u/Zestyclose_Yak3051

Secures In-Network Agreement with Florida Blue for CNSide® CSF Tumor Cell Enumeration and Molecular Profile Tests

First CNSide payer agreement to include CNSide’s new CSF Molecular Profile tests alongside tumor cell enumeration

Expands CNSide contracted payer access to approximately 164 million covered lives

HOUSTON, Oct. 08, 2026 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Cerenome, Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”), announced today that it has entered into an in-network ancillary provider agreement with Blue Cross and Blue Shield of Florida, Inc. (Florida Blue), effective October 1, 2026.

The agreement establishes contracted reimbursement for the CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration test as well as CNSide® CSF Molecular Profile tests for solid tumors and hematologic malignancies involving the central nervous system. It is the first CNSide payer agreement to include both tumor cell enumeration and molecular profiling.

The Florida Blue agreement adds approximately 6 million covered lives to CNSide’s contracted payer footprint. Combined with previously announced payer agreements, CNSide has now established in-network agreements representing approximately 164 million commercial and Medicare Advantage covered lives, reflecting continued execution of the Company’s national reimbursement strategy.

“This agreement with Florida Blue represents an important milestone in CNSide’s commercial trajectory,” said Marc Hedrick, M.D., Cerenome’s President and Chief Executive Officer. “By expanding contracted reimbursement to both cellular and molecular CSF testing, we are advancing CNSide as a broader CSF diagnostics platform for CNS oncology, combining tumor-cell analysis and molecular profiling to better characterize and monitor cancers involving the central nervous system.”

The Florida Blue agreement expands the scope of CNSide’s contracted reimbursement beyond tumor cell detection in leptomeningeal metastases to include molecular profiling of CNS malignancies. CNSide® CSF Molecular Profile - Solid Tumor provides DNA and RNA molecular profiling of CSF for patients with suspected or confirmed primary CNS tumors or solid tumors metastatic to the CNS, including brain and leptomeningeal metastases. CNSide® CSF Molecular Profile - Hematologic Malignancy provides DNA and RNA molecular profiling of CSF for patients with suspected or confirmed hematologic malignancies involving the CNS. CNSide® CSF Molecular Profile tests are now commercially available through CNSide.

The DNA and RNA CSF molecular profiling approach underlying CNSide® CSF Molecular Profile was recently evaluated in a peer-reviewed, real-world study of 1,391 evaluable CSF specimens from patients being evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS, published in The Journal of Liquid Biopsy.

The clinical utility of CNSide CSF tumor cell analysis in leptomeningeal metastases is supported by evaluation in 12 peer-reviewed publications, prospective multicenter evidence from the FORESEE clinical study, and real-world clinical experience. Since 2020, more than 11,000 CNSide® tests have been performed at more than 120 U.S. cancer institutions, supporting clinical decision-making across academic and community oncology practices nationwide.

About Florida Blue Driven by its mission of helping people and communities achieve better health, Florida Blue is the leading health insurer in Florida, and part of GuideWell, a not-for-profit health solutions company. Florida Blue offers a range of health plans and personalized care programs for individuals, families, businesses of all sizes, and Medicare beneficiaries. For over 80 years, the organization has been member centric and committed to making health care as accessible and affordable as possible. Serving more than six million members across all 67 Florida counties, Florida Blue has more than 7,000 employees, is headquartered in Jacksonville, Fla., is owned by its policyholders, and is an independent licensee of the Blue Cross Blue Shield Association.

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u/Zestyclose_Yak3051 — 7 days ago

Cerenome Expects $1.55 Million in CNSide® Third Quarter Gross Billings

Lead test on track for 200 million covered lives and beneficiaries by early 2027 after CMS meeting

On track to launch expanded CNSide testing menu with multiple tests in Q4 2026

HOUSTON, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company") today provided a third quarter 2026 business update for its wholly owned subsidiary, CNSide Diagnostics, LLC, highlighting gross payer billings, progress on Medicare coverage of its Tumor Cell Enumeration Test (TCE Test) and the expansion of the CNSide testing menu.

"Over the past few months, we have built the foundation of a reimbursed diagnostics business including clinical evidence, payer contracts, a dedicated billing code, positive CMS Medicare coverage progress, laboratory accreditation and billing infrastructure," said Russell Bradley, President and General Manager of CNSide Diagnostics. "We are on track to continue that progress across multiple areas of the business for the remainder of the year, and our team is excited about the future of CNSide."

Third Quarter 2026 CNSide Highlights:

Coverage Expansion: CNSide’s lead test, the TCE Test, now stands at 158 million contracted covered lives and is on track to begin 2027 with approximately 200 million covered lives and beneficiaries Medicare Coverage: CNSide received a favorable preliminary CMS pricing decision for CNSide PLA code 0640U with a January 1, 2027 target effective date Payer Billing: In Q3 2026, CNSide billed 222 tests representing $1.55 million of unaudited gross billings, with initial cash collections anticipated in Q4 2026 Total Test Volume: CNSide remains on track to meet or exceed an annualized run rate of 1,250 total tests in Q4 2026 Cerebrospinal Fluid Test Menu: CNSide is launching the CSF Molecular Profile Test and multiple CNSide Breast Cancer Protein Expression Assays in Q4 2026 2026 Annualized Billing Rate: CNSide is on track to achieve an annualized gross billing run rate of approximately $10 million to $12 million in Q4 2026 based on list pricing, an expanded test portfolio, and continued growth in adoption

Management to Host Conference Call and Webcast Today Management will host a conference call and webcast today at 8:30 a.m. Eastern Time to provide greater detail on CNSide diagnostics and plans for the remainder of the year. A replay will be available following the call in the Investor Relations section of the Company's website at ir.cerenome.com.

Date Wednesday, September 30, 2026 Time 8:30 a.m. Eastern Time Webcast Click here to access the webcast Dial-in (U.S./Canada) 877-270-2148 Dial-in (International) 412-902-6510 Basis of Presentation: Preliminary Results, Gross Billings and Run-Rate Figures The preliminary third-quarter gross billings figure is based on management's review of claims submitted through September 30, 2026, is subject to completion of financial close procedures and review by the Company's independent registered public accounting firm, and may differ materially from final results. "Gross billings" is an operating metric representing charges for CNSide tests submitted to payers at the Company's list prices; it is not revenue under U.S. GAAP and does not indicate amounts that will be collected. Revenue is recognized under ASC 606 net of contractual allowances and implicit price concessions and is expected to be substantially lower than gross billings. Run-rate figures apply list prices to the Company's 1,250 total annualized test order goal and historical order rates under the platform's prior owner, and assume the CNSide CSF Molecular Profile Test and CNSide Breast Cancer Protein Expression Assays launch as planned and are ordered at those rates. CNSide order rates may differ. Existing CPT codes do not establish coverage or payment for these assays on cerebrospinal fluid. Run-rate figures are not forecasts of revenue, gross billings, or collections for any period.

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u/Zestyclose_Yak3051 — 15 days ago

Cerenome Reports Seconda Quarter 2026

Cerenome Reports Second Quarter 2026 Financial Results and Business Update August 14, 2026 PDF Version HOUSTON, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence, today announced financial results for the second quarter ended June 30, 2026, and provided an overview of recent and upcoming business highlights.

"Our team made substantial progress this quarter in advancing our integrated CNS oncology platform including a full repositioning and rebranding of the Company," said Marc H. Hedrick, M.D., M.B.A., Cerenome President and Chief Executive Officer. "For the remainder of the year, I expect the progress to accelerate across all verticals, highlighted by our buildout of the diagnostic commercial organization."

Q2 2026 AND RECENT HIGHLIGHTS

Corporate

Rebranded from Plus Therapeutics, Inc. to Cerenome, Inc., effective August 3, 2026, with the Company’s common stock trading on the Nasdaq Capital Market under the ticker symbol “CNSY” REYOBIQ™ Development

Continued enrollment in the ReSPECT-LM multiple-dose clinical trial. As of June 30, 2026, approximately one-third of patients had been enrolled, with no dose-limiting toxicities observed to date, supporting the development of a recommended Phase 2 dose/dosing regimen by year-end Continued enrollment in the ReSPECT-GBM Phase 2 trial. Current enrollment rates indicate full enrollment in 2026 followed by a data readout and a subsequent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) Initial site activation of the ReSPECT-PBC pediatric brain cancer Phase 1 trial at Lurie Children’s Hospital. First dosing expected in the third quarter of 2026. Continued commercial-level manufacturing scale-up and supply chain enhancement for REYOBIQ drug supply CNSide® CSF Assay Platform

Performed 232 CNSide cerebrospinal fluid tests during the first half of 2026 and continued to grow the number of ordering providers and institutions Achieved the 2026 corporate objective for contracted commercial payer coverage of 150 million covered lives by mid-year Received Medicare Provider Transaction Access Number and dedicated American Medical Association billing identifier for CNSide Partnered with Genomic Testing Cooperative to integrate next-generation sequencing into the CNSide platform Achieved College of American Pathology or CAP accreditation, the gold standard in laboratory quality assurance, for Cerenome’s CLIA laboratory in Houston, TX Partnered with Xifin, Inc., the market leader in artificial intelligence enabled revenue cycle management for diagnostic providers, to serve as our billing and clearinghouse partner Data & Artificial Intelligence

Partnered with Ephemeral Technologies to develop native artificial intelligence, a corporate operating system and data infrastructure designed to integrate therapeutic, diagnostic and bioinformatic data sets and to facilitate advanced data analytics and machine learning across Cerenome’s CNS oncology platform SECOND QUARTER 2026 FINANCIAL RESULTS

Cash, cash equivalents and investments were $8.6 million as of June 30, 2026 and December 31, 2025 Recognized $0.4 million in grant revenue from CPRIT for the advancement of REYOBIQ in LM in the second quarter of 2026, compared with $1.4 million in grant revenue from CPRIT for the same program in the second quarter of 2025 Operating loss for the second quarter of 2026 was $9.1 million, compared with an operating loss of $1.5 million for the second quarter of 2025. The change primarily reflects expansion of CNSide commercial operations and continued funding of the REYOBIQ Phase 2 trial Net loss for the second quarter of 2026 was $9.0 million, or $1.31 per basic share, compared with net income of $5.2 million, or $0.62 per basic share, for the second quarter of 2025, which included a $6.5 million change in fair value of derivative instruments AFFIRMED ANTICIPATED MILESTONES AND OUTLOOK FOR 2026

The Company is affirming the milestone framework and outlook it provided when reporting full-year 2026 financial results, as follows:

REYOBIQ Clinical Program

Define the optimal dose/dosing interval for REYOBIQ in Leptomeningeal Metastases Complete enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma; data is expected in Q1 2027, followed by an End-of-Phase 2 meeting with the FDA Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial Complete commercial manufacturing scale-up for REYOBIQ CNSide Commercial Rollout

Expand U.S. commercial payer coverage beyond 150 million covered lives Secure Medicare coverage and reimbursement Achieve an annualized run-rate of test orders exceeding 1,250 Expand the CNSide assay platform to include a comprehensive portfolio of clinically relevant tests for patients at risk for CNS cancers

About Leptomeningeal metastases (LM) Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ™ (rhenium Re186 obisbemeda) REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program.

About CNSide Diagnostics, LLC CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.

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 and 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.

Forward-Looking Statements This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. 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," "anticipate," "intend," "believe," "estimate," "will," 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. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company's ability to maintain the listing of its common stock on Nasdaq; the success of the new rebrand; expectations pertaining to 2026 milestones, its platform and its data strategy; the results of the Company's research and development activities, including uncertainties relating to the continued clinical trials of its product candidates and therapies, and the timing and outcome of the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-PBC trials; the Company's liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company's partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions and product performance; challenges associated with radiotherapeutic manufacturing, production, and distribution capabilities necessary to support the Company's clinical trials and any commercial level product demand; and the continued success of CNSide CSF Assay, 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. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Cerenome discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, Quarterly Report on Form 10-Q for the three months ended March 31, 2026, and Current Reports on Form 8-K. These filings are available for review through the SEC's website at www.sec.gov. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations, and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact CORE IR investor@cerenome.com

(Financial Tables follow)

CERENOME, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (in thousands, except share and par value data) June 30, 2026 December 31, 2025 Assets Current assets: Cash and cash equivalents $ 2,366 $ 4,256 Restricted cash and cash equivalents — 4,502 Investments 6,221 4,356 Grant receivable 1,761 322 Other current assets 1,423 1,734 Total current assets 11,771 15,170 Property and equipment, net 1,409 257 Operating lease right-of-use assets 43 70 Goodwill 372 372 Intangible assets, net 265 333 Other assets 170 123 Total assets $ 14,030 $ 16,325 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable and accrued expenses $ 7,550 $ 5,920 Investor liability pursuant to Letter Agreement — 4,502 Operating lease liability 44 56 Deferred grant liability 927 927 Line of credit — 750 Other liabilities 46 159 Total current liabilities 8,567 12,314 Noncurrent operating lease liability — 15 Total liabilities 8,567 12,329 Commitments and contingencies (Note 8) Stockholders’ equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively — — Common stock, $0.001 par value; 2,000,000,000 shares authorized; 7,320,345 and 5,557,371 shares issued as of June 30, 2026 and December 31, 2025, respectively; 7,310,008 and 5,547,034 shares outstanding as of June 30, 2026 and December 31, 2025, respectively 7 6 Treasury stock (at cost), 10,337 shares as of June 30, 2026 and December 31, 2025, respectively (500 ) (500 ) Additional paid-in capital 537,773 520,355 Accumulated deficit (531,817 ) (515,865 ) Total stockholders’ equity 5,463 3,996 Total liabilities and stockholders’ equity $ 14,030 $ 16,325

CERENOME, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Grant revenue $ 411 $ 1,390 $ 1,439 $ 2,449 Operating expenses: Research and development 4,265 1,246 7,130 3,002 General and administrative 5,203 1,682 10,485 4,521 Total operating expenses 9,468 2,928 17,615 7,523 Operating loss (9,057 ) (1,538 ) (16,176 ) (5,074 ) Other income (expense): Interest income 56 27 246 28 Interest expense (5 ) — (22 ) (548 ) Financing expenses — 150 — (3,061 ) Warrant issuance costs — — — (964 ) Change in fair value of derivative instruments — 6,512 — (2,631 ) Total other income (expense) 51 6,689 224 (7,176 ) Net income (loss) $ (9,006 ) $ 5,151 $ (15,952 ) $ (12,250 ) Per share information Net income (loss) per share of common stock – basic $ (1.31 ) $ 0.62 $ (2.36 ) $ (12.54 ) Weighted average number of shares of common stock outstanding – basic 6,898,804 1,935,554 6,773,125 976,885 Net income (loss) per share of common stock – diluted $ (1.31 ) $ (0.16 ) $ (2.36 ) $ (12.54 ) Weighted average number of shares of common stock outstanding – diluted 6,898,804 8,366,199 6,773,125 976,885

CERENOME, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands) Six Months Ended June 30, 2026 2025 Cash flows from operating activities: Net loss $ (15,952 ) $ (12,250 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 233 223 Stock-based compensation expense 1,852 300 Noncash financing expenses — 3,061 Noncash interest expense 22 — Change in fair value of derivative instruments — 2,631 Accretion of discount on short-term investments (15 ) (22 ) Operating lease right-of-use asset amortization 27 44 Gain on sale of assets — (16 ) Increases (decreases) in cash caused by changes in operating assets and liabilities: Grant receivable (1,439 ) (450 ) Other assets 264 (265 ) Accounts payable and accrued expenses 1,778 (5,181 ) Change in operating lease liabilities (27 ) (45 ) Other liabilities (113 ) — Net cash used in operating activities (13,370 ) (11,970 ) Cash flows from investing activities: Purchases of property and equipment (1,317 ) (10 ) Proceeds from sale of property and equipment — 30 Purchase of short-term investments (14,049 ) (7,756 ) Sales of short-term investments 7,765 — Redemption of short-term investments 4,434 6,662 Net cash used in investing activities (3,167 ) (1,074 ) Cash flows from financing activities: Proceeds from credit facility 1,000 — Repayment of credit facility (1,772 ) (3,292 ) Proceeds from issuance of notes payable and warrants — 3,738 Repayment of notes payable — (3,703 ) Proceeds from sale of common stock, pre-funded warrants and warrants — 15,001 Proceeds from exercise of warrants — 882 Proceeds from sale of common stock under Lincoln Park Purchase Agreement — 2,795 Proceeds from underwritten public offering 15,000 — Proceeds from Distribution Agreement 1,853 — Payments for commissions and offering costs from Distribution Agreement (71 ) — Payment to investors pursuant to Letter Agreement (4,502 ) — Offering costs for sale of common stock (1,363 ) (220 ) Net cash provided by financing activities 10,145 15,201 Net change in cash and cash equivalents (6,392 ) 2,157 Cash, restricted cash and cash equivalents at beginning of period 8,758 76 Cash, restricted cash and cash equivalents at end of period $ 2,366 $ 2,233 Supplemental disclosure of cash flows information: Cash paid during period for: Interest $ — $ 539 Supplemental schedule of non-cash investing and financing activities: Exchange of warrants for notes payable $ — $ 3,694 Redemption of notes by issuance of common stock, pre-funded warrants and warrants $ — $ 3,512 Unpaid offering cost $ 104 $ 252

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u/Zestyclose_Yak3051 — 2 months ago

Pstv-Cerenome

Leave comments on Pstv's latest post asking them to share monthly updates on the number of Cnside tests and whether or not they are making progress toward commercialization 👍

u/Zestyclose_Yak3051 — 4 months ago