A couple of SGEN snips . . .
>>BOTHELL, Wash.--(BUSINESS WIRE)--Oct. 28, 2003-- Seattle Genetics, Inc. (Nasdaq:SGEN - News) today reported results for the third quarter and nine months ended September 30, 2003.
Revenues for the third quarter of 2003 were $1.5 million, compared with $404,000 in the third quarter of 2002. For the first nine months of 2003, revenues were $3.7 million, compared to $1.0 million for the same period in 2002.
Total operating expenses for the third quarter of 2003 were $7.0 million, compared to $6.0 million in the same period in 2002. For the first nine months of 2003, total operating expenses were $21.3 million, compared to $20.0 million in the first nine months of 2002.
Research and development expenses increased to $5.5 million in the third quarter of 2003, compared to $4.3 million in the third quarter of 2002. This growth was driven primarily by costs related to an increase in the manufacturing of clinical grade materials. General and administrative expenses were $1.2 million in the third quarter of 2003, compared to $1.1 million in the third quarter of 2002.
Net loss attributable to common stockholders for the third quarter of 2003 was $5.2 million, or $0.17 per share, compared to $5.1 million, or $0.17 per share, for the same period in 2002. For the nine months ended September 30, 2003, net loss attributable to common stockholders was $16.7 million, or $0.54 per share, compared to $17.3 million, or $0.58 per share, for the same period in 2002.
As of September 30, 2003, Seattle Genetics had $69.2 million in cash, cash equivalents, short-term and long-term investments, compared to $44.2 million as of December 31, 2002. The increase reflects proceeds from the company's $41 million private placement, which closed on July 8, 2003.
"During the third quarter, we continued to advance our product pipeline, with particular emphasis on the ongoing and near-term clinical development activities of our SGN-15, SGN-30 and SGN-40 programs," commented Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "In addition, we bolstered our financial position by completing a $41 million financing in July and added expertise to our management team with Doug Williams, who joined the company in September as Chief Scientific Officer and Executive Vice President, Research and Development."
SGN-15 Program to Focus on Lung Cancer
Seattle Genetics has been conducting phase II clinical trials of SGN-15 in combination with Taxotere® for the treatment of non-small cell lung cancer (NSCLC) and in combination with Gemzar® for the treatment of ovarian cancer.
The company previously reported encouraging preliminary data from the study of SGN-15 in combination with Taxotere for NSCLC that suggest a longer median progression-free and overall survival for patients receiving the combination therapy compared to patients receiving Taxotere alone. In addition, the data suggest a higher disease control rate in the combination arm compared to the Taxotere-only arm. The disease control rate reflects the percentage of evaluable patients demonstrating a complete response, partial response or stable disease from the combination treatment.
In the ovarian cancer trial, Seattle Genetics recently completed a safety cohort of six patients who received SGN-15 in combination with Gemzar. Although an external data monitoring committee determined that the combination therapy was well tolerated, the company has determined that NSCLC represents the best opportunity for the SGN-15 program and has decided to close its ovarian study.
"Given our emerging data, we intend to concentrate our clinical development efforts for SGN-15 on lung cancer, a disease for which there are limited therapeutic options for patients in advanced stages," added Dr. Siegall. "We expect to complete our analysis of the phase II lung study data by early 2004 and are positioning the program for future clinical development."
Recent Highlights:
On September 15, 2003, Douglas E. Williams, Ph.D. joined Seattle Genetics as Chief Scientific Officer and Executive Vice President, Research and Development. He remains a member of the company's Board of Directors, a position he has held since May 2001. Williams previously held the position of Executive Vice President, Chief Technology Officer and a member of the Board of Directors of Immunex Corporation, prior to its acquisition by Amgen (Nasdaq: AMGN - News). After Immunex's acquisition by Amgen, he became Senior Vice President and Washington Site Leader of Amgen.
On July 28, 2003, the company announced the publication of preclinical data on its SGN-35 product candidate, an antibody-drug conjugate, in Blood, the Journal of the American Society of Hematology. The research illustrates that SGN-35 is highly efficacious at low doses in preclinical models of CD30-positive malignancies including Hodgkin's disease and certain types of non-Hodgkin's lymphoma.
On July 8, 2003, Seattle Genetics completed a $41 million financing. J.P. Morgan Partners and Baker Brothers Investments led the private placement, with additional participation by Delphi Ventures, BA Venture Partners and T. Rowe Price Health Sciences Fund, Inc. At the closing, Srinivas Akkaraju, M.D., Ph.D. and Felix Baker, Ph.D., representing J.P. Morgan Partners and Baker Brothers Investments respectively, joined Seattle Genetics' board of directors. <<
>>BOTHELL, Wash.--(BUSINESS WIRE)--Dec. 8, 2003-- Seattle Genetics, Inc. (Nasdaq:SGEN - News) today announced that data from its SGN-30 phase I clinical trial and its SGN-40 preclinical program were presented at the American Society of Hematology (ASH) 2003 Annual Meeting in San Diego on Sunday, December 7, 2003.
In the phase I multi-dose clinical trial, SGN-30 was well tolerated and demonstrated antitumor activity. Preclinical data on SGN-40 showed activity in multiple models of hematologic malignancies and favorable pharmacokinetic properties.
"These data reflect the significant progress we are making with our SGN-30 and SGN-40 programs and we are on track to reach several key near-term milestones in the programs," stated Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "By early 2004 we intend to advance SGN-30 to phase II clinical trials in patients with Hodgkin's disease or anaplastic large cell lymphoma and to initiate a phase I study of SGN-40 in patients with multiple myeloma."
SGN-30 Phase I Multi-dose Clinical Trial
SGN-30, a genetically engineered monoclonal antibody (mAb), was evaluated in a multi-dose phase I clinical study designed to assess the safety, antitumor activity and pharmacokinetics of six weekly infusions of SGN-30 in patients with relapsed or refractory CD30-positive hematologic malignancies. A total of 24 patients, in six-patient cohorts, received weekly infusions of SGN-30 at doses of two, four, eight or twelve milligrams per kilogram. The enrolled patients were heavily pretreated with a median of five prior therapies and approximately 80 percent were post-bone marrow transplant.
One patient with anaplastic large cell lymphoma demonstrated a complete response lasting at least four months at a dose of eight milligrams per kilogram of SGN-30. Additionally, six of the 24 patients had stable disease. SGN-30 was well tolerated at all doses, with drug-related adverse events typically mild and consistent with mAb administration. Pharmacokinetics of multiple doses of SGN-30 were consistent with single dose pharmacokinetics and confirmed a half-life of approximately 3 weeks.
Given the favorable safety profile and evidence of antitumor activity, Seattle Genetics plans to initiate a phase II study of SGN-30 by early 2004 in patients with Hodgkin's disease or anaplastic large cell lymphoma.
SGN-40 Preclinical Studies
SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen expressed on most B cell lineage hematologic malignancies, including multiple myeloma, non-Hodgkin's lymphoma and chronic lymphocytic leukemia.
Seattle Genetics demonstrated activity of SGN-40 in multiple preclinical models of hematologic malignancies. The product candidate was well tolerated in animal models, with doses as low as 0.4 milligrams per kilogram significantly increasing survival in xenograft models. In subcutaneous models of non-Hodgkin's lymphoma, SGN-40 activity was comparable to that of rituximab given at similar doses and schedules, suggesting that SGN-40 may provide a treatment option for rituximab-insensitive or CD40-positive / CD20-negative B cell malignancies, such as multiple myeloma. Additionally, pharmacokinetic and pharmacodynamic studies suggest doses greater than or equal to one milligram per kilogram may be biologically active in humans.
Based on these preclinical findings, Seattle Genetics plans to initiate a phase I clinical trial of SGN-40 in early 2004 for patients with multiple myeloma. SGN-40 represents a targeted approach to cancer treatment and may offer a much needed therapeutic option for multiple myeloma patients, a disease for which currently available treatments can cause toxic side effects, limiting their tolerability and dosing. <<
Seems to me SGEN faces formidable competition, not just for the indications, but even the targets. Currently has $70 million in cash, representing roughly $2.50/share.
It would be interesting to know just how much advantage they need to show over taxotere monotherapy arm to hit their endpoints.
Cheers, Tuck |
