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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.
Arrowhead can update anytime, being a public listed company, they are obliged to inform the market. The CEO did indicate they may present a late-breaking paper at the coming AASLD Conference in November after they unblinded their Phase2a clinical trial data. I think their Phase2b clinical trials will commence in Q4 with results expected in 2015.
Just my understanding.
Just my understanding.
That is what I am telling you folks that they have cures for HBV. With today technology the principles work across many viruses. What they did with Ebola can be done with HBV. And you I Stephen and everyone else can forget about HBV.
But instead of writing everywhere demanding cures NOW. Exposing the corruption in medical industry. You attack people that are right!
You bet there is pressure on FDA! People are tired of dying so special interest groups in the medical community continues to profit.
So please all of you folks. Spend some time each day and write to news media exposing the truth. We have to get HBV cures released and abolish ridiculous laws FDA goes by.
But instead of writing everywhere demanding cures NOW. Exposing the corruption in medical industry. You attack people that are right!
You bet there is pressure on FDA! People are tired of dying so special interest groups in the medical community continues to profit.
So please all of you folks. Spend some time each day and write to news media exposing the truth. We have to get HBV cures released and abolish ridiculous laws FDA goes by.
Just as you mentioned. We may benefit from the dreadful Ebola outbreak.
Tekmira ($TKMR), which had its gene-silencing Ebola treatment put on hold recently only to get a sudden green light on potential production, touted the latest primate results demonstrating that its experimental drug protected monkeys infected with the Marburg virus, a close cousin of Ebola.
"These positive findings build upon our extensive work in anti-viral RNAi therapeutics and provide further validation of our strong LNP product platform, which includes RNAi therapeutics addressing chronic Hepatitis B infection and lethal hemorrhagic fever viruses," said Dr. Mark Murray, Tekmira's CEO, in a statement.
Tekmira's stock, which has soared 85% in the past month, was up about 5% in premarket trading today--proving once again that there's nothing like an outbreak to rev up a biotech company's share price. The death toll currently stands at about 1,350.
Tekmira ($TKMR), which had its gene-silencing Ebola treatment put on hold recently only to get a sudden green light on potential production, touted the latest primate results demonstrating that its experimental drug protected monkeys infected with the Marburg virus, a close cousin of Ebola.
"These positive findings build upon our extensive work in anti-viral RNAi therapeutics and provide further validation of our strong LNP product platform, which includes RNAi therapeutics addressing chronic Hepatitis B infection and lethal hemorrhagic fever viruses," said Dr. Mark Murray, Tekmira's CEO, in a statement.
Tekmira's stock, which has soared 85% in the past month, was up about 5% in premarket trading today--proving once again that there's nothing like an outbreak to rev up a biotech company's share price. The death toll currently stands at about 1,350.
My understanding is that FDA partially releases a total clinical hold on TKM-Ebola, thus allowing its clinical studies to proceed further. It is by no means an approval. It is certainly not available as a treatment.
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