On August 5, 2020 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 second quarter of 2020 (Press release, Immunomedics, AUG 5, 2020, View Source [SID1234562930]). 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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"This has been an exciting quarter for Immunomedics. Not only are we energized by the encouraging early adoption of Trodelvy by patients and physicians, which we attributed to the drug’s compelling risk/benefit profile, but we are also inspired by the remarkable topline results Trodelvy has produced in the ASCENT study," stated Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "With full data readouts in the coming months from ASCENT and the pivotal TROPHY U-01 study in metastatic urothelial cancer (mUC), either one of which could potentially support expansion of Trodelvy’s label, we look forward to updating you in the next quarters. Meanwhile, we continue to admire the dedication of healthcare workers around the globe in helping navigate these unprecedented times. They are our role models as we strive to develop new clinically meaningful treatment options for the benefit of patients with hard-to-treat cancers."

Recent Highlights and New Developments

Trodelvy has been robustly adopted by physicians to date in both the community and academic settings since its commercial launch in late April, with $20.1M net sales in first two months of launch.
The confirmatory Phase 3 ASCENT study showed that treatment with Trodelvy significantly improved progression-free survival (PFS), compared to chemotherapy, in brain metastasis negative patients with metastatic triple-negative breast cancer (mTNBC) who have previously received at least two prior therapies for metastatic disease, the primary endpoint of the study. Median PFS for patients treated with Trodelvy was 5.6 months (95% confidence interval (CI), 4.3-6.3), compared to 1.7 months (95% CI, 1.5-2.6) for chemotherapy (p<0.0001), with a hazard ratio of 0.41 (95% CI, 0.32-0.52). This study also met key secondary endpoints, including overall survival (OS) and objective response rate (ORR). The safety profile was consistent with the U.S. Food and Drug Administration (FDA)-approved label and no new safety signals were observed.
The ASCENT study results will be submitted in a supplemental Biologics License Application, anticipated to be in the fourth quarter of 2020, to the FDA seeking full approval of Trodelvy, while submission to the European Medicines Agency is expected in the first half of 2021.
Full data from the ASCENT study will also be submitted to the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 as a late-breaking abstract.
A second late-breaking abstract containing final results from the TROPHY U-01 study of Trodelvy in the full first cohort of 113 patients with mUC who have failed prior platinum-based and programmed cell death protein 1 or programmed cell death ligand 1 (PD-L1) inhibitor therapies will also be submitted to the ESMO (Free ESMO Whitepaper) Virtual Congress 2020.
At the same ESMO (Free ESMO Whitepaper) Congress, an abstract containing early clinical results on the delivery and activity of SN-38 by Trodelvy in central nervous system tumors has been accepted for oral presentation.
Patient enrollment has resumed for the Phase 3 TROPiCS-02 study of Trodelvy in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC). This study includes an early look at ORR and duration of response (DoR) from a subset of patients, the results of which could potentially support an accelerated approval submission in 2021.
The open-label Phase 2 TROPiCS-03 study of Trodelvy in metastatic non-small cell lung cancer (mNSCLC) has resumed patient enrollment at select sites. The study will be expanded to include patients with squamous carcinoma of the head and neck later this year.
The TROPHY U-01 study has started enrolling cohort 3 patients who are checkpoint inhibitor (CPI)-naïve and have failed a platinum-containing regimen in the metastatic setting to study the combination of Trodelvy and pembrolizumab.
The investigator-initiated Phase 2 NeoSTAR study of Trodelvy has dosed the first patients with localized TNBC in the neoadjuvant setting.
The Company’s ongoing clinical collaboration with Roche to evaluate Tecentriq (atezolizumab) in combination with Trodelvy in patients with mTNBC has been expanded to include mUC and mNSCLC using Roche’s MORPHEUS platform.
Dana Farber Cancer Institute has launched two studies combining Trodelvy with pembrolizumab in PD-L1-negative mTNBC and in PD-L1-positive HR+/HER2– mBC.
A new single arm, multicenter, registration-oriented Phase 2b study of Trodelvy in mTNBC patients who are refractory or relapsing after at least 2 prior standard chemotherapy regimens was launched in China by corporate partner Everest Medicines. The primary endpoint of this study is ORR. Secondary endpoints include DoR, clinical benefit rate, PFS and OS, as well as safety and tolerability.
The Company received a $60 million milestone payment from Everest Medicines for Trodelvy approval in the U.S.
Financial Results for the Second Quarter of 2020

The Company reported net product revenue for Trodelvy of $20.1 million for the quarter ended June 30, 2020, compared to no product revenue for the comparable quarter ended June 30, 2019. The FDA granted accelerated approval for Trodelvy on April 22, 2020.

Cost of goods sold was $1.7 million for the quarter ended June 30, 2020. There was no cost of goods sold for the comparable quarter ended June 30, 2019.

Research and development expenses decreased by approximately $10.4 million to $42.6 million for the second quarter ended June 30, 2020, compared to the comparable quarter ended June 30, 2019, primarily due to a decrease in manufacturing and quality costs, as all costs were expensed to research and development in the prior period and a portion of such costs are capitalized in the current period due to FDA approval of Trodelvy. The decrease was partially offset by an increase in labor costs as well as clinical development and operational costs from expansion of clinical trials with increased enrollment.

Selling, general and administrative expenses increased by $14.6 million to $28.9 million for the quarter ended June 30, 2020, compared to comparable quarter ended June 30, 2019, primarily due to increased labor costs from incentive and stock-based compensation recognized upon FDA approval of Trodelvy in the United States, as well as increase in marketing and promotions costs in connection with the commercial launch of Trodelvy.

Net loss attributable to stockholders was $66.5 million, or $0.30 per share, for the quarter ended June 30, 2020, compared to $76.0 million, or $0.40 per share, for the comparable quarter ended June 30, 2019.

As of June 30, 2020, the Company had $975.5 million in cash, cash equivalents, and marketable securities, as well as 231 million outstanding shares of common stock. This cash balance includes a $60 million milestone payment from Everest Medicines for Trodelvy approval in the United States. The Company believes its projected financial resources are adequate to support commercial launch of Trodelvy in the United States in mTNBC; continue to expand the clinical development programs for Trodelvy; invest in the broader clinical development of the ADC platform (including IMMU-130 and IMMU-140); continue scale-up manufacturing and manufacturing process improvements; and general working capital requirements.

Conference Call

The Company will host a conference call and live audio webcast with supporting slides today at 5:00 p.m. Eastern Time to discuss second quarter 2020 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 9887775. The conference call with supporting slides 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.