Encouraging STRO-002 Interim Phase 1 Clinical Data Presented at the AACR Virtual Meeting in April STRO-002 Preclinical Data Presented at 2020 AACR Virtual Annual Meeting II in June Suggests Synergy between STRO-002 and Immune Checkpoint Inhibitors STRO-001 Dose Escalation Ongoing in Phase 1 Clinical Trial for Multiple Myeloma and Lymphoma Sutro’s Partner Merck KGaA, Unveiled Preclinical Data from the Collaboration’s potential First-in-Class Bispecific Antibody-Drug
| SOUTH SAN FRANCISCO, Calif., Aug. 6, 2020 /PRNewswire/ -- Sutro Biopharma, Inc., Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, today reported its financial results for the quarter ended June 30, 2020 and its recent business highlights and developments. “Our two proprietary antibody-drug conjugate (ADC) product candidates, STRO-001 and STRO–002, are progressing in Phase 1 clinical trials. We continue to be encouraged by the dose escalation safety and anti-tumor activity data from our Phase 1 clinical trial for STRO-002, including data presented during the AACR Virtual Meeting on April 27, 2020, which demonstrate preliminary evidence of anti-tumor activity, particularly in a heavily pre-treated patient population, along with an emerging safety profile that indicates that the product candidate has been generally well tolerated,” said Bill Newell, Sutro’s Chief Executive Officer. “Additionally, each of our three current collaborations has yielded a novel oncology product candidate in clinical development or in the late stages of preclinical development, all of which were discovered and developed, and are manufactured, using our proprietary and integrated cell-free protein synthesis platform XpressCF® and site-specific conjugation platform XpressCF+™. Importantly, even with the ongoing COVID-19 pandemic, Sutro remains committed to the health and safety of both patients receiving our therapies and our employees.” Recent Business Highlights and Developments STRO-002 Clinical Program -- Encouraging STRO-002 Interim Phase 1 Clinical Data from an Ongoing Dose Escalation Study in Ovarian Cancer Presented at the AACR Virtual Meeting in April 2020
New STRO-002 Preclinical Data -- Presented at 2020 AACR Virtual Annual Meeting II in June 2020 Suggests Synergy between STRO-002 Antibody-Drug Conjugate and Immune Checkpoint Inhibitors Resulting in Tumor Regression and Adaptive Anti-Tumor Immunity
STRO-001 Clinical Program -- Phase 1 Clinical Trial and Dose Escalation Ongoing in Myeloma and Lymphoma
Cytokine-Derivative Programs (Collaboration with Merck & Co.)
BCMA ADC Clinical Program (CC-99712) (Collaboration with Bristol Myers Squibb)
MUC1-EGFR Bispecific ADC Clinical Development Candidate (M1231) (Collaboration with EMD Serono) -- Sutro’s Partner Merck KGaA, Darmstadt, Germany, Unveiled Preclinical Data from the Collaboration’s Pre-Development Candidate, a potential First-in-Class Bispecific Antibody-Drug Conjugate Targeting EGFR and MUC1 at 2020 AACR Virtual Annual Meeting II in June 2020
24-Valent Pneumococcal Conjugate Vaccine (Vaxcyte---formerly SutroVax---Relationship)
Follow-on Financing in May 2020
Second Quarter 2020 Financial Highlights Cash, Cash Equivalents and Marketable Securities As of June 30, 2020, Sutro had cash, cash equivalents and marketable securities of $207.0 million, as compared to $133.5 million as of December 31, 2019, which represents a net cash increase of $73.5 million during the first half of 2020. The cash, cash equivalents and marketable securities balance noted above does not include the value associated with Sutro’s holdings of approximately 1.6 million shares of Vaxcyte common stock, which are subject to a lock-up agreement that expires in December 2020. As of June 30, 2020, the fair value of the Vaxcyte common stock held by Sutro was $49.1 million. Net Income due to Unrealized Gain on Vaxcyte Common Stock Sutro recorded net income of $29.9 million and $10.3 million for the three and six months ended June 30, 2020, respectively, due primarily to an unrealized gain related to its Vaxcyte common stock of $48.9 million for the 2020 periods. The unrealized gain consisted of $49.1 million from the fair value of Vaxcyte common stock, offset by approximately $0.2 million in adjustments related to revaluations of certain Vaxcyte equity items. Vaxcyte common stock held by Sutro will be measured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any unrealized gains and losses recorded in Sutro’s statements of operations. Revenue Revenue was $9.5 million and $16.6 million for the three and six months ended June 30, 2020, respectively, compared to $10.5 million and $19.2 million for the same periods in 2019, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments. Operating Expenses Total operating expenses for the three and six months ended June 30, 2020, were $25.9 million and $52.2 million, respectively, compared to $24.2 million and $47.1 million for the same periods in 2019, including non-cash stock-based compensation of $3.0 million and $2.5 million, and depreciation and amortization expense of $1.1 million and $1.2 million, in the three months ended June 30, 2020 and 2019, respectively. Total operating expenses for the second quarter 2020 were comprised of research and development expenses of $17.2 million and general and administrative expenses of $8.6 million, which are expected to increase in 2020 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company. About Sutro Biopharma Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics. Sutro’s proprietary and integrated cell-free protein synthesis platform XpressCF® and site-specific conjugation platform, XpressCF+™, led to the discovery of STRO-001 and STRO-002, Sutro’s first two internally-developed ADCs. STRO-001 is a CD74-targeting ADC currently being investigated in a Phase 1 clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin lymphoma. STRO-001 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018. STRO-002 is a folate receptor alpha (FolRα)-targeting ADC, currently being investigated in a Phase 1 clinical trial of patients with ovarian and endometrial cancers. This is the second product candidate to be evaluated in clinical trials resulting from Sutro’s XpressCF® and XpressCF+™ technology platforms. A third program, CC-99712 (BCMA-targeting ADC), which is part of Sutro’s collaboration with Bristol Myers Squibb (formerly Celgene Corporation), is enrolling patients for its Phase 1 clinical trial of patients with multiple myeloma. Sutro’s proprietary technology was responsible for the discovery and manufacturing of CC-99712, for which Bristol Myers Squibb has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Bristol Myers Squibb for this BCMA ADC. Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro has designed cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies primarily directed at clinically-validated targets for which the current standard of care is suboptimal. Sutro’s platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates. In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells. Additional multimedia content from Sutro regarding STRO-001 and STRO-002 can be found here and here. Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to learn more about our passion for changing the future of oncology. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, timing of announcements of clinical results, potential benefits of the company’s product candidates and platform and potential market opportunities for the company’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company’s business, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property, the value of the Company’s holdings of Vaxcyte common stock, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Investor Contacts Xuan Yang Media Contacts Travis Kruse
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Company Codes: NASDAQ-NMS:STRO | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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