Monday, February 16, 2015 7:53:45 PM
$AHRO AND $LGBI CALL NASA. TINY FLOAT BOTTOM BOUNCERS. LGBI .003 BUZZ GROWING. Loaded AHRO on Friday. Closed down 62%. AHRO, [/b]Target $12.5 ? That was the reason the insiders bought 3 million shares in this offering at $0.75? LGBI AND AHRO are going to have a monster week IMO.
AHRO.
-------- Original Message --------
Subject: AHRO (B, $12.50): AHRO-002 Looks To Forge Shorter Path To
Revenues Via 505(b)(2) Pre-IND Filing
From: "William Gregozeski, CFA" <wgregozeski@greenridgeglobal.com>
Date: Wed, July 16, 2014 7:18 am
To: <wgregozeski@greenridgeglobal.com>
AHRO-002 Looks To Forge Shorter Path To Revenues Via 505(b)(2) Pre-IND Filing
• Pre-IND Filing for AHRO-002. Yesterday, the Company announced it filed its pre-IND documents with the FDA under the Section 505(b)(2) program for AHRO-002 to be used in conjunction with a statin for cholesterol modulation. AHRO-002 is its UDCA-based therapy, which recently was granted a patent for “Dissolution of arterial plaque”, is currently marketed by Axcan Pharmaceuticals to dissolve gallstones. Given its approved nature, AtheroNova should be able to use the gallstone safety studies and skip to a Phase 2 or Phase 2/3 trial. Management expects to meet with the FDA in the next 60 days to determine what regulatory path it can follow, at which point it will determine the timeline to revenue for AHRO-002. As it may need one or two smaller trials it is conceivable that the Company could have a market ready product in the next three to four years. However, until a regulatory path is put forward we will not include any value to this therapy, but note the growing likelihood that this will generate cash flow for the Company well ahead of AHRO-001.
• Phase 1B Trial Added In Russia. The Russian Ministry of Health (MoH), which is slated to start in the current quarter and run for 12 weeks to test the interactions between a statin and AHRO-001. This data was to be collected in RUSREG, but has been moved up and will give the Company additional data on moving forward with its non-Russian AHRO-001 regulatory work. CardioNova will fund and run this trial, with AtheroNova paying to have testing done for reverse cholesterol transport, a relatively new area of study in trying to lower cholesterol and reduce plaque.
• Timeline Update. We have added the 1B trial to the timeline, which pushed RUSREG back one full year. We also pushed back the IND filing date one quarter, from Q4:14 to Q1:15..
• Model Update. We have made no changes to our model. Our valuation is based on the US regulatory timeline, which was pushed back just one quarter.
• Maintaining Buy & $12.50 Target. With no changes to our valuation model we are maintaining our Buy rating and $12.50 target price on AtheroNova. Our target price is based on the average NPV per fully diluted share of the applied structures of the post-Phase 2 ISIS and AtheroGenics deals, as applied to AtheroNova. While there is a great deal of risk in the actual terms the Company will be able to secure and the time to do so could vary greatly (hence our 40% annual discount rate), we note that it is moving towards nearer term revenue opportunities that could bring greater clarity to the valuation. Sales in Russia after RUSREG or approval for AHRO-002 from the 505(b)(2) program could bring the Company to a cash flow positive state much sooner and could provide the capital needed for the longer AHRO-001 atherosclerosis regression program.
William Gregozeski, CFA
Director of Research
Greenridge Global, LLC
Office: +1 414 435 1110
Mobile: +1 414 248 4935
wgregozeski@greenridgeglobal.com
AHRO.
-------- Original Message --------
Subject: AHRO (B, $12.50): AHRO-002 Looks To Forge Shorter Path To
Revenues Via 505(b)(2) Pre-IND Filing
From: "William Gregozeski, CFA" <wgregozeski@greenridgeglobal.com>
Date: Wed, July 16, 2014 7:18 am
To: <wgregozeski@greenridgeglobal.com>
AHRO-002 Looks To Forge Shorter Path To Revenues Via 505(b)(2) Pre-IND Filing
• Pre-IND Filing for AHRO-002. Yesterday, the Company announced it filed its pre-IND documents with the FDA under the Section 505(b)(2) program for AHRO-002 to be used in conjunction with a statin for cholesterol modulation. AHRO-002 is its UDCA-based therapy, which recently was granted a patent for “Dissolution of arterial plaque”, is currently marketed by Axcan Pharmaceuticals to dissolve gallstones. Given its approved nature, AtheroNova should be able to use the gallstone safety studies and skip to a Phase 2 or Phase 2/3 trial. Management expects to meet with the FDA in the next 60 days to determine what regulatory path it can follow, at which point it will determine the timeline to revenue for AHRO-002. As it may need one or two smaller trials it is conceivable that the Company could have a market ready product in the next three to four years. However, until a regulatory path is put forward we will not include any value to this therapy, but note the growing likelihood that this will generate cash flow for the Company well ahead of AHRO-001.
• Phase 1B Trial Added In Russia. The Russian Ministry of Health (MoH), which is slated to start in the current quarter and run for 12 weeks to test the interactions between a statin and AHRO-001. This data was to be collected in RUSREG, but has been moved up and will give the Company additional data on moving forward with its non-Russian AHRO-001 regulatory work. CardioNova will fund and run this trial, with AtheroNova paying to have testing done for reverse cholesterol transport, a relatively new area of study in trying to lower cholesterol and reduce plaque.
• Timeline Update. We have added the 1B trial to the timeline, which pushed RUSREG back one full year. We also pushed back the IND filing date one quarter, from Q4:14 to Q1:15..
• Model Update. We have made no changes to our model. Our valuation is based on the US regulatory timeline, which was pushed back just one quarter.
• Maintaining Buy & $12.50 Target. With no changes to our valuation model we are maintaining our Buy rating and $12.50 target price on AtheroNova. Our target price is based on the average NPV per fully diluted share of the applied structures of the post-Phase 2 ISIS and AtheroGenics deals, as applied to AtheroNova. While there is a great deal of risk in the actual terms the Company will be able to secure and the time to do so could vary greatly (hence our 40% annual discount rate), we note that it is moving towards nearer term revenue opportunities that could bring greater clarity to the valuation. Sales in Russia after RUSREG or approval for AHRO-002 from the 505(b)(2) program could bring the Company to a cash flow positive state much sooner and could provide the capital needed for the longer AHRO-001 atherosclerosis regression program.
William Gregozeski, CFA
Director of Research
Greenridge Global, LLC
Office: +1 414 435 1110
Mobile: +1 414 248 4935
wgregozeski@greenridgeglobal.com
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