Palatin Technologies, Inc. Reports Fourth Quarter and Fiscal Year 2019 Results Teleconference and Webcast to be held on

Palatin Technologies, Inc. Reports Fourth Quarter and

Fiscal Year 2019 Results

Teleconference and Webcast to be held on September 12,

CRANBURY, NJ September 12, 2019 Palatin Technologies, Inc. (NYSE American:

PTN), a specialized biopharmaceutical company developing

first-in-class medicines based on molecules that modulate the

activity of the melanocortin and natriuretic peptide receptor

systems, whose product candidates are targeted, receptor-specific

therapeutics for the treatment of diseases with significant unmet

medical need and commercial potential, today announced results for

its fourth quarter and fiscal year ended June 30,

last year was a landmark one for Palatin. We are proud of the

recent FDA approval of Vyleesi and the continued advancement of our

pipeline programs, said Carl Spana, Ph.D., President and

Chief Executive Officer of Palatin. The FDA approval is an

incredible achievement and milestone, and we are excited that

premenopausal women now have a safe and effective, as-needed option

available to them for the treatment of acquired, generalized HSDD.

Our cash and accounts receivable balances at June 30, 2019 of $102

million is sufficient to cover planned operations through at least

calendar year 2021. We remain focused

on advancing discussions on Vyleesi collaborations for

territories outside the currently licensed territories of North

America, China, and Korea, and initiating multiple clinical trials

for our pipeline programs over the next several quarters for the

treatment of dry eye disease, non-infectious uveitis and ulcerative

2019 Fiscal Year Highlights and Recent Events

Sexual Desire Disorder / Vyleesi (bremelanotide

U.S. Food and Drug Administration (FDA) granted marketing approval

of AMAG Pharmaceuticals, Inc.'s New Drug Application (NDA)

for Vyleesi (bremelanotide injection), a melanocortin

receptor agonist developed by Palatin, indicated for the treatment

of premenopausal women with acquired, generalized hypoactive sexual

desire disorder (HSDD). The FDA's approval of the NDA

on June 21, 2019 triggered a $60 million milestone payment to

Palatin under its North American license agreement with AMAG that

was received in July. Additionally, Palatin is entitled to receive

tiered royalties on net sales ranging from high single-digit to low

double-digit percentages, and sales milestones based on escalating

annual net sales thresholds, the first of which is $25 million,

triggered at annual net sales of $250 million.

is the first as needed treatment for premenopausal women with

acquired, generalized HSDD. Vyleesi is currently available through

specialty pharmacies, Avella and BioPlus, and AMAG will launch

Vyleesi nationally with its full sales force in

Anti-Inflammatory / Autoimmune Programs

agonist products are under development for the treatment of

inflammatory and autoimmune diseases such as dry eye, uveitis,

diabetic retinopathy and inflammatory bowel diseases (ulcerative

positive results of a micro-dose study of radiolabeled PL8177, a

selective melanocortin receptor 1 ( MC1r ) peptide

agonist, using an oral, delayed-release, polymer formulation. The

study met all primary and secondary endpoints. PL8177 has

potential application in treatment of ulcerative colitis and other

inflammatory bowel diseases. The FDA has granted orphan drug

designation for PL8177 for the treatment of non-infectious

intermediate, posterior, pan and chronic anterior uveitis.

Non-infectious uveitis (NIU) is a group of inflammatory diseases

that produces swelling and destroys eye tissue and can result in

vision loss. A Phase 2 proof-of-concept clinical study with a

systemic formulation in NIU patients is anticipated to commence in

the fourth quarter of calendar year 2019. A Phase 2

proof-of-concept clinical study with an oral formulation in

ulcerative colitis patients is anticipated to commence in the first

quarter of calendar year 2020.

application for PL9643, a melanocortin peptide agonist, and

commencement of a Phase 2 clinical study in dry eye disease, are

currently anticipated in the first quarter of calendar year

Natriuretic Peptide Receptor ( NPR ) System

The Company has designed and is developing potential drug

candidates that are selective agonist for one or more different

natriuretic peptide receptors, including natriuretic peptide

receptor-A ( NPR-A ), natriuretic peptide receptor B

( NPR-B ), and natriuretic peptide receptor C

( NPR-C ). Active collaborations with several

institutions are ongoing for PL3994, an NPR-A agonist that has

potential utility in the treatment of a number of cardiovascular

diseases, including genetic and orphan diseases resulting from a

deficiency of endogenous active NPR-A, and PL5028, a dual

NPR-A and NPR-C agonist in development for cardiovascular diseases,

including reducing cardiac hypertrophy and fibrosis. A Phase 2A

clinical trial evaluating PL3994 in heart failure patients with

preserved left ventricular ejection fraction will begin enrollment

in the latter half of calendar year 2019. This trial is supported

by a grant from the American Heart Association.

Genetic Obesity Program

The Company's melanocortin receptor 4 ( MC4r )

peptide PL8905 and orally-active small molecule PL9610 are

currently under investigation for the treatment of rare genetic

metabolic and obesity disorders. These programs are under internal

evaluation for orphan designation and potential

and accounts receivable balances at June 30, 2019 of $102 million

is sufficient to cover planned operations through at least calendar

year 2021. Included in the

accounts receivable balance is a $60 million milestone payment due

from AMAG for the Vyleesi FDA approval, which was received in July

Debt and related liabilities decreased from $7.2 million at June

30, 2018 to $0.8 million at June 30, 2019, with a final payment

remitted in July 2019.

Fourth Quarter and Fiscal 2019 Financial Results