Filing
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): | August 12, 2009 |
ADVENTRX Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware | 001-32157 | 84-1318182 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
6725 Mesa Ridge Road, Suite 100, San Diego, California | 92121 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | 858-552-0866 |
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On August 12, 2009, ADVENTRX Pharmaceuticals, Inc. issued a press release announcing its financial results for the three and six months ended June 30, 2009. A copy of this press release is furnished as Exhibit 99.1 hereto.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The list of exhibits called for by this Item is incorporated by reference to the Exhibit Index filed with this report.
The information set forth under Item 2.02 and in Exhibit 99.1 is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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 hereunto duly authorized.
ADVENTRX Pharmaceuticals, Inc. | ||||
August 12, 2009 | By: |
/s/ Patrick L. Keran
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Name: Patrick L. Keran | ||||
Title: Vice President, Legal |
Exhibit Index
Exhibit No. | Description | |
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99.1
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Press Release, dated August 12, 2009 |
ADVENTRX PHARMACEUTICALS REPORTS
SECOND QUARTER FINANCIAL RESULTS
Conference call begins at 4:30 p.m. Eastern time today
SAN DIEGO August 12, 2009 ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial results for the three and six months ended June 30, 2009.
Following our recent successful fundraisings, we believe we have the capital to complete and submit a New Drug Application (NDA) for ANX-530 to the U.S. Food and Drug Administration later this year, said Brian M. Culley, Principal Executive Officer at ADVENTRX. Our financial results reflect a commitment to careful cash management and deployment, such as for the manufacturing work we re-started in June and successfully completed earlier this month, a key step toward our first NDA submission.
Second Quarter Financial Results
For the three months ended June 30, 2009, ADVENTRXs net loss applicable to common stock was $3.8 million, or $0.04 per share, compared with a net loss applicable to common stock of $6.4 million, or $0.07 per share, for the comparable period in 2008. Included in the net loss applicable to common stock for the 2009 second quarter was a non-cash deemed dividend expense of $1.2 million incurred in connection with the Companys June 2009 equity financing. Net loss for the three months ended June 30, 2009, which does not reflect the deemed dividend expense, was $2.6 million. Included in both net loss and net loss applicable to common stock were charges associated with the Companys reductions in force made in October 2008, and January and March 2009.
Research and development (R&D) expenses in the second quarter of 2009 were $1.5 million, a decrease of $3.1 million, or 68%,,compared with R&D expenses of $4.5 million in the second quarter of 2008. The decrease was primarily due to a $1.1 million decrease in external clinical trial expenses related to ANX-510, a $0.1 million decrease in external clinical trial expenses related to ANX-514, a $1.2 million decrease in non-clinical expenses related to ANX-514, a $0.6 million decrease in personnel expenses and a $0.1 million decrease in share-based compensation expense.
Selling, general and administrative (SG&A) expenses in the second quarter of 2009 were $1.1 million, a decrease of $1.6 million, or 59%, compared with SG&A expenses of $2.6 million in the second quarter of 2008. The decrease was primarily due to a $1.1 million decrease in personnel costs, a $0.1 million decrease in share-based compensation expense, a $0.2 million decrease in legal and professional services, a $0.1 million decrease in market research expenses and a $0.1 million decrease in travel expenses.
Year-to-Date Financial Results
For the six months ended June 30, 2009, ADVENTRXs net loss applicable to common stock was $7.0 million, or $0.08 per share, compared with a net loss applicable to common stock of $12.4 million, or $0.14 per share, for the comparable period in 2008. Included in the net loss for the 2009 period was a non-cash deemed dividend expense of $1.2 million incurred in connection with the Companys June 2009 equity financing. Net loss for the six months ended June 30, 2009, which does not reflect the deemed dividend expense, was $5.8 million. Included in both net loss and net loss applicable to common stock were charges associated with the Companys reductions in force made in October 2008, and January and March 2009.
R&D expenses for the first half of 2009 were $3.1 million, a decrease of $5.2 million, or 63%, compared with R&D expenses of $8.3 million in the first half of 2008. The decrease was primarily due to a $1.3 million decrease in external clinical trial expenses related to ANX-510, a $1.8 million decrease in non-clinical expenses related to ANX-514, a $0.2 million decrease in non-clinical expenses related to ANX-201 and ANX-211, a $0.2 million decrease in non-clinical expenses related to ANX-530, a $1.1 million decrease in personnel costs and a $0.5 million decrease in share-based compensation expense, offset by a $0.1 million increase in external clinical trial expenses related to ANX-514.
SG&A expenses in the first half of 2009 were $2.9 million, a decrease of $2.2 million, or 43%, compared with SG&A expenses of $5.0 million in the first half of 2008. The decrease was primarily due to a $1.1 million decrease in personnel costs, a $0.3 million decrease related to share-based compensation expense, a $0.4 million decrease in legal and professional services, a $0.1 million decrease in market research expenses, a $0.2 million decrease in travel expenses, and a $0.1 million decrease in insurance related expenses.
Balance Sheet Highlights
As of June 30, 2009, the Company had cash and cash equivalents of $5.4 million and stockholders equity of $2.3 million.
Conference Call and Webcast
ADVENTRX will hold a conference call today beginning at 4:30 p.m. Eastern time to review financial results for the second quarter and provide an update on its business. Individuals interested in listening to the conference call may do so by dialing (866) 305-6438 for domestic callers, or (706) 679-7161 for international callers, or from the webcast on the investor relations section of the Companys Web site at www.adventrx.com. A 48-hour telephone replay will be available approximately one hour after the conclusion of the call by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering reservation code 23355569. The webcast will be available on the Companys Web site for 14 days following the completion of the call.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company whose product candidates are designed to improve the safety of existing cancer treatments. More information can be found on the Companys website at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRXs results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to submit an NDA for ANX-530, to fund operations or pre-launch activities during the FDA review period if an NDA is submitted or launch activities should an NDA for ANX-530 be approved; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to continue as a going concern; the risk that ADVENTRX will seek protection under the provisions of the U.S. Bankruptcy Code; the risk that ADVENTRX will reassess the results of the ANX-530 bioequivalence study and determine to conduct additional bioequivalence studies of ANX-530, including in humans; the potential for regulatory authorities to require additional preclinical work and/or clinical activities to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-530, which activities may increase the cost and timeline to NDA submission or approval; the risk the FDA will determine that ANX-530 and Navelbine® are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based on a patient population other than the population on which ADVENTRX based its analysis; the risk of investigator bias in reporting adverse events as a result of the open-label nature of the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530, including validating commercial manufacturing processes and manufacturers, as well as suppliers; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; the risk that ADVENTRXs significantly reduced workforce and leadership by officers who do not have substantial previous experience in executive leadership roles will negatively impact its ability to raise capital or maintain effective disclosure controls and procedures or internal control over financial reporting; the risk that ADVENTRXs common stock will be delisted by the NYSE Amex, including as a result of failing to comply with applicable stockholder approval requirements or to maintain sufficient stockholders equity or a sufficient stock price; the risk that ADVENTRX will be unable to file timely required reports with the Securities and Exchange Commission; the risk that ADVENTRX will trigger a maintenance failure under that certain Rights Agreement, dated July 27, 2005, as amended, and be required to pay liquidated damages, including as a result of losing its eligibility to use Form S-3 if its common stock is delisted from the NYSE Amex or ADVENTRX is not timely in its filings with the Securities and Exchange Commission; and other risks and uncertainties more fully described in ADVENTRXs press releases and periodic filings with the Securities and Exchange Commission. ADVENTRXs public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement as set forth in this press release to reflect events or circumstances arising after the date on which it was made.
Contact:
ADVENTRX Pharmaceuticals
Brian Culley, Principal Executive Officer
858-552-0866
Investor Contact:
Lippert/Heilshorn & Associates, Inc.
Don Markley (dmarkley@lhai.com)
310-691-7100[Tables to Follow]
ADVENTRX Pharmaceuticals, Inc. | ||||||||||||||||
(A Development Stage Enterprise) | ||||||||||||||||
Summary Consolidated Financial Information | ||||||||||||||||
(In 000s except for per share data) | ||||||||||||||||
Consolidated Statement of Operations Data: |
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Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
Revenues |
$ | | $ | 500 | $ | 300 | $ | 500 | ||||||||
Operating expenses: |
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Research and development |
1,455 | 4,511 | 3,102 | 8,332 | ||||||||||||
Selling, general and administrative |
1,071 | 2,636 | 2,851 | 5,001 | ||||||||||||
Depreciation and amortization |
26 | 45 | 58 | 91 | ||||||||||||
Total operating expenses |
2,552 | 7,192 | 6,011 | 13,423 | ||||||||||||
Loss from operations |
(2,552 | ) | (6,691 | ) | (5,711 | ) | (12,923 | ) | ||||||||
Interest / Other income |
(43 | ) | 266 | (41 | ) | 565 | ||||||||||
Loss before income taxes |
(2,596 | ) | (6,426 | ) | (5,753 | ) | (12,359 | ) | ||||||||
Provision for income taxes |
| | | | ||||||||||||
Net loss |
$ | (2,596 | ) | $ | (6,426 | ) | $ | (5,753 | ) | $ | (12,359 | ) | ||||
Deemed Dividends on preferred stock |
(1,232 | ) | | (1,232 | ) | | ||||||||||
Net Loss applicable to common stock |
$ | (3,828 | ) | $ | (6,426 | ) | $ | (6,985 | ) | $ | (12,359 | ) | ||||
Net loss per share basic and diluted |
$ | (0.04 | ) | $ | (0.07 | ) | $ | (0.08 | ) | $ | (0.14 | ) | ||||
Weighted average shares basic and diluted |
93,389 | 90,253 | 91,838 | 90,253 | ||||||||||||
Balance Sheet Data: |
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June 30, | December 31, | |||||||||||||||
2009 | 2008 | |||||||||||||||
(unaudited) | ||||||||||||||||
Total cash and investments in securities |
$ | 5,419 | $ | 9,850 | ||||||||||||
Total current assets |
6,024 | 10,450 | ||||||||||||||
Total current liabilities |
3,871 | 3,871 | ||||||||||||||
Stockholders equity |
2,296 | 6,000 |
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