On May 9, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways, reported its financial results for the first quarter ended March 31, 2019. As of March 31, 2019, cash equivalents and investments totaled $117.0 million (Press release, Calithera Biosciences, MAY 9, 2019, View Source [SID1234536068]).

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"This year we expect to achieve multiple, key milestones in our clinical development program and several data readouts, including top-line results of the ENTRATA trial mid-year, and with our partner Incyte, data from the INCB001158 program in the second half of the year," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "In the first quarter, we’ve also made great strides in our earlier stage programs, moving our cystic fibrosis program into the clinic and presenting preclinical data on our CD73 inhibitor, which is poised to enter the clinic by year end."

First Quarter 2019 and Recent Highlights

Completed enrollment of the Phase 2 renal cell carcinoma ENTRATA trial. The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report top-line results including key efficacy and safety data in mid-2019.

Initiated Phase 1/2 clinical trial of telaglenastat (CB-839) in combination with talazoparib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s PARP inhibitor talazoparib in patients with solid tumors. Calithera expects to initiate an additional trial of the combination of telaglenastat plus the CDK4/6 inhibitor palbociclib in patients with KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer in the second quarter of 2019.

Initiated Phase 1 trial of arginase inhibitor CB-280 for the treatment of cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. The first-in-human Phase 1 trial initiated in February 2019 will evaluate the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers.

Presented preclinical data for CB-708 at AACR (Free AACR Whitepaper) Annual Meeting 2019. The preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrate that CB-708 is a potent and selective inhibitor of CD73 that has immune-mediated, single-agent activity in syngeneic mouse tumor models. In the pre-clinical studies presented, CB-708 was well-tolerated and shows enhanced anti-tumor activity in combination with checkpoint inhibitors as well as chemotherapy. Calithera anticipates that CB-708 will enter clinical trials in 2019.

Selected First Quarter 2019 Financial Results

Cash, cash equivalents and investments totaled $117.0 million at March 31, 2019.

Research and development expenses were $20.2 million for the three months ended March 31, 2019, compared with $15.5 million for the same period in the prior year. The increase of $4.7 million was primarily due to a $2.3 million increase in the telaglenastat program, including our Phase 2 CANTATA trial, an increase of $1.1 million in the INCB001158 program, an increase of $1.0 million in the CB-280 program, as well as investment in early stage research.

General and administrative expenses were $4.2 million for the three months ended March 31, 2019, compared with $3.5 million for the same period in the prior year. The increase of $0.7 million was related to higher personnel-related costs and professional services costs.

Net loss for the three months ended March 31, 2019 was $23.7 million, or $0.61 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, May 9 at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 1182244. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On May 9, 2019 Blaze Bioscience, Inc., the Tumor Paint Company, a biotechnology company dedicated to improving the lives of cancer patients through development and commercialization of products for fluorescence guided surgery, reported the publication of Phase 1 results in the peer-reviewed journal Neurosurgery (Press release, Blaze Bioscience, MAY 9, 2019, View Source [SID1234536085]). The publication entitled "Phase 1 Safety, Pharmacokinetics, and Fluorescence Imaging Study of Tozuleristide (BLZ-100) in Adults with Newly Diagnosed or Recurrent Gliomas" by Patil et al is available online in Neurosurgery Now!.

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The publication reports data from 17 subjects in a single dose, dose-escalation, open-label clinical trial conducted at Cedars-Sinai Medical Center in Los Angeles and the NEWRO Foundation in Brisbane, Australia. The primary objective of the study was to evaluate the safety and tolerability of tozuleristide in adult subjects with glioma undergoing surgery. Tozuleristide was found to be well tolerated at all tested doses with no dose limiting toxicities observed. A maximum tolerated dose was not reached. Exploratory imaging studies were conducted with the FLUOBEAM800 (Fluoptics), Odyssey CLx (LI-COR Biosciences) and SIRIS (Teal Light Surgical) imaging devices. Fluorescence signal was detected in both high- and low-grade tumors and was visible from 3 hours to 27 hours post dosing.

"Tozuleristide fluorescence visualized with a high-resolution imaging system shows great promise as a tool to increase extent of resection for both high- and low-grade gliomas while preserving critical normal brain tissue. Improved resection is the single most important factor for improving survival and quality of life in brain tumor patients. Based on these encouraging results, further clinical trials are definitely warranted," said Dr. Adam Mamelak, MD, neurosurgeon at Cedars-Sinai and senior author on the publication.

"The positive data in adult glioma subjects has paved the way for our broader pediatric brain cancer clinical trials," said Dr. Dennis Miller, Blaze Bioscience SVP of Development. "The study also pointed out the need for improved imaging devices for brain cancer surgery applications which led to the development of the Canvas Imaging System being used in our ongoing pivotal study."

About BLZ-100 (tozuleristide)

BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint platform and consists of a targeting peptide and a fluorescent dye, which emits light in the near-infrared (NIR) range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells throughout surgery, potentially enabling more precise, complete resection of cancer while sparing normal adjacent tissue. BLZ-100 has been tested in four Phase 1 clinical trials and has demonstrated clinical proof of concept in brain, breast and skin cancers. Additional potential applications of BLZ-100 include prostate, lung, colorectal and other solid tumor cancers. BLZ-100, an investigational agent, is being evaluated in a pivotal Phase 2/3 clinical study in pediatric central nervous system tumors. More details about ongoing trials are available at www.clinicaltrials.gov.

About the Canvas Imaging System

The Canvas Imaging System is an investigational medical device designed to provide high-sensitivity detection of NIR light in the operating room under ambient light conditions. The Canvas Imaging System was developed and is manufactured by Teal Light Surgical, Inc. (a wholly owned subsidiary of Blaze Bioscience, Inc.). The first Canvas Imaging System under development is adapted for use with surgical microscopes and detects both BLZ-100 and indocyanine green (ICG).

On May 9, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter of 2019 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2019, View Source [SID1234536134]).

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"The first quarter of 2019 saw critical execution across multiple programs. With respect to the global roxadustat anemia platform, we received positive topline results from analyses of pooled MACE and MACE+ data from our Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients. We and our partners continue to prepare for NDA submission to the FDA in the third quarter, with the EMA MAA submission to follow," said Thomas B. Neff, Chief Executive Officer. "In our anti-CTGF antibody program, we completed the analysis of the first year of treatment with pamrevlumab, our anti-CTGF antibody, for the 21 non-ambulatory subjects in a Phase 2 trial with favorable results in lung and cardiac functions and muscle strength from our administrative analysis suggesting promise for a new treatment option for DMD patients."

Recent Developments and Highlights

Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and EU

In the pooled analyses of around 4,000 dialysis patients, the upper bound of the 95% confidence interval (CI) was below the pre-specified non-inferiority margin for the time to first MACE+ analyses. Based on the MACE safety analyses of this population, we believe there is no clinically meaningful difference in risk of MACE between roxadustat and epoetin alfa.

In the pooled analyses of about 1,500 incident dialysis patients roxadustat demonstrated superiority to epoetin alfa in the time to first MACE+ in this subpopulation. In the MACE analysis, there is a trend toward reduced risk for patients on roxadustat, compared to epoetin alfa.

In the non-dialysis pool of approximately 4,300 patients, non-inferiority was demonstrated for roxadustat compared to placebo in the time to first MACE+, based on the upper bound of the 95% CI being below the pre-specified non-inferiority margin. We believe there is no clinically meaningful difference in risk of MACE between roxadustat and placebo.

•

Multiple MACE and MACE+ analyses in non-dialysis from the roxadustat global Phase 3 program are being performed in intent-to-treat (ITT) analyses that demonstrated comparability of roxadustat to placebo. ITT is among the several statistical methods that we will discuss with the FDA. In these ITT analyses, roxadustat was comparable based on a commonly applied non-inferiority margin of 1.3.

Additional positive efficacy results from pooled analyses were observed in the areas of:

rate of kidney function decline, as measured by eGFR, as compared to placebo

quality of life, as measured by standard endpoints, as compared to placebo

efficacy in the presence of inflammation, as compared to epoetin alfa

FibroGen and AstraZeneca will begin discussions with the U.S. Food and Drug Administration (FDA) to prepare for regulatory submission of our New Drug Application (NDA), which is anticipated in September/October 2019, with the MAA for submission to the European Medicines Agency (EMA) to follow.

Roxadustat for Anemia in CKD in China

Completed clinical site inspections by the China Food and Drug Inspection division of the National Medical Products Administration (NMPA) for Phase 3 study evaluating roxadustat for treatment of anemia in non-dialysis-dependent CKD patients.

Anticipate NMPA approval decision on roxadustat for treatment of anemia in non-dialysis-dependent CKD mid-year 2019.

Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)

Completed enrollment of the open-label portion of our global multi-center Phase 3 study in transfusion-dependent, lower risk MDS patients.

Initiated patient dosing in the double-blind, placebo-controlled portion of this Phase 3 study.

Open-label portion of China Phase 2/3 MDS study is ongoing.

Pamrevlumab for Duchenne Muscular Dystrophy (DMD)

Received Orphan Drug Designation from the FDA for treatment of Duchenne muscular dystrophy.

Administrative analysis of the first year treatment in 21 non-ambulatory DMD patients shows favorable results in lung function, cardiac function, and muscle strength.

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

On track to initiate a randomized, double-blind, placebo-controlled Phase 3 clinical trial with a primary endpoint of change in forced vital capacity (FVC) from baseline in approximately 500 patients in Q2 2019.

Pamrevlumab for Pancreatic Cancer

On track to initiate a randomized, double-blind, placebo-controlled Phase 3 study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as a neoadjuvant therapy versus placebo in combination with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer (LAPC) in approximately 260 patients in Q2 2019.

Corporate and Financial

Net loss for the first quarter of 2019 was $45.4 million, or $0.53 net loss per basic and diluted share, compared to a net loss of $41.4 million, or $0.53 net loss per basic and diluted share one year ago.

At March 31, 2019, FibroGen had $712.7 million in cash, restricted time deposits, cash equivalents, investments, and receivables, compared to $747.2 million at year-end 2018.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Thursday, May 9, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen first quarter 2019 financial results conference call, and use passcode 48545313. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 48545313#.

About Roxadustat

Roxadustat (FG-4592), discovered by FibroGen, is a first-in-class, orally administered small molecule currently approved in China for the treatment of anemia in CKD patients on dialysis. Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, has been granted Orphan Drug Designation (ODD) in each of these indications. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and for patients with locally advanced unresectable pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On May 9, 2019 Allergan plc (NYSE: AGN) reported that Chief Financial Officer Matthew Walsh will participate in a fireside chat at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas, Nevada (Press release, Allergan, MAY 9, 2019, View Source(2) [SID1234536035]). The presentation will begin at 10:40 a.m. Pacific Time (1:40 p.m. Eastern Time) on Tuesday, May 14, 2019.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: https://www.veracast.com/webca…

An archived version will be available following the live presentation and can be accessed at the same location for 90 days.

On May 9, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights, anticipated upcoming milestones and financial results for the first quarter of 2019 (Press release, BeiGene, MAY 9, 2019, View Source [SID1234536052]).

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"We made good progress in each of our business areas, including strong commercial performance in the first quarter of 2019, as we prepare for our planned launches in China and first new drug application in the United States. Our team is continuing to expand across the globe, with new trials, new indications, and importantly, new hope for patients with cancer who may not have had access or options for treating their disease," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene.
Recent Business Highlights and Upcoming Milestones
Clinical Programs
Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects
Expected Milestones in 2019

Receive approvals in China for the treatment of patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL);

Submit an initial New Drug Application (NDA) for zanubrutinib in the U.S. in 2019 or early 2020;

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with Waldenström macroglobulinemia (WM) and submit an NDA in China for WM;

Achieve first patient dosing in a Phase 1b trial conducted by MEI Pharma of zanubrutinib in combination with ME-401, an investigational selective oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor;

Complete enrollment of the Phase 3 trial of zanubrutinib compared to bendamustine plus rituximab in patients with previously untreated CLL or SLL;

Present data from the non-randomized MYD88WT cohort of the Phase 3 trial in WM;

Announce top-line results from the randomized cohort of the Phase 3 trial comparing zanubrutinib to ibrutinib in patients with WM; and

Present updated data from the global Phase 1 trial in WM and MCL; pivotal data from the China Phase 2 trials in R/R MCL and R/R CLL/SLL; data from Phase 1 obinutuzumab combination data in CLL/SLL; updated data from the Phase 1 obinutuzumab combination trial in non-Hodgkin’s lymphoma (NHL); and updated data from the global Phase 1 trial in CLL/SLL.
Tislelizumab (BGB-A317), an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Announced Phase 1 long-term exposure data and results from the structural and mechanistic analyses at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2019; and

Initiated a Phase 3 front-line trial in China of tislelizumab combined with chemotherapy compared to placebo with chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.
Expected Milestones in 2019

Receive NDA approval in China for treatment of patients with R/R classical Hodgkin’s lymphoma (cHL);

Present preliminary results of tislelizumab in Chinese patients with nasopharyngeal cancer at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago May 31 – June 4;

Announce top-line results from the pivotal Phase 2 trial in Asian patients with urothelial carcinoma (UC) and file an NDA for UC in China;

Announce top-line results from the global Phase 2 trial in second- or third-line patients with hepatocellular carcinoma (HCC) and have regulatory discussions;

Present updated China pivotal Phase 2 data in R/R cHL; updated Phase 2 chemotherapy combination data; and Phase 1 data from China trials; and

Complete or nearly complete enrollment in all four ongoing Phase 3 trials in lung and liver cancers.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor
Expected Milestones in 2019

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in late 2019 or early 2020; and

Present data from the global Phase 1 trial in patients with ovarian cancer and Phase 1 combination data in patients with solid tumors or glioblastoma multiforme.
Lifirafenib (BGB-283), an investigational RAF dimer inhibitor

In collaboration with SpringWorks Therapeutics, Inc., initiated a Phase 1b combination trial of lifirafenib in combination with PD-0325901, an investigational MEK inhibitor in patients with advanced or refractory solid tumors that harbor RAS mutations, RAF mutations, and other MAPK pathway aberrations.
Manufacturing Facilities

Substantially completed equipment installation and validation of GE Healthcare’s KUBioTM technology-based biologics manufacturing facility in Guangzhou, China.
Commercial Operations

Generated $57.42 million in product revenue in the three months ended March 31, 2019, from sales in China of ABRAXANE, REVLIMID and VIDAZA, which represents a 147% increase compared to the same period in 2018 and a 52% sequential growth compared to the previous quarter; and

Received supplementary medical insurance coverage for REVLIMID from Zhuhai, Guangdong province, China.
Corporate Developments

Announced a global collaboration agreement with BioAtla, LLC, for the development, manufacturing, and commercialization of BioAtla’s investigational Conditionally Active Biologic (CAB) CTLA-4 antibody (BA3071). BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors. Subject to regulatory clearance of the Investigational New Drug (IND) application, a Phase 1/2 multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BA3071 alone and in combination with tislelizumab is anticipated to start in the second half of 2019; and

Announced a global research and development collaboration with Ambrx, Inc. to develop next-generation biologics utilizing Ambrx’s proprietary Expanded Genetic Code technology platforms designed to allow the efficient incorporation of non-natural amino acids into proteins in both E. Coli (ReCODETM) and CHO cells (EuCODETM) for precision protein engineering.
First Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $1.64 billion as of March 31, 2019, compared to $1.81 billion as of December 31, 2018.

The decrease of $171.67 million in the first quarter of 2019 was primarily due to $171.98 million of cash used in operating activities, $29.00 million of upfront payments made under collaboration agreements, and $21.83 million for investments in property, plant and equipment primarily attributable to the build-out of the Guangzhou biologic

manufacturing facility. The decrease was partially offset by $36.70 million in proceeds from an additional drawdown under our Guangzhou factory loan.
Revenue for the first quarter ended March 31, 2019 was $77.83 million, compared to $32.54 million in the same period in 2018. The increase is attributable to increased product revenue in China and collaboration revenue under our license and collaboration agreements with Celgene.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $57.42 million for the first quarter ended March 31, 2019, compared to $23.25 million for the same period in 2018.

Collaboration revenue totaled $20.41 million for the first quarter ended March 31, 2019, compared to $9.29 million for the same period in 2018.
Expenses for the first quarter ended March 31, 2019 were $251.59 million, compared to $143.35 million in the same period in 2018.

Cost of Sales for the first quarter ended March 31, 2019 were $15.26 million, compared to $4.55 million in the same period in 2018. Cost of sales related to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the first quarter ended March 31, 2019 were $178.35 million, compared to $109.70 million in the same period in 2018. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions and commercial launch of our late-stage drug candidates, and manufacturing costs related to pre-commercial activities and supply. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $15.77 million for the first quarter ended March 31, 2019, compared to $12.05 million for the same period in 2018, due to increased headcount.

SG&A Expenses for the first quarter ended March 31, 2019 were $57.65 million, compared to $28.92 million in the same period in 2018. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $10.62 million for the first quarter ended March 31, 2019, compared to $5.34 million for the same period in 2018, due to increased headcount.

Net Loss for the first quarter ended March 31, 2019 was $167.64 million, or $0.22 per share, or $2.81 per American Depositary Share (ADS), compared to $104.60 million, or $0.16 per share, or $2.03 per ADS in the same period in 2018.