On May 9, 2018 Immunomedics, Inc. (NASDAQ:IMMU) ("Immunomedics" or the "Company"), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, reported financial results for the third quarter ended March 31, 2018 (Press release, Immunomedics, MAY 9, 2018, View Source [SID1234526371]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

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"We have made tremendous progress in achieving our regulatory, clinical and organizational objectives in the prior quarter. Through the outstanding work of our colleagues, we remain on track to file our first BLA with the FDA later this month for the approval of sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA has previously granted us Breakthrough Therapy Designation for the treatment of patients with mTNBC who received at least two prior therapies for metastatic disease," stated Michael Pehl, President and Chief Executive Officer of Immunomedics. "In addition, Rob Iannone joined us as the Head of R&D and Chief Medical Officer, and under his leadership we will continue to unlock the full potential of sacituzumab govitecan, as well as new value creation opportunities with our unique ADC platform."

Highlights of Recent Progress

In March 2018, the Phase 3 ASCENT study dosed the first patient in Europe, reflecting the encouraging progress of the confirmatory trial with sacituzumab govitecan in patients with mTNBC.

In March 2018, the Company’s abstract on the efficacy of sacituzumab govitecan for treatment-refractive, HR+, HER2- mBC was selected for oral presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

In April 2018, Immunomedics further expanded its executive leadership team with the appointment of Robert Iannone, M.D., M.S.C.E., as Head of Research & Development and Chief Medical Officer. Dr. Iannone brings more than 13 years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

In April 2018, the FDA agreed to the Company’s proposed amendments to the confirmatory ASCENT trial protocol that is under a Special Protocol Assessment (SPA). The amendments incorporated recommendations from EU National Health authorities and advice from key breast cancer experts. As a result, the sample size will be increased to 488 patients, and will ensure robust power to evaluate the key objectives in the primary population of interest. Based on strong early enrollment trends, these changes are not expected to meaningfully impact overall study timelines. Immunomedics believes that the FDA’s agreement to this SPA amendment may further increase the probability of success of the study, while leaving key study objectives and endpoints intact.
Key Upcoming Events/Anticipated Milestones

BLA submission for accelerated approval of sacituzumab govitecan in third-line mTNBC (May 2018).

Oral presentation of results with sacituzumab govitecan in patients with HR+/HER2- mBC at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting (morning of Sunday, June 3, 2018).

Investor Event at ASCO (Free ASCO Whitepaper) (evening of Sunday, June 3, 2018).
Third Quarter and Nine Months Fiscal 2018 Results

Total revenues were $0.5 million for the third fiscal quarter ended March 31, 2018 and $1.8 million for the nine months ended March 31, 2018, compared to $1.3 million in the third fiscal quarter ended March 31, 2017 and $2.4 million for the nine months ended March 31, 2017. The decreases were due primarily to lower sales volume of LeukoScan in Europe. The Company discontinued the sale of LeukoScan during the third quarter of fiscal 2018 to focus on its ADC business.

Total costs and expenses were $38.1 million for the quarter and $90.4 million for the nine months ended March 31, 2018, compared to $23.4 million in the third quarter and $54.9 million for the nine months for the prior fiscal year. The higher costs and expenses in the third quarter and nine months of fiscal 2018 were due primarily to increases in research and development expenses as well as in sales and marketing expenses. The increases in third quarter costs and expenses of fiscal 2018 were offset partially by a $3.6 million decrease in general and administrative expenses in the third quarter due primarily to higher legal and advisory fees incurred in fiscal 2017 during the Company’s proxy contest.

The increases in research and development expenses were due primarily to increases in clinical trial costs as well as increases in labor related costs in connection with preparations for the regulatory submission and launch of sacituzumab govitecan in the United States for patients with mTNBC. The increases in sales and marketing expenses were due primarily to commercial launch preparation activities.

The Company recognized $9.8 million in non-cash income for the quarter and $49.8 million in non-cash expense for the nine months ended March 31, 2018, compared to $28.3 million in non-cash expense for the third quarter and $35.6 million for the nine months for the prior fiscal year. The changes in non-cash cost were due to the change in the fair value of warrant liabilities.

Net loss attributable to stockholders was $35.5 million, or $0.21 per share, for the quarter ended March 31, 2018, compared to net loss attributable to stockholders of $59.3 million, or $0.55 per share, for the same quarter in fiscal 2017. Net loss attributable to stockholders was $156.8 million, or $1.08 per share, for the nine months ended March 31, 2018, compared to net loss attributable to stockholders of $99.9 million, or $0.97 per share, for the same period in fiscal 2017.

As of March 31, 2018, the Company had $358.8 million in cash, cash equivalents, and marketable securities which it believes is sufficient to support its next phase of growth and continue operations into 2020.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the third quarter of fiscal year 2018, and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 9679918. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.