halozyme therapeutics inc (HALO) Key Developments
Halozyme Therapeutics, Inc. and Halozyme, Inc. Enter into Amended and Restated Loan and Security Agreement with Oxford Finance LLC and Silicon Valley Bank
Jan 26 15
On January 23, 2015, Halozyme Therapeutics, Inc. and its subsidiary Halozyme, Inc. entered into the Second Amendment to Amended and Restated Loan and Security Agreement And First Amendment to Disbursement Letter with Oxford Finance LLC and Silicon Valley Bank amending and restating the loan payment schedules of the Amended and Restated Loan and Security Agreement. The amended and restated term loan repayment schedule provides for interest only payments through January 2016, followed by consecutive equal monthly payments of principal and interest in arrears starting in February 2016 and continuing through the previously established maturity date of January 2018.
Halozyme Therapeutics, Inc. Appoints Jean-Pierre Bizzari, M.D. to its Board of Directors
Jan 21 15
Halozyme Therapeutics, Inc. announced the appointment of Jean-Pierre Bizzari, M.D. to its Board of Directors. Dr. Bizzari was Group Head, Clinical Oncology Development at Celgene Corporation, a role he held since 2008. In addition, he was Chairman of Celgene's hematology oncology development committee and a member of the company's management committee. Dr. Bizzari is a member of the Scientific Advisory Board of France'sNational Cancer Institute and is a board member of Transgene.
Halozyme Therapeutics, Inc. Plans to Initiate Trial to Evaluate PEGPH20; Provides Financial Guidance for the Year 2015
Jan 12 15
Halozyme Therapeutics, Inc. anticipate expanding and accelerating the company's PEGPH20 clinical development efforts. In pancreatic cancer, the company's goal is to complete Study 202 enrollment and gain feedback from regulatory authorities on plans to initiate a registration trial for PEGPH20 in pancreatic cancer patients whose tumors accumulate high levels of hyaluronan (HA). In NSCLC, in addition to completing enrollment in the Phase 1b portion of the PRIMAL trial and initiating Phase 2, the company plan to initiate a trial to evaluate PEGPH20 in combination with a PD-1 inhibitor. Present Phase 1b (Study 201) results at ASCO-GI (poster scheduled for January 16, 2015). Complete patient enrollment in the on-going Phase 2 multi-center, randomized clinical trial (Study 202) evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer, in the second half of 2015. During the first half of 2015, the company plans to meet with the regulatory authorities to discuss the current benefit:risk of PEGPH20 and plans to initiate a registration study for PEGPH20 in metastatic pancreatic cancer. Initiate patient enrollment and dosing for a registration trial in the fourth quarter of 2015 or the first quarter of 2016, pending regulatory feedback. PEGPH20 in Combination with docetaxel (NSCLC Program). Complete patient enrollment in the on-going global Phase 1b multi-center, randomized clinical trial (PRIMAL) evaluating PEGPH20 as a second-line therapy for patients with locally advanced or metastatic NSCLC in the third quarter of 2015, pending the number of dose escalation cohorts of PEGPH20. The Phase 1b study will include both a dose escalation and dose expansion phase evaluating two different schedules. Initiate patient enrollment and dosing for the Phase 2 randomized portion of the clinical trial following the evaluation of the Phase 1b data. PEGPH20 in Combination with a PD-1 Inhibitor. Initiate a Phase 1b open label multicenter, randomized clinical trial evaluating PEGPH20 as a second-line therapy for patients with locally advanced or metastatic NSCLC whose tumors accumulate high levels of HA, in the second half of 2015. Collaboration Products: ENHANZE is Halozyme's proprietary drug delivery platform based on the Company's patented recombinant human hyaluronidase enzyme (rHuPH20). Throughout 2015, Halozyme intends to provide support for ongoing launch activities for Herceptin SC, MabThera SC and HYQVIA, as well as support the efforts of the company's collaborative partners to develop and apply ENHANZE technology to their respective targets.
The company provided financial guidance for the year 2015. The company ended 2014 with approximately $135 million in cash, cash equivalents and marketable securities (these results are unaudited) and does not anticipate the need for dilutive financing to fund operations. For the full year 2015, the company expects: Net revenues to be in the range of $85 million to $95 million. Operating expenses to be in the range of $145 million to $155 million. Net cash burn to be between $35 million and $45 million.
Halozyme Therapeutics, Inc. Provides Earnings Guidance for the Full Year 2015
Jan 7 15
Halozyme Therapeutics, Inc. provided earnings guidance for the full year 2015. For the full year 2015, the company expects net revenues to be in the range of $85 million to $95 million. Net cash burn to be between $35 million and $45 million.
Halozyme Therapeutics, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 04:00 PM
Jan 6 15
Halozyme Therapeutics, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 04:00 PM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Helen I. Torley, Chief Executive Officer, President and Director.