Subleasing.
Tenant may not, without the prior written consent of Landlord, sublease the Premises or any part thereof, or permit the use of
the Premises by any party other than Tenant. Landlord agrees that its consent to any request for subletting shall not be unreasonably
withheld. Consent to one or more assignments or subleases shall not destroy or waive this provision. Subtenants approved by the
Landlord shall become directly liable to Landlord for all obligations of Tenant hereunder without relieving Tenant’s liability
under this Lease, which shall continue notwithstanding such subletting. Consent to one or more subleases shall not destroy or
waive this provision.
18.1 Events
of Default. In addition to defaults or Events of Default specified in other sections of this Lease, the occurrence of any
of the following shall be a default by Tenant, and each shall constitute an “Event of Default” hereunder without notice
from Landlord unless expressly required herein:
a. Tenant
shall fail to pay Base Rent within seven (7) days of its due date (regardless of whether or not any legal or formal demand has
been made therefor);
b. Tenant
shall fail to pay Additional Rent within five (5) days of its due date or shall fail to make any other payment when required pursuant
to this Lease, except that
Landlord shall allow Tenant to cure such default within fifteen (15) days after written notice of such default;
c. Tenant
shall violate or fail to perform any of the terms, conditions, covenants or agreements herein made by Tenant (other than those
set forth in subsections 18.l (a) and (d)-(h) inclusive or where expressly declared to be an immediate default in other sections
of this Lease) within ten (10) days after written notice thereof from Landlord;
d. Reserved;
e. Tenant
shall be adjudicated a bankrupt or file a voluntary petition in any bankruptcy or insolvency proceeding, or if any involuntary
petition in any bankruptcy or insolvency proceeding shall be filed against Tenant and not discharged by Tenant within sixty (60)
days from the date of filing;
f. Tenant
shall make or consent to an assignment for the benefit of creditors or a common law composition of creditors, without the prior
written consent of Landlord;
g. A
receiver or trustee shall be appointed for all or substantially all of Tenant’s assets; and/or
h. Tenant shall make a transfer
in fraud of creditors.
18.2 Remedies.
Upon the occurrence of any Event of Default, Landlord shall have the option to pursue any and all of the following rights and
remedies without any notice or demand whatsoever:
a. Lease
Termination. Landlord shall have the right to immediately terminate this Lease and all rights of Tenant hereunder, in which
event Tenant shall immediately surrender the Premises to Landlord. If Tenant fails to do so, Landlord may, after twenty (20) days
written notice, enter upon and take possession of the Premises and expel or remove Tenant and its effects without being liable
to prosecution or any claim for damages therefor and Tenant shall indemnify Landlord for all costs and expenses incurred by Landlord
in connection with such termination. Such Lease termination shall not be a bar to Landlord from pursuing the remedy of Rent acceleration
pursuant to Section 18.2(b) below and Tenant agrees to waive any defense to Landlord pursuing such Rent acceleration if based
on the Lease termination.
b. Rent
Acceleration. Upon Lease termination, Landlord shall have the right to accelerate Rent in which event Tenant shall be liable
for the total of: (1) any unpaid Rent which had accrued at the time of such termination, plus (2) Base Rent for the then entire
unexpired Term of this Lease along with all amounts due as Additional Rent for the then entire unexpired Term of this Lease which
shall be capable of precise determination at the time of Landlord’s election to recover accelerated Rent, plus (3) Landlord’s
good faith estimate of all other amounts due as Additional Rent for the then entire unexpired Term of this Lease which shall not
be capable of precise determination as aforesaid (and for such purposes no estimate of any such component of Additional Rent shall
be less than the amount which would have been due if each such component continued at the highest monthly rate or amount in effect
during the twelve
(12) months immediately preceding the Event of Default). For purposes of such calculation the Term of this Lease shall be the
Term originally stated in the Basic Lease Information along with any exercised renewals thereof, taken without regard to any early
termination of the Term by virtue of an Event of Default. Tenant also shall pay any other amount necessary to compensate Landlord
for all damages arising from Tenant’s failure to perform Tenant’s obligations under this Lease until and including
time of termination and except as provided for under this Section. Rent which accrued through the date of the Event of Default,
shall include interest thereon at the Interest Rate, and accelerated Rent thereafter due shall accrue interest at the Interest
Rate until paid in full.
(1) Upon
termination, Landlord shall use commercially reasonable efforts to relet the Premises or any part thereof for such Rent and upon
such terms as Landlord in good faith deems appropriate in its sole discretion under the circumstances (“Mitigating Rent”)
with the right to make alterations and improvements to the Premises required by any new tenant as to place the Premises in a first-class
rentable condition. If an amount equal to the full Rent which would have been paid by Tenant hereunder, plus the expenses incurred
by Landlord in connection with such reletting, including without limitation, costs of cleaning, painting, repairing or refitting
the Premises, advertising, broker fees, municipal fees, and legal fees for preparation and negotiation of the replacement lease
(“Relet Charges”), shall not be realized by Landlord in connection with such reletting, Tenant shall remain liable
for all damages sustained by Landlord under this Section, including without limitation, any deficiency between the Mitigating
Rent and the Rent and Relet Charges.
(2) Should
that portion of the amounts received by Landlord as the Mitigating Rent during any month be less than the Rent payable during
that month by Tenant hereunder, then Tenant shall pay such deficiency to Landlord immediately upon Landlord’s demand therefor,
and such amount shall accrue interest at the Interest Rate from the date of demand until paid in full. Landlord shall have the
right to bring suit for collection of Rent on a monthly basis without prejudice to Landlord’s right to enforce collection
of Rent for any subsequent month or, at Landlord’s option, may be deferred until the expiration of the Term of this Lease,
in which event Tenant hereby agrees that the cause of action shall not be deemed to have accrued until the date of the scheduled
expiration of the Term of this Lease.
d. Dispossession.
The provisions of this Section 18 shall automatically operate as a notice to quit (any notice to quit being hereby expressly waived),
and Landlord may proceed to recover possession under and by virtue of the laws of the jurisdiction where the Premises are located
by legal process after twenty (20) days written notice.
| e. | CONFESSION
OF JUDGMENT FOR POSSESSION. |
(1) UPON
THE EXPIRATION OF THE TERM OF THIS LEASE OR SURRENDER HEREOF AS PROVIDED IN THIS LEASE, IT SHALL BE LAWFUL FOR ANY ATTORNEY TO
APPEAR AS ATTORNEY FOR TENANT AS WELL AS FOR ALL PERSONS CLAIMING BY, THROUGH OR UNDER TENANT AND TO SIGN AN AGREEMENT FOR ENTERING
IN ANY COMPETENT COURT AN AMICABLE ACTION
IN EJECTMENT AGAINST TENANT AND ALL PERSONS CLAIMING BY, THROUGH OR UNDER TENANT AND THEREIN CONFESS JUDGMENT FOR THE RECOVERY
BY LANDLORD OF POSSESSION OF THE PREMISES, FOR WHICH THIS LEASE SHALL BE ITS SUFFICIENT WARRANT, WHEREUPON, IF LANDLORD SO DESIRES,
A WRIT OF POSSESSION OR OTHER APPROPRIATE WRIT UNDER THE RULES OF CIVIL PROCEDURE THEN IN EFFECT MAY ISSUE FORTHWITH, WITHOUT
ANY PRIOR WRIT OR PROCEEDINGS; PROVIDED, HOWEVER, IF FOR ANY REASON AFTER SUCH ACTION SHALL HAVE BEEN COMMENCED, THE SAME SHALL
BE DETERMINED AND THE POSSESSION OF THE PREMISES REMAIN IN OR BE RESTORED TO TENANT, LANDLORD SHALL HAVE THE RIGHT AND UPON ANY
SUBSEQUENT DEFAULT OR DEFAULTS, OR UPON THE TERMINATION OF THIS LEASE UNDER ANY OF THE TERMS OF THIS LEASE TO BRING ONE OR MORE
FURTHER AMICABLE ACTION OR ACTIONS AS HEREINBEFORE SET FORTH TO RECOVER POSSESSION OF THE PREMISES AND CONFESS JUDGMENT FOR THE
RECOVERY OF POSSESSION OF THE PREMISES AS HEREINABOVE PROVIDED.
(2) IN
ANY AMICABLE ACTION OF EJECTMENT LANDLORD SHALL FIRST CAUSE TO BE FILED IN SUCH ACTION AN AFFIDAVIT MADE BY IT OR SOMEONE ACTING
FOR IT, SETTING FORTH THE FACTS NECESSARY TO AUTHORIZE THE ENTRY OF JUDGMENT AND IF A TRUE COPY OF THIS LEASE BE FILED IN SUCH
ACTION, IT SHALL NOT BE NECESSARY TO FILE THE ORIGINAL AS A WARRANT OF ATTORNEY, ANY RULE OF COURT, CUSTOM OR PRACTICE TO THE
CONTRARY NOTWITHSTANDING. IF PROCEEDINGS SHALL BE COMMENCED BY LANDLORD TO RECOVER POSSESSION UNDER THE ACTS OF ASSEMBLY AND RULES
OF CIVIL PROCEDURE, EITHER AT THE END OF THE TERM OR EARLIER TERMINATION OF THIS LEASE, OR FOR NONPAYMENT OF RENT OR ANY OTHER
REASON, TENANT WAIVES THE RIGHT TO ANY NOTICE TO REMOVE WHICH MAY BE REQUIRED BY THE LANDLORD AND TENANT ACT OF 1951, AS AMENDED
(OR ANY SIMILAR OR SUCCESSOR LAW), AND AGREES THAT TWENTY (20) DAYS NOTICE SHALL BE SUFFICIENT WHERE A LONGER PERIOD MAY BE STATUTORILY
SPECIFIED.
f. Waiver
of Redemption Rights. Tenant hereby expressly waives any and all rights of redemption granted by or under any present or future
law in the event this Lease is terminated or Tenant is evicted or dispossessed following an Event of Default.
g. Removal
of Contents by Landlord. Upon lawful termination of the Lease, Landlord shall have the right to re-enter the Premises and
remove all persons and goods from the Premises. All goods removed by Landlord may be stored in a public warehouse or elsewhere
at the cost of and for the amount of Tenant; provided no goods shall be removed until 20 days after notice of Landlord’s
intention to do so is given to Tenant and Tenant fails to remove such goods within said 20 days.
h. Sale
of Tenant’s Property. Landlord may sell, at public or private sale, all or any part of Tenant’s goods recovered
by Landlord in accordance with the foregoing Section with or without having such goods at sale. At any such sale, Landlord or
its assigns may purchase unless otherwise prohibited by law. The proceeds from any such disposition, less any and
all expenses (including legal fees) connected with the taking of possession, holding and selling of Tenant’s goods, first
shall be paid from the proceeds realized on such sale and the balance applied to amounts due to Landlord hereunder. Any surplus
shall be paid to Tenant or as otherwise required by law, and Tenant shall remain responsible for any deficiencies. In connection
herewith, Landlord shall have any and all of the remedies afforded to secured parties under the provisions of the Uniform Commercial
Code, as codified in state where the goods are located.
18.3 No
Waiver. No waiver by Landlord of any breach of any covenant, condition or agreement herein contained shall operate as a waiver
of such covenant, condition, or agreement, or of any subsequent breach thereof. No payment by Tenant or receipt by Landlord of
a lesser amount than the monthly installment of Rent herein stipulated shall be deemed to be other than on account of Rent, nor
shall any endorsement or statement on any check or letter accompanying a check for payment of Rent be deemed an accord and satisfaction,
and Landlord may accept such check or payment without prejudice to Landlord’s right to recover the balance of such Rent
or to pursue any other remedy provided in this Lease. Payment received by Landlord when Tenant is in arrears shall be applied
as Landlord determined. No re-entry by Landlord and no acceptance by Landlord of keys from Tenant shall be considered an acceptance
of a surrender of this Lease.
18.4 Right
of Landlord to Cure Tenant’s Default. Whenever Tenant defaults in the making of any payment required hereunder or in
the doing of any act herein required to be made or done by Tenant, then Landlord, with five (5) days prior notice to Tenant, may
make such payment or do such act on Tenant’s behalf but shall not be required to do so. All costs incurred by Landlord to
satisfy Tenant’s obligations, including without limitation payment of any penalty or fine which may be imposed as a result
of Tenant’s failure or violation, shall be paid by Tenant as Additional Rent within ten (10) business days of Landlord’s
demand for reimbursement (unless otherwise expressly provided herein), after which time interest shall be applied at the Interest
Rate. The making of such payment or the taking of such action by Landlord shall not operate to cure or waive such default by Tenant
nor prevent Landlord from exercising any other remedy available to Landlord.
18.5 Collection
Expenses. If Tenant is in Default under this Lease and if Landlord consults an attorney or collection agency for the collection
of any sums due from Tenant or otherwise in connection with Tenant’s performance hereunder, Tenant, whether or not proceedings
are instituted, shall reimburse Landlord for the reasonable fees for legal counsel and court costs, if any, incurred by Landlord
within ten (10) business days of Landlord’s demand for reimbursement (unless otherwise expressly provided herein, after
which time interest shall be applied at the Interest Rate. If Landlord is in Default under the Lease and if Tenant consults an
attorney in connection with Landlord’s performance hereunder, Landlord shall reimburse Tenant for reasonable fees for legal
counsel.
19. SURRENDER
AT LEASE TERMINATION. Upon the scheduled expiration or earlier termination of this Lease, Tenant shall promptly surrender
to Landlord the Premises, together with all building apparatus, machinery, replacements to mechanical and other systems serving
the Premises, Tenant’s Work, including any fixtures installed by Tenant other than Tenant’s trade fixtures, furniture,
shelving and like items except for items which Landlord, in
writing, may have permitted or required Tenant to remove at the termination of this Lease. Tenant shall return the Premises in
substantially the same condition as the Premises were delivered to Tenant at the commencement of this Lease, reasonable wear and
tear accepted and subject to Tenants Alterations and other permitted work.
20. HOLDING
OVER. If Tenant shall not immediately surrender the Premises on the scheduled expiration or earlier termination of this Lease,
then, in addition to all remedies available to Landlord for Tenant’s default, Tenant, as a result of such holding over,
shall become a tenant at will, at twice (2x) the monthly installment of Base Rent due for the last month of the Term of this Lease
together with all Additional Rent due hereunder up to and including the time Tenant vacates the Premises, and otherwise upon the
terms, conditions, covenants and agreements of this Lease, except for provisions which by their terms have expired. Tenant also
shall be liable to Landlord for all damages which Landlord suffers because of any holding over by Tenant (whether with or without
Landlord’s consent), and Tenant shall indemnify Landlord against all claims made by any other tenant or prospective tenant
against Landlord resulting from delay in delivering possession of the Premises to such other tenant or prospective tenant arising
from the holding over of the Premises by the Tenant.
| 21. | SUBORDINATION,
NONDISTURBANCE AND ATTORNMENT. |
21.1 Estoppel
Certificate. Within ten (10) business days after Landlord’s request, Tenant shall provide an estoppel certificate in
recordable form certifying (if such be the case) that this Lease is in full force and effect and that there are no defenses or
offsets thereto, or stating those claimed by Tenant, along with such other information as Landlord reasonably may request. Tenant’s
failure to deliver such statement within the time required shall be conclusive evidence of Tenant’s certification that this
Lease is in full force and effect, that there are no defenses or offsets thereto, and of such other information as Landlord has
reasonably requested.
| 21.2 | Attornment.
Tenant shall attorn to any mortgagee or purchaser of the Premises. |
21.3 Subordination.
Tenant’s rights hereunder are subordinate to the lien of any mortgage or mortgages, or to the lien resulting from any other
method of financing or refinancing, or to any ground lease, now or hereafter in force against the land of which the Premises are
a part, to all advances made upon the security thereof, and to all renewals, extensions or modifications thereof provided any
such made hereafter contain terms of non-disturbance of this Lease. Regardless of the self-operating provision of this Section,
if a prospective mortgagee or ground lessor requests Tenant to sign a subordination agreement, Tenant shall do so promptly so
long as such subordination language contains nondisturbance language.
21.4 Rights
of Mortgagee. If any act or omission of Landlord hereunder which would give Tenant the right to cancel or terminate this Lease,
or to claim a total or partial eviction, Tenant shall not exercise such right (a) until it has given written notice of such act
or omission to the holder if each mortgage and ground lease whose name and address shall have been furnished previously to Tenant
in writing, and (b) until a reasonable period for remedying such act or omission shall have elapsed following the giving of such
notice.
22. SUBDIVISION
AND EASEMENTS. Tenant’s use of the Premises shall be subject to all covenants, conditions, easements and restrictions
now or hereafter affecting or encumbering the land on which same are located. Landlord reserves the right to (a) subdivide the
land on which the Premises are located, (b) alter the boundaries of the land on which the Premises are located, and (c) grant
easements on the land on which the Premises are located and dedicate for public use portions thereof; provided, however, that
none of the foregoing shall materially interfere with Tenant’s use of the Premises. Tenant hereby consents, and subordinates
this Lease, to such subdivision, boundary revision, and/or grant or dedication of easements and agrees from time to time, at Landlord’s
request, to execute, acknowledge and deliver to Landlord, in accordance with Landlord’s instructions, all reasonable documents
or instruments necessary to effectuate Tenant’s consent thereto.
23. LIMITED
ATTORNEY-IN-FACT. If Tenant shall fail to execute any such instruments or certificates to carry out the intent of Subsections
21.1, 21.2, 21.3, 21.4, or 22 within ten (10) business days of Landlord’s written request for Tenant to execute such instruments
or certificates, then Tenant hereby irrevocably appoints Landlord as attorney-in-fact for Tenant with full power and authority
to execute and, deliver in the name of Tenant any such instruments or certificates.
24. LANDLORD’S
COVENANT OF QUIET ENJOYMENT. Landlord covenants that Tenant, and all those claiming through Tenant and permitted hereunder,
shall have quiet and peaceable enjoyment of the Premises, and all those claiming through Tenant and permitted hereunder, are not
in default of this Lease.
25. LANDLORD RIGHT OF ENTRY AND TENANT’S RENEWAL. Tenant shall give Landlord six (6) months
written notice prior to expiration of the Term or of any extension of any options to extend this Lease. Landlord shall have the
right, during the last six (6) months of the Term, to place on any portion of the Premises signs or billboards indicating that
the Premises are “For Sale” or “For Rent,” but such signs shall be of such size and so placed as not to
materially interfere with Tenant’s occupancy. At all times during this Lease, Landlord, and Landlord’s agents, upon
reasonable notice to Tenant, shall be admitted to the Premises at reasonable hours of the day to view the Premises, including
without limitation, the right to show the Premises to prospective purchasers, mortgagees, tenants or contractors.
26. RULES
AND REGULATIONS. At all times during the Term, Tenant shall comply with, and cause its employees, contractors, invitees and
licensees to comply with, all rules and regulations established by Landlord, together with such amendments and supplements thereto
as Landlord may from time to time reasonably adopt.
27. TENANT
ANNUAL REPORTS. Landlord will be required to report to certain government agencies and funding sources the total employment
at the Property, Homewood residents employed and gross sales. On an annually basis, Tenant agrees to provide Landlord upon 10
days written notice a count of total employees working at the Premises (designating full time and part time employment), total
number of Homewood residents employed and gross sales.
28. CORPORATE/PARTNERSHIP
AUTHORITY. Tenant represents that the person who executed this Lease on Tenant’s behalf has been duly authorized to
enter into this Lease and that the execution and consummation of this Lease by Tenant does not and shall not violate any provision
of any by-laws, certificate of incorporation, partnership agreement, or other agreement, order, judgment, governmental regulation
or any other obligations to which Tenant is a party or is subject.
29. BROKER.
Landlord shall pay all real estate broker and agents commissions in connection with this transaction.
30. CHANGE
IN OWNERSHIP. If the Premises is sold, or in the event of any change of legal title or equitable ownership thereof, all obligations
and rights of Landlord hereunder shall be transferred to such purchaser or assignee, and Landlord’s obligations shall terminate
and Landlord shall be released and relieved from all liability and responsibility to Tenant. Tenant shall look solely to such
purchaser or assignee for the performance of said obligations or for the enforcement thereof. Each purchaser of assignee shall
in turn have like privileges of sale, assignment and release.
31. SUCCESSORS
AND ASSIGNS. This Lease shall inure to the benefit of and shall bind the parties hereto and their respective heirs, successors
and permitted assigns to the extent that such rights hereunder may succeed and be assigned according to the terms hereof.
32. NOTICE.
All notices, demands and communications required or permitted by this Lease shall be effective only if in writing (unless otherwise
provided herein) and shall be sent by United States certified mail, return receipt requested or overnight mail deposited with
a nationally recognized carrier with a receipt therefore, postage prepaid in each case and using the address for such recipient
designated in accordance herewith. Notices shall be addressed to the other party at the addresses set forth in the Basic Lease
Information, or at such other address as either party may have furnished to the other in accordance with this Section. Any notice
so provided shall be deemed to have been delivered upon the earlier of (a) actual receipt, or (b) two (2) business days after
mailing by certified mail, return receipt requested, or (c) one (1) business day after depositing with a nationally recognized
carrier.
33. SEVERABILITY.
If any term, covenant, condition of provision of this Lease, or the application thereof to any person or circumstance, shall to
any extent be held by a court of competent jurisdiction to be invalid, void or unenforceable, the remainder of the terms, covenants,
conditions or provisions of this Lease, or the application thereof to any person or circumstance, shall remain in full force and
effect and shall in no way be affected, impaired or invalidated.
34. ENTIRE
AGREEMENT; GOVERNING LAW AND CONSENT TO JURISDICTION. This Lease is the entire agreement of Landlord and Tenant and shall
be governed, construed and enforced in accordance with substantive laws, and not the laws of conflict, of the Commonwealth of
Pennsylvania. Tenant and Landlord consent to the exclusive jurisdiction and venue of the federal and state courts located in Allegheny
County, Pennsylvania in any action on, relating to or mentioning of this Lease. This Lease shall not be amended or supplemented
unless by written agreement signed by Landlord and Tenant.
35. CONSOLIDATION
AND COUNTERPARTS. This Part II along with the accompanying Part I constitute one agreement and may be signed in any number
of counterparts, each of which shall be an original and all of which together constitute one agreement binding on the parties
hereto.
36. WAIVER
OF TRIAL BY JURY. LANDLORD AND TENANT EACH WAIVE TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM BROUGHT BY EITHER
OF THE PARTIES AGAINST THE OTHER ON ANY MATTER WHATSOEVER ARISING OUT OF OR IN ANY WAY CONNECTED WITH THIS LEASE, THE RELATIONSHIP
OF LANDLORD AND TENANT, TENANT’S USE AND OCCUPANCY OF THE PREMISES, AND/OR ANY CLAIM OF INJURY OR DAMAGE.
[Remainder
of Page Intentionally Left Blank]
IN
WITNESS WHEREOF, and intending to be legally bound, Landlord and Tenant have caused this Lease to be signed by their duly authorized
officers or agents under seal, the day and year first above written.
|
|
LANDLORD |
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Bridgeway Development Corporation |
|
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|
Jan
3, 2024 |
|
By: |
/s/ Thomas
J. Bogdewic |
Date |
|
Name: |
Thomas J. Bogdewic |
|
|
Title: |
President |
|
|
TENANT |
|
|
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Lipella Pharmaceuticals Inc. |
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Jan
3, 2024 |
|
By: |
/s/ Jonathan
Kaufman |
Date |
|
Name: |
Jonathan Kaufman |
Exhibit
31.1
CERTIFICATION
OF
PRINCIPAL EXECUTIVE OFFICER
PURSUANT
TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 302 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
Jonathan Kaufman, as the principal executive officer of the registrant, certify that:
1. I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2024, of Lipella Pharmaceuticals Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect
to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined
in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on
such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that
has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial
reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors
(or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: May 9, 2024 |
By: |
/s/
Jonathan Kaufman |
|
|
Jonathan Kaufman |
|
|
Chief Executive Officer |
|
|
(Duly Authorized Officer and Principal Executive
Officer) |
Exhibit
31.2
CERTIFICATION
OF
PRINCIPAL FINANCIAL OFFICER
PURSUANT
TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 302 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
Douglas Johnston, as the principal financial officer of the registrant, certify that:
1. I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2024, of Lipella Pharmaceuticals Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect
to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined
in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on
such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that
has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial
reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors
(or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: May 9, 2024 |
By: |
/s/
Douglas Johnston |
|
|
Douglas Johnston |
|
|
Chief Financial Officer |
|
|
(Duly Authorized Officer and Principal Financial
and Accounting Officer) |
Exhibit
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
In
connection with the Quarterly Report of Lipella Pharmaceuticals Inc. (the “Company”) on Form 10-Q for the quarter
ended March 31, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jonathan
Kaufman, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002, that:
|
(1) |
The Report fully
complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The information
contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company. |
|
|
|
Date: May 9, 2024 |
By: |
/s/
Jonathan Kaufman |
|
|
Jonathan Kaufman |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
Exhibit
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
In
connection with the Quarterly Report of Lipella Pharmaceuticals Inc. (the “Company”) on Form 10-Q for the quarter
ended March 31, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Douglas
Johnston, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002, that:
|
(1) |
The Report fully
complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The information
contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company. |
|
|
|
Date: May 9, 2024 |
By: |
/s/
Douglas Johnston |
|
|
Douglas Johnston |
|
|
Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
v3.24.1.u1
Cover - shares
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3 Months Ended |
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Mar. 31, 2024 |
May 08, 2024 |
Cover [Abstract] |
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Document Type |
10-Q
|
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Amendment Flag |
false
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Document Quarterly Report |
true
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Document Transition Report |
false
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Document Period End Date |
Mar. 31, 2024
|
|
Document Fiscal Period Focus |
Q1
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-41575
|
|
Entity Registrant Name |
Lipella
Pharmaceuticals Inc.
|
|
Entity Central Index Key |
0001347242
|
|
Entity Tax Identification Number |
20-2388040
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
7800
Susquehanna St.
|
|
Entity Address, Address Line Two |
Suite 505
|
|
Entity Address, City or Town |
Pittsburgh
|
|
Entity Address, State or Province |
PA
|
|
Entity Address, Postal Zip Code |
15208
|
|
City Area Code |
(412)
|
|
Local Phone Number |
901-0315
|
|
Title of 12(b) Security |
Common Stock, par
value $0.0001 per share
|
|
Trading Symbol |
LIPO
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
Elected Not To Use the Extended Transition Period |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
7,605,636
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v3.24.1.u1
CONDENSED BALANCE SHEETS (Unaudited) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Current Assets |
|
|
Cash and cash equivalents |
$ 2,105,299
|
$ 3,293,738
|
Grants receivable |
68,934
|
32,286
|
Prepaid expenses |
836,857
|
103,256
|
Total Current Assets |
3,011,090
|
3,429,280
|
Property and Equipment |
|
|
Furniture, fixtures and equipment |
140,294
|
140,294
|
Furniture, fixtures and equipment (Accumulated Depreciation) |
(128,265)
|
(127,544)
|
Furniture and fixtures, net |
12,029
|
12,750
|
Other Assets |
|
|
Operating lease right of use asset |
114,038
|
135,144
|
Total Assets |
3,137,157
|
3,577,174
|
Current liabilities |
|
|
Accounts payable |
293,835
|
138,016
|
Accrued expenses |
84,929
|
77,280
|
Operating lease liability |
91,705
|
89,223
|
Payroll liability |
81,412
|
80,836
|
Total Current Liabilities |
551,881
|
385,355
|
Operating lease liability, net of current portion |
23,997
|
47,371
|
Total Liabilities |
575,878
|
432,726
|
Stockholders’ equity: |
|
|
Convertible preferred stock, $0.0001 par value; 20,000,000 shares authorized; -0- shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively |
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized, 7,039,846 and 6,053,956 shares issued and outstanding at March 31, 2024 and at December 31, 2023, respectively |
704
|
605
|
Additional paid-in capital |
14,076,227
|
13,467,686
|
Accumulated deficit |
(11,515,652)
|
(10,323,843)
|
Total stockholders’ equity |
2,561,279
|
3,144,448
|
Total liabilities and stockholders’ equity |
$ 3,137,157
|
$ 3,577,174
|
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v3.24.1.u1
CONDENSED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares, outstanding |
7,039,846
|
6,053,956
|
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7,039,846
|
6,053,956
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.1.u1
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Total revenues |
$ 145,880
|
$ 118,048
|
Cost and expenses |
|
|
Research and development |
842,600
|
693,730
|
General and administrative |
520,926
|
508,750
|
Total costs and expenses |
1,363,526
|
1,202,480
|
Loss from operations |
(1,217,646)
|
(1,084,432)
|
Other income (expense) |
|
|
Interest income, net |
25,837
|
22,001
|
Interest expense related party |
|
(5,394)
|
Total other income (expense) |
25,837
|
16,607
|
Loss before income taxes |
(1,191,809)
|
(1,067,825)
|
Provision for income taxes |
|
|
Net Loss |
$ (1,191,809)
|
$ (1,067,825)
|
Loss per common share |
|
|
Basic |
$ (0.16)
|
$ (0.19)
|
Dilutive |
$ (0.16)
|
$ (0.19)
|
Weighted-average of common shares outstanding: |
|
|
Basic |
7,292,396
|
5,743,945
|
Dilutive |
7,292,396
|
5,743,945
|
Grantrevenues [Member] |
|
|
Total revenues |
$ 145,880
|
$ 118,048
|
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v3.24.1.u1
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2022 |
$ 574
|
$ 10,379,900
|
$ (5,704,878)
|
$ 4,675,596
|
Balance at beginning (in shares) at Dec. 31, 2022 |
5,743,945
|
|
|
|
Net loss |
|
|
(1,067,825)
|
(1,067,825)
|
Share based compensation |
|
208,639
|
|
208,639
|
Ending balance, value at Mar. 31, 2023 |
$ 574
|
10,588,539
|
(6,772,703)
|
3,816,410
|
Balance at ending (in shares) at Mar. 31, 2023 |
5,743,945
|
|
|
|
Beginning balance, value at Dec. 31, 2023 |
$ 605
|
13,467,686
|
(10,323,843)
|
3,144,448
|
Balance at beginning (in shares) at Dec. 31, 2023 |
6,053,956
|
|
|
|
Net loss |
|
|
(1,191,809)
|
(1,191,809)
|
Share based compensation |
|
208,640
|
|
208,640
|
Warrants converted to Common Stock |
$ 50
|
(50)
|
|
|
Warrants converted to Common Stock (in shares) |
500,000
|
|
|
|
Issuance of Common Stock |
$ 29
|
199,971
|
|
200,000
|
Issuance of Common Stock (in shares) |
289,812
|
|
|
|
Shares issued for services |
$ 20
|
199,980
|
|
200,000
|
Shares issued for services (in shares) |
196,078
|
|
|
|
Ending balance, value at Mar. 31, 2024 |
$ 704
|
$ 14,076,227
|
$ (11,515,652)
|
$ 2,561,279
|
Balance at ending (in shares) at Mar. 31, 2024 |
7,039,846
|
|
|
|
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v3.24.1.u1
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Cash flow from operating activities: |
|
|
Net loss |
$ (1,191,809)
|
$ (1,067,825)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
|
|
Depreciation and amortization |
72
|
|
Shares issued for services |
200,000
|
|
Non-cash stock option expense |
208,640
|
208,639
|
Interest expense related party net (non-cash) |
|
5,394
|
Changes in operating assets and liabilities: |
|
|
Operating right of use asset |
214
|
(34)
|
Grants receivable |
(36,648)
|
29,688
|
Prepaid expense |
(733,601)
|
188,605
|
Accounts payable |
155,819
|
(235,437)
|
Accrued expenses |
7,649
|
(208,017)
|
Payroll liability |
576
|
997
|
Net cash used in operating activities |
(1,388,439)
|
(1,077,990)
|
Cash flow from investing activities: |
|
|
Cash flow from financing activities: |
|
|
Proceeds from issuance of common stock, net of issuance costs |
200,000
|
|
Repayment of notes payable |
|
(25,000)
|
Net cash (used in) provided by financing activities |
200,000
|
(25,000)
|
Net decrease in cash, cash equivalents |
(1,188,439)
|
(1,102,990)
|
Cash, and cash equivalents at beginning of period |
3,293,738
|
5,121,743
|
Cash, and cash equivalents at end of period |
2,105,299
|
4,018,753
|
Supplemental disclosure of cash flow information: |
|
|
Interest paid |
6,234
|
|
Income taxes paid |
|
|
Issuance of common stock for forgiveness of related party note |
|
|
Issuance of common stock options for consulting services |
|
|
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v3.24.1.u1
Description of Business and Basis of Presentation
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Description of Business and Basis of Presentation |
Note
1. Description of Business and Basis of Presentation
Nature
of Business
Lipella
Pharmaceuticals Inc. (the “Company”, “we”, “us” or “our”) is a clinical-stage
biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing
these reformulations for new applications. Our operations consist of research, preclinical development and clinical development
activities, and our most advanced program is in Phase 2 clinical development. Since our inception in 2005, we have historically
financed our operations through a combination of federal grant revenue, licensing revenue, manufacturing revenue, as well as equity
and debt financing. On December 19, 2022, a reverse stock split (hereafter, the “Stock Split”) was effected, with
a 2.5 to 1 share conversion ratio for all shares of common stock, par value $0.0001 per share (“Common Stock”), outstanding.
The Company’s outstanding share and per share amounts in these financial statements have been adjusted to give effect to
the Stock Split, for all periods presented. For more information, see Note 11, “Common Stock.”
Basis
of Presentation
The
Company’s unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP
as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of
the Financial Accounting Standards Board (“FASB”).
In
the opinion of management, the accompanying unaudited condensed financial statements include all adjustments, consisting of normal
recurring adjustments, which are necessary to present fairly the Company’s financial position, results of operations, and
cash flows. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal
year. Certain information and footnote disclosure normally included in the financial statements prepared in accordance with GAAP
have been condensed or omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and
Exchange Commission (“SEC”). The unaudited condensed interim financial statements should be read in conjunction with
the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31,
2023 that was filed with the SEC on February 27, 2024 (our “Annual Report”).
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v3.24.1.u1
Going Concern
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Going Concern |
Note
2. Going Concern
The
accompanying condensed financial statements have been prepared in conformity with GAAP, which contemplate continuation of the
Company as a going concern. The Company has not established a source of revenues sufficient to cover its operating costs and will
require significant additional capital to continue its research and development programs, including progressing clinical product
candidates to commercialization and preparing for commercial-scale manufacturing and sales.
The
Company’s net loss for the three months ended March 31, 2024 and fiscal year ended December 31, 2023 was $1,191,809 and
$4,618,965, respectively. Since inception, the Company has incurred historical losses and has an accumulated deficit of $11,515,652
at March 31, 2024 and $10,323,843 at December 31, 2023, respectively. At March 31, 2024, the Company had available cash and cash
equivalents of $2,105,299 and net working capital of $2,459,209. The Company anticipates operating losses to continue for the
foreseeable future due to, among other things, costs related to: research, development of product candidates, conducting preclinical
studies and clinical trials, and administrative organization. These funds, and our funds available under existing government contracts,
may not be sufficient to enable us to meet our obligations as they come due at least for the next twelve months from the issuance
date of these financial statements.
If
we are unable to obtain additional capital (which is not assured at this time), our long-term business plan may not be accomplished,
and we may be forced to curtail or cease operations. These factors individually and collectively raise substantial doubt about
our ability to continue as a going concern. The accompanying unaudited condensed financial statements do not include any adjustments
that may result from this uncertainty.
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- DefinitionThe entire disclosure when substantial doubt is raised about the ability to continue as a going concern. Includes, but is not limited to, principal conditions or events that raised substantial doubt about the ability to continue as a going concern, management's evaluation of the significance of those conditions or events in relation to the ability to meet its obligations, and management's plans that alleviated or are intended to mitigate the conditions or events that raise substantial doubt about the ability to continue as a going concern.
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v3.24.1.u1
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note
3. Summary of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,”
in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024. There have been no material changes
to the significant accounting policies during the three-month period ended March 31, 2024, except for items mentioned below.
Use
of Estimates
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 these financial
statements. Actual results could differ from those estimates.
Adoption
of New Accounting Pronouncements
During
the three months ended March 31, 2024, no new accounting pronouncement was issued or became effective, that had or is expected
to have, a material impact on our Financial Statements.
Concentration
of Credit Risk
The
Company’s grant revenues and grant receivables are from the National Institute of Health (the “NIH”). The NIH
is an agency of the United States Department of Health & Human Services, and the Company believes amounts are fully collectible
from this agency. Contract revenues were $145,880 for the three months ended March 31, 2024, and $118,048 for the three months
ended March 31, 2024.
Earnings
Per Share
Basic
net loss per share of Common Stock is computed by dividing the net loss for the period by the weighted-average number of shares
of Common Stock outstanding during the period. Diluted net loss per common share is computed giving effect to all dilutive Common
Stock equivalents, consisting of stock options and warrants. Diluted net loss per share of Common Stock for the three months ended
March 31, 2024 and 2023 is the same as basic net loss per share, as the Common Stock equivalents were anti-dilutive due to the
net loss.
At
March 31, 2024 and 2023 the Common Stock equivalent shares were, as follows:
| |
| | |
| |
| |
March 31, | |
| |
2024 | | |
2023 | |
Shares of Common Stock issuable under equity incentive plans outstanding | |
| 2,893,000 | | |
| 2,054,000 | |
Shares of Common Stock issuable upon exercise of warrants | |
| 2,124,257 | | |
| 143,994 | |
Shares of Common Stock issuable upon conversion of Series A Preferred Stock | |
| — | | |
| — | |
Common Stock equivalent shares excluded from diluted net loss per share | |
| 5,017,257 | | |
| 2,197,994 | |
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v3.24.1.u1
Fair Value Measurements and Marketable Debt Securities
|
3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements and Marketable Debt Securities |
Note
4. Fair Value Measurements and Marketable Debt Securities
In
accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”), the Company measures
its assets and liabilities at fair value. We apply the three-level valuation hierarchy as described in ASC 820, which is based
upon the transparency of input as of the measurement date. The three levels of inputs as defined are:
Level
1 - Inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level
2 - Inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs
that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial
instruments.
Level
3 - Inputs to the valuation methodology are unobservable and significant to the fair value measurement.
At
March 31, 2024 and December 31, 2023, the Company’s financial instruments consist primarily of: cash and cash equivalents,
accounts payable and accrued liabilities. For cash equivalents, accounts payable and accrued liabilities, the carrying amounts
of these financial instruments as of March 31, 2024 and December 31, 2023 were considered representative of their fair values
due to their short term to maturity.
The
Company held no marketable securities at March 31, 2024 and December 31, 2023. For cash equivalents at March 31, 2024 and December
31, 2023, the fair value input levels are summarized below:
March 31, 2024 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Cash Equivalents (maturity less than 90 days) | |
| | | |
| | | |
| | | |
| | |
Commercial Paper | |
$ | — | | |
| — | | |
| — | | |
$ | — | |
U.S. Government | |
| — | | |
| — | | |
| — | | |
| — | |
Money market funds | |
| 1,975,063 | | |
| — | | |
| — | | |
| 1,975,063 | |
Total Cash equivalents | |
| 1,975,063 | | |
| | | |
| | | |
| 1,975,063 | |
| |
| | | |
| | | |
| | | |
| | |
Marketable Securities | |
| — | | |
| — | | |
| — | | |
| — | |
Total Cash Equivalents and Marketable Securities | |
$ | 1,975,063 | | |
$ | — | | |
$ | — | | |
$ | 1,975,063 | |
December 31, 2023 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Cash Equivalents (maturity less than 90 days) | |
| | | |
| | | |
| | | |
| | |
Commercial Paper | |
$ | — | | |
| — | | |
| — | | |
$ | — | |
U.S. Government | |
| — | | |
| — | | |
| — | | |
| — | |
Money market funds | |
| 3,052,648 | | |
| — | | |
| — | | |
| 3,052,648 | |
Total Cash equivalents | |
| 3,052,648 | | |
| | | |
| | | |
| 3,052,648 | |
| |
| | | |
| | | |
| | | |
| | |
Marketable Securities | |
| — | | |
| — | | |
| — | | |
| — | |
Total Cash Equivalents and Marketable Securities | |
$ | 3,052,648 | | |
$ | — | | |
$ | — | | |
$ | 3,052,648 | |
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v3.24.1.u1
Prepaid Expenses
|
3 Months Ended |
Mar. 31, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Prepaid Expenses |
Note
5. Prepaid Expenses
At
March 31, 2024, prepaid expenses consisted primarily of prepaid insurance of $85,891, prepaid costs of issuance of $112,548, an advance deposit with our clinical trial management partner of $372,208, and
$266,210 in other prepaid expenses related primarily to professional services. At December 31, 2023, prepaid expenses consisted
of $88,554 of prepaid insurance, and $14,702 of prepaid expenses.
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v3.24.1.u1
Accrued Expenses
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Accrued Expenses |
Note
6. Accrued Expenses
At
March 31, 2024, accrued expenses were $84,929, consisting of $19,575 of accrued clinical expenses and $65,354 of unbilled
legal expenses. At December 31, 2023, accrued expenses totaled $77,280 and consisted of $19,575 in clinical expenses, $52,050
in franchise tax expense, and $5,655 in unbilled professional services expenses.
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.1.u1
Letter of Credit
|
3 Months Ended |
Mar. 31, 2024 |
Letter Of Credit |
|
Letter of Credit |
Note
8. Letter of Credit
The
Company has a letter of credit with a bank for an aggregate available amount of $50,000 due upon demand. The letter of credit
is collateralized by substantially all of the Company’s assets and personally guaranteed by Dr. Jonathan Kaufman, the Company’s
Chief Executive Officer. The outstanding advances under the line of credit bear interest at the lending bank’s prime rate
plus 3.10%. The outstanding balance was $0 at March 31, 2024 and December 31, 2023, respectively.
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v3.24.1.u1
Stock Options
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Options |
Note
9. Stock Options
The
Company has two stock incentive plans (each, a “Stock Option Plan” and collectively, the “Stock Option
Plans”), each of which provides for the grant of both incentive stock options and non-qualified stock options. Under
the terms of the Stock Option Plans, the maximum number of shares of Common Stock for which incentive and/or non-qualified
stock options may be issued is 3,078,000 shares. This number comprises 1,078,000 stock options already issued and outstanding
(non-expired) from the 2008 stock option plan, and 2,400,000 shares of Common Stock underlying option awards that may be
issuable under the 2020 stock option plan. Incentive stock options are granted with an exercise price determined by the
Company’s board of directors (the “Board”). The terms of the vesting of such options, including
termination, are as set forth in the Stock Option Plans and their respective award agreements. Such stock options generally
expire 10 years from the date of the grant. Subject to certain exceptions for grants made to employees who are large
stockholders, stock options granted under the Stock Option Plans have an exercise price not less than the fair market value
of the underlying Common Stock on the date of such grant. If an employee leaves the Company prior to fully vesting their
option awards and the remaining unvested portion is considered forfeited, the earlier recognition of the unvested shares is
reversed during the period of forfeiture. As of March 31, 2024, there were $540,759 in unrecognized compensation costs
related to non-vested share-based compensation arrangements granted to be recognized over the remaining vesting period of
less than one year.
The
Company recognized $208,640 of compensation costs for the three months ended March 31, 2024 and $208,639 for the three months
ended March 31, 2023 related to the vesting of stock options.
The
following is an analysis of options to purchase shares of Common Stock issued and outstanding as of March 31, 2024 and December
31, 2023:
|
|
Shares |
|
|
Weighted
Average
Exercise
Price Per
Share ($) |
|
|
Weighted
Average
Remaining
Contractual
Term
(in Years) |
|
|
Aggregate
intrinsic
value ($) |
|
Outstanding as of December
31, 2022 |
|
|
2,054,000 |
|
|
|
2.84 |
|
|
|
5.51 |
|
|
|
605,687 |
|
Granted |
|
|
424,000 |
|
|
|
2.19 |
|
|
|
9.96 |
|
|
|
|
|
Expired |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(25,000 |
) |
|
|
2.19 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of December 31, 2023 |
|
|
2,453,000 |
|
|
|
2.73 |
|
|
|
5.19 |
|
|
$ |
— |
|
Granted |
|
|
440,000 |
|
|
|
0.77 |
|
|
|
9.96 |
|
|
|
|
|
Expired |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2024 |
|
|
2,893,000 |
|
|
|
2.73 |
|
|
|
4.94 |
|
|
$ |
— |
|
Vested as of March 31, 2024 |
|
|
2,346,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of March 31, 2024 |
|
|
2,346,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of December 31, 2023 |
|
|
2,272,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
A
summary of status of the Company’s non-vested stock options (exercisable for shares of Common Stock on a one-to-one basis)
as of, and changes during, the three months ended March 31, 2024 and 2023 is presented below:
|
|
Number
of
Stock Options |
|
|
Weighted-
Average Fair
Value Grant
Date |
|
Nonvested at December 31,
2022 |
|
|
434,667 |
|
|
$ |
2.82 |
|
Granted |
|
|
— |
|
|
|
2.84 |
|
Vested |
|
|
(74,000 |
) |
|
|
2.83 |
|
Expired |
|
|
— |
|
|
|
0.00 |
|
Nonvested at March 31, 2023 |
|
|
360,667 |
|
|
$ |
2.82 |
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2023 |
|
|
180,667 |
|
|
$ |
2.81 |
|
Granted |
|
|
440,000 |
|
|
|
0.55 |
|
Vested |
|
|
(74,000 |
) |
|
|
1.13 |
|
Expired |
|
|
— |
|
|
|
— |
|
Nonvested at March 31, 2024 |
|
|
546,667 |
|
|
$ |
0.66 |
|
There
were no options granted in the three months ended March 31, 2023. In the three months ended March 31, 2024, the Company granted
options as described below.
Stock
Option Grants - On March 15, 2024, the Company granted 440,000 stock options at a $0.77 strike price, vesting as follows:
one third of such grant vests on April 1, 2024, one third of such grant vests on July 1, 2024, and one third of such grant vests
on October 1, 2024.
The
weighted-average fair value of stock options on the date of grant and the assumptions used to estimate the fair value of stock
options granted during the three months ended March 31, 2024 using the Black-Scholes option-pricing model are as follows:
Three months ended March 31, 2024 | |
2024 | | |
2023 | |
Weighted-average fair value of options granted | |
$ | 0.55 | | |
| — | |
Expected volatility | |
| 86.17 | % | |
| — | % |
Expected life (in years) | |
| 5.17 | | |
| — | |
Risk-free interest rate (range) | |
| 4.33 | % | |
| — | % |
Expected dividend yield | |
$ | — | | |
| — | |
|
X |
- DefinitionTabular disclosure of number, weighted-average exercise price or conversion ratio, aggregate intrinsic value, and weighted-average remaining contractual term for outstanding and exercisable options that are fully vested and expected to vest. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur.
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v3.24.1.u1
Preferred Stock
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Preferred Stock |
Note
10. Preferred Stock
The
Company’s Series A Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”),
ranks prior, with respect to dividend rights and rights upon a liquidation event, to all Common Stock and any other series of
preferred stock which is junior to Series A Preferred Stock. Upon any matter submitted to the shareholders of the Company for
a vote, each holder of Series A Preferred Stock is entitled to the number of votes as is equal to the number of shares of Common
Stock into which such shares of Series A Preferred Stock are convertible at the time of such vote. The Series A Preferred Stock
is not entitled to any mandatory dividends.
The
Company issued 1,592,447 shares of Series A Preferred Stock at $0.60 per share over a period beginning September 2008 through
June 2013, for gross proceeds of $833,188. The implied price of the Series A Preferred Stock issuance, $0.5232 per share, is $0.0768
per share less than the $0.60 offering price. This difference is associated with the conversion terms of three debt instruments
issued from June 2006 through April 2008 that had a total face value of $351,500, and converted into a total of 789,634 of the
1,592,447 shares, which imputes the additional $122,280 to interest and/or conversion discounts. In addition, $351,500 in face
value of the debt instruments had associated warrants. All consideration upon the issuance of convertible debt plus warrants was
imputed to the debt component leaving the associated warrants having no value. All note-associated warrants have expired.
In
the year ended December 31, 2022, all 1,592,447 outstanding shares of Series A Preferred Stock were converted to Common Stock
on a 1:1 basis. After giving effect to the Stock Split, this conversion resulted in 636,979 shares of Common Stock. There were
no shares of Series A Preferred Stock outstanding at December 31, 2023 or March 31, 2024.
|
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v3.24.1.u1
Common Stock
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Common Stock |
Note
11. Common Stock
The
Company’s second amended and restated certificate of incorporation, as amended, authorizes the issuance of 200,000,000 shares
of Common Stock. On December 19, 2022, the Company effected the Stock Split, at a 2.5 for 1 ratio for all shares of Common Stock
outstanding. The Company’s outstanding share and per share amounts in these unaudited condensed financial statements have
been adjusted to give effect to the Stock Split, for all periods presented. There were 7,039,846 shares of Common Stock outstanding
as of March 31, 2024 and 6,053,956 shares outstanding as of December 31, 2023.
During
the year ended December 31, 2022, the Company issued 22,950 shares of Common Stock in forgiveness of two related party notes.
The aggregate principal and interest of the notes was $138,810. On December 22, 2022, we completed an initial public offering
(“IPO”) and listing on the Nasdaq Capital Market (“Nasdaq”) of our Common Stock at a price to the public
of $5.75 per share, which resulted in the issuance of an additional 1,217,391 shares of Common Stock. The aggregate net proceeds
from the IPO were approximately $5,000,000, after deducting underwriting discounts and commissions of $630,000 and offering expenses
of approximately $1,160,000.
On
September 15, 2023, the Company issued 60,000 shares of Common Stock in exchange for services rendered by a third party.
On
November 28, 2023, we issued 250,000 shares of Common Stock for the exercise of the same number of pre-funded warrants. See Note
12 for details of the pre-funded warrants. During the year end December 31, 2023, the Company also issued 60,000 shares of Common
Stock in exchange for services rendered by a third party.
On
February 2, 2024, we issued 196,078 shares of Common Stock in exchange for services rendered by a third party. On March 4, 2024,
500,000 shares of Common Stock were issued for the exercise of the same number of pre-funded warrants. On March 13, 2024, the Company entered into Affiliate Stock Purchase Agreements with each of Jonathan H. Kaufman, the Company's Chief Executive Officer and Chairman of its board of directors, and Michael B. Chancellor, the Company's Chief Medical Officer and a member of its board of directors, pursuant to which each of Drs. Kaufman and Chancellor purchased $100,000 of shares of common stock of the Company, in cash from the Company at $0.6901 per share, based on the official closing price of The Nasdaq Stock Market LLC for the Common Stock on March 13, 2024, resulting in the issuance of 144,906 shares of Common Stock to each of Drs. Kaufman and Chancellor.
The
Common Stock is subject to and qualified by the rights of the Series A Preferred Stock. Upon the dissolution or liquidation of
the Company, the holders of Common Stock will be entitled to receive all assets of the Company available for distribution to its
stockholders, subject to any preferential rights of any then outstanding Series A Preferred Stock.
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- DefinitionThe entire disclosure for shareholders' equity and share-based payment arrangement. Includes, but is not limited to, disclosure of policy and terms of share-based payment arrangement, deferred compensation arrangement, and employee stock purchase plan (ESPP).
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v3.24.1.u1
Warrants
|
3 Months Ended |
Mar. 31, 2024 |
Warrants |
|
Warrants |
Note
12. Warrants
No
warrants were issued in the three months ended March 31, 2024. On October 23, 2023, the Company entered into a securities purchase
agreement (the “Purchase Agreement”) with an institutional investor for the issuance and sale in a private placement
(the “Private Placement”) of pre-funded common stock purchase warrants (“Pre-Funded Warrants”) to purchase
up to 1,315,790 shares of Common Stock, with an exercise price of $0.001 per share, and common stock purchase warrants (the “Warrants”)
to purchase up to 1,315,790 shares of Common Stock, with an exercise price of $1.40 per share. The gross proceeds to the Company
from the Private Placement were approximately $2.0 million, before deducting placement agent fees and expenses and offering expenses
payable by the Company. The Warrants and the Pre-Funded Warrants are immediately exercisable for three years from issuance and
are subject to 4.99% and 9.99% beneficial ownership limitations (as applicable). The combined purchase price for one Pre-Funded
Warrant and one accompanying Warrant was $1.519. The closing of the Private Placement contemplated by the Purchase Agreement occurred
on October 25, 2023. The Company had no warrant liabilities at March 31, 2024 and December 31, 2023.
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v3.24.1.u1
Commitment and Contingencies
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitment and Contingencies |
Note
13. Commitment and Contingencies
Operating
Leases
Operating
leases are recorded as ROU assets and lease liabilities on the balance sheet. ROU assets represent our right to use the leased
assets for the lease term, and lease liabilities represent our obligation to make lease payments. Operating lease ROU assets and
liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the
Company’s leases do not provide an implicit rate, the Company uses its estimated incremental borrowing rate at the commencement
date to determine the present value of lease payments. The operating lease ROU assets also include any lease payments made and
exclude lease incentives.
The
Company entered into a lease agreement beginning July 1, 2020, for the Company’s principal headquarters on the fifth floor
of 7800 Susquehanna Street, Pittsburgh, Pennsylvania, which includes office space and sterile manufacturing operations (the “Lease”).
The Lease has a five-year term and includes an option for renewal, which is not reasonably certain and is excluded from the right
of use calculation. On July 26, 2023, the Company entered a second lease for additional space on the fourth floor of the same
building (the “Fourth Floor Lease”), commencing August 1, 2023 and co-terminating with the existing Lease on June
30, 2025. Subsequently effective January 1, 2024, the Company terminated the Fourth Floor Lease early at no penalty upon mutual
agreement with the landlord and replaced it with a lease of additional space that had become available immediately adjacent to
our existing offices (the “Suite 504 Lease”, and together with the “Lease”, “the Leases”).
The Suite 504 Lease term co-terminates with the Lease. Future minimum rent payments under the Leases as of March 31,
2024 are as follows:
Year ending | |
| |
2024 (nine months remaining) | |
$ | 72,316 | |
2025 | |
$ | 48,519 | |
Total minimum lease payments | |
$ | 120,835 | |
Less: amount representing interest | |
$ | (5,133 | ) |
Present value of minimum lease payments | |
$ | 115,702 | |
The
Leases are accounted for as a ROU asset and liability. As of March 31, 2024, the Company had $114,038 of an operating lease ROU
asset, and $91,705 and 23,997 of current and non-current lease liabilities, respectively, recorded on the balance sheets. As of
December 31, 2023, the Company had an ROU asset of $135,144 and current and non-current operating lease liabilities of $89,223
and $47,371, respectively. The lease expense for the three months ended March 31, 2024 and March 31, 2023 was $24,438 and $16,368,
respectively. Cash paid for the amounts included in the measurement of lease liabilities for the three months ended March 31,
2024 and 2023 was $23,797 and $16,402, respectively. The payments are included in the operating activities in the accompanying
statement of cash flows. The discount rates used for our right-of-use leases range from 6.25% to 7.25%.
Contract
Commitments
The
Company enters into contracts in the normal course of business with contract research organizations (“CROs”), contract
manufacturing organizations, universities, and other third parties for preclinical research studies, clinical trials and
testing and manufacturing services. These contracts generally do not contain minimum purchase commitments and are cancelable by
us upon prior written notice although, purchase orders for clinical materials are generally non-cancelable. Payments due upon
cancellation consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our
service providers, up to the date of cancellation or upon the completion of a manufacturing run.
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v3.24.1.u1
Income Taxes
|
3 Months Ended |
Mar. 31, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
Note
14. Income Taxes
The
provision for income taxes for the three months ended March 31, 2024 and 2023 was $0, resulting in an effective income tax rate
of 0% for each period. The Company’s effective tax rate for the three months ended March 31, 2024 and 2023 was primarily
due to the full valuation allowance against the Company’s net deferred tax assets.
The
Company regularly evaluates the realizability of its deferred tax assets and establishes a valuation allowance if it is more likely
than not that some or all of the deferred tax assets will not be utilized. Because of our cumulative losses, substantially all
of the deferred tax assets have been fully offset by a valuation allowance as of March 31, 2024 and December 31, 2023. We have
not paid income taxes for the year ended December 31, 2023. The income tax provision attributable to loss before income tax benefit for the three months ended March 31, 2024 differed from the amounts computed by applying the U.S. federal statutory rate of 21% as a result of the following:
Schedule of income tax provision attributable to loss before income tax benefit
| |
| | |
Statutory federal income tax rate | |
| 21.00 | % |
State taxes, net of federal benefit | |
| 7.11 | % |
Change in valuation allowance | |
| -28.11 | % |
Effective tax rate | |
| 0.00 | % |
The
Company’s 2019 through 2023 tax years remain subject to examination by the Internal Revenue Service for federal tax purposes
and the Commonwealth of Pennsylvania for state tax purposes.
|
X |
- DefinitionThe entire disclosure for income tax.
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v3.24.1.u1
Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events |
|
Subsequent Events |
Note
15. Subsequent Events
Subsequent
events have been evaluated through the date on which the unaudited condensed financial statements were issued.
On
April 10, 2024, the Company eliminated the Series A Preferred Stock, of which there were no shares outstanding.
On
May 3, 2024, the Company issued 565,790 shares of Common Stock in conversion of the same number of pre-funded warrants.
Notice of Failure to Satisfy Nasdaq Minimum
Bid Price Requirement
As disclosed in our
Current Report on Form 8-K filed with the SEC on April 19, 2024, on April 17, 2024, we received a written notification (the “Nasdaq
Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that, based upon the closing bid price of
the Common Stock for the last 30 consecutive business days, the Company was not in compliance with the requirement to maintain
a minimum bid price of $1.00 per share of its Common Stock, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum
Bid Price Requirement”). The Nasdaq Letter had no immediate effect on the listing of the Common Stock, which continues to
trade on the Nasdaq Capital Market under the symbol “LIPO” at this time.
Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until October 14, 2024, to regain
compliance with the Minimum Bid Price Requirement. If at any time before October 14, 2024, the bid price of the Common Stock
closes at $1.00
per share or more for a minimum of 10
consecutive business days, the Nasdaq staff will provide written confirmation that the Company has regained compliance with
the Minimum Bid Price Requirement and the matter will be closed.
If
the Company does not regain compliance with the Minimum Bid Price Requirement, the Company may be eligible for an additional
180-calendar day grace period. To qualify, the Company will be required to meet the continued listing requirement for market
value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of
the Minimum Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the
second compliance period. If the Company does not regain compliance with the Minimum Bid Price Requirement by October 14,
2024, and is otherwise not eligible for such additional 180-day grace period to regain such compliance, the Nasdaq staff will
provide written notice to the Company that the Common Stock will be subject to delisting. At that time, the Company may
appeal any such delisting determination to a Nasdaq hearings panel.
|
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v3.24.1.u1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Use of Estimates |
Use
of Estimates
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 these financial
statements. Actual results could differ from those estimates.
|
Adoption of New Accounting Pronouncements |
Adoption
of New Accounting Pronouncements
During
the three months ended March 31, 2024, no new accounting pronouncement was issued or became effective, that had or is expected
to have, a material impact on our Financial Statements.
|
Concentration of Credit Risk |
Concentration
of Credit Risk
The
Company’s grant revenues and grant receivables are from the National Institute of Health (the “NIH”). The NIH
is an agency of the United States Department of Health & Human Services, and the Company believes amounts are fully collectible
from this agency. Contract revenues were $145,880 for the three months ended March 31, 2024, and $118,048 for the three months
ended March 31, 2024.
|
Earnings Per Share |
Earnings
Per Share
Basic
net loss per share of Common Stock is computed by dividing the net loss for the period by the weighted-average number of shares
of Common Stock outstanding during the period. Diluted net loss per common share is computed giving effect to all dilutive Common
Stock equivalents, consisting of stock options and warrants. Diluted net loss per share of Common Stock for the three months ended
March 31, 2024 and 2023 is the same as basic net loss per share, as the Common Stock equivalents were anti-dilutive due to the
net loss.
At
March 31, 2024 and 2023 the Common Stock equivalent shares were, as follows:
| |
| | |
| |
| |
March 31, | |
| |
2024 | | |
2023 | |
Shares of Common Stock issuable under equity incentive plans outstanding | |
| 2,893,000 | | |
| 2,054,000 | |
Shares of Common Stock issuable upon exercise of warrants | |
| 2,124,257 | | |
| 143,994 | |
Shares of Common Stock issuable upon conversion of Series A Preferred Stock | |
| — | | |
| — | |
Common Stock equivalent shares excluded from diluted net loss per share | |
| 5,017,257 | | |
| 2,197,994 | |
|
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v3.24.1.u1
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
At March 31, 2024 and 2023 the Common Stock equivalent shares were, as follows: |
At
March 31, 2024 and 2023 the Common Stock equivalent shares were, as follows:
| |
| | |
| |
| |
March 31, | |
| |
2024 | | |
2023 | |
Shares of Common Stock issuable under equity incentive plans outstanding | |
| 2,893,000 | | |
| 2,054,000 | |
Shares of Common Stock issuable upon exercise of warrants | |
| 2,124,257 | | |
| 143,994 | |
Shares of Common Stock issuable upon conversion of Series A Preferred Stock | |
| — | | |
| — | |
Common Stock equivalent shares excluded from diluted net loss per share | |
| 5,017,257 | | |
| 2,197,994 | |
|
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v3.24.1.u1
Fair Value Measurements and Marketable Debt Securities (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
For cash equivalents at March 31, 2024 and December 31, 2023, the fair value input levels are summarized below: |
The
Company held no marketable securities at March 31, 2024 and December 31, 2023. For cash equivalents at March 31, 2024 and December
31, 2023, the fair value input levels are summarized below:
March 31, 2024 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Cash Equivalents (maturity less than 90 days) | |
| | | |
| | | |
| | | |
| | |
Commercial Paper | |
$ | — | | |
| — | | |
| — | | |
$ | — | |
U.S. Government | |
| — | | |
| — | | |
| — | | |
| — | |
Money market funds | |
| 1,975,063 | | |
| — | | |
| — | | |
| 1,975,063 | |
Total Cash equivalents | |
| 1,975,063 | | |
| | | |
| | | |
| 1,975,063 | |
| |
| | | |
| | | |
| | | |
| | |
Marketable Securities | |
| — | | |
| — | | |
| — | | |
| — | |
Total Cash Equivalents and Marketable Securities | |
$ | 1,975,063 | | |
$ | — | | |
$ | — | | |
$ | 1,975,063 | |
December 31, 2023 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Cash Equivalents (maturity less than 90 days) | |
| | | |
| | | |
| | | |
| | |
Commercial Paper | |
$ | — | | |
| — | | |
| — | | |
$ | — | |
U.S. Government | |
| — | | |
| — | | |
| — | | |
| — | |
Money market funds | |
| 3,052,648 | | |
| — | | |
| — | | |
| 3,052,648 | |
Total Cash equivalents | |
| 3,052,648 | | |
| | | |
| | | |
| 3,052,648 | |
| |
| | | |
| | | |
| | | |
| | |
Marketable Securities | |
| — | | |
| — | | |
| — | | |
| — | |
Total Cash Equivalents and Marketable Securities | |
$ | 3,052,648 | | |
$ | — | | |
$ | — | | |
$ | 3,052,648 | |
|
X |
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v3.24.1.u1
Stock Options (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
The following is an analysis of options to purchase shares of Common Stock issued and outstanding as of March 31, 2024 and December 31, 2023: |
The
following is an analysis of options to purchase shares of Common Stock issued and outstanding as of March 31, 2024 and December
31, 2023:
|
|
Shares |
|
|
Weighted
Average
Exercise
Price Per
Share ($) |
|
|
Weighted
Average
Remaining
Contractual
Term
(in Years) |
|
|
Aggregate
intrinsic
value ($) |
|
Outstanding as of December
31, 2022 |
|
|
2,054,000 |
|
|
|
2.84 |
|
|
|
5.51 |
|
|
|
605,687 |
|
Granted |
|
|
424,000 |
|
|
|
2.19 |
|
|
|
9.96 |
|
|
|
|
|
Expired |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(25,000 |
) |
|
|
2.19 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of December 31, 2023 |
|
|
2,453,000 |
|
|
|
2.73 |
|
|
|
5.19 |
|
|
$ |
— |
|
Granted |
|
|
440,000 |
|
|
|
0.77 |
|
|
|
9.96 |
|
|
|
|
|
Expired |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2024 |
|
|
2,893,000 |
|
|
|
2.73 |
|
|
|
4.94 |
|
|
$ |
— |
|
Vested as of March 31, 2024 |
|
|
2,346,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of March 31, 2024 |
|
|
2,346,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of December 31, 2023 |
|
|
2,272,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of status of the Company’s non-vested stock options (exercisable for shares of Common Stock on a one-to-one basis) as of, and changes during, the three months ended March 31, 2024 and 2023 is presented below: |
A
summary of status of the Company’s non-vested stock options (exercisable for shares of Common Stock on a one-to-one basis)
as of, and changes during, the three months ended March 31, 2024 and 2023 is presented below:
|
|
Number
of
Stock Options |
|
|
Weighted-
Average Fair
Value Grant
Date |
|
Nonvested at December 31,
2022 |
|
|
434,667 |
|
|
$ |
2.82 |
|
Granted |
|
|
— |
|
|
|
2.84 |
|
Vested |
|
|
(74,000 |
) |
|
|
2.83 |
|
Expired |
|
|
— |
|
|
|
0.00 |
|
Nonvested at March 31, 2023 |
|
|
360,667 |
|
|
$ |
2.82 |
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2023 |
|
|
180,667 |
|
|
$ |
2.81 |
|
Granted |
|
|
440,000 |
|
|
|
0.55 |
|
Vested |
|
|
(74,000 |
) |
|
|
1.13 |
|
Expired |
|
|
— |
|
|
|
— |
|
Nonvested at March 31, 2024 |
|
|
546,667 |
|
|
$ |
0.66 |
|
|
The weighted-average fair value of stock options on the date of grant and the assumptions used to estimate the fair value of stock options granted during the three months ended March 31, 2024 using the Black-Scholes option-pricing model are as follows: |
The
weighted-average fair value of stock options on the date of grant and the assumptions used to estimate the fair value of stock
options granted during the three months ended March 31, 2024 using the Black-Scholes option-pricing model are as follows:
Three months ended March 31, 2024 | |
2024 | | |
2023 | |
Weighted-average fair value of options granted | |
$ | 0.55 | | |
| — | |
Expected volatility | |
| 86.17 | % | |
| — | % |
Expected life (in years) | |
| 5.17 | | |
| — | |
Risk-free interest rate (range) | |
| 4.33 | % | |
| — | % |
Expected dividend yield | |
$ | — | | |
| — | |
|
X |
- DefinitionTabular disclosure of activity for outstanding award under share-based payment arrangement excluding share and unit options and nonvested award.
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v3.24.1.u1
Commitment and Contingencies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Future minimum rent payments under the Leases as of March 31, 2024 are as follows: |
The
Company entered into a lease agreement beginning July 1, 2020, for the Company’s principal headquarters on the fifth floor
of 7800 Susquehanna Street, Pittsburgh, Pennsylvania, which includes office space and sterile manufacturing operations (the “Lease”).
The Lease has a five-year term and includes an option for renewal, which is not reasonably certain and is excluded from the right
of use calculation. On July 26, 2023, the Company entered a second lease for additional space on the fourth floor of the same
building (the “Fourth Floor Lease”), commencing August 1, 2023 and co-terminating with the existing Lease on June
30, 2025. Subsequently effective January 1, 2024, the Company terminated the Fourth Floor Lease early at no penalty upon mutual
agreement with the landlord and replaced it with a lease of additional space that had become available immediately adjacent to
our existing offices (the “Suite 504 Lease”, and together with the “Lease”, “the Leases”).
The Suite 504 Lease term co-terminates with the Lease. Future minimum rent payments under the Leases as of March 31,
2024 are as follows:
Year ending | |
| |
2024 (nine months remaining) | |
$ | 72,316 | |
2025 | |
$ | 48,519 | |
Total minimum lease payments | |
$ | 120,835 | |
Less: amount representing interest | |
$ | (5,133 | ) |
Present value of minimum lease payments | |
$ | 115,702 | |
|
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Going Concern (Details Narrative) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
Net loss |
$ (1,191,809)
|
$ (1,067,825)
|
|
Accumulated deficit |
(11,515,652)
|
|
$ (10,323,843)
|
Cash and cash equivalents |
2,105,299
|
|
$ 3,293,738
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|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Accounting Policies [Abstract] |
|
|
Shares of Common Stock issuable under equity incentive plans outstanding |
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|
2,054,000
|
Shares of Common Stock issuable upon exercise of warrants |
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|
143,994
|
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For cash equivalents at March 31, 2024 and December 31, 2023, the fair value input levels are summarized below: (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
$ 1,975,063
|
$ 3,052,648
|
Marketable Securities |
|
|
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1,975,063
|
3,052,648
|
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|
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|
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|
|
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|
|
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|
|
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|
|
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|
|
Cash equivalents |
1,975,063
|
3,052,648
|
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|
|
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|
|
Cash equivalents |
1,975,063
|
3,052,648
|
Marketable Securities |
|
|
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1,975,063
|
3,052,648
|
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|
|
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|
|
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|
|
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|
|
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|
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
1,975,063
|
3,052,648
|
Fair Value, Inputs, Level 2 [Member] |
|
|
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|
|
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|
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|
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v3.24.1.u1
Prepaid Expenses (Details Narrative) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid insurance |
$ 85,891
|
$ 88,554
|
Prepaid costs |
836,857
|
103,256
|
Prepaid costs |
372,208
|
|
Other prepaid expenses |
$ 266,210
|
|
Prepaid expenses |
|
$ 14,702
|
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v3.24.1.u1
The following is an analysis of options to purchase shares of Common Stock issued and outstanding as of March 31, 2024 and December 31, 2023: (Details) - USD ($)
|
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Dec. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
|
Outstanding at beginning |
2,453,000
|
2,054,000
|
Outstanding at beginning |
$ 2.73
|
$ 2.84
|
Outstanding at beginning (in years) |
5 years 2 months 8 days
|
5 years 6 months 3 days
|
Outstanding at beginning |
|
$ 605,687
|
Granted |
440,000
|
424,000
|
Granted |
$ 0.77
|
$ 2.19
|
Granted (in years) |
9 years 11 months 15 days
|
9 years 11 months 15 days
|
Expired |
|
|
Cancelled |
|
(25,000)
|
Cancelled |
|
$ 2.19
|
Exercised |
|
|
Outstanding at ending |
2,893,000
|
2,453,000
|
Outstanding at ending |
$ 2.73
|
$ 2.73
|
Outstanding at ending (in years) |
4 years 11 months 8 days
|
|
Outstanding at ending |
|
|
Options vested |
2,346,333
|
|
Options exercisable |
2,346,333
|
2,272,333
|
X |
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v3.24.1.u1
A summary of status of the Company’s non-vested stock options (exercisable for shares of Common Stock on a one-to-one basis) as of, and changes during, the three months ended March 31, 2024 and 2023 is presented below: (Details) - $ / shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
|
Nonvested at beginning |
180,667
|
434,667
|
Nonvested at beginning |
$ 2.81
|
$ 2.82
|
Granted |
440,000
|
|
Granted |
$ 0.55
|
$ 2.84
|
Vested |
(74,000)
|
(74,000)
|
Vested |
$ 1.13
|
$ 2.83
|
Expired |
|
|
Expired |
|
$ 0.00
|
Nonvested at ending |
546,667
|
360,667
|
Nonvested at ending |
$ 0.66
|
$ 2.82
|
X |
- DefinitionThe element represents share based compensation arrangement by share based payment award options expirations in period1.
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- DefinitionThe estimated amount of dividends to be paid to holders of the underlying shares (expected dividends) over the option's term. Dividends are taken into account because payment of dividends to shareholders reduces the fair value of the underlying shares, and option holders generally do not receive dividends.
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v3.24.1.u1
Stock Options (Details Narrative) - USD ($)
|
|
3 Months Ended |
12 Months Ended |
Mar. 15, 2024 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock shares issued |
|
7,039,846
|
|
6,053,956
|
Common stock, shares outstanding |
|
7,039,846
|
|
6,053,956
|
Expected term (in years) |
|
5 years 2 months 1 day
|
|
|
Weighted average remaining contractual life |
|
5 years 2 months 8 days
|
|
5 years 6 months 3 days
|
Strike price |
|
$ 0.77
|
|
$ 2.19
|
Stock Option Plans [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock shares issued |
440,000
|
|
|
|
Expected term (in years) |
|
10 years
|
|
|
Unrecognized compensation |
|
$ 540,759
|
|
|
Weighted average remaining contractual life |
|
1 year
|
|
|
Compensation cost |
|
$ 208,640
|
$ 208,639
|
|
Strike price |
$ 0.77
|
|
|
|
Common Class A [Member] | Stock Option Plans [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock shares issued |
|
3,078,000
|
|
|
Common Class A [Member] | Stock Option Plans 2008 [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock, shares outstanding |
|
1,078,000
|
|
|
Common Class A [Member] | Stock Option Plans 2020 [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock shares issued |
|
2,400,000
|
|
|
X |
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v3.24.1.u1
Preferred Stock (Details Narrative) - USD ($)
|
3 Months Ended |
12 Months Ended |
23 Months Ended |
58 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Apr. 30, 2008 |
Jun. 30, 2013 |
Class of Stock [Line Items] |
|
|
|
|
|
|
Preferred Stock, Shares Issued |
0
|
|
0
|
|
|
|
Preferred stock, par value (in dollars per share) |
$ 0.0001
|
|
$ 0.0001
|
|
|
|
Proceeds from issuance of common stock |
$ 200,000
|
|
|
|
$ 351,500
|
$ 833,188
|
Shares converted |
|
|
|
|
789,634
|
|
Conversion discounts |
|
|
|
|
$ 122,280
|
|
Preferred stock, shares outstanding |
0
|
|
0
|
|
|
|
Description of shaes conversion |
|
|
|
Series A Preferred Stock were converted to Common Stock
on a 1:1 basis. After giving effect to the Stock Split, this conversion resulted in 636,979 shares of Common Stock.
|
|
|
Warrant [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Face value of the debt instruments |
$ 351,500
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Shares converted |
|
|
60,000
|
636,979
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Preferred Stock, Shares Issued |
|
|
|
|
|
1,592,447
|
Preferred stock, par value (in dollars per share) |
|
|
|
|
|
$ 0.60
|
Preferred stock, shares outstanding |
|
|
|
1,592,447
|
|
|
Series A Preferred Stock [Member] | Minimum [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Preferred stock, par value (in dollars per share) |
|
|
|
|
|
0.0768
|
Series A Preferred Stock [Member] | Maximum [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Preferred stock, par value (in dollars per share) |
|
|
|
|
|
$ 0.60
|
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v3.24.1.u1
Common Stock (Details Narrative) - USD ($)
|
|
|
|
|
|
|
|
3 Months Ended |
12 Months Ended |
23 Months Ended |
Mar. 13, 2024 |
Mar. 04, 2024 |
Feb. 02, 2024 |
Nov. 28, 2023 |
Sep. 15, 2023 |
Dec. 22, 2022 |
Dec. 09, 2022 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Apr. 30, 2008 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
|
|
|
200,000,000
|
200,000,000
|
|
|
Common stock, shares outstanding |
|
|
|
|
|
|
|
7,039,846
|
6,053,956
|
|
|
Common stock, shares issued |
|
|
|
|
|
|
|
7,039,846
|
6,053,956
|
|
|
Issued common stock in exchange for services |
|
|
|
|
|
|
|
|
|
|
789,634
|
Purchase Agreement [Member] | Board of Directors Chairman [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Description of stock agreements |
the Company entered into Affiliate Stock Purchase Agreements with each of Jonathan H. Kaufman, the Company's Chief Executive Officer and Chairman of its board of directors, and Michael B. Chancellor, the Company's Chief Medical Officer and a member of its board of directors, pursuant to which each of Drs. Kaufman and Chancellor purchased $100,000 of shares of common stock of the Company, in cash from the Company at $0.6901 per share, based on the official closing price of The Nasdaq Stock Market LLC for the Common Stock on March 13, 2024, resulting in the issuance of 144,906 shares of Common Stock to each of Drs. Kaufman and Chancellor.
|
|
|
|
|
|
|
|
|
|
|
IPO [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from initial public offering |
|
|
|
|
|
$ 5,000,000
|
|
|
|
|
|
Underwriting fees |
|
|
|
|
|
630,000
|
|
|
|
|
|
Offering expense |
|
|
|
|
|
$ 1,160,000
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
144,906
|
|
|
|
|
|
|
200,000,000
|
|
|
|
Description of stock split |
|
|
|
|
|
|
at a 2.5 for 1 ratio
|
|
|
|
|
Common stock, shares outstanding |
|
|
|
|
|
|
|
7,039,846
|
6,053,956
|
|
|
Accrued interest - related party |
|
|
|
|
|
|
|
|
|
$ 138,810
|
|
Shares issued, price per share |
$ 0.6901
|
|
|
|
|
|
|
|
|
|
|
Issued common stock in exchange for services |
|
|
196,078
|
|
60,000
|
|
|
196,078
|
|
|
|
Shares of common stock for the execution |
|
500,000
|
|
250,000
|
|
|
|
|
|
|
|
Issued common stock in exchange for services |
|
|
|
|
|
|
|
|
60,000
|
636,979
|
|
Purchase shares of common stock |
100,000
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] | IPO [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares issued |
|
|
|
|
|
1,217,391
|
|
|
|
|
|
Shares issued, price per share |
|
|
|
|
|
$ 5.75
|
|
|
|
|
|
Common Stock One [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares issued |
|
|
|
|
|
|
|
|
|
22,950
|
|
X |
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Warrants (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
|
|
|
3 Months Ended |
Mar. 04, 2024 |
Nov. 28, 2023 |
Oct. 23, 2023 |
Mar. 31, 2024 |
Proceeds from issuance of private placement |
|
|
|
$ 2
|
Warrant other descripion |
|
|
|
The Warrants and the Pre-Funded Warrants are immediately exercisable for three years from issuance and
are subject to 4.99% and 9.99% beneficial ownership limitations (as applicable). The combined purchase price for one Pre-Funded
Warrant and one accompanying Warrant was $1.519.
|
Warrant exercise period |
|
|
|
P3Y
|
Common Stock [Member] |
|
|
|
|
Number of warants converted |
500,000
|
250,000
|
|
|
Common Stock [Member] | Private Placement [Member] |
|
|
|
|
Number of warants converted |
|
|
1,315,790
|
|
Exercise price |
|
|
$ 0.001
|
|
Warrant [Member] |
|
|
|
|
Number of warants converted |
|
|
1,315,790
|
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Exercise price |
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|
$ 1.40
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v3.24.1.u1
Commitment and Contingencies (Details Narrative) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Loss Contingencies [Line Items] |
|
|
|
Operating lease ROU assets |
$ 114,038
|
|
$ 135,144
|
Operating lease liability current |
91,705
|
|
89,223
|
Operating lease liability noncurrent |
23,997
|
|
$ 47,371
|
Lease expense |
24,438
|
$ 16,368
|
|
Lease liabilities |
$ 23,797
|
$ 16,402
|
|
Minimum [Member] |
|
|
|
Loss Contingencies [Line Items] |
|
|
|
Discoun rates on right of use leases |
6.25%
|
|
|
Maximum [Member] |
|
|
|
Loss Contingencies [Line Items] |
|
|
|
Discoun rates on right of use leases |
7.25%
|
|
|
X |
- DefinitionThe element represents discount rates on right of use leases.
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v3.24.1.u1
v3.24.1.u1
v3.24.1.u1
Subsequent Events (Details Narrative)
|
Oct. 14, 2024
Number
$ / shares
|
May 03, 2024
shares
|
Mar. 04, 2024
shares
|
Nov. 28, 2023
shares
|
Oct. 23, 2023
shares
|
Mar. 31, 2024
$ / shares
|
Dec. 31, 2023
$ / shares
|
Common stock, par value (in dollars per share) | $ / shares |
|
|
|
|
|
$ 0.0001
|
$ 0.0001
|
Common Stock [Member] |
|
|
|
|
|
|
|
Conversion shares of common stock |
|
|
500,000
|
250,000
|
|
|
|
Common Stock [Member] | Private Placement [Member] |
|
|
|
|
|
|
|
Conversion shares of common stock |
|
|
|
|
1,315,790
|
|
|
Subsequent Event [Member] | Private Placement [Member] |
|
|
|
|
|
|
|
Description of subsequent event |
Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until October 14, 2024, to regain
compliance with the Minimum Bid Price Requirement. If at any time before October 14, 2024, the bid price of the Common Stock
closes at $1.00
per share or more for a minimum of 10
consecutive business days, the Nasdaq staff will provide written confirmation that the Company has regained compliance with
the Minimum Bid Price Requirement and the matter will be closed.
|
|
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
Conversion shares of common stock |
|
565,790
|
|
|
|
|
|
Common stock, par value (in dollars per share) | $ / shares |
$ 1.00
|
|
|
|
|
|
|
Consecutive business days | Number |
10
|
|
|
|
|
|
|
X |
- DefinitionFace amount or stated value per share of common stock.
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Lipella Pharmaceuticals (NASDAQ:LIPO)
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