On July 31, 2024 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, reported financial results for the second quarter of 2024 (Press release, Schrodinger, JUL 31, 2024, View Source [SID1234645209]).

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"We are very pleased with our results for the second quarter. We delivered 21% software revenue growth, and we see many opportunities for customers to increase their scale of adoption of our technology. Our recently announced predictive toxicology initiative reflects our commitment to investing in the science underlying our platform to drive future growth," said Ramy Farid, Ph.D., chief executive officer of Schrödinger. "Recent clinical and corporate milestones at co-founded companies further validate our platform and underscore the strength of our business model. Our proprietary therapeutics pipeline also continues to progress, and we look forward to sharing the initial Phase 1 data from each of our three lead programs next year, starting with SGR-1505 in the first half of 2025."

Second Quarter 2024 Financial Results
•Total revenue for the second quarter was $47.3 million, compared to $35.2 million in the second quarter of 2023.
•Software revenue for the second quarter increased 21% to $35.4 million, compared to $29.4 million in the second quarter of 2023. The increase reflects increased contribution from new and existing customers purchasing hosted licenses as well as the renewal of several multi-year deals.
•Drug discovery revenue was $11.9 million for the second quarter, compared to $5.8 million in the second quarter of 2023. The increase was primarily due to the recognition of milestone revenue associated with the progression of ongoing collaboration programs.
•Software gross margin increased to 80% for the second quarter, compared to 77% in the second quarter of 2023, primarily due to increased revenue in the period.
•Operating expenses were $84.1 million for the second quarter, compared to $74.9 million for the second quarter of 2023. The increase was primarily due to higher R&D expenses.
•Other expense, which includes changes in fair value of equity investments and interest income, was $1.2 million for the second quarter, compared to other income of $45.0 million for the second quarter of 2023, reflecting the difference in mark to market value of the company’s equity investments.
•Net loss for the second quarter was $54.0 million, compared to net income of $4.3 million in the second quarter of 2023.
•At June 30, 2024, Schrödinger had cash, cash equivalents, restricted cash and marketable securities of approximately $381.5 million, compared to approximately $468.8 million at December 31, 2023.

Three Months Ended
June 30,
2024 2023 % Change
(in millions)
Total revenue $ 47.3 $ 35.2 35%
Software revenue 35.4 29.4 21%
Drug discovery revenue 11.9 5.8 104%
Software gross margin 80 % 77 %
Operating expenses $ 84.1 $ 74.9 12%
Other (expense) income $ (1.2) $ 45.0 —
Net (loss) income $ (54.0) $ 4.3 —

For the three and six months ended June 30, 2024, Schrödinger reported non-GAAP net losses of $48.1 million and $110.5 million, respectively, compared to non-GAAP net losses of $56.8 million and $84.4 million for the three and six months ended June 30, 2023. A reconciliation of non-GAAP net loss to GAAP net (loss) income can be found in "Non-GAAP Information" and financial tables below.

2024 Financial Outlook
Today Schrödinger updated its 2024 full-year guidance for software gross margin and operating expense growth and maintained its other financial guidance. The company’s financial expectations for the fiscal year ending December 31, 2024, are as follows:
•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 now expected to be slightly lower than 2023 and in the range of 2022 based on the effect of the research grant from the Bill & Melinda Gates Foundation.
•Operating expense growth in 2024 is now expected to range from 8% to 10%.
•Cash used for operating activities in 2024 is expected to be above cash used for operating activities in 2023.

For the third quarter of 2024, software revenue is expected to range from $32 million to $34 million.

Recent Highlights
Platform
•In July, Schrödinger launched an initiative to expand its computational platform to predict toxicity associated with binding to off-targets. The goal of this initiative is to develop a computational solution to improve the properties of drug development candidates and reduce the risk of development failure. The project will be funded initially by a $10 million grant from the Bill & Melinda Gates Foundation and will leverage NVIDIA’s AI technology.

•In June, Schrödinger and AstraZeneca scientists published a method yielding more accurate predictions of experimental free energies for optimizing protein-protein interactions, which is central to biologics design. The case studies demonstrate how FEP+ calculations can be applied to real-world protein therapeutic design projects, potentially increasing throughput and lowering discovery costs.

Proprietary Pipeline
•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 Europe. The company expects to report initial clinical data from this study in the first half of 2025.

•Schrödinger announced today that the FDA has granted SGR-2921, the company’s investigational CDC7 inhibitor, FDA Fast Track Designation for the treatment of relapsed/refractory acute myeloid

leukemia. The Phase 1 study of SGR-2921 in patients with acute myeloid leukemia or myelodysplastic syndrome continues to enroll patients in the U.S. and EU. The company expects to report initial clinical data from this study in the second half of 2025.

•Today, Schrödinger announced the initiation of dosing in a Phase 1 clinical study of SGR-3515, an investigational Wee1/Myt1 inhibitor in patients with advanced solid tumors. The dose-escalation study is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and a recommended Phase 2 dose of SGR-3515. The company expects to report initial clinical data from this study in the second half of 2025.

Collaborators, Partners, and Co-Founded Companies
•In July, Morphic Holding, Inc., a company that Schrödinger co-founded, announced its planned acquisition by Lilly for $57 per share, or approximately $3.2 billion. Schrödinger currently owns 834,968 shares of Morphic and is entitled to low single-digit royalties on its clinical development programs, including MORF-057.

•Development programs at other companies co-founded by Schrödinger continued to progress. In May, Ajax Therapeutics, Inc. completed a Series C financing and received Investigational New Drug clearance for AJ1-11095, a type II JAK2 inhibitor. In June, Structure Therapeutics presented obesity and diabetes data from its Phase 1b/2a study of GSBR-1290, a GLP-1 receptor agonist, at the Annual Meeting of the American Diabetes Association.

Webcast and Conference Call Information
Schrödinger will host a conference call to discuss its second quarter 2024 financial results on Wednesday, July 31, 2024, at 4:30 p.m. ET. The live webcast can be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source 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.

On July 31, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 15,849,056 shares of common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 15,849,056 shares of common stock, in a registered direct offering priced at a premium to market (Press release, Sellas Life Sciences, JUL 31, 2024, View Source [SID1234645210]). The combined effective offering price for each share of common stock (or common stock equivalent in lieu thereof) and accompanying warrant is $1.325. The warrants will have an exercise price of $1.20, will be immediately exercisable and will expire five years from issuance.

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The gross proceeds to the Company are expected to be approximately $21.0 million before deducting placement agent fees and other estimated offering expenses. The offering is expected to close on or about August 1, 2024, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No 333-278334) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Syndicate Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 30, 2024 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that it has entered into an exclusive license agreement with Cortice Biosciences, Inc. ("Cortice") (Press release, CNS Pharmaceuticals, JUL 30, 2024, View Source [SID1234645151]). The Company will host a live webcast presentation to discuss the transaction on Tuesday, July 30, 2024 at 8:30 AM ET (details below). Additionally, CNS announced the launch of its new corporate branding and website, cnspharma.com.

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Under the terms of the Agreement, CNS Pharmaceuticals has obtained an exclusive license and the intellectual property rights to TPI 287, a potentially blood brain barrier permeable microtubule inhibitor, currently in development for the treatment of GBM, in exchange for an upfront payment of 616,698 shares of the Company’s common stock, as well as the possibility of future success-dependent milestone payments of cash or the Company’s common stock to Cortice. CNS Pharmaceuticals intends to advance the development of TPI 287 for an oncology indication in the United States, Canada, Mexico, and Japan, which is the territory covered by the Agreement (the "Territory"). Such development efforts will include, but may not be limited to, the prosecution and maintenance of existing and new intellectual property; preclinical and clinical development of TPI 287 including research, manufacturing, laboratory and clinical testing, regulatory filing, and marketing of TPI 287 in the Territory.

John Climaco, CEO of CNS Pharmaceuticals, stated, "For years, our team has searched for another drug candidate with the same high level of human data-supported therapeutic potential in GBM as Berubicin. The in-licensing of TPI 287 is a transformational step forward and we are prepared for the next stage to execute our vision of CNS Pharmaceuticals being the leading biopharma company developing drugs for this devastating and currently inescapably fatal disease."

"Our vision is anchored by our confidence in and commitment to our trial of Berubicin in patients with recurrent GBM. The 252 patients enrolled in its potentially pivotal trial will provide significant data about overall survival compared with Lomustine, the outcome of which will be made public in the first half of next year. Our highly experienced team that created and is executing this trial – currently one of the largest GBM studies being conducted anywhere in the world – makes us uniquely positioned to meet the challenge presented by this disease. The clinical network we have established is unparalleled by any other company’s GBM development program, and as a consequence, the TPI 287 program will require only limited capital resources prior to the release of Berubicin topline data. This will allow us to drive TPI 287 into potential registration studies in the most cost-effective manner possible. After negotiations spanning several years and following extensive scientific and clinical due diligence, we believe the highly compelling safety and efficacy data demonstrated by TPI 287 in over 350 patients to date makes it both the ideal complementary asset to Berubicin and the perfect next step in our Company’s strategic plan. Our work on bringing TPI 287 to patients begins immediately," added Mr. Climaco.

TPI 287 Key Highlights

· TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxol) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), similarly to Berubicin, TPI 287 has shown the potential to cross the BBB and treat CNS tumors.

· TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent neuroblastoma and medulloblastoma, as well as refractory prostate cancer and melanoma, and in tauopathy disease, which can result in dementia.

· In a multicenter Phase 1 study evaluating TPI 287 in combination with bevacizumab in patients with recurrent GBM, results demonstrated an objective response rate of 60% and disease control rate of 96% in 23 subjects. Progression-free survival (PFS) of 5.5 months and overall survival (OS) of 13.4 months compare favorably to bevacizumab either as monotherapy or in combination with chemotherapy in similar patients yielding PFS of 2-4 months and OS of 6-9 months. The data from this study were recently published in a manuscript titled, "Phase 1 trial of TPI 287, a microtubule stabilizing agent, in combination with bevacizumab in adults with recurrent glioblastoma1," in Neuro-Oncology Advances.

· CNS Pharmaceuticals plans to engage the U.S. FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in recurrent GBM, with the goal of initiating the study in 2025.

Samuel A. Goldlust, MD, Medical Director of Neuro-Oncology at Saint Luke’s Cancer Institute, a former investigator in the Company’s global study of Berubicin, as well as the principal investigator of studies of TPI 287 in GBM added, "The data seen to date with TPI 287 have been highly encouraging. There remains a tremendous unmet need for the GBM patient population, which I believe will require the development of a variety of effective therapeutic approaches. With the promising data demonstrated with both Berubicin and the synergies that TPI 287 has shown, I am excited for the Company to further explore and unlock the potential of TPI 287."

As previously announced in April 2024, the Company completed enrollment in its global potentially pivotal study evaluating Berubicin for the treatment of GBM. In December 2023 the Company announced the successful completion of its pre-planned interim futility analysis and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification. CNS Pharmaceuticals expects to report topline results from its potentially pivotal study of Berubicin in the first half of 2025.

"We also fully understand that the complexity and severity of GBM challenges scientists and clinicians to create novel treatment approaches for brain malignancies. As we have grown our expertise in the development of blood brain barrier permeable chemotherapeutics, we understand that multiple therapeutics may be required to effectively treat these diseases. Combinations of anthracyclines and taxanes that have shown activity for systemic disease may be more powerful as combination agents for the treatment of diseases metastatic to the brain. There is tremendous potential therapeutic synergy between Berubicin and TPI 287, and we are excited to expand our pipeline of drug candidates to offer patients with recurrent GBM an additional brain-penetrative chemotherapeutic option," added, Sandra Silberman, MD, PhD, Chief Medical Officer of CNS. "Having successfully completed enrollment in our Berubicin study, we have gained extensive experience and expertise in conducting late-stage registrational studies for recurrent GBM. That experience will now inform our clinical strategy for TPI 287 as we engage with key investigators at our active clinical sites. Our investigator network, which took years to build, can now be repurposed to save valuable time and resources, allowing us to expeditiously move forward with a similar potentially registrational study of TPI 287 in 2025."

Webcast Details

CNS Pharmaceuticals will host a live video webcast presentation with members of management and neuro-oncologist and Key Opinion Leader, Dr. Samuel Goldlust for investors, analysts, and other interested parties today, June 30, 2024 at 8:30 a.m. ET to discuss the transaction. Interested participants may register for the event here. The live webcast will be accessible on the Events page of the Investors section of the CNS website, cnspharma.com, and will be archived for 90 days.

On July 30, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported that members from the Replimune management team will host investor meetings at the following two conferences (Press release, Replimune, JUL 30, 2024, View Source [SID1234645170]):

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BTIG Virtual Biotechnology Conference
Dates: August 5-6, 2024

2024 Wedbush PacGrow Healthcare Conference
Date: Tuesday, August 13, 2024

On July 30, 2024 Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, reported an expanded collaboration with Remix Therapeutics, a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address underlying drivers of disease (Press release, Tempus, JUL 30, 2024, View Source [SID1234645188]). The collaboration between Remix and Tempus began with the licensing of specific, de-identified data cohorts and has since expanded into a broader, strategic alliance.

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Remix is leveraging Tempus’ multimodal data to interrogate specific cohorts, including Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) with Tempus’ data analytics platform, Lens. The newly expanded scope of work also includes next-generation sequencing support for Remix’s Phase I trial for REM-422, the company’s potent, selective, oral small molecule messenger RNA (mRNA) degrader.

To support its research, Remix is utilizing Tempus’ xT and xR assays to capture DNA and RNA data, as well as tracking treatment response on an exploratory research basis with xM Monitor, the company’s circulating tumor DNA (ctDNA) assay, which detects and monitors changes in circulating tumor fraction to determine response to therapy for patients with advanced cancers.

"We’re excited to work with a biotech like Remix that understands and embraces the value that Tempus’ multimodal data can bring to their important work," said Ryan Fukushima, Chief Operating Officer of Tempus. "We were able to quickly expand our collaboration and provide Remix with an array of our offerings that are uniquely positioned to support them in achieving their research and development goals."

"Tempus’ multimodal data, analytics, and sequencing support will be invaluable tools as we advance our lead candidate, REM-422, into the clinic," said Dominic Reynolds, Ph.D., Chief Scientific Officer of Remix. "This collaboration provides us with robust resources and data to propel our research forward, ultimately advancing our goal of creating meaningful new treatment options for patients."