Sonnet BioTherapuetics(SONN) - 2024 Q3 - Quarterly Results

Q3 FY2024 Financial Results and Corporate Update Recent Highlights & Patent Update The company secured key patents, advanced new drug candidates, and strengthened its financial position - Exercised warrants for $3.4 million in gross proceeds, strengthening the company's financial position[2] - Generated and characterized two new drug candidates, SON-1411 (IL18-FHAB-IL12) and SON-1400 (IL18-FHAB), expanding the pipeline[2] - The U.S. Patent and Trademark Office granted patent No. 12,006,361 for the composition of matter for product candidate SON-1210[3] - Presented the SB221 study of SON-1010 in combination with atezolizumab at the ASCO Annual Meeting in June 2024[2] Clinical Program Updates The company is advancing its lead clinical programs, SON-1010 and SON-080, with positive safety data SON-1010 Program (Solid Tumors and PROC) The SON-1010 program shows clinical benefit in 35% of patients and a favorable safety profile - Across the SB101 and SB221 trials, 35% of evaluable patients (8 of 23) with cancer showed clinical benefit, defined as Stable Disease at 4 months[6] - SON-1010 has a favorable safety profile, with patients receiving up to 25 monotherapy cycles and up to 10 combination therapy cycles without dose-limiting toxicity[6] - Pharmacokinetic (PK) data shows a 10-fold extended half-life for SON-1010 compared to standard rhIL-12, suggesting effective tumor targeting[6] SON-1010 Upcoming Milestones | Trial Phase | Indication | Milestone | Expected Timing | | :--- | :--- | :--- | :--- | | Phase 1 | Solid Tumors (Monotherapy) | Safety Data | 2H 2024 | | Phase 1 | Solid Tumors (Monotherapy) | Topline Efficacy Data | 1H 2025 | | Phase 1b/2a | PROC (Combo Therapy) | Additional Safety Data | 2H 2024 | | Phase 1b/2a | PROC (Combo Therapy) | RP2D & Topline Efficacy Data | 2H 2025 | SON-080 Program (CIPN and DPN) The SON-080 program met safety goals in its Phase 1b/2a trial and the company is seeking a partner for Phase 2 - The Data and Safety Monitoring Board for the SB211 trial concluded that SON-080 was tolerable, allowing the study to proceed to Phase 2 for CIPN[7] - Phase 1b data highlights that SON-080 was well-tolerated at doses 10-fold lower than the previously established MTD for IL-6[8] - The company is actively seeking a partnership to support the initiation of a Phase 2 clinical trial in Diabetic Peripheral Neuropathy (DPN)[9] Q3 2024 Financial Results The company reported a net loss of $3.5 million and holds cash sufficient to fund operations into November 2024 - As of June 30, 2024, the company had $3.6 million in cash, which is believed to be sufficient to fund operations into November 2024[10] - The decrease in R&D expenses was driven by cost-saving initiatives, including transitioning activities to cost-advantaged locations and suspending development on non-core programs[10] Q3 2024 vs. Q3 2023 Operating Expenses | Expense Category | Q3 2024 (ended June 30) | Q3 2023 (ended June 30) | Change | | :--- | :--- | :--- | :--- | | Research & Development | $1.7 million | $2.4 million | -$0.7 million | | General & Administrative | $1.8 million | $1.5 million | +$0.3 million | Consolidated Balance Sheets Total assets increased to $5.8 million while total liabilities decreased, resulting in stockholders' equity of $2.6 million Consolidated Balance Sheet Highlights (unaudited) | Account | June 30, 2024 | September 30, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash | $3,554,331 | $2,274,259 | | Total current assets | $5,127,771 | $4,738,229 | | Total assets | $5,796,797 | $5,429,478 | | Liabilities & Equity | | | | Total current liabilities | $3,109,854 | $5,524,595 | | Total liabilities | $3,178,691 | $5,655,458 | | Total stockholders' equity (deficit) | $2,618,106 | ($225,980) | Consolidated Statements of Operations The company reported a reduced net loss of $3.5 million for the quarter and $4.3 million for the nine-month period Statement of Operations Highlights (unaudited) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Nine Months Ended June 30, 2024 | Nine Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,727,033 | $2,409,471 | $4,538,363 | $9,972,055 | | General and administrative | $1,801,632 | $1,542,689 | $4,156,360 | $5,330,967 | | Loss from operations | ($3,528,665) | ($3,915,310) | ($8,676,097) | ($15,192,472) | | Net loss | ($3,505,555) | ($3,946,742) | ($4,308,639) | ($15,155,955) | Per Share Information (unaudited) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Nine Months Ended June 30, 2024 | Nine Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Net loss per share | ($0.70) | ($2.95) | ($0.96) | ($18.98) |