Company Reiterates Commitment to Addressing Liquidity Needs in Disciplined Manner at the Direction of the Enhanced Board and Management Team

ORLANDO, Fla., Nov. 02, 2026 (GLOBE NEWSWIRE) — Innventure, Inc. (NASDAQ: INV) (“Innventure” or the “Company”), today announced that its Board of Directors (the “Board”) has formed a Strategic Review Committee (the “Committee”) of disinterested directors to oversee a wide range of strategic matters, including an evaluation of capital strategies and other strategic priorities to create shareholder value.

“We are committed to continuing to take actions aimed at enhancing shareholder value, and we value constructive investor feedback as we work through this process,” said Bruce Brown, Chairman. “The Board and management team are focused on evaluating strategies with particular attention to capital efficiency. As the Strategic Review Committee conducts its work, Innventure remains focused on reducing parent company operating costs, addressing near-term liquidity requirements, and supporting independent fundraising efforts at each of our operating companies.”

Initiation of Strategic Review

The Committee is working with independent financial advisors to support a comprehensive review of capital strategies and has been actively considering potential avenues to strengthen the Company’s financial position. The Committee, Board, and management team will continue to act in shareholders’ best interests and support the review process. No timetable has been set for the conclusion of the review, and no decisions have been made regarding potential actions.

Capital Management and Funding Plans (ATM, Accelsius, AeroFlexx and Refinity)

Innventure has undertaken significant actions, including a decrease in headcount since the end of Q1 from 40 to 15, reducing payroll costs by approximately 57%, excluding severance costs. The Company continues to explore additional cost-cutting initiatives.

Innventure has near-term liquidity requirements at the parent-company level given that the majority of the consolidated balance sheet cash Innventure reports is attributable to Accelsius. The Company aims to meet its obligations while maintaining financial discipline, minimizing unnecessary dilution, and preserving the value of its operating company interests. Innventure is fully supportive of independent capital formation at its operating companies, including Accelsius, which has engaged Evercore Group L.L.C. to act as its financial advisor in connection with evaluating its private capital formation needs and alternatives.

To address near-term liquidity needs, Innventure established its at-the-market equity offering program (the “ATM”) on October 6, 2026, as an alternative to the $75 million Standby Equity Purchase Agreement that Innventure entered into in 2023 in connection with going public. The addition of this program does not increase the amount of capital the Company intends to raise in the aggregate. Rather, it provides an additional tool that the Company can employ selectively as capital needs arise, after considering funding requirements, prevailing market conditions and the dilutive impact on shareholders. The Company does not intend to use the ATM to raise capital for Accelsius at current share prices or raise the full $60 million available under the ATM.

Innventure continues to believe that it is in the best interest of shareholders to limit its ongoing funding of AeroFlexx and Refinity while continuing to pursue strategic alternatives for both companies, including potential sales and interim third-party financings. Accordingly, Innventure intends to conclude funding for AeroFlexx within the next month and Refinity by the end of the year, with funding during this interim period subject to the oversight of the Committee. While material cost reductions were initiated at Refinity and it was previously indicated it would be self-funded beginning in October 2026, the Company now believes that providing Refinity with limited capital in the near term is prudent to allow Refinity additional time and opportunity to achieve a potential outcome that may preserve or realize value for Innventure shareholders.

Enhanced Governance

Over the past several months, Innventure has taken steps to strengthen its governance, independence and leadership, including appointing Michael Madon as an independent director and reducing the size of the Board from nine to seven directors, six of whom are independent. The Company’s Board includes highly qualified individuals with the right mix of skills across technology and R&D commercialization, finance, capital markets, and public company governance to support management.

On September 1, Dr. Bill Grieco assumed the role of Chief Executive Officer and on October 19, Eric Stober joined as Chief Financial Officer. Dr. Grieco is a seasoned entrepreneur and proven leader in technology commercialization with 25 years of experience scaling R&D and commercialization organizations across the chemical, pharmaceutical, clean tech, and specialty materials industries. Mr. Stober is a finance executive with more than two decades of experience across public companies, capital markets, and strategic transactions, most recently serving as CFO of Capital Factory and previously as CFO of Astrotech Corporation, where he played a key role in restructuring the company and managed the sale of its satellite operations business to Lockheed Martin.

These appointments reflect the Board’s commitment to rigorous, independent oversight as the Company focuses on disciplined capital allocation and evaluates the full range of avenues to create shareholder value.

The Company recognizes the importance of providing shareholders with clear information regarding its strategic direction and capital allocation priorities. Innventure intends to provide additional updates as appropriate as it advances these initiatives and reaches meaningful milestones.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities of Innventure, Accelsius, or any of its other operating companies, nor shall there be any sale of any securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Innventure

Innventure (NASDAQ: INV) builds and scales the companies that it has founded as they commercialize new technologies. Innventure is focused on preserving and maximizing the value of its operating company interests for shareholders through disciplined capital allocation, focused execution, strong governance, and strategic initiatives. Learn more at innventure.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are often identified by future or conditional words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “will,” “potential,” “predict,” “should,” “would” and other similar words and expressions (or the negative versions of such words or expressions), but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements are based on the current assumptions and expectations of future events that are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of this press release. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the parties) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.

These risks and uncertainties include, but are not limited to, those factors described in Innventure’s public filings with the U.S. Securities and Exchange Commission, including, but not limited to, the following: Innventure’s and its subsidiaries’ ability to execute on their strategies, book sales and achieve future financial performance; Innventure’s ability to identify and execute on alternatives to strengthen its financial position; Innventure’s or each operating company’s respective ability to secure financing and/or other value-enhancing transactions, in each case as applicable, on acceptable terms or at all, including with respect to the dilution of Innventure’s interests in its operating companies; developments and projections relating to Innventure’s and its subsidiaries’ competitors and industry; the implementation, adoption, market acceptance and success of Innventure’s and its subsidiaries’ products, business models and growth strategies; Innventure’s and its subsidiaries’ ability to generate sufficient revenue and operating cash flow; the timing and magnitude of expected cash expenditures; the availability, timing and terms of additional financing, including debt or equity financing at Innventure or its subsidiaries; market conditions affecting access to capital; potential dilution resulting from future financings at Innventure or its subsidiaries; if additional funding is unavailable, or cannot be obtained on acceptable terms or in sufficient amounts or on a timely basis, AeroFlexx or Refinity may be required to wind up or cease operations; potential goodwill, intangible asset, and other asset impairment charges, write-offs of intercompany advances, and other costs and liabilities associated with any such wind-down or cessation of operations; the risk that one or both of AeroFlexx or Refinity may be unable to continue as a going concern if additional funding is not obtained; Innventure’s ability to successfully implement cost reduction initiatives; risks related to recent shareholder litigation; changes in economic conditions; competitive pressures; regulatory developments; and Innventure’s ability to maintain control over its subsidiaries.

The foregoing factors are not exhaustive. For a more complete discussion of the risks and uncertainties that may affect Innventure’s forward-looking statements, see the ‘Risk Factors’ section of Innventure’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC. Forward‑looking statements speak only as of the date of this release, and Innventure undertakes no obligation to update them, whether as a result of new information, future events, changes in assumptions or expectations, or otherwise, except as required by applicable law or the rules of any stock exchange on which Innventure’s securities are listed.

Investor Relations Contact
Kyle Nagarkar, Solebury Strategic Communications
investorrelations@innventure.com

Media Contact
Bryan Locke / Charlotte Kiaie, FGS Global
Innventure@fgsglobal.com

TORONTO, Nov. 02, 2026 (GLOBE NEWSWIRE) — Adyen, the global financial technology platform of choice for leading businesses, today shares new data that finds amid rising costs, tariff pressures and softer consumer spending, Canadian small businesses are heading into the holiday season with little room for financial disruption.

An Adyen survey of 1,015 Canadian small and medium-sized business owners found 71% say recent economic conditions such as tariffs, interest rates and inflation have affected their operations. Four in ten (40%) cite rising supply costs and a third (34%) shrinking profit margins, while 29% have lost sales or revenue due to lower consumer spending. The findings come as small business confidence dropped 10 points to 47.9 in September, according to the CFIB Business Barometer, and Canada lost 68,000 jobs in September, a second straight monthly decline. As margins shrink, how quickly businesses can access cash matters more than ever: more than half (53%) of owners say receiving payouts faster would make a difference to their business.

For many businesses, those pressures are steadily eroding the cash cushion they rely on to cover day-to-day costs. One in four (25%) surveyed owners say their business could cover wages, rent, supplies and other operating costs for less than a month without sales payouts, and 14% could last a week or less. Contrary to the assumption that cash flow is mainly a challenge for the smallest operators, the pressure intensifies as businesses grow: nearly half (47%) of businesses with 26–250 employees say the time it takes to receive funds from sales often causes cash flow challenges, more than double the rate of sole traders (20%). Among those larger businesses, 79% say faster payouts would have an impact, including 30% who say it would be significant.

When cash runs short, many owners are shouldering the financial risk personally rather than turning to traditional lenders. Half (50%) would use personal savings if they needed funding today, compared to 34% who would seek a bank loan, 17% who would seek a credit union loan and 12% who would borrow from family or friends. Personal guarantees or financial exposure (28%) and too much paperwork (25%) are the top barriers to accessing capital.

As businesses grow and their funding needs become more complex, many are beginning to look beyond traditional lenders altogether. Among businesses with 26–250 employees, 32% cite strict collateral requirements and 31% slow approval timelines as barriers to capital, and nearly one in four (23%) would turn to financing through a technology provider or software platform they already use, compared to 8% of business owners overall.

The consequences of these funding gaps would ripple out to the employees and communities that depend on these businesses. Small businesses (those with 1–99 employees) employ 46.6% of Canada’s private-sector workforce, according to Innovation, Science and Economic Development Canada. If unable to secure funding when needed, 36% of surveyed owners could delay, halt or cancel growth plans, 19% anticipate operational cutbacks such as layoffs or delayed wages (rising to 41% among businesses with 26–250 employees), and 17% say their business could close or go bankrupt.

“Canadian businesses are under real pressure right now, but there’s a clear opportunity in these findings,” said Sander Meijers, Canada Country Manager at Adyen. “Owners are telling us that faster access to their own revenue and simpler paths to funding would make a real difference, especially as they grow. Financing built into the platforms businesses already use is a modern evolution of business banking, and it can help keep teams employed, growth plans on track and local economies moving.”

Through its financial products, Adyen enables the platforms it powers to offer faster access to sales revenue and embedded financing, giving the businesses on those platforms the means to manage day-to-day operations, navigate cash flow challenges and pursue growth without waiting on traditional financing.

Methodology
These findings are from a survey conducted by Adyen in October 2026, among a sample of 1,015 Canadian small and medium-sized business owners and self-employed Canadians who are members of the Angus Reid Forum and are involved in their business’s payments, cash flow, financing or banking decisions. Respondents represent businesses with up to 250 employees. The survey was conducted in English and French. For comparison purposes only, a probability sample of this size would carry a margin of error of +/-3.1 percentage points, 19 times out of 20.

About Adyen
Adyen (ADYEN:AMS) is the financial technology platform of choice for leading companies. By providing end-to-end payments capabilities, data-driven insights, and financial products in a single global solution, Adyen helps businesses achieve their ambitions faster. With offices around the world, Adyen works with the likes of Meta, Uber, H&M, eBay, and Microsoft.

CONTACT: Contact:
Ashley McFarlane
ashley@talkshopmedia.com

SOUTH SAN FRANCISCO, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that members of its senior management team will participate in the following investor events:

Goldman Sachs’ RxChange Series: Framing Lyell’s next-generation lymphoma CAR-T data in 4Q
Format: Fireside Chat
Featured Speaker: Alexander P. Boardman, MD, Associate Physician, Division of Hematology/Oncology, Mass General Brigham Cancer Institute; Faculty of Medicine, Harvard Medical School
Date & Time: Thursday, November 5, 2026 at 11:00 am ET
Webcast Link: Here

Stifel 2026 Healthcare Conference
Format: Fireside Chat and 1×1 Meetings
Date & Time: Tuesday, November 10, 2026, at 4:00 pm ET
Webcast Link: Here

2026 Jefferies Global Healthcare Conference
Format: 1×1 Meetings
Date: Wednesday, November 18, 2026

A live webcast and subsequent replay of the Stifel fireside chat will be available in the Investors section of the Company’s website at www.lyell.com.

About Lyell Immunopharma, Inc.

Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to arm CAR T cells with enhancements needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. Lyell’s proprietary LyFE Manufacturing Center™ has commercial launch capability and is expected to have the capacity to manufacture more than 1,200 CAR T-cell doses per year. To learn more, please visit www.lyell.com.

Contact:

Lyell Investor Relations
IR@lyell.com

  • Rectitude has signed a Share Purchase Agreement to acquire 100% of Mr. Butler, adding household goods repair and personal service activities to its product portfolio.
  • Following a successful collaboration period under the RSB framework, Rectitude is formally migrating the customer contracts and intellectual property of INOS and G & L into its operations.
  • The transactions are funded through the issuance of Rectitude ordinary shares, incorporating one-year lock-up periods to align the incoming operational teams with the Company’s long-term objectives.

SINGAPORE, Nov. 02, 2026 (GLOBE NEWSWIRE) — RECTITUDE HOLDINGS LTD (Nasdaq: RECT; the “Company” or “Rectitude”), a Singapore-based provider of safety equipment and related industrial products, today announced it has entered into definitive agreements to advance its Rectitude Succession Bridge (“RSB”) model and corporate expansion strategy. The Company executed a Share Purchase Agreement to acquire MR.BUTLER PTE. LTD. (“Mr. Butler”) and separate Business Migration Agreements to formally integrate the commercial operations of INOS Pte. Ltc. (“INOS”) and G & L Hardware Marketing Pte. Ltd. (“G & L”).

Acquisition of Mr. Butler

To further expand its operational ecosystem, Rectitude entered into a Share Purchase Agreement on October 12, 2026, to acquire all issued shares of Mr. Butler, a Singapore-based company specializing in personal service activities and the repair of household goods.

The agreed consideration for the acquisition is 800,000 new Class A ordinary shares of the Company, valued contractually at US$1.00 per share. A specified percentage of these shares will be subject to a contractual holdback, generally issuable six months after completion to account for any unresolved claims. The issued shares are also subject to a one-year lock-up following completion. The transaction is expected to close five business days after the satisfaction or waiver of specified closing conditions, including material contractual consents and regulatory approvals.

Execution of RSB Model

In April 2026, Rectitude announced its strategic collaborations with INOS and G & L under the RSB, a risk-mitigated, “incubate-to-acquire” growth framework. This model allowed Rectitude to evaluate the operational fit of both companies without significant upfront capital investment. Following this successful evaluation phase, the Company has now moved to formally integrate these businesses.

On October 17, 2026, Rectitude executed Business Migration Agreements with both INOS and G & L. Under the terms of the agreements, the sellers will transfer specified customer relationships, contracts, and intellectual property, including applicable trade names, trademarks, domains, and customer lists, directly to the Company. Both sellers will provide transitional assistance for 90 days following the closing, which is scheduled for November 1, 2026, subject to customary conditions.

As consideration for each migration, the Company will issue 500,000 ordinary shares to each seller (1,000,000 shares in aggregate) at closing. The consideration shares are subject to a one-year lock-up period.

“These agreements demonstrate the practical execution of our Rectitude Succession Bridge strategy,” said Jian Zhang, Chairman, Chief Executive Officer, and Executive Director at Rectitude. “Over the past several months, we validated the financial and operational contributions of INOS and G & L within our ecosystem. Moving to a formal business migration secures their customer bases, brand assets, and technical expertise. Concurrently, acquiring Mr. Butler broadens our service capabilities in the region. Funding these transactions through equity with standard lock-up periods ensures that the founders of these businesses remain aligned with our focus on disciplined, long-term growth.”

About Rectitude

Founded in 1997 in Singapore, Rectitude is principally involved in the provision of safety equipment, encompassing essential items such as personal protective clothing, gloves, safety footwear, personal fall arrest systems, portable fire extinguishers and traffic products. The Company also offers auxiliary products such as industrial hardware tools and electrical hardware required for construction sites. Rectitude’s products and solutions are marketed to a wide array of distributor networks and end markets, both in Singapore and increasingly throughout the Southeast Asian region, including Brunei, Cambodia, Malaysia, Indonesia, and Vietnam. For more information, please visit the Company’s website: https://ir.rectitude.com.sg

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements, including, but not limited to, the Company’s plans, strategies and business development initiatives. 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 identify these forward-looking statements by words or phrases such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. 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 latest Annual Report on Form 20-F for the fiscal year ended March 31, 2026, and its other filings with the U.S. Securities and Exchange Commission.

For investor and media inquiries, please contact:

Rectitude
Investor Relations
Email: ir@rectitude.com.sg

Jackson Lin
LLYC
Phone: +1 (646) 717-4593
Email: jian.lin@llyc.global

Industry experts challenged to distinguish specialized recruiters from AI-assisted generalists, demonstrating how advanced AI can bring domain expertise into everyday enterprise recruiting workflows

NEW YORK, Nov. 02, 2026 (GLOBE NEWSWIRE) — Fusemachines Inc. (NASDAQ: FUSE) (“Fusemachines” or the “Company”), a leading provider of enterprise AI products and services, today announced the launch of a new video series called “Can the expert tell?” showcasing the technological maturity and advanced capabilities of HireFoundry.ai‘s real-time Interview Agent, a key component of its agentic AI platform for enterprise talent acquisition.

The video series challenges industry experts to determine whether they are being interviewed by a subject matter expert, a specialized recruiter, a generalist recruiter, or a generalist recruiter assisted by HireFoundry’s AI technology. Through real-world interviews across technical and professional disciplines, Fusemachines aims to demonstrate how sophisticated AI agents can augment human capabilities and bring specialized intelligence directly into existing enterprise workflows.

The “Can the Expert Tell?” Video Series

Each video challenges an industry expert to identify who is interviewing them based on how deeply the questions and follow-ups explore key competencies in their field. Can they tell which of four profiles best describes the interviewer?

  • A subject matter expert with deep domain knowledge
  • A specialized recruiter experienced in the field
  • A generalist recruiter without specialized expertise in the field
  • A generalist recruiter supported by HireFoundry.ai’s real-time Interview Agent

Before the reveal, the expert makes their guess and explains which questions and follow-ups shaped their impression. Afterward, they provide candid feedback on how effectively the conversation explored their expertise and the contribution of HireFoundry’s real-time AI assistance.

The series showcases the platform’s technological maturity through practical interviews, making its ability to support deeper competency discussions visible through the experience and feedback of participating industry experts.

Demonstrating the Technology Maturity of HireFoundry’s Interview Agent
At the heart of the series is HireFoundry’s real-time Interview Agent, which combines contextual language understanding, role-specific intelligence, and dynamic follow-up question generation to assist recruiters during live conversations.

Unlike traditional tools that provide static interview questions, HireFoundry analyzes conversations as they unfold, helping recruiters probe key competencies of the role through targeted follow-ups, even when those competencies require knowledge beyond the recruiter’s own area of expertise.

“We have reached a level of technological maturity where our Interview Agent can understand complex conversations as they happen and provide sophisticated, contextually relevant guidance to recruiters in real time,” said Anish Joshi, Head of Technology at Fusemachines. “This video series puts those capabilities to the test, demonstrating how far our technology has advanced and how specialized AI intelligence can be fused seamlessly into human workflows without removing the human from the process.”

HireFoundry.ai grounds its real-time suggestions in role requirements, company context, and the candidate’s answers. Recruiters choose which follow-ups to ask, helping them gather more detail about relevant competencies while candidates are still in the conversation to elaborate.

“The real measure of technology maturity is how effectively AI performs in real-world situations,” said Giovanni Lemus, Vice President of Product at Fusemachines. “With HireFoundry, that means helping recruiters probe core role competencies more deeply and recognize when an answer deserves a closer look, while the candidate is still there to explain, add context, or share a specific example. By inviting industry experts to experience these interviews firsthand, we’re showcasing how sophisticated AI can extend recruiters’ capabilities and enrich the human conversation.”

Fusing AI Intelligence Into Enterprise Workflows
The new series reflects Fusemachines’ broader vision of fusing humans and machines to enhance workforce capabilities, rather than replacing employees with automation.

By embedding specialized AI agents directly into familiar enterprise processes, Fusemachines aims to help organizations extend the capabilities of their existing teams, improve productivity, and make sophisticated AI accessible without requiring every employee to become a domain expert.

The “Can the expert tell?” video series will be released through Fusemachines’ digital channels, featuring unscripted interviews across a range of professional disciplines to showcase the technological maturity of HireFoundry.ai in action. Each video will feature a Fusemachines employee interviewing an external subject matter expert, demonstrating in real time how HireFoundry’s AI-powered Interview Agent can enhance human interviewing capabilities. The unscripted format is designed to provide an authentic demonstration of the technology’s sophistication and maturity in real-world scenarios. The series is intended as a product demonstration rather than a controlled scientific study or formal evaluation of HireFoundry.ai’s performance, and individual experiences and results may vary.

Fusemachines’ digital channels: LinkedIn | X | Instagram | Facebook | TikTok

About HireFoundry.ai

HireFoundry.ai is Fusemachines’ platform of AI agents supporting recruiters across resume analysis, shortlisting, live interviews, and post-interview review. Its real-time interview intelligence helps recruiters explore role-specific competencies while keeping people in control of the conversation and hiring decisions.

About Fusemachines

Founded in 2013, Fusemachines is a global provider of enterprise AI products and services, on a mission to democratize AI. Leveraging proprietary AI Studio, AI Engines and AI Agents, the Company helps drive clients’ AI Enterprise Transformation, regardless of where they are in their Digital AI journeys. With offices in North America, Asia and Latin America, Fusemachines provides a suite of enterprise AI offerings and specialty services that allow organizations of any size to implement and scale AI.

Fusemachines continues to actively pursue the mission of democratizing AI by providing high-quality AI education in underserved communities and helping organizations achieve their full potential with AI.

To learn about Fusemachines,visit www.fusemachines.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the anticipated capabilities, features, benefits, and potential uses of HireFoundry.ai and the Company’s AI agents, including HireFoundry.ai’s real-time interview intelligence; the “Can the Expert Tell?” video series, including its content, participants, and availability; customer adoption, deployment, and demand for the Company’s talent acquisition solutions; the Company’s agentic AI programs, product development initiatives, commercialization strategy, enterprise AI offerings, and expected market opportunities. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “continue,” “could,” “envision,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” “would,” and similar expressions.

These forward-looking statements are based on current expectations, estimates, assumptions, and projections and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that HireFoundry.ai or the Company’s AI agents may not achieve market acceptance or deliver expected benefits; the risk that demonstrations, including the “Can the Expert Tell?” video series, may not be representative of results in customer deployments; the risk that additional capabilities may not be successfully developed or introduced; risks of inaccurate, biased, or unintended outputs from AI systems used in hiring; uncertain and evolving laws, regulations, and standards governing artificial intelligence, automated employment decision tools, employment and anti-discrimination, privacy, consent, identity, and likeness; potential reputational harm or liability associated with the use of AI in recruitment; risks related to customer adoption and retention; the Company’s ability to develop, maintain, and enhance its products and platform; reliance on third-party platforms, including applicant tracking systems, partners, data, and infrastructure; competition in the markets in which the Company operates; cybersecurity, data privacy, regulatory, and intellectual property risks; and changing macroeconomic, industry, and market conditions.

Additional information regarding these and other risks and uncertainties is included in the Company’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K filed with the SEC on March 27, 2026, and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Forward-looking statements speak only as of the date they are made, and Fusemachines undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Media Contact:

pr@fusemachines.com

Investor Contact:

ir@fusemachines.com

+1 347 212-5075

  • Advancing NeoCloud and AI Token Factory Commercialization
  • Leveraging kt cloud’s high-performance computing, targeting scale of 512 NVIDIA Blackwell Ultra B300 GPUs

LOS ANGELES, Nov. 02, 2026 (GLOBE NEWSWIRE) — XMax Inc. (NASDAQ: XMAX) (“XMax” or the “Company”), a distributor of contemporary furniture and artificial intelligence software and platform-based service provider, today announced that it has entered into a five-year artificial intelligence (“AI”) infrastructure services agreement with DSH HYPER PTE. LTD. of Singapore (“DSH”). Under the agreement, XMax will obtain, through DSH, dedicated high-performance computing services deployed in Korea on infrastructure provided by kt cloud Co., Ltd., an affiliate of KT Corporation, formerly Korea Telecom Corp. (“kt cloud”). XMax’s wholly owned subsidiary, XMax AI Inc. (“XMax AI”), is the designated operating end user under the agreement. The Company intends to use the capacity as its core computing foundation to advance the research and development, deployment and commercialization of its NeoCloud and AI Token Factory offerings. NeoCloud​ is an AI-optimized cloud infrastructure service for enterprise AI workloads, delivering accelerated compute purpose-built for AI inference; AI Token Factory, in contrast, is an API-driven, self-operated global distributed inference platform — model-agnostic and deployment-agnostic — that sells committed compliant inference capacity scoped by jurisdiction × compliance tier, and delivers AI service products for the finance, government, industrial, and consumer goods industries.

“This agreement gives us dedicated, high-performance computing capacity on which to build our NeoCloud and AI Token Factory offerings, and we believe it represents meaningful progress in executing our AI growth strategy. Our immediate focus is to complete technical validation of our first AI Token Factory and prepare our platform for launch, and we look forward to updating investors as we make progress,” said Andy Lu, Chief Executive Officer of XMax.

Building High-Performance Computing Infrastructure Purpose-Built for AI Inference

Under the agreement, the AI cluster made available to XMax is planned to comprise 64 compute nodes, each equipped with eight NVIDIA Blackwell Ultra B300 GPUs, for a target total of 512 GPUs, plus 560TB of high-performance parallel storage. XMax intends to use the cluster primarily for high-throughput AI inference, to help optimize cost, latency and throughput.

Service began on October 29, 2026 with an initial configuration of 480 GPUs, with the full 512-GPU configuration expected to follow in phases. The five-year service commitment is subject to certain closing conditions, including approval by XMax’s board of directors and delivery of the required security guarantee and standby letter of credit (SBLC) in favor of kt cloud by November 17, 2026. The material terms of the Agreement will be disclosed in the Form 8-K filed by the Company with the SEC on November 2, 2026.

Advancing Product Commercialization with NeoCloud and the AI Token Factory at the Core

XMax AI will first use the cluster to complete development of the Company’s first AI Token Factory and launch its platform product. This work will include infrastructure integration, large-model inference optimization, model serving performance testing and commercial platform validation. Once technical validation is complete and applicable contractual, technical and regulatory requirements are met, the Company plans to commercialize a range of NeoCloud AI products and services on this infrastructure.

The planned product portfolio includes:

  • AI Token Factory services on NeoCloud for high-throughput AI inference, billed on API usage;
  • Model-as-a-Service (MaaS) providing managed model endpoints and model orchestration;
  • Enterprise-grade AI applications covering workloads such as AI agents and retrieval-augmented generation (RAG).

The Company intends to deliver these AI software and inference services through APIs, a command-line interface (CLI) and managed workspaces, and to conduct operations across the United States, Japan, Korea, and Singapore.

Five-Year Revenue Outlook

Based on the planned deployment of 512 NVIDIA Blackwell Ultra B300 GPUs for this AI infrastructure project in Korea and the anticipated commercialization progress of its NeoCloud and AI Token Factory platforms, the Company expects the related businesses supported by this project to generate more than US$100 million in cumulative revenue over the next five years. Expected revenue sources include AI inference services billed on API usage, managed model services (MaaS) and enterprise-grade AI application services. As the infrastructure is deployed, the platforms are launched and enterprise customer adoption grows, the Company plans to progressively expand the commercial use of these services.

About XMax Inc.

Headquartered in Commerce, California, XMax Inc. (NASDAQ: XMAX), formerly known as Nova LifeStyle, Inc., is a diversified company engaged in the design, sourcing, and distribution of contemporary furniture, as well as the development of artificial intelligence technologies and applications. The Company operates through an established global network of suppliers, distributors, and e-commerce channels, serving a broad customer base. The Company has expanded into artificial intelligence technologies, including AI software and platform-based services through its wholly owned subsidiaries XMax AI Inc. and Elonx AI Holdings PTE. LTD., to support future growth. By leveraging emerging technologies, the Company aims to drive diversification and long-term value creation.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding whether the board approval and security conditions are satisfied; the issuance of the SBLC; the performance of DSH and KT; delays in delivery or acceptance of capacity; currency fluctuations between the Korean won and the U.S. dollar; the planned deployment, scale, timing and performance of the AI cluster; the Company’s plans to develop, launch and commercialize NeoCloud, AI Token Factory and related offerings; and the Company’s expectations regarding future revenue and growth, including its projection of more than US$100 million in cumulative revenue over the next five years from the related businesses supported by the AI infrastructure project in Korea. These statements are based on current expectations, assumptions and analyses made by us in light of our experience and our perception of trends, current conditions and expected future developments, as well as other factors we believe are appropriate in the circumstances, and are subject to risks and uncertainties that may cause actual results to differ materially. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, forward-looking statements can be identified by the use of forward-looking terms such as “anticipate,” “estimate,” “believe,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” “should,” “will,” “expect,” “objective,” “projection,” “forecast,” “goal,” “guidance,” “outlook,” “effort,” “target,” “trajectory,” “focus,” “work to,” “attempt,” “pursue,” or the negative of these terms or other comparable terms. However, the absence of these words does not mean that the statements are not forward-looking. XMax Inc. undertakes no obligation to update any forward-looking statements except as required by law.

Investor Relations Contact
ICR LLC
XMaxIR@icrinc.com

  • In patients aged 64+: 79.2% of patients achieved a clinically meaningful response (reduced pain and improved knee function) in the Allocetra™ group vs. 47.6% in the placebo group at 12 months (p=0.027)1
     
  • Allocetra™ treatment benefit at 12 months was consistent with the response rates observed at 3 and 6 months, demonstrating a durable effect from a single treatment cycle
  • The 12-month data will be presented at the American College of Rheumatology (ACR) Convergence in a poster presentation on November 8, 2026

Nes-Ziona, Israel, Nov. 02, 2026 (GLOBE NEWSWIRE) — Enlivex Ltd. (Nasdaq: ENLV) (“Enlivex” or the “Company”), a quality longevity company powered by a prediction markets treasury, today announced favorable 12-month topline data from the randomized, double-blind, placebo-controlled Phase IIa stage of the Company’s multi-country Phase I/IIa trial (ENX-CL-05-001) evaluating Allocetra™ in patients with moderate to severe knee osteoarthritis. With 12-month follow-up now complete, the data show that a single three-injection treatment cycle of Allocetra™ produced a sustained treatment response through one year in patients with primary age-related knee osteoarthritis, the population being evaluated in the Company’s ongoing Phase IIb trial. The one-year safety and efficacy results have been selected for a poster presentation at the American College of Rheumatology (ACR) Convergence 2026 (details below).

Summary of the 12-month Topline Data, Age Group 64+

  • Sustained responder benefit at one year: The proportion of patients (age 64+) achieving a clinically meaningful response2 (reduced pain and increased knee function) was 66% higher for the Allocetra™ group than for the placebo group at 12 months, consistent with the treatment benefit observed at the earlier 3- and 6-month timepoints:
     
    • At 12 months: 79.2% responders in the Allocetra™ group vs. 47.6% in the placebo group (p=0.027)
    • This substantial treatment benefit was consistent with the response rates observed at 3 months (80% higher for the Allocetra™ group than for the placebo group; p=0.019) and 6 months (39%  higher for the Allocetra™ group than for the placebo group; p=0.168).
       
  • Improvement in pain and function maintained through 12 months: Allocetra™ produced statistically significant and clinically meaningful improvements versus placebo at 3 and 6 months. At 12 months, treatment differences continued to favor Allocetra™ and were reasonably maintained throughout one year (scale 0–100; difference vs. placebo in change from baseline), in the 64+ age group:
     
    • WOMAC3 pain: -17.5 points at 3 months (p=0.004), -15.4 points at 6 months (p=0.012), and -12.2 points at 12 months (p=0.113)
    • WOMAC function: -19.3 points at 3 months (p=0.0008), -19.5 points at 6 months (p=0.0008), and -13.1 points at 12 months (p=0.067)
       
  • Consistent age-related effect: Across analyses, patient age was the strongest predictor of treatment response, with the treatment effect increasing with age. Improvements in patient-reported outcomes were supported by objective physical performance tests and by exploratory serum biomarker and imaging analyses consistent with Allocetra™’s proposed macrophage-reprogramming mechanism of action.
     
  • Favorable safety profile through 12 months: No treatment-related serious adverse events were observed. Adverse events were predominantly transient, mild to moderate local knee reactions, consistent with previously reported data.

12-month data presentation at the ACR convergence

ACR Convergence 2026 is taking place November 6–11, 2026 at the Orange County Convention Center in Orlando, Florida.

The poster will be presented by Prof. Philip Conaghan, Consultant Rheumatologist and Director of the NIHR Leeds Biomedical Research Centre. Prof. Conaghan is an international leader in osteoarthritis and musculoskeletal imaging who has authored more than 700 publications and chaired multiple global guideline and clinical trial initiatives.

Poster Presentation

  • Title: Durable Clinical Efficacy of an Innovative Intra-Articular Apoptotic Cell Therapy in Knee Osteoarthritis: Age-Related Effect Through One Year
     
  • Abstract ID: 24454477
     
  • Session: Poster Session A (0632–0644): Osteoarthritis – Clinical Poster A
     
  • Date & Time: November 8, 2026 | 10:30 AM – 12:30 PM ET

“The 12-month results show that a single treatment cycle of Allocetra™ delivered a clinically meaningful benefit in older patients with knee osteoarthritis that was sustained through one year. In a disease with no approved disease-modifying therapies, where treatment is largely limited to symptom management or surgery, a durable response from a single treatment cycle could offer a differentiated profile for patients, physicians and payers. We are pleased that these data were selected for presentation at ACR Convergence 2026, and we look forward to topline data from our Phase IIb trial, which is enrolling this same population, by the end of the second quarter of 2027,” said Dr. Oren Hershkovitz, Chief Executive Officer of Enlivex.

About ENX-CL-05-001

ENX-CL-05-001 is a multi-center Phase I/IIa clinical trial consisting of two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee, in order to identify the dose and injection regimen for the subsequent Phase IIa stage. The Phase IIa stage was a double-blind, randomized, placebo-controlled multi-centered trial where 134 patients were randomized and treated.

About Knee Osteoarthritis

Osteoarthritis (OA) is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to continue and grow substantially, with knee OA (KOA) being the most prevalent form. There are currently no approved disease-modifying therapies; treatment is largely limited to pain relief, intra-articular steroids, or surgery, and the burden increases sharply with age. By age 60, KOA affects roughly 30% of the population, and about half of KOA patients are 60 years of age or older. This demographic is expanding with global aging trends, underscoring the need for new, durable therapies.

About Enlivex

Enlivex is a quality longevity company powered by a prediction markets treasury. The Company is advancing Allocetra™, an advanced clinical-stage immunotherapy targeting inflammatory conditions associated with aging, with a primary focus on age-related osteoarthritis. In addition to its clinical programs, Enlivex operates a prediction markets treasury strategy built around the Rain Protocol, the leading decentralized prediction markets infrastructure on Arbitrum. This dual strategy combines the development of quality longevity therapeutics with exposure to the emerging prediction markets ecosystem.

Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would,” “could,” “intends,” “estimates,” “suggests,” “target,” “has the potential to,” “goal,” and other words of similar meaning, including statements relating to the anticipated benefits of the Company’s digital asset treasury strategy; the assets to be held by the Company; the expected future market, price, trading activity, and liquidity of the RAIN token; the impact of expanded exchange listings and increased token liquidity on market participation and accessibility; the potential effects of digital asset liquidity on the liquidity of the Company’s ordinary shares; macroeconomic, political, and regulatory conditions surrounding digital assets; the Company’s plans for value creation and strategic positioning; market size and growth opportunities; regulatory conditions; competitive position; technological and market trends; future financial condition and performance; expected clinical trial results; market opportunities for the results of current clinical studies and preclinical experiments; and the effectiveness of, and market opportunities for, ALLOCETRA™ programs.

Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the risk that results from subgroup analyses and small patient populations, including those described in this press release, may not be replicated in larger trials, including the Company’s ongoing Phase IIb trial; the risk that topline data may change following a more comprehensive review of the data; the risk that RMAT designation may not lead to a faster development or regulatory review process and does not increase the likelihood of approval; risks related to the timing, conduct and outcome of clinical trials and regulatory submissions; the risk of failure to realize the anticipated benefits of the Company’s digital asset treasury strategy; changes in business, market, financial, political, and regulatory conditions; risks relating to the Company’s operations and business, including the highly volatile nature of the price, trading volume, and liquidity of RAIN and other cryptocurrencies; risks associated with digital asset exchange listings, trading venues, and market infrastructure; the risk that the price and liquidity of the Company’s ordinary shares may be correlated with the price or liquidity of the digital assets it holds; risks related to increased competition in the industries in which the Company operates; risks relating to significant legal, commercial, regulatory, and technical uncertainty regarding digital assets generally; risks relating to the treatment of crypto assets for U.S. and foreign tax purposes; and those risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this document, and the Company undertakes no obligation to update or revise any of these statements, except as required by applicable law.

Enlivex contact

Shachar Shlosberger
CFO
Enlivex Ltd.
shachar@enlivex.com 


1 Summary of the 12-month Topline Data, Age Group 64+

2 Under the OMERACT-OARSI responder criteria, the established standard for osteoarthritis trials

3 WOMAC: a widely used, standardized questionnaire to evaluate the condition and quality of life of patients with osteoarthritis of the hip and knee

COSTA MESA, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — Gold.com, Inc. (NYSE: GOLD), (“Gold.com” or the “Company”), a fully integrated alternative assets platform that offers an extensive range of precious metals, numismatic coins, and collectibles to consumers, collectors, and institutional clients worldwide, today announced the appointment of Nick Bowkett as Vice President of Trading and Business Development, effective November 2, 2026. Based in the U.K., Bowkett will be focused on accelerating growth across Europe in both wholesale and direct-to-consumer channels.

Nick’s appointment reflects our continued commitment to Europe as a core growth market for Gold.com,” said Greg Roberts, Chief Executive Officer of Gold.com. As we continue to grow our wholesale footprint across Europe, we see significant opportunity to bring our wholesale and direct-to-consumer capabilities closer together for customers across the region. Nick’s leadership experience in precious metals and proven track record of driving growth make him uniquely suited to lead that effort as we build a more unified presence in Europe

“Gold.com has built something genuinely differentiated in this industry and I’m excited to join the Company at such a pivotal time,” said Bowkett. “Its vertically integrated model and global reach create a compelling platform for growth. I look forward to working with the team to build on the momentum already underway and to help expand Gold.com’s business in the region.”

Mr. Bowkett joins Gold.com following more than 16 years at The Royal Mint, where he most recently served as Global Head of Growth, a role he held since July 2024.   In that role, he led The Royal Mint’s global expansion into new precious metals markets across both wholesale and direct-to-consumer channels, and built relationships with central banks, institutional partners and high-net-worth customers.   Earlier in his tenure, he played a key role in the London 2012 Olympic and Paralympic coin program, creating opportunities with major international sponsors including BP, Panasonic and General Electric, and later led the global relaunch of the Britannia bullion coin and the development of several successful bullion and semi-numismatic coin ranges. He also expanded The Royal Mint’s international bullion relationships across Japan, the GCC region, and Southeast Asia.

About Gold.com, Inc.

Gold.com builds on gold’s storied history and heritage to define the future of alternative asset management. Founded in 1965, Gold.com offers comprehensive solutions for all aspects of the precious metals (gold, silver, platinum, and palladium) and collectibles (including rare coins and currency) value chains. Its vertically integrated platform combines market expertise with state-of-the-art logistics, financing, and minting capabilities to serve customers, collectors, and institutional clients globally.

Gold.com’s direct-to-consumer marketplace, anchored by flagship brands JMBullion.com, Stack’s Bowers Galleries, GovMint.com, Monex Precious Metals, and Goldline, has served millions of customers. The Company’s trading and wholesale sales platform, which operates as A-Mark Precious Metals, maintains distribution and finance focused relationships with a network of sovereign and private mints and has been an “authorized purchaser” of the United States Mint since 1986. This platform is supported by the Company’s minting and refining operations which include Sunshine Minting and Silver Towne Mint, whose facilities can collectively produce in excess of three million ounces of finished precious metals products per week. Gold.com’s Collateral Finance Corporation secured lending subsidiary, CFCGoldLoans.com, extends bullion, numismatic, and sports card loans while A-Mark Global Logistics supports the Company’s operations with airport-adjacent distribution centers and IRA-approved storage depositories.

Gold.com is headquartered in Costa Mesa, California, and operates across the United States, Canada, the United Kingdom, Europe, Hong Kong, and Singapore. Learn more at www.gold.com.

Gold.com periodically provides information for investors on its corporate website, www.gold.com and its investor relations website, ir.gold.com. This includes press releases and other information about financial performance, reports filed or furnished with the SEC, information on corporate governance, and investor presentations.

Company Contact:
Steve Reiner, Executive Vice President, Capital Markets & Investor Relations
Gold.com, Inc.
1-310-587-1410
sreiner@gold.com

Investor Relations Contact:
Reed Anderson, ICR
646-277-1260
reed.anderson@icrinc.com
GOLD@icrinc.com

AUSTIN, Texas, Nov. 02, 2026 (GLOBE NEWSWIRE) — Rein Therapeutics (“Rein”) (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines in orphan pulmonary and fibrosis indications, today announced that Brian Windsor, President and Chief Executive Officer of Rein Therapeutics, will participate in a fireside chat at the Guggenheim 3rd Annual Healthcare Innovation Conference on Monday, November 9, 2026, at 11:00 a.m. ET.

A live webcast of the presentation may be accessed via the Investors section of the Rein website at ir.reintx.com. An archived replay of the event will be available on the website for approximately 90 days following the conference.

About Rein Therapeutics
Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein’s lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 has received both Orphan Drug and Fast Track designations in the U.S.

Investor Contact
IR@ReinTx.com

– Theriva received a $350,000 upfront payment at closing and is eligible for up to $91 million in regulatory and sales milestones, along with low single-digit royalties on net product sales –

– Biossil to assume all responsibility and costs for future development and commercialization of the antibiotic-degrading enzyme portfolio –

ROCKVILLE, Md., Nov. 02, 2026 (GLOBE NEWSWIRE) — Theriva™ Biologics, Inc. (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 the sale of the Company’s portfolio of antibiotic-degrading enzymes — including SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase), and SYN-006 (carbapenemase) — to Biossil Labs Inc. (Biossil), a privately held, Toronto-based, artificial intelligence (AI)-native biopharmaceutical company advancing a diverse portfolio of late-stage programs in life-threatening indications with urgent unmet needs.

Under the terms of the agreement, Biossil acquired all of Theriva’s rights, title and interest in SYN-004 (ribaxamase), and its improvements, modifications, and reformulations, including SYN-007 (reformulated ribaxamase), as well as certain assets exclusively related to SYN-006 (carbapenemase). Theriva received a $350,000 upfront payment at closing and is eligible to receive up to $3 million upon the achievement of regulatory milestones, low single-digit royalties on net product sales, subject to a cap of $250 million, and up to $88 million in potential milestones payable upon achievement of certain cumulative worldwide net sales thresholds. Biossil assumed all responsibility and costs for future development and commercialization of the acquired product portfolio pursuant to the agreement.

“We are extremely pleased to complete the sale of our antibiotic-degrading enzyme portfolio to Biossil to continue the clinical development of these gastrointestinal microbiome-protecting assets, including advancement of the Phase 1b/2a clinical trial at Washington University investigating prevention of acute graft-versus-host disease (aGVHD) and opportunistic infections in antibiotic-treated allogeneic hematopoietic cell transplant (HCT) recipients,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We have made a significant investment in SYN-004 (ribaxamase) clinical development and strongly believe that the product candidates in our antibiotic-degrading enzyme portfolio can provide clinical benefit for patients and hospital systems by reducing the incidence of infections by Clostridioides difficile, vancomycin-resistant enterococci (VRE), and carbapenem-resistant Enterobacterales (CRE), as well as the incidence and/or severity of aGVHD.”

“Gut dysbiosis, antibiotic resistant colonization, and opportunistic infections in vulnerable patients represent important unmet needs that recommend we advance this portfolio of antibiotic-degrading enzymes with rigor and equipoise,” said Alexander I. Mosa, MD, PhD, Chief Scientific Officer and Chair of Biossil.

About the SYN-004 (ribaxamase) Portfolio

SYN-004 (ribaxamase) is an orally administered prophylactic therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal tract and maintain the natural balance of the gut microbiome for the prevention of Clostridioides difficile infection (CDI), overgrowth of pathogenic organisms, and the emergence of antimicrobial resistance (AMR). SYN-004 (ribaxamase) is also being evaluated for its potential to reduce the incidence and/or severity of acute graft-versus-host disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. A previously completed, randomized, placebo-controlled Phase 2b clinical trial in 412 patients receiving IV ceftriaxone to treat a lower respiratory tract infection demonstrated that coadministered oral SYN-004 (ribaxamase) protected the gut microbiome from antibiotic-mediated dysbiosis. The SYN-004 (ribaxamase) treatment group demonstrated significantly better maintenance and recovery of the gut microbiome; a lower incidence of CDI; and reduced colonization by opportunistic and potentially pathogenic microorganisms such as vancomycin-resistant enterococci (VRE)¹.

SYN-007 is a reformulation of ribaxamase intended for oral coadministration with orally administered beta-lactam antibiotics. Preclinical proof-of-concept for gut microbiome protection by SYN-007 coadministered with oral amoxicillin has been demonstrated in dogs²,³. SYN-006 (carbapenemase) is an oral formulation of a metallo-beta-lactamase enzyme able to degrade carbapenem antibiotics in addition to beta-lactams. Preclinical proof-of-concept for gut microbiome protection by oral SYN-006 (carbapenemase) coadministered with the IV carbapenem antibiotic ertapenem has been demonstrated in a pig model⁴,⁵.

¹Kokai-Kun JF, et al. (2019). Lancet Infect Dis 19(5):487-496. ²Connelly S et al. (2019) Microorganisms 7(5):150. ³Connelly S et al. (2020) Microorganisms 8(2):152. ⁴Connelly S et al. (2019). Front Microbiol 10:101. ⁵Connelly S et al. (2019) Microorganisms 16;7(1):22.

About the Phase 1b/2a Clinical Trial at Washington University

Allogeneic hematopoietic cell transplant (HCT) recipients routinely receive long courses of IV beta-lactam antibiotics to treat infection following conditioning therapy. Antibiotic-mediated damage to the gut microbiome in allogeneic HCT recipients may lead to adverse outcomes including CDI, VRE colonization and potentially fatal bacteremia, and aGVHD. A randomized, double-blind, placebo-controlled Phase 1b/2a clinical trial has been conducted at Washington University School of Medicine in St. Louis, but enrollment is currently paused after completing 2 of 3 cohorts, to evaluate the safety, tolerability, and potential absorption of oral SYN-004 (ribaxamase) into the systemic circulation of allogeneic HCT recipients who receive one of three prespecified IV antibiotics to treat fever. The trial is also designed to evaluate potential protective effects of SYN-004 (ribaxamase) on the gut microbiome as well as generate preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allogeneic HCT recipients.

Erik R. Dubberke, MD, MSPH, Professor of Medicine at Washington University School of Medicine in St. Louis, said: “Allogeneic HCT recipients are at very high risk for both CDI and bloodstream infections due to VRE and other resistant bacteria that can colonize the gut because of frequent exposures to beta-lactam antibiotics. Ribaxamase, by protecting the gut microbiota during antibiotic exposures, has the potential to significantly improve outcomes after allogeneic HCT by preventing these infections. Also, it would really be a game-changer if ribaxamase is able to help prevent aGVHD.”

The trial intends to enroll up to 36 evaluable participants into three sequential cohorts, each evaluating a different study-assigned IV beta-lactam antibiotic. Two of the three antibiotic cohorts have been completed to date. To mitigate risk, patients in cohort 1 received IV meropenem (which is not metabolized by SYN-004) as the study-assigned antibiotic. Patients in cohort 2 were administered IV piperacillin/tazobactam as the study-assigned antibiotic. Piperacillin is metabolized by SYN-004 (ribaxamase) but is protected by the beta-lactamase inhibitor tazobactam. Safety and pharmacokinetic data for the first two cohorts were reviewed by an independent Data and Safety Monitoring Committee that recommended proceeding to cohort 3, in which patients will receive IV cefepime, which is a substrate for SYN-004 (ribaxamase). More information on the trial is available here [NCT04692181].

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 is advancing 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. With the sale of the SYN-004 (ribaxamase) antibiotic-degrading portfolio, the Company’s lead product candidate is VCN-01, 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. VCN-01 has completed a successful Phase 2b clinical trial in first-line metastatic pancreatic cancer patients treated with gemcitabine-nab-paclitaxel standard-of-care chemotherapy (published in Nature Medicine) and the Company is in discussions with regulatory agencies regarding a potential Phase 2/3 clinical trial in the treatment of retinoblastoma. For more information, please visit the Theriva Biologics website.

About Biossil

Biossil is an AI-native drug development company advancing a pipeline of late-stage, first-in-class candidates for heterogeneous and life-threatening diseases. With teams in Toronto and Boston, and partnerships with leading academic medical centers and research hospitals, Biossil integrates proprietary AI with deep clinical and translational expertise to advance promising clinical-stage assets.

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 the sale to Biossil enabling continued clinical development of the SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase) and SYN-006 (carbapenemase) antibiotic-degrading enzyme portfolio; strongly believing that the product candidates in the antibiotic-degrading enzyme portfolio can provide clinical benefit for patients and hospital systems by reducing the incidence of infections by C. difficile, vancomycin-resistant enterococci (VRE), and carbapenem-resistant Enterobacterales (CRE), as well as the incidence and/or severity of aGVHD; and Theriva receiving up to $3 million upon the achievement of regulatory milestones, low single-digit royalties on net product sales, subject to a cap of $250 million, and up to $88 million in potential milestones payable upon achievement of certain cumulative worldwide net sales thresholds; Biossil continuing the clinical development of the gastrointestinal microbiome-protecting assets, including advancement of the Phase 1b/2a clinical trial at Washington University; the belief that the product candidates in the antibiotic-degrading enzyme portfolio can provide clinical benefit for patients and hospital systems by reducing the incidence of infections by Clostridioides difficile, vancomycin-resistant enterococci (VRE), and carbapenem-resistant Enterobacterales (CRE), as well as the incidence and/or severity of aGVHD. Important factors that could cause actual results to differ materially from current expectations include, among others, Biossil’s ability to complete clinical trials and generate clinical data establishing that the product candidates in the antibiotic-degrading enzyme portfolio may deliver benefits for patients and have therapeutic potential; Biossil’s ability to achieve regulatory milestones and generate net product sales that result in sales milestone and royalty payments to Theriva; the product candidates in the antibiotic-degrading enzyme portfolio demonstrating safety and effectiveness, as well as results that are consistent with prior results; Biossil’s ability to achieve regulatory milestones and obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements; regulatory limitations relating to Biossil’s ability to promote or commercialize the product candidates for the specific indications; acceptance of product candidates in the antibiotic-degrading enzyme portfolio in the marketplace and their successful development, marketing or sale; developments by competitors that render such products obsolete or non-competitive; the ability 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.

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