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CORRECTING and REPLACING AVANT Reports Second Quarter and Six Month Financial Results

2008-08-06 07:46:00

CORRECTING and REPLACING AVANT Reports Second Quarter and Six Month Financial Results

Conference Call Wednesday, August 6 at 9:00 a.m. Eastern Time

NEEDHAM, Mass.–(EMWNews)–Please replace the release with the following corrected version due to

multiple revisions.

AVANT REPORTS SECOND QUARTER AND SIX MONTH FINANCIAL RESULTS

Conference Call Wednesday, August 6 at 9:00 a.m. Eastern Time

AVANT Immunotherapeutics, Inc. (NASDAQ: AVAN) today reported financial

results for the second quarter and six-month period ended June 30, 2008.

AVANT reported a net loss of $10.3 million, or $0.67 per share, for the

second quarter of 2008 compared to a net loss of $2.8 million, or $0.33

per share, for the second quarter of 2007. For the six months ended June

30, 2008, AVANT reported a net loss of $32.4 million, or $2.56 per

share, compared to a net loss of $6.8 million, or $0.82 per share, for

the six months ended June 30, 2007. The 2007 financial results reflect

the activities of Celldex only. As discussed in further detail later in

this release, the increase in net loss between the three-month periods

was primarily due to increased operating expenses as a result of the

merger of AVANT and Celldex, offset partially by increased revenues and

investment and other income. The increase in net loss between the

six-month periods was primarily due to non-cash charge of $17.2 million,

or $1.35 per share, relating to purchased in-process research and

development of $14.8 million and stock-based compensation expense of

$2.4 million. At June 30, 2008, AVANT reported cash and cash equivalents

of $52.4 million. This amount includes upfront payments totaling $50

million from AVANTs license and development

agreement with Pfizer for CDX-110, including a $10 million equity

investment by Pfizer. AVANT anticipates receiving a $10 million

milestone payment from Paul Royalty Fund upon GlaxoSmithKlines

U.S. launch of Rotarix®, which we expect to

receive in the second half of 2008.

During the quarter, AVANT completed one of

the largest partnership agreements in cancer immunotherapy when we

entered into an agreement with Pfizer for our novel therapeutic vaccine

candidateCDX-110,

said Anthony S. Marucci, AVANTs interim

President and Chief Executive Officer. We

continued to add to the rich data package for CDX-110 with the

presentation of positive Phase 2 survival data in patients with

glioblastoma multiforme at ASCO. In addition, we augmented our vaccine

platform, entering into a collaboration with 3M to access key toll-like

receptor (TLR) agonists for clinical study with our proprietary Antigen

Presenting Cell Targeting Technology. We are

now able to implement a comprehensive immunotherapy strategy which we

believe will open new doors to treatments for cancer and infectious

disease.

Key 2008 events recently announced:

  • Entered into an exclusive worldwide licensing agreement with Pfizer

    for our therapeutic cancer vaccine candidate, CDX-110, which is in

    Phase 2/3 development for the treatment of glioblastoma multiforme

    (GBM). This agreement also gives Pfizer exclusive rights to the

    development of EGFRvIII vaccines in other potential indications. Under

    the licensing and development agreement, Pfizer made an upfront

    payment to AVANT of $40 million and made a $10 million equity

    investment in AVANT, and thereafter Pfizer will fund all development

    costs for these programs. AVANT is also eligible to receive milestone

    payments exceeding $390 million for the successful development and

    commercialization of CDX-110 and additional EGFRvIII vaccine products,

    as well as double-digit royalties on any product sales.

  • Presented updated data from the Phase 2 ACTIVATE trial (n=21) and the

    continuation study, ACT II (n=23) of CDX-110 in patients with newly

    diagnosed EGFRvIII-positive glioblastoma multiforme (GBM) at ASCO.

    CDX-110 was generally well-tolerated with primary toxicity reported as

    local injection site reactions.

  • In the ACTIVATE study, median survival time was 26 months (95% CI:

    21.6, infinity) and median time-to-progression (TTP) was 14.2 months.

    No significant adverse events were seen in this study. Median survival

    in a historical matched cohort was 15.2 months (17/17) (95% CI: 13.9,

    20.5) (p=0.0001) with median time to progression of 7.13 months

    (p=0.0001).1

  • Preliminary results from the ACT II study currently estimate median

    overall survival to be 33.1 months, although the median has not yet

    been reached. The survival of a matched historical control group was

    14.3 months (95% CI: 13.0, 16.2) and a subgroup treated with

    temozolomide (TMZ) of 15.2 months (95% CI: 13.9, 20.5 p=0.0078).

    Overall TTP was 16.6 months (95% CI: 10.8, infinity) compared with 6.4

    months for the historical control group (95% CI: 5.0, 14.1).

  • Announced multi-year clinical research collaborations with 3M to

    access their proprietary Immune Response Modifier Resiquimod

    (and additional Toll-Like Receptor 7/8 agonists (TLR)) for clinical

    study with the Companys proprietary

    Antigen Presenting Cell (APC) Targeting Technology,

    for use as vaccine adjuvants.

  • Announced that the Division of Microbiology and Infectious Diseases of

    the National Institute of Allergy and Infectious Diseases (NIAID), an

    institute of the National Institutes of Health (NIH), has initiated a

    Phase 1 safety study of AVANTs

    investigational single-dose, oral vaccine designed to offer combined

    protection against both enterotoxigenic Escherichia coli (ETEC)

    and cholera. ETEC infection is a major cause of travelers

    diarrhea.

  • Reported results that the double-blind, placebo-controlled

    multi-center Phase 2 clinical trial of Ty800 met all primary

    endpoints. Importantly, immunogenic response was dose-dependent.

    Positive immune response or seroconversion (prospectively defined as a

    4-fold increase in anti-LPS titers over pre-dose level) rates were 65%

    (36/55) and 80% (44/55) in the low and high dose groups, respectively,

    and was significantly (p<0.001) higher

    than placebo.

  • Announced that GlaxoSmithKline (Glaxo) received approval from the U.S.

    Food and Drug Administration (FDA) for Glaxos

    Rotarix® product for the prevention of

    rotavirus gastroenteritis in infants. AVANT licensed a rotavirus

    strain to Glaxo that was used in the development of Rotarix®.

    FDA approval triggered a $1.5 million milestone payment from Glaxo,

    $750,000 of which AVANT retained.

Further Financial Highlights

The net loss for the second quarter of 2008 showed an increase of $7.5

million compared to the net loss for the same period in 2007. The

increase in net loss reflected an increase in operating expenses which

includes the combined operations of AVANT and Celldex post-merger,

offset in part by an increase in revenues. The increase in net loss also

reflected an increase in investment and other income. Research and

development (R&D) expenses in the second quarter of 2008 increased $5.2

million compared to R&D expenses in 2007 due primarily to sublicense

fees payable and increased clinical trials costs for CDX-110 and

CD-1307. General and administrative (G&A) expenses increased $3.6

million due primarily to accrued severance costs and increased

professional services expenses.

The six-month results for 2008 reflect an increase in net loss compared

to the same period in 2007. The increase in net loss reflected an

increase in operating expenses due primarily to the combined operating

expenses of the two companies from March 8 to June 30, 2008, including a

non-cash charge of $14.8 million for purchased in-process R&D and

non-cash charges of $1.1 million and $1.3 million for stock-based

compensation expense in R&D expense and G&A expense, respectively. The

increase in operating expenses also resulted from higher general and

administrative expenses, which is primarily due to increases in

personnel-related expenses and professional services costs for the

combined companies. The increase in net loss also reflected a decrease

in investment and other income.

Revenues for the first six months of 2008 increased compared with

revenues for the first six months of 2007. The increase in product

development and licensing revenue in 2008 primarily reflects recognition

of $492,020 in Pfizer deferred revenue related to CDX-110 in the second

quarter of 2008. The decrease in contracts and grants revenue in 2008

compared to 2007 primarily reflects reduced levels of vaccine

development work billable to Rockefeller University between periods. In

the first six months of 2008, AVANT also recognized $837,122 in product

royalty revenue related to royalty expense payable to CCH.

Important Information Related to AVANTs

Financial Results

On March 7, 2008, AVANT completed the merger of a wholly-owned

subsidiary of AVANT with Celldex Therapeutics, Inc. (Celldex). The

merger has created a NASDAQ-listed, fully-integrated and diversified

biopharmaceutical company with a deep pipeline of product candidates

addressing indications in oncology, infectious and inflammatory

diseases. In connection with the merger, AVANTs

board of directors approved a 1-for-12 reverse stock split of AVANTs

common stock, which became effective on March 7, 2008. As of June 30,

2008, AVANT had approximately 15.8 million shares outstanding.

The merger was accounted for using the purchase method of accounting and

was treated as an acquisition by Celldex of AVANT with Celldex being

considered the accounting acquirer even though AVANT was the issuer of

common stock and surviving legal entity in the transaction. Because

Celldex was determined to be the acquirer for accounting purposes, the

historical financial statements of Celldex became the historical

financial statements of the Company. Accordingly, the financial

statements of the Company prior to the merger reflect the financial

position, results of operations and cash flows of Celldex only.

Following the merger, the financial statements of the current three- and

six-month periods reflect the financial position, results of operation

and cash flows of Celldex for the three- and six-month periods ended

June 30, 2008 combined with the results of operations of AVANT beginning

March 8, 2008. Accordingly, the attached financial information reflects

the financial condition, results of operations and liquidity of the

Company at June 30, 2008 and historically of Celldex on a stand-alone

basis for all periods prior to March 8, 2008. The financial condition,

results of operations and liquidity of the Company as of June 30, 2008

and 2007 may not be indicative of the Companys

future performance or reflect what the Companys

financial conditions, results of operations and liquidity would have

been had the merger been consummated as of January 1 of each respective

year or had the Company operated as a separate, stand-alone entity

during the periods presented.

Webcast and Conference Call

AVANT will host a conference call and live audio webcast at 9:00 AM ET

on Wednesday, August 6, 2008 to discuss AVANTs

second quarter and six month 2008 financial results. To access the

conference call, dial 888-713-4199 (within the U.S.), or 617-213-4861

(if calling from outside the U.S.). The passcode for participants is

98796339. An audio replay will be available approximately two hours

after the call for approximately one week and can be accessed by dialing

888-286-8010 (within the U.S.), or 617-801-6888 (if calling from outside

the U.S.). The passcode I.D. number is 22696598. The replay will also be

broadcast via the Companys website, www.avantimmune.com,

after the live call. Additionally, a copy of this press release is

available by contacting Investor Relations at 781-433-0771.

About AVANT Immunotherapeutics, Inc.

AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company discovering

and developing innovative vaccines and targeted immunotherapeutics for

the treatment of cancer, infectious and inflammatory diseases. AVANT

focuses on the use of tumor-specific targets and human monoclonal

antibodies (mAbs) to precisely deliver therapeutic agents through its

novel targeted immunization

approach. In addition, AVANT is also exploiting its access to

proprietary human antibody technology for development of therapeutics

monoclonal antibodies (mAbs). AVANTs deep

product pipeline consists of products in varying stages of development,

with its lead candidate, CDX-110, partnered with Pfizer, Inc., currently

undergoing evaluation in a Phase 2/3 clinical trial in newly diagnosed

glioblastoma multiforme, one of the most aggressive forms of brain

cancer. AVANT also has five product candidates in its development

pipeline including:

  • CDX-1307, a product based on its proprietary APC Targeting Technology,

    which is in two Phase 1 clinical trials for patients with advanced

    pancreatic, bladder, breast and colon cancer;

  • TP10, a complement inhibitor, in development for transplantation and

    other indications; and

  • Three candidates based on its oral, rapidly-protecting, single-dose

    and temperature-stable vaccine technology, including combination

    vaccines for travelers, the military and global health needs.

AVANT licensed a rotavirus strain to GlaxoSmithKline that was used in

the development of Rotarix®

for the prevention of rotavirus infection. In addition, AVANT has two

human food safety vaccines for reducing salmonella infection in chickens

and eggs which have been commercialized. Additional information on AVANT

Immunotherapeutics, Inc. can be obtained through its site on the World

Wide Web: http://www.avantimmune.com.

Safe Harbor Statement Under the Private Securities Litigation

Reform Act of 1995: This release includes forward-looking statements

that are subject to a variety of risks and uncertainties and reflect

AVANTs current views with respect to future

events and financial performance. There are a number of important

factors that could cause the actual results to differ materially from

those expressed in any forward-looking statement made by AVANT. These

factors include, but are not limited to: (1) the successful integration

of the businesses, multiple technologies and programs of AVANT and

Celldex; (2) the ability to adopt AVANTs APC

Targeting TechnologyTM to develop

new, safe and effective vaccines against oncology and infectious disease

indications; (3) the ability to adapt AVANTs

vectoring systems to develop new, safe and effective orally administered

vaccines against disease causing agents; (4) the ability to successfully

complete product research and further development, including animal,

preclinical and clinical studies, and commercialization of CDX-110,

CDX-1307, CholeraGarde® (Peru-15), Ty800,

ETEC E. coli vaccine, and other products and AVANTs

expectations regarding market growth; (5) the cost, timing, scope and

results of ongoing safety and efficacy trials of CDX-110, CDX-1307,

CholeraGarde® (Peru-15), Ty800, ETEC E. coli

vaccine and other preclinical and clinical testing; (6) the ability to

negotiate strategic partnerships or other disposition transactions for

AVANTs cardiovascular programs, including

TP10 and CETi; (7) the ability of AVANT to manage multiple clinical

trials for a variety of product candidates; (8) the volume and

profitability of product sales of Megan®Vac

1, Megan®Egg

and other future products; (9) GlaxoSmithKlines,

or Glaxos, process of obtaining regulatory

approval for the sale of Rotarix®

in major commercial markets, as well as the timing and success of

worldwide commercialization of Rotarix®

by Glaxo, which is not within our control; (10) Glaxos

strategy and business plans to launch and supply Rotarix®

worldwide, including in the U.S. and other major markets, which is not

within our control, and its payment of royalties to AVANT; (11) Pfizers

and our strategy and business plans concerning the continued development

and commercialization of CDX-110; (12) AVANTs

expectations regarding its technological capabilities and expanding its

focus to broader markets for vaccines; (13) changes in existing and

potential relationships with corporate collaborators; (14) the

availability, cost, delivery and quality of clinical and commercial

grade materials produced at AVANTs own

manufacturing facility or supplied by contract manufacturers and

partners; (15) the timing, cost and uncertainty of obtaining regulatory

approvals; (16) AVANTs ability to develop

and commercialize products before competitors that are superior to the

alternatives developed by such competitors; (17) AVANTs

ability to retain certain members of management;(18) AVANTs

expectations regarding research and development expenses and general and

administrative expenses; (19) AVANTs

expectations regarding cash balances, capital requirements, anticipated

royalty payments (including those from Paul Royalty Fund), revenues and

expenses, including infrastructure expenses; (20) the ability to obtain

substantial additional funding; (21) AVANTs

belief regarding the validity of our patents and potential litigation;

and (22) certain other factors that might cause AVANTs

actual results to differ materially from those in the forward-looking

statements including those set forth under the headings Business,

Risk Factors and

Managements Discussion and Analysis of

Financial Condition and Results of Operations

in each of AVANTs Annual Report on Form

10-K, its current Reports on Form 8-K, as well as those described in

AVANTs other press releases and filings with

the Securities and Exchange Commission, from time to time. You

should carefully review all of these factors, and you should be aware

that there may be other factors that could cause these differences. These

forward-looking statements were based on information, plans and

estimates at the date of this press release, and AVANT does not promise

to update any forward-looking statements to reflect changes in

underlying assumptions or factors, new information, future events or

other changes.

1 Heimberger, A., et al. Epidermal Growth

Factor Receptor VIII Peptide Vaccination Is Efficacious Against

Established Intracerebral Tumors. Clin Cancer Res Vol. 9,

pp4247-4254, September 15, 2003.

AVANT IMMUNOTHERAPEUTICS, INC.

 

 

 

 

 

 

CONSOLIDATED STATEMENTS

Quarter

Six Months

OF OPERATIONS DATA

 

Ended June 30,

 

Ended June 30,

2008

2007

2008

2007

(Unaudited)

(Unaudited)

REVENUE

Product Development and

Licensing Agreements

$

845,529

$

116,539

$

965,393

$

233,078

Contracts and Grants

278,960

492,645

306,494

520,146

Product Royalties

 

 

837,122

 

 

 

 

 

 

837,122

 

 

 

 

 

Total Revenue

 

 

1,961,611

 

 

 

609,184

 

 

 

2,109,009

 

 

 

753,224

 

 

OPERATING EXPENSE

Research and Development

7,611,666

2,369,824

12,117,294

5,159,189

General and Administrative

4,605,482

1,049,423

7,619,386

2,578,000

Charge for Purchased In-Process

Research and Development

14,755,908

Amortization of Acquired Intangible Assets

 

 

104,164

 

 

 

29,233

 

 

 

153,058

 

 

 

58,466

 

 

Total Operating Expense

 

 

12,321,312

 

 

 

3,448,480

 

 

 

34,645,646

 

 

 

7,795,655

 

 

Operating Loss

(10,359,701

)

(2,839,296

)

(32,536,637

)

(7,042,431

)

 

Investment Income, Net

 

 

99,191

 

 

 

84,159

 

 

 

145,445

 

 

 

254,891

 

 

Net Loss

 

$

(10,260,510

)

 

$

(2,755,137

)

 

$

(32,391,192

)

 

$

(6,787,540

)

 

Basic and Diluted Net Loss per

 

Common Share

 

$

(0.67

)

 

$

(0.33

)

 

$

(2.56

)

 

$

(0.82

)

Weighted Average Common

 

Shares Outstanding

 

 

15,227,475

 

 

 

8,309,420

 

 

 

12,677,455

 

 

 

8,309,420

 

 

 

 

CONDENSED CONSOLIDATED

BALANCE SHEETS

 

 

 

 

 

June 30,

 

December 31,

2008

2007

(Unaudited)

ASSETS

Cash and Cash Equivalents

$

52,379,836

$

4,909,530

Other Current Assets

AVANT Immunotherapeutics, Inc.
Anthony S. Marucci, 781-433-0771
Interim

President and CEO
or
AVANT Immunotherapeutics, Inc.
Avery

W. Catlin, 781-433-0771
Chief Financial Officer
[email protected]
or
For

Media:
BMC Communications Group
Marissa Nelson,

212-477-9007 x21
[email protected]

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Blake Masterson

Freelance Writer, Journalist and Father of 5

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