On February 8, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended December 31, 2021 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 8, 2022, View Source [SID1234607878]).

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!

"Throughout the quarter, we’ve continued to advance towards the clinic with our proprietary Fully Human Albumin Binding (FHAB) pipeline assets, and our partnered product, SON-080," said Pankaj Mohan, Ph.D., Founder and CEO. "We continue to generate additional clinical product stability data for SON-1010 (IL12-FHAB) for the FDA and we have initiated cGMP manufacturing for SON-080 (Low-dose IL-6), with both assets on track to initiate clinical studies in the second quarter of this year. Additionally, we have completed R&D manufacturing for a non-human primate non-GLP toxicology study for SON-1210 (IL12-FHAB-IL15), with the study initiation planned for the first half of 2022 and have made important progress with our SON-1410 (IL18-FHAB-IL12) and SON-3015 (Anti-IL6-FHAB-Anti-TGFβ) bispecific assets."

"We remain pleased with our ongoing financing strategy and continue to provide the company with the funding necessary to advance our R&D activities into the clinic and grow the company in 2022," commented Jay Cross, CFO.

FY 2022 First Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates for the 2022 calendar year:

●Generating additional clinical product stability data for SON-1010 for the FDA in 1Q22; SON-1010 is on track for clinical study initiation in 2Q22.
●Completed preparations for cGMP manufacturing of SON-080, initiated manufacturing in January, and on track for clinical study initiation in 2Q22.
●Completed R&D manufacturing for SON-1210 with initiation of a non-GLP pre-clinical toxicity study in non-human primates on track for 1H22.
●Completed sequence confirmation for SON-3015 and preparing for initial in vivo mice studies in 2H22.
●Lead optimization is underway to initiate CMC with cell line development for SON-1410 in 2Q22.

FY 2022 First Quarter Ended December 31, 2021 Financial Results

●As of December 31, 2021, Sonnet had $19.4 million cash on hand.
●Research and development expenses were $4.3 million for the three months ended December 31, 2021, compared to $3.9 million for the three months ended December 31, 2020. The increase of $0.4 million was primarily due to the development of the cell lines for SON-1010, SON-1210 and SON-080, and an increase in payroll and share-based compensation expense as we continue to expand our operations.
●General and administrative expenses were $2.1 million for the three months ended December 31, 2021, compared to $2.0 million for the three months ended December 31, 2020. The increase of $0.1 million relates to an increase in consulting fees.