Peter Sanee

[Imagion Biosystems @imagionbio]

“(Imagion) has secured IND clearance from the FDA in an achievement that is the company’s most important to date…”  
Click the link to read Pitt Street Research’s recent "flash note" and learn why they think this is such a pivotal milestone: https://t.co/sU5Px0KfCW

[Pitt Street Research @PSR_Insights]

@imagionbio (ASX: $IBX) secured FDA IND! It can now commence a Phase 2 trial in MagSense, IBX's imaging agent that can detect cancers with a lower radiation dose and at an earlier stage than competing agents.
Full report here: https://t.co/BkG2ItKIh1 👍

[Imagion Biosystems @imagionbio]

We are excited to announce that the U.S. FDA has issued a Study May Proceed notice for our IND application. Clearance to advance to our Phase 2 study underscores the safety and veracity of the trial and marks a major milestone for the Company.
$IBX #MagSense #MolecularMRI

[Gassin123Charts @MrBreakouts]

$IBX 2.5c x 30m $Volume ..on Open = #FDA Clearances $$$
#ASX e Bouncy Bullish #Bio Buzzers #Breakouts $COV $RHY

[StockWire X | ASX News @StockWireX]

FDA clears @imagionbio MagSense HER2 imaging agent for Phase 1b/2 trial in HER2+ breast cancer patients $IBX

https://t.co/TmJwzoGV1S

[Memorial Sloan Kettering Cancer Center @MSKCancerCenter]

Today, MSK physician-scientist Dr. Sarat Chandarlapaty shared his research on how #cancer develops resistance to #HER2 antibody-drug conjugates during a session at #AACR26.

[Peter Sanee @peter_sanee]

$ibx Emerging Growth Conference

https://t.co/FDFvh9IauV

[Peter Sanee @peter_sanee]

@MrBreakouts https://t.co/dRfYaObcxU

[Imagion Biosystems @imagionbio]

Check out this feature from The Market Bull highlighting recent developments in our MagSense® molecular MRI technology.

$IBX

[Bhavdip Sanghavi @bhavdip143]

$IBX

🚨 $IBX UP 50% TODAY — THIS IS JUST THE BEGINNING 🚨

One of my highest conviction medtech plays just flipped the switch… and the rerate is only getting started.

MagSense® HER2 Phase 2 Clinical Trial momentum is REAL:

🔬 MANUFACTURING COMMENCED — MAJOR MILESTONE HIT

• U.S. production of the MagSense® HER2 imaging agent has officially started

• Fully GMP compliant; manufacturing to be completed by end of September

• Analytical testing to follow — then straight into IND & trial prep

• This is the KEY step toward human clinical application

🇺🇸 FDA COMMUNICATIONS ADVANCING — IND ON TRACK

• Ongoing formal engagement with FDA after positive July feedback

• IND application submission expected Q4 2025

• Strong regulatory alignment — de-risking the clinical and commercial pathway

🤝 WORLD-CLASS IMAGING COLLABORATIONS (WSU + SIEMENS)

• Active imaging protocol optimisation underway with Wayne State University (WSU)

• Siemens Healthineers, the global MRI leader, backing implementation across clinical sites

• AI-driven MRI imaging = better diagnostics, more precise cancer detection

• Results expected in September — will be included in IND filing

• Sets stage for AI-powered molecular imaging across HER2, prostate, and ovarian cancers

👩‍⚕️ BOARD UPGRADE — DR NINA WEBSTER JOINS

• Former DXB CEO, deep experience in clinical dev & commercialisation

• Strengthens execution capacity as IBX enters late-stage development

💰 FULLY FUNDED TO EXECUTE

• $3.5m raised in August

• Runway secured — no overhang, just clean runway to IND & trial commencement

🌐 MAGSENSE® TECH = A PLATFORM, NOT JUST A PRODUCT

• First-in-class non-radioactive, molecular MRI agent

• HER2 breast cancer = 400,000+ new cases annually

• MagSense® targets nodal metastases — a major unmet diagnostic need

• Potential to replace invasive biopsies with AI-optimised, high-specificity MRI imaging

• Massive pipeline potential: prostate cancer & ovarian cancer programs ready for IND studies

💡 BIG PICTURE: THIS IS A MEDTECH PLATFORM PLAY

Not just about one trial.

This is the foundation of a new molecular imaging era, starting with HER2 and expanding across high-value oncology indications.

📈 $IBX has just begun its rerate — the clinical, regulatory, and tech catalysts are all aligning.

$IBX the early stage of a medtech breakout like $4DX #4DX

🎯 Same sector. Same setup. Same asymmetry.

DYOR. Not financial advice

[Peter Sanee @peter_sanee]

@ladsgeog @AFL De Goey was in a contest going for the ball we Laird was not in a contest.

[Small Caps @SmallCapsASX]

Imagion Biosystems (#ASX: $IBX) advances MagSense HER2 imaging agent with FDA application
https://t.co/lVKcvYScio @imagionbio

[Peter Sanee @peter_sanee]

@cabelo_escobar FR1m4n2p6kX8mebPGta85NZDgfNosieNzB7RA76ZxHLh

[The Market Bull - Daily Stock News @TheMarketBullAU]

ASX: IBX Begins Manufacturing MagSense® HER2 Imaging Drug for Phase 2 Breast Cancer Study $IBX @imagionbio
🔗 https://t.co/Yz4F2nqss7

[Peter Sanee @peter_sanee]

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[Peter Sanee @peter_sanee]

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[Peter Sanee @peter_sanee]

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[Peter Sanee @peter_sanee]

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[Peter Sanee @peter_sanee]

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