On November 7, 2019 Bicycle Therapeutics plc (NASDAQ:BCYC), a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported financial results for the third quarter ended September 30, 2019 and discussed recent corporate updates (Press release, Bicycle Therapeutics, NOV 7, 2019, View Source [SID1234550656]).

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"The significant progress we have made in the past few months is instrumental to our goal of advancing our novel pipeline of Bicycle drug candidates through the clinic," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We’ve bolstered all three areas of the pipeline, namely, our wholly-owned Bicycle Toxin Conjugate and immuno-oncology programs, as well as our collaborations to develop new Bicycle-based therapies for indications beyond oncology. We have also continued to strengthen our leadership team both at the corporate and Board levels. These efforts further position the Company to evaluate the potential of Bicycles to enable possible first-in-class medicines that transform the treatment paradigm for people living with a broad range of serious diseases, in ways that existing modalities cannot."

Third Quarter 2019 and Recent Highlights

Presenting New Preclinical Data for Novel, Fully Synthetic Bicycle Tumor-targeted Immune Cell Agonists (TICAs) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. This week, Bicycle is presenting new data showing that its lead immuno-oncology candidate, BT7480, a TICA targeting Nectin-4 and agonizing CD137, rapidly penetrates tumors and effects powerful anti-tumor activity in preclinical models. In addition to data on BT7480, the Company will present preclinical research at SITC (Free SITC Whitepaper) on other emergent Bicycle TICA strategies. Details of the Company’s poster presentations on Saturday, November 9, 2019 can be found in the News section of bicycletherapeutics.com.
Enhanced Executive Team and Board of Directors. In October 2019, Bicycle announced the appointment of Nigel Crockett, Ph.D., as Chief Business Officer and of Veronica Jordan, Ph.D., to the Company’s Board of Directors.
Expanded Neuroscience Collaborations to Include Oxford University’s Oxford Drug Discovery Institute (ODDI). Bicycle announced that it will collaborate with ODDI to use Bicycle technology for the development of novel therapeutics for dementia. This expands upon the collaboration announced in May 2019 between Bicycle and the Dementia Discovery Fund (DDF), a specialized venture capital fund focused on discovering and developing novel therapies for dementia. If promising lead compounds are identified, Bicycle will have rights to the development of the resulting intellectual property and, with DDF, will have the option to jointly establish a new company to develop those compounds.
Presented New Translational Data for Lead Asset BT1718 and Preclinical Data for Other Bicycle Toxin Conjugates at AACR (Free AACR Whitepaper)-NCI-EORTC 2019. Bicycle presented new translational data for BT1718 and preclinical data for BT5528 and BT8009 during poster sessions at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The translational data for BT1718 characterize enrollment criteria for identifying expansion cohorts in the Phase IIa part of the ongoing Phase I/IIa trial.
Presented Updated Data from Phase I/IIa Trial Evaluating BT1718 in Patients with Advanced Solid Tumors at ESMO (Free ESMO Whitepaper) 2019 Annual Congress. Bicycle and Cancer Research UK presented updated data from the ongoing Phase I portion of the Phase I/IIa trial evaluating BT1718 in patients with advanced solid tumors. As of August 7, 2019, 54% of evaluable patients dosed had stable disease at the eight-week timepoint, including a patient who experienced a 45% reduction in a target lesion, and BT1718 appeared tolerable with once-weekly dosing.
Upcoming Investor Presentations

Bicycle will present at the following investor conferences in the fourth quarter of 2019:

Jefferies London Healthcare Conference on Wednesday, November 20, 2019 at 2:40 p.m. GMT (9:40 a.m. ET) in London, England
Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 3:30 p.m. ET in New York, NY
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.

Financial Results

Cash was $96.0 million as of September 30, 2019, compared with $63.4 million as of December 31, 2018. The September 30, 2019 cash balance excludes a UK research and development incentive payment of approximately $6.0 million received in October 2019.
Research and development expenses were $6.1 million for the three months ended September 30, 2019, compared to $5.6 million for the three months ended September 30, 2018. The increase of $0.4 million is primarily due to $0.3 million of incremental non-cash share-based compensation expense, as well as other personnel related costs.
General and administrative expenses were $4.8 million for the three months ended September 30, 2019, compared to $2.3 million for the three months ended September 30, 2018. The increase of $2.5 million is primarily due to a $0.9 million unfavorable effect of foreign exchange rates, $0.7 million in personnel related costs, including $0.3 million of incremental non-cash share-based compensation expense, as well as increased professional fees related to operations as a public company.
Net loss was $9.5 million, or $(0.53) basic and diluted net loss per share, for the three months ended September 30, 2019, compared to net loss of $7.7 million, or $(17.73) basic and diluted net loss per share, for the quarter ended September 30, 2018.

On November 7, 2019 Triumvira Immunologics, Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, reported that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after at least 2 prior systemic therapies (Press release, Triumvira Immunologics, NOV 7, 2019, View Source [SID1234550655]). A Phase 1/2 study (TACTIC-19) conducted in patients with CD19-positive B-cell malignancies, including DLBCL, is expected to be initiated by the end of 2019.

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"FDA’s decision to grant Fast Track designation to TAC01-CD19 is an important recognition of both Triumvira’s differentiated cell therapy technology and the critical need to develop new therapies to address the unmet medical need in the treatment of B-cell lymphomas," commented Paul Lammers, MD, MSc., President and CEO of Triumvira. "With our innovative TAC technology, we hope to significantly improve upon the limitations of existing cell therapies, including the risk of cytokine release syndrome (CRS) and neurotoxicity, which would allow us to expand the number of patients eligible to receive this type of treatment."

TAC01-CD19 will be tested at four leading lymphoma clinical study centers in the U.S. and Canada. Based on its preclinical profile, TAC01-CD19 has the potential to represent a significant advancement in T-cell therapy.

About TAC01-CD19

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T-Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T-Cell Antigen Coupler (TAC) receptor which is structurally and biologically distinct from CAR-T. The first of our pipeline product candidates, TAC01-CD19 is a novel T-cell therapy product targeting CD19, a validated target in lymphomas and leukemias. The product comprises patient-derived T-cells that have been genetically engineered to express the CD19 T-cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.

About CD19 and Diffuse Large B-Cell Lymphoma (DLBCL)

CD19 is a B-cell marker and is expressed on the surface of B-cell malignancies such as Diffuse Large B-Cell Lymphoma (DLBCL). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL impacted approximately 26,000 patients in the U.S. in 2018. While the objective response rates of 50 – 70% observed for treatment of large B-cell lymphomas with currently marketed patient-derived T-cell products are good, there still exists a significant percentage of patients who either do not benefit from treatment or who are not able to tolerate the serious toxicities associated with these products.

About U.S. FDA’s Fast Track Designation Program

The FDA’s Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address an unmet medical need. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) or Biologics License Application (BLA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.

On November 7, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its ADCETRIS (brentuximab vedotin) clinical development program at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla (Press release, Seattle Genetics, NOV 7, 2019, View Source [SID1234550654]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma (HL) and expressed on the surface of several types of peripheral T-cell lymphomas. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

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"At this year’s ASH (Free ASH Whitepaper) meeting, ADCETRIS will be featured in 15 data presentations, including updated analyses from ECHELON-1 and ECHELON-2 phase 3 frontline trials," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are encouraged by the ECHELON-1 update supporting a sustained progression-free survival benefit for ADCETRIS in combination with AVD when compared to ABVD in advanced classical Hodgkin lymphoma and additional analyses from trials evaluating ADCETRIS in combination with nivolumab. We continue to invest in our ADCETRIS clinical development program with the goal of improving outcomes for patients."

Details of oral presentations featured at ASH (Free ASH Whitepaper) include:

Safety and Efficacy of Brentuximab Vedotin in Combination with AVD in Stage II-IV HIV-Associated Classical Hodgkin Lymphoma: Results of the Phase 2 Study, AMC 085
Abstract: 130
Presenter: P. Rubinstein, Rush University Medical Center, Chicago, Ill.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:15 a.m. ET
Location: Tangerine 2 (WF2)

Brentuximab Vedotin in First Refractory/Relapsed Classical Hodgkin Lymphoma Patients Treated By Chemotherapy (ICE) before Autologous Transplantation. Final Analysis of Phase II Study
Abstract: 132
Presenter: A. Stamatoullas, Departement d’Hematologie, Centre Henry Becquerel, Rouen, France
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:45 a.m. ET
Location: Tangerine (WF2)

Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥ 60 Years
Abstract: 237
Presenter: C. Yasenchak, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, Ore.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:30 p.m. ET
Location: W224

Brentuximab Vedotin and Nivolumab for Relapsed or Refractory Classical Hodgkin Lymphoma: Long-term Follow-up Results from the Single-arm Phase 1/2 Study
Abstract: 238
Presenter: A. Moskowitz, Memorial Sloan Kettering Cancer Center, New York, N.Y.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:45 p.m. ET
Location: W224

A Phase I/II Trial of Brentuximab Vedotin (BV) Plus Rituximab (R) as Frontline Therapy for Patients with Immunosuppression-Associated CD30+ and/or EBV+ Lymphomas
Abstract: 351
Presenter: W. Pearse, Loyola University Medical Center, Maywood, Ill.
Session: Oral presentation Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Optimizing Frontline Chemotherapy
Date and Time: Sunday, December 8, 8:00 a.m. ET
Location: Hall E2

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant
Abstract: 464
Presenter: K. Savage, British Columbia Cancer Centre for Lymphoid Cancer, University of British Columbia and the Department of Medical Oncology, Vancouver, B.C., Canada
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Novel Therapies in Peripheral T-cell Lymphomas
Date and Time: Sunday, December 8, 12:15 p.m. ET
Location: Valencia D (W415D)

Details of company-sponsored presentations are as follows:

Patterns of Care and Clinical Outcomes in Peripheral T-Cell Lymphoma Patients Receiving First-Line Treatment in Routine Clinical Practice in France and the United Kingdom
Abstract: 3482
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Real-World Treatment Patterns and Overall Survival Among Medicare Fee-for-Service Beneficiaries Newly Diagnosed with Peripheral T-Cell Lymphoma (PTCL)
Abstract: 3492
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin with Chemotherapy for Stage III/IV Classical Hodgkin Lymphoma (cHL): Four-Year Update of the ECHELON-1 Study
Abstract: 4026
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of select investigator-sponsored presentations are as follows:

Long-Term Follow-up Confirms Durability of Single-Agent Brentuximab Vedotin as Pre-Transplant Salvage for Hodgkin Lymphoma
Abstract: 1555
Session: Poster Presentation
Date and Time: Saturday, December 7, 5:30-7:30 p.m. ET
Location: Hall B

A Pilot Study of Brentuximab Vedotin Combined with AVD Chemotherapy and Radiotherapy in Patients with Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Abstract: 2834
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Preliminary Results from a Phase 2 Trial of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients with CD30-Expressing Peripheral T-cell Lymphomas
Abstract: 4023
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of company-sponsored trials in progress are as follows:

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma
Abstract: 2836
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Adults Age 60 and Above
Abstract: 2852
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

A Phase 2 Study of Retreatment with Brentuximab Vedotin in Patients with cHL, sALCL or other CD30 Expressing PTCL
Abstract: 4054
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

On November 7, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will host an R&D event in New York on Tuesday, November 19, 2019 from 12:00 – 3:30 PM EST (Press release, Pieris Pharmaceuticals, NOV 7, 2019, View Source [SID1234550653]).

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The R&D event will feature presentations from management and thought leaders in immuno-oncology and respiratory diseases, including:

Michael A. Curran, PhD, Associate Professor, Department of Immunology and Scientific Director, ORBIT Platform, The UT MD Anderson Cancer Center
Geoffrey Y. Ku, MD, Assistant Attending Physician and Head, Esophagogastric Section, Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering
Anuradha Ray, PhD, Professor of Medicine, Department of Immunology and UPMC Endowed Chair in Lung Immunology Medicine, University of Pittsburgh
Sally E. Wenzel, MD, Professor of Medicine, Department of Medicine; Chair, Department of Occupational & Environmental Health; Acting Director, Asthma Environmental Lung Health Institute and UPMC Endowed Chair of Translational Airway Biology, University of Pittsburgh
Presentations will include expert discussant perspectives on recently presented data for PRS-343 and PRS-060, emerging data from the ongoing PRS-343 combination trial with atezolizumab, and perspectives on how these drug candidates could best fit into the emerging landscapes of asthma and immuno-oncology.

The event will be accessible via a live webcast through this link beginning at 12:30 PM EST on November 19, 2019.

In-person attendance is by invitation only. For more information, please contact [email protected].

On November 7, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the third quarter of 2019 and recent business highlights (Press release, Atara Biotherapeutics, NOV 7, 2019, View Source [SID1234550652]).

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"I am pleased with our recent clinical, operational and strategic progress," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "Following a comprehensive strategic portfolio review, we will focus our resources going forward on innovative off-the-shelf, allogeneic T-cell immunotherapy programs, specifically tab-cel, ATA188, ATA2271/ATA3271 and ATA3219. In parallel, we will continue to leverage the capabilities and expertise of external partners for development of autologous CAR T immunotherapies."

Following a six-month assessment of patients with progressive multiple sclerosis (MS) enrolled in cohort 3 of an ATA188 Phase 1a study, Atara selected this cohort 3 dose to initiate the randomized, double-blind, placebo-controlled Phase 1b part of this study.

"We are encouraged by the safety profile and early findings of potential efficacy for people living with progressive MS, as shown in our Phase 1a study data presented at ECTRIMS in September," said AJ Joshi, MD, Senior Vice President and Chief Medical Officer of Atara Biotherapeutics. "The decision to initiate the Phase 1b was based on achieving in cohort 3 our pre-determined criteria of a continued well-tolerated safety profile and at least 50 percent of patients achieving clinical improvement from more than one clinical study site using the criteria we defined at ECTRIMS. Recognizing these are early data, and incorporating input from external experts, we believe these results merit the acceleration of ATA188 development for progressive MS patients who have limited treatment options and in whom continual clinical decline is expected."

Recent Highlights and Anticipated Upcoming Milestones

61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Announced four abstracts highlighting robust off-the-shelf, allogeneic T-cell immunotherapy pipeline and next-generation CAR T technologies to be presented at the 61st ASH (Free ASH Whitepaper) Annual Meeting, December 7-10, 2019 in Orlando, Florida
Among these data are tab-cel long-term clinical outcomes from a multicenter expanded access protocol (EAP) study for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)
— 26 relapsed/refractory EBV+ PTLD patients were treated in a multicenter tab-cel EAP study including a subgroup of 22 patients who would have likely met eligibility criteria for Atara’s ongoing tab-cel Phase 3 studies
— An overall response rate (ORR) of 55 and 82 percent was observed in this subgroup of patients with EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) and solid organ transplant (SOT), respectively
— Estimated 2-year overall survival (OS) in this subgroup was 79 and 81 percent for HCT and SOT, respectively
Atara will present additional findings describing the hospitalization burden of patients with EBV+ PTLD
Atara’s Moffitt Cancer Center collaborators to present two abstracts detailing next-generation CAR T technologies
Tab-cel (tabelecleucel)

Atara continues to progress tab-cel Phase 3 development for patients with EBV+ PTLD
— Atara remains on track to initiate a tab-cel biologics license application (BLA) submission for patients with EBV+ PTLD in the second half of 2020
— In the U.S. and Australia, 35 sites are available for enrollment and the company is preparing to open additional sites in the U.S. and Canada
— Atara plans to submit a clinical trial application (CTA) to several European countries by the end of 2019 to enable opening EU clinical sites next year
Atara continues to see strong tab-cel investigator, physician and patient interest, and in cases where the company is not able to enroll patients in its EBV+ PTLD Phase 3 clinical studies, Atara is providing tab-cel to patients in need under its early access and single patient use programs
Atara is in discussions with the European Medicines Agency (EMA) and the outcome of these discussions will determine the timing of the tab-cel EU conditional marketing authorization (CMA) application for patients with EBV+ PTLD
Studies supporting potential additional tab-cel indications are also advancing
— A Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) is currently enrolling
— Atara expects to initiate enrollment in a Phase 2 multi-cohort study including patients with other EBV+ cancers in the second half of 2020
ATA188 for Multiple Sclerosis (MS)

Following a six-month assessment of patients with progressive MS enrolled in cohort 3 of an ATA188 Phase 1a study, Atara selected this dose to initiate the randomized, double-blind, placebo-controlled Phase 1b part of this study
In September, Atara presented safety and early findings of potential efficacy from a Phase 1a study of ATA188 in patients with progressive MS at the 35thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
— Completed enrollment in the fourth and final planned Phase 1 dose escalation cohort
— Atara expects to present additional efficacy and safety results from this study in 2020, including six and twelve-month assessments from cohorts 3 and 4
— Safety results showed across the 4 planned dose cohorts, ATA188 was well tolerated in patients with progressive forms of MS with no evidence of cytokine release syndrome, graft versus host disease or dose-limiting toxicities
Atara will not initiate a randomized study of autologous ATA190 in progressive MS at this time and will evaluate strategic options for this program
— Atara’s ATA190 portfolio decision is based on continued encouraging ATA188 results, acceleration of the ATA188 randomized Phase 1b study and the Company’s strategic focus on off-the-shelf, allogeneic T-cell immunotherapies
ATA2271/ATA3271 and ATA3219 CAR T Programs

Atara is developing a mesothelin-targeted autologous CAR T (ATA2271) for patients with advanced mesothelioma with an IND planned in 2020
— ATA2271 is designed using a novel 1XX CAR co-stimulatory domain and PD-1 dominant negative receptor (DNR) intrinsic checkpoint inhibition technology
Atara is also developing off-the-shelf, allogeneic CAR T immunotherapies targeting mesothelin (ATA3271) and CD19 (ATA3219) using its next generation technologies and EBV T cell platform
Operational

Facility commissioning and qualification activities to support clinical development at ATOM (Atara T-cell Operations and Manufacturing) are complete
— Commercial production qualification activities are progressing well and, together with our contracted manufacturing partner, are aligned with our planned commercial strategy
The Company is focused on aligning the current leadership to the Company’s new strategic priorities and actively searching for a new Global Head of Research and Development, Head of Commercial and General Counsel
Third Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments as of September 30, 2019 totaled $282.9 million, which includes $140.7 million in net proceeds from an underwritten public offering completed in July 2019
The Company believes that its current cash, cash equivalents and short-term investments are sufficient to fund planned operations into 2021
The Company reported a net loss of $71.9 million, or $1.31 per share, for the third quarter of 2019 as compared to $58.4 million, or $1.29 per share, for the same period in 2018
Total operating expenses include non-cash stock-based compensation and depreciation and amortization expenses of $13.9 million for the third quarter of 2019 as compared to $10.4 million for the same period in 2018
Research and development expenses were $53.5 million for the third quarter of 2019 as compared to $43.4 million for the same period in 2018. The increase in the third quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
— Clinical study, manufacturing and outside service costs related to our MS programs
— Research and process development costs related to our CAR T programs
— Higher employee-related and overhead costs from increased headcount and operations
Research and development expenses include $7.0 million of non-cash stock-based compensation expense for the third quarter of 2019 as compared to $4.7 million for the same period in 2018
General and administrative expenses were $19.0 million for the third quarter of 2019 as compared to $16.9 million for the same period in 2018. The increase in the third quarter of 2019 was primarily due to increases in employee-related costs driven by increased headcount to support the Company’s expanding operations
General and administrative expenses include $5.1 million of non-cash stock-based compensation expense for the third quarter of 2019 as compared to $4.6 million for the same period in 2018
Conference Call and Webcast Information

Atara will host a live conference call and webcast today at 8:00 a.m. EST to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 6069034. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.