I missed that ONCT actually had more data to present in their press release on 5/19: investor.oncternal.com/news-releases/news-release-details/oncternal-therapeutics-presents-updated-interim-data-cirmtuzumab These updates are better than what I explain in the video (additional PR in MCL and increase in CRs in CLL), but it doesn't change the concerns I have.
The $50M offering for ONCT is an ATM placeholder and does not mean that the company intends to dilute at current share prices. If anything, having an ATM shelf registration ready to go on file signals an expectation that the SP will go up, and that the company wants flexibility to raise without announcing to the market and killing the run. Also, isn’t a big part of Cirm’s bull case the increased safety/durability data? No mention of the fact that median PFS has not yet been reached for combo in MCL or CLL, even though the trials are already past MPFS for Ibrutinib alone. I agree with your concerns about management generally. I sure hope that they have a plan, and that the bizarre messaging to investors will make sense soon. Thx for the video.
I could be wrong, but my understanding was that they are executing $50M ATM here based on a shelf S-3 from April. Cirm's safety/durability are part of the bull case, and it's true that not reaching the median PFS still means that we'll get another readout about durability. I lowered my position but didn't sell it all because I do think there's upside. Time will tell. Thanks for the comment.
I think the Q2 earnings call for CCXI will be interesting to see their plans outside of ANCA vasculitis. I might be interested in the stock as we get closer to their new PDUFA in September...but there isn't much information on their other programs. Avacopan targets the C5a receptor. So after the complement cascade happens and C5 is cleaved into C5a and C5b, C5a then binds to C5aR on immune cells to further increasing an immune reaction. This C5a-C5aR interaction is sometimes associated with immune overactivation and is seen in many diseases like RA, IBD, etc. By inhibiting the C5aR, there's a chance it could help.
@@breakingbiotech ANCA-Associated Vasculitis FDA give 3 month extension and hopefully FDA gives approval. Big Mover July 2021 on 7/6/21 reported PDUFA extension to 10/7/21; NDA Acceptance 9/17/2020, PDUFA date set at July 7, 2021 with an advisory committee meeting conducted May 6, with most questions resulting in split decisions. Remission at 26 weeks: Avacopan 72.3% vs prednisone therapy 70.1%; Superior sustained remission at 52 weeks (65.7% vs 54.9%, p=0.0066) Avacopan eliminated the need for daily steroid therapy Reduction in Glucocorticoid Toxicity Index (GTI) and other accepted assessments of glucocorticoid toxicity Phase III ADVOCATE clinical trial of avacopan for ANCA and announced positive topline data demonstrating avacopan’s statistical superiority in sustaining remission at 52 weeks over the glucocorticoid-containing standard-of-care therapy Our New Drug Application (NDA) has been accepted for review by the U.S. Food and Drug Administration (FDA) for avacopan in ANCA-associated vasculitis with PDUFA goal date of July 7, 2021 the Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA) for avacopan in ANCA-associated vasculitis.
I missed that ONCT actually had more data to present in their press release on 5/19: investor.oncternal.com/news-releases/news-release-details/oncternal-therapeutics-presents-updated-interim-data-cirmtuzumab
These updates are better than what I explain in the video (additional PR in MCL and increase in CRs in CLL), but it doesn't change the concerns I have.
Great video, please make a video on CCXI/Avacopan.
The $50M offering for ONCT is an ATM placeholder and does not mean that the company intends to dilute at current share prices. If anything, having an ATM shelf registration ready to go on file signals an expectation that the SP will go up, and that the company wants flexibility to raise without announcing to the market and killing the run. Also, isn’t a big part of Cirm’s bull case the increased safety/durability data? No mention of the fact that median PFS has not yet been reached for combo in MCL or CLL, even though the trials are already past MPFS for Ibrutinib alone. I agree with your concerns about management generally. I sure hope that they have a plan, and that the bizarre messaging to investors will make sense soon. Thx for the video.
I could be wrong, but my understanding was that they are executing $50M ATM here based on a shelf S-3 from April.
Cirm's safety/durability are part of the bull case, and it's true that not reaching the median PFS still means that we'll get another readout about durability.
I lowered my position but didn't sell it all because I do think there's upside. Time will tell. Thanks for the comment.
Matt please make video on CCXI/Avacopan. it will be a great help. i realy want to understand techinal details about Avacopan.
I think the Q2 earnings call for CCXI will be interesting to see their plans outside of ANCA vasculitis. I might be interested in the stock as we get closer to their new PDUFA in September...but there isn't much information on their other programs.
Avacopan targets the C5a receptor. So after the complement cascade happens and C5 is cleaved into C5a and C5b, C5a then binds to C5aR on immune cells to further increasing an immune reaction. This C5a-C5aR interaction is sometimes associated with immune overactivation and is seen in many diseases like RA, IBD, etc. By inhibiting the C5aR, there's a chance it could help.
@@breakingbiotech ANCA-Associated Vasculitis FDA give 3 month extension and hopefully FDA gives approval. Big Mover July 2021 on 7/6/21 reported PDUFA extension to 10/7/21; NDA Acceptance 9/17/2020, PDUFA date set at July 7, 2021 with an advisory committee meeting conducted May 6, with most questions resulting in split decisions.
Remission at 26 weeks: Avacopan 72.3% vs prednisone therapy 70.1%; Superior sustained remission at 52 weeks (65.7% vs 54.9%, p=0.0066)
Avacopan eliminated the need for daily steroid therapy Reduction in Glucocorticoid Toxicity Index (GTI) and other accepted assessments of glucocorticoid toxicity
Phase III ADVOCATE clinical trial of avacopan for ANCA and announced positive topline data demonstrating avacopan’s statistical superiority in sustaining remission at 52 weeks over the glucocorticoid-containing standard-of-care therapy
Our New Drug Application (NDA) has been accepted for review by the U.S. Food and Drug Administration (FDA) for avacopan in ANCA-associated vasculitis with PDUFA goal date of July 7, 2021
the Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA) for avacopan in ANCA-associated vasculitis.
Can you review the ANVS presentation from AAIC 2021?
Avxl all the way up