Immunomedics (IMMU) Misses Q3 EPS by 9c

Immunomedics (NASDAQ: IMMU) reported Q3 EPS of ($0.49), $0.09 worse than the analyst estimate of ($0.40).

“We have made significant progress over the past nine months against important manufacturing and clinical milestones, while seeking opportunities to unlock value for sacituzumab govitecan through potential new indications and new geographies. As a result of the hard work put forth by our quality, manufacturing, and clinical/regulatory teams, we are on target to submit our Biologics License Application (BLA) for sacituzumab govitecan in late-stage metastatic triple-negative breast cancer (mTNBC) in patients who have received at least two prior therapies for metastatic disease to the FDA in late November or early December, 2019. Furthermore, we are continuing our preparations and expect to be well-positioned for a pre-approval inspection following our resubmission,” stated Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics.

In the quarter, the Company reported interim results from the Phase 2 open-label study, of sacituzumab govitecan in patients with metastatic urothelial cancer (mUC) (TROPHY-U-01) at the ESMO 2019 Congress. The results from the initial 35 cisplatin-eligible patients were highly consistent with the previously-established clinical activity and safety profile of sacituzumab govitecan and are encouraging relative to standard of care in this setting. The target enrollment of 100 patients in this cohort was reached in early October, ahead of the year-end 2019 plan. “We are pleased to have accomplished these two important goals and look forward to discussing the registrational path forward for sacituzumab govitecan in mUC with the FDA,” added Dr. Aghazadeh.

The Company has also expanded the clinical development of sacituzumab govitecan to additional metastatic solid tumors with the newly-opened multi-cohort, open-label, Phase 2 TROPiCS-03 study having dosed the first patient with non-small cell lung cancer (NSCLC). This is the first study conducted by Immunomedics in which a biomarker will be used to assess whether enrichment for Trop-2 expression may lead to higher responses in certain indications.

In the quarter, the Company entered into two important clinical collaborations to potentially advance sacituzumab govitecan to earlier lines of breast cancer treatment. While the collaboration with Roche will develop sacituzumab govitecan in the frontline setting of mTNBC by combining it with Roche’s programmed cell death ligand 1 (PD-L1)-blocking checkpoint inhibitor, atezolizumab (Tecentriq®), the German Breast Group (GBG) will conduct a multinational Phase 3 study in the curative setting for high-risk patients with human epidermal growth factor receptor 2-negative (HER2–) breast cancer who do not achieve a pathological complete response (pCR) following standard neoadjuvant therapy.

“As we get closer to resubmission, the Company will continue to accelerate its efforts towards commercial launch readiness. We have maintained a significant portion of our U.S. commercial infrastructure through a creative and productive arrangement with Janssen, and will continue to bolster our capabilities to ensure a successful launch,” added Dr. Aghazadeh.

For earnings history and earnings-related data on Immunomedics (IMMU) click here.

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