Checkpoint Therapeutics Reports First Quarter 2019 Financial Results and Recent Corporate Highlights

On May 9, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the first quarter ended March 31, 2019 (Press release, Checkpoint Therapeutics, MAY 9, 2019, View Source [SID1234536065]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to make substantial progress with our lead clinical programs, both of which have recently produced data demonstrating unequivocal activity in patients with multiple forms of cancer, including lung cancer and skin cancer. We presented data late last year in an oral presentation at the World Conference on Lung Cancer demonstrating that CK-101, our novel, oral, third-generation EGFR inhibitor, was active in patients with treatment-naïve and relapsed/refractory EGFR mutation-positive lung cancer. EGFR mutation-positive lung cancer represents approximately 20% of the 228,000 newly-diagnosed lung cancer patients in the US, and there is currently only one third-generation EGFR inhibitor approved for these patients. Our plan is to commence a phase 3 trial in first-line EGFR mutation-positive non-small cell lung cancer later this year."

Mr. Oliviero continued, "We are also excited by our progress with our anti-PD-L1 program. We announced earlier this year that we advanced cosibelimab ("cosi", formerly CK-301), our high affinity, fully-human anti-PD-L1 antibody, into potentially pivotal cohorts in several solid tumor indications. This was supported by the positive interim clinical results we announced earlier this month showing anti-tumor activity across multiple advanced cancers. We believe the early data for cosi are very exciting and may show differentiation from other drugs in this class as a result of cosi’s dual mechanism of action through the engagement of both T-cells and NK cells."

Financial Results:

Cash Position: As of March 31, 2019, Checkpoint’s cash and cash equivalents totaled $14.1 million. The Company believes its cash and cash equivalents and projected licensing revenue will be sufficient to fund its anticipated operating cash requirements for at least 12 months.
R&D Expenses: Research and development expenses for the first quarter of 2019 were $4.6 million, compared to $6.9 million for the first quarter of 2018, a decrease of $2.3 million. Research and development expenses for the first quarter of 2019 included $0.2 million of non-cash stock expenses, compared to $0.7 million for the first quarter of 2018. The Company expects research and development expenses throughout the rest of 2019 to continue to remain lower than the comparable periods in 2018.
G&A Expenses: General and administrative expenses for the first quarter of 2019 were $1.7 million, compared to $2.2 million for the first quarter of 2018, a decrease of $0.5 million. General and administrative expenses for the first quarter of 2019 included $0.6 million of non-cash stock expenses, compared to $1.1 million for the first quarter of 2018.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2019 was $5.9 million, or $0.18 per share, compared to a net loss of $8.8 million, or $0.35 per share, for the first quarter of 2018. The net loss for the first quarter of 2019 included $0.8 million of non-cash stock expenses, compared to $1.8 million for the first quarter of 2018.
Recent Corporate Highlights:

In January 2019, Checkpoint announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody cosibelimab was expanded to enroll patients in three endometrial and colorectal cohorts intended to support potential requests for accelerated approval and Biologics License Application ("BLA") submissions to the U.S. Food and Drug Administration ("FDA"). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer ("NSCLC") and cutaneous squamous cell carcinoma.
In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.
In May 2019, Checkpoint announced positive interim safety and efficacy data from its ongoing multicenter Phase 1 clinical trial of cosibelimab. Cosibelimab is a high affinity, fully-human IgG1 monoclonal antibody that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab is potentially differentiated from currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% tumor target occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types. Cosibelimab appeared to be safe and well-tolerated with no dose-limiting toxicities. Objective responses and target lesion reductions were observed across diverse tumor types, particularly in NSCLC and cutaneous squamous cell carcinoma.

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2019 Financial Results

On May 9, 2019 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the first quarter ended March 31, 2019 (Press release, Corvus Pharmaceuticals, MAY 9, 2019, View Source [SID1234536064]).

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"With the initiation of patient enrollment in our Phase1/1b trial of CPI-818, Corvus now has three agents with novel mechanisms of action in clinical trials for a wide range of cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Looking forward, we have several important milestones for each of our programs in 2019."

"For the adenosine pathway, we continue to be in a leadership position with ciforadenant (CPI-444), our small molecule inhibitor of the A2A receptor, and CPI-006, our anti-CD73 antibody. We are enrolling patients in two ciforadenant Phase 1b/2 trials and we have discovered a potentially predictive genetic biomarker, the Adenosine Signature, that may provide clinicians with the ability to select patients most likely to benefit from therapy. This positions us to potentially initiate a molecularly defined, late stage study of ciforadenant in patients with renal cell cancer around the end of the year. For CPI-006, the initial clinical data from both the monotherapy and combination arms of our Phase 1/1b clinical trial will be presented in an oral presentation at the ASCO (Free ASCO Whitepaper) annual meeting in June. In addition, we expect incremental data updates on these programs at major medical meetings over the course of the year."

"Turning to CPI-818, we are very excited to be investigating it in patients with T-cell lymphomas, a patient group that often has limited treatment options and poor clinical outcomes," continued Dr. Miller. "We believe that CPI-818 represents a novel approach for these patients and the Phase 1/1b study is designed to evaluate both anti-tumor activity and its effect on normal T-cells, which could provide valuable information for future trials of CPI-818 in other types of cancer and autoimmune diseases. We currently anticipate that initial data from the study will be presented in late 2019, providing another potential catalyst for the Company."

CPI-818, an oral, covalent, selective interleukin-2-inducible kinase (ITK) inhibitor, is based on a similar targeting strategy to that of Bruton’s tyrosine kinase (BTK) inhibitors. Key members of the scientific team at Corvus led the development of the first BTK inhibitor, ibrutinib, which is approved for the treatment of several types of B-cell lymphomas. ITK, the T-cell homologue of BTK, has many biochemical and functional similarities with BTK. T-cell lymphomas are often incurable, especially after relapse. As ITK is frequently overexpressed in T-cell lymphoma, we believe the selective inhibition of ITK may represent a new treatment strategy for this type of cancer, possibly analogous to the effects of BTK inhibition with ibrutinib in B-cell lymphomas. Unlike other ITK inhibitors, the selectivity of CPI-818 has been shown in preclinical studies to shift immune responses to a T-cytotoxic type 1 (Th1) phenotype. We believe CPI-818 has the potential to display a dual mechanism of action: direct cytotoxicity to T-cell lymphoma and enhancement of the immune system by increasing the Th1 immune response.

Recent Achievements
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Continued enrolling patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The RCC patients in the trial have failed treatments with anti-PD-(L)1 antibodies and tyrosine kinase inhibitors.
Continued enrollment of up to 65 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating ciforadenant and Tecentriq in patients who have failed no more than two prior regimens.
Presented updated data on the Adenosine Gene Signature (AdenoSig) highlighting its potential to enable patient selection for treatment with ciforadenant based on a molecularly defined gene signature, that may predict which patients may be more responsive to the adenosine blockade.
CPI-006: Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either ciforadenant or pembrolizumab. The trial is currently enrolling patients in the dose escalation phase for CPI-006 administered as a monotherapy and in combination with ciforadenant.
Initial clinical data from the Phase 1/1b study will be delivered in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. This will build upon data presented in February that demonstrated early signs of immunologic activity across multiple pathways that may be important in cancer therapy.
CPI-818: A small molecule ITK inhibitor

Initiated enrollment of CPI-818, an ITK inhibitor, in a Phase 1/1b study in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others.
Presented preclinical and biochemical studies with CPI-818 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in March highlighting the selectivity and immunologic activity of CPI-818 and its anti-tumor activity in spontaneous canine T-cell lymphoma.
Financial Results

At March 31, 2019, Corvus had cash, cash equivalents and marketable securities totaling $105.8 million, as compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018.

Research and development expenses for the three months ended March 31, 2019 totaled $9.4 million compared to $12.1 million for the same period in 2018. The decrease of $2.7 million was primarily due to a decrease in ciforadenant program costs.

The net loss for the three months ended March 31, 2019 was $11.6 million, compared to a net loss of $14.3 million for the same period in 2018. Total stock compensation expense for the three months ended March 31, 2019 was $2.0 million compared to $1.8 million of total stock compensation expense for the same period in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, May 9, 2019, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2019 financial results. The conference call can be accessed by dialing 1-800-479-1004 (toll-free domestic) or 1-720-543-0206 (international) and using the conference ID 5606517. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

Kitov to Present Clinical Development Plan for Oncology Candidate NT-219 at the
18th MIXiii-BIOMED Conference

On May 9, 2019 Kitov Pharma Ltd. (the "Company" or "Kitov") (NASDAQ/TASE: KTOV), a pharmaceutical company focused on advancing first-in-class combination oncology therapies to overcome tumor drug resistance, increase treatment response rate, and slow tumor progression, reported that its CEO, Isaac Israel, will present at 18th MIXiii-BIOMED Conference and Exhibition, the leading annual international healthcare industry meeting in Israel, to be held on May 14-16, 2019 in Tel Aviv, Israel (Press release, Kitov Pharmaceuticals , MAY 9, 2019, View Source [SID1234536063]). The oral presentation will give an overview of Kitov’s clinical development plans for its oncology candidate NT-219, including disclosing its first indication for a phase 1/2 clinical trial and trial design.

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NT-219 is a first-in-class small molecule dual inhibitor of STAT3 and IRS1/2, with the potential to prevent and overcome drug resistance in various cancer types when used in combination with existing agents.

Presentation Details:

Title: "NT-219, a First-in-class Dual Inhibitor of STAT3 and IRS1/2 is Overcoming Drug Resistance"
Session: Transformative Cancer Therapies
Presenter: Isaac Israel, chief executive officer
Date: Thursday, May 16, 2019
Time: 1:05-1:20 p.m. IST
Location: Hall A, David Intercontinental Hotel

About the MIXiii Biomed Conference

MIXiii-Biomed Conference and Exhibition is the leading annual international healthcare industry meeting in Israel. The conference serves as a meeting point for local and multinational companies, investors, technology transfer experts, university, research scientists, and government representatives. This year, the focus of the conference is expanding to the full spectrum of healthcare: from prevention to rehabilitation and everything in between. Presentations will address diagnosis, monitoring, and treatment domains, and will explore trends and innovations that are shaping the future of the healthcare system to its full extent. Fields to be included are gene editing and gene therapy, transforming medicine, personalized medicine and digital health, transformative cancer therapies, prevention and rehabilitation, new modalities of cell therapies, disruptive and advanced medical devices, and cannabis therapeutics. 18th MIXiii-Biomed will take place May 14-16, 2019, at the David Intercontinental Hotel in Tel Aviv. More information can be found at View Source

Harpoon Therapeutics Reports First Quarter 2019 Financial Results and Provides Corporate Update

On May 9, 2019 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, MAY 9, 2019, View Source [SID1234536062]).

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"Harpoon has continued to progress in 2019, both in the clinic and in its development as a company. We are pleased to now have two T cell engagers in the clinic, with dosing of the first patient with our second product candidate HPN536 in April. We continue to develop additional candidates, with IND submissions expected this year and next," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We believe TriTACs provide unique benefits in the exciting field of T cell engagers and we look forward to achieving a number of development milestones in 2019 across the TriTAC platform, including presentation of a maturing HPN424 dataset by the end of this year at a medical conference."

First Quarter 2019 Business Highlights and Other Recent Developments

In February, Harpoon successfully completed its initial public offering, raising net proceeds of approximately $71 million.

In March, Harpoon designated its fourth Tri-specific T cell Activating Construct (TriTAC) in development, HPN328, for the treatment of small cell lung cancer (SCLC). HPN328 targets delta-like 3 (DLL3), a protein highly expressed in a majority of SCLC tumors, but not in normal tissue. This selective expression makes DLL3 an attractive drug target for T cell engagers. Harpoon is currently conducting IND-enabling studies and expects to initiate a Phase 1 clinical trial of HPN328 in 2020.

In April, Harpoon dosed the first patient with HPN536, a mesothelin-targeting T cell engager, in a Phase 1/2a clinical trial for ovarian and other mesothelin-expressing solid tumors. This represents the second TriTAC that Harpoon has brought into the clinic. The study consists of two phases, an initial dose escalation phase of approximately 20 ovarian cancer patients followed by an expansion phase of up to three additional parallel cohorts of 20 patients each with ovarian, pancreatic and mesothelioma cancer. The study is designed to evaluate the safety, tolerability, pharmacokinetics and activity of HPN536. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT03872206.

Anticipated Milestones

Harpoon plans to have three TriTAC product candidates in the clinic by the end of 2019, with a fourth expected in 2020. All of Harpoon’s anticipated milestones for 2019 remain on track, as follows:

HPN424 – present additional Phase 1 data in the second half of 2019 at a medical conference

HPN536 – initiated Phase 1/2a trial in April 2019

HPN217 – initiate Phase 1 trial in the second half of 2019

HPN328 – initiate Phase 1 trial in 2020

First Quarter Financial Results

Harpoon Therapeutics ended the first quarter of 2019 with $147.6 million in cash, cash equivalents, and marketable securities compared to $89.5 million as of December 31, 2018. The increase was due to approximately $71 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.

Net loss for the first quarter ended March 31, 2019 was $13.6 million compared to $4.9 million for the first quarter ended March 31, 2018.

Revenue for the first quarter of 2019 was $1.1 million compared to $1.6 million for the first quarter of 2018. The decrease was due to an upfront payment of $0.5 million recognized in the first quarter of 2018 related to our license agreement with Werewolf Therapeutics, Inc. During both periods, revenue primarily consisted of the amortized portion of the deferred $17.0 million upfront payment received in October 2017 under our collaboration agreement with AbbVie.

Research and development expense for the first quarter of 2019 was $9.4 million compared to $5.5 million for the first quarter of 2018. The increase primarily arose from clinical development expenses and an increase in personnel-related expenses, including conducting preclinical studies, continuation of the first clinical trial for lead product candidate, HPN424, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative expense for the first quarter of 2019 was $5.8 million compared to $1.0 million for the first quarter of 2018. The increase was primarily due to an increase in legal fees, consulting and accounting services related to our 2018 year-end audit, and an increase in headcount.

Atara Biotherapeutics Announces First Quarter 2019 Financial Results and Recent Operational Progress

On May 9, 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 first quarter of 2019 and recent operational highlights (Press release, Atara Biotherapeutics, MAY 9, 2019, View Source [SID1234536061]).

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"We have made important progress advancing our T-cell immunotherapy programs across our three major value drivers: tab-cel, multiple sclerosis and next-generation CAR T," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Discussions with EMA and FDA to align on a tab-cel global regulatory strategy for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease are progressing, with outcomes of these discussions expected in the first half of 2019. We are also looking forward to upcoming clinical milestones for our off-the-shelf, allogeneic ATA188 Phase 1 program in progressive multiple sclerosis with initial safety and efficacy results expected this year. In addition, recent clinical results presented by our MSK collaborators reaffirm mesothelin as a promising target for patients with advanced mesothelioma and establish an important proof-of-concept advance for CAR T immunotherapy in solid tumors."

Atara continues to progress tab-cel (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD), with enrollment proceeding slower than anticipated. The Company is in discussions with the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) regarding the development of tab‑cel and Atara’s intention is to align on a global regulatory strategy for patients with EBV+ PTLD. Atara now plans to submit a tab‑cel EU conditional marketing authorization (CMA) application based on initial Phase 3 results in 2020. To ensure the integrity of the ongoing, open-label tab-cel Phase 3 study, the Company anticipates disclosing initial top-line EBV+ PTLD results following acceptance of the EMA CMA application.

"Global regulators recognize the critical need of new therapies to treat patients with EBV+ PTLD," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "We look forward to our continued discussions with the FDA under Breakthrough Therapy Designation and EMA based on the Priority Medicines (PRIME) regulatory pathway to bring tab‑cel to patients with this often life-threating disease as expeditiously as possible."

The Company is also advancing an off-the-shelf, allogeneic ATA188 Phase 1 study in patients with progressive multiple sclerosis (MS). Initial safety results for this study are expected to be presented at the 5th Congress of the European Academy of Neurology (EAN) in June 2019. Additional safety and efficacy results from this study are expected to be presented at a scientific congress in the second half of 2019.

Atara’s collaborators at Memorial Sloan Kettering Cancer Center (MSK) reported positive Phase 1 clinical results for their mesothelin-targeted CAR T immunotherapy for patients with solid tumors at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. Efficacy and safety results were presented for patients with malignant pleural mesothelioma who may also have received pembrolizumab and lymphodepleting chemotherapy. Following administration of a novel mesothelin-targeted CAR T, MSK investigators observed a 72% response rate in a subset of these patients. Atara expects additional results from this study to be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Based on these encouraging results, Atara and MSK are advancing development of a next-generation, mesothelin-targeted CAR T immunotherapy using a novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies, with an IND expected in 2020.

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel for patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
In the United States and Australia, 32 sites are available for enrollment, with additional sites expected to open in the United States and other geographies.
2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Expect presentations highlighting tab-cel and next-generation CAR T immunotherapy technology to be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting to be held May 31 to June 4 in Chicago.
Oral Presentation: Regional delivery of mesothelin-targeted CAR T cells for pleural cancers: Safety and preliminary efficacy in combination with anti-PD-1 agent. Abstract 2511, S406, Tuesday, June 4, 2019, 8:36 a.m. – 8:48 a.m. CDT.
Poster Presentation: Correlation of circulating EBV-targeted cytotoxic T lymphocyte precursors (EBV-CTLp) and clinical response following tabelecleucel (tab-cel) infusion in patients with EBV-driven disease. Abstract 2532, Hall A, Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. CDT.
Poster Presentation: Tabelecleucel in combination with pembrolizumab (Pembro) in platinum-pretreated, recurrent/metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma (EBV+ NPC). Abstract TPS6092, Hall A, Saturday, June 1, 2019, 1:15 p.m. – 4:15 p.m. CDT.
ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Atara expects to present initial safety results from this study during at the 5th Congress of the European Academy of Neurology (EAN) to be held June 29 to July 2 in Oslo, Norway.
Additional safety and efficacy results from this study are expected to be presented at a scientific congress in the second half of 2019.
Expect to initiate a randomized study of autologous ATA190 in progressive MS patients during the second half of 2019.
Next-Generation CAR T

Positive Phase 1 clinical results for MSK’s mesothelin-targeted CAR T immunotherapy were recently presented by our MSK collaborators at the AACR (Free AACR Whitepaper) Annual Meeting 2019.
Encouraging safety results and anti-tumor responses observed in combination with a PD-1 checkpoint inhibitor, support Atara’s plans to progress development of a next-generation, mesothelin-targeted CAR T immunotherapy using MSK’s novel 1XX CAR signaling domain and PD-1 DNR checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.
Atara plans to prioritize mesothelin CAR T development and anticipates that this program will be the first CAR T program to enter the clinic, with an IND expected in 2020.
Additional results from ongoing MSK investigator-sponsored mesothelin-targeted CAR T studies are expected to be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
Corporate

Atara’s Board of Directors is conducting a search for a new Chief Executive Officer following Dr. Ciechanover’s transition plan announced in January. Dr. Ciechanover will remain in his role as President and CEO until the earlier of the appointment of his successor or June 30, 2019.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2019 totaled $237.5 million, which the Company believes will be sufficient to fund planned operations to mid-2020.
The Company reported net losses of $66.3 million, or $1.44 per share, for the first quarter of 2019 as compared to $41.4 million, or $1.05 per share, for the same period in 2018.
Total operating expenses include total non-cash expenses of $13.9 million for the first quarter of 2019 as compared to $7.3 million for the same period in 2018.
Research and development expenses were $48.7 million for the first quarter of 2019 as compared to $28.5 million for the same period in 2018. The increase in the first 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 tab-cel and the Phase 1 clinical study of off-the-shelf, allogeneic ATA188;
higher employee-related and overhead costs from increased headcount and operations, and
an increase in facilities and information technology expenses that are allocated to our research and development function.
Research and development expenses include $6.1 million of non-cash stock-based compensation expense for the first quarter of 2019 as compared to $2.9 million for the same period in 2018.
General and administrative expenses were $19.2 million for the first quarter of 2019 as compared to $14.0 million for the same period in 2018. The increase in the first quarter of 2019 was primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $6.2 million of non-cash stock-based compensation expense for the first quarter of 2019 as compared to $4.1 million for the same period in 2018.
Conference Call and Webcast Information
Atara will host a live conference call and webcast today at 8:30 a.m. EDT 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 1956289. 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.