if FDA agree BLA Clinical August & BLA CMC

if FDA agree BLA Clinical August & BLA CMC September

Still no clue when the mTNBC injection will occur. (maybe this month or next).

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00:00 hi I'm Mike Kelly and you're watching
00:01 the stock geek podcasts where we help
00:03 investors find potentially profitable
00:05 small and mid-cap stocks that may be
00:07 undervalued on the verge of a breakout
00:09 or have other fundamental
00:11 characteristics that make them an
00:12 attractive long-term opportunity today
00:15 as part of our CEO Roadshow series we're
00:17 joined by dr. nadir poor Hassan
00:19 president and CEO of sited ein a biotech
00:21 company developing innovative treatments
00:23 for multiple therapeutic indications
00:25 based on Llorona map a novel humanized
00:28 monoclonal antibody targeting the ccr5
00:30 receptor they trade under the ticker see
00:33 ydy hi dr. poor Hassan welcome to the
00:35 show thank you
00:37 so for investors new to the story I'd
00:40 like to start off by getting an overview
00:41 of what Saito Dyne does what are your
00:44 primary pipeline drugs right now and
00:46 what indications are you seeking FDA
00:48 approval for antibody called Li Ron Lee
00:55 map in the literature in the past it was
00:58 this product originally biogenics for
01:02 HIV we continued that with HIV and we
01:06 went for an unmet medical need
01:07 population which was a small trial and
01:10 we finished that trial at our primary
01:12 endpoint but meanwhile we are developing
01:14 it for HIV for mono therapy which is the
01:18 most exciting thing the world of HIV has
01:20 ever seen and this product when we
01:22 enroll for it the center's that role
01:25 patients are overwhelming in joining
01:28 those centers to enroll in this monitor
01:30 and we were a dr. oz talking about for
01:33 some celebrities so having said that two
01:36 populations unmet medical need and which
01:40 we can change HIV and what is the
01:44 timeline for approval and commercial
01:46 release of Leron limit so but after we
01:49 had our primary endpoint be the
01:51 impressive p-value we finish the trial
01:53 with 81% suppression viral suppressed
01:55 viral load and that compared to five
01:58 therefore the same population was 45% of
02:01 so had the last product that was at 43%
02:04 so any 1% was very impressive
02:06 we met me the FDA they give us they
02:10 granted roe
02:11 review to us which allowed us to find
02:14 the final application for final approval
02:17 DLA biologic license application and we
02:20 submitted the first one third back in
02:22 March the next one third is clinical by
02:24 August and the last one hopefully by
02:27 September now August and September time
02:29 and we have to be very careful because
02:31 we still need a couple of clearance from
02:33 FDA for those timelines to happen and we
02:35 hope to let the public know very soon
02:37 but bottom line is hopefully we will be
02:40 having revenue next year okay great and
02:43 what other indications are you working
02:45 on for your monoclonal therapy right now
02:47 so we were very pleasantly surprised
02:50 when Pfizer took their HIV product to
02:52 graft versus host disease we did a small
02:55 study $10,000.00 study about $10,000 and
02:58 we were pleasantly surprised that FDA
03:00 gave us Phase two for that unmet medical
03:02 population need so then we realized that
03:08 we have indication in colon cancer and
03:11 then dr. mr. the world-renowned
03:14 oncologists who join us because he said
03:16 that your product is the only product
03:18 that has hardly any toxicity or side
03:20 effects and it's an HIV product that
03:23 could help me realize what I discovered
03:25 and what he had discovered was all the
03:28 metastasis of the cancers mainly happen
03:31 through HIV pathway which is ccr5 which
03:36 is the target of this product that we
03:38 have or marker antibody targets ccr5
03:41 which it stops the virus from getting to
03:44 the cell all the cure and premise that
03:47 relaxes or to that ccr5
03:49 we have all the key for that crop but
03:53 that's the key that also apparently
03:55 important cancer so we have a triple
03:57 negative breast cancer Phase two that's
03:59 about to inject the first patient
04:01 hopefully this month or next month we
04:03 have the graft versus host disease which
04:06 is an unmet medical need 40% of the
04:08 patient died with preferences for cities
04:10 in our animal study of GBH to be
04:12 eliminated G PhD the other me the world
04:15 that habitat we published that paper in
04:17 peer review and now we are going to
04:19 focus on April indication including not
04:22 and what can you tell us about the
04:24 recent edition of dr. Jonas sokka's
04:26 senior science advisor what what does he
04:28 bring to the team has been studying 40
04:33 lately maybe one of the largest primate
04:36 centers in the world for monkey studies
04:38 in the OHSU Oregon Health Science
04:41 University he approached us after asking
04:44 for LaRhonda map and he used that for
04:46 the last nine months or so in a study
04:49 that is do conducting his results were
04:51 so positive that he convinced his
04:53 colleagues in Thailand to do a prep
04:56 prophylactics studying for LaRhonda map
04:59 for with the center at the tie and tie
05:02 Red Cross just signed a Memorandum of
05:05 Understanding with us to go forward with
05:07 a prep study prevention and prophylaxis
05:10 in regards to cure he also has a very
05:13 interesting study that he has done and
05:15 as HBO did adopt committee a year ago
05:19 and continues to be cities news about
05:21 Timothy Brown and cure coming out all of
05:23 them are taking ccr5 the receptor on the
05:26 cell is missing
05:28 therefore the cure is happening for
05:31 Timothy Brown on perhaps and if the
05:33 second patient that God that which is
05:35 London patient now Jonas or dr. Joe
05:38 Sasha the professor associate professor
05:40 at OHSU said that in his studies he
05:42 believed the future of HIV is liran
05:45 edema because of that sees your heart
05:47 and is very excited to publish his data
05:49 which she plays it brings tremendous
05:52 major media attention to our product
05:55 which we are missing so far so just to
05:58 summarize you guys right now have a drug
06:00 that's a drug pipeline that has the most
06:03 effective treatment currently known for
06:05 HIV also targeting the ccr5 receptor
06:08 meaning that it's it's also potentially
06:10 effective for a host of other
06:12 indications is that correct I just wanna
06:14 make sure sixty percent right now have
06:25 to take multi drugs at the exact time so
06:28 every day they're taking a drug multiple
06:30 times during the day whereas with urine
06:32 and in the case of your drug it's easier
06:34 to administer because it's just a one so
06:36 we
06:36 then correct it's a sub-q it's like
06:41 insulin shot that diabetes administer to
06:45 themselves every day so when you have
06:47 something that can be that easily
06:49 administered and have hardly any
06:52 toxicity or side-effect in the patient
06:54 as they have shown when we enroll for
06:56 our child there is tremendous will for
06:59 patients to enroll that tells us that
07:01 there's a huge market opportunity and
07:03 our numbers are pointing at seven eight
07:05 billion dollars worth of market size the
07:08 monitor Gilead analyst two years ago
07:10 said if this little company decided I
07:13 had success with model therapy there
07:15 will be pushback on the sales of Gilead
07:17 so we will get noticed and our results
07:20 right now show that the higher
07:21 responders rate is there we submitted a
07:23 pivotal trial for modern therapy to FDA
07:26 again our first trial unmet medical need
07:29 population we have finished that we're
07:30 ready to have hopefully revenue next
07:33 year with that and then it cost
07:37 comparison wise how does your drug
07:39 compare to what the current treatments
07:40 are in the market are you guys you come
07:41 in way lower since it's just this once
07:43 or twice a week regimen we see patients
07:50 taking these pills for 20 years going to
07:52 have problems we don't believe we have
07:54 any of those we have patients on monitor
07:56 if you have gone for five years now with
07:58 our product so with all of those
08:00 qualification we can match any price out
08:02 there so with less toxicity less dosages
08:06 similar cost to what's out there
08:08 definitely not more so it compares very
08:10 favorably very competitive so so that
08:13 sounds good dr. poore hassan that's all
08:15 the questions we had for the show today
08:17 what what else should investors take
08:19 note of when when looking at adding this
08:22 stock to their portfolio focus on the
08:26 fundamentals when Gilead was done
08:29 unnoticed from 1992 to 1999 the stock
08:32 was around the same level as our stock
08:34 is right now the biotech companies get
08:37 their inflection
08:38 people have to pay attention before that
08:40 inflation happened our inflection in my
08:42 opinion is this year we proven our
08:44 primary endpoint finishing the trial
08:47 getting the BLS
08:48 mission accepted by FDA to continue and
08:51 our monotherapy cancer I mean these are
08:54 stacking up and I think we are ready for
08:56 that
08:56 well dr. pearl Hassan I really
08:58 appreciate you taking time out of your
08:59 busy schedule to come on the show we're
09:01 gonna continue to follow the story
09:02 closely here and I would like to get you
09:04 on in a couple months for another update
09:08 thank you take care we have been talking
09:13 doctor not a poor Hassan he's the
09:15 presidency of Saito dine to biotech
09:17 company developing innovative treatments
09:18 for multiple therapeutic indications
09:20 based on a la Rana map a novel humanized
09:23 monoclonal antibody targeting the ccr5
09:25 receptor and they trade him to the
09:26 tickler ticker
09:27 C Y dy to learn more about them please