Aug 14, 2026, 4:21 PM ETHealthcare
Cerenome — Second Quarter 2026 Earnings Summary
Financial Performance
- Cash, cash equivalents, and investments totaled $8.6 million as of June 30, 2026, unchanged from December 31, 2025.
- Grant revenue recognized in Q2 2026 was $0.4 million from CPRIT, a decrease from $1.4 million in the same period of 2025.
- Operating loss for Q2 2026 was $9.1 million, compared to an operating loss of $1.5 million in Q2 2025; the increase is attributed to the expansion of CNSide commercial operations and continued funding of the REYOBIQ Phase 2 trial.
- Net loss for Q2 2026 was $9.0 million ($1.31 per basic share), compared to net income of $5.2 million ($0.62 per basic share) in Q2 2025, which included a $6.5 million gain from the change in fair value of derivative instruments.
- For the six months ended June 30, 2026, total operating expenses were $17.6 million, with Research and Development at $7.1 million and General and Administrative at $10.5 million.
- Net loss for the six months ended June 30, 2026, was $16.0 million ($2.36 per basic share), compared to a net loss of $12.3 million ($12.54 per basic share) for the same period in 2025.
- Net cash used in operating activities for the six months ended June 30, 2026, was $13.4 million, compared to $12.0 million in the prior year period.
- Net cash provided by financing activities for the six months ended June 30, 2026, was $10.1 million, primarily driven by a $15.0 million underwritten public offering and $1.0 million proceeds from a credit facility, offset by a $4.5 million payment to investors pursuant to a Letter Agreement.
- Total assets were $14.0 million as of June 30, 2026, down from $16.3 million as of December 31, 2025; total liabilities were $8.6 million, down from $12.3 million.
- Stockholders' equity increased to $5.5 million as of June 30, 2026, from $4.0 million as of December 31, 2025.
Guidance and Future Outlook
- The Company affirmed its 2026 milestone framework and outlook.
- REYOBIQ Clinical Program: Expect to define the optimal dose/dosing interval for REYOBIQ in Leptomeningeal Metastases; complete enrollment in the ReSPECT-GBM Phase 2 trial with data expected in Q1 2027 followed by an FDA End-of-Phase 2 meeting; begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial; and complete commercial manufacturing scale-up.
- CNSide Commercial Rollout: Expect to 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; and expand the CNSide assay platform to include a comprehensive portfolio of clinically relevant tests for patients at risk for CNS cancers.
Business Segments and Product Lines
- Corporate: Rebranded from Plus Therapeutics, Inc. to Cerenome, Inc., effective August 3, 2026, with trading under the Nasdaq ticker "CNSY".
- REYOBIQ Development: Continued enrollment in the ReSPECT-LM multiple-dose clinical trial with approximately one-third of patients enrolled as of June 30, 2026, and no dose-limiting toxicities observed; continued enrollment in the ReSPECT-GBM Phase 2 trial with full enrollment expected in 2026; initial site activation of the ReSPECT-PBC pediatric brain cancer Phase 1 trial at Lurie Children's Hospital with first dosing expected in Q3 2026; and continued commercial-level manufacturing scale-up and supply chain enhancement.
- CNSide® CSF Assay Platform: Performed 232 CNSide cerebrospinal fluid tests during the first half of 2026; achieved the 2026 corporate objective for contracted commercial payer coverage of 150 million covered lives by mid-year; received a Medicare Provider Transaction Access Number and a dedicated American Medical Association billing identifier; partnered with Genomic Testing Cooperative to integrate next-generation sequencing; achieved College of American Pathology (CAP) accreditation for the Houston, TX CLIA laboratory; and partnered with Xifin, Inc. as a 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.
Market and Competitive Landscape
- Leptomeningeal metastases (LM) affect 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 with limited effective treatment options.
- REYOBIQ is being evaluated for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC trials, respectively.
- The ReSPECT-GBM trial is supported by an award from the National Cancer Institute (NCI); the ReSPECT-LM trial is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT); and the ReSPECT-PBC trial is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program.
Risks and Challenges
- Risks include the ability to maintain the listing of common stock on Nasdaq, the success of the new rebrand, and the achievement of 2026 milestones.
- Uncertainties exist regarding the results of research and development activities, including the timing and outcome of the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-PBC trials.
- The Company faces risks related to its liquidity position, capital resources, and ability to raise additional cash.
- Challenges include the success of partnering/licensing efforts, regulatory requirements, market conditions, and manufacturing, production, and distribution capabilities for radiotherapeutics.
- Future performance depends on the continued success of the CNSide CSF Assay, revenue expectations, reimbursement support, and the development utility of the assay.
Management Commentary and Tone
- Marc H. Hedrick, M.D., M.B.A., President and CEO, stated the team made substantial progress in advancing the integrated CNS oncology platform, including a full repositioning and rebranding.
- Management expects progress to accelerate across all verticals for the remainder of the year, highlighted by the buildout of the diagnostic commercial organization.
Other Key Points
- The Company completed an underwritten public offering raising $15.0 million during the six months ended June 30, 2026.
- The Company paid $4.5 million to investors pursuant to a Letter Agreement during the six months ended June 30, 2026.
- The Company drew $1.0 million on a credit facility and repaid $1.77 million during the six months ended June 30, 2026.
- Stock-based compensation expense was $1.9 million for the six months ended June 30, 2026, compared to $0.3 million in the prior year period.
- The number of common shares outstanding increased to 7,310,008 as of June 30, 2026, from 5,547,034 as of December 31, 2025.