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ARC520 -Updates on the Phase2a study
Arrowhead Reports Fiscal 2014 Third Quarter Financial Results and Provides Update on ARC-520
- Conference Call Today at 4:30 p.m. EDT
PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced financial results for its fiscal 2014 third quarter ended June 30, 2014 and provided an update on the Phase 2a study of ARC-520, its RNAi-based candidate for the treatment of chronic hepatitis B infection. The company is hosting a conference call at 4:30 p.m. EDT to discuss results. Conference call and webcast details can be found below.
ARC-520 Phase 2a Study Update
Completed dosing of 1 mg/kg and 2 mg/kg dose cohorts
Initial blinded data suggest that the magnitude of HBsAg knockdown is similar to non-human primate studies, including the chronically infected chimpanzee reported on previously
Duration of knockdown appears to be substantially more sustained than in non-human primates, with patients in the 2 mg/kg group still demonstrating substantial knockdown after 8 weeks, which is the most recent time point available
HBsAg levels appear to continue to decline in a number of patients at the 8 week time point in the 2 mg/kg group
Based on initial review, dosing less frequent than once monthly will be explored in Phase 2b
ARC-520 continues to be well tolerated, with no dropouts or serious adverse events reported
The overall rate of AEs has been lower in the Phase 2a than in the Phase 1 normal volunteer study and safety labs continue to show no indication of end organ toxicity
Enrolled and dosed additional subjects at 3 mg/kg in the still open normal volunteer study and the dose performed well, without detected differences from safety and tolerability results at the other doses. Overall AEs do not appear to be increasing in frequency or severity with dose
Received IRB and DSMB approvals to proceed and began enrolling an additional dose cohort at 3 mg/kg in the Phase 2a patient study
Fiscal 2014 Third Quarter and Recent Company Highlights
Nominated a second clinical candidate using our DPC delivery system, ARC-AAT, for the treatment of a rare liver disease associated with alpha-1 antitrypsin deficiency and hosted an analyst day to present preclinical data
Signed an agreement with The Alpha-1 Project (TAP), the venture philanthropy subsidiary of the Alpha-1 Foundation. Under the terms of the agreement, TAP will partially fund the development of ARC-AAT. In addition, TAP will make its scientific advisors available to Arrowhead, assist with patient recruitment for clinical trials through the Alpha-1 Foundation Patient Research Registry, and engage in other collaborative efforts that support the development of ARC-AAT
Initiated the final steps required to file an IND or equivalent application for ARC-AAT, including necessary toxicology studies
Expanded intellectual property protection with U.S. Patent Application number 13/535,454 covering ARC-520's siRNA component, being recently allowed by the U.S. Patent and Trademark Office
Presented data on advancements made to the DPC delivery system at multiple scientific meetings
Arrowhead added to the broad-market Russell 3000 index and small-cap Russell 2000 index
Selected Fiscal 2014 Third Quarter Financial Results
Net loss attributable to Arrowhead for the quarter was $11.6 million, or $0.22 per share based on 51.9 million weighted average shares outstanding. This compares with a net loss attributable to Arrowhead of $6.1 million, or $0.23 per share based on 26.1 million weighted average shares outstanding, for the quarter ended June 30, 2013.
Total operating expenses for the quarter were $12.7 million, compared to $6.4 million for the quarter ended June 30, 2013. Research and development related expenses were $6.4 million and general and administrative expenses were $1.6 during the quarter.
Net cash used in operating activities for the first nine months of fiscal 2014 was $24.5 million, compared with $13.6 million in the prior year period.
The company's cash and investments of cash were $188.5 million at June 30, 2014, compared to $29.8 million at September 30, 2013. The increase in the cash balance reflects financings completed in October 2013 and February 2014, plus cash inflow from exercise of warrants and stock options of $12.4 million.
Common shares outstanding at June 30, 2014, were 52.9 million, and 58.5 million assuming conversion of preferred stock outstanding.
Conference Call and Webcast Details
To participate in the conference call, please dial 855-215-6159 (toll free from the US) or 315-625-6887 (for international callers) and enter Conference ID 82825377. Investors may also access a live audio webcast of this conference call on the Company's website at http://ir.arrowheadresearch.com/events.cfm.
A replay of the webcast will be available approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 7 days. The audio replay can be accessed by dialing 855-859-2056 (toll free from the US), or 404-537-3406 (for international callers) and entering Conference ID 82825377.
About ARC-520
Arrowhead's RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the mRNA level, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead's Dynamic Polyconjugate (DPC) delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. The company is conducting a single dose Phase 2a study in chronic HBV patients, and expects to follow with a multi-dose, multi-national Phase 2b program. Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.
- Conference Call Today at 4:30 p.m. EDT
PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced financial results for its fiscal 2014 third quarter ended June 30, 2014 and provided an update on the Phase 2a study of ARC-520, its RNAi-based candidate for the treatment of chronic hepatitis B infection. The company is hosting a conference call at 4:30 p.m. EDT to discuss results. Conference call and webcast details can be found below.
ARC-520 Phase 2a Study Update
Completed dosing of 1 mg/kg and 2 mg/kg dose cohorts
Initial blinded data suggest that the magnitude of HBsAg knockdown is similar to non-human primate studies, including the chronically infected chimpanzee reported on previously
Duration of knockdown appears to be substantially more sustained than in non-human primates, with patients in the 2 mg/kg group still demonstrating substantial knockdown after 8 weeks, which is the most recent time point available
HBsAg levels appear to continue to decline in a number of patients at the 8 week time point in the 2 mg/kg group
Based on initial review, dosing less frequent than once monthly will be explored in Phase 2b
ARC-520 continues to be well tolerated, with no dropouts or serious adverse events reported
The overall rate of AEs has been lower in the Phase 2a than in the Phase 1 normal volunteer study and safety labs continue to show no indication of end organ toxicity
Enrolled and dosed additional subjects at 3 mg/kg in the still open normal volunteer study and the dose performed well, without detected differences from safety and tolerability results at the other doses. Overall AEs do not appear to be increasing in frequency or severity with dose
Received IRB and DSMB approvals to proceed and began enrolling an additional dose cohort at 3 mg/kg in the Phase 2a patient study
Fiscal 2014 Third Quarter and Recent Company Highlights
Nominated a second clinical candidate using our DPC delivery system, ARC-AAT, for the treatment of a rare liver disease associated with alpha-1 antitrypsin deficiency and hosted an analyst day to present preclinical data
Signed an agreement with The Alpha-1 Project (TAP), the venture philanthropy subsidiary of the Alpha-1 Foundation. Under the terms of the agreement, TAP will partially fund the development of ARC-AAT. In addition, TAP will make its scientific advisors available to Arrowhead, assist with patient recruitment for clinical trials through the Alpha-1 Foundation Patient Research Registry, and engage in other collaborative efforts that support the development of ARC-AAT
Initiated the final steps required to file an IND or equivalent application for ARC-AAT, including necessary toxicology studies
Expanded intellectual property protection with U.S. Patent Application number 13/535,454 covering ARC-520's siRNA component, being recently allowed by the U.S. Patent and Trademark Office
Presented data on advancements made to the DPC delivery system at multiple scientific meetings
Arrowhead added to the broad-market Russell 3000 index and small-cap Russell 2000 index
Selected Fiscal 2014 Third Quarter Financial Results
Net loss attributable to Arrowhead for the quarter was $11.6 million, or $0.22 per share based on 51.9 million weighted average shares outstanding. This compares with a net loss attributable to Arrowhead of $6.1 million, or $0.23 per share based on 26.1 million weighted average shares outstanding, for the quarter ended June 30, 2013.
Total operating expenses for the quarter were $12.7 million, compared to $6.4 million for the quarter ended June 30, 2013. Research and development related expenses were $6.4 million and general and administrative expenses were $1.6 during the quarter.
Net cash used in operating activities for the first nine months of fiscal 2014 was $24.5 million, compared with $13.6 million in the prior year period.
The company's cash and investments of cash were $188.5 million at June 30, 2014, compared to $29.8 million at September 30, 2013. The increase in the cash balance reflects financings completed in October 2013 and February 2014, plus cash inflow from exercise of warrants and stock options of $12.4 million.
Common shares outstanding at June 30, 2014, were 52.9 million, and 58.5 million assuming conversion of preferred stock outstanding.
Conference Call and Webcast Details
To participate in the conference call, please dial 855-215-6159 (toll free from the US) or 315-625-6887 (for international callers) and enter Conference ID 82825377. Investors may also access a live audio webcast of this conference call on the Company's website at http://ir.arrowheadresearch.com/events.cfm.
A replay of the webcast will be available approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 7 days. The audio replay can be accessed by dialing 855-859-2056 (toll free from the US), or 404-537-3406 (for international callers) and entering Conference ID 82825377.
About ARC-520
Arrowhead's RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the mRNA level, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead's Dynamic Polyconjugate (DPC) delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. The company is conducting a single dose Phase 2a study in chronic HBV patients, and expects to follow with a multi-dose, multi-national Phase 2b program. Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.
"My lies? "
See if that not just blatantly offesnsive what is. Did I say HBF they were all bad? uhhhh
I was talking on topic about HBV advocate as the user LuckyMan was doing of which you clearly attacked him Stephen.
Do you know anytime peace has been made with HBF you pipe up with your dumb statements. Further all you ever do is clearly attack anyone who believes we should have something better..
Hypocrisy try when you para phrazed "the one with money has control etc etc" Then that got deleted and you started back to your normal idiotic ways.
The fact being a group of people asked for some meaningful action to be taken so we could be freed from the hell which is HBV and we got ignored like a bunch of peasants by HBV advocte.
HBF at least interact and discuss things at times! Giving the admin credit where its due there!!
As HBF said they are "bound by rules" Not clearly not rules that are serving us in getting what we need quicker a cure!!!
Stephen you can attempt to bully people on here but I'm one who won't stand for it!!!
See if that not just blatantly offesnsive what is. Did I say HBF they were all bad? uhhhh
I was talking on topic about HBV advocate as the user LuckyMan was doing of which you clearly attacked him Stephen.
Do you know anytime peace has been made with HBF you pipe up with your dumb statements. Further all you ever do is clearly attack anyone who believes we should have something better..
Hypocrisy try when you para phrazed "the one with money has control etc etc" Then that got deleted and you started back to your normal idiotic ways.
The fact being a group of people asked for some meaningful action to be taken so we could be freed from the hell which is HBV and we got ignored like a bunch of peasants by HBV advocte.
HBF at least interact and discuss things at times! Giving the admin credit where its due there!!
As HBF said they are "bound by rules" Not clearly not rules that are serving us in getting what we need quicker a cure!!!
Stephen you can attempt to bully people on here but I'm one who won't stand for it!!!
Steff mate I am simply offering my opinion as others do on this forum. Am I the only person who says alot of the info from the HBV advocate is negative? Steff in all fairness you would be the better advocate in my opinion its clear you have alot more intercations with sufferers.
if you keep posting like this we will have to let medhelp know and choose what to do.it is not allowed to post wrong things especially on people who is not here to answer
I would also correct the lies made by makeadifferencenow against Christine Kukka.
Ms Kukka is a well known advocate in the Hepatitis B community. She wrote a monthly Hepatitis B Journal Review published by HBVadvocate and widely read and disseminated.
More important, Ms Kukka runs the popular blog:
"Welcome to HBV Advocate’s blog where you'll find the latest news about hepatitis B. Please submit questions and post comments."
Notice the invitation for readers to submit questions and post comments!
If that is NOT INTERACTION, I don't know what is.
Ms Kukka is a well known advocate in the Hepatitis B community. She wrote a monthly Hepatitis B Journal Review published by HBVadvocate and widely read and disseminated.
More important, Ms Kukka runs the popular blog:
"Welcome to HBV Advocate’s blog where you'll find the latest news about hepatitis B. Please submit questions and post comments."
Notice the invitation for readers to submit questions and post comments!
If that is NOT INTERACTION, I don't know what is.
Let me correct the lies made by makeadifferencenow, the same person who, using the name Randle Handle, makes regular comments on HBF Facebook Wall. Here are some examples:
Randall Handle Admin but the future may be bright no?
August 15 at 12:15am · Like
Hepatitis B Foundation Hopeful for the future, but living in the present...
August 15 at 1:00am · Like · 1
Randall Handle First time I've seen you being Philosophical lol
August 15 at 1:08am · Like
Randall Handle Judging by that post Tekmira don't sound like they have alot of solidity in what they are saying it all sounds very vague. Well they need to pull their finger out considering the speed Arrow head is moving at. But I don't know alot about them
August 14 at 8:44am · Like
Randall Handle Admin can you say your not tempted to say if this works. A "cure" all be it "functional CURE" maybe it hand??
August 14 at 8:30am
Randall Handle Read this. Lets hope one of the possible "Functional cures" comes out first
July 22 at 9:33am · Like · 1
Hepatitis B Foundation This discovery will help focus on potential cures for chronic HBV. Research and development of a safe and effective drug takes time, though I could not predict how long it will take. Personally I am very hopeful and encouraged.
July 23 at 8:03am · Like
Randall Handle Admin nice to hear you say that
July 23 at 5:58pm
I can go on. The hypocrisy ("In terms of HBF they don't update everything") is astounding. This is the same person who reads HBF Facebook regularly and makes frequent comments. Yet when the president of HBF, Ms Joan Block, was honored by the White House recently, he was upset.
Randall Handle Admin but the future may be bright no?
August 15 at 12:15am · Like
Hepatitis B Foundation Hopeful for the future, but living in the present...
August 15 at 1:00am · Like · 1
Randall Handle First time I've seen you being Philosophical lol
August 15 at 1:08am · Like
Randall Handle Judging by that post Tekmira don't sound like they have alot of solidity in what they are saying it all sounds very vague. Well they need to pull their finger out considering the speed Arrow head is moving at. But I don't know alot about them
August 14 at 8:44am · Like
Randall Handle Admin can you say your not tempted to say if this works. A "cure" all be it "functional CURE" maybe it hand??
August 14 at 8:30am
Randall Handle Read this. Lets hope one of the possible "Functional cures" comes out first
July 22 at 9:33am · Like · 1
Hepatitis B Foundation This discovery will help focus on potential cures for chronic HBV. Research and development of a safe and effective drug takes time, though I could not predict how long it will take. Personally I am very hopeful and encouraged.
July 23 at 8:03am · Like
Randall Handle Admin nice to hear you say that
July 23 at 5:58pm
I can go on. The hypocrisy ("In terms of HBF they don't update everything") is astounding. This is the same person who reads HBF Facebook regularly and makes frequent comments. Yet when the president of HBF, Ms Joan Block, was honored by the White House recently, he was upset.
They do have cures and they won't release them.
In terms of HBF they don't update everything & as for Christine Kukka she does report overwhelmingly very negative stuff I've seen her posts talking to people saying she doesn't really know use social media very. She's supposed to be HBV advocate. Look at HCV advocates Mindy Oneil & Margaret Dudley. They are always interacting with patients I've never seen Christine Kukka making herself available for patients nor interacting with us neither. Even when we requested her to petition for something curative to be released when HCV advocates support this to Christine Kukka just blatantly ignored us like we were a bunch of peasents.
But yes respect to the CEO of Arrow Head being open about their intentions!
In terms of HBF they don't update everything & as for Christine Kukka she does report overwhelmingly very negative stuff I've seen her posts talking to people saying she doesn't really know use social media very. She's supposed to be HBV advocate. Look at HCV advocates Mindy Oneil & Margaret Dudley. They are always interacting with patients I've never seen Christine Kukka making herself available for patients nor interacting with us neither. Even when we requested her to petition for something curative to be released when HCV advocates support this to Christine Kukka just blatantly ignored us like we were a bunch of peasents.
But yes respect to the CEO of Arrow Head being open about their intentions!
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