OSTX OS Therapies Inc

$OSTX in for 1k shares to begin. This appears to be the most under the radar bio now with impending rerate potential. Bone cancer is just about the worst thing to deal with.

$OSTX I know it’s rough out here in these streets. Vast majority of small cap bios taking a beating as of late, coupled with the general market being down as well. If you’ve been here for a while we’ve been here before, just with less positive news in the bank. I believe good things are on the horizon here. Keep the faith yall our time will come.

$OSTX Next up: RMAT decision, MHRA CMAA submission, pre-BLA meeting and progress toward Phase 3 init.

$OSTX A very interesting Project Orbis fact for OSTX holders 🇬🇧🇺🇸 According to OS Therapies’ latest update, since 2021, 29 oncology products led by the UK’s MHRA under Project Orbis have gone on to receive FDA approval — 29 out of 29. That’s a 100% historical record for those 29 MHRA-led oncology products. This does NOT mean FDA approval is automatic, and it certainly doesn’t guarantee the outcome for OST-HER2. But I think the historical record is worth knowing: MHRA-led Project Orbis cases since 2021: 29 → FDA-approved: 29 Historical success rate: 100% And now OST-HER2 is being coordinated under MHRA leadership within Project Orbis. For me, this is not a prediction. It’s simply a historical fact that gives me a little more confidence in the regulatory path ahead. 💪🧬 Let’s keep our feet on the ground — but this is definitely an encouraging piece of data for OSTX holders. 🚀

$OSTX Nice additions. I know Frank personally. Highly intelligent with a lot of integrity. Definitely adding to the watchlist.

$OSTX you know that OST-HER2 is being used to treat osteosarcoma and you may know that the platform was originally developed at the University of Pennsylvania. But did you know that it was originally developed specifically for breast cancer? In the late 1990s/2000s Herceptin came along and changed things in breast cancer treatment. The market became intensely crowded and forced researchers to pivot the platform to the extreme unmet need in osteosarcoma. $OSTX now envisions the platform being used as an adjuvant treatment in breast cancer—given to patients who are in remission or have had their tumors surgically removed, as a "safety net" to prevent recurrence.

$OSTX Somebody knows something. I have a feeling tomorrow is going to be a day for the ages

$OSTX OST-HER2 (Herlystic) is entering a pivotal regulatory window: ✅ FDA: Type C meeting completed in September. BLA clinical module targeted for Q4 2026, with RMAT, Rolling Review & CNPV as potential catalysts. 🇬🇧 UK: MHRA leading under Project Orbis, with CMAA submission targeted for Q4. 🇪🇺 Europe: Conditional authorization applications targeted for early 2027. 📅 Coming soon: October–November regulatory updates, BLA progress, Phase 3 initiation targeted for mid-Q4. Official FDA minutes, and potential partnerships or licensing agreements at any given moment. 🔥 Final 3-year OS data: 72.7% survival vs. 45.8% historical controls (p=0.0006)! We have just entered the most significant and potentially value driving window of time this company has ever had. Accumulate if you can. 📈📈📈

$OSTX Each PR brings our timeline more and more into focus. OSTX — realistic timeline (not including conferences) * Oct. 5-16: 📊 3-year data lock/ final analysis * Oct. 8–20: 🚨 Final 3-year OS data PR * Oct. 8–23: 🧪 FDA official minutes RMAT/Rolling Review updates * Oct. 13–31: 🇺🇸 FDA Type B Pre-BLA meeting / final BLA alignment The company says the Pre-BLA follows submission of the clinical section containing the 3-year OS data. * Oct. 15–31: 🇬🇧 MHRA CMAA submission OSTX said the complete CMAA was expected “in the coming weeks” and later said MHRA CMAA would precede the U.S. BLA. * Late Oct.–mid Nov.: 🇺🇸 U.S. BLA completed/submitted under Accelerated Approval * Nov.–Dec.: 🇪🇺🇦🇺 EMA + Australia CMAA submissions * Mid-Q4: 🧬 UK Phase 3 initiation — company currently says mid-Q4, following Phase 2b drug-product requalification. * Nov.–Dec.: 🔄 FDA/MHRA/EMA regulatory review activity + additional meetings * Late Q4 2026 → Q1 2027: 🏛️ Potential early-market-access regulatory decisions

$OSTX tomorrow is October 3 and the scheduled appointment for the last patient's 3-year check-in. A formal Data Lock Press Release could realistically drop anytime next week to mid-October.

$OSTX Just bought a 1000 shares before opening. Saw this on my Fidelity news this morning. Best of luck to us all and have a beautiful day!!

$OSTX Oh and just to cheer everyone else up. My broker Vanguard is giving a 100% buy recommendation. In terms of biotech investments Vanguard has been very good to me. You just need to be patient, like always when it comes to biotech. And cheers to ! You made me aware of this one a few months back. I am still building my position. I also have a nice stash in my IRA Roth. That's how convinced I am.

$OSTX This will launch soon enough target is around $8 then once FDA approves who knows where it will be at that point north of $20

$OSTX This is great news. This will expose many more investors to the $OSTX story. The company is gearing up for a huge Q4 2026 and a massive 2027!

$OSTX Frank Knuettel II, Chief Financial Officer of OS Therapies, noted, "With the progress we have made at both OS Therapies and OSAH, we are now in a position to evaluate strategic and/or direct capital alternatives for OSAH, directly benefiting OS Therapies shareholders. Canine osteosarcoma is one of the leading causes of death in large breed canines and we believe there is substantial value in our gene-edited, cancer immunotherapy platform for companion animal health. OST-HER2 has the potential to be the first HER2-targeted therapy in companion animal cancer treatment."

$OSTX We have just a few more trading days until October (Q4) where we’re scheduled to have a combination of regulatory milestones/designations and international investor conferences. If you haven’t been invested here very long I can tell you with a high degree of confidence that the stock price will be testing $2 again very soon. 📈📈📈

$OSTX I don’t think the market fully understands how big of a deal it is to be accepted into project Orbis! 75% - 85% of therapies get approved by the fda that are in project orbis! This is super bullish news for OS Therapies.

$OSTX it is never easy waiting through periods like this. Feels like we’re one good PR to see the whole thing take shape. If you’ve been trading biotech for a while you know it’s exactly these times that you really have to stay focused. Especially with the brutal macro backdrop. GL to all. Here’s to finding ourselves looking back on 26 as a great year for patients and investors

$OSTX Once the stock gets to$5 plus (the penny stock threshhold), we can expect some institutional buying that will keep the stock price moving upwards. A few positive press releases, along with the help of our new public relations firm, should get us to $5 plus sooner than later!

$OSTX 72.7% 3-year OS vs 45.8% historical control, p=0.0006 🔥 In metastatic osteosarcoma, where nothing new has been approved in decades. BLA under Accelerated Approval targeted for Q4