CC summary (with some spice added.)
-Pipe Financing via Paulson - $19M
-Unable to comment about Amarex
-CytoDyn is fully cooperating with SEC/DOJ.
-New President: Cyrus Arman, PhD- has over 12 years of experience in corporate, clinical, and commercial strategy for biotechnology companies, including advising C-level management and boards of directors on strategy, transactional opportunities, financing, and risk mitigation.
(Strong Ethos to likely build authority with an audience.) Has a PhD in Neuroscience and an MS in Biomedical Engineering from the University of Southern California, and a BS in Biopsychology from the University of California San Diego.
(While working under Amgen as Corporate Stategy Director, share price increased from about $60 to $185)
Lastly, was a cofounder and managing partner to a life sciences hedgefund.
(In short, I’m quite “excyrus” for Cyrus.)
-Restructuring outstanding SAMSUNG contract, and in interim making monthly payments and prepaying future services
-Focusing on stretching our money to last as long as possible for the least amount of dilution possible. As well as asking for more shares like all biotech start ups do for success.
Clinical holds on HIV and Covid-19. Company will convert data to standard accepted format.
All hands on effort to get BLA completed. FDA regulatory consulting firms, lead by former FDA regulators. (Very underrated statement).
This team has a line by line task for accountability, thus an eventual timeline for PDUFA date.
-Brazil - waiting to hear from Anvisa to proceed with the trial. (There was no clinical hold). DSMB evaluated the safety portion, the recommendation was to continue the trial. Potential to unblind the data early.
-$5 million NIH grant for OHSU to evaluate the roll of Leronlimab to generate an HIV CURE.
-“Long acting Leronlimab” can help impact and be a game changer in HIV. LAL the new LL?
-Fast track for HIV and mTNBC
Leronlimab works differently with dosage. Looking for key biomarkers in MOA for partners. Liver inflammation is significant in HIV patients.
In addition to viral entry inhibition, LL appears to work as an immunomodulator. Lower doses of LL may reduce inflammation. Higher doses may effect the immune system by increasing CD8 and NK Cells.
Placing us in unique position to look at both pathways, which most drugs are not able to perform.
Two places LL can bind to CCR5, inflammation or immunomodulation. Binding simultaneously to CCR5, to enhance the function.
1 to 1 ratio may lock the receptor in place without a conformational change. Currently, investigating how different doses of LL causes a different effect. (Imo, shows much more potential than we think).
HIV patients helped CR theorize that a certain haplotype group needed more dosage. Aka the 23% of the Nash 700Mg group that improved. Changes in biomarkers suggest a different etiology for Nash. Further exploratory studies need to be performed for this specific group.
In NASH, Biomarkers analysis showed it Reduced: CCL2, CCL3, CCL5, CCL11, CCL18, these act as a beacon to attract other cells into the area.
Big deal because it shows we work on the other biomarkers as well, not just CCL5.
CCL3 increases in severe Nash biopsies.
Since we found out we decrease it (in my opinion, LL reduction of this will likely have success in future biopsies aka Phase 3 for 350Mg).
CCL2 reduced in NASH 350Mg. Lower CCL2 correlates with less viral replication, reducing Macrophages and viral reservoir. And central nervous system invasion.
Ability to reduce this may have application to reduce HIV and NASH.
Leronlimab May then be positioned us to help those patients. (Would this indicate a preventative for Nash as well as HIV?).
Leronlimab reduced vcam-1. (key cell adhesion molecule involved in inflammation that is closely implicated in various immunological disorders, including rheumatoid arthritis, asthma, transplant rejection, and cancer).
Nash sounds like it got us enough data to know where to go with even Oncology due to VCAM-1 reduction.
Looking for LH government grants to fund the study because the design seems incredibly difficult.
-12 years exclusivity: 2031 patent
-Poster presentation - 1 of 4 with special permission to present to over 7,000 people. NASH results well received.
Summary: Great President selection, $5M NIH grant OHSU, Long acting Leronlimab may be a game changer. With Nash, we found out we don’t only help reduce CCL5, but now we reduce CCL2, 3, 11, 18 and Vcam-1, helping us realize even more potential and design for future trials such as Oncology. Drug has two pathways it can help the body and also work synergistically with multiple other drugs.
CytoDyns vision: Leronlimab will be in a similar position to Humira. (HUman Monoclonal Antibody In Rheumatoid Arthritis).
CytoDyn will try and fully realize Leronlimabs potential with multiple partnerships. (Humira costs $6,233.)
-Pipe Financing via Paulson - $19M
-Unable to comment about Amarex
-CytoDyn is fully cooperating with SEC/DOJ.
-New President: Cyrus Arman, PhD- has over 12 years of experience in corporate, clinical, and commercial strategy for biotechnology companies, including advising C-level management and boards of directors on strategy, transactional opportunities, financing, and risk mitigation.
(Strong Ethos to likely build authority with an audience.) Has a PhD in Neuroscience and an MS in Biomedical Engineering from the University of Southern California, and a BS in Biopsychology from the University of California San Diego.
(While working under Amgen as Corporate Stategy Director, share price increased from about $60 to $185)
Lastly, was a cofounder and managing partner to a life sciences hedgefund.
(In short, I’m quite “excyrus” for Cyrus.)
-Restructuring outstanding SAMSUNG contract, and in interim making monthly payments and prepaying future services
-Focusing on stretching our money to last as long as possible for the least amount of dilution possible. As well as asking for more shares like all biotech start ups do for success.
Clinical holds on HIV and Covid-19. Company will convert data to standard accepted format.
All hands on effort to get BLA completed. FDA regulatory consulting firms, lead by former FDA regulators. (Very underrated statement).
This team has a line by line task for accountability, thus an eventual timeline for PDUFA date.
-Brazil - waiting to hear from Anvisa to proceed with the trial. (There was no clinical hold). DSMB evaluated the safety portion, the recommendation was to continue the trial. Potential to unblind the data early.
-$5 million NIH grant for OHSU to evaluate the roll of Leronlimab to generate an HIV CURE.
-“Long acting Leronlimab” can help impact and be a game changer in HIV. LAL the new LL?
-Fast track for HIV and mTNBC
Leronlimab works differently with dosage. Looking for key biomarkers in MOA for partners. Liver inflammation is significant in HIV patients.
In addition to viral entry inhibition, LL appears to work as an immunomodulator. Lower doses of LL may reduce inflammation. Higher doses may effect the immune system by increasing CD8 and NK Cells.
Placing us in unique position to look at both pathways, which most drugs are not able to perform.
Two places LL can bind to CCR5, inflammation or immunomodulation. Binding simultaneously to CCR5, to enhance the function.
1 to 1 ratio may lock the receptor in place without a conformational change. Currently, investigating how different doses of LL causes a different effect. (Imo, shows much more potential than we think).
HIV patients helped CR theorize that a certain haplotype group needed more dosage. Aka the 23% of the Nash 700Mg group that improved. Changes in biomarkers suggest a different etiology for Nash. Further exploratory studies need to be performed for this specific group.
In NASH, Biomarkers analysis showed it Reduced: CCL2, CCL3, CCL5, CCL11, CCL18, these act as a beacon to attract other cells into the area.
Big deal because it shows we work on the other biomarkers as well, not just CCL5.
CCL3 increases in severe Nash biopsies.
Since we found out we decrease it (in my opinion, LL reduction of this will likely have success in future biopsies aka Phase 3 for 350Mg).
CCL2 reduced in NASH 350Mg. Lower CCL2 correlates with less viral replication, reducing Macrophages and viral reservoir. And central nervous system invasion.
Ability to reduce this may have application to reduce HIV and NASH.
Leronlimab May then be positioned us to help those patients. (Would this indicate a preventative for Nash as well as HIV?).
Leronlimab reduced vcam-1. (key cell adhesion molecule involved in inflammation that is closely implicated in various immunological disorders, including rheumatoid arthritis, asthma, transplant rejection, and cancer).
Nash sounds like it got us enough data to know where to go with even Oncology due to VCAM-1 reduction.
Looking for LH government grants to fund the study because the design seems incredibly difficult.
-12 years exclusivity: 2031 patent
-Poster presentation - 1 of 4 with special permission to present to over 7,000 people. NASH results well received.
Summary: Great President selection, $5M NIH grant OHSU, Long acting Leronlimab may be a game changer. With Nash, we found out we don’t only help reduce CCL5, but now we reduce CCL2, 3, 11, 18 and Vcam-1, helping us realize even more potential and design for future trials such as Oncology. Drug has two pathways it can help the body and also work synergistically with multiple other drugs.
CytoDyns vision: Leronlimab will be in a similar position to Humira. (HUman Monoclonal Antibody In Rheumatoid Arthritis).
CytoDyn will try and fully realize Leronlimabs potential with multiple partnerships. (Humira costs $6,233.)
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