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ABEONA THERAPEUTICS INC. - Quarter Report: 2009 June (Form 10-Q)

a10q-063009.htm
 


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

FORM 10-Q
(Mark One)
     
þ
 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the Quarterly Period Ended June 30, 2009

OR
     
o
 
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the Transition Period from                      to                     

Commission file number 0-9314

ACCESS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
 
   Delaware 
 
 83-0221517 
 (State or other jurisdiction of
 
 (I.R.S. Employer I.D. No.)
 incorporation or organization)
   
     
      2600 Stemmons Frwy, Suite 176, Dallas, TX 75207  
 
 (Address of principal executive offices)
 
     
 (214) 905-5100
(Registrant’s telephone number, including area code)

N/A
(Former name, former address and former fiscal year, if changed since last report)

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 o No þ 

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  o   No  o

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. (Check one):
             
Large accelerated filer o
 
Accelerated filer o
 
Non-accelerated filer o
 
Smaller reporting company þ
   
(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ 

As of August 12, 2009, there were 12,225,036 shares of Access Pharmaceuticals, Inc. Common Stock issued and outstanding. Also as of August 12, 2009, there were 3,120.3617 shares of Series A Convertible Preferred Stock issued and outstanding, and such shares were convertible into 10,401,196 shares of Common Stock.
 


ACCESS PHARMACEUTICALS, INC.
                     
INDEX
                     
PART I - FINANCIAL INFORMATION
         
Page No.
                     
 
Item 1.
 
Financial Statements:
           
                     
     
Condensed Consolidated Balance Sheets at June 30, 2009
   
     
(unaudited) and December 31, 2008 (unaudited)
   
15
                     
     
Condensed Consolidated Statements of Operations (unaudited) for the
 
     
three and six months ended June 30, 2009 and June 30, 2008
 
16
                     
     
Condensed Consolidated Statement of Stockholders’ Deficit (unaudited)
 
     
for the six months ended June 30, 2009
     
17
                     
     
Condensed Consolidated Statements of Cash Flows (unaudited) for the
 
     
six months ended June 30, 2009 and June 30, 2008
   
18
                     
     
Notes to Unaudited Condensed Consolidated Financial Statements
19
                     
 
Item 2.
 
Management's Discussion and Analysis of Financial Condition and
 
     
Results of Operations
         
2
                     
 
Item 3.
 
Quantitative and Qualitative Disclosures About Market Risk
 
9
                     
 
Item 4T.
 
Controls and Procedures
       
9
                     
               
PART II - OTHER INFORMATION
             
                     
 
Item 1.
 
Legal Proceedings
         
11
                     
 
Item 2.
 
Unregistered Sales of Equity Securities and Use of Proceeds
   
11
                     
 
Item 3.
 
Defaults Under Senior Securities
       
11
                     
 
Item 4.
 
Submission of Matters to a Vote of Security Holders
   
11
                     
 
Item 5.
 
Other Information
         
12
                     
 
Item 6.
 
Exhibits
           
12
                     
SIGNATURES
               
14
                     
CERTIFICATIONS
               


1



PART I –FINANCIAL INFORMATION

This Quarterly Report (including the information incorporated by reference) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties including, but not limited to the uncertainties associated with research and development activities, clinical trials, our ability to raise capital, the timing of and our ability to achieve regulatory approvals, dependence on others to market our licensed products, collaborations, future cash flow, the timing and receipt of licensing and milestone revenues, the future success of our marketed products and products in development, our sales projections, and the sales projections of our licensing partners, our ability to achieve licensing milestones and other risks described below as well as those discussed elsewhere in this Quarterly Report, documents incorporated by reference and other documents and reports that we file periodically with the Securities and Exchange Commission. These statements include, without limitation, statements relating to our ability to continue as a going concern, anticipated product approvals and timing thereof, product opportunities, clinical trials and U.S. Food and Drug Administration (“FDA”) applications, as well as our drug development strategy, our clinical development organization, expectations regarding our rate of technological developments and competition, our expectations regarding minimizing development risk and developing and introducing technology, the size of our targeted markets, the terms of future licensing arrangements, our ability to secure additional financing for our operations and our expected cash burn rate. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “could,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of such terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Risk Factors,” that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels or activity, performance or achievements expressed or implied by such forward-looking statements.
 
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We are under no duty to update any of the forward-looking statements after the date of filing this Quarterly Report to conform such statements to actual results.

ITEM 1.                       FINANCIAL STATEMENTS

The response to this Item is submitted as a separate section of this report.

ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

OVERVIEW

Access Pharmaceuticals, Inc. (together with our subsidiaries, “We”, “Access” or the “Company”) is a Delaware corporation. We are an emerging biopharmaceutical company focused on developing a range of pharmaceutical products primarily based upon our nanopolymer chemistry technologies and other drug delivery technologies. We currently have one approved product, one product at Phase 3 of clinical development, four products in Phase 2 of clinical development and four products in pre-clinical development. Low priority clinical and pre-clinical programs will be dependent on our ability to enter into collaborative arrangements. Our description of our business, including our list of products and patents, takes into consideration our acquisition of MacroChem Corporation which closed February 25, 2009.

2

 
·  
MuGard™ is our approved product for the management of oral mucositis, a frequent side-effect of cancer therapy for which there is no established treatment. The market for mucositis treatment is estimated to be in excess of $1 billion world-wide. MuGard, a proprietary nanopolymer formulation, has received marketing allowance in the U.S. from the Food & Drug Administration (“FDA”). MuGard has been launched in Germany, Italy, UK, Greece and the Nordic countries by our European commercial partner, SpePharm.
·  
Our lead development candidate for the treatment of cancer is ProLindac™, a nanopolymer DACH-platinum prodrug. We recently completed a Phase 2 clinical trial on ProLindac in the EU in patients with ovarian cancer. The clinical study had positive safety and efficacy results. We are currently planning a number of combination trials, looking at combining ProLindac with other cancer agents such as taxol and gemcitabine, in solid tumor indications including colorectal and ovarian. The DACH-platinum incorporated in ProLindac is the same active moiety as that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in excess of $2.0 billion.
·  
Thiarabine, or 4-thio Ara-C, is a next generation nucleoside analog licensed from Southern Research Institute. Previously named SR9025 and OSI-7836, the compound has been in two Phase 1/2 solid tumor human clinical trials and was shown to have anti-tumor activity. We are working with leukemia and lymphoma specialists at MD Anderson Cancer Center in Houston and intend to initiate additional Phase 2 clinical trials in adult AML, ALL and other indications.
·  
Cobalamin™ is our proprietary preclinical nanopolymer oral drug delivery technology based on the natural vitamin B12 oral uptake mechanism. We are currently developing a product for the oral delivery of insulin, and are conducting sponsored development of a product for oral delivery of human growth hormone.
·  
Angiolix® is our preclinical humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to lactadherin, a glycoprotein secreted by cancer cells, notably breast, ovarian and colorectal cancers.
·  
Cobalamin-mediated cancer targeted delivery is a preclinical technology which makes use of the fact that cell surface receptors for vitamins such as B12 are often overexpressed by cancer cells.
 
3


Access Drug Portfolio
Compound
 
Originator
 
 
Technology
 
Indication
 
Clinical
Stage (1)
                 
MuGard™
 
Access
 
Mucoadhesive
liquid
 
Mucositis
 
(510k) Marketing clearance received
 
ProLindacTM (Polymer
   Platinate, AP5346)
 
 
Access /
Univ of
London
 
 
Synthetic
polymer
 
Cancer
 
Phase 2
Thiarabine (4-thio Ara-C)
 
Southern
Research
Institute
 
 
Small
molecule
 
Cancer
 
Phase 1/2
Oral Insulin
 
 
Access
 
Cobalamin
 
Diabetes
 
Pre-clinical
Oral Delivery System
 
 
Access
 
Cobalamin
 
Various
 
Pre-clinical
Angiolix®
 
 
Immunodex,
Inc.
 
 
Humanized
monoclonal
antibody
 
 
Cancer
 
Pre-clinical
Cobalamin-Targeted Therapeutics
 
Access
 
Cobalamin
 
Anti-tumor
 
Pre-clinical

(1)  
For more information, see “Government Regulation” under Item 1 in our Annual Report on Form 10-K for the year ended December 31, 2008.

RECENT EVENTS

On August 3, 2009, we announced that we commenced a new clinical study of ProLindac in France. The study will examine dose levels and regimens of ProLindac monotherapy in cancer patients, provide additional data to support design of combinations studies, and extend the safety database. Two ovarian cancer patients have been enrolled in the study to date, and it is anticipated 6 to 12 patients will be enrolled this year in advance of enrolling patients in trial evaluating ProLindac in combination with other chemotherapies.

On July 29, 2009, we announced that we are evaluating strategic options for the commercialization of MuGard in North America. Frank Jacobucci, formerly President & CEO of Milestone Biosciences, has joined Access as a consultant, and will assist with ongoing reimbursement, manufacturing and commercial launch activities at Access, while discussions with potential licensee and co-promotion partners is ongoing.

On July 23, 2009 we announced that our European partner, SpePharm, is collecting data from a post approval study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis. In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study have been enrolled and treated, and as of the time of the update, none of these patients have experienced any oral mucositis.

On July 7, 2009 we announced new preclinical data demonstrating that thiarabine shows remarkable efficacy in the prevention and treatment of rheumatoid arthritis (RA). In a well-established animal model for RA, an exceptional restoration of joint structure was observed in the studies, which were conducted at Wayne State University School of Medicine and at Southern Research Institute.

4

 
On June 17, 2009 we announced that we signed evaluation agreements with two biopharmaceutical companies for our Cobalamin™ Oral Drug Delivery Technology. Under the terms of the agreements, both companies plan to evaluate Access’ oral insulin product in preclinical models as a prerequisite to entering licensing discussions.

On February 25, 2009, we closed our acquisition of MacroChem Corporation through the issuance of an aggregate of approximately 2.5 million shares of our common stock. In addition, we cancelled all of the outstanding debt of MacroChem in exchange for the issuance of 859,172 shares of our unregistered common stock.

LIQUIDITY AND CAPITAL RESOURCES

We have funded our operations primarily through private sales of common stock, preferred stock, convertible notes and through licensing agreements. Our principal source of liquidity is cash and cash equivalents. Licensing fees provided some funding for operations during the quarter ended June 30, 2009. As of June 30, 2009, our cash and cash equivalents were $1,231,000 and our net cash burn rate for the six months ended June 30, 2009, was approximately $241,000 per month. As of June 30, 2009, our working capital deficit was $5,842,000. Our working capital deficit at June 30, 2009 represented an increase of $1,187,000 as compared to our working capital deficit as of December 31, 2008 of $4,655,000. The increase in the working capital deficit at June 30, 2009 reflects milestone payments from our licensing agreements offset by operating expenses which included manufacturing product scale-up for our new ProLindac trial and MacroChem expenses. As of June 30, 2009, we had one convertible note outstanding in the principle amount of $5.5 million which is due September 13, 2011.

After the quarter closed we received $1,000,000 in license receipts from an existing license agreement. Our cash balance at August 12, 2009 was $1,553,000.

As of June 30, 2009, the Company did not have enough capital to achieve its long-term goals. If we raise additional funds by selling equity securities, the relative equity ownership of our existing investors would be diluted and the new investors could obtain terms more favorable than previous investors. A failure to obtain necessary additional capital in the future could jeopardize our operations.

We have generally incurred negative cash flows from operations since inception, and have expended, and expect to continue to expend in the future, substantial funds to complete our planned product development efforts. Since inception, our expenses have significantly exceeded revenues, resulting in an accumulated deficit as of June 30, 2009 of $241,226,000. We expect that our capital resources will be adequate to fund our current level of operations into the first quarter of 2010. However, our ability to fund operations over this time could change significantly depending upon changes to future operational funding obligations or capital expenditures. As a result we may be required to seek additional financing sources within the next twelve months. We cannot assure you that we will ever be able to generate significant product revenue or achieve or sustain profitability.

In order to conserve cash for the operations of Access, management, employees and consultants reduced their monthly stipends. Some consultants also agreed to take common stock and warrants for their services.

5

 
Since our inception, we have devoted our resources primarily to fund our research and development programs. We have been unprofitable since inception and to date have received limited revenues from the sale of products. We cannot assure you that we will be able to generate sufficient product revenues to attain profitability on a sustained basis or at all. We expect to incur losses for the next several years as we continue to invest in product research and development, preclinical studies, clinical trials and regulatory compliance.

SECOND QUARTER 2009 COMPARED TO SECOND QUARTER 2008

On February 25, 2009, we closed our acquisition of MacroChem Corporation through the issuance of an aggregate of approximately 2.5 million shares of our common stock. Prior to our acquisition of MacroChem, SCO, an investment company, held a majority of Access’ and MacroChem’s voting stock.  Specifically, SCO owned 53% of the voting stock of Access and 63% of the voting stock of MacroChem. A non-controlling interest of 37% existed at the merger date of MacroChem. In addition, certain members of SCO’s management serve on the board of directors of both Access and MacroChem. Based on these facts, Access and MacroChem were deemed under the common control of SCO. As the entities were deemed under common control, the acquisition was recorded using the pooling-of-interest method and the financial information for all periods presented reflects the financial statements of the combined companies in accordance with Appendix D of Statement of Financial Accounting Standards No. 141R (SFAS 141R), “Business Combinations,” for entities under common control.

Our licensing revenue for the second quarter of 2009 was $63,000 as compared to $22,000 for 2008, an increase of $41,000. We recognize licensing revenue over the period of the performance obligation under our licensing agreements.

We had sponsored research and development income of $110,000 in 2008. The research and development agreement was completed in 2008.

Total research and development spending for the second quarter of 2009 was $582,000, as compared to $10,855,000 for 2008, a decrease of $10,273,000. The decrease in expenses was primarily due to:

·  
research and development expenses incurred by MacroChem in the second quarter of 2008, which are no longer ongoing, and MacroChem’s acquisition of Virium on April 18, 2008, which resulted in a second quarter non-cash in-process research and development expense ($9,657,000);
·  
lower costs for product manufacturing for a new ProLindac clinical trial in 2009 as some manufacturing is complete and a clinical trial has started ($459,000);
·  
lower salary and related expenses ($67,000);
·  
lower scientific consulting expenses ($63,000) ;
·  
offset by higher expenses due to the cost of option grants ($72,000); and
·  
other net decreases in research spending ($99,000).

Total general and administrative expenses were $1,507,000 for the second quarter of 2009, a decrease of $772,000 compared to 2008 expenses of $2,279,000 for the same quarter. The decrease in expenses was due primarily to the following:

6

 
·  
general and administrative expenses incurred by MacroChem in the second quarter of 2008 that are no longer ongoing ($1,177,000);
·  
lower patent expenses ($172,000);
·  
lower salary and related expenses ($17,000);
·  
offset by higher business professional expenses ($214,000);
·  
higher shareholder consultant expenses ($185,000);
·  
higher expenses due to the cost of option grants ($96,000);
·  
accrual of potential liquidated damages under an investor rights agreement with certain investors ($109,000); and
·  
other net decreases in general and administrative expenses ($10,000).

Depreciation and amortization was $66,000 for the second quarter of 2009, as compared to $78,000 for 2008, a decrease of $12,000. The decrease in expenses was primarily due to assets becoming fully depreciated.

Total operating expenses for the second quarter of 2009, were $2,155,000 as compared to total operating expenses of $13,212,000 for same period in 2008, a decrease of $11,057,000 for the reasons listed above.

Interest and miscellaneous income was $2,000 for the second quarter of 2009, as compared to $40,000 for the same period in 2008, a decrease of $38,000. The decrease in interest and miscellaneous income was due to lower average cash balances during 2009 versus 2008.

Interest and other expense was $118,000 for the second quarter of 2009, as compared to $221,000 in 2008, a decrease of $103,000. The decrease in interest and other expense was due to MacroChem notes payable that were exchanged and cancelled for shares of our common stock in connection with our acquisition of MacroChem. The notes payable were issued in the second quarter of 2008.

Preferred stock dividends of $483,000 were accrued for the second quarter of 2009 and $517,000 for 2008, a decrease of $34,000. The decrease is due to preferred shareholders converting their ownership to common stock. Dividends are paid semi-annually in either cash or common stock.

Net loss allocable to common stockholders for the second quarter of 2009, was $2,691,000, or a $0.24 basic and diluted loss per common share, compared with a loss of $13,778,000, or a $1.69 basic and diluted loss per common share for the same period in 2008, a decreased loss of $11,087,000.

SIX MONTHS ENDED JUNE 30, 2009 COMPARED TO SIX MONTHS ENDED JUNE 30, 2008

On February 25, 2009, we closed our acquisition of MacroChem Corporation through the issuance of an aggregate of approximately 2.5 million shares of our common stock. Prior to our acquisition of MacroChem, SCO, an investment company, held a majority of Access’ and MacroChem’s voting stock.  Specifically, SCO owned 53% of the voting stock of Access and 63% of the voting stock of MacroChem. A non-controlling interest of 37% existed at the merger date of MacroChem. In addition, certain members of SCO’s management serve on the board of directors of both Access and MacroChem. Based on these facts, Access and MacroChem were deemed under the common control of SCO. As the entities were deemed under common control, the acquisition was recorded using the pooling-of-interest method and the financial information for all periods presented reflects the financial statements of the combined companies in accordance with Appendix D of Statement of Financial Accounting Standards No. 141R (SFAS 141R), “Business Combinations,” for entities under common control.

7

 
Our licensing revenue for the first six months of 2009 was $104,000 as compared to $39,000 for the same period of 2008. We recognize licensing revenue over the period of the performance obligation under our licensing agreement. We have received upfront licensing payments from SpePharm Holding, B.V., RHEI, JCOM and ASK.

We had sponsored research and development income of $131,000 in 2008. The research and development agreement was completed in 2008.

Total research and development spending for the first six months of 2009 was $1,269,000, as compared to $21,012,000 for the same period in 2008, a decrease of $19,743,000. The decrease in expenses was primarily due to:

·  
the Somanta acquisition resulted in a one-time non-cash in-process research and development expense in the first quarter of 2008 ($8,879,000);
·  
research and development expenses incurred by MacroChem in the first six months of 2008, which are no longer ongoing ($465,000);
·  
MacroChem’s acquisition of Virium on April 18, 2008 which resulted in a one-time non-cash in-process research and development expense ($9,657,000);
·  
lower costs for product manufacturing due to the start of a new ProLindac clinical trial ($594,000);
·  
lower salary and related expenses ($60,000);
·  
lower scientific consulting expenses ($60,000);
·  
lower travel expenses ($56,000);
·  
offset by higher expenses due to option grants ($95,000); and
·  
other net decreases in research spending ($67,000).

Total general and administrative expenses were $2,754,000 for the first six months of 2009, a decrease of $1,364,000 over 2008 expenses of $4,118,000. The decrease in spending was due primarily to the following:

·  
general and administrative expenses incurred by MacroChem in the first six months of 2008 that are no longer ongoing  ($1,996,000);
·  
lower salary and related expenses ($38,000);
·  
offset by higher business professional expenses ($302,000);
·  
accrual of potential liquidated damages under an investor rights agreement with certain investors ($267,000);
·  higher shareholder consultant expenses ($153,000);
·  
higher expenses due to the cost of option grants ($73,000); and
·  
other net decreases in general and administrative expenses ($125,000).
 
Depreciation and amortization was $132,000 for the first six months of 2009 as compared to $166,000 for the same period in 2008 reflecting a decrease of $34,000. The decrease in depreciation and amortization was due to assets becoming fully depreciated.

Total operating expenses for the first six months of 2009 were $4,155,000 as compared to total operating expenses of $25,296,000 for same period in 2008, a decrease of $21,141,000 for the reasons listed above.

Interest and miscellaneous income was $16,000 for the first six months of 2009 as compared to $141,000 for the same period of 2008, a decrease of $125,000. The decrease in interest and miscellaneous income was due to lower average cash balances during 2009 versus 2008.

8

 
Interest and other expense was $262,000 for the first six months of 2009 as compared to $329,000 in 2008, a decrease of $67,000. The decrease in interest and other expense was due to MacroChem notes payable that were exchanged and cancelled for shares of our common stock in connection with our acquisition of MacroChem. The notes payable were issued in the second quarter of 2008.

Preferred stock dividends of $963,000 were accrued for the first six months of 2009 and $1,042,000 for 2008, a decrease of $79,000. The decrease is due to preferred shareholders converting their ownership to common stock offset by a placement of preferred stock that closed in February 4, 2008. Dividends are paid semi-annually in either cash or common stock.

On February 4, 2008, we issued 272.5 shares of our Series A Preferred Stock. The shares are convertible into common stock at $3.00 per share. Based on the price of our common stock on February 4, 2008 a new conversion price was calculated for the Series A Preferred Stock and was considered to be “in the money” at the time of the agreement to exchange the convertible notes for preferred stock. This resulted in a beneficial conversion feature. The preferred stockholder has the right at any time to convert all or any lesser portion of the Series A Preferred Stock into common stock. This resulted in an intrinsic value of the preferred stock. The difference between the implied value of the preferred stock and the beneficial conversion feature was treated as preferred stock dividends of $857,000.

An additional $451,000 in preferred stock dividends was recorded in the first quarter of 2008. The change was due to preferred stock dividends and the beneficial conversion feature associated with the warrants issued in association with the sale of preferred stock in November 2007.

Net loss allocable to common stockholders for the first six months of 2009 was $5,260,000, or a $0.48 basic and diluted loss per common share, compared with a loss of $27,664,000, or a $3.45 basic and diluted loss per common share for the same period in 2008, a decreased loss of $22,404,000.

ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4T.                       CONTROLS AND PROCEDURES

Under the supervision and with the participation of our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), we evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Act”)) as of June 30, 2009. Based on this evaluation, our CEO and CFO concluded that, as of June 30, 2009, our disclosure controls and procedures were not effective. This conclusion was based on the existence of the material weaknesses in our internal control over financial reporting previously disclosed and discussed below.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our internal control system was designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes, in accordance with generally accepted accounting principles. Because of inherent limitations, a system of internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate due to change in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

9

 
Our management, including our principal executive officer and principal accounting officer, conducted an evaluation of the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework. Based on its evaluation, our management concluded in our Annual Report on Form 10-K for the year ended December 31, 2008 that there is a material weakness in our internal control over financial reporting. As of the date of this report on Form 10-Q, we have not remediated such material weakness and as a result, our Chief Executive Officer and Chief Financial Officer have concluded that a material weakness continues to exist as of the end of the period covered by this Quarterly Report on Form 10-Q and our disclosure controls and procedures were not effective. The material weakness identified did not result in the restatement of any previously reported financial statements or any related financial disclosure, nor does management believe that it had any effect on the accuracy of the Company’s financial statements for the current reporting period. A material weakness is a deficiency, or a combination of control deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

The material weakness relates to the monitoring and review of work performed by our Chief Financial Officer in the preparation of financial statements, footnotes and financial data provided to the Company’s registered public accounting firm in connection with the annual audit. All of our financial reporting is carried out by our Chief Financial Officer. This lack of accounting staff results in a lack of segregation of duties and accounting technical expertise necessary for an effective system of internal control.

In order to mitigate this material weakness to the fullest extent possible, all financial statements are reviewed by the Chief Executive Officer as well as the Chairman of the Audit Committee for reasonableness. All unexpected results are investigated. At any time, if it appears that any control can be implemented to continue to mitigate such weaknesses, it is immediately implemented. As soon as our finances allow, we will hire sufficient accounting staff and implement appropriate procedures for monitoring and review of work performed by our Chief Financial Officer.

Changes In Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2009 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.

10

 

PART II -- OTHER INFORMATION

 
ITEM 1.               LEGAL PROCEEDINGS
 
None.
 
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

On June 9, 2009, we issued 30,000 shares of Access common stock to a former executive of MacroChem for the settlement of his employment agreement. The settlement agreements specify that a portion of the settlement be paid in common stock. The issuance of shares of our common stock in settlement of these accounts was made pursuant to Section 4(2) and Rule 506 of the Securities Act of 1933, as amended.

In June 2009, we issued 126,667 shares Access common stock to several consultants for their consulting expenses. The issuance of shares of our common stock in settlement of these accounts was made pursuant to Section 4(2) and Rule 506 of the Securities Act of 1933, as amended.


ITEM 3.               DEFAULTS UPON SENIOR SECURITIES

Pursuant to the terms of the Certificate of Designations, Rights and Preferences of our Series A Cumulative Convertible Preferred Stock, we are required to pay dividends in cash or shares of our common stock, semi-annually, at the rate of 6% per annum. If funds are not currently available to pay cash dividends or if a cash payment of dividends would be impermissible under Delaware law, we may in certain circumstances pay such dividends in shares of the Company’s common stock. In order to pay such dividends in shares of the Company’s common stock, there must either be an effective registration statement covering the resale of the dividend shares, the resale must be permissible subject to an exemption from registration, or the respective holders of Series A Preferred Stock must agree to accept restricted common stock as payment of such dividends. In the event none of these three circumstances are met, and the dividends have not been paid in cash or shares of the Company’s common stock, the dividends shall continue to accrue until they are paid in cash or shares of the Company’s common stock. The Company has accrued as of June 30, 2009, dividends payable of $1,866,000.

Pursuant to the terms of an Investor Rights Agreement with the Purchasers of Series A Preferred Stock, the Company is required to maintain an effective registration statement with respect to certain shares issuable upon conversion of our outstanding preferred stock. As of June 30, 2009, the Securities and Exchange Commission had not yet declared a registration statement effective with respect to all of the shares covered by the Investor Rights Agreement, and as a result, the Company accrued $992,000 in liquidated damages as of June 30, 2009. A registration statement filed by Access relating to a portion of such securities was declared effective on November 13, 2008.


ITEM 4.               SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

The annual meeting of stockholders was held on May 27, 2009 in New York, N.Y. At that meeting the following matters were submitted to a vote of the stockholders of record. The proposals were approved by the stockholders, as follows:

11

 
Three directors were re-elected for three years terms with the following votes:

 
Steven H. Rouhandeh; 14,763,704- For; and 173,600-Withheld Authority
 
Stephen B. Howell, MD; 14,754,551- For; and 182,753- Withheld Authority
 
David P. Luci; 14,670,070- For; and 267,234- Withheld Authority

 
The terms of office as a director of Access of each of Mark J. Ahn, Mark J. Alvino, Esteban Cvitkovic and Jeffrey B. Davis continued after the meeting.

A proposal to ratify the appointment of Whitley Penn LLP as independent certified public accounts for the Company for the fiscal year ending December 31, 2009 was approved with 14,764,474- For; 13,021- Against; and 35,809- Abstain.
 
 
 ITEM 5.   OTHER INFORMATION
 
None
 
 
ITEM 6.
EXHIBITS
 

Exhibits:

2.2
Agreement and Plan of Merger, by and among Access Pharmaceuticals, Inc., Somanta Acquisition Corporation, Somanta Pharmaceuticals, Inc., Somanta Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated by reference to Exhibit 2.1 to our Form 8-K dated April 18, 2007)

2.3
Agreement and Plan of Merger, by and among Access Pharmaceuticals, Inc., MACM Acquisition Corporation and MacroChem Corporation, dated July 9, 2008.

3.0          Articles of incorporation and bylaws:

3.1
Certificate of Incorporation (Incorporated by Reference to Exhibit 3(a) of our Form 8-B dated July 12, 1989, Commission File Number 9-9134)

3.2          Certificate of Amendment of Certificate of Incorporation filed August 21, 1992

3.3
Certificate of Merger filed January 25, 1996. (Incorporated by reference to Exhibit E of our Registration Statement on Form S-4 dated December 21, 1995, Commission File No. 33-64031)

3.4
Certificate of Amendment of Certificate of Incorporation filed January 25, 1996. (Incorporated by reference to Exhibit E of our Registration Statement on Form S-4 dated December 21, 1995, Commission File No. 33-64031)

3.5
Certificate of Amendment of Certificate of Incorporation filed July 18, 1996. (Incorporated by reference to Exhibit 3.8 of our Form 10-K for the year ended December 31, 1996)

12


3.6
Certificate of Amendment of Certificate of Incorporation filed June 18, 1998. (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter ended June 30, 1998)


3.7  
Certificate of Amendment of Certificate of Incorporation filed July 31, 2000. (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter ended March 31, 2001)

3.8
Certificate of Designations of Series A Junior Participating Preferred Stock filed November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of our Registration Statement on Form S-8, dated December 14, 2001, Commission File No. 333-75136)

3.9
Amended and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of our Form 10-Q for the quarter ended June 30, 1996)

3.10
Certificate of Designations, Rights and Preferences of Series A Cumulative Convertible Preferred Stock (Incorporated by reference to Exhibit 3.10 to our Form 10-K for the year ended December 31, 2007)

3.11
Certificate of Amendment to Certificate of Designations, Rights and Preferences of Series A Cumulative Convertible Preferred Stock filed June 11, 2008 (Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the quarter ended June 30, 2008)

31.1
Certification of Chief Executive Officer of Access Pharmaceuticals, Inc. pursuant to Rule 13a-14(a)/15d-14(a)

31.2
Certification of Chief Financial Officer of Access Pharmaceuticals, Inc. pursuant to Rule 13a-14(a)/15d-14(a)

32.1*
Certification of Chief Executive Officer of Access Pharmaceuticals, Inc. pursuant to 18 U.S.C. Section 1350

32.2*
Certification of Chief Financial Officer of Access Pharmaceuticals, Inc. pursuant to 18 U.S.C. Section 1350
______________
* This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933 or the Securities and Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
 
13

 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


ACCESS PHARMACEUTICALS, INC.

 
Date:
 
August 12, 2009
 
By:
/s/ Jeffrey B. Davis
     
Jeffrey B. Davis
     
Chief Executive Officer
     
(Principal Executive Officer)
       
Date:
 
August 12, 2009
 
By:
/s/ Stephen B. Thompson
     
Stephen B. Thompson
     
Vice President and Chief Financial Officer
     
(Principal Financial and Accounting Officer
       
 
14

 
Access Pharmaceuticals, Inc. and Subsidiaries
 
Condensed Consolidated Balance Sheets
 
 
 June 30, 2009 
 
 December 31, 2008
 
 
                         ASSETS
 
 
                      
(unaudited)
 
 
 
 
 
(unaudited)
(See Note 4)
 
 
Current assets
Cash and cash equivalents
   Receivables
Prepaid expenses and other current assets
 
$        1,231,000
15,000
56,000
 
 
$        2,677,000
147,000
           173,000
 Total current assets
 1,302,000
 
 2,997,000
 
 
Property and equipment, net
 
 
70,000
 
 
 
95,000
 
 
 
Patents, net
 
 
909,000
 
 
 
1,015,000
 
 
 
Other assets
 
 
70,000
 
 
 
123,000
 
 
            Total assets
 
 
$        2,351,000
 
 
 
$        4,230,000
 
 
        LIABILITIES AND STOCKHOLDERS' DEFICIT
 
     
 
Current liabilities
  Accounts payable
  Accrued expenses
  Dividends payable
  Accrued interest payable
  Notes payable
  Current portion of deferred revenue
 
 
$        3,653,000
1,029,000
1,866,000
340,000
-
256,000
 
 
 
 
$        3,824,000
798,000
1,896,000
145,000
825,000
164,000
 
 Total current liabilities
 7,144,000
 
 7,652,000
Long-term deferred revenue
Long-term debt
3,533,000
5,500,000
 
2,245,000
5,500,000
 
 Total liabilities
 
16,177,000
 
 
15,397,000
 
Commitments and contingencies
     
 
Stockholders' deficit
Convertible Series A preferred stock - $.01 par value; authorized
2,000,000 shares; 3,207.8617 issued at June 30, 2009 and
3,242.8617 at December 31, 2008
Common stock - $.01 par value; authorized 100,000,000 shares;
issued, 11,613,605 at June 30, 2009 and 9,467,474 at
December 31, 2008
  Additional paid-in capital
  Notes receivable from stockholders
  Treasury stock, at cost – 163 shares
  Accumulated deficit
 
 
 
 
 
-
 
 
116,000
228,333,000
(1,045,000)
(4,000)
(241,226,000)
 
 
 
 
 
 
-
 
 
95,000
225,753,000
(1,045,000)
(4,000)
(235,966,000)
 
 Total stockholders' deficit
 (13,826,000)
 
 (11,167,000)
 
            Total liabilities and stockholders' deficit
 
 
$        2,351,000
 
 
 
$        4,230,000
 

The accompanying notes are an integral part of these consolidated statements.
 
15

 
Access Pharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations
(unaudited)
 
   
Three months ended
June 30,
   
Six months ended
June 30,
 
   
2009 
 
   
2008 
(See Note 4)
   
2009 
(See Note 4)
   
2008 
(See Note 4)
 
Revenues
                       
License revenues
  $ 63,000     $ 22,000     $ 104,000     $ 39,000  
Sponsored research and development
    -       110,000       -       131,000  
Total revenues
    63,000       132,000       104,000       170,000  
                                 
Expenses
                               
Research and development
    582,000       10,855,000       1,269,000       21,012,000  
General and administrative
    1,507,000       2,279,000       2,754,000       4,118,000  
Depreciation and amortization
    66,000       78,000       132,000       166,000  
Total expenses
    2,155,000       13,212,000       4,155,000       25,296,000  
                                 
Loss from operations
    (2,092,000 )     (13,080,000 )     (4,051,000 )     (25,126,000 )
                                 
Interest and miscellaneous income
    2,000       40,000       16,000       141,000  
Interest and other expense
    (118,000 )     (221,000 )     (262,000 )     (329,000 )
      (116,000 )     (181,000 )     (246,000 )     (188,000 )
Net loss
    (2,208,000 )     (13,261,000 )     (4,297,000 )     (25,314,000 )
                                 
Less preferred stock dividends
    483,000       517,000       963,000       2,350,000  
Net loss allocable to common stockholders
  $ (2,691,000 )   $ (13,778,000 )   $ (5,260,000 )   $ (27,664,000 )
                                 
Basic and diluted loss per common share
Net loss allocable to common shareholders
  $ (0.24 )   $ (1.69 )   $ (0.48 )   $ (3.45 )
                                 
Weighted average basic and diluted
common shares outstanding
    11,406,700       8,135,869       10,954,472       8,008,064  



The accompanying notes are an integral part of these consolidated statements.

16

Access Pharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Statement of Stockholders' Deficit
(unaudited)
 
     
Common Stock 
     
Preferred Stock 
             
Notes  
                 
                             
 Additional 
     
receivable  
                 
                                     
paid-in  
     
from  
      Treasury       
Accumulated  
 
     
Shares 
     
Amount 
     
Shares 
     
Amount 
     
capital 
      stockholders       
stock 
     
deficit 
 
                                                                 
Access-MacroChem,
as if combined at
December 31, 2008
(See Note 4)
      9,467,000     $ 95,000         3,242.8617     $  -     $ 225,753,000     $ (1,045,000 )   $ (4,000 )   $ (235,966,000 )
Common stock issued
   for preferred
   dividends
    894,000       9,000       -       -       847,000       -       -       -  
Warrants issued for
  services
    -       -       -       -       24,000       -       -       -  
Stock option
  compensation expense
    -       -       -       -       56,000       -       -       -  
Common stock issued
  to MacroChem
  noteholders for notes
  and accrued interest
        859,000           8,000           -           -           851,000           -           -           -  
Common stock issued
  to former
  MacroChem executives
      95,000         1,000         -         -         132,000       -       -       -  
Preferred dividends
    -       -       -       -       -       -       -       (480,000 )
Net loss
    -       -       -       -       -       -       -       (2,089,000 )
Balance at March 31,
   2009
    11,315,000       113,000       3,242.8617       -        227,663,000       (1,045,000 )     (4,000 )     (238,535,000 )
                                                                 
Warrants issued for
  services
    -       -       -       -       27,000       -       -       -  
Stock option
  compensation expense
    -       -       -       -       252,000       -       -       -  
Preferred stock
  converted into
  common stock
    117,000       1,000       (35.0000 )     -       (1,000 )     -       -       -  
Common stock issued to
  former MacroChem
  executives
      30,000         -         -         -         64,000         -         -         -  
Common stock issued
   for cash exercise of
   options
      25,000         -         -         -         14,000         -         -         -  
Restricted common
   stock issued for
   services
    127,000       2,000       -       -       314,000       -       -       -  
Preferred dividends
    -       -       -       -       -       -       -       (483,000 )
Net loss
    -       -       -       -       -       -       -       (2,208,000 )
Balance at June 30,
  2009
    11,614,000     $ 116,000       3,207.8617     $ -     $ 228,333,000     $ (1,045,000 )   $ (4,000 )   $ (241,226,000 )
                                                                 
 
The accompanying notes are an integral part of these consolidated statements.
 
17

Access Pharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows
(unaudited)
 
     
Six Months ended June 30,
 
   
2009
   
2008
 
Cash flows from operating activities:
           
     Net loss
  $ (4,297,000 )   $ (25,314,000 )
  Adjustments to reconcile net loss to cash used
              in operating activities:
               
Depreciation and amortization
    132,000       166,000  
Stock option expense
    308,000       673,000  
Stock and warrants issued for services
    564,000       100,000  
Acquired in-process research and development
    -       18,536,000  
Change in operating assets and liabilities:
               
Receivables
    132,000       (70,000 )
Prepaid expenses and other current assets
    117,000       (255,000 )
Other assets
    53,000       -  
Accounts payable and accrued expenses
    60,000       (754,000 )
Dividends payable
    (137,000 )     (25,000 )
Accrued interest payable
    229,000       209,000  
Deferred revenue
    1,380,000       1,069,000  
Net cash used in operating activities
    (1,459,000 )     (5,665,000 )
                 
Cash flows from investing activities:
               
    Capital expenditures
    (2,000 )     (31,000 )
 Proceeds from sale of asset
    1,000       -  
 Redemptions of short-term investments and certificate
    of deposits
    -       1,470,000  
 Virium acquisition by MacroChem, net of cash acquired
    -       (240,000 )
 Somanta acquisition, net of cash acquired
    -       (65,000 )
Net cash provided by (used in) investing activities
    (1,000 )     1,134,000  
                 
Cash flows from financing activities:
               
 Proceeds from debt issuance
    -       400,000  
    Payments of notes payable
    -       (639,000 )
 Proceeds from exercise of common stock options
    14,000       15,000  
    Proceeds from preferred stock issuances, net of costs
    -       2,444,000  
Net cash provided by financing activities
    14,000       2,220,000  
                 
Net decrease in cash and cash equivalents
    (1,446,000 )     (2,311,000 )
Cash and cash equivalents at beginning of period
    2,677,000       2,582,000  
Cash and cash equivalents at end of period
  $ 1,231,000     $ 271,000  
                 
Supplemental cash flow information:
               
   Cash paid for interest
  $ -     $ 8,000  
                 
Supplemental disclosure of noncash transactions:
               
Shares issued for payables, notes payable and accrued interest
    859,000       1,576,000  
Shares issued for dividends on preferred stock
    856,000       -  
  Preferred stock dividends in dividends payable
    963,000       525,000  
  Beneficial conversion feature –
     February 2008 preferred stock dividends
    November 2007 preferred stock dividends correction
    - -       857,000 451,000  
  Preferred stock issuance costs paid in cash
    -       281,000  
 Debt discount related to MacroChem convertible debt issuance
    -       93,000  
 
The accompanying notes are an integral part of these consolidated statements.

18

 
Access Pharmaceuticals, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements
Three Months Ended June 30, 2009 and 2008
(unaudited)

(1)  
Interim Financial Statements

The consolidated balance sheet as of June 30, 2009, and the consolidated statements of operations and cash flows for the three and six months ended June 30, 2009, and 2008, were prepared by management without audit. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, except as otherwise disclosed, necessary for the fair presentation of the financial position, results of operations, and changes in financial position for such periods, have been made.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted. It is suggested that these interim financial statements be read in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2008. The results of operations for the period ended June 30, 2009, are not necessarily indicative of the operating results which may be expected for a full year. The consolidated balance sheet as of December 31, 2008, contains financial information taken from the audited Access financial statements as of that date and is combined with the unaudited financial data from MacroChem, as discussed further in Note 4.

The report of our independent registered public accounting firm for the fiscal year ended December 31, 2008, contained a fourth explanatory paragraph to reflect its significant doubt about our ability to continue as a going concern as a result of our history of losses and our liquidity position, as discussed herein and in this Form 10-Q. We expect that our capital resources and expected receipts due under our license agreements will be adequate to fund our current level of operations into the first quarter of 2010. If we are unable to obtain adequate capital funding in the future or enter into future license agreements for our products, we may not be able to continue as a going concern, which would have an adverse effect on our business and operations, and investors’ investment in us may decline.

On February 25, 2009, we closed our acquisition of MacroChem Corporation through the issuance of an aggregate of approximately 2.5 million shares of our common stock. Prior to our acquisition of MacroChem, SCO, an investment company, held a majority of Access’ and MacroChem’s voting stock.  Specifically, SCO owned 53% of the voting stock of Access and 63% of the voting stock of MacroChem. A non-controlling interest of 37% existed at the merger date of MacroChem. In addition, certain members of SCO’s management serve on the board of directors of both Access and MacroChem. Based on these facts, Access and MacroChem were deemed under the common control of SCO. As the entities were deemed under common control, the acquisition was recorded using the pooling-of-interest method and the financial information for all periods presented reflects the financial statements of the combined companies in accordance with Appendix D of Statement of Financial Accounting Standards No. 141R (SFAS 141R), “Business Combinations,” for entities under common control. See also Note 4.

19

 
(2)           Intangible Assets

Intangible assets consist of the following (in thousands):

 
June 30, 2009
December 31, 2008
 
Gross
carrying
value
 
Accumulated
amortization
Gross
carrying
value
 
Accumulated
Amortization
Amortizable intangible assets
 
Patents
 
 
$         2,624
 
 
$      1,715
 
 
$     2,624
 
 
$1,609
         

Amortization expense related to intangible assets totaled $53,000 and $106,000 for each of the three and six months ended June 30, 2009 and totaled $53,000 and $107,000 for each of the three and six months ended June 30, 2008. The aggregate estimated amortization expense for intangible assets remaining as of June 30, 2009 is as follows (in thousands):
 
 
 2009    
  $         106
 2010    
 212
 2011      
 212
 2012     
 82
 2013     
 44
 over 5 years     
 253
     
 Total      
  $         909
 
 
(3)           Liquidity

The Company incurred significant losses allocable to common stockholders of $5,260,000 for the six months ended June 30, 2009 and $30,794,000 for the year ended December 31, 2008. At June 30, 2009, our working capital deficit was $5,842,000. We expect that our capital resources and receipts due under our license agreements will be adequate to fund our current level of operations into the first quarter of 2010. However, our ability to fund operations over this time could change significantly depending upon changes to future operational funding obligations or capital expenditures. As a result we may be required to seek additional financing sources and enter into future licensing agreements for our products within the next twelve months.

After the quarter closed, we received $1,000,000 in license receipts from an existing license agreement. Our cash balance at August 12, 2009 was $1,553,000.

(4)           MacroChem Acquisition

On February 25, 2009, the Company issued approximately 2,500,000 shares of its common stock in exchange for 100% of the outstanding stock and warrants of MacroChem Corporation (“MacroChem”). MacroChem’s principal activities are to develop and seek to commercialize pharmaceutical products using its proprietary drug delivery technologies. Its portfolio of proprietary product candidates is based on its drug delivery technologies: Soft Enhancement of Percutaneous Absorption (SEPA), MacroDerm and DermaPass. Its SEPA topical drug delivery technology enhances the efficiency and rate of diffusion of drugs into and through the skin. Currently, it has two clinical stage investigational new drugs: EcoNail, for the treatment of fungal infections of the nails and Pexiganan, for the treatment of mild diabetic foot infection (DFI).

20

 
Prior to our acquisition of MacroChem, SCO, an investment company, held a majority of Access’ and MacroChem’s voting stock.  Specifically, SCO owned 53% of the voting stock of Access and 63% of the voting stock of MacroChem. A non-controlling interest of 37% existed at the merger date of MacroChem. In addition, certain members of SCO’s management serve on the board of directors of both Access and MacroChem. Based on these facts, Access and MacroChem were deemed under the common control of SCO. As the entities were deemed under common control, the acquisition was recorded using the pooling-of-interest method and the financial information for all periods presented reflects the financial statements of the combined companies in accordance with Appendix D of Statement of Financial Accounting Standards No. 141R (SFAS 141R), “Business Combinations,” for entities under common control.

Upon acquisition, all outstanding warrants and any other dilutive instruments in MacroChem’s stock were cancelled. The in-the-money warrants converted with the common stock. In addition to the merger, the noteholders of MacroChem agreed to exchange their notes and interest due on the notes in the total amount of $859,000 for 859,000 restricted shares of the Access’ common stock. The value of the shares issued was determined based on the carrying value of the debt, which was established to be the more readily determinable fair value.

In addition, we issued 125,000 shares of Access common stock to former executives of MacroChem for the settlement of employment agreements.

In connection with the exchange of equity interests, $106,000 in merger costs were expensed.

The income statement for all periods presented reflects the combined carrying amount of revenue and expenses. Below is a reconciliation of summary financial data for the period ended June 30, 2009 and the combined MacroChem financial data for the six months ended June 30, 2008 and the twelve months ended December 31, 2008. The balance sheet as of December 31, 2008 also reflects the combined entities.
 
Following is a summary balance sheet at December 31, 2008:

       
   
Access Pharmaceuticals
   
MacroChem Corporation
   
Combined
 
Current assets
  $ 3,550,000     $ 82,000     $ 2,997,000  
Total assets
    4,257,000       608,000       4,230,000  
Current liabilities
    4,906,000       3,485,000       7,652,000  
Long-term deferred revenue     2,245,000        29,000        2,245,000  
Long-term debt
    5,500,000       -       5,500,000  
Stockholders’ deficit
    (8,394,000 )     (2,906,000 )     (11,167,000 )
 
Intercompany receivables/payables of $635,000 and intercompany deferred revenue of $29,000 were eliminated. Warrant liability of $104,000 is eliminated from liabilities because it was cancelled upon acquitistion
 
Following is a summary statement of operations for the six months ended June 30, 2009 and June 30, 2008 and for the year ended December 31, 2008:

21

 

   
For the six months ended June 30, 2009
   
For the year ended December 31, 2008
 
             
   
Access
Pharmaceuticals
   
MacroChem
Corporation
   
Combined
   
Access
Pharmaceuticals
   
MacroChem
Corporation
   
Combined
 
Total revenues
  $ 103,000     $ 1,000     $ 104,000     $ 291,000     $ 4,000     $ 295,000  
                                                 
Expenses
                                               
Research and development
    1,269,000       -       1,269,000       12,613,000       10,698,000       23,311,000  
General and administrative
    2,558,000       196,000       2,754,000       4,340,000       3,044,000       7,384,000  
Depreciation and
   amortization
    105,000       27,000       132,000       253,000       55,000       308,000  
      Total expenses
    3,932,000       223,000       4,155,000       17,206,000       13,797,000       31,003,000  
                                                 
Loss from operations
    (3,829,000 )     (222,000 )     (4,051,000 )     (16,915,000 )     (13,793,000 )     (30,708,000 )
                                                 
Interest and miscellaneous
   income
    16,000       -       16,000       178,000       33,000       211,000  
Interest and other expense
    (236,000 )     (26,000 )     (262,000 )     (478,000 )     (433,000 )     (911,000 )
Gain on change in value of
   warrant liability
    -       -       -       -       3,972,000       3,972,000  
      (220,000 )     (26,000 )     (246,000 )     (300,000 )     3,572,000       3,272,000  
Loss from operations
    (4,049,000 )     (248,000 )     (4,297,000 )     (17,215,000 )     (10,221,000 )     (27,436,000 )
Less preferred stock
   dividends
    (963,000 )     -       (963,000 )     (3,358,000 )     -       (3,358,000 )
Net loss allocable to
   common stockholders
  $ (5,012,000 )   $ (248,000 )   $ (5,260,000 )   $ (20,573,000 )   $ (10,221,000 )   $ (30,794,000 )
                                                 
Basic and diluted loss per
   common share
                                               
   Net loss allocable to
     common stockholders
    -       -     $ (0.48 )     -       -     $ (3.69 )
  Weighted average basic
     and diluted common
     shares outstanding
    -       -       10,954,472       -       -       8,354,031  
 

 
     
For the six months ended June, 2008 
 
 
     
Access
Pharmaceuticals 
     
MacroChem
Corporation 
     
Combined 
 
Total revenues
  $ 170,000     $ -     $ 170,000  
                         
Expenses
                       
Research and development
    10,824,000       10,188,000       21,012,000  
General and administrative
    1,933,000       2,185,000       4,118,000  
Depreciation and
   amortization
    131,000       35,000       166,000  
      Total expenses
    12,888,000       12,408,000       25,296,000  
                         
Loss from operations
    (12,718,000 )     (12,408,000 )     (25,126,000 )
                         
Interest and miscellaneous
   income
    105,000       7,000       112,000  
Interest and other expense
    (225,000 )     (75,000 )     (300,000 )
      (120,000 )     (68,000 )     (188,000 )
Loss from operations
    (12,838,000 )     (12,476,000 )     (25,314,000 )
Less preferred stock
   dividends
    (2,350,000 )     -       (2,350,000 )
Net loss allocable to
   common stockholders
  $ (15,188,000 )   $ (12,476,000 )   $ (27,664,000 )
                         
Basic and diluted loss per
   common share
                       
   Net loss allocable to
     common stockholders
    -       -     $ (3.45 )
  Weighted average basic
     and diluted common
     shares outstanding
    -       -       8,008,064  

 
 
 
 
                              For the three months ended June, 2008 
 
 
     
Access
Pharmaceuticals 
     
MacroChem
Corporation 
     
Combined 
 
Total revenues
  $ 132,000     $ -     $ 132,000  
                         
Expenses
                       
Research and development
    1,179,000       9,676,000       10,855,000  
General and administrative
    1,044,000       1,234,000       2,279,000  
Depreciation and
   amortization
    64,000       14,000       78,000  
      Total expenses
    2,287,000       10,925,000       13,212,000  
                         
Loss from operations
    (2,155,000 )     (10,925,000 )     (13,080,000 )
                         
Interest and miscellaneous
   income
    29,000       11,000       40,000  
Interest and other expense
    (117,000 )     (104,000 )     (221,000 )
      (88,000 )     (93,000 )     (181,000 )
Loss from operations
    (2,243,000 )     (11,018,000 )     (13,261,000 )
Less preferred stock
   dividends
    (517,000 )     -       (517,000 )
Net loss allocable to
   common stockholders
  $ (2,760,000 )   $ (11,018,000 )   $ (13,778,000 )
                         
Basic and diluted loss per
   common share
                       
   Net loss allocable to
     common stockholders
    -       -     $ (1.69 )
  Weighted average basic
     and diluted common
     shares outstanding
    -       -       8,135,869  
 
 
 
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 (5)           Stock Based Compensation

For the three and six months ended June 30, 2009 we recognized stock-based compensation expense of $252,000 and $308,000. For the three and six months ended June 30, 2008 we recognized stock-based compensation expense of $503,000 and $673,000.

The following table summarizes stock-based compensation for the three and six months ended June 30, 2009, and 2008:

   
Three months ended
June 30,
   
Six months ended
June 30,
 
   
2009
   
2008
   
2009
   
2008
 
Research and development
  $ 99,000     $ 26,000     $ 135,000     $ 39,000  
General and administrative
    153,000       477,000       173,000       634,000  
Stock-based compensation expense
   included in operating expense
  252,000     $ 503,000     308,000     673,000  


We granted 475,000 stock options during the second quarter of 2009 and granted no stock options in the same period of 2008. MacroChem options were cancelled upon acquistion by Access and are no longer outstanding.

Our weighted average Black-Scholes fair value assumptions used to value the 2009 and 2008 first six months grants are as follows:
 

       
 
6/30/09
  6/30/08 
Expected life
  5.5 yrs
 
6.2 yrs
Risk free interest rate
  2.4 %
 
3.0 %
Expected volatility(a)
  114 %
 
133%
Expected dividend yield
  0.0 %
 
 0.0 %
       

(a)
Reflects movements in our stock price over the most recent historical period equivalent to the expected life.

(6)           Related Parties
 
David P. Luci, one of our directors, was also the President & Chief Business Officer of MacroChem, with which we acquired on February 25, 2009 pursuant to the Merger Agreement dated July 9, 2008. We signed an amended Consulting, Settlement and Release Agreement with Mr. Luci on March 16, 2009 where he received 60,000 shares of our restricted common stock and $27,500 in a one time cash payment to settle his rights under a previous consulting agreement with MacroChem. On June 1, 2009 we signed a consulting agreement with Mr. Luci where Mr. Luci will provide consulting services to Access for cash compensation of $9,415 per month and for 200,000 shares of our restricted common stock and a cash bonus if certain events occur, as defined in the agreement. The restricted common stock vests 66,667 shares on June 1, 2009, 66,666 shares on January 1, 2010 and 66,667 shares on June 1, 2010.
 
(7)           Fair Value of Financial Instruments
 
SFAS 107-1, Interim Disclosure About Fair Value of Financial Instruments, requires disclosure about the fair value of all financial assets and liabilities for which it is practicable to estimate. The carrying value of cash, cash equivalents, receivables, accounts payable and accruals approximate fair value due to the short maturity of these items. The carrying value of the convertible long-term debt is at book value which approximates the fair value as the interest rate is at market value.
 
(8)           Subsequent Events
 
In preparing these financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through August 12, 2009, the date the financial statements were issued.

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