CDC7

Over the past three decenniums, the perception to treat cancer malignancies has improved from the time when the scientist and researches discovered the idea of inhibitors. The inhibitors are the novel class of chemotherapy which helps to block the activity of gene or protein by consequently binding to it. Since then, many therapies such as targeted antibody regimen, innovative chemotherapy drugs, oncolytic virus therapy, cancer vaccines, stem cell transplant, in addition to surgery has entered the commercial market with the primary motive is to provide treatment for endless patients suffering from cancer. Nevertheless, with the advancement together with evolution in the immunotherapy has led to the development of various inhibitors in the sector of oncology therapy. One such inhibitor is CDC 7 kinase inhibitor used to manage several types of solid cancer such as colon cancer, ovarian cancer, prostate cancer, as well as pancreas cancer in addition to blood cancer like leukemias. Download Global CDC7 Kinase Inhibitors Clinical Trials Research With the arrival of CDC 7 kinase inhibitor as an innovative treatment regimen has somewhat aided to reduce the cancer burden of multiple patients across the world. Preliminary data from the clinical and laboratories studies have illustrated the over expression of CDC 7 kinase protein results in the formation to tumor cell. One of the foremost causes for development of cancer is the mutation in CDC gene that encodes protein, CDC 7 involved in the process of DNA replication. As an outcome, mutation in CDC 7 encoding gene led to the formation of over expression of CDC 7 protein in conjugation with its protein regulator Dbf4. The year 2009 was a blessing for the domain of CDC 7 kinase inhibitor owing to the introduction of first CDC 7 kinase inhibitor, BMS-863233/ XL 413 for the treatment of patients suffering from advanced solid cancers, metastatic cancer along with refractory hematologic cancer. The initial studies was sponsored and collaborated by Bristol Myers Squibb in addition to Exelixis. However, the clinical trial was terminated at the phase I stage in the year 2011 on the account of multiple reasons such as the presence of a accumulated metabolite, buildup of the parent drug at very high levels owing to patients populace that had a poor metabolizer (PM) phenotype in addition to identification of CYP1A2 enzyme that is involved in the metabolism of the parent compound and lack of clinical efficacy. As a consequence, the candidate couldn’t proceed to phase II clinical phase stage. Nonetheless, lately in the year 2023, the contender, BMS- 863233 is also being used with chemotherapy which has correspondingly demonstrated positive outcome by significantly inhibiting cancer cell growth. Apart from utilizing the CDC 7 kinase inhibitor therapy to cure cancer malignancies, several additional studies are ongoing in the recent year which demonstrates the role of CDC 7 kinase protein in inducing viral replication, consequently leading to the development of viral infection by phosphorylating VP3 protein of the Avibirnavirus, which belongs to the family of Birnaviridae. For that reason, the CDC 7 kinase protein can be employed against cancer majorly solid malignancies as well as viral infection indications. The domain of CDC 7 kinase inhibitor is growing at a slow; but steady gait. Due to the presence of pharmaceutical companies such as Bristol-Myers Squibb, Exelixis, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Nerviano Medical Sciences, Takeda (Millennium Pharmaceuticals, Inc.) and Lin BioScience, Inc in addition to various centers and universities which include University Of Miami, Massachusetts General Hospital, Dana-Farber Cancer Institute, Tianjin Medical University Cancer Institution & Hospital are conducting clinical research in the domain with the primary purpose to developed an advance and innovative inhibitor that will target CDC 7 kinase protein in order to provide treatment for ovarian cancer, prostate cancer, solid tumor, Refractory Hematologic Cancer, Metastatic Cancer, Colorectal Cancer etc. Hitherto, only a smattering of preclinical and clinical trials is ongoing in the domain. Candidates such as LY3143921 hydrate and SGR-2921 are presently in the phase I clinical trial for the purpose to provide treatment for several cancer indications such as advanced/metastatic solid tumors, refractory hematologic cancer, colorectal cancer, high grade serous ovarian cancer in addition to non-small cell lung cancer (squamous cell variant). Apart from that, recently in the year 2023, contenders such as TQB3824 tablets, LBS-007 in conjugation with TAK-931 are the novel candidates that have been added into the global clinical pipeline for CDC 7 inhibitors. TAK-931 is the solitary medication that has reached the phase II clinical stage to treat advanced non hematologic neoplasms and at present the clinical investigations and studies are ongoing in Japan. All these example aforementioned above propose that the domain of CDC 7 inhibitor is growing and shortly will expand further owing to the increasing cancer and viral diseases indications and rise in the technological advancement.

First Quarter Total Revenue of $36.6 Million, Software Revenue of $33.4 Million Announces FDA Clearance of Investigational New Drug Application for SGR-3515, a Novel Wee1/Myt1 Inhibitor SGR-1505 and SGR-2921 on Track for Initial Phase 1 Data Readouts in Late 2024 or 2025 NEW YORK--(BUSINESS WIRE)-- Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, today announced financial results for the first quarter of 2024. “Over the past year, we have witnessed unprecedented interest in computational drug discovery, and we are excited by the growing appreciation for using computation to drive pharmaceutical innovation. We are excited about the opportunities we have to increase customer adoption of our platform this year and drive revenue growth going forward,” said Ramy Farid, Ph.D., chief executive officer of Schrödinger. “We are also pleased with the continued progress of our proprietary pipeline. Today we reported FDA clearance of our IND application for SGR-3515, our novel Wee1/Myt1 inhibitor, and expect to initiate a Phase 1 clinical study in patients with solid tumors this year. Our Phase 1 clinical studies of SGR-1505 and SGR-2921 remain on track, and we look forward to reporting data from these two trials in late 2024 or 2025.” First Quarter 2024 Financial Results Total revenue for the first quarter was $36.6 million, compared to $64.8 million in the first quarter of 2023. The decrease was primarily due to a large collaboration milestone payment that favorably impacted revenue in the first quarter of 2023. Software revenue for the first quarter increased 3.7% to $33.4 million, compared to $32.2 million in the first quarter of 2023. The increase reflects a growing contribution from hosted licenses, partially offset by multi-year agreements signed in the first quarter of 2023. Drug discovery revenue was $3.2 million for the first quarter, compared to $32.6 million in the first quarter of 2023. The first quarter of 2023 included a large collaboration milestone payment associated with the progression of a collaboration project. Software gross margin decreased to 76% for the first quarter, compared to 78% in the first quarter of 2023, largely due to higher technology expenses. Operating expenses were $86.3 million for the first quarter, compared to $76.2 million for the first quarter of 2023. The increase was primarily due to higher R&D expenses. Other income, which includes changes in fair value of equity investments and interest income/expense, was $13.2 million for the first quarter, compared to other income of $186.0 million for the first quarter of 2023. Other income for the first quarter of 2023 included a $147.3 million gain relating to the cash distributions from Nimbus in connection with the sale of Nimbus’s TYK2 inhibitor to Takeda. Net loss for the first quarter was $54.7 million, compared to net income of $129.1 million in the first quarter of 2023. For the three months ended March 31, 2024, Schrödinger reported a non-GAAP net loss of $62.4 million compared to a non-GAAP net loss of $27.6 million for the three months ended March 31, 2023. A reconciliation of non-GAAP net loss to GAAP net (loss) income can be found in “Non-GAAP Information” and financial tables below. At March 31, 2024, Schrödinger had cash, cash equivalents, restricted cash and marketable securities of approximately $435.7 million, compared to approximately $468.8 million at December 31, 2023. Three Months Ended March 31, 2024 2023 % Change (in millions) Total revenue $ 36.6 $ 64.8 (44)% Software revenue 33.4 32.2 3.7% Drug discovery revenue 3.2 32.6 (90)% Software gross margin 76 % 78 % Operating expenses $ 86.3 $ 76.2 13% Other income $ 13.2 $ 186.0 — Net (loss) income $ (54.7 ) $ 129.1 — 2024 Financial Outlook As of May 1, 2024, Schrödinger maintained its financial guidance for the fiscal year ending December 31, 2024: Software revenue growth is expected to range from 6% to 13%. Drug discovery revenue is expected to range from $30 million to $35 million. Software gross margin is expected to be similar to software gross margin for the full year 2023. Operating expense growth in 2024 is expected to range from 8% to 12%. Cash used for operating activities in 2024 is expected to be above cash used for operating activities in 2023. For the second quarter of 2024, software revenue is expected to range from $31 million to $33 million. Key Highlights Platform In March, Schrödinger launched LiveDesign Biologics, an enterprise cloud-based, informatics solution that allows drug discovery teams designing biologics to centralize access to computational modeling tools and data in a single interface. LiveDesign Biologics builds on Schrödinger’s existing LiveDesign offering, which is primarily focused on integrating tools and data for the design of small molecules. In March, Schrödinger presented the discovery of SGR-1505, its MALT1 inhibitor, during the First Time Disclosure Session at the American Chemical Society Spring 2024 Meeting. The presentation provided an overview of how Schrödinger leveraged its computational platform at scale to discover SGR-1505. Schrödinger’s platform enabled vast exploration of chemical space, evaluating 8.2 billion compounds, allowing Schrödinger to synthesize only 78 of the most promising molecules in the lead series, and identify SGR-1505 in approximately 10 months. Schrödinger is accelerating the validation of computational predictive models of off-target drug activity. There is an emerging requirement for such models to predict drug toxicity risks before animal or human studies are initiated. Schrödinger is exploring the deployment of its core technologies and capabilities, at scale, to provide computational solutions to meet these requirements. The company’s recent advances characterizing the structure of key proteins such as hERG (recently published in Cell) and cytochrome P450 enzymes are examples of these efforts. Proprietary Pipeline Today, Schrödinger also announced that the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for SGR-3515, its Wee1/Myt1 inhibitor. Schrödinger expects to initiate a Phase 1 dose-escalation trial of SGR-3515 in patients with solid tumors in the third quarter of 2024. The company is advancing the Phase 1 dose-escalation study of SGR-1505, its MALT1 inhibitor, in patients with relapsed/refractory B-cell malignancies, and enrollment is ongoing in the U.S. and EU. The company expects to report initial data from this study in late 2024 or 2025. Schrödinger also continues to advance its Phase 1 study of SGR-2921, its CDC7 inhibitor, in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. Patient enrollment is ongoing in the U.S., and the company expects to report initial data from the study in late 2024 or 2025. Today Schrödinger announced that the rights to the SOS1 inhibitor discovered and developed as part of the collaboration with Bristol Myers Squibb have reverted to Schrödinger based on portfolio prioritization decisions at BMS. In 2023, Schrödinger completed and delivered a development candidate, and BMS had been conducting IND-enabling studies. Schrödinger is progressing its discovery pipeline, including programs targeting EGFRC797S, PRMT5-MTA and NLRP3. The company continues to anticipate submitting at least one IND in 2025. Webcast and Conference Call Information Schrödinger will host a conference call to discuss its first quarter 2024 financial results on Wednesday, May 1, 2024, at 4:30 p.m. ET. The live webcast can be accessed under “News & Events” in the investors section of Schrödinger’s website, . To participate in the live call, please register for the call here. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will receive the dial-in information. The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event. Non-GAAP Information Included in this press release is certain financial information that has not been prepared in accordance with generally accepted accounting principles in the United States (GAAP). The company presents non-GAAP net income (loss) and non-GAAP net income (loss) per share, which exclude gains and losses on equity investments, changes in fair value of equity investments, and income tax benefits and expenses. Adjusting net income to exclude the impact of these items results in a financial presentation for the company without the impact of our equity investments and tax benefits and expenses. Management believes non-GAAP net income (loss) and non-GAAP net income (loss) per share are useful measures for investors, taken in conjunction with the company’s GAAP financial statements because they provide greater period-over-period comparability with respect to the company’s operating performance, by excluding non-cash mark-to-market and other valuation adjustments for the company’s equity investments, non-recurring cash distributions from the company’s equity investments and the tax impact of these distributions that are not reflective of the ongoing operating performance of the business. However, the non-GAAP measures should be considered only in addition to, not as a substitute for or as superior to, net income (loss) and net income (loss) per share or other financial measures prepared in accordance with GAAP. Other companies in Schrödinger’s industry may calculate non-GAAP net income (loss) and non-GAAP net income (loss) per share differently than we do, limiting their usefulness as comparative measures. For a reconciliation of non-GAAP net income (loss) and non-GAAP net income (loss) per share to GAAP net income (loss) and GAAP net income (loss) per share, respectively, please refer to the tables at the end of this press release. 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 , 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 statements regarding Schrödinger’s expectations about the speed and capacity of its computational platform, its financial outlook for the fiscal year ending December 31, 2024 and second quarter ending June 30, 2024, its plans to continue to invest in research and its strategic plans to accelerate the growth of its software licensing business and advance its collaborative and proprietary drug discovery programs, the long-term potential of its business, its ability to improve and advance the science underlying its platform, the initiation, timing, progress, and results of its proprietary drug discovery programs and product candidates and the drug discovery programs and product candidates of its collaborators, the clinical potential and favorable properties of its CDC7, MALT1, and Wee1 inhibitors, including SGR-1505, SGR-2921, and SGR-3515, the clinical potential and favorable properties of its collaborators’ product candidates, the expected timeline for submitting investigational new drug applications, as well as expectations related to the use of its cash, cash equivalents and marketable securities. 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 Schrödinger’s current views about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to the company and on assumptions the company has made. Actual results may differ materially from those described in these forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and important factors that are beyond Schrödinger’s control, including the demand for its software platform, its ability to further develop its computational platform, its reliance upon third-party providers of cloud-based infrastructure to host its software solutions, factors adversely affecting the life sciences industry, fluctuations in the value of the U.S. dollar and foreign currencies, its reliance upon its third-party drug discovery collaborators, the uncertainties inherent in drug development and commercialization, such as the conduct of research activities and the timing of and its ability to initiate and complete preclinical studies and clinical trials, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, uncertainties associated with the regulatory review of IND submissions, 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 the company’s Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the Securities and Exchange Commission on May 1, 2024, as well as future filings and reports by the company. Any forward-looking statements contained in this press release speak only as of the date hereof. Except as required by law, Schrödinger undertakes 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. Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except for share and per share amounts) Three Months Ended March 31, 2024 2023 Revenues: Software products and services $ 33,415 $ 32,213 Drug discovery 3,183 32,569 Total revenues 36,598 64,782 Cost of revenues: Software products and services 7,976 7,115 Drug discovery 9,732 11,974 Total cost of revenues 17,708 19,089 Gross profit 18,890 45,693 Operating expenses: Research and development 50,611 40,741 Sales and marketing 10,171 9,145 General and administrative 25,541 26,308 Total operating expenses 86,323 76,194 Loss from operations (67,433 ) (30,501 ) Other income: Gain on equity investments — 147,322 Change in fair value 8,137 35,737 Other income 5,028 2,937 Total other income 13,165 185,996 (Loss) income before income taxes (54,268 ) 155,495 Income tax expense 456 26,359 Net (loss) income $ (54,724 ) $ 129,136 Net (loss) income per share of common and limited common stockholders, basic: $ (0.76 ) $ 1.81 Weighted average shares used to compute net (loss) income per share of common and limited common stockholders, basic: 72,291,134 71,467,097 Net (loss) income per share of common and limited common stockholders, diluted: $ (0.76 ) $ 1.75 Weighted average shares used to compute net (loss) income per share of common and limited common stockholders, diluted: 72,291,134 73,818,611 Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except for share and per share amounts) Assets March 31, 2024 December 31, 2023 Current assets: Cash and cash equivalents $ 130,236 $ 155,315 Restricted cash 4,638 5,751 Marketable securities 300,843 307,688 Accounts receivable, net of allowance for doubtful accounts of $130 and $220 19,839 65,992 Unbilled and other receivables, net for allowance for unbilled receivables of $130 and $100 25,781 23,124 Prepaid expenses 12,349 9,926 Total current assets 493,686 567,796 Property and equipment, net 26,133 23,325 Equity investments 91,387 83,251 Goodwill 4,791 4,791 Right of use assets - operating leases 118,578 117,778 Other assets 3,187 6,014 Total assets $ 737,762 $ 802,955 Liabilities and Stockholders' Equity: Current liabilities: Accounts payable 9,974 $ 16,815 Accrued payroll, taxes, and benefits 19,549 31,763 Deferred revenue 49,497 56,231 Lease liabilities - operating leases 16,927 16,868 Other accrued liabilities 10,560 11,996 Total current liabilities 106,507 133,673 Deferred revenue, long-term 8,016 9,043 Lease liabilities - operating leases, long-term 108,988 111,014 Other liabilities, long-term 545 667 Total liabilities 224,056 254,397 Stockholders' equity: Preferred stock, $0.01 par value. Authorized 10,000,000 shares; zero shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively — — Common stock, $0.01 par value. Authorized 500,000,000 shares; 63,472,866 and 62,977,316 shares issued and outstanding at March 31, 2024 and December 31, 2023 , respectively 635 630 Limited common stock, $0.01 par value. Authorized 100,000,000 shares; 9,164,193 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 92 92 Additional paid-in capital 906,193 885,973 Accumulated deficit (393,142 ) (338,418 ) Accumulated other comprehensive (loss) income (72 ) 281 Total stockholders' equity 513,706 548,558 Total liabilities and stockholders' equity $ 737,762 $ 802,955 Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands) Three Months Ended March 31, 2024 2023 Cash flows from operating activities: Net (loss) income $ (54,724 ) $ 129,136 Adjustments to reconcile net (loss) income to net cash used in operating activities: Gain on equity investments — (147,322 ) Fair value adjustments (8,137 ) (35,737 ) Depreciation and amortization 1,436 1,760 Stock-based compensation 12,218 10,880 Noncash investment accretion (2,683 ) (964 ) Decrease (increase) in assets: Accounts receivable, net 46,153 9,262 Unbilled and other receivables (2,657 ) (336 ) Reduction in the carrying amount of right of use assets - operating leases 2,152 — Prepaid expenses and other assets (2,559 ) (5,750 ) (Decrease) increase in liabilities: Accounts payable (7,150 ) 2,468 Income taxes payable — 25,963 Accrued payroll, taxes, and benefits (12,214 ) (11,730 ) Deferred revenue (7,761 ) (11,603 ) Lease liabilities - operating leases (1,967 ) (623 ) Other accrued liabilities (1,383 ) 3,502 Net cash used in operating activities (39,276 ) (31,094 ) Cash flows from investing activities: Purchases of property and equipment (4,095 ) (3,580 ) Purchases of equity investments — (4,125 ) Distribution from equity investment — 111,329 Purchases of marketable securities (37,126 ) (58,823 ) Proceeds from maturity of marketable securities 46,300 127,401 Net cash provided by investing activities 5,079 172,202 Cash flows from financing activities: Issuances of common stock upon stock option exercises 392 867 Principal payments on finance leases (14 ) — Issuance of common stock upon ATM offering, net 7,627 — Net cash provided by financing activities 8,005 867 Net (decrease) increase in cash and cash equivalents and restricted cash (26,192 ) 141,975 Cash and cash equivalents and restricted cash, beginning of period 161,066 95,717 Cash and cash equivalents and restricted cash, end of period $ 134,874 $ 237,692 Supplemental disclosure of cash flow and noncash information Cash paid for income taxes $ 180 $ 86 Supplemental disclosure of non-cash investing and financing activities Purchases of property and equipment in accounts payable 501 218 Purchases of property and equipment in accrued liabilities 282 86 Acquisition of right of use assets - operating leases, contingency resolution 2,848 1,820 Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) Three Months Ended March 31, 2024 2023 (in thousands, except per share data) Net (loss) income (GAAP) $ (54,724 ) $ 129,136 Income tax expense 456 26,359 Gain on equity investment — (147,322 ) Change in fair value (8,137 ) (35,737 ) Non-GAAP net loss $ (62,405 ) $ (27,564 ) Non-GAAP net loss per share of common and limited common stockholders, basic and diluted: $ (0.86 ) $ (0.39 ) Weighted average shares used to compute net loss per share of common and limited common stockholders, basic and diluted: 72,291,134 71,467,097 View source version on businesswire.com: Contacts 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 View this news release online at:

NEW YORK--( BUSINESS WIRE )--Schrödinger (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, is providing a detailed review of its proprietary drug discovery and development programs during its Pipeline Day today, December 14, from 10:00 a.m. - 12:30 p.m. ET. “We are excited to share our first clinical data for a proprietary Schrödinger program, SGR-1505, and to outline the opportunities emerging from our broad portfolio of drug discovery programs in multiple therapeutic areas, including oncology, immunology and neurology,” stated Karen Akinsanya, Ph.D., president of R&D, therapeutics at Schrödinger. “Our therapeutics team has been very productive since we started building this portfolio. With two programs in the clinic, multiple programs in late discovery and preclinical development, and our advancing collaborations, we believe the future of our therapeutics portfolio is very promising.” SGR-1505 Clinical Progress and Program Update During Pipeline Day, Schrödinger is presenting new data showing that its novel MALT1 inhibitor, 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. In the study, SGR-1505 achieved greater than 90 percent inhibition of IL-2 secretion in activated T cells, confirming target engagement and meeting the pharmacodynamic goals for the study. The data support continued evaluation of SGR-1505 in the ongoing Phase 1 study in patients with relapsed or refractory B-cell malignancies. “The data presented from our successful healthy volunteer study demonstrate that SGR-1505 is well-tolerated with a pharmacokinetic and pharmacodynamic profile that supports continued development,” stated Margaret Dugan, M.D., chief medical officer at Schrödinger. “These data add significantly to our understanding of SGR-1505 and inform our clinical development strategy in hematologic malignancies. The SGR-1505 program is progressing well, and we look forward to continued enrollment in the patient study and reporting initial data in late 2024 or 2025.” Schrödinger is also presenting preclinical data for SGR-1505 demonstrating that SGR-1505 has favorable attributes and the potential for combination activity with standard-of-care agents in B cell malignancies. These data were presented earlier this week at the American Society of Hematology Annual Meeting. Three New Programs: EGFR C797S , PRMT5-MTA and NLRP3 Schrödinger is presenting three new proprietary discovery programs at Pipeline Day, targeting EGFR C797S , PRMT5-MTA and NLRP3. EGFR inhibitors are first-line standard of care agents for advanced non-small cell lung cancer patients with activating EGFR mutations, but relapse often occurs due to the development of resistance mutations, including EGFR C797S . Schrödinger has identified multiple EGFR C797S inhibitors and is advancing wild-type sparing, double mutant CNS-penetrant inhibitors with the potential to address brain metastases in patients whose disease progresses following first-line treatment, and to potentially achieve deeper, more durable responses through new combination regimens. PRMT5-MTA inhibition has demonstrated clinical responses in both hematologic and solid tumors with improved safety versus PRMT5 inhibitors due to a synthetic lethal targeting of cancer cells with MTAP-deletions. Schrödinger has identified selective, potent PRMT5-MTA inhibitors with potential applications in solid tumors, brain metastases and primary CNS tumors. NLRP3 is a validated target, and mutations in the NLRP3 gene are associated with a broad spectrum of inflammatory and auto-immune diseases. Schrödinger has identified structurally distinct, selective, NLRP3 inhibitors with anti-inflammatory activity in preclinical models, and is continuing to optimize peripheral and brain-penetrant leads. Broad Portfolio Addresses Synthetic Lethality and DNA-Damage Repair Schrödinger is advancing multiple oncology programs designed to exploit the intrinsic vulnerabilities of cancer cells through synthetic lethality and inhibition of DNA-damage repair. Today, the company is discussing its synthetic lethality programs, PRMT5-MTA and SGR-3515 (Wee1/Myt1). The company is also reviewing SGR-2921, which targets CDC7, a key regulator of replication stress and DNA-damage repair. Schrödinger is reporting preclinical data showing that SGR-3515 has a differentiated biochemical, biophysical and functional profile, with sustained inhibition of Wee1 and Myt1 in tumor cells. Concurrent loss of function of Wee1 and Myt1 confers selective vulnerability in cancer cells and could offer increased anti-tumor activity. SGR-3515 has potential to treat a broad range of solid tumors, including uterine and ovarian cancers. Schrödinger plans to submit an IND for SGR-3515 in the first half of 2024. Schrödinger is also discussing preclinical data presented at ASH demonstrating that SGR-2921 exhibited better activity compared to other CDC7 inhibitors, and showed anti-proliferative effects in treatment-resistant acute myeloid leukemia (AML) patient-derived samples, as well as reduction of blasts in multiple AML models. A Phase 1 study of SGR-2921 is ongoing in patients with AML or myelodysplastic syndrome, and the company expects to report initial data from the study in late 2024 or 2025. “CDC7 is a promising therapeutic target for the treatment of myelodysplastic syndromes and acute myeloid leukemia, diseases for which there is a significant unmet need in treating both frontline and relapsed/refractory patients,” stated Elie Traer, M.D., Ph.D., associate professor at the Center for Hematologic Malignancies at Oregon Health & Science University. “Targeting CDC7 with emerging investigational therapeutics, such as SGR-2921, represents an opportunity to expand our armamentarium of treatment options beyond existing targeted therapies.” Anticipated Milestones Today, Schrödinger outlined the anticipated milestones for its proprietary pipeline: Report initial data from the Phase 1 study of SGR-1505 in late 2024 or 2025 Report initial data from the Phase 1 study of SGR-2921 in late 2024 or 2025 Submit IND for SGR-3515 in the first half of 2024 and initiate a Phase 1 study in 2024 Submit an IND from its discovery portfolio in 2025 Event Information Schrödinger’s Pipeline Day will begin at 10:00 a.m. ET and is expected to conclude at approximately 12:30 p.m. ET. The live presentation can be accessed in the “Investors” section of Schrödinger’s website and will be archived for approximately 90 days. To participate in the live webcast, please register for the event here . It is recommended that participants register at least 15 minutes in advance of the event. 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 more than 800 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 statements regarding the potential advantages of Schrödinger’s computational platform, the clinical potential and favorable properties of its product candidates, including SGR-1505, SGR-2921 and SGR-3515, the potential for SGR-1505 to be used for the treatment of advanced B-cell malignancies, the potential for SGR-2921 to be used for the treatment of AML or myelodysplastic syndrome, the ability to identify any new product candidates, including from the company’s newly announced drug discovery programs, the timing, progress, and results of clinical trials for its product candidates, and the expected timing of additional IND submissions to the FDA for any product candidates the company identifies. 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 Schrödinger’s current views about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to the company and on assumptions the company has made. Actual results may differ materially from those described in these forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and important factors that are beyond Schrödinger’s control, including the uncertainties inherent in drug development and commercialization, such as the conduct of research activities and the timing of and its ability to initiate and complete preclinical studies and clinical trials, whether results from preclinical and clinical studies will be predictive of the results of later preclinical studies and clinical trials, uncertainties associated with the regulatory review of clinical trials and applications for marketing approvals and the ability to retain and hire key personnel on its business and other risks detailed under the caption “Risk Factors” and elsewhere in the company’s Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2023, filed with the Securities and Exchange Commission on November 1, 2023, as well as future filings and reports by the company. Any forward-looking statements contained in this press release speak only as of the date hereof. Except as required by law, Schrödinger undertakes 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.