Bio-Path (BPTH) 10-Q 15 May 18 2018 Q1 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2018	May 07, 2018
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2018
Document Fiscal Year Focus	2,018
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	Smaller Reporting Company
Trading Symbol	BPTH
Entity Common Stock, Shares Outstanding		11,340,756

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Current assets
Cash	$ 4,284	$ 5,965
Prepaid drug product for testing	1,256	1,117
Other current assets	330	353
Total current assets	5,870	7,435
Fixed assets
Furniture, fixtures & equipment	1,001	984
Less accumulated depreciation	(396)	(330)
Property, Plant and Equipment, Net	605	654
Other assets
Technology licenses	2,500	2,500
Less accumulated amortization	(1,771)	(1,731)
Intangible Assets, Net (Excluding Goodwill), Total	729	769
Total Assets	7,204	8,858
Current liabilities
Accounts payable	136	52
Accrued expenses	793	739
Total current liabilities	929	791
Total Liabilities	929	791
Shareholders' equity
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding	0	0
Common stock, $.001 par value; 200,000 shares authorized; 11,341 and 11,339 shares issued and outstanding, respectively	11	11
Additional paid in capital	47,337	47,213
Accumulated deficit	(41,073)	(39,157)
Total shareholders' equity	6,275	8,067
Total Liabilities & Shareholders' Equity	$ 7,204	$ 8,858

CONDENSED CONSOLIDATED BALANCE3

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands	Mar. 31, 2018	Dec. 31, 2017
Preferred Stock, par value	$ 0.001	$ 0.001
Preferred Stock, shares authorized	10,000	10,000
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	200,000
Common Stock, shares issued	11,341	11,339
Common Stock, shares outstanding	11,341	11,339

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Operating expenses
Research and development	$ 932	$ 1,026
General and administrative	987	970
Total operating expenses	1,919	1,996
Net operating loss	(1,919)	(1,996)
Other income
Change in fair value of warrant liability	0	1,596
Interest income	3	3
Total other income	3	1,599
Net loss	$ (1,916)	$ (397)
Loss per share
Net loss per share, basic and diluted	$ (0.17)	$ (0.04)
Basic and diluted weighted average number of common shares outstanding	11,341	9,565

CONDENSED CONSOLIDATED STATEME5

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Cash flow from operating activities
Net loss	$ (1,916)	$ (397)
Adjustments to reconcile net loss to net cash used in operating activities
Amortization	40	40
Depreciation	66	33
Stock-based compensation	124	249
Change in fair value of warrant liability	0	(1,596)
(Increase) decrease in assets
Prepaid drug product for testing	(139)	(1)
Other current assets	23	40
Increase (decrease) in liabilities
Accounts payable and accrued expenses	138	(208)
Net cash used in operating activities	(1,664)	(1,840)
Cash flow from investing activities
Purchases of furniture, fixtures & equipment	(17)	(424)
Net cash used in investing activities	(17)	(424)
Cash flow from financing activities
Net decrease in cash	(1,681)	(2,264)
Cash, beginning of period	5,965	9,375
Cash, end of period	4,284	7,111
Non-cash financing activities
Capital expenditures included in accrued expenses	$ 0	$ 114

Organization and Business

Organization and Business	3 Months Ended
	Mar. 31, 2018
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 RNAi nano particle drug development company utilizing a novel technology that achieves systemic delivery of antisense drug substances 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 ® in vivo ® Using DNAbilize ® Our second drug candidate, Liposomal Bcl2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an Investigational New Drug (IND) application for BP1002 in addition to completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory or relapsed lymphoma patients once we receive approval from the FDA. Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development in a pancreatic patient-derived tumor model. Previous preclinical models have shown BP1003 to successfully penetrate pancreatic tumors and to significantly enhance the efficacy of standard frontline treatments. We intend to initiate IND enabling studies of BP1003 in 2018. 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 In June 2016, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain healthcare focused institutional investors pursuant to which the Company agreed to sell an aggregate of 588,235 294,118 10.0 25,000 9.3 0.3 On May 21, 2017, the Company entered into Warrant Exercise Agreements (the “Exercise Agreements”) with certain holders (the “Exercising Holders”) of the 2016 Warrants and warrants to purchase shares of common stock that we issued in January 2014 (the “2014 Warrants,” and together with the 2016 Warrants, the “Original Warrants”). The Exercising Holders owned, in the aggregate, Original Warrants exercisable for 441,176 430,000 3.80 11,176 6.00 1.5 On June 13, 2017, the Company entered into amendments (the “Warrant Amendments”) with holders (the “Holders”) of the remaining 2016 Warrants, which amended the terms of their 2016 Warrants exercisable for 127,941 The Exercise Agreements for the 2014 Warrants resulted in the holders receiving $ 1.0 0.4 0.4 0.2 On November 3, 2017, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell an aggregate of 1,333,333 666,667 4.0 16,000 3.6 On February 8, 2018, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-10, and our common stock began trading on the split-adjusted basis on The Nasdaq Capital Market at the commencement of trading on February 9, 2018. All common stock share and per share amounts in this Quarterly Report on Form 10-Q have been adjusted to give effect to the 1-for-10 reverse stock split. As of March 31, 2018, the Company had $ 4.3 6.0 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, 2018
New Accounting Pronouncements and Changes in Accounting Principles [Abstract]
Recent Accounting Pronouncements	2. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers. In February 2016, the FASB issued ASU No. 2016-02, Leases In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation: Scope of Modification Accounting 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, 2018
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 clinical 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 made payments to its contract drug manufacturing and raw material suppliers in late 2016 and through 2017 totaling $ 1.1 0.1 1.3

Other Current Assets

Other Current Assets	3 Months Ended
	Mar. 31, 2018
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Other Current Assets	4. Other Current Assets As of March 31, 2018, Other Current Assets included prepaid expenses of $ 0.3 0.3 0.4

Accounts Payable

Accounts Payable	3 Months Ended
	Mar. 31, 2018
Accounts Payable Disclosure [Abstract]
Accounts Payable	5. Accounts Payable As of March 31, 2018, Current Liabilities included accounts payable of $ 0.1 0.1

Accrued Expenses

Accrued Expenses	3 Months Ended
	Mar. 31, 2018
Accrued Liabilities [Abstract]
Accrued Expenses	6. Accrued Expenses As of March 31, 2018, Current Liabilities included accrued expenses of $ 0.8 0.4 0.2 0.1 0.1 0.7 0.4 0.1 0.1 0.1

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2018
Stockholders' Equity Note [Abstract]
Stockholders' Equity	7. Stockholders’ Equity Stockholders’ Equity totaled $ 6.3 8.1 11,340,756

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2018
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-Based Compensation	8. Stock-Based Compensation The 2017 Plan – On December 21, 2017, the Company’s stockholders approved the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (the “2017 Plan”), which replaced the First Amended 2007 Stock Incentive Plan, as amended (the “2007 Plan”). The 2007 Plan expired by its terms in January 2018, however, no awards were made under the 2007 Plan upon approval of the 2017 Plan. The 2017 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights, Performance-Based Awards and other stock-based awards, or any combination of the foregoing to the Company’s employees, non-employee directors and consultants. As of December 31, 2017, the total number of shares reserved and available for grant and issuance pursuant to the 2017 Plan is 1,200,000 Stock-based compensation expense was $ 0.1 0.2 0.1 20,000 0.1 2018 2017 Risk-free interest rate 2.59 % 2.09 % Expected volatility 95 % 100 % Expected term in years 6.1 6.1 Dividend yield - % - % Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2017 642 $ 11.60 Granted 3 2.08 Cancelled (4) 11.88 Outstanding at March 31, 2018 641 11.58 Exercisable at March 31, 2018 573 $ 10.82 As of March 31, 2018, the aggregate intrinsic value of outstanding stock options was none. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on March 31, 2018 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, 2018. This amount changes based on the fair market value of the Company’s stock. As of March 31, 2018, unamortized stock-based compensation expense for all outstanding options was $ 0.8 2.1

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2018
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	9. Commitments and Contingencies Technology License – The Company has negotiated exclusive licenses from MD Anderson to clinically develop liposomal antisense drug products. These licenses require, among other things, the Company to reimburse MD Anderson for ongoing patent expense and an annual license maintenance fee. The annual license maintenance fee attributable to the License Agreement totaling $ 0.1 Operating Lease – 0.1 In April 2016, the Company 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 will require Bio-Path to pay $ 2,500 33,000 Drug Supplier Project Plan – The amounts paid for manufacture of the Company’s Grb2 drug substance and prexigebersen that have not been expensed total $ 1.3 1.5 0.9 0.4 0.2 0.7

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Mar. 31, 2018
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, 2018 and 2017: 2018 2017 Risk-free interest rate 2.59 % 2.09 % Expected volatility 95 % 100 % 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, 2018: Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2017 642 $ 11.60 Granted 3 2.08 Cancelled (4) 11.88 Outstanding at March 31, 2018 641 11.58 Exercisable at March 31, 2018 573 $ 10.82

Organization and Business - Add

Organization and Business - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	Feb. 08, 2018	Nov. 03, 2017	May 21, 2017	Jun. 30, 2016	Jun. 30, 2015	Mar. 31, 2018	Dec. 31, 2017	Jun. 13, 2017	Mar. 31, 2017	Dec. 31, 2016
Organization and Nature of Operations [Line Items]
Cash						$ 4,284	$ 5,965		$ 7,111	$ 9,375
Stock issued during period, shares, new issues				588,235
Proceeds from issuance initial public offering				$ 9,300
Proceeds from Warrant Exercises			$ 1,500
Class of Warrant or Right, Exercisable, Number			441,176
Class of Warrant or Right, Exercised, Number			11,176
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings						400
Gain (Loss) on Extinguishment of Debt						400
Reclassified to equity						200
Adjustments to Additional Paid in Capital, Dividends in Excess of Retained Earnings						$ 1,000
Stockholders' Equity, Reverse Stock Split	1-for-10
Reduced Exercise Price [Member]
Organization and Nature of Operations [Line Items]
Class of Warrant or Right, Exercised, Number			430,000
Class of Warrant or Right, Exercise Price of Warrants or Rights			$ 3.80
New Warrants [Member]
Organization and Nature of Operations [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights			$ 6
Class of Warrant or Right, Terms			5 years
Warrants 2016 [Member]
Organization and Nature of Operations [Line Items]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights								127,941
Warrant
Organization and Nature of Operations [Line Items]
Stock issued during period, shares, new issues				294,118
Stock issued during period, value, new issues				$ 10,000	$ 25,000
Proceeds from issuance initial public offering		$ 3,600
2016 Registered Direct Offering
Organization and Nature of Operations [Line Items]
Debt Issuance Costs, Net				$ 300
Class of Warrant or Right, Number of Securities Called by Warrants or Rights				25,000
2017 Registered Direct Offering
Organization and Nature of Operations [Line Items]
Stock issued during period, shares, new issues		1,333,333
Stock issued during period, value, new issues		$ 4,000
2017 Registered Direct Offering | Warrant
Organization and Nature of Operations [Line Items]
Stock issued during period, shares, new issues		666,667
Roth Capital Partners, Llc [Member] | 2017 Registered Direct Offering | Warrant
Organization and Nature of Operations [Line Items]
Stock issued during period, shares, new issues		16,000

Prepaid Drug Product for Test17

Prepaid Drug Product for Testing - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Dec. 31, 2017
Inventory Disclosure [Line Items]
Prepaid drug product for testing		$ 1,100
Payments to Suppliers	$ 100
Prepaid Expense, Current	$ 1,256	1,117
Drug Supplier Project Plan [Member]
Inventory Disclosure [Line Items]
Prepaid Expense, Current		$ 1,300

Other Current Assets- Additiona

Other Current Assets- Additional Information (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Other Assets Current	$ 330	$ 353
Acute Myeloid Leukemia
Other Assets Current	300
Prepaid Expenses
Other Assets Current	$ 300	$ 400

Accounts Payable - Additional I

Accounts Payable - Additional Information (Detail) - USD ($) $ in Millions	Mar. 31, 2018	Dec. 31, 2017
Accounts Payable [Line Items]
Accounts payable	$ 0.1	$ 0.1

Accrued Expenses - Additional I

Accrued Expenses - Additional Information (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Accounts Payable and Accrued Liabilities [Line Items]
Accrued expenses	$ 793	$ 739
Accrued Vacation And Bonus	200	100
Accrued Clinical And Preclinical	400	400
Accrued License Maintenance Fee	100	100
Other Accrued Liabilities	$ 100	$ 100

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Shareholders Equity [Line Items]
Common Stock, shares issued	11,341	11,339
Common Stock, shares outstanding	11,341	11,339
Stockholders Equity	$ 6,275	$ 8,067

Stock-Based Compensation - Addi

Stock-Based Compensation - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017	Dec. 31, 2017
Stock Based Compensation Plans [Line Items]
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options	$ 800
Stock-based compensation expense	$ 100	$ 200
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term	2 years 1 month 6 days
Research and Development Expense
Stock Based Compensation Plans [Line Items]
Stock-based compensation expense	$ 20,000	100
General and Administrative Expense
Stock Based Compensation Plans [Line Items]
Stock-based compensation expense	$ 100	$ 100
2007 Stock Incentive Plan
Stock Based Compensation Plans [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant			1,200,000

Weighted Average Assumptions (D

Weighted Average Assumptions (Detail)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Share Based Compensation Plans [Line Items]
Risk-free interest rate	2.59%	2.09%
Expected volatility	95.00%	100.00%
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, 2018$ / sharesshares
Share Based Compensation Plans [Line Items]
Options, Outstanding | shares	642
Options, Granted | shares	3
Options, Cancelled | shares	(4)
Options, Outstanding | shares	641
Options, Exercisable | shares	573
Weighted - Average Exercise Price, Outstanding | $ / shares	$ 11.6
Weighted - Average Exercise Price, Granted | $ / shares	2.08
Weighted - Average Exercise Price, Cancelled | $ / shares	11.88
Weighted - Average Exercise Price, Outstanding | $ / shares	11.58
Weighted - Average Exercise Price, Exercisable | $ / shares	$ 10.82

Commitments and Contingencies -

Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands	1 Months Ended
	Apr. 30, 2016	Mar. 31, 2018	Dec. 31, 2017
Product Liability Contingency [Line Items]
Accounts payable and accrued liabilities		$ 100	$ 100
Operating Leases, Future Minimum Payments Due		33,000
Prepaid Expense, Current		1,256	$ 1,117
Other Commitment, Due in Next Twelve Months		700
Drug Supplier Project Plan [Member]
Product Liability Contingency [Line Items]
Prepaid Expense, Current		1,300
Other Commitment		1,500
Manufacturer of Prexigebersen [Member]
Product Liability Contingency [Line Items]
Other Commitment		900
Manufacture of Drug Substance [Member]
Product Liability Contingency [Line Items]
Other Commitment		400
Manufacturing Development [Member]
Product Liability Contingency [Line Items]
Other Commitment		200
Office Space
Product Liability Contingency [Line Items]
Operating Leases, Future Minimum Payments Due		$ 100
Lab Space
Product Liability Contingency [Line Items]
Operating Lease Monthly Rental Payments	$ 2,500