Real Time notes from the call. These are just my notes.
MM, NP and SK on the call from CYDY.
Dr Kelly background entire year in clinical medicine emory and georgia. followed ccr5 for 2 years before joining the board. Goal is to aggresively pursue all the possible ways that LL can apply two.
NP read testimonies
ATL doctor - 3 intubated patients were saved due to LL
Other Doctor - Wife spent 3 weeks in ECU and then 3 weeks of recovery and she is now home as she continues to heal.
patients wife - husband received LL. he was given no chance of survival at that time. been in hospital since april due to other medical issues he is recovering and he is alive due to LL.
Dr Raju, Dr Yang, Dr Agresti got shout outs
This is anecdotal so we cannot get approved. we need studies
75 random M2M C-19 - Phase 2 slowed at 50 stopping on June 15th if we do not reach 75. Fantastic news. enrollment reached 75 patients today. it has reached full enrollment. PR sent out
Dr Kelly explained how this got done. had a doctor with Covid and he got an EIND. he got better and he got the rest of the patients enrolled. (WOW - thats a great story)
P3 registration. Amyrex was told to prepare. 51 patients interim data trial will be available in 203 weeks from now.
that concludes C-19
BLA - Pdufa date will be given by July 10th they had a question on Manufacturing and they had until tomorrow to get the answers back to FDA by tomorrow
Mfg update - Dr Rae will have 1.5M vials of LL 375K patients at current prices could generate 2.5B this year, should we get FDA approval Could have 6M vials in 2021 = 9B in revenue
Who distributes? NBA hoping to have it done.
MM - reaffirming final stages of definitive agreeement they will make the appropriate update.
Cancer - all trials going very well.
Kelly explains MOA for cancer. cancer cells releas rantes. LL blocks microphages that cause the tumor to grow. and turns the microphages against the tumor. immunotherapies will benefit we believe that t-regs make the current drugs more effective?
Circulating tumor cells are zero for our patients # of patients reaching out to Dr J are getting so many requests to join the trial.
NASH got greenlight for P2 NASH Clinical Trial Also PR went out as well.
Kely - moving forward soon. hepatisites secret rantes 30-40% have fatty liver disease and 3-12% get Nash. 90 patient randomized 22 week study.
MS - immune system attacks central nervous system. MOA is to stop rantes to disrupt the blood brain barrier could be helpful with alzheimer.
Submitting P2 to FDA very shortly. Montefiore want to test on 400 alzheimers patients.
shout out to inventor and co-inventor of LL
scientific advisory board update - recurring theme is that they are welcoming the idea . Dr K will announce who is on the board when appropriate.
potential partner and licensing deals
Dr k and Dr R are working SRVP of Biz. currently in discussion with asia, SA, EU and USA for Oncology and Covid-19. everyone waiting on the data.
Fundrasing and uplisting
been making lot of progress - MM updates
signed engagement letter with top bank.
uplist - very focused on oppty. based on current and anticipated revenue
focused on uplisted standare #3 or 4A this is a 6 week process that include multiple steps. as soon as we have more progress we will provide more updates.
Q&A -
HC Wainwright
P2 and P2/3 could this report in July? yes it should.
missed second question.
M2M patients assuming + data what is next step? turn into FDA adn get approval for that population. have papers out via Raju and BP
could FDA require a thrid study? it could be the case.
Jeff P.
for MM - clarification on deal. could you name the bank and any terms of the deal? has the 6 weeks begun on the uplist yet?
MM- very clear we do not have a financing deal at hand nor are we working on one or is one planned. we have simply signed an engagement letter.
MM- 6 week process has commenced. submitted eligibility review packet that takes 2 weeks. company reviews and responds to comments. once E.P cleared the next step is a letter notifying us we are clear to submit an uplist application which is easier then the E.P itself. if then we will promptly submit the application then the exchange would review and after that review we would expect an approval letter to uplist with very likely 1-4 contingencies to be cleared. CYDY is anticipating these contingencies . we expect a + outcome.
NP - CYDY turned down a larger share dilution deal that was on the table because they didnt want to dilute more than necessary. SP is way undervalued. turned down 25M @3$ with no warrants
are any contingencies around shares. MM has a surprise for everyone but cannot elaborate. MM- let me add to that. preliminary proxy is a contingency basis in case its needed for uplisting. Need for capital is high but significant unsourced capital is outstanding and deeply in the money. 100M shares outstanding warrants excercising would generate so much cash if everybody excercised warrants.
Jeff S
any analyst coverage or guidance from institutions to indicate there would be a credible established price point for revenue and stock price.
NP - HIV BLA is going to take a few months. need revenue before that. C-19 is different. BP wants to see primary endpoint in P2 then everyone is very comfortable. Uplisting is a tremendous event for us. (didnt really answer)
Peter L(ameriprise)
have ability to move up an expiration date on warrants?
NP - No but sometimes we can incentivise them to exercise.
Where are you on Mexico? In touch with Dr Tran. hoping protocol gets through FDA. looking to enroll 25 people. they have everything they need
no timeline as its dependent on Mex.
C.S.
assess competitive landscape to a C-19 treatment? marketsize comparison of C-19 vs HIV.
NP - Remdesivir is competition for LL they are going targeting $7-8B market size for C-19 next year.
SK - we are going after very large markets even mediocre success is very lucrative. some IL6 inhibitors are out there.
Nick consoco capital
NP - How many EIND had labs? first 11 at montefiore, later on a few more. but stopped when we were 11/11 so focused on P2-P2/3
FDA gave all relaxed requests that CYDY asked for, for Critical
SK - Clinical outcome measure will get us approved, not labs
Gvnmt funding - still being looked at will comment when
D. thompson
May 26th new position as commercial officer. is that CO onboard now?
NP - CO wlll be a consultant agreement then later as fulltim. they have 18 employees now.
What specifics are you looking for in CO?
NP - building sales teams, drug timelines, prep to launch product LL will sell itself so scale back expectation of full time.
HIV has Vyera need point contact to help there.
Scientific Advisory board. member count? first meeting, specifics etc? Not about quantity. its quality multiple indications put group to help us to actively pursue these indications.
Would you have a deal with the investment bank within the 6 weeks of the uplisting? MM couldnt answer?
NP - 400 alzheimers - need patients to pass screening protocol so going forward
SK - other physicians interested in joining
Cancer enrollment? more than 10 now? Mrs Kennedy? Site at Quest is handling. might be close to 20 now.
Robert B Pinnacle investments
P-140 not embraced what was the problem that others missed?
NP - bought from progenix. Paul Madden worked with us. monotherapy was key.
Competing - rems. plasma replacement therapies? viable competition?
SK - looked into this but not a real competition. we hope that at the end of the day we hope there are lots of options for the patients.
P3 CD12 trial - 69 enrolled? goal to get 390...unblind at same time of P2. are results trial going to be enough enrolled to get the FDA to approve
NP - feel very confident we have enough information
Closing comments by NP
c-19 p2 reached enrollment of 75
51 patients of interim. placebo some patients will die.
cancer all going forward
nash
alz
MS
GVHD all moving forward.
MM, NP and SK on the call from CYDY.
Dr Kelly background entire year in clinical medicine emory and georgia. followed ccr5 for 2 years before joining the board. Goal is to aggresively pursue all the possible ways that LL can apply two.
NP read testimonies
ATL doctor - 3 intubated patients were saved due to LL
Other Doctor - Wife spent 3 weeks in ECU and then 3 weeks of recovery and she is now home as she continues to heal.
patients wife - husband received LL. he was given no chance of survival at that time. been in hospital since april due to other medical issues he is recovering and he is alive due to LL.
Dr Raju, Dr Yang, Dr Agresti got shout outs
This is anecdotal so we cannot get approved. we need studies
75 random M2M C-19 - Phase 2 slowed at 50 stopping on June 15th if we do not reach 75. Fantastic news. enrollment reached 75 patients today. it has reached full enrollment. PR sent out
Dr Kelly explained how this got done. had a doctor with Covid and he got an EIND. he got better and he got the rest of the patients enrolled. (WOW - thats a great story)
P3 registration. Amyrex was told to prepare. 51 patients interim data trial will be available in 203 weeks from now.
that concludes C-19
BLA - Pdufa date will be given by July 10th they had a question on Manufacturing and they had until tomorrow to get the answers back to FDA by tomorrow
Mfg update - Dr Rae will have 1.5M vials of LL 375K patients at current prices could generate 2.5B this year, should we get FDA approval Could have 6M vials in 2021 = 9B in revenue
Who distributes? NBA hoping to have it done.
MM - reaffirming final stages of definitive agreeement they will make the appropriate update.
Cancer - all trials going very well.
Kelly explains MOA for cancer. cancer cells releas rantes. LL blocks microphages that cause the tumor to grow. and turns the microphages against the tumor. immunotherapies will benefit we believe that t-regs make the current drugs more effective?
Circulating tumor cells are zero for our patients # of patients reaching out to Dr J are getting so many requests to join the trial.
NASH got greenlight for P2 NASH Clinical Trial Also PR went out as well.
Kely - moving forward soon. hepatisites secret rantes 30-40% have fatty liver disease and 3-12% get Nash. 90 patient randomized 22 week study.
MS - immune system attacks central nervous system. MOA is to stop rantes to disrupt the blood brain barrier could be helpful with alzheimer.
Submitting P2 to FDA very shortly. Montefiore want to test on 400 alzheimers patients.
shout out to inventor and co-inventor of LL
scientific advisory board update - recurring theme is that they are welcoming the idea . Dr K will announce who is on the board when appropriate.
potential partner and licensing deals
Dr k and Dr R are working SRVP of Biz. currently in discussion with asia, SA, EU and USA for Oncology and Covid-19. everyone waiting on the data.
Fundrasing and uplisting
been making lot of progress - MM updates
signed engagement letter with top bank.
uplist - very focused on oppty. based on current and anticipated revenue
focused on uplisted standare #3 or 4A this is a 6 week process that include multiple steps. as soon as we have more progress we will provide more updates.
Q&A -
HC Wainwright
P2 and P2/3 could this report in July? yes it should.
missed second question.
M2M patients assuming + data what is next step? turn into FDA adn get approval for that population. have papers out via Raju and BP
could FDA require a thrid study? it could be the case.
Jeff P.
for MM - clarification on deal. could you name the bank and any terms of the deal? has the 6 weeks begun on the uplist yet?
MM- very clear we do not have a financing deal at hand nor are we working on one or is one planned. we have simply signed an engagement letter.
MM- 6 week process has commenced. submitted eligibility review packet that takes 2 weeks. company reviews and responds to comments. once E.P cleared the next step is a letter notifying us we are clear to submit an uplist application which is easier then the E.P itself. if then we will promptly submit the application then the exchange would review and after that review we would expect an approval letter to uplist with very likely 1-4 contingencies to be cleared. CYDY is anticipating these contingencies . we expect a + outcome.
NP - CYDY turned down a larger share dilution deal that was on the table because they didnt want to dilute more than necessary. SP is way undervalued. turned down 25M @3$ with no warrants
are any contingencies around shares. MM has a surprise for everyone but cannot elaborate. MM- let me add to that. preliminary proxy is a contingency basis in case its needed for uplisting. Need for capital is high but significant unsourced capital is outstanding and deeply in the money. 100M shares outstanding warrants excercising would generate so much cash if everybody excercised warrants.
Jeff S
any analyst coverage or guidance from institutions to indicate there would be a credible established price point for revenue and stock price.
NP - HIV BLA is going to take a few months. need revenue before that. C-19 is different. BP wants to see primary endpoint in P2 then everyone is very comfortable. Uplisting is a tremendous event for us. (didnt really answer)
Peter L(ameriprise)
have ability to move up an expiration date on warrants?
NP - No but sometimes we can incentivise them to exercise.
Where are you on Mexico? In touch with Dr Tran. hoping protocol gets through FDA. looking to enroll 25 people. they have everything they need
no timeline as its dependent on Mex.
C.S.
assess competitive landscape to a C-19 treatment? marketsize comparison of C-19 vs HIV.
NP - Remdesivir is competition for LL they are going targeting $7-8B market size for C-19 next year.
SK - we are going after very large markets even mediocre success is very lucrative. some IL6 inhibitors are out there.
Nick consoco capital
NP - How many EIND had labs? first 11 at montefiore, later on a few more. but stopped when we were 11/11 so focused on P2-P2/3
FDA gave all relaxed requests that CYDY asked for, for Critical
SK - Clinical outcome measure will get us approved, not labs
Gvnmt funding - still being looked at will comment when
D. thompson
May 26th new position as commercial officer. is that CO onboard now?
NP - CO wlll be a consultant agreement then later as fulltim. they have 18 employees now.
What specifics are you looking for in CO?
NP - building sales teams, drug timelines, prep to launch product LL will sell itself so scale back expectation of full time.
HIV has Vyera need point contact to help there.
Scientific Advisory board. member count? first meeting, specifics etc? Not about quantity. its quality multiple indications put group to help us to actively pursue these indications.
Would you have a deal with the investment bank within the 6 weeks of the uplisting? MM couldnt answer?
NP - 400 alzheimers - need patients to pass screening protocol so going forward
SK - other physicians interested in joining
Cancer enrollment? more than 10 now? Mrs Kennedy? Site at Quest is handling. might be close to 20 now.
Robert B Pinnacle investments
P-140 not embraced what was the problem that others missed?
NP - bought from progenix. Paul Madden worked with us. monotherapy was key.
Competing - rems. plasma replacement therapies? viable competition?
SK - looked into this but not a real competition. we hope that at the end of the day we hope there are lots of options for the patients.
P3 CD12 trial - 69 enrolled? goal to get 390...unblind at same time of P2. are results trial going to be enough enrolled to get the FDA to approve
NP - feel very confident we have enough information
Closing comments by NP
c-19 p2 reached enrollment of 75
51 patients of interim. placebo some patients will die.
cancer all going forward
nash
alz
MS
GVHD all moving forward.
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