On May 11, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the first quarter ended March 31, 2020 and recent company developments (Press release, TG Therapeutics, MAY 11, 2020, View Source [SID1234557486]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "The first few months of 2020 have undoubtedly been the most impactful and exciting in our Company’s history. We kicked off the year with the initiation of our first rolling regulatory submission for umbralisib in both MZL and FL and most recently reported positive topline results from our UNITY-CLL Phase 3 trial evaluating our proprietary U2 combination in patients with CLL. This positive outcome marks a major step forward in our mission of developing the best possible combination treatment options for patients with B-cell diseases." Mr. Weiss continued, "We now have three successful pivotal data sets which we believe have the potential to support regulatory approvals across MZL, FL and CLL. With more than $150 million proforma in cash on our balance sheet, we are well funded through and beyond our next set of key milestones, including the release of topline data from the ULTIMATE MS Phase 3 program, submission of an NDA/BLA for U2 in CLL, and hopefully, our first approval for umbralisib in MZL and FL, all of which are targeted to occur over approximately the next 9 months."

Recent Developments and Highlights

Chronic Lymphocytic Leukemia:

In May 2020, reported positive topline results from the Company’s UNITY-CLL Phase 3 trial evaluating U2 (the combination of umbralisib and ublituximab) in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The trial met its primary endpoint of improved progression-free survival (PFS) (p<.0001), as determined by an Independent Review Committee (IRC) and will be stopped early for superior efficacy. Regulatory submission and full data presentation targeted by year-end 2020.
Marginal Zone Lymphoma & Follicular Lymphoma:

In January 2020, received guidance from the U.S. Food and Drug Administration (FDA) allowing submission of a single New Drug Application (NDA) for marginal zone lymphoma (MZL) and follicular lymphoma (FL) indications. A rolling NDA submission for umbralisib to treat adult patients with previously treated MZL and FL was initiated, with completion of submission targeted in the first half of 2020.
In March 2020, received orphan drug designation for umbralisib from the FDA for the treatment of FL.
Multiple Sclerosis:

In May 2020, announced the publication of results from the multicenter Phase 2 trial evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS) in the Multiple Sclerosis Journal.
Awaiting topline data from the Company’s Phase 3 ULTIMATE I & II trials evaluating ublituximab in patients with RMS, targeted in second half 2020.
Board of Directors & Management:

In May 2020, appointed Sagar Lonial, MD, FACP, Professor and Chair of the Department of Hematology and Medical Oncology at the Emory University School of Medicine, as well as the Chief Medical Officer at Winship Cancer Institute of Emory University, to the Company’s Board of Directors.
In May 2020, strengthened executive team with the addition of Owen A. O’Connor, MD, PhD as Chief Scientific Officer. Dr. O’Connor most recently served as a Professor of Medicine and Experimental Therapeutics, the Director of the Center for Lymphoid Malignancies, and Co-Program Director of the Lymphoid Development and Malignancy Program in the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center.
Bolstered Balance Sheet:

In May 2020, strengthened balance sheet with more than $75 million in gross proceeds through the Company’s At-the-Market (ATM) facility, $40 million of which came from a longtime shareholder.

Key Objectives for 2020

Complete rolling NDA submission for umbralisib in patients with previously treated MZL and FL, in the first half of 2020.
Report topline results from the Phase 3 ULTIMATE I & II trials in RMS, in the second half of 2020.
Present full data from the UNITY-CLL Phase 3 trial and present full data from the FL and MZL umbralisib monotherapy cohorts of the UNITY-NHL trial at a major medical meeting, by year-end 2020.
Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients), by year end 2020.
Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801.

Financial Results for the Three Months Ended March 31, 2020

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $34.0 million for the three months ended March 31, 2020, compared to $30.9 million for the three months ended March 31, 2019. The modest increase in R&D expense is primarily attributable to costs associated with the preparation of the Company’s NDA filing for umbralisib in MZL and FL. We expect our R&D expenses to decrease during 2020 as costs associated with our main pivotal clinical trials continue to decline over the remainder of the year, partially offset by expenses associated with the expected NDA/BLA filing for U2 in CLL.

G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $5.2 million for the three months ended March 31, 2020, as compared to $1.9 million for the three months ended March 31, 2019. The increase in other G&A expenses is primarily due to the build out of our commercial team and infrastructure in anticipation of the potential commercialization of umbralisib and ublituximab. We expect G&A expenses to increase modestly during the remainder of 2020.

Net Loss: Net loss was $51.1 million for the three months ended March 31, 2020, compared to a net loss of $35.2 million for the three months ended March 31, 2019. Excluding non-cash compensation, the net loss for the three months ended March 31, 2020 was approximately $40.0 million, compared to a net loss of $33.3 million for the three months ended March 31, 2019.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $78.3 million as of March 31, 2020. Pro forma cash, cash equivalents and investment securities as of March 31, 2020 are approximately $154.3 million, after giving effect to $76.0 million of net proceeds from the utilization of the Company’s ATM sales facility during the second quarter of 2020 at an average price of $17.07. The Company believes its cash, cash equivalents and investment securities on hand as of March 31, 2020, inclusive of the proceeds raised from the ATM facility, as well as future availability under the Company’s debt and ATM facility, will be sufficient to fund the Company’s planned operations through the end of 2021.

On May 11, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the first quarter of 2020 (Press release, Molecular Templates, MAY 11, 2020, View Source [SID1234557513]). As of March 31, 2020, MTEM’s cash and investments totaled $108 million, which is expected to fund operations into 2022.

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"We continue to make meaningful progress at MTEM despite the headwinds that COVID-19 has created for clinical trial site initiation and patient enrollment," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive Officer and Scientific Officer. "We expect to report interim clinical data this year from our three MT-3724 Phase II studies and our MT-5111 Phase I study. We also expect to present preclinical data on programs against new targets and file the IND for MT-6402, our PD-L1 targeted ETB with antigen seeding, by year-end."

Company Highlights, Pipeline Status, and Upcoming Milestones

Corporate

On February 19, 2020, MTEM announced the initiation of dosing in a Phase I study investigating TAK-169 in patients with relapsed/refractory multiple myeloma. Co-developed with Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited ("Takeda"), TAK-169 is a potential first-in-class CD38-targeting ETB. As a result of achieving this milestone, MTEM received a $10 million payment from Takeda.
Impact of COVID-19

The COVID-19 pandemic has resulted in a significant slowdown in the pace of site initiations and patient enrollment across our MT-3724 Phase II programs. As a CD20-targeting agent for the treatment of hematological malignancy, MT-3724 may impair the ability to generate humoral immunity to coronavirus infection. Physicians may be less inclined to enroll patients given this concern.
MT-5111 screening and enrollment has been less impacted than MT-3724 but is still enrolling at a slower pace than was projected pre-COVID-19.
To date, MTEM has been able to continue to work at its cGMP manufacturing facility and laboratories without interruption from COVID-19. As a result, manufacturing of product supply for clinical trials and research activities to support advancement of our preclinical pipeline (including partnered programs) have not been impacted to date by COVID-19.
During the COVID-19 pandemic, MTEM is carefully and continually evaluating the potential individual patient risk associated with continuing to enroll in MTEM’s existing studies and the degree of disruption to these studies and MTEM’s business generally.
MT-3724 (CD20 ETB)

MTEM is currently conducting three ongoing Phase II studies in relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
MTEM expects to report updates on all three MT-3724 studies in 2H20.
TAK-169 (CD38 ETB)

Takeda and MTEM are conducting an ongoing Phase I study for TAK-169 in relapsed/refractory multiple myeloma.
MT-5111 (HER2 ETB)

MTEM is conducting an ongoing Phase I study of MT-5111 in HER2-positive cancers.
MTEM expects to provide a data update from the MT-5111 Phase I study in 2Q20 and release additional data from the dose escalation portion of the study in 4Q20.
Research

MTEM expects to file an IND application for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
Several other ETB candidates are in preclinical development against targets including CTLA-4, SLAMF-7, and CD45.
MTEM expects to present preclinical data on several new targets ETB programs at upcoming medical conferences including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, taking place June 22-24, 2020.
Financial Results

The net loss attributable to common shareholders for the first quarter of 2020 was $22.0 million, or $0.48 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.2 million, or $0.17 per basic and diluted share, for the same period in 2019.

Revenues for the first quarter of 2020 were $4.1 million, compared to $7.0 million for the same period in 2019. Revenues for the first quarter of 2020 were comprised of revenues from collaborative research and development agreements with Takeda and Vertex, as well as grant revenue from CPRIT. Total research and development expenses for the first quarter of 2020 were $20.6 million, compared with $8.4 million for the same period in 2019. Total general and administrative expenses for the first quarter of 2020 were $5.6 million, compared with $4.9 million for the same period in 2019.

On May 11, 2020 BiomX Inc. (the "Company") (NYSE: PHGE), a clinical-stage company developing both natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and live audio webcast on Thursday, May 14, 2020, at 8:00 a.m. ET to report first quarter 2020 financial results and provide a corporate update (Press release, BiomX, MAY 11, 2020, View Source [SID1234557530]).

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To participate in the conference call, please register at View Source ahead of the call to receive the dial-in information. A live webcast of the call will be available on the Investors section of the BiomX website and a replay will be available after its completion.

On May 11, 2020 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data across its portfolio, aimed at addressing solid tumor and hematologic malignancies in 28 types of cancer, at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, which will take place from May 29 to May 31, 2020 (Press release, Bristol-Myers Squibb, MAY 11, 2020, View Source [SID1234557449]).

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Presentations will feature clinical and non-clinical studies highlighting the potential role of immunotherapy, including combination approaches, to deliver durable treatment outcomes in multiple hard-to-treat solid tumors. In hematology, presentations will demonstrate the company’s innovative research in multiple myeloma, through both BCMA-targeted CAR T and proof-of-concept CELMoD data, suggesting targeted protein degradation as a potential new treatment approach. In addition, precision treatment approaches will explore how new biomarker insights may aid in the selection of optimal therapies for patients based on disease biology.

Accepted abstracts will be available on the ASCO (Free ASCO Whitepaper) conference website on Wednesday, May 13 at 5 p.m. EDT and the embargo will lift for all data included in these presentations at that time. Overall, data from more than 50 company-sponsored studies and collaborations will be featured at the meeting:

Solid Tumor

First presentation of results from CheckMate -9LA evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) with limited chemotherapy, and three-year follow-up data from CheckMate -227 evaluating Opdivo plus Yervoy combination in first-line metastatic non-small cell lung cancer
Treatment-free survival data from analyses of Opdivo plus Yervoy in advanced melanoma and new data in patients with immunotherapy-resistant renal cell carcinoma (RCC)
Analyses of multiple biomarkers associated with Opdivo plus Yervoy or Opdivo in patients with RCC
Cell Therapy

Pivotal trial results from KarMMa study of idecabtagene vicleucel (ide-cel; bb2121), a potential first-in-class BCMA CAR T in multiple myeloma being developed with bluebird bio
Updated data from EVOLVE Phase 1 study of orva-cel (orvacabtagene autoleucel), a fully human BCMA CAR T being developed by Juno Therapeutics, a Bristol-Myers Squibb Company, in heavily pre-treated multiple myeloma patients
Hematology

First clinical disclosure for CC-92480, a novel CELMoD agent evaluated in combination with dexamethasone in patients with relapsed and refractory multiple myeloma
Multiple analyses from the QUAZAR-001 pivotal Phase 3 study evaluating CC-486 maintenance therapy in acute myeloid leukemia
"This year’s ASCO (Free ASCO Whitepaper) meeting underscores the science-driven approach of our development program in solid tumor and hematologic malignancies, our dedication to precision medicine, as well as our commitment to helping to deliver durable improvement in patient outcomes through potentially transformative therapies," said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. "With the impact of COVID-19, we are committed to supporting patients with cancer and overcoming challenges that patients, physicians and the research community may face during this time. We look forward to coming together virtually to share important data that continues to advance innovation for patients."

Summary of Presentations:

Selected Bristol Myers Squibb studies at the 2020 ASCO (Free ASCO Whitepaper) Virtual Annual Meeting include:

Gastrointestinal Malignancies

Nivolumab (NIVO) + low-dose ipilimumab (IPI) as first-line (1L) therapy in microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Two-year clinical update
Author: Heinz-Josef Lenz
Abstract: #4040
Poster Session: Gastrointestinal Cancer—Colorectal and Anal (Poster: #32)
Phase 3 APACT trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P + gem) vs. gem alone for patients with resected pancreatic cancer (PC): outcomes by geographic
Author: Reni
Abstract: #4515
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary (Poster: #123)
Genitourinary Malignancies

Biomarker analyses from the Phase 3 CheckMate -214 trial of Opdivo plus Yervoy or sunitinib in aRCC
Author: Motzer
Abstract: #5009
Clinical Science Symposium: Updates on Immunotherapy Biomarkers Development in Kidney and Bladder Cancers
Evaluation of predictive biomarkers for Opdivo in patients with mccRCC from the CheckMate -025 (CM -025) trial
Author: Ficial
Abstract: #5023
Poster Session: Genitouinary Cancer—Kidney and Bladder (Poster: #92)
FRACTION-RCC: Innovative, high-throughput assessment of Opdivo plus Yervoy for treatment refractory aRCC
Author: Choueiri
Abstract: #5007
Oral Session: Genitourinary Cancer—Kidney and Bladder
Immunogenomic characterization of advanced clear cell RCC treated with PD-1 blockade
Author: Braun
Abstract: #5010
Clinical Science Symposium: Updates on Immunotherapy Biomarkers Development in Kidney and Bladder Cancers
Leukemia

CC-486 is safe and well-tolerated as maintenance therapy in elderly patients (≥75 years) with acute myeloid leukemia (AML) in first remission following induction chemotherapy: Results from the phase III QUAZAR AML-001 trial
Author: Ravandi
Abstract: #7530
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #303)
Enasidenib plus azacitidine significantly improves complete remission and OR vs azacitidine alone in patients with newly diagnosed AML with isocitrate dehydrogenase 2 (IDH2) mutations: Results of a randomized Phase 2 study
Author: DiNardo
Abstract: #7501
Oral Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Escalated dosing schedules of CC-486 for patients experiencing first acute myeloid leukemia (AML) relapse: Results from the phase III QUAZAR AML-001 maintenance trial
Author: Doehner
Abstract: #7513
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #286)
Health-related quality of life (HRQoL) in the Phase III QUAZAR-AML-001 trial of CC-486 maintenance therapy for patients with acute myeloid leukemia (AML) in first remission following induction chemotherapy (IC)
Author: Roboz
Abstract: #7533
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #306)
Longer-term RBC transfusion reduction in the Phase 3 MEDALIST study of luspatercept in patients with lower-risk MDS with ring sideroblasts (RS)
Author: Komrokji
Abstract: #7518
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #291)
Lymphoma

Burden of cytokine release syndrome (CRS) and neurologic events (NE) in patients (Pts) with relapsed/refractory non-Hodgkin lymphoma (NHL) receiving lisocabtagene maraleucel (Liso-cel; JCAR017) in TRANSCEND NHL 001
Author: Abramson
Abstract: #6637
Poster Session: Health Services Research, Clinical Informatics, and Quality of Care (Poster: #328)
Lisocabtagene maraleucel (liso-cel) for treatment of second-line (2L) transplant noneligible (TNE) relapsed/refractory (R/R) aggressive large B-cell non-Hodgkin lymphoma (NHL): updated results from the PILOT study
Author: Sehgal
Abstract: #8040
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia (Poster: #373)
Opdivo plus brentuximab vedotin for R/R classical Hodgkin lymphoma (cHL) in children, adolescents, and young adults (CAYA)
Author: Cole
Abstract: #8013
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia (Poster: #346)
Outpatient treatment with lisocabtagene maraleucel (liso-cel) across a variety of clinical sites from 3 ongoing clinical studies in relapsed/refractory (R/R) large B-cell lymphoma (LBCL)
Author: Bachier
Abstract: #8037
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia (Poster: #370)
Melanoma

Estimating treatment-free survival (TFS) over extended follow-up in patients (pts) with advanced melanoma (MEL) treated with immune-checkpoint inhibitors (ICIs): Five-year follow-up of CheckMate 067
Author: Regan
Abstract: #10043
Poster Session: Melanoma/Skin Cancers (Poster: #392)
Integrative tumor and immune cell multi-omic analyses predict melanoma response to immune checkpoint blockade 
Author: Anagnostou
Abstract: #10009
Clinical Science Symposium: Systems Biology Approaches to Immunotherapy Response and Toxicity
Multiple Myeloma

First-in-human phase I study of the novel CELMoD agent CC-92480 combined with dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM)
Author: Richardson
Abstract: #8500
Oral Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results
Author: Munshi
Abstract: #8503
Oral Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Orvacabtagene autoleucel (orva-cel), a B-cell maturation antigen (BCMA)-directed CAR T cell therapy for patients (pts) with relapsed/refractory multiple myeloma (RRMM): update of the phase 1/2 EVOLVE study (NCT03430011)
Author: Mailankody
Abstract: #8504
Oral Session: Hematologic Malignancies—Plasma Cell Dyscrasia
KarMMa-RW: a study of real world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa
Author: Jagannath
Abstract: #8525
Poster Session: Hematologic Malignancies—Plasma Cell Dyscrasia (Poster: #425)
Non-Small Cell Lung Cancer

Nivolumab + ipilimumab versus platinum-doublet chemotherapy as first-line treatment for advanced non-small cell lung cancer: Three-year update from CheckMate -227 Part 1
Author: Ramalingam
Abstract: #9500
Oral Session: Lung Cancer—Non-Small Cell Metastatic
Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): CheckMate -9LA
Author: Reck
Abstract: #9501
Oral Session: Lung Cancer—Non-Small Cell Metastatic
Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

On May 11, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the first quarter ended March 31, 2020 (Press release, CymaBay Therapeutics, MAY 11, 2020, View Source [SID1234557487]).

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Sujal Shah, President and CEO of CymaBay, stated, "Last week a panel of some of the most experienced and distinguished liver pathologists and hepatologists in the world completed an independent review analyzing findings from our Phase 2b study of seladelpar in patients with NASH. I am pleased to report that the panel unanimously concluded there was no clinical, biochemical or histological evidence of seladelpar-induced liver injury in the study, and as a result they also unanimously supported the lifting of the clinical hold and re-initiation of clinical development.

While we have not yet discussed full results from our investigation nor any of the panel’s conclusions with the FDA, we are planning to re-engage with the agency as quickly as possible. At this point we cannot guarantee what the next steps or timelines will be, but we are confident that we have conducted a truly rigorous, independent review to help us definitively support the conclusion that seladelpar did not cause drug-induced liver injury in our NASH phase 2b study."

Dr. Paul Watkins, Howard Q Ferguson Distinguished Professor, Schools of Medicine, Pharmacy, and Public Health, Director, Institute for Drug Safety Sciences at the University of North Carolina, Chapel Hill, said, "I was pleased to chair this esteemed independent panel of liver experts. The panel conducted a comprehensive, systematic review and discussion of all of the clinicopathological data from the seladelpar NASH Phase 2b study. In my experience, no other drug in development for NASH has been through such rigorous scrutiny of safety data at this stage of development. As we have stated, the features noted by study pathologists at end of treatment were confirmed on this review. However, these did not differ qualitatively between baseline and end of treatment. We suspect these histologic features are underreported; however, in the experience of the pathology review subcommittee, these features may be observed in patients with NASH. The panel unanimously concluded that the data in aggregate, including the lack of significant differences in histologic features or their changes across the placebo and treatment groups, do not support injury related to seladelpar."

Dr. Stephen Harrison, Medical Director, Pinnacle Clinical Research, Visiting Professor of Hepatology at Radcliffe Department of Medicine, University of Oxford, and principal investigator of the seladelpar Phase 2b study in NASH, added, "I believe CymaBay and the FDA did the right thing in putting patient safety first when development of seladelpar was halted at the end of last year until an in-depth investigation was conducted into the findings identified by study pathologists in the NASH study. At this point, the findings and additional data collected have been thoroughly investigated by leading experts in the areas of drug-induced liver injury and hepatopathology. Given the benefit observed on both NASH resolution and fibrosis with seladelpar in the NASH Phase 2b study as well as data presented at multiple medical meetings from studies of seladelpar in PBC, I am pleased that the independent review panel is supportive of restarting clinical development pending approval from the FDA."

Recent Corporate Highlights

At the end of last week, a panel of eight of the world’s foremost expert liver pathologists and hepatologists, whose collective experience relevant to CymaBay’s investigation includes drug-induced liver injury, NASH and cholestatic liver diseases, completed a four-day independent review analyzing findings from CymaBay’s NASH Phase 2b study. The panel unanimously supported lifting the clinical hold for seladelpar and re-initiation of clinical development. In addition to the chair, Dr. Paul Watkins, the panel included:
° Pierre Bedossa, MD, PhD, Professor of Pathology at the University Paris-Diderot, France, and Medical Director and CEO of LIVERPAT
° Michael Charlton, MD, Chief of Hepatology, Director of the Center for Liver Diseases and Medical Director of the Transplant Institute at the University of Chicago
° Zachary Goodman, MD, PhD, Director of Hepatic Pathology Consultation and Research, Center for Liver Disease, Inova Healthcare Services
° Neil Kaplowitz, MD, Professor of Medicine and Thomas H. Brem Chair in Medicine, Budnick Chair of Liver Disease, Keck School of Medicine, University of Southern California
° David Kleiner, MD, PhD, Head of Histopathology and Autopsy Pathology at the NIH and the Reference Pathologist for the Drug-Induced Liver Injury Network
° Willis Maddrey, MD, Professor Emeritus of Internal Medicine at The University of Texas Southwestern Medical Center
° John Vierling, MD, Professor of Medicine and Surgery, Baylor College of Medicine

CymaBay intends to reach out to the FDA to discuss all of the data it has collected to date and the results of the panel review meetings. Once initial feedback is gathered, CymaBay intends to submit a complete response to the seladelpar clinical hold to the FDA. The CymaBay Board of Directors has worked closely with management throughout the investigation and panel review and is in support of next steps to re-engage with the FDA.

As a reminder, during the fourth quarter of 2019, management implemented a restructuring program following the placement of the seladelpar program on clinical hold pending further investigation of the histologic observations noted by study pathologists in CymaBay’s Phase 2b NASH study and pending completion of its review of strategic options.

Late in the first quarter of 2020, the need for sustained cost containment was further underscored by the unexpected and rapid onset of the coronavirus pandemic and the associated travel restrictions and shelter-in-place orders issued by governmental authorities in jurisdictions where CymaBay, its partners, investigators, and vendors, conduct operations. In response to these measures, CymaBay has taken steps, such as enabling remote operations for all employees, which have allowed operating activities to continue as seamlessly as possible.

CymaBay will continue to closely monitor pandemic developments and their associated risks to the business, and will take actions available to mitigate them where possible. Further, all of CymaBay’s actions will be guided by a commitment to taking all steps possible to ensure the health and safety of its employees.

Held $176.2 million in cash, cash equivalents and short-term investments at March 31, 2020.
Mr. Shah continued, "As the next steps in our seladelpar investigation process become clear we will continue to keep our shareholders updated as appropriate, while also continuing to evaluate potential strategic alternatives. Further, we remain focused on cost containment and will look at additional steps we can take into fiscal year 2020 in order to closely control the Company’s operating expenses and associated cash burn."

First Quarter Ended March 31, 2020 Financial Results

Research and development expenses for the three months ended March 31, 2020 were $9.5 million, compared to $18.6 million for the three months ended March 31, 2019. Research and development expense in the first quarter of 2020 was significantly lower than the corresponding period in 2019 primarily due to declining clinical trial activities related to the Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, as efforts continue to scale back and shut down these studies as a result of the clinical hold on the seladelpar development program.

General and administrative expenses for the three months ended March 31, 2020 were $4.3 million, compared to $5.7 million for the three months ended March 31, 2019. General and administrative expenses in the first quarter of 2020 was lower than the corresponding period in 2019 due to lower continuing labor costs and other administrative expenses following restructuring efforts undertaken in the fourth quarter of 2019.

Net loss for the three months ended March 31, 2020 was $13.1 million, or ($0.19) per diluted share, compared to a net loss of $23.1 million, or ($0.37) per diluted share in the three months ended March 31, 2019. Net loss was lower in the first quarter of 2020 compared to the corresponding period in 2019 primarily due to a decrease in operating expenses, including clinical trial and labor related expenses.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss first quarter 2020 financial results and provide a corporate update. To access the live conference call, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID# 10009543. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source