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Schrödinger Highlights Discovery of SGR-1505, Clinical-Stage MALT1 Inhibitor, at American Chemical Society National Meeting

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Schrödinger, Inc. (Nasdaq: SDGR) presented the discovery of SGR-1505, its MALT1 inhibitor, at the ACS Spring 2024 Meeting. SGR-1505 is being evaluated in a Phase 1 study for B-cell malignancies. Schrödinger's computational platform expedited the discovery process, leading to the selection of SGR-1505 as the development candidate in just 10 months.
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The discovery of SGR-1505 as a potential MALT1 inhibitor by Schrödinger, Inc. represents a significant advancement in the field of drug discovery and development. The capability to triage over 8 billion compounds and streamline the process to select a development candidate within 10 months is a testament to the efficiency of Schrödinger's computational platform. This rapid progression contrasts sharply with the industry standard of three to six years to reach a similar stage, indicating a potential shift in the paradigm of drug discovery processes. The preclinical profile and the positive data from the Phase 1 study in healthy subjects suggest that SGR-1505 might offer a competitive edge over existing MALT1 inhibitors, which could have implications for Schrödinger's market position and future revenue streams.

In the biotechnology sector, the transition from discovery to development is a critical juncture that can significantly impact a company's valuation. Schrödinger's announcement regarding SGR-1505 has the potential to influence investor sentiment and the company's stock market performance. The efficiency of their platform in identifying a promising candidate like SGR-1505 could attract partnership opportunities, increase investment in R&D and possibly expedite the drug's time-to-market. However, it's important to remain cautious as the drug is still in early-stage clinical trials and further studies are required to confirm its efficacy and safety. The long-term success will depend on the outcomes of these trials and the drug's ability to meet the unmet medical needs in the treatment of B-cell malignancies.

From a medical research perspective, the development of SGR-1505 as a MALT1 inhibitor could offer a new therapeutic option for patients with relapsed/refractory B-cell malignancies. The limitations of current MALT1 inhibitors present a gap that SGR-1505 aims to fill. The positive data from the Phase 1 study in healthy subjects is encouraging, but it is important to see how the drug performs in patients with the targeted malignancies. The drug's efficacy, safety profile and potential side effects will be critical factors in its approval process and adoption by the medical community. The design and execution of subsequent clinical trials will be instrumental in determining the drug's viability as a treatment option.

NEW ORLEANS--(BUSINESS WIRE)-- Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, today presented the discovery of SGR-1505, its MALT1 inhibitor, during the First Time Disclosure Session at the American Chemical Society (ACS) Spring 2024 Meeting. SGR-1505 is being evaluated in a Phase 1 dose-escalation study in patients with relapsed/refractory B-cell malignancies.

The oral presentation provided an overview of how Schrödinger leveraged its computational approaches at scale to discover SGR-1505. Schrödinger’s platform enabled vast exploration of chemical space, triaging 8.2 billion compounds, synthesizing 78 of the most promising molecules in the lead series, and identifying SGR-1505 as the company’s development candidate in approximately 10 months. Reaching a development candidate can take three to six years and typically involves synthesizing up to 5,000 molecules per program.

“Designing the optimal molecule is a tremendous multi-parameter optimization challenge that requires balancing many key properties,” stated Aleksey Gerasyuto, Ph.D., head of medicinal chemistry at Schrödinger. “One of our goals in this program was to address the limitations reported with other MALT1 inhibitors. By leveraging our computational platform, our cross-functional team simultaneously and rapidly optimized key drug-like properties and designed several distinct chemical series, ultimately selecting SGR-1505 as our development candidate.”

“We believe SGR-1505 has the potential to be a best-in-class compound. The preclinical profile of SGR-1505, coupled with positive data from our recently completed Phase 1 study in healthy subjects, further increases our conviction about our MALT1 program,” said Margaret Dugan, M.D., chief medical officer at Schrödinger. “Our Phase 1 study in patients with relapsed/refractory B-cell lymphomas is progressing well, and we look forward to reporting initial data from the study in late 2024 or 2025.”

SGR-1505 Clinical Studies

Schrödinger is conducting a Phase 1 dose-escalation study in patients with relapsed/refractory B-cell lymphomas to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary signals of therapeutic activity of SGR-1505 as a monotherapy. The study is enrolling patients at multiple sites in the U.S. and Europe. Once the recommended dose is determined, an expansion cohort is planned to evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

Schrödinger recently completed a Phase 1 study showing that SGR-1505 was well tolerated in a Phase 1 study of 73 healthy volunteers. No drug-related serious adverse events or dose limiting toxicities were observed in the study. The data also confirmed target engagement, with greater than 90 percent inhibition of IL-2 secretion in activated T cells, a pharmacodynamic goal of the study.

About Schrödinger

Schrödinger is transforming the way therapeutics and materials are discovered. Schrödinger has pioneered a physics-based computational platform that enables discovery of high-quality, novel molecules for drug development and materials applications more rapidly and at lower cost compared to traditional methods. The software platform is licensed by biopharmaceutical and industrial companies, academic institutions, and government laboratories around the world. Schrödinger’s multidisciplinary drug discovery team also leverages the software platform to advance a portfolio of collaborative and proprietary programs to address unmet medical needs.

Founded in 1990, Schrödinger has approximately 850 employees and is engaged with customers and collaborators in more than 70 countries. To learn more, visit www.schrodinger.com, follow us on LinkedIn and Instagram, or visit our blog, Extrapolations.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including but not limited to those regarding the potential advantages of our computational platform, our research and development efforts for SGR-1505, the timing, progress, and results of clinical trials of SGR-1505, the clinical potential and favorable properties of SGR-1505, and the potential for SGR-1505 to be used for the treatment of advanced B-cell lymphomas. Statements including words such as “aim,” "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," “goal,” "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would" and statements in the future tense are forward-looking statements. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Actual results may differ materially from those described in the forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and factors that are beyond our control, including the uncertainties inherent in drug development and commercialization, such as the conduct of research activities and the timing of and our ability to initiate and complete preclinical studies and clinical trials, whether results from preclinical studies and early clinical trials will be predictive of results of later preclinical studies and clinical trials, uncertainties associated with the regulatory review of clinical trials and applications for marketing approvals, the ability to retain and hire key personnel and other risks detailed under the caption "Risk Factors" and elsewhere in our Securities and Exchange Commission filings and reports, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on February 28, 2024, as well as future filings and reports by us. Any forward-looking statements contained in this press release speak only as of the date hereof. Except as required by law, we undertake no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, changes in expectations or otherwise.

Matthew Luchini (Investors)

Schrödinger, Inc.

matthew.luchini@schrodinger.com

917-719-0636

Allie Nicodemo (Media)

Schrödinger, Inc.

allie.nicodemo@schrodinger.com

617-356-2325

Source: Schrödinger

The ticker symbol for Schrödinger, Inc. is SDGR.

Schrödinger, Inc. presented the discovery of SGR-1505, its MALT1 inhibitor, at the ACS Spring 2024 Meeting.

SGR-1505 is being evaluated in a Phase 1 dose-escalation study in patients with relapsed/refractory B-cell malignancies.

Schrödinger's computational platform enabled the exploration of chemical space, synthesis of promising molecules, and rapid optimization of key drug-like properties, leading to the selection of SGR-1505 as the development candidate in approximately 10 months.

Aleksey Gerasyuto is the head of medicinal chemistry at Schrödinger.
Schrodinger Inc

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schrödinger is a leading provider of advanced molecular simulations and enterprise software solutions and services for pharmaceutical, biotechnology, and materials science research. the predictive power of schrödinger's software allows scientists to accelerate their research and development, reduce research costs, and make novel discoveries that might otherwise not be possible. schrödinger also establishes deep partnerships and collaborations with companies in such fields as biotechnology, pharmaceuticals, chemicals, and electronics, and helped found the biotech company nimbus therapeutics. through significant long-term investments in basic research, schrödinger has made scientific breakthroughs across many areas of drug discovery and materials science. hundreds of peer-reviewed scientific publications by schrödinger scientists are frequently among the most heavily cited in their fields. founded in 1990, schrödinger has operations in the us, europe, japan, and india, with business part