Month: September 2026

SINGAPORE, Sept. 30, 2026 (GLOBE NEWSWIRE) — Ten-League International Holdings Limited (Nasdaq: TLIH) (the “Company” or “Ten-League”), a Singapore-based provider of turnkey project solutions, today announced its unaudited financial results for the six months ended June 30, 2026.

First Six Months of Fiscal Year 2026 Financial Highlights

• Revenue was S$33.1 million (US$25.6 million) for the six months ended June 30, 2026, with engineering consultancy service income and rental income together contributing 45.4% of total revenue, compared with 18.5% in the same period last year, reflecting continued progress in the Company’s transition towards higher-value engineering solutions and recurring rental activities.
• Growth businesses gained scale, with engineering consultancy service income increasing 669.4% to S$8.6 million (US$6.6 million) and rental income increasing 9.9% to S$6.4 million (US$5.0 million).
• Gross profit margin was 24.0% for the six months ended June 30, 2026, an increase of 0.5 percentage points from 23.5% for the same period last year.
• Net cash provided by operating activities remained strong at S$10.0 million (US$7.7 million), broadly consistent with the same period last year, supporting continued investment in the Company’s strategic priorities.
• Financial position remained sound, with cash and cash equivalents of S$10.9 million (US$8.5 million) and shareholders’ equity increasing to S$18.5 million (US$14.3 million) as of June 30, 2026.

Mr. Jison Lim, Chief Executive Officer and Chairman of Ten-League, commented, “The first half of fiscal year 2026 demonstrated meaningful progress in reshaping our revenue mix towards engineering-led solutions and recurring rental activities amid evolving market conditions. Engineering consultancy services and rental together represented 45.4% of total revenue, compared with 18.5% in the same period last year. This shift reflects the increasing contribution from our strategic focus areas, including new energy infrastructure, automation and integrated engineering solutions. The delivery and acceptance of 30 electric prime movers (“ePM”) supported significant growth in engineering consultancy service income, while rental income continued to expand. Despite softer equipment sales, gross profit margin improved to 24.0%, demonstrating the resilience of our evolving business mix.”

Mr. Lim continued, “Looking ahead, we remain focused on advancing our strategic priorities across new energy infrastructure, automation, and engineering. We will continue to enhance our engineering capabilities and provide solutions that support customers’ operational efficiency and transition toward more sustainable equipment and infrastructure. At the same time, we remain committed to fostering strategic collaborations and strengthening our network of business partners. We believe these initiatives will position Ten-League to capture emerging opportunities as Singapore’s infrastructure and industrial sectors continue to evolve, while creating sustainable long-term value for our shareholders.”

First Six Months of Fiscal Year 2026 Unaudited Financial Results

Revenues

Total revenues were S$33.1 million (US$25.6 million) for the six months ended June 30, 2026. The revenue mix continued to shift towards engineering consultancy services and rental activities, which together contributed 45.4% of total revenue, compared with 18.5% for the same period last year. This change reflects the Company’s ongoing transition from primarily equipment sales towards a broader portfolio of engineering-led, new energy and recurring rental solutions.

• Sales of heavy equipment and parts contributed 54.6% of total revenue for the six months ended June 30, 2026, compared with 81.5% for the same period last year, as contractors made greater use of rental equipment, delayed fleet replacement following significant fleet expansion over the preceding two years, and operated in a market with an oversupply of used equipment. Sales of heavy equipment and parts were S$18.1 million (US$14.0 million) for the six months ended June 30, 2026, a decrease of 41.1% from S$30.7 million for the same period last year.
• Engineering consultancy service income was S$8.6 million (US$6.6 million) for the six months ended June 30, 2026, representing 25.9% of total revenue, compared with 3.0% for the same period last year. The increase of 669.4% was mainly due to the delivery and acceptance of 30 ePM and demonstrated the Company’s increasing commercialization of engineering and new energy capabilities.
• Rental income increased 9.9% to S$6.4 million (US$5.0 million) for the six months ended June 30, 2026, and represented 19.5% of total revenue, compared with 15.5% for the same period last year. The increase reflected stronger rental demand amid economic uncertainty and high financing costs, reinforcing the contribution from recurring rental activities.

Cost of Revenue

Cost of revenue was S$25.1 million (US$19.4 million) for the six months ended June 30, 2026, a decrease of 12.8% from S$28.8 million for the same period last year.

Gross Profit

Gross profit was S$8.0 million (US$6.1 million) for the six months ended June 30, 2026, a decrease of 10.1% from S$8.8 million for the same period last year.

Gross profit margin was 24.0% for the six months ended June 30, 2026, an increase of 0.5 percentage points from 23.5% for the same period last year.

• Gross profit margin for sales of heavy equipment and parts was 15.0% for the six months ended June 30, 2026, an increase of 0.2 percentage points from 14.8% for the same period last year. The increase was mainly due to better product mix and margin even though absolute sales value decreased.
• Gross profit margin for engineering consultancy service income was 20.2% for the six months ended June 30, 2026, a decrease of 49.1 percentage points from 69.3% for the same period last year. The decrease was mainly due to the delivery and acceptance of 30 ePM.
• Gross profit margin for rental income was 54.7% for the six months ended June 30, 2026, a decrease of 5.4 percentage points from 60.1% for the same period last year. The decrease was mainly due to higher depreciation expenses.

Selling and Distribution Expenses

Selling and distribution expenses were S$0.4 million (US$0.3 million) for the six months ended June 30, 2026, an increase of 21.7% from S$0.3 million for the same period last year. The increase was due to increase of staff salary and related costs.

General and Administrative Expenses

General and administrative expenses were S$5.2 million (US$4.0 million) for the six months ended June 30, 2026, a decrease from S$5.7 million for the same period last year.

Total Other Gain (Loss), Net

Total net other loss was S$0.1 million (US$0.08 million) for the six months ended June 30, 2026, compared to a total net other gain of S$0.1 million for the same period last year.

Net Income

Net income was S$1.7 million (US$1.3 million) for the six months ended June 30, 2026, compared to S$2.4 million for the same period last year.

Basic and Diluted Income per Share

Basic and diluted income per share was S$0.59 (US$0.46) for the six months ended June 30, 2026, compared to S$0.86 for the same period last year.

Financial Condition

As of June 30, 2026, the Company had cash and cash equivalents of S$10.9 million (US$8.5 million), compared to S$10.7 million as of December 31, 2025.

Net cash provided by operating activities was S$10.0 million (US$7.7 million) for the six months ended June 30, 2026, compared to S$10.0 million for the same period last year.

Net cash used in investing activities was S$7.1 million (US$5.5 million) for the six months ended June 30, 2026, compared to net cash provided by investing activities of S$0.2 million for the same period last year.

Net cash used in financing activities was S$2.6 million (US$2.0 million) for the six months ended June 30, 2026, compared to S$5.7 million for the same period last year.

Exchange Rate Information

This announcement contains translations of certain Singapore dollar amounts into U.S. dollars for the convenience of the reader. Translations of amounts from Singapore dollars into U.S. dollars have been made at the exchange rate of S$1.2941 = US$1.00, which was the foreign exchange rate on June 30, 2026 as reported by the Board of Governors of the Federal Reserve System in its weekly release on July 6, 2026.

About Ten-League International Holdings Limited

Ten-League International Holdings Limited is a Singapore-based provider of turnkey project solutions. The Company’s business primarily consists of sales of heavy equipment and parts, heavy equipment rental and provision of engineering consultancy services to port, construction, civil engineering and underground foundation industries. The equipment is organized into four categories based on their functions and application scenarios: foundation equipment, hoist equipment, excavation equipment and port machinery. The Company also provides value-added engineering solutions under engineering consultancy services with the aim to address potential safety issues, enhance reliability and productivity and allow for customers to evaluate the performance of the equipment, the quality of the work completed and the progress of their projects. Ten-League’s mission is to provide high-quality equipment, value-added engineering solutions as well as maintenance and repair through continuous adaptation and application of new technologies. For more information, please visit the Company’s website: https://ir.ten-league.com.sg/.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can find many (but not all) of these statements by the use of words such as “believe”, “plan”, “expect”, “intend”, “should”, “seek”, “estimate”, “will”, “aim” and “anticipate” or other similar expressions in this press release. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s registration statement and other filings with the U.S. Securities and Exchange Commission (“SEC”). Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading “Risk Factors” in the Company’s Annual Reports on Form 20-F, as may be supplemented or amended by the Company’s Reports of a Foreign Private Issuer on Form 6-K.

For investor and media inquiries, please contact:

Ten-League International Holdings Limited
Investor Relations Department
Email: ir@ten-league.com.sg

Ascent Investor Relations LLC
Tina Xiao
Phone: +1 646-932-7242
Email: investors@ascent-ir.com

TEN-LEAGUE INTERNATIONAL HOLDINGS LIMITED AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Amount in thousands, except for share and per share data, or otherwise noted)
				As of Dec 31,				As of Jun 30,				As of Jun 30,
		Note		2025				2026				2026
				S$’000				S$’000				US$’000
				(Audited)				(Unaudited)				(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents					10,684				10,938				8,452
Accounts receivable, net					14,410				12,584				9,724
Contract assets					79				650				502
Inventories					15,761				6,728				5,199
Deposits, prepayments and other receivables					2,996				2,157				1,667
Total current assets					43,930				33,057				25,544
Non-current assets:
Property and equipment, net					33,137				35,807				27,670
Right-of-use assets					11				9				7
Other receivables					304				338				261
Total non-current assets					33,452				36,154				27,938
TOTAL ASSETS					77,382				69,211				53,482
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities					11,488				4,684				3,620
Amounts due to related parties					14,472				13,878				10,723
Bank borrowings					16,953				14,742				11,392
Lease liabilities					6,606				7,041				5,441
Income tax payable					993				1,038				802
Total current liabilities					50,512				41,383				31,978
Long-term liabilities:
Lease liabilities					7,558				6,759				5,223
Deferred tax liabilities					2,613				2,613				2,019
Total long-term liabilities					10,171				9,372				7,242
TOTAL LIABILITIES					60,683				50,755				39,220
Commitments and contingencies					–				–				–
Shareholders’ equity
Ordinary share, par value US$0.00025, 2,000,000,000 shares authorized, 2,940,451 ordinary shares issued and outstanding**					-*				5,778				4,465
Additional paid-in capital					5,778				–				–
Retained earnings					10,921				12,665				9,787
Accumulated other comprehensive income					-*				13				10
Total shareholders’ equity					16,699				18,456				14,262
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY					77,382				69,211				53,482

* – denotes amount less than $’000.
** – On April 13, 2026, the Company effected a 1-for-10 reverse share spilt, whereby every ten (10) issued and outstanding ordinary shares were consolidated into one (1) ordinary share, with a corresponding increase in par value from $0.000025 to $0.00025 per share. All share and per share information presented in these financial statements have been retrospectively adjusted, where applicable, to reflect this share consolidation. The consolidation did not affect total shareholders’ equity. On May 1, 2026, 16 ordinary shares were issued for no consideration to shareholders whose fractional shares were rounded up to the nearest whole share following the reverse share split.

TEN-LEAGUE INTERNATIONAL HOLDINGS LIMITED AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Amount in thousands, except for share and per share data, or otherwise noted)
				Six Months ended June 30,
		Note		2025				2026				2026
				S$’000				S$’000				US$’000
					(Unaudited)				(Unaudited)				(Unaudited)
Revenues, net					37,687				33,095				25,574
Cost of revenue					(28,840	)			(25,140	)			(19,427	)
Gross profit					8,847				7,955				6,147
Operating cost and expenses:
Selling and distribution					(306	)			(381	)			(294	)
General and administrative					(5,661	)			(5,223	)			(4,037	)
Total operating cost and expenses					(5,967	)			(5,604	)			(4,331	)
Profit from operations					2,880				2,351				1,816
Other income (expense):
(Loss)/Gain from disposal of plant and equipment					(30	)			1				1
Interest income					94				186				144
Interest expense					(430	)			(377	)			(291	)
Government grant					5				5				4
Exchange gain					251				–				–
Other income					204				87				67
Total other gain/(loss), net					94				(98	)			(75	)
Income before income taxes					2,974				2,253				1,741
Income tax expense					(591	)			(509	)			(393	)
NET INCOME					2,383				1,744				1,348
OTHER COMPREHENSIVE INCOME
Foreign currency translation adjustments					–				13				10
COMPREHENSIVE INCOME					2,383				1,757				1,358
Net income per share
Basic and diluted					0.86				0.59				0.46
Weighted average number of ordinary shares outstanding
Basic and diluted*					2,779,650				2,940,440				2,940,440

* – On April 13, 2026, the Company effected a 1-for-10 reverse share spilt, whereby every ten (10) issued and outstanding ordinary shares were consolidated into one (1) ordinary share, with a corresponding increase in par value from $0.000025 to $0.00025 per share. All share and per share information presented in these financial statements have been retrospectively adjusted, where applicable, to reflect this share consolidation. The consolidation did not affect total shareholders’ equity. On May 1, 2026, 16 ordinary shares were issued for no consideration to shareholders whose fractional shares were rounded up to the nearest whole share following the reverse share split.

TEN-LEAGUE INTERNATIONAL HOLDINGS LIMITED AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Amount in thousands, except for share and per share data, or otherwise noted)
		Six Months ended June 30,
		2025				2026				2026
		S$’000				S$’000				US$’000
		(Unaudited)				(Unaudited)				(Unaudited)
Cash flows from operating activities:
Net income			2,383				1,744				1,348
Adjustments to reconcile net income to net cash provided by operating activities
Depreciation of property and equipment			2,241				2,614				2,020
Depreciation of right-of-use assets			594				2				2
Loss on disposal of property and equipment			30				–				–
Change in working capital:
Accounts receivable			1,582				2,525				1,951
Contract assets			(342	)			(571	)			(441	)
Inventories			2,791				10,991				8,493
Related parties			161				(594	)			(459	)
Accounts payable and accrued liabilities			122				(6,804	)			(5,258	)
Income tax payable			463				45				35
Net cash provided by operating activities			10,025				9,952				7,691
Cash flows from investing activities:
Proceeds from disposal of property and equipment			47				–				–
Repayment from finance lease receivables			371				436				337
Purchase of property and equipment			(236	)			(7,572	)			(5,851	)
Net cash provided by/(used in) investing activities			182				(7,136	)			(5,514	)
Cash flows from financing activities:
Proceeds of bank borrowings			679				1,484				1,147
Deferred IPO expenses			(923	)			–				–
Repayment of bank borrowings			(266	)			–				–
Principal repayment of lease liabilities			(4,622	)			(4,057	)			(3,135	)
Payment of deferred financing costs			(597	)			(2	)			(2	)
Net cash used in financing activities			(5,729	)			(2,575	)			(1,990	)
Effect on exchange rate change on balances held in foreign currency			–				13				9
Net change in cash and cash equivalent			4,478				254				196
BEGINNING OF PERIOD			686				10,684				8,256
END OF PERIOD			5,164				10,938				8,452
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for income taxes			127				464				359
Cash paid for interest			430				377				291
Cash received from finance lease receivable interest			(94	)			(185	)			(143	)
Operating lease asset obtained in exchange for operating lease obligations			–				–				–

DELAWARE, Ohio, Sept. 30, 2026 (GLOBE NEWSWIRE) — Greif, Inc. (NYSE: GEF, GEF.B), a global leader in industrial packaging products and services, announced today it will report the company’s 2026 fourth quarter financial results after the market closes on Tuesday, November 3, 2026. A conference call will be held on Wednesday, November 4, 2026, at 8:00 a.m. ET to discuss the quarter results.

Greif will provide conference call slides in combination with the earnings press release. The conference call will include management’s prepared remarks and a question and answer session.

Participants may access the call using the following online registration link. Registrants will receive a confirmation containing dial in details and a unique conference call code for entry. Phone lines will open at 7:30 a.m. ET. A digital replay of the conference call will be available two hours following the call on the company’s web site at http://investor.greif.com.

Webcast Details
Title: Greif, Inc. Q4 2026 Earnings Conference Call
URL: https://edge.media-server.com/mmc/p/dsqxmnhz/lan/en

About Greif

Founded in 1877, Greif is a global leader in performance packaging located in over 35 countries. The company delivers trusted, innovative, and tailored solutions that support some of the world’s most demanding and fastest-growing industries. With a commitment to legendary customer service, operational excellence, and global sustainability, Greif packages life’s essentials – and creates lasting value for its colleagues, customers, and other stakeholders. Learn more about the company’s Customized Polymer, Sustainable Fiber, Durable Metal, and Innovative Closure Solutions at www.greif.com and follow Greif on Instagram and LinkedIn.

Contact:

Bill D’Onofrio
614-499-7233
bill.donofrio@greif.com

U.S. District Court for the Southern District of Florida denies motions to dismiss filed by all defendants, permitting Genius Group’s Racketeer Influenced and Corrupt Organizations Act (“RICO”) claims to proceed.

The Company’s lawsuit seeking treble damages of over $750 million against Michael Moe, Peter Ritz, John Clayton, and Michael Carter.

SINGAPORE, Sept. 30, 2026 (GLOBE NEWSWIRE) — Genius Group Limited (NYSE American: GNS) (“Genius Group”, “GNS” or the “Company”), a leading AI-powered education group, is announcing today that on September 27, 2026, the United States District Court for the Southern District of Florida denied the motions to dismiss filed in the Company’s lawsuit against defendants Michael Moe, Peter Ritz, John Clayton, and Michael Carter.

The Court’s denial of the defendants’ motions confirms that the Company has sufficiently alleged claims under the Federal and Florida State iterations of the Racketeer Influenced and Corrupt Organizations (RICO) Act, pursuant to which the Company seeks nearly $1 billion in damages.

The Company’s complaint alleges that the defendants used LZG International, Inc. (“LZGI”) to perpetrate an unlawful scheme through interstate fraudulent wire and mail transactions and to the detriment of the Company (as well as other issuers). Among other things, the Company’s complaint alleges that the defendants made false representations to deceive the Company into entering the asset purchase agreement with LZGI, which enabled the defendants to extort millions of dollars in cash and stock from the Company, and—after the Company evicted Peter Ritz and Michael Moe from their positions within Genius Group—defendants used LZGI to retaliate against the Company by seeking a preliminary injunction during early-2025.

The favorable ruling is the Company’s latest victory in the protracted battle relating to LZGI and joins, most notably, the Company prevailing in the ICC Arbitration against LZGI, pursuant to which Genius was awarded the return of the 7.4 million shares of its common stock and approximately $8 million in monetary relief.

Roger James Hamilton, CEO of Genius Group, said “This is a very positive ruling in favor of the Company. I’d like to acknowledge Mark R. Basile, Esq. and his team at The Basile Law Firm P.C., whose expertise in RICO litigation and securities violations has been instrumental in protecting Genius Group and its shareholders. From winning the ICC arbitration, to vacating the injunction at the Second Circuit, to defeating all motions to dismiss, Mark and his team have delivered results that speak for themselves. We look forward to discovery and to holding the defendants fully accountable.”

The Company remains committed to vigorously litigating its legal interests in the Southern District of Florida against the defendants with a view towards rectifying all the harm the Company has suffered at their hands.

About Genius Group

Genius Group (NYSE: GNS) is a global education group delivering AI powered, education and acceleration solutions for the future of work. Genius Group serves 6 million users in over 100 countries through its Genius City model and online digital marketplace of AI training, AI tools and AI talent. It provides personalized, entrepreneurial AI pathways combining human talent with AI skills and AI solutions at the individual, enterprise and government level. To learn more, please visit geniusgroup.ai

Forward-Looking Statements

Statements made in this press release include 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. Forward-looking statements can be identified by the use of words such as “may,” “will”, “plan,” “should,” “expect,” “anticipate,” “estimate,” “continue,” or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate and involve factors that may cause actual results to differ materially from those projected or suggested. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading “Risk Factors” in the Company’s Annual Reports on Form 20-F, as may be supplemented or amended by the Company’s Reports of a Foreign Private Issuer on Form 6-K. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. No information in this press release should be construed as any indication whatsoever of the Company’s future revenues, results of operations, or stock price.

Contacts
For enquiries, contact investor@geniusgroup.ai

LONDON and PHILADELPHIA, Sept. 30, 2026 (GLOBE NEWSWIRE) — Avacta Therapeutics (AIM: AVCT, “the Company”, “Avacta”), a life sciences company developing innovative, targeted oncology drugs, today publishes its unaudited interim results for the six months ended June 30, 2026 (“H1 26”).

H1 highlights and post period

Research & development

Next Generation pre|CISION^® pipeline

• AVA6103 (FAP-Exd)
  • Preliminary preclinical and clinical data with AVA6103 have been presented recently. Data reported in the Phase 1a trial in patients with select solid tumors demonstrate proof of mechanism with two key findings:
    • AVA6103 pre|CISION^® controlled-release exatecan demonstrates a clean safety profile through the first three dose levels, including a payload dose level 50% higher than the maximum tolerated dose (MTD) of conventional exatecan at dose level 3, and
    • The comparison of the preclinical modeled pharmacokinetic (PK) data and clinical trial PK data demonstrates an exceptional alignment through the first 3 dose levels with controlled release of exatecan evident in patients for days after dosing

• • The first head-to-head preclinical comparison of AVA6103 and Enhertu^®, a marketed antibody drug conjugate (ADC) that targets HER2, demonstrates that AVA6103 shows better antitumor activity vs. Enhertu^®, with deep and durable responses delivered by our dose dense regimen that has been applied in the FOCUS-01 trial.
  • Updated preclinical pharmacology and exposure data analyses, highlighting the favorable delivery profile, presented at the American Association for Cancer Research (AACR) Annual Meeting 2026.
  • Comparative analyses of pre|CISION^® payload delivery preclinical pharmacokinetics (PK) via AVA6103, compared with now two approved ADCs (Enhertu^® and Datroway^®), presented at the Company’s Science Day, showing the clear advantages of pre|CISION^® over traditional ADCs.
  • U.S. Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application for AVA6103 in January, 2026 and the first patient was treated in the trial in March, 2026.

• AVA6207 (Dual Payload)
  • Presented first in vivo efficacy and exposure pharmacology for the pre|CISION^® dual payload technology program at AACR 2026.
  • Presented updated in vivo studies of the dual payload delivery system AVA6207 at Science Day.

pre|CISION^® platform and First Gen (AVA6000)

• Reported data validating the pre|CISION^® ​PDC platform, with AVA6000 in patients with salivary gland cancer, where robust tumor responses are observed with low expression of fibroblast activation protein (FAP) and the persistence of FAP expression despite tumor response.
• Published new data demonstrating the favorable delivery profile and advantages of pre|CISION^® compared to a marketed antibody drug conjugate (ADC)
• AVA6000 (Faridoxorubicin, pending partnering)
  
  • Presented updated Phase 1a/1b data showing encouraging early efficacy signals for AVA6000 in salivary gland cancers at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • At the end of Phase 1 meeting, certain pivotal trial elements and the regulatory path forward with Phase 1b data were agreed with the U.S. Food and Drug Administration (FDA) for potential full regulatory approval.
  • Agreed updates with the FDA to the ongoing Phase 1 trial protocol including the removal of the maximum dosing limit and to allow flexibility in dosing levels to identify the dose for further development.

Financial

Strengthened financial position to support R&D programs:

• Completed oversubscribed placing and subscription, raising £10 million (March 2026), and raised gross proceeds of approximately £9 million in an equity fundraise (June 2026), from institutional investors and existing shareholders.
• Today, separately announcing a proposed capital raise to further strengthen the balance sheet

• Cash and short-term deposit balances at June 30, 2026, of £20.27 million (31 December 2025: £16.9 million million). As of August 31, 2026, cash held was £10.59 million.

Corporate

Strengthened leadership and corporate governance via Board appointments:

• Richard Hughes as non-executive Chairman (June 2026)
• Patrick Vink as Deputy Chairman (in July 2026)
• Mats Blom as Chair of the Audit Committee (in September 2026)

Outlook 2026 and beyond

• The design of the FOCUS-1 trial of AVA6013 and preclinical updates were presented in Trials in Progress presentations at both the American Association of Cancer Research (AACR) Conference on Pancreatic Cancer, being held on September 25-28, 2026, and the European Society for Medical Oncology (ESMO) Congress, being held on October 23-27, 2026.
• First efficacy data from the FOCUS-01 trial with AVA6103 is anticipated to be presented in H1 2027 – including data from clinical tumor biopsies which are anticipated to confirm AVA6103 is being retained in a ‘drug reservoir’ in the tumor, based on the preliminary Phase 1 data.
• The selection of the payloads and data to support clinical candidate selection for the Dual Payload Next Gen Program (AVA6207) will be presented in Q4 2026.
• Clinical data from the First Gen faridoxorubicin (AVA6000) program will also be presented in Q4 2026 at the ESMO Congress, Oct 23-27, 2026.

Christina Coughlin, CEO of Avacta, commented:

“This has been a transformative first half for Avacta, with compelling clinical validation of our pre|CISION^® platform delivering robust and durable tumor responses and demonstrating the clear advantages of our approach over conventional ADCs. The controlled-release mechanism of our Next Gen pipeline with AVA6103 as the lead asset is now working in patients, exactly as modelled, and we are moving towards initial efficacy data in 2027.

“This progress is underpinned by a strong and complementary leadership team. We have further reinforced the expertise and governance at Avacta with several senior appointments in 2026 to management and our Board, who bring the benefit of their scientific, industry, markets and financial acumen to the Company as we advance our proprietary pipeline and explore partnering opportunities to maximize the potential of our pre|CISION^® platform.

“Our financing activities have raised approximately £19.0 million in 2026 to date, which together with the anticipated proceeds of our planned capital raise being launched today, will ensure funding is in place to execute on multiple value inflection milestones, including the efficacy data on AVA6103 in H1 2027, as well as payload selection for our dual-payload program AVA6207 later this year.”

Enhertu^® (trastuzumab deruxtecan; T-DXd) is a protease cleavable-linker ADC, approved for both breast cancer and gastric cancer indications (an AstraZeneca/Daiichi Sankyo product). Datroway^® (datopotamab deruxtecan-dlnk; Dato-DXd) is a protease cleavable-linker ADC, approved for certain types of breast and lung cancer (a Daiichi Sankyo product).

For further information from Avacta, please contact:

Avacta Group plc Christina Coughlin, Chief Executive Officer	https://avacta.com/ via Cohesion Bureau
Strand Hanson Limited (Nominated Adviser) James Harris / Chris Raggett / James Dance	www.strandhanson.co.uk
Zeus (Broker) James Hornigold / George Duxberry (Investment Banking) Dominic King / Alex Bartram (Corporate Broking)	www.zeuscapital.co.uk
Cohesion Bureau Communications / Media / Investors Chris Maggos	avacta@cohesionbureau.com

About Avacta – https://avacta.com/
Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies through its proprietary pre|CISION^® platform. pre|CISION^® is a payload delivery system based on a tumor-specific protease (Fibroblast Activation Protein or FAP) that is designed to concentrate highly potent payloads in the tumor microenvironment while sparing normal tissues. Avacta’s innovative pre|CISION^® peptide drug conjugates (PDC) are a novel entry to the XDC drug class, leveraging the success of antibody drug conjugates with alternative methods of delivery beyond antibodies.

Our pre|CISION^® PDCs leverage this tumor-specific release mechanism in a small molecule format to provide unique benefits over traditional antibody drug conjugates (ADC), releasing active payload in the tumor and reducing systemic exposure and toxicity which enables dosing to be optimized to deliver the best outcomes for patients. The lead clinical program is AVA6103, a Next Generation FAP-enabled controlled release pre|CISION® version of exatecan that delivers the payload directly in the tumor with limited peripheral blood exposure and is currently in clinical development as a treatment for tumor types sensitive to exatecan including cervical cancer, HR+ breast cancer, small cell lung cancer, gastric cancer, colorectal cancer and pancreatic cancer. 

About FAP-Exd (AVA6103)

AVA6103 is the second clinical candidate and is the first asset in the pipeline based on the Next Generation innovative pre|CISION^® controlled release mechanism that provides for prolonged release of payload directly in the tumor, minimizing systemic exposure. AVA6103 is being evaluated in the FOCUS-01 Phase 1 trial (FAP-Exd in Oncologic Cancers with Unmet needS). Preclinical data suggest this approach has optimized payload delivery with a high intratumoral concentration and prolonged exposure of released payload in the tumor, coupled with limited systemic exposure to the released payload. 

Interim report

Strategic overview

We are making excellent progress in the development of our unique pre|CISION^® technology platform, pioneering a novel, differentiated class of pre|CISION^®-based medicines to revolutionize drug delivery. 

Our platform technology demonstrates multiple advantages over conventional therapeutics by addressing one of the primary challenges of effective treatment of diseases, specifically the balance between efficacy and safety. pre|CISION^®-based medicines are specifically designed to be silent (inert) in the bloodstream and in the tissues, and to only activate once in the tumor.

We are confident in Avacta’s ability to partner preCISION^® across a number of modalities and in the management team’s ability to secure the requisite funding to progress the pre|CISION® platform through multiple value driving events.

pre|CISION^® – our proprietary technology

The challenge in oncology is that the most effective therapies cause the most toxicity in normal tissues. The ability to deliver the active drug directly to the tumor is the promise of our proprietary pre|CISION^® platform. Avacta’s innovative pre|CISION^® peptide drug conjugates (PDC) are a novel entry to the XDC drug class, leveraging the success of antibody drug conjugates with alternative methods of delivery beyond antibodies.

The key aspect of pre|CISION^® peptide drug conjugate (PDC) technology is that the conjugated drug (the combination of the oncology drug and our peptide) is inert. It is incapable of entering cells and killing until the peptide is specifically released when it comes into contact with common tumor-associated protein, known as fibroblast activation protein or FAP, in the tumor.

When a pre|CISION^® PDC encounters FAP in the tumor, the peptide is cleaved and the active payload is released. The release of the payload from the pre|CISION^® compound in the tumor results in higher concentration of the drug at the tumor and lower blood and healthy tissue levels than would be achievable with standard systemic administration. Importantly, the increased toxicities (payload) at the tumor are directly associated with the pre|CISION^® medicines. 

Two factors that dictate the antitumor potential of pre|CISION^® medicines are (1) the expression of FAP in the tumor to cleave the peptide (the amount of the FAP protein that exists in the tumor) and (2) the inherent susceptibility of the associated tumors to the chemotherapy (chemicals in the drug) that is released.

We believe that pre|CISION^® can deliver higher drug levels within tumors which will lead to improved antitumor activity while reducing systemic toxicities. This will dramatically impact the therapeutic index and efficacy of a given anticancer drug. We have observed this with our first clinical program, faridoxorubicin. This program has demonstrated a dramatic reduction in the toxicities associated with conventional doxorubicin and is delivering exciting preliminary efficacy data. 

To further extend the pipeline, Avacta has invented the Next Generation Controlled Release pre|CISION technology that adds a chemical capping group and linker with two key advantages: (1) greater control over the release of the payload in the tumor, allowing optimized pharmacokinetic delivery even with payloads that have challenging PK properties, and (2) implementing the linker technology opens a large number of payloads that can be delivered with Next Gen pre|CISION, permitting a full exploration of the landscape opportunity of pre|CISION with ~90% FAP expression among solid tumors.

Programs

Our pre|CISION^® PDCs leverage this tumor-specific release mechanism in a small molecule format to provide unique benefits over traditional antibody drug conjugates (ADC), releasing active payload in the tumor and reducing systemic exposure and toxicity which enables dosing to be optimized to deliver the best outcomes for patients. The lead clinical program is AVA6103, a Next Generation FAP-enabled controlled release pre|CISION® version of exatecan that delivers the payload directly in the tumor with limited peripheral blood exposure and is currently in clinical development as a treatment for tumor types sensitive to exatecan including cervical cancer, HR+ breast cancer, small cell lung cancer, gastric cancer, colorectal cancer and pancreatic cancer. 

Our first generation asset, Faridoxorubicin (AVA6000) continues in Phase 1b. We anticipate presenting data in October, 2026, at the European Society for Medical Oncology (ESMO) meeting from the cohort of patients with salivary gland cancer. This program is intended to go forward within a partnership and discussions are ongoing regarding such an arrangement.

AVA6207 is our Next Gen Dual Payload program which is on track for the goals, in 2H 2026, of naming of the two payloads that will be included in the molecule and clinical candidate selection. Clinical candidate selection is based on the preclinical pharmacology, chemical properties of the molecule with initial assessment of manufacturing for use in the clinic. These data will be presented in the fourth quarter of 2026.

Outlook

Avacta continues to build our value proposition and our unique world-class scientific and clinical capabilities. Our data are robust and building and industry interest in our innovative platform continues to increase. We are very excited about the next stages of Avacta’s journey with the recent clinical data demonstrating proof of mechanism for AVA6103 in the clinic demonstrating the potential in the Next Gen pre|CISION platform. Our upcoming data catalysts demonstrate the progress made in the programs, including the presentation of the FOCUS-01 trial and updated preclinical work with AVA6103, our updated Farodoxorubicin data being presented in October at ESMO, and the payloads and clinical candidate selection in the Next Gen pre|CISION Dual Payload program in the fourth quarter of 2026.

Financial Review

Revenue
Revenues from continuing operations for the six months ended 30 June 2026 were £0.06 million (H1 2025: £0.06 million; FY 2025: £0.113 million).

Revenues from discontinued operations for the six months ended 30 June 2026 was £nil million (H1 2025: £6.10 million; FY 2025: £6.20 million).

Research costs and selling, general and administrative costs
Research costs relate predominantly to the clinical and pre-clinical development work of the pre|CISION^® therapeutics programs as planned increased to £9.69 million (H1 2025: £7.20 million; FY 2025: £18.76 million).

Other costs and charges
Depreciation from continuing operations decreased to £0.56 million (H1 2025: £0.73 million; FY 2025: £1.27 million). Amortization expense remained at £0.01 million (H1 2025: £0.01 million; FY 2025: £0.01 million).

The share of the costs from the AffyXell joint venture was £0.26 million (H1 2025: £0.19 million; FY 2025: £0.45 million). The share of losses reflects the Group’s 21% ownership share of the losses accumulated in the year. The Group investment remained at 21%.

Share-based payment charges were £0.54 million (H1 2025: £0.74 million; FY 2025: £2.13 million).

Operating loss
The Group’s operating loss from continuing operations decreased to £13.91 million (H1 2025: £14.18 million; FY 2025: £29.89 million).

Convertible bond costs
During the period, the Group made interest-only cash repayments of £0.66 million in accordance with the amended bond terms and settled a further £1.20 million of the debt component through an early equity conversion.

The Board continues to consider each settlement event as it arises, taking into account a range of factors including the Company’s cash runway, shareholder dilution and broader business prospects.

The bond agreement contains embedded derivatives in conjunction with an ordinary host debt liability. Accordingly, the convertible bonds are presented in the Consolidated Statement of Financial Position as two separate components: ‘Convertible bond – debt’ and ‘Convertible bond – derivative’. The derivative element is measured at fair value using a Monte Carlo option pricing model.

The derivative element was revalued as at 30 June 2026 to £3.29 million (30 June 2025: £0.27 million; 31 December 2025: £2.79 million). After taking account of the £0.37 million reduction arising from the early conversion, this resulted in a £0.87 million charge recognised in profit or loss in the period (H1 2025: £1.01 million credit; FY 2025: £1.51 million debit).

The debt element of the bond increased to £15.77 million (H1 2025: £18.17 million; 31 December 2025: £13.36 million). The movement primarily reflects a non-cash interest expense of £3.46 million and a £0.82 million loss arising from revisions to expected future cash flows, partially offset by £0.66 million of interest-only cash repayments and an early conversion of £1.20 million. As of 30 September, the outstanding loan balance is £12.00 million.

Loss for the period
The reported loss from continuing operations after taxation was £19.02 million (H1 2025: £16.13 million; FY 2025: £36.26 million).

The basic loss per share from continuing operations was 4.23p (H1 2025: 4.23p; FY 2025: 9.07p).

The basic loss per share from discontinued operations was nil (H1 2025: 3.82p; FY 2025: 0.59p).

Cash flow
The Group reported cash and cash-equivalent balances of £20.27 million (30 June 2025: £12.65 million; 31 December 2025: £16.86 million). Cash and cash-equivalents were £10.59 million as of 31 August 2026.

There was a cash outflow from operations and working capital movements of £15.69 million (H1 2025: £12.33 million; FY 2025: £24.93 million) and cash outflow from investing activities was £0.02 million (H1 2025: inflow of £8.77 million; FY 2025: inflow of £9.90 million, reflecting the proceeds of the sale of Launch and Coris).

Cash inflow from financing activities, being net proceeds from the issue of share capital and share options, net of the principal elements of lease payments amounted to £17.76 million (H1 2025: inflow of £0.67 million; FY 2025: inflow of £15.64 million). The cash inflows for H1 2026 and FY 2025 related to equity fundraising.

Financial position

Net assets as at 30 June 2026 were £3.77 million (30 June 2025: £0.14 million; 31 December 2025: £2.48 million) of which cash and cash equivalents amounted to £20.27 million (30 June 2025: £12.65 million; 31 December 2025: £16.86 million).

Right-of-use assets amounting to £0.63 million (30 June 2025: £1.77 million; 31 December 2025: £1.32 million) are recognized in relation to the Group’s leasehold properties, together with a corresponding lease liability of £0.80 million (30 June 2025: £1.97 million; 31 December 2025: £1.55 million).

Intangible assets decreased to £1.55 million (30 June 2025: £1.83 million; 31 December 2025: £1.55 million) due to amortization of intangible assets.

Liabilities in relation to the unsecured senior convertible bonds issued in October 2022 result in a fair value of the derivative element of £3.29 million (30 June 2025: £0.27 million; 31 December 2025: £2.79 million). The convertible bond debt element at 30 June 2026 was £15.77 million (30 June 2025: £18.17 million; 31 December 2025: £13.36 million).

With current committed expenses, current cash runway takes the Group into early first quarter of 2027.

Events after the reporting period

In July 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the January 2026 quarterly deferred convertible bond repayment, as referenced most recently in the financing announced on 5 June 2026, which the Company has elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £3.67 million representing principal of £2.4 million together with the associated interest and fees payable in the deferment.

In September 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the April 2026 quarterly deferred convertible bond repayment, which the Company elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £2.613 million, representing principal of £2.4 million together with the associated interest and fees payable in the deferment. Following the cash settlement of the April 2026 quarterly deferred convertible bond repayment, both deferred payments have now been satisfied.

As announced on 1 September 2026, the Board of Directors granted share options under the Company’s Equity Share Option Scheme incentive plan (“ESOS”) to all members of the Management Team (the “Options”). The Options are exercisable at an exercise price of 69 pence per share, being the mid-market closing price of the Company’s Ordinary Shares on 27 August 2026, the last trading date before the Options were granted.

As announced on 14 September 2026, Mats Blom, an experienced biotechnology finance executive and Board member with a strong track record as Chief Financial Officer in several life sciences companies, was appointed as a member of its Board of Directors and Chair of the Audit Committee. 

Condensed Consolidated Statement of Profit or Loss for the 6 months ended 30 June 2026
		Unaudited			Unaudited			Audited
	Notes	6 months ended 30 June 2026			6 months ended 30 June 2025			Year ended 31 December 2025
		£000			£000			£000
Revenue	4	56			56			113
Cost of sales		–			–			–
Gross profit		56			56			113
Research costs		(9,686	)		(7,200	)		(18,761	)
R&D expenditure credit (RDEC)		926			–			1,852
Selling, general and administrative expenses		(3,873	)		(4,470	)		(8,485	)
Adjusted EBITDA		(12,577	)		(11,614	)		(25,281	)
Exceptional expenses		23			(899	)		(754	)
Amortization expense		(5	)		(10	)		(11	)
Share of loss of associate		(259	)		(189	)		(454	)
Depreciation expense		(557	)		(728	)		(1,268	)
Share-based payment charge		(536	)		(740	)		(2,126	)
Operating loss		(13,911	)		(14,180	)		(29,894	)
Convertible bond – interest expense	6	(3,460	)		(3,865	)		(6,980	)
Convertible bond – revaluation of derivative	6	(869	)		1,009			(1,507	)
Gain/(loss) on modification of financial liabilities	6	(816	)		–			2,031
Finance income		236			217			371
Finance costs		(28	)		(53	)		(69	)
Loss before tax		(18,848	)		(16,872	)		(36,048	)
Taxation		(175	)		738			(216	)
Loss from continuing operations		(19,023	)		(16,134	)		(36,264	)
Discontinued operation
Loss on disposal of subsidiary		–			(705	)		(236	)
Loss from discontinued operation, net of tax		–			(889	)		(2,112	)
Loss for the period		(19,023	)		(17,728	)		(38,612	)
Other comprehensive income:
Foreign currency translation differences		(33	)		711			315
Total comprehensive loss for the period		(19,056	)		(17,017	)		(38,297	)
Loss per share:
Basic and diluted		(4.23p	)		(4.65p	)		(9.66p	)

Condensed Consolidated Statement of Financial Position as at 30 June 2026
		Unaudited as at			Unaudited as at			Audited as at
		30 June 2026			30 June 2025			31 December 2025
		£000			£000			£000
Assets
Property, plant and equipment		187			335			251
Right-of-use assets		631			1,765			1,319
Investment in associate		2,901			3,312			3,104
Intangible assets		1,550			1,834			1,548
Non-current assets		5,269			7,246			6,222
Trade and other receivables		5,401			3,006			4,479
Income tax receivable		–			2,400			1,861
Cash and cash equivalents		20,271			12,645			16,855
		25,672			18,051			23,195
Assets directly associated with the assets held for sale		–			3,940			–
Current assets		25,672			21,991			23,195
Total assets		30,941			29,237			29,417
Liabilities
Lease liabilities		–			(987	)		(496	)
Provisions		(38	)		(208	)		(288	)
Non-current liabilities		(38	)		(1,195	)		(784	)
Trade and other payables		(7,272	)		(6,600	)		(8,948	)
Lease liabilities		(800	)		(978	)		(1,059	)
Convertible bond – debt	6	(15,774	)		(18,165	)		(13,362	)
Convertible bond – derivative	6	(3,288	)		(273	)		(2,788	)
		(27,134	)		(26,016	)		(26,157	)
Liabilities directly associated with the assets held for sale		–			(1,882	)		–
Current liabilities		(27,134	)		(27,898	)		(26,157	)
Total liabilities		(27,172	)		(29,093	)		(26,941	)
Net assets		3,769			144			2,476
Equity attributable to equity holders of the Company
Share capital	7	47,240			39,446			44,119
Share premium		154,063			120,297			137,371
Reserves		(3,760	)		(1,506	)		(3,727	)
Retained earnings		(193,774	)		(158,093	)		(175,287	)
Total equity		3,769			144			2,476

Total equity is wholly attributable to equity holders of the parent Company.

Approved by the Board and authorized for issue on 29 September 2026.

Condensed Consolidated Statement of Changes in Equity for the 6 months ended 30 June 2026
	Unaudited		Unaudited	Unaudited		Unaudited		Unaudited		Unaudited		Unaudited
	Share Capital		Share premium	Other reserve		Translation reserve		Reserve for own shares		Retained earnings		Total Equity
	£000		£000	£000		£000		£000		£000		£000
At 1 January 2025	37,018		115,585	(1,729	)	(391	)	(2,373	)	(138,829	)	9,281
Loss for the period	–		–	–		–		–		(17,728	)	(17,728	)
Other comprehensive income for the period	–		–	–		711		–		–		711
Total comprehensive loss for the period	–		–	–		711		–		(17,728	)	(17,017	)
Transactions with owners of the company:
Exercise of options	823		120	–		–		–		–		943
Transfer of own shares	–		–	–		–		2,276		(2,276	)	–
Convertible bond – issue of shares	1,605		4,592	–		–		–		–		6,197
Equity-settled share based payment	–		–	–		–		–		740		740
At 30 June 2025	39,446		120,297	(1,729	)	320		(97	)	(158,093	)	144

Loss for the period	–	–	–		–		–		(20,734	)	(20,734	)
Other comprehensive income for the period	–	–	–		(132	)	–		–		(132	)
Total comprehensive loss for the period	–	–	–		(132	)	–		(20,734	)	(20,866	)
Transactions with owners of the company:
Issue of shares	4,273	16,993	–		–		–		–		21,266
Exercise of options	400	81	–		–		–		–		481
Transfer of own shares	–	–	–		–		(2,089	)	2,089		–
Equity-settled share based payment	–	–	–		–		–		1,451		1,451
At 31 December 2025	44,119	137,371	(1,729	)	188		(2,186	)	(175,287	)	2,476
Loss for the period	–	–	–		–		–		(19,023	)	(19,023	)
Other comprehensive income for the period	–	–	–		(33	)	–		–		(33	)
Total comprehensive loss for the period	–	–	–		(33	)	–		(19,023	)	(19,056	)
Transactions with owners of the company:
Issue of shares	2,865	15,154	–		–		–		–		18,019
Exercise of options	96	130	–		–		–		–		226
Transfer of own shares	–	–	–		–						–
Convertible bond – issue of shares	160	1,408	–		–		–		–		1,568
Equity-settled share based payment	–	–	–		–		–		536		536
At 30 June 2026	47,240	154,063	(1,729	)	155		(2,186	)	(193,774	)	3,769

Condensed Consolidated Statement of Cash Flows for the 6 months ended 30 June 2026
		Unaudited			Unaudited			Audited
	Note	6 months ended 30 June 2026			6 months ended 30 June 2025			Year ended 31 December 2025
		£000			£000			£000
Operating cash outflow from continuing operations	8	(15,689	)		(12,331	)		(24,927	)
Interest (paid)/received		(428	)		204			370
Interest elements of lease payments		(28	)		(54	)		(103	)
Income tax received		1,861			784			784
Net cash used in continuing operating activities		(14,284	)		(11,397	)		(23,876	)
Net cash from/(used in) discontinued operating activities		–			(2,189	)		(2,906	)
Net cash used in operating activities		(14,284	)		(13,586	)		(26,782	)
Cash flows from investing activities
Purchase of plant and equipment		(16	)		(43	)		(53	)
Sale of subsidiary, net of cash disposed of		–			9,517			9,984
Purchase of intangible assets		(7	)		–			–
Net cash used in continuing investing activities		(23	)		9,474			9,931
Net cash from/(used in) discontinued investing activities		–			(701	)		(31	)
Net cash used in investing activities		(23	)		8,773			9,900
Cash flows from financing activities
Proceeds from exercise of share options		226			944			1,424
Cash repayment of convertible bonds		–			–			(5,100	)
Principal elements of lease payments		(489	)		(472	)		(1,001	)
Proceeds from issue of share capital		18,950			–			22,500
Transaction costs relating to the issue of share capital		(931	)		–			(1,234	)
Net cash used in continuing financing activities		17,756			472			16,589
Net cash from/(used in) discontinued financing activities		–			194			(946	)
Net cash flow from financing activities		17,756			666			15,643
Net increase/(decrease) in cash and cash equivalents		3,449			(4,147	)		(1,239	)
Cash and cash equivalents at the beginning of the period		16,855			17,778			17,778
Effect of movements in exchange rates on cash held		(33	)		78			316
Cash and cash equivalents at the end of period, including held in disposal group		20,271			13,709			16,855
Cash held by disposal group		–			(1,064	)		–
Cash and cash equivalents at end of year		20,271			12,645			16,855

Notes to the unaudited condensed consolidated financial statements
for the 6 months ended 30 June 2026

1)   Basis of preparation

Avacta Group plc (‘the Company’) is a company incorporated in England and Wales under the Companies Act 2006. These condensed consolidated interim financial statements as at and for the 6 months ended 30 June 2026 (“interim financial statements”) comprise the Company and its subsidiaries (together referred to as ‘the Group’).

The interim financial statements for the 6 months ended 30 June 2026 are unaudited. This information does not constitute statutory accounts as defined in Section 435 of the Companies Act 2006. The financial figures for the year ended 31 December 2025, as set out in this report, do not constitute statutory accounts but are derived from the statutory accounts for that financial year. The statutory accounts for the year ended 31 December 2025 were prepared under IFRS and have been delivered to the Registrar of Companies. The auditors reported on those accounts. Their report was unqualified, did not draw attention to any matters by way of emphasis and did not include a statement under Section 498 of the Companies Act 2006.

The Board confirms that, to the best of its knowledge, these condensed financial statements have been prepared in accordance with IAS34 Interim Financial Reporting and should be read in conjunction with the Group’s last annual consolidated financial statements as at and for the year ended 31 December 2025 (‘last annual financial statements’). They do not include all of the financial information required for a complete set of IFRS financial statements. However, selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Group’s financial position and performance since the last annual financial statements.

The Group’s operations and results are not impacted by seasonal fluctuations.

The Board approved these interim financial statements for issue on 29 September 2026.

Going concern

The Financial Statements have been prepared on a going concern basis. The Company’s going concern assessment has been performed as part of the Group’s going concern assessment. 

During the six months ended 30 June 2026, the Group reported a loss from continuing operations of £19.0 million and incurred net cash used in operating activities of £15.7 million.

As at 30 June 2026, cash and cash equivalents were £20.3 million. The Group has external borrowings in the form of a convertible bond, with a principal amount outstanding of £19.2 million as at 30 June 2026.

During the six months ended 30 June 2026, the Group completed equity placings and subscriptions raising gross proceeds of £19.0 million. During the period, the Group also made an interest-only cash repayment of £0.7 million in respect of the convertible bond and a partial conversion resulted in the derecognition of £1.2 million of the host debt liability. 

The Group continues to advance its clinical trials and generate successful data and expects to report further findings in late 2026 and early 2027. Following the data, the Group will evaluate partnering and out-licensing opportunities. 

The Group faces significant risks associated with successful execution of its strategy. These risks include, but are not limited to technology and product development, introduction and market acceptance of new products and services, changes in the marketplace, liquidity, competition from existing and new competitors which may enter the marketplace and retention of key personnel. As a clinical stage oncology business, the Directors anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, growth plans and further development of our technology.

The Directors have considered detailed cash flow forecasts that extended to 31 December 2027, which is at least twelve months from the date of approval of these financial statements (“the going concern period”). The forecasts indicate that we currently have enough cash to fund our planned operations into early first quarter of 2027. The forecasts consider current and future economic conditions that are expected to prevail over the period. These forecasts include assumptions regarding the timing and quantum of investment in the therapeutic development programs together with various scenarios which reflect growth plans, opportunities, risks and mitigating actions. The Board is focused on both the short-term and long-term financing strategy to achieve the company goals including obtaining additional funding through the capital markets.

The forecast therefore shows the Group and the Parent Company are dependent on raising funds to advance their key projects and investments to remain cash positive during the going concern period. There are currently no agreements in place and there is no certainty that funds will be raised within the appropriate timeframe. This indicates that a material uncertainty exists that may cast significant doubt on the Group and the Parent Company’s ability to continue as a going concern, and therefore they may be unable to realise their assets and discharge their liabilities in the normal course of business.

However, the directors have a reasonable expectation that the required funding will be forthcoming. As a result, the directors believe that the Group and the Company will continue as a going concern for a period of at least 12 months from the date of approval of these financial statements and have therefore prepared the financial statements on a going concern basis.

The financial statements do not include any adjustments that would result from the basis of preparation being inappropriate.

2)   Use of judgements and estimates and significant accounting policies

The preparation of the interim financial statements requires management to make judgements and estimates that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates.

Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to estimates are recognised prospectively.

The significant judgements made by management in applying the Group’s accounting policies and the key sources of estimation uncertainty are consistent with those disclosed in the Group’s annual financial statements for the year ended 31 December 2025.

The accounting policies applied in these interim financial statements are consistent with those applied in the Group’s consolidated financial statements for the year ended 31 December 2025. A number of new standards and amendments became effective from 1 January 2026 but have not had a material impact on the Group’s financial statements.

3)  Segmental reporting

Operating segments – continuing operations

In the view of the Board of Directors, the Group has one (2025: one) reportable segment in continuing operations: Therapeutics. Segment reporting has been presented on this basis for continuing operations. The Directors recognise that the operations of the Group are dynamic and therefore this position will be monitored as the Group develops.

The principal activity of Therapeutics is the development of novel cancer therapies harnessing proprietary technology.

The previous second reportable segment as the diagnostics division which is currently under a divestment strategy and being held for sale. All reporting for this segment will be presented as discontinuing operations.

Segment revenue represents revenue from external customers arising from sale of goods and services, plus inter-segment revenues. Inter-segment transactions are priced on an arm’s length basis. Segment results, assets and liabilities include items directly attributable to a segment as well as those that can be allocated on a reasonable basis.

The Group’s revenue to destinations outside the UK amounted to 100% (2024: 100%) of total revenue. The revenue analysis below is based on the country of registration of the customer:

		6 months ended 30 June 2026		6 months ended 30 June 2025		Year ended 31 December 2025
£000
South Korea		56		56		113
		56		56		113

During the six month period ended 30 June 2026, there were no transactions with a single external customer that exceeded 10% of the Group’s revenue, being £56,000.

During the six month period ended 30 June 2025, there were no transactions with a single external customer that exceeded 10% of the Group’s revenue, being £56,000.

During the year 31 December 2025, transactions with one external customer in the Therapeutics segment amounted individually to 10% or more of the Group’s revenues from continuing operations, being £113,000.

Operating segment analysis for the six months ended 30 June 2026
	Therapeutics			Central overheads1			Total (continuing)			Diagnostics (discontinued)
	£000			£000			£000			£000
Revenue	56			–			56			–
Cost of goods sold	–			–			–			–
Gross profit	56			–			56			–
Research costs	(9,686	)		–			(9,686	)		–
R&D expenditure credit (RDEC)	926			–			926			–
Selling, general and administrative expenses	(1,932	)		(1,941	)		(3,873	)		–
Adjusted EBITDA	(10,636	)		(1,941	)		(12,577	)		–
Exceptional expenses	–			23			23			–
Depreciation expense	(543	)		(14	)		(557	)		–
Amortization expense	(2	)		(3	)		(5	)		–
Share of loss of associate	(259	)		–			(259	)		–
Share-based payment expense	(321	)		(215	)		(536	)		–
Segment operating loss	(11,761	)		(2,150	)		(13,911	)		–

¹Central overheads, which relate to operations of the Group functions, are not allocated to the operating segments.

Operating profit/loss is the measure of profit or loss regularly reviewed by the Board. Other items comprising the Group’s loss before tax are not monitored on a segmental basis.

The information reported to the Board does not include balance sheet information at the segment level.

Operating segment analysis for the six months ended 30 June 2025
	Therapeutics			Central overheads1			Total (continuing)			Diagnostics (discontinued)
	£000			£000			£000			£000
Revenue	56			–			56			6,102
Cost of goods sold	–			–			–			(3,285	)
Gross profit	56			–			56			2,817
Research costs	(7,200	)		–			(7,200	)		–
Selling, general and administrative expenses	(1,493	)		(2,977	)		(4,470	)		(3,465	)
Adjusted EBITDA	(8,637	)		(2,977	)		(11,614	)		(648	)
Exceptional expenses	–			(899	)		(899	)		–
Depreciation expense	(609	)		(119	)		(728	)		(233	)
Amortization expense	(3	)		(7	)		(10	)		(31	)
Share of loss of associate	(189	)		–			(189	)		–
Share-based payment expense	(365	)		(375	)		(740	)		–
Segment operating loss	(9,803	)		(4,377	)		(14,180	)		(912	)

¹Central overheads, which relate to operations of the Group functions, are not allocated to the operating segments.

Operating profit/loss is the measure of profit or loss regularly reviewed by the Board. Other items comprising the Group’s loss before tax are not monitored on a segmental basis.

The information reported to the Board does not include balance sheet information at the segment level.

Operating segment analysis for the year ended 31 December 2025
	Therapeutics			Central overheads1			Total (continuing)			Diagnostics (discontinued)
	£000			£000			£000			£000
Revenue	113			–			113			6,199
Cost of goods sold	–			–			–			(3,272	)
Gross profit	113			–			113			2,927
Research costs	(18,761	)		–			(18,761	)		–
R&D expenditure credit (RDEC)	1,852			–			1,852			–
Selling, general and administrative expenses	(4,378	)		(4,106	)		(8,485	)		(4,804	)
Adjusted EBITDA	(21,174	)		(4,106	)		(25,281	)		(1,877	)
Exceptional expenses	–			(754	)		(754	)		–
Depreciation expense	(1,121	)		(147	)		(1,268	)		–
Amortization expense	(6	)		(5	)		(11	)		–
Share of loss of associate	(454	)		–			(454	)		–
Share-based payment expense	(827	)		(1,299	)		(2,126	)		(65	)
Segment operating loss	(23,582	)		(6,312	)		(29,894	)		(1,942	)

¹Central overheads, which relate to operations of the Group functions, are not allocated to the operating segments.

Operating profit/loss is the measure of profit or loss regularly reviewed by the Board. Other items comprising the Group’s loss before tax are not monitored on a segmental basis.

The information reported to the Board does not include balance sheet information at the segment level.

4)   Revenue

The Group’s operations and main revenue streams are those described in the last annual financial statements. The Group’s revenue is all derived from contracts with customers.

Disaggregation of revenue

In the following table, revenue is disaggregated by its nature. The table also includes a reconciliation of the disaggregated revenue with the Group’s reportable segments (see Note 3).

Six months ended 30 June 2026

£’000	Therapeutics	Continuing operations	Diagnostics (discontinued)	Total
Nature of revenue
Sale of goods	–	–	–	–
Provision of services	–	–	–	–
Licence-related income	56	56	–	56
	56	56	–	56

Six months ended 30 June 2025

£’000	Therapeutics	Continuing operations	Diagnostics (discontinued)	Total
Nature of revenue
Sale of goods	–	–	5,807	5,807
Provision of services	–	–	294	294
Licence-related income	56	56	–	56
	56	56	6,102	6,158

Year ended 31 December 2025

£’000	Therapeutics	Continuing operations	Diagnostics (discontinued)	Total
Nature of revenue
Sale of goods	–	–	5,922	5,922
Provision of services	–	–	277	277
License-related income	113	113	–	113
	113	113	6,199	6,312

5)   Earnings per share

Total Earnings Per Shares	Unaudited			Unaudited			Audited
£’000	6 months ended 30 June 2026			6 months ended 30 June 2025			Year ended 31 December 2025
Loss for the period	(19,023	)		(17,728	)		(38,612	)
Weighted average number of shares (number)	449,438,000			381,243,598			399,784,000
Basic and diluted loss per ordinary share	(4.23	)		(4.65	)		(9.66	)

Continuing Earnings Per Share	Unaudited			Unaudited			Audited
£’000	6 months ended 30 June 2026			6 months ended 30 June 2025			Year ended 31 December 2025
Loss for the period	(19,023	)		(16,134	)		(36,264	)
Basic and diluted loss per ordinary share	(4.23	)		(4.23	)		(9.07	)

Discontinued Earnings Per Share	Unaudited			Unaudited			Audited
£’000	6 months ended 30 June 2026			6 months ended 30 June 2025			Year ended 31 December 2025
Loss for the period	–			(1,594	)		(2,348	)
Basic and diluted loss per ordinary share	–			(3.82	)		(0.59	)

6) Convertible bond

In October 2022, the Group issued senior unsecured convertible bonds (the “Bonds”) with a principal value of £55.0 million to a fund advised by Heights Capital Ireland LLC. The Bonds were issued at 95% of par, generating net proceeds of £52.25 million after placement fees, and bear interest at a fixed coupon of 6.5% per annum, payable quarterly in arrears.

The Bonds have a maturity of five years and include conversion and settlement features that allow repayment in either cash or ordinary shares of Avacta Group plc, at the Group’s option, subject to the contractual terms of the instrument. The Bonds also contain conversion rights permitting the bondholder to convert all or part of the outstanding balance at specified times during the term.

The convertible bond is accounted for as a hybrid financial instrument comprising a host debt liability and an embedded derivative representing the equity-linked conversion and settlement features. The host debt liability is measured at amortised cost while the embedded derivative is measured at fair value through profit or loss. The embedded derivative is valued using a Monte Carlo option pricing model and is classified as a Level 3 fair value measurement under the IFRS fair value hierarchy.

On 20 October 2025, amendments to the terms of the Bonds became effective. The amendments were assessed under IFRS 9 and determined to represent a substantial modification of the liability. Accordingly, the original host debt liability was derecognised and a new host debt liability was recognised at fair value. The embedded derivative remained bifurcated from the host debt liability and continues to be measured separately at fair value through profit or loss.

During the six months ended 30 June 2026, the Group made an interest-only repayment of £0.66 million in cash. In addition, a partial conversion of the Bonds resulted in the derecognition of £1.20 million of host debt liability and £0.37 million of derivative liability, with the corresponding amounts recognised within share capital and share premium. During the period, the carrying amount of the host debt liability was adjusted to reflect revisions to expected future cash flows arising from changes to the repayment profile, including the acceleration of a previously deferred repayment into July 2026. This resulted in a charge of £0.82 million, which has been recognised within Gain/(loss) on modification of financial liabilities in the Consolidated Statement of Profit or Loss.

At 30 June 2026, the carrying amount of the host debt liability was £15.77 million (30 June 2025: £18.17 million; 31 December 2025: £13.36 million) and the carrying amount of the derivative liability was £3.29 million (30 June 2025: £0.27 million; 31 December 2025: £2.79 million). Interest expense recognised in respect of the host debt liability during the period amounted to £3.46 million (H1 2025: £3.87 million; FY 2025: £6.98 million). The remeasurement of the derivative liability resulted in a £0.87 million loss recognised in profit or loss during the period (H1 2025: £1.01 million gain; FY 2025: £1.51 million loss).

Events during the six months ended 30 June 2026

• On 13 May 2026, a partial conversion of the Bonds resulted in the settlement of £1.20 million of the host debt liability through the issue of ordinary shares. The associated derivative liability of £0.37 million was also derecognised and recognised within equity.

Events following the six months ended 30 June 2026

• In July 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the January 2026 quarterly deferred convertible bond repayment, as referenced most recently in the financing announced on 5 June 2026, which the Company has elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £3.67 million representing principal of £2.4 million together with the associated interest and fees payable in the deferment.
• In September 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the April 2026 quarterly deferred convertible bond repayment, which the Company has elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £2.613 million, representing principal of £2.4 million together with the associated interest and fees payable in the deferment. Following the cash settlement of the April 2026 quarterly deferred convertible bond repayment, both deferred payments have now been satisfied.

	Convertible bond – derivative			Convertible bond – debt
	£000			£000
At 1 January 2025	1,281			20,497
Repayments (equity settled)	–			(6,197	)
Interest expense	–			3,865
Revaluation of derivative	(1,008	)		–
At 30 June 2025	273			18,165
Derecognition of old financial liability	–			(17,289	)
Recognition of new modified liability	–			15,258
Repayments (cash settled)	–			(5,887	)
Interest expense	–			3,115
Revaluation of derivative	2,515			–
At 31 December 2025	2,788			13,362
Repayments interest only (cash settled)	–			(663	)
Early conversion (equity settled)	(369	)		(1,200	)
Revision to expected cash flows	–			816
Interest expense	–			3,460
Revaluation of derivative	869			–
At 30 June 2026	3,288			15,774

7)   Share capital

	Unaudited Six months ended 30 June 2026		Unaudited Six months ended 30 June 2025		Audited Year ended 31 December 2025
	£000		£000		£000
Allotted, called up and fully paid:
– 471,626,143 (H1 2025: 393,690,542, 2025: 440,415,495 ordinary shares of 10p each	47,163		39,369		44,042
– 19,327,344 deferred shares of 0.4p each	77		77		77
	47,240		39,446		44,119

During the period, the following ordinary share issues occurred:

• On 7 April 2026, 15,873,016 ordinary shares of 10p each were allotted and issued at 63p per share pursuant to a placing and subscription.
• On 6 May 2026, 580,791 ordinary shares of 10p each were allotted and issued following the exercise of options held by Bach Biosciences LLP.
• On 18 May 2026, 1,604,063 ordinary shares of 10p each were issued on conversion of a portion of the unsecured convertible bond.
• On 2 June 2026, 793,651 ordinary shares of 10p each were allotted and issued at 63p per share pursuant to a subscription.
• On 11 June 2026, 12,792,859 ordinary shares of 10p each were allotted and issued at 70p per share pursuant to a placing.
• On 11 June 2026, 64,284 ordinary shares of 10p each were allotted and issued at 70p per share pursuant to subscriptions.

Additionally, during the period a total of 375,000 ordinary shares of 10p each were allotted and issued following the exercise of vested employee share options. Options were exercised at prices ranging from 10p to 25p per share.

The April and June 2026 placings, together with the associated subscriptions, raised gross proceeds of approximately £18.95 million before expenses.

8)   Operating cash outflow from operations

	Unaudited			Unaudited			Audited
	6 months ended 30 June 2026			6 months ended 30 June 2025			Year ended 31 December 2025
	£000			£000			£000
Cash flow from operating activities
Loss for the period	(19,023	)		(17,017	)		(38,612	)
Adjustments for:
Loss from discontinued operations	–			889			2,112
Amortization	5			10			11
Impairment losses	–			–			–
Depreciation	557			728			1,268
Net (gain) / loss on disposal of property, plant and equipment	(54	)		–			284
Net (gain) / loss on disposal of Subsidiary	–			705			236
Share of loss of associate	259			189			454
Equity-settled share-based payment charges	536			740			2,126
Loss / (gain) on fair value of convertible bond	869			(1,009	)		1,506
Increase in investment in associate	(56	)		(56	)		(113	)
Net finance costs	4,067			3,754			6,782
Taxation	(750	)		(737	)		(1,635	)
Operating cash outflow before changes in working capital	(13,590	)		(11,804	)		(26,997	)
(Increase) / decrease in trade and other receivables	(173	)		(1,250	)		(1,020	)
Increase / (decrease) in trade and other payables	(1,926	)		723			3,090
Operating cash outflow from operations	(15,689	)		(12,331	)		(24,927	)

9)  Events after the reporting period

In July 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the January 2026 quarterly deferred convertible bond repayment, as referenced most recently in the financing announced on 5 June 2026, which the Company has elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £3.67 million representing principal of £2.4 million together with the associated interest and fees payable in the deferment.

In September 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the April 2026 quarterly deferred convertible bond repayment, which the Company has elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £2.613 million, representing principal of £2.4 million together with the associated interest and fees payable in the deferment. Following the cash settlement of the April 2026 quarterly deferred convertible bond repayment, both deferred payments have now been satisfied.

As announced on 1 September 2026, the Board of Directors granted share options under the Company’s Equity Share Option Scheme incentive plan (“ESOS”) to all members of the Management Team (the “Options”). The Options are exercisable at an exercise price of 69 pence per share, being the mid-market closing price of the Company’s Ordinary Shares on 27 August 2026, the last trading date before the Options were granted.

As announced on 14 September 2026, Mats Blom, an experienced biotechnology finance executive and Board member with a strong track record as Chief Financial Officer in several life sciences companies, was appointed as a member of its Board of Directors and Chair of the Audit Committee. 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

Alabama hub serves more than 1,200 payroll, HR, benefits customers as Asure expands its focus on employers with 10 to 100 employees

AUSTIN, Texas, Sept. 30, 2026 (GLOBE NEWSWIRE) — Asure Software, Inc. (Nasdaq: ASUR), a provider of payroll and HR solutions for employers and enterprise payroll tax and treasury infrastructure, will sponsor The University of Alabama’s 72nd Annual Human Resources Management Conference on October 21–22 in Tuscaloosa and the following day will host an open house at its Gardendale, Alabama, hub office on October 23. Together, the events mark Asure’s commitment to accelerate investment in serving the fast-growing base of Alabama employers.

Asure’s Alabama hub serves more than 1,200 of the company’s direct customers. That existing customer base, combined with what Asure sees as strong growth among Alabama businesses with 10 to 100 employees, has shaped its decision to expand the hub’s role. The company is particularly keen on the tech-fueled Huntsville market, which is growing over 250% faster than the state’s overall labor force. Statewide, Alabama employers face increasing demands across payroll, HR, benefits, time and attendance, and compliance.

“More than 1,200 direct customers already rely on our local Alabama team. That gives us a strong foundation for serving more employers across the state,” said Pat Goepel, Chairman and CEO of Asure. “We see an opportunity to uniquely help Alabama’s businesses growing from 10 employees to 100: they want state of the art payroll and HR support, and value local expert support. Investing in Gardendale brings those capabilities close to home.”

Hosted by The University of Alabama at the Bryant Conference Center, the annual human resources management conference brings together HR professionals, business owners and managers for sessions on workforce management, compensation, employee development and employment law. Asure’s sponsorship connects the company with the professionals advising Alabama employers as their workforce needs evolve.

The October 23 open house 12:30pm to 4pm will bring customers, prospective customers and local business leaders together at Asure’s Gardendale hub at 2447 Decatur Highway, Gardendale. Over celebrated barbeque from Bessemer’s famous Bob Sykes BBQ, Asure plans to introduce attendees to the team serving its Alabama customers and discuss how its payroll and HR solutions help employers manage the operational work that accompanies growth. The event follows the two-day Tuscaloosa conference and extends Asure’s engagement with employers beyond the conference floor.

“The conference is an opportunity to listen to Alabama employers and their HR, compensation, and benefits leaders, and the open house is an opportunity to show them the team behind our service,” Goepel added. “Our investment in Gardendale reflects the scale of the business we already support here and our confidence in the state’s employers.”

For conference information, visit https://training.ua.edu/hrm/. For invitations and to RSVP to the October 23 open house 12:30pm-4pm at 2447 Decatur Highway, visit https://offers.asuresoftware.com/asure-bbq-open-house.

About Asure Software

Asure (Nasdaq: ASUR) provides payroll and HR solutions for employers and enterprise payroll tax and treasury infrastructure for large organizations. For employers, Asure’s platform covers payroll, HR, recruiting, time and attendance, benefits, and compliance — delivered through AsureCentral, its connected platform, or through AsureWorks, its managed services offering for employers who prefer to outsource the work entirely. For large enterprises, Asure’s payroll tax and treasury infrastructure handles multi-jurisdiction tax filing, funding, and money movement, integrating with platforms including Workday, Oracle, and SAP. For more information, visit www.asuresoftware.com.

Investor Relations Contact

Patrick McKillop
Vice President, Investor Relations
Asure Software
617-335-5058
patrick.mckillop@asuresoftware.com

•      Rocket Doctor AI Inc. CEO, Dr. Essam Hamza to present live on October 7, 2026.
•      Presentation will highlight Rocket Doctor AI’s growth story, recent milestones, and strategy.

Vancouver, BC, Sept. 30, 2026 (GLOBE NEWSWIRE) — Rocket Doctor AI Inc. (CSE: AIDR, OTC: AIRDF, Frankfurt: 939) (“Rocket Doctor AI” or the “Company”), a physician-built, AI-powered healthcare technology company focused on empowering doctors and expanding access to high-quality care, is pleased to announce that it will be presenting on October 7, 2026 at National Investment Banking Association (NIBA)’’s 153rd Investment Conference in Fort Lauderdale, Florida. CEO of Rocket Doctor AI Inc., Dr. Essam Hamza, will present a high-level overview of the company’s highlights, platform, recent milestones, and growth strategy.

Dr. Essam Hamza, CEO of Rocket Doctor AI, commented, “I am thrilled to present at NIBA’s 153rd Investment Conference in Fort Lauderdale. This event offers a fantastic opportunity to overview Rocket Doctor AI’s growth story and strategy, as well as connecting with market leading investment professionals, financing partners, and market makers.”

About National Investment Banking Association

The National Investment Banking Association (NIBA) is a non-profit organization that has been serving the micro-cap and small-cap investment community for almost 50 years. NIBA’s 153rd Investment Conference website is available here: https://nibas-152nd-investment-conference.events.accessnewswire.com/

About Rocket Doctor AI Inc.

Rocket Doctor AI Inc. delivers physician-built, AI-powered solutions designed to make high-quality healthcare accessible throughout the entire patient journey. A cornerstone of the company’s proprietary technology is the Global Library of Medicine (GLM), a clinically validated decision support system developed with input from hundreds of physicians worldwide.

Alongside the GLM is Rocket Doctor Inc, and its AI-powered digital health platform and marketplace. Having helped empower over 350 MDs to provide care to more than 800,000 patient visits, our proprietary technology software and systems enable doctors to independently launch and manage their own virtual or hybrid in-person practices – improving efficiency, restoring autonomy to MDs, and expanding patient access to care.

By reducing administrative burdens and ensuring greater consistency in care, our technology creates more time for meaningful physician-patient interactions. We are committed to reaching underserved, rural, and remote communities in Canada who often lack access to family doctors and supporting patients on Medicaid and Medicare in the United States. With advanced AI, large language models, and connected medical devices, Rocket Doctor AI is redefining modern healthcare – making it more scalable, equitable, and patient-centered.

To learn more about Rocket Doctor AI Inc’s products and services, contact: www.rocketdoctor.ai or email: info@rocketdoctor.ai

FOR ADDITIONAL INFORMATION, CONTACT:

Dr. Essam Hamza, CEO, Rocket Doctor AI essam.hamza@rocketdoctor.ai

Dr. Bill Cherniak, CEO, Rocket Doctor Inc. bill@rocketdoctor.io

For media inquiries, contact: media@rocketdoctor.ai

Call: +1 (778) 819 8321

Cautionary Statements

This news release contains forward-looking statements relating to the future operations of Rocket Doctor AI Inc. and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the Company’s participation at the National Investment Banking Association (NIBA) 153rd Investment Conference  Conference, the Company’s platform, solutions, milestones, growth strategy, and future plans and objectives of Rocket Doctor AI Inc., are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from Rocket Doctor AI Inc.’s expectations include other risks detailed from time to time in the filings made by Rocket Doctor AI Inc. with securities regulators.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of Rocket Doctor AI Inc. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and Rocket Doctor AI Inc. will only update or revise publicly the included forward-looking statements as expressly required by Canadian securities law.

– Publication in this premier journal after rigorous peer review validates the VIRAGE study and supports the continued evaluation of VCN-01 in the treatment of metastatic pancreatic cancer –

– Data are consistent with an immune mediated mechanism of action for VCN-01 that may enhance the antitumor effects of a range of coadministered pancreatic cancer therapies –

– The feasibility of administering more frequent repeated VCN-01 doses to potentially improve clinical outcomes in metastatic pancreatic cancer patients is currently being evaluated in the VIRAGE2 Phase 2a clinical trial –

ROCKVILLE, Md., Sept. 30, 2026 (GLOBE NEWSWIRE) — Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that detailed analysis of results from the VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic cancer patients were published in Nature Medicine. The article, entitled “Intravenous hyaluronidase-expressing oncolytic adenovirus with chemotherapy in metastatic pancreatic cancer: a randomised phase 2b trial”, can be read here.

“We are proud to see the peer-reviewed results from the VIRAGE trial published in Nature Medicine and made available to the entire scientific community,” said Manel Cascalló, PhD, General Director of Theriva Biologics S.L. and co-author of the article. “As elaborated in the publication, improved overall survival, progression free survival, and duration of response were observed in metastatic pancreatic cancer patients treated with VCN-01 combined with standard-of-care (SoC) gemcitabine/nab-paclitaxel chemotherapy compared to patients receiving SoC chemotherapy alone. Moreover, the Kaplan-Meier survival analysis and the timing of responses in VCN-01 treated patients suggest an immune mediated mechanism of action for VCN-01 in addition to its stroma degrading effects. We are excited about the potential for VCN-01 in different cancer therapy combinations, and we are extremely grateful to the patients who participated in VIRAGE, their families, our clinical investigators and their teams, and our co-authors for their commitment, dedication and diligence.”

As previously reported, greater improvements in patient survival during the VIRAGE study were observed in metastatic pancreatic cancer patients receiving 2 doses of VCN-01 administered 3 months apart, Following End-of-Phase 2 feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), Theriva has recently initiated VIRAGE2; a small Phase 2a study designed to evaluate the feasibility of more frequent, repeated dosing of VCN-01 in combination with SoC chemotherapy. The first patient in VIRAGE2 was treated in August 2026, and the study is expected to complete enrollment during the second half of 2026. Initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027. Results from VIRAGE2 will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial. For more details see About VIRAGE2 below.

In parallel with VIRAGE2, Theriva is engaging with the FDA to finalize the design of a potential Phase 2/3 study evaluating VCN-01 in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy. VCN-01 has received Rare Pediatric Disease designation for the treatment of retinoblastoma and may be eligible to receive a Priority Review Voucher if VCN-01 is approved in this indication by September 30, 2029.

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (PDAC) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action is intended to enable VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials in different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). VCN-01 has also been made available for compassionate use in retinoblastoma patients, and 2 patients have been treated in this program. VCN-01 has been granted Orphan Drug designation for the treatment of metastatic PDAC and retinoblastoma in Europe and the USA, as well as FDA Fast Track designation for the treatment of metastatic PDAC and Rare Pediatric Disease designation for the treatment of retinoblastoma. More information on VCN-01 clinical trials is available at Clinicaltrials.gov.

About VIRAGE

VIRAGE (EUCT 2024-511290-30-00; NCT05673811) was a two-arm, Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. A total of 112 patients were enrolled at 5 sites in the U.S. and 9 sites in Spain. In both the control and VCN-01 (zabilugene almadenorepvec) treatment arms, patients received gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy in repeated 28-day cycles until disease progression. In the VCN-01 treatment arm only, patients were also administered intravenous VCN-01 seven-days prior to starting the first and fourth cycles of gemcitabine/nab-paclitaxel treatment (study days 1 and ~92 respectively). As previously reported and presented, PDAC patients in the VCN-01 plus gemcitabine/nab-paclitaxel SoC treatment arm demonstrated increased overall survival, progression free survival, and duration of response compared to patients in the control arm treated with gemcitabine/nab-paclitaxel SoC alone. Greater improvements in these parameters were observed in patients who received 2 doses of VCN-01 administered 3 months apart, and the pharmacokinetics of VCN-01 were not different between the 2 doses despite the presence of neutralizing antibodies.

About VIRAGE2

VIRAGE2 (EUCT: 2026-525566-21-00; NCT07701486) is a Phase 2a, single-arm, open-label, clinical trial in 6 evaluable patients with histologically confirmed, newly diagnosed metastatic PDAC enrolled at a single site in Spain. Patients are intended to receive at least three “macrocycles” of VCN-01 (zabilugene almadenorepvec) and gemcitabine/nab-paclitaxel SoC chemotherapy, followed by SoC gemcitabine/nab-paclitaxel cycles until disease progression. In each VCN-01 macrocycle, intravenous VCN-01 is administered on day 1 followed by gemcitabine/nab-paclitaxel SoC chemotherapy on days 8, 15, 22, 36, 43, and 50. Macrocycles are repeated on days 57 and 113. The primary objective of the VIRAGE2 trial is to evaluate whether administration of at least 3 doses of VCN-01, with 2 months between doses, is well tolerated by patients without adversely impacting VCN-01 pharmacodynamics. Primary endpoints for the trial are the adverse event profile and levels of VCN-01 viral genomes in blood. Secondary endpoints include objective response rate, duration of response, progression free survival, overall survival, and circulating levels of anti-VCN-01 neutralizing antibodies. Exploratory endpoints include estimates of potential VCN-01 shedding by measuring VCN-01 viral genomes in sputum and stool. The study is not formally powered for evaluation of clinical efficacy endpoints and is intended to support evaluation of the potential efficacy of the more frequent repeated dosing regimen in subsequent clinical trials.

About Theriva™ Biologics, Inc.

Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidate is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial remains open with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. Enrollment is paused and completion of this trial is pending receipt of grant funding or funding through a partnership or other collaboration. For more information, please visit Theriva™ Biologics’ website at www.therivabio.com.

Forward-Looking Statement

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding publication in Nature Medicine validating the VIRAGE study and supporting the continued evaluation of VCN-01 in the treatment of metastatic pancreatic cancer; more frequent, repeated VCN-01 potentially improving clinical outcomes in metastatic pancreatic cancer patients; the potential for VCN-01 in different cancer therapy combinations, the VIRAGE2 study expecting to complete enrollment during the second half of 2026; initial pharmacodynamic and safety/tolerability data from VIRAGE2 being anticipated by Q3 2027; results from the VIRAGE2 study informing the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial; administering at least 3 doses of VCN-01 in the VIRAGE2 trial given approximately 2 months apart in combination with standard-of-care chemotherapy; finalizing with the FDA the design of a potential Phase 2/3 study evaluating VCN-01 in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy; and receiving a Priority Review Voucher if VCN-01 is approved for the treatment of retinoblastoma by September 30, 2029. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize protocols for future clinical trials evaluating VCN-01; results of future trials supporting further clinical development of VCN-01 and supporting the benefits of more frequent repeated dosing of VCN-01; the Company’s ability to obtain development funding and/or partnerships; the Company’s commencement of planned clinical trials, which remains subject to sufficient financing; the Company’s ability to raise capital and/or enter into one or more strategic alternatives, that may include a business combination, merger or reverse merger; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in cancer patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat cancer patients; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

For further information, please contact:
Investor Relations:
Kevin Gardner
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com

Source: Theriva Biologics, Inc.

Starcloud’s SC-1L compute payload to operate onboard Firefly’s Elytra spacecraft in lunar orbit, validating capabilities for a future orbital lunar data center

*Rendering of Firefly’s Elytra vehicle in lunar orbit with Starcloud’s compute payload onboard

CEDAR PARK, Texas, Sept. 30, 2026 (GLOBE NEWSWIRE) — Firefly Aerospace (Nasdaq: FLY), a market leading space and defense technology company, today announced a new commercial payload agreement with Starcloud to demonstrate advanced AI computing capabilities in lunar orbit. Starcloud’s computing payload, designated SC-1L, will fly onboard Firefly’s Elytra orbital vehicle to validate the core capabilities of a future data center around the Moon that can support lunar surface and orbital infrastructure.

“We’re proud to collaborate with innovative customers like Starcloud and collectively take another step toward establishing the infrastructure that will power a permanent human and robotic presence at the Moon,” said Ray Allensworth, Vice President of Spacecraft at Firefly Aerospace. “By pairing Starcloud’s AI computing payload with our Elytra vehicle and Solux vision system, we’re demonstrating how data can be captured, processed, and delivered from lunar orbit, laying the groundwork for the computing infrastructure future lunar operations will depend on.”

Integrated on Elytra, Starcloud’s SC-1L processor will ingest data from Firefly’s onboard Solux vision system, perform high-power AI computing on orbit, and rapidly transmit the processed data back to Earth. The demonstration builds directly on Starcloud’s recent AI computing demonstration in low Earth orbit, extending those proven capabilities into lunar orbit.

Starcloud is being onboarded to Firefly’s third lunar mission that’s targeted to launch no earlier than 2028. For this mission, Firefly’s Elytra orbiter will first serve as the transfer vehicle and communications relay for Firefly’s Blue Ghost lander that will land on the Moon’s Gruithuisen Domes and operate several science and technology instruments as part of NASA’s Commercial Lunar Payload Services (CLPS) initiative. Following completion of the mission, Elytra will remain in lunar orbit for five years to enable customer payload and imaging operations, including Starcloud’s demonstration.

“Space is the future of data centers, and the Moon is the next frontier for that vision,” said Ezra Feilden, Cofounder and CTO at Starcloud. “We successfully validated our ability to run and train AI models on enterprise grade GPUs in low Earth orbit, and now we’re taking this proven technology to lunar orbit. Onboard Firefly’s Elytra vehicle, we’ll demonstrate high-power AI computing and further prove we can process massive volumes of data right where it’s generated to support the growing infrastructure beyond Earth.”

Formerly known as Sol3, Firefly’s Solux vision system onboard Elytra enables spacecraft to autonomously navigate, land, and track their orientation in space environments where Global Navigation Satellite Systems (GNSS) and GPS are unavailable. Elytra will also have high-resolution telescopes onboard to enable Firefly’s Ocula lunar imaging service that provides advanced lunar surface mapping, mineral detection, and reconnaissance.

This will be the second Elytra vehicle Firefly is deploying to lunar orbit following the launch of Blue Ghost Mission 2, targeted for no earlier than 2027. Each Elytra vehicle is designed to remain in lunar orbit for up to five years, enabling more rapid revisit times of the lunar surface for government and commercial customers.

Firefly also recently announced a collaboration with NVIDIA to process data on orbit for its Ocula lunar imaging service. The Ocula data will be rapidly processed onboard Elytra in lunar orbit and autonomously transmitted back to Earth utilizing the NVIDIA Jetson module and Firefly’s AI software through its SciTec subsidiary. This allows Firefly to mitigate downlink constraints from the Moon by processing data in lunar orbit before it is transmitted to Earth as real-time, actionable insights.

About Firefly Aerospace
Firefly Aerospace is a space and defense technology company on a mission to reliably and repeatedly launch, land, and operate space systems from Earth to the Moon and beyond. As the partner of choice for responsive space missions, Firefly is the first commercial company to launch a satellite to orbit with approximately 24-hour notice and the first to achieve a successful landing on the Moon. Established in 2017, Firefly’s engineering, manufacturing, and test facilities are co-located in central Texas to enable rapid innovation and vertical integration for the company’s small- to medium-lift launch vehicles, lunar landers, and orbital vehicles. For more information, visit www.fireflyspace.com.

Forward-Looking Statement
This press release contains “forward-looking statements” including, but not limited to, statements regarding the expected capabilities and demonstrations of Elytra, Solux and Ocula lunar imaging service, expected launch dates for Blue Ghost missions, AI capabilities, statements of Firefly’s Vice President of Spacecraft, and other statements regarding Firefly’s future expectations, beliefs, plans, objectives, financial condition, assumptions, future events, or performance that are not historical facts. In some cases, you can identify forward-looking statements because they contain words such as “allows” “enable,” “may,” “position,” “will,” “expects,” “plans,” “anticipates,” “could,” “would,” “target”, “set,” “intends,” “support,” and “believes.” There may also be negative words or other similar terms or expressions that concern our expectations, strategy, plans, or intentions. Not all forward-looking statements contain such identifying words. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates, or expectations will be achieved.

Various risks that could cause actual results to differ from those expressed by the forward-looking statements included in this press release include, but are not limited to: our failure to manage our growth effectively, including the increasing technological complexity of our business, and our ability to achieve and maintain profitability; the potential for delayed or failed launches, and any failure of our launch vehicles and spacecraft to operate as intended; our inability to deliver software on time or of a quality that our customers demand; the hazards and operational risks that our products and service offerings are exposed to, including the wide and unique range of risks due to the unpredictability of space; the inability to realize our backlog; the fluctuation of our operating results; adverse publicity stemming from any incident involving us, our competitors, or our customers; the failure to adequately protect our proprietary intellectual property rights; our inability to comply with our contractual obligations; and other risk factors set forth in our filings with the Securities and Exchange Commission. 

Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. These statements are based on management’s current expectations, assumptions, and beliefs concerning future developments, which are inherently subject to uncertainties, risks, and changes in circumstances that are difficult to predict. We cannot assure you that the events reflected in the forward-looking statements will occur; actual events could differ materially from those described in the forward-looking statements. We undertake no intent or obligation to publicly update or revise any of the estimates and other forward-looking statements made in this announcement, whether as a result of new information, future events or otherwise, except as required by law.

Media Contact
press@fireflyspace.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3111ca86-936c-41ba-9720-bd90184f89e6

– Loop Diuretic Route of Administration Option Is Delivered As A Single-Use Nasal Spray –

– Nasal Route Offers a Direct Path to Systemic Absorption Without Relying on the GI Tract –

ANN ARBOR, Mich., Sept. 30, 2026 (GLOBE NEWSWIRE) — With more than six million Americans living with heart failure and healthcare systems increasingly focused on delivering care beyond traditional care settings, Esperion, a company wholly-owned by ARCHIMED, is launching a nationwide effort to raise awareness of ENBUMYST™ (bumetanide nasal spray), a short-term nasal diuretic indicated for the treatment of edema associated with congestive heart failure. As the healthcare landscape prepares for the implementation of the Centers for Medicare & Medicaid Services’ Ambulatory Specialty Model (ASM) in 2027, Esperion aims to educate clinicians, patients, and caregivers about available treatment options and the role novel routes of administration have in heart failure care.

“The implementation of the Ambulatory Specialty Model in 2027 reflects a broader transformation in how heart failure care is delivered and managed,” said Bill Fairey, Interim President and CEO, Esperion. “We believe innovation extends beyond molecules to include how therapies are delivered. Through our acquisition of ENBUMYST, we have expanded Esperion’s portfolio with a novel intranasal route of administration, and we are committed to helping stakeholders understand the full spectrum of treatment options available for patients living with heart failure.”

“For many patients living with heart failure, worsening edema can quickly lead to an emergency department visit for IV therapy. The availability of intranasal bumetanide provides clinicians another treatment option for appropriate patients outside of traditional IV-dependent care settings,” said Andrew P. Ambrosy, MD, MPH, cardiologist and clinician-investigator at Kaiser Permanente Northern California Division of Research and lead author of the ENBUMYST bioequivalence study. “Having a short-term, at-home intranasal treatment option available offers clinicians greater flexibility in how diuretic therapy can be delivered.”

To help patients, caregivers, clinicians, and healthcare stakeholders navigate an evolving heart failure care landscape, Esperion is advancing several education and awareness initiatives, including:

• Strategic targeting of integrated delivery networks navigating the new ASM model effective in January 2027.
• Focused educational materials for HCPs, including nurse practitioners and physician assistants, as well as patients with heart failure and their caregivers.
• Presence at several HF-focused medical meetings during the second half of 2026 and into 2027.
• Partnerships with several leading patient and professional organizations, such as the Heart Failure Society of America, supporting medical professionals and heart failure patients.
• Initiation of robust data generation activities to support the use of ENBUMYST in heart failure treatment.

The Ambulatory Specialty Model (ASM) for heart failure is a mandatory Centers for Medicare & Medicaid Services (CMS) value-based payment model scheduled to launch on January 1, 2027, and continue through December 31, 2031. The model is designed to hold participating specialty providers accountable for the cost and quality of care delivered to Medicare beneficiaries with heart failure across selected geographic regions.

What is ENBUMYST?

ENBUMYST is a prescription medicine used in adults to treat swelling caused by excess fluid in the body (edema) from congestive heart failure, liver disease, and kidney disease.

What is the most important information I should know about ENBUMYST?

• ENBUMYST is a diuretic that helps your body remove fluid. Losing too much fluid can cause dehydration, low blood volume, and increase the risk of blood clots. Blood abnormalities may include decreased salts (electrolytes), and increased nitrogen, glucose and uric acid. The risk of these abnormalities is higher in elderly people, those using higher doses, or those who do not get enough electrolytes by mouth.
• You should not use ENBUMYST if you have severe electrolyte loss.
  Tell your healthcare provider if you experience unusual thirst; dizziness or lightheadedness; weakness or tiredness; fast heart rate; dry mouth or tongue; sudden pain; redness or swelling in your joints; pain, swelling, redness, or warmth in your leg; shortness of breath or fast breathing; high blood sugar; dark urine; pale, tight, cool or clammy skin; muscle cramps; confusion.

Do not use ENBUMYST if you have low or no urine production or are allergic to bumetanide or to any of the ingredients in ENBUMYST.

Before using ENBUMYST, tell your healthcare provider if you have low electrolytes, are on a low-salt diet, have diarrhea, diabetes, nasal problems such as a runny or stuffy nose or polyps, a history of nasal injury or surgery, are or plan to become pregnant, are or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescriptions, over-the-counter medicines, vitamins, and herbal supplements.

ENBUMYST may cause serious side effects, such as worsening kidney function and ringing in the ears or hearing loss.

The most common side effects of ENBUMYST include dehydration, headache, muscle cramps, dizziness, low blood pressure, nausea, and abnormal brain functioning with certain liver problems.

These are not all the possible side effects of ENBUMYST. Talk to your healthcare provider for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

About Esperion
Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.

With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases. For more information, visit esperion.com and follow Esperion on LinkedIn and X.

About ARCHIMED
With offices in Europe, North America and Asia, ARCHIMED is a leading investment firm focused exclusively on healthcare industries. Its mix of operational, medical, scientific and financial expertise allows ARCHIMED to serve as both a strategic and financial partner to healthcare businesses. Prioritized areas of focus include Animal & Environmental Health, Biopharma Products, Consumer Health, Diagnostics, Healthcare IT, Life Science Tools & Services, and MedTech. ARCHIMED helps partners internationalize, acquire, innovate and expand their products and services. ARCHIMED manages €9 billion across its various funds. Since inception, ARCHIMED has been a committed Impact investor, both directly and through its EURÊKA Foundation. For more information about ARCHIMED, please visit www. ARCHIMED.group.

Esperion Contact Information: 
Tiffany Aldrich  
corporateteam@esperion.com  
(616) 443-8438 

NUC-7738 is protected by over 85 issued patents worldwide

EDINBURGH, United Kingdom, Sept. 30, 2026 (GLOBE NEWSWIRE) — NuCana plc (NASDAQ: NCNA) (“NuCana” or the “Company”) announced that the European Patent Office (“EPO”) has granted an important patent covering the composition of matter for NUC-7738.

This patent (EP 3683225) is a key component of the patent protection for NUC-7738, which currently consists of over 85 issued patents worldwide. The composition-of-matter patent covers the chemical structure of NUC-7738, NuCana’s novel anti-cancer agent currently being evaluated in the Phase 2 part of a Phase 1/2 clinical study (NuTide:701) in combination with Keytruda^® (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma.

Securing this patent represents an important milestone for NuCana, further strengthening the Company’s long-term global intellectual property strategy and the potential commercial protection of NUC-7738.

Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer, said: “We are delighted that the EPO has granted this important new patent, which further strengthens the intellectual property protection of NUC-7738 and reflects the strength and novelty of our science. This composition-of-matter patent is a critical addition to our global patent estate for NUC-7738, which now spans over 85 issued patents worldwide, and builds upon similar composition-of-matter patents previously granted in both the United States and China. This underscores our commitment to protecting NUC-7738’s long-term commercial potential across all major markets. With cash resources expected to fund our planned operations into 2029, we believe we are well positioned to advance the clinical development of NUC-7738 and to deliver on a number of important milestones over the remainder of 2026 as we work to bring meaningful new treatment options to patients with cancer.”

About NuCana

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, they have significant shortcomings that limit their efficacy and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome the key limitations of nucleoside analogs and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s pipeline includes NUC-7738 and NUC-3373. NUC-7738 is a novel anti-cancer agent that disrupts RNA polyadenylation, profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. NUC-7738 is in the Phase 2 part of a Phase 1/2 study which is evaluating NUC-7738 as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in patients with melanoma. NUC-3373 is a targeted thymidylate synthase (“TS”) inhibitor designed to overcome key pharmacological limitations associated with other TS inhibitors. NUC-3373 has recently been evaluated in a Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with the PD-1 inhibitor pembrolizumab for patients with advanced solid tumors and in combination with docetaxel for patients with lung cancer, and NuCana is currently evaluating further characterization of mode of action and target indications for further clinical studies of NUC-3373.

Forward-Looking Statements
This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of the Company. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Company’s planned and ongoing clinical studies for the Company’s product candidates and the potential advantages of those product candidates, including NUC-7738 and NUC-3373; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the Company’s goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; the utility of prior non-clinical and clinical data in determining future clinical results; and the sufficiency of the Company’s current cash and cash equivalents to fund its planned operations into 2029. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, our ability to raise additional capital sufficient to fund our planned operations and the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on March 19, 2026, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

For more information, please contact:

NuCana plc
Hugh S. Griffith
Chief Executive Officer
+44 131-357-1111
info@nucana.com

ICR Healthcare
Chris Brinzey
+1 339-970-2843
Chris.Brinzey@ICRHealthcare.com