CYDY: Feb 25th Conference Call Transcript Text—

CYDY: Feb 25th Conference Call Transcript Text— auto-generated by YouTube

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00:01 greetings and welcome to the Saito dine
00:03 investment community conference call at
00:05 this time all participants are in a
00:07 listen-only mode a question-and-answer
00:09 session will follow the formal
00:11 presentation if anyone should require
00:13 operator assistance during the
00:14 conference please press star 0 on your
00:16 telephone keypad as a reminder this
00:18 conference is being recorded it is now
00:20 my pleasure to introduce your host
00:22 Michael Mulholland chief financial
00:23 officer thank you sir
00:25 you may begin thank you hello everyone
00:29 and thank you for joining us today this
00:31 is Michael Mulholland chief financial
00:33 officer of sighted I'm joining us on
00:36 today's call is our president and CEO
00:38 dr. nadir poor Hassan and our chief
00:42 medical officer dr. Richard Castel
00:45 before we begin it is essential that we
00:48 provide you with important cautionary
00:50 language related to certain federal
00:52 securities laws our remarks during
00:55 today's conference call
00:56 will include forward-looking statements
00:59 forward-looking statements are not
01:01 guarantees of future performance and
01:04 involve known and unknown risks and
01:07 uncertainties and other factors that are
01:12 difficult to predict actual results may
01:15 be materially different from any future
01:17 results expressed or implied by such
01:20 forward-looking statements these risks
01:23 and uncertainties include among other
01:25 matters statements regarding LaRhonda
01:28 Maps potential efficacy in certain
01:31 immunology and oncology indications the
01:34 company's ongoing ability to raise
01:36 additional new capital that clinical
01:39 trials may not can commence or proceed
01:42 as planned
01:43 products that appear promising in early
01:46 trials may not subsequently prove to be
01:49 viable on safety or efficacy grounds
01:52 products may not receive regulatory
01:54 approval or market acceptance
01:57 competition may reduce the commercial
01:59 potential of our products we may
02:01 experience product recalls manufacturing
02:04 issues or product liability and our
02:08 patents may be challenged or
02:10 unenforceable
02:12 although forward-looking statements help
02:14 to provide complete information about
02:16 the company forward-looking statements
02:18 may be less reliable than historical
02:21 information the company undertakes no
02:24 obligation to update publicly these
02:27 forward-looking statements except as
02:29 required by law please refer to our
02:32 recent quarterly and annual reports
02:34 filed with the Securities and Exchange
02:36 Commission for more information about
02:39 the risks and uncertainties that could
02:41 cause actual results to differ
02:43 materially versus our current
02:46 expectations I will now turn our call
02:50 over to dr. nadir paratha knotter thank
02:54 you Mike
02:55 thank you everyone for participating in
02:58 today's site reliance shareholders
03:00 conference call before I update all of
03:03 our shareholders their owners of our
03:06 company
03:07 Cyberdyne I would like to quickly
03:10 discuss what I believe is in the minds
03:13 of most of our shareholders which is
03:16 canceiied align fund itself to get to
03:20 revenue the simple and short answer is
03:25 we believe we can do this and we believe
03:29 we can do this much easier than the last
03:33 four years and our resume of raising
03:37 funds of close to 170 million dollars in
03:41 the last seven years speaks for itself
03:44 and this is all thanks to Paulson
03:48 investments and great trust they have in
03:51 our data science and our mission we also
03:56 have a spoken in the past about
03:58 non-dilutive fundraising and we are
04:01 pursuing that in parallel to all of our
04:04 other activities from investors with
04:08 less knowledge of biotech and drug
04:10 development might think one hundred
04:12 seventy million dollars that cited I
04:14 raised was a lot of money and why do we
04:17 still need more funding to get to
04:20 revenue this is a great question and I
04:23 like to address that
04:25 to answer this question I will now read
04:28 a couple of paragraphs from a couple of
04:31 different articles which anyone can
04:34 access from a simple google search the
04:37 first one quote various sources indicate
04:41 that it can cause more than 1 billion
04:44 dollars to bring one product to the
04:47 market another article I will quote is
04:50 from John Hopkins Bloomberg School of
04:52 Public Health called clinical trials
04:56 that support FDA approvals of new drugs
04:59 have a median cost of 19 million dollars
05:03 according to a new study by a team
05:06 including researchers from John Hopkins
05:08 Bloomberg School of Public Health the 19
05:11 million medians figure represents less
05:14 than 1% of the average total cost of
05:18 developing a new drug which in recent
05:21 years have been estimated as between 2
05:24 to 3 billion dollars if we accept these
05:29 numbers and if we use the lower figure
05:32 of 2 billion then we have used less than
05:35 10% to get to where we are today
05:38 this means excited I had about 170
05:43 million dollars worth of expenses in the
05:46 last almost 10 years and produce all the
05:50 opportunities that many may call it too
05:53 good to be true I agree that all we have
05:57 accomplished is too good but not too
06:00 good to be true but simply true because
06:03 facts are clear and those who check the
06:06 facts carefully like pulse on investment
06:09 I agreed with me because they rely on
06:12 facts in today's call I would like to
06:16 cover another very important fact about
06:19 the amount of expenses cited I had to
06:22 get to the point we are today and that
06:25 is not only we have produced all the
06:29 current opportunities for our
06:31 shareholders but we also have about 200
06:34 million dollars worth of Lear on the map
06:36 GMP products
06:38 that more than half our commercial or
06:41 phase three great product this is
06:43 evaluated at $120,000 per patient per
06:47 year current price for the same
06:50 indication now please let me stay this
06:52 fax one more time even though it seems
06:55 too good to be true but it is true while
06:58 it is too good that we used less than
07:01 10% of what normally take to have the
07:05 following opportunities one mono therapy
07:07 successful investigative trial in my
07:10 opinion that could lead to first phase
07:13 three pivotal trial of HIV for the only
07:15 sub-q weekly injectable humanized
07:18 monoclonal antibody for HIV space and
07:23 number two or be la that everybody knows
07:27 about biologic license applications we
07:30 are hopeful that if all goes well we
07:33 will be having revenue from that that
07:35 path in 2020 number three is GVHD
07:40 Phase two since the GVHD
07:41 graft-versus-host disease with orphan
07:44 drug designation already given to us
07:46 number four phase one B - two triple
07:49 negative breast cancer with orphan drug
07:51 designation file number five with the
07:53 prognostic test that could be in
07:55 licensing agreements this year and
07:57 number six eight preclinical trials that
08:00 was just recently announced that we are
08:02 engaging - in and the last is an amazing
08:06 amount of commercial / Phase three
08:08 product that could give us back quite a
08:11 bit of or expenses that we have used to
08:15 get to this point when we get revenue so
08:19 with all these explanation in regards to
08:21 our expenses I will now update you on
08:24 current sided ice activity
08:29 my first item of update is the subject
08:33 of non-dilutive financing in regards to
08:36 commercializing lire on the maps I
08:38 designed do have a plan for
08:40 commercializing of lire on the map
08:42 program for you that could also lead to
08:45 non diluted financing sorry rank
08:50 currently is in discussions with
08:52 commercialization pharmaceuticals the
08:55 right of sales of lire on the map with
08:57 different pharmaceuticals and as of now
09:00 we are evaluating offers for the right
09:04 of commercialization of the only map for
09:07 certain indication for several millions
09:10 of dollars of upfront payment and
09:13 milestone payments we are in the process
09:16 of evaluating our counteroffer to these
09:19 offers detail of whether we accept or
09:22 reject any of these offers will be
09:24 shared with everyone at an appropriate
09:27 time because of the interest like this
09:30 in commercialization rights for pro lire
09:33 on the map we are now interviewing
09:36 appropriate candidates to hire a
09:38 full-time business development person to
09:42 be 100% focused in exploring all the
09:45 opportunities for literally map for
09:48 commercialized commercialization in US
09:51 or Europe this person will be in charge
09:54 of this program and this is a new role
09:57 that we will have inside of that other
10:02 non-dilutive fundraising potential will
10:05 be covered by doctor to stern in regards
10:07 to or prognostic tips in regards to
10:12 making product for large revenue after
10:15 launch and where is sighted I'm going to
10:19 get funding to produce half a billion
10:22 dollar water product to kick off our
10:24 revenues in most likely 2020 I'm very
10:29 pleased so now that sided ein currently
10:32 is in discussions with a major biologic
10:35 CMO a large biological manufacturing
10:38 company this company has given us an
10:40 offer
10:42 to produce over 500 million dollars
10:45 worth of commercial product this amount
10:48 is again based on 120,000 per year per
10:50 session and the half a billion of
10:52 LaRhonda map can be delivered in the
10:55 second half of 2020
10:57 with delayed payment to late 2020 we
11:02 don't have to pay a single dime till the
11:05 product is sent to us we like this deal
11:11 and are in the process of signing the
11:13 final agreement and this should put an
11:16 end to it speculation of how would sited
11:18 I supply the product to the market
11:21 without having any funds for this
11:24 purpose this I could say is our first
11:28 non-dilutive effort saving Saturday from
11:31 the elusive rays of significant amount
11:34 in order to have enough lire on the map
11:37 for commercialization so now I will
11:41 update everyone with our combination
11:44 therapy and mono therapy trial so our
11:49 PLA is delayed and everyone had seen in
11:54 our PowerPoint we have changed at the
11:56 second quarter and it might even become
11:58 third quarter so let me tell you why as
12:05 we work with FDA we have to obey
12:09 everything the FDA says which is very
12:12 logical and is for the safety of people
12:15 in the world
12:16 the FDA has read our press releases out
12:19 of it and they realize that we have said
12:22 that our seven hundred milligram dose
12:24 has much better efficacy than 350
12:28 milligram
12:28 the population that we're going to
12:31 submit be la for or included in the
12:35 population is patients who have unmet
12:39 medical needs they don't have enough
12:40 regimen and practically they're on
12:43 functional mono therapy when they take
12:45 for one for FDA indicated that so you
12:50 have two choices one is to redo the
12:53 whole trial which would take four to
12:55 five
12:55 with a 700 milligram but they also
12:59 articulated a very good situation for us
13:02 they said why don't you just take a
13:05 hundred patients from your mono therapy
13:07 dad were injected with 700 milligram
13:10 which could delay us four to six months
13:12 from March time that we give out and
13:14 then we will be okay and we will approve
13:17 this if all things are in place and if
13:20 everything is good with them they will
13:22 not make seven hundred milligram an
13:23 issue and it was approved this product
13:26 for 700 milligram now this is huge for
13:29 us because this could give us a better
13:31 outcome for the for the result and the
13:34 patients could benefit more from our
13:36 product but it happens that it would
13:39 delay us to second quarter in the second
13:41 quarter or maybe end up second third
13:42 quarter the reason I say second quarter
13:45 or third quarter is because once we
13:49 produced a hundred patients data we will
13:52 have to see how fast we can get that
13:54 data that they asked for and how long
13:56 each patient has to go for we are in
13:58 discussions with FDA and worst case
14:01 scenario is end of third quarter best
14:04 case scenario at the end of second
14:05 quarter as always we will work very hard
14:08 and non-stop to make sure we can make
14:11 the best time that as possible as
14:13 everyone knows it took us four and a
14:15 half years to take a path of that would
14:17 have take twenty years with the old path
14:19 progeny has in place for pro-1 for the
14:22 only map so hopefully our resume is
14:25 strong and we will be able to get this
14:28 to the finish line of getting be a late
14:30 submission quickly as possible in
14:33 regards to mono therapy trial we are to
14:36 present at CROI on march 4th our
14:39 abstract was accepted and we are excited
14:41 to go back to croy and say that our last
14:45 trial that we presented at CROI that had
14:48 only 40% responders rate now is change
14:54 and there with a seven hundred milligram
14:56 we have much better data and 525
14:59 milligram
15:00 so that we will follow through but we
15:03 are working on our pivotal trial and
15:05 once we submit our first part of our BL
15:07 a which is already complete
15:09 one third of a non-clinical section then
15:12 we will follow with our protocol for a
15:15 mono therapy pivotal trial so in regards
15:20 to our next update which is
15:21 graft-versus-host disease we have dr.
15:25 Castel who have interviewed the
15:28 principal investigators and we are now
15:30 ready to reinitiate and we have order RC
15:33 or to reinitiate the graft-versus-host
15:36 disease hopefully to have data interim
15:39 result to look at we also have orphan
15:42 drug designation for this indication and
15:44 we are going forward as before in
15:47 regards to triple negative breast cancer
15:50 and other results that we received that
15:53 was very positive I will now pass it
15:55 over to dr. Paz tell dr. Purcell I think
16:00 you Donna um it's good afternoon
16:02 everybody
16:03 I have three items to touch on as
16:06 updates since the last investor
16:09 conference the first is to speak briefly
16:12 about the prognostic test that can lead
16:15 to speak about the new indications in
16:18 different cancers for more on the map
16:20 and the third is to update the investors
16:23 on the orphan drug designation
16:26 application to the FDA was recently
16:29 filed the prognostic test is a test that
16:33 was acquired by Cyberdyne a technology
16:37 which is a high very high predictive
16:40 value for determining the outcome of the
16:44 patient's prostate cancer based on a
16:47 gene signature has an algorithm the
16:50 current process is we are developing a
16:54 kit in collaboration with a strategic
16:58 partner and completing analytical
17:00 validation with the intent of submitting
17:03 a 510 K to the FDA
17:05 the second area to to mention is that
17:10 based on recent preclinical studies
17:14 looking at cancer metastasis and
17:18 cooperative studies looking at the
17:21 expression of CC
17:23 five in a number of different cancers
17:26 sited on has elected to conduct
17:30 metastatic analyses using a number of
17:34 different types of cancers the purpose
17:37 of this is we believe that ccr5 is an
17:41 important mechanism guiding cancer
17:44 metastasis that this may be a general
17:47 principle relevant to a variety of
17:49 different types of cancers that
17:51 overexpressed ccr5 and cited ein has
17:55 acquired a research laboratory which has
17:59 sophisticated technologies in order to
18:01 test this hypothesis i with created a
18:06 hierarchy of need focusing on prostate
18:09 cancer pancreatic cancer melanoma colon
18:12 cancer and lung because these particular
18:15 types of metastatic cancers kill
18:18 patients quite rapidly and again the
18:22 results are based on the strategy is
18:26 based on the findings we have in highly
18:29 anesthetic human triple negative breast
18:30 cancer preclinical studies so again in
18:34 order for any cost-effective series and
18:37 studies with the intent to use mechanism
18:42 of action ccr5 dependent metastasis of
18:46 cancers as the over action strategy
18:49 the third element i would like to update
18:53 investors honors the recent submission
18:56 to the FDA of an orphan drug designation
18:59 caller on a map based on preclinical
19:03 studies the results of these studies
19:06 which were using human breast cancer in
19:10 a xenograph mouse model demonstrated a
19:13 greater than 98% reduction in the
19:16 metastatic tumor volume of these animals
19:19 and because this was conducted over a
19:23 six-week period of time so although the
19:28 untreated animal untreated animals
19:31 developed massive metastases at six
19:34 weeks we were unable to formally to tear
19:37 the tester season one I treated mice
19:41 clearly will continue to update the
19:43 investors on these particular studies
19:46 that these provided the compelling and
19:49 rational basis for a submission of
19:52 orphan drug designation with the FDA
19:55 this was announced February 20th so
19:58 these are the three highlights from the
20:01 oncology component of the company or
20:05 which has been positive progress since
20:08 the last update and again thank you so
20:10 much for you for your time and interest
20:12 today back to you know Ellie thank you
20:24 dr. Purcell
20:25 operator can you please go to Question
20:28 and Answer absolutely ladies and
20:30 gentlemen at this time we will be
20:31 conducting the question-and-answer
20:32 session if you would like to ask a
20:35 question please press star 1 on your
20:36 telephone keypad
20:37 the confirmation tone will indicate that
20:39 your line is in the question queue you
20:41 may press star 2 if you would like to
20:43 remove your question from the queue for
20:45 participants using speaker equipment and
20:47 baby necessary to pick up your handset
20:48 before pressing the star keene our first
20:53 question is coming from the line of yi
20:55 Chen what HD wainwright please proceed
20:57 with your question thank you for taking
21:00 my question my question is as you plan
21:03 to advance rata map into preclinical
21:08 studies in multiple cancer indications
21:10 what are the timeframes after which we
21:13 can expect to see some print preclinical
21:16 results thank you dr. Chen for your
21:20 question
21:21 as I have said before and we are
21:23 confident on that that this year we will
21:26 have interim results and could be in the
21:29 second quarter
21:30 that's a little bit you know short
21:33 timeframe that's best-case scenario but
21:35 worst-case scenario I believe we will
21:37 have interim result in third quarters
21:40 okay and if you observed positive
21:43 results in multiple cancer models
21:47 do you rather advanced candidate into
21:50 all indications or would you pick one
21:53 cancer one or two cancer indications
21:55 that are the most promising dr. Patel
21:58 could you please answer the following
22:00 questions yes it has been an approval
22:05 now on one occasion by the FDA of
22:09 mechanism as the rationale for treatment
22:13 so in this case the rationale would be
22:18 cancer type agnostic ccr5 mechanism
22:22 mediated cancer and I think this has
22:26 been the rationale for more recent drug
22:31 approvals for example checkpoint
22:33 inhibitors which are PDL one positive
22:36 tumors similarly I think the rationale
22:39 here and certainly a cultural shift and
22:43 a strong push from FDA is to consider
22:46 mechanism based therapies in an organ
22:51 agnostic way we're going shifting here
22:54 from a concept of thinking about
22:57 melanoma or pancreatic cancer prostate
22:59 cancer rather ccr5 positive metastatic
23:03 cancer and testing patients for ccr5 in
23:08 their tumor and we're circulating tumor
23:09 cells and initiating therapy based on
23:12 those criterion that answers your
23:16 question yes thank you for the
23:19 clarification Thanks Thank You our next
23:27 question from the line of Krishna choir
23:28 a private investor please proceed with
23:30 your question yes sir don't we thank you
23:35 all for taking my call as you mentioned
23:38 financing through Paulson has been a
23:41 billable component cheap the successes
23:44 that I'm and tujhe financing is
23:49 something that sever means to be a big
23:51 question mark
23:52 so I find it concerning disconcerning
23:57 the recent pay raise
24:00 that the executives have ordered
24:01 themselves have you rationalized how do
24:04 you get to the shareholders not this was
24:06 an appropriate take with yourselves
24:09 absolutely thank you for your question
24:12 and I'd be delighted to answer that
24:14 first allow me to remind all our
24:17 stockholder everybody that are all
24:20 compensation matters for senior
24:22 management are handled by compensation
24:26 committee of the board of directors
24:27 which is compromised comprised solely of
24:31 independent directors now it was the
24:35 Compensation Committee determination
24:37 that management has achieved
24:38 extraordinary milestones in recent
24:42 months specifically six months for the
24:45 long-term benefit of the company and its
24:48 shareholders this accomplishment I'd
24:50 like to share with everyone
24:51 first the completion of an all-stock
24:55 acquisition of precision and it's smooth
24:58 transition into our company we firmly
25:01 believe this acquisition may potentially
25:03 reshape and redefine Cyberdyne future
25:08 this acquisition brought to our company
25:11 first one of the world's pre-eminent
25:14 oncologist dr. Richard Estelle who also
25:17 served as our chief medical officer and
25:20 will also oversee the lead all and undid
25:23 all the cancer and other immunological
25:25 indications for Leon dmap second one was
25:28 a pro portfolio of intellectual property
25:31 that provided protection in certain
25:34 areas of science that is currently being
25:36 explored by Big Pharma
25:38 next was a prognostic test in the
25:41 prostate prostate cancer area which has
25:44 the opportunity to provide a licensing
25:46 opportunity and the last was also has
25:49 announced last week we now have our own
25:53 laboratory facilities which will enable
25:55 our company to accelerate evaluating
25:58 preclinical and cancer indication now
26:02 that's just for the acquisition of the
26:04 process in the next accomplishment was
26:07 the initiation of Phase one B - to human
26:10 trial for triple negative breast cancer
26:13 which is truly a significant milestone
26:15 stunning results from our mouse model
26:17 that prompted not only to fight for
26:21 orphan drug designation but initiate
26:23 eight new preclinical studies that could
26:26 put this little company on eight Phase
26:28 two for only a half one and a half to
26:31 two million dollars the next
26:34 accomplishment was since we announced
26:36 our intention to acquire prestige in in
26:39 late August 2018 we have raised
26:42 approximately 40 million dollars on
26:45 terms which have saved the company
26:48 approximately 40 million shares of
26:51 dilution compared to the offering terms
26:53 in the prior 18 months to that so we
26:57 paid 27 million shares for all the stuff
27:02 we have received from processing
27:04 acquisition and pay 27 million from this
27:08 40 million saving that transgene cause
27:11 that is specifically dr. Richard Castel
27:14 truly amazing in my opinion management
27:17 has been actively engaged in discussion
27:20 with several parties for licensing
27:22 agreement as I Anna and as I just
27:24 mentioned we now have offers on the
27:26 table for significant amount of upfront
27:29 non diluted cash and milestones now we
27:33 will send our counteroffer and the
27:36 shareholders will know exact situation
27:39 with these offers at the appropriate
27:41 time and then lastly the management has
27:44 made advancement in his preparation for
27:48 commercialization post anticipated
27:51 approval now before we thought we're
27:53 going to need maybe 50 60 million
27:55 dollars to make enough product for 2020
27:59 revenue hopefully potential that we
28:02 might have if you have approval so now
28:04 having a situation where we were able to
28:08 negotiate with a very large biological
28:12 manufacturing to give us half a billion
28:14 dollar water product without any payment
28:17 that's that's what I call non diluting
28:19 that's what I call amazing
28:21 accomplishment and that's not me saying
28:24 that this is the compensation committee
28:26 day
28:27 they realize that this was extraordinary
28:29 and the amount of race I was given is
28:31 maybe few percentage five percent of
28:35 what we raise so with what we raise with
28:38 what we say it's amazing I think
28:40 encouraging the management to stay on
28:42 the same track and continuously produce
28:45 what we have was important to them I
28:47 assume and they made that decision next
28:53 question please
28:54 Thank You our next question is from the
28:57 line of David Callahan a private
28:58 investor please just leave with your
28:59 question David since the very beginning
29:08 and I thank you and your team for all
29:11 the great progress you have done with
29:14 the HIV and the cancer but I have a
29:16 question on the article that came out
29:18 and seeking alpha and it if it's too
29:23 good to be true and it's probably too
29:25 good to be true would you expound on
29:27 that a little bit
29:30 definitely David and thank you for being
29:32 one of the original investors who helped
29:34 me to be able to purchase Lear on the
29:36 map which we now enjoy all its benefits
29:41 before I indicated that when I heard
29:44 that there was a negative article about
29:46 us know about a few months ago I wanted
29:49 to read it I wanna know what is negative
29:51 about this progress that we have made
29:53 and as I read it I realized that facts
29:57 were not correct I reached out to the
29:59 very honest and author who was a very
30:01 good man in my opinion to be able to
30:04 look at the fact and after he looks at
30:06 the fact he came back and we tracked his
30:10 writing and wrote another article after
30:12 interviewing me and dr. Postel and I was
30:14 very pleased with that but this article
30:16 doesn't say the fact or you know
30:20 different than what we're saying they're
30:21 just saying that the facts are too good
30:23 to be true and I believe that these are
30:25 too good but they are all true and I
30:28 like to mention see of this for example
30:30 or be a late submission that is ready to
30:34 go
30:34 that's not fiction that's a fact we had
30:38 our primary endpoint we are one of the
30:40 five
30:40 according to the website that say there
30:42 is only one out of 5,000 make it we are
30:45 one of those we hit our primary end
30:48 point we finish the trial with 81%
30:51 responders right to suppress white
30:54 although and we're very proud of that
30:56 and then the article goes on and says
30:58 there is sa EES don't these doesn't this
31:02 company realize sa is happening even in
31:05 placebo well that's correct but we put
31:07 the SA under the column where it says
31:09 related to pro 140 lire on Lima if a
31:13 patient is in a clinical trial and God
31:15 forbid they get hit by their core and
31:17 break their leg that's let's say EE but
31:21 it's not related to the drug so when
31:23 it's not really related to the drug then
31:25 we call it these are this product has
31:28 zero serious adverse event in the last
31:31 670 patient that we're using it so the
31:35 the person who said SAE there has to be
31:39 something I want to make sure that we
31:41 give that information the next thing
31:43 that article says which I read it very
31:45 carefully says this company has negative
31:48 200 million dollars in deficit and I
31:50 explained that very clearly we're proud
31:53 of how much money we were able to use
31:55 and number of accomplishment and I'd
31:57 like to know if there's any other
31:58 company who has come close to that
32:00 milestone that we have achieved and then
32:03 there the article also says how do you
32:06 how are they going to commercialize this
32:07 product is the problem for you going to
32:09 commercialize itself well as I said
32:12 right now there is many offers on the
32:14 table that we were working I believe
32:16 zoom up the last product that was
32:18 humanized monoclonal antibody got
32:19 commercialized they made a deal with
32:21 another company and they so I mean this
32:23 is a very simple thing but please if if
32:26 you think it's too good to be true
32:28 my suggestion is check the fact if the
32:31 facts are we have B la then check the
32:33 box if you have the mono therapy trial
32:35 successful where we believe it's
32:37 successful and pivotal trial come check
32:39 the box if GB HD has received orphan
32:41 drug designation and green light for a
32:44 face to check the box and if triple
32:46 negative breast cancer is a new cancer
32:48 world that we are entering with lots of
32:51 good data check the box and if the day
32:54 from mouse came that the hey they
32:56 suppress I mean I'm sorry the the
32:58 metastases did not happen and it's
33:01 compared to morale rock and we keep
33:02 rockin data study and Mahabharat
33:04 finishing that kind of study has already
33:08 been used in human and eliminated
33:11 Chancellor from some of the patients
33:12 this is a stunning and yes it's too good
33:15 but it's also true it's not too good to
33:18 be true and then they're saying that how
33:21 they're going to get the product because
33:23 of the finances well we just explained
33:25 half a billion dollar water product is
33:29 offered to us to be made by a very
33:32 credible CMO and we are very excited
33:37 because the payments for it is deferred
33:39 to the end of 2020 but thanks for your
33:42 question Dave next question please thank
33:45 you once again ladies and gentlemen to
33:47 ask a question at this time please press
33:49 star 1 on your telephone keypad our next
33:52 question from the line of shanku pottier
33:54 a private investor please proceed with
33:55 your question thank you thank you dr.
34:00 poore asan and dr. pastel it was
34:01 actually as a pleasure meeting you in
34:03 person at noble khan last month i wanted
34:06 to ask a question that you know that I
34:07 had asked there and can you further
34:10 clarify or describe some of the out
34:12 licensing activities that you might do
34:14 and specifically whether these
34:15 partnerships that you're looking for are
34:17 in specific fields of use and whether
34:21 the partners are already in these fields
34:24 of use so a transition you know with
34:26 Lorana lab might be easier or is this
34:29 opt or is this going to be a field of
34:31 use that is also new to the partner
34:33 company that's a very good question I
34:36 appreciate that shine it was great
34:38 meeting you at the conference we are
34:41 working with few different
34:43 commercialization company few of them
34:45 have told us that they are already in
34:47 HIV and they are
34:49 very happy to go to HIV the ones that
34:52 haven't been in HIV so that was no
34:54 problem but very soon we will put a
34:56 PowerPoint we will place the power point
34:59 in our website for everyone to see the
35:01 exact plan for commercialization this is
35:04 not a simple powerpoints and very
35:07 complex and very detailed we are working
35:10 right now with some very incredible
35:13 business development people who have
35:15 done many deals in this field and they
35:18 can't wait to do deals for us but the
35:21 talk that we have with these folks it is
35:24 all about HIV GVHD
35:28 cancer and the potential for other
35:30 cancers besides triple negative breast
35:32 cancer and everything is on the table
35:34 and we are very happy that we see they
35:37 are there are offers there are people
35:40 who really say hey we all definitely
35:42 understand this there are very large
35:45 pharmaceuticals that are coming to the
35:48 table and there are very large
35:49 manufacturing which companies are saying
35:52 that they're willing to risk and make
35:54 all the product for us even though we
35:56 don't have approval yet but they're
35:57 willing to start that process for half a
35:59 billion dollar worth of products so it's
36:02 a major thing ee thank you for your
36:04 question any other questions thank you
36:08 we have a few additional questions our
36:09 next question is in the line of Greg
36:11 garner with millennium please proceed
36:12 with your question thank you for taking
36:17 my question thanks for doing the webcast
36:18 gentleman a couple items that just on
36:22 the the FDA wanting to extend the or the
36:27 additional tests you know testing with a
36:30 hundred patients has that started
36:32 already or is it something they don't
36:34 need started rolling I'm just wondering
36:36 well Greg that's a great question thank
36:39 you for that we have already started
36:42 injecting patient with 700 milligram
36:45 quite a bit of time before even the FDA
36:48 asked for that data so we are working on
36:51 that very carefully there is a timeline
36:54 that they want these patients to pass
36:56 certain points and we're going to be
36:59 negotiating with FDA at this time we are
37:01 accepting everything FDA said but
37:03 hopefully in future if we're able to get
37:05 better timeline then we can do it faster
37:07 but we do have some patients already
37:10 with 700 milligrams
37:12 their data and we are going to have a
37:16 much firmer timeline and announced that
37:19 at the given time but right now
37:21 worst-case scenario end of third quarter
37:23 best-case scenario second quarter that's
37:25 all I can say but I'm very very thankful
37:27 to the agency for not making us go and
37:30 redo the whole trial with 700 milligram
37:33 that would have it take four to five
37:34 years thank you the next question thank
37:39 you the next question is from the line
37:40 of Matt Salter a private investor please
37:42 proceed with your question
37:44 yeah good afternoon not her thanks for
37:47 taking my call I heard you talk about in
37:50 fact we've got we've got a situation
37:53 where we can commercialize about 500
37:56 million dollars of product that would be
38:01 actually the market value what is the
38:03 cost to produce 500 million dollars of
38:06 the product so the cost analysis comes
38:10 out to be where our cost of good is very
38:13 small but usually the companies don't
38:15 talk about the cost of good because
38:17 there are other costs involved but I can
38:20 tell you that we are very close to Big
38:23 Pharma's cost of good at certain level
38:25 with the certain conditions which means
38:27 we have to do a much bigger run through
38:30 that for example instead of doing a
38:32 2,000 liter runs we need 15,000 liter
38:34 runs obviously when we are doing deal
38:37 with a big manufacturing company they
38:40 are going to do it at a much higher
38:41 scale we want to have pre prefilled
38:45 syringe which that will say was 20 30
38:49 percent of the cost because you don't
38:50 have to have waste in each a while so
38:53 there are many things I've worked with
38:54 we we are very confident that our cost
38:57 is aligned with other HIV products but
39:00 I'm just not going to be able to give
39:02 you exact cost oh good I do know
39:03 nobody's like that cost of good and I'm
39:05 very proud of it but it is for your
39:07 comfort it is in line with other
39:09 pharmaceutical HIV products okay you
39:12 know I can I can definitely understand
39:14 that and respect that there was some
39:16 talk of possibly having a patch instead
39:19 of a syringe is that something that was
39:21 just maybe a rumor as there been any
39:23 talks about that absolutely nothing
39:26 because we have approval for certain
39:29 paths with by a read up and we
39:32 we have approval to do phase three with
39:35 certain things we finished phase three
39:37 now that phase three however we did that
39:40 that's the one that's going to be looked
39:42 at by FDA to give us up for work and the
39:45 label would be exactly what was in the
39:47 under protocol for Phase three so no
39:50 patches will be looked at this time for
39:52 us we're just going to go straight with
39:54 the sub-q which we believe most of the
39:56 patients or maybe all of them have told
39:58 us that that they do not have problem
40:01 with the pain okay well well thank you
40:05 another question on the pointing I think
40:07 Paulson has definitely been a good
40:10 friend and they we've raised a
40:11 tremendous amount of money through
40:12 Paulson no question about it and
40:15 obviously if we can go to non diluted
40:17 route that's going to be something would
40:20 be quite positive to the share price
40:21 because it seems like the the share
40:23 price is really tied to these raises and
40:26 I think one thing from a shareholder
40:28 standpoint is that you know many of us
40:30 invested in higher terms than what we're
40:32 now raising money out which is difficult
40:35 but it is part of the part of the
40:36 landscape so when we talked about moving
40:39 forward this commercialization and
40:41 upfront payments are we looking at a
40:44 situation that that might be substantial
40:46 enough to veer away from the Paulson
40:49 raises or the Paulson raises something
40:50 that we intend to go forward with on a
40:53 continual basis I mean for example I
40:54 noticed there's a breast cancer event
40:57 down in Hollywood coming up this week
41:00 and it looks like that's probably a
41:02 prelude to another Paulson raised where
41:05 where are we at with this in terms of
41:07 where you think we're going to go with
41:08 the future of financing I mean obviously
41:10 you don't know for sure but is the plan
41:12 to tie to veer away from that with the
41:15 with the commercialization and the
41:16 upfront payments or am i off base there
41:19 no that's a great question and let me
41:21 answer there was several parts to it
41:24 first of all in regards to how much we
41:28 need to get to revenue that number is
41:31 not gigantic that's just a you know
41:34 percentage of what we already raised and
41:36 Mike Mulholland can't weigh in on that
41:38 at the later time perhaps but you also
41:41 said that if we do commercialization
41:44 deal with a commercial
41:46 a pharmaceutical that would be non
41:48 diluted but it is enough we are not in
41:51 liberty of talking about that at this
41:53 time because of the CD age we have
41:55 signed but I want to just mention one
41:58 thing horse and raise all these funds
42:01 for a product that was in phase two with
42:04 a small potential and they're funding
42:07 the tremendous amount of work but I
42:09 don't want to take credit for something
42:11 Paulson did which is in regards to cross
42:13 the gene Paulson has been our partner
42:16 they have done all of these things that
42:18 we are enjoying from precision because
42:20 of pulse on telling us this is the path
42:24 that would help everybody and they the
42:27 senior management at Council have been
42:29 shoulder to shoulder working with us and
42:32 helping and guiding us so I want to make
42:34 sure everybody gets that because a lot
42:36 of people think oh Paulson is raising
42:37 funds and blah blah you know I want to
42:40 make sure that everybody understands
42:42 Paulson allowed me to do things with our
42:45 management team all of us as a united
42:48 front that we could have never
42:50 accomplished not just the money but with
42:53 the path of going forward so with that I
42:55 can tell you that we they won possum
42:58 they want us to raise this money they
43:00 don't want us to raise money they don't
43:01 want us to go and raise another funny
43:03 they're telling us it's time to stop
43:05 raising funds and try to materialize one
43:09 of these deals they're helping us with
43:11 these deals event so we can't go forward
43:14 without raising funds because they want
43:16 the shareholders that came through them
43:18 to have maximum benefit and we're
43:21 working together and we look forward to
43:23 put out some news that would give you
43:25 more clarity about what I'm saying thank
43:28 you okay so to be clear so it sort of be
43:32 clear the Paulson is actually saying you
43:37 know what look we've come a long ways if
43:40 we can find ways to raise funds non
43:43 diluted we would encourage that because
43:47 is that what I'm hearing from you is
43:49 that that absolutely yes absolutely
43:53 because one of the one of the most
43:56 difficult parts of this investment is
43:59 the time of these raises to the share
44:02 price it seems like whatever news comes
44:04 out no matter how positive it is it's
44:06 basically the rinse and repeat deal to
44:10 where we're going to buy the shares but
44:11 we're going to go ahead and sell them in
44:13 favor of the warrants and this cycle
44:14 continues so obviously from a
44:16 shareholder perspective and a value
44:18 perspective I think what the
44:20 shareholders are really hoping for and
44:22 wants to see is when is that arbitrage
44:25 going to be broken to where we actually
44:27 break out and see the real value of what
44:30 LaRhonda mob is because what it feels
44:32 like right now is it from from a share
44:34 price perspective it we're getting a
44:37 different signal saying you know what
44:39 will the market sees are completely
44:40 different but actually that whole
44:42 dynamic is tied towards these raises
44:45 which you know what it's a little
44:47 deflating to the shareholder I love
44:49 what's going on with the science I know
44:50 how hard you guys are working but I
44:52 think we're the shareholders is coming
44:54 from is that when can we break that you
44:57 know break out of that that that
44:59 paradigm so to speak so what I'm hearing
45:01 is is that you guys are working hard to
45:02 go in that direction absolutely and just
45:06 for your comforting and I want to just
45:08 say it is that when they're giant like
45:11 Gilead take from 1992 to 1999 seven
45:15 years of deluding themselves I did know
45:17 very low prices below $1 sometimes they
45:20 were at 29 cents average per in a whole
45:22 year you realize it took him seven years
45:24 to get things moving forward we have
45:27 taken four and a half years to get to
45:29 this point and having eight potential
45:32 phase two in cancer arena and having
45:35 triple negative breast cancer initiated
45:37 and grabbed by Cisco's and all of these
45:39 are giving us potential to raise money
45:42 with at this level just a little bit
45:45 more just to get to revenue now with the
45:48 stock price move if we get to revenue or
45:50 if we file our B la well I can elaborate
45:54 on what the stock will do but I can tell
45:56 you that when a company starts selling
45:58 half a billion dollars that's going to
46:00 change the whole thing now when would
46:02 everybody give us credit I'm not focused
46:05 on that even though I feel the pain of
46:07 every shareholders I get up every
46:09 morning hoping that people will give us
46:11 credit but I'm not
46:13 stop making sure that everything is in
46:15 place for us to have success and the way
46:17 we're going we hit our primary end point
46:19 we don't think something that everybody
46:22 could take some comfort but the stock
46:25 price is in our mind that's why Paul
46:27 Sartre has also accepted to help us with
46:30 the event that we are putting on
46:32 February 28th not that we are going to
46:34 raise money from the because for this
46:37 event that's absolutely not the case
46:39 we're not even allowed to have anybody
46:41 in that place to participate in any
46:43 fundraising because of SEC rules and
46:46 regulations which we follow very closely
46:48 so we are wanting to have enough
46:53 visibility so people can see what we
46:56 have and those people who check out our
46:58 science and just dig in a little bit to
47:00 go while we impress but thank you for
47:04 your question any other questions thank
47:07 you our next question is from the line
47:08 of Harry Fannin Zia what's Healthcare
47:10 Capital Advisors pleased to see with
47:12 your question the progress that you're
47:17 making but I wanted to just to follow up
47:21 on a comment that I think nadir you
47:23 started with it
47:24 you if you could get a product to market
47:27 on 170 million is that is very capital
47:30 efficient but we don't have a product to
47:33 market yet so my question is what is the
47:37 anticipated time and capital necessary
47:42 to hit these value creating milestones
47:45 that you've talked about and do we have
47:48 enough capital in the bank or with the
47:51 amount of capital we have in the bank
47:52 how far can we get can we get three
47:55 months or two years or somewhere in
47:58 between so it's good so we we have we
48:06 have a situation right here that's very
48:08 complex but we need to make sure we
48:11 raise funds at the right price we have
48:13 offered that we have rejected before the
48:17 lower valuation that people wanted to
48:19 give us one we're fighting for every
48:22 inch right now but do we do we raise the
48:25 funds
48:26 I mean how much more money do we need to
48:28 get to revenue perhaps that's the
48:30 question that you want me to answer is
48:31 that right well I also just want to know
48:34 how long can we last at the current firm
48:36 oh so we don't raise quite a bit of
48:40 money to have 12 months of 24 months
48:43 cash on hand because we believe our
48:45 company is undervalued big-time and if I
48:48 was going to accept the offer which I
48:50 rejected it before for 20 million at 30
48:54 cents or 20 cents
48:55 I think the shareholders would have
48:57 valid arguments saying that I didn't do
48:59 my work the right way I have to keep
49:02 what I have the price of this shares
49:04 right now add and try to raise the
49:06 awareness about our company so hopefully
49:09 we can be evaluated at a different price
49:11 but timing is also everything I know
49:14 every shareholder wants us to be having
49:16 revenue in 2020 should I slow down our
49:20 fundraising and just try to bring ever
49:22 more visibility and slow down all the
49:25 processes so we can get perhaps
49:28 commercial in 2021 but we spent some
49:31 money at this to get publicity and and
49:34 you have a higher value that's not the
49:37 path we chosen we said we're going to go
49:39 forward and if we have to be deluded
49:41 another 20% perhaps I will just I'm just
49:45 throwing numbers you know then to get to
49:47 revenue and have all these indications
49:50 come true for us that we are working on
49:53 then that I think that's what we have to
49:55 do but we're not talking about time in
49:57 December Mikey would you elaborate yeah
50:00 I think the key message that not ours
50:03 trying to share here is one of
50:06 incremental capital raises which is
50:09 founded on the premise of our valuation
50:15 incrementing up we heard you and we
50:19 understand very well the overall impact
50:24 on the valuation of the company for
50:25 cereal raises at 50 cents
50:27 however it's important to to appreciate
50:31 that
50:32 we believe we have a number of clinical
50:40 developments between now and the balance
50:44 of the year that that is going to that
50:47 has a strong potential of possibly
50:51 having a very positive effect on the
50:54 valuation of the company and that's why
50:57 we are looking at we are raising capital
51:00 at a very judicious pace to ensure that
51:05 we're being as opportunistic as possible
51:07 on what we believe our future valuation
51:12 catalysts for the shareholders okay
51:16 thank you for your question next
51:17 question please this is the last
51:19 question please thank you our final
51:22 question will come from the line of
51:22 Ashley Daniel a private investor please
51:25 proceed with your question yes go ahead
51:31 yeah so one of the reasons I believe the
51:34 price is getting affected is because of
51:37 the exchange do you have any plans to
51:39 move it to some Nasdaq or New York Stock
51:43 Exchange or one of the bigger ones
51:45 absolutely great question so we believe
51:48 that we need to get to $2 level or $4
51:52 levels either from New York Stock
51:55 Exchange or Nasdaq we believe we like to
51:58 give ourself a chance to do this
51:59 organically not reverse split and we
52:02 believe we have plenty of plenty of
52:06 opportunities hopefully to make that
52:08 possibly happen now for that reason Mike
52:12 Mulholland our CFO is working very hard
52:16 to file the application for both Nasdaq
52:19 and New York Stock Exchange because if
52:21 that opportunity arises we want to make
52:24 sure we're completely ready and move
52:27 forward to the exchange where we help we
52:29 are held hostage in my opinion
52:31 OTC B I mean the amount of shares that
52:35 we sold in the past as a last caller
52:38 elaborated about people selling and
52:40 keeping the warrants this is the way it
52:42 is and we need to be able to have said
52:45 you know buying power in the market
52:47 that's what we need visibility but in
52:49 the higher exchange there will be
52:51 institutions involved and those t
52:53 will not be a problem but our our -
52:56 stones that coming up convinced us that
52:59 we need to wait a little bit and let
53:01 this talk get to those levels
53:02 organically do you think you have some
53:06 sort of timeline in which you're gonna
53:10 hit your milestones any kind of
53:12 indication at what period can given one
53:14 of the bigger exchanges yeah so the
53:17 triple negative breast cancer result
53:20 that to me was stunning in a mice model
53:23 and if if mera Bharat leaves the same
53:27 mouse model and then it was great and
53:29 then went right to human trial in
53:31 Germany and in German the group showed
53:34 that some of the patients had metastases
53:37 cancer metastases disappeared to me if
53:41 we're able to do that kind of thing and
53:43 have interim results that is strong I
53:45 think we this is a milestone that will
53:48 really be interesting to us in regards
53:51 to graft-versus-host disease we
53:52 reinitiated to hope to see that
53:54 elimination of graft versus host in the
53:57 mice model with that panel to be the
53:59 same way in the human model we will find
54:02 the human studies we would see about
54:04 that and the preclinical studies of all
54:07 the other a cancer indication or you
54:10 know followed very carefully we do have
54:13 BL a submission our first component
54:16 should be submitted soon we do have mono
54:19 therapy if we are able to get pivotal
54:21 tried this would be the first mono
54:23 therapy ever in the world of HIV with a
54:26 humanized monoclonal antibody self
54:28 injectable once a week so these are
54:31 pretty powerful milestones so let us get
54:35 there and we want to hopefully get there
54:37 before second quarter on some of them
54:39 and before third quarter under others so
54:42 as per the milestone and timeline we
54:44 were working it I am the founder Kristin
54:47 to dr. Patel people Pfizer brought Mary
54:51 crack and their own women we know what
54:55 is the major difference and why is that
54:58 our only map or the pro one party is
55:02 showing better results or a much better
55:04 effective rate there
55:06 Fiser grunts okay yes I hope you can
55:15 hear me yes I think that yes so there's
55:19 not been a direct head-to-head
55:21 comparison in patience of these
55:24 different therapies you know the way I'd
55:28 characterize it is that we have
55:31 preclinical data using specific doses
55:35 and I can only say that based on the
55:39 doses that we used in the preclinical
55:41 studies we've been able to see a more
55:46 sustained suppression of the metastatic
55:50 phenotype so there are a number of
55:52 different variables that could be
55:54 responsible for this thing including the
55:56 dose of therapy and bioavailability and
56:00 other issues that we don't really
56:01 understand but I'd say that it is not
56:05 there my intention to imply that one is
56:08 the superior technology than the other
56:11 this is certainly not been exhaustively
56:14 examined by any by any stretch we're
56:18 going to refer to a single study that
56:22 we've conducted a preclinical study and
56:25 I think that there's enormous
56:26 opportunities the important point to
56:28 take home really is the principle that
56:30 in the case of ccr5 it plays an
56:35 absolutely important role in cancer
56:38 metastasis and that small molecule
56:40 inhibitors of ccr5 and a humanized
56:43 monoclonal antibody have demonstrated a
56:47 substantial efficacy in these
56:49 preclinical studies again we're in Zinna
56:52 graft model for human cancer so again
56:57 emphasize that none of my comments were
56:59 or should be construed to state that
57:01 with in any way compare these directly
57:04 nor have we determined whether or not
57:06 they would have similar or superior
57:08 efficacy in the clinical studies because
57:10 those clinical studies have not been
57:12 conducted rather I'd say this is a
57:15 message of theirs profound opportunity
57:19 in the
57:20 ccr5 cancer metastasis space I hope
57:24 that's helpful answer to the question of
57:27 course thank you thank you thank you and
57:31 with that we would like to wrap it up
57:34 operator no more question announced but
57:37 I'll just gives you more comments about
57:39 finishing comments so thank you again
57:43 everyone for being on the call today to
57:46 summarize we have our blh submission it
57:49 could happen
57:49 the full amount by the end of second
57:52 quarter best-case scenario worst-case
57:53 scenario end of third quarter
57:55 monotherapy pivotal trial is being
57:57 worked on triple negative breast cancer
58:00 the initiation of the patient's
58:02 injection could happen any week now and
58:04 the interim results we hope to have in
58:07 third quarter with the regards to grab
58:10 purses hostesses we reinitiated our
58:12 study in regards to manufacture product
58:15 we had some good results to tell our
58:17 shareholders and in regards to
58:19 commercialization of four one four there
58:22 are opportunities that we are evaluating
58:24 at this time with that I want to thank
58:26 everybody again and have a great day