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I agree with the other comment. CERCLA liability from Landfills, Superfund sites, etc could be as much if not more than the PWS settlement. This liability will take many years to play out and is only worsened by the fact that the new EPA drinking water limits for PFAS are ultra low. This means they will be tested and found more frequently.
FL
The ABAXX YouTube link was posted on Feb 1 on Josh Crumbs Twitter feed. Here is a more direct link.
Here is a link to a quick primer on ABAXX.
https://twitter.com/JoshCrumb?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor
FL
ABAXX Revisited
I almost hate to post here, for fear of sounding like a penny stock pumper. I posted a while ago about ABAXX opening a new commodities exchange based in Singapore. At the time they were a long way from securing the necessary approvals, so it was easy to discount the post as a pipe dream. ABAXX has now received the necessary approvals and intends to start trading Nickel Sulphate and LNG this quarter. Lithium, precious metals and carbon credits will follow. The listing will move to the new CBOE exchange in the near future after they start generating revenue. Currently they trade only on the OTC and the Canadian Venture exchange. I think if you dig into what the company is about or listen to the conference call, you will see that that ABAXX is seeking to reshape the commodity trading markets and therefore the company extremely applicable to the content tracked on this board.
https://finance.yahoo.com/news/abaxx-provides-q1-corporate-120000094.html
FL
Prior to BCART I had done well with my MDx investments. Vysis,- acquired by Abbott, Ventana -acquired by Roche and Genomic Health - acquired by EXAS, The Idylla platform looked to situated in a great spot at the crossroads of personalized medicine and automation. It's ability to recover results in about 30% of the samples that could not be analyzed by NGS methods due to degraded or insufficient DNA seemed to guarantee it a place in lab or hospital diagnostic work flow. In hindsight, the management tripled the workforce too fast and then labored to roll out new assay content, did not secure IVD registrations in other jurisdictions, I'm still mad that they never fixed their EGFR assay amplification curve issues with the T790 mutation . This mutation is key for their partner AZN's drug Tagrisso CDx use. I contacted IR a few years ago and was told a fix was in the works and would be released within a year when the revamped assay was rolled out. I'm still waiting.
You once asked why fast TAT MDx mattered relative to waiting for NGS results. Shortly after clinical oncology guidelines came out for NSCLC and the guidelines emphasized speed to treatment. Idylla had the potential to shave 2 to 3 weeks off the time required for actionable results, This was achieved by conducting the analysis at the POC. By not correcting a very fixable amplification curve issue, with the T790 mutation it is almost like management was sabotaging their own product. They did the same by increasing headcount before cash flows picked up. Most recently, they constructed a 3rd manufacturing line in China before the Pacific materialized with registration approvals in China and Japan. I suspect the Chinese will acquire this asset and access to the IP for next to nothing.
Sorry about the diatribe, but BCART was a sore spot in my speculation history.
Regards FL
I was hoping no-one would ever remember my venturing into BCART.
A few years ago I thought BCART exhibited similarities to Cepheid with an oncology focus. Instead it had more in common with Theranos (mismanagement and deception). While the automated MDx product was very real and well received by the user community they were never able to scale toward profitability. I attribute most of this to lame management. While they gained EU registration approvals with relative ease, they languished as RUO assays in most other markets (US, China, Japan). I became especially disenchanted when the Idylla system did not flourish coming out of Covid. If an automated MDx could not excel with the manpower shortages associated with the pandemic, I'm not sure it could ever.
I took my losses and sold out (but for a few shares to remind me of the mistakes made) the past couple years in order to harvest tax losses. The problem referenced was an internal issue in Schwab Global's interpretation of the SEC review of the overseas listing . They corrected it so I could liquidate the position. I suspect that BCART will be acquired for peanuts in short order.
FL
I'm not going to pretend to be a CRVS expert. I feel like the Lugano update was a sell the news story for many of the recent momentum traders that wanted to book their profits.. I think the results were decent,
The TCL patients in the trial were refractory and had received a median of 3 prior treatments.
There was a 43% ORR (CR or PR) in the portion of the population with ALC >900 and stable disease in 12 of 14 patients. From what I recall of a previous press release, the mean survival of these patients under the current SOC (chemo) is only a couple months. So I think the results in that subpopulation are good when compared to the outcome under SOC. I think there may have been a reaction to the fact that 10 of the trial enrollees were no longer participating. However, this is consistent with the fact that CRVS has been advising that patients with an ALC<900 were unlikely to receive benefit from treatment with 818 since their immune response is degraded. Ultimately, this may be a reason why 818 should be a front line treatment for the disease.
Miller has a good track record with bringing MABs to market. He believes in the future enough to forgo salary and take most of his compensation in the form of stock options. He has a tightrope to walk with the limited cash runway but I think he has shown that he is adept at negotiating with potential partners and the FDA.
As I posted a couple weeks ago, I booked some of my profits after a 400% run so I'm playing with the houses' money. I think I'll refill shares in the coming days.
FL
Thanks Dew,
Probably time to write calls on part of the position. The run up into the June ICML poster presentation is getting pretty frothy. While Richard Miller has been a proven winner in the past, a considerable element of uncertainty remains in trials, funding and also the future competitive landscape.
I see considerable research coming down the pipe on T-cell oncology treatments (although not specifically T cell lymphoma-TCL). Some of the speculation on CPI-818 has extended to it's potential use for treatment of solid tumors. This optimism accounts for some of the run-up. The Biontech MRNA vaccine treatment of pancreatic cancer, IOVA TIL treatments, Genmab, AZN treatments, etc. all seem to be be targeting similar mobilization of T cell immune response, so I have no idea what the future competitive landscape might look like. The present SOC for TCL is pretty miserable but given the research I think the landscape is shifting. Miller is painting a good story about an expedited path to approval, but given the small trial, there are a lot of hurdles to clear.
Regards FL
CRVS in Compliance w Nasdaq requirements.
https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=317420846&type=PDF&symbol=CRVS&cdn=8b04f14c9e2d1c64ebccb4bc39e0ffde&companyName=Corvus+Pharmaceuticals+Inc.&formType=8-K&formDescription=Current+report+pursuant+to+Section+13+or+15%28d%29&dateFiled=2023-04-24
FL
Crescendo and Biontech appear to be targeting the development of novel, targeted T cell enhancing therapeutics for treatment of cancer. BionTech looks to be exploring several approaches " mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules".. They are in early clinical trial for prostate cancer..
I wonder to what extent CRVS has crossed BionTech's radar. Looking at the links it looks like Biontech has collaborations with Genmab, so monoclonal antibody approaches to T cell modulation have to be high on their list.
FL
https://finance.yahoo.com/news/angle-plc-announces-pharma-services-060000021.html
https://investors.biontech.de/news-releases/news-release-details/biontech-and-crescendo-biologics-announce-global-collaboration
Up more than 20% on 12X volume. Looks like institutional investors are taking notice!
FL
Miller cutting his compensation in lieu of stock option based comp speaks strongly as to where he thinks CRVS is headed,
FL
Bill,
IHUB Biotech Values is also a good board for for less company specific Biotech discussion. I tried posting this on Yahoo but it was censored and restricted.
FL
Good conversation you two are having. Most of it well above my pay grade. However, without the same grasp of details, I was also arriving at a similar big picture scenario. Continue IB with patients with ACL>900 and update results in Lugano in June and then hopefully the data lines up for the Phase 3 registration trial mtg with FDA with fast track Orphan drug status.
CAR-T Gene therapy was mentioned in the prior posts as a possible competing treatment for PTCL. I believe Miller really took a few shots at this line of treatment in one of his previous presentations. If CAR-T does show promise and make it to market, I doubt that this treatment would be priced less than $500,000.
Given the difficulties treating PTCL and the relative rare occurrence rate. I agree w the 8K annual estimate in the US based on the following:
https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21589
Given this limited US market, I can see the FDA-Orphan drug pathway as reasonable shot. I have no idea how it would be priced. $150K is certainly consistent w other life saving treatments. If trials are successful, I would also assume that the emphasis would shift to front line treatment or combo in order to reach patients before their immune response is degraded by Chemo.
Thanks for the discussion.
FL
Kenyon
I think you' re correct, Early clinical trial studies being done by companies with little wherewithal to last to late stage trials are being valued at 0. That is why CRVS trades at less than cash. I have bar-belled a portion of my portfolio to include these cheap lottery ticket speculative stocks such as CRVS. On the other side I maintain long term dividend paying stalwarts.
FL
I don't have any idea what the relative timing is for the KCC ciforadenant trials.
But definitely worth keeping an eye on it, as well.
I suspect the Angel trials will also be altered to enroll based on participant ACL levels.
Have a good weekend.
FL
Upcoming Catalysts for CRVS.
1) AACR presentation on 818 in Mid April;
2) ICML presentation in Lugano in Mid June;
3) Top Line data on ongoing Angel Phama trials in China;
4) Meeting with FDA to design the 818 Phase 3 Registrational trial;
5) Announcement of a Big Pharma partner for Clinical Trials??????
Any others I'm missing. For some reason Yahoo blocks this content.
FL
Upcoming Catalysts for CRVS.
1) AACR presentation on 818 in Mid April;
2) ICML presentation in Lugano in Mid June;
3) Top Line data on ongoing Angel Phama trials in China;
4) Meeting with FDA to design the 818 Phase 3 Registrational trial;
5) Announcement of a Big Pharma partner for Clinical Trials??????
Any others I'm missing. For some reason Yahoo blocks this content.
FL
The situation you describe is pretty common with a lot of innovative types. I agree that the focus seems to be constantly shifting. Remember 006 use for Covid? I think focusing on 818 use for T-Cell Lymphoma is the right target. The SOC (chemo) has a miserable PFS rate and it tears down the immune system. So a positive registration trialfor 818 has the potential to launch a front line treatment before the patients immune system and ACL threshold is decimated. CRVS needs to execute a positive mtg with FDA and land a decent partnership. If Miller is correct and 818 has application for solid tumors, immune disorders, etc., the licensing of one indication to bring in the cash infusion will be seen as well worth it.
Hopefully others from Yahoo board follow. Not sure what business model they are following but the dissatisfaction level is off the charts.
Regards FL.
Yes, I am a CRVS holder. Yahoo is having problems censoring posts, so I have suggested that the posters jump to IHUB. I've also posted on Biotech values.
I like the science at CRVS and love Millers track record, but I can't shake the feeling that he may be trying to pull a rabbit from the hat when his back is to the wall. A lot is riding on his upcoming meeting with the FDA.
FL
CRVS Biomarker
I think the term biomarker is a somewhat non typical in this case, Rather than a molecular driver such as BRAF, RAS, EGFR he is referring to ALC acting a a coarse indicator of a functioning immune system. 818 use for ITK inhibition requires a functional immune response,
" We now know that 818 induces a host antitumor cell mediated response that requires normal functioning T-cells. We have observed that a minimum absolute lymphocyte count or ALC above 900 per cubic millilitre of blood is required for response. Normal ALC ranges from 1,000 to 4,000."
https://finance.yahoo.com/news/corvus-pharmaceuticals-inc-nasdaq-crvs-100803417.html
In any case the Phase IB enrollment continues using this indicator so it should become apparent whether the use of this indicator helps better target the ongoing trial.
Miller has an impressive record of bring drugs to market. However, I doubt that the FDA sought him out to design the Phase 3 trial. He has likely exploited long term relationships since he is approaching a rather desperate period (risk of delisting. only a year of cash, etc.). I view CRVS as some what of a long shot lottery ticket, unless they announce a deep pocketed partner in the next couple months.
Regards FL
Any thoughts on CRVS meeting with FDA to design Phase III Trial for CPI 818?
https://corvuspharma.gcs-web.com/news-releases/news-release-details/corvus-pharmaceuticals-provides-business-update-and-reports-14
Seems like the use of ALC as a biomarker should have been pretty intuitive. The company only has cash for a year or so, so they will need to partner. Strange that none of the analysts asked about potential partners.
FL
Market does not like CRVS update on Mupadolimab.
https://finance.yahoo.com/news/corvus-pharmaceuticals-presents-updated-data-120000523.html
Don't see anything in the presentation that is strongly negative other than CD73 target is a crowded area.
FL
Pulled the trigger. Should never regret taking a profit but I probably will.
FL
Blade
I'm looking at selling a third of my position since it will allow me to remove my initial investment so the remaining position is strictly houses money. I'm concerned that CRVS will take advantage of the runup to do a capital raise. This could result in a much lower reset that will not allow trailing stops to be effective.
Any thoughts?
FL
I'm watching to see to what extent they are able to crack major commodity trading houses in London, Zurich and NY.
Good Luck FL
Glad your not intimidated by Canadian Microcaps
The cost of nat gas in the producing areas has ranged from about $2.00 to $4.0 per mBTU whereas when delivered to Asia in the form of LNG the price has ranged from $8.30 (last winter) to $16 in 2014 (during the polar vortex). Given that range and the potential for spikes in pricing 40% does not seem that unreasonable. With regards to the exchange Josh Crumb in the attached interview definitely indicates that a move to a higher profile exchange (probably Nasdaq) is contemplated once they are generating revenue.
Santafe2
I don't thick that blockchain is particularly useful to LNG markets. Josh Crumb ABAXX CEO did a podcast (Smarter Markets) where he discussed the use of blockchain for allowing commodity provenance data to be tracked and available to commodity purchasers. In the case of ag commodities it could be used to certify only organic farming methods have been utilized. Or it could potentially be used has proof of sustainable practices. LNG is the 1st market they are going after since it is seen as a bridge to future lower carbon energy sources and because there is currently no direct LNG benchmark.
I see ABAXX moving to the Nasdaq in 2022 once they are generating revenue.
The big question for now is whether the market for an LNG commodity exchange will materialize. Right now there is no LNG spot market. Prices very tremendously from a few bucks per BCF in producing areas to over $10 in many Asian user markets. The fee structures are negotiated but there are no good benchmarks for hedging risks that might develop while the LNG is in transport. For instance, Shawn Hackett (Ag commodity trader) is predicting that this years La Nina could result in a repeat of the 2014 polar vortex. This could play havoc on nat gas and especially LNG markets. Therefore, he predicts that there is considerable need for an LNG benchmark to support producer, transporter, and end user hedging.
ABAX is the product of a reverse merger of a Canadian iron mining firm. I thought they should have sold the proven iron ore assets since it is not integral to their business model, but as discussed by the Seeking Alpha piece they continue to hold these assets.
Regards
FL
I can't fault anyone for not following an OTC/Canadian microcap. Here is a SA primer on ABAXX. I'd be interested in the opinion of the board's energy and commodity market investors. I'm long and consider ABAXX highly speculative since it is pre-revenue. However, they have been delivering on the milestones for an extremely ambitious business model.
FL
https://seekingalpha.com/article/4439689-abaxx-technologies-asymmetric-risk-reward-profile-with-near-term-positive-catalysts
ABXXF
Anyone here have any opinions on ABXXF. They just received Singapore approval for an LNG commodity exchange. It trades in Canada and OTC in the US. I've Invested in it for my Kids Roth accounts and in a personal speculative account. ABXXF is an investment that meets their ESG requirements (not an easy task). ABXXF is pre-revenue but today's approval is moving them closer to a likely Q4 exchange launch. Now the question is whether the exchange launch will be welcomed by the market.
FL
ASCO Abstracts out at 5pm today,
I expect NVS will be unveiling the results for prostate radioligand therapy.
https://finance.yahoo.com/news/1-novartis-says-radioligand-therapy-170822320.html
FL
QWO v SOLY
ENDP is marketing QWO as permanent treatment of Cellulite whereas the SOLY video indicates it is a temporary treatment. I don't know if that means the fibroids re-establish themselves or that new ones develop which could be the case for either treatment. The tattoo removal using the same cartridge gives SOLY a larger potential market.
Regards FL
QWO
We'll have to wait to see what type of traction the product gets. I think that looking at plastic surgeon marketing ads (and a bunch are popping up) are probably biased & misleading since they have a strong incentive to offer new revenue generating procedures, regardless of the aesthetic benefits. However, the fact that 53% of the women that had Cellfina (essentially the same end result of removing the cellulite causing fibroids using an 18 gauge reciprocating blade considered the process worthwhile is a hopeful sign. I have to believe that dissolving the fibroid is less painful (bruising etc.) probably resulting in a more favorability opinion.
To me, the bigger ENDP concern is the opioid litigation. Unlike Purdue I think Endo has a better case, since they voluntarily pulled their product.
FL
ENDP
I've learned not to underestimate how vain people can be. ENDP has not announced the price. and avoided the question during earnings Q&A. The attached includes some conjecture on that topic. Facing litigation this quarter, I don't think I'd put pricing out there either.
FL
https://www.alphabeautics.com/beauty/cost-of-qwo/
Any Thoughts on ENDO and QWO hitting the market this week?
I quickly scanned the board and did not see anything on this topic. A quick review of the internet suggests plastic surgery/cosmetic Drs are jumping to offer the product.
I know that given the current pandemic the treatment of cellulite is not an urgent medical priority. However, having missed the market opportunity for botox, I wonder whether cellulite might tap a similar cosmetic niche. Of course investors in ENDO might want to wait a couple months until the uncertainty of opiate litigation has passed. I bought a small position in a taxable account (in case the litigation goes bad) betting the risk reward makes sense.
Any thoughts?
FL
I have a much smaller position but may add. The risk-reward looks enticing and I agree that the management team has a great track record. Interesting that they are advancing ciforadenant in the combo trial as part of an academic consortium collaboration. I was looking for an announcement that they were partnering with big pharma and would get a cash injection. With the clinical trials moving forward they will need more cash. 006 would appear to be a prime candidate for a BARDA grant. So I won't be surprised for an announcement on that front.
I kind of look at CRVS as a bit of a hedge on COVID mutation and diminishing vaccine effectiveness. Its one of those things you hope does not materialize but having a technology that is not based solely on the spike protein that can impart longer lasting memory B-cell response seems attractive given the pandemic uncertainties.
Regards
FL
Blade
I've been interested in CRVS as a cheap way to play the anti CD73 antibodies & adenosine inhibitors. Richard Miller has a pretty good track record of bringing drugs to market, mostly with Pharmacyclics. So I'm thinking it might be worth a bit of speculation. CRVS is pretty limited in terms of cash, especially going into clinical trials. However, companies with similar pipelines (i.e., SURF) have garnered a fair amount of partner interest.
Do you have an opinion on CRVS as a speculation? It trades horribly but at a market cap of $115M it seems too cheap for the potential pipeline. I'm thinking that the announcement of a partner would remove a major doubt weighing the stock down.
Any thoughts?
FL
Looks like BCART may be contemplating being acquired. Guess we'll have to wait for details in the next few days. Unusual for a company so far from being accretive.
FL
https://www.globenewswire.com/news-release/2019/08/27/1906828/0/en/Press-release-Biocartis-NV-Invitation-to-the-Special-Shareholders-Meeting.html
Biocartis no longer tradable for U.S. residents.
Tried to add to my position during the weakness this week and it was thwarted. After first claiming it was a FINRA suspension, the Schwab Global representative indicated it was a "regulation S" suspension. From what I can see this regulation pertains to Safe Harbor to offer US securities abroad or to make Foreign securities available to US residents. Schwab would offer no other details or the name of a SEC person more familiar with suspension.
This type of suspension appears most common with improper advertisement or solicitation of purchase offers. My purchases were totally unsolicited I became aware of the firm after the GHDX partnerships were announced.
The conspiracy theorist in me believes this is in response to an upcoming announcement that BCART and Wonfu are breaking ground on a Chinese cartridge manufacturing facility. Based on the attached press release, I believe that the Chinese have completed their validation program. BCARTs Sept 2018 Wonfu Agreement indicated they would proceed with local manufacturing once the Chinese completed validation.
https://www.scitechnol.com/peer-review/biocartis-idylla-proves-fast-and-accurate-in-detecting-oncogenic-kras-and-egfr-mutations-in-paraffin-embedded-tumor-samples-VT7n.php?article_id=9132
FL
Dew, I was aware of the Sysmex claim of superior sensitivity in the MAF<1% cases. I have not been too concerned since they're Oncobeam test has a 5-7 day TAT and increased costs. Their are NGS players providing similar sensitivity and TAT as sysmex. The recent William Blair Investor event featuring Guardant stresses the importance of them reducing the TAT to be able to access the diagnostic-prescription window. I read this as their CDx partners want 1st crack at the prescription by partnering with a CDx partner that turns results around quicker.
Sysmex does not bother to discuss the concordance in the higher MAF cases. Idylla is very versatile in that it can analyze solid biopsy samples and/or liquid samples with only a few minutes of hands on time. The pathology journals I've reviewed are very specific that no one diagnostic platform performs best in all situations. Idylla has performed well enough that Journal of clinical oncology felt it was appropriate for first line MDx analysis.
FL