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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)

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

 

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			Page
PART I	FINANCIAL INFORMATION
Item 1	Financial Statements
	1)	Condensed Balance Sheets at June 30, 2009 (unaudited) and December 31, 2008	3
	2)	Condensed Statements of Operations for the three months and six months ended June 30, 2009 and 2008 (unaudited) and cumulative from March 19, 2001 (inception) to June 30, 2009 (unaudited)	4
	3)	Condensed Statements of Cash Flows for the six months ended June 30, 2009 and 2008 (unaudited) and cumulative from March 19, 2001 (inception) to June 30, 2009 (unaudited)	5
	4)	Notes to Condensed Financial Statements (unaudited)	6
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations		22
Item 3	Quantitative and Qualitative Disclosures About Market Risk		31
Item 4	Controls and Procedures		31
PART II	OTHER INFORMATION
Item 1	Legal Proceedings		32
Item 1A	Risk Factors		32
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds		32
Item 3	Defaults Upon Senior Securities		32
Item 4	Submission of Matters to a Vote of Security Holders		33
Item 5	Other Information		33
Item 6	Exhibits		34
SIGNATURES			35

																		Cumulative
																		from March 19,
		Three Months								Six Months								2001
		Ended June 30,								Ended June 30,								(Inception) to
		2009				2008				2009				2008				June 30, 2009
Revenues:
Research		$	18,750			$	18,750			$	37,500			$	37,500			$	487,500
Expenses:
General and administrative			838,630				682,471				1,561,737				1,248,451				16,426,176
Research and development			872,231				71,206				1,594,157				851,172				14,826,001
Patent fees			96,666				62,539				150,803				106,204				1,072,636
Depreciation and amortization			12,355				10,054				24,346				27,699				527,550
Total Expenses			1,819,882				826,270				3,331,043				2,233,526				32,852,363
Loss from Operations			(1,801,132	)			(807,520	)			(3,293,543	)			(2,196,026	)			(32,364,863	)
Other (Income) Expense:
Realized loss/(gain) on marketable securities			(11,025	)			-				(11,025	)			22,365				9,341
Interest (income)			(7,293	)			(60,676	)			(14,902	)			(168,117	)			(1,126,256	)
Interest expense			-				-				-				-				301,147
Beneficial conversion feature			-				-				-				-				1,625,000
Total Other (Income) Expense			(18,318	)			(60,676	)			(25,927	)			(145,752	)			809,232
Net Loss Before Provision for Income Taxes			(1,782,814	)			(746,844	)			(3,267,616	)			(2,050,274	)			(33,174,095	)
Provision for Income Taxes			-				-				-				-				-
Net Loss		$	(1,782,814	)		$	(746,844	)		$	(3,267,616	)		$	(2,050,274	)		$	(33,174,095	)
Loss per share, basic and diluted		$	(0.03	)		$	(0.01	)		$	(0.06	)		$	(0.04	)
Weighted average number of shares outstanding, basic and diluted			58,214,542				55,935,649				57,120,095				55,638,945

										Cumulative
										From March 19,
		Six Months								2001
		Ended June 30,								(Inception) to
		2009				2008				June 30, 2009
Cash Flows from Operating Activities:
Net loss		$	(3,267,616	)		$	(2,050,274	)		$	(33,174,095	)
Adjustments to reconcile net loss to net cash used in operating activities:
Beneficial conversion feature			-				-				1,625,000
Compensatory stock			-				-				21,877
Depreciation and amortization			24,346				27,699				527,550
Stock option compensation expense			342,029				317,911				4,198,863
Amortization of deferred revenue			(37,500	)			(37,500	)			(487,500	)
Realized (gains) losses on marketable securities			(11,025	)			22,365				9,341
Changes in assets and liabilities:
Prepaid expenses and other			137,747				(154,857	)			(229,018	)
Accounts payable and accrued expenses			409,796				(250,026	)			768,690
Net Cash (Used in) Operating Activities			(2,402,223	)			(2,124,682	)			(26,739,292	)
Cash Flows from Investing Activities:
Restricted cash			(100,000	)			-				(100,000	)
Purchase of equipment			(9,547	)			(25,174	)			(534,879	)
Purchase of marketable securities			(1,196,824	)			(5,848,176	)			(10,595,000	)
Proceeds from sales of marketable securities			4,758,079				4,475,582				10,585,659
Payment of licensing fees			-				-				(356,216	)
Net Cash Provided by (Used in) Investing Activities			3,451,708				(1,397,768	)			(1,000,436	)
Cash Flows from Financing Activities:
Proceeds from units, net			2,775,000				-				2,775,000
Issuance of common stock			-				931,201				22,536,753
Stock subscription receivable			-				(12,000	)			-
Proceeds from long-term debt			-				-				5,150,000
Proceeds from research contribution			-				-				1,500,000
Principal payments on long-term debt			-				-				(28,410	)
Net Cash Provided by Financing Activities			2,775,000				919,201				31,933,343
Net Increase (Decrease) in Cash and Cash Equivalents			3,824,485				(2,603,249	)			4,193,615
Cash and Cash Equivalents - beginning of period			369,130				3,809,571				-
Cash and Cash Equivalents - end of period		$	4,193,615			$	1,206,322			$	4,193,615
Supplemental Cash Flow Information:		$	-			$	-			$	301,147
Interest paid
Non-cash financing and investing activities:
Warrants issued		$	-			$	-			$	2,816,853

 

1.	Operations and Organization

2.	Recent Accounting Pronouncements Affecting the Company

In September 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position (“FSP”) Statement of Financial Accounting Standards ("SFAS") No. 157, “Fair Value Measurements” (“SFAS 157”), to define how the fair value of assets and liabilities should be measured in accounting standards where it is allowed or required.  In addition to defining fair value, the Statement established a framework within GAAP for measuring fair value and expanded required disclosures surrounding fair value measurements.  In February 2008, the FASB issued FASB Staff Positions (FSP) SFAS No. 157-2, “Effective Date of FASB Statement No. 157”, which delayed the effective date by one year for all nonfinancial assets and nonfinancial liabilities, except those that are recognized or disclosed at fair value in the financial statements on a recurring basis.  In October 2008, the FASB issued FSP FAS 157-3, “Determining the Fair Value of a Financial Asset When the Market for that Asset is Not Active”, to clarify the application of SFAS 157 in a market that is not active and provides an example to illustrate key considerations in determining the fair value of a financial asset when the market for that financial asset is not active.  This FSP was effective immediately.  In April 2009, the FASB issued FSP FAS 157-4, “Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions that are Not Orderly”, to provide additional guidance for estimating fair value when the volume and level of activity for the asset or liability have significantly decreased.  This FSP will be effective for interim and annual reporting periods ending after June 15, 2009.  We adopted SFAS 157 for financial assets and financial liabilities on January 1, 2008, and the adoption did not have a material impact on our financial position, results of operations, or cash flows.  We adopted SFAS 157 for nonfinancial items on January 1, 2009, and the adoption did not have a material impact on our financial position, results of operations, or cash flows.  We currently do not have any financial assets that are valued using inactive markets, and as such are not impacted by the issuances of FSP 157-3 and FSP 157-4.  See Note 13 to the Condensed Financial Statements for additional discussion on fair value measurement.

3.	Prepaid Expenses and Other Current Assets

		June 30,				December 31,
		2009				2008
Deposits on contracts		$	163,954			$	294,337
Other assets			65,064				72,428
		$	229,018			$	366,765

4.	Equipment, Net

		June 30,				December 31,
		2009				2008
Furniture and fixtures		$	31,713			$	31,713
Office equipment			70,276				70,276
Lab and computer equipment			422,178				421,343
Leasehold improvements			10,712				2,000
			534,879				525,332
Less accumulated depreciation			(448,561	)			(433,120	)
Net carrying amount		$	86,318			$	92,212

5.	Intangible Asset, Net

		June 30,				December 31,
		2009				2008
Revaax license, original cost		$	356,216			$	356,216
Less accumulated amortization			(78,989	)			(70,084	)
Balance (net)		$	277,227			$	286,132

2009		$	8,905
2010			17,811
2011			17,811
2012			17,811
2013			17,811
Thereafter			197,078
		$	277,227

6.	Accounts Payable and Accrued Expenses

		June 30,				December 31,
		2009				2008
Trade payables		$	243,157			$	136,906
Accrued expenses			383,655				98,486
Payroll liabilities			141,878				123,502
		$	768,690			$	358,894

7.	Deferred Revenue

8.	Net Loss per Common Share

9.	Stockholders’ Equity

a)

On May 10, 2001 the Company issued 3,600,000 shares of common stock to the Company's founders for $1.

b)

On August 10, 2001 the Company issued:

i)

1,208,332 shares of common stock to the directors of the Company for cash of $1,450,000.

ii)

958,334 shares of common stock to Rexgene for cash of $550,000.

iii)

360,000 shares of common stock in a private placement to individual investors for cash of $1,080,000.

c)

On October 10, 2001 the Company issued 400,000 shares of common stock to Chong Kun Dang Pharmaceutical Corp. ("CKD") for cash of $479,991 and 400,000 shares of common stock to an individual investor for cash of $479,991.

d)

On October 10, 2001 the Company issued 200,000 shares of common stock to CKD for cash of $479,985.

e)

Since inception, the Company's founders have transferred 800,000 shares of the common stock described in a) to officers and directors of the Company.

f)

In July 2003, the shareholders described in b)(iii) and e) transferred an aggregate of 1,268,332 shares of common stock to a voting trust.  The trust allows for the unified voting of the stock by the trustees.  The appointed trustees are senior management of the Company who, together with their existing shares, control a majority of the voting power of the Company.

g)

On August 20, 2003 the Company issued 500,000 shares of common stock to KT&G Corporation for cash of $2,000,000.

h)

On October 29, 2004, an option holder exercised options to purchase shares of the Company’s common stock for cash of $1,800 and the Company issued an aggregate of 1,500 shares.

i)

Pursuant to the agreement and plan of merger which occurred on May 13, 2005, (i) each share of the issued and outstanding common stock of Rexahn, Corp (“Rexahn”) (other than dissenting shares) was converted into the right to receive five shares of Rexahn Pharmaceuticals common stock; (ii) each issued, outstanding and unexercised option to purchase a share of Rexahn common stock was converted into an option to purchase five shares of Rexahn Pharmaceuticals common stock and (iii) the par value of Rexahn's common stock was adjusted to reflect the par value of Corporate Road Show. Com Inc. (“CRS”) common stock.  In the acquisition merger, 289,780,000 CRS pre-reverse stock split shares were converted into 2,897,802 post-reverse stock split Rexahn Pharmaceuticals shares, and an additional 500,000 post-reverse stock split Rexahn Pharmaceuticals shares were issued to a former executive of CRS. For purposes of the Statement of Stockholders' Equity, the five-for-one stock split is reflected as a one-line adjustment.  All shares and earnings per share information has been retroactively restated in these financial statements.

j)

On August 8, 2005, the Company issued, in a transaction exempt from registration under the Securities Act, 4,175,000 shares of common stock at a purchase price of $2.00 per share.

k)

On October 3, 2005, the Company issued 7,000 shares of common stock for $21,877 and $7,500 cash in exchange for services.

l)

On December 2, 2005, the holders of a convertible note, representing $1,300,000 aggregate principal amount, exercised their option to convert the entire principal amount of the note into the Company's common stock.  Based on a $2.00 per share conversion price, the holders received an aggregate of 650,000 shares.

m)

On December 27, 2005, option holders exercised options to purchase shares of the Company's common stock for cash of $9,600 and the Company issued an aggregate of 40,000 shares.

n)

On February 22, 2006, an option holder exercised options to purchase shares of the Company's common stock for cash of $1,200 and the Company issued an aggregate of 5,000 shares.

o)

On April 12, 2006, an option holder exercised options to purchase shares of the Company’s common stock for cash of $3,409 and the Company issued an aggregate of 14,205 shares.  On the same date, the Company agreed to repurchase common stock from the option holder based on the then market price for treasury in exchange for the aggregate purchase price of $28,410 in cash.

p)

On May 13, 2006, holders of the $3,850,000 convertible notes issued on February 28, 2005, exercised their rights to convert the entire principal amount of the notes into shares of the Company’s common stock.   Based on a $1.00 per share conversion price, the Company issued 3,850,000 shares of common stock in connection with the conversion.

q)

On October 9, 2006, an option holder exercised options to purchase shares of the Company’s common stock for cash of $2,400 and the Company issued an aggregate of 10,000 shares.

s)

On December 19, 2006, an option holder exercised options to purchase shares of the Company's common stock for cash of $6,000 and the Company issued an aggregate of 25,000 shares.

t)

On April 18, 2007, an option holder exercised options to purchase shares of the Company's common stock for cash of $14,400 and the Company issued an aggregate of 18,000 shares.

u)

On July 23, 2007, an option holder exercised options to purchase shares of the Company's common stock for cash of $12,000 and the Company issued an aggregate of 15,000 shares.

v)

On September 27, 2007, an option holder exercised options to purchase shares of the Company's common stock for cash of $15,600 and the Company issued an aggregate of 19,500 shares.

w)

On December 18, 2007, the Company issued 4,857,159 units at a price $1.40 per share for total gross proceeds of $6,800,023.  Investors also were issued one warrant for every five shares purchased.  One warrant will entitle the holder to purchase an additional share of common stock at a purchase price of $1.80 at any time over a period of three years from the date of the closing of the private placement valued at $1,103,164 on closing and were charged to additional paid in capital. Private placement closing costs of $139,674, including 107,144 warrants issued, valued at $91,119, were recorded as a reduction of the issuance proceeds.

x)

On December 27, 2007, an option holder exercised options to purchase shares of the Company's common stock for cash of $18,000 and the Company issued an aggregate of 75,000 shares.

y)

On March 20, 2008, the Company issued 642,858 units consisting of one share of the Company’s common stock and one warrant for every five common shares purchased in a private placement at a price of $1.40 per unit for total gross proceeds of $900,001. One warrant will entitle the holder to purchase an additional share of common stock at a price of $1.80 at any time over a period of three years from the date of the private placement. The warrants were valued at $220,005 and were charged to additional paid-in-capital.

z)

On May 30, 2008, an option holder exercised options to purchase shares of the Company's common stock for cash of $7,200 and the Company issued an aggregate of 30,000 shares.

aa)

On June 2, 2008, an option holder exercised options to purchase shares of the Company's common stock for cash of $12,000 and the Company issued an aggregate of 50,000 shares.

ab)

On June 30, 2008, an option holder exercised options to purchase shares of the Company's common stock for cash of $12,000 and the Company issued an aggregate of 10,000 shares.

ac)

On May 19, 2009 the Company entered into a securities purchase agreement to issue 2,857,143 shares of common stock at a price of $1.05 per share to an institutional investor for total gross proceeds of $3,000,000.  The investor was also issued:

1)

Series I warrants to purchase 2,222,222 shares of common stock at a purchase price of $1.05 per share at any time before September 30, 2009;

2)

Series II warrants to purchase 1,866,666 shares of common stock at a purchase price of $1.25 per share at any time from December 3, 2009 to June 5, 2012; and

3)

Series III warrants to purchase 1,555,555 shares of common stock at a purchase price of $1.50 per share at any time from December 3, 2009 to June 5, 2014.

ad)

On June 9, 2009, the Company issued 1,833,341 shares of common stock and 862,246 warrants to purchase common stock at a purchase price of $1.05 per share to existing stockholders pursuant to the anti-dilution protection provisions of the private placements transacted on December 24, 2007 and March 20, 2008.  The warrants were valued at $174,004 and recorded as a reduction in issuance proceeds of the May 19, 2009 transaction as described above.

 

10.	Stock-Based Compensation

	Six Months Ended
	June 30,
	2009	2008
Black-Scholes weighted average assumptions:
Expected dividend yield	-	-
Expected volatility	108%	104% - 106%
Risk free interest rate	2.55%-5.60%	1.87%-4.99%
Expected term (in years)	1 - 5 years	0.2 - 5 years

		2009								2008
		Shares				Weighted Avg.				Shares				Weighted Avg.
		Subject				Option				Subject				Option
		to Options				Prices				to Options				Prices
Outstanding at January 1st			7,760,795			$	1.01				6,045,795			$	0.97
Granted			130,000				1.23				200,000				2.72
Exercised			-				-				(90,000	)			0.35
Cancelled			-				-				(50,000	)			1.34
Outstanding at June 30th			7,890,795			$	1.01				6,105,795			$	0.99

		Shares Subject to Options				Weighted Avg. Option Prices			Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
Outstanding at June 30, 2009			7,890,795			$	1.01		6.3 years		$	650,569
Exercisable at June 30, 2009			5,878,045			$	0.96		1.5 years		$	592,525
		Shares Subject to Options				Weighted Avg. Option Prices			Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
Outstanding at June 30, 2008			6,105,795			$	0.99		6.7 years		$	13,692,985
Exercisable at June 30, 2008			4,683,795			$	0.95		6.3 years		$	10,962,805

11.	Income Taxes

		June 30,  2009				December 31, 2008
Net operating loss carry-forwards		$	12,606,156			$	11,364,336
Valuation allowance			(12,606,156	)			(11,364,336	)
Net deferred tax assets		$	-			$	-

12.	Commitments and Contingencies

a)

The Company has contracted with various vendors to provide research and development services. The terms of these agreements usually require an initiation fee and monthly or periodic payments over the term of the agreement, ranging from 6 months to 24 months. The costs to be incurred are estimated and are subject to revision. As of June 30, 2009, the total contract value of these agreements was approximately $5,080,775 and the Company had made payments totaling $3,325,707 under the terms of the agreements as of June 30, 2009.  All of these agreements may be terminated by either party upon appropriate notice as stipulated in the respective agreements.

b)

The Company and three of its key executives entered into employment agreements. Each of these agreements was renewed on August 10, 2009 and expires on August 10, 2012.  The agreements result in annual commitments of $200,000, $350,000 and $250,000.

c)

Regulation by governmental authorities in the United States and in other countries constitutes a significant consideration in our product development, manufacturing and marketing strategies. The Company expects that all drug candidates will require regulatory approval by appropriate governmental agencies prior to commercialization and will be subjected to rigorous pre-clinical, clinical, and post-approval testing, as well as to other approval processes by the FDA and by similar health authorities in foreign countries. United States federal regulations control the ongoing safety, manufacture, storage, labeling, record keeping, and marketing of all biopharmaceutical products intended for therapeutic purposes. The Company believes that it is in compliance in all material respects with currently applicable rules and regulations.

d)

On August 19, 2008, the Company entered into an agreement with KCSA Strategic Communications (“KCSA”) for KCSA to provide investor relations services to the Company.  Under this agreement, the Company agreed to a monthly fixed retainer amount of $7,000 commencing on August 19, 2008.  In December 2008, the monthly retainer was reduced to $4,000 per month.  In accordance with the agreement, the contract may be terminated by either party upon 30 days prior written notice to the other party.

e)

On April 6, 2009, the Company entered into an agreement with Rodman & Renshaw, LLC (“Rodman”) for Rodman to serve as placement agent for the Company.  Under this agreement, the Company agreed to pay a cash fee to Rodman immediately upon the closing of the placement equal to 6% of the aggregate gross proceeds raised in the placement plus a cash fee payable immediately on each exercise of the warrants issued to the purchasers in the placement that are solicited by Rodman equal to 6% of the aggregate proceeds received by the Company in connection with such exercise; and such number of warrants (the “Rodman Warrants”) issuable to Rodman or its designees at the closing to purchase shares of common stock equal to 5% of the aggregate number of shares sold in the placement, plus any shares underlying any convertible securities or units sold in the placement.  In accordance with the agreement, the contract ended on July 31, 2009.  The Company paid $180,000 and issued the placement agent warrants to purchase up to an aggregate of 142,857 shares of our common stock at an exercise price of $1.3125 per share.

f)

On April 20, 2009, Amarex, LLC filed suit against us in the Circuit Court of Montgomery County, Maryland, seeking damages for an alleged breach of a contract between the Company and Amarex, LLC entered into on January 6, 2006.  Amarex, LLC claims damages of $93,156 plus interest.  On May 22, 2009, the Company filed an answer and an affirmative defense to the complaint denying the claims of damages made by Amarex, LLC.  On June 16, 2009, the Company filed a counterclaim against Amarex, LLC for breach of the same contract in the amount of $354,824 plus interest.  The court has ordered the Company and Amarex, LLC to proceed with a non-binding mediation.

g)

On April 27, 2009, we added a Change Order to the original Single Service Agreement, dated March 15, 2006 with Aptuit, Inc. for packaging and labeling of Archexin(TM) for our Phase II pancreatic cancer study.  The total cost of the Change Order is $16,800, none of which was paid as of June 30, 2009.

h)

On May 4, 2009, the NYSE Amex (the “Exchange”) accepted the Company’s proposed compliance plan which addresses how the Company intends to regain compliance with the continued listing standards within a maximum of 18 months.  On July 7, 2009, the Company received a notice from the Exchange indicating that it had regained compliance with the requirements of the NYSE Amex Company Guide for the continued listing of its common stock on the Exchange, and that its common stock therefore was no longer subject to delisting.

i)

On May 21, 2009, the Company entered into a 1 year license agreement to use lab space commencing on July 1, 2009.  The Company agreed to pay monthly payments of $4,554 from October 1, 2009 to June 30, 2010.  The license agreement shall terminate on June 30, 2010 and may be renewed for two additional terms of one year upon 60 days prior to the expiration of the agreement.

j)

On May 22, 2009, we were notified by the Financial Industry Regulatory Authority (“FINRA”) that FINRA, on behalf of NYSE Amex, is conducting a review of trading in our common stock surrounding the May 12, 2009 announcement of the results of an animal study that further demonstrates that our drug candidate Zoraxel is a potential new-class of therapeutic for the effective treatment of sexual dysfunction.

k)

On June 10, 2009, we entered into a Research Services Agreement with University of Maryland, Baltimore to evaluate melanoma research.  The total cost of these services is $27,951, of which $20,964 was paid as of June 30, 2009.

l)

On June 16, 2009, we contracted with Baptist Cancer Institute as a clinical site for our Phase IIa clinical study for Archexin(TM) for pancreatic cancer.  The estimated cost for the study is $83,250, none of which was paid as of June 30, 2009.

m)

On June 22, 2009, we entered into a License Agreement with KRICT to acquire 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 June 30, 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.

n)

On June 29, 2009, the Company signed a 5 year lease for 5,466 square feet of office space in Rockville, Maryland commencing on June 29, 2009.  The lease requires annual base rents of $76,524 with increases over the next five years.  Under the leasing agreement, the Company pays its allocable portion of real estate taxes and common area operating charges.  Rent paid under the Company’s former lease during the six months period ended June 30, 2009 was $112,973 (2008 - $109,683).

2009		$	38,262
2010			108,418
2011			148,593
2012			158,835
2013			162,806
Thereafter			82,408
		$	699,322

 

13.	Fair Value Measurements

 

 

Level 1 Inputs —

Unadjusted quoted prices in active markets for identical assets or liabilities that is 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.

						Fair Value Measurements as of June 30, 2009
		Total				Level 1				Level 2				Level 3
Assets:
Restricted cash equivalents		$	100,000				-			$	100,000				-

						Fair Value Measurements as of December 31, 2008
		Total				Level 1				Level 2				Level 3
Assets:
State Authority Auction Rate Bonds		$	2,999,750				-			$	2,999,750				-

 

·

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

·

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;

·

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 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;