2013 Q3 Form 10-Q Financial Statement
#000114420413045992 Filed on August 14, 2013
Income Statement
Concept | 2013 Q3 | 2013 Q2 | 2012 Q2 |
---|---|---|---|
Revenue | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Cost Of Revenue | |||
YoY Change | |||
Gross Profit | |||
YoY Change | |||
Gross Profit Margin | |||
Selling, General & Admin | $810.0K | $240.0K | $250.0K |
YoY Change | 224.0% | -4.0% | -21.88% |
% of Gross Profit | |||
Research & Development | $568.6K | $156.0K | $190.0K |
YoY Change | 3.38% | -17.88% | 35.71% |
% of Gross Profit | |||
Depreciation & Amortization | $40.00K | $40.00K | $50.00K |
YoY Change | -20.0% | -20.0% | 0.0% |
% of Gross Profit | |||
Operating Expenses | $1.394M | $428.6K | $787.8K |
YoY Change | 65.92% | -45.59% | 69.87% |
Operating Profit | -$1.394M | -$428.6K | -$787.8K |
YoY Change | -45.59% | 69.87% | |
Interest Expense | $0.00 | $0.00 | $0.00 |
YoY Change | |||
% of Operating Profit | |||
Other Income/Expense, Net | $521.00 | $1.402K | -$56.00 |
YoY Change | -2603.57% | -105.49% | |
Pretax Income | -$1.390M | -$430.0K | -$790.0K |
YoY Change | 65.48% | -45.57% | 71.74% |
Income Tax | $0.00 | $0.00 | $0.00 |
% Of Pretax Income | |||
Net Earnings | -$1.393M | -$427.2K | -$787.8K |
YoY Change | 65.86% | -45.77% | 70.25% |
Net Earnings / Revenue | |||
Basic Earnings Per Share | |||
Diluted Earnings Per Share | -$3.658M | -$1.303M | -$2.724M |
COMMON SHARES | |||
Basic Shares Outstanding | 75.38M shares | 58.87M shares | |
Diluted Shares Outstanding |
Balance Sheet
Concept | 2013 Q3 | 2013 Q2 | 2012 Q2 |
---|---|---|---|
SHORT-TERM ASSETS | |||
Cash & Short-Term Investments | $4.100M | $1.930M | $160.0K |
YoY Change | 1142.42% | 1106.25% | -86.89% |
Cash & Equivalents | |||
Short-Term Investments | |||
Other Short-Term Assets | $200.0K | $46.41K | $46.49K |
YoY Change | 53.85% | -0.17% | -7.02% |
Inventory | |||
Prepaid Expenses | |||
Receivables | |||
Other Receivables | |||
Total Short-Term Assets | $4.300M | $2.253M | $504.4K |
YoY Change | 834.78% | 346.63% | -60.28% |
LONG-TERM ASSETS | |||
Property, Plant & Equipment | |||
YoY Change | |||
Goodwill | |||
YoY Change | |||
Intangibles | $1.492M | $1.661M | |
YoY Change | -10.17% | ||
Long-Term Investments | |||
YoY Change | |||
Other Assets | |||
YoY Change | |||
Total Long-Term Assets | $1.450M | $1.492M | $1.661M |
YoY Change | -9.94% | -10.17% | -30.51% |
TOTAL ASSETS | |||
Total Short-Term Assets | $4.300M | $2.253M | $504.4K |
Total Long-Term Assets | $1.450M | $1.492M | $1.661M |
Total Assets | $5.750M | $3.745M | $2.165M |
YoY Change | 177.78% | 72.95% | -40.84% |
SHORT-TERM LIABILITIES | |||
YoY Change | |||
Accounts Payable | $40.00K | $165.9K | $31.15K |
YoY Change | -42.86% | 432.63% | 55.74% |
Accrued Expenses | $130.0K | $4.892K | $86.59K |
YoY Change | -31.58% | -94.35% | -56.71% |
Deferred Revenue | |||
YoY Change | |||
Short-Term Debt | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Long-Term Debt Due | |||
YoY Change | |||
Total Short-Term Liabilities | $170.0K | $267.9K | $243.0K |
YoY Change | -37.04% | 10.22% | 10.47% |
LONG-TERM LIABILITIES | |||
Long-Term Debt | $0.00 | $0.00 | |
YoY Change | |||
Other Long-Term Liabilities | |||
YoY Change | |||
Total Long-Term Liabilities | $0.00 | $0.00 | $0.00 |
YoY Change | |||
TOTAL LIABILITIES | |||
Total Short-Term Liabilities | $170.0K | $267.9K | $243.0K |
Total Long-Term Liabilities | $0.00 | $0.00 | $0.00 |
Total Liabilities | $170.0K | $267.9K | $243.0K |
YoY Change | -37.04% | 10.22% | 10.47% |
SHAREHOLDERS EQUITY | |||
Retained Earnings | |||
YoY Change | |||
Common Stock | $75.38K | $58.87K | |
YoY Change | 28.05% | ||
Preferred Stock | |||
YoY Change | |||
Treasury Stock (at cost) | |||
YoY Change | |||
Treasury Stock Shares | |||
Shareholders Equity | $5.580M | $3.477M | $1.922M |
YoY Change | |||
Total Liabilities & Shareholders Equity | $5.750M | $3.745M | $2.165M |
YoY Change | 177.78% | 72.95% | -40.84% |
Cashflow Statement
Concept | 2013 Q3 | 2013 Q2 | 2012 Q2 |
---|---|---|---|
OPERATING ACTIVITIES | |||
Net Income | -$1.393M | -$427.2K | -$787.8K |
YoY Change | 65.86% | -45.77% | 70.25% |
Depreciation, Depletion And Amortization | $40.00K | $40.00K | $50.00K |
YoY Change | -20.0% | -20.0% | 0.0% |
Cash From Operating Activities | -$720.0K | -$570.0K | -$630.0K |
YoY Change | 33.33% | -9.52% | 142.31% |
INVESTING ACTIVITIES | |||
Capital Expenditures | $0.00 | $0.00 | $0.00 |
YoY Change | -100.0% | ||
Acquisitions | |||
YoY Change | |||
Other Investing Activities | |||
YoY Change | |||
Cash From Investing Activities | $0.00 | $0.00 | $0.00 |
YoY Change | -100.0% | ||
FINANCING ACTIVITIES | |||
Cash Dividend Paid | |||
YoY Change | |||
Common Stock Issuance & Retirement, Net | |||
YoY Change | |||
Debt Paid & Issued, Net | |||
YoY Change | |||
Cash From Financing Activities | 2.880M | 2.210M | 210.0K |
YoY Change | 305.63% | 952.38% | -70.83% |
NET CHANGE | |||
Cash From Operating Activities | -720.0K | -570.0K | -630.0K |
Cash From Investing Activities | 0.000 | 0.000 | 0.000 |
Cash From Financing Activities | 2.880M | 2.210M | 210.0K |
Net Change In Cash | 2.160M | 1.640M | -420.0K |
YoY Change | 1170.59% | -490.48% | -193.33% |
FREE CASH FLOW | |||
Cash From Operating Activities | -$720.0K | -$570.0K | -$630.0K |
Capital Expenditures | $0.00 | $0.00 | $0.00 |
Free Cash Flow | -$720.0K | -$570.0K | -$630.0K |
YoY Change | 33.33% | -9.52% | 152.0% |
Facts In Submission
Frame | Concept Type | Concept / XBRL Key | Value | Unit |
---|---|---|---|---|
dei |
Document Period End Date
DocumentPeriodEndDate
|
2013-06-30 | ||
dei |
Document Fiscal Year Focus
DocumentFiscalYearFocus
|
2013 | ||
dei |
Document Type
DocumentType
|
10-Q | ||
dei |
Amendment Flag
AmendmentFlag
|
false | ||
dei |
Document Fiscal Period Focus
DocumentFiscalPeriodFocus
|
Q2 | ||
dei |
Trading Symbol
TradingSymbol
|
BPTH | ||
CY2013Q3 | dei |
Entity Common Stock Shares Outstanding
EntityCommonStockSharesOutstanding
|
75380214 | shares |
dei |
Entity Registrant Name
EntityRegistrantName
|
BIO-PATH HOLDINGS INC | ||
dei |
Entity Central Index Key
EntityCentralIndexKey
|
0001133818 | ||
dei |
Current Fiscal Year End Date
CurrentFiscalYearEndDate
|
--12-31 | ||
dei |
Entity Filer Category
EntityFilerCategory
|
Smaller Reporting Company | ||
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Preferred Stock Par Or Stated Value Per Share
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|
0.001 | |
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Preferred Stock Par Or Stated Value Per Share
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|
0.001 | |
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Preferred Stock Shares Authorized
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Preferred Stock Shares Authorized
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Preferred Stock Shares Issued
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Common Stock Shares Authorized
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Common Stock Shares Authorized
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Cash
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|
1927226 | USD |
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Cash
Cash
|
534046 | USD |
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Other Inventory
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|
279180 | USD |
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Other Inventory
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|
195000 | USD |
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Other Assets Current
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Other Assets Current
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Finite Lived License Agreements Gross
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Finite Lived License Agreements Gross
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Finite Lived Intangible Assets Accumulated Amortization
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|
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Finite Lived Intangible Assets Accumulated Amortization
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|
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Intangible Assets Net Excluding Goodwill
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|
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Intangible Assets Net Excluding Goodwill
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Liabilities
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Preferred Stock Value
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Additional Paid In Capital
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Other Additional Capital
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|
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Other Additional Capital
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|
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Development Stage Enterprise Deficit Accumulated During Development Stage
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|
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Development Stage Enterprise Deficit Accumulated During Development Stage
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Liabilities And Stockholders Equity
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Revenues
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General And Administrative Expense
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|
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|
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Operating Expenses
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Operating Expenses
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Operating Expenses
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Investment Income Interest
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|
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Other Nonoperating Income
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Other Nonoperating Income
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|
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|
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CY2013Q2 | us-gaap |
Other Nonoperating Expense
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|
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CY2012Q2 | us-gaap |
Other Nonoperating Expense
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|
269 | USD |
us-gaap |
Other Nonoperating Expense
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|
345 | USD | |
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Other Nonoperating Expense
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|
398 | USD | |
us-gaap |
Other Nonoperating Expense
OtherNonoperatingExpense
|
4518 | USD | |
CY2013Q2 | us-gaap |
Nonoperating Income Expense
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|
1402 | USD |
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Share Based Compensation
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|
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Share Based Compensation
ShareBasedCompensation
|
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Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
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Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
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Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
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Increase Decrease In Other Current Assets
IncreaseDecreaseInOtherCurrentAssets
|
3836 | USD | |
us-gaap |
Payments To Acquire Intangible Assets
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|
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Payments To Acquire Intangible Assets
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|
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Payments To Acquire Intangible Assets
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|
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Net Cash Provided By Used In Investing Activities
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|
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Net Cash Provided By Used In Investing Activities
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|
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Net Cash Provided By Used In Investing Activities
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|
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Nonoperating Income Expense
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|
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Nonoperating Income Expense
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|
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Nonoperating Income Expense
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|
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Nonoperating Income Expense
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|
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Net Income Loss
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Net Income Loss
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Net Income Loss
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Net Income Loss
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Earnings Per Share Basic And Diluted
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|
-0.01 | |
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Earnings Per Share Basic And Diluted
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|
-0.01 | |
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Earnings Per Share Basic And Diluted
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|
-0.02 | ||
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Earnings Per Share Basic And Diluted
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|
-0.02 | ||
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Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
|
-0.28 | ||
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Weighted Average Number Of Share Outstanding Basic And Diluted
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|
66606105 | shares |
CY2012Q2 | us-gaap |
Weighted Average Number Of Share Outstanding Basic And Diluted
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|
58868713 | shares |
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Weighted Average Number Of Share Outstanding Basic And Diluted
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|
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Weighted Average Number Of Share Outstanding Basic And Diluted
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|
58625066 | shares | |
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Weighted Average Number Of Share Outstanding Basic And Diluted
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|
47534377 | shares | |
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Adjustment For Amortization
AdjustmentForAmortization
|
80312 | USD | |
us-gaap |
Adjustment For Amortization
AdjustmentForAmortization
|
96612 | USD | |
us-gaap |
Adjustment For Amortization
AdjustmentForAmortization
|
1057047 | USD | |
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Other Asset Impairment Charges
OtherAssetImpairmentCharges
|
0 | USD | |
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Other Asset Impairment Charges
OtherAssetImpairmentCharges
|
345000 | USD | |
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Other Asset Impairment Charges
OtherAssetImpairmentCharges
|
690000 | USD | |
us-gaap |
Issuance Of Stock And Warrants For Services Or Claims
IssuanceOfStockAndWarrantsForServicesOrClaims
|
0 | USD | |
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Issuance Of Stock And Warrants For Services Or Claims
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|
18500 | USD | |
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Issuance Of Stock And Warrants For Services Or Claims
IssuanceOfStockAndWarrantsForServicesOrClaims
|
318500 | USD | |
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
29557 | USD | |
us-gaap |
Increase Decrease In Other Current Assets
IncreaseDecreaseInOtherCurrentAssets
|
-1950 | USD | |
us-gaap |
Increase Decrease In Other Current Assets
IncreaseDecreaseInOtherCurrentAssets
|
46411 | USD | |
us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
-61388 | USD | |
us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
-73108 | USD | |
us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
267856 | USD | |
us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-1122781 | USD | |
us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-1029521 | USD | |
us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-8163408 | USD | |
us-gaap |
Proceeds From Convertible Debt
ProceedsFromConvertibleDebt
|
0 | USD | |
us-gaap |
Proceeds From Convertible Debt
ProceedsFromConvertibleDebt
|
0 | USD | |
us-gaap |
Proceeds From Convertible Debt
ProceedsFromConvertibleDebt
|
435000 | USD | |
us-gaap |
Repayments Of Convertible Debt
RepaymentsOfConvertibleDebt
|
0 | USD | |
us-gaap |
Repayments Of Convertible Debt
RepaymentsOfConvertibleDebt
|
0 | USD | |
us-gaap |
Repayments Of Convertible Debt
RepaymentsOfConvertibleDebt
|
15000 | USD | |
us-gaap |
Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
|
2515961 | USD | |
us-gaap |
Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
|
264709 | USD | |
us-gaap |
Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
|
10555344 | USD | |
us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
2515961 | USD | |
us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
264709 | USD | |
us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
10975344 | USD | |
us-gaap |
Cash Period Increase Decrease
CashPeriodIncreaseDecrease
|
1393180 | USD | |
us-gaap |
Cash Period Increase Decrease
CashPeriodIncreaseDecrease
|
-789812 | USD | |
us-gaap |
Cash Period Increase Decrease
CashPeriodIncreaseDecrease
|
1927226 | USD | |
CY2011Q4 | us-gaap |
Cash
Cash
|
952252 | USD |
CY2007Q2 | us-gaap |
Cash
Cash
|
0 | USD |
CY2012Q2 | us-gaap |
Cash
Cash
|
162440 | USD |
us-gaap |
Interest Paid
InterestPaid
|
0 | USD | |
us-gaap |
Interest Paid
InterestPaid
|
0 | USD | |
us-gaap |
Interest Paid
InterestPaid
|
445 | USD | |
us-gaap |
Income Taxes Paid
IncomeTaxesPaid
|
0 | USD | |
us-gaap |
Income Taxes Paid
IncomeTaxesPaid
|
0 | USD | |
us-gaap |
Income Taxes Paid
IncomeTaxesPaid
|
0 | USD | |
us-gaap |
Conversion Of Stock Amount Converted1
ConversionOfStockAmountConverted1
|
0 | USD | |
us-gaap |
Conversion Of Stock Amount Converted1
ConversionOfStockAmountConverted1
|
0 | USD | |
us-gaap |
Conversion Of Stock Amount Converted1
ConversionOfStockAmountConverted1
|
420000 | USD | |
CY2011 | us-gaap |
Other Asset Impairment Charges
OtherAssetImpairmentCharges
|
345000 | USD |
CY2011 | bpth |
Percentage Of Change In Depreciation Amortization Of Intangible Assets And Asset Impairment And Other Charges Operating
PercentageOfChangeInDepreciationAmortizationOfIntangibleAssetsAndAssetImpairmentAndOtherChargesOperating
|
0.5 | pure |
bpth |
Other Asset Impairment Charges Sirna License
OtherAssetImpairmentChargesSirnaLicense
|
345000 | USD | |
CY2013Q2 | us-gaap |
Proceeds From Issuance Of Private Placement
ProceedsFromIssuanceOfPrivatePlacement
|
2500000 | USD |
us-gaap |
Nature Of Operations
NatureOfOperations
|
<table border="0" style="clear:both;width:100%; table-layout:fixed;"> <tr> <td></td> </tr> </table> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif "> <table style="clear:both;MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.25in"> <div><strong>1.</strong></div> </td> <td> <div><strong>Organization and Business</strong></div> </td> </tr> </table> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt"><font size="2"> </font></div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> Bio-Path is a development stage company with its lead cancer drug candidate, Liposomal Grb-2 (L-Grb-2 or BP-100-1.01), currently in clinical trials. The Company was founded with technology from The University of Texas, MD Anderson Cancer Center (“MD Anderson”) and is dedicated to developing novel cancer drugs under an exclusive license arrangement. The Company has drug delivery platform technology with composition of matter intellectual property for systemic delivery of antisense. Bio-Path also plans to investigate developing liposome tumor targeting technology, which has the potential to be developed to augment the Company’s current delivery technology to improve further the effectiveness of its antisense. In addition to its existing technology under license, the Company expects to maintain a close working relationship with key members of the MD Anderson staff, which has the potential to provide Bio-Path with additional drug candidates in the future. Bio-Path also expects to broaden its technology to include cancer drugs other than antisense, including drug candidates licensed from institutions other than MD Anderson.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> Bio-Path believes that its core technology, if successful, will enable it to be at the center of emerging genetic and molecular target-based therapeutics that require systemic delivery of DNA and RNA-like material. The Company’s two lead liposomal antisense drug candidates are targeted to treat acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, acute lymphoblastic leukemia and follicular lymphoma, and if successful, could potentially be used in treating many other indications of cancer. For example, recently in July of 2013 Bio-Path announced that it was initiating development of its lead cancer drug Liposomal Grb-2 to treat triple negative breast cancer (TNBC) and inflammatory breast cancer (IBC), two cancers characterized by formation of aggressive tumors and relatively high mortality rates.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> Bio-Path is currently treating patients with its lead cancer drug candidate Liposomal Grb-2 in a Phase I clinical trial. In March of 2010, Bio-Path received written notification from the U.S. Food and Drug Administration (the “FDA”) that its application for Investigational New Drug (“IND”) status for L-Grb-2 had been granted. This enabled the Company to commence its Phase I clinical trial to study L-Grb-2 in human patients, which began in the third quarter 2010.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The Phase I clinical trial is a dose-escalating study to determine the safety and tolerance of escalating doses of L-Grb-2. The study will also determine the optimal biologically active dose for further development. The pharmacokinetics of L-Grb-2 in patients will be studied, making it possible to investigate whether the delivery technology performs as expected based on pre-clinical studies in animals. In addition, patient blood samples from the trial will be tested using a new assay developed by the Company to measure down-regulation of the target protein, the critical scientific data that will demonstrate that the delivery technology does in fact successfully deliver the antisense drug substance to the cell and across the cell membrane into the interior of the cell where expression of the target protein is blocked. The clinical trial is being conducted at The University of Texas MD Anderson Cancer Center.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The original IND granted by the FDA in March of 2010 allowed the Company to proceed with a Phase I clinical trial having five (5) cohorts culminating in a maximum dose of 50 mg/m<sup>2</sup>. However, in November of 2012, the Company announced that since there had been no evidence of significant toxicity from treatment of patients with L-Grb-2, the Company was proceeding with requesting the FDA to allow higher dosing in patients. The Principal Investigator for the clinical trial, in consultation with Bio-Path’s Board of Directors, advised that with the absence of any real toxicity barriers, the Company should continue to evaluate higher doses of Liposomal Grb-2. The absence of significant toxicity provides a significant opportunity for the Company to test higher doses in patients in order to find a dose that provides maximum potential benefit and duration of anti-leukemia effect. These actions were approved and a revised protocol is in place allowing higher dosing. The Company announced in June of 2013 that it completed Cohort 5, successfully treating three patients at a dose 60 mg/m<sup>2</sup>, which had been increased from 50 mg/m<sup>2</sup>in the revised protocol. The Company has enrolled three patients in Cohort 6 for treatment at a dose of 90 mg/m<sup>2</sup>.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> Patients eligible for enrollment into the Phase I clinical trial have refractory or relapsed Acute Myeloid Leukemia (AML), Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (CML) and Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) and who have failed other approved treatments. These are patients with very advanced stages of the disease, and consequently, not all patients enrolled are able to complete the four-week treatment cycle because of progressive disease, which is unrelated to the treatment with Liposomal-Grb-2.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The Principal Investigator for the Phase I clinical trial, Jorge Cortes, M.D., is a leading expert in the treatment of CML, AML, MDS and ALL. Because the results of the first trial produced unexpected and clinically interesting results in some patients, the Principal Investigator prepared an abstract of the results of the first cohort that was accepted for presentation at the American Society of Hematology annual meeting in December of 2011. Results that demonstrated potential anti-leukemia benefits in treated patients were included in the presentation. The Principal Investigator is currently preparing an abstract of updated information for presentation at the American Society of Hematology annual meeting in December of 2013.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> An important outcome for the Phase I clinical trial is the ability to assess for the first time the performance of the Company’s delivery technology platform in human patients. The Company has developed two new assays to be able to provide scientific proof of concept of the delivery technology. The first involves a novel detection method for the drug substance in blood samples that will be used to assess the pharmacokinetics of the drug. The second involves a method to measure down-regulation of the target protein in a patient blood sample that was achieved. The latter measurement will provide critical proof that the neutral liposome delivery technology delivered the drug substance to the cell and was able to transport it across the cell membrane into the interior to block cellular production of the Grb-2 protein.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> In this regard, in August of 2013 Bio-Path made a major announcement that its liposomal delivery technology achieved a major milestone in the development of antisense therapeutics based on a scientific assay confirming that treating patients with its drug candidate BP-100-1.01 inhibits the Grb-2 disease-causing target protein in patients with blood cancers. Inhibition of the disease-causing protein has the effect of down regulating the disease. This will allow for Liposomal Grb-2 to be used potentially in combination with current frontline treatments. This discovery also points to the potential use of a liposomal antisense treatment as a standalone treatment to transform and manage a disease, which has a disease causing protein, as a chronic disorder. This accomplishment is potentially a significant breakthrough for antisense therapeutics, whose development, to date, as a class of therapeutics has been severely limited by a lack of a systemic delivery mechanism that can safely distribute the drug throughout the body and get the antisense drug substance across the cell membrane into the interior of the cell. Further, we expect that scientific proof of principal for our delivery technology may lead to licensing and business development opportunities, furthering our business model.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> Being platform technology, a successful demonstration of the delivery technology in this study will allow the Company to begin expanding Bio-Path’s drug candidates by simply applying the delivery technology template to multiple new drug product targets. In this manner, Bio-Path can quickly build an attractive drug product pipeline with multiple drug product candidates for treating cancer as well as treating other important diseases including diabetes, cardiovascular conditions and neuromuscular disorders. Currently, the Company is researching potential targets for which it can apply its liposomal antisense drug delivery technology.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The Phase I clinical trial is typically ended when a maximum tolerated dose (MTD) is encountered. However, due to the lack of toxicity of the drug to date, it is not expected that a MTD will be encountered. As a result, the optimal biological dose will be determined and this dose will be used in the following Phase II clinical trial. The Company plans to evaluate patients at the close of Cohort 6 to evaluate whether the Phase I clinical trial should be ended at that time. It is expected that the down regulation assay will be a factor in the evaluation of whether we have reached optimal inhibition. It is noted, however, that the lack of toxicity is a major advantage for the drug candidate BP-100-1.01 since it allows higher levels of drug to be administered to the patient, increasing the potential therapeutic benefit.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> Bio-Path has also been working with the Principal Investigator to finalize plans for Phase II clinical trials in Liposomal Grb-2. Significantly, these plans include three Phase II trials, one each for CML, AML and MDS, of the drug candidate Liposomal Grb-2 in salvage therapy for very advanced patients.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> At the end of January 2012, the Company’s Board of Directors held a strategic planning session. Among several topics was a discussion of Company’s liposomal siRNA technology. The siRNA discussion covered a broad range of topics including intellectual property, the amount of development that would be needed and the overall impression of diminishing acceptance of siRNA technology by the pharmaceutical industry and equity market investors. The Board compared this to our core liposomal antisense technology, which has a stronger intellectual property position, a method of action blocking expression of disease-causing proteins that is better understood in the scientific community and a much easier path for development than liposomal siRNA technology. Since both antisense and siRNA are means to block expression of disease-causing proteins, the Board concluded that there was no apparent reason to develop a second, higher-risk siRNA method of blocking protein expression when the development of the liposomal antisense method is now much further along and showing promising results. After this discussion the Board decided to discontinue development of the licensed liposomal siRNA technology and the Company commenced discussions regarding this decision with MD Anderson to determine with them whether to modify the license to include other products, postpone the license or simply abandon the license. As an interim step pending final resolution of this matter, the Company took a charge of $<font style=" FONT-SIZE: 10pt">345,000</font> at the end of the fiscal year ending December 31, 2011 to reduce the carrying value of the siRNA license by fifty percent (<font style=" FONT-SIZE: 10pt">50</font>%). This amount represented one half of the value of the common stock given to MD Anderson when the original siRNA license was finalized. In June 2012, the Company decided to write-off the balance of the carrying value of the siRNA license, representing $<font style=" FONT-SIZE: 10pt">345,000</font>, and cancel the license.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The Company was founded in May of 2007 as a Utah corporation. In February of 2008, Bio-Path 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. Bio-Path has become a publicly traded company (symbol OTCBB: BPTH) as a result of this merger. 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 including readying and now conducting a Phase I clinical trial in its lead drug product candidate Liposomal Grb-2.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> An important milestone was achieved for the Company in the second quarter, 2012 when Bio-Path’s common stock began trading on the quality-controlled OTCQX. OTCQX is the highest tier, premier trading platform for OTC companies. The Company also announced that it had retained Roth Capital Partners to serve as the Company’s Designated Advisor for Disclosure (“DAD”) on OTCQX, responsible for providing guidance on OTCQX requirements.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> As of June 30, 2013, Bio-Path had $<font style=" FONT-SIZE: 10pt">1,927,226</font> in cash on hand. During the second quarter of 2013, the Company received approximately $<font style=" FONT-SIZE: 10pt">2.5</font> million in cash from the sale of shares of common stock in a private placement and direct offering that have both been closed. The Company has since opened a new private placement in the second quarter of 2013 with the goal of raising up to $<font style=" FONT-SIZE: 10pt">4</font> million from the sales of shares of its common stock. Bio-Path plans to begin raising significant amounts of additional development capital at anticipated higher share prices once there is demonstration of proof-of-concept of Bio-Path’s technology in human patients.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt">  </div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> As the Company has not begun its planned principal operations of commercializing a product candidate, the accompanying financial statements have been prepared in accordance with principles established for development stage enterprises.</div> </div> | ||
CY2013Q2 | bpth |
Proceeds From Issuance Of Private Placement Two
ProceedsFromIssuanceOfPrivatePlacementTwo
|
4000000 | USD |
CY2013Q2 | us-gaap |
Accounts Payable Current And Noncurrent
AccountsPayableCurrentAndNoncurrent
|
165897 | USD |
CY2012Q4 | us-gaap |
Accounts Payable Current And Noncurrent
AccountsPayableCurrentAndNoncurrent
|
57000 | USD |
CY2013Q2 | us-gaap |
Accounts Payable Trade Current And Noncurrent
AccountsPayableTradeCurrentAndNoncurrent
|
114200 | USD |
CY2013Q2 | us-gaap |
Accounts Payable Other Current
AccountsPayableOtherCurrent
|
6800 | USD |
CY2013Q2 | bpth |
Accounts Payable To Public Filing Services
AccountsPayableToPublicFilingServices
|
6000 | USD |
CY2013Q2 | bpth |
Accounts Payable To Professional Fees Current
AccountsPayableToProfessionalFeesCurrent
|
15900 | USD |
CY2008Q2 | bpth |
Fair Value Of Common Stock Issued
FairValueOfCommonStockIssued
|
180000 | USD |
CY2008Q2 | bpth |
Common Stock Additional Shares Issued
CommonStockAdditionalSharesIssued
|
24 | shares |
CY2011Q4 | bpth |
Stock Issued During Period Shares Stock Warrants Exercised
StockIssuedDuringPeriodSharesStockWarrantsExercised
|
1920000 | shares |
CY2011Q4 | bpth |
Stock Issued During Period Value Warrant Exercises
StockIssuedDuringPeriodValueWarrantExercises
|
576000 | USD |
CY2012Q3 | bpth |
Stock Issued During Period Shares Contingent Considerations
StockIssuedDuringPeriodSharesContingentConsiderations
|
50000 | shares |
CY2012Q3 | bpth |
Issuance Of Common Stock Shares For Service
IssuanceOfCommonStockSharesForService
|
18500 | shares |
CY2012Q3 | us-gaap |
Issuance Of Stock And Warrants For Services Or Claims
IssuanceOfStockAndWarrantsForServicesOrClaims
|
795001 | USD |
CY2012Q4 | us-gaap |
Issuance Of Stock And Warrants For Services Or Claims
IssuanceOfStockAndWarrantsForServicesOrClaims
|
708600 | USD |
CY2013Q1 | us-gaap |
Issuance Of Stock And Warrants For Services Or Claims
IssuanceOfStockAndWarrantsForServicesOrClaims
|
346201 | USD |
CY2013Q2 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod
|
25000 | shares |
CY2013Q2 | us-gaap |
Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
|
0.54 | |
CY2013Q2 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Weighted Average Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsWeightedAverageVolatilityRate
|
1.75 | pure |
CY2013Q2 | bpth |
Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGrantDateFairValue
|
12975 | USD |
CY2013Q2 | us-gaap |
Stock Option Plan Expense
StockOptionPlanExpense
|
13538 | USD |
CY2013Q2 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Award Vesting Period1
ShareBasedCompensationArrangementByShareBasedPaymentAwardAwardVestingPeriod1
|
P1Y | |
CY2013Q2 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod
|
0 | shares |
CY2013Q2 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Grants In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsGrantsInPeriod
|
0 | shares |
CY2013Q2 | bpth |
Accrued Liabilities Related Party Current
AccruedLiabilitiesRelatedPartyCurrent
|
37050 | USD |
us-gaap |
Cost Of Reimbursable Expense
CostOfReimbursableExpense
|
75000 | USD | |
CY2013Q2 | bpth |
Accrued Patent Expense Current
AccruedPatentExpenseCurrent
|
25000 | USD |
bpth |
Drug Product Testing Agreement Consideration To Be Paid In Stages
DrugProductTestingAgreementConsiderationToBePaidInStages
|
340000 | USD | |
bpth |
Drug Product Estimated Cost
DrugProductEstimatedCost
|
165000 | USD | |
CY2012Q3 | us-gaap |
Proceeds From Issuance Of Private Placement
ProceedsFromIssuanceOfPrivatePlacement
|
4000000 | USD |
us-gaap |
Basis Of Accounting
BasisOfAccounting
|
<div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif "> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt"></div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The accompanying interim financial statements have been prepared with the instructions to Form 10-Q pursuant to the rules and regulations of the Securities and Exchange Commission and, therefore, do not include all information and footnotes necessary for a complete presentation of our financial position, results of operations, cash flows, and stockholders’ equity in conformity with generally accepted accounting principles. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations and financial position have been included and all such adjustments are of a normal recurring nature. The unaudited quarterly financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10-K of Bio-Path Holdings, Inc. (together with its subsidiary, “Bio-Path” or the “Company”) as of and for the fiscal year ended December 31, 2012. The results of operations for the period ended June 30, 2013, are not necessarily indicative of the results for a full-year period.</div> <div style="clear:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt"></div> </div> |