On May 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 that its first quarter 2019 financial results will be released before the market opens on Thursday, May 9, 2019 (Press release, Atara Biotherapeutics, MAY 7, 2019, View Source [SID1234535884]). Following the release, the Company will host a live conference call and webcast at 8:30 a.m. EDT to discuss the Company’s financial results and recent operational highlights.

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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.

On May 7, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the first quarter of 2019 and associated Company developments (Press release, Supernus, MAY 7, 2019, View Source [SID1234535883]).

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Commercial Update

First quarter 2019 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 199,520, an 11.0% increase over the first quarter of 2018.

In the fourth quarter of 2018, wholesalers, distributors, and pharmacies increased their inventory holdings as compared to the prevailing inventory levels in the third quarter of 2018. As previously disclosed, the Company estimated that this caused net product sales to be approximately $10 million higher in the fourth quarter of 2018 than it would have been otherwise, had inventory levels remained consistent quarter to quarter.

This process was effectively reversed in the first quarter of 2019, with net product sales decreasing in the first quarter of 2019 by an estimated $10 million, as compared both to the prior year as well as the prior quarter.

In addition, net product sales were impacted by the growing prevalence of high deductible patient plans, their seasonal effect on first quarter prescription trends, and the seasonal increase in our use of copay assistance. Consequently, gross to net deductions were higher by approximately $4 million, as compared to the first quarter of 2018.

Progress of Product Pipeline

During its Investor Day held on April 16, 2019, the Company provided a product pipeline update as set forth below.

SPN-812 – Novel non-stimulant for the treatment of ADHD

During March 2019, the Company announced data from the fourth and final Phase III study for SPN-812 (P304) that confirm positive results from the previous three Phase III studies on SPN-812, announced in December 2018.
The Company continues to expect to submit a New Drug Application (NDA) for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration (FDA) approval, in the second half of 2020.
A Phase III program in adult patients is anticipated to start in the second half of 2019.
SPN-810 – Novel treatment of Impulsive Aggression in patients with ADHD

Enrollment in the Phase III trials (P301 and P302) continues with data from both trials expected in the second half of 2019.
The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch it, pending FDA approval, in the second half of 2021.
Enrollment in the open label extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10.5 months, which the Company believes is an encouraging sign of the tolerability and efficacy of SPN-810.
Patient dosing continues in the Phase III trial (P503) in adolescent patients.
SPN-604 – Novel treatment of bipolar disorder

The Company expects to start a pivotal Phase III program for the treatment of bipolar disorder in the fourth quarter of 2019.
Operating Expenses

Research and development expenses in the first quarter of 2019 were $15.4 million, as compared to $18.9 million in the same quarter last year. This decrease is due to the completion of the four Phase III clinical trials for SPN-812, three of which were completed in December 2018 and one completed in March 2019. The decrease was partially offset by the manufacture of validation and registration lots for SPN-812 to support the Company’s upcoming submission of its New Drug Application (NDA).

Selling, general and administrative expenses in the first quarter of 2019 were $41.0 million, as compared to $36.8 million in the same quarter last year. This increase was primarily due to the development and production of promotional materials and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR.

Operating Earnings and Earnings Per Share

Operating earnings in the first quarter of 2019 were $25.4 million, compared to $31.4 million in the same quarter last year. The decrease in operating earnings was primarily due to decreased net product sales. Excluding the negative impact to net product sales from the aforementioned inventory drawdown in the first quarter, operating earnings would have been approximately $9.5 million higher than in 2018.

Net earnings (GAAP) in the first quarter of 2019 were $18.3 million, or $0.34 per diluted share, compared to $26.4 million, or $0.49 per diluted share, in the same period last year. In addition to the impact of lower operating earnings for the first quarter of 2019, net earnings (GAAP) were subject to a higher effective tax rate in the first quarter of 2019 relative to the first quarter of 2018. The tax rate in the first quarter of 2018 benefited from stock option exercises.

Weighted-average diluted common shares outstanding were approximately 54.0 million in the first quarter of 2019, as compared to approximately 53.8 million in the prior year period.

"Our financial results for the first quarter were adversely impacted by several factors, converging all at once: the fourth quarter 2018 inventory buildup impacting shipments in first quarter 2019: first quarter seasonal insurance plan dynamics putting pressure on prescription growth coupled with increased gross-to-net deductions through our copay assistance; and the increase in the effective tax rate compared to same period in 2018," said Jack Khattar, President and CEO of Supernus. "Aside from the effective tax rate, these one-time events are not expected to have a continuing effect in the subsequent quarters. We have already seen in the second quarter of 2019 a normalization of shipments and prescription trends"

Balance Sheet Highlights

As of March 31, 2019, the Company had $815.5 million in cash, cash equivalents, marketable securities, and long term marketable securities, compared to $774.8 million at December 31, 2018. This increase primarily reflects cash generated from operations in the first quarter of 2019.

Financial Guidance

For full year 2019, the Company reiterates its prior guidance for net product sales, research and development expenses, operating earnings, and effective tax rate as set forth below:

Net product sales in the range of $435 million to $455 million
Research and development expenses in the range of $70 million to $80 million
Operating earnings in the range of $160 million to $180 million
Effective tax rate of approximately 23% to 25%
Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, May 8, 2019. An accompanying webcast also will be provided.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 8139879
Conference Call Name: Supernus Pharmaceuticals First Quarter 2019 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

On May 7, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported first quarter 2019 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 7, 2019, View Source;p=RssLanding&cat=news&id=2397573 [SID1234535881]).

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"We have made great progress in recent months in advancing TIL therapy toward commercialization. In April, we dosed the first patient in the pivotal study, Cohort 4 of the innovaTIL-01 melanoma trial, bringing us a step closer to our goal of filing for regulatory approval of lifileucel in 2020," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We are pleased that three Iovance abstracts submitted to ASCO (Free ASCO Whitepaper) have been accepted, two of which include data updates from our fully enrolled Cohort 2 of our melanoma program and data from our ongoing LN-145 cervical study being presented for the first time in a medical conference at the 2019 meeting."

Recent Achievements and Upcoming Milestones

Clinical

In April 2019, the company announced that the first patient was dosed in Cohort 4 of the pivotal innovaTIL-01 study of lifileucel in metastatic melanoma.
New interim data from Cohort 2 of the innovaTIL-01 melanoma study and data from the ongoing innovaTIL-04 cervical cancer study will be presented on June 1, 2019 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
The company closed the IOV-LUN-201 study and instead will add an additional arm to the IOV-COM-202 study, adapting clinical development plans to reflect advances in the treatment landscape for non-small cell lung cancer.
The protocol for innovaTIL-04, the Phase 2 study in cervical cancer, was amended to increase the sample size to 59 and to modify the primary endpoint of Objective Response Rate (ORR) to be determined by a Blinded Independent Review Committee (BIRC). The company made the changes in anticipation of a meeting with the U.S. Food and Drug Administration (FDA) planned for later this year to discuss the registration pathway for LN-145 in cervical cancer.
Regulatory

In February 2019, LN-145 received Fast Track designation from the FDA for the cervical cancer indication.
Research

In April 2019, persistence and biomarker data from Cohort 2 of the innovaTIL-01 study of lifileucel in the treatment of advanced melanoma were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The presentation described results of an analysis of circulating T cells at 42 days post-infusion, highlighting the uniqueness of clonal profiles in TIL therapy in melanoma. The results support potential use of a polyclonal product such as Iovance bulk TIL in the treatment of melanoma and likely other cancers with high mutational load solid tumors.
Researchers at Iovance have generated data in collaboration with Roswell Park Cancer Center from the 22-day Gen 2 process of generating TIL from patient derived bladder cancer tumor tissue. An abstract describing the data has been accepted for presentation at the upcoming AACR (Free AACR Whitepaper) "Bladder Cancer: Transforming the Field" conference taking place May 18-21, 2019.
Corporate

In May 2019, the company opened a satellite office in Philadelphia, Pennsylvania. The office will house various functions including members of the Iovance legal and manufacturing teams.
First Quarter 2019 Financial Results

Net loss for the quarter ended March 31, 2019 was $37.0 million, or $0.30 per share, compared to net loss of $26.5 million, or $0.31 per share for the quarter ended March 31, 2018.

Research and development expenses were $30.9 million for the quarter ended March 31, 2019, an increase of $11.0 million, compared to $19.9 million for the same period ended March 31, 2018. The increase in research and development expenses was primarily attributable to an increase in the total number of patients in our clinical studies which in turn results in higher manufacturing and clinical study costs, technology transfer expenses and an increase in research and development headcount.

General and administrative expenses were $9.1 million for the quarter ended March 31, 2019, an increase of $2.1 million compared to $7.0 million for the same period ended March 31, 2018. The increase was primarily attributable to an increase in general and administrative headcount and higher stock based compensation.

Cash, Cash Equivalents and Short-term Investments

At March 31, 2019, the company held $440.0 million in cash, cash equivalents, and short-term investments compared to $468.5 million at December 31, 2018.

Webcast and Conference Call

Iovance will host a conference call and live audio webcast to discuss financial results and provide a corporate update today at 4:30 p.m. EDT.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7393657. The live webcast can be accessed under "News & Events: Investor Calendar" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source An archived webcast will be available in the Investors section of www.iovance.com for thirty days following the call.

On May 7, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2019 financial results and highlighted upcoming milestones (Press release, Kura Oncology, MAY 7, 2019, View Source [SID1234535880]).

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"We have made considerable progress over the past quarter, as we continue to execute against our first registration-directed trial for tipifarnib in patients with HRAS mutant squamous head and neck cancers," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Meanwhile, our elucidation of the CXCL12 pathway as a therapeutic target of tipifarnib, coupled with identification of associated farnesylated proteins, offers the potential to significantly expand the population of patients who may benefit from treatment with tipifarnib. Ultimately, we believe that CXCL12 pathway biomarkers could enable registrational strategies for tipifarnib in multiple hematologic and solid tumor indications."

"Now, we look forward to a series of important milestones," continued Dr. Wilson, "beginning with an update from our ongoing Phase 2 trial of tipifarnib in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12-positive peripheral T-cell lymphoma (PTCL), which was accepted for oral presentation at both the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and the International Conference on Malignant Lymphoma (ICML) next month. This will be followed by additional data from our ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including head and neck squamous cell carcinoma (HNSCC) and other squamous cell carcinomas (SCCs), as well as an update from our ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) later in the year."

Recent Highlights

Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Kura’s global, multi-center, open-label, non-comparative registration-directed trial of tipifarnib continues on track. The clinical trial has two cohorts: A non-interventional screening and outcomes cohort (SEQ-HN) and a treatment cohort (AIM-HN). AIM-HN is designed to enroll at least 59 evaluable patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN initiated in November 2018 and is expected to take approximately two years to fully enroll.

Farnesylated proteins associated with CXCL12 expression – In April 2019, Kura reported new findings at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting suggesting that gene expression of the exclusively farnesylated proteins RHOE and PRICKLE2 is strongly associated with CXCL12 expression in bone marrow stroma. These findings provide key evidence supporting the inhibition of the CXCL12 pathway as a mechanism of action mediating the activity of tipifarnib and other farnesyl transferase inhibitors.

Potential expansion to other CXCL12+ lymphoma indications – Kura reported additional findings at AACR (Free AACR Whitepaper) identifying CXCL12 expression as a potential biomarker of clinical benefit in patients with diffuse large B-cell lymphoma (DLBCL) as well as mycosis fungoides, the most common form of cutaneous T-cell lymphoma (CTCL). The results were obtained from an analysis of a subset of samples from a previously conducted Phase 2 trial of tipifarnib in patients with relapsed and refractory lymphomas and are consistent with similar findings from the Company in other indications such as PTCL, acute myeloid leukemia (AML) and pancreatic cancer.

Emerging pipeline of clinical-stage drug candidates – Kura is advancing two additional pipeline programs: KO-947, a small molecule inhibitor of extracellular signal-related kinase (ERK), and KO-539, a potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) interaction. The Company continues to evaluate dosing regimens for KO-947 and anticipates having data from its Phase 1 clinical trial later this year. Meanwhile, the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KO-539 and the Company is preparing to initiate a Phase 1 clinical trial in patients with relapsed or refractory AML in mid-2019.

Financial Results

Research and development expenses for the first quarter of 2019 were $10.4 million, compared to $11.6 million for the first quarter of 2018.

General and administrative expenses for the first quarter of 2019 were $4.6 million, compared to $3.4 million for the first quarter of 2018.

Net loss for the first quarter of 2019 was $13.9 million, compared to $14.6 million for the first quarter of 2018.

Cash, cash equivalents and short-term investments totaled $165.5 million as of March 31, 2019, compared with $179.0 million as of December 31, 2018.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2021.

Upcoming Milestones

Additional data from the ongoing Phase 2 trial of tipifarnib in PTCL, including duration of response data from the AITL cohort and additional data from the CXCL12-positive PTCL cohort, at EHA (Free EHA Whitepaper) and ICML in June 2019

Additional data on biomarkers associated with elevated CXCL12 expression at EHA (Free EHA Whitepaper) and ICML in June 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including HNSCC and other SCCs, in the second half of 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in CMML in 2019

Data from the Phase 1 dose-escalation trial of KO-947 in 2019

Initiation of the Phase 1 clinical trial of KO-539 in mid-2019

Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 7, 2019, to discuss the financial results for the first quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 4436235. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

On May 7, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, reported its financial results for the first quarter ended March 31, 2019 and provided an update on the company’s recent achievements and anticipated upcoming milestones (Press release, Audentes Therapeutics, MAY 7, 2019, View Source [SID1234535866]).

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"We are excited by the continued strong momentum across our business," stated Matthew R. Patterson, Chairman and Chief Executive Officer. "We recently presented new positive data from ASPIRO, the Phase 1/2 study of AT132 for the treatment of XLMTM, at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper). These data further support the compelling profile of this important product candidate and help further our progress toward the goal of making AT132 globally available to patients living with XLMTM as rapidly as possible."

Mr. Patterson continued, "In our Pompe disease program, this quarter we successfully completed an initial NHP safety study of our product candidate AT845 and the encouraging results give us added confidence as we complete GLP toxicology and dose-ranging studies to support a third quarter IND submission. Finally, we are thrilled to have recently announced the expansion of our technology platform and development pipeline with the addition of programs utilizing vectorized antisense to address Duchenne muscular dystrophy and myotonic dystrophy, two devastating neuromuscular diseases."

Recent Achievements & Upcoming Key Events

AT132 for X-Linked Myotubular Myopathy (XLMTM):

Presented new positive data from ASPIRO at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper).
The ASGCT (Free ASGCT Whitepaper) data set included safety and efficacy assessments out to 48 weeks of follow-up for six treated patients in dose Cohort 1 (1×1014 vg/kg) and 24 weeks for three treated patients in dose Cohort 2 (3×1014 vg/kg).
Patients receiving AT132 achieved reductions in ventilator dependence not previously observed in chronically ventilated patients with neuromuscular disorders, including four patients achieving ventilator independence and all other treated patients demonstrating sustained and clinically meaningful reductions in ventilator use.
The data also demonstrated sustained improvements in neuromuscular function in both dose cohorts with corresponding achievement of clinically meaningful motor milestones. Additionally, muscle biopsy data continued to show robust tissue transduction, protein expression, and histological improvements in 24 and 48-week muscle biopsies in all patients, with evidence of more rapid pathological improvement by week 24 in the Cohort 2 biopsy samples.
AT132 has been generally well-tolerated and has shown a manageable safety profile across both dose cohorts with no clinically meaningful safety differences between doses to date.
Enrollment of an additional three to five patients in Cohort 2 (3×1014 vg/kg) of ASPIRO is ongoing.
On track to select optimal dose of AT132 in the second quarter of 2019. Plan to provide an updated data package to FDA and on track to provide update on the license application submission plans for AT132 in the third quarter of 2019.
Next clinical data presentation planned at the 24th International Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark, October 1-5, 2019.
AT845 for Pompe Disease:

Successfully completed an initial non-GLP NHP study, which showed a clean safety profile.
Previously planned GLP toxicology and dose-ranging studies in progress.
On track to file IND in the third quarter of 2019.
AT702/AT751/AT753 for Duchenne Muscular Dystrophy (DMD):

Announced exclusive license agreement with the Research Institute at Nationwide Children’s Hospital to develop AT702, an AAV-antisense candidate designed to induce exon 2 skipping for DMD caused by duplications of exon 2 and mutations in exons 1-5 of the dystrophin gene. Conducting additional preclinical work of AT702 and plan to commence a Phase 1/2 study at Nationwide Children’s in the fourth quarter of 2019.
Separate from the Nationwide Children’s collaboration, conducting preclinical work to advance AT751 and AT753, additional vectorized exon skipping candidates designed to treat DMD patients with genotypes amenable to exon 51 and exon 53 skipping. Both AT751 and AT753 utilize the same vector construct backbone as AT702, enabling a potentially accelerated path into clinical development.
Initial programs target more than 25% of patients with DMD. Plan to leverage vectorized exon skipping platform to develop further product candidates to address up to 80% of DMD patients over time.
AT466 for Myotonic Dystrophy (DM1):

Collaboration announced with Nationwide Children’s to evaluate vectorized RNA knockdown and vectorized exon skipping for DM1.
Preclinical studies are underway, and IND planned for 2020.
AT342 for Crigler-Najjar Syndrome and AT307 for CASQ2-CPVT:

Completed a strategic review of our product candidates and plan to focus on those programs that have the potential to create the greatest long-term value for patients and shareholders.
Plan to explore outlicensing opportunities to continue to advance these important and promising gene therapy programs.
Manufacturing:

Announced new internal cGMP plasmid manufacturing facility, further establishing the company’s leadership in AAV manufacturing and enabling the rapid advancement of neuromuscular programs from preclinical development to commercialization.
Made continued progress on chemistry, manufacturing, and controls (CMC) BLA and MAA-readiness efforts for AT132 based on FDA and EMA feedback on the company’s preliminary filing strategy.
Corporate:

Expanded leadership team with the additions of Mark Meltz, Senior Vice President, General Counsel, to lead the legal, compliance, and corporate governance functions and Sarah Spencer, Vice President, Corporate Communications, to lead internal and external communications to build global awareness of the company, its mission, culture, and innovative product portfolio.
First Quarter 2019 Financial Results

Cash Position: At March 31, 2019, Audentes had cash, cash equivalents and marketable securities of $375.0 million, which is expected to fund operations into 2021.
Research and Development Expenses: Research and development expenses were $39.8 million for the first quarter of 2019 compared to $19.9 million for the same period in 2018, an increase of $19.9 million. The increase in research and development expense was primarily attributable to increased R&D headcount and related facility costs, a one-time licensing fee of $7.0 million related to the AT702 program, increased internal manufacturing costs, increased clinical trial expenses for our AT132 program, increased pre-clinical and clinical trial planning costs for our AT845 program, and an increase in stock compensation expense.
General and Administrative Expenses: General and administrative expenses were $12.0 million for the first quarter of 2019 compared to $6.5 million for the same period in 2018, an increase of $5.5 million. The increase in general and administrative expenses was primarily attributable to increased headcount and related facility costs, increased professional service and consulting fees, higher costs related to public company regulatory compliance and increase in stock compensation expense.
Net Loss: Net loss was $49.4 million for the first quarter of 2019 compared to $25.6 million for the same period in 2018.
Conference Call
At 4:30 p.m. Eastern Time today, Audentes management will host a conference call and a simultaneous webcast to discuss its first quarter 2019 financial results and provide a corporate update. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investors + Media section of the Audentes website at www.audentestx.com. Alternatively, please call (833) 659-8620 (U.S.) or (409) 767-9247 (international) and dial the conference ID# 6839198 to access the call.

A replay of the webcast will be available on the Audentes website for approximately 30 days.