On August 9, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Vicinium for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer (NMIBC) (Press release, Eleven Biotherapeutics, AUG 9, 2018, View Source [SID1234528823]). Vicinium, Sesen Bio’s lead product candidate, is currently being evaluated in a Phase 3 registration trial, the VISTA Trial, for the treatment of patients with high-grade NMIBC who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.

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"The granting of this designation is an important milestone for Sesen Bio, and we believe it exemplifies the urgent need for a new treatment option for people with NMIBC for whom bladder removal is the recommended course after BCG," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We are highly encouraged by the differentiated product profile of Vicinium in NMIBC, with a unique mechanism of action, positive three-month data presented earlier this year and favorable tolerability in patients treated to-date. With Fast Track designation, we look forward to determining the optimal registration path and assessing the opportunity for accelerated approval to bring Vicinium to patients as quickly as possible."

The FDA’s Fast Track process is designed to expedite the development and review of drugs used to treat serious or life-threatening conditions and fill an unmet medical need. Fast Track designation allows for frequent communication and interactions with the review team at the FDA throughout the drug development and review process, with the goal of providing faster drug approval and greater patient access.

Enrollment is complete in the Phase 3 VISTA Trial and the company expects to report 12-month efficacy results in mid-2019.

About Vicinium
Vicinium, also known as VB4-845, is Sesen Bio’s lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Twelve-month data from the trial are anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On August 9, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, reported its operating and financial results for the second quarter ended June 30, 2018 (Press release, Dova Pharmaceuticals, AUG 9, 2018, View Source [SID1234528822]).

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"In the second quarter, we achieved our most significant milestone in Dova’s corporate history with the approval and launch of DOPTELET in the United States" said Alex C. Sapir, President and Chief Executive Officer of Dova. "We are pleased with the feedback we are hearing from physicians both in terms of how the drug is performing clinically, as well as the reimbursement support their patients are receiving through DOVA1SOURCE. This has translated to a high level of payer approval, as over 80% of referrals have been approved. In addition, we remain well-positioned financially, with approximately $135M in cash and equivalents to fund the operational success of the company for the foreseeable future."

DOPTLET Launch Highlights

·On May 21st, DOPTELET was approved by the U.S. Food and Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. DOPTELET was launched in the United States on June 4th.

·A total of 148 health care professionals have prescribed DOPTELET to their patients since launch with an increasing number using DOPTELET for multiple patients within their practice.

· For prescriptions that have completed the adjudication process with payers, the Company has seen greater than 80% of those prescriptions approved by the payer with an average approval time of 6.9 days.

·The Company has made significant progress in its outreach efforts to target prescribers having reached 62% of top hepatologists an average of 3.1 times since launch.

· Pivotal Phase 3 data for DOPTELET were published in Gastroenterology (View Source). The data were also highlighted at several key global scientific conferences including Digestive Disease Week (DDW) 2018, the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), and the 64th International Society on Thrombosis and Haemostasis (ISTH).

Other Important Highlights for the Quarter

·On April 27th, the Company submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure. The EMA has granted a Standard Review Assessment with a targeted decision date of July 2019.

· A supplemental New Drug Application (sNDA) for the treatment of patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to a previous treatment remains on track for submission to the FDA in the third quarter of 2018.

· The Company has initiated a Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT).

· The Company repaid, in full, the secured promissory note that was issued to Eisai on March 31, 2016 of $31.1 million. The Company refinanced a portion of the note by entering into a Loan and Security Agreement with Silicon Valley Bank (SVB) for $20.0 million on April 17, 2018. The loan matures on April 17, 2021 unless a specified revenue milestone is achieved in which case the maturity date will be extended to April 17, 2022.

·Nancy J. Wysenski, an industry veteran with over 30 years of commercial and sales leadership, joined the Company’s Board of Directors. As the former Chief Commercial Officer at Vertex, she was responsible for launching Incivek, a treatment for hepatitis C, which is considered by many to be the most successful drug launch in U.S. history.

Dova will provide an update and additional details on DOPTELET’s launch activities during today’s call as well as at its upcoming Investor and Analyst Day scheduled for September 20, 2018 in New York City, New York. To RSVP for this event, please email John Woolford at [email protected].

Second Quarter and Financial Results

Dova reported a net loss of $20.0 million for the second quarter of 2018, compared to a net loss of $5.5 million for the same period in 2017.

For the second quarter of 2018, Dova reported net product sales from DOPTELET of $2.0 million. The Company recognizes revenue using the sell-in methodology when products are delivered to its specialty pharmacy partners. The majority of net sales recognized in the quarter were related to the initial stocking of DOPTELET at the specialty pharmacies. In addition, in March 2018, Dova entered into an exclusive distribution agreement with Shanghai Fosun Pharmaceutical Industrial

Development Co., Ltd., (Fosun Pharma Industrial). Dova received a $5.0 million upfront payment from Fosun Pharma Industrial of which $2.6 million was recognized as revenue during the second quarter of 2018. There were no product sales or other revenue in the second quarter of 2017.

Cost of product sales for the second quarter were $0.5 million, of which approximately $0.3 million consisted of a one-time stock-based compensation charge.

Research and development expenses were $4.5 million in the second quarter of 2018, compared to $3.3 million for the same period in 2017. The increase was primarily due to the initiation of Phase 3 clinical trials to evaluate DOPTELET for patients with thrombocytopenia undergoing surgery regardless of disease etiology and chemotherapy-induced thrombocytopenia.

Selling, general and administrative expenses were $18.6 million in the second quarter of 2018, compared to $1.9 million for the same period in 2017. The increase was primarily due to building Dova’s commercial infrastructure to support the launch of DOPTELET, increased corporate infrastructure, and additional costs associated with operating as a public company.

As of June 30, 2018, Dova had $134.7 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, August 9, 2018 at 4:30 p.m. ET to discuss second quarter 2018 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 9093837 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS

Most common adverse reactions (> 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

On August 9, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer biology, reported financial results and business highlights for the second quarter 2018 (Press release, Cyclacel, AUG 9, 2018, View Source [SID1234528821]).

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The Company’s net loss applicable to common shareholders for the three months ended June 30, 2018 was $1.9 million. As of June 30, 2018, cash and cash equivalents totaled $19.8 million.

"Phase 1 data presented for CYC065, our lead CDK inhibitor, at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighted CYC065’s potential for durable suppression of Mcl-1, a protein that enables cancer cells to survive," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel." The oral presentation provided proof of the drug’s mechanism in patients with advanced solid tumors. Durable suppression of Mcl-1 for at least 24 hours was demonstrated in 11 of 13 patients after a single dose of CYC065 at the recommended Phase 2 level. Suppression of the Mcl-1 mediated survival pathway leads to rapid induction of apoptosis in Mcl-1 dependent cancer cells. CYC065’s mechanism has also been shown to reverse drug resistance associated with the addiction of cancer cells to cyclin E, a partner protein of CDK2. In furtherance of these findings, we will shortly initiate a CYC065 study in combination with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia, or CLL. We are also planning additional studies in advanced leukemias. During the quarter, we also achieved an important objective with the FDA’s clearance of the IND for CYC140, an internally-discovered, novel inhibitor of Polo-like-kinase 1, or PLK1."

Key Company Highlights

·Patient enrollment continues for part 2 of the CYC065 monotherapy Phase 1 study in patients with advanced solid tumors. Part 2 is evaluating an increased dosing frequency of 2 days per week for 2 weeks of a three-week cycle. Part 2 will also look to evaluate the efficacy of CYC065 in Mcl-1, MYC or cyclin E amplified cancers through the monitoring of select biomarkers relevant to CYC065’s mechanism of action.

·Cyclacel continues to prepare for initiation of a Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. A poster presented at the 2018 AACR (Free AACR Whitepaper) highlighted preclinical data supporting the enhanced effect of combination therapy with CYC065 and venetoclax in CLL tumor samples, including those with 17p deletions. A CYC065-venetoclax combination regimen was active in two CLL samples resistant to either agent alone supporting the hypothesis that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.

·Patient enrollment continues for part 3 of the Phase 1 combination study evaluating sapacitabine and seliciclib (Cyclacel’s first-generation CDK inhibitor) in patients with advanced cancer, including BRCA positive breast, ovarian and pancreatic cancer patients. The objective of part 3 of the study is to test a revised dosing schedule to evaluate safety and initial efficacy.

·Cyclacel has submitted briefing documents and scheduled meetings with certain European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The Company believes that the subgroup findings from the Phase 3 SEAMLESS study have defined a patient population for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone.

·The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CYC140, the Company’s internally-discovered, novel inhibitor of Polo-like-kinase 1, or PLK1. A first-in-human Phase 1 study is being planned.

Key Upcoming Business Objectives

·Initiate Phase 1b clinical trial evaluating CYC065 in combination with venetoclax in patients with relapsed or refractory CLL;

·Start enrollment in a Phase 1b/2 IST of sapacitabine and an approved PARP inhibitor combination treatment in patients with BRCA mutant breast cancer;

·Initiate CYC065 Phase 1b in advanced leukemias;

·Provide a clinical update from part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced cancers;

·Conduct EU regulatory authority meetings regarding the SEAMLESS study of sapacitabine in elderly AML;

·Initiate Phase 1 trial evaluating CYC140, a PLK1 inhibitor; and

·Provide clinical update and complete enrollment of part 3 of the Phase 1 study of the sapacitabine and seliciclib combination in BRCA positive, breast, ovarian and pancreatic cancer patients.

Financial Highlights

As of June 30, 2018, cash and cash equivalents totaled $19.8 million, compared to $23.9 million as of December 31, 2017. The decrease of $4.1 million was primarily due to net cash used in operating activities.

Research and development expenses were $1.2 million for each of the three months ended June 30, 2018 and 2017.

General and administrative expenses were $1.3 million for each of the three months ended June 30, 2018 and 2017.

Other income, net for the three months ended June 30, 2018 was $0.1 million compared to $34,000 for the same period of the previous year.

The United Kingdom research and tax credits were $0.5 million for the three months ended June 30, 2018 compared to $0.3 million for the same period in 2017.

Net loss for the three months ended June 30, 2018 was $1.9 million compared to $2.2 million for the same period in 2017.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 4689089

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On August 9, 2018 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiovascular indications, reported financial results for the three and six months ended June 30, 2018 and provides a business update (Press release, Caladrius Biosciences, AUG 9, 2018, View Source [SID1234528816]).

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Highlights of the 2018 second quarter and first six months include:

Received regenerative medicine advanced therapy ("RMAT") designation from the U.S. Food and Drug Administration ("FDA") for the Company’s late-stage CD34 cell therapy program CLBS14-RfA for the treatment of refractory angina, which is similar to breakthrough therapy designation, in that it provides increased agency meeting opportunities, the potential for accelerated approval and is reserved for therapies which treat a serious condition while showing preliminary evidence of addressing an unmet medical need;

Received SAKIGAKE designation from the Japan Ministry of Health, Labour and Welfare ("MHLW") for the proprietary CD34 cell therapy CLBS12 for the treatment of no-option critical limb ischemia ("CLI"), which reflects MHLW’s expectation of "prominent effectiveness" based on mechanism-of-action data from non-clinical and early clinical trials and provides an expedited path to potential conditional approval in Japan for products that show sufficient safety evidence and signals of efficacy in a Phase 2 study;

Sold our ownership interest in a non-core development-stage counter-flow centrifugation system to Hitachi Chemical Advanced Therapeutics Solutions for $2.5 million;

Continued enrollment in a Phase 2 clinical trial in Japan with CLBS12 for the treatment of no-option CLI;

Continued enrollment in a Phase 2 clinical trial with the CD34 cell therapy CLBS14-CMD for the treatment of coronary microvascular dysfunction ("CMD"); and

Continued follow-up analysis of The Sanford Project: T-Rex Study Phase 2 clinical trial of CLBS03 in type 1 diabetes after completing enrollment and reporting six-month results on 50% of trial subjects in the first quarter of 2018 that concluded the treatment is well-tolerated and non-futile for therapeutic effect.

Management Commentary

"During the second quarter, we continued to advance our CD34 cell therapy programs. We took a major step forward as we reactivated the Investigational New Drug Application ("IND") for CLBS14-RfA as the sponsor and now have three development programs targeting three indications for our CD34 technology. Additionally, with receipt of RMAT designation for CLBS14-RfA, we are afforded an opportunity to work with the FDA to more rapidly and efficiently advance the development of a therapeutic candidate with the potential to impact a condition with no known effective treatment options and high morbidity. We also advanced our Phase 2 clinical trial in Japan that is evaluating CLBS12 for the treatment of no-option CLI, a condition for which we were granted SAKIGAKE designation from the MHLW in early April. As a result, we now have two potential nearer-term commercial opportunities," said Dr. David J. Mazzo, President and Chief Executive Officer of Caladrius.

"I am also pleased to report that enrollment in our Phase 2 study of CLBS14-CMD for the treatment of coronary microvascular dysfunction continues to progress as expected and that we remain on track to complete patient follow-up and primary endpoint analysis of The Sanford Project: T-Rex Study with anticipated top-line results reported in early 2019," Dr. Mazzo continued. "Finally, as a result of continued fiscal discipline, augmented by $2.5 million of non-dilutive funding received from the sale to Hitachi Chemical Advanced Therapeutics Solutions in June of our rights to a counter-flow centrifugation cell processing device, our cash position remains strong."

Second Quarter Financial Highlights

Research and development expenses for the second quarter of 2018 were $2.1 million, a 50% decrease compared with $4.3 million for the second quarter of 2017. The decline was due to significantly lower costs in our CLBS03 clinical program in type 1 diabetes upon the completion of enrollment in December 2017, which was partially offset by costs related to the initiation of clinical trials in late 2017 and early 2018 for CLBS12 in critical limb ischemia and CLBS14-CMD in coronary microvascular dysfunction, respectively.

General and administrative expenses for the second quarter of 2018 were $2.1 million, compared with $3.4 million for the second quarter of 2017. The decrease was due to the sale of our counter-flow centrifugation system to Hitachi in the second quarter of 2018, which resulted in a one-time $1.4 million gain included in general and administrative expenses.

The net loss from continuing operations for the second quarter of 2018 was $4.1 million, or $0.42 per share, compared with $2.0 million, or $0.22 per share, for the second quarter of 2017.

Six Month Financial Highlights

Research and development expenses for the first six months of 2018 were $4.4 million, a 45% decrease compared with $8.0 million for the first six months of 2017. The decline was due to significantly lower costs in our CLBS03 clinical program in type 1 diabetes upon the completion of enrollment in December 2017, which was partially offset by costs related to the initiation of clinical trials in late 2017 and early 2018 for CLBS12 in critical limb ischemia and CLBS14-CMD in coronary microvascular dysfunction, respectively.

General and administrative expenses for the first six months of 2018 were $5.0 million, compared with $6.1 million for the first six months of 2017. The decrease was due to the sale of our counter-flow centrifugation system to Hitachi in the second quarter of 2018, which resulted in a one-time $1.4 million gain included in general and administrative expenses.

The net loss from continuing operations for the first six months of 2018 was $9.1 million, or $0.95 per share, compared with $8.7 million, or $0.99 per share, for the first six months of 2017.

Balance Sheet Highlights

As of June 30, 2018, Caladrius had cash, cash equivalents and marketable securities of $50.3 million, compared with $60.1 million as of December 31, 2017. Based on existing programs and projections, the Company continues to remain confident that its cash balances and additional grant funding, along with continued disciplined expense management, will allow it to fund its current business plan beyond 2019.

Conference Call

Caladrius’ management will host a conference call for the investment community today beginning at 4:30 p.m. Eastern time to review financial results, provide a Company update and answer questions.

Stockholders and other interested parties may participate in the conference call by dialing (866) 595-8403 (domestic), or (706) 758-9979 (international), and providing conference ID: 8899285. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/investors/news-events.

For those unable to participate on the live conference call, a replay will be available through August 15, 2018, and can be accessed by dialing (855) 859-2056 or (404) 537-3406. All listeners should provide the following replay access code: 8899285.

The webcast replay will be archived on the Company’s website for 90 days at www.caladrius.com.

On August 9, 2018 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 June 30, 2018 (Press release, Arca biopharma, AUG 9, 2018, View Source [SID1234528815]).

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"The second quarter of this year saw an important milestone for the Gencaro development program with the completion of an End-of-Phase 2 FDA meeting that provided important guidance for the next steps in our development of Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "With work underway on completing the Gencaro Phase 3 trial protocol and continued progress with IND enabling activities for AB171 in PAD and HF, we believe ARCA is advancing our pipeline of genetically-targeted therapeutics to address the unmet medical needs of patients with cardiovascular disease."

Pipeline Update

Gencaro (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation (AF) and chronic heart failure with reduced left ventricular ejection fraction (HFrEF).

In April 2018, Medtronic, Inc. and ARCA agreed to extend their current U.S., Canadian and European Clinical Trial Collaboration Agreement for one additional year.

In May 2018, results from ARCA’s GENETIC-AF Phase 2B clinical trial were presented in a "Late Breaking Clinical Trials" oral presentation at the European Society of Cardiology (ESC) Heart Failure 2018 World Congress.

In June 2018, ARCA held an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review the GENETIC-AF data and potential future Gencaro development plans.

FDA concurrence to proceed into Phase 3 was reached. ARCA anticipates submitting a Special Protocol Assessment (SPA) application for the proposed Gencaro Phase 3 clinical trial in the third quarter of 2018. Progress to Phase 3 is dependent on the Company receiving additional funding.
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 were continued in the second quarter.

IND-enabling non-clinical studies are anticipated to begin in the first half of 2019.
Second Quarter 2018 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $9.6 million as of June 30, 2018, compared to $11.8 million as of December 31, 2017. 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 first quarter of 2019.

Research and development (R&D) expenses for the quarter ended June 30, 2018 totaled $1.2 million compared to $4.5 million for the corresponding period of 2017. The $3.3 million decrease in research and development expenses in the second quarter of 2018 as compared to the second quarter 2017 was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial. The Company expects R&D expenses in 2018 to be lower than 2017 as the GENETIC-AF clinical trial has been completed.

General and administrative (G&A) expenses for the quarter ended June 30, 2018 were $1.0 million, relatively unchanged compared to the $1.1 million in the second quarter of 2017. ARCA expects G&A expenses in 2018 to be consistent with those in 2017 as it maintains administrative activities to support ongoing operations.

Total operating expenses for the quarter ended June 30, 2018 were $2.2 million compared to $5.6 million for the second quarter of 2017. The decrease in total operating expenses for the second quarter of 2018 was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $2.1 million, or $0.15 per share, for the second quarter of 2018 compared to $5.5 million, or $0.59 per share, for the second quarter of 2017.