Searched for notes, found zsmith’s
Dr. B’s Nash and ms info was interesting, I’ll need to listen again.
Con call notes:
CYDY 12/17/2019 Investor Call
BLA Timeline
Non-Clinical (filed months ago)
Clinical
Were waiting to submit 700mg to FDA, did that in Nov.
FDA is discussing that with CYDY
FDA is most likely to go with 700mg dose
Just waiting for FDA for what they (FDA) wants re: 700mg dose from MONO trial
CMC
Stability data should be done by the end of the month
Could be delayed a couple of weeks into January
++++
mTNBC
Protocol
1st patient results were very promising
4th blood test resulted in notably sustained response to LERO
When can we have several more patients with same results?
4 potential patients, hope to enroll most of them this month
Compassionate Use Protocol
Many people reaching out to us. Enrollment is picking up, screening is happening now.
++++
Licensing Agreement (non-HIV)
NASH – sent results to many BP. In discussions with several of them. Will let SH know when something substantial.
CANCER – several phara companies interested, including int’l.
++++
Prevention of HIV
MOU (Tai Red Cross) – 1,200 patients. A lot of activities on this program. One arm will have once per month LERO treatment (not once per week).
++++
MS Study
Very nice results from Dr. Dennis Burger (in the past).
Dr. Burger – MS attacks mylean sheath around nerve cells -- ultimately leads to paralysis. CCR5 is involved in ‘pathogenisis’ of MS. Biogen has a monoclonal anti-body in this space. Tested hypothesis in EAE in mice. LERO tested at Providence Hospital, LERO administered after 1st sypmptoms developed in mice. ½ of animals didn’t develop a 2nd round of paralysis. One caveat: LERO is highly effective in recognizing CCR5 (and poor at recognizing mice CCR5) – can’t expect stunning results in mice models. Same thing happened in NASH (poorer results in mice vs. “humanized mice” (human bone marrow stem cells) – “stunning results in NASH” with humanized mice. Don’t know if they can use “humanized mice” in MS study – yet. Expect they can go directly to P2 study. P2 protocol has been designed for MS with local doctor/professor.
++++
Licensing Agreement
Few minutes ago, signed licensing agreement.
Vyera Pharmaceutical
www.vyera.com
$87.5M
50% royalty
$4M investment Registered Direct
***
Yu Chen, HC Wainright
Q: Structure deal
A: Will 8k the details
Q: Confident BLA submission will be completed Jan 2020?
A: Yes. Hope to even have by end of Dec. Very confident in Jan.
Paul, PI
Q: When enroll additional tNBC patients?
A: Naïve, sending biopsy, hoping for at least 2 this month.
Q: Any more test results back from existing patients?
A: Results – will be announcing all results that they can announce via PR.
MiL – will PR updates.
Shashank, PI
Q: CMC submission – of AGC or Samsung?
A: BLA has to be with AGC, b/c all methods were validated in US. Samsung will be at a future time. 1st Commerical batches will be via AGC.
Q: Uplist?
A: Waiting for organic uplift. Don’t know when the SP will react.
Steve Karnik, PI
Q: Basket study. Other (obscure) indications.
Eric Scheilenger, PI
Q: Party signing agreement
A: Will be 8k’ed. Vyera Pharmaceuticals.
Matt E., PI
Q: How far out is cancer (significant headway)? Does HIV diminish cancer development?
A: Not at all, it will help. USA only. COMBO and MONO – only.
Nick K(?), Tenxxx Capital
Q: Plan and amount of funding to bridge the gap btw now and milestone payment?
A: Make-up things as they go. Don’t raise any more money until end of February. Have many options. Might have to raise a few more million before end of Feb. (small amounts).
Q: Vyera doesn’t have rights to PreP?
A: Didn’t want to discuss it.
Michael,
Q: IncellDx –did sell anything to them yet?
A: Very small numbers at this time.
Paul Wellan, PI
Q: Wife suffering from TNBC for 2yrs.
Misui, PI
Q: IRB was approved for mTNBC Nov. 12th, plan to open more centers? Was expecting more enrollment.
A: Controlling cash cost for protocol. Expanded access have ~20 people reaching out.
Dr. B’s Nash and ms info was interesting, I’ll need to listen again.
Con call notes:
CYDY 12/17/2019 Investor Call
BLA Timeline
Non-Clinical (filed months ago)
Clinical
Were waiting to submit 700mg to FDA, did that in Nov.
FDA is discussing that with CYDY
FDA is most likely to go with 700mg dose
Just waiting for FDA for what they (FDA) wants re: 700mg dose from MONO trial
CMC
Stability data should be done by the end of the month
Could be delayed a couple of weeks into January
++++
mTNBC
Protocol
1st patient results were very promising
4th blood test resulted in notably sustained response to LERO
When can we have several more patients with same results?
4 potential patients, hope to enroll most of them this month
Compassionate Use Protocol
Many people reaching out to us. Enrollment is picking up, screening is happening now.
++++
Licensing Agreement (non-HIV)
NASH – sent results to many BP. In discussions with several of them. Will let SH know when something substantial.
CANCER – several phara companies interested, including int’l.
++++
Prevention of HIV
MOU (Tai Red Cross) – 1,200 patients. A lot of activities on this program. One arm will have once per month LERO treatment (not once per week).
++++
MS Study
Very nice results from Dr. Dennis Burger (in the past).
Dr. Burger – MS attacks mylean sheath around nerve cells -- ultimately leads to paralysis. CCR5 is involved in ‘pathogenisis’ of MS. Biogen has a monoclonal anti-body in this space. Tested hypothesis in EAE in mice. LERO tested at Providence Hospital, LERO administered after 1st sypmptoms developed in mice. ½ of animals didn’t develop a 2nd round of paralysis. One caveat: LERO is highly effective in recognizing CCR5 (and poor at recognizing mice CCR5) – can’t expect stunning results in mice models. Same thing happened in NASH (poorer results in mice vs. “humanized mice” (human bone marrow stem cells) – “stunning results in NASH” with humanized mice. Don’t know if they can use “humanized mice” in MS study – yet. Expect they can go directly to P2 study. P2 protocol has been designed for MS with local doctor/professor.
++++
Licensing Agreement
Few minutes ago, signed licensing agreement.
Vyera Pharmaceutical
www.vyera.com
$87.5M
50% royalty
$4M investment Registered Direct
***
Yu Chen, HC Wainright
Q: Structure deal
A: Will 8k the details
Q: Confident BLA submission will be completed Jan 2020?
A: Yes. Hope to even have by end of Dec. Very confident in Jan.
Paul, PI
Q: When enroll additional tNBC patients?
A: Naïve, sending biopsy, hoping for at least 2 this month.
Q: Any more test results back from existing patients?
A: Results – will be announcing all results that they can announce via PR.
MiL – will PR updates.
Shashank, PI
Q: CMC submission – of AGC or Samsung?
A: BLA has to be with AGC, b/c all methods were validated in US. Samsung will be at a future time. 1st Commerical batches will be via AGC.
Q: Uplist?
A: Waiting for organic uplift. Don’t know when the SP will react.
Steve Karnik, PI
Q: Basket study. Other (obscure) indications.
Eric Scheilenger, PI
Q: Party signing agreement
A: Will be 8k’ed. Vyera Pharmaceuticals.
Matt E., PI
Q: How far out is cancer (significant headway)? Does HIV diminish cancer development?
A: Not at all, it will help. USA only. COMBO and MONO – only.
Nick K(?), Tenxxx Capital
Q: Plan and amount of funding to bridge the gap btw now and milestone payment?
A: Make-up things as they go. Don’t raise any more money until end of February. Have many options. Might have to raise a few more million before end of Feb. (small amounts).
Q: Vyera doesn’t have rights to PreP?
A: Didn’t want to discuss it.
Michael,
Q: IncellDx –did sell anything to them yet?
A: Very small numbers at this time.
Paul Wellan, PI
Q: Wife suffering from TNBC for 2yrs.
Misui, PI
Q: IRB was approved for mTNBC Nov. 12th, plan to open more centers? Was expecting more enrollment.
A: Controlling cash cost for protocol. Expanded access have ~20 people reaching out.
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