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250-511 | Administration of Symantec(TM) Data Loss(R) Prevention 11

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250-511 - Administration of Symantec(TM) Data Loss(R) Prevention 11 - braindump

Vendor Symantec
Exam Number 250-511
Exam Name Administration of Symantec(TM) Data Loss(R) Prevention 11
Questions 176 Q & A
Recent Update October 16, 2018
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250-511 exam Dumps Source : Administration of Symantec(TM) Data Loss(R) Prevention 11

Test Code : 250-511
Test Name : Administration of Symantec(TM) Data Loss(R) Prevention 11
Vendor Name : Symantec
Q&A : 176 Real Questions

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Symantec Administration of Symantec(TM) Data

Salesforce broadcasts consumer 360 service, Apple Partnership | killexams.com Real Questions and Pass4sure dumps

First identify: ultimate name: electronic mail tackle: Password: ascertain Password: Username:

Title: C-level/President manager VP body of workers (associate/Analyst/and many others.) Director

feature:

position in IT decision-making technique: Align enterprise & IT dreams Create IT method check IT needs control seller Relationships evaluate/Specify brands or providers different role Authorize Purchases now not involved

Work phone: enterprise: enterprise dimension: business: highway handle city: Zip/postal code State/Province: nation:

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Google Chrome 70 is coming. Are your safety certificates so as? | killexams.com Real Questions and Pass4sure dumps

previous this yr, I wrote about what security professionals should do to put together for the upcoming Google distrust time limit. I noted that DigiCert had taken a number of steps that ended in a easy process this spring for the first of two distrust dates. we now have yet another date drawing near when Google Chrome 70 will distrust all TLS certificates issued from the Symantec PKI.

Given what I’ve discovered from DigiCert, I suppose confident that DigiCert is managing the Chrome 70 process easily this time round, too.

Plan to part out Symantec certificates

For those unfamiliar with the particulars of this, in 2017 Google and Mozilla decided to deprecate all Symantec-issued digital certificates according to their assessment that Symantec didn't as it should be validate its SSL certificates previous to issuing them to shoppers.

Google and Mozilla then decided to place in location a multi-step plan to mistrust any certificates issued from the Symantec PKI. This plan phased out Symantec certificates over the subsequent yr and a half. as an alternative of following the Google plan, Symantec elected to promote its certificates enterprise to DigiCert. regardless of the transaction, the requirement to replace all certificates issued from the Symantec PKI remained intact, requiring hundreds of thousands of certificates to get replaced during 2018. To aid valued clientele in changing their certificates, DigiCert contacted every certificates holder, providing free replacement certificates chained to the trusted DigiCert roots.

the first most important mistrust date changed into on December 1, 2017, when no extra TLS certificates can be issued during the Symantec PKI. earlier than that date, DigiCert cut over all issuance techniques to its PKI and validation methods. The next predominant mistrust date changed into March 15, 2018, when Chrome 66 beta distrusted all Symantec TLS certificates issued earlier than June 1, 2016. 

The final predominant step in this distrust event is scheduled for Oct. sixteen, 2018, when Chrome 70 good will mistrust all TLS certificates issued from the Symantec PKI. (This date might also alternate in accordance with Google’s release time table.) Upon release of Chrome 70, any web page nevertheless the use of a Symantec certificates may have an interstitial warning a couple of non-private connection.

HTTPS is now in all places, making certificates compliance obligatory

regularly occurring knowledge was once that handiest sites that deal with economic or other sensitive facts required certificates, however instances have changed. today over 80 p.c of net site visitors is “https”, which contains many base pages. there has been a speedy pressure to https all over the place, and it won’t be long when basically every page is comfortable.

Google is ushering that along. Chrome now marks all HTTP net pages as “now not comfy” in the browser address bar. also, notwithstanding the web site is monitor handiest, the warning clients will see may scare them off and cause them talk over with a competitor, so it’s something all safety specialists that manage sites may still be concerned about. 

different platforms additionally crack down on Symantec certificates

It’s crucial to note that despite the fact Chrome 70 is the place the instant challenge is, other platforms will be doing the same issue with Symantec-issued certificates. Mozilla's date is across the equal time as Chrome's, however the user base is a good deal smaller. Apple has not issued a final date, however the primary phase has been accomplished, so older certificates won’t work. Microsoft nonetheless has no introduced date, however the business has incredible controls for the mistrust difficulty, so there should still no longer be plenty of an affect in the beginning.

conform to Chrome distrust now

My assistance to safety leaders is to focus on the difficulty now, forward of the Chrome date. Google had essentially the most aggressive date, so complying with Chrome mistrust skill the other dates down the street won’t be of difficulty as a result of a compliant certificates will be in vicinity. I mentioned this before, but it surely’s price reiterating that here is whatever all businesses should still conform to inspite of the intention of the web page. 

companies that have a big number of websites might locate this a burdensome system as a result of changing certificates manually can be time-drinking, tedious, and filled with error because of the variety of steps involved. DigiCert has put a couple of automation equipment in location to make the system of checking and upgrading convenient. It is rarely full automation, as a couple of guide steps are required, however the technique of relocating from the non-compliant Symantec certificates to a present one is enormously more convenient than before, so complexity is not any longer a barrier.

DigiCert has completed a good job disposing of any obstacles to doing a free alternative with them. They’ve managed to simplify the process right down to a pair clicks in a client internet portal, akin to how an administrator would renew a certificate about to run out.

I checked in with DigiCert, the brand new owner of the Symantec CA company, on how the upgrade of the Symantec consumer base has gone. to this point, about ninety nine % of the Alexa 1 million (which makes up the huge majority of web traffic) base domains have been changed devoid of difficulty. the majority of all impacted certificates are reissued or in technique. The past dates have come and gone devoid of concern, and i expect an analogous outcomes with the remaining step developing in mid-October.


Symantec warns of China-based mostly espionage crusade concentrated on satellites | killexams.com Real Questions and Pass4sure dumps

A China-based cyber community is accomplishing an in depth hacking crusade by means of concentrated on satellite tv for pc, telecom and defense companies within the u.s. and Southeast Asia, a U.S. cybersecurity firm warned this week.

The purpose of the hacking community, referred to as "Thrip," is likely national cyber espionage, security researchers at Symantec Corp. spoke of on Tuesday.

"Thrip’s assault on telecoms and satellite tv for pc operators exposes the opportunity that the attackers may intercept and even alter communications site visitors from agencies and consumers," Symantec observed in a statement, including that the most stressful discovery is an try and manage satellites via infecting linked computers with malware.

commercial

"The assault group seemed to be notably interested in the operational facet of the company, hunting for and infecting computer systems operating utility that displays and controls satellites. this suggests to us that Thrip’s motives go past spying and may additionally include disruption," Symantec wrote in a separate blog publish.

Satellites play a primary position in telecommunications, receiving and transmitting phone and cyber web alerts in addition to mapping and geolocation information.

Symantec said in Tuesday's remark that it has tracked Thrip seeing that 2013 and currently accompanied that the cyber community seems to have "discovered new tools and innovations used by the community during this most contemporary set of attacks."

The possibility of the more advantageous hacking toolbox is further compounded via Thrip's means to reside smartly hidden.

"They function very quietly, mixing in to networks, and are handiest found out using artificial intelligence that may determine and flag their movements," Symantec Chief executive Greg Clark referred to in a press release.

The business says it found out the new assaults through its artificial intelligence-primarily based targeted attack Analytics, which helped the researchers spot the malicious conduct that was hiding in legitimate IT administration tools.




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250-511 exam Dumps Source : Administration of Symantec(TM) Data Loss(R) Prevention 11

Test Code : 250-511
Test Name : Administration of Symantec(TM) Data Loss(R) Prevention 11
Vendor Name : Symantec
Q&A : 176 Real Questions

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Administration of Symantec(TM) Data Loss(R) Prevention 11

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Cyber Security Market in Depth Professional Survey Report 2018-2022 | killexams.com real questions and Pass4sure dumps

(MENAFN Editorial) iCrowdNewswire - Sep 18, 2018

The Global Cyber Security Market was worth USD 58.13 billion in the year 2012 and is expected to reach approximately USD 173.57 billion by 2022, while registering itself at a compound annual growth rate (CAGR) of 10.35% during the forecast period.

Cyber Security - Top Major Market Players:

The major players in the market are Symantec Software Solutions Private Limited, Trend Micro, Cisco Systems, Check Point Software Technologies and Fortinet Inc.

Sample Copy of the Report here @ www.crystalmarketresearch.com/report-sample/IC10289 .

Cyber security is the group of practices, technologies and procedures intended to ensure data, networks, programs and computers from attacks, unauthorized access or damage. Security incorporates both cyber security and physical security in computing context. Guaranteeing cyber security requires composed endeavors all through a data framework. A standout amongst the trickiest components of cyber security is the constantly and rapidly developing nature of security dangers. The conventional approach has been to concentrate most assets on the most vital framework segments and secure against the greatest known dangers, which required abandoning some less essential framework parts undefended and some less unsafe dangers not ensured against. Such an approach is deficient in the present condition.

The emergence of cloud storage has increased the chances of data breaches and cybercrimes. The institution of Internet of Things (IoT) is opening up attack surfaces, using vulnerabilities for network frameworks. This is bringing about the adoption of remote and endpoint security being one of the prime factors that influence the development of the cyber security market. The emerging economies, for example, China, India, Hong Kong, South Korea, and, have high motivating forces in consolidating their IT structures.

The Global Cyber Security market is segmented as follows:

Cyber Security - By Region:

North America - U.S, Canada, MexicoEurope - Germany, France, UK, Italy, Spain, Rest of EuropeAsia-Pacific - Japan, China, Australia, India, South Korea, Rest of Asia PacificRest of the World - Brazil, South Africa, Saudi Arabia, United Arab Emirates, Others

Cyber Security - Regional Outlook and Trend Analysis:

In 2015 Asia Pacific represented more than 21 percent share of the global industry. The expanding dependence on the Internet has expanded vulnerabilities, giving chances to programmers and assailants. South Korea, Singapore, and Singapore have expanded the extent of their cyber policy structure and the viability of their execution. Nonetheless, nations, for example, Australia, India, and China are concentrating on bringing together the organization of the cyber policy under the government divisions. Latin America is expected to be a developing locale over the gauge time frame. The area has one of the most elevated penetrations of cell phones prompting vulnerabilities for digital assaults as these gadgets are a simple focus for malware attack, stressing the requirement for the advancement of compelling cybercrime security and policies.

Cyber Security - Service Outlook and Trend Analysis

Security models are being outsourced by associations to third party suppliers inferable from lacking security experts in-house, hence boosting the development of security benefits over the estimate time frame. Rising demand for cloud-based security administrations to diminish costs and enhance profitability is anticipated to drive the development of security services over the figure time frame. Managed services are anticipated to have a high development attributable to the expanding dangers from regular extremist exercises. The rising government expenditure for the usage of cyber security arrangements in India and China is boosting the development of security services.

Cyber Security - By Component:

SolutionsUnified threat managementIDS/IPSData Loss Prevention (DLP)

Identity Access Management (IAM)Security Information and Event Management (SIEM)Distributed Denial of Service (DDoS)Risk and compliance managementOther Solutions

ServicesProfessional servicesManaged services

Cyber Security - By Security Type:

Enterprise securityCloud securityNetwork securityApplication securityOther Security Types

Cyber Security - By Deployment:

CloudOn-premise

Cyber Security - By Organization:

Small and medium enterprisesLarge enterprises

Cyber Security - By Application:

IT & TelecomBFSIRetailHealthcareAutomotiveDefense/governmentOther Applications

For more information, click on the below link @ www.crystalmarketresearch.com/report/cyber-security-market .

Cyber Security - Application Outlook and trend Analysis

The BFSI section is anticipated to encounter a solid development in the cyber security market in the upcoming years. The segment is expanding its cyber security expenditure in light of the developing breaches and risks. The expanded utilization of versatility channels for financial transactions and correspondence is expanding the susceptibility for cyberattacks. Banks have actualized a two-factor confirmation for online and mobile banking, which has a high exposure to threats because of the risks like loss of gadget and frail passwords. The defense/government segment is changing progressively as dangers from regular exercises are not any more the main concerns. The assignment of resources for growing investment and research and development of defense programs are foreseen to remain the key patterns in the cyber security industry. For example, the United States President proposed a financial plan of USD 14 billion for 2016 for the digital security endeavors over the administration to shield the private and government systems from cyber assaults.

Read Premium News from OpenPR of 'Cyber Security Market @ https://www.openpr.com/news/1244743/Cyber-Security-Market-Development-Strategy-CAGR-10-35-forecasted-period-2018-2022-Symantec-Software-Solutions-Private-Limited-Trend-Micro-Cisco-Systems-Check-Point-Software-Technologies-and-Fortinet-Inc.html .

Cyber Security - Table of Contents:

1.Introduction

2.Executive Summary

3.Market Overview

4.Cyber Security Market, By Component4.1.Introduction4.2.The Cyber Security Market Assessment and Forecast, By Component, 2012-20224.3.Solutions4.4.Services5.Cyber Security Market, By Security Type5.1.Introduction5.2.The Cyber Security Market Assessment and Forecast, By Security Type 2012-20225.3.Enterprise security5.4.Cloud security5.5.Network security5.6.Application security5.7.Other Security Types…

Key findings of the Cyber Security Market:

The healthcare segment is anticipated to encounter significant development in the upcoming years. The health insurers are the prime focus of the cyber assaults like spear phishing and Advanced Persistent Threats (APTs). The violations and breaks in this area are ascending as the cost of stolen medical record is expanding.

The rising requirement for Security-as-a-Service (SaaS) and cloud-based solutions is anticipated to render growth opportunities to the service segment.

The North American cyber security industry is foreseen to develop at substantial pace in the following years. The expanding cybercrime costs are empowering the district to concentrate on building a solid strength framework for dealing with cybercrimes.

MEA is foreseen to develop at considerable rate over the forecast period. The locale is implementing computerized innovations and applications at a speedier pace, expanding the danger of digital assaults. The extension of digitization all through the area has made cyber security a need for associations.

To avail discount, please click on the link @ www.crystalmarketresearch.com/check-discount/IC10289 .

To be continued…

About Crystal Market Research:

Crystal Market Research is a U.S. based market research and business intelligence company. Crystal offers one stop solution for market research, business intelligence, and consulting services to help clients make more informed decisions. It provides both syndicated as well as customized research studies for its customers spread across the globe. The company offers market intelligence reports across a broad range of industries including healthcare, chemicals & materials, technology, automotive, and energy.

Contact Information:

Judy304 South Jones Blvd, Suite 1896,Las Vegas NV 89107,United StatesToll Free: +1-888-213-4282Email: [email protected]

MENAFN1809201800703403ID1097451517

Cyber Security Market in Depth Professional Survey Report 2018-2022

TherapeuticsMD Announces Multiple Presentations Related to Imvexxy™ and TX-001HR at the 2018 Annual Meeting of the North American Menopause Society | killexams.com real questions and Pass4sure dumps

BOCA RATON, Fla.--(Business Wire)--TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced the schedule of ten oral presentations and posters at NAMS 2018, the annual meeting of the North American Menopause Society being held in San Diego, California on October 3-6, 2018, related to ImvexxyTM (estradiol vaginal inserts) and TX-001HR, the Company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

There will be three oral presentations reviewing the findings of the Phase 3 Replenish Trial of TX-001HR and the systemic profile of Imvexxy (TX-004HR).

“We are pleased to present additional data from the Replenish Trial that further support the safety and efficacy of TX-001HR as the first bio-identical combination hormone therapy of estradiol and progesterone,” said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. “The FDA PDUFA target action date for TX-001HR is October 28, 2018. If approved, TX-001HR would provide an FDA-approved treatment option for the millions of postmenopausal women who are currently seeking treatment for moderate to severe vasomotor symptoms using unapproved compounded hormones.”

The posters and presentations will be made available on the Investors & Media section of the company’s website at www.therapeuticsmd.com.

 

Oral Presentations

  Date:         October 4, 2018 Time: 4:45-5:00 pm Title:

Effects of Single-Capsule 17β-Estradiol/Progesterone (TX-001HR) on Metabolic Parameters and Cardiovascular Outcomes in Menopausal Women of the REPLENISH Trial

  Date: October 5, 2018 Time: 4:15-4:30 pm Title: 17β-Estradiol/Progesterone in a Single, Oral, Softgel Capsule (TX-001HR) Significantly Increased the Number of Symptom-free Days in the REPLENISH Trial   Date: October 5, 2018 Time: 5:00-5:15 pm Title:

Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule (TX-004HR) in Menopausal Women with Moderate-to-Severe Dyspareunia

 

Posters

Date: October 4, 2018 Time: 6:00-7:00 pm   Title: Physical Characteristics of TX-004HR: An Ultra-Low-Dose (4- and 10-µg) Estradiol Softgel Capsule Vaginal Insert   Title: A 17β-Estradiol, Softgel, Vaginal Capsule (TX-004HR) Demonstrated an Early Onset of Action for Treating Vulvar and Vaginal Atrophy (VVA) and Moderate-to-Severe Dyspareunia   Title: Systemic Estradiol Levels with Low-Dose Vaginal Estrogens May Differ by Dose and by Product   Title: Correlations of Serum Estradiol and Estrone Concentrations with Menopausal Outcomes and Bleeding   Title: Effects of Single-Capsule 17β-Estradiol/Progesterone (TX-001HR) on Weight and Blood Pressure in Menopausal Women of the REPLENISH Trial   Title: Estradiol and Progesterone Bioavailability for Moderate-to-Severe Vasomotor Symptom Treatment and Endometrial Protection with the Continuous-Combined Regimen of TX-001HR (Oral Estradiol and Micronized Progesterone Capsules)   Title: TX-001HR is Associated with a Clinically Meaningful Effect on Severity of Moderate-to-Severe Vasomotor Symptoms in the REPLENISH Trial  

About Imvexxy

Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Imvexxy is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg dose representing the lowest approved dose of vaginal estradiol available. The full prescribing information may be viewed by visiting www.Imvexxy.com.

IMPORTANT SAFETY INFORMATION FOR IMVEXXY

  WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens

• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia

• The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)

• The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

 

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia

• The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)

• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer

• The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

 

CONTRAINDICATIONS

  • Imvexxy™ is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Imvexxy; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
  • WARNINGS AND PRECAUTIONS

  • Imvexxy is intended only for vaginal administration. Systemic absorption may occur with the use of Imvexxy.
  • The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
  • The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
  • Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice.
  • Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
  • Women on thyroid replacement therapy should have their thyroid function monitored.
  • ADVERSE REACTIONS

  • The most common adverse reaction with Imvexxy (incidence ≥ 3 percent) and greater than placebo was headache.
  • Please note that this information is not comprehensive. Please visit www.Imvexxy.com for the Full Prescribing Information, including the Boxed WARNING.

    About TherapeuticsMD, Inc.

    TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

    Forward-Looking Statements

    This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: whether the FDA will approve the NDA for the company’s TX-001HR product candidate and whether such approval will occur by the PDUFA target action date; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXYTM, ANNOVERATM and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan agreement; the length, cost and uncertain results of the company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates or adversely affect the commercialization of the company’s current or future approved products; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

    TherapeuticsMD, Inc.Investor Contact:Nichol Ochsner, 561-961-1900, ext. 2088Vice President Investor RelationsNochsner@TherapeuticsMD.com


    ARCA biopharma Announces Second Quarter 2018 Financial Results and Provides Corporate Update | killexams.com real questions and Pass4sure dumps

    WESTMINSTER, Colo., Aug. 09, 2018 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the quarter ended June 30, 2018.

    “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.

    About ARCA biopharma

    ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, 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) which recently completed a Phase 2B clinical trial. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted AF prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by FDA. ARCA is also developing AB171, a thiol-substituted isosorbide mononitrate, as a potential genetically-targeted treatment for peripheral arterial disease (PAD) and for heart failure (HF). For more information, please visit www.arcabio.com.

    Story Continues

    Safe Harbor Statement

    This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of ARCA’s financial resources to support its operations through the end of the first quarter of 2019, potential future development plans for Gencaro, the expected features and characteristics of Gencaro or AB171, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat AF, AB171’s potential to treat HF, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically-targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.  These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2017, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.

    Investor & Media Contact:Derek Cole720.940.2163derek.cole@arcabio.com

    (Tables follow)

      ARCA BIOPHARMA, INC.   BALANCE SHEET DATA  (in thousands)  (unaudited)     June 30, 2018   December 31, 2017 Cash, cash equivalents & marketable securities $9,635   $11,752 Working capital $8,950   $10,229 Total assets $10,067   $12,365 Total stockholders’ equity $8,998   $10,275        

     

        ARCA BIOPHARMA, INC.       STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS   (unaudited)         Three Months Ended     Six Months Ended     June 30,     June 30,     2018     2017     2018     2017                                     (in thousands, except share and per share amounts)   Costs and expenses:                               Research and development $ 1,154     $ 4,508     $ 2,874     $ 7,754   General and administrative   1,002       1,051       2,055       2,186   Total costs and expenses   2,156       5,559       4,929       9,940   Loss from operations   (2,156 )     (5,559 )     (4,929 )     (9,940 )                                 Interest and other income   43       39       84       84   Interest expense   (3 )     (2 )     (6 )     (4 ) Net loss $ (2,116 )   $ (5,522 )   $ (4,851 )   $ (9,860 )                                 Change in unrealized loss on marketable securities   —       4       2       14   Comprehensive loss $ (2,116 )   $ (5,518 )   $ (4,849 )   $ (9,846 )                                 Net loss per share:                               Basic and diluted $ (0.15 )   $ (0.59 )   $ (0.35 )   $ (1.07 ) Weighted average shares outstanding:                               Basic and diluted   13,923,512       9,324,822       13,772,947       9,210,186                                  

    A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740



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