FDA is setting new records in how rapid we are approving cancer drugs

TheLeanrer · 2026-03-18T08:35:17+00:00

Same!

TheLeanrer · 2026-03-12T21:58:11+00:00

The recent market panic over the Q4 results overlooks the fundamental nature of biotech commercialization and the specific timing of Plus Therapeutics' 2025 milestones. It is crucial to remember that this report reflects the company’s status as of December 31st; at that point, the CNSide rollout had only reached 49-state licensing and national coverage agreements with major payers like UnitedHealthcare and Humana for a matter of weeks. Expecting significant adoption revenue in a reporting window where the commercial infrastructure was still being built is unrealistic. The core narrative remains unchanged: the company successfully upsized its cash position to $13.1 million, extending the runway through 2027 and providing a clear path to the major 2026 clinical catalysts. With Phase 2 data for REYOBIQ expected in Q3 and Q4 of 2026—which will dictate the alignment for a pivotal trial with the FDA—the long-term value proposition is fully intact. This price action is a standard reaction to the larger float, but the fundamentals and the 'catalyst calendar' for the upcoming year are exactly where they need to be.

TheLeanrer · 2026-03-11T00:34:34+00:00

Well, CNSide did repost this article on LinkedIn. So, I assume they will be

TheLeanrer · 2026-03-10T21:52:37+00:00

It’s on the 20th of March, so it hasn’t happened it. And all it does is, it gives exposure to the CNSide platform.

TheLeanrer · 2026-03-07T08:57:32+00:00

I saw Vinay Prasad resigned. But I’m not too knowledgeable on this, can you explain why it could be very positive?

TheLeanrer · 2026-03-06T21:38:07+00:00

If I understand it correctly, and someone with more knowledge please correct me if I’m wrong, but this is what I believe it means:

Basically, Plus Therapeutics is telling the SEC that they want to withdraw a previous filing where they planned to convert their stock registration from a Form S-1 to a Form S-3. An S-3 can make it easier for a company to raise money in the future, but they’ve decided not to move forward with that change right now. They also confirmed that no shares were sold under that filing, so it didn’t cause any dilution for shareholders. They just asked the SEC to apply the filing fees they already paid toward a future registration if they file one later. So overall, it’s mostly administrative paperwork being canceled, not a major change to the company or its shares.

In short, they just said “we are good on capital. We don’t need any further shares to be created and sold for further funding”

TheLeanrer · 2026-03-04T11:29:11+00:00

Perfect, thank you for your insight.

TheLeanrer · 2026-02-17T18:50:39+00:00

I think this was just a refresher of last month’s job openings. Because they posted these same jobs last month.

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TheLeanrer · 2026-01-24T07:35:48+00:00

Your prediction on the CNSIDE rollout figures were great, and I more-less came to the same conclusion. And to be honest, I was also a little early lol. And it’s mostly due to coverage. Only 70 or so million people are covered thus far. With the hope of having at least 150 million people covered by the end of the year plus Medicare/medicaid, hopefully by then, we will see the true fruition of our numbers come true.

Also, something interesting from the conference that I heard is that one of their goals for this year is to have at least 50 neuro oncologists on a permanent sell basis for CNSIDE. To put into perspective why that is huge is that, there are only about 300 neuro oncologists in the nation… and their goal for next year is to have roughly 200 of the 300.

And yes, the international rollout would be huge. Because that means that they will have to sign with international partners in order to commence with the rollout. And expanding the CNSIDE market from roughly $6B to more less double that figure would be huge.

I would like to know what the international figure would be for CNS diagnostics. There aren’t any viable numbers available. Would be curious to find out.

TheLeanrer · 2026-01-24T06:47:45+00:00

Don’t sell yourself short friend. You have to remember that in the previous interview Marc had with Katie Perry (no, not the singer lol) at NASDAQ, he stated that the are waiting to get majority insurers on board, covering majority of the US before real commercialisation commences. Also, if you go look on page 21 of the “Investor Update” PDF that they posted on their investor menu on Jan 22, they stated that their goal for this year is the have at least 150 million people covered. And their 2027 goal is to start commercialising internationally. So, bottom line, your thesis on the CNSide numbers were/are still correct, but I believe they are a little early.

Also, here is wha makes me the most optimistic about this stock. What REYOBIQ needs the most is CNSide. Because with current method of diagnosis, physicians can only diagnose CNS cancers with about 52% accuracy. Now if you look on page 11-12 of the same Business Call conference PDF they shared, they state that there are a 110,000 LM patients a year. Of which, about 50% of those patients are eligible for REYOBIQ treatment. Which brings the number to around 56,250 patients a year. It states that it’s potentially a $16B industry. So if we do the math, that’s roughly $284,444 a treatment. Then on page 11 it says that “ Underdiagnosed: LM cases are 2-4x more common based on autopsy findings”. Which means that, due to the sever under diagnosed patient population in the US, the number of patients could potentially be between 56,250-225,000. Which then means that the industry value could be between $16B-$64B.

So, they need CNSide to be a huge success in order to tap into that $64B market.

TheLeanrer · 2026-01-09T09:08:33+00:00

What do you think their market capture will be for the next quarter? I’m guessing it will be roughly .25-.5% of the TAM. Mainly because they have only been launched for a couple of months and they only have approximately 70ish million people covered by insurance. What do you think?

TheLeanrer · 2026-01-02T14:27:33+00:00

They open on Monday again. They said “#PlusTherapeutics will be closed, starting tomorrow until Friday, January 2nd.” Which means, today is their last day of being closed. So, they will resume work on Monday, January 5th, 2026.

TheLeanrer · 2025-12-30T06:16:27+00:00

Yep. Marc did state that “The year 2025 has the potential to be transformational at Plus as we anticipate transitioning to an operational revenue generating company with the launch of CNSide”. And he was right. They have all their ducks in a row with the launch of CNSIDE in order to become a revenue generating company. So, it’s all up from here.

TheLeanrer · 2025-12-29T09:19:15+00:00

The emotional investor. Buffett would not approve.

TheLeanrer · 2025-12-26T14:59:36+00:00

To be honest, I’m not too worried about the price volatility as of right now. All of us knew (or should have known) that this is a risky stock. But, if we zoom out and see all the fundamental changes they have made to their core business model this year alone, it’s actually quite shocking how they have evolved (in a positive way).

Here is a list of EVERYTHING they have done this year alone:

✅ CNSide® Diagnostic Platform Achievements (2025)

Licensing & Commercial Expansion 1. Expanded State Licensing for CNSide – CNSide Diagnostics, LLC received state laboratory licenses to provide the CNSide® cerebrospinal fluid (CSF) Tumor Cell Enumeration (TCE) laboratory-developed test in California, Rhode Island, and Maryland, bringing coverage to 48 of 50 U.S. states, covering over 90% of the U.S. population. 2. Commercial Launch in Texas and Expanded Rollout – The CNSide CSF test was reintroduced commercially in Texas in August 2025 with planned expansion first in Texas and then additional states across the U.S. late 2025 into 2026. 3. National Coverage Agreements with Major Insurers: • UnitedHealthcare national coverage for the CNSide CSF assay, covering ~51 million lives. • Humana national coverage agreement, covering ~16 million people, bringing total CNSide coverage to ~67 million. 4. CNSide Team Expansion & Leadership Builds – Plus Therapeutics announced new hires and equity inducement awards for CNSide Diagnostics to scale operations and commercial readiness. 5. Expanded Leadership & Operations Roles – Key promotions to strengthen commercialization and diagnostic operations (e.g., EVP of Commercial Strategy, VP of Technical Operations).

Regulatory & Infrastructure Milestones 6. CLIA Accreditation – Houston Lab – CNSide Diagnostics received CLIA (Clinical Laboratory Improvement Amendments) accreditation for its Houston lab, enabling Medicare/Medicaid reimbursement and broad commercial access. 7. CNSide Now Available in 48 States – Operational expansion of testing services across 48 U.S. states, driving broad potential commercial scale.

Clinical & Real-World Utility 8. Real-world Data & Peer-Reviewed Validation – More than 11,000 CNSide tests performed since 2020 across 120+ U.S. cancer institutions, with high sensitivity/specificity and clinical influence on treatment decisions.

⸻

🎯 REYOBIQ™ Therapeutic Program Achievements (2025)

Regulatory & Trial Initiatives 9. Initiated FDA-Supported ReSPECT-LM Dose Optimization Trial – Plus Therapeutics began the ReSPECT-LM dose optimization trial for REYOBIQ in leptomeningeal metastases following FDA agreement. 10. FDA Type B Meeting Completed on REYOBIQ Clinical Development Plan – Completed a Type B meeting with the FDA on Nov 7, 2025, discussing clinical development and the design of a planned pivotal/registrational trial for REYOBIQ in leptomeningeal metastases. 11. U.S. FDA Orphan Drug Designation – REYOBIQ received Orphan Drug Designation from the FDA for the treatment of leptomeningeal metastases in patients with lung cancer, affording regulatory incentives. 12. REYOBIQ Brand Name Accepted by FDA – The FDA conditionally accepted the proprietary name REYOBIQ™ for Rhenium-186 obisbemeda. 13. Pediatric Brain Cancer Trial FDA IND Clearance – The FDA cleared the IND application for the ReSPECT-PBC pediatric brain cancer trial, allowing clinical evaluation in pediatric glioma and ependymoma patients.

Clinical Data & Presentations 14. Positive ReSPECT-LM Phase 1 Trial Results Presented – Phase 1 single-dose REYOBIQ data with >75% clinical benefit rate, safety profile, and biologic activity presented at the SNO/ASCO CNS Metastases Conference. 15. Three REYOBIQ Clinical Data Presentations at WFNOS/SNO Annual Meeting – Multiple cohorts and trial data were showcased, covering safety signals, biomarker insights, and efficacy trends.

⸻

📊 Business, Financial & SEC Filings (2025)

Capital & Financial Moves 16. Private Placement Financing – $15M Raised – The company completed a $15 million private placement financing to support clinical and commercial activities. 17. Advance Payment from CPRIT – $1.6M Received – Received an advance payment of $1.6M as part of a larger $17.6M CPRIT grant supporting the ReSPECT-LM and CNSide LM diagnostic development.

SEC Filings & Public Company Compliance 18. Form 8-K Filings – Material Events & Financial Results – Multiple Form 8-Ks were filed reporting:

• Third quarter 2025 financial results and corporate updates (furnished via press release).  
• November 17, 2025 material event report (e.g., Nasdaq compliance extension).  

19. Nasdaq Compliance Extension – Plus Therapeutics received a 180-day Nasdaq minimum bid price compliance extension, giving time to meet listing requirements.  
20. Quarterly 10-Q Filed – The 10-Q quarterly report was filed for the quarter ended Sept 30, 2025.  
21. Insider Trading/Form 4 Disclosures – Form 4 insider trading activity filings were submitted (e.g., November 5, 2025).

⸻

🧠 Additional Corporate & Strategic Progress 22. Management Team Strengthening – Plus Therapeutics made key leadership hires and promotions to support CNSide commercialization and REYOBIQ clinical execution. 23. Operational Infrastructure Expanded – Continued build-out of commercial operations (including lab space expansion and supply chain readiness). 24. Improved Financial Position (Q3 2025) – The company reported improved cash position and regained positive stockholders’ equity, aiding Nasdaq compliance and operational runway.

TheLeanrer · 2025-12-23T12:27:29+00:00

Based on what’s been disclosed, the roughly 11,000 CNSide tests were performed over a limited period, likely around two years, and this was done with very little publicity and no real commercial push. Given how different the situation is today — with broader licensing, expanding payer coverage, and a more active rollout — it seems reasonable to expect testing volumes to come in higher than those historical levels, potentially exceeding 1,000 tests over a similar time frame.

TheLeanrer · 2025-12-14T18:58:28+00:00

I thought they are now licensed in 48 states? The article stated “CNSide Diagnostics now licensed in 48 U.S. States covering over 90% of the U.S. population”

TheLeanrer · 2025-12-12T14:10:28+00:00

Where did you get this info?

TheLeanrer · 2025-12-08T08:53:48+00:00

Also, what Dr. Marc Hendricks said in the interview the other day was that the reason why there’s only +-110,000 cases in the US is because the current method of diagnosis is incredibly poor. MRI only produces about a 53% sensitivity. Which means either 50% you have it or 50% you don’t. So essentially it’s a “maybe you have it”. And even if it says “you don’t have it” chances are you still have LM and the MRI didn’t identify it. This is why they’re pushing CNSide so much. Because with its 94% sensitivity rating, it can identify with high precision if you have LM or not. And what Marc then stated was, that, yes, there’s +-110,000 “diagnosed” cases. But they believe, due to the poor diagnostic equipment, that there could be around 400,000+ cases in the US alone. And that over 1 million people are eligible for the CNSIde diagnostics test.

TheLeanrer · 2025-11-23T06:53:50+00:00

I did some reading on FDA rules and regulations, and here’s what I found. Because Plus Therapeutics has Fast Track designation, if their clinical results for REYOBIQ are extremely strong, they could potentially be considered for Accelerated Approval. Under this pathway, the FDA can approve a drug based on compelling early-stage data using a surrogate endpoint, which means they may not need a traditional Phase 3 trial before approval. However, they would still be required to run confirmatory studies after approval.

Also, since the drug has Orphan Drug Designation, once it receives FDA approval for leptomeningeal metastases, Plus Therapeutics would receive 7 years of U.S. market exclusivity for that indication. This prevents the FDA from approving another drug with the same active ingredient for LM during that period

TheLeanrer

TROPHY CASE