Favrille, Incorporated

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Favrille Announces Resolution of Debt Obligations and Plans for Maximizing Assets

www.prnewswire.com

Favrille, Inc. (Nasdaq: FVRL) is a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer. (PRNewsFoto/Favrille, Inc.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/07-07-2008/0004844613&EDATE=

Biotech Stocks: Drug stocks rally; Kosan rockets on takeover deal (at MarketWatch)

www.marketwatch.com | May 29, 2008

Drug stocks rally as shares of Kosan Biosciences mark a threefold gain on news the company has agreed to be bought by Bristol-Myers Squibb for $5.50 a share in cash.

http://www.marketwatch.com/news/story/drug-stocks-rally-kosan-rockets/story.aspx?guid=%7BB81CD1CD%2D8ABC%2D4E89%2D877A%2DC5D1DA2D7637%7D&siteid=yhoof

Favrille, Inc. Announces Workforce Reduction

www.biospace.com | May 29, 2008

SAN DIEGO, May 29 /PRNewswire-FirstCall/ -- Favrille, Inc. today announced that it has provided a notice to 132 of its 144 employees, including six of its eight executive officers, that their employment with the Company will end on June 6, 2008. This workforce reduction follows the announcement

http://www.biospace.com/news_story.aspx?StoryID=98272&full=1

Favrille to cut 132 out of 144 employees after drug fails

feeds.marketwatch.com | May 29, 2008

NEW YORK (MarketWatch) -- Favrille Inc. said Thursday that it is cutting 132 of 144 employees including 6 of its 8 executive officers as of June 6. This comes after Phase 3 trials for its lead product, Specifid, in which it failed to show benefit. The remaining employees will manage a plan to

http://feeds.marketwatch.com/~r/marketwatch/marketpulse/~3/300503980/story.aspx

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Favrille Investors: Wait Patiently For Final Phase III Results - Seeking Alpha

biotech.seekingalpha.com

Two weeks ago Favrille Inc. (FVRL) released preliminary results from its phase III trial concerning its lead drug candidate FavID. FavID is an active immunotherapy used in conjunction with Rituxan for the treatment of B-cell non-Hodgkins lymphoma.

http://biotech.seekingalpha.com/article/21200

Camstar Life Sciences | Manufacturing Execution Systems (MES) | Favrille | Press Release

Favrille is currently in Phase III clinical trials for FavId®, an active immunotherapy for the treatment of follicular B-cell non-Hodgkin’s lymphoma.

http://www.camstar.com/pr/080306.aspx

Favrille inks deal with Berlex

www.retailnet.com

Biotech company Favrille has entered into an agreement with Berlex, a U.S. affiliate of Bayer Schering Pharma AG, Germany, to focus on studying the use of Favrille's active immunotherapy, Favld, in conjunction with Berlex's growth factor Leukine in patients with B-cell non-Hodgkins lymphoma.

http://www.retailnet.com/story.cfm?ID=35272

Clinical Trials With Klh

Favrille > Clinical Trials > Non-Hodgkin's Lymphoma Clinical Trial Summary FavId (Idiotype/KLH) is an investigational immunotherapy being studied in people with follicular non-Hodgkin's Lymphoma. Many doctors may not be aware of Favrille's Phase III ... http://www.favrille.

http://www.clinicalassistance.com/clinical-trials-with-klh.php

 

Favrille to Host Conference Call and Live Webcast to Discuss First Quarter 2008 Financial Results

Favrille, Inc. (Nasdaq: FVRL), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced today that it will host a conference call and live webcast at 5:00 p.m. Eastern Time on Thursday, May 8, 2008 to discuss the Company's first quarter 2008 financial results. A press release will be issued after the U.S. stock markets close that day.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080404/LAF521LOGO)

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(TM) (formerly FavId(R)), is based upon unique genetic information extracted from a patient's tumor. Specifid is currently under investigation in a Phase 3 registration trial for patients with follicular B-cell non-Hodgkin's lymphoma (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.

SOURCE Favrille, Inc.

http://www.favrille.com

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Tags: cancer   clinical   conference   financial results   investigation   manufacturing   nasdaq   nhl   technology   trial   web  

Companies: Favrille Inc (FVRL)

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Favrille Reports First Quarter 2008 Financial Results - Zibb.com

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.

http://www.favrille.com

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Companies: Favrille Inc (FVRL)

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Favrille Halts Lead Cancer Drug Trials, Fails To Meet Goal In Late-Stage Study - Zibb.com

May 28, 2008 (FinancialWire) Favrille Inc. (NASDAQ: FVRL) said it will end development of its lead experimental cancer drug, Specifid, because it failed to meet the main goal in a late-stage trial, essentially wiping out about 86 percent of the company's market value.

In the late-stage trial, Favrille was evaluating Specifid in patients who had already received Rituxan, made by Genentech's (NYSE: DNA), which is the current standard of care, for the treatment of follicular B-cell non-Hodgkin's lymphoma, a cancer that affects the lymphatic system.

Following standard treatment with Rituxan, patients received Specifid plus Bayer AG's Leukine in the treatment arm or dummy drug plus Leukine in the control arm.

As of March 31, the company had $19.7 million in cash. Under its debt agreement, Favrille needs to have $14.5 million in available cash and equivalents. The company has $9 million in debt.

The company said analysis of time to progression, the primary endpoint of the trial, failed to show a statistically significant improvement in the treatment arm compared to the control arm.

Favrille said that the analysis of all subgroups did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors.

According to Favrille, Specifid is an active immunotherapy agent that is based upon genetic information extracted from a patient's tumor and is designed to stimulate the immune system

FinancialWire" is a fully independent, proprietary news wire service of Investrend Information (a division of Investrend Communications, Inc.). FinancialWire" news is written by professional journalists, dedicated to pure journalistic standards. FinancialWire" does not receive or accept any compensation from any individual or subject company (or representative thereof) for its news or opinions. All FinancialWire" news is available at http://www.financialwire.net . Please address any inquiries to feedback@financialwire.net .

Free annual reports for companies mentioned in the news are available at http://investrend.ar.wilink.com/?level=279 .

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Companies: Favrille Inc (FVRL), Genentech, Inc. (DNA)

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Favrille Announces Results from Phase 3 Registration Trial of Specifid in Patients with Follicular

Favrille, Inc. (Nasdaq: FVRL) today announced results from the Company's Phase 3 registration trial of Specifid(TM) following Rituxan(R) in patients with follicular B-cell non-Hodgkin's lymphoma (NHL).

(Logo: http://www.newscom.com/cgi-bin/prnh/20080404/LAF521LOGO )

Analysis of time to progression (TTP), the primary endpoint in the trial, failed to show a statistically significant improvement in the treatment arm, Specifid plus Leukine(R) (sargramostim, GM-CSF) following Rituxan, compared to the control arm, placebo plus Leukine following Rituxan. Analysis of all subgroups also did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors.

The safety profile was comparable between the two arms and consistent with what has been observed in previous Specifid trials. Most adverse events reported in the trial were of low grade.

"We are clearly very disappointed with the data from this trial, particularly on behalf of the patients and their families," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "Based on these results, we are discontinuing development of Specifid and are currently evaluating steps to conserve cash and recognize value on our assets. We wish to thank all of our employees and the patients, clinical investigators and trial coordinators for their support and dedication."

About the Phase 3 Registration Trial

Favrille initiated its Phase 3 randomized, placebo-controlled, double-blind registration trial of Specifid for follicular B-cell NHL in July 2004. The Company completed enrollment in January 2006 with 349 patients randomized into the trial. The trial was open to both treatment-naive and previously treated patients, ultimately enrolling a much larger treatment-naive population (78%). Patients were randomized at a one-to-one ratio to receive either Specifid or placebo following a standard course of Rituxan. The trial was conducted at 67 centers in the U.S.

Conference Call and Webcast

Favrille's management team will host a conference call today at 8:30 a.m. Eastern Time to discuss the information contained in this press release. A live audio webcast will be available on the Investor Relations section of the Company's web site at www.favrille.com . Alternatively, callers may participate in the conference call by dialing (866) 831-6267 or (617) 213-8857, passcode 99549869. 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 20389415.

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.

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 and clinical development 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 continue its operations, conserve cash or recognize value on our assets and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. 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.

SOURCE Favrille, Inc.

http://www.favrille.com

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Tags: cancer   ceo   clinical   conference   law   nasdaq   nhl   population   president   research   technology   trial   web  

Companies: Favrille Inc (FVRL)

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