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NeOnc Provides Business Update and Reports Q1 2026 Financial Results

(Positive)
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NeOnc Technologies (Nasdaq:NTHI) reported Q1 2026 results and key clinical milestones. Phase 1 for NEO212 is complete with a 610 mg recommended Phase 2 dose and early signs of possible clinical activity. NEO100 Phase 2a in recurrent IDH1‑mutant high‑grade glioma is fully enrolled, with an interim readout expected around August 2026.

NeOnc raised a PIPE financing anchored by a $10 million Cinctive Capital commitment and had $138,601 in cash at March 31, 2026, plus a $10 million undrawn credit line, which is expected to fund operations into September 2026. Q1 2026 net loss was $8.8 million ($(0.38) per share), including $2.7 million in non‑cash stock‑based compensation, implying non‑GAAP normalized cash operating expenses of about $6.1 million.

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Positive

  • Phase 1 NEO212 completed; Phase 2 dose set at 610 mg
  • NEO100 Phase 2a fully enrolled; interim data expected August 2026
  • PIPE financing anchored by $10 million Cinctive Capital commitment
  • Cash, PIPE, and credit line expected to fund operations into September 2026
  • Q1 2026 net loss $8.8 million vs. $32.3 million in Q1 2025
  • Non-GAAP normalized cash operating expenses about $6.1 million for Q1 2026

Negative

  • Cash and cash equivalents only $138,601 at March 31, 2026
  • Operating runway currently projected only into September 2026
  • Q1 2026 net loss of $8.8 million, or $(0.38) per share
  • R&D expenses increased to $1.29 million from $0.99 million year over year

News Market Reaction – NTHI

-2.91%
1 alert
-2.91% Session close to close
$145.80M Market Cap
0.4x Rel. Volume

In the May 18 session, NTHI declined 2.91%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines NEO212’s transition to a 610 mg Phase 2 dose, encouraging NEO100 efficacy...
Analysis

This announcement combines NEO212’s transition to a 610 mg Phase 2 dose, encouraging NEO100 efficacy signals of 24% remission and 44% six‑month PFS, and added capital from a $10M PIPE plus an effective resale shelf. At the same time, Q1 2026 showed an $8.8M net loss and cash of just $138,601. Investors may watch upcoming FDA interactions, interim NEO100 data, and additional financing steps.

Key Figures

NEO212 RP2D: 610 mg Radiographic remission: 24% Six-month PFS: 44% +5 more
8 metrics
NEO212 RP2D 610 mg Recommended Phase 2 dose from completed Phase 1 dose escalation
Radiographic remission 24% Previously reported rate in NEO100 recurrent high-grade glioma study
Six-month PFS 44% Previously reported six-month progression-free survival for NEO100
PIPE commitment $10 million Anchoring PIPE financing from Cinctive Capital Management
Cash & equivalents $138,601 Balance as of March 31, 2026
Undrawn credit line $10 million Undrawn line of credit available to support operations
Q1 2026 net loss $8.8 million Compared with $32.3 million net loss in Q1 2025
Non-cash stock comp $2.7 million Portion of Q1 2026 net loss from stock-based compensation

Previous Earnings Reports

4 past events · Latest: Apr 14 (Positive)
Same Type Pattern 4 events
Date Event Sentiment 24h Move Catalyst
Apr 14 2025 results context Positive +1.7% Insider purchases plus context on 2025 losses, charges, and cash runway.
Apr 01 Q4 2025 results Negative -13.1% Q4 net loss widened despite clinical progress and PIPE financing disclosure.
Nov 14 Q3 2025 update Positive -12.3% Strategic partnership, NIH grants, and FDA go-ahead for NEO212 Phase II.
Aug 19 Q2 2025 results Neutral -3.2% New $50M partnership and NIH grant alongside higher expenses and net loss.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings updates often mix clinical progress and financing with persistent losses; historically, reactions skew slightly negative with occasional positive alignment when updates emphasize partnerships or insider buying.

Recent Company History

Across recent earnings events since Aug 2025, NeOnc repeatedly paired CNS oncology progress with financing moves. Prior releases highlighted a $50M Quazar strategic partnership, $2.5M NIH grants, FDA authorization for a NEO212 Phase II trial, and insider purchases. However, net losses remained sizable. Today’s Q1 2026 update continues this pattern, emphasizing NEO212 Phase 1 completion, NEO100 Phase 2a status, and a PIPE anchored by $10M while still reporting a substantial quarterly loss.

Key Terms

phase 2a, phase 1, type b end-of-phase 1 meeting, accelerated approval, +3 more
7 terms
phase 2a medical
"NEO100, our fully enrolled Phase 2a study in recurrent IDH1-mutant high-grade glioma"
Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.
phase 1 medical
"We successfully completed the Phase 1 dose-escalation portion of NEO212"
Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.
type b end-of-phase 1 meeting regulatory
"request a Type B End-of-Phase 1 meeting with the FDA"
A Type B end-of-Phase 1 meeting is a formal checkpoint between a drug developer and a regulatory agency (such as the U.S. Food and Drug Administration) held after first-in-human safety studies to review results and agree on the plan for the next clinical stage. For investors it matters because this meeting can clarify whether a program can advance, what additional testing or changes are required, and how soon costly Phase 2 trials and potential value-driving milestones will occur—like a go/no‑go review that shapes timetable, cost, and risk.
accelerated approval regulatory
"evaluate potential pathways toward accelerated regulatory review"
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
pipe financing financial
"Operationally, we strengthened our balance sheet through a PIPE financing"
Pipe financing is a way for companies to raise money quickly by selling new shares or bonds directly to investors, often before their stock is publicly traded or in the early stages of a project. It’s similar to a company securing a loan from investors, providing quick capital needed for growth or operations. For investors, it can offer opportunities for early involvement and potentially higher returns, but it may also carry increased risk due to the immediate nature of the deal.
fast-track regulatory
"advancing under FDA Fast-Track and Investigational New Drug (IND) status"
A fast-track designation is a regulatory status granted to a potential medical product that aims to speed up development and review because it could address an unmet medical need. For investors, it means the company may reach approval milestones and market access sooner than usual — like getting a VIP pass through airport lines — which can reduce time, cost and risk in bringing a product to patients and revenue.
investigational new drug (ind) regulatory
"advancing under FDA Fast-Track and Investigational New Drug (IND) status"
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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CALABASAS, Calif., May 18, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company advancing two Phase 2 programs in central nervous system (CNS) cancers, today announced financial results for the first quarter ended March 31, 2026, and provided an update on recent operational achievements and upcoming milestones.

Amir Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented:

“The first quarter of 2026 marked a transformational period for NeOnc as we advanced both of our lead clinical programs toward important regulatory and value-creation milestones. We successfully completed the Phase 1 dose-escalation portion of NEO212 and established 610 mg as the recommended Phase 2 dose. Importantly, we observed encouraging early signs of clinical activity and potential durable disease stabilization in heavily pretreated recurrent GBM and brain metastasis patients, despite the study being primarily designed to evaluate safety.

We are now preparing to request a Type B End-of-Phase 1 meeting with the FDA to align on the design of a potentially pivotal registrational Phase 2 study and evaluate potential pathways toward accelerated regulatory review.

For NEO100, our fully enrolled Phase 2a study in recurrent IDH1-mutant high-grade glioma continues progressing toward an anticipated interim data readout later this year. Previously reported results, including a 24% radiographic remission rate, 44% six-month progression-free survival, and the absence of significant toxicity, continue to reinforce our confidence in the therapeutic potential of NEO100 as we approach this important milestone.

Operationally, we strengthened our balance sheet through a PIPE financing anchored by a $10 million commitment from Cinctive Capital, expanded our executive leadership team with the appointment of David Choi as Chief Accounting Officer, and continued advancing our Middle East strategic initiatives through NuroMENA.

We believe the anticipated FDA engagement for NEO212 and the upcoming NEO100 interim data readout position NeOnc for what could become one of the most significant periods of clinical and strategic inflection in the Company’s history. My conviction in NeOnc’s long-term opportunity and clinical direction is reflected in my recent open-market purchase of more than $500,000 of NTHI shares.”

First Quarter and Recent Highlights

Clinical Milestones & Data

  • NEO212 — Phase 1 Complete, Recommended Phase 2 Dose (RP2D) Set at 610 mg:
    • Early signs of possible clinical efficacy, including potential durable disease control in heavily pretreated recurrent GBM and brain metastasis patients, observed even within the safety-focused phase
    • The company intends to request a Type B End-of-Phase 1 FDA meeting to align on a potential pivotal, registrational Phase 2 study
    • Exploring an Accelerated Approval pathway
  • NEO100 — Phase 2a Fully Enrolled: Phase 2a trial for IDH1-mutant recurrent high-grade glioma, with an interim data readout expected in approximately August 2026.

Strengthening Leadership & Securing Growth Capital

  • PIPE Financing: Raised a PIPE investment anchored by a $10 million commitment from Cinctive Capital Management, strengthening the balance sheet to advance clinical priorities.
  • Cash Position: As of March 31, 2026, the Company had cash and cash equivalents of $138,601, which together with the PIPE proceeds and undrawn line of credit, is expected to fund planned operations into September 2026.
  • Undrawn Line of Credit: The Company also maintains a $10 million undrawn line of credit, providing additional financial flexibility and access to capital to support ongoing clinical development and operational initiatives.
  • Chief Accounting Officer: Appointed David Choi as CAO to oversee the Company’s accounting, financial reporting, internal controls, and corporate governance functions.

Corporate & Investor Outreach

  • Featured in New to The Street segments on Bloomberg Television and Fox Business
  • Hosted investor calls and a key opinion leader (KOL) conference call presenting clinical data updates

Financial Results for Q1 2026

  • G&A expenses: $488,709 vs. $849,485 in Q1 2025, reflecting less marketing, rent, travel, and Middle East partnership-related costs in 2026.
  • R&D expenses: $1,286,336 vs. $998,222 in Q1 2025, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation of the NEO100-3 study, and overall patient recruitment activity.
  • Net loss: $8.8 million or $(0.38) per diluted share, compared to $32.3 million or $(1.78) per diluted share in Q1 2025. The year-over-year improvement reflects the significant reduction in non-cash stock-based compensation and listing-related advisory fees recognized in Q1 2025 in connection with the Company's public listing. Approximately 31% of the Q1 2026 net loss reflects $2.7 million of non-cash stock-based compensation, resulting in normalized cash operating expenses of approximately $6.1 million for the quarter (~$24.4 million annualized). Normalized cash operating expenses is a non-GAAP measure; a reconciliation is provided below.

Reconciliation of GAAP Net Loss to Non-GAAP Normalized Cash Operating Expenses (unaudited)

 Three Months Ended
March 31, 2026
GAAP net loss$(8,819,932)
Add: Non-cash stock-based compensation expense 2,732,397 
Non-GAAP normalized cash operating expenses$(6,087,535)


ABOUT NEONC TECHNOLOGIES HOLDINGS, INC.

NeOnc Technologies Holdings, Inc. is a clinical-stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood-brain barrier. The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.

For more about NeOnc and its pioneering technology, visit https://neonc.com.

Important Cautions Regarding Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information.

Please refer to the “Risk Factors” section of our Quarterly and Annual reports on Form 10-Q and 10-K as filed with the Securities and Exchange Commission, along with other cautionary language in that report and risk factors and other cautionary language in our subsequent filings with the Securities and Exchange Commission, which outline important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the fact that results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials; announced or published data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data; and our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable.

We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations.

“NEO100” and “NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc.

Company Contact:
info@neonc.com

Investor Contact:
James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com


FAQ

What clinical milestones did NeOnc (NTHI) report for NEO212 in Q1 2026?

NeOnc reported completion of the NEO212 Phase 1 trial and set 610 mg as the recommended Phase 2 dose. According to NeOnc, early signs of possible clinical activity and potential durable disease control were observed in heavily pretreated recurrent GBM and brain metastasis patients.

When is the NEO100 Phase 2a interim data readout expected for NeOnc (NTHI)?

The NEO100 Phase 2a interim data readout is expected around August 2026. According to NeOnc, the trial in recurrent IDH1‑mutant high‑grade glioma is fully enrolled, and previously reported data showed a 24% radiographic remission rate and 44% six‑month progression‑free survival.

How much cash and runway does NeOnc (NTHI) have after Q1 2026?

NeOnc reported cash and cash equivalents of $138,601 as of March 31, 2026. According to NeOnc, this, together with PIPE proceeds and a $10 million undrawn credit line, is expected to fund planned operations into September 2026, supporting ongoing clinical development.

What were NeOnc (NTHI) Q1 2026 operating expenses and net loss?

NeOnc reported a Q1 2026 net loss of $8.8 million, or $(0.38) per diluted share. According to NeOnc, about $2.7 million was non‑cash stock‑based compensation, resulting in non‑GAAP normalized cash operating expenses of approximately $6.1 million, or $24.4 million annualized.

How did NeOnc (NTHI) Q1 2026 R&D and G&A expenses compare to Q1 2025?

In Q1 2026, R&D expenses were $1.29 million versus $0.99 million in Q1 2025, while G&A declined to $0.49 million from $0.85 million. According to NeOnc, R&D reflected active trial work, and lower G&A stemmed from reduced marketing and partnership costs.

What is the size and purpose of NeOnc (NTHI) PIPE financing announced in 2026?

NeOnc secured a PIPE financing anchored by a $10 million commitment from Cinctive Capital Management. According to NeOnc, the proceeds are intended to strengthen the balance sheet, support its NEO100 and NEO212 clinical programs, and fund broader operational and strategic initiatives.

What regulatory next steps is NeOnc (NTHI) planning for NEO212 after Phase 1?

NeOnc plans to request a Type B End‑of‑Phase 1 meeting with the FDA for NEO212. According to NeOnc, the goal is to align on a potentially pivotal registrational Phase 2 study design and explore possible pathways toward accelerated regulatory review.