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Good report out on CG0070 at today's AUA Annual Meeting.
May 3 Results
It also looks like one of the original Ceregene founders is still looking at using our AAV2 technology to treat Alzheimers, this time with a different payload. Here's the phase 1 clinical trial that is underway. Even if this works, by the time it completes its testing and regulatory approval, I can't imagine we would have any stake remaining.
AAV2-BDNF Clinical Trial
Excellent find JTFM. It amazes me how we have to find these things out ourselves and the management team is not sharing these wins and giving us a view of the pipeline. This looks like a large business, but there are multiple product forms.
Another way to look at this is that the treatment area (PAH) is a rare disease in pulmonology. Maybe this will be one of our first home grown rare disease products within the strategic treatment areas. It would be interesting to know it the strategy came first, or the opportunities drove the strategy to start up a pulmonology team. Regardless, it is excellent work.
Excellent action JTFM. Power to the press!
Here's a well-written article about testosterone for women. First time I have seen a reporter dig on this topic.
Can Testosterone Aid Women's Menopause
Here's my favorite part:
When asked to elaborate on why these two products were not approved, the FDA told MedPage Today in an email that the agency is generally unable to discuss existing or potential applications and that the data requested was confidential commercial information. Neither Procter & Gamble or BioSante Pharmaceuticals responded to a request for comment as of press time.
Thanks JTFM for an excellent summary of the bull case.
Another ten-year study. Hopefully the Libigel study is next.
50% Reduction in Breast Cancer Incidence
We will get a read out on the CG0070 Phase 2 study with Keytruda at the early June ASCO meeting.
CG0070 ASCO Meeting
That would be great and ahead of any final FDA approval. They probably owe us some milestone payments too.
Thank you JTFM. It would be great to see the Libigel study published. There is certainly a lot of activity in this space. I just hope some of it translates into money in our pocket.
Here's another article.
Long Covid
Here are a couple of parts I like:
The work has yet to undergo peer review, the typical process by which scientific studies are vetted, but I’m highlighting it now given the enormity of need in long COVID — recent data from the Centers for Disease Control and Prevention showed some 8.8 million people in the U.S. were living with the condition in 2022 — and this team’s track record in conducting high quality research.[/I]
]We can’t let the opportunity go to waste. For too long, sex hormone differences have been seen as an inconvenient liability in clinical trials rather than a variable worth considering. Until recently, many drugs were only studied in male mice (lest the results be muddied by fluctuating female hormones) and even human tests skewed toward men.
Meanwhile, chronic conditions like ME/CFS (commonly known as chronic fatigue syndrome), Lyme’s disease and now long COVID, tend to be more common or more severe in women. Time and again, those women’s symptoms are dismissed as psychological rather than physical.
This latest study illuminates our limited knowledge about the role of hormones in chronic disease and should be a clarion call for more work in long COVID and beyond. That can help "start to right the wrongs of this sort of sexism and ableism in women’s health,” says David Putrino, director of rehabilitation innovation for the Mount Sinai Health System, who helped lead the study
I finished looking at the current status of Biosante GVAX patents. Healthtree is the sole assignee for two of them and shares assignment with Bristol Meyers for a third. Aduro (Chinook) is still listed for others and CG oncology for one as well.
This investment is always full of surprises which is why it has maintained my interest for so long. Here's the latest one. The GVAX trademark is now owned by "Healthtree Inc".
GVAX.com
I can't make heads or tails out of why this "foundation" would own this. However, when you look at the contact info you get directed here:
Meridian Therapeutics
Two of the principals of this company (Borrello and Noonan) are actually the researchers at Johns Hopkins investigating GVAX for multiple myeloma. It is the best testimony that they are now personally involved in its commercialization.
Maybe someday ANIP will get around and share our potential royalty pipeline.
Healhtree Inc is also listed as the assignee now for one of the Biosante patents (US7901902B2) for pancreatic cancer. Don't know the significance of this either.
Thank you JTFM. With the reported continued category expansion, this means that our product must be taking share from them and then capturing all of the category growth. Great news.
Thanks again JTFM. Hopefully they did use the same royalty term definition in the CG0070 agreement. That "or" statement could end up having a lot of value. It is sad that we are paying a high royalty to Merck for a decades-old Cortrophin Gel, but CG Oncology is apparently unwilling to do the same.
There will be a 12-month readout on the pivotal phase 3 study coming up in May. I like the comment from their president that “we are excited to share encouraging 12-month Phase 3 monotherapy results from the BOND-003 study at AUA 2024". Any idea when they would begin the FDA approval process? Can they use the 12 month results or do they have to wait until the trial officially finishes next year?
Urology Conference
Thanks JTFM. What a payday that would be. We better get some questions on this at the next conference call.
Here is the press release when the original deal was done.
Cold Genesys Deal
Make em pay (from the CG Oncology 10K)...
On March 4, 2024, a complaint was filed against us in the Superior Court of the State of Delaware by ANI Pharmaceuticals, Inc. seeking a declaratory judgement that an assignment and technology transfer agreement between us and ANI, dated November 15, 2010, obligates us to pay ANI a royalty on certain "net sales" of cretostimogene. We dispute the allegations and intend to vigorously defend this matter.
Thanks auh2oman.
Thanks for the update JTFM. Maybe the old adage about a watched pot not boiling applies here. We know this is too big of an opportunity to not do something about it and our product is in the driver's seat. MVP Capital has stuck around too which may be an indicator.
Here's a related trial that is scheduled to be completed early next year.
Evanthea Trial
If you check out the investigators, they are all touting precision and functional medicine in their individual practices. I did not look at every one of them, but the few I did all used testosterone in their practice for women.
Wow, at 7-20K per unit, that is a lot of zeros for a market opportunity. Current sales then have only captured a small fraction of this.
Another great dig JTFM. This bodes very well for us given, from your findings, Medicare represented such a large portion of the category peak sales.
Another great find JTFM. I thought Acthar Gel had broader approved indications, but as your reference shows, we actually have more. I agree with you then that more should be said about our addressable market.
On a positive note, ANIP is chasing some of these indications now which bodes well then for continued category expansion. It is curious that "pulmonology' does not appear to be on the list of indications, but was the one of the first pilot programs they launched ahead of gouty arthritis. Must be a larger market opportunity which makes an even stronger bull case.
Thanks JTFM for tracking this. A bullish development to be sure. It seems like the smaller plans are definitely favoring our product because of the price differential.
Great news JTFM! Glad to see our government being fiscally responsible (or maybe they are ANIP investors, who knows). What a great tailwind for the future.
That's an excellent source . You always earn your JTFM moniker.
For the technical geeks out there, Sangamo just announced a 10-100X improvement in the penetration of the blood-brain barrier in pre-clinical testing with non-human primates over the reference AAV9 (CERE-110) treatment. They are restructuring their company to now focus on neurology. I doubt our Ceregene intellectual property will still have any value here, but it is great to see progress against these nasty neurological diseases.
March Investor Presentation
I continue to admire the legacy of the Cell Genesys team that got all of this started.
Thank you JTFM. These results directly mimic what we have been speaking about for a long time now. I don't get the hold up given these are tangible benefits and there is a decade of safety data.
I regularly check the clinical trial site, but no change from the last update in October 2021.
I should know better. Share price is alway brought down after earnings. Should have sold some to re-buy later. It does not help that the CEO telegraphed that the quarter would be weaker albeit because of a known pattern in Cortrophin sales.
Thank you auh2oman.
Thanks JTFM. Spitball away. What an attractive buyout candidate now with $200M in the bank, a growing Cortrophin franchise, pipeline of material new drug launches, potential royalties in one of the hottest biotech companies right now, and lets not forget testosterone and all of the remaining hidden assets of the company.
I read yesterday that Kodak has a billion dollar surplus in their pension fund that they plan to tap into. Given their strategic shift to pharmaceuticals maybe they could be a suitor.
Great news JTFM. Makes you wonder why the company does not advertise these pipeline initiatives. This one looks like it will be very material.
Just for fun...
Stocks that Will Double in 2024 (See #10)
I agree JTFM, just like the Yescarta situation. Hopefully, our patent position here is not as convoluted as Yescarta's was. The good thing is that this asset is no longer hidden. Maybe we may even get a question from an analyst someday. Hard to miss having a royalty agreement with a $2B oncology company for their lead asset that is performing so well for the patients.
I was pleasantly surprised at the number of shares held and that we still had them.
Congrats all.
Here is an update on CG Oncology from the 10K:
On November 15, 2010, ANI, formerly Biosante, entered into an assignment and technology transfer agreement and stock subscription agreement (collectively the "CG Agreement") with CG Oncology, Inc. formerly, Cold Genesys, Inc. (“CG Oncology”), pursuant to which the Company sold to CG Oncology exclusive, worldwide rights to develop and commercialize BioSante’s oncolytic virus technology. The technology includes a replication-competent adenovirus that has completed clinical trials for treatment of superficial bladder cancer. Under the terms of the CG Agreement, the Company received an equity investment in CG Oncology, an upfront cash payment and the right to receive future royalty payments. Historically, this equity investment was recorded at cost and as of December 31, 2023, this equity investment was valued at zero. On January 24, 2024, CG Oncology completed their Initial Public Offering, at an offering price of $19.00 per share. The Company currently holds 219,925 shares of common stock in CG Oncology. As of February 27, 2024 these shares are valued at approximately $10.2 million.
On February 28, 2024, CG Oncology disputed the Company's rights to receive royalties. The dispute is unresolved at this time.
Interesting development dasgrunt. Medpharm has the MedSpray technology. I believe it was used in Axiron which is now discontinued. I recall JTFM mentioning it once before. Maybe there is a Libigel angle here although Medpharm is not a production manufacturing company.
Another possibility is that we will see more 505B introductions by ANIP behind the MedSpray delivery technology.
Good news JTFM. It looks like there are two possible treatment modes. One on a pre-natal basis to prevent it from occurring (it would be hard to prove that in a clinical study) and the other to treat the condition itself.
On a separate topic, it looks like they finally sold the Oakville plant for $14M. Deal will close in March.
Oakville Plant Sale
Thank you JTFM.
Science wins. Here is one of the best proof points I have seen about the "cardio-protective" effect of testosterone for post-menopausal women.
Higher Testosterone Associated with Higher HDL
Meanwhile CGON is up to almost $47/share.
Hey North. The Teva acquisition is another good possibility. They have a stake there as well. It looks like they don't fool around so it should not be long before we see what they are up to.
Rubric owns a 14% stake in Mereo Biopharma and recently gained 4 board seats there. Maybe they want a go to market US team for Mereo's pipeline.
Mereo Board Seats
We have a new "activist" hedge fund acquiring more than a 5% stake recently. .
Rubric Capital Management
They also recently acquired a large stake in the Russell which is a bullish sign for us. They also appear to be a large rare disease investor. Interestingly, their recent stake in Heron Therapeutics may.show a sign of things to come. They were able to negotiate three board seats. If you look at Heron's stock performance after their investment, it has rebounded remarkably from a long term significant decline.
What activism do they have in store for us? Maybe they want to have a say in where our $200M in cash goes. Just speculating, but maybe this is who has been buying Sammy's shares.
Now really speculating, maybe they have been reading our board and want to unlock the value of all of our hidden assets.