PROLOR Biotech, Inc. - FORM 10-Q

Attached files

file	filename
EX-31.1 - PROLOR Biotech, Inc.	v221399_ex31-1.htm
EX-32.1 - PROLOR Biotech, Inc.	v221399_ex32-1.htm
EX-32.2 - PROLOR Biotech, Inc.	v221399_ex32-2.htm
EX-31.2 - PROLOR Biotech, Inc.	v221399_ex31-2.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2011

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 000-52691

PROLOR BIOTECH, INC.

(Exact name of registrant as specified in its charter)

	Nevada		20-0854033
	(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

	3 Sapir Street, Weizmann Science Park
	Nes-Ziona, Israel		74140
	(Address of principal executive offices)		(Zip Code)

(866) 644-7811

(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 x 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 ¨ 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 the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check one):

Large accelerated filer	¨	Accelerated Filer	x
Non-accelerated filer	¨ (Do not check if a smaller reporting company)	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 x

APPLICABLE ONLY TO CORPORATE ISSUERS:

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. As of May 3, 2011 there were 54,230,962 shares of common stock, par value $0.00001 per share (“Common Stock”), outstanding.

PROLOR BIOTECH, INC.

INDEX TO FORM 10-Q FILING

FOR THE QUARTER ENDED MARCH 31, 2011

Table of Contents

		Page

PART I

ITEM 1.	Financial Statements	3

ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	13

ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	22

ITEM 4T.	Controls and Procedures	22

PART II

ITEM 1A	Risk Factors	23

ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds	23

ITEM 3.	Defaults Upon Senior Securities	23

ITEM 4.	(Removed and Reserved)	23

ITEM 5.	Other Information	23

ITEM 6.	Exhibits	23

SIGNATURES		24

CERTIFICATION

PART I

– FINANCIAL INFORMATION

ITEM 1.

Financial Statements.

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

CONSOLIDATED BALANCE SHEETS

	March 31, 2011			December 31, 2010
	(Unaudited)			(Audited)
ASSETS
Current Assets:
Cash and cash equivalents	$	22,335,006		$	24,474,458
Short term deposits		319,357			1,439,269
Accounts receivable and prepaid expenses		505,676			642,392
Restricted cash		171,160			102,932
Total Current Assets		23,331,199			26,659,051

Long-term Assets:
Property and equipment, net		380,470			350,284
Severance pay fund		212,163			193,346
Long term deposit		2,365			2,320
Total Long Term Assets		214,528			545,950

Total Assets	$	23,926,197		$	27,205,001

LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities:
Trade payables	$	151,889		$	429,063
Related parties		54,853			207,306
Accrued expenses and other liabilities		1,309,652			1,353,235
Total Current Liabilities		1,516,394			1,989,604

Liability in Respect of Employees Severance Payments		264,529			220,838

Commitments and Contingent Liabilities
Shareholders' Equity:
Stock capital -
Common stock of $ 0.00001 par value – 300,000,000 shares of common stock authorized 54,222,222 and 54,116,628 shares issued and outstanding as of March 31, 2011 and December 31, 2010, respectively.		542			541
Additional paid-in capital		60,195,665			59,577,974
Deficit accumulated during the development stage		(38,050,933	)		(34,583,956	)
Total Shareholders' Equity		22,145,274			24,994,559

Total Liabilities and Shareholders' Equity	$	23,926,197		$	27,205,001

The accompanying notes are an integral part of the consolidated financial statements

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

							Period from May 31, 2005
	For the three months ended						(date of inception)
	March 31,						to March 31,
	2011			2010			2011

Revenues	$	-		$	-		$	-

Operating expenses:
In-process research and development write-off					-			3,222,831
Research and development, net		3,035,261			1,002,434			21,355,802
General and administrative		708,896			485,493			14,385,465
Total operating expenses		3,744,157			1,487,927			38,964,098

Operating (loss)		(3,744,157	)		(1,487,927	)		(38,964,098	)

Financial income		277,180			1,319			1,272,121
Financial (expenses)		-			(67,750	)		(358,956	)

Net (loss)		(3,466,977	)		(1,554,358	)		(38,050,933	)

(Loss) per share (basic & diluted)	$	(0.08	)	$	(0.04	)	$	(1.30	)

Weighted average number of shares outstanding		43,359,771			35,730,803			29,318,741

The accompanying notes are an integral part of the consolidated financial statements.

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

							Period from May 31, 2005
							(date of inception)
	For the three months ended March 31,						to March 31,
	2011			2010			2011
Cash flows from operating activities
Net (loss)	$	(3,466,977	)	$	(1,554,358	)	$	(38,050,933	)
Adjustments to reconcile net (loss) to net cash (used in) operating activities:
Depreciation		26,924			20,239			312,826
In-process research and development write-off		-			-			3,222,831
Stock based compensation		460,400			200,995			8,539,610
(Increase) in accounts receivable and prepaid expenses		136,716			(463,290)			(505,399)
Increase (decrease) in accrued severance pay, net		43,691			31,115			264,529
(Increase) in accounts receivable and prepaid expenses		136,716			(463,290	)		(505,399	)
Increase (decrease) in trade payables		(277,174	)		20,586			141,785
(Decrease) increase in related parties		(152,453	)		(148,455	)		54,853
Long term deposit exchange rate differences		(45	)		(22	)		(89	)
Increase (decrease) in accrued expenses and other liabilities		(43,583	)		137,785			1,188,636
Net cash used in operating activities		(3,272,501	)		(1,755,405	)		(24,831,351	)

Cash flows from investing activities
Purchase of property and equipment		(57,110	)		(16,157	)		(678,940	)
Payment for the acquisition of ModigeneTech Ltd.		-			-			(474,837	)
Assets held for employees’ severance payments		(18,817	)		(13,614	)		(212,163	)
Long term (deposit)		-			(12	)		(2,276	)
Short term (deposit) release		1,119,912			(98,664	)		(319,357	)
Restricted cash		(68,228	)		(4,171	)		(171,160	)
Net cash (used in) provided by investing activities		975,757			(132,618	)		(1,858,733	)

Cash flows from financing activities
Short term bank credit		-			-			(2,841	)
Proceeds from loans		-			-			(173,000	)
Principal payment of loans		-			-			173,000
Proceeds from issuance of shares		-			24,145,358			47,188,418
Proceeds from exercise of options		125,000			213,788			1,011,388
Proceeds from exercise of warrants		32,292			126,482			828,125
Net cash provided by financing activities		157,292			24,485,628			49,025,090

Increase (decrease) in cash and cash equivalents		(2,139,452	)		22,597,605			22,335,006
Cash and cash equivalents at the beginning of the period		24,474,458			3,521,866			-
Cash and cash equivalents at the end of the period	$	22,335,006		$	26,119,471		$	22,335,006

The accompanying notes are an integral part of the unaudited consolidated financial statements.

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

					Period from May 31, 2005
					(date of inception)
	For the three months ended March 31,				to March 31,
	2011		2010		2011
Non cash transactions:

Employee options exercised into shares	$	-	$	-	$	140
Issuance of common stock in reverse acquisition	$	-	$	-	$	73
Conversion of preferred stock to common stock	$	-	$	-	$	18
Cashless exercise of 56,947 outstanding stock warrants and issuance of 42,667 underlying shares of common stock	$	1	$	-	$	7

Additional information:

Cash paid for income taxes	$	-	$	-	$	-
Cash paid for interest expense	$	12	$	4	$	353,748

The accompanying notes are an integral part of the unaudited consolidated financial statements.

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2011

(Unaudited)

NOTE 1:-

GENERAL

PROLOR Biotech, Inc. (“the Company”) was formed on August 22, 2003 under the laws of the state of Nevada. The Company is engaged in the development of therapeutic proteins with extended half-lives, through its subsidiaries, Modigene Inc., a Delaware corporation, and ModigeneTech Ltd., an Israeli-based subsidiary.

The Company is devoting substantially all of its efforts toward research and development activities. The Company’s activities also include raising capital, recruiting personnel and building infrastructure. In the course of such activities, the Company has sustained operating losses and expects such losses to continue for the foreseeable future. The Company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations. The Company’s deficit accumulated during the development stage aggregated $38,050,933 as of March 31, 2011. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis. The Company believes that its current cash resources will enable the continuance of the Company’s activities for at least a year with no need for additional financing.

NOTE 2:-

SIGNIFICANT ACCOUNTING POLICIES

Basis of presentation:

The accompanying unaudited financial statements of the Company are presented in accordance with the requirements of Form 10-Q and Article 10 of Regulation S-X. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) have been condensed or omitted pursuant to such U.S. Securities and Exchange Commission (“SEC”) rules and regulations. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made. The results for these interim periods are not necessarily indicative of the results for the entire year. The accompanying financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2010 and the notes thereto included in the Company’s Report on Form 10-K filed with the SEC on March 15, 2011.

Principles of consolidation:

The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries Modigene Inc. and ModigeneTech Ltd.

Intercompany transactions and balances have been eliminated upon consolidation.

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2011

(Unaudited)

NOTE 2:-

SIGNIFICANT ACCOUNTING POLICIES (continued):

Loss per share:

Basic and diluted losses per share are presented in accordance with ASC No. 260 “Earnings per share”. Outstanding share options and warrants, convertible preferred stock and restricted stock have been excluded from the calculation of the diluted loss per share because all such securities are antidilutive.

The number of shares of Common Stock issuable upon exercise or conversion of the foregoing securities that has been excluded from calculations for the three months ended March 31, 2011 and 2010 and the period from May 31, 2005 (date of inception) to March 31, 2011 was 18,450,260, 12,075,765 and 8,013,260, respectively.

Fair value measurements:

As defined in ASC 820-10, Fair Value Measurements and Disclosures (“ASC 820-10”), fair value is based on 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. ASC 820-10 establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

Level 2: Other inputs that are observable, directly or indirectly, such as quoted prices for similar assets and liabilities or market corroborated inputs.

Level 3: Unobservable inputs are used when little or no market data is available, which requires the Company to develop its own assumptions about how market participants would value the assets or liabilities. The fair value hierarchy gives the lowest priority to Level 3 inputs.

In determining fair value, the Company utilizes valuation techniques in its assessment that maximize the use of observable inputs and minimize the use of unobservable inputs.

The following table presents the Company’s financial assets and liabilities that are carried at fair value, classified according to the three categories described above:

	Fair Value Measurements at March 31, 2011
			Quoted Prices in Active		Significant Other		Significant
			Markets for Identical Assets		Observable Inputs		Unobservable Inputs
	Total		(Level 1)		(Level 2)		(Level 3)

Cash and cash equivalents	$	22,335,006	$	22,335,006	$	-	$	-
Short term deposits		319,357		319,357		-		-
Restricted cash		171,160		171,160		-		-
Total assets at fair value	$	22,825,523	$	22,825,523	$	-	$	-

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2011

(Unaudited)

NOTE 2:-

SIGNIFICANT ACCOUNTING POLICIES (continued):

Fair value measurements: (continued)

	Fair Value Measurements at December 31, 2010
			Quoted Prices in Active		Significant Other		Significant
			Markets for Identical Assets		Observable Inputs		Unobservable Inputs
	Total		(Level 1)		(Level 2)		(Level 3)

Cash and cash equivalents	$	24,474,458	$	24,474,458	$	-	$	-
Short term deposits		1,439,269		1,439,269
Restricted cash		102,932		102,932		-		-
Total assets at fair value	$	26,016,659	$	26,016,659	$	-	$	-

NOTE 3:-

RECENT ACCOUNTING PRONOUNCEMENTS

In January 2010, the FASB issued Accounting Standards Update No. 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements. The amendments in this update require new disclosures and clarifications of existing disclosures related to transfers in and out of Level 1 and Level 2 fair value measurements, further disaggregation of fair value measurement disclosures for each class of assets and liabilities and additional details of valuation techniques and inputs utilized. This update is consistent with the Company's current accounting application for fair value measurements and disclosures.

In April, 2010, the FASB issued Accounting ASU No. 2010-13, “Compensation-Stock Compensation (Topic 718)—Effect of Denominating the Exercise Price of a Share-Based Payment Award in the Currency of the Market in Which the Underlying Equity Security Trades—a consensus of the FASB Emerging Issues Task Force” (“ASU 2010-13”). ASU 2010-13 provides amendments to Topic 718 to further clarify that an employee share-based payment award with an exercise price denominated in the currency of a market in which a substantial portion of the entity’s equity securities trades should classify such an award as equity. The amendments in this update do not expand the recurring disclosures required by Topic 718. The amendments in this update are effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2010. The company adopted this standard in January, 2011 which did not have a material impact on its financial statements.

Other recently issued updates predominantly comprised technical corrections to accounting literature or updates applicable to industries other than the Company’s. None of such updates are expected to a have a material impact on the Company's financial position, results of operations or cash flows.

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2011

(Unaudited)

NOTE 4:-

EMPLOYEES' STOCK OPTION PLANS

The Company issued stock options to purchase shares of Common Stock under the Company’s 2005 Stock Incentive Plan (the “2005 Plan”) and the Company’s 2007 Equity Incentive Plan (the “2007 Plan”).

The Company accounts for stock-based compensation using the fair value recognition provisions of ASC No. 718 “Compensation – stock compensation”, The fair value of each stock option is calculated based upon grant date fair value using the Black-Scholes option-pricing model.

The following is a summary of the stock options granted under the 2005 and 2007 Plans:

	For the three months ended
	March 31, 2011
	Number of Options			Weighted Average Exercise Price

Outstanding at the beginning of the period		5,134,346		$	1.11
Exercised		(50,000	)	$	2.50
Forfeited		(5,000	)	$	6.23
Issued under the 2007 plan		189,000		$	6.23
Outstanding at the end of the period		5,268,346		$	1.29

Options exercisable		3,526,118		$	1.11

	For the three months ended
	March 31, 2010
	Number of Options			Weighted Average Exercise Price

Outstanding at the beginning of the period		4,785,439		$	1.11
Exercised		(165,323	)	$	1.29
Issued under the 2005 plan		50,000		$	2.35
Issued under the 2007 plan		500,000		$	2.40
Outstanding at the end of the period		5,170,116		$	1.24

Options exercisable		2,536,074		$	1.18

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2011

(Unaudited)

NOTE 4:-

EMPLOYEES' STOCK OPTION PLANS (continued)

The options outstanding as of March 31, 2011 have been separated by exercise prices, as follows:

				Remaining Weighted Average
Exercise Price		Options Outstanding		Contractual Life (years)		Options Exercisable
$	0.650		375,000		7.85		274,167
$	0.879		983,264		5.02		983,264
$	0.900		1,937,239		6.92		1,452,929
$	0.930		25,000		6.93		25,000
$	1.318		93,855		5.26		93,855
$	1.500		121,169		7.07		60,585
$	2.000		425,000		6.11		425,000
$	2.500		73,189		2.93		73,819
$	2.350		50,000		8.77		12,500
$	2.400		500,000		8.79		125,000
$	6.470		500,000		9.76		-
$	6.230		184,000		6.60		-
			5,268,346				3,526,118

Weighted average fair values and average exercise prices of options at date of grant and total aggregate intrinsic value of outstanding options are as follows:

	March 31,
	2011		2010
Weighted average fair value on date of grant	$	1.15	$	0.82
Total aggregate intrinsic value	$	21,744,503	$	17,027,595

Stock-based compensation expense for the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (date of inception) to March 31, 2011 was $460,400, $200,995 and $8,539,610, respectively.

Stock-based compensation expenses for the period from May 31, 2005 (date of inception) through March 31, 2011 includes $3,876,960 expensed in the acquisition of a subsidiary and on behalf of deferred compensation on restricted shares.

PROLOR BIOTECH, INC. AND SUBSIDIARIES

(A development stage company)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2011

(Unaudited)

NOTE 5:-

STOCK WARRANTS

	For the three months ended
	March 31, 2011
	Number of warrants			Weighted Average Exercise Price

Outstanding and exercisable at the beginning of the period		2,300,231		$	2.045
Exercised		(46,565	)	$	2.500
Exercised		(23,299	)	$	0.880
Outstanding and exercisable at the end of the period		2,230,367		$	2.150

	For the three months ended
	March 31, 2010
	Number of warrants			Weighted Average Exercise Price

Outstanding and exercisable at the beginning of the period		3,558,924		$	2.18
Exercised		(70,546	)	$	2.19
Outstanding and exercisable at the end of the period		3,488,378		$	2.18

Total aggregate intrinsic value of warrants outstanding as of March 31, 2011 and 2010 was $8,475,089 and $7,742,637, respectively.

NOTE 6:-

COMMITMENTS AND CONTINGENT LIABILITIES

On March 13, 2011, ModigeneTech Ltd. entered into a rent agreement for the lease of new office premises. Aggregate minimum rental commitments under the non-cancelable lease as of March 31, 2011, are as follows:

Year ended March 31,
2012	$	222,848
2013	$	222,848
2014	$	245,133
2015	$	245,133
2016	$	245,133
	$	1,181,095

NOTE 7:-

COMMON STOCK

In January 2011, the Company issued 50,000 shares of the Company’s common stock upon the exercise of 50,000 warrants at an exercise price of $2.50 per share and 29,465 shares of common stock upon the cashless exercise of 40,146 outstanding warrants.

In February 2011, the Company issued 8,750 shares of the Company’s common stock upon the exercise of outstanding stock warrants at an exercise price of $2.50 per share and 9,986 shares of common stock upon the cashless exercise of 11,368 outstanding warrants.

In March 2011, the Company issued 4,167 shares of the Company’s common stock upon the exercise outstanding stock warrants at an exercise price of $2.50 per share and 7,383 shares of common stock upon the cashless exercise of 5,433 outstanding warrants.

As of March 31, 2011 there were 54,222,222 shares of common stock issued and outstanding with a stated par value of $0.00001 per share.

NOTE 8:-

SUBSEQUENT EVENTS

As defined in FASB ASC 855-10, “Subsequent Events”, subsequent events are events or transactions that occur after the balance sheet date but before financial statements are issued or available to be issued.

Subsequent to March 31, 2011 and through May 2, 2011, 2,800 new common shares were issued in connection with the exercise of outstanding warrants and options.

ITEM 2.

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

Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”), about our expectations, beliefs or intentions regarding our product development efforts, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual operations or results to differ materially from the operations and results anticipated in forward-looking statements. These factors include, but are not limited to the factors contained in “Item 1A — Risk Factors” of our Annual Report on Form 10-K as updated by our subsequently filed Forms 10-Q or other documents we file with the SEC. We do not undertake any obligation to update forward-looking statements, except as required by applicable law. We intend that all forward-looking statements be subject to the safe harbor provisions of PSLRA. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the consolidated financial statements and the related notes thereto that appear in Item 1 of this Quarterly Report on Form 10-Q.

The discussion and analysis of the Company’s financial condition and results of operations are based on the Company’s financial statements, which the Company has prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires the Company 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, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, the Company evaluates such estimates and judgments, including those described in greater detail below. The Company bases its estimates on historical experience and on various other factors that the Company believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Overview

We are a development stage biopharmaceutical company utilizing patented technology to develop longer-acting, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales. We have obtained certain exclusive worldwide rights from Washington University in St. Louis, Missouri to use a short, naturally-occurring amino acid sequence (peptide) that has the effect of slowing the removal from the body of the therapeutic protein to which it is attached. This Carboxyl Terminal Peptide (CTP) can be readily attached to a wide array of existing therapeutic proteins, stabilizing the therapeutic protein in the bloodstream and extending its life span without additional toxicity or loss of desired biological activity. We are using the CTP technology to develop new, proprietary versions of certain existing therapeutic proteins that have longer life spans than therapeutic proteins without CTP. We believe that our products will have greatly improved therapeutic profiles and distinct market advantages.

We believe our products in development will provide several key advantages over our competitor’s existing products:

significant reduction in the number of injections required to achieve the same or superior therapeutic effect from the same dosage;

extended patent protection for proprietary new formulations of existing therapies;

faster commercialization with greater chance of success and lower costs than those typically associated with a new therapeutic protein; and

manufacturing using industry-standard biotechnology-based protein production processes.

Merck & Co. has developed the first novel protein containing CTP, named ELONVA®, a long-acting CTP-modified version of the fertility drug follicle stimulating hormone (FSH). On January 28, 2010, Merck received marketing authorization from the European Commission for ELONVA® with unified labeling valid in all European Union Member States. Merck licensed the CTP technology from Washington University (prior to the formation of Modigene Delaware) for application only to Follicle Stimulating Hormone (FSH) and three other hormones, human Chorionic Gonadotropin (hCG), Luteinizing Hormone (LH) and Thyroid-Stimulating Hormone (TSH). Our license for CTP technology extends to all other human therapeutic applications.

Our internal product development program is currently focused on extending the life span of the following biopharmaceuticals, in an effort to provide patients with improved therapies that may enhance their quality of life:

Human Growth Hormone (hGH)

Factor IX

Anti-Obesity Peptide Oxyntomodulin

Factor VIIa

Interferon β and Erythropoietin (EPO)

Atherosclerosis and rheumatoid arthritis long-acting therapies

We believe that the CTP technology will be broadly applicable to these as well as other best-selling therapeutic proteins in the market and will be attractive to potential partners because it will allow them to extend proprietary rights for therapeutic proteins with near-term patent expirations.

Critical Accounting Policies

The historical financial statements of the Company included with this Quarterly Report have been prepared in accordance with GAAP. The significant accounting policies followed in the preparation of the financial statements, on a consistent basis, are described below.

Use of Estimates: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

Financial Statements in United States Dollars:The functional and reporting currency of the Company is the U.S. dollar, as the U.S. dollar is the primary currency of the economic environment in which the Company has operated and expects to continue to operate in the foreseeable future. The majority of the operation of the Company’s R&D subsidiary, ModigeneTech Ltd. (“Modigenetech”), are currently conducted in Israel. Most of the Israeli expenses are currently determined and paid in U.S. dollars. Financing and investing activities including loans and equity transactions are made in U.S. dollars. The majority of our assets are held in the United States.

Monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars. All transaction gains and losses from the remeasurement of monetary balance sheet items are reflected in the statements of operations as financial income or expenses, as appropriate.

Principles of Consolidation: The consolidated financial statements include the accounts of the Company’s wholly-owned subsidiary, Modigene Delaware, and its wholly-owned subsidiary, ModigeneTech. Intercompany transactions and balances have been eliminated upon consolidation.

Cash Equivalents: For purposes of reporting within the statement of cash flows, the Company considers all cash on hand, cash accounts not subject to withdrawal restrictions or penalties and all highly liquid debt instruments purchased with a maturity of three months or less to be cash and cash equivalents.

Accounts receivable: Accounts receivable are recorded at net realizable value consisting of the carrying amount less the allowance for uncollectible accounts. As of March 31, 2011 the Company had no accrued allowance for uncollectible accounts.

Property and Equipment: Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated by the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows:

	%

Office furniture and equipment		6

Laboratory equipment		15

Computers and electronic equipment		33

Leasehold improvements		25

The Company reviews the carrying value of its long-lived assets, including intangible assets subject to amortization, for impairment whenever events or circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability of these assets is measured by comparing the carrying value of the assets to the undiscounted cash flows estimated to be generated by those assets over their remaining economic life. If the undiscounted cash flows are not sufficient to recover the carrying value of the assets, the assets are considered impaired. The impairment loss is measured by comparing the fair value of the assets to their carrying value. Fair value is determined by either a quoted market price or a value determined by a discounted cash flow technique, whichever is more appropriate under the circumstances involved. No impairments were recognized from May 31, 2005 (inception date) to March 31, 2011.

Research and Development Costs and Participation: Research and development (“R&D”) costs are expensed as they are incurred and consist of salaries, benefits and other personnel-related costs, fees paid to consultants, clinical trials and related clinical manufacturing costs, license and milestone fees, and facilities and overhead costs. R&D expenses consist of independent R&D costs and costs associated with collaborative R&D and in-licensing arrangements. Participation from government for development of approved projects are recognized as a reduction of expenses as the related costs are incurred.

Severance Pay: The liability of ModigeneTech for severance pay is calculated pursuant to the Severance Pay Law in Israel, based on the most recent salary for each employee multiplied by the number of years of such person’s employment as of the balance sheet date and is presented on an undiscounted basis. ModigeneTech’s employees are entitled to one month’s salary for each year of employment or a portion thereof. Since January 1, 2010 all new employment agreements entered into by the Company implement Section 14 of the Severance Pay Law, mandating that upon termination of such employees’ employment, the Company shall release to them all the amounts accrued in their insurance policies, which are mandated by Israeli law. While the Company funds the insurance policies, payment of severance amounts is ultimately the obligation of the respective insurance companies; therefore, because the severance pay risks have been irrevocably transferred to the severance funds administered by the insurance companies, the severance pay liabilities and deposits covered by these plans since January 1, 2010 are not reflected in the Company’s balance sheet.

Pursuant to employment and consulting agreements with certain of our key employees, such persons, upon retirement, will be entitled to receive lump-sum payments; therefore the Company does not accumulate severance pay for these persons, and the sum will be accrued when the conditions to such payments under these agreements have been satisfied. Severance (income) expense for the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011 was $24,874, $17,501 and $52,366, respectively.

Income Taxes: The Company accounts for income taxes in accordance with the provisions of ASC 740-10, Income Taxes. ASC 740-10 requires companies to recognize deferred tax assets and liabilities based on the differences between financial reporting and tax bases of assets and liabilities. These differences are measured using the enacted tax rates and laws that are expected to be in effect when the temporary differences are expected to reverse. A valuation allowance is established against net deferred tax assets, if based on the weighted available evidence, it is more likely than not that all or a portion of the deferred tax assets will not be realized.

Concentrations of Credit Risk: Financial instruments that potentially subjected the Company to concentrations of credit risk consist principally of cash and cash equivalents.

Cash and cash equivalents are invested in major banks in Israel and the United States. Such deposits in the United States are not fully insured. Management believes that the financial institutions that hold the Company’s investments are financially sound, and, accordingly, minimal credit risk exists with respect to these investments.

The Company has no off-balance sheet concentration of credit risk, such as foreign exchange contracts or other foreign hedging arrangements.

Royalty-bearing Grants: Royalty-bearing grants from the Government of Israel for participation in the development of approved projects are recognized as a reduction of expenses as the related costs are incurred. Funding is recognized at the time ModigeneTech is entitled to such grants, on the basis of the costs incurred.

Research and development grants received by ModigeneTech for the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011 were $135,242, $57,319 and $3,518,839, respectively.

Loss per Share: Basic and diluted losses per share are presented in accordance with ASC 260-10 “Earnings per share”. Outstanding share options, warrants and restricted shares have been excluded from the calculation of the diluted loss per share because all such securities are antidilutive. The total weighted average number of shares of Common Stock related to outstanding options warrants and restricted shares excluded from the calculations of diluted loss per share was 18,450,260, 12,075,765 and 8,013,260 for the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, respectively.

Results of Operation

Three Months Ended March 31, 2011 Compared to the Three Months ended March 31, 2010

Revenue

The Company has not generated any revenue from operations since its inception. To date, the Company has funded its operations primarily through grants from the Israeli Office of the Chief Scientist (the “OCS”) and the sale of equity securities. If the Company’s development efforts result in clinical success, regulatory approval and successful commercialization of the Company’s products, then the Company could generate revenue from sales of its products.

Research and Development Expense

The Company expects its research and development expense to increase as it continues to develop its product candidates. Research and development expense consists of:

internal costs associated with research and development activities;

payments made to third party contract research organizations, contract manufacturers, investigative sites, and consultants;

manufacturing development costs;

personnel-related expenses, including salaries, benefits, travel, and related costs for the personnel involved in the research and development;

activities relating to the advancement of product candidates through preclinical studies and clinical trials; and

facilities and other expenses, which include expenses for rent and maintenance of facilities, as well as laboratory and other supplies.

These costs and expenses are partially funded by grants received by the Company from the OCS. There can be no assurance that the Company will continue to receive grants from the OCS in amounts sufficient for its operations, if at all.

The Company expects its research and development expenditures to increase significantly in the near future in connection with the ongoing production of its protein drug candidates. The Company intends to continue to hire new employees, in research and development, in order to meet its operation plans.

The Company has multiple research and development projects ongoing at any one time. The Company utilizes its internal resources, employees and infrastructure across multiple projects and tracks time spent by employees on specific projects. The Company believes that significant investment in product development is a competitive necessity and plans to continue these investments in order to realize the potential of its product candidates.

For the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, the Company incurred net research and development expense of $3,035,261, $1,002,434 and $21,355,802, respectively. The increase for the three months ended March 31, 2011 as compared to the 2010 period resulted primarily from an increase in development expenses associated with the manufacturing of high quantities of non-GMP and GMP of hGH-CTP. The successful development of the Company’s product candidates is subject to numerous risks, uncertainties, and other factors. Beyond the next twelve months, and even during the next twelve months, the Company cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or the period, if any, in which material net cash inflows may commence from the Company’s product candidates or any of the Company’s other development efforts. This is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials which vary significantly over the life of a project as a result of differences arising during clinical development, including:

completion of such preclinical and clinical trials;

receipt of necessary regulatory approvals;

the number of clinical sites included in the trials;

the length of time required to enroll suitable patients;

the number of patients that ultimately participate in the trials;

adverse medical events or side effects in treated patients;

lack of comparability with complementary technologies;

obtaining capital necessary to fund operations, including research and development efforts; and

the results of clinical trials.

The Company’s expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights. The Company may obtain unexpected results from its clinical trials. The Company may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of the foregoing variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the United States Food and Drug Administration (“FDA”) or other regulatory authorities were to require the Company to conduct clinical trials beyond those which it currently anticipates will be required for the completion of the clinical development of a product candidate, or if the Company experiences significant delays in enrollment in any of its clinical trials, the Company could be required to expend significant additional financial resources and time on the completion of clinical development. Drug development may take several years and millions of dollars in development costs. If the Company does not obtain or maintain regulatory approval for its products, its financial condition and results of operations will be substantially harmed.

General and Administrative Expense

General and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense for persons serving in the Company’s executive and administration functions. Other general and administrative expense includes facility-related costs not otherwise included in research and development expense and professional fees for legal and accounting services. For the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, the Company incurred general and administrative expense of $708,896, $485,493, and $14,385,465, respectively. The increase for the three months ended March 31, 2011 as compared to the 2010 period resulted mainly from an increase in stock-based compensation. The Company expects that general and administrative expense will increase as the Company adds additional personnel.

Financial Expense and Income

Financial expense and income consists of the following:

interest earned on the Company’s cash and cash equivalents;

interest expense on short term bank credit and loans; and

expense or income resulting from fluctuations of the New Israeli Shekel, in which a portion of the Company’s assets and liabilities are denominated, against the U.S. dollar and the Euro.

For the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, the Company incurred net financial income/(expense) of $277,180, ($66,431) and $913,165, respectively. The financial income for the first quarter of 2011 increased as compared to the expense for the first quarter of 2010 primarily from interest earned on a higher cash and cash equivalents balance for the 2011 period, as well as favorable currency fluctuations on deposits in Israeli Shekels.

Stock-based Compensation

The Company’s stock-based compensation expense is recorded according to ASC 718-10, “Compensation - Stock Compensation”, which requires the measurement and recognition of compensation expense for all stock-based payment awards made to employees and directors, including employee stock options under the Company’s stock plans, based on estimated fair values.

ASC 718-10 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statement of operations. The Company estimates the fair value of stock options granted using the Black-Scholes-Merton option-pricing model.

The Company estimates the fair value of stock options granted using the Black-Scholes-Merton option-pricing model. For the three months ended March 31, 2011 and March 31, 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, the Company incurred stock-based compensation expense of $460,400, $200,995 and $8,539,610, respectively. The increase for the three months ended March 31, 2011 as compared to the 2010 period was primarily due to a greater number of options granted and a higher fair value of such options on the respective grant dates.

The Company applies ASC 505 "Equity" with respect to options and warrants issued to non-employees. ASC 505 requires the use of an option valuation model to measure the fair value of the options at the grant date.

Cash Flows

For the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, net cash used in operations was approximately $3,272,501, $1,755,405 and $24,831,351, respectively. The increase for the three months ended March 31, 2011 as compared to the 2010 period resulted primarily from increased research and development expenses.

For the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, net cash (used in) provided by investing activities was $975,757, ($132,618) and $(1,858,733), respectively. The increase for the three months ended March 31, 2011 as compared to the 2010 period resulted primarily from a cash investment in a bank deposit.

For the three months ended March 31, 2011 and 2010 and for the period from May 31, 2005 (inception date) through March 31, 2011, net cash provided by financing activities was $157,292, $24,485,628 and $49,025,090, respectively. The decrease for the three months ended March 31, 2011 as compared to the 2010 period resulted from our issuance of Common Stock in a private placement that closed in March 2010.

Liquidity and Capital Resources

The Company expects to incur losses from operations for the foreseeable future. The Company expects to incur increasing research and development expenses, including expenses related to the hiring of personnel and additional clinical trials. The Company expects that general and administrative expenses will also increase as the Company expands its finance and administrative staff, adds infrastructure, and incurs additional costs related to being a public company in the United States, including the costs of directors’ and officers’ insurance, investor relations programs, and increased professional fees. Our future capital requirements will depend on a number of factors, including the continued progress of our research and development of product candidates, the timing and outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing, and our success in developing markets for our product candidates.

At March 31, 2011, we had approximately $22.3 million of cash and cash equivalents, and we believe that our existing cash and cash equivalents and short-term investments will be sufficient to enable us to fund our operating expenses and capital expenditure requirements at least for the next eighteen months. We have based this estimate on assumptions that may prove to be wrong and are subject to change, and we may be required to use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials. Our future capital requirements will depend on many factors, including the progress and results of our clinical trials, the duration and cost of discovery and preclinical development, and laboratory testing and clinical trials for our product candidates, the timing and outcome of regulatory review of our product candidates, the number and development requirements of other product candidates that we pursue, and the costs of commercialization activities, including product marketing, sales, and distribution. We do not anticipate that we will generate product revenues for at least the next several years, and we expect continuing operating losses to result in increases in our cash used in operations over the next several years. To the extent that our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. We cannot assure you that we will be able to consummate any such offerings or financings or enter into any such arrangements on terms favorable to us or at all.

Effects of Inflation and Currency Fluctuation

Inflation generally affects the Company by increasing costs of labor and clinical trials. The Company does not believe that inflation has had a material effect on its results of operations for the three months ended March 31, 2011 or 2010.

Currency fluctuations could affect the Company by increasing or decreasing costs mainly for goods and services acquired in Israel. The Company does not believe currency fluctuations have had a material effect on its results of operations for the three month periods ended March 31, 2011 or 2010.

Off-Balance Sheet Arrangements

The Company had no off-balance sheet arrangements as of March 31, 2011.

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

The information in Item 2 under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Effects of Inflation and Currency Fluctuation” is incorporated herein by reference.

Interest Rate Risk

We have no debt outstanding nor do we have any investments in debt instruments other than highly liquid short-term investments. Accordingly, we consider our interest rate risk exposure to be insignificant at this time.

ITEM 4.

Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain a system of disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) that is designed to provide reasonable assurance that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to management in a timely manner. Our Chief Executive Officer and Chief Financial Officer evaluated this system of disclosure controls and procedures as of the end of the period covered by this quarterly report and, based on such evaluation, have concluded that the system was operating effectively as of such date to ensure appropriate disclosure.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Rule 13a-15 of the Exchange Act that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II

OTHER INFORMATION

ITEM 1.

Legal Proceedings.

None.

ITEM 1A

Risk Factors

There have been no material changes in our risk factors since the filing of our Annual Report on Form 10-K for the year ended December 31, 2010.

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

None.

ITEM 3.

Defaults Upon Senior Securities.

None.

ITEM 4.

(Removed and Reserved).

ITEM 5.

Other Information.

None.

ITEM 6.

Exhibits.

10.1

Fourth Amendment to Consulting Agreement between PROLOR Biotech, Inc. and Abraham Havron, Ph.D., incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 6, 2011.

10.2

Fifth Amendment to Employment Agreement between PROLOR Biotech, Inc. and Shai Novik, incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on January 6, 2011.

10.3

Fifth Amendment to Employment Agreement between ModigeneTech Ltd. and Dr. Eyal Fima, incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the SEC on January 6, 2011.

31.1

Certification of Chief Executive Officer pursuant to Item 601(b)(31) of Regulation S-K (Filed herewith).

31.2

Certification of Principal Financial Officer pursuant to Item 601(b)(31) of Regulation S-K (Filed herewith).

32.1

Certification of Chief Executive Officer pursuant to Item 601(b)(32) of Regulation S-K (Filed herewith).

32.2

Certification of Principal Financial Officer pursuant to Item 601(b)(32) of Regulation S-K (Filed herewith).

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.

		PROLOR BIOTECH, INC.

May 10, 2011		/s/ Abraham Havron
Date		Abraham Havron
		Chief Executive Officer

EXHIBIT INDEX

10.1

10.2

10.3

31.1

Certification of Chief Executive Officer pursuant to Item 601(b)(31) of Regulation S-K (Filed herewith).

31.2

Certification of Principal Financial Officer pursuant to Item 601(b)(31) of Regulation S-K (Filed herewith).

32.1

Certification of Chief Executive Officer pursuant to Item 601(b)(32) of Regulation S-K (Filed herewith).

32.2

Certification of Principal Financial Officer pursuant to Item 601(b)(32) of Regulation S-K (Filed herewith).

PROLOR Biotech, Inc. - FORM 10-Q - May 10, 2011

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PROLOR Biotech, Inc. Reports