mlkrborn
14 years ago
CRGN is one of 4 mentioned as trading below cAsh value and hence free pipeline!
4 Biotechs with "Free" Pipelines
Jason Napodano, CFA & Brian Marckx, CFA
On Thursday May 14, 2009, 11:41 am EDT
Allergan Inc., Alexza Pharmaceuticals Inc.
Highlights include Acadia Pharmaceuticals (NasdaqGM: ACAD - News), Alexza Pharmaceuticals (NasdaqGM: ALXA - News), CombinatoRx (NasdaqGM: CRXX - News) and CuraGen Corp. (NasdaqGM: CRGN - News).
The market share recovered significantly from the early March lows, but for small biotechnology firms, it has been anything but easy. Several names in our coverage universe are trading at multi-year lows. We have also noticed that five are trading below or near cash levels.
The first is Acadia Pharmaceuticals (NasdaqGM: ACAD - News), currently trading with a market capitalization of $67 million. Based on our financial model, Acadia should exit the June 2009 quarter with roughly $66 million in cash on hand. That means investors are essentially buying Acadia and getting the pipeline for free.
Acadia's leading pipeline drug is pimavanserin, a phase III 5-HT2A inverse agonist under development for the treatment of Parkinson's disease psychosis, or PDP. Acadia just recently signed a development and commercialization partnership with Biovail (NYSE: BVF - News) worth up to $395 million plus royalties. Biovail plans to expand pimavanserin's development into Alzheimer's disease psychosis (ADP) shortly.
Acadia also has research collaborations with Allergan (NYSE: AGN - News) and Meiji Seika Kaisha as well. Operating burn is less than $10 million per quarter, so the $66 million on hand should last Acadia into 2011.
Next up is Alexza Pharmaceuticals (NasdaqGM: ALXA - News), currently trading with a market capitalization of $55 million, with an estimated $32 million to still be on hand at the end of June 2009. Alexza has a total of four drugs in clinical development, all using the company's proprietary drug delivery technology, Staccato, which vaporizes unformulated drug compounds for aerosol into the lungs.
Alexza is developing two doses of a Staccato loxapine, one for acute agitation in patients with schizophrenia and another for migraine, that offer partnering opportunities later in the year. AZ-004 has completed phase III trials and Alexza is preparing the new drug application (NDA) to be filed in the first quarter of 2010. We estimate Alexza's current cash balance is enough to fund operations to through the NDA filing.
CombinatoRx (NasdaqGM: CRXX - News) currently trades with a market value of $33 million. We estimate cash at the end of June 2009 will be $36 million. The company has had a difficult time over the past year. Its leading pipeline candidate, Synavive, failed a phase IIb osteoarthritis program in October 2008.
Synavive is a combination of two generic drugs, dipyridamole and prednisolone. Despite the failure, management believes the highest dose tested in the trial showed encouraging enough trends to continue development with a new, more-tolerable, formulation.
Another drug, CRx-401, failed a phase II program in type 2 diabetes also in 2008. Yet, besides Synavive and CRx-401, CombinatoRx is developing CRx-191 for psoriasis and prednisporin for persistent allergic conjunctivitis.
The company also recently struck a strategic alliance with Novartis (NYSE: NVS - News) focused on the discovery of novel anticancer combinations. CombinatoRx has enough cash to fund operations into 2012.
CuraGen Corp. (NasdaqGM: CRGN - News) is the name in our coverage trading with the biggest valuation discount to cash. CuraGen currently has a market capitalization of $57 million, with $76 million in cash estimated to be on hand at the end of June 2009.
CuraGen has one drug candidate, CR-011, in clinical stage development for cancer indications. CR-011-vcMMAE is an antibody-drug conjugate developed for metastatic melanoma and breast cancer in phase II trials.
Two years ago the company had nearly a dozen candidates under various stages of development. Several high-profile failures and assets sales later, CuraGen is now banking on only CR-011. As a result, in February 2009, the company announced it was exploring strategic alternatives to enhance shareholder value.
Our best guess is that management will look to partner or sell CR-011 to a larger organization. The cash balance is enough to fund operations into 2010, or longer if someone else picks up the future development costs for CR-011.
We often tell investors there's no such thing as a value biotech, but when stocks start trading at or below cash levels, opportunities exists. We have Hold ratings on all four above stocks.
All have had their share of key pipeline failures over the past few quarters: Acadia with ACP-104, Alexza with AZ-002 and AZ-003, CombinatoRx with Synavive and CRx-401 and CuraGen with Velafermin. And, the risks of future failure or massive dilution are still high.
However, all the above names have at least one active program that could drive significant value in the long-run. At the above prices, you are essentially buying the cash on the balance sheet and getting the pipeline for free. Burn is always an issue, but all four names have catalysts coming ahead of when the burn will deplete the existing balance. Therefore, these four names represent a good starting point for risk-loving / value-seeking biotech investors.
surf1944
15 years ago
CuraGen Reports Second Quarter 2009 Financial Results
Further Reduces Outstanding Convertible Debt in July 2009 Reaches Agreement to Settle Recent Class Action Lawsuits
Press Release
Source: CuraGen Corporation
On Friday July 31, 2009, 6:00 am EDT
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Companies:CuraGen Corp.
BRANFORD, Conn., July 31 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN - News) today reported its financial results for the second quarter of 2009 and announced that it had further reduced its outstanding convertible debt and reached an agreement in principle, expressed in a memorandum of understanding, to settle recent shareholder class action lawsuits filed in the State of Connecticut and the State of Delaware in connection with the proposed merger between CuraGen Corporation and Celldex Therapeutics, Inc. The settlement is subject to documentation and court approval.
During the three and six month periods ended June 30, 2009, CuraGen utilized $3.8 million and $7.8 million, respectively, of cash and investments for operations, which includes cash paid for legal, audit and strategic advisor fees of $0.6 million and $0.7 million for the three and six month periods ended June 30, 2009, respectively. As of June 30, 2009, CuraGen had $76 million of cash and investments and $14.1 million of 4% convertible subordinated notes due February 2011. CuraGen repurchased $1.64 million of its 4% convertible subordinated notes for $1.39 million in July 2009 and as of July 31, 2009, had $12.5 million of 4% convertible subordinated notes outstanding. During 2009, through privately negotiated transactions, CuraGen has repurchased $6.5 million of convertible subordinated notes at an average cost of 80% of par.
For the three and six months ended June 30, 2009, CuraGen reported total operating expenses of $4.7 and $8.3 million, respectively, which included costs incurred for legal, audit and strategic advisor fees of $1.5 million and $1.6 million for the three and six month periods ended June 30, 2009, respectively.
CuraGen is continuing to enroll patients in clinical trials of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB. "We continue to be very positive about the development opportunities for CR011 in breast cancer and melanoma," commented Dr. Timothy M. Shannon, President and Chief Executive Officer of CuraGen. "We look forward to presenting updated data for the breast cancer study in the second half of 2009."
In July 2009, CuraGen also reached an agreement in principle and signed a memorandum of understanding to settle two shareholder class action lawsuits that had been filed in connection with the proposed merger between CuraGen Corporation and Celldex Therapeutics, Inc. The settlement is subject to documentation and court approval. "While we continue to deny any wrongdoing or liability with respect to the claims asserted in the class action suits, unfortunately, the monthly costs of defending against these lawsuits far outweighed the benefits of continued litigation. Therefore, we have agreed to the terms of a settlement, which will include additional disclosure in the final proxy statement regarding the merger and, if approved by the court, a payment for the shareholder plaintiffs' attorneys' fees and expenses. Although we expect to have some increases to our initial projections of net cash at closing from the repurchase of debt at a discount as partial offsets, we now expect that the settlement payment and the monthly defense costs in connection with these class action suits will result in a decrease in the net cash at closing from our original projection of $54.5 million to between $53.5 and $54.0 million," commented Dr. Shannon.
The revised projected net cash figures results in a reduction of the expected purchase price for CuraGen from $94.5 million or $1.56 per fully diluted share, to between $93.5 million and $94.0 million or $1.54 - $1.55 per fully diluted share. The proposed merger is projected to close in the third quarter of 2009.
peewee
15 years ago
CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer
Date : 06/17/2009 @ 6:30AM
Source : PR Newswire
Stock : Curagen (MM) (CRGN)
Quote : 1.34 0.0 (0.00%) @ 8:00PM
CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer
- 12 week progression free rate supports advancement into second stage of Simon 2-Stage designed trial -
BRANFORD, Conn., June 17 /PRNewswire-FirstCall/ -- CuraGen Corporation (NASDAQ:CRGN) announced today that its Phase I/II Trial evaluating CR011-vcMMAE for the treatment of patients with advanced breast cancer has met the efficacy criteria for advancement to the second stage of enrollment. To date, 29 patients have been enrolled in this trial, including 15 in the Phase II portion. Two of the first four evaluable Phase II patients were progression-free at 12 weeks, therefore, as part of the Simon 2-Stage design, the Phase II trial will now advance to the second stage and enroll a total of approximately 25 patients. The principal investigator of the study is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research Program and Associate Professor of Clinical Medicine, /Weill Cornell. CuraGen anticipates presenting updated results from this study during the second half of 2009.
About CR011-vcMMAE
CR011-vcMMAE is an antibody-drug conjugate (ADC) being developed by CuraGen that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. The ADC is designed to be stable in the bloodstream. Following intravenous administration, CR011-vcMMAE targets and binds to GPNMB, a specific protein that is predominantly expressed on the surface of cancer cells, including melanoma, breast cancer and glioma. Upon internalization by the targeted cell, CR011-vcMMAE is designed to release MMAE from CR011 to produce a cell-killing effect. CR011-vcMMAE is currently in two Phase II trials assessing its safety and efficacy in the treatment of melanoma and for the treatment of metastatic breast cancer, and in a Phase I trial to evaluate the safety and activity of alternate dosing schedules.
About Breast Cancer
Breast cancer is the most common cancer in women and a leading cause of death in the United States. According to the American Cancer Society, more than 180,000 women will be diagnosed with invasive breast cancer in 2009 with more than 40,000 deaths attributed to this disease. Despite recent advances in therapy, the median survival of patients with metastatic breast cancer is 2 to 3 years, while patients with "triple-negative" or "basal-like" breast cancer have limited treatment options and poorer outcomes. Therefore, a significant unmet need remains for novel therapeutic approaches for patients with locally advanced and metastatic breast cancer who have failed other therapies.
About CuraGenCuraGen Corporation (NASDAQ:CRGN) is a clinical-stage biopharmaceutical company developing promising approaches for the treatment of cancer. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com/.
Forward-Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to CuraGen's development program for CR011-vcMMAE, including CuraGen's ability to advance CR011-vcMMAE through Phase II clinical trials for melanoma and metastatic breast cancer, to explore additional doses and schedules of this antibody-drug conjugate, and to explore the potential of CR011-vcMMAE in a patient population in need of new therapies may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including the risk that any one or more of CuraGen's drug development programs will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources, the success of competing products and technologies, CuraGen's stage of development as a biopharmaceutical company, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGen's history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGen's products, processes and technologies, CuraGen's ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights, as well as those risks, uncertainties and factors referred to in CuraGen's Quarterly Report on Form 10-Q for the period ended March 31, 2009 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by CuraGen from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, CuraGen's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. CuraGen is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts: Sean Cassidy Chief Financial Officer
Ronit Simantov, M.D.
Chief Medical Officer
(888) 436-6642
CRGN-P
DATASOURCE: CuraGen Corporation
CONTACT: Sean Cassidy, Chief Financial Officer, , or
Ronit Simantov, M.D., Chief Medical Officer, , both of
CuraGen Corporation, +1-888-436-6642
Web Site: http://www.curagen.com/
surf1944
15 years ago
CuraGen to Present CR011-vcMMAE Data at ASCO
On Thursday May 28, 2009, 6:30 am EDT
- Update from Advanced Breast Cancer and Melanoma Studies
- Conference Call to be Hosted on Wednesday, June 3, 2009 at 11:00 am
BRANFORD, Conn., May 28 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN - News) today announced plans for three data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB, in patients with advanced breast cancer and melanoma at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida.
The titles, dates, and times of the presentations are as follows:
#9032 A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate targeting glycoprotein NMB in patients with advanced melanoma. Sunday, May 31, 2009, poster presentation from 8:00 AM - 12:00 PM with a discussion session from 11:30 AM - 12:30 PM.
#9063 Pharmacokinetics of CR011-vcMMAE, an antibody-drug conjugate, in a phase I study of patients with advanced melanoma. Monday, June 1, 2009, poster presentation from 8:00 AM - 12:00 PM.
#1067 A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate, in patients with locally advanced or metastatic breast cancer. Monday, June 1, 2009, poster presentation from 1:00 PM - 5:00 PM.
Abstracts are available and can be viewed on the ASCO Web site at www.asco.org.
Reprints of the presentations will be made available on CuraGen's website at http://www.curagen.com or can be requested by emailing info@curagen.com following the presentations.
Conference Call Details and Dial-in Information
Date: Wednesday, June 3, 2009
Time: 11:00 a.m. EDT
Dial-in: (877)-856-1956 (U.S. and Canada)
(719)-325-4771 (international)
Webcast: Access available at http://www.curagen.com
About CR011-vcMMAE
CR011-vcMMAE is an antibody-drug conjugate (ADC) being developed by CuraGen that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. The ADC is designed to be stable in the bloodstream. Following intravenous administration, CR011-vcMMAE targets and binds to GPNMB, a specific protein that is predominantly expressed on the surface of cancer cells, including melanoma, breast cancer and gliomas. Upon internalization into the targeted cell, CR011-vcMMAE is designed to release MMAE from CR011 to produce a cell-killing effect. CR011-vcMMAE is currently in two Phase II trials assessing the safety and efficacy in the treatment of melanoma and for the treatment of metastatic breast cancer, and in a Phase I trial to evaluate the safety and activity of alternate dosing schedules.
startingboy
16 years ago
interesting! BRANFORD, Conn., Feb 18, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- CuraGen Corporation (Nasdaq: CRGN) announced today that it is undertaking a review of a broad range of strategic alternatives to enhance shareholder value.
Robert E. Patricelli, Chairman of the Board of CuraGen commented that "The Board believes that management is making exciting progress as CR011 moves through the current Phase II clinical trials and that it has taken the necessary actions over the past two years to ensure that CuraGen is a well capitalized organization in a difficult external financing environment. The Board further believes we should consider strategic alternatives that could enhance shareholder value. These alternatives range from selling or licensing CR011, to acquiring additional assets or business lines, to selling the company. The company will retain an investment bank to assist the Board with its strategic review. During our evaluation process, management will remain focused on executing our current business plan."
Dr. Timothy M. Shannon, President and Chief Executive Officer, also announced that CuraGen has retained JSB-Partners to identify potential acquirers of CR011-vcMMAE. "In an ongoing multi-center study in heavily pretreated patients with breast cancer, CR011 is well tolerated and there is early evidence of activity. Our Phase II program in melanoma also continues to show promising activity", commented Dr. Shannon. "The potential to move CR011-vcMMAE into more advanced development in both patients with breast cancer and patients with melanoma makes this a good time to seek strategic interest in the marketplace."
There is no assurance that this process will result in any changes to the Company's current business plans or lead to any specific action or transaction. While the process is underway, the Company does not intend or expect to disclose any developments regarding the process until, if ever, a definitive agreement is entered into or the board determines to terminate the process.
"We ended 2008 with $88 million of cash and investments on hand, have a clinically active attractive Phase II development asset, and over $500 million in net operating loss carryforwards (NOLs). Yet, our stock price does not reflect the intrinsic value of our assets and we continue to trade at a deep discount to our cash." commented Dr. Shannon. "We seek to address these value disconnects through the strategic review process."
The Company also recently completed a privately negotiated transaction with a holder of the Company's 4% Convertible Subordinated Notes due February 2011 (the "2011 Notes") in which the Company retired a total of $4.8 million of the 2011 Notes for an aggregate purchase price of $3.8 million or a 21% discount off of face value. This transaction added $1.0 million of net cash to the Company's balance sheet. The Company now has $14.1 million of the 2011 Notes outstanding. The Company's burn guidance for the first half of 2009 remains unchanged at $7.0 to $8.0 million and the Company now expects to end the second quarter of 2009 with between $76 and $77 million of cash and investments.
Conference Call Details and Dial-in Information
Date: Wednesday, February 18, 2009
Time: 11:00 a.m. EST
Dial-in: 877-856-1955 (domestic) 719-325-4796 (international)
Webcast: Access available at http://www.curagen.com
Replays will be available starting at 2 pm, EST, February 18, 2009 until midnight, March 18, 2009 at 888-203-1112, passcode-8727431
Forward-Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company's revenue, expenses, depreciation, amortization, asset impairment charges, losses, income, and future cash and investment positions, the timing and expected results of our clinical programs, and the development and marketability of planned drugs, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including the risk that any one or more of CuraGen's drug development programs will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources, the success of competing products and technologies, CuraGen's stage of development as a biopharmaceutical company, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGen's history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGen's products, processes and technologies, CuraGen's ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights, as well as those risks, uncertainties and factors referred to in CuraGen's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by CuraGen from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, CuraGen's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. CuraGen is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CRGN-F
Contacts:
Sean Cassidy
Vice President and Chief Financial Officer
scassidy@curagen.com
203-871-4400
SOURCE CuraGen Corporation
http://www.curagen.com
surf1944
16 years ago
CuraGen Completes Enrollment in Phase II Trial of CR011-vcMMAE in Metastatic Melanoma
Thursday September 11, 6:30 am ET
- Preliminary results to be presented on November 1, 2008 at 2008 iSBTc Annual Meeting -
BRANFORD, Conn., Sept. 11 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, today announced that it has completed the enrollment of patients into its Phase II trial evaluating CR011-vcMMAE for the treatment of advanced melanoma. CuraGen also announced today that Phase II results from this trial will be presented during an oral session at the 23rd Annual Meeting of the International Society for Biological Therapy of Cancer (iSBTc), being held October 31 -- November 2, 2008, in San Diego, CA. The trial will be presented by Dr. Patrick Hwu, Co-Principal Investigator and Professor and Chairman of the Department of Melanoma Medical Oncology at The University of Texas, M.D. Anderson Cancer Center.
"We are very pleased with the clinical progress achieved with CR011-vcMMAE. Completing enrollment in this melanoma study ahead of schedule highlights the external support for this novel antibody-drug conjugate from our investigators," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen. "We expect that treatment of patients will still be ongoing in this Phase II trial at the time of iSBTc, and therefore look forward to presenting the first data from all treated patients in November, and anticipate that final results from the study will be available during the first half of 2009."
A total of 36 patients were enrolled in this Phase II open-label, multi-center trial evaluating the efficacy and safety of CR011-vcMMAE 1.88 mg/kg administered intravenously once every three weeks in patients with unresectable Stage III or Stage IV melanoma. Eligible patients had progressive disease at trial entry and may have received one prior cytotoxic regimen and any number of prior immunotherapies. Clinical efficacy endpoints include objective response rate, progression free rate, time to response and duration of response.
CuraGen is also continuing the Phase I portion of the trial evaluating the use of a weekly as well as a two out of every three week regimen of CR011-vcMMAE to explore the optimal dose and schedule of administration. Results from these more frequent dosing schedules are expected to be available in the first half of 2009.
In addition, CR011-vcMMAE is being studied in an ongoing Phase II trial in patients with metastatic breast cancer who have received previous chemotherapy. It is anticipated that preliminary results from the breast cancer trial will be presented in the first half of 2009.
CR011-vcMMAE targets glycoprotein NMB (GPNMB), which is overexpressed in a variety of cancers including melanoma, breast cancer and brain tumors. CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-human monoclonal antibody against GPNMB linked to a potent tubulin destabilizing agent, monomethyl auristatin E (MMAE). The enzyme-sensitive linker, which was licensed from Seattle Genetics, is designed to be stable in the bloodstream and to release MMAE inside tumor cells, resulting in cancer cell death.
iSBTc Presentation Details
Title: Phase I/II Study of CR011-vcMMAE, an Antibody-Drug Conjugate
targeting GPNMB, for the Treatment of Patients with Advanced
Melanoma
Type: Oral presentation
Presenter: Dr. Patrick Hwu
Session: Tumor Targeting Monoclonal Antibodies
Date/Time: November 1, 2008 from 2:45 p.m. to 4:15 p.m.
surf1944
16 years ago
CuraGen Reports Second Quarter 2008 Financial Results and Clinical Progress of CR011-vcMMAE
Tuesday July 29, 6:30 am ET
- Results from Phase II Melanoma Trial Expected in the Fourth Quarter -
BRANFORD, Conn., July 29 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, today reported its financial results for the second quarter of 2008 and updated clinical progress of CR011-vcMMAE.
For the quarter ended June 30, 2008, CuraGen reported income from continuing operations of $39.3 million, or $0.69 per share, compared to a loss from continuing operations of $21.6 million, or $0.39 per share, during the same period in 2007. For the six months ended June 30, 2008, CuraGen reported income from continuing operations of $32.5 million or $0.57 per share, as compared to a loss from continuing operations of $37.5 million or $0.67 per share, during the same period in 2007. Significant one time transactions during the second quarter of 2008 included the sale of the rights to belinostat to TopoTarget A/S for approximately $38 million in cash and the repurchase of $50.9 million of debt for $43.2 million in privately negotiated transactions.
As of June 30, 2008, CuraGen had cash, restricted cash and investments of $95.0 million. CuraGen also today reaffirmed previously provided guidance related to the planned use of approximately $6 to $8 million in cash and investments to fund operations during the second half of 2008. The Company expects to end 2008 with approximately $87 to $89 million of cash and investments.
"We are very pleased with the improvement of our balance sheet during the second quarter and the rapid progress CR011-vcMMAE has made in the clinic during the first half of 2008. Over the past six months, the CR011-vcMMAE clinical development program has achieved milestones ahead of schedule including initiation of the Phase II breast cancer trial and accelerated enrollment of patients into the Phase II melanoma trial," commented Dr. Tim Shannon, President and Chief Executive Officer of CuraGen. "Over the remainder of 2008, we look forward to completing enrollment in the melanoma study and subsequently presenting updated results during the fourth quarter of this year."
surf1944
16 years ago
CuraGen Announces Initiation of Phase II Trial of CR011-vcMMAE in Patients with Advanced Breast Cancer
Wednesday June 25, 6:30 am ET
BRANFORD, Conn., June 25 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today the treatment of the first patient in its CR011-vcMMAE Phase II breast cancer study.
The Phase II trial is an open-label, multi-center study of CR011-vcMMAE administered intravenously once every three weeks to patients with locally-advanced or metastatic breast cancer who have received prior therapy. This study will enroll up to approximately 40 patients to confirm the maximum tolerated dose (MTD) in this population and to assess efficacy using a Simon 2-Stage design with an endpoint of progression-free rate at 12 weeks. The principal investigator is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research Program and Associate Professor of Clinical Medicine, NewYork-Presbyterian Hospital/Weill Cornell.
"We believe that GPNMB is a promising target in breast cancer, and we look forward to better understanding how CR011-vcMMAE could be used in the treatment of this disease," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen Corporation. "We are confident in our ability to continue the rapid development of this program and look forward to providing updated CR011-vcMMAE results for the treatment of melanoma by the end of 2008 and the presentation of preliminary results from this newly initiated study in breast cancer during the first half of 2009."
CR011-vcMMAE targets a protein known as glycoprotein NMB (GPNMB), which is overexpressed in a variety of cancers including breast cancer, melanoma, and brain tumors. CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-human monoclonal antibody against GPNMB linked to a potent tubulin stabilizing agent, monomethyl auristatin E (MMAE). The enzyme-sensitive linker, which was licensed from Seattle Genetics, is designed to be stable in the bloodstream and to release MMAE inside tumor cells, resulting in cancer cell death.
Dr. Ronit Simantov, Vice President and Chief Medical Officer commented, "Preclinical studies have shown that GPNMB is expressed in aggressive breast cancers and is believed to play a role in promoting invasion and metastasis of breast cancer cells. Furthermore, conjugating an antibody against this biologically relevant target with MMAE, a cytotoxic drug that belongs to a class of therapeutics known to be active against breast cancer, represents a novel approach to treating this disease."
Objective responses have been observed in patients with advanced melanoma treated with CR011-vcMMAE. A Phase II study of CR011-vcMMAE in patients with melanoma is currently enrolling patients, and preclinical studies with CR011-vcMMAE for the treatment of gliomas are ongoing.
surf1944
16 years ago
CuraGen Repurchases $50.9 Million of 2011 Convertible Debt for $43.2 Million
Wednesday May 14, 6:30 am ET
BRANFORD, Conn., May 14 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN) announced today the completion of a series of privately negotiated transactions with holders of the Company's 4% Convertible Subordinated Notes due February 2011 (the "2011 Notes") in which the Company retired a total of $50.9 million of the 2011 Notes for an aggregate purchase price of $43.2 million, reflecting an aggregate discount of approximately 15.1% off of face value. CuraGen currently has approximately $100 million or $1.72 per share, in cash and investments on hand, and has $19.0 million of the 2011 Notes outstanding.
With the completion of these transactions, CuraGen will eliminate a total of approximately $5.6 million in interest payments on the 2011 Notes to maturity. The Company now anticipates ending 2008 with cash and investments of approximately $92 million, or $1.59 per share.
"Our planned, systematic strengthening of CuraGen's balance sheet continues with these latest transactions, which have increased our net cash position by approximately $8 million," stated Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen Corporation. "Over the past 16 months, we have increased our net cash position by approximately $87 million, while eliminating over $157 million in debt and over $40 million in annual operating and interest expenses. We believe we are well capitalized with over $100 million to develop our un-partnered antibody drug conjugate, CR011-vcMMAE, in metastatic melanoma and breast cancer and to explore other potential near-term value creation opportunities."
About CuraGen
CuraGen Corporation (Nasdaq: CRGN - News) is a clinical-stage biopharmaceutical company developing promising approaches for the treatment of cancer. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
surf1944
17 years ago
CuraGen Sells Ownership of Belinostat to TopoTarget A/S
- CuraGen to receive approximately $45 million in cash, stock and future milestone payments -
- Provides updated financial guidance for 2008 -
- Conference call to be hosted today at 9:00 a.m. EDT -
BRANFORD, Conn., April 22 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company, announced today that it has sold its ownership in belinostat, a Phase I/II histone deacetylase inhibitor, to TopoTarget A/S (Copenhagen Stock Exchange: TOPO) for approximately $39 million upfront in a combination of cash and stock. CuraGen will receive $26 million in cash and 5 million shares of TopoTarget common stock, currently valued at approximately $13 million, and $6 million in potential commercial milestone payments related to future net sales and sublicenses of belinostat. CuraGen will no longer have any funding requirements for belinostat as TopoTarget will immediately assume all financial and operational responsibility for the ongoing clinical development.
'CuraGen is working to create and unlock value within our portfolio while providing a strong and clear risk / reward profile for our investors. After a thorough review of our current strategic options, we feel the most effective use of our resources and best potential value creation opportunity for shareholders is based on CR011-vcMMAE, our un-partnered antibody-drug conjugate, currently in Phase II for the treatment of patients with metastatic melanoma and moving toward Phase II in metastatic breast cancer. We believe that today's deal represents a great opportunity for CuraGen, and its shareholders, by further strengthening our balance sheet by adding close to $45 million this year in cash and investments and from the reduction in anticipated cash use during 2008,' commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen.
CuraGen also provided today updated 2008 financial guidance. As a result of this transaction, CuraGen expects to end 2008 with approximately $135 million in cash and investments compared to the previously provided guidance of approximately $90 million. During the second half of 2008, CuraGen anticipates using approximately $6 to $8 million of cash and investments to fund operations.
Dr. Shannon further commented, 'With CR011-vcMMAE showing promise in areas of substantial unmet need, we will evaluate opportunities to create additional value from this program over the course of the year, including strategic partnerships. With approximately $145 million in cash and investments today and an exciting product in Phase II with significant potential upside, we believe CuraGen is in an excellent position of having meaningful resources on hand, a low cash burn and the flexibility to pursue potential business development opportunities for novel products that we are seeing in the marketplace.'
'This transaction also allows TopoTarget to focus on belinostat as it potentially moves into a Phase III trial in patients with PTCL in the second half of 2008,' said Dr. Shannon. 'They have been good partners and we wish them success with the continued development of the product.'
Conference Call Details and Dial-in Information
Date: Tuesday, April 22, 2008
Time: 9:00 a.m. EDT
Dial-in: 877-272-5391 (domestic)
706-758-4315 (international)
Passcode: 44717174
Webcast: Access to the live webcast is available at
http://www.curagen.com .
A replay of the conference call will be available starting at 12:00 p.m. Eastern time on Tuesday, April 22, 2008 through Thursday, May 22, 2008 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 44717174. An archive of the webcast will be available for 30 days at http://www.curagen.com .
surf1944
17 years ago
CuraGen Reports First Quarter 2008 Financial Results
Tuesday April 22, 6:30 am ET
- CR011-vcMMAE in Phase II for melanoma, to begin Phase II for breast cancer -
- Conference call to be hosted today at 9:00 a.m. EDT -
BRANFORD, Conn., April 22 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN) today reported its financial results for the first quarter of 2008. For the quarter ended March 31, 2008, CuraGen reported a net loss of $6.8 million, or $0.12 per share, compared to a net loss of $17.0 million, or $0.31 per share, for the same period in 2007.
During the first quarter, CuraGen incurred costs totaling $1.5 million for milestones related to the advancement of CR011-vcMMAE into Phase II clinical development. Of the decrease in cash and investments of $7.6 million during the first quarter of 2008, $2.6 million was related to non-recurring restructuring payments and payments associated with a previously discontinued program.
As of March 31, 2008, CuraGen had cash, restricted cash and investments of approximately $107.4 million. Following this morning's announced transaction with TopoTarget A/S, CuraGen currently projects a total of approximately $145 million in cash, restricted cash and investments at April 30, 2008.
CuraGen has also revised its 2008 financial guidance. CuraGen anticipates ending 2008 with approximately $135 million of cash and investments compared to previously provided guidance of $90 million. During the second half of 2008, CuraGen anticipates using approximately $6 to $8 million of cash and investments to fund operations.
"During the first quarter we continued to make progress strengthening our balance sheet and working to enhance shareholder value. We believe that our increased cash position and reduced anticipated cash burn for 2008 provides us with ample resources to advance CR011-vcMMAE through Phase II and the ability to act on promising business development initiatives that could diversify our pipeline," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen. "With the recent advancement of CR011-vcMMAE into Phase II, we also look forward to the presentation of updated clinical trial results on this program in June at the 2008 ASCO Annual Meeting."
In addition, CuraGen today announced plans to begin Phase II development of CR011-vcMMAE in metastatic breast cancer. The first study for this indication will be an uncontrolled clinical trial of CR011-vcMMAE for the treatment of patients with locally advanced or metastatic breast cancer who have received previous chemotherapy. Enrollment is scheduled to begin in the third quarter.
"GPNMB, the antigen recognized by the CR011 antibody-drug conjugate, has emerged as an important target in breast cancer. The unmet need and market potential of breast cancer make this an excellent opportunity for value creation with CR011-vcMMAE where we can leverage the experience we already have with the drug in melanoma," said Dr. Shannon, "and we look forward to providing data from the breast program as they emerge."
Upcoming Presentation on CR011-vcMMAE
ASCO 2008 Annual Meeting, May 30 - June 3, Chicago, IL
- "A Phase I/II Study of CR011-vcMMAE, an Antibody Toxin Conjugate Drug,
in Patients with Unresectable Stage III /IV Melanoma." Poster
discussion. Sunday, June 1, 2008 from 2:00 p.m. - 6:00 p.m. Poster
Board #: 18. Location: W375e.
Conference Call Details and Dial-in Information
Date: Tuesday, April 22, 2008
Time: 9:00 a.m. EDT
Dial-in: 877-272-5391 (domestic)
706-758-4315 (international)
Passcode: 44717174
Webcast: Access to the live webcast is available at
http://www.curagen.com.
A replay of the conference call will be available starting at 12:00 p.m. Eastern time on Tuesday, April 22, 2008 through Thursday, May 22, 2008 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 44717174. An archive of the webcast will be available for 30 days at http://www.curagen.com.
surf1944
17 years ago
CuraGen Advances CR011-vcMMAE into Phase II
Wednesday April 9, 6:30 am ET
- Clinical trial expanded to further evaluate activity of CR011-vcMMAE for advanced melanoma -
- Preliminary Phase I/II results to be presented in June at 2008 ASCO Annual Meeting -
BRANFORD, Conn., April 9, 2008 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today that it has advanced CR011-vcMMAE, an antibody-drug conjugate (ADC), into Phase II for the treatment of patients with unresectable Stage III and Stage IV melanoma. CuraGen also announced today that updated data from the ongoing Phase I/II trial with CR011-vcMMAE will be presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 30 - June 3, 2008 in Chicago, IL.
"We are pleased with the progress achieved in the CR011-vcMMAE clinical program," commented Dr. Ronit Simantov, Vice President of Medical Development and Chief Medical Officer. "Advancing this program into Phase II is an important development milestone as we look to establish the role of CR011-vcMMAE in the treatment of patients with advanced melanoma."
"Antibodies have made a significant impact in cancer treatment, and we believe that ADCs represent the next generation of antibody technologies. Over the last year, ADCs have demonstrated proof-of-concept activity against both solid tumors and hematologic malignancies," said Dr. Timothy M. Shannon, President and Chief Executive Officer of CuraGen. "We are encouraged by the activity observed to date with CR011-vcMMAE and are looking forward to reporting updated results at ASCO in June."
CR011-vcMMAE is an ADC comprised of a fully-human monoclonal antibody against glycoprotein NMB (GPNMB) attached to a potent, synthetic drug monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC recognizes GPNMB, a novel, selective target that plays a role in the ability of cancer cells to invade and metastasize. CR011-vcMMAE contains an enzyme-cleavable linker designed to be stable in the bloodstream and to release MMAE after internalization into tumor cells that express GPNMB, resulting in cancer cell death.
ASCO Presentation Details
A poster entitled "A phase I/II study of CR011-vcMMAE, an antibody toxin conjugate drug in patients with unresectable stage III/IV melanoma," is scheduled to be presented by Patrick Hwu, M.D., Ph.D., Professor and Chairman of the Department of Melanoma Medical Oncology at M.D. Anderson Cancer Center, on Sunday, June 1, 2008 from 2:00 - 6:00 p.m. The poster session will be followed by a poster discussion from 5:00 - 6:00 p.m.
scstocks
17 years ago
Hello Brig, I am not showing them with no debt, and was wondering the source for that info, if that's what you meant, so I can update mine. I do show that they are eliminating debt, pretty quickly, imo.
From yahoo news:
http://biz.yahoo.com/prnews/080131/neth038.html?.v=37
"As of December 31, 2007, CuraGen had cash, restricted cash and investments of $115.0 million. At December 31, 2007, CuraGen had outstanding convertible debt of $69.9 million due February 2011, compared to $176.2 million at December 31, 2006."
Yahoo isn't always up on their stats, they are showing crgn with 139 cash and 109 debt as of 12/31/07......under key statistics.....
Got to love the way they are paying that debt down.
Take Care.
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Tina
17 years ago
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