Published:
Favrille Reports First Quarter 2008 Financial Results
SAN DIEGO, May 8 /PRNewswire-FirstCall/ -- Favrille, Inc. (Nasdaq: FVRL),
a biopharmaceutical company developing patient-specific, active
immunotherapies for the treatment of cancer, today reported its financial
results for the first quarter ended March 31, 2008. Net loss for the quarter
was $10.5 million, or $0.25 per share, compared to $10.5 million, or $0.34 per
share, for the same period in 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/20080404/LAF521LOGO)
"As we prepare for the unblinding of our Phase 3 data, we find ourselves
at a critical inflection point," said John P. Longenecker, Ph.D., President
and Chief Executive Officer of Favrille. "The outcome of this trial will not
only define the future of our Company but, we believe, could ultimately change
the course of treatment for non-Hodgkin's lymphoma patients. If successful,
Specifid(TM) (mitumprotimut-T, formerly FavId(R)) would be a groundbreaking
cancer therapy, the culmination of nearly a decade of collaboration between
our employees, investors, clinical investigators, trial coordinators and
patients."
First Quarter 2008 Financial Review
Research and development expense was approximately $8.1 million for the
first quarter of 2008, compared to approximately $8.0 million for the same
period in 2007. The increase is primarily due to additional operating expenses
associated with Favrille's commercial-scale manufacturing facility,
stock-based compensation, additional personnel and consulting and outside
services to support the Company's Phase 3 registration trial of Specifid,
offset by a decrease in manufacturing supplies related to the completion of
patient enrollment in the Phase 3 trial and a decrease in cash bonus expense.
Total stock-based compensation included in research and development expense
was approximately $560,000 for the quarter, compared to approximately $400,000
for the first quarter of 2007.
Marketing, general and administrative expense was approximately $2.6
million for the first quarter of 2008, compared to approximately $2.9 million
during the same period in 2007. The decrease is primarily due to a decrease in
cash bonus expense, stock-based compensation and travel expenses. Total
stock-based compensation included in marketing, general and administrative
expense was approximately $560,000 for the quarter, compared to approximately
$660,000 for the first quarter of 2007.
As of March 31, 2008, Favrille had cash, cash equivalents and short-term
investments of $19.7 million, compared to $29.9 million at December 31, 2007.
The decrease is primarily due to net cash used to fund ongoing operations.
Loan and security agreements with Favrille's senior lenders require the
Company to maintain a minimum of $15 million in available cash, cash
equivalents and short-term investments. In the event Favrille's available cash
should fall below the minimum requirement, the lenders could require a letter
of credit equal to the outstanding loan balances at that time, in which case
the Company would be required to use a significant amount of its available
cash for collateral.
"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 Tamara A. Seymour,
Chief Financial Officer of Favrille. "We expect that our cash on hand is
sufficient to fund operations through our Phase 3 data analysis this quarter,
after which we will explore our financing options."
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 April 2008. As of the data cutoff date, 205 of
the 349 patients randomized have experienced disease progression (relapsed)
according to investigator determination. Final analysis will be based on a
central radiology assessment of the patients' CT scans. Median follow-up for
ongoing patients is 31 months from randomization (range 21 to 41 months), or
approximately 34 months from the initiation of Rituxan treatment (range 24 to
44 months). Based on the protocol's assumptions, this range of follow-up would
provide sufficient power to detect a significant difference between the two
arms for time to progression (TTP), the primary endpoint in the trial.
Conference Call and Webcast Information
Favrille management will host a conference call today to discuss the first
quarter 2008 financial results at 5:00 p.m. Eastern Time. A live audio webcast
of management's presentation will be available on the Investor Relations
section of the Company's web site at http://www.favrille.com. Alternatively,
callers may participate in the conference call by dialing (888) 713-4205 or
(617) 213-4862, passcode 61931952. To pre-register for this call, please go to
https://www.theconferencingservice.com/prereg/key.process?key=PFYXYBR33.
Callers who pre-register will be given a unique PIN to gain immediate access
to the call and bypass the live operator. You may pre-register at any time,
including up to and after the call start time. A telephone replay of the call
will also be available for 48 hours. The telephone replay can be accessed by
dialing (888) 286-8010 or (617) 801-6888, passcode 61738291.
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.
Copyright © 2009, PRNewswire
Copyright © 2009, NewsBlaze,
Daily NewsTags: ,HEA,MTC,BIO,ERN,CCA,CA-Favrille-Q1-Earns
Search News
Daily News
