[X]
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
[ ]
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
95-4078884
|
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
|
4B Cedar Brook Drive
Cranbury, New Jersey
|
08512
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of Each Class
|
Name of Each Exchange
on Which Registered
|
|
Common Stock, par value $.01 per share
|
NYSE MKT
|
Large accelerated filer [ ] | Accelerated filer [ ] | |
Non-accelerated filer [ ]
(Do not check if a smaller reporting company)
|
Smaller reporting company [X] |
Page
|
||
PART I
|
||
Item 1.
|
Business
|
1
|
Item 1A.
|
Risk Factors
|
18
|
Item 1B.
|
Unresolved Staff Comments
|
37
|
Item 2.
|
Properties
|
37
|
Item 3.
|
Legal Proceedings
|
37
|
Item 4.
|
Mine Safety Disclosures
|
37
|
PART II
|
||
Item 5.
|
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
|
38
|
Item 6.
|
Selected Financial Data
|
38
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
39
|
Item 7A.
|
Quantitative and Qualitative Disclosures About Market Risk
|
43
|
Item 8.
|
Financial Statements and Supplementary Data
|
44
|
Item 9.
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
65
|
Item 9A.
|
Controls and Procedures
|
65
|
Item 9B.
|
Other Information
|
65
|
PART III
|
||
Item 10.
|
Directors, Executive Officers and Corporate Governance
|
66
|
Item 11.
|
Executive Compensation
|
70
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
|
76
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence
|
80
|
Item 14.
|
Principal Accountant Fees and Services
|
81
|
PART IV
|
||
Item 15.
|
Exhibits, Financial Statement Schedules
|
82
|
● |
Bremelanotide, an on-demand subcutaneous injectable peptide melanocortin receptor agonist, for treatment of FSD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual response. Bremelanotide is in Phase 3 clinical trials, with patient enrollment projected to be completed this year, and topline results in the third quarter of calendar 2016;
|
● |
Melanocortin receptor-4, or MC4r, compounds for treatment of obesity and diabetes. Results of our studies involving MC4r peptides suggest that certain of these peptides may have significant commercial potential for treatment of conditions responsive to MC4r activation, including FSD, erectile dysfunction or ED, obesity and diabetes;
|
● |
PL-3994, a natriuretic peptide receptor-A, or NPR-A, agonist, for treatment of cardiovascular and pulmonary indications. PL-3994 is our lead natriuretic peptide receptor product candidate, and is a synthetic mimetic of the neuropeptide hormone atrial natriuretic peptide, or ANP. PL-3994 is in development for treatment of heart failure, acute exacerbations of asthma and refractory hypertension; and
|
● |
Melanocortin receptor-1, or MC1r, agonist peptides for treatment of inflammatory and dermatologic disease indications. Our MC1r peptide drug candidates are highly specific, with substantially greater binding and efficacy at MC1r than at other melanocortin receptors. We have selected one of our MC1r peptide drug candidates, designated PL-8177, as a clinical trial candidate.
|
●
|
Using our technology and expertise to develop and commercialize products in our active drug development programs;
|
●
|
Entering into strategic alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that we are developing;
|
●
|
Partially funding our product development programs with the cash flow generated from research collaboration and license agreements and any potential future agreements with third parties; and
|
●
|
Completing development and seeking regulatory approval of bremelanotide for FSD and our other product candidates.
|
●
|
completion of preclinical laboratory tests, preclinical animal testing and formulation studies;
|
●
|
submission to the FDA of an IND, which must be in effect before clinical trials may commence;
|
●
|
submission to the FDA of an NDA that includes preclinical data, clinical trial data and manufacturing information;
|
●
|
payment of substantial user fees for filing the NDA and other recurring user fees;
|
●
|
FDA review of the NDA;
|
●
|
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities; and
|
●
|
FDA approval of the NDA, including approval of all product labeling.
|
●
|
recordkeeping requirements;
|
●
|
periodic reporting requirements;
|
●
|
GMP requirements related to all stages of manufacturing, testing, storage, packaging, labeling and distribution of finished dosage forms of the product;
|
●
|
monitoring and reporting of adverse experiences with the product; and
|
●
|
advertising and promotional reporting requirements and restrictions.
|
●
|
restrictions on the marketing or manufacturing of a product;
|
●
|
Warning Letters or Untitled Letters from the FDA asking us, our collaborators or third-party contractors to take or refrain from taking certain actions;
|
●
|
withdrawal of the product from the market;
|
●
|
the FDA’s refusal to approve pending applications or supplements to approved applications;
|
●
|
voluntary or mandatory product recall;
|
●
|
fines or disgorgement of profits or revenue;
|
●
|
suspension or withdrawal of regulatory approvals;
|
●
|
refusals to permit the import or export of products;
|
●
|
product seizure; and
|
●
|
injunctions or the imposition of civil or criminal penalties.
|
●
|
the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs;
|
●
|
federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
●
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
|
●
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
●
|
the federal physician sunshine requirements under the Affordable Care Act, which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; and
|
●
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
|
●
|
continuing to conduct preclinical development and clinical trials;
|
●
|
participating in regulatory approval processes;
|
●
|
formulating and manufacturing products, or having third parties formulate and manufacture products;
|
●
|
post-approval monitoring and surveillance of our products;
|
●
|
conducting sales and marketing activities, either alone or with a partner; and
|
●
|
obtaining additional capital.
|
● |
the ability to raise additional capital on acceptable terms, or at all;
|
●
|
timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;
|
●
|
whether we are required by the FDA or similar foreign regulatory agencies to conduct additional clinical trials beyond those planned to support the approval and commercialization of our product candidates or any future product candidates;
|
●
|
acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities;
|
●
|
our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities, the safety and efficacy of our product candidates or any future product candidates;
|
●
|
the prevalence, duration and severity of potential side effects experienced with our product candidates or future approved products, if any;
|
●
|
the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;
|
●
|
achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any;
|
●
|
the ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our product candidates or any future product candidates, remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with GMP;
|
●
|
a continued acceptable safety profile and efficacy during clinical development and following approval of our product candidates or any future product candidates;
|
●
|
our ability to successfully commercialize our product candidates or any future product candidates in the United States and internationally, if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others;
|
●
|
acceptance by physicians and patients of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments;
|
●
|
our and our partners’ ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates;
|
●
|
our and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and
|
●
|
our ability to in-license or acquire additional product candidates or commercial-stage products that we believe can be successfully developed and commercialized.
|
●
|
the results of our Phase 3 clinical trials for bremelanotide for FSD;
|
●
|
the timing of, and the costs involved in, obtaining regulatory approvals for bremelanotide for FSD and our other product candidates;
|
●
|
the number and characteristics of any additional product candidates we develop or acquire;
|
●
|
the scope, progress, results and costs of researching and developing bremelanotide for FSD, PL-3994 or any future product candidates, and conducting preclinical and clinical trials;
|
●
|
the cost of commercialization activities if bremelanotide for FSD, PL-3994 or any future product candidates are approved for sale, including marketing, sales and distribution costs;
|
●
|
the cost of manufacturing bremelanotide for FSD, PL-3994 or any future product candidates and any products we successfully commercialize and maintaining our related facilities;
|
●
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms and timing of such arrangements;
|
●
|
the degree and rate of market acceptance of any future approved products;
|
●
|
the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments;
|
●
|
any product liability or other lawsuits related to our products;
|
●
|
the expenses needed to attract and retain skilled personnel;
|
●
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and
|
●
|
the timing, receipt and amount of sales of, or royalties on, future approved products, if any.
|
●
|
timely completion of, or need to conduct additional, clinical trials, including our Phase 3 clinical trials in the United States for bremelanotide for FSD, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the accurate and satisfactory performance of third-party contractors;
|
●
|
our ability to demonstrate to the satisfaction of the FDA the safety and efficacy of bremelanotide for FSD or any future product candidates through clinical trials;
|
●
|
whether we are required by the FDA or other similar foreign regulatory agencies to conduct additional clinical trials to support the approval of bremelanotide for FSD or any future product candidates;
|
●
|
the acceptance of parameters for regulatory approval, including our proposed indication, primary endpoint assessment and primary endpoint measurement, relating to our lead indications of bremelanotide for FSD;
|
●
|
our success in educating physicians and patients about the benefits, administration and use of bremelanotide for FSD or any future product candidates, if approved;
|
●
|
the prevalence and severity of adverse events experienced with bremelanotide for FSD or any future product candidates or approved products;
|
●
|
the adequacy and regulatory compliance of the autoinjector device, supplied by an unaffiliated third party, to be used as part of our bremelanotide combination product;
|
●
|
the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;
|
●
|
our ability to raise additional capital on acceptable terms to achieve our goals;
|
●
|
achieving and maintaining compliance with all regulatory requirements applicable to bremelanotide for FSD or any future product candidates or approved products;
|
●
|
the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments;
|
●
|
the effectiveness of our own or our future potential strategic collaborators’ marketing, sales and distribution strategy and operations;
|
●
|
our ability to manufacture clinical trial supplies of bremelanotide for FSD or any future product candidates and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current GMP;
|
●
|
our ability to successfully commercialize bremelanotide for FSD or any future product candidates, if approved for marketing and sale, whether alone or in collaboration with others;
|
●
|
our ability to enforce our intellectual property rights in and to bremelanotide for FSD or any future product candidates;
|
●
|
our ability to avoid third-party patent interference or intellectual property infringement claims;
|
●
|
acceptance of bremelanotide for FSD or any future product candidates, if approved, as safe and effective by patients and the medical community; and
|
●
|
a continued acceptable safety profile and efficacy of bremelanotide for FSD or any future product candidates following approval.
|
●
|
lack of effectiveness of any product candidate during clinical trials or the failure of our product candidates to meet specified endpoints;
|
●
|
failure to design appropriate clinical trial protocols;
|
●
|
uncertainty regarding proper dosing;
|
●
|
inability to develop or obtain a supplier for an autoinjector device that meets the FDA’s medical device requirements;
|
●
|
insufficient data to support regulatory approval;
|
●
|
inability or unwillingness of medical investigators to follow our clinical protocols;
|
●
|
inability to add a sufficient number of clinical trial sites; or
|
● |
the availability of sufficient capital to sustain operations and clinical trials.
|
●
|
product approval or clearance;
|
●
|
regulatory compliance;
|
●
|
good manufacturing practices;
|
●
|
intellectual property rights;
|
●
|
product introduction; and
|
●
|
marketing and competition.
|
●
|
discovery of serious or unexpected toxicities or side effects experienced by study participants or other safety issues;
|
●
|
slower than expected rates of subject recruitment and enrollment rates in clinical trials resulting from numerous factors, including the prevalence of other companies’ clinical trials for their product candidates for the same indication, or clinical trials for indications for which patients do not as commonly seek treatment;
|
●
|
difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;
|
●
|
difficulty in obtaining institutional review board, or IRB, approval for studies to be conducted at each site;
|
●
|
delays in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials;
|
●
|
inadequacy of or changes in our manufacturing process or the product formulation or method of delivery;
|
●
|
changes in applicable laws, regulations and regulatory policies;
|
●
|
delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective contract research organizations, or CROs, clinical trial sites and other third-party contractors;
|
●
|
failure of our CROs or other third-party contractors to comply with contractual and regulatory requirements or to perform their services in a timely or acceptable manner;
|
●
|
failure by us, our employees, our CROs or their employees or any partner with which we may collaborate or their employees to comply with applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security and recordkeeping for drug, medical device and biologic products;
|
●
|
delays in the scheduling and performance by the FDA of required inspections of us, our CROs, our suppliers, or our clinical trial sites, and violations of law or regulations by discovered in the course of FDA inspections;
|
●
|
scheduling conflicts with participating clinicians and clinical institutions; or
|
●
|
difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data.
|
●
|
perceptions by members of the healthcare community, including physicians, about its safety and effectiveness;
|
●
|
cost-effectiveness relative to competing products and technologies;
|
●
|
availability of reimbursement for our products from third-party payers such as health insurers, health maintenance organizations and government programs such as Medicare and Medicaid; and
|
●
|
advantages over alternative treatment methods.
|
●
|
regulatory authorities may withdraw their approval of the product;
|
●
|
we may be required to reformulate such products or change the way the product is manufactured;
|
●
|
we may become the target of lawsuits, including class action suits; and
|
●
|
our reputation in the market place may suffer resulting in a significant drop in the sales of such products.
|
●
|
reliance on the third party for regulatory compliance and quality assurance;
|
●
|
the possible breach of the manufacturing agreement by the third party because of factors beyond our control;
|
●
|
the possible termination or non-renewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us; and
|
●
|
drug product supplies not meeting the requisite requirements for clinical trial use.
|
●
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, in return for or to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal health care program such as the Medicare and Medicaid programs;
|
●
|
the federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients to providers of “designated health services” with whom the physician or a member of the physician’s immediate family has an ownership interest or compensation arrangement, unless a statutory or regulatory exception applies;
|
●
|
federal false claims laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us to the extent that our interactions with customers may affect their billing or coding practices; and
|
●
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers.
|
●
|
restrictions on the products or manufacturing process;
|
●
|
warning letters;
|
●
|
civil or criminal penalties;
|
●
|
fines;
|
●
|
injunctions;
|
●
|
imposition of a Corporate Integrity Agreement requiring heightened monitoring of our compliance functions, overseen by outside monitors, and enhanced reporting requirements to, and oversight by, the FDA and other government agencies;
|
●
|
product seizures or detentions and related publicity requirements;
|
●
|
suspension or withdrawal of regulatory approvals;
|
●
|
regulators or IRBs may not authorize us or any potential future collaborators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
●
|
total or partial suspension of production; and
|
●
|
refusal to approve pending applications for marketing approval of new product candidates.
|
●
|
completion of non-clinical tests including preclinical laboratory and formulation studies and animal testing and toxicology;
|
●
|
submission to the FDA of an Investigational New Drug, or IND, application, which must become effective before clinical trials may begin, and which may be placed on “clinical hold” by the FDA, meaning the trial may not commence, or must be suspended or terminated prior to completion;
|
●
|
performance of adequate and well-controlled Phase 1, 2 and 3 human clinical trials to establish the safety and efficacy of the drug for each proposed indication, and potentially post-approval or Phase 4 studies to further define the drug’s efficacy and safety, generally or in specific patient populations;
|
●
|
submission to the FDA of a New Drug Application, or NDA, that must be accompanied by a substantial “user fee” payment;
|
●
|
FDA review and approval of the NDA before any commercial marketing or sale; and
|
●
|
compliance with post-approval commitments and requirements.
|
●
|
require changes to manufacturing methods;
|
●
|
require recall, replacement or discontinuance of one or more of our products;
|
●
|
require additional recordkeeping;
|
●
|
limit or restrict our ability to engage in certain types of marketing or promotional activities;
|
● |
alter or eliminate the scope or terms of any currently available regulatory exclusivities; and
|
● |
restrict or eliminate our ability to settle any patent litigation we may bring against potential generic competitors.
|
●
|
the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents;
|
●
|
if and when patents will be issued;
|
●
|
whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; and
|
●
|
whether we will need to initiate litigation or administrative proceedings, which may be costly whether we win or lose.
|
●
|
obtain licenses, which may not be available on commercially reasonable terms, if at all;
|
●
|
redesign our products or processes to avoid infringement;
|
●
|
stop using the subject matter claimed in the patents held by others;
|
●
|
pay damages; or
|
●
|
defend litigation or administrative proceedings, which may be costly whether we win or lose, and which could result in a substantial diversion of our management resources.
|
●
|
publicity regarding actual or potential clinical results relating to products under development by our competitors or us;
|
●
|
delay or failure in initiating, completing or analyzing preclinical or clinical trials or unsatisfactory designs or results of these trials;
|
●
|
interim decisions by regulatory agencies, including the FDA, as to clinical trial designs, acceptable safety profiles and the benefit/risk ratio of products under development;
|
●
|
achievement or rejection of regulatory approvals by our competitors or by us;
|
●
|
announcements of technological innovations or new commercial products by our competitors or by us;
|
●
|
developments concerning proprietary rights, including patents;
|
●
|
developments concerning our collaborations;
|
●
|
regulatory developments in the United States and foreign countries;
|
●
|
economic or other crises and other external factors;
|
●
|
period-to-period fluctuations in our revenue and other results of operations;
|
●
|
changes in financial estimates by securities analysts; and
|
●
|
sales of our common stock (or the perception that such sales could occur).
|
●
|
60,592 shares issuable on the conversion of immediately convertible Series A Convertible preferred stock, subject to adjustment, for no further consideration;
|
●
|
5,077,290 shares issuable on the exercise of stock options, at exercise prices ranging from $0.60 to $24.90 per share;
|
●
|
1,028,017 shares issuable under restricted stock units which vest on dates between June 11, 2016 and June 11, 2019, subject to the fulfillment of service conditions; and
|
●
|
115,061,618 shares issuable on the exercise of warrants at exercise prices ranging from $0.01 to $1.00 per share.
|
●
|
a limited availability of market quotations for our securities;
|
●
|
reduced liquidity with respect to our securities;
|
●
|
a determination that our shares of common stock are “penny stock” which will require brokers trading in our shares of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of common stock;
|
●
|
a limited amount of news and analyst coverage for our company; and
|
●
|
a decreased ability to issue additional securities or obtain additional financing in the future.
|
FISCAL YEAR ENDED JUNE 30, 2015
|
HIGH
|
LOW
|
||||||
Fourth Quarter
|
$ | 1.58 | $ | 0.85 | ||||
Third Quarter
|
1.34 | 0.65 | ||||||
Second Quarter
|
0.93 | 0.59 | ||||||
First Quarter
|
1.28 | 0.82 | ||||||
FISCAL YEAR ENDED JUNE 30, 2014
|
HIGH
|
LOW
|
||||||
Fourth Quarter
|
$ | 1.43 | $ | 0.97 | ||||
Third Quarter
|
1.50 | 0.73 | ||||||
Second Quarter
|
0.83 | 0.56 | ||||||
First Quarter
|
0.76 | 0.59 |
Period
|
Total Number of Shares Purchased (1)
|
Weighted Average Price Paid 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
|
||||||||||||
April 1-30, 2015
|
- | - | - | - | ||||||||||||
May 1-31, 2015
|
240 | $ | 1.04 | - | - | |||||||||||
June 1-30, 2015
|
136,644 | $ | 0.92 | - | - | |||||||||||
Total
|
136,884 | $ | 0.92 | - | - |
● |
the development and testing of products in animals and humans;
|
● |
product approval or clearance;
|
● |
regulatory compliance;
|
●
|
GMP compliance;
|
●
|
intellectual property rights;
|
●
|
product introduction;
|
●
|
marketing, sales and competition; and
|
●
|
obtaining sufficient capital.
|
Payments due by Period
|
||||||||||||||||||||
Total
|
Less than 1 Year
|
1 - 3 Years
|
3 - 5 Years
|
More than 5 Years
|
||||||||||||||||
Facility operating leases
|
$ | 1,144,510 | $ | 255,986 | $ | 445,837 | $ | 442,687 | $ | - | ||||||||||
Capital lease obligations
|
72,844 | 29,138 | 43,706 | - | - | |||||||||||||||
Notes payable
|
12,595,583 | 915,000 | 9,126,833 | 2,553,750 | - | |||||||||||||||
Total contractual obligations
|
$ | 13,812,937 | $ | 1,200,124 | $ | 9,616,376 | $ |
2,996,437
|
$ | - |
Page
|
|
Report of Independent Registered Public Accounting Firm
|
45
|
Consolidated Balance Sheets
|
46
|
Consolidated Statements of Operations
|
47
|
Consolidated Statements of Stockholders’ Equity
|
48
|
Consolidated Statements of Cash Flows
|
49
|
Notes to Consolidated Financial Statements
|
50
|
June 30, 2015 | June 30, 2014 | |||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 27,299,268 | $ | 12,184,605 | ||||
Prepaid expenses and other current assets
|
1,896,747 | 156,393 | ||||||
Total current assets
|
29,196,015 | 12,340,998 | ||||||
Property and equipment, net
|
123,158 | 160,748 | ||||||
Other assets
|
155,279 | 57,308 | ||||||
Total assets
|
$ | 29,474,452 | $ | 12,559,054 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 1,106,484 | $ | 261,280 | ||||
Accrued expenses
|
6,223,483 | 1,508,958 | ||||||
Capital lease obligations
|
25,871 | - | ||||||
Unearned revenue
|
- | 1,000,000 | ||||||
Total current liabilities
|
7,355,838 | 2,770,238 | ||||||
Notes payable, net of discount
|
9,781,086 | - | ||||||
Capital lease obligations
|
41,749 | - | ||||||
Other non-current liabilities
|
91,304 | - | ||||||
Total liabilities
|
17,269,977 | 2,770,238 | ||||||
Commitments and contengencies (Note 11)
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock of $0.01 par value – authorized 10,000,000 shares;
|
||||||||
Series A Convertible; issued and outstanding 4,697 shares as of June 30, 2015 and 2014, respectively
|
47 | 47 | ||||||
Common stock of $0.01 par value – authorized 300,000,000 shares;
|
||||||||
issued and outstanding 57,128,433 shares as of June 30, 2015 and 39,416,595 as of June 30, 2014, respectively
|
571,284 | 394,166 | ||||||
Additional paid-in capital
|
303,332,460 | 283,428,356 | ||||||
Accumulated deficit
|
(291,699,316 | ) | (274,033,753 | ) | ||||
Total stockholders’ equity
|
12,204,475 | 9,788,816 | ||||||
Total liabilities and stockholders’ equity
|
$ | 29,474,452 | $ | 12,559,054 |
Year Ended June 30,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
REVENUES:
|
||||||||||||
License and contract
|
$ | 12,951,730 | $ | - | $ | 10,361 | ||||||
OPERATING EXPENSES:
|
||||||||||||
Research and development
|
24,560,233 | 10,826,921 | 10,528,691 | |||||||||
General and administrative
|
5,677,654 | 4,960,731 | 5,066,830 | |||||||||
Total operating expenses
|
30,237,887 | 15,787,652 | 15,595,521 | |||||||||
Loss from operations
|
(17,286,157 | ) | (15,787,652 | ) | (15,585,160 | ) | ||||||
OTHER INCOME (EXPENSE):
|
||||||||||||
Investment income
|
35,439 | 18,923 | 42,734 | |||||||||
Interest expense
|
(661,697 | ) | (6,211 | ) | (8,411 | ) | ||||||
Foreign exchange transaction loss
|
(284,656 | ) | - | - | ||||||||
Increase in fair value of warrants
|
- | - | (7,069,165 | ) | ||||||||
Gain on disposition of supplies and equipment
|
- | - | 4,620 | |||||||||
Total other income (expense), net
|
(910,914 | ) | 12,712 | (7,030,222 | ) | |||||||
Loss before income taxes
|
(18,197,071 | ) | (15,774,940 | ) | (22,615,382 | ) | ||||||
Income tax benefit
|
531,508 | 1,846,646 | 1,753,208 | |||||||||
NET LOSS
|
$ | (17,665,563 | ) | $ | (13,928,294 | ) | $ | (20,862,174 | ) | |||
Basic and diluted net loss per common share
|
$ | (0.15 | ) | $ | (0.13 | ) | $ | (0.21 | ) | |||
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share
|
121,014,506 | 106,679,476 | 97,618,714 |
Additional
|
||||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
Paid-in
|
Accumulated
|
|||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||||||||
Balance, July 1, 2012
|
4,997 | 50 | 34,900,591 | 349,006 | 240,725,127 | (239,243,285 | ) | 1,830,898 | ||||||||||||||||||||
Stock-based compensation
|
- | - | 500,000 | 5,000 | 620,031 | - | 625,031 | |||||||||||||||||||||
Sale of common stock units, net of costs
|
- | - | 3,873,000 | 38,730 | 17,403,075 | - | 17,441,805 | |||||||||||||||||||||
Reclassification of warrants from liability to equity
|
- | - | - | - | 24,030,128 | - | 24,030,128 | |||||||||||||||||||||
Withholding taxes related to restricted stock units
|
- | - | (158,264 | ) | (1,583 | ) | (85,828 | ) | - | (87,411 | ) | |||||||||||||||||
Series A Conversion
|
(300 | ) | (3 | ) | 1,621 | 16 | (13 | ) | - | - | ||||||||||||||||||
Net loss
|
- | - | - | - | - | (20,862,174 | ) | (20,862,174 | ) | |||||||||||||||||||
Balance, June 30, 2013
|
4,697 | 47 | 39,116,948 | 391,169 | 282,692,520 | (260,105,459 | ) | 22,978,277 | ||||||||||||||||||||
Stock-based compensation
|
- | - | 378,750 | 3,788 | 817,552 | - | 821,340 | |||||||||||||||||||||
Withholding taxes related to restricted stock units
|
- | - | (129,103 | ) | (1,291 | ) | (118,716 | ) | - | (120,007 | ) | |||||||||||||||||
Warrant exercises
|
- | - | 50,000 | 500 | 37,000 | - | 37,500 | |||||||||||||||||||||
Net loss
|
- | - | - | - | - | (13,928,294 | ) | (13,928,294 | ) | |||||||||||||||||||
Balance, June 30, 2014
|
4,697 | 47 | 39,416,595 | 394,166 | 283,428,356 | (274,033,753 | ) | 9,788,816 | ||||||||||||||||||||
Stock-based compensation
|
- | - | 705,833 | 7,058 | 1,160,221 | - | 1,167,279 | |||||||||||||||||||||
Sale of common stock units, net of costs
|
- | - | 2,050,000 | 20,500 | 18,535,611 | - | 18,556,111 | |||||||||||||||||||||
Issuance of warrants on debt
|
- | - | - | - | 267,820 | - | 267,820 | |||||||||||||||||||||
Withholding taxes related to restricted stock units
|
- | - | (174,568 | ) | (1,746 | ) | (162,390 | ) | - | (164,136 | ) | |||||||||||||||||
Warrant exercises
|
- | - | 15,130,573 | 151,306 | 102,842 | - | 254,148 | |||||||||||||||||||||
Net loss
|
- | - | - | - | - | (17,665,563 | ) | (17,665,563 | ) | |||||||||||||||||||
Balance, June 30, 2015
|
4,697 | $ | 47 | 57,128,433 | $ | 571,284 | $ | 303,332,460 | $ | (291,699,316 | ) | $ | 12,204,475 |
The accompanying notes are an integral part of these consolidated financial statements
|
Year Ended June 30,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net loss
|
$ | (17,665,563 | ) | $ | (13,928,294 | ) | $ | (20,862,174 | ) | |||
Adjustments to reconcile net loss to net cash
|
||||||||||||
used in operating activities:
|
||||||||||||
Depreciation and amortization
|
117,590 | 111,906 | 111,844 | |||||||||
Accrued interest and amortization on premium/discount
|
- | - | (1,365 | ) | ||||||||
Gain on disposition of supplies and equipment
|
- | - | (4,620 | ) | ||||||||
Non-cash interest expense
|
87,087 | - | - | |||||||||
Stock-based compensation
|
1,167,279 | 821,340 | 625,031 | |||||||||
Increase in fair value of warrants
|
- | - | 7,069,165 | |||||||||
Changes in operating assets and liabilities:
|
||||||||||||
Accounts receivable
|
- | - | 27,631 | |||||||||
Prepaid expenses and other assets
|
(1,667,139 | ) | 176,697 | 816,605 | ||||||||
Accounts payable
|
845,204 | (77,446 | ) | 43,832 | ||||||||
Accrued expenses
|
4,666,196 | (311,859 | ) | (1,475,319 | ) | |||||||
Unearned revenue
|
(1,000,000 | ) | 1,000,000 | - | ||||||||
Other non-current liabilities
|
91,304 | - | - | |||||||||
Net cash used in operating activities
|
(13,358,042 | ) | (12,207,656 | ) | (13,649,370 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Proceeds from sale/maturity of investments
|
- | 5,249,654 | 750,000 | |||||||||
Proceeds from sale of supplies and equipment
|
- | - | 4,620 | |||||||||
Purchases of property and equipment
|
- | (6,239 | ) | (59,607 | ) | |||||||
Purchases of investments
|
- | - | (5,998,289 | ) | ||||||||
Net cash provided by (used in) investing activities
|
- | 5,243,415 | (5,303,276 | ) | ||||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Payments on capital lease obligations
|
(12,380 | ) | (19,909 | ) | (22,277 | ) | ||||||
Payment of withholding taxes related to restricted
|
||||||||||||
stock units
|
(115,808 | ) | (36,377 | ) | (87,411 | ) | ||||||
Proceeds from exercise of common stock warrants
|
254,148 | 37,500 | - | |||||||||
Proceeds from the sale of common stock and warrants, net
|
||||||||||||
of costs
|
18,556,111 | - | 34,402,768 | |||||||||
Proceeds from the issuance of notes payable and warrants
|
10,000,000 | - | - | |||||||||
Payment of debt issuance costs
|
(209,366 | ) | - | - | ||||||||
Net cash provided by (used in) financing activities
|
28,472,705 | (18,786 | ) | 34,293,080 | ||||||||
NET INCREASE (DECREASE) IN CASH
|
||||||||||||
AND CASH EQUIVALENTS
|
15,114,663 | (6,983,027 | ) | 15,340,434 | ||||||||
CASH AND CASH EQUIVALENTS, beginning of year
|
12,184,605 | 19,167,632 | 3,827,198 | |||||||||
CASH AND CASH EQUIVALENTS, end of year
|
$ | 27,299,268 | $ | 12,184,605 | $ | 19,167,632 | ||||||
SUPPLEMENTAL CASH FLOW INFORMATION:
|
||||||||||||
Cash paid for interest
|
$ | 483,306 | $ | 6,211 | $ | 8,411 | ||||||
Equipment acquired under capital lease
|
80,000 | - | - | |||||||||
Issuance of warrants in connection with debt financing
|
267,820 | - | - |
Carrying Value
|
Quoted prices in
active markets
(Level 1)
|
Other quoted/observable inputs (Level 2)
|
Significant unobservable inputs
(Level 3)
|
|||||||||||||
June 30, 2015:
|
|
|
|
|||||||||||||
Money Market Account
|
$ | 26,946,378 | $ | 26,946,378 | $ | - | $ | - | ||||||||
June 30, 2014:
|
||||||||||||||||
Money Market Account
|
$ | 9,495,656 | $ | 9,495,656 | $ | - | $ | - |
June 30,
|
June 30,
|
|||||||
2015
|
2014
|
|||||||
Clinical study costs
|
$ | 1,641,605 | $ | - | ||||
Insurance premiums
|
30,039 | 25,140 | ||||||
Other
|
225,103 | 131,253 | ||||||
$ | 1,896,747 | $ | 156,393 |
June 30,
|
June 30,
|
|||||||
2015
|
2014
|
|||||||
Office equipment
|
$ | 1,180,210 | $ | 1,180,210 | ||||
Laboratory equipment
|
397,608 | 317,608 | ||||||
Leasehold improvements
|
751,226 | 751,226 | ||||||
2,329,044 | 2,249,044 | |||||||
Less: Accumulated depreciation and amortization
|
(2,205,886 | ) | (2,088,296 | ) | ||||
$ | 123,158 | $ | 160,748 |
June 30,
|
June 30,
|
|||||||
2015
|
2014
|
|||||||
Clinical study costs
|
$ | 5,594,839 | $ | 617,055 | ||||
Other research related expenses
|
176,105 | 463,695 | ||||||
Professional services
|
201,831 | 211,711 | ||||||
Other
|
250,708 | 216,497 | ||||||
$ | 6,223,483 | $ | 1,508,958 |
June 30, 2015
|
||||
Notes payable under venture loan
|
$ | 10,000,000 | ||
Unamortized related debt discount
|
(218,914 | ) | ||
Notes payable
|
$ | 9,781,086 |
Year Ending June 30,
|
||||
2016
|
$ | - | ||
2017
|
4,000,000 | |||
2018
|
4,000,000 | |||
2019
|
2,000,000 | |||
10,000,000 | ||||
Less: debt discount
|
(218,914 | ) | ||
Net
|
$ | 9,781,086 |
Year Ending June 30,
|
||||
2016
|
$ | 255,985 | ||
2017
|
224,493 | |||
2018
|
221,344 | |||
2019
|
221,344 | |||
2020
|
221,344 | |||
$ | 1,144,510 |
Year Ending June 30,
|
||||
2016
|
$ | 29,138 | ||
2017
|
29,138 | |||
2018
|
14,568 | |||
72,844 | ||||
Amount representing interest
|
(5,224 | ) | ||
Net
|
$ | 67,620 |
Shares of Common
|
Exercise Price per
|
Latest Termination
|
|||||
Stock
|
Share
|
Date
|
|||||
575,000 | 1.00 |
February 23, 2016
|
|||||
1,978,262 | 1.00 |
March 1, 2016
|
|||||
20,771,740 | 1.00 |
March 2, 2017
|
|||||
16,973,206 | 0.01 |
July 3, 2022
|
|||||
35,488,380 | 0.01 |
September 27, 2022
|
|||||
666,666 | 0.75 |
December 23, 2019
|
|||||
24,949,325 | 0.01 |
December 23, 2024
|
|||||
101,402,579 |
Number of Shares
|
Weighted Average Exercise Price
|
Weighted Average Remaining Term in Years
|
Agregate Instrinsic Value
|
|||||||||||||
Outstanding - July 1, 2012
|
2,181,853 | $ | 3.50 | 7.7 | ||||||||||||
Granted
|
1,807,300 | 0.65 | ||||||||||||||
Forfeited
|
(74,985 | ) | 5.20 | |||||||||||||
Expired
|
(62,720 | ) | 11.91 | |||||||||||||
Outstanding - June 30, 2013
|
3,851,448 | 1.99 | 8.2 | |||||||||||||
Granted
|
603,400 | 1.02 | ||||||||||||||
Forfeited
|
(161,900 | ) | 0.68 | |||||||||||||
Expired
|
(50,975 | ) | 24.95 | |||||||||||||
Outstanding - June 30, 2014
|
4,241,973 | 1.63 | 7.7 | |||||||||||||
Granted
|
975,800 | 1.06 | ||||||||||||||
Forfeited
|
(78,810 | ) | 1.92 | |||||||||||||
Expired
|
(8,733 | ) | 36.47 | |||||||||||||
Outstanding - June 30, 2015
|
5,130,230 | $ | 1.46 | 7.3 | $ | 432,309 | ||||||||||
Exercisable at June 30, 2015
|
3,209,517 | $ | 1.77 | 6.3 | $ | 285,387 | ||||||||||
Expected to vest at June 30, 2015
|
1,472,033 | $ | 0.92 | 9.0 | $ | 119,766 |
2015
|
2014
|
2013
|
||||||||||
Risk-free interest rate
|
1.9 | % | 1.9 | % | 1.8 | % | ||||||
Volatility factor
|
83.4 | % | 97.1 | % | 101.0 | % | ||||||
Dividend yield
|
0 | % | 0 | % | 0 | % | ||||||
Expected option life (years)
|
6.1 | 6.1 | 8.6 | |||||||||
Weighted average grant date fair value
|
$ | 0.76 | $ | 0.80 | $ | 0.56 |
2015
|
2014
|
2013
|
||||||||||
Outstanding at beginning of year
|
957,150 | 757,500 | 250,000 | |||||||||
Granted
|
785,800 | 603,400 | 757,500 | |||||||||
Forfeited
|
(9,100 | ) | (25,000 | ) | - | |||||||
Vested
|
(705,833 | ) | (378,750 | ) | (250,000 | ) | ||||||
Outstanding at end of year
|
1,028,017 | 957,150 | 757,500 |
June 30,
|
June 30,
|
|||||||
2015
|
2014
|
|||||||
Net operating loss carryforwards
|
$ | 94,332,000 | $ | 87,801,000 | ||||
Research and development tax credits
|
7,357,000 | 6,871,000 | ||||||
Basis differences in fixed assets and other
|
1,208,000 | 1,003,000 | ||||||
102,897,000 | 95,675,000 | |||||||
Valuation allowance
|
(102,897,000 | ) | (95,675,000 | ) | ||||
Net deferred tax assets
|
$ | - | $ | - |
Three Months Ended
|
||||||||||||||||
June 30,
|
March 31,
|
December 31,
|
September 30,
|
|||||||||||||
2015
|
2015
|
2014
|
2014
|
|||||||||||||
(amounts in thousands, except per share data)
|
||||||||||||||||
Revenues
|
$ | - | $ | - | $ | 8,020 | $ | 4,932 | ||||||||
Operating expenses
|
11,782 | 8,722 | 5,697 | 4,038 | ||||||||||||
Other income (expense), net
|
(306 | ) | (428 | ) | (78 | ) | (99 | ) | ||||||||
(Loss) income before income taxes
|
(12,088 | ) | (9,150 | ) | 2,245 | 795 | ||||||||||
Income tax benefit
|
- | - | 532 | - | ||||||||||||
Net (loss) income
|
$ | (12,088 | ) | $ | (9,150 | ) | $ | 2,777 | $ | 795 | ||||||
Basic net (loss) income per
common share
|
$ | (0.09 | ) | $ | (0.07 | ) | $ | 0.03 | $ | 0.01 | ||||||
Diluted net (loss) income per
common share
|
$ | (0.09 | ) | $ | (0.07 | ) | $ | 0.03 | $ | 0.01 | ||||||
Weighted average number of
|
||||||||||||||||
common shares outstanding
|
||||||||||||||||
used in computing basic net
|
||||||||||||||||
(loss) income per common share
|
134,207,300 | 134,008,239 | 109,314,460 | 106,953,898 | ||||||||||||
Weighted average number of
|
||||||||||||||||
common shares outstanding
|
||||||||||||||||
used in computing diluted net
|
||||||||||||||||
(loss) income per common share
|
134,207,300 | 134,008,239 | 109,815,718 | 107,946,021 | ||||||||||||
Three Months Ended
|
||||||||||||||||
June 30,
|
March 31,
|
December 31,
|
September 30,
|
|||||||||||||
2014 | 2014 | 2013 | 2013 | |||||||||||||
(amounts in thousands, except per share data)
|
||||||||||||||||
Revenues
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Operating expenses
|
4,321 | 3,364 | 3,610 | 4,492 | ||||||||||||
Other income (expense), net
|
1 | 4 | 4 | 3 | ||||||||||||
Loss before income taxes
|
(4,320 | ) | (3,360 | ) | (3,606 | ) | (4,489 | ) | ||||||||
Income tax benefit
|
- | 1,847 | - | - | ||||||||||||
Net loss
|
$ | (4,320 | ) | $ | (1,513 | ) | $ | (3,606 | ) | $ | (4,489 | ) | ||||
Basic and diluted net loss per
common share
|
$ | (0.04 | ) | $ | (0.01 | ) | $ | (0.03 | ) | $ | (0.04 | ) | ||||
Weighted average number of
|
||||||||||||||||
common shares outstanding
|
||||||||||||||||
used in computing basic and
|
||||||||||||||||
diluted net loss per common share
|
106,735,765 | 106,709,340 | 106,668,186 | 106,609,720 |
Name
|
Age
|
Position with Palatin
|
|||
Carl Spana, Ph.D.
|
52 |
Chief Executive Officer, President and a Director
|
|||
John K.A. Prendergast, Ph.D. (3)
|
61 |
Director, Chairman of the board of directors
|
|||
Robert K. deVeer, Jr. (1) (2)
|
69 |
Director
|
|||
Zola P. Horovitz, Ph.D. (3)
|
80 |
Director
|
|||
J. Stanley Hull (1) (2)
|
63 |
Director
|
|||
Alan W. Dunton, M.D. (1) (2)
|
61 |
Director
|
|||
Angela Rossetti (1) (3)
|
62 |
Director
|
|||
Arlene M. Morris (2) (3)
|
63 |
Director
|
|||
(1) Member of the audit committee.
(2) Member of the compensation committee.
(3) Member of the nominating and corporate governance committee.
|
●
|
The audit committee assists the board in its oversight of the integrity of the financial reporting and our compliance with applicable legal and regulatory requirements. It also oversees our internal controls and compliance activities, and meets privately with representatives from our independent registered public accounting firm.
|
●
|
The compensation committee assists the board in its oversight of risk relating to compensation policies and practices. The compensation committee annually reviews our compensation policies, programs and procedures, including the incentives they create and mitigating factors that may reduce the likelihood of excessive risk taking, to determine whether they present a significant risk to our company.
|
Name
|
Age
|
Position with Palatin
|
|||
Carl Spana, Ph.D.
|
52 |
Chief Executive Officer, President and Director
|
|||
Stephen T. Wills, MST, CPA
|
58 |
Chief Financial Officer, Chief Operating Officer, Executive Vice President, Secretary and Treasurer
|
Name and Principal Position
|
Fiscal
Year
|
Salary
($)
|
Stock
awards (1) ($)
|
Option
awards (1) ($)
|
Nonequity incentive plan compensation (2)($)
|
All
other
compensation
(3)($)
|
Total
($)
|
Carl Spana, Ph.D., Chief Executive Officer and President
|
2015
|
462,500
|
226,800
|
234,832
|
195,000
|
18,937
|
1,138,069
|
2014
|
450,000
|
178,500
|
143,083
|
170,000
|
22,500
|
964,083
|
|
Stephen T. Wills, MST, CPA, Chief Financial Officer, Chief Operating Officer and Executive Vice President
|
2015
|
422,500
|
205,200
|
211,916
|
203,000
|
18,438
|
1,061,054
|
2014
|
410,000
|
153,000
|
122,643
|
140,000
|
17,376
|
843,019
|
|
(1)
|
Amounts in these columns represent the aggregate grant date fair value for stock awards and option awards computed using the Black-Scholes model. For a description of the assumptions we used to calculate these amounts, see Note 11 to the consolidated financial statements included in this Annual Report.
|
(2)
|
Bonus amounts.
|
(3)
|
Consists of matching contributions to 401(k) plan.
|
●
|
annual discretionary bonus compensation, in an amount to be decided by the compensation committee and approved by the board, based on achievement of yearly performance objectives; and
|
●
|
participation in all benefit programs that we establish, to the extent the executive’s position, tenure, salary, age, health and other qualifications make him eligible to participate.
|
Option awards (1)
|
Stock awards (2)
|
||||||||||||||||||||||
Name
|
Option or
stock
award
grant
date
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
|
Option
exercise
price
($)
|
Option
expiration
date
|
Number of shares or units of stock that have not vested
(#)
|
Market value of shares or units of stock that have not vested
($) (3)
|
||||||||||||||||
Carl Spana
|
07/01/05
|
7,500 | - | 37.50 |
07/01/15
|
||||||||||||||||||
07/01/05
|
8,300 | - | 17.50 |
07/01/15
|
|||||||||||||||||||
10/06/06
|
12,500 | - | 24.90 |
10/06/16
|
|||||||||||||||||||
03/26/08
|
28,125 | - | 2.80 |
03/26/18
|
|||||||||||||||||||
03/26/08
|
4,687 | - | 5.00 |
03/26/18
|
|||||||||||||||||||
03/26/08
|
4,688 | - | 6.60 |
03/26/18
|
|||||||||||||||||||
07/01/08
|
25,000 | - | 1.80 |
07/01/18
|
|||||||||||||||||||
07/01/09
|
25,000 | - | 2.80 |
07/01/19
|
|||||||||||||||||||
06/22/11
|
300,000 | - | 1.00 |
06/22/21
|
|||||||||||||||||||
07/17/12
|
75,000 | 75,000 | 0.72 |
07/17/22
|
|||||||||||||||||||
06/27/13
|
137,500 | 137,500 | 0.62 |
06/27/23
|
|||||||||||||||||||
06/25/14
|
43,750 | 131,250 | 1.02 |
06/25/24
|
|||||||||||||||||||
06/25/14
|
87,500 | 77,875 | |||||||||||||||||||||
06/11/15
|
- | 300,000 | 1.08 |
06/11/25
|
|||||||||||||||||||
06/11/15
|
210,000 | 186,900 | |||||||||||||||||||||
Total Stock Awards
|
297,500 | $ | 264,775 | ||||||||||||||||||||
Stephen T. Wills
|
07/01/05
|
5,000 | - | 37.50 |
07/01/15
|
||||||||||||||||||
07/01/05
|
7,300 | - | 17.50 |
07/01/15
|
|||||||||||||||||||
10/06/06
|
10,000 | - | 24.90 |
10/06/16
|
Option awards (1)
|
Stock awards (2)
|
||||||||||||||||||||||
Name
|
Option or
stock
award
grant
date
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
|
Option
exercise
price
($)
|
Option
expiration
date
|
Number of shares or units of stock that have not vested
(#)
|
Market value of shares or units of stock that have not vested
($) (3)
|
03/26/08
|
22,500 | - | 2.80 |
03/26/18
|
|||||||||||||||||||
03/26/08
|
3,750 | - | 5.00 |
03/26/18
|
|||||||||||||||||||
03/26/08
|
3,750 | - | 6.60 |
03/26/18
|
|||||||||||||||||||
07/01/08
|
20,000 | - | 1.80 |
07/01/18
|
|||||||||||||||||||
07/01/09
|
20,000 | - | 2.80 |
07/01/19
|
|||||||||||||||||||
06/22/11
|
250,000 | - | 1.00 |
06/22/21
|
|||||||||||||||||||
07/17/12
|
67,500 | 67,500 | 0.72 |
07/17/22
|
|||||||||||||||||||
06/27/13
|
125,000 | 125,000 | 0.62 |
06/27/23
|
|||||||||||||||||||
06/25/14
|
37,500 | 112,500 | 1.02 |
06/25/24
|
|||||||||||||||||||
06/25/14
|
75,000 | 66,750 | |||||||||||||||||||||
06/11/15
|
- | 270,000 | 1.08 |
06/11/25
|
|||||||||||||||||||
06/11/15
|
190,000 | 169,100 | |||||||||||||||||||||
Total Stock Awards
|
265,000 | $ | 235,850 |
(1)
|
Stock option vesting schedules: all options granted on or before June 22, 2011 have fully vested. Options granted after June 22, 2011 vest over four years with 1/4 of the shares vesting per year starting on the first anniversary of the grant date, provided that the named executive officer remains an employee. See “Termination and Change-In-Control Arrangements” below.
|
(2)
|
Stock award vesting schedule: stock awards consist of restricted stock units granted on June 25, 2014, which had not vested as of June 30, 2015, but will vest as to the remaining 50% on June 25, 2016; and restricted stock units granted on June 11, 2015, which will vest as to 50% on each of June 11, 2016 and June 11, 2017, provided that the named executive officer remains an employee. See “Termination and Change-In-Control Arrangements” below.
|
(3)
|
Calculated by multiplying the number of restricted stock units by $0.89, the closing market price of our common stock on June 30, 2015, the last trading day of our most recently completed fiscal year.
|
Termination and Change-In-Control Arrangements
|
(a)
|
some person or entity acquires more than 50% of the voting power of our outstanding securities;
|
(b)
|
the individuals who, during any twelve month period, constitute our board of directors cease to constitute at least a majority of the board of directors;
|
(c)
|
we enter into a merger or consolidation; or
|
(d)
|
we sell substantially all our assets.
|
(a)
|
the occurrence of (i) the executive’s material breach of, or habitual neglect or failure to perform the material duties which he is required to perform under, the terms of his employment agreement; (ii) the executive’s material failure to follow the reasonable directives or policies established by or at the direction of our board of directors; or (iii) the executive’s engaging in conduct that is materially detrimental to our interests such that we sustain a material loss or injury as a result thereof, provided that the breach or failure of performance is not cured, to the extent cure is possible, within ten days of the delivery to the executive of written notice thereof;
|
(b)
|
the willful breach by the executive of his obligations to us with respect to confidentiality, invention and non-disclosure, non-competition or non-solicitation; or
|
(c)
|
the conviction of the executive of, or the entry of a pleading of guilty or nolo contendere by the executive to, any crime involving moral turpitude or any felony.
|
(a)
|
any material adverse change in the executive’s duties, authority or responsibilities, which causes the executive’s position with us to become of significantly less responsibility, or assignment of duties and responsibilities inconsistent with the executive’s position;
|
(b)
|
a material reduction in the executive’s salary;
|
(c)
|
our failure to continue in effect any material compensation or benefit plan in which the executive participates, unless an equitable arrangement has been made with respect to such plan, or our failure to continue the executive’s participation therein (or in a substitute or alternative plan) on a basis not materially less favorable, both in terms of the amount of benefits provided and the level of the executive’s participation relative to other participants;
|
(d)
|
our failure to continue to provide the executive with benefits substantially similar to those enjoyed by the executive under any of our health and welfare insurance, retirement and other fringe-benefit plans, the taking of any action by us which would directly or indirectly materially reduce any of such benefits, or our failure to provide the executive with the number of paid vacation days to which he is entitled; or
|
Name
|
Fees earned or paid in cash ($)
|
Stock awards
($) (2)
|
Option awards
($) (1) (2)
|
Total ($)
|
||||||||||||
John K.A. Prendergast, Ph.D.
|
90,500 | 43,200 | 27,969 | 161,669 | ||||||||||||
Perry B. Molinoff, M.D. (3)
|
49,000 | 11,700 | 34,552 | 95,252 | ||||||||||||
Robert K. deVeer, Jr.
|
57,500 | 21,600 | 13,984 | 93,084 | ||||||||||||
Zola P. Horovitz, Ph.D.
|
51,000 | 21,600 | 13,984 | 86,584 | ||||||||||||
Robert I. Taber, Ph.D. (3)
|
51,000 | 11,700 | 34,552 | 97,252 | ||||||||||||
J. Stanley Hull
|
45,000 | 21,600 | 13,984 | 80,584 | ||||||||||||
Alan W. Dunton, M.D.
|
56,000 | 21,600 | 13,984 | 91,584 | ||||||||||||
Angela Rossetti
|
43,000 | 21,600 | 13,984 | 78,584 | ||||||||||||
Arlene Morris (4)
|
- | 21,600 | 13,984 | 35,584 |
(1)
|
The aggregate number of shares underlying option awards and stock awards outstanding at June 30, 2015 for each director was:
|
Option awards
|
Stock awards
|
|||||||
Dr. Prendergast
|
318,350 | 40,000 | ||||||
Mr. deVeer
|
189,000 | 20,000 | ||||||
Dr. Horovitz
|
185,500 | 20,000 | ||||||
Mr. Hull
|
187,166 | 20,000 | ||||||
Dr. Dunton
|
112,500 | 20,000 | ||||||
Ms. Rossetti
|
65,000 | 20,000 | ||||||
Ms. Morris
|
20,000 | 20,000 | ||||||
(2)
|
Amounts in these columns represent the aggregate grant date fair value for stock awards and option awards computed using the Black-Scholes model. For a description of the assumptions we used to calculate these amounts, see Note 11 to the consolidated financial statements included in this Annual Report. Amounts in this column include options granted on June 11, 2015 for our current fiscal year ending June 30, 2016.
|
(3)
|
Drs. Molinoff and Taber ceased serving as directors effective June 11, 2015.
|
(4)
|
Ms. Morris was elected as a director effective June 11, 2015.
|
Equity Compensation Plan Information
as of June 30, 2015
|
||||||||||||
Plan category
|
Number of securities to be issued upon exercise of outstanding options,
warrants and rights
|
Weighted-average exercise price of outstanding options, warrants
and rights
|
Number of securities remaining available for future issuance under equity compensation plans (excluding securities
reflected in column (a))
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity compensation plans approved by security holders
|
6,158,247 | (1) | $ | 1.46 | (2) | 3,255,866 | ||||||
Equity compensation plans not approved by security holders
|
- | - | - | |||||||||
Total
|
6,158,247 | 3,255,866 |
(1)
|
Consists of 4,641,100 options and 1,028,017 restricted stock units granted under our 2011 Stock Incentive Plan, 479,130 options granted under our 2005 Stock Plan and 10,000 options granted under our 1996 Stock Option Plan. Both our 2005 Stock Plan and 1996 Stock Option Plan have terminated, but termination does not affect awards that are currently outstanding under these plans. The shares subject to outstanding awards under the 2005 Stock Plan, if forfeited prior to exercise, will become available for issuance under the 2011 Stock Incentive Plan.
|
(2)
|
The amount in column (a) for equity compensation plans approved by security holders includes 1,028,017 shares reserved for issuance on vesting of outstanding restricted stock units, granted under our 2011 Stock Incentive Plan, which vest on various dates through June 11, 2019, subject to the fulfillment of service conditions. Because no exercise price is required for issuance of shares on vesting of the restricted stock units, the weighted-average exercise price in column (b) does not take the restricted stock units into account.
|
●
|
each director, each of the named executive officers, and all current directors and officers as a group; and
|
●
|
all persons who, to our knowledge, beneficially own more than five percent of the common stock or Series A preferred stock.
|
Class
|
Name of beneficial owner
|
Amount and nature of beneficial ownership
|
Percent
of class
|
Percent of total voting
power
|
|||||||||
Common
|
Carl Spana, Ph.D.
|
1,298,089 | (1) | 1.9 | % | * | |||||||
Common
|
Stephen T. Wills
|
1,183,852 | (2) | 1.7 | % | * | |||||||
Common
|
John K.A. Prendergast, Ph.D.
|
318,849 | (3) | * | * | ||||||||
Common
|
Robert K. deVeer, Jr.
|
210,726 | (4) | * | * | ||||||||
Common
|
Zola P. Horovitz, Ph.D.
|
195,666 | ( 5) | * | * | ||||||||
Common
|
J. Stanley Hull
|
187,166 | (6) | * | * | ||||||||
Common
|
Alan W. Dunton, M.D.
|
121,686 | (7) | * | * | ||||||||
Common
|
Angela Rossetti
|
66,666 | (8) | * | * | ||||||||
Common
|
Arlene M. Morris
|
6,666 | (9) | * | * | ||||||||
All current directors and executive officers as a group (nine persons)
|
3,589,366 | (10) | 5.1 | % | 1.8 | % |
(1)
|
Includes 693,750 shares of common stock underlying outstanding options and 50,000 shares of common stock underlying outstanding warrants but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(2)
|
Includes 593,750 shares of common stock underlying outstanding options and 50,000 shares of common stock underlying outstanding warrants but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(3)
|
Includes 287,082 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(4)
|
Includes 173,666 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(5)
|
Includes 170,166 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(6)
|
Includes 170,166 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(7)
|
Includes 99,166 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(8)
|
Includes 51,666 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(9)
|
Consists of 6,666 shares of common stock underlying outstanding options but does not include shares of common stock underlying outstanding options or restricted stock unit awards that have not vested and will not vest within 60 days.
|
(10)
|
Includes 2,346,078 shares of common stock underlying outstanding options and warrants.
|
Class
|
Name and address of beneficial owner
|
Amount and nature of beneficial ownership (1)
|
Percent
of class
|
Percent of total voting
power
|
|||||||||
Common
|
QVT Financial LP
1177 Avenue of the Americas, 9th Floor
New York, New York 10036
|
6,986,818 | (2) | 9.9 | % | 7.5 | % | ||||||
Common
|
James E. Flynn
780 Third Avenue, 37th Floor
New York, NY 10017
|
5,250,000 | (3) | 7.4 | % | 2.9 | % | ||||||
Series A
Preferred
|
Steven N. Ostrovsky
43 Nikki Ct.
Morganville, NJ 07751
|
500 | 12.4 | % | * | ||||||||
Series A
Preferred
|
Thomas L. Cassidy IRA Rollover
38 Canaan Close
New Canaan, CT 06840
|
500 | 12.4 | % | * | ||||||||
Series A
Preferred
|
Jonathan E. Rothschild
300 Mercer St., #28F
New York, NY 10003
|
500 | 12.4 | % | * | ||||||||
Series A
Preferred
|
Arthur J. Nagle
19 Garden Avenue
Bronxville, NY 10708
|
250 | 6.2 | % | * | ||||||||
Series A
Preferred
|
Thomas P. and Mary E. Heiser, JTWROS
10 Ridge Road
Hopkinton, MA 01748
|
250 | 6.2 | % | * | ||||||||
Series A
Preferred
|
Carl F. Schwartz
31 West 87th St.
New York, NY 10016
|
250 | 6.2 | % | * | ||||||||
Series A
Preferred
|
Michael J. Wrubel
3650 N. 36 Avenue, #39
Hollywood, FL 33021
|
250 | 6.2 | % | * | ||||||||
Series A
Preferred
|
Myron M. Teitelbaum, M.D.
175 Burton Lane
Lawrence, NY 11559
|
250 | 6.2 | % | * | ||||||||
Series A
Preferred
|
Laura Gold Galleries Ltd. Profit Sharing Trust Park South Gallery at Carnegie Hall
154 West 57th Street, Suite 114
New York, NY 10019
|
250 | 6.2 | % | * | ||||||||
Series A
Preferred
|
Laura Gold
180 W. 58th Street
New York, NY 10019
|
250 | 6.2 | % | * | ||||||||
Series A
Preferred
|
Nadji T. Richmond
20 E. Wedgewood Glen
The Woodlands, TX 77381
|
230 | 5.7 | % | * |
1. Financial statements: The following consolidated financial statements are filed as a part of this report under Item 8 – Financial Statements and Supplementary Data:
|
3. Exhibits: The exhibits, listed on the accompanying exhibit index that is set forth after the signature page, are filed or incorporated by reference (as stated thereon) as part of this Annual Report on Form 10-K.
|
Signature
|
Title
|
Date
|
|
/s/ Carl Spana
|
President, Chief Executive Officer and Director
|
September 18, 2015
|
|
Carl Spana
|
(principal executive officer)
|
||
/s/ Stephen T. Wills
|
Executive Vice President, Chief Financial Officer
|
September 18, 2015
|
|
Stephen T. Wills
|
and Chief Operating Officer (principal financial and accounting officer)
|
||
/s/ John K.A. Prendergast
|
Chairman and Director
|
September 18, 2015
|
|
John K.A. Prendergast
|
|||
/s/ Robert K. deVeer, Jr
|
Director
|
September 18, 2015
|
|
Robert K. deVeer, Jr.
|
|||
/s/ Zola P. Horovitz
|
Director
|
September 18, 2015
|
|
Zola P. Horovitz
|
|||
/s/ J. Stanley Hull
|
Director
|
September 18, 2015
|
|
J. Stanley Hull
|
|||
/s/
Alan W. Dunton
|
Director
|
September 18, 2015
|
|
Alan W. Dunton
|
|||
/s/ Angela Rossetti
|
Director
|
September 18, 2015
|
|
Angela Rossetti
|
|||
/s/ Arlene M. Morris
|
Director
|
September 18, 2015
|
|
Arlene M. Morris
|
Exhibit Number
|
Description
|
Filed Herewith
|
Form
|
Filing Date
|
SEC File No.
|
|||||||||
3.1 |
Restated Certificate of Incorporation of Palatin Technologies, Inc., as amended.
|
10-K |
September 27, 2013
|
001-15543 | ||||||||||
3.2 |
Bylaws of Palatin Technologies, Inc.
|
10-Q |
February 8, 2008
|
001-15543 | ||||||||||
4.1 |
Warrant Agreement, dated March 1, 2011, between American Stock Transfer
& Trust Company and Palatin Technologies, Inc.
|
10-Q |
May 13, 2011
|
001-15543 | ||||||||||
4.2 |
Form of Series A Warrant Certificate.
|
10-Q |
May 13, 2011
|
001-15543 | ||||||||||
4.3 |
Form of Series B Warrant Certificate.
|
10-Q |
May 13, 2011
|
001-15543 | ||||||||||
4.4 |
Form of Underwriters’ Warrant.
|
10-Q |
May 13, 2011
|
001-15543 | ||||||||||
4.5 |
Warrant issued to Noble International Investments, Inc.
|
10-Q |
February 14, 2012
|
001-15543 | ||||||||||
4.6 |
Warrant issued to Noble International Investments, Inc.
|
10-Q |
February 14, 2012
|
001-15543 | ||||||||||
4.7 |
Form of Series A 2012 Warrant.
|
8-K |
July 6, 2012
|
001-15543 | ||||||||||
4.8 |
Form of Series B2012 Warrant.
|
8-K |
July 6, 2012
|
001-15543 | ||||||||||
4.9 |
Form of Series C 2014 Common Stock Purchase Warrant.
|
8-K |
December 30, 2014
|
001-15543 | ||||||||||
4.10 |
Form of Series D 2014 Common Stock Purchase Warrant.
|
8-K |
December 30, 2014
|
001-15543 | ||||||||||
4.11 |
Form of Series E 2015 Common Stock Purchase Warrant.
|
8-K |
July 7, 2015
|
001-15543 | ||||||||||
4.12 |
Form of Series F 2015 Common Stock Purchase Warrant.
|
8-K |
July 7, 2015
|
001-15543 | ||||||||||
4.13 |
Form of Series G 2015 Common Stock Purchase Warrant.
|
8-K |
July 7, 2015
|
001-15543 | ||||||||||
10.1†† |
1996 Stock Option Plan, as amended.
|
10-K |
September 28, 2009
|
001-15543 | ||||||||||
10.2†† |
Form of Option Certificate (Incentive Option) Under the 2005 Stock Plan.
|
8-K |
September 21, 2011
|
001-15543 | ||||||||||
10.3†† |
Form of Incentive Stock Option Under the 2005 Stock Plan.
|
8-K |
September 21, 2011
|
001-15543 | ||||||||||
10.4†† |
Form of Opinion Certificate
(Non-Qualified Opinion) Under the 2005 Stock Plan.
|
8-K |
September 21, 2011
|
001-15543 | ||||||||||
10.5†† |
Form of Non-Qualified Stock Option Agreement Under the 2005 Stock Plan.
|
8-K |
September 21, 2011
|
001-15543 | ||||||||||
10.6†† |
2007 Change in Control Severance Plan.
|
10-Q |
February 8, 2008
|
001-15543 | ||||||||||
10.7†† |
2005 Stock Plan, as amended.
|
10-Q |
May 15, 2009
|
001-15543 | ||||||||||
10.8†† |
Form of Executive Officer Option Certificate.
|
10-Q |
May 14, 2008
|
001-15543 | ||||||||||
10.9†† |
Form of Amended Restricted Stock Unit Agreement.
|
10-Q |
May 14, 2008
|
001-15543 | ||||||||||
10.10†† |
Form of Amended Option Certificate (Incentive Option) Under the 2005 Stock Plan.
|
10-Q |
May 14, 2008
|
001-15543 | ||||||||||
10.11 |
Form of Securities Purchase Agreement for Palatin Technologies, Inc.’s August 2009 Registered Direct Offering.
|
8-K |
August 13, 2009
|
001-15543 |
Exhibit Number
|
Description
|
Filed Herewith
|
Form
|
Filing Date
|
SEC File No.
|
||||||||||
10.12†† |
Employment Agreement, effective as of July 1, 2013, between Carl Spana and Palatin Technologies, Inc.
|
10-K |
September 27, 2013
|
001-15543 | |||||||||||
10.13†† |
Employment Agreement, effective as of July 1, 2013, between Stephen T. Wills and Palatin Technologies, Inc.
|
10-K |
September 27, 2014
|
001-15543 | |||||||||||
10.14 |
Underwriting Agreement, dated
February 24, 2011, by and between Roth Capital Partners, LLC and Palatin Technologies, Inc.
|
8-K |
February 24, 2011
|
001-15543 | |||||||||||
10.15†† |
2011 Stock Incentive Plan, as amended.
|
S-8 |
July 31, 2015
|
333-206009 | |||||||||||
10.16†† |
Form of Restricted Share Unit Agreement Under the 2011 Stock Incentive Plan.
|
10-Q |
May 13, 2011
|
001-15543 | |||||||||||
10.17†† |
Form of Nonqualified Stock Option Agreement Under the 2011 Stock Incentive Plan.
|
10-Q |
May 13, 2011
|
001-15543 | |||||||||||
10.18†† |
Form of Incentive Stock Option Agreement under the 2011 Stock Incentive Plan.
|
10-Q |
May 13, 2011
|
001-15543 | |||||||||||
10.19 |
Letter Agreement, dated October 7, 2011, between Biotechnology Value Fund, L.P. and Palatin Technologies, Inc.
|
8-K |
October 7, 2011
|
001-15543 | |||||||||||
10.20 |
Purchase Agreement, dated July 2, 2012, by and between QVT Fund IV LP, QVT Fund V LP and Quintessence Fund L.P. and Palatin Technologies, Inc.
|
8-K |
July 6, 2012
|
001-15543 | |||||||||||
10.21 |
Registration Rights Agreement, dated July 2, 2012, by and between QVT Fund IV LP, QVT Fund V LP and Quintessence Fund L.P. and Palatin Technologies, Inc.
|
8-K |
July 6, 2012
|
001-15543 | |||||||||||
10.22 |
Venture Loan and Security Agreement, dated December 23, 2014, by and between Palatin Technologies, Inc. and Horizon Technology Finance Corporation and Fortress Credit Co LLC.
|
8-K |
December 30, 2014
|
001-15543 | |||||||||||
10.23 |
Securities Purchase Agreement, dated December 23, 2014, by and between Palatin Technologies, Inc. and the investors named therein.
|
8-K |
December 30, 2014
|
001-15543 | |||||||||||
10.24 |
Registration Rights Agreement, dated December 23, 2014, by and between Palatin Technologies, Inc. and the investors named therein.
|
8-K |
December 30, 2014
|
001-15543 | |||||||||||
10.25 |
Placement Engagement Letter, dated December 22, 2014, by and between Palatin Technologies, Inc. and Piper Jaffray & Co.
|
8-K |
December 30, 2014
|
001-15543 | |||||||||||
10.26 |
Amended and Restated Venture Loan and Security Agreement, dated July 2, 2015, by and between Palatin Technologies, Inc. and Horizon Technology Finance Corporation, Fortress Credit Co LLC, Horizon Credit II LLC and Fortress Credit Opportunities V CLO Limited.
|
8-K |
July 7, 2015
|
001-15543 |
Exhibit Number
|
Description
|
Filed Herewith
|
Form
|
Filing Date
|
SEC File No.
|
10.27 |
Securities Purchase Agreement, dated July 2, 2015, by and between Palatin Technologies, Inc. and the investors named therein.
|
8-K |
July 7, 2015
|
001-15543 | |||||||||||
10.28 |
Registration Rights Agreement, dated July 2, 2015, by and between Palatin Technologies, Inc. and the investors named therein.
|
8-K |
July 7, 2015
|
001-15543 | |||||||||||
10.29† |
License, Co-Development and Commercialization Agreement, dated August 29, 2014, by and between Chemical Works of Gedeon Richter Plc. and Palatin Technologies, Inc.
|
10-K/A |
October 9, 2014
|
001-15543 | |||||||||||
10.30 |
Termination Agreement, dated September 16, 2015, by and between Chemical Works of Gedeon Richter Plc. and Palatin Technologies, Inc.
|
X | |||||||||||||
21 |
Subsidiaries of Palatin Technologies, Inc.
|
X | |||||||||||||
23 |
Consent of KPMG LLP.
|
X | |||||||||||||
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 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
X | |||||||||||||
Certification of principal financial officer pursuant to U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
X | ||||||||||||||
101.INS
|
XBRL Instance Document.
|
X | |||||||||||||
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
X | |||||||||||||
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
X | |||||||||||||
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document.
|
X | |||||||||||||
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
X | |||||||||||||
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
X |
A.
|
Palatin and Gedeon Richter entered into a License Agreement (as hereinafter defined); and
|
B.
|
The Parties desire to terminate to the License Agreement in its entirety by mutual written agreement in accordance with the terms and conditions set forth in this Termination Agreement.
|
1.
|
DEFINITIONS
|
2.
|
TERMINATION OF LICENSE AGREEMENT
|
3.
|
REPRESENTATIONS AND WARRANTIES OF GEDEON RICHTER
|
4.
|
MISCELLANEOUS
|
If to Palatin:
Palatin Technologies, Inc.
4-B Cedar Brook Drive
Cranbury, New Jersey 08512
USA
|
If to Gedeon Richter:
Chemical Works of Gedeon Richter Plc.
Budapest 1103
Gyömrői út 19-21.
Hungary
|
PALATIN TECHNOLOGIES, INC.
|
CHEMICAL WORKS OF GEDEON
RICHTER PLC.
|
Date: September 16, 2015
|
Date: 15
th
September 2015
|
By: /s/ Carl Spana
|
By: /s/ Árpád Götze
|
Print Name: Carl Spana
|
Print Name: Árpád Götze
|
Title: President and Chief Executive
Officer
|
Title: Director, Business Development
|
Date: September 16, 2015
|
Date: 15
th
September 2015
|
By: /s/ Stephen T. Wills
|
By: /s/ György Németh
|
Print Name: Stephen T. Wills
|
Print Name: Dr. György Németh
|
Title: Chief Financial Officer and
Chief Operating Officer
|
Title: Director, Medical Division
|
Name of Subsidiary
|
State of Incorporation
|
Name Under Which
Subsidiary Does Business
|
RhoMed Incorporated
|
New Mexico
|
RhoMed Incorporated
|
1.
|
I have reviewed this Annual Report on Form 10-K of Palatin Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiary, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors:
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ Carl Spana
|
|
Carl Spana, President and Chief Executive Officer
|
1.
|
I have reviewed this Annual Report on Form 10-K of Palatin Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiary, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors:
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ Stephen T. Wills
|
|
Stephen T. Wills, Executive Vice President, Chief Financial Officer and Chief Operating Officer
|
Dated: September 18, 2015
|
/s/ Carl Spana
|
|
Carl Spana, President and Chief Executive Officer (Principal Executive Officer)
|
|
/s/ Stephen T. Wills
|
|
Stephen T. Wills, Executive Vice President, Chief Financial Officer and Chief Operating Officer (Principal Financial Officer)
|