2014 Q1 Form 10-K Financial Statement

#000114420414019417 Filed on March 31, 2014

View on sec.gov

Income Statement

Concept 2014 Q1 2013 2012 Q4
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $380.0K $1.630M $260.0K
YoY Change 58.33% 64.65% 18.18%
% of Gross Profit
Research & Development $107.6K $1.519M $90.00K
YoY Change -73.16% 34.09% -84.48%
% of Gross Profit
Depreciation & Amortization $0.00 $0.00 $40.00K
YoY Change -100.0% -20.0%
% of Gross Profit
Operating Expenses $510.2K $3.269M $430.0K
YoY Change -22.21% 26.58% -46.25%
Operating Profit -$510.2K -$3.269M
YoY Change -22.21% 26.58%
Interest Expense $10.00K $0.00 $0.00
YoY Change
% of Operating Profit
Other Income/Expense, Net $5.334K $3.227K $0.00
YoY Change -5897.83% 2172.54%
Pretax Income -$500.0K -$3.266M -$430.0K
YoY Change -24.24% 26.47% -46.25%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$504.9K -$3.266M -$430.0K
YoY Change -23.04% 26.47% -46.25%
Net Earnings / Revenue
Basic Earnings Per Share
Diluted Earnings Per Share -$1.111M -$9.083M -$1.387M
COMMON SHARES
Basic Shares Outstanding 89.24M shares 62.22M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2014 Q1 2013 2012 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $16.82M $3.550M $530.0K
YoY Change 5700.0% 569.81% -44.21%
Cash & Equivalents
Short-Term Investments
Other Short-Term Assets $157.5K $110.0K $42.58K
YoY Change 4.98% -54.17% -12.11%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $17.23M $3.670M $771.6K
YoY Change 3815.07% 376.62% -33.12%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles $1.371M $1.572M
YoY Change -24.32%
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $1.371M $1.410M $1.572M
YoY Change -10.37% -10.19% -24.32%
TOTAL ASSETS
Total Short-Term Assets $17.23M $3.670M $771.6K
Total Long-Term Assets $1.371M $1.410M $1.572M
Total Assets $18.60M $5.080M $2.344M
YoY Change 844.04% 117.09% -27.46%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $238.0K $80.00K $57.00K
YoY Change 240.04% 14.29% -53.1%
Accrued Expenses $78.88K $220.0K $137.7K
YoY Change -64.15% -15.38% 198.73%
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 $420.0K $290.0K $329.2K
YoY Change 44.81% -12.12% 4.15%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $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 $420.0K $290.0K $329.2K
Total Long-Term Liabilities $0.00 $0.00 $0.00
Total Liabilities $420.0K $290.0K $329.2K
YoY Change 44.81% -12.12% 4.15%
SHAREHOLDERS EQUITY
Retained Earnings
YoY Change
Common Stock $89.24K $62.22K
YoY Change 6.67%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $18.18M $4.780M $2.015M
YoY Change
Total Liabilities & Shareholders Equity $18.60M $5.080M $2.344M
YoY Change 844.04% 117.09% -27.46%

Cashflow Statement

Concept 2014 Q1 2013 2012 Q4
OPERATING ACTIVITIES
Net Income -$504.9K -$3.266M -$430.0K
YoY Change -23.04% 26.47% -46.25%
Depreciation, Depletion And Amortization $0.00 $0.00 $40.00K
YoY Change -100.0% -20.0%
Cash From Operating Activities -$544.4K -$2.313M -$420.0K
YoY Change -1.19% 16.04% 0.0%
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% -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $13.81M $5.331M
YoY Change 4418.79% 233.14%
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $13.81M $5.331M 630.0K
YoY Change 4418.79% 233.14% 26.0%
NET CHANGE
Cash From Operating Activities -$544.4K -$2.313M -420.0K
Cash From Investing Activities $0.00 $0.00 0.000
Cash From Financing Activities $13.81M $5.331M 630.0K
Net Change In Cash $13.27M $3.018M 210.0K
YoY Change -5508.01% -821.6% -800.0%
FREE CASH FLOW
Cash From Operating Activities -$544.4K -$2.313M -$420.0K
Capital Expenditures $0.00 $0.00 $0.00
Free Cash Flow -$544.4K -$2.313M -$420.0K
YoY Change -1.19% 16.04% 35.48%

Facts In Submission

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CY2013 us-gaap Nature Of Operations
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<div style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif "> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt"></div> <table style="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><b>1.</b></div> </td> <td> <div><b>Organization and Business</b></div> </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" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">Bio-Path Holdings, Inc. (&#8220;Bio-Path&#8221; or the &#8220;Company&#8221;) 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 (&#8220;MD Anderson&#8221;) 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&#8217;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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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&#8217;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, 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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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 &#8220;FDA&#8221;) that its application for Investigational New Drug (&#8220;IND&#8221;) 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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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 are now being tested using a new assay developed by the Company to measure down-regulation of the target protein, the critical scientific data needed to 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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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 requested the FDA to allow higher dosing in patients. The Principal Investigator for the clinical trial, in consultation with Bio-Path&#8217;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 of 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> and currently has two (2) evaluable patients. The Company is currently awaiting drug resupply to complete Cohort 6.</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">An important outcome for the Phase I clinical trial is the ability to assess for the first time the performance of the Company&#8217;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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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. Subsequently, in the fall of 2013 the Principal Investigator prepared an abstract of updated information on the results of the clinical trial though Cohort 5, which was accepted for presentation at the American Society of Hematology annual meeting in December of 2013. Highlights from the presentation prepared by Dr. Cortes for the meeting included:</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;TEXT-INDENT: 0.5in; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify"><i>Data from the Phase I clinical trial</i></div> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Among 18 evaluable patients, nine experienced at least a 50 percent reduction in peripheral or bone marrow blasts from baseline.</div> </td> </tr> </table> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Five patients demonstrated transient improvement and/or stable disease, three of whom received a total of five cycles each.</div> </td> </tr> </table> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Two patients, in addition to achieving marked blast percentage declines, also experienced transient improvement in leukemia cutis lesions.</div> </td> </tr> </table> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px 0pt 0.5in; FONT: 10pt Times New Roman, Times, Serif"> </div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px 0pt 0.5in; FONT: 10pt Times New Roman, Times, Serif"> &#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px 0pt 0.5in; FONT: 10pt Times New Roman, Times, Serif"> <i>Disease Stabilization in MDS and AML</i></div> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Two patients with MDS, a 53-year old male and a 72-year old female, both achieved disease stabilization and continued therapy for five cycles before disease progression.</div> </td> </tr> </table> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>A 54-year old HIV positive male with AML achieved stable disease and marked reduction in peripheral blasts, continuing therapy for five cycles before disease progression.</div> </td> </tr> </table> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px 0pt 0.5in; FONT: 10pt Times New Roman, Times, Serif"> &#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px 0pt 0.5in; FONT: 10pt Times New Roman, Times, Serif"> <i>Experience in CML-Blast Phase</i></div> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Patient with myeloid blast crisis of CML</div> </td> </tr> </table> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Prior therapies consist of: imatinib, dastinib, nilotinib, DCC-2036, Cytarabine + Fludarabine + Dasatinib + Gemtuzumab, PHA-739358, Clofarabine + Dasatinib</div> </td> </tr> </table> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Upon start of BP-100-1.01 patient showed a significant reduction in blasts from 81 percent to 5 percent but due to leptomeningeal disease progression discontinued therapy before full cycle.</div> </td> </tr> </table> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px 0pt 0.5in; FONT: 10pt Times New Roman, Times, Serif"> <i>&#160;</i></div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px 0pt 0.5in; FONT: 10pt Times New Roman, Times, Serif"> <i>Inhibition of Target Grb-2 Protein</i></div> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>Grb-2 levels were compared to baseline prior to treatment.</div> </td> </tr> </table> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>On day 15, BP-100-1.01 decreased Grb-2 in five of eight samples tested (average reduction 55 percent)</div> </td> </tr> </table> <table style="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: 1in"></td> <td style="WIDTH: 0.25in"> <div>-</div> </td> <td> <div>End of treatment day15, BP-100-1.01 decreased Grb-2 levels in eight out of nine patients (average reduction 45 percent).</div> </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" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">Being platform technology, a successful demonstration of the delivery technology in this study will allow the Company to begin expanding Bio-Path&#8217;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 and has already identified one new candidate.</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">As noted previously, the Company has completed two of the three evaluable patients required to close Cohort 6. Once Cohort 6 is completed the Company and the Principal Investigator will determine whether the optimal biological dose has been reached, which would allow the Phase I trial to be ended. Since there has been no toxicity to date in the trial and none is expected even at a higher dose in a potential seventh cohort, the trade-off is ending the clinical trial sooner after Cohort 6 or waiting to complete a seventh cohort with a higher dose and potentially even better anti-leukemia benefits in the patient. Also previously noted, the Company is waiting for the arrival of the next drug batch, expected to be mid-second quarter of 2014. This has been slowed by the drug substance manufacturer&#8217;s backlog, which was lengthened somewhat after being acquired in the summer of 2013. In addition, plans and evaluation of manufacturing scale-up of the drug substance batch size continued. Scale-up of manufacturing batch size produced divergence from desired drug substance product parameters, with some product in the fourth quarter of 2013 not being acceptable for use. The most recent manufacturing scale-up drug substance batch appears to have corrected this with excellent product performance testing. Scale-up of manufacturing output of drug substance product and final drug product is critical to meeting the anticipated potential for high volume requirements of Bio-Path&#8217;s drug products for patients in multiple diseases. The larger size drug substance and final product batch sizes will also substantially drive down manufacturing cost per drug unit. The recent success on the part of the Company in raising capital should also improve drug supply by providing the financial resources that will enable the Company to commit to multiple drug batches beyond those required to satisfy near-term requirements.</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">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;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">&#160;</div> <div style="CLEAR:both; FONT-FAMILY:Times New Roman;FONT-SIZE: 10pt;MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif" align="justify">At the end of January 2012, the Company&#8217;s Board of Directors held a strategic planning session. Among several topics was a discussion of Company&#8217;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. 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CY2013 dei Entity Registrant Name
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BIO-PATH HOLDINGS INC
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ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsWeightedAverageVolatilityRate
1.89 pure
CY2013Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Weighted Average Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsWeightedAverageVolatilityRate
2.45 pure
CY2013 us-gaap Legal Fees
LegalFees
8343 USD
CY2013 bpth Firm Owes Facility Expenses
FirmOwesFacilityExpenses
6880 USD
CY2013Q4 bpth Authorised Capital To Be Raised
AuthorisedCapitalToBeRaised
100000000 USD
CY2014Q1 us-gaap Proceeds From Issuance Initial Public Offering
ProceedsFromIssuanceInitialPublicOffering
13750000 USD
CY2007Q2 us-gaap Stockholders Equity
StockholdersEquity
USD
CY2008Q2 us-gaap Stockholders Equity Other
StockholdersEquityOther
0 USD

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0001144204-14-019417-index-headers.html Edgar Link pending
0001144204-14-019417-index.html Edgar Link pending
0001144204-14-019417.txt Edgar Link pending
0001144204-14-019417-xbrl.zip Edgar Link pending
bpth-20131231.xml Edgar Link completed
bpth-20131231.xsd Edgar Link pending
bpth-20131231_cal.xml Edgar Link unprocessable
bpth-20131231_def.xml Edgar Link unprocessable
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bpth-20131231_pre.xml Edgar Link unprocessable
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