Stonegate Capital Partners Updates Coverage on NeOnc Technologies Holdings, Inc. (NTHI) 2Q26

NeOnc Technologies (NASDAQ: NTHI) received an updated coverage report highlighting stronger clinical and regulatory positioning in 2Q26.

Rhea-AI Summary

NeOnc Technologies (NASDAQ: NTHI) received an updated coverage report highlighting stronger clinical and regulatory positioning in 2Q26. Lead asset NEO100 achieved its Phase 2a primary endpoint, with six‑month PFS of 48.9% by RANO 2.0 versus a 20% benchmark (p=0.0047), median OS of 26.09 months, and no major toxicities. The company plans to seek an FDA Type B meeting to discuss a potential registrational program. NEO212 advanced through Phase 2 CMC clearance and FDA feedback indicating a possible accelerated approval pathway. R&D expenses rose to $2.6M from $0.7M year over year, while management expands development into meningioma and pediatric brain tumors, noting that funding remains important as activity increases.

Positive

• NEO100 Phase 2a PFS-6 48.9% vs 20% benchmark (p=0.0047)
• NEO100 median OS 26.09 months with no major toxicities reported
• NEO100 moving toward potential registrational trial after positive Phase 2a readout
• NEO212 gains Phase 2 CMC clearance and potential accelerated approval feedback
• Pipeline expansion with NEO100 in meningioma and pediatric brain tumors

Negative

• Confirmation of NEO100 results still requires a randomized study
• R&D expenses increased to $2.6M vs $0.7M year over year
• Company notes funding remains important as development activity expands

Argus Aug 14 session 27 alerts

+31.78% close to close 27.7x rel. volume Open Argus

Details

Market move: NTHI +31.78% in the Aug 14 session. Phase 2a clinical data

+27.7% Peak in 3 hr 2 min

$120.99M Market Cap

On Aug 14, the first trading day after this news, NTHI closed 31.78% above the previous close. Argus tracked a peak move of +27.7% during that session. Our momentum scanner recorded 27 alerts for this stock that day. Relative volume reached 27.7x the daily average during tracking.

Data tracked by StockTitan Argus for the Aug 14 session.

Key Figures

Six-month PFS: 48.9% PFS benchmark: 20% P-value: p=0.0047 +4 more

Six-month PFS

48.9%

NEO100 Phase 2a, by RANO 2.0

PFS benchmark

20%

Pre-specified benchmark for NEO100 Phase 2a

P-value

p=0.0047

NEO100 Phase 2a primary endpoint

Median OS

26.09 months

NEO100 Phase 2a readout

Current salvage therapy

6-9 months

Management-cited survival comparison in recurrent brain cancer

R&D expense

$2.6M

2Q26, versus $0.7M year over year

Prior-year R&D expense

$0.7M

Year-over-year comparison for 2Q26

Historical Context

5 past events · Latest: Aug 12

5 events

1. Aug 12

   NEO100 clinical data

   24h Move

   -21.1%

   Phase 2a data met the primary endpoint with positive survival and tolerability results.

2. Aug 12

   NEO100 clinical data

   24h Move

   -21.1%

   Topline Phase 2a results reported positive progression-free survival and overall survival.

3. Aug 10

   Phase 2a data preview

   24h Move

   +0.0%

   The company scheduled release of topline Phase 2a results for August 12.

4. Aug 10

   2Q26 earnings report

   24h Move

   +0.0%

   Higher R&D spending and net loss were reported alongside clinical progress.

5. Aug 10

   Investor conference call

   24h Move

   +0.0%

   Management scheduled a webcast to discuss Phase 2a results and regulatory next steps.

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

Key Terms

kaplan-meier estimation, type b fda meeting, cmc clearance

3 terms

kaplan-meier estimation technical

"by RANO 2.0 using Kaplan-Meier estimation versus a pre-specified 20%"

Kaplan-Meier estimation is a statistical method that estimates the probability of a particular event not having occurred by different times, using patient-level time-to-event data while accounting for people who leave the study or are lost to follow-up. It matters to investors because it shows how long a treatment’s benefits or risks last in clinical trials—like a survival curve that reveals durability and timing of outcomes, which can affect regulatory decisions, market potential, and valuation.

type b fda meeting regulatory

"intending to request a Type B FDA meeting"

A Type B FDA meeting is a scheduled checkpoint between a drug or medical device developer and the U.S. Food and Drug Administration about key development milestones—commonly used for end-of‑Phase 2 reviews or pre‑approval discussions. Think of it as a formal progress review where the regulator can confirm the path forward, request more data, or highlight problems; outcomes can materially change project timelines, costs and the likelihood of eventual approval, so investors watch them closely.

cmc clearance regulatory

"NEO212 also gained regulatory momentum through Phase 2 CMC clearance"

A CMC clearance is a regulatory sign-off that the chemistry, manufacturing and controls (CMC) information for a drug or biologic meets an authority’s standards. It covers how the product is made, the quality of ingredients, manufacturing controls and consistency, similar to a factory inspection plus a recipe review. Investors care because it affects whether a product can move forward in clinical testing, approval or commercialization, and influences timelines and risk.

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Dallas, Texas--(Newsfile Corp. - August 13, 2026) - NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI). Stonegate Capital Partners Updates Coverage on NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI). 2Q26 meaningfully improves the clinical setup for NTHI, with NEO100 delivering a positive Phase 2a readout and NEO212 gaining regulatory clarity. NEO100 met its primary endpoint with six-month PFS of 48.9% by RANO 2.0 using Kaplan-Meier estimation versus a pre-specified 20% benchmark (p=0.0047), while median OS reached 26.09 months and no major toxicities were reported. We view the survival signal as the more important read through, with management citing 6-9 months for current salvage therapy in recurrent brain cancer, although confirmation in a randomized study remains the next test. The readout moves NEO100 into a potential registrational program, with the Company intending to request a Type B FDA meeting. Financial results are secondary, with R&D increasing to $2.6M vs. $0.7M y/y.

To view the full announcement, including downloadable images, bios, and more, click here.

Key Takeaways:

• NEO100's Phase 2a readout materially strengthens the lead program, with PFS-6 of 48.9% versus the 20% benchmark and median OS of 26.09 months. The favorable tolerability profile and lack of major toxicities further support the potential for chronic, patient-friendly treatment and move NEO100 toward a registrational-stage opportunity.

• FDA alignment is now the key near-term catalyst, with NeOnc planning a Type B meeting to determine NEO100's registrational trial design, endpoints and potential approval pathway. NEO212 also gained regulatory momentum through Phase 2 CMC clearance and FDA feedback indicating a potential accelerated approval pathway.

• The investment case is broadening beyond a single trial or asset, with NEO100 extending into meningioma and pediatric brain tumors while NEO212 provides a differentiated second clinical program. This platform breadth increases longer-term optionality, although funding remains important as development activity expands.

Click image above to view full announcement.

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About Stonegate
Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.

Contacts:

Stonegate Capital Partners
(214) 987-4121
info@stonegateinc.com
Source: Stonegate, Inc.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/309582

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were the key NEO100 Phase 2a results reported for NeOnc Technologies (NTHI) in 2Q26?

NEO100 met its primary endpoint with six-month PFS of 48.9% versus a 20% benchmark. According to the company, median overall survival reached 26.09 months and no major toxicities were reported, supporting further development and discussions on a potential registrational trial.

How does the 2Q26 clinical update affect NeOnc Technologies (NTHI) registrational plans for NEO100?

The positive Phase 2a readout positions NEO100 for a potential registrational program. According to the company, it intends to request an FDA Type B meeting to discuss trial design, endpoints, and the potential approval pathway for NEO100 in recurrent brain cancer.

What regulatory progress did NEO212 achieve for NeOnc Technologies (NTHI) in 2Q26?

NEO212 gained regulatory momentum with Phase 2 CMC clearance and FDA feedback suggesting a potential accelerated approval pathway. According to the company, this establishes NEO212 as a differentiated second clinical program alongside NEO100, broadening the overall investment and development case.

How did NeOnc Technologies (NTHI) R&D spending change in 2Q26 and what does it imply?

Research and development expenses increased to $2.6 million from $0.7 million year over year. According to the company, this reflects expanding clinical and regulatory activity across NEO100 and NEO212, while management also notes that funding remains important as development programs broaden.

How is NeOnc Technologies (NTHI) expanding its NEO100 program beyond the initial indication?

NEO100 is extending into meningioma and pediatric brain tumors, broadening the clinical platform. According to the company, this expansion increases longer-term optionality by adding new indications, complementing the recurrent brain cancer work highlighted in the recent Phase 2a readout.

What are the main risks or next steps for NeOnc Technologies (NTHI) after the 2Q26 update?

Key next steps include securing FDA alignment for a registrational NEO100 trial and completing a randomized study. According to the company, continued funding is important as development activity expands across NEO100 and NEO212, despite encouraging Phase 2a and regulatory signals.