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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

 

 

For the transition period from             to

Commission File No.:001-34079

Rexahn Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware		11-3516358
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)

15245 Shady Grove Road, Suite 455

Rockville, MD 20850

(Address of principal executive offices, including zip code)

Telephone: (240) 268-5300

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ  No ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “accelerated filer,” “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large Accelerated Filer	¨	Accelerated Filer	¨
Non-Accelerated Filer	¨	Smaller reporting company	þ
(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes ¨  No þ

Indicate the number of shares outstanding of each of the issuer’s classes of common stock as of the latest practicable date:  178,253,318 shares of common stock outstanding as of August 13, 2014.

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REXAHN PHARMACEUTICALS, INC.

TABLE OF CONTENTS

 

		Page
PART I	FINANCIAL INFORMATION	3
Item 1	Financial Statements (Unaudited)	3
	1)    Condensed Balance Sheet as of June 30, 2014 and December 31, 2013	3
	2)    Condensed Statement of Operations for the three and six months ended June 30, 2014 and 2013	4
	3)    Condensed Statement of Cash Flows for the six months ended June 30, 2014 and 2013	5
	4)    Notes to the Condensed Financial Statements	7
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28
Item 3	Quantitative and Qualitative Disclosures About Market Risk	36
Item 4	Controls and Procedures	36
PART II	OTHER INFORMATION	37
Item 6	Exhibits	37
SIGNATURES		38

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REXAHN PHARMACEUTICALS, INC.

Condensed Balance Sheet

(Unaudited)

 

		June 30, 2014				December 31, 2013
ASSETS
Current Assets:
Cash and cash equivalents		$	38,104,488			$	18,688,031
Marketable securities (note 3)			100,000				100,000
Prepaid expenses and other current assets (note 4)			901,297				507,165
Total Current Assets			39,105,785				19,295,196
Restricted Cash Equivalents (note 14)			78,156				196,130
Equipment, Net (note 5)			60,712				65,172
Total Assets		$	39,244,653			$	19,556,498
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable and accrued expenses (note 6)		$	1,539,851			$	933,758
Deferred Research and Development Arrangements (note 7)			678,156				833,630
Other Liabilities (note 8)			134,466				129,564
Warrant Liabilities (note 12)			6,583,403				5,034,058
Total Liabilities			8,935,876				6,931,010
Commitments and Contingencies (note 14)
Stockholders’ Equity (note 10):
Preferred stock, par value $0.0001, 100,000,000 authorized shares, none issued and outstanding			-				-
Common stock, par value $0.0001, 500,000,000 authorized shares, 178,266,533 and 146,732,000 issued and 178,153,318 and 146,717,795 outstanding			17,827				14,673
Additional paid-in capital			117,636,102				85,449,932
Accumulated deficit			(87,216,742	)			(72,810,707	)
Treasury stock, 113,215 and 14,205 shares, at cost			(128,410	)			(28,410	)
Total Stockholders’ Equity			30,308,777				12,625,488
Total Liabilities and Stockholders’ Equity		$	39,244,653			$	19,556,498

 

(See accompanying notes to the condensed financial statements)

 

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REXAHN PHARMACEUTICALS, INC.

Condensed Statement of Operations

(Unaudited)

 

		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2014				2013				2014				2013
Revenues:
Research		$	-			$	-			$	-			$	-
Expenses:
General and administrative			1,702,489				857,946				3,115,945				2,068,698
Research and development			1,701,407				925,130				2,972,981				1,477,596
Patent fees			95,410				121,216				167,430				257,707
Depreciation and amortization			9,630				9,235				18,674				18,551
Total Expenses			3,508,936				1,913,527				6,275,030				3,822,552
Loss from Operations			(3,508,936	)			(1,913,527	)			(6,275,030	)			(3,822,552	)
Other Income (Expense)
Interest income			38,035				11,433				70,326				21,451
Unrealized gain/(loss) on fair value of warrants			3,665,365				(1,206,656	)			(7,995,159	)			(837,754	)
Financing expense			-				-				(206,172	)			-
Total Other Income (Expense)			3,703,400				(1,195,223	)			(8,131,005	)			(816,303	)
Income (Loss) Before Provision for Income Taxes			194,464				(3,108,750	)			(14,406,035	)			(4,638,855	)
Provision for income taxes			-				-				-				-
Net Income (Loss)		$	194,464			$	(3,108,750	)		$	(14,406,035	)		$	(4,638,855	)
Net income (loss) per share, basic and diluted		$	0.00			$	(0.03	)		$	(0.08	)		$	(0.04	)
Weighted average number of shares outstanding, basic and diluted			177,729,738				119,547,716				173,942,196				119,488,693

(See accompanying notes to the condensed financial statements)

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REXAHN PHARMACEUTICALS, INC.

Condensed Statement of Cash Flows

(Unaudited)

		For the Six Months Ended
		June 30,
		2014				2013
Cash Flows from Operating Activities:
Net loss		$	(14,406,035	)		$	(4,638,855	)
Adjustments to reconcile net loss to net cash used in operating activities:
Compensatory stock			336,000				137,200
Depreciation and amortization			18,674				18,551
Stock-based compensation			260,868				426,322
Amortization of deferred research and development arrangements			(155,474	)			(382,121	)
Unrealized loss on fair value of warrants			7,995,159				837,754
Financing expense			206,172				-
Amortization of deferred lease incentive			(6,221	)			(10,000	)
Deferred lease expenses			11,123				(10,466	)
Changes in assets and liabilities:
Prepaid expenses and other current assets			(394,132	)			(201,863	)
Accounts payable and accrued expenses			606,093				(231,770	)
Net Cash Used in Operating Activities			(5,527,773	)			(4,055,248	)
Cash Flows from Investing Activities:
Restricted cash equivalents			117,974				522,922
Purchase of equipment			(14,214	)			(1,609	)
Net Cash Provided by Investing Activities			103,760				521,313
Cash Flows from Financing Activities:
Issuance of common stock and units, net of issuance costs			18,634,247				-
Proceeds from exercise of stock options			258,955				-
Proceeds from exercise of stock warrants			5,947,268				26,739
Net Cash Provided by Financing Activities			24,840,470				26,739
Net Increase (Decrease) in Cash and Cash Equivalents			19,416,457				(3,507,196	)
Cash and Cash Equivalents – beginning of period			18,688,031				13,486,543
Cash and Cash Equivalents - end of period		$	38,104,488			$	9,979,347

(See accompanying notes to the condensed financial statements)

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REXAHN PHARMACEUTICALS, INC.

Condensed Statement of Cash Flows (continued)

(Unaudited)

 

		For the Six Months Ended
		June 30,
Supplemental Cash Flow Information		2014				2013
Non-cash financing and investing activities:
Warrants issued		$	3,691,429			$	-
Warrant liability extinguishment from exercise of warrants		$	10,137,243			$	16,820
Shares withheld for net stock option exercise		$	100,000			$	-

 

(See accompanying notes to the condensed financial statements)

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1.	Operations and Organization

 

Operations

 

Rexahn Pharmaceuticals, Inc. (the “Company,” or “Rexahn Pharmaceuticals”), a Delaware corporation, is a biopharmaceutical company whose principal operations are the discovery, development and commercialization of innovative treatments for cancer and other medical needs.  The Company had an accumulated deficit of $87,216,742 at June 30, 2014 and anticipates incurring losses through fiscal year 2014 and beyond.  The Company has not yet generated commercial revenues and has funded its operating losses to date through the sale of shares of its common stock and warrants to purchase shares of its common stock, convertible debt, financings, interest income from cash and cash equivalents, and proceeds from reimbursed research and development costs.    The Company believes that its cash, cash equivalents, and marketable securities, will be sufficient to cover its cash flow requirements for its current activities for at least the next 24 months.  Management has the capability of managing the Company’s operations within existing cash available by focusing on select research and development activities, selecting projects in conjunction with potential financings and milestones, and efficiently managing its general and administrative affairs.

 

Basis of Presentation

 

The accompanying unaudited condensed financial statements of the Company have been prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information.  Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.  In the opinion of the Company’s management, all adjustments (consisting of only normal recurring accruals) considered necessary for a fair presentation of the Company’s financial position as of June 30, 2014 and December 31, 2013 and of the results of operations for the three and six months ended June 30, 2014 and cash flows for the six months ended June 30, 2014 and 2013 have been included.  Operating results for the three and six months ended June 30, 2014 are not necessarily indicative of results that may be expected for any other interim period or the full fiscal year ending December 31, 2014. The accompanying unaudited financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 (“2013 Form 10-K”).  Information included in the condensed balance sheet as of December 31, 2013 has been derived from the Company’s audited financial statements for the year ended December 31, 2013 included in the 2013 Form 10-K.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future.  Actual results may ultimately differ from these estimates.  These estimates are reviewed periodically, and as adjustments become necessary, they are reported in earnings in the period in which they become available.

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2.	Recent Accounting Pronouncements Affecting the Company

In June 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-10, “Development Stage Entities: Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation.”  ASU 2014-10 eliminates several of the reporting requirements for development stage entities, including the requirement to present inception to date information in the statements of income, cash flows, and shareholder equity, and to label the financial statements as those of a development stage entity.  ASU 2014-10 also clarifies that the guidance in Accounting Standards Codification (“ASC”) Topic 275, “Risks and Uncertainties”, is applicable to entities that have not commenced principal operations, and eliminates an exception to the sufficiency-of-equity risk criterion for development stage entities, and will require all reporting entities that have an interest in development stage enterprises to apply consistent consolidation guidance for variable interest entities.  ASU 2014-10 is effective for all annual reporting periods beginning after December 15, 2014, with early adoption permitted.  The Company adopted ASU 2014-10 during the three months ended June 30, 2014, and removed the incremental reporting requirements for development stage entities from the financial statements for the three and six months ended June 30, 2014.

3.	Marketable Securities

Cost and fair value of the Company’s marketable securities are as follows:

 

		Cost				Gross Unrealized				Fair
Securities available-for-sale		Basis				Gains/(Losses)				Value
June 30, 2014:
State and municipal obligations		$	100,000			$	-			$	100,000
December 31, 2013:
State and municipal obligations		$	100,000			$	-			$	100,000

Amortized cost and fair value at June 30, 2014 by contractual maturity are shown below.  Expected maturities will differ from contractual maturities because the Company may redeem certain securities at par.

 

Maturity		Cost Basis				Fair Value
10 years or more		$	100,000			$	100,000

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4.	Prepaid Expenses and Other Current Assets

 

		June 30, 2014				December 31, 2013
Deposits on contracts		$	251,251			$	37,760
Prepaid expenses and other assets			650,046				469,405
		$	901,297			$	507,165

Deposits on contracts consist of deposits on research and development contracts for services that had not been incurred as of the balance sheet date.  Prepaid expenses and other assets include prepaid general and administrative expenses, such as insurance, rent, investor relations fees and compensatory stock issued for services not yet incurred as of the balance sheet date.

5.	Equipment, Net

 

		June 30,				December 31,
		2014				2013
Furniture and fixtures		$	62,071			$	59,133
Office equipment			45,753				41,752
Lab and computer equipment			425,195				425,195
Leasehold improvements			127,116				119,841
Total equipment			660,135				645,921
Less: Accumulated depreciation and amortization			(599,423	)			(580,749	)
Net carrying amount		$	60,712			$	65,172

 

Depreciation and amortization expense was $9,630 and $9,235 for the three months ended June 30, 2014 and 2013, respectively, and $18,674 and $18,551 for the six months ended June 30, 2014 and 2013, respectively.

6.	Accounts Payable and Accrued Expenses

 

		June 30,				December 31,
		2014				2013
Trade payables		$	506,667			$	251,687
Accrued expenses			93,262				25,367
Accrued research and development contract costs			763,134				215,211
Payroll liabilities			176,788				441,493
		$	1,539,851			$	933,758

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7.	Deferred Research and Development Arrangements

 

Rexgene Biotech Co., Ltd.

 

In 2003, the Company entered into a collaborative research agreement with Rexgene Biotech Co., Ltd. (“Rexgene”), a shareholder.  Rexgene is engaged in the development of pharmaceutical products in Asia and has agreed to assist the Company with the research, development and clinical trials necessary for registration of the Company’s drug candidate Archexin in Asia.  This agreement provides Rexgene with exclusive rights to license, sublicense, make, have made, use, sell and import Archexin in Asia.  In accordance with the agreement, Rexgene paid the Company a one-time fee of $1,500,000 in 2003.  The agreement terminates at the later of 20 years or the term of the patent.  The amortization reduces research and development expenses for the periods presented.

The Company is using 20 years as its basis for recognition and accordingly research and development expenses were reduced by $18,750 and $37,500 for the three and six months ended June 30, 2014 and 2013, respectively.  The remaining $637,500 and $675,000 to be amortized at June 30, 2014 and December 31, 2013, respectively, are reflected as deferred research and development arrangements on the balance sheet.  The payment from Rexgene is being used in the cooperative funding of the costs of development of Archexin. Royalties of 3% of net sales of licensed products will become payable by Rexgene to the Company on a quarterly basis once commercial sales of Archexin begin in Asia.  The product is still under development and commercial sales in Asia are not expected to begin until at least 2015.  Under the terms of the agreement, Rexgene does not receive royalties on the Company’s net sales outside of Asia.

 

Teva Pharmaceutical Industries, Ltd.

 

On September 21, 2009, the Company closed on a securities purchase agreement (the “Purchase Agreement”) with Teva Pharmaceutical Industries Limited (“Teva”), and contemporaneous with the execution and delivery of this agreement, the parties executed a research and exclusive license option agreement (the “RELO Agreement”) pursuant to which the Company agreed to use proceeds from the issuance and sale of shares to Teva to fund a research and development program for the pre-clinical development of RX-3117.  On November 27, 2012, the Company and Teva entered into a second amendment to the RELO Agreement, pursuant to which Teva provided the Company with an additional $926,000 of research funding for the development of RX-3117, which was recorded as restricted cash on the Company’s balance sheet.  The contribution from the second amendment was recorded in deferred research and development arrangements on the balance sheet.  Costs incurred for the development of RX-3117 are paid from restricted cash, reduce the deferred research and development arrangement and therefore are not an expense in the Company’s statement of operations.  As of June 30, 2014 and December 31, 2013, the Company had proceeds remaining of $40,656 and $158,630, respectively, which are included in restricted cash and  deferred research and development arrangements on the balance sheet.  During the six months ended June 30, 2014 and 2013, $117,974 and $344,621, respectively, were reduced from the deferred research and development arrangement for costs incurred for the development of RX-3117 or for amounts returned to Teva as funds not allocated to specific projects.  On August 28, 2013, the Company announced that Teva had decided not to exercise its option to license RX-3117, and as a result the RELO Agreement was terminated.  The proceeds remaining from the restricted cash will be used to pay for unbilled expenses.

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8.	Other Liabilities

On June 29, 2009, the Company entered into a five-year office lease agreement as disclosed in Note 14.  The lessor agreed to grant a leasehold improvement allowance of $100,000 to the Company to be used for the construction cost of improvements to the leased property, which included architectural and engineering fees, government agency plan check, permit and other fees, sales and use taxes, testing and inspection costs and telephone and data cabling and wiring in the premises.  The Company accounted for the benefit of the leasehold improvement allowance as a reduction of rental expense over the five-year term of the office lease.

On June 7, 2013, the Company entered into the first amendment to the lease agreement, also disclosed in Note 14. According to the terms of the amendment, the Company extended the lease term until June 30, 2019, and the amendment term began on July 1, 2013.  The lessor agreed to grant an additional leasehold improvement allowance of $54,660 to the Company to be used for further construction to the leased property, furniture and equipment.  The Company accounts for this benefit, including the unamortized portion from the original lease agreement, as a reduction of rental expense over the six-year amended term of the lease.

 

The following table sets forth the cumulative deferred lease incentive:

 

		June 30, 2014				December 31, 2013
Deferred lease incentive		$	154,660			$	154,660
Less accumulated amortization			(92,443	)			(86,222	)
Balance		$	62,217			$	68,438

The lease agreement, as amended and disclosed above, requires an initial annual base rent with annual increases over the next six years.  The Company recognizes rental expense on a straight-line basis over the term of the lease, which resulted in a deferred rent liability of $72,249 and $61,126 as of June 30, 2014 and December 31, 2013, respectively.

 

9.	Net Loss per Common Share

 

Basic loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period.  Diluted loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding, plus the number of common share equivalents that would be dilutive.  As of June 30, 2014 and December 31, 2013, there were stock options and warrants to acquire, in the aggregate, 24,290,805 and 34,325,663 shares of our common stock, respectively, that are potentially dilutive. However, diluted loss per share for all periods presented is the same as basic loss per share because the inclusion of common share equivalents would be anti-dilutive. The Company is not disclosing the number of weighted average diluted shares outstanding for the three months ended June 30, 2014 because the impact is immaterial.

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10.	Common Stock

 

The following transactions occurred from January 1, 2014 to June 30, 2014:

 

a)

On January 21, 2014 the Company closed on a registered direct public offering to issue and sell 19,047,620 shares of common stock and warrants to purchase up to 4,761,905 shares of common stock.  The common stock and warrants were sold in units, consisting of common stock and a warrant to purchase 0.25 shares of common stock, at a price of $1.05 per share, and the warrants have an exercise price of $1.28 per share.  The total gross proceeds of the offering were $20,000,001.  The warrants issued are exercisable beginning six months and one day after the closing date until the five-year anniversary of the closing date and were recorded as liabilities at fair value.

 

The total closing costs of the offering were $1,365,754, which consisted of placement agent and other professional fees.  Based upon the estimated fair value of the stock and warrants in the units, the Company allocated $206,172 to financing expense and $1,159,582 as stock issuance costs.

 

A summary of the allocation of the proceeds of the offering is shown below:

 

Gross Proceeds:		$	20,000,001
Allocated to liabilities:
Warrant liabilities			3,691,429
Allocated to equity:
Common stock and additional paid-in capital			16,308,572
Total allocated gross proceeds:		$	20,000,001

b)

On February 10, 2014, the Company issued 300,000 shares of stock to two vendors in exchange for investor relations and financial advisory services.  The market value of the stock issued was $1.12, and the total market value of the issuance was $336,000.

 

c)

On April 14, 2014, an option holder exercised 125,000 stock options by a net exercise.  The Company withheld 99,010 shares in treasury as payment for the exercise price, and issued 25,990 shares to the option holder.

 

d)

During the six months ended June 30, 2014, option holders exercised stock options to purchase shares of the Company’s common stock for cash of $258,955, and the Company issued 323,693 shares.

 

e)

During the six months ended June 30, 2014, warrant holders exercised warrants to purchase shares of the Company’s common stock for cash of $5,947,268, and the Company issued 11,738,220 shares.

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11.	Stock-Based Compensation

 

As of June 30, 2014, the Company had 10,306,601 options outstanding.

 

At the Company’s Annual Meeting of the Stockholders held on June 10, 2013, the Company’s stockholders voted to approve the Rexahn Pharmaceuticals, Inc. 2013 Stock Option Plan (the “2013 Plan”).  Under the 2013 Plan, the Company grants stock options to key employees, directors and consultants of the Company.  A total of 17,000,000 shares of common stock have been reserved for issuance pursuant to the 2013 Plan.  As of June 30, 2014, there were 1,848,499 options outstanding under the 2013 Plan, and 15,151,501 shares were available for issuance from the 2013 Plan.

 

On August 5, 2003, the Company established a stock option plan (the “2003 Plan”).  Under the 2003 Plan, the Company granted stock options to key employees, directors and consultants of the Company.  With the adoption of the 2013 Plan, no new stock options may be issued under the 2003 Plan, but previously issued options under the 2003 Plan remain outstanding until their expiration.  As of June 30, 2014, there were 8,458,102 outstanding options under the 2003 Plan.

 

For the majority of the grants to employees, the vesting period is 30% on the first anniversary of the grant date, an additional 30% on the second anniversary of the grant date and the remaining 40% on the third anniversary.  Options expire between five and ten years from the date of grant. For grants to non-employee consultants of the Company, the vesting period is between one and three years, subject to the fulfillment of certain conditions in the individual stock agreements, or 100% upon the occurrence of certain events specified in the individual stock agreements.

 

Accounting for Employee Awards

 

The Company’s results of operations for the three months ended June 30, 2014 and 2013 include share-based employee compensation expense totaling $130,873 and $54,371, respectively.  The Company’s results of operations for the six months ended June 30, 2014 and 2013 include share based compensation expense totaling $240,315 and $420,482.  Such amounts have been included in the statement of operations in general and administrative and research and development expenses.  No income tax benefit has been recognized in the statement of operations for share-based compensation arrangements as the Company has provided for a 100% valuation allowance on its deferred tax assets.

 

Employee stock option compensation expense is the estimated fair value of options granted amortized on a straight-line basis over the requisite vesting service period for the entire portion of the award.

 

Accounting for Non-Employee Awards

 

Stock compensation expenses related to non-employee options were $1,645 for the three months ended June 30, 2014.  There were no stock option expenses related to non-employee options during the three months ended June 30, 2013.  Stock compensation expenses related to non-employee options were $20,553 and $5,840 for the six months ended June 30, 2014 and 2013, respectively.  Such amounts have been included in the statement of operations in general and administrative and research and development expenses.

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Summary of Stock Compensation Expense Recognized

 

Total stock-based compensation recognized by the Company in the three and six months ended June 30, 2014 and 2013 is as follows:

		Three Months Ended June 30,								Six Months Ended June 30,
		2014				2013				2014				2013
Statement of operations line item:
General and administrative:
Payroll		$	97,605			$	40,535			$	178,516			$	390,914
Consulting and other professional fees			-				-				-				3,893
Research and development:
Payroll			33,268				13,836				61,799				29,568
Consulting and other professional fees			1,645				-				20,553				1,947
Total		$	132,518			$	54,371			$	260,868			$	426,322

Summary of Stock Option Transactions

 

There were 955,999 stock options granted at an exercise price of $1.14 with a fair value of $774,992, 20,000 stock options granted at an exercise price of $1.35 and a fair value of $19,678, 62,500 stock options granted at an exercise price of $0.98 and a fair value of $44,606, and 360,000 stock options granted at an exercise price of $0.90 and a fair value of $234,534 during the six months ended June 30, 2014.  There were 1,200,000 stock options granted at an exercise price of $0.37 with a fair value of $320,465, 550,000 stock options granted at an exercise price of $0.31 with a fair value of $122,497, 250,000 stock options granted at an exercise price of $0.39 and a fair value of $69,529, and 300,000 stock options granted at an exercise price of $0.50 and a fair value of $107,086 during the six months ended June 30, 2013.

 

The fair value of options at the date of grant was estimated using the Black-Scholes option pricing model.  The Company took into consideration guidance under ASC 718, “Compensation-Stock Compensation” and Staff Accounting Bulletin No. 107 (“SAB 107”) when reviewing and updating assumptions.  The expected volatility is based upon historical volatility of the Company’s stock.  The expected term is based upon the simplified method as allowed under SAB 107.

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The assumptions made in calculating the fair values of options are as follows:

 

		Six Months Ended June 30,
		2014				2013
Black-Scholes weighted average assumptions
Expected dividend yield			0	%			0	%
Expected volatility			92-97	%			94-96	%
Risk free interest rate			1.5-1.7	%			0.75-1.13	%
Expected term (in years)		5 years				5 years

 

The following table summarizes the employee and non-employee share-based transactions:

		2014								2013
		Number of Options				Weighted Average Exercise Price				Number of Options				Weighted Average Exercise Price
Outstanding at
January 1			9,356,795			$	0.92				7,741,795			$	1.03
Granted			1,398,499				1.07				2,300,000				0.37
Exercised			(448,693	)			0.80				-				-
Expired			-				-				-				-
Cancelled			-				-				-				-
Outstanding at June 30			10,306,601			$	0.94				10,041,795			$	0.88

The following table summarizes information about stock options outstanding as of June 30, 2014 and December 31, 2013:

 

		Number of Options				Weighted Average Exercise Price			Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
Outstanding at June 30, 2014			10,306,601			$	0.94		5.2 years		$	1,494,382
Exercisable at June 30, 2014			8,118,102			$	0.97		4.0 years		$	1,133,182
Outstanding at December 31, 2013			9,356,795			$	0.92		4.8 years		$	350,865
Exercisable at December 31, 2013			7,956,795			$	0.99		4.0 years		$	199,795

---

The total intrinsic value of the options exercised was $48,125 and $115,528 for the three and six months ended June 30, 2014.  There were no options exercised during the three and six months ended June 30, 2013.  The weighted average fair value of the options vested was $0.38 and $0.36 for the six months ended June 30, 2014 and 2013, respectively.

 

A summary of the Company’s unvested options as of June 30, 2014 and changes during the six months ended June 30, 2014 is presented below:

 

		2014
		Number of Options				Weighted Average Fair Value at Grant Date
Unvested at January 1, 2014			1,400,000			$	0.34
Granted			1,398,499			$	0.77
Vested			(610,000	)		$	0.38
Cancelled			-			$	-
Unvested at June 30, 2014			2,188,499			$	0.60

 

As of June 30, 2014 and December 31, 2013, there was $1,118,918 and $281,957 of total unrecognized compensation cost, respectively, related to all unvested stock options, which is expected to be recognized over a weighted average vesting period of 2.0 years and 1.7 years, respectively.

12.

Warrants

 

As of June 30, 2014, warrants to purchase 13,984,204 shares were outstanding, having exercise prices ranging from $0.41 to $1.50 and expiration dates ranging from October 23, 2014 to January 21, 2019.

		2014								2013
		Number of warrants				Weighted average exercise price				Number of warrants				Weighted average exercise price
Balance, January 1			24,968,868			$	0.86				21,656,142			$	0.89
Issued during the period			4,761,905			$	1.28				-			$	-
Exercised during the period			(12,058,871	)		$	0.52				(56,650	)		$	0.47
Expired during the period			(3,687,698	)		$	1.71				-			$	-
Balance, June 30			13,984,204			$	1.06				21,599,492			$	0.89

 

At June 30, 2014 and December 31, 2013, the average remaining contractual life of the outstanding warrants was 3.5 and 3.2 years, respectively.

---

The warrants issued to investors in the June 2009, October 2009, June 2010, March 2011 and December 2012 offerings contain a provision for net cash settlement in the event that there is a fundamental transaction (contractually defined as a merger, sale of substantially all assets, tender offer or share exchange).  If a fundamental transaction occurs in which the consideration issued consists principally of cash or stock in a non-public company, then the warrant holder has the option to receive cash, equal to the fair value of the remaining unexercised portion of the warrant.  Due to this contingent redemption provision, the warrants require liability classification in accordance with ASC 480 and are recorded at fair value.  The warrants issued to investors in the July 2013, October 2013 and January 2014 offerings contain a fundamental transaction provision, but the warrant holders only have an option as to the type of consideration received if the holders of common stock receive an option as to their consideration.  In addition, the warrants issued in the June 2009, October 2009, June 2010, March 2011, December 2012, July 2013, October 2013, and January 2014 offerings contain a cashless exercise provision that is exercisable only in the event that a registration statement is not effective. That provision may not be operative if an effective registration statement is not available because an exemption under the U.S. securities laws may not be available to issue unregistered shares.  As a result, net cash settlement may be required, and the warrants require liability classification.

ASC 820 provides requirements for disclosure of liabilities that are measured at fair value on a recurring basis in periods subsequent to the initial recognition.  Fair values for warrants are determined using the Binomial Lattice (“Lattice”) valuation technique. The Lattice model provides for dynamic assumptions regarding volatility and risk-free interest rates within the total period to maturity. Accordingly, within the contractual term, the Company provided multiple date intervals over which multiple volatilities and risk free interest rates were used. These intervals allow the Lattice model to project outcomes along specific paths that consider volatilities and risk free rates that would be more likely in an early exercise scenario.

Significant assumptions are determined as follows:

Trading market values—Published trading market values;

Exercise price—Stated exercise price;

Term—Remaining contractual term of the warrant;

Volatility—Historical trading volatility for periods consistent with the remaining terms;

Risk-free rate—Yields on zero coupon government securities with remaining terms consistent with the remaining terms of the warrants.

Due to the fundamental transaction provision, which could provide for early redemption of the warrants, the model also considered the probability the Company would enter into a fundamental transaction during the remaining term of the warrant. Because the Company is not yet achieving positive cash flow, management believes the probability of a fundamental transaction occurring over the term of the warrant is unlikely and therefore estimates the probability of entering into a fundamental transaction to be 5%.  For valuation purposes, the Company also assumed that if such a transaction did occur, it was more likely to occur towards the end of the term of the warrants.

The significant unobservable inputs used in the fair value measurement of the warrants include management’s estimate of the probability that a fundamental transaction may occur in the future.  Significant increases (decreases) in the probability of occurrence would result in a significantly higher (lower) fair value measurement.

---

The following table summarizes the fair value of the warrants as of the respective balance sheet dates:

 

		Fair Value as of:
Warrant Issuance:		June 30, 2014				December 31, 2013
June 5, 2009 financing:
Series III warrants		$	-			$	11
Warrants to placement agent			-				1
October 23, 2009 financing:
Warrants to institutional investors			32,112				19,689
June 30, 2010 financing
Warrants to institutional investors			-				10
March 31, 2011 financing:
Warrants to institutional investors			1,059,450				311,360
December 4, 2012 financing:
Warrants to institutional investors			139,968				2,124,444
Warrants to placement agent			23,605				222,286
July 26, 2013 financing:
Warrants to institutional investors			1,214,938				1,148,390
Warrants to placement agent			60,294				83,808
October 16, 2013 financing:
Warrants to institutional investors			1,444,796				1,051,454
Warrants to placement agent			194,673				72,605
January 21, 2014 financing:
Warrants to institutional investors			2,413,567				-
Total:		$	6,583,403			$	5,034,058

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The following table summarizes the number of shares indexed to the warrants as of the respective balance sheet or transaction dates:

 

		Number of Shares indexed as of:
Warrant Issuance		June 30, 2014				December 31, 2013
June 5, 2009 financing:
Series III warrants			-				1,555,555
Warrants to placement agent			-				132,143
October 23, 2009 financing:
Warrants to institutional investors			778,333				1,228,333
June 30, 2010 financing
Warrants to institutional investors			-				2,000,000
March 31, 2011 financing:
Warrants to institutional investors			3,333,333				3,333,333
December 4, 2012 financing:
Warrants to institutional investors			221,600				7,418,503
Warrants to placement agent			40,000				880,000
July 26, 2013 financing:
Warrants to institutional investors			2,000,000				3,990,000
Warrants to placement agent			124,032				456,000
October 16, 2013 financing:
Warrants to institutional investors			2,317,309				3,567,309
Warrants to placement agent			407,692				407,692
January 21, 2014 financing:
Warrants to institutional investors			4,761,905				-
Total:			13,984,204				24,968,868

The assumptions used in calculating the fair values of the warrants are as follows:

 

June 5, 2009 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	-			$	0.51
Estimated future volatility			-				109	%
Dividend			-				-
Estimated future risk-free rate			-				0.13	%
Equivalent volatility			-				43-45	%
Equivalent risk-free rate			-				0.05-0.06	%

---

October 23, 2009 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	0.87			$	0.51
Estimated future volatility			109	%			109	%
Dividend			-				-
Estimated future risk-free rate			0.06	%			0.13	%
Equivalent volatility			43	%			57	%
Equivalent risk-free rate			0.03	%			0.07	%

 

June 30, 2010 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	-			$	0.51
Estimated future volatility			-				109	%
Dividend			-				-
Estimated future risk-free rate			-				0.13	%
Equivalent volatility			-				49	%
Equivalent risk-free rate			-				0.06	%

 

March 31, 2011 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	0.87			$	0.51
Estimated future volatility			109	%			109	%
Dividend			-				-
Estimated future risk-free rate			1.05	%			1.58	%
Equivalent volatility			89	%			71	%
Equivalent risk-free rate			0.20	%			0.27	%

 

December 4, 2012 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	0.87			$	0.51
Estimated future volatility			109	%			109	%
Dividend			-				-
Estimated future risk-free rate			0.85-1.98	%			1.58-2.72	%
Equivalent volatility			89-90	%			69-73	%
Equivalent risk-free rate			0.16-0.38	%			0.22-0.40	%

---

July 26, 2013 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	0.87				0.51
Dividend			-				-
Equivalent volatility			88-89	%			69-77	%
Equivalent risk-free rate			0.16-0.49	%			0.22-0.62	%

 

October 16, 2013 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	0.87				0.51
Dividend			-				-
Equivalent volatility			89	%			69-76	%
Equivalent risk-free rate			0.16-0.53	%			0.20-0.52	%

 

January 21, 2014 financing:		June 30, 2014				December 31, 2013
Trading market prices		$	0.87				-
Dividend			-				-
Equivalent volatility			87	%			-
Equivalent risk-free rate			0.57	%			-

---

Changes in the fair value of the warrant liabilities, carried at fair value, as reported as “unrealized gain (loss) on fair value of warrants” in the statement of operations:

 

		Three Months Ended June 30, 2014				Three Months Ended June 30, 2013				Six Months Ended June 30, 2014				Six Months Ended June 30, 2013
Exercised and Expired Warrants		$				$				$				$	144
June 5, 2009 financing:
Series III warrants			80,889				47				11				30,069
Warrants to placement agent			8,484				(53	)			1				2,802
October 23, 2009 financing:			-
Warrants to institutional investors			284,047				(15,355	)			(309,903	)			26,040
June 30, 2010 financing
Warrants to institutional investors			61,000				200				10				9,000
March 31, 2011 financing:
Warrants to institutional investors			725,883				(116,666	)			(748,090	)			(20,000	)
December 4, 2012 financing:
Warrants to institutional investors			55,683				(1,004,301	)			(4,170,019	)			(837,321	)
Warrants to placement agent			9,359				(70,528	)			(523,891	)			(48,488	)
July 26, 2013 financing:
Warrants to institutional investors			501,262				-				(1,699,355	)			-
Warrants to placement agent			28,959				-				(264,579	)			-
October 16, 2013 financing:
Warrants to institutional investors			604,836				-				(1,435,140	)			-
Warrants to placement agent			95,196				-				(122,066	)			-
January 21, 2014 financing:
Warrants to institutional investors			1,209,767				-				1,277,862				-
Total:		$	3,665,365			$	(1,206,656	)		$	(7,995,159	)		$	(837,754	)

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13.	Income Taxes

 

No provision for federal and state income taxes was required for the three and six months ended June 30, 2014 and 2013 due to the Company’s operating losses and increased deferred tax asset valuation allowance.  At June 30, 2014 and December 31, 2013, the Company had unused net operating loss carry-forwards of approximately $74,749,000 and $69,036,000, which expire at various dates through 2034.  Some of this amount may be subject to annual limitations under certain provisions of the Internal Revenue Code related to “changes in ownership.”

 

As of June 30, 2014 and December 31, 2013, the deferred tax assets related to the aforementioned carry-forwards have been fully offset by valuation allowances, because significant utilization of such amounts is not presently expected in the foreseeable future.

 

Deferred tax assets and valuation allowances consist of:

 

		June 30,				December 31,
		2014				2013
Net Operating Loss Carryforwards		$	29,168,000				26,924,000
Stock Compensation Expense			2,084,900				2,028,200
Book tax differences on assets and liabilities			315,000				424,000
Valuation Allowance			(31,567,900	)			(29,376,200	)
Net Deferred Tax Assets		$	-			$	-

The Company files income tax returns in the U.S. federal and Maryland state jurisdictions.  Tax years for fiscal 2010 through 2014 are open and potentially subject to examination by the federal and Maryland state taxing authorities.

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14.	Commitments and Contingencies

 

a)

The Company has contracted with various vendors for research and development services. The terms of these agreements usually require an initial fee and monthly or periodic payments over the term of the agreement, ranging from two months to 36 months. The costs to be incurred are estimated and are subject to revision. As of June 30, 2014, the total estimated cost to be incurred under these agreements was approximately $28,200,000, and the Company had made payments totaling $21,608,667 since inception under the terms of the agreements.  All of these agreements may be terminated by either party upon appropriate notice as stipulated in the respective agreements.

 

b)

On June 22, 2009, the Company entered into a License Agreement with Korea Research Institute of Chemical Technology (“KRICT”) to acquire the rights to all intellectual properties related to Quinoxaline-Piperazine derivatives that were synthesized under a Joint Research Agreement.  The initial license fee was $100,000, all of which was paid as of December 31, 2009.  The agreement with KRICT calls for a one-time milestone payment of $1,000,000 within 30 days after the first achievement of marketing approval of the first commercial product arising out of or in connection with the use of KRICT’s intellectual properties.  As of June 30, 2014, the milestone has not occurred.

 

c)

On June 29, 2009, the Company signed a five-year commercial lease agreement for 5,466 square feet of office space in Rockville, Maryland.  The lease agreement required annual base rent with increases over the next five years.  Under the lease agreement, the Company pays its allocable portion of real estate taxes and common area operating charges. Rent paid under the Company’s lease during the three months ended June 30, 2014 and 2013, including the amendment terms described below, was $37,579 and $40,199, respectively, and rent paid during the six months ended June 30, 2014 and 2013 was $62,631 and $80,398, respectively.

 

On June 7, 2013, the Company entered into the first amendment to the lease agreement. According to the terms of this amendment, the Company extended the lease term until June 30, 2019.  The amendment term began on July 1, 2013 with a base rent of $100,210 and requires annual base rent increases over the remaining term of the lease.

 

Future rental payments over the next five years are as follows:

 

For the remaining six months ending December 31:	2014		$	77,043
For the year ending December 31:	2015			156,000
	2016			159,881
	2017			163,871
	2018			167,970
	2019			85,024
	Total		$	809,789

In connection with the lease agreement, the Company issued a letter of credit of $100,000 in favor of the lessor.  On August 2, 2010, and July 1, 2011 the letter of credit was amended and reduced to $50,000 and $37,500, respectively.  The Company has restricted cash equivalents of the same amount for the letter of credit.

---

 

d)

On September 21, 2009, the Company closed on the Purchase Agreement with Teva, and contemporaneous with the execution and delivery of this agreement, the parties executed the RELO Agreement, pursuant to which the Company agreed to use proceeds from the issuance and sale of shares to Teva to fund a research and development program for the pre-clinical development of RX-3117.  On December 27, 2012, the Company received $926,000 from Teva in accordance with a second amendment to the RELO Agreement, entered into on November 27, 2012. The Company did not issue equity for this transaction.  On August 28, 2013, the Company announced that Teva had decided not to exercise its option to license RX-3117, and as a result the RELO Agreement was terminated.  The remaining proceeds of $40,656, which is included in restricted cash equivalents at June 30, 2014 will be used to pay for unbilled expenses.

 

e)

The Company has established a 401(k) plan for its employees.  The Company has elected to match 100% of the first 3% of an employee’s compensation plus 50% of an additional 2% of the employee’s deferral. Expense related to this matching contribution aggregated to $24,584 and $20,531 for the three months ended June 30, 2014 and 2013, respectively, and $45,284 and $38,247 for the six months ended June 30, 2014 and 2013, respectively.

 

f)

On June 24, 2013 and May 30, 2012, the Company signed a one-year renewal to use laboratory space commencing on July 1, 2013 and 2012, respectively.  The lease requires monthly rental payments of $4,554.  Rent paid under the Company’s lease during the three and six months ended June 30, 2014 and 2013 was $13,662 and $27,324, respectively.

 

g)

In July 2013, the Company entered into an exclusive license agreement with the University of Maryland, Baltimore for a novel drug delivery platform, Nano-Polymer Drug Conjugate Systems.  RX-21101 is the Company’s first drug candidate utilizing this platform.  The agreement requires the Company to make payments to the University of Maryland if RX-21101 or any products from the licensed delivery platform achieve development milestones.  As of June 30, 2014, no development milestones have occurred.

 

h)

In October 2013, the Company signed an exclusive license agreement with the Ohio State Innovation Foundation, for a novel oligonucleotide drug delivery platform, Lipid-Coated Albumin Nanoparticle (“LCAN”).  The agreement requires the Company to make payments to the Ohio State Innovation Foundation or any products from the licensed delivery platform achieve development milestones.  As of June 30, 2014, no development milestones have occurred.

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15.	Fair Value Measurements

 

ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, not adjusted for transaction costs.  ASC 820 also establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels giving the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).

The three levels are described below:

Level 1 Inputs —

Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible by the Company;

 

Level 2 Inputs —

Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly;

 

Level 3 Inputs —

Unobservable inputs for the asset or liability including significant assumptions of the Company and other market participants.

 

The following tables present assets and liabilities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy.

 

		Fair Value Measurements at June 30, 2014
		Total				Level 1				Level 2				Level 3
Assets:
Restricted Cash Equivalents		$	78,156			$	40,656			$	37,500			$	-
Marketable Securities			100,000				100,000				-				-
Total Assets:		$	178,156			$	140,656			$	37,500			$	-
Liabilities:
Warrant Liabilities		$	6,583,403				-				-			$	6,583,403

 

		Fair Value Measurements at December 31, 2013
		Total				Level 1				Level 2				Level 3
Assets:
Restricted Cash Equivalents		$	196,130			$	158,630			$	37,500			$	-
Marketable Securities			100,000				100,000				-				-
Total Assets:		$	296,130			$	258,630			$	37,500			$	-
Liabilities:
Warrant Liabilities		$	5,034,058				-				-			$	5,034,058

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As of June 30, 2014 and December 31, 2013, the Company’s restricted cash equivalents are comprised of the following:

a)

Money market funds valued at the net asset value of shares held by the Company and classified within Level 1 of the fair value hierarchy;

b)

Certificate of deposit valued based upon the underlying terms of a letter of credit, as disclosed in Note 14 and classified within Level 2 of the fair value hierarchy.

Marketable securities consist of state authority and municipal security fund bonds that are valued at fair value and classified within level 1 of the fair value hierarchy.

The fair value methodology for the warrant liabilities is disclosed in Note 12.

The carrying amounts reported in the financial statements for cash and cash equivalents (Level 1), prepaid expenses, and other current assets and accounts payable and accrued expenses approximate fair value because of the short term maturity of these financial instruments.

The following table sets forth a reconciliation of changes in the six months ended June 30, 2014 and 2013 in the fair value of the liabilities classified as level 3 in the fair value hierarchy:

 

		Warrant Liabilities
Balance at January 1, 2014		$	5,034,058
Additions			3,691,429
Unrealized losses, net			7,995,159
Unrealized gains on expiration			-
Transfers out of level 3			(10,137,243	)
Balance at June 30, 2014		$	6,583,403

 

		Warrant Liabilities
Balance at January 1, 2013		$	2,842,065
Additions			-
Unrealized losses, net			837,754
Unrealized gains on expiration			-
Transfers out of level 3			(16,820	)
Balance at June 30, 2013		$	3,662,999

Additions consist of the fair value of warrant liabilities upon issuance.  Transfers out of Level 3 for warrant liabilities consist of warrant exercises, where the liability is converted to additional paid-in capital upon exercise.  The Company’s policy is to recognize transfers in and transfers out as of the actual date of the event or change in circumstance that caused the transfer.  There were no significant transfers in and out of Levels 1 and 2 for the three and six months ended June 30, 2014 and 2013.

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Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.

OVERVIEW

The following discussion should be read in conjunction with the unaudited condensed financial statements and notes thereto set forth in Item 1 of this Quarterly Report on Form 10-Q and the audited condensed financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2013.

 Except for the historical information contained herein, the matters discussed in this Quarterly Report on Form 10-Q may be deemed to be forward-looking statements that involve risks and uncertainties.  We make such forward-looking statements, pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.  In this Quarterly Report on Form 10-Q, words such as “believe,” “estimate,” “expect,” “anticipate,” “may,” “intend” and other similar expressions, are intended to identify forward-looking statements.  We caution that forward-looking statements are based largely on our expectations, and are subject to a number of known and unknown risks and uncertainties that are subject to change based on factors that are, in many instances, beyond our control.  Actual results, performance or achievements may differ materially from those contemplated, expressed, or implied by the forward-looking statements.

The following factors, among others, could cause our financial performance to differ materially from that expressed in such forward-looking statements:

·

our lack of profitability and the need for additional capital to operate our business;

·

our drug candidates being in early stages of development, including pre-clinical development;

·

our ability to obtain the necessary U.S. and worldwide regulatory approvals for our drug candidates;

·

successful and timely completion of clinical trials for our drug candidates;

·

demand for and market acceptance of our drug candidates;

·

our ability to identify partners and collaborators for the development of certain of our drug candidates and, if identified, to enter into mutually agreeable relationships with those partners and collaborators;

·

the availability of qualified third-party researchers and manufacturers for our drug development programs;

·

our ability to develop and obtain protection of our intellectual property; and

·

other risks and uncertainties, including those detailed from time to time in our filings with the Securities and Exchange Commission (the “SEC”).

The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report on Form 10-Q, in our Annual Report on Form 10-K for the year ended December 31, 2013, and in our other filings with the SEC.

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These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

We are a clinical biopharmaceutical company dedicated to the discovery, development and commercialization of innovative treatments for cancer patients that target specific proteins that are over expressed in cancer cells and not present in normal healthy tissues.  This approach differs from existing chemotherapeutic agents that inhibit the growth of both cancer cells and normal healthy tissues at similar doses. Our pipeline features one oncology candidate in Phase II clinical trials, two oncology candidates in Phase I clinical trials, two drug candidates not currently being actively developed and several other drug candidates in pre-clinical development. Our strategy is to continue building a significant product pipeline of innovative drug candidates that we will commercialize alone or with partners.  We intend to initially develop drug candidates for cancers that are orphan indications and then expand into more highly prevalent cancers.

Since our inception, our efforts and resources have been focused primarily on developing our pharmaceutical technologies, raising capital and recruiting personnel.  We have no product sales to date, and we will not generate any product sales until we receive approval from the Food and Drug Administration (the “FDA”) or equivalent foreign regulatory bodies to begin selling our pharmaceutical candidates.  Our major sources of working capital have been proceeds from various private financings, primarily private sales of common stock and debt securities and collaboration agreements with our strategic investors.

Recently Issued Accounting Standards

In June 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-10, “Development Stage Entities: Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation.”  ASU 2014-10 eliminates several of the reporting requirements for development stage entities, including the requirement to present inception to date information in the statements of income, cash flows, and shareholder equity, and to label the financial statements as those of a development stage entity.  ASU 2014-10 also clarifies that the guidance in Accounting Standards Codification (“ASC”) Topic 275, “Risks and Uncertainties”, is applicable to entities that have not commenced principal operations, and eliminates an exception to the sufficiency-of-equity risk criterion for development stage entities, and will require all reporting entities that have an interest in development stage enterprises to apply consistent consolidation guidance for variable interest entities. ASU 2014-10 is effective for all annual reporting periods beginning after December 15, 2014, with early adoption permitted.  We adopted ASU 2014-10 during the three months ended June 30, 2014, and removed the incremental reporting requirements for development stage entities from the financial statements for the three and six months ended June 30, 2014.

Results of Operations

Comparison of the Three and Six Months Ended June 30, 2014 and June 30, 2013

Total Revenues

We had no revenues for the three and six months ended June 30, 2014 or 2013.

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General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related expenses for executive, finance and other administrative personnel, recruitment expenses, professional fees and other corporate expenses, including business development, investor relations, and general legal activities.

General and administrative expenses increased $844,543, or 98.4%, to $1,702,489 for the three months ended June 30, 2014 from $857,946 for the three months ended June 30, 2013.  General and administrative expenses increased $1,047,247, or 48.7%, to $3,115,945 for the six months ended June 30, 2014 from $2,068,698 for the six months ended June 30, 2013.  The increase is primarily attributable to increases in several expense categories, including investor relations, financial advisory services relating to the Company’s financing activities, legal and professional fees related to corporate organizational matters, and proxy solicitation fees for our shareholder meeting.  During the three and six months ended June 30, 2014, we engaged additional firms to provide these investor relations and professional services, and some of these firms were compensated with compensatory stock in addition to cash payments.

Research and Development Expenses

Research and development expenses consist primarily of salaries and related personnel costs, fees paid to consultants and outside service providers for laboratory development and other expenses relating to the design, development, testing, and enhancement of our drug candidates.  We expense our research and development costs as they are incurred.

Research and development expenses increased $776,277, or 83.9%, to $1,701,407 for the three months ended June 30, 2014, from $925,130 for the three months ended June 30, 2013.  Research and development expenses increased $1,495,385, or 101.2%, to $2,972,981 for the six months ended June 30, 2014 from $1,477,596 for the six months ended June 30, 2013.  The increase in both the three and six months ended June 30, 2014 is primarily attributable to the clinical trials that were on-going during these periods.  During the six months ended June 30, 2014, one of our drug candidates, Archexin, entered a Phase IIa clinical trial to study its safety and efficacy in patients with metastatic renal cell carcinoma (“RCC”), and another drug candidate, RX-3117, entered a Phase Ib clinical trial to study its safety and efficacy in patients with solid tumors.

Patent Fees

Our patent fees decreased $25,806, or 21.3%, to $95,410 for the three months ended June 30, 2014, from $121,216 for the three months ended June 30, 2013.  Our patent fees decreased $90,277, or 35.0%, to $167,430 for the six months ended June 30, 2014, from $257,707 for the six months ended June 30, 2013.  The decrease is primarily attributable to a partial reduction of our patent fees related to our central nervous system patents, as well as translation fees associated with regionalizing patents in foreign jurisdictions during the three and six months ended June 30, 2013.

Depreciation and Amortization

Depreciation and amortization expense essentially remained flat for the three and six months ended June 30, 2014 compared to the three and six months ended June 30, 2013, increasing $395 and $123, or 4.3%, and 0.7%, respectively.

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Interest Income

Interest income increased $26,602, or 232.7% to $38,035 for the three months ended June 30, 2014 from $11,433 for the three months ended June 30, 2013.  Interest income increased $48,875, or 227.8% to $70,326 for the six months ended June 30, 2014 from $21,451 for the six months ended June 30, 2013.  The increase is due to an increase in interest rates and higher cash balances on our cash and cash equivalents for the three and six months ended June 30, 2014 compared to the three and six months ended June 30, 2013.

Unrealized Gain/ (Loss) on Fair Value of Warrants

Our warrants are recorded as liabilities at fair value, and the warrants are valued using a lattice model.  Changes in the fair value of warrants are recorded as an unrealized gain or loss in our statement of operations.  During the three months ended June 30, 2014 and 2013, we recorded an unrealized gain (loss) on the fair value of our warrants of $3,665,365 and $(1,206,656), respectively.  During the six months ended June 30, 2014 and 2013, we recorded an unrealized loss on the fair value of our warrants of $7,995,159 and $837,754, respectively.  Estimating fair values of warrants requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the warrant with related changes to external market factors.  The large unrealized gain for the three months ended June 30, 2014 primarily resulted from a decreased stock price of the underlying common stock at June 30, 2014, compared to March 31, 2014, while the large unrealized loss for the six months ended June 30, 2014 primarily resulted from an increased stock price of the underlying common stock at June 30, 2014 compared to December 31, 2013.

Financing Expense

We incurred $206,172 of financing expenses during the six months ended June 30, 2014, related to our registered direct offering in January 2014.  We did not incur financing expenses during the six months ended June 30, 2013.

Net Income (Loss)

As a result of the above, net income (loss) for the three and six months ended June 30, 2014 was $194,464, and ($14,406,035) or $0.00 and ($0.08) per share, respectively, compared to ($3,108,750) and ($4,638,855) or ($0.03) and ($0.04) per share, for the three and six months ended June 30, 2013.

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Research and Development Projects

Research and development costs are expensed as incurred.  Research and development costs consist primarily of salaries and related personnel costs, costs to acquire pharmaceutical products and product rights for development and amounts paid to contract research organizations, hospitals and laboratories for the provision of services and materials for drug development and clinical trials.  Costs incurred in obtaining the license rights to technology in the research and development stage that have no alternative future uses are expensed as incurred.  Our research and development programs are related to our oncology clinical stage drug candidates, Archexin, RX-3117 and Supinoxin, and our pre-clinical stage drug candidates, RX-0047-Nano, Archexin-Nano and RX-21101.  As we expand our clinical studies, we will enter into additional development agreements.  Significant additional expenditures will be required if we complete our clinical trials, start new trials, apply for regulatory approvals, continue development of our technologies, expand our operations and bring our products to market.  The eventual total cost of each clinical trial is dependent on a number of uncertainties such as trial design, the length of the trial, the number of clinical sites and the number of patients.  The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive and uncertain.  Because the successful development of our most advanced drug candidates, Archexin, RX-3117 and Supinoxin, is uncertain, and because RX-0047-Nano, Archexin-Nano, and RX-21101 are in early-stage development, we are unable to estimate the costs of completing our research and development programs, the timing of bringing such programs to market and, therefore, when material cash inflows could commence from the sale of these drug candidates, if any.  If these projects are not completed as planned, our results of operations and financial condition would be negatively affected.

Archexin^®

Archexin is a potential best-in-class, potent inhibitor of the protein kinase phosphorylated Akt-1, which is over expressed in cancer cells and which we believe plays a critical role in cancer cell proliferation, survival, angiogenesis, metastasis and drug resistance.  Archexin has received “orphan drug” designation from the FDA, for RCC, glioblastoma, ovarian cancer, stomach cancer and pancreatic cancer.  That designation provides tax incentives for clinical research and a waiver of user fees.  In addition, a drug that is approved for its orphan-designated use receives seven years of exclusivity after approval, during which the FDA generally cannot approve another product with the same active moiety for the same indication.

 In August 2012, we announced top line results of an open label 2-stage Phase IIa clinical trial for Archexin that was designed to assess the safety and efficacy of Archexin in combination with gemcitabine.  Gemcitabine is used to treat pancreatic, breast, ovarian and lung cancers.  Gemcitabine is a member of a group of chemotherapy drugs known as anti-metabolites.  It prevents cells from making DNA and RNA, which stops cell growth and causes cells to die.  Stage 1 was the dose-finding portion of the study, and Stage 2 was the dose-expansion portion of the study using the dose identified in Stage 1 administered with gemcitabine.   The study enrolled 31 subjects aged 18 to 65 with metastatic pancreatic cancer at nine centers in the United States and India.  The primary endpoint was overall survival following four cycles of therapy with a six month follow-up.  For those evaluable patients, the study demonstrated that treatment with Archexin in combination with gemcitabine provided a median survival rate of 9.1 months compared to the historical survival data of 5.65 months for standard single agent gemcitabine therapy.   The most frequent reported adverse events were constipation, nausea, abdominal pain and pyrexia, regardless of relatedness.

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We initiated a Phase IIa clinical proof-of-concept clinical trial of Archexin in January 2014 to study its safety and efficacy in patients with metastatic RCC. In the trial, Archexin will be administered in combination with everolimus (Afinitor®), and will be conducted in two stages.  The first stage will be dose ranging, with up to three dose groups with three RCC patients each, to determine its maximal tolerated dose (“MTD”) in combination with everolimus.  Once the MTD has been determined, thirty RCC patients eachwill be randomized to either Archexin in combination with everolimus or everolimus alone, in a ratio of 2:1.  Rexahn plans to complete the initial safety component of this study in the fourth quarter of 2014 or early 2015.   We own one issued U.S. patent for Archexin.

RX-3117

 

 RX-3117 is a small molecule nucleoside compound with an anti-metabolite mechanism of action, and we believe it has therapeutic potential in a broad range of cancers including colon, lung, and pancreatic cancer.  RX-3117 has also been shown to be effective in inhibiting the growth of gemcitabine-resistant human cancers and in improving overall survival in pre-clinical animal models.  We completed an exploratory Phase I clinical study of RX-3117 in 2012 that demonstrated the oral bioavailability of RX-3117 in humans with no adverse effects reported in the study.   In January 2014, we initiated a Phase Ib clinical trial to study the safety, tolerability, dose-limiting toxicities and MTD of RX-3117 in patients with solid tumors.  Secondary endpoints will include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117.  Rexahn has completed testing of three dose groups (30, 60 and 100mg) and is in the middle of recruiting the fourth dose group (150mg). Based on the progress of the RX-3117 clinical development program and the level of interest expressed from a number of oncology-focused pharmaceutical companies, Rexahn is continuing its discussions with multiple companies to explore collaborative business structures in an effort to maximize the potential upside value of the program.

Supinoxin (RX-5902)

 

Supinoxin is a potential first-in-class small molecule that inhibits the phosphorylation of p68 RNA helicase, a protein that we believe plays a key role in cancer growth, progression and metastasis. Phosphorylated p68, which is highly expressed in cancer cells, but not in normal cells, results in up-regulation of cancer-related genes and a subsequent proliferation or tumor growth of cancer cells.  Supinoxin selectively blocks phosphorylated p68, thereby decreasing the proliferation or growth of cancer cells.  In pre-clinical tissue culture models and in-vivo xenograft models, Supinoxin has demonstrated single-agent tumor growth inhibition synergism with cytotoxic agents and activity against drug resistant cancer cells.  In particular, in in-vivo xenograft models of human RCC and pancreatic cancer, treatment with Supinoxin on days 1 to 20 in mouse models produced a survival benefit beyond 65 days.  In July 2012, we submitted an investigational new drug (“IND”) application to the FDA for Supinoxin. We initiated a Phase I clinical trial in August 2013 to study Supinoxin’s safety and efficacy in patients with solid tumors.  Four doses (25mg, 50mg, 100mg, and 150mg) have been tested and the MTD of Supinoxin has not yet been achieved. Testing in the fifth dose group (225mg) is ongoing.

Pre-clinical Pipeline

Archexin-Nano, RX-0047-Nano and RX-21101 are all in a pre-clinical stage of development.

Research and Development Process

 

We have engaged third-party contract research organizations and other investigators and collaborators, such as universities and medical institutions, to conduct our pre-clinical studies, toxicology studies and clinical trials.  Engaging third-party contract research organizations is typical practice in our industry. However, relying on such organizations means that the clinical trials and other studies described above are being conducted at external locations and that the completion of these trials and studies is not within our direct control. Trials and studies may be delayed due to circumstances outside our control, and such delays may result in additional expenses for us.

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Collaboration and License Agreements

In July 2013, we entered into an exclusive license agreement with the University of Maryland, Baltimore for a novel drug delivery platform, Nano-Polymer-Drug Conjugate Systems.  This platform combines existing chemotherapeutic agents with a proprietary polymer carrier that contains a signaling moiety to direct the agents into a tumor.  RX-21101 is our first drug candidate utilizing this platform and is a conjugated form of docetaxel, a common chemotherapy agent.

In October 2013, we entered into an exclusive license agreement with the Ohio State Innovation Foundation, an affiliate of the Ohio State University, for a novel oligonucleotide drug delivery platform, Lipid-Coated Albumin Nanoparticle (“LCAN”).  The LCAN platform incorporates both cationic lipid and cationized albumin that can form an electrostatic complex with oligonucleotides and be co-encapsulated by lipids.  Archexin-Nano is our first drug candidate to be developed with this platform.

Liquidity and Capital Resources

Operating Activities

Cash used in operating activities was $5,527,773 for the six months ended June 30, 2014.  The operating cash flows during the six months ended June 30, 2014 reflect our net loss of $14,406,035, which includes an unrealized loss on fair value of warrants of $7,995,159 and a net increase of cash components of working capital and other non-cash charges totaling $888,103.  Cash used in operating activities was $4,055,248 for the six months ended June 30, 2013.

Cash provided by investing activities was $103,760 for the six months ended June 30, 2014, which consisted of a decrease in restricted cash of $117,974 offset by $14,214 for the purchase of equipment.  Cash provided by investing activities for the six months ended June 30, 2013 was $521,313.

Cash provided by financing activities was $24,840,470 for the six months ended June 30, 2014, which consisted of net proceeds of $18,634,247 from our registered direct public offering in January 2014, $258,955 from the exercise of stock options and $5,947,268 from the exercise of stock warrants.  Cash provided by financing activities was $26,739 for the six months ended June 30, 2013.

We will need to raise additional capital through public or private equity or debt offerings or through arrangements with strategic partners or other sources in order to continue to develop our drug candidates.  There can be no assurance that additional capital will be available when needed or on terms satisfactory to us, if at all.  If we are not able to raise sufficient additional capital, we will have to reduce our research and development activities. We will first reduce research and development activities associated with our pre-clinical compounds.  To the extent necessary, we will then reduce our research and development activities related to some or all of our clinical drugs.

Contractual Obligations

We have a variety of contractual obligations, as more fully described in our annual report on Form 10-K.  These obligations include, but are not limited to, contractual obligations in connection with license agreements (including related milestone payments), lease payments, employee compensation and incentive program expenses, and contracts with various vendors for research and development services.  As of June 30, 2014, the total contract value of our agreements with vendors for research and development services was approximately $28,200,000, and we had made payments totaling $21,608,667 under the terms of the agreements.

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Current and Future Financing Needs

We have incurred negative cash flow from operations since we started our business.  We have spent, and expect to continue to spend, substantial amounts in connection with implementing our business strategy, including our planned product development efforts, our clinical trials and our research and development efforts.  We will need to raise additional capital through public or private equity or debt offerings or through arrangements with strategic partners or other sources in order to continue to develop our drug candidates.  There can be no assurance that additional capital will be available when needed or on terms satisfactory to us, if at all.  If we are not able to raise sufficient additional capital, we will have to reduce our research and development activities. The Company believes that its cash, cash equivalents, and marketable securities will be sufficient to cover its cash flow requirements for its current activities for at least the next 24 months.

The actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control.  These factors include the following:

·

the progress of our product development activities;

·

the number and scope of our product development programs;

·

the progress of our pre-clinical and clinical trial activities;

·

the progress of the development efforts of parties with whom we have entered into collaboration agreements;

·

our ability to maintain current collaboration programs and to establish new collaboration arrangements;

·

the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and

·

the costs and timing of regulatory approvals.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

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Item 3.  Quantitative and Qualitative Disclosures About Market Risk.

Per Item 305(e) of Regulation S-K, a smaller reporting company is not required to provide the information required by this item.

Item 4.  Controls and Procedures

Disclosure Controls and Procedures

As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (“CEO”) along with our Chief Financial Officer (“CFO”), of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)).  Based on that evaluation, the CEO along with the CFO concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report.

Our management, including the CEO and CFO, does not expect that our disclosure controls and internal controls will prevent all errors and all fraud.  A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.  Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.  These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake.  Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls.

Changes in Internal Control Over Financial Reporting

There have not been any changes in our internal controls over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) during the quarter ended June 30, 2014 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

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PART II. Other Information

 

Item 6.  Exhibits.

Exhibit No	Description
31.1	Certification of Chief Executive Officer pursuant to Rules 13a-14(a) / 15d-14(a)
31.2	Certification of Chief Financial Officer pursuant to Rules 13a-14(a) / 15d-14(a)
32.1	Certification of Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2	Certification of Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101	The following materials from Rexahn Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q, formatted in Extensible Business Reporting Language (“XBRL”): i) Condensed Balance Sheet, ii) Condensed Statement of Operations, iii) Condensed Statement of Cash Flows and (iv) Notes to the Financial Statements.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

		REXAHN PHARMACEUTICALS, INC.
		(Registrant)
	By:	/s/ Peter D. Suzdak
Date: August 13, 2014		Peter D. Suzdak
		Chief Executive Officer (principal executive officer)
	By:	/s/ Tae Heum Jeong
Date: August 13, 2014		Tae Heum Jeong
		Chief Financial Officer and Secretary (principal financial and accounting officer)

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INDEX TO EXHIBITS

Quarterly Report on Form 10-Q

Dated June 30, 2014

 

Exhibit No	Description	Location
31.1	Certification of Chief Executive Officer pursuant to Rules 13a-14(a) / 15d-14(a)	Filed herewith
31.2	Certification of Chief Financial Officer pursuant to Rules 13a-14(a) / 15d-14(a)	Filed herewith
32.1	Certification of Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002	Filed herewith
32.2	Certification of Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002	Filed herewith
101.INS	XBRL Instance Document	Filed herewith
101.SCH	XBRL Taxonomy Extension Schema	Filed herewith
101.CAL	XBRL Taxonomy Extension Calculation Linkbase	Filed herewith
101.DEF	XBRL Taxonomy Extension Definition Linkbase	Filed herewith
101.LAB	XBRL Taxonomy Extension Label Linkbase	Filed herewith
101.PRE	XBRL Taxonomy Extension Presentation Linkbase	Filed herewith

 

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