surf1944
17 years ago
Coley Pharmaceutical Group Reports Third Quarter and Nine-month Financial Results
-- Recent Events in Drug Development Programs Highlighted --
WELLESLEY, Mass., Nov. 1 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY), a biopharmaceutical company discovering and developing a novel class of drug candidates known as TLR Therapeutics(TM), today reported financial results for the third quarter and nine months ended September 30, 2007.
FINANCIAL UPDATES
Financial Results for the Third Quarter
Net loss decreased in the third quarter of 2007 by $2.1 million to $6.4 million from a loss of $8.5 million in the same period of 2006. The decrease in net loss is due primarily to a $3.0 million reduction in operating expenses.
Revenue of $5.1 million in the third quarter of 2007 was substantially unchanged compared to the same period of 2006.
Research and development (R&D) expenses totaled $8.6 million for the three months ended September 30, 2007 versus $11.0 million in the same period of 2006. The $2.4 million decrease in R&D expenses is primarily due to a reduction in clinical trial and drug development expenses associated with the suspension of the ACTILON(TM) clinical development program. Consistent with Coley's strategy to pioneer the development of second-generation TLR Therapeutics, discovery research and preclinical expenses within R&D increased $0.8 million over the same quarter in the prior year.
General and administrative (G&A) expenses were $2.8 million in the third quarter of 2007 versus $3.4 million in the third quarter of 2006. This decrease is primarily attributable to a reduction in external consulting fees.
As of September 30, 2007, unrestricted cash, cash equivalents and marketable securities totaled $87.8 million compared to $107.0 million as of December 31, 2006. Shares outstanding at September 30, 2007 were approximately 26.6 million.
Financial Results for Nine Months Ended September 30, 2007
For the nine months ended September 30, 2007, Coley reported a net loss of $28.2 million versus $24.6 million in the same period of 2006. The $3.6 million increase in net loss is due primarily to a $16.8 million purchased technology charge which was associated with Coley's acquisition in June 2007 of 3M Company's therapeutic Toll-like receptor (TLR) assets, partially offset by an $11.0 million increase in revenue and a $3.7 million decrease in operating expenses.
Revenue increased by $11.0 million to $26.0 million in the nine months ended September 30, 2007 compared to the same period of 2006. Collaborator revenue increased by $10.4 million due primarily to license fees recognized in the second quarter of 2007 from Merck & Co., Inc. and Dynavax Technologies Corporation.
R&D expenses decreased by $5.3 million to $27.4 million for the nine months ended September 30, 2007 versus $32.7 million in the same period of 2006 primarily as a result of suspending the clinical development of ACTILON.
2007 year-to-date cash used by operations decreased by $14.9 million to $13.4 million compared to $28.3 million during the same period in 2006. The decrease is primarily due to an increase of $10.0 million in cash received from collaborators and a reduction in operating expenses, excluding the charge for purchased technology.
RECENT EVENTS
-- Coley initiated a Phase I clinical safety trial of CPG 52364, its
proprietary, orally-available, small molecule TLR7, 8 and 9 antagonist
drug candidate. CPG 52364 is designed to specifically inhibit TLRs 7,
8 and 9 and to block inappropriate immune system activity underlying
certain autoimmune diseases, including systemic lupus erythematosus,
rheumatoid arthritis and psoriasis.
-- Coley's partner, Pfizer, selected an additional TLR9 agonist drug
candidate for development for the potential treatment of cancers. The
compound was discovered and characterized by Coley as part of a
Screening Agreement signed by the two companies in 2005. Under the
agreement, Pfizer funds research, development and characterization of
novel TLR9 agonists and has exclusive rights to two of these newly
discovered compounds. This second generation drug candidate should
complement Pfizer's ongoing clinical programs for PF-3512676, Coley's
most advanced TLR9 agonist therapeutic drug candidate for the treatment
of cancer.
-- Pfizer is currently investigating PF-3512676 in combination with
non-cytotoxic anti-cancer agents. A Phase II clinical trial evaluating
PF-3512676 in combination with Tarceva(R) for the treatment of
refractory non-small cell lung cancer, and a Phase I clinical trial
evaluating PF-3512676 in combination with Pfizer's anti-CTLA4 antibody,
tremelimumab, for the treatment of advanced melanoma are both underway.
Pfizer is currently planning additional clinical trials with PF-3512676
to evaluate its safety and potential efficacy in other cancer
indications.
-- Coley has received a milestone payment of $3.0 million from
GlaxoSmithKline. The milestone payment was triggered by the initiation
of GSK's Phase III clinical trial of its MAGE-A3 immunotherapeutic,
incorporating VaxImmune, in patients with early-stage, completely
resected non-small cell lung cancer (stage IB, II or IIIA NSCLC).
-- sanofi-aventis completed a Phase I safety study of AVE-0675 in the US.
The French regulatory authority (AFSSAPS) has approved the protocol for
a second Phase I study with AVE-0675.
UPDATED 2007 Financial Guidance
Coley adjusted its full year financial guidance for net loss, R&D expenses, cash burn and year end cash, based on nine month financial results and on the timing and cost of ongoing and planned clinical trials. Coley estimates its full-year 2007 net loss to be in the range of $35.0 million to $37.0 million, full year R&D expenses to be approximately $37.0 million inclusive of stock compensation expense and estimated cash burn to be between $28.0 million to $30.0 million. Cash and securities at December 31, 2007 are estimated to range from $77.0 million to $79.0 million.
INVESTOR CALL
Coley will host an investor conference call at 4:30 p.m. U.S. Eastern Time on November 1, 2007 with company management to discuss third quarter 2007 financial results.
To access the live audio broadcast or the subsequent archived recording of the call, please visit the Investor Center section of the Coley website at http://www.coleypharma.com. Please log onto Coley's website several minutes prior to the start of the call to ensure adequate time for any software download that may be required. A replay of this webcast will be available through November 15, 2007.
Investors may participate in the conference call by dialing either +1-888-713-4217 in the U.S. or +1-617-213-4869 outside the U.S. and typing in the passcode 20929767. A replay of this call will be available at +1-888-286-8010 (U.S.) or +1- 617-801-6888 (international) using the passcode 82770375 until November 15, 2007.
The webcast is also being distributed through the Thomson StreetEvents Network to both institutional and individual investors. Individual investors can listen to the call at http://www.fulldisclosure.com and institutional investors can access the call via http://www.streetevents.com.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, allergy and asthma disorders, autoimmune diseases and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis Vaccines and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Coley's estimated financial results for the fiscal year ending December 31, 2007. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
September 30, December 31,
2007 2006
Assets
Cash, cash equivalents and marketable
securities $87,779 $107,046
Accounts receivable 875 448
Deferred royalty fees 4,967 6,258
Property and equipment, net 5,418 4,597
Other assets 4,032 3,926
Total assets $103,071 $122,275
Liabilities and Shareholders' Equity
Current liabilities $6,670 $6,206
Deferred revenue (current and long-term) 31,373 41,469
Note payable 3,439 3,117
Payable due to 3M (current and long-term) 12,255 -
Other long-term liabilities 922 841
Shareholders' equity 48,412 70,642
Total liabilities and shareholders'
equity $103,071 $122,275
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
Revenue
Collaborative agreements $4,155 $4,387 $22,769 $12,395
Government contracts and grants 957 701 3,223 2,619
Total revenue 5,112 5,088 25,992 15,014
Operating expenses
Research and development 8,633 10,966 27,372 32,685
Purchased technology - - 16,757 -
General and administrative 2,799 3,413 9,614 9,385
Royalty expense 507 539 2,964 1,599
Total operating expenses 11,939 14,918 56,707 43,669
Loss from operations (6,827) (9,830) (30,715) (28,655)
Other income, net 406 1,346 2,558 4,051
Net loss ($6,421) ($8,484) ($28,157) ($24,604)
Net loss per share
Basic and diluted net loss per share ($0.24) ($0.32) ($1.06) ($0.94)
Weighted average shares used to
compute basic and diluted
loss per share 26,566 26,314 26,503 26,203
Note 1: For the nine months ended September 30, 2007, the Company recorded
charges of $1.5 million associated with the Company's January 2007
decision to suspend its independent clinical development of ACTILON of
which $0.9 million was recorded within research and development expenses
and $0.6 million was recorded within general and administrative expenses.
Note 2: For the nine months ended September 30, 2007, the Company recorded
a $16.8 million charge for research assets purchased from 3M.
Note 3: The following tables show stock-based compensation expense
included in the condensed consolidated statement of operations for the
three and nine months ended September 30, 2007 and 2006.
(In thousands)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
Research and development $672 $627 $2,170 $1,880
General and administrative 800 731 2,581 2,102
Total stock-based
compensation expense $1,472 $1,358 $4,751 $3,982
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Nine Months Ended
September 30,
2007 2006
Net cash used in operating activities ($13,409) ($28,335)
Cash flows from investing activities
Net maturities of marketable
securities 36,751 3,078
First annual payment for purchased
technology (5,000) -
Purchases of property and equipment (1,532) (672)
Other (111) 46
Net cash provided by investing activities 30,108 2,452
Cash flows from financing activities
Principal payments of capital lease
obligations (129) (714)
Proceeds from stock option exercises 205 537
Proceeds from repayment of
shareholder note - 44
Net cash provided by (used in) financing
activities 76 (133)
Exchange rate effect on cash and cash
equivalents 705 442
Net increase (decrease) in cash and
cash equivalents 17,480 (25,574)
Cash and cash equivalents, beginning
of period 52,505 85,911
Cash and cash equivalents, end of period $69,985 $60,337
Marketable securities, end of period $17,794 $53,571
Cash, cash equivalents, and
marketable securities, end of period $87,779 $113,908
SOURCE Coley Pharmaceutical Group, Inc.
Source: PR Newswire (November 1, 2007 - 4:06 PM EDT)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
Coley Pharmaceutical Group Diversifies Pipeline with First-in-Class TLR Antagonist for the Treatment of Systemic Lupus Erythematosus
-- CPG 52364, Coley's First Orally-Available, Small Molecule Drug Candidate, Enters Phase I Clinical Development --
WELLESLEY, Mass., Oct. 29 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY), today announced that it has dosed its first subject in a Phase I safety study of its novel, orally-available TLR Therapeutic(TM) drug candidate for the treatment of Systemic Lupus Erythematosus, or SLE. The candidate, CPG 52364, is a small molecule Toll- Like Receptor (TLR) antagonist designed to specifically inhibit TLRs 7, 8 and 9 and inhibit disease development in SLE and other autoimmune disorders. CPG 52364 has been designed to interfere at an early stage of the immune cascade by blocking the inappropriate immune activation of all three of these TLRs, and to treat the underlying cause of the disease without causing general suppression of immune function.
The Phase I study is a double-blind, placebo-controlled, randomized clinical trial designed to examine the safety, tolerability and pharmacokinetics of ascending doses of CPG 52364. The compound will be administered as a single oral dose in approximately 40 healthy volunteers.
'Coley is committed to innovation in TLR Therapeutic drug development, and we are pleased to have furthered our objective of pipeline diversification by advancing this first-in-class TLR antagonist compound into the clinic,' commented Robert L. Bratzler, Ph.D., President and Chief Executive Officer of Coley Pharmaceutical Group. 'We believe there is solid preclinical evidence and strong scientific rationale that validate CPG 52364 for the treatment of SLE, and potentially other autoimmune diseases, such as rheumatoid arthritis (RA) and psoriasis, where TLRs 7, 8 and 9 are inappropriately activated. As with our other clinical efforts, we are hopeful that we can make a contribution to medicine with a new potential therapy for a disease that today remains a large unmet medical need.'
CPG 52364's Mechanism of Action in SLE
The defining characteristic of SLE is the production of autoantibodies, abnormal antibodies produced against the body's own tissues or organs. In SLE, these autoantibodies bind to DNA and/or RNA, and their associated cellular proteins, forming 'immune complexes'. Immune complexes containing anti-DNA antibodies activate TLR9, while immune complexes that contain RNA activate TLR7 and TLR8.
Recent studies show that the development and progression of SLE are driven by the inappropriate activation of TLR7, TLR8 and TLR9. TLRs7 and 9 are present within B cells, which secrete high levels of interferon-alpha and contribute to disease severity. TLR8 is expressed in monocytes and other dendritic cells, which are thought to produce proinflammatory cytokines, which further contribute to disease process. Other studies have indicated that autoimmunity in rheumatoid arthritis (RA) and psoriasis also is mediated through one or more of these TLRs.
Coley evaluated and selected TLR7, 8 and 9 as important targets by elucidating the therapeutic mechanism of action for a commonly used treatment for SLE and RA. For many years, SLE and RA patients have been treated with certain antimalarial drugs as a treatment for SLE, such as hydroxychloroquine (HCQ), which was serendipitously discovered to be a moderately effective therapy for the disease. The therapeutic mechanism for HCQ in these autoimmune diseases had been unknown, until research from Coley and other scientists revealed that the compound is an antagonist of TLR9, and to a lesser extent TLRs7 and 8.
Based on the new recognition by Coley that the efficacy of HCQ appears to result from blocking TLRs 7, 8 and 9, Coley designed and developed CPG 52364 to inhibit these TLRs more effectively. In Coley's preclinical studies, CPG 52364 showed a marked increase in therapeutic potency compared to HCQ, preventing the development of anti-DNA antibodies in SLE-prone mice, while also exhibiting an improved safety profile.
In addition to its activity as a monotherapy, preclinical data showed that the combination of CPG 52364 with HCQ delivers added efficacy, suggesting that CPG 52364 could be used clinically either in combination with HCQ or as a replacement therapy for HCQ in the first-line treatment of SLE.
Coley plans to present data from its preclinical research with CPG 52364 at The 71st annual meeting of the American College of Rheumatology (ACR) at the new Boston Convention and Exhibition Center in Boston, Massachusetts. Dr. Arthur Krieg, Coley's Executive Vice President of Research and Development and Chief Scientific Officer will deliver a presentation on Friday, November 9, 2007 at 2:45pm EST, entitled, 'Antimalarials are More Effective at Inhibiting Toll-Like Receptor 9 than at Inhibiting Antigen Presentation' (Presentation #1310).
Dr. Grayson Lipford, Vice President, Basic Research for Coley Pharmaceutical Group, plans to present a poster entitled, 'Selective Toll-like Receptor 7/8/9 Antagonists for the Oral Treatment of Autoimmune Diseases,' (Poster Board #210). The poster will be available for viewing on Saturday, November 10, 2007 from 8:00am to 4:30pm EST.
About Systemic Lupus Erythematosus (SLE)(1)
SLE is a chronic autoimmune disease that affects nearly 500,000 Americans. The disease, which is nine times more prevalent in women than men, and is also more prevalent in minorities, occurs when the immune system produces antibodies that cause inflammation, pain and damage to various tissues and organs in the body.
SLE is a leading cause of kidney disease, stroke, and premature cardiovascular disease in women of childbearing age. There is no known cure for this disease.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, asthma and allergy, autoimmune disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development either independently or with partners, and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi- aventis, GlaxoSmithKline, Merck, Novartis and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.
surf1944
17 years ago
Coley Pharmaceutical Group Receives $3.0 Million Milestone Payment from GlaxoSmithKline
WELLESLEY, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY), today announced that the company has received a $3.0 million milestone payment from GlaxoSmithKline (GSK) associated with the initiation of GSK's Phase III clinical trial in non-small cell lung cancer (NSCLC) of an immunotherapeutic cancer vaccine containing Coley's VaxImmune(TM) vaccine adjuvant.
In June 2007, GSK announced the launch of the largest Phase III clinical trial in lung cancer to evaluate the MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) in patients with early stage, completely resected NSCLC. VaxImmune is one of the components of MAGE-A3 ASCI, intended to increase an anti-tumor immune response. The randomized, double-blind, and placebo-controlled Phase III clinical trial, known as the MAGRIT trial (MAGE- A3 as Adjuvant Non-Small Cell Lung Cancer Immunotherapy) will target enrollment of about 2,270 patients with stage IB, II or IIIA resectable NSCLC. The primary endpoint of the trial is disease-free survival. The $3 million development milestone was triggered by the initiation of this Phase III trial.
VaxImmune is Coley's proprietary TLR9 agonist designed to induce both an enhanced antibody response and a potent killer T cell immune response when used in conjunction with vaccines in order to achieve and sustain a clinical response without compromising safety. Coley has granted GSK worldwide licenses for the use of VaxImmune in GSK's vaccines in development for certain cancers and infectious diseases.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, asthma and allergy and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development either independently or with partners, and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
SOURCE Coley Pharmaceutical Group, Inc.
Source: PR Newswire (October 26, 2007 - 11:35 AM EDT)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
Coley Pharmaceutical Group Adopts Shareholder Rights Plan
WELLESLEY, Mass., Oct. 8 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY), a biopharmaceutical company discovering and developing a novel class of drug candidates known as TLR Therapeutics(TM), announced today that its Board of Directors has adopted a Stockholder Rights Plan (the 'Rights Plan') that is designed to strengthen the ability of the Board of Directors to protect Coley's stockholders. The plan was not adopted in response to any unsolicited offer or takeover attempt.
Each stockholder of record of the Company on October 15, 2007, will receive a dividend of one Right for each outstanding share of Common Stock held. Each Right represents the right to purchase, under certain circumstances, one one-hundredth of a share of a new series of preferred stock of the Company. The Rights will be triggered ten days after a public announcement of the acquisition by a person or group of 15 percent or more of Coley's Common Stock, or ten days after the commencement of a tender or exchange offer for the Common Stock that would result in the acquisition of 15 percent or more of the Common Stock. The Rights will expire October 5, 2017, unless redeemed or exchanged earlier by Coley's Board of Directors. The Rights distribution will not result in a taxable event to Coley stockholders.
The Rights Plan is designed to protect Coley stockholders against abusive or coercive takeover tactics and other takeover tactics that are not in the best interests of the company and its stockholders, such as acquisitions of control without paying all stockholders a fair premium, coercive tender offers and inadequate offers. It is not intended to prevent an offer that the Board concludes is in the best interest of Coley and its stockholders. A complete copy of the Rights Plan will be included in a Form 8-K to be filed by Coley with the Securities and Exchange Commission. In addition, stockholders of record of Coley on October 15, 2007, will be mailed a detailed summary of the Rights Plan.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, allergy and asthma disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis Vaccines and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to Coley's Rights Plan. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
SOURCE Coley Pharmaceutical Group, Inc.
Source: PR Newswire (October 8, 2007 - 7:
surf1944
17 years ago
Coley Pharmaceutical Group Reports Second Quarter and Six-month Financial Results
WELLESLEY, Mass., Aug. 2 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY), a biopharmaceutical company discovering and developing a novel class of drug candidates known as TLR Therapeutics(TM), today reported financial results for the second quarter and six months ended June 30, 2007.
FINANCIAL UPDATES
Financial Results for the Second Quarter
Net loss increased in the second quarter of 2007 by $5.7 million to $14.0 million from a loss of $8.3 million in the same period of 2006. The increase in net loss is due primarily to a $16.8 million purchased technology charge associated with Coley's acquisition of 3M Company's therapeutic Toll-like receptor (TLR) assets.
Revenues increased by $10.5 million in the second quarter of 2007 to $15.4 million compared to $4.9 million in the same period of 2006. The increase in revenue primarily resulted from new licensing agreements with Merck & Co., Inc. and Dynavax Technologies Corporation, as well as from an increase of $0.9 million in cost reimbursement from Pfizer Inc for development services incurred on their behalf under our licensing agreement with them.
Research and development (R&D) expenses totaled $8.7 million for the three months ended June 30, 2007 versus $10.9 million in the same period of 2006. The $2.2 million decrease in R&D expenses is primarily due to a reduction in clinical trial and drug development expenses associated with the suspension of the ACTILON(TM) clinical development program. Consistent with Coley's strategy to pioneer the development of second-generation TLR Therapeutics, discovery research and preclinical expenses within R&D increased $0.7 million over the same quarter in the prior year.
Coley reported a $16.8 million charge in the three months ended June 30, 2007 to acquire 3M's therapeutic TLR assets. This charge for purchased technology represents the present value of the $20.0 million purchase price.
General and administrative (G&A) expenses were $2.9 million in the second quarter of 2007 versus $3.1 million in the second quarter of 2006. This decrease is primarily attributable to reduced compensation expense associated with the suspension of the ACTILON clinical development program.
Royalty expense increased by $1.4 million to $2.0 million in the three months ended June 30, 2007 from $0.6 million in the same period of 2006. The increase resulted primarily from royalties paid to the University of Iowa Research Foundation (UIRF) and the Ottawa Health Research Institute (OHRI) related to licensing payments received from Merck and Dynavax.
As of June 30, 2007, unrestricted cash, cash equivalents and marketable securities totaled $95.9 million compared to $107.0 million as of December 31, 2006. Shares outstanding at June 30, 2007 were approximately 26.5 million.
Financial Results for Six Months Ended June 30, 2007
For the six months ended June 30, 2007, Coley reported a net loss attributable to shareholders of $21.7 million versus $16.1 million in the same period of 2006. The increase in net loss is primarily attributed to the charges associated with purchased technology from 3M.
Revenues increased by $11.0 million to $20.9 million in the six months ended June 30, 2007 compared to the same period of 2006. Collaborator revenue increased by $10.6 million due primarily to license fees received from Merck and Dynavax. Revenue earned from cost reimbursement increased by $1.2 million due to reimbursement from Pfizer for development services under our licensing agreement with them.
Research and development expenses decreased by $3.0 million to $18.7 million for the six months ended June 30, 2007 versus $21.7 million in the same period of 2006 primarily as a result of suspending the clinical development of ACTILON.
2007 year-to-date cash used by operations decreased by $13.0 million to $5.9 million compared to the same period in 2006. The decrease is primarily due to an increase of $10.8 million in cash received from collaborators and a reduction in operating expenses, excluding the charge for purchased technology.
SECOND QUARTER EVENTS
Commenting on the previously announced clinical setback of PF-3512676, Dr. Robert Bratzler, Coley's President and Chief Executive Officer, stated, 'The failure of PF-3512676 in combination with cytotoxic chemotherapy to add benefit in the treatment of advanced non-small cell lung cancer was disappointing. Pfizer is continuing its trials of PF-3512676 in refractory non-small cell lung cancer in combination with Tarceva(R) and in advanced melanoma in combination with Pfizer's anti-CTLA-4 (cytotoxic T lymphocyte antigen-4) targeted monoclonal antibody (CP-675,206). In the coming months, we hope to provide additional clarity on Pfizer's ongoing and planned clinical programs with PF-3512676.'
Dr. Bratzler continued, 'Despite the setback, we and our collaborators continued to make steady progress this quarter advancing our pipeline of clinical and late-stage preclinical product candidates. In particular, GlaxoSmithKline announced this past quarter that VaxImmune(TM) will be entering Phase III clinical testing as part of GSK's immunotherapeutic for lung cancer. Coley remains focused on creating value by advancing our unpartnered proprietary TLR therapeutics pipeline while maximizing, through partnerships, the potential of our vaccine adjuvant, VaxImmune.'
In the second quarter of 2007, Coley broadened its pipeline, advanced its partnered programs and capitalized on the value of its intellectual property, including:
-- Acquisition of 3M's therapeutic Toll-like receptor (TLR) assets. The
acquisition includes a pipeline of clinical and preclinical small
molecule candidates targeting TLR7 and TLR8, an intellectual property
estate and a library of small molecule compounds that stimulate TLR7
and TLR8.
-- Merck obtained a non-exclusive license to incorporate Coley's vaccine
adjuvant, VaxImmune, into vaccines being developed by Merck for certain
infectious diseases and Alzheimer's disease.
-- GlaxoSmithKline announced plans to initiate a Phase III clinical trial
of its MAGE-A3 immunotherapeutic, incorporating VaxImmune, in patients
with early stage, completely resected non-small cell lung cancer (stage
IB, II or IIIA NSCLC).
-- sanofi-aventis completed patient enrollment in a Phase I safety trial
of AVE-0675 which is being developed for the treatment of asthma.
-- Coley granted Dynavax a non-exclusive license under Coley's
immunostimulatory oligonucleotide patent estate for the
commercialization of HEPLISAV(TM), a hepatitis B prophylactic vaccine,
currently in Phase III clinical trials.
2007 FINANCIAL GUIDANCE AND OUTLOOK
Based on the licensing revenue in the second quarter from Merck and Dynavax, as well as the acquisition of 3M's therapeutic TLR assets, Coley is updating its 2007 financial guidance. Coley now expects its full-year net loss to be approximately $37.0 million to $39.0 million and its estimated cash burn to be between $30.0 million and $33.0 million in 2007. As a result, Coley expects unrestricted cash, cash equivalents and marketable securities to be in the range of $74.0 million to $77.0 million at the end of 2007.
-- Revenues: Coley expects 2007 revenue to be in the range of
approximately $30.0 million to $32.0 million. This includes revenues
from Coley's ongoing licensing agreements with Pfizer and other
collaborators, as well as Merck and Dynavax licensing revenues recorded
in the first six months of 2007, and revenues from government
contracts.
-- Research and Development (R&D) Expense: Coley continues to estimate
that its research and development expenses will be approximately $39.0
million in 2007, inclusive of stock compensation expense.
-- Purchased Technology: Coley's second quarter 2007 purchase of 3M's
therapeutic TLR assets resulted in a $16.8 million charge.
-- General and Administrative (G&A) Expense: Coley continues to estimate
that its general and administrative expenses for 2007 are expected to
by approximately $12.0 million, inclusive of stock compensation
expense.
-- Stock Compensation Expense: Coley estimates stock compensation expense
of approximately $6.5 million for 2007. Of this amount, approximately
$3.2 million will be recorded as G&A expense, and approximately $3.3
million will be recorded as R&D expense.
-- Capital Expenditures and Loan Repayments: Coley continues to estimate
that its capital expenditures for 2007 will be approximately $2.0
million. Coley also expects to repay a bank loan of approximately $2.0
million.
INVESTOR CALL
Coley will host an investor conference call at 4:30 p.m. U.S. Eastern Time on August 2, 2007 to discuss second quarter 2007 financial results.
To access the live audio broadcast or the subsequent archived recording of the call, please visit the Investor Center section of the Coley website at www.coleypharma.com. Please log onto Coley's website several minutes prior to the start of the call to ensure adequate time for any software download that may be required. A replay of this webcast will be available through August 16, 2007.
Investors may participate in the conference call by dialing either + 1-888-680-0878 in the U.S. or + 1-617-213-4855 outside the U.S. and typing in the passcode 33063062. A replay of this call will be available at + 1-888-286-8010 (U.S.) or +1-617-801-6888 (international) using the passcode 73949500 until August 16, 2007.
The webcast is also being distributed through the Thomson StreetEvents Network to both institutional and individual investors. Individual investors can listen to the call at www.fulldisclosure.com and institutional investors can access the call via www.streetevents.com.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, allergy and asthma disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis Vaccines and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Coley's estimated financial results for the fiscal year ending December 31, 2007. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early-stage clinical trials may not be indicative of results in later- stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
June 30, December 31,
2007 2006
Assets
Cash, cash equivalents and marketable
securities $95,926 $107,046
Accounts receivable 698 448
Deferred royalty fees 5,430 6,258
Property and equipment, net 4,462 4,597
Other assets 4,127 3,926
Total assets $110,643 $122,275
Liabilities and Shareholders' Equity
Current liabilities $6,695 $6,206
Deferred revenue (current and long-term) 35,221 41,469
Note payable 3,241 3,117
Payable due to 3M (current and long-term) (1) 11,757 -
Other long-term liabilities 942 841
Shareholders' equity 52,787 70,642
Total liabilities and shareholders'
equity $110,643 $122,275
(1) In the six months ended June 30, 2007, the Company recorded an $11.8
million obligation to 3M for research assets purchased from them. Under
the terms of the agreement, 3M will receive guaranteed cash payments
totaling $20.0 million over a three year period. The $11.8 million
represents the present value of the $20.0 million payable less $5.0
million paid in June 2007.
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2007 2006 2007 2006
Revenue
Collaborative agreements $14,262 $3,983 $18,614 $8,007
Government contracts and grants 1,095 894 2,266 1,918
Total revenue 15,357 4,877 20,880 9,925
Operating expenses
Research and development 8,706 10,902 18,739 21,719
Purchased technology 16,757 - 16,757 -
General and administrative 2,932 3,109 6,815 5,972
Royalty expense 1,983 555 2,457 1,060
Total operating expenses 30,378 14,566 44,768 28,751
Loss from operations (15,021) (9,689) (23,888) (18,826)
Other income, net 1,001 1,359 2,152 2,705
Net loss ($14,020) ($8,330) ($21,736) ($16,121)
Net loss per share
Basic and diluted net loss per
share ($0.53) ($0.32) ($0.82) ($0.62)
Weighted average shares used to
compute basic and diluted
loss per share 26,508 26,230 26,470 26,147
Note 1: For the six months ended June 30, 2007, the Company recorded
charges of $1.5 million associated with the Company's January 2007
decision to suspend its independent clinical development of
ACTILON of which $0.9 million was recorded within research and
development expenses and $0.6 million was recorded within general
and administrative expenses.
Note 2: For the three and six months ended June 30, 2007, the Company
recorded a $16.8 million charge for research assets purchased
from 3M.
Note 3: The following tables show stock-based compensation expense
included in the condensed consolidated statement of operations for
the three and six months ended June 30, 2007 and 2006.
(In thousands)
Three Months Ended Six Months Ended
June 30, June 30,
2007 2006 2007 2006
Research and development $704 $563 $1,498 $1,253
General and administrative 770 700 1,781 1,371
Total stock-based
compensation expense $1,474 $1,263 $3,279 $2,624
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Six Months Ended
June 30,
2007 2006
Net cash used in operating activities ($5,905) ($18,893)
Cash flows from investing activities
Net maturities (purchases) of
marketable securities 16,020 (11,501)
First annual payment for purchased
technology (5,000) -
Purchases of property and equipment (423) (384)
Other (113) 46
Net cash provided by (used
in) investing activities 10,484 (11,839)
Cash flows from financing activities
Principal payments of capital lease
obligations (75) (590)
Proceeds from stock option exercises 118 512
Proceeds from repayment of
shareholder note - 44
Net cash provided by (used
in) financing activities 43 (34)
Exchange rate effect on cash and cash
equivalents 274 376
Net increase (decrease) in cash and
cash equivalents 4,896 (30,390)
Cash and cash equivalents, beginning
of period 52,505 85,911
Cash and cash equivalents, end of
period $57,401 $55,521
Marketable securities, end of period $38,525 $65,763
Cash, cash equivalents, and
marketable securities, end of period $95,926 $121,284
SOURCE Coley Pharmaceutical Group, Inc.
Source: PR Newswire (August 2, 2007 - 3:05 PM EST)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
Coley Pharmaceutical Group Grants Dynavax License for Commercialization of HEPLISAV(TM)
WELLESLEY, Mass. and BERKELEY, Calif., June 28 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) and Dynavax Technologies Corporation (Nasdaq: DVAX) today announced they have entered into a license agreement relating to certain TLR Therapeutics(TM) patents from Coley.
Under the terms of the agreement, Dynavax receives a non-exclusive license under Coley's immunostimulatory oligonucleotide patent estate for the commercialization of HEPLISAV(TM), a hepatitis B prophylactic vaccine, currently in Phase 3 clinical trials. Coley will receive a $5.0 million up- front payment. Coley is also eligible to receive up to an additional $5.0 million upon regulatory approvals of HEPLISAV, as well as royalty payments for any future sales of HEPLISAV.
About HEPLISAV and Hepatitis B
HEPLISAV is currently being evaluated in a Phase 3 clinical trial in Canada and in Europe. The multi-center trial, known as PHAST (Phase 3 HeplisAv Short-regimen Trial), is comparing a two-dose regimen of HEPLISAV administered at 0 and 1 month to the conventional three-dose regimen of Engerix-B(R). The enrollment target of the study is approximately 2,000 subjects, ages 11 to 55 years. Dynavax expects to submit a BLA in 2008 for approval of the product with a database of approximately 4,000 patients
In several previous clinical studies, HEPLISAV has been shown to provide seroprotection against hepatitis B faster and with fewer doses than conventional hepatitis B vaccines. Additionally, HEPLISAV has provided 100% seroprotection in all subjects who have received the full regimen, including those who are difficult-to-immunize.
About Coley's TLR Therapeutics(TM)
Coley's TLR Therapeutics are a new class of investigational drug candidates that target certain immune cells through Toll-like receptors. The patents licensed today to Dynavax relate to Coley's Toll-like receptor 9(TLR9) agonist technology that induce enhanced antigen-specific antibody and T-cell immune responses when used in combination with vaccines. Coley's TLR9 agonist drug candidate has been included in approximately 35 clinical trials of vaccines in development for use in various cancer indications, infectious diseases and biowarfare defense. The most advanced clinical program with Coley's TLR9 agonist vaccine adjuvant candidate is a planned Phase III clinical trial under the direction of GlaxoSmithKline (GSK) as part of a treatment for resectable, early stage lung cancer.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, asthma and allergic diseases and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GSK, Novartis Vaccines, Merck and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com .
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. The company's TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax's pipeline includes: HEPLISAV, a hepatitis B vaccine in Phase 3; TOLAMBA(TM), a ragweed allergy immunotherapeutic; a therapy for non- Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. A preclinical asthma and COPD program is partnered with AstraZeneca. The National Institutes of Health (NIH) partially funds preclinical work on a vaccine for influenza; Symphony Dynamo, Inc., funds the company's colorectal cancer trials and a preclinical hepatitis C therapeutic program. While the NIH and Symphony provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com .
Safe Harbor Statements
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to royalty payments for any future product sales involving HEPLISAV. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
This press release contains forward-looking statements concerning Dynavax that are subject to a number of risks and uncertainties, including statements about Dynavax's Heplisav hepatitis B vaccine and financial terms of its agreement with Coley. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Dynavax's business, including difficulties or delays in development; achieving the objectives of collaborative and licensing efforts; and obtaining regulatory approval for Heplisav; the scope and validity of patent protection; possible claims based on the patent rights of others; the ability to obtain additional financing to support operations; and other risks detailed in the 'Risk Factors' section of Dynavax's Quarterly Report on Form 10-Q. Dynavax undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
TLR Therapeutics is a trademark of Coley Pharmaceutical Group. HEPLISAV is a trademark of Dynavax Technologies Corporation. All other trademarks are the property of their respective holders.
SOURCE Coley Pharmaceutical Group, Inc.
surf1944
17 years ago
Cash and cash equivalents, beginning of period 52,505 85,911
Cash and cash equivalents, end of period $53,831 $63,686
Marketable securities, end of period $43,930 $70,431
Cash, cash equivalents, and marketable
securities, end of period $97,761 $134,117
SOURCE Coley Pharmaceutical Group, Inc.
Source: PR Newswire (May 3, 2007 - 4:06 PM EDT)
Coley Pharmaceutical Group Reports First Quarter Financial Results
WELLESLEY, Mass., May 3 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY), a biopharmaceutical company discovering and developing a novel class of drug candidates known as TLR Therapeutics(TM), today reported financial results for the first quarter of 2007.
FINANCIAL UPDATES
First Quarter Results
Coley reported a net loss in the first quarter of 2007 of $7.7 million, which is substantially unchanged versus the same period of 2006.
Coley reported charges in the first quarter of 2007 of $1.5 million associated with the company's January 2007 decision to suspend its independent clinical development of ACTILON(TM) for the treatment of Hepatitis C virus (HCV). The $1.5 million charge is comprised of $1.2 million in employee severance costs and outplacement support services, as well as $0.3 million in non-cash stock compensation expense.
Total revenues were $5.5 million in the first quarter of 2007 compared to $5.0 million in the first quarter of 2006. Revenues increased in the first quarter primarily as a result of reimbursement from Pfizer for development services incurred on its behalf.
Research and development (R&D) expenses totaled $10.0 million for the first quarter of 2007 versus $10.8 million in the first quarter of 2006, or a decrease of 7.3%, primarily due to the suspension of the clinical development of ACTILON. Consistent with Coley's strategy to pioneer the development of second-generation TLR Therapeutics, discovery research and preclinical expenses within R&D increased approximately 19.0% in the first quarter, or $0.8 million, over the same quarter in the prior year. Offsetting this increase was a $1.8 million decline in ACTILON clinical development expenses over the first quarter of 2006.
General and administrative (G&A) expenses were $3.9 million in the first quarter of 2007 versus $2.9 million in the first quarter of 2006. The $1.0 million increase in G&A expenses is primarily attributable to employee severance costs and non-cash stock compensation expense associated with the suspension of ACTILON clinical development.
As of March 31, 2007, cash, cash equivalents and marketable securities totaled $97.8 million compared to $107.0 million at December 31, 2006. Common shares outstanding at March 31, 2007 were approximately 26.5 million.
Clinical and Business Development Updates
The first quarter of 2007 was marked by progress for each of Coley's current clinical-stage compounds.
PF-3512676 for Cancer
-- In early April 2007, Pfizer achieved target patient enrollment of
approximately 800 patients in a Phase III clinical trial designed to
assess the efficacy and safety of PF-3512676 administered in
combination with standard-of-care chemotherapy, paclitaxel/carboplatin,
compared to the efficacy and safety of chemotherapy alone, for the
first-line treatment of advanced Stage IIIb/IV non-small cell lung
cancer (NSCLC).
- In December 2006, Pfizer achieved target patient enrollment of
approximately 800 patients in a separate Phase III clinical trial
designed to assess the safety and efficacy of PF-3512676 administered
in combination with standard-of-care chemotherapy,
gemcitabine/cisplatin, compared to chemotherapy alone, also for the
first line treatment of advanced NSCLC.
- The primary endpoint for these Phase III clinical trials is overall
survival. Historically, median survival with standard-of-care
chemotherapy is 7 to 10 months.
-- Also in the first quarter of 2007, Pfizer expanded the breadth of its
clinical investigation of PF-3512676. Pfizer has initiated a Phase I
clinical trial of PF-3512676 combined with their anti-CTLA-4 (cytotoxic
T lymphocyte antigen-4) targeted monoclonal antibody in patients with
advanced malignant melanoma.
AVE-0675 for Allergy and Asthma
-- In January, Coley was notified by its partner, sanofi-aventis, that the
US Food and Drug Administration (FDA) lifted its clinical hold on a
Phase I clinical trial of AVE-0675. A Phase I clinical trial has now
been initiated by sanofi-aventis to assess the safety of AVE-0675, a
first-in-class TLR9 agonist monotherapy delivered via inhalation, for
the treatment of allergy and allergic rhinitis.
VaxImmune(TM)
-- Coley added two new licensees to its expanding roster of blue-chip
vaccine developers using the company's vaccine adjuvant, VaxImmune.
- Merck & Co., Inc. licensed VaxImmune for incorporation into vaccines
being developed for certain infectious diseases and Alzheimer's
disease. In exchange for a worldwide, non-exclusive license, Merck
will pay Coley an upfront license fee of $4.0 million. Coley is also
eligible to receive milestone payments of up to $33 million, as well
as royalties from the sale of any products that are commercialized
under the agreement.
- Coley signed a non-exclusive license agreement with Emergent
BioSolutions for the incorporation of VaxImmune in the development of
Emergent's new anthrax vaccines.
2007 Financial Guidance
Coley's 2007 financial guidance remains unchanged from that previously provided in February 2007. Based on our current operating plan, Coley continues to expect its full-year net loss to be from approximately $25.0 million to $29.0 million and its estimated cash burn to be between $35.0 million and $39.0 million in 2007. As a result, Coley continues to expect unrestricted cash, cash equivalents and marketable securities to be in the range of $68.0 million to $72.0 million at the end of 2007.
Investor Update Call
Coley will be hosting a conference call and webcast today, May 3, 2007 at 4:30 p.m. U.S. Eastern Daylight Time with company management to discuss first quarter results.
To access the live audio broadcast or the subsequent archived recording, visit the Investor Center section of the Coley website located at http://www.coleypharma.com . Please log onto Coley's website several minutes prior to the start of the call to ensure adequate time for any software download that may be required. The webcast is also being distributed through the Thomson StreetEvents Network to both institutional and individual investors. Individual investors can listen to the call at
http://www.fulldisclosure.com and institutional investors can access the call via http://www.streetevents.com .
Investors may participate in the conference call by dialing either +1-866-510-0710 in the U.S. or +1-617-597-5378 outside the U.S. and typing in the passcode 60238934. A replay of the call may also be accessed via telephone by dialing +1-888-286-8010 (U.S.) or +1-617-801-6888 (international) with the passcode 43210799. The archived webcast and replay of the call will be available through May 17, 2007.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, allergy and asthma disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis Vaccines and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com .
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to the future development of second-generation TLR Therapeutics, Coley's ability to receive license fees or royalties from license agreements with third parties, and Coley's financial results for 2007. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
March 31, December 31,
2007 2006
Assets
Cash, cash equivalents and marketable
securities $97,761 $107,046
Accounts receivable 1,101 448
Deferred royalty fees 5,813 6,258
Property and equipment, net 4,336 4,597
Other assets 3,903 3,926
Total assets $112,914 $122,275
Liabilities and Shareholders' Equity
Accounts payable and accrued expenses $5,876 $6,206
Deferred revenue (current and long-term) 38,186 41,469
Note payable 3,179 3,117
Other noncurrent liabilities 805 841
Shareholders' equity 64,868 70,642
Total liabilities and shareholders
equity $112,914 $122,275
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31,
2007 2006
Revenue
Collaborative agreements $4,352 $4,024
Government contracts and grants 1,171 1,025
Total revenue 5,523 5,049
Operating expenses
Research and development 10,033 10,817
General and administrative 3,883 2,863
Royalty expense 474 505
Total operating expenses 14,390 14,185
Loss from operations (8,867) (9,136)
Other income, net 1,152 1,346
Net loss ($7,715) ($7,790)
Net loss per share
Basic and diluted net loss per share ($0.29) ($0.30)
Weighted average shares used to compute
basic and diluted loss per share 26,432 26,063
Note 1: For the three months ended March 31, 2007, the company recorded
charges of $1.5 million associated with the company's January 2007
decision to suspend its independent clinical development of
ACTILON of which $0.9 million was recorded within research and
development expenses and $0.6 million was recorded within general
and administrative expenses.
Note 2: The following tables show stock-based compensation expense
included in the condensed consolidated statement of operations for
the three months ended March 31, 2007 and 2006.
Three Months Ended
March 31,
2007 2006
Research and development $794 $690
General and administrative 1,011 671
Total stock-based compensation expense $1,805 $1,361
Coley Pharmaceutical Group, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Three Months Ended
March 31,
2007 2006
Net cash used in operating activities ($9,395) ($8,780)
Cash flows from investing activities
Net maturities / (purchases) of marketable
securities 10,618 (13,433)
Purchases of property and equipment (56) (187)
Other 59 46
Net cash provided by (used in) investing
activities 10,621 (13,574)
Cash flows from financing activities
Principal payments of capital lease obligations (41) (381)
Proceeds from stock option exercises 65 372
Proceeds from repayment of shareholder note -- 40
Net cash provided by financing activities 24 31
Exchange rate effect on cash and cash equivalents 76 98
Net increase (decrease) in cash and cash
equivalents 1,326 (22,225)
Cash and cash equivalents, beginning of period 52,505 85,911
Cash and cash equivalents, end of period $53,831 $63,686
Marketable securities, end of period $43,930 $70,431
Cash, cash equivalents, and marketable
securities, end of period $97,761 $134,117
SOURCE Coley Pharmaceutical Group, Inc.
Source: PR Newswire (May 3, 2007 - 4:06 PM EDT)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
SPANK:
Coley Pharmaceutical Group Announces Pfizer's Discontinuation of Clinical Trials for PF-3512676 Combined with Cytotoxic Chemotherapy in Advanced Non Small Cell Lung Cancer
WELLESLEY, Mass., June 20 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced that its partner Pfizer has discontinued the development program in lung cancer for PF-3512676, an investigational compound, in combination with cytotoxic chemotherapy. This includes two Phase 3 clinical trials and two Phase 2 clinical trials.
A scheduled interim analysis of the Phase 3 clinical trials by an independent Data Safety Monitoring Committee (DSMC) showed that there was no evidence that PF-3512676 produced additional clinical efficacy over that achieved with the standard cytotoxic chemotherapy regimen alone. The DSMC concluded that the risk-benefit profile did not justify continuation of the trials.
'This news is surprising based on the signs of clinical activity observed with PF-3512676 in Coley's Phase II randomized clinical trial and we are disappointed with this setback in the program,' said Robert L. Bratzler, Ph.D., President and Chief Executive Officer of Coley Pharmaceutical Group. 'We remain focused on advancing our portfolio of TLR Therapeutic candidates for the treatment of cancer, allergy and asthma, lupus and rheumatoid arthritis, and as a vaccine adjuvant, including novel small molecules and RNA- based drugs targeting TLRs7, 8 and 9.'
Investor Call
Coley will be hosting a conference call and webcast today, Wednesday, June 20, 2007 at 4:30 p.m. U.S. Eastern Daylight Time with company management to discuss this development.
To access the live audio broadcast or the subsequent archived recording, visit the Investor Center section of the Coley website located at http://www.coleypharma.com. Please log onto Coley's website several minutes prior to the start of the call to ensure adequate time for any software download that may be required. The webcast is also being distributed through the Thomson StreetEvents Network to both institutional and individual investors. Individual investors can listen to the call at http://www.fulldisclosure.com and institutional investors can access the call via http://www.streetevents.com.
Investors may participate in the conference call by dialing either + 1.866.770.7051 in the U.S. or +1.617.213.8064 outside the U.S. and typing in the passcode 87620189. A replay of the call may also be accessed via telephone by dialing +1.888.286.8010 (U.S.) or +1.617.801.6888(international) with the passcode 61166535. The archived webcast and replay of the call will be available through July 4, 2007.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, allergy and asthma disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis Vaccines and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
SOURCE Coley Pharmaceutical Group
Source: PR Newswire (June 20, 2007 - 1:57 PM EDT)
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17 years ago
Coley Pharmaceutical Group's Vaccine Adjuvant, VaxImmune, to Enter Phase III Clinical Testing as Part of GlaxoSmithKline's Novel Cancer Immunotherapeutic in Non-Small Cell Lung Cancer
WELLESLEY, Mass., June 5 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced that its vaccine adjuvant, VaxImmune(TM), will be evaluated in a Phase III clinical trial as part of GlaxoSmithKline's (GSK) MAGE-A3 cancer immunotherapeutic in patients with early stage, completely resected non-small cell lung cancer (stage IB, II or IIIA NSCLC). This will be Coley's second Toll-like receptor 9 (TLR9) agonist drug candidate to be studied in Phase III clinical trials for the treatment of NSCLC.
GSK's Phase III trial will evaluate MAGE-A3 ASCI as adjuvant therapy in MAGE-A3 positive patients with NSCLC. MAGE-A3 is a tumor-specific antigen that is expressed in a variety of cancers, including NSCLC, with no expression in normal cells. Expression of the MAGE-A3 gene has been observed in testicular cells but without antigen presentation capabilities.
GSK's ASCI represents a novel class of medicines designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. These cancer immunotherapeutics combine tumor antigens, delivered as purified recombinant proteins, and GSK's proprietary Adjuvant Systems which are specific combinations of immunostimulating compounds selected to increase the anti-tumor immune response. VaxImmune is one of the components of the GSK proprietary Adjuvant System which will be used in the MAGE-A3 ASCI evaluated in the Phase III trial.
VaxImmune is a proprietary TLR9 agonist designed to induce both an enhanced antibody response and a potent killer T cell immune response to vaccines against infectious diseases or cancer in order to achieve and sustain a clinical response without compromising safety. Coley has granted GSK worldwide licenses for the use of VaxImmune in GSK's vaccines in development for certain cancers and infectious diseases.
The GSK Phase III clinical trial which was announced today will target enrollment of about 2,270 patients. The randomized, double-blind, and placebo- controlled MAGRIT trial (MAGE-A3 as Adjuvant Non-Small Cell Lung Cancer Immunotherapy) will enroll patients with stage IB, II or IIIA resectable NSCLC. The MAGE-A3 ASCI administration will be initiated in two groups of patients: after surgery and standard chemotherapy in one group of patients and after surgery in patients who are not receiving chemotherapy. The primary endpoint of the trial is disease-free survival.
The initiation of this Phase III clinical trial will trigger a milestone payment to Coley.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, allergy and asthma disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis Vaccines and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to those relating to the initiation of the Phase III MAGRIT trial. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
SOURCE Coley Pharmaceutical Group, Inc.
Source: PR Newswire (June 5, 2007 - 9:45 AM EDT)
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