On August 12, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results for the second quarter ended June 30, 2021 and provided a business update (Press release, Silverback Therapeutics, AUG 12, 2021, View Source [SID1234586445]).
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"The second quarter was notable for the significant progress we made across our entire pipeline of tissue-targeted therapies, with SBT6050, our HER2-TLR8 ImmunoTAC leading the way with continued robust enrollment in our Phase 1/1b study," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are deeply appreciative of the patients, their families, and our clinical investigators who continue to contribute to the SBT6050-101 clinical trial, and we look forward to providing the first update of the clinical data at the ESMO (Free ESMO Whitepaper) conference in September."
Recent Highlights
SBT6050 (HER2-TL8 ImmunoTAC) clinical abstract accepted for poster presentation at the European Society for Medical Oncology ("ESMO") 2021 Annual Meeting. The presentation will provide an update on the monotherapy dose-escalation arm (Part 1) and the pembrolizumab combination dose-escalation arm (Part 3) of the SBT6050-101 Phase 1/1b study. Details of the upcoming ESMO (Free ESMO Whitepaper) poster presentation are as follows:
Title: "Interim results of a Phase 1/1b study of SBT6050 monotherapy and pembrolizumab combination in patients with advanced HER2-expressing or amplified solid tumors" Klempner, S., et al.
Poster Number: 209P
Session Date and Time: The ePoster will be released virtually on Thursday, September 16th at 8:30 AM Central European Summer Time / 2:30 AM Eastern Standard Time
Announced a clinical supply agreement with Regeneron to evaluate SBT6050 in combination with Libtayo (cemiplimab), a PD-1 inhibitor. Under the terms of the agreement, Silverback will expand the ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo in tumor-specific dose expansion cohorts, initially in HER2-expressing non-small cell lung and gastric cancers.
GLP toxicology study for SBT6290 (Nectin4-TLR8 ImmunoTAC) is nearing completion, with IND filing on track for the fourth quarter of 2021. Dosing was initiated in the GLP toxicology study in the second quarter and cGMP manufacturing of the drug product for Phase 1 clinical supply has been completed, with release testing in progress.
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV) continues to advance through preclinical development with early CMC activities initiated including selection of the clone and creation of a master cell bank. The GLP toxicology study is expected to commence in the first quarter of 2022.
Second Quarter Financial Results
For the second quarter ended June 30, 2021, Silverback reported a net loss of $24.5 million, compared to a net loss of $6.5 million for the comparable period in 2020. For the six months ended June 30, 2021, Silverback reported a net loss of $43.4 million, compared to a net loss of $11.7 million for the comparable period in 2020. Included in the net losses for the three and six months ended June 30, 2021 were $4.7 million and $9.0 million of non-cash stock-based compensation compared to $128,000 and $175,000 for the same periods in 2020.
Research and development expenses for the second quarter ended June 30, 2021 were $17.7 million, compared to $5.1 million for the same period in 2020. Research and development expenses for the six months ended June 30, 2021 were $30.0 million compared to $9.5 million for the same period in 2020. The increases in the Company’s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, through preclinical development and the continued clinical development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advancements.
General and administrative expenses for the second quarter ended June 30, 2021 were $6.8 million, compared to $1.3 million for the same period in 2020. General and administrative expenses for the six months ended June 30, 2021 were $13.4 million, compared to $2.2 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2021, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.
As of June 30, 2021, Silverback reported cash and cash equivalents of $359.7 million, compared to $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months.