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$FSDC a potential game changer in Age-Related Macular Degeneration (GA). 2 types of AMD: Wet and Dry AMD. Dry AMD affects roughly 80-90% of individuals with AMD. The Wet AMD affects roughly 10-15% of individuals. Advanced stage of Dry AMD is known as Geographic Atrophy (GA).
$FSDC Currently no available treatments for GA. Will focus on Wet AMD in a later thread for $OCUL. VEGF not the only driver of AMD disease progression but only pathway where approved txs focused on so far. Anti-VEGF agents worked for a minority of AMD patients in Wet AMD pts.
$FSDC Lets talk about AMD population: 5 million people suffering from GA globally and 1 million in US alone. 2 companies currently working on GA a) $APLS drug Pegcetacoplan currently in PH3 and data in Q3 2021.
$FSDC $APLS targets C3 therapy to regulate the over activation of Complement thus reducing GA lesion growth. Focus of this thread is $FSDC Precision medicine company treatment for genetically defined AMD.
$FSDC
1) FSDC brings a Whole new paradigm shift in targeting a genetically subset of AMD pts. with complement dysregulation.
2) Gemini Therapeutics and FS Development Corp. MERGER vote Feb 3rd.
3) GEM 103 granted fast track designation by FDA
1) FSDC brings a Whole new paradigm shift in targeting a genetically subset of AMD pts. with complement dysregulation.
2) Gemini Therapeutics and FS Development Corp. MERGER vote Feb 3rd.
3) GEM 103 granted fast track designation by FDA
$FSDC
4) GEM 103 is a recombinant human complement H to address AMD in genetically defined subsets of AMD pts caused by CFH loss of function variants.
5) CFH loss of function variants are present in roughly 40% of pts. with Dry AMD that could progress to GA.
4) GEM 103 is a recombinant human complement H to address AMD in genetically defined subsets of AMD pts caused by CFH loss of function variants.
5) CFH loss of function variants are present in roughly 40% of pts. with Dry AMD that could progress to GA.
$FSDC
6) GEM 103 designed to address both complement hyperactivity and restore Retinal health in pts. with AMD. 7) GEM 103 expected to restore complement regulation by blocking the detrimental effects and retaining the beneficial effects.
6) GEM 103 designed to address both complement hyperactivity and restore Retinal health in pts. with AMD. 7) GEM 103 expected to restore complement regulation by blocking the detrimental effects and retaining the beneficial effects.
$FSDC
8) This mechanism of action is in contrast to that of complement pathway inhibitors like $APLS which block the detrimental and beneficial effects of complement activation.
9) PH1 results demonstrate promising safety profile and PK and biomarker changes in genetically AMD.
8) This mechanism of action is in contrast to that of complement pathway inhibitors like $APLS which block the detrimental and beneficial effects of complement activation.
9) PH1 results demonstrate promising safety profile and PK and biomarker changes in genetically AMD.
$FSDC
10) Currently ongoing PH2A trial will provide insights into GEM 103 and topline data in 1H2021 ( catalyst).
11) PH 2B/3 pivotal trial in 2H2021 with interim results at 6mos and pivotal PH3 at 12mos.
12)Top funds including Orbimed and recently Opaleye took a 5.34% stake.
10) Currently ongoing PH2A trial will provide insights into GEM 103 and topline data in 1H2021 ( catalyst).
11) PH 2B/3 pivotal trial in 2H2021 with interim results at 6mos and pivotal PH3 at 12mos.
12)Top funds including Orbimed and recently Opaleye took a 5.34% stake.
$FSDC
13) Expected post transaction approximate equity value of $465 million and expected to provide cash runway into 2023
14) Announced initiation of GEM 103 Ph 2a study as an Add-On to Anti-VEGF for tx of Wet AMD pts. as well.
13) Expected post transaction approximate equity value of $465 million and expected to provide cash runway into 2023
14) Announced initiation of GEM 103 Ph 2a study as an Add-On to Anti-VEGF for tx of Wet AMD pts. as well.
$FSDC Valuation summed nicely by @JamesEKrause
" If #CFH completely halts drusen and dAMD growth, that is the most spectacular result and my dream. If it halts this growth by 50% that would be much better than $APLS. Either should bring a > $5B mkt cap."
" If #CFH completely halts drusen and dAMD growth, that is the most spectacular result and my dream. If it halts this growth by 50% that would be much better than $APLS. Either should bring a > $5B mkt cap."
