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Striving to Treat Inflammation Safely and More Effectively

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How this company’s novel therapeutics might be the next big thing in treating autoimmune and more

In a world with countless pharmaceuticals, it can be hard to know that the treatment you’re on is the one that’s right for you. After all, you want the medicine you’re taking to work, but you don’t want it to be harmful to your health. More and more, people want therapeutic treatments that focus on harnessing the body’s natural ability to heal itself.

That’s exactly what Palatin Technologies (NYSE: PTN) is doing. Palatin develops novel therapeutics designed to help resolve the unmet needs of patients who live with a variety of inflammatory and autoimmune diseases.

It does it by creating potent compounds that work in tandem with the body’s ability to reduce inflammation via the melanocortin system. By leveraging its expert knowledge of the melanocortin system, Palatin is able to create solutions that offer an unprecedented approach to resolving inflammation allowing affected tissues time to heal. With a focus on ocular diseases, Palatin tackles full-scale therapeutics development, from drug discovery through FDA approval.

 

What is the Melanocortin System?

The melanocortin system is controlled by a group of five related receptors that receive inputs from hormones, nutrients, and afferent neural inputs. The system as a whole is essential to the body’s control of a variety of physiological functions, including inflammation, immune response, metabolism, steroid hormone production, and sexual function.

Palatin is focused on harnessing the melanocortin system in the following areas:

  • Brain – Melanocortin receptors in the hypothalamus affect weight maintenance and energy use. Melanocortin medicines can help patients reduce food intake and lose weight.
  • Eyes – Multiple cells and tissues in the eyes contain melanocortin receptors, providing the opportunity to use natural pathways to aid in reducing disease-associated inflammation.
  • Colon – Bowel inflammation can be reduced by locally engaging receptors found on intestinal epithelial cells immune cells.
  • Kidney – Podocytes essential kidney cells express the melanocortin receptor 1 (MCR1). By activating these cells via medicines that engage the MCR1, it may be possible to improve kidney function in a variety of kidney diseases.

Palatin addresses the needs of patients by researching, designing, and developing highly selective peptides and small molecule agonists designed to target specific melanocortin receptors. The goal is to develop novel medicines that provide relief to individuals who suffer from inflammation and autoimmune diseases.

 

First Out of the Gate

Palatin was the first company to develop this unique approach to the melanocortin system and get approval for novel melanocortin based medicine. The Palatin team is widely regarded as pioneers and experts in developing melanocortin based medicines.

It all started when the company developed Vyleesi®, a novel FDA approved medicine used to treat women living with generalized hypoactive sexual desire disorder (HSDD). This extremely successful treatment has helped countless women take control of their sex drive and improve their quality of life by extension.

The creation of Vyleesi® established Palatin as a leader in melanocortin system-based treatments and led them to move on to develop additional ​​groundbreaking therapeutics for inflammatory and autoimmune diseases, with a focus on ocular conditions.

 

Backed By Science

Once Palatin began to tap into the utility of melanocortin pathways as a method of developing novel medicines it kept that momentum going.

Palatin’s corporate presentation puts it best, “Our development arm builds on our proven success in bringing a melanocortin therapeutic from the lab to market by using our experience to propel our programs in ocular and autoimmune diseases from discovery to approval.”

In regard to its focus on ocular conditions, Palatin knows that the stakes are high. Over 20 million people in the United States suffer from dry eye disease (DED) and yet there are very few treatments to help relieve the irritation, redness, discharge, and blurred vision it causes. The scientists at Palatin see DED for what it is – a chronic, painful, debilitating inflammatory condition that requires a new, innovative course of treatment.

So Palatin got to work, developing a truly novel class of drugs that selectively bind to melanocortin receptors (MCR), that directly activate natural pathways that resolve disease inflammation in the eye. These drugs also have the advantage of better addressing the discomfort caused by inflammation in the tissues in the eye. The product is currently called the PL9643 ophthalmic solution, but we’ll get into this a little more later.

For now, we can’t go on without addressing Palatin’s advancement in autoimmune therapeutics. Melanocortin-based treatments have incredible potential to address autoimmune-related inflammation with far fewer complications than traditional broad immunosuppressant treatments.

The research work done by Palatin and academic laboratories demonstrate the potential of melanocortin based medicines as treatment for ulcerative colitis (UC). This is good news for the nearly 1 million people in the U.S. who suffer from autoimmune diseases, like UC, that result in chronic colon inflammation. Palatin is currently working on MCR1 agonist (PL8177), a delayed release, oral formula designed to maximize local treatment for diseased bowels while minimizing adverse systemic effects.

 

Feast Your Eyes on This

Recently, Palatin’s dry eye treatment, PL9643, entered Phase 3 clinical trials with the initiation of its pivotal MELODY-1 clinical study. During the course of the study in cities across the United States subjects will be enrolled to help evaluate the potential of PL9643 as a treatment for DED. Results of the study are expected to be released in the latter half of 2022.

“We are excited to initiate the MELODY-1 study of PL9643 in patients suffering from dry eye disease,” said Carl Spana, Ph.D., CEO and President of Palatin. “This is the second melanocortin peptide Palatin has advanced into Phase 3, demonstrating Palatin’s expertise and efficiency in melanocortin peptide development for indications with unmet medical need.”

The pivotal Phase 3 MELODY-1 clinical study is a multi-center, randomized, double-masked, and vehicle-controlled study. It’s designed to determine the efficacy and safety of the melanocortin agonist, PL9643 ophthalmic solution. The framework for the study is based on the successful results of Phase 2 and a successful end-of-phase meeting with the U.S. Food and Drug Administration. If all goes well, Palatin hopes to submit the treatment to the NDA within the first half of 2024.

And, given that the Phase 2 study demonstrated marked improvements in both the signs and symptoms of DED after only two weeks of treatment, with no safety signals and excellent tolerability, the future of Palatin’s PL9643 treatment is looking pretty bright.

 

First-in-Class Equals First in Patents

As a company pioneering the development of melanocortin based medicines , Palatin knows how important it is to protect its intellectual property. Recently, the U.S. Patent and Trademark Office issued a Notice of Allowance for Application No.: 16/927,347, which relates to the use of melanocortin peptides to decrease pro-inflammatory cytokine production and expression associated with cytokine storm.

Carl Spana, Ph.D., President and CEO of Palatin, spoke about the recent patent application saying, “We continue to strengthen our intellectual property surrounding our melanocortin receptor-1 peptide portfolio, particularly when early data suggest they can help resolve the overproduction and expression of pro-inflammatory cytokines associated with many diseases, including acute viral infections such as COVID-19. We continue to develop this technology as part of our diversified platform.”

Palatin’s platform is, indeed, diverse. With multiple programs in development, this patent is only one part of a family of patents that relates to melanocortin receptor-1 peptides and covers additional intellectual property relating to the use of high potency melanocortin receptor-1 peptides.

Speaking of patents, the United States Patent and Trademark Office issued Notices of Final Determination and Requirement for Election on a patent term extension for two U.S. patents covering Vyleesi®. Pursuant to the Drug Price Competition and Patent Term Restoration Act, U.S. patent 6,794,489 for Vyleesi® was extended for the maximum term and has an expiration date of June 28, 2025.

 

Innovation in Medicine

It’s clear that Palatin Technologies knows what it’s doing but, as an investor, you’re probably wondering how this vast experience translates to financial gain. So, let’s take a look at the financials.

Starting with Vyleesi®, Palatin announced that for the third quarter of 2021, gross product sales amounted to $1.4 million with a net product revenue of $159,482. This is a huge improvement over the previous quarter when gross product sales reached $809,100, with negative net product revenue of $(288,560).

Recently, Palatin announced results for the fiscal third quarter ending on March 31, 2022. Financial results from that quarter included the following highlights:

  • Net loss for the quarter was $7.6 million, compared to a net loss of $5.7 million for the same period in 2021.
  • As of March 31, 2022, the Company had cash and investments of $37.7 million, compared to $47.3 million as of December 31, 2021, and $60.1 million as of June 30, 2021, and no debt.
  • Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Gross product sales increased 67%, net product revenue increased 200% and prescriptions increased 20%, over the prior quarter.

This most recent quarter also brought significant results from the company’s Vyleesi Hypoactive Sexual Desire Disorder (HSDD) treatment for women. The goal of the Vyleesi program is to demonstrate product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company.

For the quarter ended March 31, 2022, Vyleesi achieved:

  • Gross product sales increased 67% over the prior quarter, decreased 27% over the comparable quarter in 2021.
  • Net product revenue increased 200% over the prior quarter, increased 144% over the comparable quarter in 2021.
  • Total prescriptions dispensed increased 20% over the prior quarter, flat compared to the comparable quarter in 2021.
  • Refill rates, commercial insurance reimbursement, and net revenue per prescription dispensed increased over the prior quarter and comparable quarter in 2021.

Investors, patients, and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com.

Some other notable product highlights include:

  • The initiation of the pivotal Phase 3 clinical program in DED patients in December 2021, using its PL9643 melanocortin agonist.
  • Reporting positive effects of PL8177 on treating ulcerative colitis in an animal disease model, including genomic data characterizing the anti-inflammatory effects of melanocortin agonists.
  • Planning for a phase 2 oral formulation study of PL8177 in UC patients that are currently scheduled to start in the first half of the calendar year 2022.
  • The presentation of the protective effects of PL8331 and PL9654 in mouse models of retinopathy, at the 2021 Annual Meeting of the American Society of Retina Specialists.
  • Plans to continue to strengthen its R&D department with key appointments who have demonstrated a high level of expertise in their fields.

Believe us, we understand that this is a lot of complex medical data. What it all comes down to is this: Palatin has the experience and leadership to be successful.

It’s one of the leading companies creating medicines based on the melanocortin system utilizing the body’s natural defenses to create a well-rounded, safe, and efficient treatment for a variety of inflammatory and autoimmune diseases.

The Company has a science-driven approach to bringing potential treatments to patients by responding to the challenges inherent to drug design and development with agility, expertise, and determination.

Palatin’s innovation is unmatched, their grit unparalleled, and their future is undeniably promising. As Palatin Technologies (NYSE: PTN) continues to explore uncharted waters, smart investors would do well to jump on board this ship before too many others do.

 

PR and News

 

Management Team: 

Carl Spana, PhD

CEO, President and Director

Carl Spana, the co-founder of Palatin, has been the Chief Executive Officer and President since June 14, 2000. He has been a director of Palatin since June 1996 and has been a director of their wholly-owned subsidiary, RhoMed Incorporated, since July 1995. From June 1996 through June 14, 2000, Dr. Spana served as an executive vice president and our chief technical officer.

From June 1993 to June 1996, Dr. Spana was vice president of Paramount Capital Investments, LLC, a biotechnology and biopharmaceutical merchant banking firm, and of The Castle Group Ltd., a medical venture capital firm. Through his work at Paramount Capital Investments and The Castle Group, Dr. Spana co-founded and acquired several private biotechnology firms.

From July 1991 to June 1993, Dr. Spana was a research associate at Bristol-Myers Squibb, a publicly held pharmaceutical company, where he was involved in scientific research in the field of immunology. Dr. Spana received his Ph.D. in molecular biology from Johns Hopkins University and his BS in biochemistry from Rutgers University.

 

Stephen T. Wills, CPA, MST

Chief Financial Officer, Chief Operating Officer, and Treasurer and Secretary

Mr. Wills has served on the board of directors of MediWound Ltd. (Nasdaq: MDWD), a biopharmaceutical company focused on treatment in the fields of severe burns, chronic and other hard to heal wounds, since April 2017, and as Chairman since January 2018, and also has served on the board of directors of Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, since March 2019 (audit, compensation, and finance committee member), and of Amryt Pharma, a biopharmaceutical company focused on developing and delivering treatments to help improve the lives of patients with rare and orphan diseases, since September 2019 (chairman of audit committee and member of the compensation and finance committee).

Mr. Wills has also served on the board of trustees and executive committee of The Hun School of Princeton, a college preparatory day and boarding school, since 2013, and as its Chairman since June 2018. Mr. Wills served as Executive Chairman and Interim Principal Executive Officer of Derma Sciences, Inc., a provider of advanced wound care products, from December 2015 to February 2017, when Derma Sciences was acquired by Integra Lifesciences (Nasdaq: IART).

Previously, Mr. Wills served on the board of directors of Derma Sciences as the lead director and chairman of the audit committee from June 2000 to December 2015. Mr. Wills served as the Chief Financial Officer of Derma Sciences from 1997 to 2000. Mr. Wills served as the President and Chief Operating Officer of Wills, Owens & Baker, P.C., a public accounting firm, from 1991 to 2000. Mr. Wills, a certified public accountant, earned his Bachelor of Science in accounting from West Chester University, and a Master of Science in taxation from Temple University.

 

Stephen A. Slusher

Chief Legal Officer and Assistant Secretary

Previously, Stephen A. Slusher was a partner in a boutique intellectual property law firm in Albuquerque, New Mexico, Peacock Law PC, where he remains of counsel. Earlier in his career, he was involved in the creation of several biotechnology companies. He is a registered patent attorney and licensed attorney and has developed the intellectual property strategy for Palatin. Mr. Slusher received his B.A. degree from St. John’s College in Santa Fe, New Mexico, and his J.D. degree from the University of New Mexico.

 

Michael B. Raizman, M.D.

Chief Medical Officer

Michael B. Raizman is a cornea and cataract specialist at Ophthalmic Consultants of Boston and the New England Eye Center at Tufts Medical Center.

Dr. Raizman received his medical training at the University of Michigan and Harvard Medical School. He completed two fellowships at the Massachusetts Eye & Ear Infirmary, followed by three years of post-doctoral research at Harvard Medical School, funded by grants from the National Institutes of Health.

Dr. Raizman served on the full-time faculty at Harvard Medical School from 1988-1991. Dr. Raizman is an Associate Professor of Ophthalmology at Tufts University School of Medicine, where he has directed the Corneal Fellowship Program and the Cornea and Cataract Service since 1992. In that capacity, he has trained over 50 Cornea Fellows. He is on the medical staff of the Massachusetts General Hospital, Massachusetts Eye and Ear, and Tufts Medical Center.

Dr. Raizman has pioneered many advancements in the field of cornea and inflammatory eye disease. Since the early 1990s has led to advances in laser therapy of eye disorders, post-operative inflammation, and more recently the development of techniques in corneal crosslinking. He has participated in over 100 clinical trials and published the results of trials, primarily in corneal surgery and ocular drug therapy.

Dr. Raizman has served on multiple medical and advisory boards as well as journal editorial boards. He received a Senior Honor Award from the American Academy of Ophthalmology for his scientific presentations and educational activities. He has delivered over 350 invited lectures throughout the United States, Canada, Mexico, South America, Europe, and Asia and has been a visiting professor at the medical schools of Columbia University, UCLA, University of Michigan, University of Texas, Loyola, Jefferson Medical College, and others.

He delivered a distinguished alumnus lecture at the University of Michigan and was the invited speaker at the 30-year reunion of his Harvard ophthalmology class. He has delivered multiple named lectures and authored over 100 peer-reviewed medical journal articles, as well as numerous book chapters and books. In 2020, he was named the “Ophthalmologist of the Year” by the National Keratoconus Foundation.

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  • Period of Campaign - 02/22/2022 - 05/22/2022

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