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250-511 exam Dumps Source : Administration of Symantec(TM) Data Loss(R) Prevention 11
Test Code : 250-511
Test designation : Administration of Symantec(TM) Data Loss(R) Prevention 11
Vendor designation : Symantec
: 176 true Questions
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Symantec Administration of Symantec(TM) Data
MOUNTAIN VIEW, Calif.--(business WIRE)--Symantec Corp. (NASDAQ:SYMC), the global leader in cyber safety, today added Symantec advanced random insurance policy (ATP), the first solution that can notice and remediate superior threats across manage facets, from a single console with only a click, everything and not using a new endpoint agents to set up.
advanced threats, reminiscent of ransomware, far flung entry trojans, advanced persistent threats (APTs) and 0 day attacks, are on the upward thrust and protection authorities can now not rely on the expend of particular person aspect products at each and every manage component to cease them. The procedure of uncovering risk data across endpoint, community and electronic mail gateways is manual and time-drinking, which offers attackers an side. Symantec ATP correlates suspicious exercise throughout everything handle aspects and prioritizes the activities that pose probably the most risk to an organization. once a vital risk is recognized, it will possibly now be rapidly contained and new instances may likewise be blocked.
Symantec ATP makes it possible for valued clientele to:
discover a full ambit of threats from APTs to zero day assaults throughout endpoint, community and electronic mail, with pass-handle factor detection and environmental search
Prioritize what concerns most by way of correlating the possibility intelligence from throughout local control facets with everything that Symantec sees globally through its big telemetry
Remediate the threats speedy through containment of endpoints and blocking off new cases throughout manage aspects, with one click, from a single console
Leverage latest investments in Symantec Endpoint safety and e mail safety.cloud, with out deploying any new endpoint brokers
“security gurus are constantly on their toes trying to pomp screen and stop the subsequent cyber-attack,” mentioned Michael A. Brown, president and CEO, Symantec. “We’re relocating the trade forward with Symantec advanced danger protection with the aid of giving clients an entire photo of their all traffic from a single console. Now they could lucid out the hubbub and quickly find and remediate an assault.”
cutting back the hubbub for customers with Symantec ATP occurs in a brace of methods. First, Symantec’s sizable world possibility intelligence combined with local customer records means companies possess a more redress view of which threats pose the greatest risk interior their infrastructure. moreover, Symantec ATP comprises Symantec CynicTM, a brand new cloud-based sandboxing and payload detonation carrier to find and prioritize nowadays’s most superior threats. It additionally includes SynapseTM, a pass-control aspect correlation talent that collects suspicious activity across endpoints, networks and e-mail to prioritize people who are of premiere possibility to the firm.
“Our new Synapse and Cynic technologies labor together to supply up to 30 percent superior detection than latest products out there1,” said Balaji Yelamanchili, executive vice president and accepted manager of enterprise security company, Symantec. “earlier than, a security professional would requisite to manually determine to peer if a suspicious file became appropriately blocked. With their new applied sciences constructed into Symantec ATP, they carry out the legwork for shoppers, cutting down on their search and remediation time.”
“The regular traffic uses 75 distinctive protection products,” Yelamanchili added. “That overload creates possibility for attackers because it slows down detection. Symantec ATP makes it possible for security professionals to click on as soon as and remediate everything over across everything three control features.”
Symantec ATP enhances present installations of SymantecTM Endpoint coverage and e mail protection.cloud devoid of requiring any new endpoint brokers. This enables consumers to installation a brand new installing of Symantec ATP in under an hour and hunt attacks in minutes. The product can likewise export its wealthy intelligence into third birthday celebration security incident sustain managers (SIEMs). As Symantec ATP evolves, the enterprise plans to open it up to third party technology partners, together with firewall and different security product vendors, allowing consumers to extend the cost of their current investments.
“Securing a sizable pan-European stock exchange is tall stakes and their IPO in 2014 introduced an immense diploma of complexity to securing their facts. as the world has viewed, one technical glitch can rock the markets and judgement fiscal, criminal and reputational harm. Euronext became to market-chief Symantec to at ease its infrastructure and signed on to gawk at various an early version of Symantec’s superior probability insurance plan. Already it’s featuring improved visibility into what’s happening on Euronext’s endpoints; and doing it in a less complicated, quicker more efficient way. because of this, Euronext has prioritised and reduced the variety of talents safety incidents,” celebrated Marc green, Head of random and Vulnerability management, Euronext.
“in reality, going forward, greater prevention, detection, response and prediction capabilities are everything crucial to contend with every kind of attacks, ‘advanced’ or now not. in addition, these should still no longer be viewed as siloed capabilities; rather, they may still labor intelligently together as an built-in, adaptive device to constitute an entire insurance draw system for advanced threats.” (supply: Gartner, Designing an Adaptive security architecture for insurance policy From superior attacks 12 February 2014, Gartner Foundational 19 November 2014)
“As corporations' security estates become greater complicated, in response to a dynamic danger panorama, CISOs demand a platform that integrates and manages their safety operations. in a similar way, to address competencies shortages, they requisite a mechanism that automates as an dreadful lot of their safety operations as feasible, and in specific detects and remediates threats prerogative away,” mentioned Duncan Brown, analysis Director, European protection practice, IDC.
“Our strategic relationship with Symantec has bought an extra raise with the addition of the Symantec superior probability protection. at the present time of cyber threats, they firmly agree with that ATP will tremendously raise valued clientele’ defenses by means of embedding sophisticated possibility detection and remediation capabilities into their current security portfolio. by using leveraging Wipro’s commercial enterprise protection solutions’ potential and Symantec’s efficient expertise prowess, they are expecting to considerably enhance their shoppers’ aplomb in their Cyber insurance draw and risk management approach,” referred to Sheetal Mehta, VP & international Head – commercial enterprise safety options, Wipro.
“In nowadays’s dynamic world, corporations, greater than ever, are challenged by way of safety requirements because the facts resides in public, inner most and virtual environments. The truth of the BYOD phenomenon internal corporations possess made facts possibility management the entire extra vital,” referred to Kalyan Kumar, SVP & Chief Technologist, HCL technologies. “In this kind of state of affairs, Symantec advanced threat protection is a state-of–the-paintings reply that not handiest acts as an early warning device however allows consumers to hold full edge of Symantec’s vast amounts of threat intelligence to aid prioritize the incidents that aren’t caught by way of different factor products across the enterprise IT atmosphere. It’s precisely what their purchasers are seeking – a simple technique to manage and forestall the next mega breach.”
Pricing and Availability
Symantec superior random coverage might be obtainable by using conclusion of calendar 12 months 2015.starting MSRP is $40 per person yearly to at ease one manage pointStarting MSRP is $60 per person yearly to cozy two handle pointsStarting MSRP is $70 per person annually to relaxed three manage elements
Symantec agency (NASDAQ:SYMC) is the global leader in cybersecurity. operating one of the most world’s largest cyber intelligence networks, they observe more threats, and give protection to greater shoppers from the subsequent era of assaults. We assist organizations, governments and individuals relaxed their most crucial records at any status it lives.
forward-looking STATEMENTS: Any ahead-looking indication of plans for items is introductory and everything future liberate dates are tentative and are discipline to change. Any future free up of the product or planned modifications to product ability, functionality, or office are discipline to ongoing contrast through Symantec, and might or might likewise not be applied and should not be considered arduous commitments by Symantec and may not be relied upon in making procuring selections.
1 supply: Miercom, Symantec advanced random insurance policy: network, April 2015. http://miercom.com/pdf/experiences/20150218.pdf
Most concomitant products Articles
Endpoint security products from CrowdStrike and Symantec both made eSecurity Planet's record of top conclusion point detection and response (EDR) solutions – and while each and every product has an dreadful lot to proffer traffic shoppers, there are key variations between them. What follows an analysis of every solution's key aspects, in addition to some strengths and weaknesses.
The base line
each solutions are rated highly through clients in addition to traffic analysts. CrowdStrike's cloud structure makes deployment strangely short and easy, notwithstanding the incontrovertible fact that or not it's a long way less advantageous offline makes it unsuitable for air-gapped networks. Symantec offers each an on-premises solution and a cloud-primarily based one, featuring a wider ambit of alternatives for shoppers – but it's frequently considered as being greater complicated to manage than its opponents.
CrowdStrike EDR Highlights
Overview: CrowdStrike Falcon insight leverages signatureless AI and indicator-of-assault (IOA) based mostly probability prevention to proffer protection to users from everything kinds of cyberattacks. Falcon offers contextualized probability intelligence with particulars on the hazard, and a five-second search appliance allows for teams to discover and investigate current and historic possibility exercise by means of going lower back one 2nd, someday or one year of pastime. The solution’s cloud-based mostly architecture is designed to give hasty response without placing any stress on purchasers' endpoints.
recent traits: improvements over the past twelve months encompass:
a appliance manage characteristic for visibility and administration of USB instruments
A Vulnerability assessment characteristic, opting for vulnerabilities and missing updates on endpoints through immediately monitoring and examining patches on each and every system
Mapping of detection to a framework based on MITRE ATT&CK to speed up figuring out, triage and response
true-time response movements
Docker support, allowing the setting up of the Falcon agent on hosts operating the Docker container platform so the host can be secured while consumers expend Docker
elevated integration of the Falcon OverWatch managed detection and response carrier
Analysts' take: Gartner says the combination of Falcon OverWatch with Falcon perception EDR is certainly compelling for businesses with wee or no SOC teams. The Falcon insight EDR agent offers parity throughout home windows, Mac OS and Linux systems, and valued clientele document essential and straightforward deployments, in portion as a result of the answer's cloud structure. nevertheless, the research arduous says Falcon's EDR functionality requires knowledgeable technical personnel to fabricate expend of, and its offline insurance draw is vastly superior when related to the cloud-based Falcon platform, making it unsuitable for air-gapped (secure, remoted) networks.
Symantec EDR Highlights
Overview: Symantec EDR uses behavioral evaluation at the endpoint and AI-based mostly analytics in the cloud to discover superior assaults. The reply provides a comprehensive set of detection, investigation and remediation capabilities for everything tiers of investigators, together with automatic investigation playbooks and user conduct analytics. Incident responders can immediately search, determine and comprise impacted endpoints whereas investigating threats the usage of a conclusion of on-premises and cloud-primarily based sandboxing.
recent tendencies: improvements over the ultimate 12 months include:
assist for targeted assault Analytics (TAA), leveraging AI algorithms to become sensible of suspicious undertaking and rising threats in Symantec Endpoint insurance draw information accumulated and correlated in a immense records lake
guide for MITRE ATT&CK tactics and ideas and MITRE Cyber Analytics, enabling investigators to gawk and filter hobbies and incidents by MITRE ATT&CK tactics with a purpose to map movements to the ATT&CK matrix
brought more than a dozen detections from the MITRE Cyber Analytics Repository (motor vehicle) as computerized investigation playbooks
Analysts' take: Gartner says Symantec is the primary seller to proffer malware coverage, EDR, device hardening and deception capabilities in a single agent, and its big deployment throughout a really tremendous population of both client and company endpoints offers it a very huge view into the random landscape throughout many verticals. still, the research company says Symantec is perceived as extra knotty and useful resource-intensive to exploit than its competitors, and its managed safety capabilities are extra expensive than those from more recent providers.
EDR Product rankings
listed here are eSecurity Planet's scores of every solution's key facets.
performance: shoppers of each vendors record solid performance, with minimal possess an sequel on on endpoints. essentially the most fresh Forrester Wave file on EDR options gave CrowdStrike the optimum ranking of everything EDR companies proven – 4.fifty six out of five – and gave Symantec a score of two.72 out of five. The rating is based on a variety of criteria, including configurability, agent effectiveness, forensic capabilities, deployment alternatives and response movements.
Detection and response: In fresh checking out, Forrester rated CrowdStrike's detection capabilities at four.eight out of 5, and its response capabilities at four.6 out of 5. Symantec's detection capabilities were rated at 2.0 out of 5, and its response capabilities at four.2 out of 5. Symantec shoppers report stronger possibility detection and containment with the addition of computer getting to know and other superior anti-malware facets, Gartner noted.
cost: while CrowdStrike is extra expensive than many other options, cloud statistics storage and managed detection and response are protected. Symantec presents managed features, however those features are greater tall priced than those from other providers.
Implementation and management: CrowdStrike's cloud architecture makes deployment certainly effortless, whatever clients time and again cite in studies. Symantec presents each cloud-primarily based and on-premises alternate options, making it more desirable suited for hybrid environments. both options require expert technical personnel to manage, although managed detection and response services can be found.
assist: Gartner says Symantec purchasers file incongruous assist experiences, even when giant organizations are offered with committed aid personnel. nevertheless, some reviewers spoke of the identical of CrowdStrike's tech aid.
Cloud features: both organizations present cloud-based mostly options, besides the fact that children CrowdStrike's offering is purely cloud-based, giving Symantec the portion in hybrid environments.
Gartner Peer Insights clients give CrowdStrike Falcon an middling rating of four.6 out of 5, with Symantec EDR following at a yardstick of four.0 stars out of 5. IT imperative Station clients supply CrowdStrike 4.0 stars out of 5, and Symantec four.1 out of 5.
CrowdStrike reviewers repeatedly stated the product’s ease of deployment, calling it "short and effortless to install" and reporting that "the sensor is truly lightweight and has no longer been considerable when operating on even aid-limited computer systems." different reviewers wrote that "the hobbies administration of this reply is manageable," and that CrowdStrike has "a different proposition with their cloud-primarily based fashion as neatly because the research group."
Symantec reviewers said that "implementation changed into effortless." They referred to "short whitelisting and blacklisting and informative reporting" as key advantages, including that the reply "has provided visibility insights that they were no longer receiving from other items." yet another reviewer pointed out the product "matches very neatly with their existing strategies and strategies," calling it "a superb product to give protection to your environment."
study more experiences written via users of CrowdStrike and Symantec.
The CrowdStrike Falcon platform is absolutely cloud-based mostly, allowing it to be deployed within hours, and supports windows, Mac and Linux programs.
Symantec EDR presents cloud, on-premises and hybrid deployment models, and supports windows, Mac and Linux methods.
CrowdStrike Falcon insight is purchasable for an annual subscription payment per endpoint, with a free ordeal purchasable. AWS gives some pricing information.
Symantec EDR is priced per consumer per 12 months, with quantity discounting. Trials can be found. CDW presents some pricing information.
A China-based mostly cyber group is carrying out an extensive hacking drive by way of focused on satellite, telecom and protection organizations in the united states and Southeast Asia, a U.S. cybersecurity company warned this week.
The purpose of the hacking group, called "Thrip," is probably going countrywide cyber espionage, safety researchers at Symantec Corp. mentioned on Tuesday.
"Thrip’s storm on telecoms and satellite tv for pc operators exposes the probability that the attackers could intercept or even alter communications traffic from enterprises and consumers," Symantec spoke of in a press release, including that the most stressful discovery is an try to handle satellites by means of infecting linked computer systems with malware.
"The assault community gave the impression to be principally drawn to the operational aspect of the company, hunting for and infecting computer systems running application that screens and controls satellites. this suggests to us that Thrip’s factors depart beyond spying and can additionally encompass disruption," Symantec wrote in a separate blog publish.
Satellites play a necessary office in telecommunications, receiving and transmitting phone and information superhighway alerts as well as mapping and geolocation information.
Symantec observed in Tuesday's observation that it has tracked Thrip in view that 2013 and currently followed that the cyber group looks to possess "found out new tools and concepts used via the community in this most fresh set of attacks."
The possibility of the more suitable hacking toolbox is extra compounded by way of Thrip's means to reside smartly hidden.
"They office very quietly, blending in to networks, and are most efficient create the expend of ersatz intelligence that may determine and flag their actions," Symantec Chief government Greg Clark celebrated in a statement.
The traffic says it create out the new attacks through its ersatz intelligence-based targeted assault Analytics, which helped the researchers spot the malicious habits that become hiding in reputable IT administration equipment.
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—APeX-2 24-week safety and efficacy data of once-daily oral BCX7353 for prophylaxis of hereditary angioedema (HAE) attacks on-track for Q2 2019—
—Full ZENITH-1 results substantiate safety and efficacy profile of oral 750 mg BCX7353 for upcoming phase 3 ordeal in acute treatment of HAE—
—Oral Factor D inhibitor, BCX9930, advancing to phase 1 evolution for complement-mediated diseases—
—Recent $100 million debt financing increases pecuniary flexibility—
RESEARCH TRIANGLE PARK, N.C., March 04, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (BCRX) today announced pecuniary results for the fourth quarter and full year ended December 31, 2018, and provided a corporate update.
“In a year with many transformative milestones for BioCryst, it has been exciting to observe so much progress already in the first two months of the year. The strong phase 2 clinical data from their now-completed ZENITH-1 ordeal propels their BCX7353 acute program for HAE into phase 3 development. With the very propitious preclinical profile of BCX9930, another novel BioCryst-invented oral drug for rare diseases, they are advancing that program into the clinic in the second quarter for the treatment of complement-mediated diseases. They likewise added further rare disease expertise to their board and increased their pecuniary flexibility with a $100 million debt agreement,” said Jon Stonehouse, president and chief executive officer of BioCryst.
“We remain on-track for the readout of their APeX-2 ordeal next quarter, and an NDA filing of BCX7353 for HAE prophylaxis by the halt of the year. They are thoughtfully pile their commercial leadership and infrastructure to execute a successful launch that meets the pressing demand for a once-daily oral therapy that will allow HAE patients to live a more routine life,” Stonehouse added.
The company has dosed the first patients in its APeX-J ordeal in Japan, designed to champion potential Japanese approval of BCX7353 for the prevention of HAE attacks.
On March 4, 2019, the company announced that it is advancing BCX9930, an oral Factor D inhibitor, into phase 1 clinical evolution in the second quarter of 2019 for the treatment of complement-mediated diseases.
On February 23, 2019, the company announced data from the completed ZENITH-1 ordeal (including the 250 mg and 500 mg dose cohorts) of BCX7353 for the acute treatment of HAE attacks at the annual meeting of the American Academy of Allergy, Asthma & Immunology. The company plans to commence a phase 3 trial, ZENITH-2, in the summer of 2019.
On February 6, 2019, the company announced it had entered into a $100 million secured credit facility with MidCap pecuniary reliance pursuant to the terms and conditions of an amended and restated credit and security agreement.
On January 4, 2019, the company announced it had appointed Steve Aselage to its board of directors.
On January 2, 2019, the company announced the dosing of the first theme in a randomized, placebo-controlled phase 1 clinical ordeal to evaluate intravenous galidesivir, its investigational broad-spectrum antiviral drug, in well volunteers.
Fourth Quarter 2018 Corporate Developments
On November 20, 2018, BioCryst announced that it had appointed Theresa Heggie to its board of directors.
On November 16, 2018, BioCryst presented data that showed an oral formulation of BCX7353 was rapidly absorbed and exhibited a long half-life, two necessary characteristics of desired new acute treatments for HAE attacks, at the annual scientific meeting of the American College of Allergy, Asthma & Immunology.
Upcoming Key Milestones
HAE Program – BCX7353
Report 24-week safety and efficacy results from the APeX-2 clinical ordeal (Q2 2019)
Begin a phase 3 clinical ordeal of oral BCX7353 for the acute treatment of HAE (Summer 2019)
File a new drug application (NDA) for oral BCX7353 for the prevention of HAE attacks with the U.S. Food and Drug Administration (FDA) (Q4 2019)
Complement Factor D Inhibitor Program – BCX9930
Begin a phase 1 ordeal of BCX9930, an oral Factor D inhibitor for treatment of complement-mediated diseases, in well subjects (Q2 2019)
Report phase 1 results (Q4 2019)
ALK-2 Inhibitor Program – BCX9250
Begin a phase 1 clinical ordeal of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva, in well subjects (2H 2019)
Fourth Quarter 2018 pecuniary Results
For the three months ended December 31, 2018, total revenues were $2.7 million, compared to $3.9 million in the fourth quarter of 2017. The diminish was primarily due to a reduction of royalty revenue associated with differences in the onset and severity of the influenza seasons between the two periods. This diminish was partially offset by increased revenue from government contracts for galidesivir development, which was higher in the fourth quarter of 2018.
Research and evolution (R&D) expenses for the fourth quarter of 2018 increased to $23.4 million from $16.9 million in the fourth quarter of 2017, primarily due to increased spending on the company’s HAE and preclinical programs.
General and administrative (G&A) expenses for the fourth quarter of 2018 decreased slightly to $4.5 million, compared to $4.7 million in the fourth quarter of 2017. The diminish was primarily due to the lack of merger-related costs in the fourth quarter of 2018 associated with the company’s terminated merger with Idera Pharmaceuticals, Inc. (Idera). The diminish in G&A expense due to the lack of merger expenses was largely offset by higher commercial and medical affairs expenses in the fourth quarter of 2018.
Interest expense was $2.4 million in the fourth quarter of 2018, compared to $2.2 million in the fourth quarter of 2017 and was associated with enhancing their secured credit facility in July 2018.
Net loss for the fourth quarter of 2018 was $27.4 million, or $0.25 per share, compared to a net loss of $19.5 million, or $0.20 per share, for the fourth quarter of 2017.
Cash, cash equivalents and investments totaled $128.4 million at December 31, 2018, and reflect a diminish from $159.0 million at December 31, 2017. Cash and investments reflect the proceeds from a July 2018 enhancement to their secured credit facility and an August 2018 public equity offering, offset by routine operating expenses and merger-related costs incurred in the 12-month period. Operating cash expend for the fourth quarter of 2018 was $22.6 million, and for the full year of 2018 was $93.4 million.
On February 6, 2019, the company announced it had entered into a $100 million secured credit facility with MidCap pecuniary reliance which further enhanced the company’s cash position with $20 million of immediate additional non-dilutive capital and provided additional pecuniary flexibility by providing the talent to draw another $50 million of milestone-based non-dilutive capital.
Full Year 2018 pecuniary Results
For the full year ended December 31, 2018, total revenues were $20.7 million, compared to $25.2 million in the full year ended December 31, 2017. The diminish in revenue was primarily associated with infrequent revenue events that occurred in 2017 that did not recur in 2018, as well as a $2.1 million diminish in revenue associated with evolution activities under U.S. government contracts in 2018. The non-recurring 2017 events were the recognition of $4.1 million of royalty revenue from Japanese government stockpiling of RAPIACTA® and the recognition of $1.5 million of peramivir product sales from the company’s commercial partner, Green Cross Corporation. These decreases were partially offset by a $5.0 million milestone associated with the European Medicines Agency’s (EMA) approval of peramivir (ALPIVABTM) recognized in the second quarter of 2018.
R&D expenses in 2018 increased to $84.9 million from $67.0 million in 2017, primarily due to increased spending on their HAE and preclinical programs. These increases were partially offset by a diminish in the company’s peramivir and galidesivir evolution spending in 2018.
G&A expenses in 2018 increased to $29.5 million, compared to $13.9 million in 2017. The extend was primarily due to approximately $11 million of merger-related costs associated with the company’s terminated merger with Idera and a $4.9 million reserve for collectability of the EMA approval milestone of peramivir.
Interest expense was $9.2 million in 2018, compared to $8.6 million in 2017.
Net loss for 2018 was $101.3 million, or $0.98 per share, compared to a net loss of $65.8 million, or $0.78 per share, for 2017.
Financial Outlook for 2019
BioCryst expects net operating cash expend to be in the ambit of $105 to $130 million, and its 2019 operating expenses to be in the ambit of $120 to $145 million. The company’s operating expense ambit excludes equity-based compensation expense due to the vicissitude in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.
Conference convene and Webcast
BioCryst management will host a conference convene and webcast at 8:30 a.m. ET today to debate the pecuniary results and provide a corporate update. The live convene may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 1271286. A live webcast of the convene and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the convene will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID# 1271286.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that deal rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing evolution programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, gratify visit the Company's website at www.BioCryst.com.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may judgement BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect their current views with respect to future events and are based on assumptions and are theme to risks and uncertainties. Given these uncertainties, you should not status undue reliance on these forward-looking statements. Some of the factors that could move the forward-looking statements contained herein include: that developing any HAE product candidate may hold longer or may be more expensive than planned; that ongoing and future preclinical and clinical evolution of BCX9930, BCX9250 and their HAE second generation drug candidates (including APeX-2, APeX-S and APeX-J) may not possess positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not promote human clinical trials with product candidates as expected; that the FDA, EMA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in detain of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates; that actual pecuniary results may not be consistent with expectations, including that 2019 operating expenses and cash usage may not be within management's expected ranges. gratify refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on contour 10-K, Quarterly Reports on contour 10-Q, and Current Reports on contour 8-K, everything of which identify necessary factors that could judgement the actual results to disagree materially from those contained in BioCryst’s projections and forward-looking statements.
Contact:John Bluth+1 919 859 firstname.lastname@example.org
BIOCRYST PHARMACEUTICALS, INC.
CONSOLIDATED pecuniary SUMMARY
(in thousands, except per share)
Statements of Operations (Unaudited)
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Twelve Months Ended
Collaborative and other research and development
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Research and development
General and administrative
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Loss from operations
Interest and other income
(Loss) gain on odd currency derivative
Basic and diluted net loss per common share
Weighted middling shares outstanding
Balance Sheet Data (in thousands)
December 31, 2018
December 31, 2017
Cash, cash equivalents and investments
Receivables from collaborations
Non-recourse notes payable
Senior credit facility
Shares of common stock outstanding
Note 1: Derived from audited pecuniary statements.
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August 09, 2018 16:15 ET | Source: ARCA biopharma, Inc.
Dr. Bristow - Photo
Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.
ARCA biopharma, Inc.
WESTMINSTER, Colo., Aug. 09, 2018 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today reported pecuniary results for the quarter ended June 30, 2018.
“The second quarter of this year saw an necessary milestone for the Gencaro evolution program with the completion of an End-of-Phase 2 FDA meeting that provided necessary guidance for the next steps in their evolution of Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation,” commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. “With labor underway on completing the Gencaro phase 3 ordeal protocol and continued progress with IND enabling activities for AB171 in PAD and HF, they believe ARCA is advancing their pipeline of genetically-targeted therapeutics to address the unmet medical needs of patients with cardiovascular disease.”
Gencaro (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation (AF) and inveterate 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 ordeal Collaboration Agreement for one additional year.
In May 2018, results from ARCA’s GENETIC-AF phase 2B clinical ordeal 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 evolution 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 ordeal 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 launch in the first half of 2019.
Second Quarter 2018 Summary pecuniary 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 enough to fund its operations, at its projected cost structure, through the halt of the first quarter of 2019.
Research and evolution (R&D) expenses for the quarter ended June 30, 2018 totaled $1.2 million compared to $4.5 million for the corresponding era of 2017. The $3.3 million diminish in research and evolution 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 ordeal 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 champion 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 diminish in total operating expenses for the second quarter of 2018 was primarily due to the diminish 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 inveterate 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 call 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 champion of the GENETIC-AF trial. The Gencaro evolution program has been granted hasty Track designation by FDA. ARCA is likewise 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, gratify visit www.arcabio.com.
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 talent of ARCA’s pecuniary resources to champion its operations through the halt of the first quarter of 2019, potential future evolution plans for Gencaro, the expected features and characteristics of Gencaro or AB171, including the potential for genetic variations to call individual patient response to Gencaro, Gencaro’s potential to deal AF, AB171’s potential to deal 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 disagree 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 pecuniary resources and whether they will be enough to meet its traffic objectives and operational requirements; ARCA may not be able to raise enough capital on acceptable terms, or at all, to continue evolution 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 contour 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.email@example.com
ARCA BIOPHARMA, INC.
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ARCA BIOPHARMA, INC.
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