On October 30, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the third quarter of 2019 (Press release, Immunomedics, OCT 30, 2019, View Source [SID1234550038]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.
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"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 (Free ESMO Whitepaper) 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.
Recent Company Highlights
At the ESMO (Free ESMO Whitepaper) 2019 Congress, the Company presented interim data from the open-label Phase 2 TROPHY-U-01 study that showed an overall response rate of 29 percent, including two confirmed complete responses, six confirmed partial responses (PRs) and two additional PRs pending confirmation, in 35 patients with metastatic urothelial cancer who had relapsed or were refractory to immune checkpoint inhibitors (CPI) and platinum-based chemotherapy. This study has now reached target enrollment of 100 platinum-eligible patients who have progressed after prior CPI and platinum-based therapies.
The Company announced a clinical collaboration with Roche to evaluate the safety and efficacy of combining sacituzumab govitecan with atezolizumab (Tecentriq), Roche’s PD-L1-blocking checkpoint inhibitor, as a frontline treatment of patients with metastatic or inoperable locally advanced TNBC. Patients with newly-diagnosed mTNBC will be randomized to receive the combination of atezolizumab and sacituzumab govitecan or nab-paclitaxel plus atezolizumab as standard of care. Roche will be responsible for conducting this randomized study.
In addition, the Company and GBG have entered into a collaboration to develop sacituzumab govitecan as a potential treatment for patients with HER2– breast cancer in the curative setting. The multinational, post-neoadjuvant Phase 3 SASCIA study will be conducted under the sponsorship of GBG and enroll approximately 1,200 high-risk patients with HER2– breast cancer who do not achieve a pCR following standard neoadjuvant therapy. Patients will be randomized to receive either sacituzumab govitecan or treatment of physician’s choice.
In the open-label, Trop-2-enriched multi-cohort Phase 2 TROPiCS-03 study (NCT03964727), the first patient with NSCLC has been dosed. The primary endpoint of this study is overall response rate with duration of response and progression-free survival serving as secondary endpoints.
Third Quarter and Nine Months 2019 Financial Results
The Company had no revenues for the quarter and nine months ended September 30, 2019, due primarily to the discontinued sale of LeukoScan in February 2018 in order for the Company to focus on its ADC business. Revenues in the comparable nine months ended September 30, 2018 was $0.9 million.
Total costs and expenses were $86.8 million for the quarter and $233.6 million for the nine months ended September 30, 2019, compared to $57.2 million for the comparable quarter and $148.1 million for the nine months ended September 30, 2018. The increases were due primarily to increased expenses in research and development and sales and marketing, partially offset by decreases in general and administrative expenses. The increases in research and development costs were mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for mTNBC in the United States and expanded clinical development of sacituzumab govitecan into other indications.
The Company had no non-cash warrant-related income or expense for the quarter and nine months ended September 30, 2019, compared a $1.2 million of non-cash gain for the comparable quarter and a $47.8 million warrant-related expense for the nine months ended September 30, 2018, due to changes in the fair value of then outstanding warrants. There were no warrants outstanding as of September 30, 2019 and December 31, 2018.
Interest expense was $9.7 million for the quarter and $30.3 million for the nine months ended September 30, 2019, compared to $10.1 million for the comparable quarter and $30.5 million for the nine months ended September 30, 2018. The decreases were due primarily to changes in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.
Net loss attributable to stockholders was $94.3 million, or $0.49 per share, for the quarter ended September 30, 2019, compared to $64.2 million, or $0.34 per share, for the comparable quarter ended September 30, 2018. Net loss attributable to stockholders was $257.6 million, or $1.34 per share, for the nine months ended September 30, 2019, compared to $216.7 million, or $1.24 per share, for the nine months ended September 30, 2018.
As of September 30, 2019, the Company had $369.2 million in cash, cash equivalents, and marketable securities. The Company believes this amount is adequate to support its clinical development plan for sacituzumab govitecan, further build its clinical and manufacturing infrastructure and fund its operations through 2020.
Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss third quarter 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 3164368. 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.