Favrille, Inc. News
Favrille Reports First Quarter 2008 Financial Results
"As we prepare for the unblinding of our Phase 3 data, we find ourselves at a critical inflection point," said
First Quarter 2008 Financial Review
Research and development expense was approximately
Marketing, general and administrative expense was approximately
As of
"For the past eight years we have worked diligently to fund the company, from inception up to and including our Phase 3 registration trial, while making every effort to maximize shareholder value," said
Phase 3 Registration Trial Update
Favrille reached the data cutoff date for its Phase 3 registration trial of Specifid following Rituxan(R) in patients with follicular B-cell non-Hodgkin's lymphoma (NHL) in
Conference Call and Webcast Information
Favrille management will host a conference call today to discuss the first quarter 2008 financial results at
About Favrille, Inc.
Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, Specifid (mitumprotimut-T, formerly FavId), is based upon unique genetic information extracted from a patient's tumor. Specifid is currently under clinical investigation in a Phase 3 registration trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of cutaneous T-cell lymphoma.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Favrille's product candidates, proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to Favrille's ability to fund operations through the primary endpoint analysis of its Phase 3 clinical registration trial progress and timing of clinical trials for Specifid, including difficulties or delays in development, testing, manufacturing and marketing Specifid or Favrille's other product candidates; whether Favrille's lenders require a letter of credit equal to its outstanding loan balances and the related use of cash; Favrille's ability to obtain additional financing to support its operations; changes in timelines for the availability of data from Favrille's Phase 3 clinical trial; Favrille's ability to obtain marketing approval for Specifid or Favrille's other product candidates and the timing of any such approvals, including whether a clinically meaningful response improvement can serve as the basis for accelerated approval of Specifid and whether it will receive expedited review as a result of the Fast Track designation; Favrille's ability to demonstrate that its idiotype protein produced from insect cell lines may stimulate a more effective immune response compared to idiotype protein derived from mammalian cells; Favrille's ability to manufacture sufficient quantities of Specifid for use in clinical trials and, if Specifid receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using Specifid; potential delays in patient enrollment; and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. In addition, conclusions regarding the safety and efficacy of Favrille's product candidates cannot be made until the results of future clinical trials of longer duration in more patients are known. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
FAVRILLE, INC. (a development stage company) BALANCE SHEETS (in thousands, except share and per share data) March 31, December 31, 2008 2007 (unaudited) Assets Current assets: Cash and cash equivalents $ 16,089 $ 26,362 Short-term investments 3,569 3,577 Other current assets 1,007 806 Total current assets 20,665 30,745 Property and equipment, net 32,276 33,293 Restricted cash 3,571 3,451 Other assets 423 466 Total assets $ 56,935 $ 67,955 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued liabilities $ 3,106 $ 3,551 Current portion of debt 5,046 5,275 Warrants liability 2,403 2,492 Total current liabilities 10,555 11,318 Debt, less current portion 5,097 6,342 Deferred rent 15,596 15,415 Commitments and contingencies Stockholders' equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding at March 31, 2008 and December 31, 2007, respectively - - Common stock, $0.001 par value; 75,000,000 shares authorized; 41,299,598 and 41,168,432 issued and outstanding at March 31, 2008 and December 31, 2007, respectively 41 41 Additional paid-in capital 235,101 233,807 Accumulated other comprehensive income 2 7 Deficit accumulated during the development stage (209,457) (198,975) Total stockholders' equity 25,687 34,880 Total liabilities and stockholders' equity $ 56,935 $ 67,955 FAVRILLE, INC. (a development stage company) STATEMENTS OF OPERATIONS (in thousands, except per share data) Unaudited Three Months ended March 31, 2008 2007 Operating expenses: Research and development $ 8,063 $ 7,997 Marketing, general and administrative 2,556 2,912 Total operating expenses 10,619 10,909 Interest income 281 565 Interest expense (233) (187) Change in valuation of warrants 89 - Total other income, net 137 378 Net loss $ (10,482) $ (10,531) Net loss per share: Basic and diluted $ (0.25) $ (0.34) Weighted-average shares — basic and diluted 41,182 30,690 FAVRILLE, INC. (a development stage company) STATEMENTS OF CASH FLOWS (in thousands) Unaudited Three Months ended March 31, 2008 2007 Operating activities: Net loss $ (10,482) $ (10,531) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 1,080 659 Stock-based compensation 1,117 1,054 Amortization of premium/discount on short-term investments (29) (177) Change in valuation of warrants (89) - Other 1 36 Changes in operating assets and liabilities: Other assets (163) (420) Accounts payable and accrued liabilities (315) (1,178) Deferred rent 181 466 Net cash used in operating activities (8,699) (10,091) Investing activities: Purchases of property and equipment (187) (3,990) Purchases of short-term investments (468) (6,263) Maturities of short-term investments 500 14,900 Restricted cash (120) - Net cash provided by (used in) investing activities (275) 4,647 Financing activities: Proceeds from debt - 4,362 Payments on debt (1,476) (1,186) Issuance of common stock and warrants 177 10,207 Net cash provided by (used in) financing activities (1,299) 13,383 Net increase (decrease) in cash and cash equivalents (10,273) 7,939 Cash and cash equivalents at beginning of period 26,362 14,249 Cash and cash equivalents at end of period $ 16,089 $ 22,188 Supplemental non-cash activities: Capitalized interest recorded as property, plant and equipment $ 63 $ 127 Accrued asset acquisitions $ (130) $ 238 Leasehold improvements acquired under tenant improvement allowance $ - $ 3,669
SOURCE Favrille, Inc.
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