On May 4, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported financial results for the first quarter ended March 31, 2022, and highlighted recent Company progress (Press release, Omega Therapeutics, MAY 4, 2022, View Source [SID1234613521]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted with the preclinical data emerging from our OMEGA platform, for example, from our OTX-2002 program where we demonstrated the ability to downregulate the overexpression of the c-Myc (MYC) oncogene in models of hepatocellular carcinoma (HCC) as shared at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We also recently announced additional preclinical data that will be presented at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, in which a different Omega Epigenomic ControllerTM (OEC) candidate showed the ability to regulate MYC expression resulting in decreased viability of cancer cells in both in vitro and in vivo models of non-small cell lung cancer (NSCLC). We are pleased to see this further validation of our targeted mRNA therapeutics and their potential to control gene expression through epigenomic programming. We look forward to advancing a broad portfolio of OECs and are keenly focused on advancing into the clinic this year, starting with our expected Investigational New Drug (IND) Application for OTX-2002 in the first half of 2022."

Recent Business Highlights

Development Pipeline and Platform

OTX-2002: OTX-2002 is a novel, engineered, and programmable mRNA therapeutic targeting MYC in patients with HCC. In preclinical studies, OTX-2002 demonstrated its ability to potently downregulate MYC oncogene expression by epigenetically targeting the MYC insulated genomic domain (IGD). The Company is pleased to announce that it remains on track to file an IND for OTX-2002 in the first half of 2022.
Presented New OTX-2002 Preclinical Data in Hepatocellular Carcinoma at AACR (Free AACR Whitepaper) 2022 that Highlighted the Potential of OTX-2002 to Downregulate Overexpression of the MYC Oncogene in Models of HCC: Results showed that OTX-2002 suppresses MYC gene expression resulting in a loss of cancer cell viability in vitro and reduces tumor growth in in vivo HCC xenograft models. The data also demonstrated the potential of the OMEGA platform to engineer programmable epigenetic mRNA therapeutics that successfully regulate gene expression by targeting IGDs. The poster presentation can be accessed on our website at View Source
Abstract on OEC for Non-Small Cell Lung Cancer Selected for Presentation at the Upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting: New data highlight the potential of an OEC to downregulate overexpression of the MYC oncogene in models of NSCLC. The results showed on-target changes to the epigenetic profile of the MYC IGD. Treatment also resulted in dose-dependent downregulation of MYC mRNA expression, leading to significant reduction of cell viability in NSCLC cell lines as well as decreased tumor growth in murine xenograft NSCLC models. Results will be further discussed during a poster presentation on May 18, 2022, from 5:30 p.m. through 6:30 p.m. EDT.
Additional OEC Development: Beyond HCC and NSCLC, the Company is working on multiple programs in preclinical studies, including acute respiratory distress syndrome (ARDS) with CXCL1-3/IL8, alopecia with SFRP1, liver disease with HNF4a, and additional undisclosed targets. Omega continues to anticipate nominating two OEC development candidates in the middle of 2022.
OMEGA Epigenomic Programming Platform: Omega is creating a new generation of programmable epigenetic mRNA medicines that are designed to control the fundamental epigenetic processes to correct the root cause of disease by restoring aberrant gene expression to homeostasis without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs with high target specificity to durably tune the expression of single or multiple genes. Omega is advancing multiple preclinical development programs in oncology, immunology, regenerative medicine, and select monogenic diseases.
Corporate

Joshua Reed to join as Chief Financial Officer, employment expected to commence on May 23, 2022: Mr. Reed has experience in finance, capital raising, business development, investor relations, and managing all aspects of the financial close process.
Roger Sawhney, M.D., to serve as Chief Business Officer effective on the date of the commencement of Mr. Reed’s employment: In this new role, Mr. Sawhney, currently Omega’s Chief Financial Officer, will focus on the Company’s business development efforts as Omega looks to accelerate the potential of its epigenomic programing platform.
Ling Zeng, Esq., appointed Chief Legal and Administrative Officer: Ms. Zeng has extensive management experience working with companies in the healthcare industry at various stages of their lifecycle, with responsibilities around legal, operations, reputation, intellectual property, corporate governance, and compliance.
Kevin McManus appointed Chief Human Resources Officer: Mr. McManus has extensive experience in developing and implementing strategies to enhance growth and attract and retain talent while strengthening company culture.
First Quarter 2022 Financial Results

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $200.8 million.

Research and development (R&D) expenses for the first quarter of 2022 were $14.2 million, compared to $9.7 million for the first quarter of 2021. The $4.5 million increase in R&D expense was primarily related to discovery and preclinical development costs and personnel-related expenses as the Company continues to support research and development growth and advance its pipeline and discovery portfolio.

General and administrative (G&A) expenses for the first quarter of 2022 were $5.4 million, compared to $2.7 million for the first quarter of 2021. The $2.7 million increase in G&A expense was primarily related to personnel-related expenses and increased costs to operate as a public company, and higher professional fees to support business growth.

Net loss for the first quarter of 2022 was $20.2 million, compared to $13.5 million for the first quarter of 2021, driven predominantly by increased R&D and G&A expenses to support the Company’s growth and operations as a public company.

On May 4, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the first quarter of 2022 and recent corporate updates (Press release, Mirati, MAY 4, 2022, View Source [SID1234613520]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Mirati continues to make significant progress across our pipeline, as we focus on executing our ambitious goals," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "This includes working toward our first potential commercial launch in the U.S. this year with adagrasib for the treatment of patients with previously-treated KRASG12C-mutated lung cancer and advancing the adagrasib program in earlier lines of therapy and across additional tumors. In addition, we completed enrollment of our Phase 3 trial evaluating sitravatinib in advanced lung cancer, continue to enroll patients in an ongoing Phase 1 study with our MTA cooperative PRMT5 inhibitor, MRTX1719, and continue to advance our novel preclinical programs. These milestones, combined with our strong financial position enable us to continue to invest in the advancement of our broad targeted oncology portfolio and prepare to become a successful commercial stage company."

Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)
•Announced two oral presentations at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Presentations to include full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pre-treated non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation and late-breaking data on adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases.
•Presented preclinical data describing the mechanism of adagrasib CNS penetration at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data were simultaneously published in the journal of Clinical Cancer Research, which also included preliminary clinical experience in patients with active, untreated CNS metastases.
Sitravatinib (Potent TAM receptor inhibitor)
•Completed enrollment in the global, registrational Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC. The Company expects to reach the number of events needed to trigger an interim analysis of overall survival in Q4 2022.
MRTX1719 (MTA Cooperative PRMT5 inhibitor)
•Enrolling patients in an ongoing Phase 1 dose escalation cohort of the Company’s investigational MTA-cooperative PRMT5 inhibitor, MRTX1719, with initial clinical data expected in 2023.
1

MRTX1133 (Potent and selective KRASG12D inhibitor)
•Presented preclinical results on the pharmacogenomics of the Company’s investigational KRASG12D inhibitor, MRTX1133, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company plans to file an IND application for this program in the second half of 2022.
MRTX0902 (Potent SOS-1 inhibitor)
•Presented preclinical results on the design and discovery of the Company’s investigational SOS1 inhibitor, MRTX0902, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company expects to file an IND application for this program in the second half of 2022.
First Quarter 2022 Financial Results
•Ended the first quarter with approximately $1.3 billion in cash, cash equivalents, and short-term investments.
•Research and development expenses for the first quarter of 2022 were $131.0 million, compared to $104.1 million for the same period in 2021. The increase in research and development expenses is primarily due to an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense, an increase in expense associated with the development of adagrasib, sitravatinib and MRTX1719, an increase in preclinical and early discovery activities, as well as an increase in other research and development costs, offset by a decrease in expense for MRTX1133. The Company recognized research and development-related share-based compensation expenses of $26.3 million during the first quarter of 2022, compared to $14.5 million for the same period in 2021.
•General and administrative expenses for the first quarter of 2022 were $54.0 million, compared to $28.4 million for the same period in 2021. The increase is due to an increase in salaries and other employee-related expenses, which includes an increase in share-based compensation expense, an increase in professional services expense primarily associated with commercial scale up, an increase in insurance, rent and other facilities-related costs. The Company recognized general and administrative-related share-based compensation expenses of $16.6 million in the first quarter of 2022, compared to $10.2 million for the same period in 2021.
•Net loss for the first quarter of 2022 was $188.4 million, or $3.40 per share basic and diluted, compared to a net loss of $135.7 million, or $2.67 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on May 4, 2022 at 4:30 p.m. ET/ 1:30 p.m. PT during which company executives will review financial information for the first quarter of 2022 and provide a corporate update.
Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 313-209-4906 or international +1 800-406-5356, confirmation code: 6391007.
A replay of the call will be available approximately 2 hours after the event has ended at the same website.

On May 4, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported financial results for the quarter ended March 31, 2022 (Press release, Allogene, MAY 4, 2022, View Source [SID1234613519]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This month marks the fourth anniversary of Allogene. I am immensely proud of all that we have accomplished in such a short period of time, including our ability to treat more patients with our pipeline of AlloCAR T candidates than anyone else in the field," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Every advance we make in manufacturing, clinical development, and research brings us one step closer to achieving our vision of making CAR T therapy accessible to all eligible patients."

Corporate Highlights
Cell Forge 1 (CF1), Allogene’s commercial scale manufacturing facility located in Newark, California is now operational and producing GMP material with the intent of supplying ALLO-501A for the planned pivotal study as well as other clinical trials. CF1 is projected to have the ability to manufacture approximately 20,000 ALLO-501A AlloCAR T doses annually at scale.

In March, the Company published its inaugural ESG report. The report details Allogene’s commitment to corporate integrity and sustainable business operations and highlights its priorities: employees, the environment, and patients, including increasing their access to potential life-saving products.

Pipeline Updates
Hematologic Malignancies
Enrollment in the Phase 1 ALLO-501A ALPHA2 trial in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) has re-opened with the goal of offering AlloCAR T to patients while the Company prepares to launch the pivotal Phase 2 ALPHA2 trial. The single-arm pivotal ALPHA2 trial of ALLO-501A in r/r LBCL is planned to initiate mid-2022. The single-arm ALPHA2 trial is on track to begin mid-year 2022 with FDA discussions directed at finalizing clinical trial design and Chemistry Manufacturing and Controls (CMC) requirements.

The EXPAND trial, planned to support registration of the lymphodepleting agent ALLO-647, is intended to demonstrate the contribution of ALLO-647 to the lymphodepletion regimen and benefit to patient outcomes.

Enrollment has also resumed in trials targeting BCMA for the treatment of patients with r/r multiple myeloma (MM), including the UNIVERSAL trial with ALLO-715 and the IGNITE trial with TurboCAR candidate, ALLO-605. During the quarter, preclinical data was published demonstrating the superior long-term in vitro myeloma-killing activity of allogeneic anti-BCMA
CAR T cells from healthy donors compared with anti-BCMA CAR T cells from patients with MM. The findings were published in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

In May 2022, the Company was granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for ALLO-605 for the treatment of MM.

The Company intends to provide an update on its CD19 and BCMA programs by the end of the year.

Solid Tumors
ALLO-316 is the Company’s first AlloCAR T candidate for solid tumors. The Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (RCC). The trial, now in its second dose level cohort, continues to accrue patients.

In April, the Company presented preclinical data at the 2022 AACR (Free AACR Whitepaper) Annual Meeting which support the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing cancers. The findings were simultaneously published in AACR (Free AACR Whitepaper)’s Cancer Research.

In March, the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and the five-year survival rate for patients with advanced kidney cancer is less than 15%, highlighting the need for innovation.

First Quarter Financial Results
•Research and development expenses were $60.2 million for the first quarter of 2022, which includes $11.1 million of non-cash stock-based compensation expense.
•General and administrative expenses were $19.9 million for the first quarter of 2022, which includes $11.2 million of non-cash stock-based compensation expense.
•Net loss for the first quarter of 2022 was $79.9 million, or $0.56 per share, including non-cash stock-based compensation expense of $22.3 million.
•The Company had $733.1 million in cash, cash equivalents, and investments as of March 31, 2022.

2022 Financial Guidance
•Allogene continues to expect full year GAAP Operating Expenses to be between $360 million and $390 million including estimated non-cash stock-based compensation expense of $90 million to $100 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 6579454. The webcast will be made
available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On May 4, 2022 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the first quarter of 2022 (Press release, Schrodinger, MAY 4, 2022, View Source [SID1234613518]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We began 2022 with a strong quarter, which included software revenue of $33.1 million, a 26 percent increase over the first quarter of 2021, driven primarily by continued adoption and scale up by existing customers," said Ramy Farid, Ph.D., chief executive officer of Schrödinger. "We are also seeing continued progress across our collaborative and internal drug discovery pipeline, further demonstrating the impact of our platform. Last month, we presented preclinical data from our Wee1 program, which highlighted our opportunity to advance a potential best-in-class Wee1 inhibitor into the clinic. We are working rapidly to progress our three most advanced internal programs into clinical development and are on track to submit an investigational new drug application for our MALT1 inhibitor, SGR-1505, to the FDA in the first half of 2022."

Strategic Objectives and Recent Business Highlights

In February 2022, Schrödinger laid out several strategic objectives for 2022-2023. Recent highlights include the following:

Internal Pipeline

Schrödinger is on track to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for SGR-1505, its MALT1 inhibitor, in the first half of 2022. The company continues to plan to initiate a Phase 1 clinical study of SGR-1505 in patients with relapsed and resistant lymphoma in the second half of 2022. MALT1 is considered a potential therapeutic target for several non-Hodgkin’s B-cell lymphomas.

In April, Schrödinger presented new preclinical data from its Wee1 inhibitor program at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data underscore the therapeutic potential of Schrödinger’s Wee1 inhibitors for use as monotherapy and as part of combination therapy with other agents. Wee1 is emerging as a potentially important therapeutic target for a range of solid tumors, including ovarian and uterine cancer. Schrödinger continues to expect to select a Wee1 development candidate this year.

The company continues to advance its CDC7 development candidate through IND-enabling studies and expects to submit an IND to the FDA in early 2023. Targeting proteins such as CDC7 that play important roles in DNA replication and replication stress is gaining momentum as a new therapeutic approach based on the proliferative capacity of cancer cells to bypass DNA damage responses.

Schrödinger also continues to advance multiple undisclosed research programs in the areas of oncology and immunology.

Collaborative Programs

In March 2022, Morphic Therapeutic announced the initiation of a Phase 2a clinical study of MORF-057 in patients with moderate to severe ulcerative colitis. MORF-057 is a potent and selective, oral small molecule inhibitor of the α4β7 integrin being studied in patients with gastrointestinal disorders, initially targeting inflammatory bowel disease.

Materials Science

Today, Schrödinger announced that it recently entered into a three-year collaboration with Eonix LLC to accelerate the discovery and design of materials for safer, energy dense lithium ion batteries. As part of the agreement, Schrödinger received an equity stake in Eonix.

Underlying Science

During the first quarter, Schrödinger scientists continued to make scientific advances and were authors on 11 publications in peer-reviewed life sciences and materials science journals. Recent publications include reporting a novel extension to our neural network interaction potentials to more accurately model charge-charge interactions. Schrödinger anticipates that these improvements may enable more predictive modeling of polarization effects, reactivity, and polymorph stability, among a number of other endpoints of high importance to drug discovery and materials design.

2022 Financial Outlook

As of May 4, 2022, Schrödinger maintained 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 revenue 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 second quarter of 2022, software revenue is expected to range from $28 to $30 million.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its first quarter 2022 financial results on Wednesday, May 4, 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 7896009. 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.

On May 4, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported that members of its senior management team will participate in the BofA Securities 2022 Healthcare Conference on Wednesday, May 11 at 5:20 pm PT (Press release, Lyell Immunopharma, MAY 4, 2022, View Source [SID1234613517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat can be accessed through the investor relations section of the Company’s website at www.lyell.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 90 days following the presentation date.