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.

On May 4, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that it will webcast its presentation at the BofA Securities 2022 Healthcare Conference at 3:20 p.m. PT on Wednesday, May 11, 2022 (Press release, Sana Biotechnology, MAY 4, 2022, View Source [SID1234613516]). The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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!

The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

On May 4, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2022 financial results and provided a corporate update (Press release, Kura Oncology, MAY 4, 2022, View Source [SID1234613515]).

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 continue to operate from a position of strength, armed with three independent drug development programs, near-term clinical milestones and cash runway through 2024," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Our team continues to execute, having completed enrollment of the Phase 1b expansion cohorts for our menin inhibitor, ziftomenib, and we remain very encouraged by the safety profile, tolerability and clinical activity we are observing in the study. We continue to assess patients in the Phase 1b for safety and tolerability, pharmacokinetics and exposure, as well as efficacy, and we look forward to identifying a recommended Phase 2 dose for ziftomenib and reporting topline data from the study next quarter."

Recent Highlights

Enrollment completed in Phase 1b expansion cohorts for ziftomenib – Kura has completed enrollment of the patients in the Phase 1b portion of KOMET-001 required to identify a recommended Phase 2 dose for ziftomenib. The Phase 1b portion was designed to enroll two expansion cohorts – 200 mg and 600 mg – with each cohort comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed and/or refractory acute myeloid leukemia (AML). The goal of the Phase 1b portion is dose optimization, and the two doses were selected based on the encouraging clinical activity, safety profile and tolerability demonstrated in the Phase 1a portion of KOMET-001. Kura remains on track to identify the recommended Phase 2 dose for ziftomenib and report topline data from the Phase 1b portion of KOMET-001 in the third quarter of 2022, with a more complete dataset reserved for presentation at a medical meeting in the fourth quarter of 2022.

Expanded opportunity for tipifarnib in head and neck squamous cell carcinoma – Enrollment continues in the Phase 1/2 clinical trial (KURRENT-HN) of tipifarnib in combination with the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The initial cohort includes patients who have PIK3CA-dependent HNSCC, and Kura expects to dose the first patient in an HRAS overexpression cohort in the third quarter of 2022. The Company believes the combination with alpelisib has the potential to drive deeper and more durable responses than either agent as monotherapy and to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC.

Preclinical data support use of tipifarnib to prevent relapse to osimertinib – In April 2022, preclinical data supporting the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR mutant non-small cell lung cancer (NSCLC) were reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Kura is now preparing to initiate a Phase 1 trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutated NSCLC and expect to dose the first patient in the third quarter of 2022. The Company intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, Kura’s next-generation farnesyl transferase inhibitor (FTI), through investigational new drug (IND)-enabling studies.
Financial Results

Research and development expenses for the first quarter of 2022 were $20.9 million, compared to $20.3 million for the first quarter of 2021. The increase in R&D expenses was primarily due to increases in ziftomenib clinical trial and personnel costs.

General and administrative expenses for the first quarter of 2022 were $11.9 million, compared to $10.6 million for the first quarter of 2021. The increase in G&A expenses was primarily due to increases in professional fees and non-cash share-based compensation.

Net loss for the first quarter of 2022 was $32.5 million, compared to a net loss of $30.7 million for the first quarter of 2021. This included non-cash share-based compensation expense of $6.7 million, compared to $5.1 million for the same period in 2021.

Cash, cash equivalents and short-term investments totaled $480.1 million as of March 31, 2022, compared with $518.0 million as of December 31, 2021. Based on its current plans, management expects that current cash, cash equivalents and short-term investments will fund current operations through 2024.
2022 Milestones

Identify the recommended Phase 2 dose of ziftomenib and report topline data from the Phase 1b study in the third quarter.

Present updated data from KOMET-001 at a medical meeting in the fourth quarter.

Dose the first patient in the HRAS overexpression cohort of the KURRENT-HN trial by the third quarter.

Dose the first patient in the KURRENT-LUNG trial in the third quarter.

Submit an IND application for KO-2806 in the fourth quarter.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, May 4, 2022, to discuss the financial results for the first quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (844) 826-3035 for domestic callers and (412) 317-5195 for international callers and entering the conference code: 10166202. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.