u/Freedom5567


Cerenome | CNSide | REYOBIQ | Nasdaq: CNSY
Cerenome Launches CNSide® CSF Molecular Profile Tests

 
New DNA and RNA tests expand CNSide beyond leptomeningeal metastases to molecular profiling across CNS oncology
 
CNSide Diagnostics, LLC, a wholly owned subsidiary of Cerenome, Inc. (Nasdaq: CNSY), today announces the commercial launch of two new cerebrospinal fluid (CSF)-based molecular profiling tests, available to health care professionals in the United States beginning October 12, 2026:
CNSide® CSF Molecular Profile – Solid Tumor (DNA & RNA)
CNSide® CSF Molecular Profile – Hematologic Malignancies (DNA & RNA)
This launch expands the patient population CNSide can serve. While CNSide® CSF Tumor Cell Enumeration (TCE) is focused on patients with suspected or confirmed leptomeningeal metastases (LM), the new Molecular Profile tests extend CSF-based molecular testing to primary central nervous system (CNS) tumors, solid tumors that have metastasized to the CNS, and hematologic malignancies that involve the CNS.
 
“With these two new tests, CNSide can serve more patients with cancer in the CNS and give their physicians information they can act on,” said Russell Bradley, President and General Manager of CNSide Diagnostics, LLC. “Molecular Profile adds DNA and RNA findings, including potentially actionable alterations, to the cellular information CNSide already provides, and extends CNSide beyond LM to primary CNS tumors and hematologic cancers involving the CNS.”
 
The new tests analyze more than 300 cancer-related genes in cell-free DNA and more than 1,600 transcripts by RNA sequencing, enabling broad characterization of genomic and transcriptomic alterations, including sequence variants, copy-number alterations, and gene fusions. The Hematologic Malignancies test also supports molecular assessment of clonality.
 
The approach underlying CNSide CSF Molecular Profile was recently evaluated in a real-world, peer-reviewed study by Albitar et al., investigators at Genomic Testing Cooperative (GTC), published in The Journal of Liquid Biopsy. The study analyzed 1,391 evaluable CSF specimens from patients being evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS. Researchers identified cancer-related molecular findings in 78.4% of evaluable specimens. The study characterized multiple classes of molecular abnormalities, including sequence variants, copy-number and chromosomal alterations, gene fusions, and clonality.
 
CNSide CSF Molecular Profile is offered through CNSide Diagnostics’ collaboration with GTC, announced in July 2026. GTC performs the DNA and RNA sequencing and bioinformatics analysis. CNSide Diagnostics manages test ordering, results delivery, physician support and billing.
 
The launch builds on CNSide’s established experience in CSF-based oncology diagnostics. Since 2020, more than 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions. The clinical utility of CNSide CSF tumor-cell analysis in LM has been evaluated in 12 peer-reviewed publications, prospective multicenter evidence from the FORESEE clinical study, and real-world clinical experience.
 
Ordering Information
Beginning October 12, 2026, health care professionals may order CNSide CSF Molecular Profile tests through CNSide Diagnostics for patients with primary CNS tumors, solid tumors that have metastasized to the CNS, or hematologic malignancies involving the CNS. For patients with suspected or confirmed LM, Molecular Profile may be ordered on its own or, when clinically appropriate, alongside TCE: TCE detects and quantifies tumor cells, while Molecular Profile characterizes the DNA and RNA alterations of the disease, providing complementary information from the same CSF specimen. Coverage decisions and reimbursement amounts vary by payer and patient benefit design.
 
CNSide CSF Tumor Cell Enumeration is a laboratory-developed test performed by CNSide Diagnostics, LLC in its CLIA-certified, CAP-accredited laboratory in Houston, Texas. CNSide CSF Molecular Profile tests are laboratory-developed tests currently performed for CNSide Diagnostics by Genomic Testing Cooperative, LCA, a CLIA-certified and CAP-accredited reference laboratory. These tests have not been cleared or approved by the U.S. Food and Drug Administration and are available through CNSide Diagnostics to health care professionals in the U.S.
 
Read More on ir.cerenome.com
CNSide Website

IN CASE YOU MISSED IT
Cerenome Shares Updated Corporate Deck

View Presentation

Recent News & Events

Finding One Cancer Cell in Spinal Fluid: The Test Changing Brain Metastasis Care
The BioHub Podcast

Our President and CEO, Dr. Marc Hedrick, and Russell Bradley, President & GM of CNSide Diagnostics, recently joined Benjamin O'Keefe on The BioHub - by Avetix Podcast to discuss how Cerenome is tackling the toughest CNS cancer challenges head-on.
WATCH HERE

Early Disease Detection and Beating CNS Cancers

Base to Base Biotech Podcast

Marc Hedrick, CEO of Cerenome, speaks to the Base to Base Biotech Podcast about a combined approach to tackling central nervous system (CNS) cancers
LISTEN HERE





Cerenome, Inc. (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted radiotherapeutics and proprietary data and artificial intelligence. The Company’s CNSide® cerebrospinal fluid diagnostic platform is designed to support the diagnosis, molecular characterization and longitudinal monitoring of patients with CNS cancers. Its lead therapeutic platform, REYOBIQ™ (rhenium-186 obisbemeda) is being developed for leptomeningeal metastases, recurrent glioblastoma and pediatric brain cancer. CerIQ, the Company’s proprietary data analytics and artificial intelligence platform, is being developed to connect and analyze diagnostic, therapeutic, imaging, bioinformatic and operational data across the organization. By bringing these capabilities together, Cerenome is building an integrated CNS oncology platform intended to improve clinical development, generate actionable disease intelligence and advance more precise care for patients with CNS cancers.
Cerenome, Inc., 6420 Levit Green Blvd, Suite 210, Houston, TX 77021, USA, 210-974-6900
Unsubscribe Manage preferences

Something from today’s CNSide update really stood out to me when I went back and compared it with what management previously said about 2027.
Cerenome expects approximately $1.55 million in CNSide gross billings for Q3 from 222 tests.
That works out to approximately:
$1,550,000 ÷ 222 = $6,982 in gross billings per test
That’s substantially higher than what we were expecting.
Now go back to what Marc Hedrick previously said when asked about CNSide reaching profitability. Management estimated that, based on the tumor cell enumeration test alone, somewhere around 5,000 tests would roughly get CNSide there.
Cerenome has also stated its goal is for CNSide Diagnostics to reach breakeven in 2027.
Now apply today’s Q3 billing rate:
5,000 tests × $6,982 = approximately $34.9 million in gross billings
To be clear, gross billings are NOT the same thing as recognized revenue or cash collected. Reimbursement rates, collections and timing all matter.
But there is another important piece here.
That previous 5,000 test estimate was based on the TCE test alone. Cerenome is now preparing to launch an expanded CNSide testing menu with multiple tests in Q4 2026, while continuing to expand insurance coverage and targeting approximately 200 million covered lives and beneficiaries by early 2027.
So we’re no longer looking at exactly the same CNSide business that management was looking at when that 5,000 test estimate was discussed.
The numbers are starting to give us a much clearer picture of what CNSide could become at scale.
222 tests = ~$1.55M gross billings
5,000 tests at the same average = ~$34.9M gross billings
And that’s before we know what impact the expanded testing menu could have on billings per patient.
The next thing I will be watching closely is how much of these gross billings ultimately converts into recognized revenue and cash collections.
That’s where we’ll really start seeing the economics of CNSide come together.

Cerenome has appointed Samantha Fowlkes as Vice President and Head of Commercial Sales for CNSide Diagnostics.
She brings more than 20 years of experience in oncology diagnostics, precision medicine and laboratory services, including senior leadership positions at Caris Life Sciences, Genoptix and Labcorp.
But the title is what really caught my attention.
Head of Commercial Sales.
Cerenome has spent the last year building the foundation around CNSide. Coverage, reimbursement, laboratory infrastructure and institutional adoption have all been moving forward.
Now they’re bringing in an experienced oncology diagnostics executive specifically to drive sales.
That tells me the focus is shifting from building the commercial infrastructure to actually using it.
More ordering physicians.
More institutions.
More CNSide tests.
More revenue.
And remember, CNSide isn’t some theoretical product waiting years to reach the market. It’s already being ordered and reimbursed.
Now Cerenome needs to scale it.
You don’t bring in someone with this kind of background as Head of Commercial Sales because you’re planning to stand still.
2026 has been about putting the pieces in place.
The next question is how quickly they can turn those pieces into meaningful commercial growth.

HOUSTON, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Cerenome, **Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”)**today highlights data from two scientific posters presented at the 2026 Society for Neuro-Oncology/American Society of Clinical Oncology (SNO/ASCO) CNS Metastases Conference, held August 13–15 in Boston. One presentation featured updated pharmacokinetic (PK), pharmacodynamic (PD), dosimetry, safety and activity data for REYOBIQ™ (rhenium-186 obisbemeda) in patients with leptomeningeal metastases (LM), including emerging safety data from the ongoing repeated-dosing program. The second was an update of a previously reported health economics analysis evaluating the impact of CNSide®-enabled earlier LM detection and therapeutic management.
“The data presented at SNO/ASCO underscore the rationale behind Cerenome’s integrated approach to leptomeningeal metastases – from earlier and more definitive detection and quantitative disease monitoring with CNSide, to targeted local therapy with REYOBIQ,” said Marc H. Hedrick, M.D., Cerenome President and Chief Executive Officer. “The REYOBIQ findings provide additional support for broad CSF distribution, limited systemic exposure in most patients, and the continued evaluation of repeat dosing. The CNSide analysis reinforces the potential economic value of earlier, information-rich disease management. Together, these data demonstrate the potential of connecting diagnostics, therapeutics and longitudinal data to improve the management of CNS cancers.”
As previously announced, both posters will be available on the Publications page of Cerenome’s website following the conclusion of the conference.
REYOBIQ ReSPECT-LM and ReSPECT-LMM Data
A poster titled, “ReSPECT-LM: Pharmacokinetic and Pharmacodynamic Assessment of Rhenium Obisbemeda in Leptomeningeal Metastases with Emerging Data from Repeated Dosing (ReSPECT-LMM)” was presented by Andrew Brenner, M.D., Ph.D., of The University of Texas Health Science Center at San Antonio. The analysis included updated safety, activity, PK and dosimetry findings from the single-administration study, along with emerging data from the ongoing repeated-dosing program.
Key findings included:
In the ongoing repeated-dosing ReSPECT-LMM study, Cohort 1a cleared with no dose-limiting toxicities, with enrollment ongoing in additional cohorts.
PK showed rapid ( ̴24 hours) redistribution of drug within the CSF with clearance of the REYOBIQ from the lateral ventricle at a half-life of 1.7 hours. By clearing the ventricles quickly, drug remains available at high doses in the cerebral spinal fluid.
Bulk RNA-Seq demonstrated rapid ( ̴5 hours) induction of cell-death (apoptosis) genes, with peak activity occurring at 24 hours. Data promoting cell-death supports REYOBIQ’s established radiopharmaceutical mechanism of action and highlights its rapid onset target activity.

CNSide Cost-of-Care Analysis
The second poster, titled, “Economic Impact of Earlier Detection and Therapeutic Management of Leptomeningeal Metastases Using CNSide®: A Cost-of-Care Analysis,” was presented by Kelly Kreitzburg Ondrasek, Ph.D., Medical Science Liaison at CNSide Diagnostics. The analysis evaluated the potential economic and clinical impact of a CNSide-enabled care pathway incorporating earlier definitive LM diagnosis, targeted treatment, and quantitative disease monitoring. 
The model estimated average LM-related treatment costs of approximately $119,550 per month, or approximately $717,300 over six months. Under modeled scenarios incorporating earlier LM confirmation and optimized management, a CNSide-enabled pathway was estimated to reduce monthly LM-related costs by approximately 33-47%. 
About Cerenome
Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The Company’s CNSide® Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing. Its lead therapeutic platform, REYOBIQ™ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation. By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value, visit https://www.cerenome.com. 
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the timing and implementation of the Company’s revenue cycle management and clearinghouse services through XiFin, the timing of the commencement of billing and submission of the Company’s test backlog, the potential market for the CNSide CSF Assay, the timing in which the CNSide CSF Assay is commercially launched and commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates.
Investor Contact
CORE IR
IR@cerenome.com



What has me especially tempted is what we still haven’t heard from the symposium.
We know they brought in 3 individuals to speak, and I have a hard time believing Cerenome would include them if what they had to say wasn’t meaningful to the story being presented.
Then there are another 5 people involved beyond those 3. Who are they? Could some be patients or survivors? I honestly don’t know, and I’m not claiming they are. But considering we already know there are long term survivors in both the LM and GBM programs, it certainly has me wondering.
Add that to everything else happening with CNSide, LM, GBM and manufacturing, and I keep coming back to the same conclusion.
There is still risk here, but from where I’m sitting, there seem to be an awful lot of pieces lining up in a positive direction.
And yes, I’m seriously tempted to buy more. Possibly another 3K

Something interesting about the upcoming ABTA Annual Conference on September 18 to 20.
Cerenome has the ABTA conference listed on its own Events and Media calendar, yet there doesn’t appear to be any Cerenome presentation or participation publicly listed by ABTA yet.
What makes that interesting is the relationship already there.
ABTA has featured patient stories from BOTH REYOBIQ programs.
Jim Stockand is a recurrent GBM survivor who participated in ReSPECT GBM.
Dr. Marlyn Cabrera is an LM survivor who participated in ReSPECT LM.
These aren’t random stories either. The ABTA material was sponsored by Plus Therapeutics, now Cerenome.
So we have ABTA publicly highlighting a survivor from each of Cerenome’s 2 major REYOBIQ programs, and Cerenome now specifically listing the September ABTA conference on its corporate calendar.
Does that mean these patients will be involved in September? We don’t know, and I wouldn’t claim that. But I find the connection very interesting, especially since we still don’t know exactly what Cerenome’s participation at ABTA will involve.
Maybe it’s simply patient outreach and awareness. Maybe there’s more planned. Either way, I think it’s worth keeping an eye on.
I’m also expecting we could see the transcript tomorrow from last week’s SNO/ASCO CNS Metastases Symposium. I’m especially interested in the LM discussion and hearing exactly what the 3 independent guest speakers had to say. We have seen some of the information presented, but hearing the full discussion and perspectives from those 3 experts could provide a lot more context.
A few interesting pieces still waiting to fall into place.

No one seems to be very active on the new r/Cerenome community. It looks like most people would rather stay here than start over from scratch.
With nearly 1,000 members already here, along with years of valuable posts, DD, and discussions, I personally think it would be a shame to lose all of that history.
I’m going to try changing the display name to Cerenome once I have access to a desktop. Unfortunately, Reddit doesn’t allow the subreddit URL to be changed.
Ultimately, though, this community belongs to all of us. If you’d rather keep everything here and simply rebrand the community to Cerenome, let me know. If you think moving to a brand-new subreddit is the better option, I’d like to hear that too.
What do you think?

It’s encouraging to see PSTV/CNSY holding up while the broader market is under pressure. In my opinion, the market may be starting to price in the upcoming clinical catalysts and the progress the company has made over the past year. Time will tell, but the next several months should be very interesting.

https://stockanalysis.com/stocks/pstv/transcripts/699442-investor-update/

After going through the transcript, I think there were several important points that deserve more attention.

For me, the biggest takeaway is the REYOBIQ LM pathway and what the current trial is designed to accomplish.

Eric stated the current trial will position the company for either a follow on registration study or potential accelerated approval.

That statement is important.

This upcoming LM data is not just another clinical update. The goal is to generate the information needed to determine the next regulatory step. Earlier this year, after the FDA Type B meeting, the company also stated that the FDA indicated accelerated approval may be appropriate for the LM indication.

Of course, nothing is guaranteed and the FDA will decide based on the final data package, but the pathway being discussed is clear.

Look at what has been accomplished and what is being built around this:

• ReSPECT LM Phase 2 data expected Q3 2026 • FDA alignment planned following dose optimization results • Pivotal readiness remains a 2026 goal • REYOBIQ manufacturing scale up progressing in parallel • Second GMP manufacturing site added through SpectronRx • CNSide Diagnostics commercial expansion underway • New PLA code for CNSide active • CAP accreditation achieved • Medicare enrollment completed • Multiple national payer coverage wins • CNSide platform expansion planned with additional testing capabilities • AI strategy being integrated into the broader CNS oncology vision

This is what I think many are missing. The rebrand to Cerenome was not simply a name change. The company is trying to combine therapeutics, diagnostics, clinical data and AI into one CNS oncology platform.

REYOBIQ is the targeted radiotherapy side.

CNSide is the diagnostic and disease monitoring side.

AI has the potential to connect the data and improve decisions over time.

The company has also continued hiring experienced people, expanding manufacturing, building reimbursement infrastructure and preparing for later stage development.

Companies do not usually build all of these pieces if the plan is to stand still.

There is still risk. Clinical data needs to deliver. Regulatory decisions need to happen. Commercial execution matters.

But compare where the company was a year ago versus today. The foundation being built is much larger.

In my opinion, the next few months could be transformational as LM data arrives and the next FDA steps become clearer.

The June 30th business update call is becoming more interesting the deeper I dig.

Back on May 19, PSTV announced a partnership with Ephemeral Technologies to deploy an AI execution platform focused on CNS oncology. At the time, many investors seemed to overlook it.

Fast forward to today’s announcement and management mentions AI multiple times, including plans to discuss its “native artificial intelligence development plans.”

What stands out is that Marc Hedrick specifically identified the company’s 3 areas of focus as: 1. Diagnostics (CNSide) 2. Therapeutics (REYOBIQ) 3. Artificial Intelligence

That is a notable shift in messaging.

If AI is being integrated with CNSide’s growing database of CSF diagnostics, treatment response data, and patient outcomes, PSTV could be building something much larger than a standalone diagnostic or drug company.

The timing is also interesting:

• June 30 business update call • July 1 CNSide PLA code goes live • Q3 expected LM data update • August SNO ASCO CNS conference

I will be listening closely for any details on how AI connects CNSide diagnostics with REYOBIQ treatment decisions and outcome tracking.

The market already understands the diagnostics story and the radiotherapeutic story.

It may soon be learning about the AI story as well.

Does This Look Like the End of a Company?

TLDR: Over the last 11 to 12 months PSTV has completed LM Phase 1, advanced LM and GBM into ongoing Phase 2 development, held two Type B FDA meetings, received Orphan Drug Designation, secured Medicare enrollment, achieved CAP accreditation, expanded CNSide to 49 licensed states, obtained a PLA code and Category III CPT code, expanded payer coverage to approximately 81 million covered lives, added a second GMP manufacturing partner, received ISPOR Blue Ribbon recognition, strengthened its leadership team, and continued advancing both its therapeutic and diagnostic businesses.

Investors can debate valuation, timelines, dilution, and execution risk. However, the idea that the company has not made meaningful progress over the past year simply does not align with the record.

I originally put together a milestone summary several months ago. Given everything that has occurred since then, I thought it was worth revisiting and updating the list. If I’ve missed anything please don’t hesitate to chime in!

There has been a lot of discussion about share price performance, dilution, financing activity, and the reverse split. Those discussions are fair.

At the same time, it is also worth reviewing what the company has actually accomplished over roughly the last 11 to 12 months.

Phase 1 Clinical Results

ReSPECT LM Phase 1 successfully completed.

Established 44.1 mCi as the recommended Phase 2 dose.

Demonstrated favorable safety and tolerability.

No dose limiting toxicities observed at the recommended Phase 2 dose.

Presented data showing median overall survival substantially exceeding historical leptomeningeal metastases benchmarks.

Generated the clinical foundation supporting advancement into Phase 2 dose optimization and discussions regarding future pivotal development.

ReSPECT GBM Phase 1 successfully completed.

Demonstrated the ability to safely deliver high localized radiation doses directly into recurrent glioblastoma tumors.

Presented data showing a significant relationship between higher absorbed dose and improved survival outcomes.

Patients receiving greater than 100 Gy demonstrated median overall survival approaching 17 months compared with approximately 6 months in patients receiving less than 100 Gy.

One patient remained alive beyond 29 months at the time of presentation.

Generated the clinical rationale supporting continued advancement of the GBM program into Phase 2 development.

Clinical Development Progress

Advanced ReSPECT LM into the Phase 2 dose optimization portion of the trial.

Initiated multidose treatment evaluation in LM.

Expanded LM treated patient count to 37 patients.

Reported encouraging survival signals in LM patients.

Advanced GBM treated patient count to 53 patients.

Continued advancement toward completion of Phase 2 GBM enrollment.

Maintained progress in the pediatric brain cancer program supported through Department of Defense funding.

Regulatory Progress

Completed Type B FDA meetings in November 2025 and January 2026.

Received constructive FDA feedback regarding future development plans.

Discussed potential pivotal study framework.

Discussed overall survival as a primary endpoint.

Discussed accelerated approval considerations.

Received FDA Orphan Drug Designation for REYOBIQ in pediatric malignant gliomas.

Received expanded designation including progressive pediatric ependymoma.

Scientific Visibility

Presented clinical data at WFNOS.

Presented clinical data at SNO.

Maintained a presence at major neuro oncology conferences and scientific meetings.

CNSide Commercial Expansion

Expanded CNSide commercialization efforts.

Expanded CNSide state licensure footprint to 49 states.

Expanded institutional adoption.

Supported more than 120 cancer institutions.

Expanded commercial operations, customer support, and commercialization infrastructure.

Reimbursement and Market Access

Secured UnitedHealthcare coverage.

Secured Humana coverage.

Secured Highmark coverage.

Secured Blue Shield of California coverage.

Expanded covered lives to approximately 81 million.

Received a unique PLA code for CNSide.

Successfully enrolled CNSide Diagnostics as a Medicare clinical laboratory.

Received Medicare PTAN enrollment.

Health Economics

Completed economic analysis evaluating CNSide’s impact on LM care.

Presented findings at ISPOR.

Demonstrated potential healthcare cost reductions approaching 40 percent.

Received Blue Ribbon recognition for health economics research.

Strengthened the payer value proposition for CNSide.

Laboratory and Quality Systems

Maintained CLIA certification.

Achieved CAP accreditation.

Strengthened commercial credibility with providers, payers, and institutions.

Manufacturing and Supply Chain

Added SpectronRx as a second GMP manufacturing partner.

Expanded manufacturing capacity for REYOBIQ.

Improved supply chain redundancy.

Advanced manufacturing readiness for later stage development and potential commercialization.

Leadership and Organizational Expansion

Added Dr. Raphael Lis as Chief Medical Officer.

Importance: Strengthens clinical development, regulatory strategy, FDA engagement, and future pivotal study planning.

Added Ron Andrews to the Board of Directors.

Importance: Brings decades of diagnostics and molecular diagnostics leadership experience from major healthcare and diagnostics organizations, directly supporting CNSide commercialization and growth strategy.

Added Randy H. Goodman, PhD, MHA, as Vice President of Value Strategy and Health Economics & Outcomes Research.

Importance: Supports reimbursement strategy, payer adoption, health economics analysis, market access initiatives, and long term commercialization efforts.

Added Eric J. Daniels, MD, MBA, as Chief Development Officer.

Importance: Strengthens clinical development execution and supports advancement toward potential pivotal studies.

Expanded expertise across clinical development, diagnostics, reimbursement, market access, health economics, commercialization, and research.

Funding and Non Dilutive Support

Continued support from the 17.6 million dollar CPRIT grant for ReSPECT LM.

Continued National Cancer Institute support for ReSPECT GBM.

Continued support from the 3 million dollar Department of Defense grant for pediatric brain cancer development.

Corporate and Financial Progress

Completed public financing.

Strengthened the balance sheet.

Increased cash and investments to approximately 15.1 million dollars as of March 31, 2026.

Maintained funding for both clinical development and CNSide commercialization activities.

Corporate Milestones

Completed reverse split and regained Nasdaq compliance.

Maintained Nasdaq listing.

AMA approved Category III CPT code for convection enhanced delivery procedures used with REYOBIQ.

Category III CPT code becomes effective January 2027.

LM dose optimization data remains guided for Q3 2026.

GBM data remains guided for Q1 2027.

Bottom Line

The share price has clearly struggled.

Shareholders have every right to be frustrated with dilution, financing activity, the reverse split, and the stock’s performance.

Those concerns are legitimate.

At the same time, over the last 11 to 12 months the company has generated encouraging Phase 1 clinical data in both LM and GBM, advanced ongoing Phase 2 programs, completed multiple FDA interactions, secured Orphan Drug Designation, expanded payer coverage, enrolled with Medicare, achieved CAP accreditation, expanded manufacturing capacity, strengthened commercial readiness, added experienced industry leaders, and continued executing on both the therapeutic and diagnostic sides of the business.

Investors can debate valuation, timelines, financing decisions, and execution risk.

But the full picture should include both the stock performance and the operational milestones achieved during that same period.

That is quite a list of accomplishments for any company, let alone one with a market capitalization of roughly 30 million dollars.

I was checking the ReSPECT trial website and noticed both programs have been updated.

ReSPECT-LM (NCT07098806) increased from 36 to 37 patients treated.

ReSPECT-GBM (NCT01906385) increased from 51 to 53 patients treated.

That’s a combined increase of 3 treated patients since the last counts many of us were tracking.

Not a company press release. Not a headline. Just a quiet update directly from the trial website showing continued patient activity across both programs.

For anyone following PSTV closely, it’s another sign that enrollment and treatment activity continue to move forward while we wait for the next clinical update.

Always worth keeping an eye on the details!

Latest reported numbers show roughly 1.16M shares sold short against a float of only about 6.8M shares post split, putting short interest around the 17% to 19% range depending on the source.

What’s also interesting is that short interest has actually come down from the previous reporting period, yet it still remains very elevated relative to the float. That tells me bears have reduced some exposure, but there is still a meaningful short position sitting here.

The overall setup is what really stands out:

Small float Thin liquidity Elevated borrow costs Multiple clinical and reimbursement catalysts ahead And roughly a week or more to cover based on average volume

That combination can create serious pressure if momentum or unexpected news hits.

Meanwhile, the company continues advancing both sides of the platform:

CNSide expanding payer access and Medicare enrollment progress REYOBIQ continuing to advance through GBM and LM clinical development, with previously reported GBM survival data remaining a key area investors are watching.

Definitely an interesting setup developing here.

I was digging through the actual ISPOR presentation database and found more than just the original headline about up to 40% cost reduction.

This is where it gets interesting.

The presentation appears to frame CNSide not only around lowering healthcare costs, but also around improving patient outcomes and quality of life measurements used by payers. That matters because reimbursement discussions are not only about “does it work?” but also “does it improve care while lowering costs?”

Some points that stood out:

Up to 40% reduction in LM related healthcare costs

LM care costs can exceed $100,000 per month in advanced cases

Median inpatient admissions around $20,000

Discussion around QALY measurements which are commonly used in payer and reimbursement analysis

This is not new REYOBIQ efficacy data and this is not an OS update, so I want to be clear about that.

But if CNSide can potentially improve detection, reduce healthcare burden, and support better patient outcomes, that starts becoming a broader commercialization story rather than simply a diagnostic test story.

Clinical data moves stocks. Reimbursement and adoption can build businesses.

Just my thoughts after digging through the ISPOR material.

Source / ISPOR presentation:

https://www.ispor.org/heor-resources/presentations-database/presentation-cti/ispor-2026/poster-session-1-4/economic-impact-of-earlier-detection-and-therapeutic-management-of-leptomeningeal-metastases-using-cnside-a-cost-of-care-analysis

CNSide keeps advancing commercially. Medicare enrollment is now complete, they secured the PLA billing code, added Blue Shield of California, and are now at roughly 81M covered lives. They also reaffirmed the goal of exceeding 150M covered lives in 2026. That side of the business is clearly moving forward.

REYOBIQ also continues progressing across LM, GBM, and pediatric brain cancer.

One thing that really stood out to me was the FDA Orphan Drug Designation update. PSTV originally requested designation for pediatric malignant gliomas, but the FDA actually broadened the designation beyond what the company requested to also include progressive pediatric ependymoma.

That is not something the FDA had to do.

To me, that suggests the agency may see broader potential applicability for REYOBIQ across pediatric CNS tumors and highlights the level of unmet need in these indications. It does not guarantee approval obviously, but I do think it was an important detail in the release that Some people may overlook.

They also continue scaling manufacturing with SpectronRx added as a second GMP site. Small biotechs usually do not invest heavily into commercial manufacturing readiness unless they believe they have a real path forward.

The company also reaffirmed constructive FDA feedback and continued pivotal-trial readiness language.

Most importantly in my opinion: LM data is expected in Q3 2026.

If LM shows strong survival improvement again, I think the market could begin seriously re-rating PSTV well before GBM data even arrives. A move back above the $9.50 warrant level would obviously become a major point of interest because warrant exercises could potentially bring in substantial additional capital, potentially extending runway further into 2027 without the company immediately needing another financing.

Cash burn is still real of course. Operating expenses increased as they expanded CNSide commercialization and continued Phase 2 execution. This is still a clinical-stage biotech, so execution matters.

GBM timing also appears to have shifted slightly from prior expectations. Earlier investor expectations were leaning toward late 2026 data, while today’s release now guides GBM data into Q1 2027. Personally, I do not view that as thesis-breaking, but it is fair to acknowledge it.

Overall though, today’s update still looked more like a company actively building toward commercialization and pivotal readiness rather than one slowing down.

People are starting to miss the bigger picture here.

Look at what is already being shown with REYOBIQ.

For recurrent GBM, historical therapies such as bevacizumab based approaches have often shown median overall survival in roughly the 7 to 10 month range, while PSTV has already reported approximately 17 months median overall survival in patients receiving ≥100 Gy. That is approaching 2x historical survival ranges and is not something you casually ignore.

Now look at LM.

LM is one of the most devastating CNS conditions with historical survival often around 2 to 6 months, and PSTV has already reported approximately 9 months median overall survival at the recommended Phase 2 dose. Depending on the comparison used, that represents a meaningful improvement versus historical outcomes.

And here is the part many seem to overlook…

This is not even including the ongoing Phase 2 strategy involving multiple doses.

The GBM data discussed above came from earlier findings, and LM has moved into a multidose design intended to optimize therapeutic exposure. Nobody can claim improved survival yet because the data still has to mature, but if increased and sustained exposure translates into better outcomes, the upside becomes very interesting.

Then add everything else around it:

CNSide reimbursement progress

Medicare enrollment progress

Manufacturing scale up already underway

FDA discussions involving overall survival and accelerated approval pathways

Diagnostics and therapeutics under one roof

At some point the discussion changes from “Can PSTV survive?” to “How big can PSTV become if the data continues holding up?”

Not financial advice. Just connecting publicly available information.