On May 6, 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 first quarter of 2020 (Press release, Immunomedics, MAY 6, 2020, View Source [SID1234557129]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
As the world responds to the outbreak of COVID-19, the thoughts of the Immunomedics team are with those affected, the staff who are providing essential services and healthcare workers fighting at the front lines of this pandemic. We also thank our colleagues, who are working tirelessly under the constraints of the current environment, to support the Company’s mission of delivering breakthrough treatments to those in need.
"We entered 2020 with strong momentum across our operations," stated Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "Following a successful biologics license application resubmission in late 2019, we were pleased to receive accelerated approval for Trodelvy in late April and accomplished our goal of bringing this therapy to patients with metastatic triple-negative breast cancer (mTNBC). Trodelvy was launched within days of receiving FDA approval and transformed Immunomedics into a fully-integrated biopharmaceutical company in the process. We also announced the early stoppage of our confirmatory Phase 3 ASCENT study due to compelling evidence of efficacy and look forward to reporting topline study results in mid-2020. These data are expected to establish Trodelvy as a new standard of care in mTNBC and help improve the lives of people with hard-to-treat cancers worldwide. Finally, we significantly strengthened our balance sheet with an over-subscribed follow-on offering that will allow us to build on our momentum during the growth period ahead."
Recent Highlights and New Developments
The Phase 3 confirmatory ASCENT study of Trodelvy in third-line mTNBC was halted early due to compelling evidence of efficacy across multiple endpoints, based on the unanimous recommendation by the independent Data Safety Monitoring Committee during its recent routine review of the study. Topline readout is expected around mid-2020.
Trodelvy received accelerated approval from the FDA for the treatment of adult patients with mTNBC who have received at least two prior therapies for metastatic disease. Trodelvy is the first ADC approved by the FDA specifically for previously-treated mTNBC and is also the first FDA-approved anti-Trop-2 ADC.
Commercial launch of Trodelvy is underway, with the first patient treated within days of FDA approval and a National Drug Rebate Agreement with The Centers for Medicare & Medicaid Services fully executed.
The Company entered into a clinical collaboration with Dana-Farber Cancer Institute to conduct two Phase 2 studies to evaluate the safety and efficacy of combining Trodelvy with pembrolizumab (Keytruda), Merck’s anti-programmed cell death protein 1 (PD-1) antibody, in patients with (i) mTNBC and (ii) hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC). In the mTNBC study, approximately 110 newly-diagnosed patients, who are programmed cell death ligand 1 (PD-L1)-negative, will be randomized to receive the combination of Trodelvy and pembrolizumab or Trodelvy alone. The same combination of Trodelvy and pembrolizumab will be used in the second randomized study in approximately 110 hormonal treatment- and chemotherapy-refractory patients with PD-L1-positive, HR+/HER2– mBC. Primary endpoint for both studies is progression-free survival. Other clinical outcome measures, including overall survival, objective response rate by RECIST 1.1, duration of response, and clinical benefit rate, will be used as secondary endpoints.
An abstract containing early results from cohort 2 of TROPHY U-01 study of Trodelvy in metastatic urothelial cancer patients who are platinum-ineligible and progressed after prior checkpoint inhibitor therapy has been accepted for poster presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual meeting. Topline data from the full first cohort of 100 patients with prior platinum-based and PD-1 or PD-L1 inhibitor therapies are expected to be available in the second half of 2020.
Additionally, an abstract from a Phase 1/2 study of Trodelvy in patients with previously-treated metastatic endometrial cancer has also been accepted for poster presentation at the 2020 ASCO (Free ASCO Whitepaper) virtual meeting.
In adhering to federal and local guidelines on COVID-19, in March 2020 the Company proactively suspended activation of new study sites and slowed the enrollment of new patients for certain clinical studies. The Company continues to work closely with investigators and the FDA to ensure the safety of patients considering the health risks posed by the pandemic, while preserving the integrity of the studies.
Enrollment into the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2– mBC is expected to resume in late May 2020 at select sites that have been carefully vetted for their ability to ensure normal clinical trial operations and patient safety.
The Company’s leadership team has been strengthened by the appointments of Harout Semerjian as President and Chief Executive Officer, and Dr. Loretta M. Itri as Chief Medical Officer. Dr. Behzad Aghazadeh remains as Executive Chairman while Scott Canute has resumed his role as a member of the Board of Directors.
John Stubenrauch has been appointed Senior Vice President, Global Head of Manufacturing. Mr. Stubenrauch has decades of experience in global commercial manufacturing across organizations, including AstraZeneca and Merck. Dr. Morris Rosenberg, who helped support the manufacturing operations leading up to Trodelvy’s commercial launch, will be stepping down from the management team, effective May 15, 2020, to pursue the next chapter in his career.
The Company raised approximately $464.6 million in net proceeds through a public offering of common stock.
Financial Results for the First Quarter of 2020
Total costs and expenses were $82.0 million for the three months ended March 31, 2020, compared to $79.6 million for the comparable quarter ended March 31, 2019. The increase was primarily due to a $4.3 million increase in research and development expenses and a $0.2 million increase in sales and marketing expenses, partially offset by a $2.1 million decrease in general and administrative expenses.
Interest expense was $13.5 million for the three months ended March 31, 2020, compared to $10.0 million for the comparable quarter March 31, 2019. The increase was 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 $93.0 million, or $0.44 per share, for the three months ended March 31, 2020, compared to $87.3 million, or $0.46 per share, for the comparable quarter ended March 31, 2019.
As of March 31, 2020, the Company had $540.6 million in cash, cash equivalents, and marketable securities. On May 1, 2020, the Company closed on its previously announced underwritten public offering of common stock with net proceeds of approximately $464.6 million. 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); continued scale up of manufacturing and manufacturing process improvements; and general working capital requirements.
Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss first 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 9146008. 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.