On February 03, 2016 Immunomedics, Inc., (Nasdaq:IMMU) reported financial results for the second quarter ended December 31, 2015 (Filing, 8-K, Immunomedics, FEB 3, 2016, View Source [SID:1234508963]). The Company also highlighted recent key developments and planned activities for its clinical pipeline.
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Second Quarter Fiscal 2016 Results
Total revenues for the second quarter of fiscal year 2016, which ended on December 31, 2015, were $0.7 million, as compared to total revenues of $1.0 million for the same quarter last fiscal year. The decrease of $0.3 million in total revenues this quarter was primarily the result of $0.2 million lower LeukoScan product sales, due equally to unfavorable currency fluctuations and lower sales volume in Europe, and a $0.1 million decline in research and development revenues from fewer number of government funded research grants.
Total costs and expenses for the current quarter were $16.4 million, as compared to $12.5 million for the same period in 2014, representing an increase of $3.9 million or 31%. This increase was driven primarily by $3.9 million increased research and development expenses from higher product development expenses related to the Phase 3 PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan for the therapy of patients with advanced pancreatic cancer and the Phase 2 antibody-drug conjugates’ clinical trials. The increase in research and development expenses was partially offset by a $0.2 million lowered legal and professional expenses, principally related to the arbitration proceedings with Takeda-Nycomed, which concluded during the 2015 fiscal year.
Interest expense this quarter related to the 4.75% Convertible Senior Notes due 2020 was $1.4 million, which included the amortization of $0.2 million debt issuance costs. There was no interest expense for the same quarter last fiscal year.
An income tax benefit of $3.2 million was recorded during the current quarter, the result of cash proceeds received for the sale of a portion of our New Jersey State tax net operating losses and research and development tax credits. There were no similar tax benefits during the previous quarter.
Net loss attributable to our stockholders this quarter was $13.7 million, or $0.15 per share, compared with a net loss attributable to our stockholders of $11.4 million, or $0.12 per share, for the same quarter in fiscal 2015. The $2.3 million increase in net loss this quarter was primarily due to the increase in research and development expenses and interest expense for the Convertible Senior Notes, which was partially offset by the $3.2 million tax benefits received.
First Half Fiscal 2016 Results
For the first half of fiscal year 2016, total revenues were $1.4 million, as compared to total revenues of $2.1 million for the same period last fiscal year. The decrease of $0.7 million in total revenues was primarily due to a $0.4 million reduction in research and development revenue from a decline in the number of government funded research grants and $0.3 million lowered LeukoScan sales, due to unfavorable currency fluctuations and lower sales volume in Europe.
Total costs and expenses for the six-month period ended December 31, 2015 were $31.2 million, as compared to $26.0 million for the same period in 2014, representing an increase of $5.2 million or 20%. This increase was driven primarily by $7.4 million higher research and development expenses for product development expenses related to the Phase 3 PANCRIT-1 and the Phase 2 antibody-drug conjugates’ clinical trials. The increase in research and development expenses this period was partially offset by the $2.4 million decrease in general and administrative expenses attributable primarily to reduced legal and professional fees related to the arbitration proceedings with Takeda-Nycomed.
Interest expense this period related to the 4.75% Convertible Senior Notes was $2.8 million and included the amortization of $0.4 million debt issuance costs. There was no interest expense for the same period last fiscal year.
An income tax benefit of $3.2 million was recorded for the current period, the result of cash proceeds received for the sale of a portion of our New Jersey State tax net operating losses and research and development tax credits. No tax benefits were received during the previous period.
Net loss attributable to our stockholders this period was $29.1 million, or $0.31 per share. This compares to net loss attributable to our stockholders of $23.8 million, or $0.26 per share, for the same period last fiscal year. The $5.3 million increase in net loss this period was primarily due to increased research and development costs related to clinical trials and interest expense for the Convertible Senior Notes, partially offset by the income tax benefits received and lower legal and professional fees, as described above.
As of December 31, 2015, cash, cash equivalents and marketable securities totaled $76.0 million. On January 21, 2016, the Company received another $1.9 million in proceeds as a result of a second sale of our New Jersey State net operating losses and research and development tax credits.
"The $5.1 million total cash proceeds that the Company received from the State of New Jersey’s Technology Business Tax Certificate Transfer Program has allowed us to continue to advance our key clinical programs according to plan, as exemplified by the recent Special Protocol Assessment for a future Phase 3 trial for sacituzumab govitecan in patients with triple-negative breast cancer," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "We are pleased with the current enrollment into the ongoing pivotal Phase 3 PANCRIT-1 study in patients with advanced pancreatic cancer, which is expected to complete enrollment this calendar year," added Mr. Pfreundschuh.
The Company’s key clinical developments and future planned activities:
Sacituzumab Govitecan (IMMU-132)
The Company has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer.
Improved progression-free survival (PFS) with an interim median PFS of 7.0 months was reported at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference in patients with triple-negative breast cancer (TNBC) treated with sacituzumab govitecan. (View Source)
Continuing positive results in heavily pretreated, metastatic TNBC were presented in a poster discussion session at the 2015 San Antonio Breast Cancer Symposium in San Antonio, Texas. Interim results included an objective response rate of 31% by RECIST 1.1 in 58 evaluable patients, with 78% of these responding patients confirmed with a follow-up computed tomography scan, including 2 patients with a complete response. (View Source).
IMMU-114
At the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, Florida, the Company reported initial results of a Phase 1, first-in-man clinical study of subcutaneous injections of IMMU-114 in patients with relapsed non-Hodgkin lymphoma and chronic lymphocytic leukemia, which showed 50% of patients having objective evidence of treatment activity, including one patient with a complete response. (More information on the results can be assessed at View Source)