MAIA MAIA Biotechnology Inc

$MAIA Considering insiders were loading up just over a month ago and current low prices ... I'm adding to stack!

$MAIA *yawn* Shorts out here trying to make people panic. Boring. There's are well-known catalysts on the horizon. No one is worried if it drifts between now or then but day traders. Save your FUD for someone else.

$MAIA I am quite bullish on $MAIA, even though the SP is disappointing at the moment. Even though the $2.3M from National Institutes of Health (NIH) don't seem much, but it is a huge achievement: Obtaining federal funding for clinical-stage biotech trials is competitive and requires rigorous peer-review panels composed of top independent oncologists and scientists. The award of a $2.3 million NIH grant to fund the U.S. Phase 2 expansion sites serves as a strong peer-reviewed validation of THIO's underlying biology and clinical rationale.

$MAIA Merck's 2028 Keytruda patent cliff is approaching, and potential replacement strategies keep facing challenges. Today's reported Moderna/Merck cancer vaccine data triggered a roughly 25% Moderna selloff despite positive Phase 3 results. As expectations get tested, promising outside therapies like MAIA's THIO could become increasingly attractive. Timing is everything. $MAIA $MRK $MRNA

$MAIA I’m just happy patients were recruited in the trials! Let’s go team ! Patients deserve all the thanks for their courage !

$MAIA $OSTX I'm primary MAIA but bought a bag of OSTX on great news and (Odd) dip at 1.68 . the OSTX news this morning is genuinely strong clinical news. This isn't just a conference announcement or corporate update. The final Phase 2b 3-year overall-survival results for Herlystic (OST-HER2) were: - 72.7% alive at 3 years with Herlystic - 45.8% in the comparable historical-control group - p = 0.0006, which is highly statistically significant - 41 patients were enrolled; four were lost to follow-up. Stock Titan And there's an important improvement from the September interim analysis. That earlier result was 71.2% vs. 45.8%, p=0.002. The final analysis moved survival up to 72.7% and strengthened the statistical significance to p=0.0006.

$MAIA Been digging into the company’s trial and market a lot and the setup looks better the deeper I go. As a long term investor, I personally do not care what the share price looks like in the short term. I add every week, whether it’s higher or lower. It doesn’t sit in the bigger picture. I am strictly going to give my thoughts on the data/trial and the companies market. To me, everything else is moot and a red herring. The basics on (THIO104) - a P3 3L trial, so two prior lines including immunotherapy and platinum chemo, and patients need acquired resistance to their prior checkpoint inhibitor, meaning primary non responders are out. The control arm is investigators choice of docetaxel, gemcitabine, or vinorelbine, but docetaxel is only allowed if the patient hasnt had it, and most 3L patients already got it in 2L. The bulk control is mostly the weaker agents, which I’d pin at 75%. Supporting literature and specifically ATALANTE1, which had a similar acquired resistance population on docetaxel or pemetrexed, came in at 7.5 months, real world post IO taxane data is around 7.3, and 3L vinorelbine after IO lands around 6.5 to 8. Ive got the control group around 7.3 months. On our side, THIO101 showed a 17.8 mOS in 3L with a 5.6-month PFS, and that was in a population that included primary non responders and some fourth line patients, so arguably tougher than THIO104. The 8 patients on the Phase 3 dose had a 5.5-month PFS with 75% alive at 6 months (stack some curves/napkin math on that gets you a 15 mOS), and Part C put up a replicated 90.5% disease control rate in an all docetaxel exposed group. When most patients arent progressing early and PFS is roughly double what the vinorelbine and gemcitabine patients typically get, fewer people drop off treatment early, more stay on long enough for the immune priming to actually work, and you get less premature dropout with cleaner survival data. Crossover shouldnt be much of a worry. THIO isnt available outside of trials, sponsors running an OS trial with an unapproved drug rarely allow control patients to switch over, and after failing 3L chemo there are very few effective options left, so the control arms survival shouldnt get inflated by later treatments the way it did in some earlier NSCLC trials. The mechanism will certainly help our arm with the curve shape too. THIO hits telomeres and kills cancer cells within days, then the checkpoint inhibitor comes in on primed immune cells. Fast direct kill should separate the curves early, which is what you want with a 131 event interim, and the immune piece should drive a long term survival tail for the final. Very bullish for interim and FA. With the chemo arm progressing around the 3 month mark, Id expect separation early rather than late, which is what shapes the true HR in an unweighted log rank cox HR SAP (very likely). My estimate is 14 to 17 months for the THIO arm vs about 7-8 for control, so an HR around .50 depending on survival curves, and the trial would have to fall to roughly 9.5 months before it actually misses stat sig. Lots of cushion there. The margin of safety is massive. Between the tiny 70m market cap, weak control arm, the acquired resistance enrichment, replicated disease control, and steady insider buying, I like the risk/reward a lot here. Contingent on the upcoming Phase 2C data we receive in the coming months, I’d assign an 83% chance we meet statistical significance at final analysis. On the 3L market, expansion, and Telomerase positive cancer types - Let’s start with the base case MAIA is building toward. Some people on here say the # isn’t 50k, while others stand behind it and claim it is. For now, I’m going to go off of MAIA’s investor deck slides and what they’ve put in front is us. You can adjust the math accordingly based on what you think the true addressable population is. At MAIA’s claimed 50,000 US addressable patients a year who are resistant to CI’s/chemo agents and $150,000 per patient, the theoretical 3L US market is $7.5 billion annually. As there are no approved therapies or SOC in 3L, penetration will run high if the spread sheets look good. At a hypothetical 50% share, thats roughly 3.7b in peak sales. At 65%, which is relatively plausible here for an OS winner against single agent chemo with nothing better, it’s about $4.8b. The precedent is that the FDA grants labeling flexibility in a market with no SOC/high unmet need, so the 50-65% penetration is very realistic, especially with a .50 HR. I temper my expectations to 45-50%, although the 65-70% is certainly a possibility if stars align, which is rare but possible in biotech. The margin profile is strong. THIO is a small molecule nucleoside analog, a modified version of a DNA building block made through standard chemical synthesis, so it doesnt need the expensive living cell manufacturing that antibodies and ADCs require. Its also given at low doses for only three days per 21 day cycle, so the amount of drug per patient is tiny relative to a price around $150,000, which pushes the cost of goods down to roughly 1% of revenue. At 1% COGS, gross margin is essentially 99%. Even if the real number lands at 3-5%, which is more typical for a small molecule, it’s still exceptionally high. The cemiplimab component is billed separately by Regeneron, so THIO keeps its own economics. The real costs are commercial, being a US oncology launch runs a few hundred million dollars a year in sales force, medical affairs, and market access. At 4b in sales, operating margins of 65% are realistic, which is exactly why big pharma would rather buy this than compete with it. Once again, if you disagree, tailor your expectations accordingly based on what you believe the margins and pricing are. Second line is where the market roughly doubles. Most 1L patients now get chemo and immunotherapy together, so when they progress they already have the same resistance profile THIO104 is enrolling, just one line earlier. Some 2L use could come quickly through label wording or NCCN guideline listing, but a broad 2L label would need a confirmatory trial. Docetaxel only control makes for a tougher comparator than THIO104 faces, with a control median of 10-12 months instead of about 7. If THIO104 hits with an HR around 0.5, Id put the odds of a successful 2L trial at roughly 70%. The effect would likely shrink against a stronger control with biology carrying over. A lucky 2L label could add another 1b in peak US sales, while an AA could win another $1-3 billion in peak sales on top of that, since patients would be on therapy longer. Then theres the a bigger piece we’re all invested for - the telomerase story. Roughly 85% of cancers reactivate telomerase, which is the theoretical ceiling for the platform. The near term pieces are the investigator run HCC trial at UT Southwestern, testing THIO plus cadonilimab against cadonilimab alone before surgery, and MAIAs preclinical work in other telo positive cancer types, including second generation telomere targeting molecules. Their real value is strategic. Each positive readout in another tumor type turns the 85% statistic from theory into evidence, and thats what moves an acquirer from paying for a single NSCLC drug to paying for a platform. If THIO104 seems a success, pharma will certainly price in the pan cancer optionality to a fair extent. I believe this story will end similar to Apogee and the company will be purchased after a P3 success. What number is that? I really don’t know. If I had to pin a certain scenario/number on a buyout, I’d assume a couple of bidders would be desperate for the TAM/optionality, and the price would land around 13b with a .5 HR. NFA. Conduct your own DD.

$MAIA It is likely that MAIA will need to raise more capital in the second half of 2027, but we have also seen MAIA's ability to control costs and extend their existing capital immensely. They made their cash extend almost a full extra quarter at the end of 2025 and the beginning of 2026. If the interim results are insufficient, then they will need to extend Phase 3 out to full analysis which requires another 50 events. This would probably take 2 more quarters. If we assume that MAIA requires another 4 quarters of cash after running out in mid-2027, then they'll probably need to raise another $30M. That would be another 20M - 30M shares and would but us at about 125M - 150M shares on a fully diluted basis. However, if MAIA get big results and the share price jumps massively, warrants and options will be executed and a massive injection of cash will hit the balance sheet with no further dilution and we'll be at about 100M full diluted with about $50M in the bank 🥂

$MAIA MAIA's stock price, like the prices of all pre-approval biotechs, reflects the changes in the money supply caused by our senile politicians (and the frac-reserve system that they were bribed into allowing, with no reserve requirements... literally no checks on bank money creation even inside the US, let alone the Eurodollars, since March 26, 2020.) It has exactly nothing to do with the technology. MAIA insiders still own almost 9% of the stock. Stocks in general are still overpriced by historical standards. Nothing stops the indexes from fluctuating. But we're still holding an underpriced treatment applicable to the 85% of cancer that is telomerase-positive. GLTA

$MAIA GERN is great case study for biotech investors: 1) It took forever to get Rytelo approved and that caused immense stock dilution. $1.7B invested in the company over 30 years, and now it's worth $600M. Investing $1.7B in the S&P 500 over that time would have created well over $10B in wealth. 2) The science is fundamentally flawed because of the lag time in the MoA and the toxicity that extended dosing causes. 3) It's valuation is absurdly high compared to its market potential and profitability potential. Its sales are abysmal after 2.5 years on the market. MAIA has better MoAs, 100M shares on a fully diluted basis, and low valuation compared to its market potential 🥂 there is a lot of room for double digit price multiples 🥂

$MAIA We may be getting some collateral damage from the GERN trial failure in MF. Fortunately our MOA is completely different.

$MAIA All top pharma companies will know about MAIA by the end of this week thanks to the Prix Galean Awards 🥂 New posters have been going over their commercial forecasts for ateganosine which is nice to see. I already went over my range of estimates years ago and concluded that $2B in peak sales is a conservative estimate of ateganosine's market potential in NSCLC, which would command an $8B buyout. Factoring in pan-cancer potential, easy manufacturing compared to biologics, high profit margins because it's a small molecule, the big pharma patent cliff, and M&A frenzy, the odds of a $10B+ buyout are significant 🥂

$MAIA I disagree the TAM is only 14-20k 3L patients annually. Here are reasons why that number is too low. When an effective, well tolerated option appears in a later line such as our drug, Ateganosine, more patients will move and get treated there. 51.6% of patients starting first line reach 2L, which on 75K first line starts is roughly 39K patients. On the note of 1L-2L, that half of 51.6% comes from 2015-2021 data. Since then, first line chemo IO has extended survival, which means more patients live long enough to reach both 2L and 3L. One reason only about half of them go on to 3L is because the options are toxic chemo with poor results. If an approved drug with criteria I gave raises that 2L to 3L transition from 50% to a realistic 75%, you get about 30k patients reaching 3L. The follow up bias in these cohorts pushes it north of 32k only off of these two variables alone. Some who would have gone to hospice or supportive care after 2L progression get a 3L course instead. Some patients who progress but decline chemo due so because of toxicity, which is once again another reason why the 27% isnt going to be accurate. An approved, well tolerated drug with a strong survival benefit would recapture the majority of them. This is a historical cohort that describes an outdated funnel, not the one MAIA would launch into in 2028 ish. Another fact - the 27% statistic measures patients who actually received third line treatment, and it completely excludes patients who reached progression but never received another treatment due to the fact that chemo options are terrible, there is no SOC, and there’s no approved therapy for this specific population. On top of that, historical attrition combines mortality, deteriorating performance status, and decisions against additional treatment. A substantially better treatment will address the latter category, meaning observed utilization will underestimate future demand (2025 PMC study). This happens very frequently in other cancers as later line therapies improved. I’m not pinning a certain number to this as it’s more so subjective (but objectively true in the real world), but the number wouldn’t be 15-20k patients moving to 3L if our drug scores like I’ve said a realistic but unprecedented .50 HR with a 15 mOS and ultimately receives approval in this market with such a massive unmet need. Theres no direct literature to support an exact, precise increase in patients in an NSCLC specific population, so you need to read between the lines and stack realistic assumptions contingent on the success of THIO104. On the surface of 2L->3L, it’s obvious there is a bunch of white space that needs filling based on the unmet need. In NSCLC study cohorts, patients who entered late had limited follow up, and some hadn't reached 3L yet when data collection ended, even though they eventually would. Real world line of therapy rates tend to understate the true lifetime rate for that reason. Also, the real world base most people use undercounts annual first line starts. Stage IV at diagnosis is only part of the advanced population. A large share of patients diagnosed at earlier stages recur later and then start first line treatment for advanced disease. I believe your base only accounts patients who are advanced at diagnosis, you're leaving out the recurrence pool entirely, and every one of those patients is a potential 3L patient down the road. At the 180 mg Phase 3 dose, there were no drug related grade 4 events. Many 3L candidates are too frail for docetaxel or other chemo. A well tolerated option like Ateganosine expands the pool of patients oncologists are willing to treat, not just the share who choose to. I never included this but since you made a new post challenging my 3L population, NCCN matters here in 3L, not just 2L which is the only line I did include off label. Once a 3L drug shows a strong OS benefit on top of receiving approval, it gets listed in the guidelines, community oncologists start offering it instead of referring to hospice, and payers cover it. The 27% reflects a world of a subpopulation where 3L meant toxic chemo with single digit response rates. Adjust your calculations to a real world population outside of a narrower newly diagnosed only cohort, change what's available in 3L, and you change how many patients get there. These variables will simultaneously stack together and foster a true increase in the 3L market if Ateganosine receives approval. My own opinion will still likely be 35k patients who reach 3L annually and 28k ish who are THIO eligible after a 20% haircut after accounting for driver mutated patients and ineligible ECOG patients. My TAM relative to your number for the broader US 3L market is 150k (assumed) x 35k = 5.25B. My true, THIO eligible US 3L TAM (which is what you need to model) is 150k (assumed) x 28k = 4.2B

$MAIA IMO - If readout is positive, whether it’s halted at IA or success at FA, this is a $30 stock same day. My bets are placed at these prices.

$MAIA Excellent, excellent explanation of MAIA’s true market. Thank you for going in depth on this, and I figured this deserved a reshare as a post on the main board as it’s been topic of discussion recently and many people here could benefit from this. Frickin genius, lol. Have always loved your work here and on Capricor.

$MAIA Loading up by mid summer next year we can grasp on whether Chemo is outpacing Anteganosine or not. I sold early on SLS because i was unsure but i believe i have another shot at the prize here even with dilution also i think Regeneron probably has 👀 on this trial ready to pounce if they see something here on this drug with an offer or partnership.

$MAIA As I posted months ago (and was bashed for) when this was ~$1.50, that massive $150M shelf overhang is likely taking this down well below $1 before year end and the chart showing the drip down all year could also exert even more downward pressure motivated by tax loss selling.

$MAIA Another failed Lung Cancer trial ….ArriVent BioPharma (AVBP) shares crashed over 48% to an all-time low on October 6, 2026, after its Phase 3 FURVENT trial for lung cancer treatment failed to meet its primary endpoint. 📉 Trial Setback • Failed Endpoint: Firmonertinib missed progression-free survival in non-small cell lung cancer. • Market Impact: Stock plunged over 48% to a record low near $12.09. • Response Rate: Showed a 60% confirmed response rate versus 33% for chemotherapy.

$MAIA IOVA performing similar to standard of care with an MOA that includes surgery to harvest tumor, weeks of manufacturing, lymphodepleting chemo, and high dose IL-2 in the hospital at a limited number of centers keeps our competition at a minimum. They will take roughly 2-5k 2L patients annually. No more than that. It will doesn’t meaningfully affect our hypothetical NCCN 2A off label listing via compendium. Feel bad for the shareholders who at the -30%, but on the flip side, our revenue will stay the same. Cheers 🥂

$MAIA this may reach the level of GERN even without a failed trial, Zero conviction, at least GERN has an approved drug which is selling. Clearly the excitement should be on this side with interesting science and the upside for treating many indications. We keep buying here as it's possibe that positive interim news hit before dilution, which should make it double, triple or quadruple from here easily, but without a halt for efficacy they will need to dilute or partner right after the pump. Can't believe we're getting shares for just above a buck here. At these levels, moderately =>