Sonnet Biotherapeutc Hldng Inc Stock Price, News & Analysis

Sonnet BioTherapeutics Holdings (NASDAQ:SONN) announced the pricing of an underwritten public offering of 13,888,888 shares of common stock at a price of $1.08 per share, expected to generate approximately $15 million in gross proceeds before expenses.

This offering includes investor warrants enabling the purchase of up to 27,777,776 additional shares. Net proceeds will be used for further R&D, clinical trials, and general corporate purposes. The offering is set to close on February 10, 2023, pending customary conditions.

Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) announced the successful completion of two IND-enabling toxicology studies for SON-1210, its lead bifunctional therapeutic candidate. The studies showed no serious adverse events, and SON-1210 was well-tolerated at doses 50 times higher than expected human levels. Observations included a controlled rise in interferon gamma (IFNg) without cytokine release syndrome or off-target toxicity. The results pave the way for regulatory filings in the first half of 2023, aimed at initiating human trials, particularly for targeting cancers by stimulating an immune response.

Sonnet BioTherapeutics (NASDAQ:SONN) announced dosing of 24 healthy volunteers in a Phase 1 clinical trial for SON-1010, aimed at assessing safety and pharmacokinetics (PK). SON-1010 shows a remarkable half-life of approximately 112 hours, significantly longer than the 12 hours of rhIL-12. Early results indicate successful induction of interferon gamma (IFNg) with minimal adverse events, allowing for potential dose escalation. The findings support the effectiveness of the F_HAB platform in enhancing drug delivery to tumors, suggesting promising implications for future cancer therapies and potential market opportunities.

Sonnet BioTherapeutics (NASDAQ: SONN) announced a clinical collaboration with Roche to evaluate its lead product, SON-1010, alongside atezolizumab in a study targeting platinum-resistant ovarian cancer. Scheduled to begin in Q2 2023, the Phase 1b/2a trial (SB221) will assess safety and efficacy. SON-1010 is designed to enhance immune response in the tumor microenvironment, potentially improving treatment options for patients with limited alternatives. This marks Sonnet's first combination study, highlighting its importance for the company's growth strategy.

Sonnet BioTherapeutics Holdings (NASDAQ:SONN) reported its fiscal year 2022 results, highlighting significant development milestones. The company initiated two Phase 1 trials for SON-1010, showing promising safety data, and commenced a Phase 1b/2a trial for SON-080, with results anticipated in H1 2023. Sonnet plans a 30% operational expense reduction starting Q2 2023, focusing on enhancing pipeline efficiency and leveraging cost-effective R&D locations. After raising $6.5 million in common stock sales, Sonnet's cash on hand was $3.1 million as of September 30, 2022. Research and development expenses rose to $21.4 million, mainly due to advancing clinical trials.

Sonnet BioTherapeutics announced encouraging interim results from Phase 1 trials of SON-1010, a novel immunotherapeutic targeting advanced solid tumors. A total of 36 subjects have been dosed, with an ongoing dose escalation approved by safety review committees. Key findings include controlled induction of IFNγ and no instances of cytokine release syndrome. Notably, all but one patient remain in the study, and one has displayed tumor improvement after 6 months. The safety profile is favorable, with mild to moderate adverse events, suggesting SON-1010's potential in enhancing immunotherapy.

Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) announced a webcast on November 2, 2022, at 8:30 am ET to share initial clinical data from two studies involving SON-1010. The SB101 trial assesses the safety of SON-1010 in cancer patients, focusing on establishing the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Concurrently, the SB102 trial evaluates SON-1010 doses in healthy volunteers. Both studies aim to understand safety, pharmacokinetics, and immunogenicity, setting the stage for future immunotherapy combinations.

Sonnet BioTherapeutics (NASDAQ:SONN) announced a collaboration with Janssen Biotech to evaluate its products SON-1010, SON-1210, and SON-1410. The evaluation will focus on in vitro and in vivo efficacy in preclinical models, leveraging Janssen's proprietary cell therapy assets. If successful, Sonnet may pursue an expanded collaboration. This represents Sonnet's first head-to-head evaluation, which could inform oncology indications and potentially lead to a license agreement, as stated by CEO Pankaj Mohan.

Sonnet BioTherapeutics Holdings announced it has regained compliance with Nasdaq's minimum bid price requirement, meeting the $1.00 bid price for 10 consecutive trading days by September 30, 2022. However, the company is still not compliant with the stockholders' equity requirement of $2.5 million, having received a notice from Nasdaq on August 22, 2022. Sonnet has until October 6, 2022, to submit a plan to regain compliance, which, if accepted, could grant an extension of up to 180 days.