MORRIS PLAINS, N.J., May 7, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today reported financial results for the third quarter ended March 31, 2014. The Company also highlighted recent key developments and planned activities for its clinical pipeline. Third Quarter Fiscal 2014 Results Total revenues for the third quarter of fiscal year 2014, which ended on March 31, 2014, were $1.2 million as compared to total revenues of $1.7 million for the same quarter last fiscal year. The decrease of $0.5 million in total revenues this quarter was primarily due to a $0.7 million reduction in research and development revenue due to the timing of research activities from research grants, which is partially offset by a $0.2 million increase in LeukoScan sales volume in Europe. Total costs and expenses for the three-month period ended March 31, 2014 were $10.7 million, as compared to $9.9 million for the same period in 2013, representing an increase of $0.8 million or 8%. This increase was driven primarily by $0.7 million higher general and administrative expenses due primarily to increased legal and professional fees ($0.5 million) and increased employee-related costs ($0.2 million). Net loss attributable to our stockholders this quarter was $9.5 million, or $0.11 per basic share. This compares to net income attributable to our stockholders of $8.6 million, or $0.11 per basic share for the same quarter in fiscal 2013, representing a decrease of $18.1 million, or 210%. The decrease in net income this quarter resulted mainly from the non-recurring $16.7 million arbitration settlement in the comparable period in the previous year. Also, operating losses increased by $1.3 million in the third quarter of fiscal 2014 when compared to the comparable quarter in fiscal 2013. Nine Months Fiscal 2014 Results For the nine-month period ended March 31, 2014, total revenues were $7.9 million as compared to total revenues of $3.6 million for the same period last fiscal year. The $4.3 million increase in total revenues this period was primarily due to $4.6 million in license fee revenue earned upon fulfilling the Company's obligations under the Algeta Service Agreement, as amended.
Total costs and expenses for the nine-month period ended March 31, 2014 were $31.5 million, as compared to $26.7 million for the same period in 2013, representing an increase of $4.8 million, or 18%. This increase was driven primarily by $1.9 million higher research and development expenses mostly from increased manufacturing costs for materials used for the antibody-drug conjugates' clinical trials and the initiation of the clivatuzumab tetraxetan Phase III clinical trial for the treatment of patients with pancreatic cancer. An increase in general and administrative expenses of $1.5 million, primarily due to higher legal costs ($0.7 million) and employee-related costs ($0.4 million), and the costs of licensing fees and other revenue of $1.2 million related to the Algeta service agreement also contributed to the higher total costs and expenses.Net loss attributable to our stockholders for the first nine months of fiscal year 2014 was $23.6 million or $0.28 per basic share. This compares to net loss attributable to our stockholders of $3.7 million or $0.05 per basic share, for the same period last fiscal year. The increase in net loss of $19.9 million this period resulted primarily from the $16.7 million arbitration settlement and $2.6 million insurance proceeds both received during the previous year. The Company has no long-term debt and as of March 31, 2014, cash, cash equivalents and marketable securities totaled $20.9 million. In May 2014, the Company sold 9 million shares of its common stock at an offering price of $3.35 per share resulted in gross proceeds to the Company of approximately $30 million. The Company has granted the underwriters a 30-day option to purchase up to an additional 1.35 million shares of common stock. Any proceeds from the exercise of the underwriters' option to purchase additional shares will be incremental to the initial offering proceeds.
"The net proceeds from the sale of our common stock will be used primarily for Phase III trial for 90Y-clivatuzumab tetraxetan and ongoing Phase II expansion trials for IMMU-132 and IMMU-130, and for working capital and general corporate purposes," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "As detailed in our recent R&D day presentation, we believe we have a robust and exciting clinical pipeline that is in mid- to late-stage development and we look forward to advancing them in diseases that are underserved," added Mr. Pfreundschuh.The Company's key clinical developments and future planned activities: Clivatuzumab tetraxetan
- Outside clinical investigator will present results from the randomized Phase Ib study of fractionated yttrium-90-labeled clivatuzumab tetraxetan in patients with pancreatic cancer having 2 or more prior therapies at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer: Innovations in Research and Treatment on Tuesday, May 20, 2014, and at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO) on Sunday, June 1, 2014, in a Poster Highlights Session.
- Multiple partial responses, including 2 patients with small-cell lung cancer, 2 with triple-negative breast cancer and 1 with colorectal cancer, from the ongoing Phase I/II study of IMMU-132 in patients with solid cancers were reported at the 2014 Annual Meeting of AACR. More information on the results can be obtained from the Company's press release at http://www.immunomedics.com/pdfs/news/2014/pr04072014a.pdf.
- Results of 13 pancreatic cancer patients with CT-assessments from the Phase I/II trial of IMMU-132 will be presented at the AACR Special Conference on Pancreatic Cancer: Innovations in Research and Treatment on Tuesday, May 20, 2014.
- Additional Phase II data from the IMMU-132 trial will be provided at the 2014 Annual Meeting of ASCO on Monday, June 2, 2014, in a Poster Highlights Session.
- Two partial responders with durable responses were reported at the 2014 AACR Annual Meeting from the 3 Phase I studies using 3 different IMMU-130 dosing schedules in patients with metastatic colorectal cancer. For more information, please refer to the Company's press release at http://www.immunomedics.com/pdfs/news/2014/pr04072014b.pdf.
- Results from the more frequent dosing schedules of IMMU-130 once or twice-weekly for 2 weeks followed by one week of rest in a 3-week cycle will be updated at the 2014 ASCO Annual Meeting on Sunday, June 1, 2014.
|Condensed Consolidated Balance Sheets|
|March 31,||June 30,|
|Cash and cash equivalents||$ 4,989,639||$ 41,326,000|
|Accounts receivable, net of allowance for doubtful accounts||714,327||622,830|
|Other current assets||74,011||1,631,172|
|Property and equipment, net||1,980,398||2,086,911|
|Value of life insurance policies||562,010||594,832|
|Other long-term assets||30,000||30,000|
|$ 26,253,123||$ 47,927,353|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$ 4,477,862||$ 3,950,866|
|$ 26,253,123||$ 47,927,353|
|Condensed Consolidated Statements of Operations|
|Three Months Ended||Nine Months Ended|
|March 31,||March 31,|
|License fee and other revenues||$ --||$ 126,667||$ 4,623,333||$ 126,667|
|Research & development||229,106||858,182||797,120||1,254,571|
|Total Revenues||$ 1,154,341||1,736,466||7,854,612||3,600,035|
|Costs and Expenses||10,676,215||9,929,958||31,542,856||26,715,070|
|Interest and Other (Expense) Income||(10,715)||16,754,433||31,793||19,358,892|
|(Loss) Income before Income Tax (Expense) Benefit||(9,532,589)||8,560,941||(23,656,451)||(3,756,143)|
|Income Tax (Expense) Benefit||(1,372)||19,879||(1,372)||(19,496)|
|Net (Loss) Income||(9,533,961)||8,580,820||(23,657,823)||(3,775,639)|
|Less Net (Loss) Income attributable on noncontrolling interest||(28,359)||(27,783)||(78,778)||(77,045)|
|Net (Loss) Income attributable to Immunomedics, Inc. stockholders||$ (9,505,602)||$ 8,608,603||$(23,579,045)||$ (3,698,594)|
|Net (Loss) Income per Common Share attributable to Immunomedics, Inc. stockholders:|
|Basic||$ (0.11)||$ 0.11||$ (0.28)||$ (0.05)|
|Diluted||$ (0.11)||$ 0.11||$ (0.28)||$ (0.05)|
|Weighted average number of common shares outstanding:|
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