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Sutro Biopharma(STRO) - 2024 Q3 - Quarterly Report
2024-11-13 21:34
Product Development - The company is developing site-specific and novel-format antibody drug conjugates (ADCs) using its proprietary XpressCF® and XpressCF+® platforms, targeting clinically validated cancer treatments [123]. - The most advanced product candidate, STRO-002 (luvelta), is designed for patients with FRα-expressing cancers, including ovarian cancer, and has shown promising preliminary efficacy data in Phase 1 trials [124][126]. - The company initiated a Phase 2/3 study (REFRαME-O1) in June 2023, enrolling 57 patients, with plans to randomize approximately 516 patients in Part 2 of the study [132]. - The company is also exploring luvelta in combination with bevacizumab, showing an ORR of 56% at the recommended Phase 2 dose [134]. - The IND for treating FRα-expressing non-small cell lung cancer (NSCLC) with luvelta was cleared by the FDA in early 2024, with a Phase 2 study initiated in August 2024 [137]. - The company plans to file an IND for its preclinical asset STRO-004 in the second half of 2025, targeting tissue factor with a differentiated safety profile [140]. - The company has entered into collaborations with leading pharmaceutical companies, including licensing agreements for luvelta in Greater China with Tasly, which received its first IND clearance in August 2023 [141]. Financial Performance - The company reported a net loss of $155.0 million for the nine months ended September 30, 2024, compared to a net loss of $137.9 million for the same period in 2023, reflecting an increase in losses [144]. - Total revenue for the three months ended September 30, 2024, was $8.5 million, down 50% from $16.9 million in the same period of 2023 [159]. - Revenue from Astellas Pharma for the three months ended September 30, 2024, was $7.7 million, a decrease of 23% from $10.0 million in the same period of 2023 [160]. - The accumulated deficit as of September 30, 2024, was $714.4 million, indicating significant ongoing financial challenges [144]. - Operating expenses for the three months ended September 30, 2024, totaled $76.4 million, a 25% increase from $60.9 million in the same period of 2023 [159]. - The company had a loss from operations of $67.9 million for the three months ended September 30, 2024, compared to a loss of $44.0 million in the same period of 2023, representing a 54% increase in operational losses [159]. - Total revenue decreased by $8.4 million to $40.0 million for the three months ended September 30, 2024, compared to the same period in 2023 [161]. - Research and development expenses increased by $16.4 million, or 36%, to $62.0 million for the three months ended September 30, 2024 [162]. - General and administrative expenses decreased by $0.9 million, or 6%, to $14.0 million for the three months ended September 30, 2024 [163]. - Total revenue increased by $7.2 million, or 18%, to $47.2 million for the nine months ended September 30, 2024, compared to the same period in 2023 [168]. - Research and development expenses increased by $54.3 million, or 43%, to $181.0 million for the nine months ended September 30, 2024 [170]. - General and administrative expenses decreased by $6.4 million, or 14%, to $39.4 million for the nine months ended September 30, 2024 [171]. Cash Flow and Financing - Cash, cash equivalents, and marketable securities totaled $388.3 million as of September 30, 2024 [176]. - The company sold 667,780 shares of Vaxcyte common stock for net proceeds of $74.0 million during the three months ended September 30, 2024 [177]. - Cash used in operating activities for the nine months ended September 30, 2024 was $119.8 million, compared to $125.7 million for the same period in 2023 [193][194]. - Cash provided by investing activities for the nine months ended September 30, 2024 was $131.0 million, primarily from maturities and sales of marketable securities of $394.5 million [195]. - Cash provided by financing activities for the nine months ended September 30, 2024 was $94.1 million, mainly from $71.5 million of net proceeds from an underwritten offering [197]. - The company had cash, cash equivalents, and marketable securities of $388.3 million as of September 30, 2024, up from $333.7 million as of December 31, 2023 [203]. - The company may seek additional financing through public or private equity offerings, debt financings, and collaborations, but adequate funding may not be available on acceptable terms [189]. Lease Obligations - The aggregate estimated base rent payments due over the San Carlos Lease Extension Period is approximately $4.2 million [184]. - The aggregate estimated base rent payments due over the Industrial Lease Extension Period is approximately $4.3 million [185]. - The total estimated base rent payments due over the Sublease term is approximately $39.1 million, including a potential financial benefit of $5.2 million in rent abatement [187]. Interest Rate and Risk Management - The company does not engage in investments for trading or speculative purposes and has not used derivative financial instruments to manage interest rate risk exposure [204]. - The company does not anticipate being exposed to material risks due to changes in interest rates [204]. - A hypothetical 10% change in market interest rates would not have a material impact on the company's financial statements [204]. - The company believes that its cash, cash equivalents, or marketable securities do not have a significant risk of default or illiquidity [204].
Sutro Biopharma(STRO) - 2024 Q3 - Quarterly Results
2024-11-13 21:30
Exhibit 99.1 Sutro Biopharma Reports Third Quarter 2024 Financial Results and Business Highlights - Expects to deliver three Investigational New Drug (IND) applications in next three years based on nextgeneration ADC technology - -Two new clinical trials, REFRαME-P1, a registration-enabling trial of luvelta for pediatric patients with rare leukemia, and REFRαME-L1, a Phase 2 trial of luvelta for patients with non-small cell lung cancer, are underway - - Sutro presented data from the Phase 1b study of luvelt ...
Sutro Biopharma Reports Third Quarter 2024 Financial Results and Business Highlights
GlobeNewswire News Room· 2024-11-13 21:30
- Expects to deliver three Investigational New Drug (IND) applications in next three years based on next-generation ADC technology - - Two new clinical trials, REFRαME-P1, a registration-enabling trial of luvelta for pediatric patients with rare leukemia, and REFRαME-L1, a Phase 2 trial of luvelta for patients with non-small cell lung cancer, are underway - - Sutro presented data from the Phase 1b study of luvelta in combination with bevacizumab at ESMO 2024 demonstrating a 56% response rate at the recommen ...
Sutro Biopharma's Competitive ADCs Position It For Future Growth In Oncology
Seeking Alpha· 2024-09-23 16:46
Sutro Biopharma, Inc. (NASDAQ: STRO ) specializes in antibody-drug conjugates [ADCs] for oncology therapeutics. The company leverages its proprietary XpressCF and XpressCF+ platforms to produce complex proteins without using living cells. This gives STRO more control over protein synthesis and site-specific drug My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science f ...
Sutro Biopharma Announces Updated Data from Phase 1b Study of Luvelta in Combination with Bevacizumab at ESMO 2024
GlobeNewswire News Room· 2024-09-14 07:00
- 4.3 mg/kg of luveltamab tazevibulin (luvelta) in combination with standard dose of bevacizumab (15 mg/kg) every 3 weeks resulted in a 56% objective response rate in patients with late-stage ovarian cancer and was selected to be the recommended phase 2 dose (RP2D) - - Luvelta in combination with bevacizumab demonstrated encouraging preliminary antitumor activity (35% response rate) across all explored dose ranges - - Expansion at RP2D is ongoing with an additional 23 patients enrolled to date; expansion da ...
Sutro Biopharma (STRO) Rises 9% in the Past Week: Here's Why
ZACKS· 2024-08-26 15:50
Sutro Biopharma (STRO) , a clinical-stage company, is focused on developing novel antibody drug conjugates or ADC candidates using its proprietary drug development platforms to treat several oncology indications. The company's pipeline comprises only one candidate, luveltamab tazevibulin or luvelta (formerly known as STRO002), which is being developed for various FRα-expressing cancers. Sutro Biopharma's shares gained 8.9% in the past week after the company announced that it has begun enrollment in its glob ...
Sutro Biopharma, Inc. (STRO) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2024-08-13 22:45
Sutro Biopharma, Inc. (STRO) came out with a quarterly loss of $0.59 per share versus the Zacks Consensus Estimate of a loss of $0.76. This compares to loss of $0.64 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 22.37%. A quarter ago, it was expected that this company would post a loss of $0.92 per share when it actually produced a loss of $0.95, delivering a surprise of -3.26%. Over the last four quarters, the company has ...
Sutro Biopharma(STRO) - 2024 Q2 - Quarterly Report
2024-08-13 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol Name of each exchange on which registered Common stock, $0.001 par value STRO The Nasdaq Stock Market LLC (Nasdaq Global Market) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period ...
Sutro Biopharma(STRO) - 2024 Q2 - Quarterly Results
2024-08-13 20:30
Exhibit 99.1 Sutro Biopharma Reports Second Quarter 2024 Financial Results, Business Highlights and Select Anticipated Milestones - Sutro will present updated data from the ongoing Phase 1b study of luvelta in combination with bevacizumab in a poster presentation at ESMO 2024; expansion study is ongoing with data expected in the first half of 2025 - - REFRαME-O1 Part 2 (randomized portion) of the Phase 3 trial of luvelta for treatment of platinum-resistant ovarian cancer (PROC) is underway - - REFRαME-P1, a ...
Sutro Biopharma Reports Second Quarter 2024 Financial Results, Business Highlights and Select Anticipated Milestones
GlobeNewswire News Room· 2024-08-13 20:30
- Sutro will present updated data from the ongoing Phase 1b study of luvelta in combination with bevacizumab in a poster presentation at ESMO 2024; expansion study is ongoing with data expected in the first half of 2025 - - REFRαME-O1 Part 2 (randomized portion) of the Phase 3 trial of luvelta for treatment of platinum-resistant ovarian cancer (PROC) is underway - - REFRαME-P1, a registration-enabling trial of luvelta for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is expected to b ...