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Share Name | Share Symbol | Market | Type |
---|---|---|---|
FluoroPharma Medical Inc (CE) | USOTC:FPMI | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.0001 | 0.00 | 01:00:00 |
[X]
|
ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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[ ]
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
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Nevada
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20-8325616
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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Large accelerated filer [ ]
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Accelerated filer [ ]
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Non-accelerated filer [ ]
(Do not check if a smaller reporting company)
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Smaller reporting company [X]
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Page
Number
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1
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7
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16
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16
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16
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16
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17
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18
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18
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22
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22
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22
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22
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22
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23
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27
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31
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||
32
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32
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||
33
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||
35
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●
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will be found to be ineffective or unsafe;
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●
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will not receive necessary regulatory clearances;
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●
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will be unable to get to market in a timely manner;
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●
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will not be capable of being produced in commercial quantities at reasonable costs;
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●
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will not be successfully marketed; or
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●
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will not be widely accepted by the medical community.
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●
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disagreement with the design or implementation of our clinical trials;
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●
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disagreement with our interpretation of data from preclinical studies or clinical trials;
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●
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our failure to demonstrate to the satisfaction of the FDA or other regulatory agency that a product candidate is safe and effective for any indication;
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●
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the results of clinical trials may not meet the level of statistical significance required for approval;
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●
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our inability to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; or
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●
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the manufacturing processes or facilities of third party manufacturers with which we or our collaborators contract for clinical and commercial supplies may not be acceptable.
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●
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obtaining regulatory clearance to commence a clinical trial;
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●
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identifying, recruiting and training suitable clinical investigators;
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●
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reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites;
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●
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obtaining sufficient quantities of a product candidate for use in clinical trials;
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●
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obtaining Investigator Review Board, or IRB, or ethics committee approval to conduct a clinical trial at a prospective site;
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●
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identifying, recruiting and enrolling patients to participate in a clinical trial; and
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●
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retaining patients who have initiated a clinical trial but may withdraw due to adverse events from the compounds, insufficient efficacy, fatigue with the clinical trial process or personal issues.
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●
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
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●
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inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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●
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unforeseen safety issues or any determination that the clinical trial presents unacceptable health risks; and
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●
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lack of adequate funding to continue the clinical trial.
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●
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infringement claims that, with or without merit, can be costly and time consuming to litigate, can delay the regulatory approval process and can divert management’s attention from our core business strategy;
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●
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substantial damages for past infringement which we may have to pay if a court determines that our products or technologies infringe upon a competitor’s patent or other proprietary rights;
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●
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if a license is available from a holder, we may have to pay substantial royalties or grant cross licenses to our patents or other proprietary rights; and
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●
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redesigning our process so that it does not infringe the third party intellectual property, which may not be possible, or which may require substantial time and expense including delays in bringing our own products to market.
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●
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limited indications of regulatory approvals;
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●
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the establishment and demonstration in the medical community of the clinical efficacy and safety of our product candidates and their potential advantages over existing diagnostic compounds;
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●
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the prevalence and severity of any side effects;
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●
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our ability to offer our product candidates at an acceptable price;
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●
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the relative convenience and ease of administration of our products;
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●
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the strength of marketing and distribution support; and
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●
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sufficient third party coverage or reimbursement.
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●
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develop and market products that are less expensive or more effective than our future products;
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●
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commercialize competing products before we or our partners can launch any products developed from our product candidates;
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●
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operate larger research and development programs or have substantially greater financial resources than we do;
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●
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initiate or withstand substantial price competition more successfully than we can;
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●
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have greater success in recruiting skilled technical and scientific workers from the limited pool of available talent;
|
●
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more effectively negotiate third party licenses and strategic relationships; |
●
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secure reimbursement faster; and
|
●
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take advantage of acquisition or other opportunities more readily than we can.
|
·
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the U.S. federal healthcare program anti-kickback law, which prohibits, among other things, persons and entities from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for a healthcare item or service, or the purchasing or ordering of an item or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid;
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·
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the U.S. federal false claims and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting or causing to be presented, claims for payment by government funded programs such as Medicare or Medicaid that are false or fraudulent, and which may apply to us by virtue of statements and representations made to customers or third parties;
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·
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the U.S. federal Health Insurance Portability and Accountability Act, or HIPAA, which prohibits, among other things, executing a scheme to defraud healthcare programs;
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·
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, imposes requirements relating to the privacy, security, and transmission of individually identifiable health information, and requires notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;
|
·
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the federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value to physicians, other healthcare providers and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members, which is published in a searchable form on an annual basis; and
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·
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state laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws that may be broader in scope and also apply to commercial insurers and other non-federal payors, requirements for mandatory corporate regulatory compliance programs, and laws relating to patient data privacy and security.
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●
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results from and any delays in our clinical trials;
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●
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failure or delays in entering additional product candidates into clinical trials;
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●
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failure or discontinuation of any of our research programs;
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●
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delays in establishing new strategic relationships;
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●
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delays in the development or commercialization of our potential products;
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●
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market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts’ reports or recommendations;
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●
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actual and anticipated fluctuations in our financial and operating results;
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●
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developments or disputes concerning our intellectual property or other proprietary rights;
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●
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introduction of technological innovations or new commercial products by us or our competitors;
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●
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issues in manufacturing our potential products;
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●
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market acceptance of our potential products;
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●
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third party healthcare reimbursement policies;
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●
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FDA or other domestic or foreign regulatory actions affecting us or our industry;
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●
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litigation or public concern about the safety of our product candidates; and
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●
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additions or departures of key personnel.
|
2015
|
High
|
Low
|
||||||
First Quarter
|
$
|
0.50
|
$
|
0.35
|
||||
Second Quarter
|
$
|
0.45
|
$
|
0.30
|
||||
Third Quarter
|
$
|
0.43
|
$
|
0.24
|
||||
Fourth Quarter
|
$
|
0.37
|
$
|
0.30
|
||||
2014
|
||||||||
First Quarter
|
$
|
0.74
|
$
|
0.51
|
||||
Second Quarter
|
$
|
0.90
|
$
|
0.67
|
||||
Third Quarter
|
$
|
0.68
|
$
|
0.56
|
||||
Fourth Quarter
|
$
|
0.62
|
$
|
0.40
|
Plan category
|
Number of securities to be issued upon exercise of outstanding options, warrants and rights (a)
|
Weighted-average exercise price of outstanding options, warrants and rights (b)
|
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)
|
|||||||||
Equity compensation plans approved by shareholders
|
4,996,095
|
$
|
0.65
|
1,318,405
|
||||||||
Equity compensation plans not approved by shareholders
|
--
|
--
|
--
|
|||||||||
Total
|
4,996,095
|
$
|
0.65
|
1,318,405
|
●
|
employee-related expenses, which include salaries and benefits, and rent expense;
|
●
|
license fees and annual payments related to in-licensed products and intellectual property;
|
●
|
expenses incurred under agreements with CROs, investigative sites and consultants that conduct or provide other services relating to our clinical trials and a substantial portion of our preclinical activities;
|
●
|
the cost of acquiring clinical trial materials from third party manufacturers; and
|
●
|
costs associated with non-clinical activities, patent filings and regulatory filings.
|
●
|
support of our expanded R&D activities;
|
●
|
an expanding infrastructure and increased professional fees and other costs associated with the compliance with the Exchange Act, the Sarbanes-Oxley Act and stock exchange regulatory requirements and compliance; and
|
●
|
business development and financing activities.
|
Name
|
Age
|
Position
|
||||
Thomas H. Tulip, Ph.D.
|
63
|
Chief Executive Officer, President and Director
|
||||
Tamara Rhein
|
43
|
Chief Financial Officer
|
||||
Walter Witoshkin
|
70
|
Chairman of the Board
|
||||
Peter S. Conti, M.D., Ph.D.
|
59
|
Director
|
||||
Lawrence Atinsky
|
46
|
Director
|
||||
W. Austin Lewis, IV
|
39
|
Director
|
||||
Johan M. (Thijs) Spoor
|
43
|
Director
|
●
|
evaluating the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or engage new independent auditors;
|
●
|
reviewing and approving the engagement of our independent auditors to perform audit services and any permissible non- audit services;
|
●
|
reviewing our annual and quarterly financial statements and reports and discussing the statements and reports with our independent auditors and management;
|
●
|
reviewing with our independent auditors and management significant issues that arise regarding accounting principles and financial statement presentation, and matters concerning the scope, adequacy and effectiveness of our financial controls;
|
●
|
preparing the report that the SEC will require in our annual proxy statement; and
|
●
|
reviewing and providing oversight with respect to any related party transactions and monitoring compliance with our Code of Ethics; and
|
●
|
reviewing our corporate goals and objectives relevant to our executives’ compensation, evaluating the executives’ performance in light of such goals and objectives and determining executive compensation levels based on such evaluations;
|
●
|
reviewing and making recommendations to the Board with respect to non-executive officer compensation and independent director compensation;
|
●
|
administering our incentive compensation and equity-based plans; and
|
●
|
preparing the report that the SEC will require in our annual proxy statement and Form 10-K.
|
Year
|
Salary ($)
|
Bonus ($)
|
Stock Awards ($)
|
Option Awards ($)
|
Non-Equity Incentive Plan Compensation($)
|
All Other Compensation ($)
|
Total ($)
|
|||||||||||||||||
Johan M. (Thijs) Spoor
|
2015
|
266,459
|
(1)
|
266,459
|
||||||||||||||||||||
2014
|
305,000
|
(2)
|
305,000
|
|||||||||||||||||||||
2013
|
293,750
|
50,000
|
343,750
|
|||||||||||||||||||||
Tamara Rhein
|
2015
|
130,000
|
130,000
|
|||||||||||||||||||||
2014
|
130,000
|
15,169
|
145,169
|
|||||||||||||||||||||
2013
|
100,000
|
10,000
|
10,000
|
45,610
|
165,610
|
|||||||||||||||||||
Thomas H. Tulip
|
2015
|
77,744
|
(3)
|
-
|
-
|
52,204
|
129,948
|
Options awards
|
Stock awards
|
|||||||||||||||||||||
Name
|
Number of securities underlying unexercised options (#) exercisable
|
Number of securities underlying unexercised options (#) unexercisable
|
Equity incentive plan awards: Number of securities underlying unexercised unearned options (#)
|
Option exercise price ($)
|
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 ($)
|
Equity incentive plan awards: Number of unearned shares, units or other rights that have not vested (#)
|
Equity incentive plan awards: Market or payout value of unearned shares, units or other rights that have not vested ($)
|
|||||||||||||
Johan M. (Thijs) Spoor
|
450,000
|
$
|
0.50
|
12/03/2020
|
-
|
-
|
-
|
-
|
||||||||||||||
600,000
|
$
|
0.50
|
5/01/2021
|
-
|
-
|
-
|
-
|
|||||||||||||||
600,000
|
$
|
0.84
|
9/19/2022
|
-
|
-
|
-
|
-
|
|||||||||||||||
-
|
-
|
-
|
-
|
|||||||||||||||||||
Tamara Rhein
|
10,500
|
$
|
1.05
|
12/05/2021
|
-
|
-
|
-
|
-
|
||||||||||||||
40,000
|
40,000
|
$
|
0.83
|
6/25/2022
|
-
|
-
|
-
|
-
|
||||||||||||||
66,667
|
33,333
|
$
|
0.83
|
01/02/2023
|
-
|
-
|
-
|
-
|
||||||||||||||
25,000
|
25,000
|
$
|
0.51
|
02/13/2024
|
-
|
-
|
-
|
-
|
||||||||||||||
Thomas H. Tulip
|
500,000
|
$
|
0.35
|
10/05/2025
|
-
|
-
|
-
|
-
|
Name
|
Fees Earned or Paid in Cash ($)
|
Stock Awards ($)
|
Option Awards ($)
|
Non-Equity Incentive Plan Compensation ($)
|
Change in Pension Value and Nonqualified Deferred Compensation Earnings
|
All Other Compensation ($)
|
Total ($)
|
|||||||||||||||||||||
Walter Witoshkin
|
$
|
30,000
|
(1)
|
-
|
$
|
-
|
-
|
-
|
$
|
116,000
|
(2)
|
$
|
146,000
|
|||||||||||||||
Peter S. Conti
|
$
|
30,000
|
(3)
|
-
|
$
|
-
|
-
|
-
|
$
|
-
|
$
|
30,000
|
||||||||||||||||
Lawrence Atinsky
|
$
|
30,000
|
(4)
|
-
|
$
|
-
|
-
|
-
|
$
|
-
|
$
|
30,000
|
||||||||||||||||
Joseph Pierro
|
$
|
26,250
|
(5)
|
-
|
$
|
-
|
-
|
-
|
$
|
-
|
$
|
26,250
|
||||||||||||||||
Andrew Sassine
|
$
|
30,000
|
(
6
)
|
-
|
$
|
-
|
-
|
-
|
$
|
-
|
$
|
30,000
|
||||||||||||||||
W. Austin Lewis, IV
|
$
|
5,000
|
(7) |
-
|
$
|
-
|
-
|
-
|
$
|
-
|
$
|
5,000
|
Name and Address of Beneficial Owner
(1)
|
Number of
Shares Beneficially Owned
|
Percentage Beneficially
Owned
(2)
|
||||
Thomas H. Tulip
(3)
|
0
|
0.0
|
%
|
|||
Tamara Rhein
(4)
|
214,604
|
0.7
|
%
|
|||
Johan (Thijs) Spoor
(5)
|
1,928,211
|
6.0
|
%
|
|||
Walter Witoshkin
(6)
|
243,345
|
0.7
|
%
|
|||
Peter S. Conti
(7)
|
534,083
|
1.6
|
%
|
|||
Lawrence Atinsky
(8)
|
259,015
|
0.8
|
%
|
|||
W. Austin Lewis, IV
(9)
|
8,849,999
|
27.0
|
%
|
|||
Platinum Long Term Growth VII LLC
(10)
|
1,815,193
|
5.5
|
%
|
|||
All executive officers and directors as a group (7 persons)
|
12,029,258
|
36.2
|
%
|
(1)
|
Unless otherwise indicated in the footnotes to the following table, each person named in the table has sole voting and investment power and that person’s address is c/o FluoroPharma Medical, Inc., 8 Hillside Avenue, Suite 108, Montclair, N.J. 07042.
|
(2)
|
Based upon 33,219,792 shares of our common stock issued and outstanding.
|
(3)
|
Does not include 500,000 shares of common stock issuable upon exercise of options at $0.35 per share which are held by Dr. Tulip but not currently exercisable nor exercisable within 60 days of March 15, 2016.
|
(4)
|
Includes 10,000 shares of common stock, 18,393 shares of common stock issuable upon conversion of Series B Preferred Stock, 10,711 shares of common stock underlying warrants, 10,500 shares of common stock issuable upon exercise of options at $1.05 per share, 140,000 shares of common stock issuable upon exercise of options at $0.83 per share and 25,000 shares of common stock issuable upon exercise of options at $0.51. Does not include 40,000 shares of common stock issuable upon exercise of options at $0.83 per share and 25,000 shares of common stock issuable upon exercise of options at $0.51 per share which are held by Ms. Rhein but not currently exercisable nor exercisable within 60 days of March 15, 2016.
|
(5)
|
Includes 200,398 shares of common stock, 42,857 shares of common stock issuable upon conversion of Series B Preferred Stock, 34,956 shares of common stock underlying warrants, 1,050,000 shares of common stock issuable upon exercise of options at $0.50 per share and 600,000 shares of common stock issuable upon exercise of options at $0.84 per share.
|
(6)
|
Does not include 161,250 restricted shares that vest upon the earlier of (i) the occurrence of a Change of Control, as defined in the 2011 Equity Incentive Plan; (ii) the successful completion of a Phase II clinical trial for any of the Company’s products; or (ii) the determination by the Board to provide for immediate vesting. Does include 75,000 shares of common stock issuable upon exercise of options at $0.95 per share, 17,857 shares of common stock issuable upon exercise of options at $1.40 per share, 125,488 shares of common stock issuable upon exercise of options at $0.83 per share, and 25,000 shares of common stock issuable upon exercise of options at $$0.53 per share.
|
(7)
|
Includes 35,738 shares of common stock, 45,000 shares of common stock issuable upon exercise of options at $0.95 per share, 285,000 shares of common stock issuable upon exercise of options at $0.16 per share, 17,857 shares of common stock issuable upon exercise of options at $1.40 per share, 125,488 shares of common stock issuable upon exercise of options at $0.83 per share, and 25,000 shares of common stock issuable upon exercise of options at $0.53 per share.
|
(8)
|
Includes 30,000 shares of common stock issuable upon conversion of Series B Preferred Stock, 24,956 shares of common stock underlying warrants, 125,488 shares of common stock issuable upon exercise of options at $0.83 per share, 25,000 shares of common stock issuable upon exercise of options at $0.53 per share and 53,571 shares of common stock issuable upon conversion of outstanding convertible notes. Does not include any shares of common stock issued or issuable as accrued interest pursuant to the convertible notes.
|
(9)
|
Includes 100,000 shares of common stock and 178,571 shares of common stock issuable upon conversion of outstanding convertible notes. Also includes, 5,714,236 shares of common stock issuable upon conversion of the convertible notes at $0.35 per share and 2,857,143 shares of common stock issuable upon exercise of the warrants at $0.50 per share held by Lewis Opportunity Fund. Does not include any shares of common stock issued or issuable as accrued interest pursuant to the convertible notes. W. Austin Lewis, IV is an affiliate of Lewis Opportunity Fund and has voting and dispositive power with respect to such shares.
|
(10)
|
Includes 1,815,193 shares of common stock. The number of shares beneficially owned by Platinum Long Term Growth VII LLC does not include 4,523,076 shares of common stock underlying 4,523,076 shares of Series B Preferred Stock and 6,020,214 shares of common stock underlying warrants, exercisable at $0.53 per share, beneficially owned by Platinum-Montaur Life Sciences, LLC. The terms of such Series B Preferred Stock and warrants provide that the holder may not convert or exercise such securities to the extent such conversion or exercise could result in the holder beneficially owning more than 4.99% of our outstanding common stock, unless waived by the holder on at least 61 days’ notice and subject to the terms of such securities. Assuming such blocker provisions were waived and the full conversion and exercise of the Series B Preferred Stock and warrants held by Platinum-Montaur Life Sciences, LLC, such holder would beneficially own, together with Platinum Long Term Growth Fund VII LLC, approximately 47% of our issued and outstanding common stock. Michael Goldberg has the voting and dispositive power over the securities held for the account of this beneficial owner. The address of Platinum Long Term Growth VII LLC is 152 West 57th Street, 4th Floor, New York, NY 10019.
|
SERVICES
|
2015
|
2014
|
||||||
Audit fees
|
$
|
75,500
|
$
|
72,500
|
||||
Audit-related fees
|
14,000
|
21,500
|
||||||
Tax fees
|
-
|
-
|
||||||
All other fees
|
-
|
-
|
||||||
Total fees
|
$
|
89,500
|
$
|
94,000
|
Exhibit No.
|
Description
|
2.1
|
Agreement and Plan of Merger, dated as of May 16, 2011, by and among FluoroPharma Medical, Inc., FPI Merger Corporation and FluoroPharma, Inc. (Incorporated by reference to the Company’s Current Report on Form 8-K/A filed with the Securities and Exchange Commission on July 12, 2011).
|
2.2
|
Certificate of Merger, dated May 16, 2011 merging FPI Merger Corporation with and into FluoroPharma, Inc. (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2011).
|
3.1
|
Articles of Incorporation (Incorporated by reference to the Company’s Registration Statement on Form SB-2 filed on November 7, 2007).
|
3.2
|
Bylaws (Incorporated by reference to the Company’s Registration Statement on Form SB-2 filed on November 7, 2007).
|
3.3
|
Certificate of Designation of the Relative Rights and Preferences of the Series A Preferred Stock, filed with the Secretary of State of Nevada on May 13, 2011 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2011).
|
3.4
|
Certificate of Designation of the Relative Rights and Preferences of the Series B Preferred Stock, filed with the Secretary of State of Nevada on September 18, 2013 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 19, 2013)
|
4.1
|
Form of 2012 Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on November 21, 2012).
|
4.2
|
Form of 2011 Warrant (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2011).
|
4.3
|
Form of Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 19, 2013).
|
4.4
|
Form of Warrant (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on January 7, 2014).
|
4.5
|
Form of 2014 Promissory Note (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on July 25, 2014).
|
4.6
|
Form of Amendments to 2014 Promissory Note (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on January 22, 2016).
|
4.7
|
Form of 2015 Convertible Note (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on June 3, 2015).
|
4.8
|
Form of 2015 Warrant (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on June 3, 2015).
|
10.1
|
Exclusive License Agreement with Massachusetts General Hospital dated as of April 27, 2009, as amended.** +
|
10.2
|
Securities Purchase Agreement dated November 19, 2012 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 21, 2012).
|
10.3
|
Registration Rights Agreement dated November 19, 2012 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 21, 2012).
|
10.4
|
Form of 2011 Subscription Agreement - Lead Investor (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2011).
|
10.5
|
Form of 2011 Registration Rights Agreement (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2011).
|
10.6
|
Form of Securities Purchase Agreement dated September 18, 2013 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 19, 2013).
|
10.7
|
Form of Registration Rights Agreement dated September 18, 2013 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 19, 2013).
|
10.8
|
Form of Securities Purchase Agreement dated December 31, 2013 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 7, 2014).
|
10.9
|
Form of Registration Rights Agreement dated December 31, 2013 (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on January 7, 2014).
|
10.10
|
FluoroPharma Medical, Inc. 2011 Incentive Plan (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2011).
|
10.11
|
Lease Agreement between Hillside Square, LLC and FluoroPharma Medical, Inc. dated as of September 8, 2011 (Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2011).
|
10.12
|
Second Amendment to Lease Agreement between Hillside Square, LLC and FluoroPharma Medical, Inc. dated as of February 2015 (Incorporated by reference to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2015).
|
10.13
|
Employment Agreement dated August 22, 2012 between the Company and Tamara Rhein (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 22, 2012).
|
10.14
|
Amendment to Employment Agreement dated October 5, 2015 between the Company and Tamara Rhein (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on October 8, 2015).
|
10.15
|
Employment Agreement dated October 5, 2015 between the Company and Thomas H. Tulip (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on October 8, 2015).
|
10.16
|
Note Purchase Agreement dated July 22, 2014 (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on July 25, 2014).
|
10.17
|
Note and Warrant Purchase Agreement dated May 28, 2015 (Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on June 3, 2015).
|
14.1
|
Code of Ethics adopted by the Board of Directors (Incorporated by reference to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2012).
|
21
|
List of Subsidiaries (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2011).
|
|
23.1*
|
Consent of Wolf & Company, P.C.
|
|
31.1*
|
Certification of Chief Executive Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934.
|
|
31.2*
|
Certification of Chief Financial Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934.
|
|
32.1*
|
Certification of Chief Executive Officer pursuant to Section 1350.
|
|
32.2*
|
Certification of Chief Financial Officer pursuant to Section 1350.
|
|
101.INS*
|
XBRL Instance Document.
|
101.SCH*
|
XBRL Schema Document.
|
101.CAL*
|
XBRL Calculation Linkbase Document.
|
101.LAB*
|
XBRL Label Linkbase Document.
|
101.PRE*
|
XBRL Presentation Linkbase Document.
|
101.DEF*
|
XBRL Definition Linkbase Document.
|
++ The XBRL-related information in Exhibit 101 to this Registration Statement on Form S-1 shall not be deemed “filed” or a part of this registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, and is not filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of those sections.
|
FluoroPharma Medical, Inc.
|
|||
March 30, 2016
|
By:
|
/s/ Thomas H. Tulip
|
|
Thomas H. Tulip, Ph.D.
|
|||
President and Chief Executive Officer
|
|||
(Principal Executive Officer)
|
/s/ Thomas H. Tulip |
|
March 30, 2016
|
Thomas H. Tulip, Ph.D.
|
||
President, Chief Executive Officer & Director
(Principal Executive Officer)
|
||
/s/ Tamara Rhein |
March 30, 2016
|
|
Tamara Rhein
|
||
Chief Financial and Accounting Officer
(Principal Accounting Officer)
|
||
/s/ Peter S. Conti |
March 30, 2016
|
|
Peter S. Conti, M.D., Ph.D.
|
||
Director
|
||
March 30, 2016
|
||
Lawrence Atinsky
|
||
Director
|
||
/s/ Walter Witoshkin |
March 30, 2016
|
|
Walter Witoshkin
|
||
Director
|
/s/ W. Austin Lewis |
March 30, 2016
|
|
W. Austin Lewis
|
||
Director
|
/s/Johan M. (Thijs) Spoor |
March 30, 2016
|
|
Johan M. (Thijs) Spoor
|
||
Director
|
Page Number
|
|||
Report of Independent Registered Public Accounting Firm
|
F-2
|
||
Consolidated Balance Sheets at December 31, 2015 and 2014
|
F-3
|
||
Consolidated Statements of Operations for the years ended December 31, 2015 and 2014
|
F-4
|
||
Consolidated Statements of Stockholders' Deficit for the years ended December 31, 2015 and 2014
|
F-5
|
||
Consolidated Statements of Cash Flows for the years ended December 31, 2015 and 2014
|
F-6
|
||
Notes to Consolidated Financial Statements
|
F-7
|
December 31, 2015
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
|||||||||||||
Current Liabilities:
|
||||||||||||||||
Derivative liabilities
|
$
|
-
|
$
|
--
|
$
|
1,526,060
|
$
|
1,526,060
|
December 31, 2014
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
|||||||||||||
Current Assets:
|
||||||||||||||||
Trading securities
|
$
|
39,930
|
$
|
--
|
$
|
--
|
$
|
39,930
|
||||||||
Current Liabilities:
|
||||||||||||||||
Derivative liabilities
|
$
|
-
|
$
|
--
|
$
|
1,354,319
|
$
|
1,354,319
|
Year Ended
|
Year Ended
|
|||||||
December 31, 2015
|
December 31, 2014
|
|||||||
Fair value at beginning of the year
|
$
|
1,354,319
|
$
|
2,549,196
|
||||
Issuance of derivative warrant liability
|
397,363
|
-
|
||||||
Embedded conversion feature
|
490,340
|
-
|
||||||
Modification and reclassification of outstanding warrants
|
-
|
114,923
|
||||||
2,242,022
|
2,664,119
|
|||||||
Change in fair value
|
(715,962)
|
(1,309,800)
|
||||||
Fair value at end of the year
|
$
|
1,526,060
|
$
|
1,354,319
|
2015
|
2014
|
|||||||
Risk-free interest rate
|
2.07
|
%
|
3.40
|
% | ||||
Expected volatility
|
49.42
|
%
|
60.13
|
% | ||||
Dividend yield
|
none
|
none
|
||||||
Expected term
|
6.5 years
|
5.5 years
|
December 31,
2015
|
December 31,
2014
|
||||||
Prepaid expenses and other:
|
|||||||
Prepaid insurance
|
$
|
39,756
|
$
|
24,576
|
|||
Deferred closing costs
|
136,260
|
83,941
|
|||||
Annual license fee
|
104,167
|
-
|
|||||
Other
|
74,232
|
50,332
|
|||||
Prepaid expenses and other
|
$
|
354,415
|
$
|
158,849
|
|||
Property and equipment:
|
|||||||
Computers and office equipment
|
$
|
73,911
|
$
|
67,217
|
|||
Machinery and equipment
|
112,421
|
112,421
|
|||||
Less: accumulated depreciation
|
(175,283
|
)
|
(167,911
|
)
|
|||
Property and equipment, net
|
$
|
11,049
|
$
|
11,727
|
|||
Accrued expenses and other:
|
|||||||
Professional fees
|
$
|
49,703
|
$
|
47,028
|
|||
Accrued dividends Series B Preferred Stock
|
1,041,894
|
588,588
|
|||||
Deferred salary
|
88,958
|
63,542
|
|||||
Accrued interest on Notes Payable
|
327,203
|
53,749
|
|||||
Accrued research and development
|
39,268
|
170,292
|
|||||
Other
|
56,579
|
151,412
|
|||||
Accrued expenses and other
|
$
|
1,603,605
|
$
|
1,074,611
|
December 31, 2015
|
December 31, 2014
|
|||||||
Technology license
|
$
|
413,398
|
$
|
413,398
|
||||
Less: accumulated amortization
|
(94,851
|
)
|
(55,858
|
)
|
||||
Intangibles, net
|
$
|
318,547
|
$
|
357,540
|
Number of Shares
Under Warrants
|
Exercise
Price
Per Share
|
Weighted
Average Exercise Price
|
||||||||||
Warrants issued and exercisable at December 31, 2014
|
14,854,035
|
$
|
0.50 - 1.33
|
$
|
0.76
|
|||||||
Warrants Issued/Exchanged
|
4,985,524
|
$
|
0.50
|
$
|
0.50
|
|||||||
Warrants Expired/Forfeited
|
(3,558,395
|
)
|
$
|
1.29
|
$
|
1.29
|
||||||
Warrants Exercised
|
-
|
$
|
-
|
$
|
-
|
|||||||
Warrants issued and exercisable at December 31, 2015
|
16,281,164
|
$
|
0.35 - 1.33
|
$
|
0.48
|
Exercise Price
|
Number of Shares Under Warrants
|
Weighted Average Remaining Contract Life in Years
|
Weighted Average Exercise Price
|
|||||||||||
$
|
0.35
|
8,676,408
|
2.75
|
$
|
0.35
|
|||||||||
$
|
0.50
|
4,378,295
|
4.75
|
$
|
0.50
|
|||||||||
Total warrants accounted for as
derivative liability
|
13,054,703
|
3.42
|
$
|
0.40
|
$
|
0.50
|
607,229
|
4.79
|
$
|
0.50
|
|||||||||
$
|
0.83
|
2,108,500
|
2.80
|
$
|
0.83
|
|||||||||
$
|
0.84
|
20,000
|
0.59
|
$
|
0.84
|
|||||||||
$
|
0.85
|
281,912
|
1.56
|
$
|
0.85
|
|||||||||
$
|
0.95
|
20,000
|
0.75
|
$
|
0.95
|
|||||||||
$
|
1.00
|
165,417
|
3.13
|
$
|
1.00
|
|||||||||
$
|
1.33
|
23,403
|
0.07
|
$
|
1.33
|
|||||||||
Total warrants accounted for as equity
|
3,226,461
|
3.04
|
$
|
0.78
|
||||||||||
Total for all warrants outstanding
|
16,281,164
|
3.35
|
$
|
0.48
|
Options Outstanding
|
Weighted Average
Exercise Price
|
|||||||
Outstanding at December 31, 2014
|
4,644,428
|
$
|
0.68
|
|||||
Options granted
|
625,000
|
$
|
0.39
|
|||||
Options forfeited
|
(273,333)
|
$
|
0.58
|
|||||
Options exercised
|
-
|
$
|
-
|
|||||
Outstanding at December 31, 2015
|
4,996,095
|
$
|
0.65
|
Options Exercisable
|
Weighted Average Exercise
Price per Share
|
|||||||
Exercisable at December 31, 2014
|
3,781,096
|
$
|
0.68
|
|||||
Exercisable at December 31, 2015
|
4,312,762
|
$
|
0.68
|
December 31, 2015
|
December 31, 2014
|
|||||||
Gross deferred tax assets:
|
||||||||
Net operating loss carry-forwards
|
$
|
9,099,986
|
$
|
7,761,239
|
||||
Stock based expenses
|
1,094,424
|
1,133,147
|
||||||
Tax credit carry-forwards
|
363,607
|
390,560
|
||||||
Capital loss carry-forwards & unrealized losses on investments
|
462,128
|
350,547
|
||||||
Long lived assets
|
129,204
|
33,866
|
||||||
11,149,349
|
9,669,359
|
|||||||
Deferred tax asset valuation allowance
|
(11,149,349
|
)
|
(9,669,359
|
)
|
||||
Net deferred tax asset
|
$
|
-
|
$
|
-
|
December 31, 2015
|
December 31, 2014
|
|||||||
Income taxes benefit (expense) at statutory rate
|
34.00
|
%
|
34.00
|
%
|
||||
State income tax, net of federal benefit
|
(5.94
|
)%
|
(5.94
|
)%
|
||||
Permanent differences
|
||||||||
Meals & entertainment
|
(0.1
|
)%
|
(0.01
|
)%
|
||||
Share-based compensation & Warrant adjustments
|
2.56
|
%
|
6.65
|
%
|
||||
Change in valuation allowance
|
(30.62
|
)%
|
(34.61
|
)%
|
||||
0
|
%
|
0
|
%
|
1 Year FluoroPharma Medical (CE) Chart |
1 Month FluoroPharma Medical (CE) Chart |
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