UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act Of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter) |
|
| |||
(State or other jurisdiction |
| (Commission |
| (IRS employer |
of incorporation) |
| File Number) |
| identification number) |
| ||
(Address of principal executive offices) |
| (Zip Code) |
Registrant's telephone number, including area code: (
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
| Trading Symbol(s) |
| Name of Each Exchange on Which Registered |
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by checkmark 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. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 16, 2023, we issued a press release including results for our quarter ended March 31, 2023 and announcing a teleconference and webcast to be held May 16, 2023, at 11:00 a.m. Eastern time, which will include a discussion on results of operations in greater detail and an update on corporate developments. We have attached a copy of the press release as an exhibit to this report.
The information in this Item 2.02 and the corresponding information in the attached Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and the corresponding information in the attached Exhibit 99.1 shall not be incorporated into any registration statement or other document filed with the Securities and Exchange Commission by the company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
| 2 |
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 hereunto duly authorized.
| PALATIN TECHNOLOGIES, INC. |
| |
|
|
|
|
Date: May 16, 2023 | By: | /s/ Stephen T. Wills |
|
|
| Stephen T. Wills, CPA, MST |
|
|
| Executive Vice President, Chief Financial Officer and Chief Operating Officer |
|
| 3 |
EXHIBIT INDEX
| 4 |
EXHIBIT 99.1
Palatin Reports Third Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update
|
| · | Phase 3 PL9643 Data in Patients with Dry Eye Disease Presented at KOL Event | |
|
|
|
|
|
|
|
| o | Analysis of Lead-In Population of Initial 120 Patients Showed Statistical Separation for Clinical Efficacy Across Multiple Signs and Symptoms of Dry Eye along with Excellent Patient Safety and Tolerability |
|
|
|
|
|
|
|
| o | Final Data Expected Second Half Calendar Year 2023 |
|
|
|
|
|
|
| · | Phase 2 Clinical Study of Oral PL8177 in Patients with Ulcerative Colitis | |
|
|
|
|
|
|
|
| o | Interim Analysis Targeted for Second Half Calendar Year 2023 |
|
|
|
|
|
|
|
| o | Topline Results Currently Expected First Half Calendar Year 2024 |
|
|
|
|
|
|
| · | Vyleesi® | |
|
|
|
|
|
|
|
| o | Net Product Revenue Increased 16% Over the Prior Quarter |
|
|
|
|
|
|
|
| o | Prescriptions Dispensed Increased 27% Over the Prior Quarter |
|
|
|
|
|
|
|
| o | 5 Consecutive Quarters of Double-Digit Growth |
|
|
|
|
|
|
| · | Received $4.7 Million of Non-Dilutive Funding Through NJ Economic Development Program | |
|
|
|
|
|
|
| · | Teleconference and Webcast to be held on May 16, 2023, at 11:00 AM ET | |
|
|
|
|
|
CRANBURY, NJ – May 16, 2023 /PRNewswire/ – Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced financial results for its fiscal third quarter ended March 31, 2023.
“On the development front, we are excited that the analysis of the data for the Lead-In population of the initial 120 patients in our Phase 3 PL9643 clinical study demonstrated statistically significant positive effects on multiple endpoints for both signs and symptoms, including excellent patient safety and tolerability,” said Carl Spana, Ph.D., President and CEO of Palatin. “On the commercial front, we are pleased with Vyleesi’s fifth consecutive quarter of double-digit growth in net product revenue and dispenses. We are particularly pleased that Vyleesi’s quarterly net product revenue exceeds Vyleesi quarterly operating expenses.”
Business Highlights and Recent Updates
| · | Anti-Inflammatory / Autoimmune Programs | |||
|
|
|
|
|
|
|
| o | PL9643 melanocortin agonist for the treatment of dry eye disease (DED) | ||
|
|
|
|
|
|
|
|
| – | Review of Phase 3 clinical study data in patients with DED at Key Opinion Leader (KOL) Event. | |
|
|
|
|
|
|
|
|
|
| • | Analysis of Lead-In population of initial 120 patients completing 12 weeks of treatment showed statistical separation for clinical efficacy across multiple signs and symptoms of dry eye along with excellent patient safety and tolerability. |
-More-
| 1 |
|
| – | Presented initial Phase 3 clinical data at the Association of Research in Vision and Ophthalmology (ARVO) 2023 Annual Conference. |
|
| · | Data demonstrated positive effects on signs and symptoms. |
|
|
|
|
|
| · | Consistent clinical efficacy across multiple signs and symptoms of dry eye along with excellent safety and tolerability - a differentiating product profile. |
|
| – | Pivotal Phase 3 clinical study patient enrollment continuing. |
|
| · | Final data currently expected second half of calendar year 2023. |
|
| – | Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT04268069. |
|
| o | PL8177 oral melanocortin agonist for the treatment of ulcerative colitis (UC): |
|
| – | Interim assessment is currently expected to occur in the second half of calendar year 2023. |
|
|
|
|
|
| – | Topline results currently expected in the first half of calendar year 2024. |
|
|
|
|
|
| – | Digestive Disease Week Annual Conference. |
|
| · | Preclinical data shows PL8177 was found to be efficacious in animal models of inflammatory bowel disease. |
|
|
|
|
|
| · | Clinical data confirms PL8177 oral formulation is delivered and contained in the colon. |
|
| – | Frontiers in Immunology published a preclinical study demonstrating oral PL8177 provides therapeutic effects in inflammatory bowel disease and pharmacokinetic data showing PL8177 remains restricted to the gut. |
|
|
|
|
|
| – | Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT05466890. |
|
| o | Bremelanotide BREAKOUT study (BMT 701) in patients with diabetic kidney disease: |
|
| – | Enrollment is currently expected to be completed in the second half of calendar year 2023. |
|
|
|
|
|
| – | Topline results currently expected first half of calendar year 2024. |
|
|
|
|
|
| – | Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT05709444. |
|
| o | Preclinical data on melanocortin agonist PL8331 demonstrating therapeutic effects in diabetic retinopathy and uveitis published in the International Journal of Molecular Sciences. |
-More-
| 2 |
| · | Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate commercial product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company. |
|
| o | For the fiscal third quarter ended March 31, 2023: |
|
| – | Gross product sales were $3.4 million, an increase of 31% over the prior quarter, and an increase of 165% over the comparable quarter last year. |
|
|
|
|
|
| – | Net product revenue of $1.2 million increased 16% over the prior quarter and increased 453% over the comparable quarter last year. |
|
|
|
|
|
| – | Total prescriptions dispensed increased 27% over the prior quarter and increased 147% over the comparable quarter last year. |
|
|
|
|
|
| – | Refill rates, commercial insurance reimbursement, and net revenue per prescription dispensed continued with positive and impactful results and trends, versus the prior quarter and comparable quarter last year. |
|
| o | Issued a patent, titled “Use of Bremelanotide in Patients with Controlled Hypertension” with a term through April 29, 2041. |
|
|
|
|
|
| o | Patients and healthcare providers can learn more about HSDD and Vyleesi atwww.vyleesi.com andwww.vyleesipro.com. |
| · | Other: |
|
| o | Palatin received $4.7 million in January 2023 from the State of New Jersey’s Technology Business Tax Certificate Transfer Program sponsored by The New Jersey Economic Development Authority. |
Fiscal Third Quarter Ended March 31, 2023 Financial Results
Revenue
Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals, and license and contract revenue.
Vyleesi gross product sales to pharmacy distributors were $3.4 million, with net product revenue of $1.2 million, compared to gross product sales of $1.3 million and net product revenue of $0.2 million for the comparable quarter last year. Gross product sales increased 165% and net product revenue increased 453% over the comparable quarter last year.
Operating Expenses
Total operating expenses were $8.5 million, compared to $8.0 million for the comparable quarter last year. The increase in operating expenses was mainly the result of higher spending on our marketing efforts of Vyleesi.
Cash Flows
Palatin’s net cash used in operations was $1.4 million, compared to net cash used in operations of $9.5 million for the same period last year. The decrease in net cash used in operations is mainly due to the Company’s receipt of proceeds from the sale of the State of New Jersey NOLs and working capital changes for the quarter ended March 31, 2023.
-More-
| 3 |
Net Loss
Palatin’s net loss was $7.1 million, or $(0.63) per basic and diluted common share, compared to a net loss of $7.6 million, or $(0.80) per basic and diluted common share for the comparable quarter last year.
The decrease in net loss over the comparable quarter last year, was mainly due to an increase in net product revenue of Vyleesi of $1.0 million offset by an increase in operating expenses of $0.5 million.
Cash Position
As of March 31, 2023, Palatin’s cash and cash equivalents were approximately $19.6 million plus $1.7 million of accounts receivables, compared to cash and cash equivalents of $21.2 million with $6.5 million of accounts and other receivables as of December 31, 2022, and $29.9 million with $1.8 million of accounts receivable as of June 30, 2022.
Based on its current operating plan, the Company believes that existing cash and cash equivalents and receivables will be sufficient to fund currently anticipated operating expenses through calendar year 2023.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on May 16, 2023, at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-506-0062 (US) or 1-973-528-0011 (International), participant access code 555988. The audio webcast and replay can be accessed by logging on to the “Investor/Webcasts” section of Palatin’s website at http://www.palatin.com. A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), participant access code 48459. The webcast and telephone replay will be available through May 30, 2023.
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor (“MCr”) system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. 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 medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
-More-
| 4 |
About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about market potential of Vyleesi and other Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, Palatin's ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, sales of Vyleesi in the United States and elsewhere in the world, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release.
| Investor Inquiries: Stephen T. Wills, CPA, MST CFO/COO (609) 495-2200 Info@Palatin.com | Media Inquiries: Paul Arndt, MBA, LifeSci Advisors Managing Director (646) 597-6992 Paul@LifeSciAdvisors.com |
Palatin Technologies® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.
###
(Financial Statement Data Follows)
| 5 |
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)
|
|
| Three Months Ended March 31, |
|
| Nine Months Ended March 31, |
| ||||||||||
|
|
| 2023 |
|
| 2022 |
|
| 2023 |
|
| 2022 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
| REVENUES |
|
|
|
|
|
|
|
|
|
|
|
| ||||
| Product revenue, net |
| $ | 1,195,675 |
|
| $ | 216,097 |
|
| $ | 3,091,745 |
|
| $ | 447,719 |
|
| License and contract |
|
| - |
|
|
| - |
|
|
| - |
|
|
| 250,000 |
|
| Total revenues |
|
| 1,195,675 |
|
|
| 216,097 |
|
|
| 3,091,745 |
|
|
| 697,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Cost of products sold |
|
| 129,235 |
|
|
| 46,908 |
|
|
| 314,438 |
|
|
| 130,012 |
|
| Research and development |
|
| 4,830,327 |
|
|
| 4,980,074 |
|
|
| 15,224,896 |
|
|
| 13,891,235 |
|
| Selling, general and administrative |
|
| 3,537,376 |
|
|
| 3,009,528 |
|
|
| 10,220,518 |
|
|
| 10,163,830 |
|
| Gain on purchase commitment |
|
| - |
|
|
| - |
|
|
| (1,027,322 | ) |
|
| - |
|
| Total operating expenses |
|
| 8,496,938 |
|
|
| 8,036,510 |
|
|
| 24,732,530 |
|
|
| 24,185,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Loss from operations |
|
| (7,301,263 | ) |
|
| (7,820,413 | ) |
|
| (21,640,785 | ) |
|
| (23,487,358 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OTHER INCOME (EXPENSE) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Investment income |
|
| 234,044 |
|
|
| 1,127 |
|
|
| 509,006 |
|
|
| 4,100 |
|
| Foreign currency (loss) gain |
|
| (77,266 | ) |
|
| 190,719 |
|
|
| (352,121 | ) |
|
| 64,000 |
|
| Interest expense |
|
| (3,434 | ) |
|
| (3,019 | ) |
|
| (18,523 | ) |
|
| (11,423 | ) |
| Total other income (expense), net |
|
| 153,344 |
|
|
| 188,827 |
|
|
| 138,362 |
|
|
| 56,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Loss before income taxes |
|
| (7,147,919 | ) |
|
| (7,631,586 | ) |
|
| (21,502,423 | ) |
|
| (23,430,681 | ) |
| Income tax benefit |
|
| - |
|
|
| - |
|
|
| 4,674,999 |
|
|
| - |
|
| NET LOSS |
| $ | (7,147,919 | ) |
| $ | (7,631,586 | ) |
| $ | (16,827,424 | ) |
| $ | (23,430,681 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and diluted net loss per common share |
| $ | (0.63 | ) |
| $ | (0.80 | ) |
| $ | (1.59 | ) |
| $ | (2.46 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share |
|
| 11,432,380 |
|
|
| 9,552,214 |
|
|
| 10,613,830 |
|
|
| 9,537,768 |
|
| 6 |
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Balance Sheets
(unaudited)
|
|
| March 31, 2023 |
|
| June 30, 2022 |
| ||
| ASSETS |
|
|
|
|
|
| ||
| Current assets: |
|
|
|
|
|
| ||
| Cash and cash equivalents |
| $ | 19,632,330 |
|
| $ | 29,939,154 |
|
| Accounts receivable |
|
| 1,699,110 |
|
|
| 1,780,020 |
|
| Inventories |
|
| 630,033 |
|
|
| 944,471 |
|
| Prepaid expenses and other current assets |
|
| 2,277,498 |
|
|
| 1,932,454 |
|
| Total current assets |
|
| 24,238,971 |
|
|
| 34,596,099 |
|
|
|
|
|
|
|
|
|
|
|
| Property and equipment, net |
|
| 713,567 |
|
|
| 539,314 |
|
| Right-of-use assets - operating leases |
|
| 599,442 |
|
|
| 878,465 |
|
| Other assets |
|
| 56,916 |
|
|
| 56,916 |
|
| Total assets |
| $ | 25,608,896 |
|
| $ | 36,070,794 |
|
|
|
|
|
|
|
|
|
|
|
| LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
| Current liabilities: |
|
|
|
|
|
|
|
|
| Accounts payable |
| $ | 2,786,313 |
|
| $ | 3,157,617 |
|
| Accrued expenses |
|
| 5,536,033 |
|
|
| 6,875,216 |
|
| Short-term operating lease liabilities |
|
| 301,169 |
|
|
| 371,124 |
|
| Short-term finance lease liabilities |
|
| 104,998 |
|
|
| 100,921 |
|
| Other current liabilities |
|
| 3,122,850 |
|
|
| 5,754,986 |
|
| Total current liabilities |
|
| 11,851,363 |
|
|
| 16,259,864 |
|
|
|
|
|
|
|
|
|
|
|
| Long-term operating lease liabilities |
|
| 320,490 |
|
|
| 529,398 |
|
| Long-term finance lease liabilities |
|
| 73,141 |
|
|
| 152,407 |
|
| Other long-term liabilities |
|
| 3,771,400 |
|
|
| 2,861,250 |
|
| Total liabilities |
|
| 16,016,394 |
|
|
| 19,802,919 |
|
|
|
|
|
|
|
|
|
|
|
| Series B and Series C Redeemable Convertible Preferred Stock of $0.01 par value: authorized 9,000,000 shares, 9,000,000 shares issued and outstanding as of June 30, 2022, with a liquidation preference of $15,000,000 |
|
| - |
|
|
| 15,000,000 |
|
| Escrowed proceeds |
|
| - |
|
|
| (15,000,000 | ) |
|
|
|
|
|
|
|
|
|
|
| Stockholders equity: |
|
|
|
|
|
|
|
|
| Preferred stock of $0.01 par value authorized 10,000,000 shares (including amounts authorized for authorized for Series B and Series C Redeemable Convertible Preferred Stock): |
|
|
|
|
|
|
|
|
| Shares issued and outstanding designated as follows: |
|
|
|
|
|
|
|
|
| Series A Convertible: authorized 4,030 shares as of March 31, 2023: issued and outstanding 4,030 shares as of March 31, 2023 and June 30, 2022 |
|
| 40 |
|
|
| 40 |
|
| Common stock of $0.01 par value authorized 300,000,000 shares: issued and outstanding 11,152,680 shares as of March 31, 2023 and 9,270,947 shares as of June 30, 2022 |
|
| 111,527 |
|
|
| 92,709 |
|
| Additional paid-in capital |
|
| 414,302,055 |
|
|
| 404,168,822 |
|
| Accumulated deficit |
|
| (404,821,120 | ) |
|
| (387,993,696 | ) |
| Total stockholders equity |
|
| 9,592,502 |
|
|
| 16,267,875 |
|
| Total liabilities, redeemable convertible preferred stock, and stockholders equity |
| $ | 25,608,896 |
|
| $ | 36,070,794 |
|
| 7 |
Cover |
May 16, 2023 |
|---|---|
| Cover [Abstract] | |
| Entity Registrant Name | Palatin Technologies, Inc. |
| Entity Central Index Key | 0000911216 |
| Document Type | 8-K |
| Amendment Flag | false |
| Entity Emerging Growth Company | false |
| Document Period End Date | May 16, 2023 |
| Entity Incorporation State Country Code | DE |
| Entity Tax Identification Number | 95-4078884 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Entity File Number | 001-15543 |
| Entity Address Address Line 1 | 4B Cedar Brook Drive |
| Entity Address City Or Town | Cranbury |
| Entity Address State Or Province | NJ |
| Entity Address Postal Zip Code | 08512 |
| City Area Code | 609 |
| Local Phone Number | 495-2200 |
| Security 12b Title | Common Stock |
| Trading Symbol | PTN |
| Security Exchange Name | NYSE |
| Pre Commencement Issuer Tender Offer | false |