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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Halozyme Therapeutics Incorporated | NASDAQ:HALO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.09 | 0.23% | 39.91 | 37.13 | 41.05 | 40.74 | 39.79 | 40.67 | 902,802 | 01:00:00 |
Date of Report (Date of Earliest Event Reported): | May 11, 2015 |
Delaware | 001-32335 | 88-0488686 | |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
11388 Sorrento Valley Road, San Diego, California | 92121 |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: | (858) 794-8889 |
Exhibit No. | Description |
99.1 | Press release dated May 11, 2015 |
HALOZYME THERAPEUTICS, INC. | ||||
May 11, 2015 | By: | /s/ Harry J. Leonhardt,, Esq. | ||
Name: | Harry J. Leonhardt,, Esq. | |||
Title: | Senior Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary |
Exhibit No. | Description | |
99.1 | Press release dated May 11, 2015 |
• | Announced plans to initiate a Phase 3 clinical study (Study 301) in metastatic pancreatic cancer patients with high-hyaluronan (HA) tumors: Based on feedback following a Type B meeting with the FDA, the company intends to initiate a Phase 3 study that will allow for a potential marketing application based on either progression free survival (PFS) or overall survival. Use of PFS as the basis for marketing approval will be subject to the overall benefit and risk associated with Halozyme’s investigational new drug, PEGPH20, combined with nab-paclitaxel (ABRAXANE®) and gemcitabine therapy, including the: |
◦ | Magnitude of the PFS treatment effect observed; |
◦ | Toxicity profile; and |
◦ | Interim overall survival |
• | Presented in January the interim results of Study 202 evaluating PEGPH20 with gemcitabine and ABRAXANE (nab-paclitaxel) in metastatic pancreatic cancer patients: In a retrospectively defined sub-population of patients, the data showed a statistically significant doubling in median PFS in metastatic pancreatic cancer patients with high levels of HA who were treated with PEGPH20 combined with nab-paclitaxel (ABRAXANE) and gemcitabine (9.2 months vs. 4.3 months in patients treated with nab-paclitaxel ABRAXANE and gemcitabine alone). The potential risk profile, including rate of thromboembolic events, was also evaluated. |
• | Initiated enrollment in a Phase 1b/2 clinical trial of investigational PEGPH20 in non-small cell lung cancer (NSCLC): The company began enrollment in the Phase 1b/2 randomized clinical trial (PRIMAL) of PEGPH20 in combination with docetaxel as a second-line therapy for patients with locally advanced and metastatic NSCLC. |
• | Published preclinical study results of PEGPH20 in Molecular Cancer Therapeutics (Singha et al., February 2015 14:523-532): Data highlights the use and potential of PEGPH20 to enhance the anti-cancer activity of the accompanying immunotherapy (trastuzumab and immune cells) in high-HA breast and ovarian cancer preclinical models. The paper expands on previously reported data in a poster presentation at the ASCO 2015 Gastrointestinal Cancers Symposium in San Francisco. The manuscript was written and funded by Halozyme. |
• | Daratumumab selected as the first product candidate under Janssen collaboration: In March, Genmab A/S announced plans for a Phase 1 clinical trial of a subcutaneous formulation of the anti-CD38 antibody daratumumab using the ENHANZE™ technology. Daratumumab is being developed under a collaboration between Janssen and Genmab A/S since August 2012 when Genmab granted Janssen an exclusive worldwide license to develop, manufacture, and commercialize daratumumab. Daratumumab, a human monoclonal antibody that targets CD38, is in clinical development as a single agent and in combination with standard of care therapies in several settings of multiple myeloma. |
• | Revenues for the first quarter of 2015 were $18.7 million, compared to $12.0 million for the first quarter of 2014. Revenues in the first quarter included $6.8 million in royalty revenue from sales of products under collaboration agreements, $6.1 million in product sales of bulk rHuPH20 for use in manufacturing collaboration products for Roche, $3.8 million in Hylenex® recombinant (hyaluronidase human injection) product sales, and $2.0 million in collaboration revenues. Royalty revenues represent October to December 2014 sales as a result of the one quarter lag in royalty reports. |
• | Research and development expenses for the first quarter of 2015 were $16.7 million, compared to $21.4 million for the first quarter of 2014. The decrease was primarily due to a planned decrease in expenses associated with the diabetes program. |
• | Selling, general and administrative expenses for the first quarter of 2015 were $9.4 million, compared to $10.3 million for the first quarter of 2014. The decrease was primarily due to a decrease in compensation expenses. |
• | The net loss for the first quarter of 2015 was $15.1 million, or $0.12 per share, compared to a net loss for the first quarter of 2014 of $26.5 million, or $0.22 per share. |
• | Cash, cash equivalents and marketable securities were $128.5 million at March 31, 2015, compared to $135.6 million at December 31, 2014. Net cash used in the first quarter of 2015 was approximately $7.1 million. |
• | 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 to $45 million. |
Three Months Ended | |||||||
March 31, | |||||||
2015 | 2014 | ||||||
Revenues: | |||||||
Product sales, net | $ | 9,860 | $ | 8,568 | |||
Royalties | 6,775 | 799 | |||||
Revenues under collaborative agreements | 2,031 | 2,599 | |||||
Total revenues | 18,666 | 11,966 | |||||
Operating expenses: | |||||||
Cost of product sales | 6,494 | 5,520 | |||||
Research and development | 16,684 | 21,415 | |||||
Selling, general and administrative | 9,399 | 10,250 | |||||
Total operating expenses | 32,577 | 37,185 | |||||
Operating loss | (13,911 | ) | (25,219 | ) | |||
Other income (expense): | |||||||
Investment and other income, net | 102 | 47 | |||||
Interest expense | (1,299 | ) | (1,376 | ) | |||
Net loss | $ | (15,108 | ) | $ | (26,548 | ) | |
Basic and diluted net loss per share | $ | (0.12 | ) | $ | (0.22 | ) | |
Shares used in computing basic and diluted net loss per share | 125,299 | 118,943 |
March 31, 2015 | December 31, 2014 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 44,287 | $ | 61,389 | |||
Marketable securities, available-for-sale | 84,212 | 74,234 | |||||
Accounts receivable, net | 7,725 | 9,149 | |||||
Inventories | 7,482 | 6,406 | |||||
Prepaid expenses and other assets | 9,623 | 10,143 | |||||
Total current assets | 153,329 | 161,321 | |||||
Property and equipment, net | 2,732 | 2,951 | |||||
Prepaid expenses and other assets | 2,564 | 1,205 | |||||
Restricted cash | 500 | 500 | |||||
Total assets | $ | 159,125 | $ | 165,977 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,299 | $ | 3,003 | |||
Accrued expenses | 12,813 | 13,961 | |||||
Deferred revenue, current portion | 6,367 | 7,367 | |||||
Current portion of long-term debt, net | 3,730 | — | |||||
Total current liabilities | 26,209 | 24,331 | |||||
Deferred revenue, net of current portion | 46,259 | 47,267 | |||||
Long-term debt, net | 45,985 | 49,860 | |||||
Other long-term liabilities | 3,127 | 3,167 | |||||
Stockholders’ equity: | |||||||
Common stock | 127 | 126 | |||||
Additional paid-in capital | 502,980 | 491,694 | |||||
Accumulated other comprehensive loss | (27 | ) | (41 | ) | |||
Accumulated deficit | (465,535 | ) | (450,427 | ) | |||
Total stockholders’ equity | 37,545 | 41,352 | |||||
Total liabilities and stockholders’ equity | $ | 159,125 | $ | 165,977 |
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