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PALATIN TECHNOLOGIES INC

For the period ended Dec 31, 2023. Filed Feb 14, 2024.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Dec 31, 2023 · Filed Feb 14, 2024

PTN$6.89-4.7%Stored close · as of Nov 10, 2026

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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, 2023

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)

Delaware95-4078884
(State or other jurisdiction ofincorporation or organization)(I.R.S. Employer Identification No.)
4B Cedar Brook DriveCranbury, New Jersey08512
(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 ClassTrading SymbolName of Each Exchange on Which Registered
Common Stock, par value $0.01 per sharePTNNYSE 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, 2024):16,136,640

PALATIN TECHNOLOGIES, INC.Table of Contents

Page
PART I – FINANCIAL INFORMATION
Item 1. · Financial Statements (Unaudited)
Consolidated Balance Sheets as of December 31, 2023 and June 30, 20235
Consolidated Statements of Operations for the Three and Six Months Ended December 31, 2023 and 20226
Consolidated Statements of Changes in Stockholders Deficiency for the Three and Six Months Ended December 31, 20237
Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders Equity for the Three and Six Months Ended December 31, 20228
Consolidated Statements of Cash Flows for the Six Months Ended December 31, 2023 and 20229
Notes to Consolidated Financial Statements10
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations23
Item 3.Quantitative and Qualitative Disclosures About Market Risk27
Item 4.Controls and Procedures27
PART II – OTHER INFORMATION
Item 1.Legal Proceedings28
Item 1A.Risk Factors28
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds48
Item 3.Defaults Upon Senior Securities48
Item 4.Mine Safety Disclosures48
Item 5.Other Information48
Item 6.Exhibits49
Signatures50

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 significant operating losses since our inception and our need to obtain additional financing has caused management to determine there is substantial doubt regarding our ability to continue as a going concern;
·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;
·the ability of Cosette Pharmaceuticals, Inc. (“Cosette”), which acquired Vyleesi® (the trade name for bremelanotide) for the treatment of premenopausal women with hypoactive sexual desire disorder (“HSDD”) from us, to increase sales and make sales-based milestone payments to Palatin;
·the results of clinical trials with our late-stage products, including
oPL9643, an ophthalmic peptide solution for dry eye disease (“DED”), which entered Phase 3 clinical trials in the fourth quarter of calendar year 2021, with top line results from the first Phase 3 clinical trial to be announced in the second half of February, 2024;
oPL8177, an oral peptide formulation for treatment of ulcerative colitis, which entered Phase 2 clinical trials in the third quarter of calendar year 2022; and
oa proof-of-concept melanocortin agonist clinical trial for diabetic nephropathy, which entered a Phase 2 clinical in the fourth quarter of calendar year 2022;
·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 third-party collaborators to timely carry out their duties under their agreements with us;
·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;
·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, 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;
·our ability to timely recognize and identify any material weaknesses in our accounting controls and procedures; 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.

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