0001144204-11-050273.txt : 20110829 0001144204-11-050273.hdr.sgml : 20110829 20110829142651 ACCESSION NUMBER: 0001144204-11-050273 CONFORMED SUBMISSION TYPE: 10-Q/A PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20110630 FILED AS OF DATE: 20110829 DATE AS OF CHANGE: 20110829 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIO-PATH HOLDINGS INC CENTRAL INDEX KEY: 0001133818 STANDARD INDUSTRIAL CLASSIFICATION: RETAIL-MISCELLANEOUS SHOPPING GOODS STORES [5940] IRS NUMBER: 870652870 STATE OF INCORPORATION: UT FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q/A SEC ACT: 1934 Act SEC FILE NUMBER: 000-53404 FILM NUMBER: 111062476 BUSINESS ADDRESS: STREET 1: 3293 HARRISON BOULEVARD STE 230 CITY: OGDEN STATE: UT ZIP: 84403 BUSINESS PHONE: 8013995500 MAIL ADDRESS: STREET 1: 3293 HARRISON BOULEVARD STE 230 CITY: OGDEN STATE: UT ZIP: 84403 FORMER COMPANY: FORMER CONFORMED NAME: OGDEN GOLF CO CORP DATE OF NAME CHANGE: 20010205 10-Q/A 1 v232666_10qa.htm 10-Q/A Unassociated Document
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q/A
(Amendment No. 1)
 
(Mark One)
 
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended June 30, 2011
 
Or
 
¨  TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from ________________________
 
Commission file number: 000-53404
 
Bio-Path Holdings, Inc.
(Exact name of registrant as specified in its charter)
 
Utah
 
87-0652870
(State or other jurisdiction of
 
(I.R.S. employer
incorporation or organization
 
identification No.)
 
2626 South Loop, Suite 180, Houston, TX 77054
(Address of principal executive offices)
 
Registrant's telephone no., including area code: (801) 580-2326
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes x    No ¨
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes x    No ¨
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer  ¨
Accelerated filer  ¨
Non-accelerated filer    ¨ (Do not check if a smaller reporting company)
Smaller reporting company x
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ x No
 
At  August 12, 2011, the Company had 56,146,296 outstanding shares of common stock, no par value.

 
 

 

EXPLANATORY NOTE
 
The purpose of this Amendment No. 1 to our Quarterly Report on Form 10-Q for the period ended June 30, 2011 (“Form 10-Q”), as filed with the Securities and Exchange Commission on August 15, 2011, is to furnish Exhibit 101 – Interactive Data File in accordance with Rule 405 of Regulation S-T.
 
No other changes have been made to the Form 10-Q other than the furnishing of the exhibit described above. This Amendment No. 1 to the Form 10-Q speaks as of the original filing date of the Form 10-Q, and does not reflect subsequent events occurring after the original filing date of the Form 10-Q or modify or update in any way disclosures made in the Form 10-Q.
 
 
 

 

ITEM 6.  EXHIBITS
 
Exhibit No.
 
Description of Exhibit
3.1
 
Restated Articles of Incorporation (incorporated by reference to exhibit 3.2 to the registrant’s current report on Form 8-A filed on September 10, 2008).
3.2
 
Bylaws (incorporated by reference to exhibit 3.2 to the registrant’s current report on Form 8-A filed on September 10, 2008).
3.3
 
Articles of Merger relating to the merger of Biopath Acquisition Corp. with and into Bio-Path, Inc. (incorporated by reference to exhibit 3.2 to the registrant’s current report on Form 8-K filed on February 19, 2008).
3.4
 
Amendment No. 1 to Bylaws (incorporated by reference to exhibit 3.2 to the registrant’s current report on Form 8-K filed on June 21, 2010)
4.1
 
Specimen Stock certificate (incorporated by reference to exhibit 3.2 to the registrant’s current report on Form 8-A filed on September 10, 2008)
31*
 
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
32*
 
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
101**  
Interactive data files pursuant to Rule 405 of Regulation S-T: (i) the Consolidated Balance Sheets as of June 30, 2011 and December 31, 2010, (ii) the Consolidated Statements of Operations for the three and six months ended June 30, 2011and 2010 and from inception (May 10, 2007) through June 30, 2011, (iii) the Consolidated Statements of Cash Flows for the six months ended June 30, 2011 and 2010 and from inception (May 10, 2007) through June 30, 2011 and (iv) the notes to Unaudited Consolidated Financial Statements Ending June 30, 2011.
 
*
These exhibits were previously included in the registrants Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, which was filed on August 15, 2011.
 
**
Filed herewith.

 
 

 

SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
Dated: August 29, 2011
BIO-PATH HOLDINGS, INC.
   
 
By
/s/ Peter H. Nielsen,
   
Chief Executive Officer, President/Principal Executive
   
Officer, Chief Financial Officer, Principal Financial Officer

 
 

 
EX-101.INS 2 bpth-20110630.xml XBRL INSTANCE DOCUMENT 56146296 220723 146526 3663948 56146 56146296 10000000 1266806 684226 8240877 0 50000 0.001 11627956 3663948 0 3443225 56146296 0.001 200000000 220723 3081368 45147 24197 2397142 1221659 602424 567249 246758 84141 3108504 49401 278600 49400605 10000000 644437 579754 7185402 0 244479 74217 0.001 9719147 88400 3108504 0 2861746 49400605 0.001 200000000 246758 3043821 72993 88400 2464067 238565 928667 45147 -727201 74705 -4272959 300000 3171 420000 2808116 220723 -8240877 316013 684226 15000 727201 -8556890 244479 5801819 435000 1221659 8556890 5523361 6221819 -0.20 41525482 334546 564266 2773570 2354167 136950 2896579 202580 Q2 BPTH BIO-PATH HOLDINGS INC false Smaller Reporting Company 2011 10-Q 2011-06-30 0001133818 --12-31 <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">8.&#xA0;</font> Stockholders&#x2019; Equity</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-STYLE: italic"> Issuance of Common Stock</font> &#x2013; In May and June of 2007, the Company issued 6,505,994 shares of common stock for $6,506 in cash to founders of the Company.&#xA0; In August of 2007, the Company issued 3,975,000 shares of common stock for $993,750 in cash to investors in the Company pursuant to a private placement memorandum.&#xA0; In August of 2007 the Company issued an additional 1,333,334 shares of common stock for $1,000,000 in cash to investors in the Company pursuant to a second round of financing.&#xA0; The Company issued 530,833 in common stock to the Placement Agent as commission for the shares of common stock sold to investors.&#xA0; In November of 2007, the Company issued 3,138,889 shares in common stock to MD Anderson as partial consideration for its two technology licenses from MD Anderson.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In February of 2008, the Company completed a reverse merger with Ogden Golf Co. Corporation and issued 38,023,578 shares of common stock of the public company Bio-Path Holdings (formerly Ogden Golf Co. Corporation) in exchange for pre-merger common stock of Bio-Path, Inc.&#xA0; In addition, shareholders of Ogden Golf Co. Corporation retained 3,600,000 shares of common stock of Bio-Path Holdings.&#xA0; In February of 2008 Bio-Path issued 80,000 shares of common stock to strategic consultants pursuant to executed agreements and the fair value was expensed upfront as common stock for services.&#xA0; In April of 2008, the Company issued 200,000 shares of common stock to a firm in connection with introducing Bio-Path, Inc. to its merger partner Ogden Golf Co. Corporation.&#xA0; The fair value of this stock issuance was expensed upfront as common stock for services valued at $180,000.&#xA0; In April of 2008, the Company recorded an additional 24 shares for rounding in accordance with FINRA rules.&#xA0; In December of 2008, the Company issued 100,000 shares of common stock to an investor relations firm for services.&#xA0; The fair value of this stock issuance was expensed upfront as common stock for services valued at $40,000.&#xA0; There were no issuances of shares during the first quarter of 2009.&#xA0; In June of 2009, the Company issued 660,000 shares of common stock and warrants to purchase an additional 660,000 shares of common stock for $165,000 in cash to investors in the Company pursuant to a private placement memorandum.&#xA0; The warrants must be exercised within two years from the date of issuance. The exercise price of the warrants is $1.50 a share.&#xA0; In connection with this private placement, the Company issued 66,000 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.&#xA0; There were no issuances of shares during the fourth quarter of 2009.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In November and December of 2009, the Company sold shares of common stock and warrants to purchase shares of common stock for $675,000 in cash to investors pursuant to a private placement memorandum.&#xA0; These shares were not issued by the December 31, 2009 year end.&#xA0; In January 2010, the Company issued these investors 2,700,000 shares of common stock and warrants to purchase an additional 2,700,000 shares of common stock.&#xA0; The warrants must be exercised within two years from the date of issuance. The exercise price of the warrants is $1.50 a share.&#xA0; In January 2010, the Company also sold an additional 900,000 shares of common stock and warrants to purchase an additional 900,000 shares of common stock for $225,000 in cash to investors in the Company pursuant to a private placement memorandum.&#xA0; The warrants must be exercised within two years from the date of issuance and the exercise price is $1.50 a share.&#xA0; In connection with these private placement sales of equity, the Company issued 360,000 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In May of 2010, the Company issued 780,000 shares of common stock and warrants to purchase an additional 780,000 shares of common stock for $273,000 in cash to investors in the Company pursuant to a private placement memorandum.&#xA0; The warrants must be exercised within two years from the date of issuance. The exercise price of the warrants is $1.50 a share.&#xA0; In connection with this private placement, the Company issued 78,000 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In June of 2010, the Company signed an equity purchase agreement for up to $7 million with Lincoln Park Capital Fund, LLC (&#x201C;LPC&#x201D;), a Chicago-based institutional investor.&#xA0; Under the terms of the equity purchase agreement, the Company has the right to sell shares of its common stock to LPC from time to time over a 24-month period in amounts between $50,000 and $1,000,000 up to an aggregate amount of $7 million depending upon certain conditions set forth in the purchase agreement including that a registration statement related to the transaction has been declared effective by the U.S. Securities and Exchange Commission (&#x201C;SEC&#x201D;).&#xA0; As a result, a registration statement was filed and later declared effective by the SEC on July 12, 2010.&#xA0; Upon signing the agreement, the Company received $200,000 from LPC as an initial purchase in exchange for 571,429 shares (&#x201C;Initial Purchase Shares&#x201D;) of the Company&#x2019;s common stock and warrants to purchase 571,429 shares of the Company&#x2019;s common stock at an exercise price of $1.50 per share.&#xA0; Subsequent purchases of the Company&#x2019;s common stock by Lincoln Park under the agreement do not include warrants.&#xA0; In connection with the signing of the LPC financing agreement, the Company issued LPC 12,000 shares of the Company&#x2019;s common stock for its due diligence efforts and 566,801 shares of the Company&#x2019;s common stock as a commitment fee for the balance of the $7 million equity purchase commitment. <!--EFPlaceholder--></font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In July of 2010, the Company received $150,000 from LPC in exchange for 375,000 shares of the Company&#x2019;s common stock.&#xA0; LPC was also issued 6,251 shares of the Company&#x2019;s common stock as a commitment fee in connection with the purchase of the 375,000 shares of common stock.&#xA0; No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In September of 2010, the Company received $50,000 from LPC in exchange for 125,000 shares of the Company&#x2019;s common stock.&#xA0; LPC was also issued 2,084 shares of the Company&#x2019;s common stock as a commitment fee in connection with the purchase of the 125,000 shares of common stock.&#xA0; No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In October of 2010, the Company received $50,000 from LPC in exchange for 135,135 shares of the Company&#x2019;s common stock.&#xA0; LPC was also issued 2,084 shares of the Company&#x2019;s common stock as a commitment fee in connection with the purchase of the 135,135 shares of common stock.&#xA0; No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In November of 2010, the Company received $50,000 from LPC in exchange for 135,135 shares of the Company&#x2019;s common stock.&#xA0; LPC was also issued 2,084 shares of the Company&#x2019;s common stock as a commitment fee in connection with the purchase of the 135,135 shares of common stock.&#xA0; No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">From November 2010 through April of 2011 the Company sold shares of common stock for $1,794,205 in cash to investors pursuant to a private placement memorandum.&#xA0; In June of 2011, the Company issued 5,980,685 shares of common stock to these investors.&#xA0; In connection with this private placement, in June of 2011 the Company issued 598,069 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.&#xA0; No warrants to purchase additional shares of common stock of the Company were issued to these investors in connection with the sale of the common stock.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In June of 2011, the Company received $50,000 from LPC in exchange for 164,853 shares of the Company&#x2019;s common stock.&#xA0; LPC was also issued 2,084 shares of the Company&#x2019;s common stock as a commitment fee in connection with the purchase of the 164,853 shares of common stock.&#xA0; No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">As of June 30, 2011, there were 56,146,296 shares of common stock issued and outstanding.&#xA0; There are no preferred shares outstanding as of June 30, 2011.</font></div> </div> -27846 -37547 1302 <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">10.&#xA0;</font> Commitments and Contingencies</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-STYLE: italic"> Technology License &#x2013; Related Party -</font> The Company has negotiated exclusive licenses from the MD Anderson Cancer Center to develop drug delivery technology for antisense and siRNA drug products and to develop liposome tumor targeting technology.&#xA0; These licenses require, among other things, the Company to reimburse MD Anderson for ongoing patent expense.&#xA0; Accrued license payments totaling $50,000 are included in Current Liabilities as of June 30, 2011.&#xA0; As of June 30, 2011, the Company estimates reimbursable past patent expenses will total approximately $125,000 for the antisense license.&#xA0; The Company will be required to pay when invoiced the patent expenses at the rate of $25,000 per quarter.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-STYLE: italic"> Drug Supplier Project Plan</font> - In June of 2008, Bio-Path entered into a Project Plan agreement with a contract drug manufacturing supplier for delivery of drug product to support commencement of the Company&#x2019;s Phase I clinical trial of its first cancer drug product.&#xA0; The Company commenced this trial and was enrolling patients by the end of the second quarter 2010.&#xA0; Previously in 2008 and 2009, the Company paid $608,440 to this manufacturer and its drug substance raw material supplier.&#xA0; During the first quarter 2011, $88,400 previously carried on the balance sheet as of December 31, 2010 as prepaid drug product for testing was charged to R&amp;D expense after the manufacturer delivered the final lot of drug product under this contract to the Company.&#xA0; As of June 30, 2011 there were no further obligations under the drug supplier project plan with the contract manufacturer.</font></div> </div> -375647 271 240664 <div> 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&#x2019; equity in conformity with generally accepted accounting principals. 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.&#xA0; 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. as of and for the fiscal year ended December 31, 2010.&#xA0; The results of operations for the period ended June 30, 2011, are not necessarily indicative of the results for a full-year period. </div> -26035 <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">11.&#xA0;</font> Subsequent Events</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In July of 2011, the Company submitted a grant to the U.S. Government&#x2019;s National Institute of Health (NIH) for a grant to fund development of Liposomal Grb-2 for treatment of breast cancer.&#xA0; The initial phase of the grant funds preclinical work in animal tumor models.&#xA0; However, if work from the grant is successful there is the potential for follow-on funding to pay for a Phase I clinical trial treating late-stage breast cancer patients with Liposomal Grb-2.&#xA0; The grant request is for approximately $140,000 for the initial phase.&#xA0; In addition to paying for direct out-of-pocket costs of the preclinical studies the initial grant submitted has components for overhead recovery and a profit fee.<!--EFPlaceholder--></font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In late July of 2011, the Company&#x2019;s medical advisory team conferred with the Principal Investigator of Bio-Path Phase I clinical trial to review safety data from the first cohort of the trial.&#xA0; Based on this review, the Company and Principal Investigator concurred to proceed to the second cohort in the trial, which involves treating the patients with a dose that is double the dose used in the first cohort.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In July of 2011, the Company announced that it had relocated its corporate office to Houston, Texas.&#xA0; This location is located on the south side of the Texas Medical Center near the MD Anderson Cancer Center.</font></div> </div> <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">12.&#xA0;</font> New Accounting Pronouncements</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">From time to time, new accounting pronouncements are issued by FASB that are adopted by the Company as of the specified effective date.&#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.</font></div> </div> -1055474 1031 -244479 104473 <div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">1.&#xA0;</font> Organization and Business</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Bio-Path Holdings, Inc. (together with its subsidiary, &#x201C;Bio-Path&#x201D; or the &#x201C;Company&#x201D; or &#x201C;we,&#x201D; &#x201C;us&#x201D; or &#x201C;our&#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.&#xA0; The Company was founded with technology from The University of Texas, MD Anderson Cancer Center (&#x201C;MD Anderson&#x201D;) dedicated to developing novel cancer drugs under an exclusive license arrangement.&#xA0; The Company has drug delivery platform technology with composition of matter intellectual property that enables systemic delivery of antisense and small interfering RNA (&#x201C;siRNA&#x201D;).&#xA0; Bio-Path has also licensed 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 and siRNA drugs under development as well as future liposome-based delivery technology drugs.&#xA0; 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 a strong pipeline of promising drug candidates in the future.&#xA0; Bio-Path also expects to broaden its technology to include cancer drugs other than antisense and siRNA, including drug candidates licensed from institutions other than MD Anderson.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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.&#xA0; 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.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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.&#xA0; 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.&#xA0; 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 of 2010.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The Phase I clinical trial is a dose-escalating study to determine the safety and tolerance of escalating doses of L-Grb-2.&#xA0; The study will also determine the optimal biologically active dose for further development.&#xA0; 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.&#xA0; The trial will evaluate five doses of L-Grb-2 and it is intended that a sufficient number of patients will be enrolled in the study to achieve 18 to 30 evaluable patients.&#xA0; An evaluable patient is a patient who is able to complete the four-week treatment cycle.&#xA0; The clinical trial is being conducted at MD Anderson.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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.&#xA0; 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.&#xA0; Enrollment continued in the Phase I clinical trial&#xA0; &#xA0;through the end of the second quarter of 2011, with fourteen patients having been enrolled into the study.&#xA0; At the low initial dose levels in the clinical trial, it initially took longer than expected for the Principal Investigator to recruit patients into the trial. <!--EFPlaceholder--></font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">At the end of July 2011, the sixth evaluable patient completed the full treatment cycle, which completed requirements for the first cohort.&#xA0; The Company, its medical advisors and the Principal Investigator agreed that the data demonstrated that Liposomal Grb-2 was safe enough to proceed to the next cohort of the trial, which will treat patients in the trial with a dose that is double the dose used in the first cohort.&#xA0; As a result of this review, the first cohort was closed and the second cohort was opened for recruiting patients into the clinical trial.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">It is important to note two patients that completed the full four week treatment cycle of the Phase I trial were placed on continuing treatment for additional cycles based on the Principal Investigator&#x2019;s assessment that treatment with the drug Liposomal Grb-2 was benefiting these patients.&#xA0; This was described as a remarkable and unexpected result based on the initial, low dose being given to patients in the first cohort.&#xA0; Bio-Path&#x2019;s FDA-approved protocol for the Phase I clinical trial provides that the Principal Investigator may continue treatment of a patient beyond the initial cycle if, in the Principal Investigator&#x2019;s opinion, the patient is exhibiting stable disease, or else, has improvement of his or her disease.&#xA0; In the circumstance where a patient is continuing treatment beyond the requirements of the Phase I trial, the Company is required to supply the drug at no charge for the continuing treatments but it is not required to incur additional hospital costs.&#xA0; Although it is too early to draw any scientific conclusions about any effect that the Company&#x2019;s drug candidate Liposomal-Grb-2 has on patients being treated in the trial, the effects of apparent stabilization in some patients is expected to help in recruiting new patients into the clinical trial.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The Principal Investigator for the Phase I clinical trial, Dr. Jorge Cortes, is a leading expert in the treatment of CML, AML and ALL.&#xA0; Because the results of the first cohort produced unexpected and clinically interesting results in some patients, the Principal Investigator is preparing an abstract of the results thereof to be submitted for review and potential inclusion at the American Hematology Society annual meeting in December.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The Company expects that an additional 12 months could be required to complete the Phase I clinical trial, or longer depending on patient enrollment and the incidence of non-evaluable patients.&#xA0; We are seeking an additional 13-16 evaluable patients to complete the trial.&#xA0; 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.&#xA0; Additional costs to completion of the Phase I clinical trial are estimated to range from $750,000 to $1.2 million.&#xA0; Bio-Path believes it has sufficient resources and access to additional resources if needed to meet its obligations in this regard.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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.&#xA0; 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.&#xA0; 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.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The Company was founded in May of 2007 as a Utah corporation.&#xA0; 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.&#xA0; 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.&#xA0; Bio-Path has become a publicly traded company (symbol OTCBB: BPTH) as a result of this merger.&#xA0; &#xA0;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.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">At the end of June 2011, Bio-Path had $1,221,659 in cash on hand.&#xA0; During the second quarter 2011, the Company sold in a private placement approximately $1.8 million of its common stock for cash.&#xA0; The amount of cash resources in Company accounts is expected to fund Bio-Path&#x2019;s operations well into the second half of 2011, when the Company could have preliminary data from its Phase I clinical trial to start early assessments of the utility of the drug and the delivery technology.&#xA0; The Company 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.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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.</font></div> </div> 37547 -1056505 1396288 983094 -88400 <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">5.&#xA0;</font> Accrued Expense</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">As of June 30, 2011, Current Liabilities included accrued expense of $146,526.&#xA0; R&amp;D expenses related to MD Anderson treating patients in the Phase I clinical trial comprised $50,000 of this amount and expenses for clinical trial monitors represented an additional $5,000.&#xA0; Accrued expenses for travel to suppliers, meetings and conferences totaled approximately $16,000. Expenses of being a public company of approximately $5,000 were accrued for auditors and attorney fees, plus business wire services.&#xA0; Management bonus pool accrual comprises $69,375 of accrued expense as of June 30, 2011.</font></div> </div> 1056505 <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">9.&#xA0;</font> Stock Options and Warrants</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-STYLE: italic"> Stock Options -</font> There were no stock option awards in 2010.&#xA0; Total stock option expense for the year 2010 totaled $477,356.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In February of 2011 the Company made a stock option grant for services to purchase in the aggregate 20,000 shares of the Company&#x2019;s common stock.&#xA0; Terms of the stock option grant require, among other things, that the individual continues to provide services over the vesting period of the option, which is four years from the date that the option was granted.&#xA0; The exercise price of the option is $0.53 a share, which was the closing price of the common stock at the date of grant.&#xA0; The stock option grant was not for current management and officers of the Company.&#xA0; The Company determined the fair value of the stock options granted using the Black Scholes model and expenses this value monthly based upon the vesting schedule of the stock option award.&#xA0; For purposes of determining fair value, the Company used an average annual volatility of one hundred sixty six percent (166%), which was calculated based on the closing price of the Company&#x2019;s stock over the preceding five years.&#xA0; The risk free rate of interest used in the model was taken from a table of the market rate of interest for U. S. Government Securities for the date of the stock option award and the effective term.&#xA0; &#xA0;The Company used the simplified method to determine the expected term of the options due to the lack of historical data.&#xA0; The total value of the stock option granted was determined using this methodology to be $10,260, which is being expensed over the four years following the date of grant based on the stock option vesting schedule.<!--EFPlaceholder--></font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Total stock option expense for the first quarter of 2011 totaled $119,981.&#xA0; Of this amount, $15,205 related to stock options for personnel involved in R&amp;D activities and $104,776 related to stock options for management involved in general and administrative functions.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In June of 2011 the Company made two stock option grants to purchase in the aggregate 125,000 shares of the Company&#x2019;s common stock for service as a director of the Company and for consulting services.&#xA0; &#xA0; Terms of the stock option grant require, among other things, that the individual continues to provide services over the vesting period of the option, which is one year from the date of grant for the director service stock option and four years from the date of grant for the consulting service stock option.&#xA0; The exercise price of the options is $0.33 a share, which was the closing price of the common stock at the date of grant.&#xA0; The stock option grants were not for current management and officers of the Company.&#xA0; The Company determined the fair value of the stock options granted using the Black Scholes model and expenses this value monthly based upon the vesting schedule of the stock option award.&#xA0; For purposes of determining fair value, the Company used an average annual volatility of one hundred sixty two percent (162%), which was calculated based on the closing price of the Company&#x2019;s stock over the preceding five years.&#xA0; The risk free rate of interest used in the model was taken from a table of the market rate of interest for U. S. Government Securities for the date of the stock option award and the effective term.&#xA0; The Company used the simplified method to determine the expected term of the options due to the lack of historical data.&#xA0; The total fair value of the stock option granted was determined using this methodology to be $39,600, which is being expensed following the date of grant based on the stock option vesting schedule.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Total stock option expense for the second quarter of 2011 totaled $120,684.&#xA0; Of this amount, $16,082 related to stock options for personnel involved in R&amp;D activities and $104,602 related to stock options for management involved in general and administrative functions and directors.</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-STYLE: italic"> Warrants -</font>&#xA0; There were no warrants for services granted in 2010 and there was no warrant expense for the year 2010.&#xA0; There were no warrants for services granted in the first or second quarters of 2011 and there was no warrant expense for the first or second quarters 2011.&#xA0; Warrants issued in connection with the sale of units of common stock were for cash value received and as such were not grants of compensation-based warrants.</font></div> </div> <div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">2.&#xA0;</font> Related Party</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Based on its stock ownership in the Company, MD Anderson meets the criteria to be deemed a related party of Bio-Path.&#xA0; In the second quarter ending June 30, 2011, MD Anderson received $25,000 in cash from the Company for patent expenses previously accrued and related to the Company&#x2019;s technology license, plus an additional $25,000 in expense was accrued for R&amp;D related clinical trial expense, <font style="FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal"> and $5,115 in cash for patent expense related to the Company's technology license.</font></font> As of June 30, 2011, the Company had accrued expenses due to the related party totaling $100,000, comprised of $50,000 in accrued license payments related to the Company&#x2019;s Technology License and $50,000 in accrued R&amp;D related expense for the clinical trial.&#xA0; See Note 6.</font></div> </div> 674812 1396288 -0.02 50524887 <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">4.&#xA0;</font> Grants Receivable</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">As of December 31, 2010, Current Assets included grants receivable of $244,479.&#xA0; This represents a grant award that Bio-Path received in October 2010 for its application to receive grant funding from the U.S. Government&#x2019;s Qualifying Therapeutic Discovery Project Program.&#xA0; The Company received these grant funds during the first week of February 2011.</font></div> </div> <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">7.&#xA0;</font> Additional Paid In Capital For Shares To Be Issued</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In November and December of 2010, the Company sold shares of common stock for $278,600 in cash to investors pursuant to a private placement memorandum.&#xA0; These shares were not issued by the December 31, 2010 year end.&#xA0; In February and March of 2011, the Company sold additional shares of common stock for $763,302 in cash to investors pursuant to a private placement memorandum.&#xA0; During the second quarter of 2011, the Company sold additional shares of common stock for $752,303 in cash pursuant to this private placement memorandum.&#xA0; At the end of the second quarter 2011, the Company closed this offering and issued 5,980,685 shares of common stock to investors.&#xA0; In connection with this private placement, the Company issued 598,069 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.</font></div> </div> <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">6.&#xA0;</font> Accrued License Payments &#x2013; Related Party</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Accrued license payments &#x2013; related party totaling $50,000 were included in Current Liabilities as of June 30, 2011.&#xA0; This amount represents patent expenses for the licensed technology from the MD Anderson Cancer Center.&#xA0; It is expected that the accrued license payments will be made to MD Anderson in 2011.</font></div> </div> <div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">3.&#xA0;</font> Prepaid Drug Product for Testing</font></div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#xA0;</div> <div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future R&amp;D activities are deferred and capitalized.&#xA0; Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed.&#xA0; The Company incurred installments to its contract drug manufacturing and raw material suppliers totaling $88,400 during 2010 pursuant to a Project Plan and Supply Agreement (see Note 11.) for the manufacture and delivery of the Company&#x2019;s lead drug product for testing in a Phase I clinical trial.&#xA0; This amount was carried on the Balance Sheet as of December 31, 2010 at cost as Prepaid Drug Product for Testing and was expensed when the drug product was received by the Company in 2011.&#xA0; As of June 30, 2011, the Company had supplies of drug product on hand for use in the clinical trial estimated to be sufficient for requirements through the summer of 2011.</font></div> </div> 31286 179421 209378 75000 306693 28267 -92189 1046 -415414 467 286656 147943 -917755 579 96009 92189 -918334 542778 35175 918334 566576 542778 -0.02 47087307 72352 117300 214304 351758 202580 1111 91 -462748 1020 -463768 463768 324574 -0.01 51649169 16082 104602 25000 114194 314 293 -426814 21 -426835 426835 296032 -0.01 47565012 36176 106534 130803 0001133818 bpth:AllOtherMember 2010-04-01 2010-06-30 0001133818 us-gaap:GeneralAndAdministrativeExpenseMember 2010-04-01 2010-06-30 0001133818 us-gaap:ResearchAndDevelopmentExpenseMember 2010-04-01 2010-06-30 0001133818 2010-04-01 2010-06-30 0001133818 bpth:AllOtherMember 2011-04-01 2011-06-30 0001133818 bpth:RelatedPartyTransactionsMember 2011-04-01 2011-06-30 0001133818 us-gaap:GeneralAndAdministrativeExpenseMember 2011-04-01 2011-06-30 0001133818 us-gaap:ResearchAndDevelopmentExpenseMember 2011-04-01 2011-06-30 0001133818 2011-04-01 2011-06-30 0001133818 bpth:LincolnParkCapitalFundLLCMember 2010-01-01 2010-06-30 0001133818 bpth:AllOtherMember 2010-01-01 2010-06-30 0001133818 us-gaap:GeneralAndAdministrativeExpenseMember 2010-01-01 2010-06-30 0001133818 us-gaap:PrivatePlacementMember 2010-01-01 2010-06-30 0001133818 us-gaap:ResearchAndDevelopmentExpenseMember 2010-01-01 2010-06-30 0001133818 2010-01-01 2010-06-30 0001133818 bpth:AllOtherMember 2011-01-01 2011-06-30 0001133818 bpth:RelatedPartyTransactionsMember 2011-01-01 2011-06-30 0001133818 us-gaap:GeneralAndAdministrativeExpenseMember 2011-01-01 2011-06-30 0001133818 us-gaap:PrivatePlacementMember 2011-01-01 2011-06-30 0001133818 us-gaap:ResearchAndDevelopmentExpenseMember 2011-01-01 2011-06-30 0001133818 2011-01-01 2011-06-30 0001133818 bpth:LincolnParkCapitalFundLLCMember 2007-05-10 2011-06-30 0001133818 bpth:AllOtherMember 2007-05-10 2011-06-30 0001133818 bpth:RelatedPartyTransactionsMember 2007-05-10 2011-06-30 0001133818 us-gaap:GeneralAndAdministrativeExpenseMember 2007-05-10 2011-06-30 0001133818 us-gaap:PrivatePlacementMember 2007-05-10 2011-06-30 0001133818 us-gaap:ResearchAndDevelopmentExpenseMember 2007-05-10 2011-06-30 0001133818 2007-05-10 2011-06-30 0001133818 2010-12-31 0001133818 2009-12-31 0001133818 2010-06-30 0001133818 2011-06-30 0001133818 2011-08-12 shares iso4217:USD iso4217:USD shares Represents 928,667 shares of common stock Research and development expense includes stock option expenses of $16,082 and $36,176 for the quarters ending 6/30/2011 and 6/30/2010, respectively; $31,286 and $72,352 for the six month periods ending 6/30/2011 and 6/30/2010, respectively; and $334,546 for the period from inception through 6/30/2011 General & administrative expense includes stock for services, stock option and warrant expenses of $104,602 and 106,534 for the quarters ending 6/30/2011 and 6/30/2010, respectively; $209,378 and $214,304 for the six month periods ending 6/30/2011 and 6/30/2010, respectively; and $2,773,570 for the period from inception through 6/30/2011 EX-101.SCH 3 bpth-20110630.xsd XBRL TAXONOMY EXTENSION SCHEMA 101 - Document - Document and Entity Information link:calculationLink link:presentationLink link:definitionLink 103 - Statement - CONSOLIDATED BALANCE SHEETS link:calculationLink link:presentationLink link:definitionLink 104 - Statement - CONSOLIDATED BALANCE SHEETS (Parenthetical) link:calculationLink link:presentationLink link:definitionLink 105 - Statement - CONSOLIDATED STATEMENTS OF OPERATIONS link:calculationLink link:presentationLink link:definitionLink 106 - Statement - CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) link:calculationLink link:presentationLink link:definitionLink 107 - Statement - CONSOLIDATED STATEMENTS OF CASH FLOWS link:calculationLink link:presentationLink link:definitionLink 108 - Disclosure - Basis of Presentation link:calculationLink link:presentationLink link:definitionLink 109 - Disclosure - Organization and Business link:calculationLink link:presentationLink link:definitionLink 110 - Disclosure - Related Party link:calculationLink link:presentationLink link:definitionLink 111 - Disclosure - Prepaid Drug Product for Testing link:calculationLink link:presentationLink link:definitionLink 112 - Disclosure - Grants Receivable link:calculationLink link:presentationLink link:definitionLink 113 - Disclosure - Accrued Expense link:calculationLink link:presentationLink link:definitionLink 114 - Disclosure - Accrued License Payments - Related Party link:calculationLink link:presentationLink link:definitionLink 115 - Disclosure - Additional Paid In Capital For Shares To Be Issued link:calculationLink link:presentationLink link:definitionLink 116 - Disclosure - Stockholders' Equity link:calculationLink link:presentationLink link:definitionLink 117 - Disclosure - Stock Options and Warrants link:calculationLink link:presentationLink link:definitionLink 118 - Disclosure - Commitments and Contingencies link:calculationLink link:presentationLink link:definitionLink 119 - Disclosure - Subsequent Events link:calculationLink link:presentationLink link:definitionLink 120 - Disclosure - New Accounting Pronouncements link:calculationLink link:presentationLink link:definitionLink EX-101.CAL 4 bpth-20110630_cal.xml XBRL TAXONOMY EXTENSION CALCULATION LINKBASE EX-101.DEF 5 bpth-20110630_def.xml XBRL TAXONOMY EXTENSION DEFINITION LINKBASE EX-101.LAB 6 bpth-20110630_lab.xml XBRL TAXONOMY EXTENSION LABEL LINKBASE EX-101.PRE 7 bpth-20110630_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE XML 8 R3.htm IDEA: XBRL DOCUMENT  v2.3.0.11
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)
Jun. 30, 2011
Dec. 31, 2010
Preferred Stock, par value $ 0.001 $ 0.001
Preferred Stock, shares authorized 10,000,000 10,000,000
Preferred Stock, shares issued 0 0
Preferred Stock, shares outstanding 0 0
Common Stock, par value $ 0.001 $ 0.001
Common Stock, shares authorized 200,000,000 200,000,000
Common Stock, shares issued 56,146,296 49,400,605
Common Stock, shares outstanding 56,146,296 49,400,605
Additional paid in capital for shares to be issued, shares of common stock   928,667
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CONSOLIDATED STATEMENTS OF OPERATIONS (USD $)
3 Months Ended 6 Months Ended 50 Months Ended
Jun. 30, 2011
Jun. 30, 2010
Jun. 30, 2011
Jun. 30, 2010
Jun. 30, 2011
Revenue          
Operating expense          
General & administrative 324,574 [1] 296,032 [1] 674,812 [1] 566,576 [1] 5,523,361 [1]
Total operating expense 463,768 426,835 1,056,505 918,334 8,556,890
Net operating loss (463,768) (426,835) (1,056,505) (918,334) (8,556,890)
Other income          
Interest income 1,111 314 1,302 1,046 74,705
Other income         244,479
Other expense (91) (293) (271) (467) (3,171)
Total Other Income 1,020 21 1,031 579 316,013
Net Loss (462,748) (426,814) (1,055,474) (917,755) (8,240,877)
Loss per share          
Net loss per share, basic and diluted $ (0.01) $ (0.01) $ (0.02) $ (0.02) $ (0.20)
Basic and diluted weighted average number of common shares outstanding 51,649,169 47,565,012 50,524,887 47,087,307 41,525,482
All Other
         
Operating expense          
Research and development 114,194 [2] 130,803 [2] 306,693 [2] 351,758 [2] 2,896,579 [2]
Related Party Transactions
         
Operating expense          
Research and development $ 25,000   $ 75,000   $ 136,950
[1] General & administrative expense includes stock for services, stock option and warrant expenses of $104,602 and 106,534 for the quarters ending 6/30/2011 and 6/30/2010, respectively; $209,378 and $214,304 for the six month periods ending 6/30/2011 and 6/30/2010, respectively; and $2,773,570 for the period from inception through 6/30/2011
[2] Research and development expense includes stock option expenses of $16,082 and $36,176 for the quarters ending 6/30/2011 and 6/30/2010, respectively; $31,286 and $72,352 for the six month periods ending 6/30/2011 and 6/30/2010, respectively; and $334,546 for the period from inception through 6/30/2011
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Document and Entity Information
6 Months Ended
Jun. 30, 2011
Aug. 12, 2011
Document Information [Line Items]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Jun. 30, 2011
Document Fiscal Year Focus 2011  
Document Fiscal Period Focus Q2  
Trading Symbol BPTH  
Entity Registrant Name BIO-PATH HOLDINGS INC  
Entity Central Index Key 0001133818  
Current Fiscal Year End Date --12-31  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   56,146,296
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Accrued Expense
6 Months Ended
Jun. 30, 2011
Accrued Expense
5.  Accrued Expense
 
As of June 30, 2011, Current Liabilities included accrued expense of $146,526.  R&D expenses related to MD Anderson treating patients in the Phase I clinical trial comprised $50,000 of this amount and expenses for clinical trial monitors represented an additional $5,000.  Accrued expenses for travel to suppliers, meetings and conferences totaled approximately $16,000. Expenses of being a public company of approximately $5,000 were accrued for auditors and attorney fees, plus business wire services.  Management bonus pool accrual comprises $69,375 of accrued expense as of June 30, 2011.
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Commitments and Contingencies
6 Months Ended
Jun. 30, 2011
Commitments and Contingencies
10.  Commitments and Contingencies
 
Technology License – Related Party - The Company has negotiated exclusive licenses from the MD Anderson Cancer Center to develop drug delivery technology for antisense and siRNA drug products and to develop liposome tumor targeting technology.  These licenses require, among other things, the Company to reimburse MD Anderson for ongoing patent expense.  Accrued license payments totaling $50,000 are included in Current Liabilities as of June 30, 2011.  As of June 30, 2011, the Company estimates reimbursable past patent expenses will total approximately $125,000 for the antisense license.  The Company will be required to pay when invoiced the patent expenses at the rate of $25,000 per quarter.
 
Drug Supplier Project Plan - In June of 2008, Bio-Path entered into a Project Plan agreement with a contract drug manufacturing supplier for delivery of drug product to support commencement of the Company’s Phase I clinical trial of its first cancer drug product.  The Company commenced this trial and was enrolling patients by the end of the second quarter 2010.  Previously in 2008 and 2009, the Company paid $608,440 to this manufacturer and its drug substance raw material supplier.  During the first quarter 2011, $88,400 previously carried on the balance sheet as of December 31, 2010 as prepaid drug product for testing was charged to R&D expense after the manufacturer delivered the final lot of drug product under this contract to the Company.  As of June 30, 2011 there were no further obligations under the drug supplier project plan with the contract manufacturer.
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Organization and Business
6 Months Ended
Jun. 30, 2011
Organization and Business
1.  Organization and Business
 
Bio-Path Holdings, Inc. (together with its subsidiary, “Bio-Path” or the “Company” or “we,” “us” or “our”) 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”) dedicated to developing novel cancer drugs under an exclusive license arrangement.  The Company has drug delivery platform technology with composition of matter intellectual property that enables systemic delivery of antisense and small interfering RNA (“siRNA”).  Bio-Path has also licensed 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 and siRNA drugs under development as well as future liposome-based delivery technology drugs.  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 a strong pipeline of promising drug candidates in the future.  Bio-Path also expects to broaden its technology to include cancer drugs other than antisense and siRNA, including drug candidates licensed from institutions other than MD Anderson.
 
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 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.
 
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 “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 of 2010.
 
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.  The trial will evaluate five doses of L-Grb-2 and it is intended that a sufficient number of 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 MD Anderson.
 
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 the end of the second quarter of 2011, with fourteen patients having been enrolled into the study.  At the low initial dose levels in the clinical trial, it initially took longer than expected for the Principal Investigator to recruit patients into the trial.
 
At the end of July 2011, the sixth evaluable patient completed the full treatment cycle, which completed requirements for the first cohort.  The Company, its medical advisors and the Principal Investigator agreed that the data demonstrated that Liposomal Grb-2 was safe enough to proceed to the next cohort of the trial, which will treat patients in the trial with a dose that is 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.
 
It is important to note two patients that completed the full four week treatment cycle of the Phase I trial were placed on continuing treatment for additional cycles based on the Principal Investigator’s assessment that treatment with the drug Liposomal Grb-2 was benefiting these patients.  This was described as a remarkable and unexpected result based on the initial, low dose being given to patients in the first cohort.  Bio-Path’s FDA-approved protocol for the Phase I clinical trial provides that the Principal Investigator may continue treatment of a patient beyond the initial cycle if, in the Principal Investigator’s opinion, the patient is exhibiting stable disease, or else, has improvement of his or her disease.  In the circumstance where a patient is continuing treatment beyond the requirements of the Phase I trial, the Company is required to supply the drug at no charge for the continuing treatments but it is not required to incur additional hospital costs.  Although it is too early to draw any scientific conclusions about any effect that the Company’s drug candidate Liposomal-Grb-2 has on patients being treated in the trial, the effects of apparent stabilization in some patients is expected to help in recruiting new patients into the clinical trial.
 
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 cohort produced unexpected and clinically interesting results in some patients, the Principal Investigator is preparing an abstract of the results thereof to be submitted for review and potential inclusion at the American Hematology Society annual meeting in December.
 
The Company expects that an additional 12 months could be required to complete the Phase I clinical trial, or longer depending on patient enrollment and the incidence of non-evaluable patients.  We are seeking an additional 13-16 evaluable patients to complete the trial.  Since, at the Principal Investigator’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.  Additional costs to completion of the Phase I clinical trial are estimated to range from $750,000 to $1.2 million.  Bio-Path believes it has sufficient resources and access to additional resources if needed to meet its obligations in this regard.
 
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.  Being platform technology, a successful demonstration of the delivery technology in this study will allow the Company to immediately 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.
 
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 BP-100-1.01.
 
At the end of June 2011, Bio-Path had $1,221,659 in cash on hand.  During the second quarter 2011, the Company sold in a private placement approximately $1.8 million of its common stock for cash.  The amount of cash resources in Company accounts is expected to fund Bio-Path’s operations well into the second half of 2011, when the Company could have preliminary data from its Phase I clinical trial to start early assessments of the utility of the drug and the delivery technology.  The Company 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.
 
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.
XML 15 R14.htm IDEA: XBRL DOCUMENT  v2.3.0.11
Additional Paid In Capital For Shares To Be Issued
6 Months Ended
Jun. 30, 2011
Additional Paid In Capital For Shares To Be Issued
7.  Additional Paid In Capital For Shares To Be Issued
 
In November and December of 2010, the Company sold shares of common stock for $278,600 in cash to investors pursuant to a private placement memorandum.  These shares were not issued by the December 31, 2010 year end.  In February and March of 2011, the Company sold additional shares of common stock for $763,302 in cash to investors pursuant to a private placement memorandum.  During the second quarter of 2011, the Company sold additional shares of common stock for $752,303 in cash pursuant to this private placement memorandum.  At the end of the second quarter 2011, the Company closed this offering and issued 5,980,685 shares of common stock to investors.  In connection with this private placement, the Company issued 598,069 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.
XML 16 R19.htm IDEA: XBRL DOCUMENT  v2.3.0.11
New Accounting Pronouncements
6 Months Ended
Jun. 30, 2011
New Accounting Pronouncements
12.  New Accounting Pronouncements
 
From time to time, new accounting pronouncements are issued by FASB that are adopted by the Company as of the specified effective date.  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’s financial statements upon adoption.
XML 17 R15.htm IDEA: XBRL DOCUMENT  v2.3.0.11
Stockholders' Equity
6 Months Ended
Jun. 30, 2011
Stockholders' Equity
8.  Stockholders’ Equity
 
Issuance of Common Stock – In May and June of 2007, the Company issued 6,505,994 shares of common stock for $6,506 in cash to founders of the Company.  In August of 2007, the Company issued 3,975,000 shares of common stock for $993,750 in cash to investors in the Company pursuant to a private placement memorandum.  In August of 2007 the Company issued an additional 1,333,334 shares of common stock for $1,000,000 in cash to investors in the Company pursuant to a second round of financing.  The Company issued 530,833 in common stock to the Placement Agent as commission for the shares of common stock sold to investors.  In November of 2007, the Company issued 3,138,889 shares in common stock to MD Anderson as partial consideration for its two technology licenses from MD Anderson.
 
In February of 2008, the Company completed a reverse merger with Ogden Golf Co. Corporation and issued 38,023,578 shares of common stock of the public company Bio-Path Holdings (formerly Ogden Golf Co. Corporation) in exchange for pre-merger common stock of Bio-Path, Inc.  In addition, shareholders of Ogden Golf Co. Corporation retained 3,600,000 shares of common stock of Bio-Path Holdings.  In February of 2008 Bio-Path issued 80,000 shares of common stock to strategic consultants pursuant to executed agreements and the fair value was expensed upfront as common stock for services.  In April of 2008, the Company issued 200,000 shares of common stock to a firm in connection with introducing Bio-Path, Inc. to its merger partner Ogden Golf Co. Corporation.  The fair value of this stock issuance was expensed upfront as common stock for services valued at $180,000.  In April of 2008, the Company recorded an additional 24 shares for rounding in accordance with FINRA rules.  In December of 2008, the Company issued 100,000 shares of common stock to an investor relations firm for services.  The fair value of this stock issuance was expensed upfront as common stock for services valued at $40,000.  There were no issuances of shares during the first quarter of 2009.  In June of 2009, the Company issued 660,000 shares of common stock and warrants to purchase an additional 660,000 shares of common stock for $165,000 in cash to investors in the Company pursuant to a private placement memorandum.  The warrants must be exercised within two years from the date of issuance. The exercise price of the warrants is $1.50 a share.  In connection with this private placement, the Company issued 66,000 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.  There were no issuances of shares during the fourth quarter of 2009.
 
In November and December of 2009, the Company sold shares of common stock and warrants to purchase shares of common stock for $675,000 in cash to investors pursuant to a private placement memorandum.  These shares were not issued by the December 31, 2009 year end.  In January 2010, the Company issued these investors 2,700,000 shares of common stock and warrants to purchase an additional 2,700,000 shares of common stock.  The warrants must be exercised within two years from the date of issuance. The exercise price of the warrants is $1.50 a share.  In January 2010, the Company also sold an additional 900,000 shares of common stock and warrants to purchase an additional 900,000 shares of common stock for $225,000 in cash to investors in the Company pursuant to a private placement memorandum.  The warrants must be exercised within two years from the date of issuance and the exercise price is $1.50 a share.  In connection with these private placement sales of equity, the Company issued 360,000 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.
 
In May of 2010, the Company issued 780,000 shares of common stock and warrants to purchase an additional 780,000 shares of common stock for $273,000 in cash to investors in the Company pursuant to a private placement memorandum.  The warrants must be exercised within two years from the date of issuance. The exercise price of the warrants is $1.50 a share.  In connection with this private placement, the Company issued 78,000 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.
 
In June of 2010, the Company signed an equity purchase agreement for up to $7 million with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor.  Under the terms of the equity purchase agreement, the Company has the right to sell shares of its common stock to LPC from time to time over a 24-month period in amounts between $50,000 and $1,000,000 up to an aggregate amount of $7 million depending upon certain conditions set forth in the purchase agreement including that a registration statement related to the transaction has been declared effective by the U.S. Securities and Exchange Commission (“SEC”).  As a result, a registration statement was filed and later declared effective by the SEC on July 12, 2010.  Upon signing the agreement, the Company received $200,000 from LPC as an initial purchase in exchange for 571,429 shares (“Initial Purchase Shares”) of the Company’s common stock and warrants to purchase 571,429 shares of the Company’s common stock at an exercise price of $1.50 per share.  Subsequent purchases of the Company’s common stock by Lincoln Park under the agreement do not include warrants.  In connection with the signing of the LPC financing agreement, the Company issued LPC 12,000 shares of the Company’s common stock for its due diligence efforts and 566,801 shares of the Company’s common stock as a commitment fee for the balance of the $7 million equity purchase commitment.
 
In July of 2010, the Company received $150,000 from LPC in exchange for 375,000 shares of the Company’s common stock.  LPC was also issued 6,251 shares of the Company’s common stock as a commitment fee in connection with the purchase of the 375,000 shares of common stock.  No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.
 
In September of 2010, the Company received $50,000 from LPC in exchange for 125,000 shares of the Company’s common stock.  LPC was also issued 2,084 shares of the Company’s common stock as a commitment fee in connection with the purchase of the 125,000 shares of common stock.  No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.
 
In October of 2010, the Company received $50,000 from LPC in exchange for 135,135 shares of the Company’s common stock.  LPC was also issued 2,084 shares of the Company’s common stock as a commitment fee in connection with the purchase of the 135,135 shares of common stock.  No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.
 
In November of 2010, the Company received $50,000 from LPC in exchange for 135,135 shares of the Company’s common stock.  LPC was also issued 2,084 shares of the Company’s common stock as a commitment fee in connection with the purchase of the 135,135 shares of common stock.  No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.
 
From November 2010 through April of 2011 the Company sold shares of common stock for $1,794,205 in cash to investors pursuant to a private placement memorandum.  In June of 2011, the Company issued 5,980,685 shares of common stock to these investors.  In connection with this private placement, in June of 2011 the Company issued 598,069 shares of common stock to the Placement Agent as commission for the shares of common stock sold to investors.  No warrants to purchase additional shares of common stock of the Company were issued to these investors in connection with the sale of the common stock.
 
In June of 2011, the Company received $50,000 from LPC in exchange for 164,853 shares of the Company’s common stock.  LPC was also issued 2,084 shares of the Company’s common stock as a commitment fee in connection with the purchase of the 164,853 shares of common stock.  No warrants to purchase additional shares of common stock of the Company were issued to Lincoln in connection with the sale of the common stock.
 
As of June 30, 2011, there were 56,146,296 shares of common stock issued and outstanding.  There are no preferred shares outstanding as of June 30, 2011.
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Accrued License Payments - Related Party
6 Months Ended
Jun. 30, 2011
Accrued License Payments - Related Party
6.  Accrued License Payments – Related Party
 
Accrued license payments – related party totaling $50,000 were included in Current Liabilities as of June 30, 2011.  This amount represents patent expenses for the licensed technology from the MD Anderson Cancer Center.  It is expected that the accrued license payments will be made to MD Anderson in 2011.
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CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $)
6 Months Ended 50 Months Ended
Jun. 30, 2011
Jun. 30, 2010
Jun. 30, 2011
CASH FLOW FROM OPERATING ACTIVITIES      
Net loss $ (1,055,474) $ (917,755) $ (8,240,877)
Adjustments to reconcile net loss to net cash used in operating activities      
Amortization 104,473 96,009 684,226
Common stock issued for services     300,000
Stock options and warrants 240,664 286,656 2,808,116
(Increase) decrease in assets      
Grants receivable 244,479    
Drug product for testing 88,400    
Other current assets 27,846 (28,267) (45,147)
Increase (decrease) in liabilities      
Accounts payable and accrued expenses (26,035) 147,943 220,723
Net cash used in operating activities (375,647) (415,414) (4,272,959)
CASH FLOW FROM INVESTING ACTIVITIES      
Purchase of exclusive license - related party (37,547) (92,189) (727,201)
Net cash used in investing activities (37,547) (92,189) (727,201)
CASH FLOW FROM FINANCING ACTIVITIES      
Proceeds from convertible notes     435,000
Cash repayment of convertible notes     (15,000)
Net proceeds from sale of common stock 1,396,288 542,778 5,801,819
Net cash from financing activities 1,396,288 542,778 6,221,819
NET INCREASE/(DECREASE) IN CASH 983,094 35,175 1,221,659
Cash, beginning of period 238,565 567,249  
Cash, end of period 1,221,659 602,424 1,221,659
Cash paid for      
Interest      
Income taxes      
Non-cash financing activities      
Common stock issued upon conversion of convertible notes     420,000
Private Placement
     
Non-cash financing activities      
Common stock issued 179,421 117,300 564,266
Related Party Transactions
     
Non-cash financing activities      
Common stock issued     2,354,167
Lincoln Park Capital Fund, LLC
     
Non-cash financing activities      
Common stock issued   $ 202,580 $ 202,580
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Related Party
6 Months Ended
Jun. 30, 2011
Related Party
2.  Related Party
 
Based on its stock ownership in the Company, MD Anderson meets the criteria to be deemed a related party of Bio-Path.  In the second quarter ending June 30, 2011, MD Anderson received $25,000 in cash from the Company for patent expenses previously accrued and related to the Company’s technology license, plus an additional $25,000 in expense was accrued for R&D related clinical trial expense, and $5,115 in cash for patent expense related to the Company's technology license. As of June 30, 2011, the Company had accrued expenses due to the related party totaling $100,000, comprised of $50,000 in accrued license payments related to the Company’s Technology License and $50,000 in accrued R&D related expense for the clinical trial.  See Note 6.
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Prepaid Drug Product for Testing
6 Months Ended
Jun. 30, 2011
Prepaid Drug Product for Testing
3.  Prepaid Drug Product for Testing
 
Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future R&D activities are deferred and capitalized.  Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed.  The Company incurred installments to its contract drug manufacturing and raw material suppliers totaling $88,400 during 2010 pursuant to a Project Plan and Supply Agreement (see Note 11.) for the manufacture and delivery of the Company’s lead drug product for testing in a Phase I clinical trial.  This amount was carried on the Balance Sheet as of December 31, 2010 at cost as Prepaid Drug Product for Testing and was expensed when the drug product was received by the Company in 2011.  As of June 30, 2011, the Company had supplies of drug product on hand for use in the clinical trial estimated to be sufficient for requirements through the summer of 2011.
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Subsequent Events
6 Months Ended
Jun. 30, 2011
Subsequent Events
11.  Subsequent Events
 
In July of 2011, the Company submitted a grant to the U.S. Government’s National Institute of Health (NIH) for a grant to fund development of Liposomal Grb-2 for treatment of breast cancer.  The initial phase of the grant funds preclinical work in animal tumor models.  However, if work from the grant is successful there is the potential for follow-on funding to pay for a Phase I clinical trial treating late-stage breast cancer patients with Liposomal Grb-2.  The grant request is for approximately $140,000 for the initial phase.  In addition to paying for direct out-of-pocket costs of the preclinical studies the initial grant submitted has components for overhead recovery and a profit fee.
 
In late July of 2011, the Company’s medical advisory team conferred with the Principal Investigator of Bio-Path Phase I clinical trial to review safety data from the first cohort of the trial.  Based on this review, the Company and Principal Investigator concurred to proceed to the second cohort in the trial, which involves treating the patients with a dose that is double the dose used in the first cohort.
 
In July of 2011, the Company announced that it had relocated its corporate office to Houston, Texas.  This location is located on the south side of the Texas Medical Center near the MD Anderson Cancer Center.
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Grants Receivable
6 Months Ended
Jun. 30, 2011
Grants Receivable
4.  Grants Receivable
 
As of December 31, 2010, Current Assets included grants receivable of $244,479.  This represents a grant award that Bio-Path received in October 2010 for its application to receive grant funding from the U.S. Government’s Qualifying Therapeutic Discovery Project Program.  The Company received these grant funds during the first week of February 2011.
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CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) (USD $)
3 Months Ended 6 Months Ended 50 Months Ended
Jun. 30, 2011
Jun. 30, 2010
Jun. 30, 2011
Jun. 30, 2010
Jun. 30, 2011
Research and Development Expense
         
Equity compensation $ 16,082 $ 36,176 $ 31,286 $ 72,352 $ 334,546
General and Administrative Expense
         
Equity compensation $ 104,602 $ 106,534 $ 209,378 $ 214,304 $ 2,773,570
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Basis of Presentation
6 Months Ended
Jun. 30, 2011
Basis of Presentation
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 principals. 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. as of and for the fiscal year ended December 31, 2010.  The results of operations for the period ended June 30, 2011, are not necessarily indicative of the results for a full-year period.
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Stock Options and Warrants
6 Months Ended
Jun. 30, 2011
Stock Options and Warrants
9.  Stock Options and Warrants
 
Stock Options - There were no stock option awards in 2010.  Total stock option expense for the year 2010 totaled $477,356.
 
In February of 2011 the Company made a stock option grant for services to purchase in the aggregate 20,000 shares of the Company’s common stock.  Terms of the stock option grant require, among other things, that the individual continues to provide services over the vesting period of the option, which is four years from the date that the option was granted.  The exercise price of the option is $0.53 a share, which was the closing price of the common stock at the date of grant.  The stock option grant was not for current management and officers of the Company.  The Company determined the fair value of the stock options granted using the Black Scholes model and expenses this value monthly based upon the vesting schedule of the stock option award.  For purposes of determining fair value, the Company used an average annual volatility of one hundred sixty six percent (166%), which was calculated based on the closing price of the Company’s stock over the preceding five years.  The risk free rate of interest used in the model was taken from a table of the market rate of interest for U. S. Government Securities for the date of the stock option award and the effective term.   The Company used the simplified method to determine the expected term of the options due to the lack of historical data.  The total value of the stock option granted was determined using this methodology to be $10,260, which is being expensed over the four years following the date of grant based on the stock option vesting schedule.
 
Total stock option expense for the first quarter of 2011 totaled $119,981.  Of this amount, $15,205 related to stock options for personnel involved in R&D activities and $104,776 related to stock options for management involved in general and administrative functions.
 
In June of 2011 the Company made two stock option grants to purchase in the aggregate 125,000 shares of the Company’s common stock for service as a director of the Company and for consulting services.    Terms of the stock option grant require, among other things, that the individual continues to provide services over the vesting period of the option, which is one year from the date of grant for the director service stock option and four years from the date of grant for the consulting service stock option.  The exercise price of the options is $0.33 a share, which was the closing price of the common stock at the date of grant.  The stock option grants were not for current management and officers of the Company.  The Company determined the fair value of the stock options granted using the Black Scholes model and expenses this value monthly based upon the vesting schedule of the stock option award.  For purposes of determining fair value, the Company used an average annual volatility of one hundred sixty two percent (162%), which was calculated based on the closing price of the Company’s stock over the preceding five years.  The risk free rate of interest used in the model was taken from a table of the market rate of interest for U. S. Government Securities for the date of the stock option award and the effective term.  The Company used the simplified method to determine the expected term of the options due to the lack of historical data.  The total fair value of the stock option granted was determined using this methodology to be $39,600, which is being expensed following the date of grant based on the stock option vesting schedule.
 
Total stock option expense for the second quarter of 2011 totaled $120,684.  Of this amount, $16,082 related to stock options for personnel involved in R&D activities and $104,602 related to stock options for management involved in general and administrative functions and directors.
 
Warrants -  There were no warrants for services granted in 2010 and there was no warrant expense for the year 2010.  There were no warrants for services granted in the first or second quarters of 2011 and there was no warrant expense for the first or second quarters 2011.  Warrants issued in connection with the sale of units of common stock were for cash value received and as such were not grants of compensation-based warrants.
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CONSOLIDATED BALANCE SHEETS (USD $)
Jun. 30, 2011
Dec. 31, 2010
Current assets    
Cash $ 1,221,659 $ 238,565
Grants receivable   244,479
Prepaid drug product for testing   88,400
Other current assets 45,147 72,993
Total current assets 1,266,806 644,437
Other assets    
Technology licenses - related party 3,081,368 3,043,821
Less Accumulated Amortization (684,226) (579,754)
Intangible Assets, Net (Excluding Goodwill), Total 2,397,142 2,464,067
TOTAL ASSETS 3,663,948 3,108,504
Current liabilities    
Accounts payable 24,197 88,400
Accrued expense 146,526 84,141
Accrued license payments - related party 50,000 74,217
Total current liabilities 220,723 246,758
Long term debt    
TOTAL LIABILITIES 220,723 246,758
Shareholders' Equity    
Preferred Stock, $.001 par value 10,000,000 shares authorized, no shares issued and outstanding    
Common Stock, $.001 par value, 200,000,000 shares authorized 56,146,296 and 49,400,605 shares issued and outstanding as of 6/30/11 and 12/31/10, respectively 56,146 49,401
Additional paid in capital 11,627,956 9,719,147
Additional paid in capital for shares to be issued   278,600 [1]
Accumulated deficit during development stage (8,240,877) (7,185,402)
Total shareholders' equity 3,443,225 2,861,746
TOTAL LIABILITIES & SHAREHOLDERS' EQUITY $ 3,663,948 $ 3,108,504
[1] Represents 928,667 shares of common stock
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