On August 4, 2022 AstraZeneca and MSD reported it’s Lynparza (olaparib) has been approved in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (Press release, AstraZeneca, AUG 4, 2022, View Source [SID1234617441]).

This approval by the European Commission was based on results from the OlympiA Phase III trial published in The New England Journal of Medicine in June 2021 and follows the recommendation for approval in the EU by the Committee for Medicinal Products for Human Use of Lynparza in this setting.1 In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.0001).

Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 32% versus placebo (based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.

Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020.2 Approximately 90% of all breast cancer patients worldwide are diagnosed with early breast cancer and BRCA mutations are found in approximately 10% of HER2-negative patients in Europe.3-5

Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London, said: "Today’s approval marks a new era of care in Europe for patients with an inherited form of breast cancer. For patients with high-risk early-stage breast cancer, including those with germline BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and systemic treatment. Olaparib is the first PARP inhibitor to demonstrate improved overall survival for high-risk early-stage breast cancer patients with germline BRCA mutations and I am hopeful it will become a new standard of care."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said:
"With this approval, Lynparza is now the first and only PARP inhibitor available for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe. We can now bring the benefits of Lynparza to this earlier setting to help reduce the risk of life-threatening recurrence."

Dr Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: "Today’s approval offers patients with germline BRCA-mutated HER2-negative early-stage breast cancer a new, much-needed treatment option. Lynparza as adjuvant treatment can significantly reduce the risk of disease recurrence and death, reinforcing the importance of conducting germline BRCA testing as soon as possible after diagnosis."

In March 2022, Lynparza was approved in the US for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. Lynparza is also approved in the US, EU, Japan, and many other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. In the EU, this indication also includes patients with locally advanced breast cancer.

Notes

Financial considerations
Following this approval for Lynparza in the EU, AstraZeneca will receive a regulatory milestone payment from MSD of $75m, anticipated to be booked as Collaboration Revenue during the third quarter of 2022.

Early breast cancer
Early breast cancer is defined as cancer confined to the breast with or without regional lymph node involvement, and the absence of distant metastatic disease.6,7 In the EU, breast cancer alone accounts for approximately 29% of all cancers in women with 1 in 7 women developing the disease in their lifetime. In 2020, breast cancer accounted for an estimated 350,000 new cases and over 90,000 deaths.8 Despite advancements in the treatment of early breast cancer, up to 30% of patients with high-risk clinical and/or pathologic features recur within the first few years and patients with gBRCA mutations are more likely to be diagnosed at a younger age than those without these mutations.5,9

Breast cancer is one of the most biologically diverse tumour types with various factors fuelling its development and progression.10 The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease.11

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OlympiA
OlympiA is a Phase III, double-blind, parallel group, placebo-controlled, multicentre trial testing the efficacy and safety of Lynparza tablets versus placebo as adjuvant treatment in patients with gBRCAm high-risk HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.12

The primary endpoint of the trial was iDFS defined as time from randomisation to date of first locoregional or distant recurrence or new cancer or death from any cause.1

The OlympiA Phase III trial is led by the Breast International Group in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, the US National Cancer Institute, AstraZeneca and MSD. The trial is sponsored by NRG Oncology in the US and by AstraZeneca outside the US.

BRCA
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells.9 When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional alterations that can lead to cancer. Cancers with BRCA mutations are more likely to be sensitive to PARP inhibitors including Lynparza.13-16

Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents (such as new hormonal agents – NHAs).

Inhibition of PARP proteins with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.

Lynparza is currently approved in a number of countries across PARP-dependent tumour types with defects and dependencies in the DDR pathway including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination repair deficient (HRD)-positive advanced ovarian cancer, respectively; for gBRCAm, HER2-negative metastatic breast cancer (in the EU and Japan this includes locally advanced breast cancer); for gBRCAm, HER2-negative high-risk early breast cancer (in the EU and US); for gBRCAm metastatic pancreatic cancer; and HRR gene-mutated metastatic castration-resistant prostate cancer (BRCAm only in the EU and Japan).

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types.

Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. The companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines independently.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge and redefine the current clinical paradigm for how breast cancer is classified and treated, to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex and Zoladex and the next-generation oral selective oestrogen receptor degrader (SERD) and potential new medicine camizestrant.

The PARP inhibitor, Lynparza, is an approved targeted treatment option for early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD continue to research Lynparza in breast cancer patients with an inherited BRCA mutation.

Building on the initial approvals of Enhertu, a HER2-directed antibody drug conjugate (ADC), in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings.

To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On August 4, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, Deciphera Pharmaceuticals, AUG 4, 2022, View Source [SID1234617466]).

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"We delivered strong commercial performance in the second quarter with QINLOCK, and we advanced our portfolio of product candidates with best-in-class potential," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "Germany recently awarded a ‘major additional benefit’ rating for QINLOCK in its indication in advanced GIST, which is the first time an orphan oncology treatment has received this rating for its lead indication since the introduction of the German benefit assessment of medicinal products over 10 years ago. This, along with a strong commercial launch in Germany and a successful post-approval paid access program in France, demonstrate the potential for QINLOCK to transform how GIST is treated around the world."

Mr. Hoerter continued, "We are also excited that the initial data from the Phase 1 study of DCC-3116, our potential first-in-class autophagy inhibitor, has been selected for an oral presentation at ESMO (Free ESMO Whitepaper) next month. Additionally, enrollment in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT is on track and updated results from the Phase 1/2 study will be presented at ESMO (Free ESMO Whitepaper) next month, and finally, we expect to nominate the development candidate from our pan-RAF research program by the fourth quarter."

Second Quarter 2022 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $31.5 million in QINLOCK net product revenue in the second quarter of 2022, including $23.7 million in U.S. net product revenue and $7.8 million in international net product revenue, an increase of 43% from net product revenue of $22.0 million in the second quarter of 2021.
Received a "major additional benefit" rating from Germany’s Federal Joint Committee (G-BA). QINLOCK is the first orphan oncology treatment in Germany to receive this rating for its lead indication and the only GIST treatment awarded with this recognition.
Vimseltinib

Continued patient enrollment in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT who are not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST v1.1 by blinded independent radiologic review.
Expects to present updated results from the ongoing Phase 1/2 study in TGCT patients in a poster presentation at the ESMO (Free ESMO Whitepaper) Congress 2022 in September.
DCC-3116

Expects to present data in an oral presentation as a Proffered Paper at the ESMO (Free ESMO Whitepaper) Congress 2022 from the single agent dose escalation portion of the Phase 1 study of DCC-3116 in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.
Expects to initiate three Phase 1b study combination dose escalation cohorts in the second half of 2022:
In combination with trametinib, a Food and Drug Administration (FDA)-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1, or RAF mutations.
In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1, or RAF mutations.
In combination with sotorasib, an FDA- approved KRASG12C inhibitor, in patients with advanced or metastatic solid tumors with KRASG12C mutations.
Proprietary Drug Discovery Platform

Expects to nominate a development candidate by the fourth quarter of 2022 from the pan-RAF research program discovered using the Company’s novel switch-control kinase inhibitor platform.
Corporate Updates

Appointed Kelley Dealhoy as Senior Vice President and Chief Business Officer to develop and lead the Company’s business development efforts and corporate strategy initiatives. Ms. Dealhoy brings 20 years of life science leadership experience to the role and joined Deciphera from Novartis, where she most recently served as Vice President of Business Development for the Oncology Division.
Published the 2021 Environmental, Social, and Governance (ESG) Report, highlighting our current practices and initiatives in several important ESG-related areas as of the 2021 fiscal year.
Second Quarter 2022 Financial Results

Revenue: Total revenue for the second quarter of 2022 was $32.5 million, which includes $31.5 million of net product revenue of QINLOCK and $1.0 million of collaboration revenue compared to $23.6 million of total revenue, including $22.0 million of net product revenue of QINLOCK and $1.5 million of collaboration revenue, for the same period in 2021.
Cost of Sales: Cost of sales were $1.8 million in the second quarter of 2022 compared to $1.3 million in the same period in 2021. Cost of sales for newly launched products will not include the full cost of manufacturing until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. The Company expects to continue to sell zero cost inventories of QINLOCK in the U.S. through 2022.
R&D Expenses: Research and development expenses for the second quarter of 2022 were $44.9 million, compared to $60.0 million for the same period in 2021. The decrease was primarily due to lower clinical trial costs related to QINLOCK, including INTRIGUE, our Phase 3 study for the treatment of second-line GIST for which top-line results were announced in November 2021, and the discontinuation of our rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, partially offset by an increase in clinical trial costs related to our Phase 1 study of DCC-3116 and preclinical costs. Non-cash, stock-based compensation was $5.4 million and $5.6 million for the second quarters of 2022 and 2021, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2022 were $29.6 million, compared to $32.8 million for the same period in 2021. The decrease was primarily due to a decrease in professional and consultant fees. Non-cash, stock-based compensation was $7.6 million and $6.8 million for the second quarters of 2022 and 2021, respectively.
Net Loss: For the second quarter of 2022, Deciphera reported a net loss of $43.1 million, or $0.60 per share, compared with a net loss of $70.4 million, or $1.21 per share, for the same period in 2021.
Cash Position: As of June 30, 2022, cash, cash equivalents, and marketable securities were $393.1 million, compared to $275.4 million as of March 31, 2022. In April 2022, the Company completed an underwritten public offering that resulted in aggregate net proceeds of $163.4 million. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, August 4, 2022, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BI14cfe386c5004efcba5c94f8783e2435. A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On August 4, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported second quarter and first half 2022 financial results and corporate updates (Press release, Iovance Biotherapeutics, AUG 4, 2022, View Source [SID1234617531]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance continues to solidify our global leadership across all three aspects of our mission to innovate, develop and deliver TIL therapy for patients with cancer. During the second quarter we executed toward our top priority, to submit the BLA for lifileucel in metastatic melanoma, while preparing for commercialization and advancing our robust immuno-oncology pipeline. Following our recent pre-BLA meeting in late July, we are finalizing our BLA to begin submission this month. With many opportunities to create significant value for cancer patients and our shareholders, Iovance is a true pioneer in the industry, driven by our experienced executive leadership team and talented organization with deep cell therapy experience."

Second Quarter 2022 Highlights and Recent Corporate Updates

Regulatory

Iovance TIL therapy (lifileucel) in metastatic melanoma (post-anti-PD-1): Iovance held a successful pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in late July 2022. The FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4 of the C-144-01 clinical trial, including duration of follow up, and the potency assay matrix. The FDA agreed the clinical and safety dataset was sufficient for BLA review. Iovance will commence a rolling BLA submission for lifileucel in metastatic melanoma this month and complete the submission during the fourth quarter.
Clinical

Iovance TIL therapy (lifileucel) in metastatic melanoma:
Positive clinical data in advanced (post-anti-PD-1) metastatic melanoma: Iovance reported positive clinical data from the C-144-01 clinical trial and plans to present additional results at a medical meeting in the second half of 2022.
Frontline (anti-PD-1 naïve) metastatic melanoma: Iovance remains on track to open a Phase 3 trial of lifileucel in combination with pembrolizumab in frontline metastatic melanoma in late 2022. The trial is intended to expand the opportunity for lifileucel as an earlier treatment and serve as a confirmatory study for C-144-01 clinical trial Cohort 4.
Poster at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: A translational science poster highlighting the potential for lifileucel to benefit patients with melanoma regardless of immune checkpoint inhibitor (ICI) exposure and independent of tumor biomarkers of mutational burden, single-gene mutations, or inflammation.
Iovance TIL therapy (LN-145) in second-line mNSCLC: Enrollment is ongoing at more than 30 active clinical sites in the U.S., Canada and Europe for the IOV-LUN-202 trial of LN-145 in patients with mNSCLC. Iovance is engaged in discussions with the FDA about the potential for IOV-LUN-202 to serve as a registrational trial for LN-145 in mNSCLC and intends to execute an updated regulatory strategy based on this dialogue and feedback.

First in human trial of genetically modified Iovance TIL therapy IOV-4001: site activation and patient recruitment are underway in the IOV-GM1-201 clinical trial of Iovance’s first genetically modified TIL therapy, IOV-4001, for the treatment of previously treated advanced melanoma or mNSCLC. IOV-4001 leverages the gene editing TALEN technology licensed from Cellectis to inactivate PD-1 expression.

Iovance TIL therapy (lifileucel) in advanced cervical cancer: Following FDA discussions and feedback on a registration strategy to address the shift in frontline standard of care, Iovance plans to reopen Cohort 2 of the ongoing C-145-04 trial to enroll additional patients who have received prior anti-PD-1 therapy. The expanded Cohort 2 is intended to support a BLA in cervical cancer following progression on chemotherapy and pembrolizumab.
Research Programs for Next-Generation TIL Therapies and Related Technologies

Several targets for genetic modification using the gene-editing TALEN technology, including double genetic knock-out programs, are advancing in preclinical development.

Additional research and preclinical studies include approaches to increase TIL potency using CD39/69 double negative TILs and gene knock-in targets as well as development of a novel interleukin-2 (IL-2) analog (IOV-3001).
Manufacturing

The Iovance Cell Therapy Center (iCTC) is currently operating flex suites for clinical manufacturing and core suites for BLA readiness activities.

Iovance is building capacity to treat thousands of cancer patients annually, with capacity at iCTC for 2,000+ patients and flexibility to expand existing shell space to supply 5,000+ patients per year.
Corporate

Iovance entered into an amendment to its license agreement with the National Institutes of Health (NIH) to include additional exclusive, worldwide patent rights to TIL products expressing IL-12, expanded rights to TIL selection technologies, and additional non-exclusive, worldwide patent rights to certain technologies related to enhancing TIL potency.

Cash position of $430.9 million at June 30, 2022 is expected to be sufficient into 2024.

Iovance currently owns more than 50 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity into 2038. More information on Iovance’s patent portfolio can be found on the Intellectual Property page on www.iovance.com.
Second Quarter and First Half 2022 Financial Results

Iovance had $430.9 million in cash, cash equivalents, investments and restricted cash at June 30, 2022, compared to $602.1 million at December 31, 2021. The cash position is expected to be sufficient to fund current and planned operations into 2024.

Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "As a late-stage oncology company approaching potential commercialization, we continue to maintain a strong balance sheet through prudent investments in commercial launch preparations, internal manufacturing and pipeline expansion. Our cash position is expected to take us through several milestones to create value for patients and shareholders."

Net loss for the second quarter ended June 30, 2022, was $99.3 million, or $0.63 per share, compared to a net loss of $81.4 million, or $0.53 per share, for the second quarter ended June 30, 2021. Net loss for the six months ended June 30, 2022, was $191.0 million, or $1.21 per share, compared to a net loss of $156.8 million, or $1.04 per share, for the same period ended June 30, 2021.

Research and development expenses were $73.4 million for the second quarter ended June 30, 2022, an increase of $11.3 million compared to $62.1 million for the same period ended June 30, 2021. Research and development expenses were $141.7 million for the six months ended June 30, 2022, an increase of $23.6 million compared to $118.1 million for the same period ended June 30, 2021.

The increases in research and development expenses in the second quarter and first half of 2022 over the prior year periods were primarily attributable to growth of the internal research and development team, including stock-based compensation expense, as well as facility-related and internal research program costs, which were partially offset by lower clinical and manufacturing costs driven by completion of enrollment of pivotal clinical trials.

General and administrative expenses were $26.3 million for the second quarter ended June 30, 2022, an increase of $7.0 million compared to $19.3 million for the same period ended June 30, 2021. General and administrative expenses were $49.7 million for the six months ended June 30, 2022, an increase of $10.8 million compared to $38.9 million for the same period ended June 30, 2021.

The increase in general and administrative expenses in the second quarter and first half of 2022 compared to the prior year periods were primarily attributable to growth of the internal general and administrative and commercial teams, including stock-based compensation expense, facility-related costs associated with the build out of the new corporate headquarters, as well as costs associated with pre-commercial activities.

For additional information, please see the Company’s Selected Condensed Consolidated Balance Sheet and Statement of Operations below.

Webcast and Conference Call

To participate in the conference call, please register at https://register.vevent.com/register/BI25a798dba7074946a0aa3082d603bf41. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.iovance.com. The archived webcast will also be available for one year

On August 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 second quarter of 2022 (Press release, Schrodinger, AUG 4, 2022, View Source [SID1234617547]).

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"We are very pleased with our performance for the quarter and for the first six months of 2022, with both software and drug discovery revenue contributing to strong growth, and our cash position is strong," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "Additionally, we are seeing continued progress across our collaborative and internal drug discovery pipeline. In the second quarter, our investigational new drug application for our MALT1 inhibitor, SGR-1505, was cleared to proceed to Phase 1 clinical development. We are on track to initiate our Phase 1 study of SGR-1505 in patients with relapsed or refractory B-cell lymphoma in the fourth quarter of 2022."

At June 30, 2022, Schrödinger had cash, cash equivalents, restricted cash and marketable securities of approximately $513 million, compared to approximately $529 million at March 31, 2022.

Recent Company Highlights

Collaborative Programs and Internal Pipeline

In June, Schrödinger announced that its investigational new drug (IND) application for its MALT1 inhibitor, SGR-1505, was cleared to proceed to Phase 1 clinical development. Schrödinger expects to initiate a Phase 1 trial of SGR-1505 in patients with relapsed or refractory B-cell lymphoma in the fourth quarter of 2022. The planned multi-center, dose-escalation study will be conducted in patients with relapsed or refractory B-cell lymphoma to evaluate the safety, pharmacokinetics, pharmacodynamics, and early signals of clinical activity of SGR-1505 as a monotherapy. Once the recommended dose is determined, an expansion cohort is planned to evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.
Schrödinger continues to optimize multiple lead series within its Wee1 program and expects to select a Wee1 development candidate with a differentiated profile by the end of this year and to submit an IND at the end of 2023. Wee1 is emerging as a potentially important therapeutic target for a range of solid tumors, including ovarian and uterine cancer.
Schrödinger continues to advance its CDC7 inhibitor, SGR-2921, through IND-enabling studies. The company expects to submit an IND to the U.S. Food and Drug Administration (FDA) in the first half of 2023 and to initiate a Phase 1 clinical study in the second half of 2023, subject to regulatory clearance. 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 is progressing multiple undisclosed research programs in the areas of oncology and immunology. In the first half of this year, the company added four new programs to its wholly-owned pipeline, for a total of six early discovery programs, including targets with first-in-class potential.
The company’s collaborative programs continue to progress through discovery, preclinical and clinical development. A total of eight collaborative programs are in the clinic, which underscores the impact of its platform.
Underlying Science

Schrödinger continues to make scientific advances underlying the predictive power of the company’s computational platform. Schrödinger scientists were authors on seven recent publications in peer-reviewed life sciences and materials science journals, including the publication of data validating the use of the company’s recently developed next-generation induced fit docking methods to optimize homology models to enable predictive modeling of targets where experimental structures have been unavailable, broadening the applicability of Schrödinger’s platform. Additionally, Nimbus Therapeutics and Schrödinger scientists co-authored a manuscript based on data from the companies’ ongoing collaboration describing how Schrödinger’s predictive computational methods accelerated Nimbus’s discovery of potent, selective Tyk2 inhibitors with activity in preclinical models of psoriasis.
In June, Schrödinger hosted its second annual Educator’s Day, which brought together educators from across the globe to discuss the growing opportunity for incorporating computational tools in the classroom. Schrödinger is committed to empowering and training the next generation of computational scientists, and Educator’s Day is one component of Schrödinger’s ongoing educational initiatives.
2022 Financial Outlook

As of August 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 third quarter of 2022, software revenue is expected to range from $23 million to $25 million.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its second quarter 2022 financial results on Thursday, August 4, 2022, 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 August 4, 2022 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported second quarter 2022 financial results and recent corporate highlights (Press release, Relay Therapeutics, AUG 4, 2022, View Source [SID1234617563]).

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"We are excited to welcome Dr. Sekar Kathiresan to our board of directors and look forward to his contributions based on his experiences as a leading academic physician and founder and CEO of an innovative biotechnology company," said Sanjiv Patel, M.D., Relay Therapeutics’ president and chief executive officer. "Over the next 12 months, we will continue to build upon our achievements this year and deliver upon the next anticipated milestones for RLY-4008 and our growing breast cancer portfolio."

Recent Corporate Highlights

Continued to enroll patients across both dose escalation cohorts of the first-in-human trial for RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, assessing it as a single agent for patients with unresectable or metastatic solid tumors with PI3Kα mutation and evaluating RLY-2608 in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer

At June 27th analyst and investor event, disclosed:

Three new programs as part of a growing HR+/HER2- breast cancer franchise: selective CDK2 inhibitor, ERα degrader and chemically distinct pan mutant-PI3Kα inhibitor (RLY-5836)
Based on discussions with the U.S. Food and Drug Administration (FDA), alignment on the design of a single arm trial for the selective FGFR2 inhibitor RLY-4008 in pan-FGFR (FGFRi) treatment-naïve FGFR2-fusion cholangiocarcinoma (CCA) to potentially support an accelerated approval path
Interim data from the once daily (QD) dosing schedule of RLY-4008 shared with the FDA demonstrated confirmed partial responses in 8 out of 13 (62%) FGFRi-naïve FGFR2-fusion CCA patients, including all four of the patients treated at the registrational trial dose of 70 mg QD
Within the breast cancer franchise, anticipate disclosing initial clinical data of pan-mutant PI3Kα inhibitor RLY-2608 in the first half of 2023, clinical start for the selective CDK2 inhibitor in the fourth quarter of 2023 or first quarter of 2024, and development candidate nomination for ERα degrader in 2023
Within the tumor agnostic portfolio, anticipate disclosing additional data updates for RLY-4008 in the second half of 2022 and 2023, and the initiation of the combination trial of SHP2 inhibitor GDC-1971 (RLY-1971) with atezolizumab in the second half of 2022
Appointment of New Board Member

Dr. Kathiresan joins Relay Therapeutics’ board of directors, bringing a unique perspective based on his broad experience as a clinician, academic and company founder. Dr. Kathiresan is co-founder and CEO of Verve Therapeutics. He is a cardiologist and scientist who has focused his career on understanding the inherited basis for heart attack and leveraging those insights to improve the care of cardiovascular disease. Based on his groundbreaking discoveries in human genetic mutations that confer resistance to cardiovascular disease, Dr. Kathiresan co-founded Verve Therapeutics with a vision to create a pipeline of single-course, gene editing therapies focused on addressing the root causes of this highly prevalent and life-threatening disease.

Prior to joining Verve, Dr. Kathiresan’s roles included director of the Massachusetts General Hospital (MGH) Center for Genomic Medicine, director of the Cardiovascular Disease Initiative at the Broad Institute and professor of medicine at Harvard Medical School. There, Dr. Kathiresan’s research laboratory focused on understanding the inherited basis for blood lipids and myocardial infarction. For his research contributions, he has been recognized by the American Heart Association with its highest scientific honor – a Distinguished Scientist Award and by the American Society of Human Genetics with the 2018 Curt Stern Award.

Dr. Kathiresan received a B.A. in history from the University of Pennsylvania and received an M.D. from Harvard Medical School. He completed his clinical training in internal medicine and cardiology at MGH and his postdoctoral research training in human genetics at the Framingham Heart Study and the Broad Institute.

Second Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2022, cash, cash equivalents and investments totaled approximately $838 million compared to $958 million as of December 31, 2021. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into at least 2025.

R&D Expenses: Research and development expenses were $60.5 million for the second quarter of 2022, as compared to $45.1 million for the second quarter of 2021. The increase was primarily due to $3.4 million of additional employee related costs, $8.0 million related to clinical trial expenses and $3.4 million related to preclinical programs.

G&A Expenses: General and administrative expenses were $17.5 million for second quarter of 2022, as compared to $14.4 million for the second quarter of 2021. The increase was primarily due to $3.0 million of additional employee related costs, including an increase in stock-based compensation of $1.0 million.

Net Loss: Net loss was $76.8 million for the second quarter of 2022, or a net loss per share of $0.71, as compared to a net loss of $193.4 million for the second quarter of 2021, or a net loss per share of $2.10. Net loss for the second quarter of 2021 included one-time expenses of $134.9 million associated with the acquisition of ZebiAI Therapeutics, Inc.