Regulatory risk decreased significantly, I guess, as the authorities signaled they would accept surrogate data for the marketing authorization. Also the first sales forecasts! 50 mil in Europe alone already by 2027.
There was certainly a lot more in that news…
The biggest biotech in the portfolio.
Interesting. Apparently it’s the financing that’s on investors’ minds?
Yeah, it’s touch and go whether the cash will be enough for PRV. I guess some shitty, massively dilutive emergency share issue is what’s being feared here. Personally, I’m not afraid and I’ve got skin in the game in a big way.
So, it’s not worth following my lead (I always take a beating).
Interesting companies…
GeneDx (ticker WGS) sells state-of-the-art genetic testing. The stock price movements over a 5-year timeline are unparalleled;
From the 2021 peaks to the 2023 lows, the stock dropped approximately -99.85%. From those depths, on the brink of total bankruptcy, the stock then rose about +13,000% in two years. To my regret, I haven’t participated in this repricing; the stock has looked expensive the whole time 
A profit was made in Q2/2025, but Q3 and Q4 were loss-making, and yesterday we saw another turn in the roller coaster as the 2026 revenue guidance was dialed down by about -15% from the forecast given just 3 months ago.
The revolving door is spinning again at the FDA. This time, there is speculation that Trump might also be ousting Makary: https://www.fiercepharma.com/pharma/trump-plans-fire-fda-chief-makary-report. Prasad was forced out just moments before. It is not easy to plan multi-year trials if the FDA leadership and policies are constantly changing.
Earlier this week, a news article also emerged stating that the FDA might potentially be reassessing its decision on Ebvallo cell therapy: https://www.fiercepharma.com/pharma/fda-reconsider-surprisingly-rejected-cell-therapy-ebvallo-could-uniqure-be-next. This could potentially have a positive impact on uniQure’s Huntington’s disease therapy, which the FDA recently rejected, contrary to its previous guidelines. uniQure seems to have risen quite strongly over the past week, so this might have further positive impact on that.
QURE is a mouth-watering case. I’m betting on common sense prevailing; you can’t demand an invasive sham brain surgery as a comparator. Q3 will see the release of 4-year data. That will provide further evidence for the skeptics as to whether this is truly an active drug or not. A marketing authorization application will also be submitted in the UK during Q3. Over on X, there are biotech writers I consider smart both for and against the case.
I’ve gone through dozens of hype-biotechs on X and Reddit, and after a “strict” screening, https://maiabiotech.com/ $maia made the cut.
MAIA is the only one in the world (at least based on Googling and AI) developing a clinical-stage cancer drug (ateganosertib) targeting telomeres, which EXPLODES cancer cells from the inside and awakens the patient’s own immune response to join the fight.
In heavily pre-treated, third-line lung cancer, their “lead” drug has produced a median overall survival of 17.8 months. That is nearly triple compared to the historical 5.8-month standard of care. Several patients have already exceeded two years of survival without additional treatments.
The company just recently successfully raised 33 million dollars. This pot guarantees peace to work and funds the interim analysis of the crucial Phase 3 trial that just launched, which I understand is in early 2027.
They have Fast Track status, of course.
Current market cap is 80 million. The market is tens of billions.
What I’m pondering myself is what would be the right time to invest in this… likely a little now and more closer to the interim analysis.
Here is a presentation from January: https://d1io3yog0oux5.cloudfront.net/_ab664557b00bbaa916cc8662b7ef36db/maiabiotech/db/2216/20771/pdf/2026-01-13+MAIA+Biotechnology+-+Presentation+Deck.pdf
Please “bear” this into pieces (give me some bear cases) so I don’t lose my money again.
Here is a quick read from SalkunRakentaja regarding Moderna. 
Moderna’s stock rose nearly 12 percent on the Nasdaq stock exchange on Friday. This was driven by primary results published in the New England Journal of Medicine, showing that the company’s mRNA-based influenza vaccine candidate outperformed a traditional comparator in older adults.
Publication in a peer-reviewed journal gives the results a different level of weight compared to the company’s own earnings day press release.
Subheadings:
Goes straight to the trash bin for me. Promotional PR releases. Where is the safety data hidden? It can be found in the 2023 release at least—20% had elevated liver values. That is a lot. The toxicity profile is a critical question for a telomerase drug. See Imetelstat.
Isn’t this actually bullish for $maia’s THIO? If Imetelstat’s side effects included significant myelosuppression (luuydinsuppressio) + trashing liver values and it still received marketing authorization? With $maia’s drug, only liver values rise, which is an issue in all other standard treatments as well (and whose monitoring + management is fairly routine), but in addition, the patient lives 3x longer.
Interesting pipeline with this company. Strong preliminary results. I am not familiar with this industry. A few observations.
First of all, US firms and others, including a certain domestic cancer drug developer, are good at praising themselves. However, the results speak for themselves.
The background of the company’s management is from Eastern Europe. Scientific Director Sergei M. Gryaznov is, as I see it, from Russia. His scientific output is largely related to telomere biology and his scientific ranking is quite high.
Phase 3 studies are being conducted in Romania, Poland, Turkey, and Taiwan, likely to minimize costs. Recruitment is ongoing, follow-up time is 2 years, ready in 2028 if all goes well.
Reports describing the company’s finances are dismal. The burn rate is approximately 25 MUSD/year. The cash position was 8M at the turn of the year. Now 33M more has been raised; I couldn’t find the source with a superficial investigation. There are likely warrants outstanding. It doesn’t look great. A lot of additional money is needed. The Phase 3 study population is 300.
Regarding the elevation of liver values, it may be partly explained by metastatic seeding in the liver due to the advanced stage of the disease.
It is always worth considering the reasons behind a company’s low valuation; here are some. Perhaps it’s worth following, though.
Well, it depends. Imetelstat was also studied for solid tumors, but development was discontinued. An increase in liver values is always a bit of a red flag. Of course, we have drugs that raise them, but when such figures are observed at this stage of development, it increases the risk that the drug has too poor a safety profile. The company itself describes the safety profile as “acceptable.” I couldn’t find in the press release whether elevated bilirubin levels were observed in addition to enzymes, which would be essential information. It’s also a red flag for me that this safety information wasn’t in the investor presentation but was somewhat hidden. It could be, of course, that I’m just being overly skeptical, etc. But since there are so many more or less “scams” in biotech, one just becomes cynical.
I must admit I’m also a bit skeptical about this outfit, as there are many uncertainties. That doesn’t necessarily mean they won’t succeed or that the promising start won’t continue, but that remains to be seen and I won’t be jumping in for now.
Happy bear-posting! Thank you.
Yeah, the cash will last for about 15 months until that interim reading in 2027, which might be enough to apply for marketing authorization.
It could go to zero, but I think I’ll take a small speculative bet on this precisely because of the massive upside.
