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
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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Has our collaboration with LineaRX/APDN for molecular detection of invasive Circulating Tumor Cells (iCTCs) been replaced by our bio-marker collaboration with Evotec?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
