On August 8, 2022 Sesen Bio (Nasdaq: SESN) reported operating results for the second quarter ended June 30, 2022 (Press release, Sesen Bio, AUG 8, 2022, View Source [SID1234617809]). During the quarter, the Company paused clinical development of its lead asset, Vicineum for the treatment of non-muscle invasive bladder cancer (NMIBC), and turned its primary focus to the assessment of potential strategic alternatives with the goal of maximizing shareholder value, which it believes will be complete by the end of 2022 .

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!

Business Updates

On July 11, 2022, Sesen Bio participated in a Type B Meeting with the US Food and Drug Administration (FDA). During the meeting, the Company and the FDA discussed outstanding items related to the Company’s proposed protocol and statistical analysis plan design elements for an additional Phase 3 clinical trial for Vicineum for the treatment of NMIBC, which the Company had been evaluating for potential resubmission of a Biologics License Application for Vicineum.

On July 15, 2022, the Company executed an asset purchase agreement (the "Roche Asset Purchase Agreement") with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio. Pursuant to the Roche Asset Purchase Agreement, Roche purchased all patent rights and know-how related to the monoclonal antibody EBI-031 and all other IL-6 antagonist monoclonal antibody technology owned by Sesen Bio for up to $70 million. This includes a $40 million payment made by Roche to the Company upon execution of the Roche Asset Purchase Agreement, and an additional $30 million payable to Sesen Bio upon Roche’s initiation of a Phase 3 clinical trial with EBI-031 for a defined indication if initiated prior to December 31, 2026.

As a result of the Roche Asset Purchase Agreement, the Company’s previous license agreement with Roche dated June 10, 2016 (the "Roche License Agreement") was terminated. Prior to the termination of the Roche License Agreement, the Company had received $50 million in upfront and milestone payments from Roche.

On July 18, 2022, Sesen Bio announced that it had made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum following recent discussions with the FDA, which included feedback that had implications on the size, timeline, and costs of the required additional Phase 3 clinical trial for the treatment of NMIBC. The Company continues to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with a larger infrastructure, and as such, intends to seek a partner that can execute further development to realize the full potential of Vicineum.

As a result of this decision, the Company has turned its primary focus to the careful assessment of strategic alternatives with the goal of maximizing shareholder value. As previously disclosed, the Company is actively working with an investment bank in the assessment process, and believes it will be complete by the end of 2022.

On July 20, 2022, Sesen Bio announced the approval of a restructuring plan to reduce operating expenses and to better align its workforce with the needs of its business following the decision to pause further development of Vicineum in the US. Execution of the restructuring plan is expected to be substantially complete by the end of the fourth quarter of 2022.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $161.2 million as of June 30, 2022, compared to $151.1 million as of June 30, 2021.
R&D Expenses: Research and development expenses for the second quarter of 2022 were $29.9 million compared to $7.2 million for the same period in 2021. The increase of $22.7 million was primarily due to the expense of prepaid balances related to consumables and manufacturing reservations, as the balances were evaluated and deemed to have no future value ($25.2 million). This increase was partially offset by lower costs associated with manufacturing ($2.5 million).
G&A Expenses: General and administrative expenses for the second quarter of 2022 were $15.6 million compared to $6.8 million for the same period in 2021. The increase of $8.8 million was primarily due to an increase in legal expense ($10.3 million). This increase was driven by the preliminary settlement of the securities and derivative litigation, net of expected insurance recovery ($8.6 million), related legal fees ($0.9 million), legal fees related to the internal review ($0.3 million), and other legal expenses ($0.5 million). This increase was partially offset by a decrease in marketing and commercial expenses, which were incurred in the second quarter of 2021 in preparation for potential commercial launch of Vicineum but were discontinued as a result of the Complete Response Letter from the FDA received in August 2021 ($1.5 million).
Non-Cash Related Expenses:
Intangibles impairment charge for the second quarter of 2022 was $27.8 million. In light of assumption changes in market share for Vicineum and the Company’s strategic decision to voluntarily pause further development of Vicineum in the US, the Company performed an interim impairment test for In-Process Research and Development (IPR&D) assets and goodwill. This resulted in the full impairment of IPR&D assets ($14.7 million) and goodwill ($13.1 million).
The change in the fair value of contingent consideration was a decrease of $37.3 million for the second quarter of 2022, compared to an increase of $13.6 million for the same period in 2021. This decrease was due to a change in projected net sales for Vicineum subject to contingent consideration liability, which was based upon projected net sales in the Greater China region in the second quarter of 2022 compared to projected net sales worldwide in the second quarter of 2021.
Income Tax Benefit: Benefit from income tax was $3.9 million for the second quarter of 2022. In connection with the intangibles impairment charge for the second quarter of 2022, the Company wrote-down the associated deferred tax liability by $4.0 million as a benefit. This was partially offset by $0.1 million in income tax paid to foreign jurisdictions pursuant to the Company’s license agreement with Qilu Pharmaceutical. There was no tax benefit or provision in the second
quarter of 2021.
Net Loss: Net loss was $32.0 million, or $0.16 per basic and per diluted share, for the second quarter of 2022, compared to net loss of $25.4 million, or $0.15 per basic and diluted share, for the same period in 2021. The change was primarily attributable to increases in R&D and G&A expenses ($31.5 million), primarily driven by the reduction of prepaid balances related to consumables and manufacturing reservations and the preliminary settlements of the securities and derivative litigation. Additionally, license and related revenue recognized decreased ($2.2 million). This was partially offset by favorable changes in non-cash related expenses of $27.0 million (including tax benefit).
About Vicineum

Vicineum, a locally administered fusion protein, is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio has completed the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. On July 18, 2022, Sesen Bio announced that it had made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs, following recent discussions with the FDA. The Company continues to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with a larger infrastructure, and as such intends to seek a partner for further development of Vicineum while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology therapies, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On August 8, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of novel peptide therapeutics to address difficult-to-treat cancers, reported that the company will conduct a sub-study of its ongoing Phase 1-2 clinical trial of ST101 in recurrent and newly diagnosed GBM patients (Press release, Sapience Therapeutics, AUG 8, 2022, View Source [SID1234617808]). The sub-study will be conducted by Sapience in collaboration with principal investigators at Columbia University and Northwestern University. Partial funding for the sub-study was awarded to Fabio Iwamoto, Principal Investigator at Columbia University, through a research grant from the Ben and Catherine Ivy Foundation.

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 study is a multi-site, open-label surgical sub-study of the Phase 1-2 protocol ST101 to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in 18 patients with recurrent (n=6) and newly diagnosed GBM (n=12). The primary objectives of the study will be to evaluate the safety and tolerability of ST101 as monotherapy in recurrent GBM patients post resection and in newly diagnosed GBM patients in combination with radiation ± temozolomide post resection. The secondary objectives of the study will be to determine the penetration of ST101 in the brain and its correlation with plasma levels. In both study arms, patients will be resected following two to four doses of ST101 and will continue on ST101 following surgery.

"We are thrilled to continue to evaluate the therapeutic potential of ST101, which has demonstrated very promising clinical data in the ongoing Phase 1-2 study with confirmed partial responses in multiple tumor types, including GBM. In the surgical sub-study, we aim to demonstrate further evidence of ST101’s ability to penetrate the brain and inhibit transcription of C/EBPβ, which is a master regulator of GBM tumors," said Fabio Iwamoto, Principal Investigator at Columbia University. "Our team at Columbia remains very excited about our work with Sapience and we look forward to continuing to deliver clinical benefit to cancer patients with ST101."

ST101 is a first-in-class peptide antagonist of C/EBPβ with a dual mechanism of action. ST101 antagonism of C/EBPβ promotes (1) a more favorable immune tumor microenvironment by inhibiting formation of immunosuppressive myeloid-derived suppressor cells (MDSCs) and (2) cytotoxic activity in tumor cells by disrupting C/EBPβ-driven oncogenic activity. In its ongoing Phase 1-2 study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM, a durable RECIST 1.1-confirmed partial response in a patient with cutaneous melanoma and long-lasting stable disease in several additional patients.

Alice Bexon, Sapience’s Chief Medical Officer, commented, "We remain very pleased with ST101’s clinical profile and we look forward to evaluating ST101 in the surgical sub-study announced today. The data generated from this study, if positive, will provide early safety and efficacy signs that would allow us to advance ST101 into a first-line therapeutic option for GBM, which would be transformative for this patient population."

About ST101 and the Phase 1-2 Study
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On August 8, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported that it will host an investor conference call on Wednesday, August 10, 2022 at 1:30 p.m. Pacific Time to discuss its financial and operating results for the second quarter 2022 as well as provide a corporate update (Press release, Adamis Pharmaceuticals, AUG 8, 2022, View Source [SID1234617807]). The company’s press release concerning its second quarter 2022 financial results is expected to be available after 1 p.m. Pacific Time on August 10, 2022, and on its website.

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!

David J. Marguglio, President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the year, and certain goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link, with a replay available shortly after the live event.

On August 8, 2022 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the second quarter of 2022 and provided an update on the Company’s business operations and clinical development programs (Press release, Reata Pharmaceuticals, AUG 8, 2022, View Source [SID1234617806]).

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!

Recent Company Highlights

Omaveloxolone in Patients with Friedreich’s Ataxia

Following the announcement of the positive data from the MOXIe Part 2 study in October 2019, the U.S. Food and Drug Administration ("FDA") stated that it did not have any concerns with the reliability of the modified Friedreich’s ataxia rating scale ("mFARS") primary endpoint results in the MOXIe Part 2 study and requested additional evidence of persuasiveness to support a New Drug Application ("NDA") filing. We then began a series of interactions with the FDA to provide additional evidence of effectiveness to support a single study approval. This ultimately led to a pre-NDA meeting and subsequent NDA submission in March 2022 after FDA’s review of our Delayed-Start Analysis, which it had requested.

In May 2022, the FDA accepted for filing our NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia and granted Priority Review. The FDA has granted Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation to omaveloxolone for the treatment of Friedreich’s ataxia. The FDA advised us that it is planning to hold an advisory committee meeting to discuss the application, and our application has been assigned a Prescription Drug User Fee Act ("PDUFA") target action date of November 30, 2022.

We recently completed a mid-cycle communication meeting with the FDA. The purpose of the mid-cycle communication meeting is for the FDA to provide the sponsor with an update of the status of the NDA review, including any issues identified. While we have not received formal minutes from the FDA, in the preliminary agenda for, and during, the mid-cycle communication meeting, the FDA stated that it has not identified any new significant issues, but it continues to have concerns regarding the strength of the efficacy evidence. The FDA did not identify any significant clinical safety issues. The FDA stated that the safety review is ongoing, and they are continuing to evaluate the cardiac safety of omaveloxolone in patients with Friedreich’s ataxia. They have not identified any other major safety concerns at this stage of their review.

During the mid-cycle meeting, we proposed to address FDA’s concerns in three ways. First, we presented updated results from the Delayed-Start Analysis using a March 2022 data cut-off, which contain new, later time points and increased numbers of patients at later time points than the prior analysis. Second, we proposed to submit a new propensity-matched matched analysis of MOXIe Extension data using the largest, most robust Friedreich’s ataxia natural history study to provide additional clinical data that could be considered confirmatory evidence. Third, we discussed an additional NDA amendment containing compelling mechanistic evidence in the setting of Friedreich’s ataxia’s well-understood disease pathophysiology, which could also serve as confirmatory evidence. The FDA acknowledged these data and agreed that we could submit the updated data to the NDA. We have submitted the following additional data and analyses to the FDA.

Results from March 2022 Data Cut-Off of MOXIe Extension

Results of the updated Delayed-Start Analysis from the March 2022 data cut-off demonstrated that the between-group difference in mFARS observed at the end of the placebo-controlled MOXIe Part 2 treatment period (LS mean difference = -2.17 ± 1.09) was preserved at MOXIe Extension Week 72 in the delayed-start period (LS mean difference = -2.91 ± 1.44). Consistent with a persistent treatment effect on disease, the upper limit of the 90% Confidence Interval ("CI") for the difference estimate was less than zero (-0.09), meeting the threshold for demonstrating significant evidence of non-inferiority. Additionally, the between group difference in mFARS was maintained at Extension Week 96, 120, and 144 (LS mean difference = -2.19 ± 1.38, -2.74 ± 1.26, and -2.58 ± 1.47 respectively), and the threshold for non-inferiority was met at Extension Week 120 with an upper limit of the 90% CI of -0.106.

Post Hoc Propensity-Matched Analysis of MOXIe Extension

We recently completed a post hoc analysis comparing the mFARS progression of omaveloxolone-treated patients in the open-label MOXIe Extension trial to the progression of propensity score-matched untreated patients in the largest natural history study of Friedreich’s ataxia, Clinical Outcome Measures in Friedreich’s ataxia ("FA-COMS"). All patients enrolled in the MOXIe Extension study with at least one post-baseline assessment (n=136) were matched one to one with patients from the FA-COMS study (n=136) using five baseline characteristics, or covariates, including sex, baseline age, age of Friedreich’s ataxia onset, baseline mFARS score, and baseline gait score, which have been demonstrated to be predictive of disease progression. Demographics and baseline characteristics were highly comparable between MOXIe Extension patients and the matched FA-COMS external control group.

In the Primary Pooled Population (n=136 per group), patients in the matched FA-COMS group progressed 6.61 mFARS points at Year 3, whereas patients treated with omaveloxolone in MOXIe Extension progressed 3.00 points for a difference of -3.61 mFARS points (nominal p=0.0001). In this analysis, progression in mFARS was 55% slower in MOXIe Extension patients treated with omaveloxolone compared to matched untreated patients in the FA-COMS study.

Mechanistic Validation of Nrf2 Target Biomarkers in Friedreich’s Ataxia

We have provided additional pharmacodynamic information to the FDA including an integrated and detailed presentation of the disease pathophysiology of Friedreich’s ataxia, a review of the available pharmacodynamic data, justification of the relevance of these data in Friedreich’s ataxia and an explanation of the relationship between the mechanistic data and the observed biomarker and clinical treatment effects in patients treated with omaveloxolone. Substantial evidence demonstrates that Nrf2 levels and activity are suppressed in cells from patients with Friedreich’s ataxia and in preclinical animal models of the disease. Omaveloxolone restores Nrf2 levels and increases the expression of Nrf2 target genes, including those that encode ferritin and gamma-glutamyl transferase ("GGT"), in nonclinical models. Treatment with omaveloxolone in MOXIe Part 1 resulted in dose-dependent increases in Nrf2 activity, as assessed by serum ferritin and GGT levels. Data from MOXIe Part 2 showed an association between omaveloxolone-induced Nrf2 activity and measures of neurological function, with larger increases in Nrf2 target levels associated with larger improvements in mFARS scores.

"We look forward to continuing to work with FDA on its review of our NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia, a rare, genetic, debilitating, and degenerative neuromuscular disorder with no approved therapies," said Warren Huff, Reata’s Chief Executive Officer. "We have submitted these additional data and analyses to the FDA and are continuing to prepare for the upcoming Advisory Committee meeting."

Bardoxolone Methyl in Patients with Chronic Kidney Disease Caused by Alport Syndrome

We received a Complete Response Letter ("CRL") from the FDA in February 2022 with respect to its review of our NDA for bardoxolone methyl ("bardoxolone") in the treatment of patients with chronic kidney disease caused by Alport syndrome. The CRL indicated the FDA cannot approve the NDA in its present form. We have recently requested a Type C meeting to discuss the program and continue to work with the FDA to confirm our next steps on our Alport syndrome program.

Second Quarter Financial Highlights

Cash and Cash Equivalents

On June 30, 2022, we had cash and cash equivalents and marketable securities of $481.5 million, as compared to $590.3 million on December 31, 2021.

GAAP and Non-GAAP Research and Development ("R&D") Expenses

R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $39.3 million for the second quarter of 2022, as compared to $40.1 million for the same period of the year prior.

Non-GAAP R&D expenses were $33.0 million for the second quarter of 2022, as compared to $34.8 million, for the same period of the year prior.1

GAAP and Non-GAAP General and Administrative ("G&A") Expenses

GAAP G&A expenses were $25.1 million for the second quarter of 2022, as compared to $22.0 million, for the same period of the year prior.

Non-GAAP G&A expenses were $17.6 million for the second quarter of 2022, as compared to $14.0 million for the same period of the year prior.1

GAAP and Non-GAAP Net Loss

The GAAP net loss for the second quarter of 2022, was $73.6 million, or $2.02 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $72.7 million, or $2.00 per share, on both a basic and diluted basis, for the same period of the year prior.

[1] See "Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.

The non-GAAP net loss for second quarter of 2022, was $49.4 million, or $1.36 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $48.0 million, or $1.32 per share, on both a basic and diluted basis, for the same period of the year prior.1

Cash Guidance

The Company reaffirms its existing cash & cash equivalents and marketable debt securities will be sufficient to enable it to fund operations through the end of 2024.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses, which exclude stock-based compensation expense; non-GAAP G&A expenses as GAAP G&A expenses, which exclude stock-based compensation expense; non-GAAP operating expenses as GAAP operating expenses, which exclude stock-based compensation expense; non-GAAP net loss as GAAP net loss, which excludes stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties; and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted, which excludes stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants of stock options and restricted stock units and changes in the Company’s stock price, which impact the fair value of these awards. The Company has excluded the impact of accreted non-cash interest expense from liability related to sale of future royalties as it may be calculated differently from, and therefore may not be comparable to, peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods.

Because management believes certain items, such as stock-based compensation expense and non-cash interest expense from liability related to sales of future royalties, can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Conference Call Information

Reata’s management will host a conference call on August 8, 2022, at 8:30 am ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using access code 964090. The webcast link is View Source

Second quarter 2022 financial results to be discussed during the call will be included in an earnings press release that will be available on the Company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast of the conference call will be accessible for at least 90 days after the event at View Source.

On August 8, 2022 Guardant Health Inc. (Nasdaq: GH), a leading precision oncology company, and Blueprint Medicines Corporation (Nasdaq: BPMC) reported they are presenting new data demonstrating that the EGFR C797X mutation is the most common resistance mechanism to osimertinib therapy for patients with advanced non-small cell lung cancer (NSCLC) (Press release, Guardant Health, AUG 8, 2022, View Source [SID1234617805]). The results are being reported today at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer in Vienna.

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 real-world study improves our understanding of how resistance mutations to osimertinib emerge over time, with new insights on when EGFR C797X mutations overtake MET amplifications as the most commonly acquired resistance mechanism," said Suresh Ramalingam, M.D., FACP, FASCO, executive director of Winship Cancer Institute of Emory University, who served as the principal investigator for the study. "The analysis characterizes the increased frequency of EGFR C797X mutations as patients are treated with first-line osimertinib for longer durations, reinforcing the need for next-generation EGFR inhibitors to address C797X-driven resistance."

A collaborative effort between Guardant Health, Blueprint Medicines and Winship Cancer Institute, the study analyzed de-identified clinical and genomic data using the GuardantINFORM real-world evidence platform, which includes more than 65,000 adults with advanced NSCLC. The analysis evaluated genomics data from the Guardant360 circulating tumor DNA (ctDNA) test for more than 2,000 patients who had any EGFR mutation and treatment with osimertinib, a third-generation EGFR TKI (tyrosine kinase inhibitor) and the current standard of care for patients with advanced-stage NSCLC with common EGFR mutations. The study incorporated ctDNA results up to five years after patients initiated osimertinib therapy.

Cumulatively, the analysis indicated that EGFR C797X mutations were 1.25 times more common than MET amplification when osimertinib was used as first-line therapy and 2.4 times more common when it was used as second-line therapy. In patients likely to experience disease progression after first-line treatment with osimertinib, the cumulative incidence of EGFR C797X mutations was 12.5 percent. MET amplifications were the most common resistance mutation in the first year of osimertinib treatment, and EGFR C797X mutations exceeded the rate of MET amplifications in years two through five.

"This study is an excellent example of how real-world data from the GuardantINFORM platform can be used to shed new light on resistance mechanisms in lung cancer therapy," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The analysis provided critical insights about resistance mutations that can contribute to the development of more effective therapies for lung cancer."

"We are committed to developing transformative precision therapies that prevent or overcome treatment resistance, which represents an important medical need for patients with EGFR-mutant, non-small cell lung cancer," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "Our collaboration with Guardant Health advances our efforts to characterize dynamic treatment resistance patterns in lung cancer, helping inform therapeutic strategies, including novel combinations, that may prolong patient benefit."

Blueprint_Logo_RGB_full-color (1).jpg Guardant Health

About GuardantINFORM
The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 225,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon and prostate.