#Silverback release update#
#Silverback release full#

Research and development expenses for the fourth quarter ended Decemwere $15.9 million, compared to $8.8 million for the same period in 2020.

#Silverback release full#

Net loss for the fourth quarter and full year of 2021 included non-cash stock-based compensation expense of $5.2 million and $19.2 million, respectively, compared to $2.3 million and $2.6 million for the same periods in 2020, respectively. For the year ended December 31, 2021, Silverback reported a net loss of $89.5 million, compared to a net loss of $32.9 million for 2020. It will be difficult to part with valued team members who have been so committed to the organization, and IвЂ™d like to thank each one of them for their valuable contributions towards our mission to develop the next generation of tissue targeted therapeutics.вЂќДЇor the fourth quarter ended December 31, 2021, Silverback reported a net loss of $23.5 million, compared to a net loss of $13.1 million for the comparable period in 2020. Shawver added, вЂњOver the course of the next few days and weeks, we are restructuring our workforce and allocating resources around our new strategic priorities.

Estimated cash runway extended into the second half of 2026 following strategic prioritizationДr.

Restructure workforce to focus resources on SBT8230 program and discovery pipeline, reducing headcount by 27%.

#Silverback release update#

Provide an update on SilverbackвЂ™s discovery pipeline in the fourth quarter of 2022.Open enrollment for a Phase 1 single ascending dose study of SBT8230 in healthy volunteers in the first half of 2023.Complete the Phase 1 regulatory submission for SBT8230 in the fourth quarter of 2022.Key Strategic Priorities and Cash Runway Extension Silverback will continue advancement of early-stage discovery research that is focused on exploring different antigen targets, novel linker technologies, and small molecule payloads that expand the reach of the ImmunoTAC platform. Silverback initiated Phase 1-enabling toxicology studies for SBT8230 in the first quarter of 2022. At the AASLD Liver Meeting 2021, Silverback presented preclinical studies demonstrating that SBT8230 was efficiently delivered to the liver, resulting in myeloid cell activation in the liver but not in the blood. Liver-localized TLR8 agonism has the potential to lead to durable responses and possibly seroconversion, an important determinant of functional cure. In non-human-primate studies, SBT8230 demonstrated lower serum exposures compared to SBT6050 due to its efficient localization to liver. An anti-viral immune response is achieved through activation of myeloid cells and subsequent indirect activation of B cells and T cells. ASGR1 is highly expressed in liver and is restricted in its expression to this organ. SBT8230 is comprised of an ASGR1 monoclonal antibody conjugated to a TLR8 linker-payload and is designed to elicit an anti-viral immune response by targeting TLR8 activation to the liver. We continue to advance SBT8230 and are on track to complete a Phase 1 regulatory submission in the fourth quarter of 2022.вЂќ вЂњThe comparative preclinical data between SBT6050 and SBT8230 suggest that the clinical safety, pharmacokinetic and pharmacodynamic profiles for SBT8230 will likely be different than those for SBT6050, given the significant differences in preclinical serum exposures and expected overall conjugate disposition for SBT8230 in patients due to its efficient liver targeting. вЂњOur understanding of TLR8 conjugates in preclinical species and in the clinic provides a lens for interpretation of the preclinical characteristics of SBT8230,вЂќ said Valerie Odegard, Ph.D., president and chief scientific officer. SBT8230 (ASGR1-TLR8 ImmunoTAC conjugate for chronic HBV)

SBT6290, comprised of the same linker payload conjugated to a Nectin4 antibody, was expected to show a similar clinical profile and, therefore, this development program was also discontinued. Further development was discontinued based on limited monotherapy anti-tumor activity and cytokine-related adverse events that limited the dose in combination with pembrolizumab. A dose response was observed in serum and intratumoral exposure, and in pharmacodynamic markers, inclusive of data that demonstrates immune activation in biopsies collected from patients after treatment. In the Phase 1/1b trial, a total of 58 patients were enrolled and received SBT6050 as monotherapy and in combination with a checkpoint inhibitor at dose levels ranging from 0.15 mg/kg through 1.2 mg/kg with the length of patient experience ranging from 2 weeks through 41 weeks. Silverback has discontinued the SBT6050 development program. SBT6050 and SBT6290 (HER2-TLR8 and Nectin4-TLR8 ImmunoTAC conjugates for oncology)