2012 Q2 Form 10-Q Financial Statement

#000114420412029702 Filed on May 15, 2012

View on sec.gov

Income Statement

Concept 2012 Q2 2012 Q1 2011 Q1
Revenue $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $250.0K $230.0K $350.0K
YoY Change -21.88% -34.29% 29.63%
% of Gross Profit
Research & Development $190.0K $240.0K $240.0K
YoY Change 35.71% 0.0% 9.09%
% of Gross Profit
Depreciation & Amortization $50.00K $50.00K $50.00K
YoY Change 0.0% 0.0% 0.0%
% of Gross Profit
Operating Expenses $787.8K $522.6K $592.7K
YoY Change 69.87% -11.83% 20.97%
Operating Profit -$787.8K -$522.6K -$592.7K
YoY Change 69.87% -11.83%
Interest Expense $0.00 $0.00 $0.00
YoY Change
% of Operating Profit
Other Income/Expense, Net -$56.00 $400.00 $11.00
YoY Change -105.49% 3536.36%
Pretax Income -$790.0K -$522.2K -$592.7K
YoY Change 71.74% -11.89% 20.96%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$787.8K -$522.2K -$592.7K
YoY Change 70.25% -11.89% 20.96%
Net Earnings / Revenue
Basic Earnings Per Share
Diluted Earnings Per Share -$2.724M -$1.793M -$2.360M
COMMON SHARES
Basic Shares Outstanding 58.87M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2012 Q2 2012 Q1 2011 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $160.0K $580.0K $770.0K
YoY Change -86.89% -24.68% 71.11%
Cash & Equivalents
Short-Term Investments
Other Short-Term Assets $46.49K $56.33K $50.00K
YoY Change -7.02% 12.66% -93.24%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $504.4K $654.2K $820.0K
YoY Change -60.28% -20.23% -31.67%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles $1.661M $2.054M
YoY Change
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $1.661M $2.054M $2.440M
YoY Change -30.51% -15.81% 1.67%
TOTAL ASSETS
Total Short-Term Assets $504.4K $654.2K $820.0K
Total Long-Term Assets $1.661M $2.054M $2.440M
Total Assets $2.165M $2.708M $3.260M
YoY Change -40.84% -16.92% -9.44%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $31.15K $58.45K $30.00K
YoY Change 55.74% 94.82%
Accrued Expenses $86.59K $70.91K $160.0K
YoY Change -56.71% -55.68% -52.94%
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 $243.0K $246.6K $190.0K
YoY Change 10.47% 29.79% -44.12%
LONG-TERM LIABILITIES
Long-Term Debt $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 $243.0K $246.6K $190.0K
Total Long-Term Liabilities $0.00 $0.00 $0.00
Total Liabilities $243.0K $246.6K $190.0K
YoY Change 10.47% 29.79% -44.12%
SHAREHOLDERS EQUITY
Retained Earnings
YoY Change
Common Stock $58.87K $58.49K
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $1.922M $2.462M $3.070M
YoY Change
Total Liabilities & Shareholders Equity $2.165M $2.708M $3.260M
YoY Change -40.84% -16.92% -9.44%

Cashflow Statement

Concept 2012 Q2 2012 Q1 2011 Q1
OPERATING ACTIVITIES
Net Income -$787.8K -$522.2K -$592.7K
YoY Change 70.25% -11.89% 20.96%
Depreciation, Depletion And Amortization $50.00K $50.00K $50.00K
YoY Change 0.0% 0.0% 0.0%
Cash From Operating Activities -$630.0K -$400.2K -$125.0K
YoY Change 142.31% 220.23% -56.91%
INVESTING ACTIVITIES
Capital Expenditures $0.00 -$30.00K -$30.00K
YoY Change -100.0% 0.0% 0.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 -$25.00K -$32.43K
YoY Change -100.0% -22.92% 8.11%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $49.76K $684.6K
YoY Change -92.73% 242.3%
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 210.0K 49.76K 684.6K
YoY Change -70.83% -92.73% 242.3%
NET CHANGE
Cash From Operating Activities -630.0K -400.2K -125.0K
Cash From Investing Activities 0.000 -25.00K -32.43K
Cash From Financing Activities 210.0K 49.76K 684.6K
Net Change In Cash -420.0K -375.4K 527.2K
YoY Change -193.33% -171.21% -539.34%
FREE CASH FLOW
Cash From Operating Activities -$630.0K -$400.2K -$125.0K
Capital Expenditures $0.00 -$30.00K -$30.00K
Free Cash Flow -$630.0K -$370.2K -$94.97K
YoY Change 152.0% 289.79% -63.47%

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<div style="FONT: 10pt Times New Roman, Times, Serif"> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> <b>11. New Accounting Pronouncements</b></p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> From time to time, new accounting pronouncements are issued by FASB that are adopted by the Company as of the specified effective date.&#xA0;&#xA0;If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company&#x2019;s financial statements upon adoption.</p> </div>
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<div style="FONT: 10pt Times New Roman, Times, Serif"> <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: 0px"></td> <td style="WIDTH: 0.25in"><b>1.</b></td> <td><b>Organization and Business</b></td> </tr> </table> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> Bio-Path Holdings, Inc. (&#x201C;Bio-Path&#x201D; or the &#x201C;Company&#x201D;) 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 (&#x201C;MD Anderson&#x201D;) 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&#x2019;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.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="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&#x2019;s two lead liposomal antisense drug candidates treat acute myeloid leukemia, chronic myelogenous leukemia, acute lymphoblastic leukemia and follicular lymphoma, and if successful, could potentially be used in treating many other indications of cancer.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="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 (L-Grb-2 or BP-100-1.01) in a Phase I clinical trial. In March of 2010, Bio-Path received written notification from the U.S. Food and Drug Administration (the &#x201C;FDA&#x201D;) that its application for Investigational New Drug (&#x201C;IND&#x201D;) 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.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="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 trial will evaluate five doses of L-Grb-2 and patients will be enrolled in the study to achieve 18 to 30 evaluable patients. An evaluable patient is a patient who is able to complete the four-week treatment cycle. The clinical trial is being conducted at The University of Texas MD Anderson Cancer Center.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="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. Enrollment continued in the Phase I clinical trial through March 31, 2012.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> At the end of July 2011, the Company completed requirements for treating patients in the first cohort. The Company, its medical advisors and the Principal Investigator agreed that the data from the first cohort demonstrated that Liposomal Grb-2 was safe enough to proceed to the next cohort of the trial, which treated patients in the trial with a dose that was double the dose used in the first cohort. As a result of this review, the first cohort was closed and the second cohort was opened for recruiting patients into the clinical trial. In January of 2012, the Company completed requirements for treating patients in the second cohort. The Company, its medical advisors and the Principal Investigator agreed that the data from the second cohort demonstrated that Liposomal Grb-2 was safe enough to proceed to the third cohort of the trial, which is treating patients with a dose of 20 mg/m<sup>2</sup>, which is double the dose used in the second cohort. At the end of April, 2012, there were three evaluable patients in Cohort 3. As a result, a meeting of the Company&#x2019;s medical advisory board was being scheduled to close the cohort and proceed to Cohort 4. Significantly, in the third cohort, all three patients completed the treatment cycle and were evaluable and, because of apparent stabilization from treatment with Bio-Path drug candidate Liposomal Grb-2, had received extended treatment cycles or were on hold for additional treatments pending increased supply of drug.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The Principal Investigator for the Phase I clinical trial, Dr. Jorge Cortes, is a leading expert in the treatment of CML, AML 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 Hematology Society annual meeting in December. Results from the second cohort also demonstrated potential anti-leukemia benefits in treated patients.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> The Company expects that the patient testing requirements of the Phase I clinical trial will be completed during 2012. Since, at the Principal Investigator&#x2019;s recommendation, some patients who are benefiting from the treatment are being placed on continuing therapy beyond the requirements of the clinical trial, additional expenses may be incurred as the Company is required to supply drug at no charge for the continuing treatment. Based on the experience treating patients in Cohort 3, when all three patients benefited from treatment with Liposomal Grb-2 and were apparently stabilized, the assumption for drug requirements for Cohort 4 and beyond have increased significantly. Specifically, the assumption now is that all patients will benefit from treatment with the drug candidate Liposomal Grb-2 and be eligible to receive up to six months of treatments. In this regard, the Company is in the process of increasing the capacity of its drug supply chain, adding new suppliers for the Grb-2 drug substance and for the final drug product. Substantially increased supplies of the drug candidate Liposomal Grb-2 should be available in June of 2012. Additional costs to completion of the Phase I clinical trial are estimated to range from $500,000 to $650,000. Bio-Path believes it has sufficient resources and access to additional resources to meet its obligations in this regard.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="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&#x2019;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.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="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 immediately begin expanding Bio-Path&#x2019;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.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> At the end of January 2012, the Company&#x2019;s Board of Directors held a strategic planning session. Among several topics was a discussion of Company&#x2019;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. The Company has 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 $345,000 at the end of the fiscal year ending December 31, 2011 to reduce the carrying value of the siRNA license by fifty percent (50%). This amount represents one half of the value of the common stock given to MD Anderson when the original siRNA license was finalized.</p> <p style="TEXT-ALIGN: justify; TEXT-INDENT: 0.5in; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="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&#x2019;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 BP-100-1.01.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> As of March 31, 2012, Bio-Path had $576,823 in cash on hand. During the first quarter, 2012 the Company raised $50,000 through the sale of shares of its common stock to Lincoln Park Capital. The Company initiated a private placement at the beginning of the second quarter of 2012 to raise up to $2 million through the sale of shares of common stock to accredited investors. 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&#x2019;s technology in human patients.</p> <p style="TEXT-ALIGN: justify; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="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.</p> </div>
CY2012Q1 us-gaap Payments To Acquire Intangible Assets
PaymentsToAcquireIntangibleAssets
25000
CY2012Q1 us-gaap Operating Income Loss
OperatingIncomeLoss
-522627
CY2012Q1 us-gaap Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
49760
CY2012Q1 us-gaap Cash Period Increase Decrease
CashPeriodIncreaseDecrease
-375429
CY2012Q1 us-gaap Increase Decrease In Inventories
IncreaseDecreaseInInventories
-132000
CY2012Q1 us-gaap Operating Expenses
OperatingExpenses
522627
CY2012Q1 us-gaap General And Administrative Expense
GeneralAndAdministrativeExpense
231314
CY2012Q1 us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
49760
CY2012Q1 us-gaap Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
-0.01
CY2012Q1 bpth Weighted Average Number Basic Diluted Shares Outstanding
WeightedAverageNumberBasicDilutedSharesOutstanding
58381419 shares

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