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Yeah Muroc you sobered me up. And is is such a small trial as far as patient size and single clinic.
Apologies for the delayed response.
GLTUA
Yeah Muroc you sobered me up. And is is such a small trial as far as patient size and single clinic.
Apologies for the delayed response.
GLTUA
Trial completion date is end of this month. It normally takes 60-90 days to analyze the data and publish results.
I don’t think you will see anything as far as news until end of this year or early 2022.
Murocman
Welcome aboard Stone. Most encouraging aspect for a quick rise is the model established by our closest competitor:[/quote]Rafael Pharmaceutical’s first-in-class clinical lead compound, CPI-613® (devimistat), targets enzymes that are involved in cancer[/quote]We were attached at the hip in 2019. Then funding came through. They quickly rose to $50, now in mid-$30z.
We're both holding strong repeaentation within the Precision Promise trials being conducted by PANcreatic Cancer Action Network (PANCAN). Similar promising interim reports.
RAFAEL has a high level of Israeli backing. A little more past coverage from Israeli press ca. 2019.
As you say, it takes. Takes money too and we finally have it.
RAFAEL's CP-619 and our SM-88 seem to be THE LEADERs in the field of Cancer Metabolism Based Therapy (CMBT). Our's targets the Tyrosine amino acid which is crucial in metabolic control system.
Rafael's targets glucose consumption process later in the stages of metabolc processes.¯\_(?)_/¯
Both areas way TF over my head, but there you have it.
Pandemic has really hurt real progress in each company's trials. Hopefully, our sarcoma updates at the end of this will bring us positive news.
GKTUA
I am a new investor in TYME. I AM NOT a new investor in ONCOLOGY stocks. If I learned anything it is if you are looking for a quick killing ONCOLOGY stocks is not the place to be. If you are a long hauler it can be very rewarding. Most of the CANCER stocks I am invested in I have done so because I have an interest in the areas they are attempting to treat.
Most of those folks that trade in this area are considered to be in the older population and do not act out as fools in any online chat area (WHICH IS A BREATH OF FRESH AIR). I wish everyone good luck here and if you all become successful that will be fantastic for you but even more it will mean tYME has accomplished something that sick people can benefit from.
Apologies for this long over-due reply murocman. Got some great family events going on with our new grandson ANDDDDD couple other projects.
Going back to the CLINICAL TRIAL updates, for our Ewnings Sarcoma, check out the fields in this spreadsheet on the site. Primary Results should be released 31 October 2021. You can change the columns on the far right control box.
Last release was April 1st where our effort to date was "we passed futility", something like that. Really meaning we proved promising at that time. https://clinicaltrials.gov/ct2/results?term=SM-88&cond=Ewing+Sarcoma+AND+%22Ewing+Sarcoma%22.
In speaking with our IR rep
Jonathan Echardt TYME IR
investorrelations@tymeinc.com
(917) 334-7284
is very helpful. Early in the board shake up, last June, he did indicate tackling advanced metastatic Pancreatic Cancer was a great target, and everybody was failing to achieve it. Hinted realignment back to breast cancer was probable. And so be it.
Thinking that the financing received then came with the caveat that the old board had to go.
New board has been more open in completely answering questions I've submitted. Got blown off a lot under the old tenure.
This is where we were on Breast Cancer project that lost funding a couple of years ago. https://people.com/health/head-of-the-class-khrystyne-haje-recovered-stage-iv-breast-cancer/
Alrighty Murocman, again my aplogies for over due response
Thanks Mcsharkey. My frustration was not meant to be directed at you but more so at the company.
They have some promising molecules and technology in a tough space but the progress seems to be excruciatingly slow.
The fact that it took a formal ‘strategic review’ to figure out the best bang for the buck is to focus on 2nd rather than 3rd line Pancan treatment does not inspire confidence as to the company’s market savvy. Hopefully the science and data continue to be compelling.
Murocman
Here Ya Go Muroc, all!
I did screw up with our new regime (since June), last Board presented the timeline dates in Fiscal Year entries. In that, today's last day of the first half of FY 22. Got straightened out on that over the phone, and the following e-mails between me and Investor Relations.[/quote]Good Day Lisa, Jon!
Any information about current status or insight into our relationship with Sarcoma Oncology Research Center, LLC (Sponsor) and collaboration with Joseph Ahmed Foundation is appreciated.
No Trial updates since April on this. Here's a link to the Clinical Trial records on this.
https://clinicaltrials.gov/ct2/show/NCT03778996?term=SM-88&cond=Sarcoma&draw=2&rank=1
Thank You. Very Respectfully
***************************************************************
Investor Relations
Sep 30, 2021, 4:20 PM (1 day ago)
to me, Lisa
Hello Mike,
Lisa might have responded, but it is not really accurate that there have been no updates on this.
In June we presented interim data from this trial at ASCO (link).
-->
Also in June, as part of our strategic overview, we highlighted this as an area of continued focus for us. I believe we said the trial had enrolled 16 of the 24 patients, and we guided for completion of enrollment by 1H next year. (link)
Given that sarcoma is a pretty rare cancer, and this trial is really out of the one site, the enrollment is not bad. This site normally has patients travel from across the US, but this was obviously reduced during COVID. Based on what we know today, we believe our guidance for completing enrollment is achievable.
I hope this helps[/quote]Here's the link for INTERIM DATA PR: https://tymeinc.com/investors/press-releases/press-release-details/2021/TYME-Announces-Abstract-Selected-for-Publication-at-the-2021-American-Society-of-Clinical-Oncology-Annual-Meeting/default.aspx
Here's a link to the new Corporate Board's COMPANY slide show. Go to page 23 for the current timeline.
https://s22.q4cdn.com/265040820/files/doc_presentations/2021/06/TYME_Q4FY21_jun10_rs-compressed.pdf[/quote]Apologies for my oversight. I am asking about how this entry on the sarcoma files of the Clinical Trial's site:[/quote]Estimated Primary Completion Date:October 31, 2021
And, here's a link to the SPONSOR of our trial: https://sarcomaoncology.com/
This link is to our test on the Clinical Trial site: https://clinicaltrials.gov/ct2/show/NCT03778996?term=SM-88&cond=Sarcoma&draw=2&rank=1
Good Job on calling me out Muroc. Maybe by Halloween ¯\_(?)_/¯???
GLTUA
I don’t see anything in their last corporate presentation about Sarcoma data by June 30th. In fact it says enrollment won’t be complete until 1st Half 2022 as well as a Pancreatic cancer data update H1 2022.
It doesn’t look like much going on until then.
GLTA,
Murocman
Damn Chillin,
Came back to Earth pretty damn fast. And I erred (effed up) in that table. We havw an INSIDER offering since 15 April. Revised all the outstanding options for 6 Million shares total at $1.53.
Last week Carberry bought ln the market price over 100k. Just wish he'd exercised his options.
So I think there's a low probabilty of an offering. Maybe those options are poison pills.
Here's a link to the S-8. https://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=14872887-950-14376&type=sect&TabIndex=2&companyid=873303&ppu=%252fdefault.aspx%253fsym%253dTYME
A lot of clean up of old SEC records in it...
.
Hoping for Sarcoma news. This is the last week of the first half of FY22.
Finally. They better not do an offering once results are released. What are the odds of that occurring? McSharkey
Thanks for the date
Sarcoma data due by 30 Sept. Great pre-markt action. Previous Close 1.0500
Open 1.0700
Bid 1.1400 x 27000
Ask 1.1200 x 2200
Day's Range 1.0501 - 1.1350
52 Week Range 0.8500 - 4.9900
Volume 2,099,388
Avg. Volume 6,685,6
GLTUA
Sarcoma data due by 30 Sept. Great pre-markt action. Previous Close 1.0500
Open 1.0700
Bid 1.1400 x 27000
Ask 1.1200 x 2200
Day's Range 1.0501 - 1.1350
52 Week Range 0.8500 - 4.9900
Volume 2,099,388
Avg. Volume 6,685,6
GLTUA
Time 4 TYME to run! ain't going below 1.00 now at 1.05
FYI
Questions submitted too late for Earnings call and considered a distraction if covered in Annual Meeting/ Proxie Vote Earnings Call.
ANSWER FROM INVESTOR RELATIONS IN ALL CAPITAL LETTERS
*****************************************
For next Tuesday's Investors Meeting and Proxy Vote, I'm asking for clarification on several topics.
Has our collaboration with LineaRX/APDN for molecular detection of invasive Circulating Tumor Cells (iCTCs) been replaced by our bio-marker collaboration with Evotec?
CTCS WERE BEING EXAMINED IN PROSTATE CANCER MAINLY. HOWEVER, AS PART OF OUR STRATEGIC REVIEW, IT WAS DETERMINED THAT WE WERE NOT CURRENTLY GOING TO FOCUS ON PROSTATE, AND THAT WE NEEDED TO FOCUS ON BROADER MORE TRADITIONAL BIOMARKERS THAN JUST CTCS. WHILE THIS DOESN’T MEAN WE MIGHT NOT USE THEM IN THE FUTURE, CURRENTLY WE ARE FOCUED ON THE EFFORTS AT EVOTEC MAYO AND OTHER PLACE, AS WELL AS USING CIRCULATING TUMOR DNA IN OUR BREAST CANCER TRIAL THAT ALL THE KOLS SAID WAS A MORE VALIDATED BIOMARKER THERE.
As of Evotec's own investors' meeting there is no mention of us within their meeting's video stream, or on pharma-partnerships.
EVOTEC IS A SERVICE CORPORATION AND WORK WITH HUNDREDS OF COMPANIES, INCLUDE THE LARGEST PHARMA COMPANIES AND SMALL BIOTECHS LIKE OURSELVES. I DOUBT THEY WOULD LIST ALL OF THEIR CUSTOMERS.
EVOTEC DOES HAVE AN INVESTMENT ARM WHERE THEY CAN INVEST IN COMPANIES OR SUPPORT RESEARCH. (A VERY SMALL PORTION OF THEIR ACTIVITIES.) I BELIEVE THAT IS THE LINK THAT YOU FORWARDED. THIS IS NOT THE TYPE OF RELATIONSHIP WE HAVE WITH EVOTEC CURRENTLY.
NCT03512756 - TYME's self-sponsored clinical trial with some collaboration with LINeaRX and Eagle Pharma, from milestones graphic below updates are due now-> end of September (1H22). To summarize, data listed on the Clinical Trial site was Last Update Posted : June 21, 2021. In our collaboration with Eagle RX:
Jan 7, 2020 Tyme Technologies and Eagle Pharmaceuticals Announce Strategic Collaboration
///////OUR MILESTONE PAYMENT CAVEATS\\\\\\\\\\\\\
In addition, TYME will receive a $20 million MILESTONE payment upon the successful completion of the first to occur of the following three events:
(1) Achievement of the primary endpoint of overall survival in its TYME-88-Panc pivotal trial;
.....or
(2) Achievement of the primary endpoint of overall survival in the PanCAN Precision Promise? SM-88 registration arm;
.....or
(3) U.S. Food and Drug Administration (FDA) approval of SM-88 in any cancer.
This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.
THIS SEEMS CORRECT. SINCE THE 3RD LINE TRIAL OF PANCREATIC IS BEING SHUT DOWN, (NCT03512756) THE REMAINING EVENTS WOULD BE THE ONES TO FOCUS ON. FOR PANCAN YOU SHOULD NOTE THE EVENT IS THE PRIMARY ENDPOINT AT THE END OF THE TRIAL. THIS WOULD BE BASED ON SURVIVAL RESULTS FROM ~175 PATIENTS TREATED WITH SM-88. PRIOR TO THAT “FINAL” DATA, THERE IS A “GRADUATION” FROM THE PHASE 2 PORTION OF THE TRIAL ~100 PATIENTS, TO THE CONFIRMATORY PHASE 3 PORTION ~75 ADDITIONAL PATIENTS. WHILE WE BELIEVE IT WOULD BE ENCOURAGING THAT SM-88 GRADUATES TO THIS “CONFIRMATORY” PORTION (MAINLY BECAUSE THERE WOULD APPEAR A BENEFIT THAT NEEDS CONFIRMING), THIS GRADUATION WOULD NOT TRIGGER THE MILESTONE.
AS PRECISION PROMISE COME OUT OF THE PANDEMIC, OPENS UP ITS ADDITIONAL SITES, WE MIGHT HAVE A BETTER IDEA OF WHEN THESE EVENTS COULD OCCUR, BUT TO BE CLEAR- WE ARE BLIND TO THE EXACT ENROLLMENT OF OUR ARM AND THESE ARE BASED ON OUR ESTIMATES OF SOME OVERALL ENROLLMENT AND OTHER ITEMS THAT WE USE TO TRIANGLATE THE POTENTIAL STATUS OF OUR ARM.
Hoping the trial status and working collaborations be fully discussed. If our therapeutics (i.e. SM-88, SM-18, et al) are now being manufactured by EVOTEC, please expound. Updates on our working agreements with EAGLE and LinEARX also requested.
WE CAN’T REALLY SAY MUCH MORE ON PARTNERSHIPS THAN WHAT IS IN THE PUBLIC DOMAIN. EVOTEC – WE HAVE SAID WE HAVE STARTED WORK WITH. LINEARX WAS MAINLY A TRIAL THAT IS NOW COMPLETE OR STOPPED. EAGLE, THE ONLY THING WE CAN REALLY SAY IS THAT THIS WAS MORE OF A COMMERCIAL AGREEMENT, SO ACTIVITIES WOULD NOT REALLY HAPPEN UNTIL CLOSER TO COMMERCIALIZATION. OTHER THAN THAT, YOU CAN LOOK AT THEIR HOLDINGS AND SEE IF THEY HAVE SOLD SHARES (I DON’T BELIEVE THEY HAVE.)
Also from the milestone schedule:
NCT04720664-OASIS_Breast_Cancer, Last Update Posted : May 27, 2021, from the graphic: First Patient Enrolled 3Q21 (Oct -Dec 2020) is well passed.
We are currently nearing the end of 1H22. Reporting on our current NCT03778996 - Joseph Ahmed Foundation trial.
I THINK THAT YOU WILL SEE THAT ON THIS SLIDE WE TRIED TO MAKE IT CLEAR THAT THESE MILESTONES ARE IN CALENDAR QUARTERS (BELOW THE SNAPSHOT YOU PASTED). SINCE WE DIDN’T EVEN ANNOUNE THIS TRIAL UNTIL AFTER THE FY 3Q21, IT WOULD NOT BE LOGICAL THAT FIRST PATIENT ENROLLED WOULD HAVE BEEN IN 20
Great article....thank you for posting!
Yeah Enviro, haven't got any answers from my submittal. Tapping on their Window.
Here's a positive Seeking Alpha piece on us. Ahhh, I agree with the author. This is at least his 3d article on us. AND, I'm not writing it. We still have over due reports on Breast Cancer, and UPDATES DUE NOW till end of September on sarcoma.
That link I promisedIS HERE & CLICK :)
Hope this Weekend is/was everything you dreamed for:)
Peace!
Thank you for the info Mc
For next Tuesday's Investors Meeting and Proxy Vote, I'm asking for clarification on several topics.
Has our collaboration with LineaRX/APDN for molecular detection of invasive Circulating Tumor Cells (iCTCs) been replaced by our bio-marker collaboration with Evotec?
As of Evotec's own investors' meeting there is no mention of us within their meeting's video stream, or on their presentation @https://www.evotec.com/en/innovate/pharma-partnerships.
NCT03512756 - TYME's self-sponsored clinical trial with some collaboration with LINeaRX and Eagle Pharma, from milestones graphic below updates are due now-> end of September (1H22). To summarize, data listed on the Clinical Trial site was Last Update Posted : June 21, 2021. In our collaboration with Eagle RX:
Jan 7, 2020 Tyme Technologies and Eagle Pharmaceuticals Announce Strategic Collaboration
///////OUR MILESTONE PAYMENT CAVEATS\\\\\\\\\\\\\
In addition, TYME will receive a $20 million MILESTONE payment upon the successful completion of the first to occur of the following three events:
(1) Achievement of the primary endpoint of overall survival in its TYME-88-Panc pivotal trial;
.....or
(2) Achievement of the primary endpoint of overall survival in the PanCAN Precision Promise? SM-88 registration arm;
.....or
(3) U.S. Food and Drug Administration (FDA) approval of SM-88 in any cancer.
This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.
Hoping the trial status and working collaborations be fully discussed. If our therapeutics (i.e. SM-88, SM-18, et al) are now being manufactured by EVOTEC, please expound. Updates on our working agreements with EAGLE and LinEARX also requested.
Also from the milestone schedule:
NCT04720664-OASIS_Breast_Cancer, Last Update Posted : May 27, 2021, from the graphic: First Patient Enrolled 3Q21 (Oct -Dec 2020) is well passed.
We are currently nearing the end of 1H22. Reporting on our current NCT03778996 - Joseph Ahmed Foundation trial.
VR
Insider buy today, finally, Van Tornout Jan M, a whopping 1K shares for $1.05 registered on EDGAR near close. Probably kept us above a $buck.
Been the doldrums a while now:) Hovering just above a buck isn't anything new Enviro. August 24th? Who knows. The short Q&A session took me off guard. I'll get my questions ready for that. Grand kid is a distraction:)
He's over in England, my daughter and son-in-law live in the London suburb of Crawley. Per my daughter's request, we're holding off till Labor Day then go spend a month together.
Here's a You-Tube by Frank Profido a poster on Yahoo found.
This may bounce around the one dollar range for a while till we see some exciting news.
Congrats mcsharkey on your first grandchild....I have two...they live about 3 hrs from me ...see them about once a month...facetime is also a very good thing.
Well nuts,
Today's telecon/10Q kind of an abbreviated rehash. Not close to expansion of programs I was hoping for.
It did shed light on our collaboration with EVOTECH, largely a European bio tech, and use of biomarkers vs. PET scans (e.g. Invasive Circulating Tumor Cells (iCTCs) ) in monitoring clinical effect of therapies.
With my first notice of EVOTECH collaboration.
Question arises on whether our SM-88 may be in used over in European Clinical Trials, coincidentally, EVOTECH is having their own investor meeting tomorrow:
(11 August 2021 Half-year 2021 Interim Report and webcast, https://www.evotec.com/en/invest/investor-relations-events).[/quote]
On to the 24th of August, and our proxy vote. Hope for me was today's meeting would add a ballot item onto the existing ballot. Didn't happen.
Cash Burn rate only investable news today,
IMHO
GLTUA
Evotec A.G.
Biotechnology company
evotec.com
Evotec SE is a publicly listed drug discovery and development company headquartered in Hamburg, Germany. The company operates globally, largely through external alliances with pharmaceutical and biotechnology companies, academic institutions, patient advocacy groups, and venture capitalists. Wikipedia
Stock price: EVTCY (OTCMKTS) $86.75 0.00 (0.00%)
Aug 6, 3:17 PM EDT - Disclaimer
Revenue: 446.4 million EUR (2019)
Headquarters: Hamburg, Germany
Founder: Manfred Eigen
Founded: 1993
Number of employees: 3,030 (2020)
That works for me Enviro. Sorry fo the late response. My daughter went into a two-day labor for my first grand-child (James Christopher). So, dunno, got some hopes for tomorrow morning's 8k telecon
I know filling the gap is not always necessary...but gap has been filled ...now no longer technical (which I do pay attention to) but it is prove it "tyme", this will be news driven with $$ flowing in later...hopefully all works out...we shall see.
I like to combine technical's with actual evaluation.
Yeah Enviro,
Here's a wild anal ist guess that makes me wonder, [/quote]LINK[/quote]The 8K is due at this time anyway. Previously, under the old board, 8Ks just released without any telecon. We had a few, and obviously all positive. Weren't accompanied with anything equivalent to EDGAR re-portable events.
Dunno. 8K being reported two full weeks before Proxy Votes. Got a wild guess just as ahhh crazed as the Wall Street Zen analysis. Maybe something to be added to proxy during the 8K presentation.
Crazy talk.
Here's a link to last Investor Presentation, made with Cunningham's 10 June telecon: [link]https://s22.q4cdn.com/265040820/files/doc_presentations/2021/06/TYME_Q4FY21_jun10_rs-compressed.pdf[/url][tag]Link[/tag]
Page 23 of that lists two important milestones also due out ANYTIME NOW:
Sarcoma Trial Enrollment Completion - 1H22
Pancreatic Cancer Data Update (PART 1) – 1H22
We'll see. GLTUA
Market not liking the presser???
Not big volume so I am not sure.
Press Conference coming up. Thinking oositive thoughts. Came out after hours
24 August has been set for our Annual Investors Meeting with proxy vote on critical matters. No reverse split, no buyout offer. We have been removed from the Russell 3000 evidently due to the wild swings around our offering sale of $100 Million. That occurred 18 June. Link to Russell delistings here:
https://content.ftserussell.com/sites/default/files/ru3000_deletions_20210618.pdf
This is NOT that big of a deal. We are not tied to a full index rise or fall. ahhhh not much else to say.
Our 1st Quarter earnings report are due AT ANY TIME. No earnings to speak of, it will be around our CASH BURN.
Most of the noise here would be included within our proxy ballot which eligible shareholders have received.
We have 5 active trials currently at https://clinicaltrials.gov/ct2/results?cond=&term=sm-88&cntry=&state=&city=&dist=&number=Link.
Have a great weekend all.
IDK is a great answer! Me too ah either?¿(
¯\_(?)_/¯
IDK is a great answer! Me too ah either?¿(
¯\_(?)_/¯
Idk, but if they don't get things in order and flowing smoothly, I'll have to move on.
1st Quarter earnings due at anytime Chillin'. Only thing I know we can go on are Cash BURN Rate.[/quote]
[/quote]EVENTS DUE THIS QUARTER (2nd)
Cash on Hand End of FY 21 $107.5 Million March 31, 2021
$ Burn Predic 10 June Investor Call $24 Mill per anum
Loaded the Low today at 1.23
It seems like a great patent. Apparently the market doesn't like it though
My layman’s read of the PR is that this is a pretty broad patent and definitely could be a money maker in licensing for anyone else wanting to use this tech. It also makes them a more attractive acquisition target for that reason as well.
Murocman
Does seem to have support. Maybe tomorrow it will climb past 2.5
I believe we will recover and climb higher, the volume is insane
Agrees! Let's see 3+
Good, looking better now. This should be trading over 3 dollars
Go over to stocktwits, this is getting some unbeleivable attention over there.
Seems to be fizzling out even with the good news. Kinda odd
Question is, does this quadruple today? Or does the news just fizzle
Finally some good news, let's go TYME!!
Why? There aren’t any earnings nor will there be for some time.
Murocman
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