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[X]
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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[ ]
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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95-4078884
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.)
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4C Cedar Brook Drive
Cranbury, New Jersey
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08512
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(Address of principal executive offices)
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(Zip Code)
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Page
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PART I – FINANCIAL INFORMATION
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2
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3
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4
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5
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13
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16
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16
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PART II – OTHER INFORMATION
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17
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17
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25
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25
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25
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25
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25
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March 31,
2011
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Pro-forma
March 31,
2011
|
June 30,
2010
|
||
| (Note 9) | ||||
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ASSETS
|
||||
|
Current assets:
|
||||
|
Cash and cash equivalents
|
$ 22,032,649
|
$ 22,032,649
|
$ 5,405,430
|
|
|
Available-for-sale investments
|
-
|
-
|
3,462,189
|
|
|
Accounts receivable
|
-
|
-
|
2,879
|
|
|
Prepaid expenses and other current assets
|
539,361
|
539,361
|
393,313
|
|
|
Total current assets
|
22,572,010
|
22,572,010
|
9,263,811
|
|
|
Property and equipment, net
|
1,511,892
|
1,511,892
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2,388,365
|
|
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Restricted cash
|
350,000
|
350,000
|
475,000
|
|
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Other assets
|
253,403
|
253,403
|
261,701
|
|
|
Total assets
|
$ 24,687,305
|
$ 24,687,305
|
$ 12,388,877
|
|
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||
|
Current liabilities:
|
||||
|
Capital lease obligations
|
$ 19,393
|
$ 19,393
|
$ 19,670
|
|
|
Accounts payable
|
386,261
|
386,261
|
155,795
|
|
|
Accrued compensation
|
211,941
|
211,941
|
-
|
|
|
Unearned revenue
|
70,796
|
70,796
|
-
|
|
|
Accrued expenses
|
1,208,920
|
1,208,920
|
2,219,466
|
|
|
Total current liabilities
|
1,897,311
|
1,897,311
|
2,394,931
|
|
|
Capital lease obligations
|
-
|
-
|
14,284
|
|
|
Warrant liability
|
6,370,555
|
-
|
-
|
|
|
Deferred rent
|
258,161
|
258,161
|
661,389
|
|
|
Total liabilities
|
8,526,027
|
2,155,472
|
3,070,604
|
|
|
Commitments (Note 6)
|
||||
|
Stockholders' equity:
|
||||
|
Preferred stock of $.01 par value – authorized 10,000,000 shares;
|
||||
|
Series A Convertible; issued and outstanding 4,997 shares as of March 31, 2011 and June 30, 2010, respectively
|
50
|
50
|
50
|
|
|
Common stock of $.01 par value – authorized 40,000,000 shares; issued and outstanding 34,900,591 and 11,702,818 shares as of March 31, 2011 and June 30, 2010, respectively
|
349,006
|
349,006
|
117,028
|
|
|
Additional paid-in capital
|
234,493,100
|
240,863,655
|
218,236,723
|
|
|
Accumulated other comprehensive income
|
-
|
-
|
138,650
|
|
|
Accumulated deficit
|
(218,680,878)
|
(218,680,878)
|
(209,174,178)
|
|
|
Total stockholders’ equity
|
16,161,278
|
22,531,833
|
9,318,273
|
|
|
Total liabilities and stockholders’ equity
|
$ 24,687,305
|
$ 24,687,305
|
$ 12,388,877
|
|
Three Months Ended March 31,
|
Nine Months Ended March 31,
|
|||||||
|
2011
|
2010
|
2011
|
2010
|
|||||
|
REVENUES:
|
||||||||
|
License and contract
|
$ 61,294
|
$ 2,559,852
|
$ 472,849
|
$ 13,505,770
|
||||
|
Grant
|
-
|
-
|
846,768
|
-
|
||||
|
Total revenues
|
61,294
|
2,559,852
|
1,319,617
|
13,505,770
|
||||
|
OPERATING EXPENSES:
|
||||||||
|
Research and development
|
1,722,432
|
3,356,956
|
7,159,634
|
8,739,389
|
||||
|
General and administrative
|
955,547
|
1,238,187
|
3,226,798
|
3,526,883
|
||||
|
Total operating expenses
|
2,677,979
|
4,595,143
|
10,386,432
|
12,266,272
|
||||
|
Income (loss) from operations
|
(2,616,685)
|
(2,035,291)
|
(9,066,815)
|
1,239,498
|
||||
|
OTHER INCOME (EXPENSE):
|
||||||||
|
Investment income
|
18,982
|
16,641
|
72,342
|
120,270
|
||||
|
Interest expense
|
(1,974)
|
(2,287)
|
(5,607)
|
(9,303)
|
||||
|
Increase in fair value of warrants
|
(1,257,691)
|
-
|
(1,257,691)
|
-
|
||||
|
Gain on sale of securities
|
58,956
|
-
|
119,346
|
-
|
||||
|
Gain (loss) on sale/disposition of supplies and equipment
|
(7,466)
|
-
|
(5,666)
|
95,000
|
||||
|
Total other income (expense)
|
(1,189,193)
|
14,354
|
(1,077,276)
|
205,967
|
||||
|
Income (loss) before income taxes
|
(3,805,878)
|
(2,020,937)
|
(10,144,091)
|
1,445,465
|
||||
|
Income tax benefit
|
-
|
-
|
637,391
|
998,408
|
||||
|
NET INCOME (LOSS)
|
$ (3,805,878)
|
$ (2,020,937)
|
$ (9,506,700)
|
$ 2,443,873
|
||||
|
Basic net income (loss) per common share
|
$ (0.17)
|
$ (0.20)
|
$ (0.65)
|
$ 0.20
|
||||
|
Diluted net income (loss) per common share
|
$ (0.17)
|
$ (0.20)
|
$ (0.65)
|
$ 0.20
|
||||
|
Weighted average number of common shares outstanding used in computing basic net income (loss) per common share
|
22,832,109
|
9,987,323
|
14,669,131
|
9,575,314
|
||||
|
Weighted average number of common shares outstanding used in computing diluted net income (loss) per common share
|
22,832,109
|
9,987,323
|
14,669,131
|
9,646,791
|
||||
|
Nine Months Ended March 31,
|
||||
|
2011
|
2010
|
|||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||
|
Net income (loss)
|
$ (9,506,700)
|
$ 2,443,873
|
||
|
Adjustments to reconcile net loss to net cash
|
||||
|
used in operating activities:
|
||||
|
Depreciation and amortization
|
865,507
|
969,076
|
||
|
Loss (gain) on sale/disposition of supplies and equipment
|
5,666
|
(95,000)
|
||
|
Gain on sale of available-for-sale investments
|
(119,346)
|
-
|
||
|
Stock-based compensation
|
516,270
|
807,506
|
||
|
Amortization of deferred revenue
|
-
|
(11,955,553)
|
||
|
Increase in fair value of warrants
|
1,257,691
|
-
|
||
|
Changes in operating assets and liabilities:
|
||||
|
Accounts receivable
|
2,879
|
(21,564)
|
||
|
Prepaid expenses and other assets
|
(12,750)
|
112,465
|
||
|
Accounts payable
|
230,466
|
474,827
|
||
|
Accrued expenses and compensation and deferred rent
|
(1,201,833)
|
(331,477)
|
||
|
Deferred revenues
|
-
|
5,000,000
|
||
|
Unearned revenues
|
70,796
|
-
|
||
|
Net cash used in operating activities
|
(7,891,354)
|
(2,595,847)
|
||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||
|
Proceeds from sale of supplies and equipment
|
5,300
|
95,000
|
||
|
Purchases of property and equipment
|
-
|
(6,995)
|
||
|
Proceeds from sale of available-for-sale investments
|
3,442,885
|
-
|
||
|
Net cash provided by investing activities
|
3,448,185
|
88,005
|
||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||
|
Payments on capital lease obligations
|
(14,561)
|
(83,066)
|
||
|
Payment of withholding taxes related to restricted stock units
|
(26,196)
|
(165,861)
|
||
|
Proceeds from sale of common stock units and warrant and
|
||||
|
exercise of common stock options
|
21,111,145
|
5,153,786
|
||
|
Net cash provided by financing activities
|
21,070,388
|
4,904,859
|
||
|
NET INCREASE IN CASH AND CASH EQUIVALENTS
|
16,627,219
|
2,397,017
|
||
|
CASH AND CASH EQUIVALENTS, beginning
|
||||
|
of period
|
5,405,430
|
4,378,662
|
||
|
CASH AND CASH EQUIVALENTS, end of period
|
$ 22,032,649
|
$ 6,775,679
|
||
|
SUPPLEMENTAL CASH FLOW INFORMATION:
|
||||
|
Cash paid for interest
|
$
5,607
|
$
9,303
|
||
|
Unrealized gain (loss) on available-for-sale investments
|
$ (19,304)
|
$
10,070
|
||
|
Three months ended March 31,
|
Nine months ended March 31,
|
||||||
|
2011
|
2010
|
2011
|
2010
|
||||
|
Net income (loss) per common share – Basic:
|
|||||||
|
Net income (loss)
|
$ (3,805,878)
|
$ (2,020,937)
|
$ (9,506,700)
|
$ 2,443,873
|
|||
|
Net income allocated to Series A Preferred Shares
|
-
|
-
|
-
|
(499,700)
|
|||
|
Net income (loss) available to common stockholders
|
$ (3,805,878)
|
$ (2,020,937)
|
$ (9,506,700)
|
$ 1,944,173
|
|||
|
Weighted average common shares outstanding
|
22,832,109
|
9,987,323
|
14,669,131
|
9,575,314
|
|||
|
Net income (loss) per common share - Basic
|
$ (0.17)
|
$ (0.20)
|
$ (0.65)
|
$ 0.20
|
|||
|
Net income (loss) per common share – Diluted:
|
|||||||
|
Net income (loss)
|
$ (3,805,878)
|
$ (2,020,937)
|
$ (9,506,700)
|
$ 2,443,873
|
|||
|
Net income allocated to Series A Preferred Shares
|
-
|
-
|
-
|
(499,700)
|
|||
|
Net income (loss) available to common stockholders
|
$ (3,805,878)
|
$ (2,020,937)
|
$ (9,506,700)
|
$ 1,944,173
|
|||
|
Weighted average common shares outstanding
|
22,832,109
|
9,987,323
|
14,669,131
|
9,575,314
|
|||
|
Dilutive securities
|
-
|
-
|
-
|
71,477
|
|||
|
Weighted average common and dilutive shares outstanding
|
22,832,109
|
9,987,323
|
14,669,131
|
9,646,791
|
|||
|
Net income (loss) per common share - Diluted
|
$ (0.17)
|
$ (0.20)
|
$ (0.65)
|
$ 0.20
|
|||
|
March 31,
|
June 30,
|
|||
|
2011
|
2010
|
|||
|
Cost
|
$ -
|
$ 3,323,539
|
||
|
Gross unrealized gains
|
-
|
173,658
|
||
|
Gross unrealized losses
|
-
|
(35,008)
|
||
|
Total available-for-sale investments
|
$ -
|
$ 3,462,189
|
||
|
Fair Value
|
Quoted prices in active markets (Level 1)
|
Quoted prices in active markets (Level 2)
|
Quoted prices in active markets (Level 3)
|
|
|
March 31, 2011:
|
||||
|
Assets:
|
||||
|
Money Market Fund
|
$ 21,689,828
|
$ 21,689,828
|
$ -
|
$ -
|
|
Mutual Funds
|
$ -
|
$ -
|
$ -
|
$ -
|
|
Liabilities:
|
||||
|
Warrant liability
|
$ 6,370,555
|
$ -
|
$ -
|
$ 6,370,555
|
|
June 30, 2010:
|
||||
|
Assets:
|
||||
|
Money Market Fund
|
$ 4,111,051
|
$ 4,111,051
|
$ -
|
$ -
|
|
Mutual Funds
|
$ 3,462,189
|
$ 3,462,189
|
$ -
|
$ -
|
|
June 30, 2010
|
$ -
|
|
Fair value on issuance
|
5,112,864
|
|
Change in fair value
|
1,257,691
|
|
March 31, 2011
|
6,370,555
|
|
Three months ended March 31,
|
Nine months ended March 31,
|
|||||||
|
2011
|
2010
|
2011
|
2010
|
|||||
|
Net income (loss)
|
$ (3,805,878)
|
$ (2,020,937)
|
$ (9,506,700)
|
$ 2,443,873
|
||||
|
Unrealized gain (loss) on available-for-sale investments
|
(9,781)
|
17,996
|
(19,304)
|
10,070
|
||||
|
Comprehensive income (loss)
|
$ (3,815,659)
|
$ (2,002,941)
|
$ (9,526,004)
|
$ 2,453,943
|
||||
|
March 1,
2011
|
March 31,
2011
|
||||
|
Aggregate fair value
|
$ 5,112,864
|
$ 6,370,555
|
|||
|
Exercise price
|
$ 1.00
|
$ 1.00
|
|||
|
Expected volatility
|
105
|
%
|
105
|
%
|
|
|
Remaining contractual term (years)
|
6
|
5.92
|
|||
|
Risk-free interest rate
|
2.47
|
%
|
2.62
|
%
|
|
|
Expected dividend yield
|
0
|
%
|
0
|
%
|
|
|
Common stock price (per share)
|
$ 0.86
|
$ 1.03
|
|
|
·
|
Bremelanotide, a peptide melanocortin receptor agonist, for treatment of sexual dysfunction, targeting female sexual dysfunction (FSD) and erectile dysfunction (ED) in patients non-responsive to current therapies.
|
|
|
·
|
Peptide melanocortin receptor agonists for treatment of FSD and ED.
|
|
|
·
|
PL-3994, a peptide mimetic natriuretic peptide receptor A (NPRA) agonist, for treatment of acute exacerbations of asthma, heart failure and refractory or difficult-to-control hypertension.
|
|
|
·
|
the development and testing of products in animals and humans;
|
|
|
·
|
product approval or clearance;
|
|
|
·
|
regulatory compliance;
|
|
|
·
|
good manufacturing practices;
|
|
|
·
|
intellectual property rights;
|
|
|
·
|
product introduction;
|
|
|
·
|
marketing, sales and competition; and
|
|
|
·
|
obtaining sufficient capital.
|
|
|
·
|
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 availability of sufficient capital to sustain operations and clinical trials;
|
|
|
·
|
timely completion of clinical site protocol approval and obtaining informed consent from subjects;
|
|
|
·
|
the rate of patient enrollment in clinical studies;
|
|
|
·
|
adverse medical events or side effects in treated patients; and
|
|
|
·
|
lack of effectiveness of the product being tested.
|
|
|
·
|
product approval or clearance;
|
|
|
·
|
regulatory compliance;
|
|
|
·
|
good manufacturing practices;
|
|
|
·
|
intellectual property rights;
|
|
|
·
|
product introduction; and
|
|
|
·
|
marketing and competition.
|
|
|
·
|
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 (IND) application, which must become effective before clinical trials may begin;
|
|
|
·
|
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;
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submission to the FDA of a New Drug Application (NDA); and
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FDA review and approval of the NDA before any commercial marketing or sale.
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perceptions by members of the healthcare community, including physicians, about its safety and effectiveness;
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cost-effectiveness relative to competing products and technologies;
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availability of reimbursement for our products from third party payors such as health insurers, health maintenance organizations and government programs such as Medicare and Medicaid; and
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advantages over alternative treatment methods.
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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;
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if and when patents will be issued;
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whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; and
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whether we will need to initiate litigation or administrative proceedings, which may be costly whether we win or lose.
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obtain licenses, which may not be available on commercially reasonable terms, if at all;
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redesign our products or processes to avoid infringement;
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stop using the subject matter claimed in the patents held by others;
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pay damages; or
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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.
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26,865 shares issuable on the conversion of immediately convertible Series A Convertible preferred stock, subject to adjustment, for no further consideration;
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24,479,617 shares issuable on the exercise of warrants at exercise prices ranging from $1.00 to $28.20 per share, including 21,575,000 shares issuable on the exercise of warrants that are exercisable starting March 2, 2012 at an exercise price of $1.00 per share; and
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709,438 shares issuable on the exercise of stock options, at exercise prices ranging from $1.30 to $42.50 per share.
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publicity regarding actual or potential clinical results relating to products under development by our competitors or us;
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delay or failure in initiating, completing or analyzing preclinical or clinical trials or unsatisfactory designs or results of these trials;
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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;
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achievement or rejection of regulatory approvals by our competitors or by us;
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announcements of technological innovations or new commercial products by our competitors or by us;
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developments concerning proprietary rights, including patents;
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developments concerning our collaborations;
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regulatory developments in the United States and foreign countries;
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economic or other crises and other external factors;
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period-to-period fluctuations in our revenue and other results of operations;
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changes in financial estimates by securities analysts; and
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sales of our common stock.
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be proportionate to the reverse split ratio;
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last in the marketplace for any length of time;
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remain at a price sufficient to meet the listing requirements of the NYSE Amex; or
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be sufficient to facilitate raising capital.
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Warrant Agreement dated as of March 1, 2011, between Palatin and American Stock Transfer & Trust Company, a New York limited liability trust company.
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Definitive form of Series A Warrant certificate pursuant to Palatin’s effective registration statement No. 333-170227 on Form S-1.
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Definitive form of Series B Warrant certificate pursuant to Palatin’s effective registration statement No. 333-170227 on Form S-1.
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Definitive form of underwriters’ warrant to purchase common stock pursuant to Palatin’s effective registration statement No. 333-170227 on Form S-1.
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2011 Stock Incentive Plan.*
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Form of Restricted Share Unit Agreement under the 2011 Stock Incentive Plan.*
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Form of Nonqualified Stock Option Agreement under the 2011 Stock Incentive Plan.*
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Form of Incentive Stock Option Agreement under the 2011 Stock Incentive Plan.*
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Certification of Chief Executive Officer.
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Certification of Chief Financial Officer.
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Certification by Chief Executive Officer pursuant to 18 U.S.C. Section 1350.
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Certification by Chief Financial Officer pursuant to 18 U.S.C. Section 1350.
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Palatin Technologies, Inc.
(Registrant)
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Date: May 13, 2011
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/s/ Carl Spana
Carl Spana, Ph.D.
President and
Chief Executive Officer (Principal
Executive Officer)
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Date: May 13, 2011
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/s/ Stephen T. Wills
Stephen T. Wills
Executive Vice President - Operations
and
Chief Financial Officer (Principal
Financial and Accounting Officer)
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Warrant Agreement dated as of March 1, 2011, between Palatin and American Stock Transfer & Trust Company, a New York limited liability trust company.
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Definitive form of Series A Warrant certificate pursuant to Palatin’s effective registration statement No. 333-170227 on Form S-1.
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Definitive form of Series B Warrant certificate pursuant to Palatin’s effective registration statement No. 333-170227 on Form S-1.
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Definitive form of underwriters’ warrant to purchase common stock pursuant to Palatin’s effective registration statement No. 333-170227 on Form S-1.
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2011 Stock Incentive Plan.*
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Form of Restricted Share Unit Agreement under the 2011 Stock Incentive Plan.*
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Form of Nonqualified Stock Option Agreement under the 2011 Stock Incentive Plan.*
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Form of Incentive Stock Option Agreement under the 2011 Stock Incentive Plan.*
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Certification of Chief Executive Officer.
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No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|