UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended December 31, 2025
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: 001-15543
PALATIN
TECHNOLOGIES, INC.
(Exact
name of registrant as specified in its charter)
Delaware
95-4078884
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
301
Carnegie Center Drive , Suite 304
Princeton ,
New Jersey
08540
(Address
of principal executive offices)
(Zip
Code)
(609)
495-2200
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
Trading
Symbol
Name
of Each Exchange
on
Which Registered
Common
Stock, par value $0.01 per share
PTN
NYSE
American
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, as amended during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate
the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date (February
13, 2026): 1,772,199
PALATIN
TECHNOLOGIES, INC .
Table
of Contents
Page
Special Note Regarding Forward-Looking Statements
ii
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Consolidated Balance Sheets as of December 31, 2025 and June 30, 2025
1
Consolidated Statements of Operations for the Three and Six months ended December 31, 2025 and 2024
2
Consolidated Statements of Changes in Stockholders’ Equity (Deficiency) for the Three and Six months ended December 31, 2025
3
Consolidated Statements of Changes in Stockholders’ Deficiency for the Three and Six months ended December 31, 2024
4
Consolidated Statements of Cash Flows for the Six months ended December 31, 2025 and 2024
5
Notes to Consolidated Financial Statements
6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3. Quantitative and Qualitative Disclosures About Market Risk
24
Item 4. Controls and Procedures
24
PART II – OTHER INFORMATION
24
Item 1. Legal Proceedings
25
Item 1A. Risk Factors
25
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
26
Item 3. Defaults Upon Senior Securities
26
Item 4. Mine Safety Disclosures
26
Item 5. Other Information
26
Item 6. Exhibits
27
Signatures
28
i
Special
Note Regarding Forward-Looking Statements
In
this Quarterly Report on Form 10-Q (this “Quarterly Report”) references to “we,” “our,” “us,”
the “Company” or “Palatin” mean Palatin Technologies, Inc. and its subsidiary.
Statements
in this Quarterly Report, as well as oral statements that may be made by us or by our officers, directors, or employees acting on our
behalf, that are not historical facts constitute “forward-looking statements,” which are made pursuant to the safe harbor
provisions of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The forward-looking statements
in this Quarterly Report do not constitute guarantees of future performance. Investors are cautioned that statements that are not strictly
historical facts contained in this Quarterly Report, including, without limitation, the following are forward-looking statements:
●
our
ability to obtain additional financing on terms acceptable to us, or at all, including unavailability of funds or delays in receiving
funds as a result of economic disruptions;
●
our
expectation that we will incur losses for the foreseeable future and may never achieve or maintain profitability;
●
our
business, financial condition, and results of operations may be adversely affected by increases in costs of and delays in conducting
human clinical trials and the performance of our contractors and suppliers, reduction in our productivity or the productivity of
our contractors and suppliers, supply chain constraints, and labor shortages;
●
whether
Boehringer Ingelheim International GmbH (“Boehringer Ingelheim”), which in August 2025 acquired certain Palatin intellectual
property to first-in-class melanocortin receptor-targeted peptides developed by Palatin, will be able to successfully develop a product
for the treatment of retinal diseases, including diabetic retinopathy;
●
the
results of further development, clinical trials and the timing of regulatory submissions with our late-stage products, including
PL7737, an oral small molecule MC4R agonist, with an IND filing projected in the first half of calendar year 2026; a novel once-weekly
melanocortin receptor-4 (“MC4R”) peptide agonist for obesity indications, with an Investigational New Drug (“IND”)
filing projected in the second half of calendar year 2026; PL8177, an oral peptide formulation for treatment of ulcerative colitis,
which reported positive topline data in a Phase 2 clinical trial proof-of-concept trial in the first quarter of 2025; and an MC4R
agonist for diabetic nephropathy, which reported positive topline date in the fourth quarter of 2024;
●
estimates
of our expenses, future revenue and capital requirements;
●
our
ability to achieve profitability;
●
our
ability to advance product candidates into, and successfully complete, clinical trials;
●
the
initiation, timing, progress and results of future preclinical studies and clinical trials, and our research and development programs;
●
the
timing or likelihood of regulatory filings and approvals;
●
our
expectations regarding the clinical efficacy and utility of our melanocortin agonist product candidates for treatment of inflammatory
and autoimmune related diseases and disorders, including ocular indications;
●
our
ability to compete with other products and technologies treating the same or similar indications as our product candidates;
●
the
ability of our contract manufacturers to perform their manufacturing activities for us in compliance with applicable regulations;
●
our
ability to recognize the potential value of our licensing arrangements with third parties;
●
the
potential to achieve revenues from the sale of our product candidates;
●
our
ability to obtain adequate reimbursement from private insurers and other healthcare payers;
●
our
ability to maintain product liability insurance at a reasonable cost or in sufficient amounts, if at all;
ii
●
the
performance and retention of our management team, senior staff professionals, other employees, and third-party contractors and consultants;
●
the
scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology
in the United States and throughout the world;
●
our
compliance with federal and state laws and regulations;
●
the
timing and costs associated with obtaining regulatory approval for our product candidates;
●
the
impact of fluctuations in foreign exchange rates;
●
the
impact of any geopolitical instability, economic uncertainty, financial markets volatility, or capital markets disruption resulting
from the ongoing military conflict between Russia and Ukraine or conflicts in the Middle East, and any resulting effects on our revenue,
financial condition, or results of operations;
●
the
impact of legislative or regulatory healthcare reforms in the United States;
●
our
ability to adapt to changes in global economic conditions as well as competing products and technologies; and
●
our
ability to remain listed on the NYSE American stock exchange.
Such
forward-looking statements involve risks, uncertainties and other factors that could cause our actual results to be materially different
from historical results or from any results expressed or implied by such forward-looking statements. Our future operating results are
subject to risks and uncertainties and are dependent upon many factors, including, without limitation, the risks identified under the
caption “Risk Factors” and elsewhere in this Quarterly Report, and any of those made in our other reports filed with the
U.S. Securities and Exchange Commission (the “SEC”). Except as required by law, we do not intend, and undertake no obligation,
to publicly update forward-looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence
of unanticipated events.
iii
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements.
PALATIN
TECHNOLOGIES, INC .
and
Subsidiary
Consolidated
Balance Sheets
(unaudited)
December
31, 2025
June
30, 2025
ASSETS
Current
assets:
Cash
and cash equivalents
$ 14,476,162
$ 2,564,265
Accounts
Receivable
1,636,325
-
Other
receivables
-
29,468
Prepaid
expenses and other current assets
1,354,992
325,695
Total
current assets
17,467,479
2,919,428
Property
and equipment, net
113,485
129,444
Right-of-use
assets - operating leases
346,764
161,166
Other
assets
-
56,916
Total
assets
$ 17,927,728
$ 3,266,954
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
Current
liabilities:
Accounts
payable
$ 5,453,080
$ 6,998,806
Accrued
expenses
659,841
881,412
Short-term
operating lease liabilities
219,727
129,812
Total
current liabilities
6,332,648
8,010,030
Long-term
operating lease liabilities
129,061
33,969
Total
liabilities
6,461,709
8,043,999
Commitments
and contingencies (Note 10)
-
Stockholders’
equity (deficiency):
Preferred
stock of $ 0.01 par value – authorized 10,000,000 shares: shares issued and outstanding designated as follows:
Series
A Convertible: authorized 4,030 shares as of December 31, 2025: issued and outstanding 4,030 shares as of December 31, 2025 and June
30, 2025
40
40
Series
D Convertible: authorized 3,400 shares as of December 31, 2025: issued and outstanding 3,400 shares as of December 31, 2025 and June
30, 2025
34
34
Preferred stock value
34
34
Common
stock of $ 0.01 par value – authorized 300,000,000 shares:
issued
and outstanding 1,757,199 shares as of December 31, 2025 and 929,597 shares as of June 30, 2025
17,572
9,296
Common
stock of $0.01 par value – authorized 300,000,000 shares: issued and outstanding 1,757,199 shares as of December 31, 2025
and 929,597 shares as of June 30, 2025
17,572
9,296
Additional
paid-in capital
473,108,599
454,287,484
Accumulated
deficit
( 461,660,226 )
( 459,073,899 )
Total
stockholders’ equity (deficiency)
11,466,019
( 4,777,045 )
Total
liabilities and stockholders’ equity (deficiency)
$ 17,927,728
$ 3,266,954
The
accompanying notes are an integral part of these consolidated financial statements.
1
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Consolidated
Statements of Operations
(unaudited)
2025
2024
2025
2024
Three
Months Ended December 31,
Six
Months Ended December 31,
2025
2024
2025
2024
REVENUES
Collaboration
and license
$ 116,036
$ -
$ 8,963,586
$ -
OPERATING
EXPENSES
Research
and development
4,319,767
3,429,479
6,845,533
9,173,233
General
and administrative
3,124,817
1,681,844
4,785,548
3,702,775
Gain
on sale of Vyleesi
-
( 2,500,000 )
-
( 2,500,000 )
Total
operating expenses
7,444,584
2,611,323
11,631,081
10,376,008
Loss
from operations
( 7,328,548 )
( 2,611,323 )
( 2,667,495 )
( 10,376,008 )
OTHER
INCOME (EXPENSE)
Investment
income
65,185
29,044
83,668
107,620
Foreign
currency transaction gain
-
143,600
-
12,000
Interest
expense
( 498 )
( 3,803 )
( 2,500 )
( 9,743 )
Total
other income (expense), net
64,687
168,841
81,168
109,877
NET
LOSS
$ ( 7,263,861 )
$ ( 2,442,482 )
$ ( 2,586,327 )
$ ( 10,266,131 )
Basic
and diluted net loss per common share
$ ( 2.86 )
$ ( 5.92 )
$ ( 1.47 )
$ ( 25.36 )
Weighted
average number of common shares outstanding used in computing basic and diluted net loss per common share
2,539,632
412,697
1,755,641
404,799
The
accompanying notes are an integral part of these consolidated financial statements.
2
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Consolidated Statements of Changes in Stockholders’ Equity (Deficiency)
(unaudited)
Three
Months Ended December 31, 2025
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Stockholders’
Equity (Deficiency)
Series A Convertible Preferred Stock
Series D Convertible Preferred Stock
Common
Stock
Additional Paid-in
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance
September 30, 2025
4,030
$ 40
3,400
$ 34
973,291
$ 9,734
$ 454,782,956
$ ( 454,396,365 )
$ 396,399
Stock-based
compensation
-
-
-
-
6,456
64
310,675
-
310,739
Withholding
taxes related to restricted stock units
-
-
-
-
( 1,530 )
( 15 )
( 19,429 )
( 19,444 )
Equity
financing, net of costs
-
-
-
-
659,384
6,594
16,904,860
-
16,911,454
Warrant
excercises
-
-
-
-
119,598
1,195
1,129,537
-
1,130,732
Net
loss
-
-
-
-
-
-
-
( 7,263,861 )
( 7,263,861 )
Fractional
shares
-
-
-
-
-
-
-
-
-
Shares released from abeyance
-
-
-
-
-
-
-
-
-
Balance
December 31, 2025
4,030
40
3,400
34
1,757,199
17,572
473,108,599
( 461,660,226 )
11,466,019
Six
Months Ended December 31, 2025
Stockholders’
Equity (Deficiency)
Series A Convertible Preferred Stock
Series D Convertible Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance
June 30, 2025
4,030
$ 40
3,400
$ 34
929,597
$ 9,296
$ 454,287,484
$ ( 459,073,899 )
$ ( 4,777,045 )
Stock-based
compensation
-
-
-
-
6,456
64
478,387
-
478,451
Withholding
taxes related to restricted stock units
-
-
-
-
( 1,530 )
( 15 )
( 19,429 )
-
( 19,444 )
Equity
financing, net of costs
-
-
-
-
659,384
6,594
16,904,860
-
16,911,454
Warrant
excercises
-
-
-
-
163,357
1,633
1,457,297
-
1,458,930
Fractional
shares
-
-
-
-
( 65 )
-
-
-
-
Net
loss
-
-
-
-
-
-
-
( 2,586,327 )
( 2,586,327 )
Balance
December 31, 2025
4,030
40
3,400
34
1,757,199
17,572
473,108,599
( 461,660,226 )
11,466,019
The
accompanying notes are an integral part of these consolidated financial statements.
3
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Consolidated
Statements of Changes in Stockholders’ Deficiency
(unaudited)
Three
Months Ended December 31, 2024
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Stockholders’ Deficiency
Series A Convertible Preferred Stock
Common Stock
Additional Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance September 30, 2024
4,030
$ 40
19,548,167
$ 195,481
$ 441,709,073
$ ( 449,590,199 )
$ ( 7,685,605 )
Stock-based compensation
-
-
-
-
348,955
-
348,955
Warrant exercises
-
-
3,907,679
39,077
3,358,946
-
3,398,023
Net loss
-
-
-
-
-
( 2,442,482 )
( 2,442,482 )
Balance December 31, 2024
4,030
40
23,455,846
234,558
445,416,974
( 452,032,681 )
( 6,381,109 )
Six Months Ended December 31, 2024
Stockholders’ Deficiency
Series A Convertible Preferred Stock
Common Stock
Additional Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance June 30, 2024
4,030
$ 40
17,926,640
$ 179,266
$ 441,475,747
$ ( 441,766,550 )
$ ( 111,497 )
Balance
4,030
$ 40
17,926,640
$ 179,266
$ 441,475,747
$ ( 441,766,550 )
$ ( 111,497 )
Stock-based compensation
-
-
232,941
2,329
695,649
-
697,978
Withholding taxes related to restricted stock units
-
-
( 54,691 )
( 547 )
( 98,935 )
-
( 99,482 )
Shares released from abeyance
1,443,277
14,433
( 14,433 )
-
Warrant exercises
-
-
3,907,679
39,077
3,358,946
-
3,398,023
Net loss
-
-
-
-
-
( 10,266,131 )
( 10,266,131 )
Balance December 31, 2024
4,030
40
23,455,846
234,558
445,416,974
( 452,032,681 )
( 6,381,109 )
Balance
4,030
40
23,455,846
234,558
445,416,974
( 452,032,681 )
( 6,381,109 )
The
accompanying notes are an integral part of these consolidated financial statements.
4
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Consolidated
Statements of Cash Flows
(unaudited)
2025
2024
Six Months Ended December 31,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 2,586,327 )
$ ( 10,266,131 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
28,775
152,620
Decrease in right-of-use asset
63,120
179,677
Unrealized foreign currency transaction loss
-
( 12,000 )
Stock-based compensation
478,451
697,978
Gain on sale of Vyleesi
-
( 2,500,000 )
Changes in operating assets and liabilities:
Accounts receivable
( 1,636,325 )
-
Other receivables
29,468
-
Prepaid expenses and other assets
( 972,381 )
( 10,841 )
Accounts payable
( 1,545,726 )
2,616,304
Accrued expenses
( 221,571 )
( 2,534,346 )
Operating lease liabilities
( 63,711 )
( 186,580 )
Net cash used in operating activities
( 6,426,227 )
( 11,863,319 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of Vyleesi
-
2,500,000
Purchases of property and equipment
( 12,816 )
-
Net cash (used in) provided by investing activities
( 12,816 )
2,500,000
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of withholding taxes related to restricted stock units
( 19,444
)
( 99,482
)
Proceeds from the sale of common stock and warrants, net
16,911,453
-
Payment of finance lease obligations
-
( 46,014 )
Proceeds from exercise of warrants
1,458,931
3,398,023
Net cash provided by financing activities
18,350,940
3,252,527
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
11,911,897
( 6,110,792 )
CASH AND CASH EQUIVALENTS, beginning of period
2,564,265
9,527,396
CASH AND CASH EQUIVALENTS, end of period
$ 14,476,162
$ 3,416,604
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 2,500
$ 9,743
The
accompanying notes are an integral part of these consolidated financial statements.
5
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
(1)
ORGANIZATION
Nature
of Business - Palatin Technologies, Inc. (“Palatin” or the “Company”) is a biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor (“MCR”) system. The Company’s
product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and
commercial potential.
Melanocortin
Receptor System. The MCR system has effects on food intake, metabolism, sexual function, inflammation, and immune system responses.
There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which
activate receptor function, or receptor-specific antagonists, which block receptor function, can have significant pharmacological effects.
The
Company’s product development activities focus primarily on use of MC4R agonists for treatment of obesity, with a primary focus
on rare neuroendocrine diseases. The Company is developing MC4R small molecule agonists and peptide agonists with potential utility in
obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, Prader-Willi syndrome, and other orphan
indications.
The
Company is also developing, dependent on resources for development activities, MC1R agonist products with potential to treat ocular diseases
and inflammatory and autoimmune diseases, such as uveitis, and inflammatory bowel disease. A product candidate MC1R agonist for treatment
of dry eye disease, known as keratoconjunctivitis sicca, has been licensed to a third party, and a family of MC1R compounds for treatment
of retinal diseases, including diabetic retinopathy and diabetic macular edema, has been licensed to Boehringer Ingelheim. The Company
believes that the MC1R agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged
by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses.
The
Company’s prior commercial product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in
June 2019 for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women. Vyleesi was initially licensed
to AMAG Pharmaceuticals, Inc. in January 2017, terminated July 2020, and subsequently sold to Cosette Pharmaceuticals Inc. (“Cosette”)
in December 2023.
Reverse
Stock Split - On August 11, 2025, a reverse stock split of 1-for-50 of issued and outstanding
common stock was made effective by the Company. Retroactive effect for the reverse stock split was made to the Company’s outstanding
common stock, stock options, common stock warrants, and preferred stock conversion features, including all share and per-share data,
for all periods presented in the consolidated financial statements.
Business
Risks and Liquidity – The Company has incurred operating losses and negative cash flows from operations since inception and
will need additional funding to complete its planned product development efforts. As shown in the accompanying consolidated financial
statements, the Company had an accumulated deficit as of December 31, 2025, of $ 461,660,226 and a net loss for the three and six months
ended December 31, 2025 of $ 7,263,861 and $ 2,586,327 , respectively. The Company anticipates incurring significant expenses in the future
as a result of spending on its development programs and will require substantial additional financing or revenues to continue to fund
its planned activities. To achieve sustained profitability, if ever, the Company, alone or with others, must successfully develop and
commercialize its technologies and proposed products, conduct successful preclinical studies and clinical trials, obtain required regulatory
approvals, and successfully manufacture and market such technologies and proposed products. The time required to achieve sustained profitability
is highly uncertain, and the Company may never be able to achieve profitability on a sustained basis, if at all.
As
of December 31, 2025, the Company’s cash and cash equivalents were $ 14,476,162 and current liabilities were $ 6,332,648 . Management
intends to utilize existing capital resources for general corporate purposes and working capital, including clinical development of the
Company’s MC1R and MC4R programs, and development of other portfolio products.
The
Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 205-40, Presentation of Financial Statements — Going Concern , which requires management to assess the Company’s
ability to continue as a going concern for one year after the date the consolidated financial statements are issued. While the Company
has raised funding in the past, the ability to raise funding in future periods is not considered probable, as defined under the accounting
standards. As such, under the requirements of ASC 205-40, management may not consider the potential for future funding in their assessment
of the Company’s ability to meet its obligations for the next year.
6
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
Based
on the Company’s current operating and development plans, the Company expects that its existing cash and cash equivalents as of
the date of this filing will be sufficient to enable it to fund operations through the next twelve months following the issuance of the
financial statements.
Concentrations
– Concentrations in the Company’s assets and operations subject it to certain related risks. Financial instruments that
subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents, and accounts receivable. The Company’s
cash and cash equivalents are primarily invested in one investment account sponsored by a large financial institution. The Company’s
revenue and accounts receivable are generated by one customer.
(2)
BASIS
OF PRESENTATION
The
accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted
in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q. Accordingly,
they do not include all of the information and footnote disclosures required to be presented for complete financial statements. In the
opinion of management, these consolidated financial statements contain all adjustments (consisting of normal recurring adjustments) considered
necessary for fair presentation. The results of operations for the three and six months ended December 31, 2025, may not necessarily
be indicative of the results of operations expected for the full fiscal year.
The
accompanying unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements
and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2025, filed with the U.S. Securities
and Exchange Commission (“SEC”), which includes consolidated financial statements as of June 30, 2025 and 2024 and for the
fiscal years then ended.
(3)
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation – The consolidated financial statements include the accounts of the Company and its wholly-owned inactive
subsidiary. All intercompany accounts and transactions have been eliminated in consolidation.
Use
of Estimates – The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual
results could differ from those estimates.
Cash,Cash Equivalents – Cash and cash equivalents include cash on hand, cash in banks, and all highly liquid investments with a
purchased maturity of less than three months. Cash equivalents consisted of $ 13,925,210 and $ 2,286,603 in a money market account at December
31, 2025 and June 30, 2025, respectively.
Fair
Value of Financial Instruments – The Company’s financial instruments consist primarily of cash equivalents, accounts
receivable, and accounts payable. Management believes that the carrying values of cash equivalents, accounts receivable, and accounts
payable are representative of their respective fair values based on the short-term nature of these instruments.
Credit
Risk – Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of
cash and cash equivalents. Total cash and cash equivalents balances have exceeded balances insured by the Federal Depository Insurance
Company.
Segment
Information – The Chief Operating Decision Maker (the “CODM”) assesses performance for its segment based on net
loss, which is reported on the consolidated statements of operations. The measure of segment assets is reported on the balance sheet
as total assets. The CODM uses cash forecast models in deciding how to invest into the segment. The CODM analyzes the Company’s
net loss and monitors budget versus actual results to assess the performance of the Company.
Property
and Equipment – Property and equipment consists of office and laboratory equipment, office furniture, and leasehold improvements
and includes assets acquired under finance leases. Property and equipment are recorded at cost. Depreciation is recognized using the
straight-line method over the estimated useful lives of the related assets, generally five years for laboratory and computer equipment,
seven years for office furniture and equipment, and the lesser of the term of the lease or the useful life for leasehold improvements.
Amortization of assets acquired under finance leases is included in depreciation expense. Maintenance and repairs are expensed as incurred
while expenditures that extend the useful life of an asset are capitalized.
7
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
Impairment
of Long-Lived Assets – The Company reviews its long-lived assets for impairment whenever events or changes in circumstances
indicate that the carrying amount of the assets may not be fully recoverable. To determine recoverability of a long-lived asset, management
evaluates whether the estimated future undiscounted net cash flows from the asset are less than its carrying amount. If impairment is
indicated, the long-lived asset would be written down to fair value. Fair value is determined by an evaluation of available price information
at which assets could be bought or sold, including quoted market prices, if available, or the present value of the estimated future cash
flows based on reasonable and supportable assumptions.
Leases
– At lease inception, the Company determines whether an arrangement is or contains a lease. Operating leases are included in operating
lease right-of-use (“ROU”) assets, short-term operating lease liabilities, and long-term operating lease liabilities in the
consolidated financial statements. Finance leases are included in property and equipment for ROU assets, short-term finance lease liabilities,
and long-term finance lease liabilities in the consolidated financial statements. ROU assets represent the Company’s right to use
leased assets over the term of the lease. Lease liabilities represent the Company’s contractual obligation to make lease payments
over the lease term. ROU assets and lease liabilities are recognized at the commencement date. The lease liability is measured as the
present value of the lease payments over the lease term. The Company uses the rate implicit in the lease if it is determinable. When
the rate implicit in the lease is not determinable, the Company uses an estimate based on a hypothetical rate provided by a third party
as the Company currently does not have issued debt. Lease terms may include renewal or extension options to the extent they are reasonably
certain to be exercised. The assessment of whether renewal or extension options are reasonably certain to be exercised is made at lease
commencement. Factors considered in determining whether an option is reasonably certain of exercise include, but are not limited to,
the value of any leasehold improvements, the value of renewal rates compared to market rates, and the presence of factors that would
cause incremental costs to the Company if the option were not exercised.
The
ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at
or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases,
the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs,
plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease
payments is recognized on a straight-line basis over the lease term. For finance leases, the ROU asset is subsequently amortized using
the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless
the lease transfers ownership of the underlying asset to the Company or the Company is reasonably certain to exercise an option to purchase
the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU
asset is recognized and presented as an operating expense separately from interest expense on the lease liability.
The
Company has elected not to recognize an ROU asset and obligation for leases with an initial term of twelve months or less. The expense
associated with short-term leases is included in selling, general and administrative expenses in the statements of operations. To the
extent a lease arrangement includes both lease and non-lease components, the Company has elected to account for the components as a single
lease component.
On
December 11, 2025, the Company entered into an office lease agreement at 304 Carnegie Center Drive in Princeton, New Jersey. In connection
with the execution of the lease, the Company recorded a right-of-use asset and corresponding lease liability of $ 248,718 in accordance
with ASC 842.
Revenue
Recognition – For licenses of intellectual property, the Company assesses at contract inception whether the intellectual property
is distinct from other performance obligations identified in the arrangement. If the licensing of intellectual property is determined
to be distinct, revenue is recognized for non-refundable, upfront license fees when the license is transferred to the customer, and the
customer can use and benefit from the license. If the licensing of intellectual property is determined not to be distinct, then the license
is bundled with other promises in the arrangement into one performance obligation. The Company determines if the bundled performance
obligation is satisfied over time or at a point in time. If the Company concludes that the non-refundable, upfront license fees will
be recognized over time, the Company assesses the appropriate method of measuring proportional performance.
8
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
Research,
development and regulatory milestone payments are considered variable consideration subject to constraint and excluded from the transaction
price until it is probable that a significant reversal would not occur. At each reporting period, the Company will assess whether there
still is significant uncertainty associated with the variable consideration and revenue relating to the milestones recorded in the period
where the significant uncertainty is resolved.
Sales-based
royalty and milestone payments resulting from customer contracts solely or predominately for the license of intellectual property will
only be recognized upon occurrence of the underlying sale or achievement of the sales milestone in the future and such sales-based royalties
and milestone payments will be recognized in the same period earned.
The
Company recognizes revenue for research and development services under customer agreements as the services are performed. The Company
records these services as revenue and not as a reduction of research and development expenses as the Company is the principal in the
research and development activities based upon its control of such activities, which is part of its ordinary activities.
Research,
development and regulatory milestone payments are generally due 30 business days after the milestone is achieved. Sales milestone payments
are generally due 45 business days after the calendar year in which the sales milestone is achieved. Royalty payments are generally due
on a quarterly basis 20 business days after being invoiced.
Research
and Development Costs – The costs of research and development activities are charged to expense as incurred, including the
cost of equipment for which there is no alternative future use.
Accrued
Expenses – Third parties perform a significant portion of the Company’s development activities. The Company reviews the
activities performed under all contracts each quarter and accrues expenses and the amount of any reimbursement to be received from its
collaborators based upon the estimated amount of work completed considering milestones achieved. Estimating the value or stage of completion
of certain services requires judgment based on available information. If the Company does not identify services performed for it but
not billed by the service provider, or if it underestimates or overestimates the value of services performed as of a given date, reported
expenses will be understated or overstated.
Stock-Based
Compensation – The Company charges to expense the fair value of stock options and other equity awards granted to employees
and nonemployees for services. Compensation costs for stock-based awards with time-based vesting are determined using the quoted market
price of the Company’s common stock on the grant date or for stock options, the value determined utilizing the Black-Scholes option
pricing model, and are recognized on a straight-line basis, while awards containing a market condition are valued using multifactor Monte
Carlo simulations and are recognized over the derived service period. Compensation costs for awards containing a performance condition
are determined using the quoted price of the Company’s common stock on the grant date or for stock options, the value determined
utilizing the Black-Scholes option pricing model and are recognized based on the probability of achievement of the performance condition
over the service period. Forfeitures are recognized as they occur.
Income
Taxes – The Company and its subsidiary file consolidated federal and separate-company state income tax returns. Income taxes
are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis
and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to
apply to taxable income in the years in which those temporary differences or operating loss and tax credit carryforwards are expected
to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that
includes the enactment date. The Company has recorded and continues to maintain a full valuation allowance against its deferred tax assets
based on the history of losses incurred and lack of experience projecting future product revenue and sales-based royalty and milestone
payments.
9
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
Net
Loss per Common Share – Basic and diluted loss per common share (“EPS”) are calculated in accordance with the provisions
of FASB ASC Topic 260, Earnings per Share .
For
the three and six months ended December 31, 2025 and 2024, no additional common shares were added to the computation of diluted EPS because
to do so would have been anti-dilutive. The potential number of common shares excluded from diluted EPS during the three and six months
ended December 31, 2025 and 2024 were 8,592,769 and 261,195 , respectively.
Included
in the weighted average common shares used in computing basic and diluted net loss per common share are 5,453 and 5,594 vested restricted
stock units that had not been issued as of December 31, 2025 and 2024 due to a provision in the restricted stock unit agreements to delay
delivery.
Translation
of foreign currencies – Transactions denominated in currencies other than the Company’s functional currency (U.S. Dollar)
are recorded based on exchange rates at the time such transactions arise. Subsequent changes in exchange rates result in transaction
gains and losses, which are reflected in the consolidated statements of operations as unrealized (based on the applicable period-end
exchange rate) or realized upon settlement of the transactions.
(4)
New
Accounting Pronouncements
In
November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income- Expense Disaggregation Disclosures (Subtopic
220-40): Disaggregation of Income Statement Expenses. ASU 2024-03 enhances financial reporting by requiring additional information about
specific expense categories in the notes to financial statements at interim and annual reporting periods. The guidance is effective for
public business entities for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December
15, 2027. Early adoption is permitted. The Company is currently planning to adopt this guidance when effective. The Company is assessing
the impact of the adoption on the Company’s consolidated financial statements and accompanying footnotes but expects the impact
will be enhanced disclosures related to income statement expenses.
In
December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. ASU 2023-09 enhances the transparency about income
tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information.
The guidance is effective for public business entities for annual periods beginning after December 15, 2024. For entities other than
public business entities, the amendments are effective for annual periods beginning after December 15, 2025. Early adoption is permitted.
The Company is currently planning to adopt this guidance when effective. The Company is assessing the impact of the adoption on the Company’s
consolidated financial statements and accompanying footnotes.
(5)
AGREEMENT
WITH BOEHRINGER INGLEHEIM
On
August 14, 2025, the Company entered into a Research Collaboration, License and Patent Assignment Agreement (the “Assignment Agreement”)
with Boehringer Ingelheim International GmbH (“Boehringer Ingelheim” or “BI”) to research, develop and commercialize
first-in-class melanocortin receptor-targeted peptides developed by the Company for the treatment of retinal diseases, including diabetic
retinopathy.
Under
the terms of the Assignment Agreement, the Company assigned certain patent rights and provided a license to Boehringer Ingelheim (the
“Assigned Patents”), and the Company will conduct research services on behalf of Boehringer Ingelheim at Boehringer Ingelheim’s
expense focused on development during a two-year period, which Boehringer Ingelheim has the right to extend by up to six months. The
Company retains an exclusive, fully-paid license to PL9643 for treatment of dry eye disease. The Company determined that two performance
obligations exist under the Assignment Agreement (i) patents and license assignment and (ii) research and development services.
The
patents and license assignment performance obligation relates to intellectual property that is distinct from other performance obligations
identified in the arrangement. The consideration received for this performance obligation includes both fixed cash consideration and
variable consideration subject to constraint. During the three and six months ended December 31, 2025, the Company recorded $ 2,340,000
in revenue related to the assignment and transfer of the patents and license to BI for which BI can benefit and use. The Company received
approximately $ 2,000,000 of cash related to the upfront payment as the cash received was net of foreign withholding taxes which were
recognized in accounts receivable at December 31, 2025, as the Company expects to receive a refund during FY 2026. Additionally, during
the six months ended December 31, 2025, the Company was notified that BI had successfully completed the first research milestone and
accordingly the Company recorded $ 6,490,000 of revenue during the quarter. In October 2025, the Company received approximately $ 5,400,000
of cash related to the achievement of this milestone as the cash received was net of foreign withholding taxes that the Company expects
to receive as a refund during FY 2026. Variable consideration related to the remaining future milestones was fully constrained because
the Company cannot conclude that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur,
given the inherent uncertainty of success with these future milestones. The Company may receive up to $ 21,200,000 in near-term research
milestone payments and up to $ 307,000,000 in success-based development, regulatory, and commercial milestone payments, plus tiered royalties
on net commercial sales of products.
10
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
The
research and development services performance obligation relates to specific research activities during the research term, and BI will
reimburse the Company for these activities at a full-time equivalent (“FTE”) rate of € 300,000 (approximately $ 346,341 )
per year per FTE, up to 3.25 FTEs, inclusive of direct labor, supplies, and allocated overhead. The Company will invoice BI for actual
hours worked, and BI is obligated to pay within contractually defined timelines. During the three and six months ended December 31, 2025,
the Company recorded $ 116,036 and $ 133,586 of revenue for research and development services performed.
During
the three and six months ended December 31, 2025, the Company recorded revenue related to the Assignment Agreement, which consisted of
the upfront payment for the Assigned Patents, the achievement of a research milestone during September 2025, and FTE related reimbursements
as follows:
SCHEDULE OF ASSIGNMENT AGREEMENT
Three Months Ended
December 31, 2025
Six Months Ended
December 31, 2025
License and assignment of intellectual property
$ -
$ 2,340,000
Research, development and regulatory milestones achieved
-
6,490,000
FTE Reimbursements for research and development services
116,036
133,586
Total
$ 116,036
$ 8,963,586
(6)
RELEASE
AND SETTLEMENT AGREEMENT
On
June 5, 2025, the Company entered into a Release and Settlement Agreement (the “Settlement Agreement”) with Cosette pursuant
to which the Cosette resolved all outstanding obligations and commercialization covenants related to such sales-based milestone payments
and inventory purchase commitments by remitting a single lump sum payment of $ 630,000 and the assumption of outstanding manufacturing
and supply purchase commitments, with the Company retaining the right to receive 20% of a $ 3,000,000 milestone payment based on the first
commercial sale in Korea, in full satisfaction and release of all such future obligations. As a result, the Company recorded a gain on
the sale of Vyleesi of $ 3,130,000 and a gain on inventory purchase commitments of $ 2,117,900 , for the fiscal year ended June 30, 2025.
(7)
PREPAID
EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consist of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
December 31,
June 30,
2025
2025
Clinical / regulatory costs
$ 903,725
$ 24,080
Insurance premiums
101,637
86,043
Other
349,630
215,572
Total prepaid expenses
and other current assets
$ 1,354,992
$ 325,695
11
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
(8)
FAIR
VALUE MEASUREMENTS
The
fair value of cash equivalents is classified using a hierarchy prioritized based on inputs. Level 1 inputs are quoted prices (unadjusted)
in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active
markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially
the full term of the financial instrument. Level 3 inputs are unobservable inputs based on management’s own assumptions used to
measure assets and liabilities at fair value. A financial asset’s or liability’s classification within the hierarchy is determined
based on the lowest level input that is significant to the fair value measurement.
The
following table provides the assets carried at fair value:
SCHEDULE OF FAIR VALUE ASSET MEASUREMENT
Carrying Value
Quoted prices in
active markets
(Level 1)
Other
quoted/observable inputs (Level 2)
Significant
unobservable inputs
(Level 3)
December 31, 2025:
Cash equivalents - Money market funds
$ 13,925,210
$ 13,925,210
$ -
$ -
June 30, 2025:
Cash equivalents - Money market funds
$ 2,286,603
$ 2,286,603
$ -
$ -
(9)
ACCRUED
EXPENSES
Accrued
expenses consist of the following:
SCHEDULE OF ACCRUED EXPENSES
December 31,
June 30,
2025
2025
Clinical / regulatory costs
$ 542,643
$ 282,761
Other research related expenses
3,693
86,372
Professional Services
105,565
323,510
Other
7,940
188,769
Total accrued
expenses
$ 659,841
$ 881,412
(10)
COMMITMENTS
AND CONTINGENCIES
Inventory
Purchases – The Company had certain supply agreements relating to the Vyleesi product with certain manufacturers and suppliers,
including Catalent Belgium S.A (“Catalent”), Ypsomed AG (“Ypsomed”), and Lonza Ltd (“Lonza”), all
of which were transferred to Cosette on June 5, 2025, pursuant a Release and Settlement Agreement with Cosette (see Note 6).
Contingencies
– The Company accounts for litigation losses in accordance with ASC 450-20, Loss Contingencies . In addition, the Company
is subject to other contingencies, such as product liability, arising in the ordinary course of business. Loss contingency provisions
are recorded for probable losses when management is able to reasonably estimate the loss. Any outcome upon settlement that deviates from
the Company’s best estimate may result in additional expense or in a reduction in expense in a future accounting period. The Company
records legal expenses associated with such contingencies as incurred.
The
Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business.
On
February 13, 2025, a complaint was filed in the Supreme Court of the State of New York, County of New York, captioned H.C. Wainwright
& Co., LLC (“Wainwright”) v. Palatin Technologies, Inc., Case No: 650878/2025. The complaint named the Company as defendant,
asserting three causes of action for breach of contract and seeking monetary damages of approximately $ 1,000,000 and the award of warrants
allegedly due. The breach of contract claims relate to engagement agreements entered into by the Company and Wainwright in 2023 and 2024.
On
November 17, 2025, the Company entered into a settlement and release agreement with Wainwright to resolve all outstanding disputes between
the parties. Pursuant to the settlement, the Company paid Wainwright $ 500,000 in cash which was recorded in G&A and issued warrants
to purchase 10,000 shares of the Company’s common stock at an exercise price of $ 10.00 per share, exercisable beginning January
12, 2026, with a two-year term. In addition, the Company repriced 6,007 outstanding Wainwright warrants to an exercise price of $ 10.00
per share. The parties mutually released all claims, and the Company extinguished all remaining obligations under the prior engagement
arrangements.
12
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
(11)
SEGMENT
INFORMATION
The
Company views its operations and manages its business in one operating segment: life science. The table below summarizes the significant
expense categories for the life science segment regularly provided to the Company’s Chief Financial Officer/Chief Operating Officer
(the “CFO/COO”), its Chief Operating Decision Maker (the “CODM”).
The
accounting policies of the Company’s segment are the same as those described in the summary of significant accounting policies.
The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations. The
measure of segment assets is reported on the balance sheet as total assets. The CODM uses cash forecast models in deciding how to invest
into the segment. The CODM analyzes the Company’s net loss and monitors budget versus actual results to assess the performance
of the Company.
SCHEDULE OF SEGMENT BASED ON NET LOSS
2025
2024
2025
2024
Three Months Ended December 31,
Six Months Ended December 31,
2025
2024
2025
2024
Total Revenues
$ 116,036
$ -
$ 8,963,586
$ -
Less:
Program spend
2,290,073
1,888,065
3,260,702
5,969,102
Personnel costs
3,155,910
2,170,379
5,294,829
4,438,182
Gain on sale of Vyleesi
-
( 2,500,000 )
-
( 2,500,000 )
Administrative costs (a)
1,998,601
1,052,879
3,075,550
2,468,724
Other
segment items (b)
( 64,687 )
( 168,841 )
( 81,168 )
( 109,877 )
Segment net loss
$ ( 7,263,861 )
$ ( 2,442,482 )
$ ( 2,586,327 )
$ ( 10,266,131 )
(a) Contains depreciation
and amortization. Depreciation was $ 14,388 amd $ 28,775 for the three and six months ended December 31, 2025, respectively, compared to
$ 71,830 and $ 152,620 for the three and six months ended Decmber 31, 2024, respectively.
(b) Other segement
items include investment income, interest expense and foreign currency (gain)loss, which are disclosed in the consolidated financial
statements.
(12)
STOCKHOLDERS’
EQUITY (DEFICIENCY)
Series
D Convertible Preferred Stock – On June 10, 2025, the Company entered into a securities purchase agreement (the “Purchase
Agreement”) with certain accredited investors (the “Purchasers”), pursuant to which the Company agreed to sell and
issue, in a private placement (the “June 2025 Private Placement”), (i) an aggregate of 3,400 shares of the Company’s
newly designated Series D Convertible Preferred Stock, par value $0.01, with a stated value of $100 per share (the “Series D Preferred
Stock”), initially convertible into up to 61,816 shares of the Company’s common stock (such shares underlying the Preferred
Stock, the “Conversion Shares”), par value $0.01 per share at an initial conversion price of $ 5.50 , and (ii) Series I common
stock purchase warrants (the “Series I Warrants”) to purchase up to an aggregate of 123,636 shares of Common Stock (such
shares underlying the Series I Warrants, the “Series I Warrant Shares”). The Series D Preferred Stock and Series I Warrants
were sold at a combined offering price of $ 5.50 per share of Preferred Stock and accompanying Series I Warrants. The Purchasers in the
June 2025 Private Placement consisted of Carl Spana, the Company’s President and Chief Executive Officer, Stephen T. Wills, the
Company’s Executive Vice President, Chief Financial Officer, and Chief Operating Officer, John K.A. Prendergast, a director on
and Chairperson of the Company’s board of directors, and Alan W. Dunton, a director on the Company’s board of directors,
who are all related parties of the Company. The Series D Preferred Stock has a dividend rate of 8 % per annum, which when declared may,
at the option of the Company, be paid in cash or can accrete and be added to the stated value of the Series D Preferred Stock. Subject
to the rights of any class or series of stock senior to or equivalent to the Series D Preferred Stock , the Series D Preferred Stock
shall be entitled to be paid in the event of liquidation, dissolution or winding up of the Company, out of available funds and assets,
prior and in preference to any distribution on any junior stock, an amount per share equal to the then stated value of the Series D Preferred
Stock and declared but unpaid dividends. Each share of Series D Preferred Stock is convertible at any time, at the option of the holder,
and such conversion could dilute the value of our common stock to current stockholders and could adversely affect the market price of
our common stock. The conversion price decreases if we sell common stock (or equivalents) for a price per share less than the conversion
price and is also subject to adjustment upon the occurrence of a merger, reorganization, consolidation, reclassification, stock dividend
or stock split which results in an increase or decrease in the number of shares of common stock outstanding. The June 2025 Private Placement
closed on June 13, 2025. The gross proceeds from the June 2025 Private Placement, before deducting offering expenses, were $ 340,000 .
13
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
Series
A Convertible Preferred Stock – As of December 31, 2025, 4,030 shares of Series A Convertible Preferred Stock were outstanding.
Each share of Series A Convertible Preferred Stock is convertible at any time, at the option of the holder, into the number of shares
of common stock equal to $ 100 divided by the Series A Conversion Price. As of December 31, 2025, the Series A Conversion Price was $ 260.86 ,
and each share of Series A Convertible Preferred Stock is convertible into approximately 0.38 shares of common stock. The Series A Conversion
Price is subject to adjustment, under certain circumstances, upon the sale or issuance of common stock for consideration per share less
than either (i) the Series A Conversion Price in effect on the date of such sale or issuance, or (ii) the market price of the common
stock as of the date of such sale or issuance. The Series A Conversion Price is also subject to adjustment upon the occurrence of a merger,
reorganization, consolidation, reclassification, stock dividend or stock split which will result in an increase or decrease in the number
of shares of common stock outstanding. Shares of Series A Convertible Preferred Stock have a preference in liquidation, including certain
merger transactions, of $ 100 per share, or $ 403,000 in the aggregate as of December 31, 2025. Additionally, the Company may not pay a
dividend or make any distribution to holders of any class of stock unless the Company first pays a special dividend or distribution of
$ 100 per share to holders of the Series A Convertible Preferred Stock.
Financing
Transactions – On November 5, 2025, the Company entered into an underwriting agreement with A.G.P./Alliance Global Partners
(“A.G.P.”) relating to the Company’s public offering of 2,430,769 shares of common stock (or pre-funded warrants in
lieu thereof) together with Series J warrants to purchase up to 2,430,769 shares of common stock (the “Series J Warrants”),
and Series K warrants to purchase up to 2,430,769 shares of common stock (the “Series K Warrants”) at a combined public offering
price of $ 6.50 per share of common stock and accompanying Series J and Series K Warrants (the “November 2025 Offering”).
The underwriters also had an option to purchase up to an additional 364,615 shares of the Company’s common stock and associated
Series J and K Warrants on the same terms and conditions.
Each
Series J Warrant has an exercise price of $ 6.50 per share and is immediately exercisable. The Series J Warrants expire on the earlier
of (i) the eighteen-month anniversary of the original issuance date or (ii) on the 31st calendar day following the date that the Company
receives the FDA acceptance of the Company’s Investigational New Drug for an in-house obesity treatment compound (long-acting peptide
or oral small molecule) (the “FDA Exercise Period”). Each Series K Warrant has an exercise price of $ 8.125 per share and
is immediately exercisable. The Series K Warrants expires on the five-year anniversary of the original issuance date, however, if a holder’s
Series J Warrants have not been terminated in accordance with their terms prior to the expiration of the FDA Exercise Period, such holder’s
Series K Warrants will terminate automatically upon the earlier of the (i) eighteen-month anniversary of the original issuance date of
the Series J Warrants or (ii) expiration of the FDA Exercise Period and prior to the five-year anniversary of the issuance of the Series
K Warrant.
The
gross proceeds to the Company from the November 2025 Offering, before deducting the underwriting discounts and commissions and offering
expenses, were approximately $ 18,200,000 , including the exercise by the underwriters to purchase an additional 364,615 shares of the
Company’s common stock and associated Series J and K Warrants. The pre-funded warrants are exercisable at a nominal exercise of
$ 0.0001 per share until exercised in full and may not be exercised to the extent such exercise would cause the holder to beneficially
own more than 4.99% or 9.99%, as applicable, of the Company’s outstanding common stock. The November 2025 Offering closed on November
12, 2025, and was subject to the satisfaction of customary closing conditions.
On
May 7, 2025, the Company announced the closing of a reduced previously announced public offering with participation from institutional
and accredited investors consisting of 146,479 shares of common stock together with Series F warrants to purchase up to 146,479 shares
of common stock (the “Series F Warrants”), Series G warrants to purchase up to 146,479 shares of common stock (the “Series
G Warrants”), and Series H warrants to purchase up to 146,479 shares of common stock (the “Series H Warrants”), at
a combined public offering price of $ 7.50 per share of common stock and accompanying warrants (the “May 2025 Offering”).
14
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
The
Series F Warrants have an exercise price of $ 15.00 per share, are immediately exercisable and expire on the five-year anniversary of
the original issuance date, subject to the certain terms as defined in such warrant. The Series G Warrants have an exercise price of
$ 7.50 per share, are immediately exercisable and expire on the earlier of (i) the 24-month anniversary of the original issuance date
or (ii) the expiration of the FDA Exercise Period (as such term is defined in the Series G Warrant). The Series H Warrants will be issuable
to the holder upon their exercise of the Series G Warrants, will have an exercise price of $ 11.25 per share, will be immediately exercisable
upon issuance and will expire on the 24-month anniversary of its issuance date.
The
Company received aggregate gross proceeds from the May 2025 Offering of approximately $ 1,100,000 million. The Company used the net proceeds
from the May 2025 Offering primarily for working capital and general corporate purposes.
On
February 10, 2025, the Company entered into definitive agreements with a single healthcare focused institutional investor for the purchase
and sale of 93,760 shares of its common stock (or common stock equivalents in lieu thereof) in a registered direct offering (the “February
2025 RD Offering”) at a purchase price of $ 50.00 per share.
The
Company also agreed to issue to the same investor in a concurrent private placement warrants to purchase up to an aggregate of 93,760
shares of common stock (the “February 2025 Private Placement” and, together with the February 2025 RD Offering, the “February
2025 Offering”). The warrants issued in the concurrent February 2025 Private Placement have an exercise price of $ 50.00 per share,
are exercisable 181 days after their issuance and expire approximately five and a half years from the date of issuance.
The
gross proceeds from the February 2025 Offering totaled $ 4,687,786 with net proceeds after deducting
the placement agent fees and offering expenses, amounting to $ 4,309,641 . The Company used the net proceeds from the Offering for
general corporate purposes. The Company paid the placement agents a cash fee equal to 7.0 % of the aggregate gross proceeds of the February
2025 Offering.
On
February 11, 2025, the Company entered into a sales agreement (the “2025 Sales Agreement”) with A.G.P., pursuant to which
the Company may, from time to time, sell shares of the Company’s common stock at market prices by methods deemed to be an “at-the-market
offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”). The
2025 Sales Agreement and related prospectus is limited to sales of up to an aggregate maximum of $6.0 million of shares of the Company’s
common stock. The Company pays A.G.P. 3.0% of the gross proceeds as a commission.
No
proceeds were raised under the 2025 Sales Agreement during the three and six months ended December 31, 2025.
On
April 12, 2023, the Company entered into a new equity distribution agreement (the “2023 Equity Distribution Agreement”) with
Canaccord Genuity LLC (“Canaccord”), pursuant to which the Company may, from time to time, sell shares of the Company’s
common stock at market prices by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under
the Securities Act . The 2023 Equity Distribution Agreement and related prospectus is limited to sales of up to an aggregate maximum
$50.0 million of shares of the Company’s common stock. The Company pays Canaccord 3.0% of the gross proceeds as a commission.
No
proceeds were raised under the 2023 Equity Distribution Agreement during the three and six months ended December 31, 2025 and 2024.
15
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
Stock
Warrants – During the three and six month ended December 31, 2025, the Company received proceeds from the following warrant
exercises:
SCHEDULE OF WARRANT EXERCISES
Three Months Ended
December 31, 2025
Six Months Ended
December 31, 2025
Series
Exercise
Price
Warrants
Proceeds
Warrants
Proceeds
Series F Warrants
$ 15.00
16,866
$ 252,990
16,866
$ 252,990
Series G Warrants
$ 7.50
32,165
241,238
75,924
569,437
Series H Warrants
$ 11.25
30,599
344,239
30,599
344,239
Series J Warrants
$ 6.50
19,984
129,896
19,984
129,896
Series K Warrants
$ 8.125
19,984
162,370
19,984
162,370
119,598
$ 1,130,732
163,357
$ 1,458,931
As
a result of the Series G warrant exercises, investors received 32,165 and 75,924 Series H warrants at an exercise price of $ 11.25 per
share for the three and six months ended December 31, 2025, respectively.
On
December 13, 2024, the Company entered into a letter agreement (the “December
2024 Inducement Letter”) with a holder (the “December 2024 Exercising Holder”) of outstanding common stock purchase
warrants that the Company issued on June 24, 2024, with an initial exercise price of $ 94.00 , and October 24, 2023, with an initial exercise
price of $ 106.00 (the “December 2024 Existing Warrants”). To induce the exercise of a portion of the December 2024 Existing
Warrants by the December 2024 Exercising Holder, the Company agreed to adjust the exercise price of such portion of the December 2024
Existing Warrants to $ 43.75 . Pursuant to the December 2024 Inducement Letter, the December 2024 Exercising Holder agreed to exercise,
for cash, the December 2024 Existing Warrants to purchase an aggregate of 78,153 shares of common stock at the adjusted exercise price
in exchange for the Company’s agreement to issue to the December 2024 Exercising Holder Series C common stock purchase warrants
to purchase 78,153 shares of common stock (the “Series C Warrants”) and Series D common stock purchase warrants to purchase
39,076 shares of common stock (the “Series D Warrants” and together with the Series C Warrants, the “December 2024
Inducement Warrants,” and the shares issuable upon exercise of the December 2024 Inducement Warrants, the “December 2024
Inducement Warrant Shares”). The Company received aggregate gross proceeds of $ 3,419,219 from the exercise of the December
2024 Existing Warrants by the December 2024 Exercising Holder (the “December 2024 Warrant Inducement”). The incremental value
of the December 2024 Warrant Inducement was recorded as an offering expense against the proceeds received in additional paid-in capital.
16
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
As
of December 31, 2025, the Company had outstanding warrants for shares of common stock as follows:
SCHEDULE OF OUTSTANDING STOCK PURCHASE WARRANTS
Shares of Common
Exercise Price per
Latest Expiration
Description
Stock
Share
Date
May 2022 Warrants
1,333
$ 625.00
May 11, 2026
October 2022 Placement Agent Warrants
1,818
$ 10.00
October 31, 2027
October 2023 Placement Agent Warrants
2,358
$ 10.00
October 20, 2028
January 2024 Private Warrants
36,630
$ 273.00
February 1, 2028
January 2024 Placement Agent Warrants
1,831
$ 10.00
February 1, 2028
June 2024 Series B Warrants
37,712
$ 94.00
July 25, 2030
December 2024 Series C Warrants
78,153
$ 43.75
December 17, 2029
December 2024 Series D Warrants
39,076
$ 43.75
July 25, 2030
February 2025 Series E Warrants
93,760
$ 50.00
August 12, 2030
May 2025 Series F Warrants
129,613
$ 15.00
May 8, 2030
May 2025 Series G Warrants
70,555
$ 7.50
May 8, 2027
May 2025 Series H Warrants
45,325
$ 11.25
- **
June 2025 Series I Warrants
123,636
$ 5.50
July 25, 2030
November 2025 Pre-funded Warrants
2,136,000
$ 0.0001
N/A
November 2025 Series J Warrants
2,775,400
$ 6.50
- ***
November 2025 Series K Warrants
2,775,400
$ 8.13
- ****
November 2025 Placement Agent Warrants
55,907
$ 8.13
November 12, 2030
November 2025 HCW Settlement Warrants
10,000
$ 10.00
January 12, 2028
* 5,228 warrants
expire June 24, 2029
** Expire 24 months
following the intial exercise date
*** Expires the earlier
of (i) the 18 -month anniversary of the Initial Exercise Date if FDA IND acceptance has not been received, or (ii) 31 days after notice
of FDA IND acceptance, in each case adjusted to the next Trading Day; provided that under clause (ii) the date is extended until a registration
statement and prospectus are available for 30 consecutive days.
**** Expire on the 5 -year
anniversary of the Initial Exercise Date, or, if the Holder’s Series J Common Stock Purchase Warrant terminates pursuant to
clause (ii) thereof prior to full cash exercise, the same Termination Date as the Series J Warrant, in each case adjusted to the
next Trading Day; provided that the date is extended until a registration statement and prospectus are available for 30 consecutive
days following notice of FDA IND acceptance.
Stock
Options – For the three and six months ended December 31, 2025, the Company recorded stock-based compensation related to stock
options of $ 153,442 and $ 241,683 , respectively. For the three and six months ended December 31, 2024, the Company recorded stock-based
compensation related to stock options of $ 177,673 and $ 355,407 , respectively.
17
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
A
summary of stock option activity is as follows:
SCHEDULE OF STOCK OPTION ACTIVITY
Number of Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Term in
Years
Aggregate
Intrinsic
Value
Outstanding - June 30, 2025
44,805
$ 302.00
7.3
Granted
39,550
21.38
Fractional shares
( 14 )
Forfeited
( 590 )
113.24
Exercised
-
-
Expired
( 4,031 )
487.56
Outstanding - December 31, 2025
79,720
$ 159.26
8.3
$ -
Exercisable at December 31, 2025
24,769
$ 407.63
6.0
$ -
Expected to vest at December 31, 2025
54,951
$ 46.57
9.4
$ -
Stock
options granted to the Company’s executive officers and employees generally vest over a 48-month period, while stock options granted
to its non-employee directors vest over a 12-month period.
During
the three months ended December 31, 2025, executive officers of the Company were granted an aggregate of 16,000 time-based stock options
and 16,000 performance-based stock options. The time-based options vest ratably over four years. The performance-based options vest over
four years , upon certification by the Compensation Committee that specified performance objectives have been achieved. Compensation expense
for these awards will be recognized when achievement of the applicable performance conditions is considered probable.
In
addition, the executive officers received an aggregate of 48,000 performance-based stock options with an 18-month performance period.
These options vest upon acceptance by the FDA of an IND application for an in-house compound, subject to certification by the Compensation
Committee.
All
of the stock option grants described above are subject to stockholders approving an increase in the Company’s 2011 Equity Incentive
Plan. In accordance with ASC 718, no compensation cost related to these awards will be recognized until stockholder approval is obtained
and the awards are considered granted for accounting purposes.
Included
in the outstanding options in the table above are 5,376 and 2,857 unvested performance-based stock options granted to executive officers
and other employees, respectively, which were granted in June 2022, 2023, 2024 and December 2025. Grants in June 2022, 2023, 2024 and
December 2025 were 1,211 , 4,777 , 5,299 and 1,743 , respectively. The performance-based stock options vest on annual performance criteria
through the fiscal years ending June 30, 2030 relating to advancement of MC1R programs, including initiation of clinical trials and licensing
of Vyleesi in additional countries or regions.
Restricted
Stock Units – For the three and six months ended December 31, 2025, the Company recorded stock-based compensation related to
restricted stock units (“RSUs”) of $ 157,298 and $ 236,768 , respectively. For the three and six months ended December 31, 2024,
the Company recorded stock-based compensation related to RSUs of $ 171,281 and $ 342,571 , respectively.
A
summary of RSU activity is as follows:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Outstanding at June 30, 2025
22,787
Granted
24,950
Forfeited
-
Vested
( 6,456 )
Expirations
( 635 )
Fractional shares
-
Outstanding at December 31, 2025
40,646
18
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Notes
to Consolidated Financial Statements
During
the three months ended December 31, 2025, executive officers of the Company were granted, subject to stockholder approval, an aggregate
of 13,000 time-based RSUs and 13,000 performance-based RSUs. The time-based RSUs vest ratably over four years. The performance-based
RSUs vest over four years , upon certification by the Compensation Committee that specified performance objectives have been achieved.
Compensation expense for these awards will be recognized when achievement of the applicable performance conditions is considered probable.
In
addition, the executive officers received an aggregate of 39,000 performance-based RSUs with an 18-month performance period. These RSUs
vest upon acceptance by the FDA of an IND application for an in-house compound, subject to certification by the Compensation Committee.
The
RSU grants described above are subject to stockholders approving an increase in the Company’s 2011 Equity Incentive Plan. In accordance
with ASC 718, no compensation cost related to these awards will be recognized until stockholder approval is obtained and the awards are
considered granted for accounting purposes.
Included
in outstanding RSUs in the table above are 5,453 vested shares that have not been issued as of December 31, 2025, due to a provision
in the RSU agreements for deferred delivery.
Time-based
RSUs granted to the Company’s executive officers, other employees, and non-employee directors generally vest over 48 months, 48
months, and 12 months, respectively.
Included
in the outstanding RSUs in the table above are 3,628 and 2,198 unvested performance-based RSUs granted to executive officers and other
employees, respectively, which were granted in June 2022, 2023, 2024 and December 2025. Grants in June 2022, 2023, 2024 and December
2025 were 814 , 3,049 , 3,689 and 1,432 RSUs, respectively. The performance-based RSUs vest on annual performance criteria through the
fiscal years ending June 30, 2028, relating to advancement of MC1R programs, including initiation of clinical trials.
(13)
SUBSEQUENT
EVENT
On
January 8, 2026, the Company entered into a sublicense agreement (the “Altanispac Agreement”) with Altanispac Labs, LLC (“Altanispac”),
exclusively licensing PL9643, an MCR1 agonist for dry eye disease. In partial consideration for the rights to PL9643, the Altanispac
Agreement provided for upfront consideration in the form of non-cash debt cancellation of approximately $ 3,800,000 , which is reflected
in the Company’s current liabilities as of December 31, 2025. This $ 3,800,000 will be recognized as license revenue in the Company’s
Consolidated Statements of Operations for the quarter ending March 31, 2026.
In
addition, the agreement provides for potential future payments to the Company under the sublicensing agreement, including the sale
of the asset, commercialization of the product, and royalties. The receipt of future payments is dependent upon future events that
are uncertain and not within the control of the Company. The Company will recognize amounts related to future payments, if earned,
in the period such amounts become realizable and earned, in accordance with applicable accounting guidance.
19
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis should be read in conjunction with the consolidated financial statements and notes to the consolidated
financial statements filed as part of this report and the audited consolidated financial statements and notes thereto included in our
Annual Report on Form 10-K for the year ended June 30, 2025.
The
following discussion and analysis contain forward-looking statements within the meaning of the federal securities laws. You are urged
to carefully review our description and examples of forward-looking statements included earlier in this Quarterly Report immediately
prior to Part I, under the heading “Special Note Regarding Forward-Looking Statements.” Forward-looking statements are subject
to risk that could cause actual results to differ materially from those expressed in the forward-looking statements. You are urged to
carefully review the disclosures we make concerning risks and other factors that may affect our business and operating results, including
those made in this Quarterly Report and our Annual Report on Form 10-K for the year ended June 30, 2025, as well as any of those made
in our other reports filed with the SEC. You are cautioned not to place undue reliance on the forward-looking statements included herein,
which speak only as of the date of this document. We do not intend, and undertake no obligation, to publish revised forward-looking statements
to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events.
Critical
Accounting Policies and Estimates
Our
significant accounting policies, which are described in the notes to our consolidated financial statements included in this report and
in our Annual Report on Form 10-K for the year ended June 30, 2025, have not changed during the three and six months ended December 31,
2025. We believe that our accounting policies and estimates relating to the carrying value of inventory, revenue recognition, accrued
expenses, purchase commitment liabilities, warrants and stock-based compensation are the most critical.
Our
Business
We
are a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin
receptor systems. Our product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant
unmet medical need and commercial potential. Our primary focus is the development of novel ‘next generation’ melanocortin-4
receptor (“MC4R”) agonists for treatment of rare neuroendocrine diseases.
Melanocortin
Receptor System. The melanocortin receptor (“MCR”) system has effects on food intake, metabolism, sexual function, inflammation,
and immune system responses. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of
receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have
significant pharmacological effects.
Our
prior commercial product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in June 2019 and was
initially marketed in the United States by AMAG Pharmaceuticals, Inc. (“AMAG”) for the treatment of hypoactive sexual desire
disorder (“HSDD”) in premenopausal women pursuant to a license agreement for Vyleesi for North America, which was entered
into on January 8, 2017 (the “AMAG License Agreement”). The AMAG License Agreement was terminated effective July 24, 2020,
and we commenced marketing Vyleesi in North America. Effective December 19, 2023, Cosette Pharmaceuticals, Inc.(“Cosette”)
acquired all rights to Vyleesi. As disclosed in Note 6 to the Consolidated Financial Statements, effective June 5, 2025, we entered into
a Release and Settlement Agreement with Cosette.
In
August 2025, as disclosed in Note 5 to the Consolidated Financial Statements, we entered into a Research Collaboration, License and Patent
Assignment Agreement with Boehringer-Ingelheim International GmbH (“Boehringer Ingelheim”) to research, develop and commercialize
first-in-class melanocortin receptor-targeted peptides we developed for the treatment of retinal diseases, including diabetic retinopathy.
In
January 2026, as disclosed in Note 13 to the Consolidated Financial Statements, we entered into a sublicense agreement with Altanispac
Labs, LLC to exclusively license PL9643, a clinical development MCR1 agonist for the treatment of dry eye disease.
Our
new product development activities focus on obesity, primarily MC4R agonists for the treatment of rare MC4R pathway diseases, like hypothalamic
obesity (HO) and Prader-Willi syndrome (PWS); and secondarily on ocular, gastroenterology, and renal indications. We are actively engaged
in discussions with potential partners and licensees that have the financial and operational resources to progress non-obesity products
through development, approval and commercialization.
20
Pipeline
Overview
The
following charts illustrate the status of our drug development programs. Multiple clinical trials are planned in calendar year 2026 for
treatment of rare MC4R pathway diseases:
The
following programs have been out-licensed, or are available to out-license or otherwise transfer:
Our
Strategy
Key
elements of our business strategy include:
●
Maintaining
a team to create, develop and commercialize MC4R agonists addressing unmet medical needs for rare MC4R pathway diseases;
●
Entering
into strategic alliances and partnerships with companies to facilitate the development, manufacture, marketing, sale, and distribution
of product candidates that we are developing, including products for indications other than obesity;
●
Partially
funding our product development programs with the cash flow generated from the sale of Vyleesi to Cosette, our agreement with Boehringer
Ingelheim, and existing license agreements, as well as any future research, collaboration, or license agreements; and
●
Completing
development and seeking regulatory approval of certain of our product candidates.
21
Corporate
Information
We
were incorporated under the laws of the State of Delaware on November 21, 1986 and commenced operations in the biopharmaceutical area
in 1996. Our corporate offices are located at 301 Carnegie Center Drive, Suite 304 Princeton, New Jersey 08540, and our telephone number
is (609) 495-2200. We maintain an Internet site, where among other things, we make available free of charge on and through this website
our Forms 3, 4 and 5, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d) and Section 16 of the Exchange Act as soon as reasonably practicable after
we electronically file such material with, or furnish it to, the SEC. Our website and the information contained in it or connected to
it are not incorporated into this Quarterly Report on Form 10-Q. The reference to our website is an inactive textual reference only.
The
SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that
file electronically with the SEC ( www.sec.gov ).
Results
of Operations
As
we continue to explore commercial opportunities and partners in both U.S. and international markets, we remain attentive to evolving
global economic conditions, including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although
these factors have not had a material impact on our operations to date, future changes in trade regulations, tariff structures, or logistical
constraints could influence the cost, availability, or timing of materials, services and other components associated with the development
of our product candidates and manufacturing capabilities. We continue to monitor these developments closely to maintain operational efficiency
and help mitigate potential future impacts.
Three
and Six months ended December 31, 2025, Compared to the Three and Six months ended December 31, 2024:
Revenues
– For the three and six months ended December 31, 2025, we recognized $116,036 and $8,963,586 in collaboration and license
revenue compared to $0 for the three and six months ended December 31, 2024. The increase in collaboration and license revenue is related
to the BI Agreement which consisted of an upfront payment, the achievement of a research milestone during the three months ended September
30, 2025, and FTE related reimbursements.
Research
and Development – Research and development expenses were $4,319,767 and $6,845,533 for the three and six months ended December
31, 2025, respectively, compared to $3,429,479 and $9,173,233 for the three and six months ended December 31, 2024, respectively. The
increase for the three months ended December 31, 2025 compared to the three months ended December 31, 2024 was primarily related to an
increase in spending on our MCR programs. The decrease for the six months ended December 31, 2025 compared to the six months ended December
31, 2024 was primarily related to a decrease in spending on our MCR programs.
Research
and development expenses related to our MCR programs were $2,290,073 and $3,260,702 for the three and six months ended December 31, 2025,
respectively, compared to $1,888,065 and $5,969,102 for the three and six months ended December 31, 2024, respectively. The increase
for the three months ended December 31, 2025 compared to the three months ended December 31, 2024 was primarily related to an increase
in spending on our MCR programs. The decrease for the six months ended December 31, 2025 compared to the six months ended December 31,
2024 was primarily related to a decrease in spending on our MCR programs.
The
amounts of project spending above exclude general research and development spending which was $2,029,694 and 3,584,831 for the three
and six months ended December 31, 2025, respectively, compared to $1,662,717 and $3,204,131 for the three and six months ended December
31, 2024. The increase is primarily attributable to an increase in compensation-related expenses.
Cumulative
spending from inception to December 31, 2025, was approximately $311,900,000 on our Vyleesi program and approximately $254,500,000 on
all our other programs (which include melanocortin receptor agonists, other discovery programs and terminated programs). Due to various
risk factors described in our Annual Report on Form 10-K for the year ended June 30, 2025, under “Risk Factors,” including
the difficulty in currently estimating the costs and timing of future Phase 1 clinical trials and larger-scale Phase 2 and Phase 3 clinical
trials for any product under development, we cannot predict with reasonable certainty when, if ever, a program will advance to the next
stage of development or be successfully completed, or when, if ever, related net cash inflows will be generated.
22
General
and Administrative – Selling, general and administrative expenses, which consist mainly of compensation and related costs,
were $3,124,817 and $4,785,548 for the three and six months ended December 31, 2025, respectively, compared to $1,681,844 and $3,702,775
for the three and six months ended December 31, 2024, respectively. The increase is a result of increased compensation costs and professional
fees.
Other
Income (Expense) – For the three and six months ended, December 31, 2025, total other income (expense), net was $64,687 and
$81,168, respectively. For the three and six months ended, December 31, 2024, total other income (expense), net was $168,841 and $109,877,
respectively. The decrease was a result of a decrease in investment income and foreign currency translation gain, offset by a decrease
in interest expense.
Liquidity
and Capital Resources
Since
inception, we have generally incurred net operating losses, primarily related to spending on our research and development programs. We
have financed our net operating losses primarily through debt and equity financings and amounts received under collaborative and license
agreements.
Our
product candidates are at various stages of development and will require significant further research, development, and testing and some
may never be successfully developed or commercialized. We may experience uncertainties, delays, difficulties, and expenses commonly experienced
by early-stage biopharmaceutical companies, which may include unanticipated problems and additional costs relating to:
●
the
development and testing of products in animals and humans;
●
product
approval or clearance;
●
regulatory
compliance;
●
good
manufacturing practices (“GMP”) compliance;
●
intellectual
property rights;
●
product
introduction;
●
marketing,
sales, and competition; and
●
obtaining
sufficient capital.
Failure
to enter into or successfully perform under collaboration agreements and obtain timely regulatory approval for our product candidates
and indications would impact our ability to generate revenues and could make it more difficult to attract investment capital for funding
our operations. Any of these possibilities could materially and adversely affect our operations and require us to curtail or cease certain
programs.
During
the six months ended December 31, 2025, net cash used in operating activities was $6,426,227 compared to $11,863,319 for the six months
ended December 31, 2024. The decrease was primarily related to license and produce revenue recognized during the six months ended December
31, 2025.
During
the six months ended December 31, 2025, net cash used in investing activities was $12,816 which consisted of cash used for the purchase
of property and equipment. During the six months ended December 31, 2024, net cash provided by investing activities was $2,500,000, which
consisted of proceeds from the sale of Vyleesi.
During
the six months ended December 31, 2025, net cash provided by financing activities was $18,350,940 which consisted of proceeds $16,911,453
of proceeds from an equity financing and $1,458,932 of proceeds from the exercise of warrants, offset by $19,444 for payment of withholding
taxes related to RSUs. During the six months ended December 31, 2024, net cash provided by financing activities was $3,252,527, which
consisted of $3,398,023 of proceeds from the exercise of warrants, offset by $99,482 for payment of withholding taxes related to RSUs
and $46,014 for payment of finance lease obligations
We
have incurred cumulative negative cash flows from operations since our inception, and have expended substantial funds to advance our
planned product development efforts. Continued operations are dependent upon our ability to complete equity or debt financing activities
and to enter into additional licensing or collaboration arrangements. As of December 31, 2025, our cash and cash equivalents were $14,476,162
and our current liabilities were $6,332,648.
On
January 8, 2026, we entered into a sublicense agreement (the “Altanispac Agreement”) with Altanispac Labs, LLC (“Altanispac”),
exclusively licensing PL9643, an MCR1 agonist for dry eye disease. In partial consideration for the rights to PL9643, the Altanispac
Agreement provided for upfront consideration in the form of non-cash debt cancellation of approximately $3,800,000, which is reflected
in our current liabilities as of December 31, 2025. We will recognize this $3,800,000 million as license revenue in our Consolidated
Statements of Operations for quarter ending March 31, 2026. There have been no material changes outside the ordinary course of business
to our contractual obligations and commitments, as disclosed in our Annual Report on Form 10-K for the year ended June 30, 2025.
23
We
intend to utilize existing capital resources for general corporate purposes and working capital requirements, including preclinical and
clinical development of our MC4R programs for the treatment of rare MC4R pathway diseases.
Based
on the Company’s current operating and development plans, the Company expects that its existing cash and cash equivalents as of
the date of this filing will be sufficient to enable it to fund operations through the next twelve months following the issuance of the
financial statements.
We
will need additional funding to complete required clinical trials for our product candidates and development programs and, if those clinical
trials are successful (which we cannot predict), to complete submission of required regulatory applications to the FDA. However, current
economic conditions (including current economic uncertainty, high interest rates, rising inflation, tariffs, and the potential for local
and/or global economic recession) may negatively impact our operations, including possible effects on our financial condition, ability
to access the capital markets on attractive terms or at all, liquidity, operations, suppliers, industry, and workforce. We will continue
to evaluate the impact that these events could have on the operations, financial position, and the results of operations and cash flows
during fiscal year 2026 and beyond.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
required to be provided by smaller reporting companies.
Item
4. Controls and Procedures.
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our
disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as of the end of the period covered by
this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls
and procedures were effective as of December 31, 2025.
There
were no changes in our internal control over financial reporting that occurred during the fiscal quarter ended December 31, 2025, that
have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.
24
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings.
We
may be involved, from time to time, in various claims and legal proceedings arising in the ordinary course of our business. On February
13, 2025, a complaint was filed in the Supreme Court of the State of New York, County of New York, captioned H.C. Wainwright &
Co., LLC (“Wainwright”) v. Palatin Technologies, Inc. , Case No: 650878/2025. The complaint names the Company as defendant,
asserting three causes of action for breach of contract and seeking monetary damages of approximately $1,000,000and the award of warrants
allegedly due. The breach of contract claims relate to engagement agreements entered into by the Company and Wainwright during 2023 and
2024. On March 20, 2025, the Company filed its answer in response to the complaint, in which it denied all liability and asserted several
affirmative defenses. In November 2025, the Company entered into a Settlement and Release Agreement with Wainwright, pursuant to which
the complaint was dismissed and the Company paid Wainwright $500,000, issued warrants to purchase 10,000 shares of the Company’s
common stock at an exercise price of $10.00 per share, and repriced 6,007 other warrants to an exercise price of $10.00 per share.
We
are not currently a party to any other claim or legal proceeding.
Item
1A. Risk Factors.
This
report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates,
forecasts and projections about us, our future performance, our business, our beliefs, and our management’s assumptions. These
statements are not guarantees of future performance, and they involve certain risks, uncertainties and assumptions that are difficult
to predict. You should carefully consider the risks and uncertainties facing our business.
Other
than set forth below, there have been no material changes to our risk factors disclosed in Part I, Item 1A, of our Annual Report on Form
10-K for the year ended June 30, 2025.
Inadequate
funding for the FDA, the SEC and other U.S. government agencies leading to government shut downs or other disruptions to these agencies’
staffing and operations could prevent new products and services from being developed or commercialized in a timely manner or otherwise
prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively
impact our operations.
The
ability of the FDA to review and approve new products can be affected by a variety of factors, including government funding, ability
to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times
at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC, and other government agencies
on which our operations may rely, including those that fund research and development activities is subject to the political process,
which is inherently fluid and unpredictable.
Disruptions
at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies,
which would adversely affect our business. For example, in recent years, the U.S. government shut down and certain regulatory agencies,
such as the FDA and the SEC, had to furlough critical employees and stop critical activities. If a prolonged government shutdown continues
to occur, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have
a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets
and obtain necessary capital in order to properly capitalize and continue our operations.
If
a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting
their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory
authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Separately,
the risk factor from our Annual Report on Form 10-K for the year ended June 30, 2025, titled “ Our common stock has been suspended
from trading on the NYSE American. If we fail to regain compliance with the NYSE American listing standards, our common stock may be
delisted from the NYSE American ”, is no longer a material risk to the Company, as the Company resumed trading on the NYSE American
effective November 12, 2025.
25
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
As
disclosed in the table below, 1,530 shares of common stock were withheld during the three months ended December 31, 2025, at the direction
of the employees and as permitted under the 2011 Stock Incentive Plan in order to pay the minimum amount of tax liability owed by the
employees from the vesting of previously issued restricted stock units:
Fiscal
Month Period
Total
Number
of
Shares
Purchased
(1)
Weighted
Average
Price
per Share
Total
Number of
Shares
Purchased
as
Part
of Publicly
Announced
Plans
or
Programs
Maximum
Number of Shares
that
May Yet be
Purchased
Under
Announced
Plans or
Programs
October 1, 2025 through October
31, 2025
-
$ -
-
-
November 1, 2025
through November 30, 2025
912
6.97
-
December
1, 2025 through December 31, 2025
618
21.38
-
-
Total
1,530
$ 12.71
-
-
(1)
Consists solely of 1,530 shares that were withheld to satisfy tax withholding amounts due from employees upon the vesting of previously
issued restricted stock units.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
During
the Company’s fiscal quarter ended December 31, 2025, no director or officer, as defined in Rule 1a-1(f), adopted or terminated
a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of
Regulation S-K.
26
Item
6. Exhibits.
Exhibits
filed or furnished with this report:
Exhibit
Number
Description
Filed
Herewith
Form
Filing
Date
SEC
File No.
3.1
Amended and Restated Bylaws of Palatin Technologies, Inc.
8-K
September
17, 2021
001-15543
3.2
Restated Certificate of Incorporation of Palatin Technologies, Inc., as amended.
10-K
September
27, 2013
001-15543
3.3
Certificate of Amendment to the Restated Certificate of Incorporation of Palatin Technologies, Inc., as amended.
8-K
August
31, 2022
001-15543
3.4
Certificate of Decrease of Series A Convertible Preferred Stock.
10-Q
May
16, 2022
001-15543
3.5
Certificate of Designation of the Rights, Powers, Preferences, Privileges, and Restrictions, of the Series D Convertible Preferred Stock of Palatin Technologies, Inc.
8-K
June
13, 2025
001-15543
3.6
Certificate of Amendment to Restated Certificate of Incorporation, filed with the Delaware Secretary of State on August 6, 2025.
8-K
August
8, 2025
001-15543
4.1
Form of Pre-Funded Common Stock Purchase Warrant.
8-K
February
10, 2025
001-15543
4.2
Form of Series E Common Stock Purchase Warrant.
8-K
February
10, 2025
001-15543
4.3
Form of Pre-Funded Warrant.
8-K
November
6, 2025
001-15543
4.4
Form of Series J Common Stock Purchase Warrant
8-K
November
6, 2025
001-15543
4.5
Form of Series K Common Stock Purchase Warrant
8-K
November
6, 2025
001-15543
10.1
Underwriting Agreement, dated November 5, 2025, by and among Palatin Technologies, Inc. and A.G.P./Alliance Global Partners.
8-K
November
6, 2025
001-15543
31.1
Certification of Chief Executive Officer.
X
31.2
Certification of Chief Financial Officer.
X
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.
*
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.
*
101.INS
Inline
XBRL Taxonomy Extension Instance Document (the instance document does not appear on the Interactive Data File because its XBRL tags
are embedded within the Inline XBRL document).
X
101.SCH
Inline
XBRL Taxonomy Extension Schema Document.
X
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document.
X
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
X
104
Cover
Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
X
*In
accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports
on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certification furnished
in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed”
for purposes of Section 18 of the Exchange Act. Such certification will not be deemed to be incorporated by reference into any filing
under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.
†
Management contract or compensatory plan or arrangement.
27
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.
Palatin
Technologies, Inc.
(Registrant)
/s/
Carl Spana
Date:
February 17, 2026
Carl
Spana, Ph.D.
President
and
Chief
Executive Officer (Principal
Executive
Officer)
/s/
Stephen T. Wills
Date:
February 17, 2026
Stephen
T. Wills, CPA, MST
Executive
Vice President, Chief Financial
Officer and Chief Operating Officer
(Principal
Financial and Accounting Officer)
28
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.