Month: September 2026

8.3

PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY
A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE
Rule 8.3 of the Takeover Code (the “Code”)

1.        KEY INFORMATION

(a)   Full name of discloser:	Rathbones Group Plc
(b)   Owner or controller of interests and short positions disclosed, if different from 1(a):         The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named.
(c)   Name of offeror/offeree in relation to whose relevant securities this form relates:         Use a separate form for each offeror/offeree	NextEnergy Solar Fund Ltd
(d)   If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
(e)   Date position held/dealing undertaken:         For an opening position disclosure, state the latest practicable date prior to the disclosure	18/09/2026
(f)   In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?         If it is a cash offer or possible cash offer, state “N/A”	No

2.        POSITIONS OF THE PERSON MAKING THE DISCLOSURE

If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

(a)      Interests and short positions in the relevant securities of the offeror or offeree to which the disclosure relates following the dealing (if any)

Class of relevant security:	Ordinary NPV
	Interests		Short positions
	Number	%	Number	%
(1)   Relevant securities owned and/or controlled:	5,822,009	1.01%
(2)   Cash-settled derivatives:
(3)   Stock-settled derivatives (including options) and agreements to purchase/sell:
TOTAL:	5,822,009	1.01%

All interests and all short positions should be disclosed.

Details of any open stock-settled derivative positions (including traded options), or agreements to purchase or sell relevant securities, should be given on a Supplemental Form 8 (Open Positions).

(b)      Rights to subscribe for new securities (including directors’ and other employee options)

Class of relevant security in relation to which subscription right exists:
Details, including nature of the rights concerned and relevant percentages:

3.        DEALINGS (IF ANY) BY THE PERSON MAKING THE DISCLOSURE

Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 3(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in.

The currency of all prices and other monetary amounts should be stated.

(a)        Purchases and sales

Class of relevant security	Purchase/sale	Number of securities	Price per unit
Ordinary NPV	Sale	12,100	48.979p

(b)        Cash-settled derivative transactions

Class of relevant security	Product description e.g. CFD	Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position	Number of reference securities	Price per unit

(c)        Stock-settled derivative transactions (including options)

(i)        Writing, selling, purchasing or varying

Class of relevant security	Product description e.g. call option	Writing, purchasing, selling, varying etc.	Number of securities to which option relates	Exercise price per unit	Type e.g. American, European etc.	Expiry date	Option money paid/ received per unit

(ii)        Exercise

Class of relevant security	Product description e.g. call option	Exercising/ exercised against	Number of securities	Exercise price per unit

(d)        Other dealings (including subscribing for new securities)

Class of relevant security	Nature of dealing e.g. subscription, conversion	Details	Price per unit (if applicable)
Ordinary NPV

4.        OTHER INFORMATION

(a)        Indemnity and other dealing arrangements

Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the person making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none”

None

(b)        Agreements, arrangements or understandings relating to options or derivatives

Details of any agreement, arrangement or understanding, formal or informal, between the person making the disclosure and any other person relating to: (i)   the voting rights of any relevant securities under any option; or (ii)   the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none”

None

(c)        Attachments

Is a Supplemental Form 8 (Open Positions) attached?

No

Date of disclosure:	21/09/2026
Contact name:	Lydia Cotterill – Compliance Department
Telephone number:	0151 237 1176

Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service.

The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s disclosure requirements on +44 (0)20 7638 0129.

The Code can be viewed on the Panel’s website at.

8.3

PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY
A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE
Rule 8.3 of the Takeover Code (the “Code”)

1.        KEY INFORMATION

(a)   Full name of discloser:	Rathbones Group Plc
(b)   Owner or controller of interests and short positions disclosed, if different from 1(a):         The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named.
(c)   Name of offeror/offeree in relation to whose relevant securities this form relates:         Use a separate form for each offeror/offeree	Eleco Plc
(d)   If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
(e)   Date position held/dealing undertaken:         For an opening position disclosure, state the latest practicable date prior to the disclosure	18/09/2026
(f)   In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?         If it is a cash offer or possible cash offer, state “N/A”	No

2.        POSITIONS OF THE PERSON MAKING THE DISCLOSURE

If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

(a)      Interests and short positions in the relevant securities of the offeror or offeree to which the disclosure relates following the dealing (if any)

Class of relevant security:	1p Ordinary Shares
	Interests		Short positions
	Number	%	Number	%
(1)   Relevant securities owned and/or controlled:	1,157,620	1.37%
(2)   Cash-settled derivatives:
(3)   Stock-settled derivatives (including options) and agreements to purchase/sell:
TOTAL:	1,157,620	1.37%

All interests and all short positions should be disclosed.

Details of any open stock-settled derivative positions (including traded options), or agreements to purchase or sell relevant securities, should be given on a Supplemental Form 8 (Open Positions).

(b)      Rights to subscribe for new securities (including directors’ and other employee options)

Class of relevant security in relation to which subscription right exists:
Details, including nature of the rights concerned and relevant percentages:

3.        DEALINGS (IF ANY) BY THE PERSON MAKING THE DISCLOSURE

Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 3(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in.

The currency of all prices and other monetary amounts should be stated.

(a)        Purchases and sales

Class of relevant security	Purchase/sale	Number of securities	Price per unit
1p Ordinary Shares	Sale	850	229.36p

(b)        Cash-settled derivative transactions

Class of relevant security	Product description e.g. CFD	Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position	Number of reference securities	Price per unit

(c)        Stock-settled derivative transactions (including options)

(i)        Writing, selling, purchasing or varying

Class of relevant security	Product description e.g. call option	Writing, purchasing, selling, varying etc.	Number of securities to which option relates	Exercise price per unit	Type e.g. American, European etc.	Expiry date	Option money paid/ received per unit

(ii)        Exercise

Class of relevant security	Product description e.g. call option	Exercising/ exercised against	Number of securities	Exercise price per unit

(d)        Other dealings (including subscribing for new securities)

Class of relevant security	Nature of dealing e.g. subscription, conversion	Details	Price per unit (if applicable)
1p Ordinary Shares

4.        OTHER INFORMATION

(a)        Indemnity and other dealing arrangements

Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the person making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none”

None

(b)        Agreements, arrangements or understandings relating to options or derivatives

Details of any agreement, arrangement or understanding, formal or informal, between the person making the disclosure and any other person relating to: (i)   the voting rights of any relevant securities under any option; or (ii)   the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none”

None

(c)        Attachments

Is a Supplemental Form 8 (Open Positions) attached?

No

Date of disclosure:	21/09/2026
Contact name:	Lydia Cotterill – Compliance Department
Telephone number:	0151 237 1176

Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service.

The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s disclosure requirements on +44 (0)20 7638 0129.

The Code can be viewed on the Panel’s website at.

ANNOUNCEMENT

A.P. Møller – Mærsk A/S – Transactions in connection with share buy-back program
On 5 February 2026, A.P. Møller – Mærsk A/S (the “Company”) announced a share buy-back program of up to DKK 6.3bn (around USD 1bn) to be executed over a period of 12 months. The second phase of the share buy-back program will run from 13 August 2026 up to 29 January 2027. The shares to be acquired will be limited to a total market value of DKK 3.15 billion (around USD 500m).

The share buy-back program will be executed under EU Commission Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 (the “Safe Harbour Regulation”).

The following transactions have been made under the program in the period 14 September to 18 September 2026:

	Number of A shares	Average purchase price A shares, DKK	Transaction value, A shares, DKK
Accumulated, last announcement	44,198		726,177,680
14 September 2026	250	22,402.2400	5,600,560
15 September 2026	250	22,309.6800	5,577,420
16 September 2026	250	21,980.9600	5,495,240
17 September 2026	250	21,902.6400	5,475,660
18 September 2026	250	21,779.2000	5,444,800
Total 14-18 September 2026	1,250		27,593,680
Accumulated in the second phase of the program	7,200		151,416,990
Accumulated under the program	45,448		753,771,360
	Number of B shares	Average purchase price B shares, DKK	Transaction value, B shares, DKK
Accumulated, last announcement (market and the Foundation)	176,792		2,972,327,550
14 September 2026	877	23,259.3957	20,398,490
15 September 2026	877	23,164.6294	20,315,380
16 September 2026	877	22,791.0718	19,987,770
17 September 2026	877	22,712.4173	19,918,790
18 September 2026	877	22,530.9350	19,759,630
Total 14-18 September 2026	4,385		100,380,060
Bought from the Foundation*	615	22,891.6898	14,078,389
Accumulated in the second phase of the program (market and the Foundation)	28,800		628,917,724
Accumulated under the program (market and the Foundation)	181,792		3,086,785,999

*) According to a separate agreement, A.P. Møller og Hustru Chastine Mc-Kinney Møllers Familiefond (the Foundation) participates on a pro rata basis to the shares purchased in the share buy-back program.

With the transactions stated above, the Company owns a total of 45,448 A shares and 241,430 B shares as treasury shares, corresponding to 1.95% of the share capital. Details of each transaction are included as appendix.

Copenhagen, 21 September 2026

Contact persons:
Head of Investor Relations, Martin Dunwoodie, tel. +45 3363 3484
Head of Media Relations, Jesper Lov, tel. +45 6114 1521

Page 1 of 1

Attachments

• Announcement – Transactions in connection with share buy-back program – week 38 2026
• Daily transactions in connection with share buy-back program – week 38 2026

WAM-V unmanned surface vessels integrated with U.S. command and control and supported training for the U.S. Navy and Marine Corps personnel in autonomous operations during the multinational exercise in Portugal

MONROE TOWNSHIP, N.J., Sept. 21, 2026 (GLOBE NEWSWIRE) — Ocean Power Technologies, Inc. (“OPT” or the “Company”) (NYSE American: OPTT), a leader in maritime operational infrastructure and autonomous ocean systems, today announced that three classes of its WAM-V^® unmanned surface vessels operated across multiple mission sets at REPMUS 2026, the multinational robotic experimentation exercise led by the Portuguese Navy in close collaboration with NATO, the University of Porto, and the European Defense Agency (EDA).

The annual exercise brings together military forces, academia, and technology companies from across the globe to test, develop, and integrate unmanned systems into real-world maritime operations. The exercise is designed to drive multi-domain interoperability among allied maritime unmanned systems under realistic operational conditions.

Over the course of the exercise, OPT vessels supported five mission sets: rapid environmental assessment; mine countermeasures; harbor security; surveillance and reconnaissance; and above-water warfare.

The WAM-V 8 conducted rapid environmental assessment, delivering bathymetric survey data in amphibious surf zones in support of landing and raiding forces, and was beach-launched ahead of amphibious operations. The WAM-V 16 supported mine countermeasures tasking in the beach and harbor approaches for harbor security. The `WAM-V 22 operated in above-water warfare, including surface target identification under operational tasking, and conducted intelligence, surveillance and reconnaissance.

OPT vessels integrated with U.S. command and control during the exercise and were the only U.S. unmanned surface vessels to do so. A WAM-V 22 was also employed to train U.S. Navy and Marine Corps personnel in basic autonomous operations.

“The test of an unmanned system isn’t whether it performs at a demonstration. It’s whether an operational commander will task it alongside everything else he’s responsible for,” said Jason Weed, Chief Operating Officer of OPT. “At REPMUS, our vessels weren’t on display; they were given work. Three different classes, five different missions, inside someone else’s operational picture. That’s the capability our customers are actually buying.”

For more information about Ocean Power Technologies, visit www.OceanPowerTechnologies.com.

ABOUT OCEAN POWER TECHNOLOGIES

OPT provides intelligent maritime solutions and services that enable safer, cleaner, and more productive ocean operations for the defense and security, oil and gas, science and research, and offshore wind markets, including Merrows™, which provides AI capable seamless integration of Maritime Domain Awareness Systems across platforms. Our PowerBuoy^® platforms provide clean and reliable electric power and real-time data communications for remote maritime and subsea applications. We also provide WAM-V^® unmanned surface vessels (USVs) and marine robotics services. The Company’s headquarters is in Monroe Township, New Jersey, with an additional office in Richmond, California. To learn more about OPT’s products, services and solutions, visit www.OceanPowerTechnologies.com.

FORWARD-LOOKING STATEMENTS

This release may contain forward-looking statements that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the Company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates that could be inaccurate and subject to risks and uncertainties, including the Company’s ability to support maritime missions, integrate WAM-V platforms with customer command and control systems, and deliver operator training and customer services, the conversion of potential customers to contracts and the realization of the potential revenue thereunder. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company’s most recent Forms 10-Q and 10-K and subsequent filings with the U.S. Securities and Exchange Commission for further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.

Contact Information

Investors: 203-561-6945 or investorrelations@oceanpowertech.com

Media: 609-730-0400 x402 or MediaRelations@oceanpowertech.com

LAS VEGAS, Nevada, Sept. 21, 2026 (GLOBE NEWSWIRE) — High Roller Technologies, Inc. (“High Roller” or the “Company”) (NYSE: ROLR), a publicly traded online gaming and prediction markets company, today announced that Chief Executive Officer Seth Young will participate in PREDICT 2026, The Prediction Markets Conference™, taking place October 6–7, 2026, at the New York Marriott Marquis in New York City. Young will participate in the following panel discussion:

Panel: The Future of Interactive Gaming: Innovation, Technology & Scale
Date: Tuesday, October 6, 2026
Time: 2:15–2:55 p.m. Eastern Time
Participants:

• Seth Young, Chief Executive Officer, High Roller Technologies
• Travis Geiger, Co-Founder, WagerWire
• Dustin Gouker, Founder, Event Horizon
• Dan Wallach, Gaming Law and Sports Betting Attorney, Wallach Legal US

As prediction markets gain traction, the panel will examine the technology, market-making, liquidity and payment infrastructure supporting new sectors at scale, along with the use of AI and data analytics to improve personalization and engagement and emerging opportunities across entertainment, esports, creator-driven markets and live events.

Young will also be available for one-on-one meetings during the conference. Investors, analysts and other interested parties may request a meeting through the conference’s one-on-one meeting platform.

Registration: Details are available on the PREDICT 2026 conference website.

About High Roller Technologies, Inc.

High Roller Technologies, Inc. (NYSE: ROLR) is a publicly traded online gaming and prediction markets company, known for its innovative casino brands High Roller and Fruta, and its prediction markets brand, ROLR. The Company delivers cutting-edge real-money consumer facing products that are intuitive and user-friendly. With a diverse portfolio of over 6,000 premium online casino games from more than 90 leading game providers, High Roller Technologies offers an immersive and engaging gaming experience in the rapidly expanding multi-billion-dollar iGaming industry. As an award-winning operator, High Roller Technologies continues to redefine the future of market engagement through innovation, performance, and a commitment to excellence.

For more information, please visit the Company’s investor relations website and follow High Roller Technologies on X, Facebook, and LinkedIn.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions, the commercial launch timing of the ROLR™ prediction markets platform. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the ability of the Company to successfully complete the closed beta on the anticipated timeline, risks related to platform stability, scalability and technical readiness, the regulatory environment applicable to prediction markets, the Company’s ability to attract and retain platform users, and general market and economic conditions and such factors as discussed throughout Part I, Item 1A. Risk Factors and Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of our Annual Report on Form 10-K for the year ended December 31, 2025, Part I. Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations and Part II, Item 1A. Risk Factors, of our quarterly report on Form 10-Q for the quarter ended June 30, 2026 and in our other filings with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact
Investor Relations
ir@highroller.com
800-460-1039

COMPANY ANNOUNCEMENT NO 50/2026 – September 21, 2026

On August 17, 2026, Royal Unibrew announced a share buy-back program, cf. company announcement no. 44/2026.

The share buy-back program will be executed under EU Commission Regulation No. 596/2014 of the European Parliament and Council of April 16, 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 (the “Safe Harbour Regulation”). 

The share buy-back program is expected to be realized in the period from August 18, 2026, to December 8, 2026. The total transaction value of the share buy-backs in the period will not exceed DKK 300m.

The following transactions have been made under the program:

	Number of Shares	Average purchase price DKK	Transaction value, DKK
Accumulated, last announcement	172,848	427.09	73,821,189
September 14, 2026	7,000	421.02	2,947,146
September 15, 2026	8,000	420.86	3,366,918
September 16, 2026	8,000	420.63	3,365,061
September 17, 2026	8,000	420.65	3,365,227
September 18, 2026	12,000	414.88	4,978,513
Total accumulated under the program	215,848	425.50	91,844,054

With the transactions stated above Royal Unibrew owns a total of 1,998,436 shares, corresponding to 4.1% of the share capital. The total amount of shares in the company is 49,300,000, including treasury shares.

For further information please contact:
Flemming Ole Nielsen (Head of Investor Relations)
E-mail: Flemming.Nielsen@royalunibrew.com
Telephone: +45 25 41 68 04

Encl.

Attachments

• RU_Announcement_50 SBB
• Encl_announcement_50-2026_SSB-SEPT14-SEPT18

DENVER, Sept. 21, 2026 (GLOBE NEWSWIRE) — (247marketnews.com) – NeOnc Technologies Holdings’ (NASDAQ: NTHI) NEO100 deserves attention; not just because its Phase 2a study has suddenly solved brain cancer, but because it is testing a different answer to one of the field’s oldest problems.

The disease is aggressive. Patients may have already undergone surgery, radiation and temozolomide. Once the tumor returns, treatment options narrow, and the central problem is not simply finding another molecule that can kill cancer cells. It is getting an effective amount of that molecule to the right place without creating unacceptable toxicity elsewhere.

Recurrent high-grade glioma is where oncology’s promises tend to collide with biology.

NEO100 is an intranasal formulation of purified perillyl alcohol. The Company’s basic proposition is straightforward: rather than asking a drug to cross the blood-brain barrier from the bloodstream, deliver it through the nose and attempt to reach the brain through the olfactory pathway. The approach turns drug delivery itself into part of the therapeutic strategy.

On August 12, 2026, NeOnc reported topline results from the Phase 2a portion of NEO100-01, an open-label study in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The 24-patient study reported six-month progression-free survival of 48.9%, compared with a 20% benchmark specified in the study design for standard of care. The Company reported a one-sided p-value of 0.0047. Median overall survival was 26.09 months, while overall survival at six months was 86.7%.

Those are attention-getting numbers and one of the next steps could be demonstrating that NEO100 works in a randomized trial and establish that nose-to-brain delivery is superior to conventional systemic treatment.

The Phase 2a study enrolled 24 patients. It was open-label and compared its primary endpoint with a prespecified historical benchmark rather than a concurrent randomized control group. The reported six-month PFS estimate also has a confidence interval of 26.3% to 68.1%, illustrating how much uncertainty remains around an estimate derived from such a small population.

That is precisely what makes the NEO100 story interesting. The experiment is testing two hypotheses at once. The first is therapeutic: can perillyl alcohol meaningfully control recurrent IDH1-mutant high-grade glioma? The second is logistical and biological: can intranasal delivery provide a practical way of getting a drug into the central nervous system?

The Second Question may Ultimately Prove as Important as the First

For decades, the blood-brain barrier has been treated as both a biological defense system and a drug-development obstacle. It protects the brain from potentially harmful substances circulating in the blood, but that protection also prevents many cancer drugs from reaching tumors at therapeutically useful concentrations. Researchers have pursued molecular engineering, nanoparticles, focused ultrasound, convection-enhanced delivery and other strategies to circumvent or temporarily alter the barrier.

An intranasal approach offers a different proposition. Instead of breaking the barrier down, it tries to exploit an anatomical route around it.

The attraction is obvious. A patient in the NEO100 program can self-administer the drug at home. The Company says the recommended regimen is intranasal dosing four times daily in 28-day cycles. The Phase 2a report said no major toxicities were observed and that adverse events were predominantly low-grade.

Home Administration matters in Oncology more than the Phrase Suggests

A treatment that requires hospitalization, infusion infrastructure or repeated invasive procedures carries a burden beyond its pharmacology. A treatment that can be administered by a patient at home potentially changes the practical economics and experience of therapy. For patients living with recurrent brain cancer, avoiding another procedure can be clinically meaningful even before the question of efficacy is settled.

The most intriguing detail in the August readout may be the distribution of outcomes rather than the headline PFS figure. NeOnc reported that five of the 24 patients remained on treatment at the time of the readout. One patient had an ongoing partial response beyond 114 days, while another patient was reported to have remained progression-free for roughly 19 months.

That kind of long tail is precisely what researchers will want to understand.

Is it evidence of a biologically distinct subgroup? Is IDH1 mutation status identifying patients unusually sensitive to the treatment? Is the apparent tail reproducible? Or does a small sample simply make unusual individual outcomes disproportionately visible?

NeOnc pointed to a biological rationale involving IDH1-mutant tumors, saying earlier Phase 1 experience had shown long-term survivors carrying an IDH1 mutation. That is an interesting hypothesis, but a hypothesis is not the same as a validated predictive biomarker.

The Next Stage Therefore Matters Enormously

NeOnc has said it intends to request a Type B meeting with the FDA to discuss a potential registrational path for NEO100 in recurrent IDH1-mutant high-grade glioma. The question for regulators will not simply be whether the Phase 2a result cleared its prespecified statistical benchmark. It will be whether the design, population, endpoint and magnitude of the observed effect provide an adequate foundation for the next development step.

That is where the distinction between a promising Phase 2a study and a medicine becomes unavoidable.

A successful oncology drug has to survive multiple forms of scrutiny: statistical, clinical, manufacturing, regulatory and practical. The more unusual the delivery mechanism, the more important it becomes to demonstrate not merely that patients received the drug, but that the delivery strategy produces clinically meaningful benefit.

There is also a Larger Lesson Here

Brain-cancer drug development often becomes a contest between elegant biology and brutal logistics. A molecule can look compelling in a laboratory and fail because insufficient drug reaches the tumor. A delivery technology can look ingenious and fail because the therapeutic payload is not sufficiently active. NEO100 is attempting to solve both problems with one strategy.

That is a high bar and the encouraging part is that the Phase 2a study appears to have generated a signal worth investigating.

The more interesting conclusion is that NEO100 has made the blood-brain barrier itself part of the clinical experiment.

If larger and better-controlled studies reproduce the signal, the significance could extend beyond perillyl alcohol or NeOnc. It would strengthen the case for intranasal delivery as a genuine CNS-development strategy.

The nose spray has not yet changed brain-cancer care, but it has, however, produced enough evidence to make the question worth asking seriously.

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Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company’s ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company’s filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.