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$(TM)$ 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$(R)$ 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(TM) (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(R), designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide(R) 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
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 Six Months Ended June
30, 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