Sutro Biopharma, Inc. - STRO STOCK NEWS

Sutro Biopharma has initiated REFRαME-P1, a registration-enabling trial of luveltamab tazevibulin (luvelta) for pediatric patients with CBF/GLIS AML. The study follows encouraging compassionate use data presented in December 2023, showing 42% complete remission in patients with ≥5% blasts. CBF/GLIS AML is a rare, aggressive leukemia affecting infants and young children, with an average onset age of 18 months and over 80% chemotherapy resistance rate. The global trial will evaluate luvelta's efficacy and safety in children under 12 years with CBF/GLIS AML, with most sites planned to open by year-end.

Sutro Biopharma (NASDAQ: STRO) is hosting an investor webcast to showcase its proprietary cell-free platform and next-generation ADC innovation. The company highlights three approaches: increasing potency safely with higher drug-antibody ratio exatecan ADCs, combining payloads to overcome tumor resistance with dual-payload ADCs (ADC2), and delivering immunostimulatory ADCs (iADC) that combine immune activation with cytotoxic payloads.

Key highlights include:

• STRO-004, a tissue factor-targeting ADC, demonstrated greater anti-tumor activity and lower toxicities in preclinical models
• Plans to file an IND for STRO-004 in the second half of 2025
• Dual-payload ADCs (ADC2) show increased anti-tumor activity in preclinical models
• iADCs provide a novel mechanism of action, bridging innate and adaptive immunity
• Sutro plans to deliver three INDs over the next three years

Sutro Biopharma (NASDAQ: STRO), a clinical-stage oncology company specializing in site-specific and novel-format antibody-drug conjugates (ADCs), has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). On September 16, 2024, the Compensation Committee of Sutro's Board of Directors granted 60,000 restricted stock units (RSUs) of Sutro common stock to a new employee.

The grant was made as an inducement for the employee's acceptance of employment with Sutro. The RSUs are subject to the terms of Sutro's 2021 Equity Inducement Plan. Vesting will occur over four years, with one-fourth of the shares vesting on the one-year anniversary of the employee's hire date and annually thereafter, contingent on the employee's continued service with Sutro.

Sutro Biopharma (NASDAQ: STRO) announced updated data from its Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for epithelial ovarian cancer (EOC) at ESMO 2024. Key findings include:

- 56% objective response rate at the recommended phase 2 dose (RP2D) of 4.3 mg/kg luvelta with 15 mg/kg bevacizumab
- 35% overall response rate across all dose ranges
- Efficacy observed regardless of Folate Receptor-α (FRα) expression
- No new safety signals compared to individual agents
- Expansion phase ongoing with 23 additional patients; data expected in H1 2025

The combination shows promise as a non-biomarker driven approach for EOC treatment, potentially benefiting a broader patient population.

Sutro Biopharma (NASDAQ: STRO), a clinical-stage oncology company specializing in antibody drug conjugates (ADCs), has announced a Research Forum to showcase its pipeline of next-generation ADCs. The event is scheduled for October 10, 2024, at 1:30 p.m. PT / 4:30 p.m. ET and will be accessible via live webcast.

Investors and interested parties can join the presentation by visiting https://ir.sutrobio.com/news-events/ir-calendar. For those unable to attend the live event, an archived replay will be made available on the company's website following the presentation.

This forum represents an opportunity for Sutro Biopharma to highlight its innovative approach to ADC development and provide insights into its near-term pipeline, potentially impacting investor interest and the company's stock performance.

Sutro Biopharma (NASDAQ: STRO) has initiated the REFRαME-L1 global Phase 2 study of luveltamab tazevibulin (luvelta) for non-small cell lung cancer (NSCLC) patients with Folate Receptor-α (FRα) expressing tumors. The trial is now open for enrollment, with initial data expected in H1 2025. Luvelta, an antibody drug conjugate (ADC), shows promise in treating NSCLC patients with lower FRα expression profiles. The study targets a significant unmet need, as lung cancer is the leading cause of cancer-related deaths worldwide, with a 5-year survival rate as low as 8% for metastatic disease. Approximately 30% of adenocarcinoma NSCLC patients have FRα expression, making it an attractive therapeutic target.

Sutro Biopharma (NASDAQ: STRO) reported its Q2 2024 financial results and business highlights. Key points include:

• Updated data from the Phase 1b study of luvelta with bevacizumab to be presented at ESMO 2024
• Phase 3 trial of luvelta for platinum-resistant ovarian cancer is underway
• Registration-enabling trial for pediatric AML patients expected in H2 2024
• Phase 2 trial for NSCLC treatment to start in H2 2024
• As of June 30, 2024, Sutro had $426.0 million in cash, equivalents, and marketable securities
• Q2 2024 revenue was $25.7 million, up from $10.4 million in Q2 2023
• Total operating expenses for Q2 2024 were $74.4 million

Sutro Biopharma announced the appointment of Dr. Barbara Leyman as Chief Business Development Officer, effective July 8, 2024. Dr. Leyman brings 20 years of life science industry experience to Sutro and has a strong track record in business development, investing, and corporate strategy. Sutro's CEO, Bill Newell, highlighted her arrival at a critical time as the company progresses luvelta in two registration-directed trials. Dr. Leyman has previously held leadership roles at GenEdit, Lyell Immunopharma, and Calico Life Sciences. She was also a Head of Life Sciences Investment Fund at LRM and served on various biopharmaceutical boards. As part of her induction, Dr. Leyman received stock options and restricted stock units, vesting over four years.

Sutro Biopharma announced its Q1 2024 financial results, highlighting significant progress in its clinical pipeline. Key achievements include FDA clearance for a Phase 2 NSCLC trial with luvelta and ongoing Phase 2 studies for luvelta in ovarian cancer and in combination with bevacizumab. Sutro's cash position is strong with $267.6 million in cash and investments, bolstered by $75 million from the Ipsen licensing deal and $75 million from an equity offering. Despite a slight revenue increase to $13.0 million, operating expenses rose to $69.6 million, resulting in a net loss. The company is preparing for several clinical and corporate milestones in 2024, aiming to advance its ADC technologies.