On May 8, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering, developing and commercializing novel vaccines and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Dynavax Technologies, MAY 8, 2019, View Source [SID1234535937]).

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"HEPLISAV-B net product revenue was $5.6 million for the first quarter of this year, which was in line with our expectations," said Eddie Gray, chief executive officer of Dynavax. "As the only two-dose hepatitis B vaccine, we are focused on making HEPLISAV-B the standard of care hepatitis B adult vaccine in the U.S. On the immuno-oncology development front, we will have three SD-101 data presentations at ASCO (Free ASCO Whitepaper)."

First Quarter and Recent Business Highlights

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

First quarter 2019 sales of $5.6 million compared to $3.9 million in the fourth quarter 2018
The company has achieved sales into 3 of the 4 top national retail pharmacy chains, and contracting efforts are underway to secure additional pharmacy partners
More than 1,454 individual customers have purchased HEPLISAV-B since launch
Only 4% of doses sold to date were to customers who have not reordered after at least 45 days
15 of the top 20 Integrated Delivery Networks (IDNs) have made HEPLISAV-B available to order
557 of the targeted 1,419 accounts have made HEPLISAV-B available to order, representing 50% of the targeted adult hepatitis B market
164 of the top 300 targeted customers have ordered HEPLISAV-B
In May, the company announced the enrollment of the first patient in an open-label, single-arm study of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis. The study is designed to evaluate immunogenicity and safety.
Immuno-oncology

SD-101

Three Dynavax abstracts have been accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2019 in June.

Abstract #6039, "Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naive patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)"

Abstract #9534, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy"

Abstract #9555, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy"
DV281

Dynavax presented phase 1b data on inhaled DV281 TLR9 agonist at the 2019 AACR (Free AACR Whitepaper) Annual Meeting. Key highlights from the clinical data presentation include:

In this safety study, two doses of DV281 monotherapy followed by combination with nivolumab was well tolerated

Inhalation of DV281 leads to dose-dependent target engagement as measured by induction of IFN-regulated genes at all evaluated dose levels

DV281 plus nivolumab demonstrates early signs of antitumor activity in heavily pretreated patients
Financial Results

Product Revenue, Net. Dynavax’s first commercial product, HEPLISAV-B, was launched in the first quarter of 2018. Net product revenue for the first quarter of 2019 was $5.6 million, compared to $0.2 million for the first quarter of 2018. Product revenue from sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts and other fees.

Cost of Sales – Product. Cost of sales – product, for the first quarter of 2019 was $1.8 million, compared to $0.2 million for the first quarter of 2018. Included in cost of sales – product, are fill, finish and overhead costs for HEPLISAV-B incurred after U.S. Food and Drug Administration (FDA) approval. A higher percentage of HEPLISAV-B inventory sold in 2019 used components manufactured after FDA approval compared to 2018, when most of the expense associated with product sold was expensed to research and development prior to approval. The company expects its HEPLISAV-B cost of sales to increase in future periods as it produces and then sells inventory that reflects the full cost of manufacturing the product.

R&D Expenses. Research and development expenses for the first quarter of 2019 were $21.2 million, compared to $19.0 million for the first quarter of 2018. The increase reflects additional personnel and clinical trial expense for ongoing development of SD-101 and DV281.

SG&A. Selling, general and administrative expenses for the first quarter of 2019 were $18.3 million, compared to $16.9 million for the first quarter of 2018. The increase was due primarily to additional personnel in support of HEPLISAV-B commercial activities.

Net Loss. Net loss for the first quarter of 2019 was $39.7 million, or $0.62 per basic and diluted share, compared to a net loss of $39.0 million, or $0.63 per basic and diluted share, for the first quarter of 2018.

Cash Position. Cash, cash equivalents and marketable securities totaled $183.2 million at March 31, 2019, compared to $145.5 million at December 31, 2018. In March 2019, Dynavax exercised its option to draw down $75 million of non-dilutive capital under its existing term loan agreement with CRG Servicing LLC.

Conference Call and Webcast Information

Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. To access the call, participants may dial (855) 327-6837 (domestic) or (631) 891-4304 (international) and refer to conference ID 10006654. The live call will be webcast and can be accessed in the "Investors and Media" section of the company’s website at www.dynavax.com. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

For more information about HEPLISAV-B, visit View Source

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.

On May 8, 2019 IVERIC bio (Nasdaq: ISEE) reported financial and operating results for the first quarter ended March 31, 2019 and provided a business update (Press release, Ophthotech, MAY 8, 2019, View Source [SID1234535936]).

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"2019 is a transformational year for the Company," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "Our recent re-branding and corporate name change reflects our commitment to develop gene therapy treatments for patients with orphan inherited retinal diseases. We believe this is an important time for the Company as we advance our diversified pipeline with multiple IRD gene therapy research and development programs, including programs for rhodopsin-mediated autosomal dominant retinitis pigmentosa, BEST1 related retinal diseases, Leber congenital amaurosis type 10 and Stargardt disease. We expect to enter into the clinic with IC-100, our RHO-adRP product candidate, in 2020. Our therapeutics programs continue to remain on track with clinical data for Zimura expected in the fourth quarter of 2019 and the second half of 2020. We look forward to the exciting opportunities that lie ahead to generate value for our shareholders."

First Quarter/Recent 2019 Highlights

As part of the Company’s transformation strategy to focus on discovering and developing novel gene therapy solutions to treat orphan inherited retinal diseases (IRDs) with significant unmet medical needs, the Company rebranded to IVERIC bio, Inc. In conjunction with the corporate rebrand, the Company began trading on the Nasdaq Global Select Market under the new ticker symbol "ISEE" on April 17, 2019.

Natural history studies and IND enabling activities for IC-100 are ongoing. The Company expects to initiate a Phase 1/2 clinical trial for IC-100 in 2020.

In April 2019, the Company entered into an exclusive global license agreement with the University of Pennsylvania (Penn) and the University of Florida Research Foundation for rights to develop and commercialize novel adeno-associated virus gene therapy product candidates for the treatment of BEST1 related retinal diseases, including Best vitelliform macular dystrophy, also known as Best disease. The Company is currently developing IC-200, its product candidate from this program, for Best disease and other BEST1 related retinal diseases. Natural history and other preclinical studies with Penn, including in collaboration with researchers at the Perelman School of Medicine at the University of Pennsylvania and the University of Pennsylvania School of Veterinary Medicine, and IND enabling activities for IC-200 are ongoing. The Company expects to initiate a Phase 1/2 clinical trial for IC-200 in the first half of 2021.

The Company’s sponsored research programs to evaluate a minigene strategy for both LCA10, caused by mutations in the CEP290 gene, and autosomal recessive Stargardt disease, caused by

mutations in the ABCA4 gene, are ongoing. The Company expects to receive research results for the LCA10 program during this year and expects to receive research results for the Stargardt minigene ABCA4 program during 2020.

Initial top-line data for the Company’s ongoing Phase 2b clinical trial of Zimura (avacincaptad pegol sodium), which is a C5 complement inhibitor, for the treatment of geographic atrophy secondary to dry age-related macular degeneration remains on track for data to be available in the fourth quarter of 2019. In February 2019, the Company completed patient enrollment in its Phase 2b clinical trial assessing the efficacy and safety of Zimura monotherapy in patients with autosomal recessive Stargardt disease. Initial top-line data is expected to be available in the second half of 2020.

Effective January 1, 2019, Calvin W. Roberts, M.D., Senior Vice President and Chief Medical Officer, Eye Care at Bausch Health Companies and Clinical Professor of Ophthalmology at Weill Medical College of Cornell University, was elected to IVERIC bio’s Board of Directors.

2019 Operational Update
As of March 31, 2019, the Company had $116.6 million in cash and cash equivalents. The Company estimates its year end 2019 cash and cash equivalents will range between $80 million and $85 million based on its current 2019 business plan, including the continued preclinical development of IC-100 and IC-200, the continuation of its ongoing collaborative gene therapy sponsored research programs, the continued clinical development of Zimura and the continued preclinical development of its HtrA1 inhibitor program. This estimate does not reflect any expenditures resulting from additional sponsored research agreements the Company may enter into or the potential in-licensing or acquisition of additional product candidates or technologies or any associated development that the Company may pursue.

2019 Financial Highlights

R&D Expenses: Research and development expenses were $7.7 million for the quarter ended March 31, 2019, unchanged from the same period in 2018 as increases in costs associated with the Company’s gene therapy programs were offset by decreases in costs associated with the Company’s Zimura programs.

G&A Expenses: General and administrative expenses were $5.5 million for the quarter ended March 31, 2019, compared to $5.6 million for the same period in 2018. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure.

Net Income: The Company reported a net loss for the quarter ended March 31, 2019 of $12.5 million, or ($0.30) per diluted share, compared to net loss of $13.1 million, or ($0.36) per diluted share, for the same period in 2018.

Conference Call/Web Cast Information
IVERIC bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for May 8, 2019 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-224-1005 (USA) or 323-794-2551 (International), passcode 9765307. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the IVERIC bio website at: www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 9765307.

On May 8, 2019 Ziopharm Oncology, Inc. (Nasdaq: ZIOP), a clinical stage immuno-oncology company developing next generation cell and gene therapies, reported its financial results for the first quarter ended March 31, 2019, and provided an update on the Company’s recent activities (Press release, Ziopharm, MAY 8, 2019, View Source [SID1234535935]).

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"We are on track to achieve significant clinical milestones in 2019. All three of our novel immuno-oncology programs are expected to be in the clinic this year," said Laurence Cooper, M.D., Ph.D., CEO of Ziopharm. "We are looking forward to treating patients with solid tumors mid-year with the first non-viral, neoantigen-specific TCR-T cell therapy at the National Cancer Institute (NCI). Our Controlled IL-12 platform is expected to open a phase 2 combination trial with Regeneron’s Libtayo this quarter, and we expect to begin a third-generation Sleeping Beauty platform, CD19-specific CAR-T phase 1 trial at MD Anderson Cancer Center in the second half of 2019."

David Mauney, M.D., President of Ziopharm, added, "Our stated focus for the year centers on executional excellence and increasing shareholder value, as we advance our cutting-edge science with each of our programs in the clinic this year. We are pleased to report significant progress with each of these articulated goals and look forward to continuing these efforts throughout the remainder of 2019."

Program Updates

Sleeping Beauty TCR-T Therapies

The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with T-cell receptors, or TCRs. Under a Cooperative Research and Development Agreement (CRADA), which was recently extended through January of 2022, the NCI plans to initiate a Phase 1 clinical trial to treat patients with a variety of metastatic/advanced solid tumors using our Sleeping Beauty platform to genetically modify patient-derived T cells to target patient-specific neoantigens.

Phase 1 trial for TCR-T cell therapy expected to begin in mid-2019: This trial is scheduled to begin treating patients in mid-2019 under the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI.

Sleeping Beauty CAR-T Therapies

Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CAR-T cells, co-expressing membrane-bound interleukin-15, or mbIL15, with a safety switch, enabling T cells to be infused within two days after genetic modification. This work on our third-generation Sleeping Beauty technology is undertaken in collaboration with MD Anderson Cancer Center in the United States and will be accomplished in Greater China through a joint venture, Eden BioCell.

Third-generation phase 1 trial for rapid personalized manufacture of Sleeping Beauty CD19-specific CAR-T with mbIL15 expected to begin 2H2019: The Company reaffirms guidance on beginning this trial and treating patients at MD Anderson Cancer Center in the second half of this year. Ziopharm announced in June 2018 that the FDA placed this investigator-led IND on clinical hold and requested additional information demonstrating that the product meet a minimum threshold for overall cell viability. The Company, in partnership with MD Anderson Cancer Center, has made significant progress toward achieving this threshold in manufacturing through improved engineering and cell processing, and expects to be in the clinic at MD Anderson in the second half of this year.

Eden BioCell to advance third-generation Sleeping Beauty CD19-specific CAR-T for Greater China: Announced at the end of December 2018, Ziopharm is forming Eden BioCell, a joint venture with partner TriArm Therapeutics, to develop and commercialize Sleeping Beauty-generated CD19-specific CAR-T in Greater China. With staffing and planning already under way, Ziopharm looks forward to providing some initial detail on clinical development plans for Eden BioCell later in the year.

Controlled IL-12

Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, as a drug to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit cancer-fighting T cells into solid tumors. In the setting for the treatment of recurrent glioblastoma (rGBM), Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex as a monotherapy and in combination with immune checkpoint inhibitors.

Ziopharm abstracts accepted for the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting: Titles of accepted abstracts have been released by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) for the upcoming Annual Meeting in Chicago (May 31-June 4, 2019):

Evaluation of Controlled IL-12 as Monotherapy in Subjects with Recurrent GBM. Poster #242, Abstract 2053 in Hall A. (June 2, 2019 8:00 to 11:00 am)

Evaluation of Controlled IL-12 in Combination with PD-1 Inhibitor in Subjects with Recurrent GBM. Poster #209, Abstract 2020 in Hall A (June 2, 2019 8:00 to 11:00 am). Oral Presentation June 2, 2019 4:30 to 6:00 pm in S404.

FDA grants Fast Track status to Controlled IL-12 program: Ziopharm announced last month that FDA granted Fast Track designation for our Controlled IL-12 program for the treatment of rGBM in adults. The Fast Track program is designed to facilitate the expedited development and review of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

Enrollment completed in phase 1 monotherapy expansion substudy: Ziopharm announced in February that it rapidly completed enrollment and treated a total of 36 patients in less than six months in a substudy to expand a phase 1 trial evaluating its Controlled IL-12 platform as a monotherapy for the treatment of rGBM. The trial was over-enrolled by 11 patients, which the Company attributes to enthusiasm stemming from encouraging survival and tumor biopsy data. Additional data from the monotherapy studies will be presented through a poster at ASCO (Free ASCO Whitepaper) 2019.

Third cohort has begun in combination substudy with OPDIVO (nivolumab): Ziopharm announced in March that it had completed two dosing cohorts in its phase 1 substudy of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO, an immune checkpoint inhibitor targeting programmed death-1 (PD-1). The Company has begun the third cohort for this study to evaluate the safety and tolerability of this combination regimen, establish optimal dosing of veledimex and OPDIVO, and measure overall patient survival. The Company expects to complete enrollment in the second quarter of 2019. Preliminary data from this trial will be shared at ASCO (Free ASCO Whitepaper) next month in an oral presentation.

Phase 2 combination trial with Regeneron’s Libtayo (cemiplimab-rwlc) expected to open 2Q2019: The Company, in collaboration with Regeneron Pharmaceuticals, expects to open a phase 2 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo to treat patients with rGBM. The Company expects to enroll approximately 30 patients in this trial.

First Quarter 2019 Financial Results

Net loss applicable to the common shareholders for the first quarter of 2019 was $13.4 million, or $(0.08) per share, compared to a net loss of $21.1 million, or $(0.15) per share, for the first quarter of 2018. The decreased net loss to common shareholders resulted primarily from the elimination of approximately $5.1 million of dividends to preferred shareholders caused by the forfeiture and return of all of the Company’s Series 1 preferred stock in October 2018, along with the changes in research and development expenses and general and administrative expenses noted below.

Research and development expenses were $9.5 million for the first quarter of 2019, compared to $10.2 million for the first quarter of 2018. The decrease in research and development expenses for the three months ended March 31, 2019 is primarily due to decreased clinical costs related to our cell therapy programs.

General and administrative expenses were $4.1 million for the first quarter of 2019, compared to $6.2 million for the first quarter of 2018. The decrease in general and administrative expenses for the three months ended March 31, 2019 is primarily due to decreased stock compensation and other employee-related costs.

The Company ended the quarter with unrestricted cash resources of approximately $51.5 million.

In addition, a prepayment of approximately $26.4 million remains for programs to be conducted by the Company at MD Anderson Cancer Center under the current Research and Development Agreement.

The Company believes its current resources will be sufficient to fund its planned operations into the second quarter of 2020.

Conference Call Webcast

The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 9185154. To access the live webcast or the subsequent archived recording, visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

On May 8, 2019 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, Arca biopharma, MAY 8, 2019, View Source [SID1234535934]).

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"In the first part of this year, we continued to make progress on our lead development program Gencaro, achieving an agreement with the FDA on our Special Protocol Assessment for the PRECISION-AF Phase 3 clinical trial evaluating Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "Importantly, the GENETIC-AF Phase 2B clinical trial results, which are guiding our Phase 3 development, were accepted and published in JACC: Heart Failure."

Pipeline Update

Gencaro (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

In February 2019, ARCA received a Special Protocol – Agreement Letter from the U.S. Food and Drug Administration (FDA) on its Special Protocol Assessment (SPA) application for the Phase 3 PRECISION-AF clinical trial. Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF by the end of 2019.

In April 2019, GENETIC-AF Phase 2B clinical trial results were published in the Journal of the American College of Cardiology: Heart Failure in the paper "GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population".
AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for heart failure (HF) and peripheral arterial disease (PAD).

Chemistry, manufacturing and controls (CMC) activities continued in the first quarter.

Subject to securing additional financing, IND-enabling non-clinical studies are anticipated to begin in the second half of 2019, and an IND submission is anticipated in the first half of 2020.
First Quarter 2019 Summary Financial Results

Cash, cash equivalents and marketable securities were $8.0 million as of March 31, 2019, compared to $6.6 million as of December 31, 2018. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of the third quarter of 2019.

Research and development (R&D) expenses for the three months ended March 31, 2019 were $0.7 million compared to $1.7 million for the corresponding period of 2018. The $1.1 million decrease in R&D expenses was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial in 2018.

General and administrative (G&A) expenses for the three months ended March 31, 2019 were $1.1 million similar to $1.1 million in the first quarter of 2018. The Company expects G&A expenses in 2019 to be consistent with those in 2018 as it maintains administrative activities to support our ongoing operations.

Total operating expenses for the three months ended March 31, 2019 were $1.8 million compared to $2.8 million for the corresponding period of 2018. The decrease in total operating expenses was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $1.7 million, or $1.86 per share, for the first quarter of 2019 compared to $2.7 million, or $3.61 per share, for the first quarter of 2018.

The Company will need to raise additional capital to fund future operations and develop Gencaro or any other product candidates, complete a partnership or other possible strategic transactions.

On May 8, 2019 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2019 (Press release, Athersys, MAY 8, 2019, View Source [SID1234535933]).

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Highlights of the first quarter of 2019 and recent events include:

Announced positive results from our exploratory clinical study of MultiStem cell therapy for treatment of acute respiratory distress syndrome ("MUST-ARDS"), showing reduced mortality and greater ventilator-free and ICU-free days in patients with moderate to severe ARDS;

The MUST-ARDS study has been selected for presentation at the American Thoracic Society International Conference on May 20, 2019;

Our partner in Japan, HEALIOS K.K. ("Healios"), announced its first patient enrolled in the ONE-BRIDGE study in Japan, evaluating MultiStem cell therapy treatment of patients who suffer from pneumonia-induced ARDS;

Advanced ischemic stroke program, supporting Healios’ TREASURE study and ramping up our MASTERS-2 Phase 3 registrational study;

Announced plans to host an investor day in New York City on May 14, 2019 that will highlight the Company’s capabilities and technologies, as well as progress made developing the MultiStem product platform and future plans;

Participated in several investor conferences and media interviews, including "The Stem Cell Podcast" and the "Forbes Book Podcast" as the featured guest; also featured live on TD Ameritrade’s "The WatchList";

Launched a revamped website with a simplified design, improved functionality and enhanced content to help educate our visitors;

Recognized revenues of $1.4 million for the quarter ended March 31, 2019 and net loss of $13.0 million, or $0.09 net loss per share, for the quarter ended March 31, 2019; and

Ended the 2019 first quarter with $51.0 million of cash and cash equivalents.
"We made continued progress in the first quarter of 2019 in advancing our key initiatives, reflected by the release of results from our ARDS study and the continued progress of enrollment in our Phase 3 MASTERS-2 trial and the TREASURE registrational study being conducted by our partner in Japan for treating ischemic stroke," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "We are working collaboratively with Healios in multiple areas, which includes supporting their initiation of the ONE-BRIDGE study for ARDS, and we further strengthened our core capabilities."
"In addition, we have maintained a solid balance sheet as we continue to implement our strategic plan, working toward the achievement of our key goals on behalf of our shareholders and the patients we are committed to helping," concluded Dr. Van Bokkelen.

First Quarter Results
Revenues increased to $1.4 million for the three months ended March 31, 2019 compared to $1.1 million for the three months ended March 31, 2018. Our revenues are generally derived from license fees, manufacturing-related activities for Healios, other royalty and related contract revenue from our collaborations, and grant revenue. Revenues from our collaboration with Healios increased quarter-over-quarter related to our manufacturing services. Royalty revenues from RTI Surgical, Inc. have concluded with its discontinuation of distribution of the licensed product.
Research and development expenses increased to $11.4 million for the three months ended March 31, 2019 from $8.9 million for the comparable period in 2018. The $2.5 million increase is primarily associated with increased clinical trial and manufacturing process development costs of $1.9 million, increased personnel costs of $0.4 million, and increased stock compensation costs of $0.1 million. Included in our clinical costs are costs associated with providing manufacturing services to Healios, which are invoiced to Healios in accordance with the collaboration agreements.
General and administrative expenses increased to $3.1 million for the three months ended March 31, 2019 from $2.7 million in the comparable period in 2018. The $0.4 million increase was due primarily to increased legal and professional fees, consulting services, and stock compensation costs compared to the same period last year.
Net loss for the first quarter was $13.0 million in 2019 compared to a net loss of $10.2 million in 2018. The difference of $2.8 million reflects the above variances, as well as a decrease of $0.2 million in other income.
In the three months ended March 31, 2019, net cash used in operating activities was $5.5 million compared to $5.7 million in the three months ended March 31, 2018. At March 31, 2019, we had $51.0 million in cash and cash equivalents, compared to $51.1 million at December 31, 2018.

Conference Call
William (B.J.) Lehmann, President and Chief Operating Officer, and Laura Campbell, Senior Vice President of Finance, will host a conference call today to review the results as follows:

Date

May 8, 2019
Time

4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada

(877) 396-3286
Telephone access: International

(647) 689-5528
Access code

6595362
Live webcast

www.athersys.com, under the Investors section

We encourage shareholders to listen using the webcast link and to use the phone line if you intend to ask a question. A replay will be available at www.athersys.com under the Investors section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on May 15, 2019 by dialing (800) 585-8367 or (416) 621-4642 and entering Encore passcode 6595362.