Kineta Invited to Participate in the Cowen 42nd Annual Health Care Virtual Conference

On February 24, 2022 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that the company will participate in Cowen’s 42nd Annual Health Care Conference which is taking place virtually on March 7 – 9, 2022 (Press release, Kineta, FEB 24, 2022, View Source;utm_medium=rss&utm_campaign=kineta-invited-to-participate-in-the-cowen-42nd-annual-health-care-virtual-conference [SID1234608971]). Members of Kineta’s management team will be available for one-on-one meetings during the conference. The conference incorporates presentations, fireside chats and innovative panel discussions hosted by members of the Cowen research team that focus on various aspects of the health care industry.

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Schrödinger Reports Financial Results for the Fourth Quarter and Full Year 2021

On February 24, 2022 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided its financial outlook for 2022 (Press release, Schrodinger, FEB 24, 2022, View Source [SID1234608987]).

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Schrödinger also announced today the promotion of Karen Akinsanya, Ph.D., from executive vice president and chief biomedical scientist to president of R&D, therapeutics. The promotion reflects Dr. Akinsanya’s extraordinary contributions to leading Schrödinger’s drug discovery team, which leverages the company’s platform at scale, as well as her strategic contributions to expanding and advancing the company’s collaborative and wholly-owned programs.

"We are very pleased to have delivered a strong year, capped by fourth quarter software revenue of $38.6 million, a 55 percent increase over the fourth quarter of 2020. Looking ahead, we expect continued scale up and adoption of our software platform as our collaborators and customers continue to experience success in rapidly generating high-quality molecules to advance the next generation of therapeutics and materials," said Ramy Farid, Ph.D., chief executive officer of Schrödinger. "I’m also thrilled to announce Karen’s promotion today. Karen came to Schrödinger in 2018 with a vision to transform and accelerate drug discovery and has made incredible progress building a pipeline and a team that spans discovery to early clinical development."

"Our software platform is critical to our success in both our collaborative and internal drug discovery pipeline, and we are pleased to see multiple programs advance into preclinical and clinical development. This includes seven collaborative programs that have advanced into the clinic, which underscores the impact of our platform," stated Dr. Akinsanya. "Our internal pipeline is also advancing, and later this year we expect to initiate our first Phase 1 clinical study of our MALT1 inhibitor in patients with relapsed and resistant lymphoma."

2022 Financial Outlook

As of February 24, 2022, Schrödinger outlined the following expectations for the fiscal year ending December 31, 2022:

Total revenue expected to range from $161 million to $181 million, representing 17 percent to 31 percent growth over 2021

Total software revenue expected to range from $126 million to $136 million, representing 11 percent to 20 percent growth over 2021

Total drug discovery expected to range from $35 million to $45 million, representing 42 to 82 percent growth over 2021

Operating expense growth is expected to be slightly lower than the 42 percent reported for the year ended December 31, 2021

Software gross margin percentage is expected to be in the mid-70s

For the first quarter of 2022, software revenue is expected to range from $28 to $30 million.

2022-2023 Key Strategic Goals

Today, Schrödinger laid out the following strategic objectives for 2022-2023:

Ongoing growth in adoption and scale up of software platform, with target ACV growth of over 20 percent in 2023

Inflection in drug discovery revenue in 2023, with target 2023 drug discovery revenue of at least $100 million – excludes potential revenue from partnering the company’s three lead internal programs

IND submission for the MALT1 program in first half of 2022, IND submission for the CDC7 program in early 2023 and IND submission for the Wee1 program in 2023

Initiate a Phase 1 clinical study for the MALT1 program in the second half of 2022, and initiate Phase 1 clinical studies for the CDC7 and Wee1 programs in 2023

Publication of data from internal programs in peer-reviewed forums, including presentation of preclinical data from the Wee1 program in the first half of 2022

Multiple new internal programs leveraging internal structural biology capabilities

Materials science collaborations in multiple verticals, such as clean energy and sustainable materials

Recent Business Highlights

Internal Pipeline

Presented preclinical data from MALT1 program at ASH (Free ASH Whitepaper): In December, Schrödinger presented preclinical data on the company’s MALT1 allosteric inhibitor program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating that its MALT1 inhibitors showed single agent and combination anti-tumor activity with approved anti-cancer therapies in preclinical models of B-cell lymphoma. The data presented suggest that targeting MALT1 may expand therapeutic options for patients with selected B-cell lymphomas, such as activated B-cell subtype of diffuse large B cell lymphoma, with the possibility of expanding into other B-cell lymphomas such as mantle cell lymphoma.

Expanded internal pipeline: During 2021, Schrödinger added two new programs to its internal pipeline in the areas of oncology and immunology.

Collaborative Programs

In January 2022, Nimbus announced initiation of a Phase 2b study of its investigational oral allosteric TYK2 inhibitor in patients with active psoriatic arthritis.

In November 2021, Nimbus announced the initiation of its first-in-human Phase 1/2 study of its HPK1 inhibitor, NDI-101150, in patients with solid tumors.

Underlying Science

Published 27 peer-reviewed papers across life sciences and materials science in 2021: During 2021, Schrödinger scientists continued to make scientific advances and were authors on 27 publications in peer-reviewed life sciences and materials sciences journals. Recent publications include an article in collaboration with Janssen to assess the performance of affinity predictions as well as data from a collaboration with scientists at Samyang Corp. aimed at accelerating the design of photoinitiators, which are light sensitive molecules used in inks and coatings, adhesives and other products.

Corporate

Acquired XTAL Biostructures to expand structural biology capabilities: Last month, Schrödinger announced the $6 million all-cash purchase of XTAL BioStructures, Inc., a private company based in the Greater Boston area that provides structural biology services, including biophysical methods, protein production and purification, and X-ray crystallography, to the pharmaceutical and biotechnology industries. The acquisition of XTAL BioStructures enables Schrödinger to pursue scientific advancements in the field of structural biology, augment its ability to produce high quality target structures for its drug discovery programs, and expand its future offerings to include an advanced and differentiated service that provides

customers access to protein structures that have been computationally validated and are ready for structure-based virtual screening and lead optimization.

Established operations in South Korea and expanded presence in India: In January 2022, Schrödinger established operations in Seoul, South Korea to strengthen its global expansion efforts, enhance competitive positioning and support both life science and materials sciences customers in this region. In December 2021, Schrödinger expanded its operations in Hyderabad, India. Employees in the Hyderabad location will focus on a broad range of strategic initiatives across the company, including software development and support of Schrödinger’s software platform, and its drug discovery programs.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its fourth quarter and full year 2021 financial results on Thursday, February 24, 2022, at 4:30 p.m. ET. To participate in the live call, please dial (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and refer to conference ID 3169814. The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

BiomX Presenting at Three Upcoming Investor Conferences

On February 24, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported that Jonathan Solomon, Chief Executive Officer of BiomX, will present at the 2022 Aegis Virtual Conference on February 24, 2022, the Chardan 4th Annual Microbiome Medicines Summit on March 1, 2022 and the Oppenheimer & Co. 32nd Annual Healthcare Conference on March 17, 2022 (Press release, BiomX, FEB 24, 2022, View Source [SID1234609005]).

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2022 Aegis Virtual Conference – February 23-25, 2022

Date & Time:

Thursday, March 24, 2:30 PM EST

Presenter:

Jonathan Solomon

Conference registration:

Link

Chardan 4th Annual Microbiome Medicines Summit – March 1, 2022

Date & Time:

Tuesday, March 1, 8:30 AM EST

Presenter:

Conference registration:

Jonathon Solomon

Link

Oppenheimer & Co. 32nd Annual Healthcare Conference – March 15-17, 2022

Date & Time:

Thursday, March 17, 2:00 PM EST

Presenter:

Jonathan Solomon

Conference registration:

Link

Live webcasts of presentations will also be accessible through the Investors section of the Company’s website at View Source Following the events, the webcasts will be archived on the BiomX website.

Aucentra initiates its Phase 1a/b study of Auceliciclib in Glioblastoma Multiforme (GBM) patients in combination with Temozolomide

On February 24, 2022 Aucentra Therapeutics reported that it has received regulatory approval to progress to a Phase 1a/b clinical trial of Auceliciclib (AU3-14) in combination with Temozolomide for recurrent/refractory GBM patients (Press release, Aucentra, FEB 24, 2022, View Source [SID1234609032]). Aucentra’s first-in-human clinical trial commenced in June 2021 and is currently enrolling participants at cohort 4 across three sites in Australia with the primary objective of evaluating the safety and tolerability of Auceliciclib as a monotherapy in patients with advanced solid tumours.

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To date, the ongoing Phase 1a monotherapy arm has shown Auceliciclib to be well tolerated and safe at dose levels up to cohort 4 when administered orally once daily for 21 days per cycle. Based on the encouraging results, Aucentra obtained regulatory approval on 15th February 2022 to concurrently conduct a GBM patient arm, which involves dose escalation as a combination therapy of Auceliciclib together with standard of care Temozolomide therapy for relapsed and refractory GBM patients. This combination therapy escalation arm will then expand at the recommended Phase 2 dose level and further evaluate the potential efficacy of Auceliciclib in improving patient outcomes for this difficult to treat disease. The approval to proceed to the combination arm is based on the encouraging preliminary safety data from the monotherapy Phase 1a arm, and on the supporting preclinical data, which has revealed synergistic efficacy when used in combination with Temozolomide. This clinical trial has been designed specifically to provide an alternative treatment option for GBM patients where there is a large unmet need due to limited treatment options for this aggressive disease.

Aucentra would like to express sincere gratitude to the Principal Investigators at our clinical trial sites in Australia, Dr Ganessan Kichenadasse, Dr Hui Gan and Dr Adam Cooper who have supported us in achieving this significant milestone. Aucentra also recognises the contribution of the key team members Professor Shudong Wang, Dr Paul Wabnitz, Dr Jasmine Karanjia and Ms Charmaine Symons who have been instrumental in the conceptualization, design and successful execution of this trial. Aucentra would like to acknowledge Seed-Start funding from the Government of South Australia, Department for Innovation and Skills that supports the GBM component of this trial.

Kronos Bio Reports Recent Business Progress and Fourth-Quarter and Full-Year 2021 Financial Results

On February 24, 2022 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, reported recent business progress and fourth-quarter and full-year 2021 financial results (Press release, Kronos Bio, FEB 24, 2022, View Source [SID1234608972]).

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"We had a successful year, marked by the significant progress we made across our clinical pipeline, including initiating our registrational Phase 3 AGILITY study of entospletinib, and initiating our Phase 1/2 study of KB-0742 and subsequently reporting positive initial results from the KB-0742 study," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We expect to announce the initiation of our third clinical trial later this quarter. We continue to dose-escalate KB-0742 and anticipate reaching the recommended Phase 2 dose and sharing additional Phase 1 data in the fourth quarter."
KB-0742 Update
•Kronos Bio is continuing to enroll patients in the Phase 1/2 trial of KB-0742. KB-0742 is the company’s internally discovered, highly selective, orally administered cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified and other transcriptionally addicted solid tumors. Kronos Bio reported positive initial data from the study last year and is continuing to dose escalate.
•The company expects to announce a recommended Phase 2 dose and announce updated Phase 1 data in Q4 2022.
•While the first stage of the study does not mandate enrollment of patients with MYC amplification or other evidence of transcriptional addiction, as the trial nears pharmacologically active dose levels, the company anticipates increased enrollment of patients who may be more likely to respond to CDK9 inhibition.
SYK Inhibitor Program Update
•Kronos Bio expects to dose the first patient in a Phase 1b/2 clinical trial of lanraplenib in the first quarter of 2022. This trial will evaluate lanraplenib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with the current standard of care, gilteritinib.
•To better focus on and prioritize the company’s resources on the areas of highest unmet need, Kronos Bio has decided not to proceed at this time with its previously planned second Phase 1b/2 clinical trial of lanraplenib in combination with venetoclax/azacitidine.
Fourth-Quarter Company Highlights
•Kronos Bio dosed the first patient in the registrational Phase 3 AGILITY clinical trial of entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK), in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy. This trial is the first in AML to

Exhibit 99.1
use measurable residual disease (MRD) as the primary endpoint and has the potential to support accelerated approval of entospletinib by the U.S. Food and Drug Administration as a treatment for patients newly diagnosed with NPM1-mutated AML who are fit for intensive induction. The company expects to share data from the trial in the second half of 2023.
•Kronos Bio announced positive data from the ongoing Phase 1/2 clinical trial of KB-0742. The initial analysis of the ongoing dose escalation stage of the trial demonstrated a differentiated pharmacokinetic profile and evidence of target engagement for KB-0742.
•Kronos Bio appointed Roshawn Blunt to its Board of Directors. Ms. Blunt has decades of experience in the commercialization of new therapeutics, including oncology medicines, with expertise in patient access, reimbursement and health policy. Her expertise will be highly relevant as Kronos Bio advances its lead programs.
•Kronos Bio announced its multi-year collaboration with Tempus Labs, Inc., a leader in artificial intelligence and precision medicine, during the fourth quarter. The agreement provides Kronos Bio with access to real-world patient genomic and transcriptomic data and data analytics tools, with the goal of accelerating the development of the company’s current and future clinical portfolio.
Fourth-Quarter and Full-Year 2021 Financial Highlights
•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $339.5 million in cash, cash equivalents and investments as of December 31, 2021, the company anticipates sufficient resources to fund its planned operations into the second half of 2024.

•R&D Expenses: Research and development expenses were $50.8 million for the fourth quarter of 2021, which includes non-cash stock-based compensation expense of $3.4 million. For the full year of 2021, research and development expenses were $112.9 million, which includes non-cash stock-based compensation expense of $13.0 million.

Research and development expenses for the fourth quarter included the $29.0 million milestone paid to Gilead Sciences upon initiation of Kronos Bio’s registrational Phase 3 clinical trial of entospletinib in December 2021.

•G&A Expenses: General and administrative expenses were $11.6 million for the fourth quarter of 2021, which includes non-cash stock-based compensation expense of $4.0 million. For the full year of 2021, general and administrative expenses were $38.5 million, which includes non-cash stock-based compensation expense of $13.3 million.

•Net Loss: Net loss for the fourth quarter of 2021 was $62.3 million, or $1.13 per share, including non-cash stock-based compensation of $7.4 million. Net loss for the full-year 2021 was $151.1 million, or $2.76 per share, including non-cash stock-based compensation expense of $26.2 million.