SAN DIEGO, Nov. 14 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. today announced financial results for the nine months ended September 30, 2005.
ADVENTRX reported a net loss of $3.5 million, or $0.06 per share, for the third quarter of 2005, compared with a net loss of $2.1 million, or $0.04 per share, for the third quarter of 2004.
“In the third quarter ADVENTRX experienced increased visibility to the investment community with the Company’s selection to the new Russell Microcap(TM) Index and with a $20 million private equity placement led by Carl Icahn,” said Evan M. Levine, ADVENTRX president and chief executive officer. “We increased the size of our board of directors with the appointment of Keith Meister who was nominated to the board by Carl Icahn in accordance with the terms of the private equity financing.”
“We made significant progress in the past several months with the clinical development for our lead product, CoFactor(TM), as well as expanding and building our product pipeline. We announced that the Phase II ‘COFU’ clinical trial was completing patient follow up and that two abstracts containing independently-reported COFU clinical data were submitted for consideration in the 2006 Gastrointestinal Cancers Symposium program in January. Additionally, we reported that approximately 25% of patients were enrolled and 21 clinical sites were opened for patient enrollment in the Phase IIb clinical trial in Europe and India. We are continuing to recruit sites for our Phase III pivotal clinical trial in metastatic colorectal cancer and currently expect to begin patient dosing in the first quarter of 2006.”
“Furthermore, we announced results from an in vitro study indicating that Thiovir(TM), our non-nucleoside reverse transcriptase inhibitor (NNRTI), demonstrated effectiveness against human immunodeficiency virus type-1 (HIV-1), which is resistant to other NNRTIs and nucleoside reverse transcriptase inhibitors (NRTIs).”
“Finally, in alignment with our strategy to develop drugs that address issues such as safety, we announced the acquisition of certain rights to ANX-530, a novel formulation of vinorelbine tartrate that has been shown to reduce vein irritation compared with the commercially available form of vinorelbine. We have initiated discussions with the FDA for the clinical trial design and a pre-investigational new drug (IND) meeting with the FDA has been scheduled for December.”
Third Quarter and First Three Quarters of 2005 Financial Review
Research and development expenses for the third quarter of 2005 were $1.7 million, versus $984,000 for the third quarter of 2004. This increase was due primarily to increased costs of the Company’s Phase IIb clinical trial as patients continued to be enrolled in the trial as well as increased preclinical costs related to drug development.
General and administrative expenses for the 2005 third quarter were $1.9 million, compared with $1.2 million for the same period in 2004. This increase is due primarily to employee and non-employee stock-based compensation charges and amounts payable for a legal settlement which executed in October 2005.
For the nine months ended September 30, 2005, net loss was $9.7 million, or $0.17 per share, compared with a net loss of $4.3 million, or $0.09 per share, for the same period in 2004.
For the first nine months of 2005, research and development expenses were $5.7 million, compared with $2.1 million for the first nine months of 2004. The increase for the nine months is primarily due to expenses related to Phase II CoFactor clinical trials and hiring of personnel.
General and administrative expenses for first nine months of 2005 were $4.2 million, compared with $2.3 million for the same period in 2004. The increase was due to factors discussed above as well as increased personnel costs due to new hires, increased facility costs related to the new leased office space and increased consulting expense related primarily to SOX 404 compliance efforts.
The Company reported that it expects research and development expenses to significantly increase in 2006 from levels reported in the third quarter of 2005 as it ramps up for a pivotal Phase III CoFactor clinical trial and continues patient enrollment in its Phase IIb CoFactor clinical trial. The Company also expects that general and administrative expenses will increase measurably during the remainder of 2005 as it prepares for compliance with Section 404 of the Sarbanes-Oxley Act.
ADVENTRX reported cash, cash equivalents and short-term investments of approximately $25.5 million as of September 30, 2005, compared with $13.0 million as of December 31, 2004.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. The Company’s lead compound, CoFactor(TM), is a biomodulator of 5-fluorouracil (5-FU), a widely used cancer chemotherapy. CoFactor is currently being tested with 5-FU in Phase II and Phase IIb clinical trials as a first line treatment of metastatic colorectal cancer. In addition, CoFactor has received clearance under a special protocol assessment from the FDA to begin a Phase III pivotal clinical trial for metastatic colorectal cancer. More information can be found on the Company’s Web site at www.adventrx.com.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management’s current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s last quarterly report on Form 10-Q, as well as other reports that the Company files from time to time with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY (A Development Stage Enterprise) Condensed Consolidated Balance Sheets September 30, December 31, 2005 2004 (unaudited) Assets Current assets: Cash and cash equivalents $18,506,914 $13,032,263 Accrued interest income 9,365 10,808 Prepaid expenses 537,400 115,144 Short-term investments 7,007,637 Other current assets 88,755 -- Assets available for sale -- 108,000 Total current assets 26,150,071 13,266,215 Property and equipment, net 348,142 285,304 Other assets 58,386 57,268 Total assets $26,556,599 $13,608,787 Liabilities and Shareholders’ Equity Current liabilities: Accounts payable $417,309 $532,327 Accrued liabilities 1,088,272 628,754 Accrued salary and related taxes 186,804 57,315 Total current liabilities 1,692,385 1,218,396 Other long-term liabilities 62,429 -- Total liabilities 1,754,814 1,218,396 Commitments and contingencies -- -- Shareholders’ equity: Common stock, $0.001 par value. Authorized 100,000,000 shares; issued 67,146,298 shares in 2005 and 53,834,237 shares in 2004 67,147 53,835 Additional paid-in capital 69,611,168 47,553,497 Deficit accumulated during the development stage (44,840,158) (35,182,194) Accumulated other comprehensive income (loss) (1,625) -- Treasury stock, 23,165 shares at cost (34,747) (34,747) Total shareholders’ equity 24,801,785 12,390,391 Total liabilities and shareholders’ equity $26,556,599 $13,608,787 ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY (A Development Stage Enterprise) Condensed Consolidated Statements of Operations (unaudited) Three months ended Nine months ended September 30, September 30, 2005 2004 2005 2004 Interest income $159,373 $28,055 $261,292 $44,742 159,373 28,055 261,292 44,742 Operating expenses: Research and development 1,720,257 983,665 5,661,663 2,053,131 General and administrative 1,887,260 1,155,716 4,161,171 2,315,936 Depreciation and amortization 34,331 12,481 96,422 19,199 Total operating expenses 3,641,848 2,151,862 9,919,256 4,388,266 Net loss $(3,482,475) $(2,123,807) $(9,657,964) $(4,343,524) Loss per common share -- basic and diluted $(.06) $(.04) $(.17) $(.09)
ADVENTRX Pharmaceuticals, Inc.
CONTACT: Andrea Lynn of ADVENTRX Pharmaceuticals, +1-858-552-0866
Web site: http://www.adventrx.com//
