Bio-Path (BPTH) 10-Q 10 May 16 2016 Q1 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2016	May. 04, 2016
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2016
Document Fiscal Year Focus	2,016
Document Fiscal Period Focus	Q1
Entity Registrant Name	BIO-PATH HOLDINGS INC
Entity Central Index Key	1,133,818
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Trading Symbol	BPTH
Entity Common Stock, Shares Outstanding		89,762,872

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Current assets
Cash	$ 6,473	$ 8,854
Prepaid drug product for testing	611	560
Other current assets	750	179
Total current assets	7,834	9,593
Fixed assets
Furniture, fixtures & equipment	123	123
Less Accumulated Depreciation	(61)	(51)
Property, Plant and Equipment, Net	62	72
Other assets
Technology licenses	2,500	2,500
Less Accumulated Amortization	(1,450)	(1,410)
Intangible Assets, Net (Excluding Goodwill), Total	1,050	1,090
Total Assets	8,946	10,755
Current liabilities
Accounts payable	201	54
Accrued expense	699	883
Total current liabilities	900	937
Total Liabilities	900	937
Shareholders' Equity
Preferred Stock, $.001 par value 10,000,000 shares authorized, no shares issued and outstanding	0	0
Common Stock, $.001 par value, 200,000,000 shares authorized 89,762,872 and 89,762,872 shares issued and outstanding as of 3/31/16 and 12/31/15, respectively	90	90
Additional paid in capital	35,207	35,112
Accumulated deficit	(27,251)	(25,384)
Total shareholders' equity	8,046	9,818
Total Liabilities & Shareholders' Equity	$ 8,946	$ 10,755

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2016	Dec. 31, 2015
Preferred Stock, par value	$ 0.001	$ 0.001
Preferred Stock, shares authorized	10,000,000	10,000,000
Preferred Stock, shares issued	0	0
Preferred Stock, shares outstanding	0	0
Common Stock, par value	$ 0.001	$ 0.001
Common Stock, shares authorized	200,000,000	200,000,000
Common Stock, shares issued	89,762,872	89,762,872
Common Stock, shares outstanding	89,762,872	89,762,872

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Revenue	$ 0	$ 0
Operating expenses
Research and development	1,020	593
General and administrative	849	786
Total operating expenses	1,869	1,379
Net operating loss	(1,869)	(1,379)
Other income (expense)
Interest income	2	4
Total other income (expense)	2	4
Net loss	$ (1,867)	$ (1,375)
Net loss per share, basic and diluted	$ (0.02)	$ (0.02)
Basic and diluted weighted average number of common shares outstanding	89,763	89,763

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Cash flow from operating activities
Net loss	$ (1,867)	$ (1,375)
Adjustments to reconcile net loss to net cash used in operating activities
Amortization	40	40
Depreciation	10	10
Stock-based compensation	95	92
(Increase) decrease in assets
Prepaid drug product for testing	(51)	(204)
Other current assets	(571)	(22)
Increase (decrease) in liabilities
Accounts payable and accrued expenses	(37)	54
Net cash used in operating activities	(2,381)	(1,405)
Net increase (decrease) in cash	(2,381)	(1,405)
Cash, beginning of period	8,854	13,859
Cash, end of period	$ 6,473	$ 12,454

Organization and Business

Organization and Business	3 Months Ended
	Mar. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Business	1. Organization and Business The Company is a clinical and preclinical stage oncology focused antisense drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. The Company’s drug delivery and antisense technology, called DNAbilize™, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. The Company believes this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize™ delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of proteins in blood diseases and solid organs. Using DNAbilize™ as a platform for drug manufacturing, the Company currently has two antisense drug candidates in development to treat a total of five different disease indications. The Company’s lead drug candidate, Liposomal Grb2 (“BP1001”), targets the protein Grb2 and is preparing to enter the efficacy portion of Phase II clinical trials for acute myeloid leukemia and the safety segment of a Phase II clinical trial for blast phase and accelerated phase chronic myelogenous leukemia. BP1001 is also in preclinical studies for solid tumors, including triple negative breast cancer and inflammatory breast cancer. The Company’s second drug candidate, Liposomal Bcl2 (“BP1002”), targets the protein Bcl2, which is responsible for driving cell proliferation in up to 60% of all cancers. BP1002 is in preparation for an Investigational New Drug application and expected to begin a Phase I clinical trial for lymphoma in 2016. Bio-Path Subsidiary was founded in May 2007 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with Ogden Golf Co. Corporation, a public company traded over the counter that had no current operations. The name of Ogden Golf was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path, Inc. became the directors and officers of Bio-Path Holdings, Inc. The Company’s operations to date have been limited to organizing and staffing the Company, acquiring, developing and securing its technology and undertaking product development for a limited number of product candidates. In June 2015, the Company established an “at the market” (“ATM”) program through which it may offer and sell up to $ 25.0 As of March 31, 2016, Bio-Path had $ 6.5 As the Company has not begun its planned principal operations of commercializing a product candidate, the Company’s activities are subject to significant risks and uncertainties, including the potential requirement to secure additional funding, the outcome of the Company’s clinical trials, and failing to operationalize the Company’s current drug candidates before another company develops similar products.

Recent Accounting Pronouncement

Recent Accounting Pronouncements	3 Months Ended
	Mar. 31, 2016
New Accounting Pronouncements and Changes in Accounting Principles [Abstract]
Recent Accounting Pronouncements	2. Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. Management is currently evaluating the impact of future adoption of the new standard on the Company’s consolidated financial statements. Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company’s consolidated financial statements.

Prepaid Drug Product for Testin

Prepaid Drug Product for Testing	3 Months Ended
	Mar. 31, 2016
Prepaid Drug Product For Testing [Abstract]
Prepaid Drug Product for Testing	3. Prepaid Drug Product for Testing Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. The Company incurred installments to its contract drug manufacturing and raw material suppliers totaling $ 0.6 0.6

Other Current Assets

Other Current Assets	3 Months Ended
	Mar. 31, 2016
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Other Current Assets	4. Other Current Assets As of March 31, 2016, Other Current Assets included prepaid expenses of $0.8 million, comprised primarily of prepayments made to the Company’s clinical research organization in preparation for our Phase II clinical trial for BP1001 in AML. As of December 31, 2015, Other Current Assets included prepaid expenses of $0.2 million.

Accounts Payable

Accounts Payable	3 Months Ended
	Mar. 31, 2016
Accounts Payable Disclosure [Abstract]
Accounts Payable	5. Accounts Payable As of March 31, 2016, Current Liabilities included accounts payable of $ 0.2 0.1

Accrued Expense

Accrued Expense	3 Months Ended
	Mar. 31, 2016
Accrued Liabilities [Abstract]
Accrued Expense	6. Accrued Expense As of March 31, 2016, Current Liabilities included accrued expense of $0.7 million for clinical trial expenses, accrued license payments, legal fees, audit fees, accrued vacation and management bonus accrual. As of December 31, 2015, Current Liabilities included accrued expense of $0.9 million.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2016
Stockholders' Equity Note [Abstract]
Stockholders' Equity	7. Stockholders’ Equity As of March 31, 2016, there were 89,762,872

Stock-Based Compensation and Wa

Stock-Based Compensation and Warrants	3 Months Ended
	Mar. 31, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-Based Compensation and Warrants	8. Stock-Based Compensation and Warrants The Plan - In 2007, the Company adopted the First Amended 2007 Stock Incentive Plan, as amended (the “Plan”). The Plan provides for the grant of Incentive Stock Options, Nonqualified Stock Options, Restricted Stock Awards, Restricted Stock Unit Awards, Performance Awards and other stock-based awards, or any combination of the foregoing to the Company’s key employees, non-employee directors and consultants. Under the Plan, the exercise price is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options intended to qualify as qualified incentive stock options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. All grants provide for accelerated vesting if there is a change of control, as defined in the Plan. Stock-based compensation expense was $0.1 million for the three months ended March 31, 2016 and March 31, 2015. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for the three months ended March 31, 2016 and March 31, 2015 was approximately $53,000 and $63,000, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended March 31, 2016 and March 31, 2015 was approximately $42,000 and $29,000, respectively. 2016 2015 Risk-free interest rate 1.49 % 1.74 % Expected volatility 108 % 145 % Expected term in years 6.1 6.1 Dividend yield - % - % Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2015 5,752 $ 1.05 Granted 150 1.40 Outstanding at March 31, 2016 5,902 1.06 Exercisable at March 31, 2016 5,166 $ 0.99 As of March 31, 2016, the aggregate intrinsic value of outstanding stock options was $9.1 million. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on March 31, 2016 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on March 31, 2016. This amount changes based on the fair market value of the Company’s stock. Warrants - There were no warrants for services granted during the three months ended March 31, 2016. The Company had 10,000 warrants for services outstanding as of March 31, 2016 with a weighted average exercise price of $0.90. The warrants issued in connection with the sale of units of common stock were for cash value received and as such were not grants of compensation-based warrants.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2016
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	9. Commitments and Contingencies Technology License – Operating Lease Drug Supplier Project Plan

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2016
Subsequent Events [Abstract]
Subsequent Events	10. Subsequent Event In April 2016, Bio-Path entered into a three-year lease agreement for lab space located in Bellaire, Texas. The term of lease began on May 1, 2016 and terminates on April 30, 2019 and requires Bio-Path to pay $2,500 per month over the term of the lease.

Stock-Based Compensation and 16

Stock-Based Compensation and Warrants (Tables)	3 Months Ended
	Mar. 31, 2016
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions	The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the three months ended March 31, 2016 and 2015: 2016 2015 Risk-free interest rate 1.49 % 1.74 % Expected volatility 108 % 145 % Expected term in years 6.1 6.1 Dividend yield - % - %
Schedule of Share-based Compensation, Stock Options, Activity	The following summary represents option activity under the Company’s stock-based compensation plan for the three months ended March 31, 2016: Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2015 5,752 $ 1.05 Granted 150 1.40 Outstanding at March 31, 2016 5,902 1.06 Exercisable at March 31, 2016 5,166 $ 0.99

Organization and Business - Add

Organization and Business - Additional Information (Detail) - USD ($) $ in Thousands	1 Months Ended
	Jun. 30, 2015	Mar. 31, 2016	Dec. 31, 2015	Mar. 31, 2015	Dec. 31, 2014
Organization and Nature of Operations [Line Items]
Cash		$ 6,473	$ 8,854	$ 12,454	$ 13,859
Warrant
Organization and Nature of Operations [Line Items]
Stock issued during period, value, new issues	$ 25,000

Prepaid Drug Product for Test18

Prepaid Drug Product for Testing - Additional Information (Detail) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Inventory Disclosure [Line Items]
Prepaid drug product for testing	$ 611	$ 560

Other Current Assets - Addition

Other Current Assets - Additional Information (Detail) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Other Assets Current	$ 750	$ 179
Prepaid Expenses [Member]
Other Assets Current	$ 800	$ 200

Accounts Payable - Additional I

Accounts Payable - Additional Information (Detail) - USD ($) $ in Millions	Mar. 31, 2016	Dec. 31, 2015
Accounts Payable [Line Items]
Accounts payable	$ 0.2	$ 0.1

Accrued Expense - Additional In

Accrued Expense - Additional Information (Detail) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Accounts Payable and Accrued Liabilities [Line Items]
Accrued expense	$ 699	$ 883

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Detail) - shares	Mar. 31, 2016	Dec. 31, 2015
Shareholders Equity [Line Items]
Common Stock, shares issued	89,762,872	89,762,872
Common Stock, shares outstanding	89,762,872	89,762,872
Preferred Stock Shares Outstanding	0	0

Stock-Based Compensation and 23

Stock-Based Compensation and Warrants - Additional Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Stock Based Compensation Plans [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value	$ 9,100,000
Stock-based compensation expense	$ 100,000	$ 100,000
Warrants
Stock Based Compensation Plans [Line Items]
Class of Warrant or Right, Outstanding	10,000
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 0.90
Research and Development Expense
Stock Based Compensation Plans [Line Items]
Stock-based compensation expense	$ 42,000	29,000
General and Administrative Expense [Member]
Stock Based Compensation Plans [Line Items]
Stock-based compensation expense	$ 53,000	$ 63,000

Weighted Average Assumptions (D

Weighted Average Assumptions (Detail)	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Share Based Compensation Plans [Line Items]
Risk-free interest rate	1.49%	1.74%
Expected volatility	108.00%	145.00%
Expected term in years	6 years 1 month 6 days	6 years 1 month 6 days
Dividend yield	0.00%	0.00%

Option Activity Under Plan (Det

Option Activity Under Plan (Detail) shares in Thousands	3 Months Ended
	Mar. 31, 2016$ / sharesshares
Share Based Compensation Plans [Line Items]
Outstanding | shares	5,752
Granted | shares	150
Outstanding | shares	5,902
Exercisable | shares	5,166
Weighted - Average Exercise Price, Outstanding | $ / shares	$ 1.05
Weighted - Average Exercise Price, Granted | $ / shares	1.40
Weighted - Average Exercise Price, Outstanding | $ / shares	1.06
Weighted - Average Exercise Price, Exercisable | $ / shares	$ 0.99

Commitments and Contingencies -

Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015	Dec. 31, 2015
Product Liability Contingency [Line Items]
Accounts payable and accrued liabilities	$ 100
Drug Product Testing Agreement Consideration To Be Paid In Stages	500	$ 600
Operating Leases, Future Minimum Payments Due	300
Other Inventory, Gross	611		$ 560
Drug Supplier Commitments Development	100
First Drug [Member]
Product Liability Contingency [Line Items]
Other Inventory, Gross	600
Second Drug [Member]
Product Liability Contingency [Line Items]
Other Inventory, Gross	$ 100

Subsequent Events - Additional

Subsequent Events - Additional Information (Detail) - Subsequent Event [Member]	1 Months Ended
	Apr. 30, 2016USD ($)
Subsequent Event [Line Items]
Operating Leases, Rent Expense, Minimum Rentals	$ 2,500
Lessee Leasing Arrangements, Operating Leases, Term of Contract	3 years
Lease Expiration Date	Apr. 30, 2019
Operating Leases Lease Commencement Date	May 1, 2016