Tag: GlobeNewswire

• 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 3^rd 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.

ROCHESTER, NEW YORK, Nov. 02, 2026 (GLOBE NEWSWIRE) — Syntec Optics Holdings, Inc. (Nasdaq: OPTX), a leading provider of deep-tech space solutions, has secured a nearly 25% increase in orders for advanced space reconnaissance, building on a major program announced two months ago.

Dean Rudy, CFO, stated: “Our open capacity, increased profitability, and bank debt-free balance sheet allow us to scale unhindered. Alongside leading innovators, we can support increases in enduring U.S. government priorities for Earth imaging and sensing.”

Building on the 2019 pivot away from legacy mega-satellites, the multi-billion-dollar frameworks of 2021 established resilient, proliferated LEO constellations. Today, defense leaders are advancing this technology frontier further.

“Our team is excited to help drive forward the next steps in this cross-administration-backed seven-year vision,” added Rudy.  

Matt Carey, VP of Business Development, said, “For us, this marks the foundational stage of unlocking the limitless potential of space.”

With thousands of specialized optical laser links produced for commercial space-to-space communication, Syntec solidifies its role as a key partner in modern reconnaissance, secure satellite communications, orbital safety, and rocket launches.

About Syntec Optics

Headquartered in Rochester, N.Y., Syntec Optics Holdings, Inc. (NASDAQ: OPTX) is one of the nation’s largest bespoke makers of high-precision optics. It pushes the limits of light-based technologies to connect and protect the world. Syntec supports critical missions ranging from low-Earth-orbit satellites to advanced next-gen connected-battlefield defense platforms, moon rocket actuators, AI data centers, and life sciences. As light-enabled technologies continue to account for a significant portion of global economic output—representing nearly $20 trillion of the $111 trillion in total worldwide production as of 2024—Syntec Optics remains positioned at the forefront of the modern optical revolution.

For more information, visit syntecoptics.com.

Forward-Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this press release, including statements as to the intended use of net proceeds from the public offering, are forward-looking statements. Some of these forward-looking statements can be identified by the use of forward-looking words, including “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “plan,” “targets,” “projects,” “could,” “would,” “continue,” “forecast” or the negatives of these terms or variations of them or similar expressions. All forward-looking statements are subject to risks, uncertainties, and other factors (some of which are beyond the control of Syntec Optics), which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. All forward-looking statements are based upon estimates, forecasts and assumptions that, while considered reasonable by Syntec Optics and its management, as the case may be, are inherently uncertain and many factors may cause the actual results to differ materially from current expectations which include, but are not limited to: 1) risk outlined in any prior SEC filings; 2) ability of Syntec Optics to successfully increase market penetration into its target markets; 3) the addressable markets that Syntec Optics intends to target do not grow as expected; 4) the loss of any key executives; 5) the loss of any relationships with key suppliers including suppliers abroad; 6) the loss of any relationships with key customers; 7) the inability to protect Syntec Optics’ patents and other intellectual property; 8) the failure to successfully execute manufacturing of announced products in a timely manner or at all, or to scale to mass production; 9) costs related to any further business combination; 10) changes in applicable laws or regulations; 11) the possibility that Syntec Optics may be adversely affected by other economic, business and/or competitive factors; 12) Syntec Optics’ estimates of its growth and projected financial results for the future and meeting or satisfying the underlying assumptions with respect thereto; 13) the impact of any pandemic, including any mutations or variants thereof and the Russian/Ukrainian or Israeli conflict, and any resulting effect on business and financial conditions; 14) inability to complete any investments or borrowings in connection with any organic or inorganic growth; 15) the potential for events or circumstances that result in Syntec Optics’ failure to timely achieve the anticipated benefits of Syntec Optics’ customer arrangements; and 16) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in prior SEC filings. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Syntec Optics does not give any assurance that Syntec Optics will achieve its expected results. Syntec Optics does not undertake any duty to update these forward-looking statements except as otherwise required by law.

For further information, please contact:

Investor Relations

InvestorRelations@syntecoptics.com 

SOURCE: Syntec Optics Holdings, Inc. (Nasdaq: OPTX)

DURHAM, N.C, Nov. 02, 2026 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the Company will release its financial results for the three months and nine months ended September 30, 2026, on Tuesday, November 10, 2026. Management will host a webcast and conference call at 8:00 a.m. Eastern Time to provide a corporate and financial update.

Title	Humacyte 2026 Third Quarter Financial Results and Corporate Update
Date	November 10, 2026
Time	8:00 a.m. Eastern Time
Conference Details	1-877-704-4453 (U.S. Investors) 1-201-389-0920 (International Investors) 13763173 (Conference ID)
Call me™	Click Here
Webcast	Click Here

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for Symvess, the acellular tissue engineered vessel (ATEV), in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). The Company is preparing for human clinical study in coronary artery bypass graft surgery, and preclinical development is also underway in the treatment of type 1 diabetes, pediatric heart disease, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended June 30, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com

MONTREAL and CHARLOTTE, N.C., Nov. 02, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced new data showing that CARDAMYST® (etripamil) nasal spray converted approximately two-thirds of patients who experienced recurrent symptomatic paroxysmal supraventricular tachycardia (PSVT) after a prior catheter ablation to normal heart rhythm within 30 minutes. The subgroup analysis of the Phase 3 RAPID clinical trial will be presented by David Bharucha, MD, Ph.D., FACC, Chief Medical Officer of Milestone Pharmaceuticals in a moderated poster session at the American Heart Association (AHA) Scientific Sessions 2026 on Saturday, November 7. CARDAMYST is FDA-approved for the conversion of acute symptomatic episodes of PSVT to sinus rhythm in adults.

“Most patients do well after ablation but a subset continues to have episodes, and we have had limited options to offer them for treating an episode outside of an emergency room setting,” said James E. Ip, MD, Professor of Medicine and Director of Cardiac Pacing and Implantable Devices at Weill Cornell Medicine, a cardiac electrophysiologist at New York-Presbyterian/Weill Cornell Medical Center, and lead author of the analysis. “These data, although from a small group, are encouraging because the response to etripamil nasal spray in patients with a prior ablation is similar to what we observed across the broader RAPID population. For patients considering a repeat procedure, having a self-administered option to treat an episode should be a meaningful part of the conversation they have with their cardiologist.”

Catheter ablation is a procedure intended to treat PSVT, a common type of rapid heart rhythm, and it is successful for most patients. A small proportion of patients continue to have episodes afterward, and treatment options for these patients are limited.

Data Highlights

• Prior ablation was reported in 6.6% of all randomized patients (46 of 692) in RAPID and in 6.0% of those with adjudicated, confirmed PSVT in the efficacy population (11 of 184), confirming that a subset of patients continue to experience confirmed PSVT recurrences after ablation.
• In the prior-ablation subgroup (N=11), 66.7% of etripamil-treated patients (n=6) converted to sinus rhythm at 30 minutes, compared with 20.0% of placebo-treated patients (n=5), consistent with the conversion observed in the overall RAPID efficacy population. These are descriptive data, and this subgroup analysis was not powered for between-group comparison.
• Safety in the prior-ablation subgroup was assessed using continuous ECG recordings and adverse-event reporting, including monitoring for AV block and prolonged pauses.

The authors concluded that etripamil should be considered a potential treatment option for patients who have incomplete resolution after ablation or who are considered high risk for a repeat procedure.

“In this analysis from the RAPID trial, patients with recurrent PSVT after a prior ablation responded to etripamil in a manner consistent with the overall trial population,” said David Bharucha, MD, Ph.D., FACC. “Thus, we believe these findings reinforce the overall data which show etripamil to be a safe and effective treatment option, and support this drug to be used as a self-administered treatment for patients who may have continued episodes of PSVT after ablation.”

The subgroup analysis draws on the overall RAPID trial, which met its primary endpoint. In the prior-ablation efficacy subgroup (N=11), patients had a mean age of 50.9 years, 82% were female, and 54.5% were taking an oral AV nodal-acting medication. Six patients received etripamil and five received placebo.

RAPID (NCT03464019) was a randomized, double-blind, event-driven, placebo-controlled Phase 3 study evaluating a single or repeat 70 mg dose of etripamil, self-administered by patients during a perceived PSVT episode, with a repeat dose permitted per protocol. Episodes were adjudicated from ambulatory ECG recordings. The efficacy population included patients who self-administered study drug during an adjudicated, confirmed, AV nodal-dependent PSVT episode; patients with post-conversion dosing, non-AV nodal-dependent events, or substantial ECG signal loss were excluded. To enroll, patients with a prior PSVT ablation were required to have documented ECG evidence of recurrent PSVT after the procedure.

CARDAMYST Product Theater

Milestone will also host a Product Theater at AHA Scientific Sessions 2026 titled “How Can CARDAMYST, the first and only FDA-approved, self-administered treatment for PSVT in adults, be used in a Health Care Professional’s practice?” on Saturday, November 7, from 9:30 to 10:15 am CT. The presenter will be Matthew Budoff, MD, FACC, FAHA, of the Department of Medicine, Lundquist Institute at Harbor-UCLA.

About CARDAMYST 

CARDAMYST^® (etripamil) nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. The product is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT. Currently, etripamil is in Phase 2 development for treatment of PSVT in pediatric patients and Phase 3 development for control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com. 

U.S. FDA Indication
CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil)

What is CARDAMYST?

CARDAMYST is a prescription medicine used to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT).

It is not known if CARDAMYST is safe and effective in children.

Do not use CARDAMYST if you:

• are allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete list of ingredients in CARDAMYST.
• have limitations in activities due to heart failure (moderate to severe heart failure).
• have Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm pattern called pre-excitation (delta wave) on an electrocardiogram (ECG).
• have sick sinus syndrome without a permanent pacemaker.
• have second degree or higher atrioventricular (AV) block.

Before using CARDAMYST, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of fainting.
• have low blood pressure.
• are pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this time, pump and throw away your breast milk. Talk to your healthcare provider about the best way to feed your baby after using CARDAMYST.

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

What are the possible side effects of CARDAMYST?

CARDAMYST may cause serious side effects, including:

• Fainting due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST may cause dizziness and fainting, especially in people with a history of fainting and certain heart problems, or people with a history of fainting during an episode of PSVT. Use CARDAMYST while sitting in a safe area where you will not fall if you become dizzy or lightheaded. Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after using CARDAMYST, caregivers should place you on your back and seek medical help.

The most common side effects of CARDAMYST include nasal discomfort, nasal congestion, runny nose, throat irritation, and nosebleed.

These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information 
https://milestonepharma.com/etripamilprescribinginformation.pdf for CARDAMYST.

About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR. https://milestonepharma.com/.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: Milestone’s business strategy and plans; the commercialization and market adoption of CARDAMYST; expectations regarding the potential role of CARDAMYST as a self-administered treatment option for patients experiencing recurrent PSVT after catheter ablation; the anticipated presentations at AHA Scientific Sessions 2026; Milestone’s development plans for etripamil in additional indications and patient populations; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of Milestone’s clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs and conflicts, and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related to the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Investor Relations
Kevin Gardner, kgardner@lifesciadvisors.com

Media Relations
Rebecca Novak, rnovak@milestonepharma.com 

CALABASAS, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, today announced that data from its intranasal NEO100 and oral NEO212 programs will be presented in two posters on Friday, November 13, at the 31st Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), held November 12 to 15, 2026, at the Pennsylvania Convention Center in Philadelphia.

“We look forward to presenting data from both of our clinical programs at SNO,” said Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc. “These presentations reflect the progress we are making in bringing new approaches to patients with brain cancer.”

Presentation Details

Title: Durable Radiographic Remission and Prolonged Survival with Intranasal NEO100 in Recurrent WHO Grade III/IV IDH1-Mutant Astrocytoma: Updated Results from a Phase 1/2a Study and Compassionate Use Experience
Abstract Number: CTNI-26
Presentation Type: Poster
Session: Poster Session
Presenter: Thomas C. Chen, MD, PhD, University of Southern California and NeOnc Technologies Holdings, Inc.
Date and Time: Friday, November 13, 2026, 7:30 to 9:30 p.m. EST
Location: Exhibit Halls D and E, Second Floor, Pennsylvania Convention Center, Philadelphia

Title: Oral NEO212 in TMZ-Resistant Recurrent GBM and Brain Metastases: Phase 1 Safety, PK, and Early Signals of Activity
Abstract Number: CTNI-27
Presentation Type: Poster
Session: Poster Session
Presenter: Josh Neman, PhD, University of Southern California and NeOnc Technologies Holdings, Inc.
Date and Time: Friday, November 13, 2026, 7:30 to 9:30 p.m. EST
Location: Exhibit Halls D and E, Second Floor, Pennsylvania Convention Center, Philadelphia

About NEO100

NEO100 is a highly purified form of perillyl alcohol administered intranasally. Its delivery approach is designed to provide a non-invasive route to the brain. NEO100 remains investigational, and its safety and efficacy have not been established.

About NEO212

NEO212 is an investigational oral conjugate of temozolomide and NEO100. It is being studied for CNS cancers, including recurrent glioblastoma. Preclinical studies support further evaluation of its potential activity and delivery characteristics; clinical efficacy and safety have not been established. NEO212 is being developed under an FDA investigational new drug application.

About NeOnc Technologies Holdings, Inc.

NeOnc Technologies Holdings, Inc. is a clinical-stage biopharmaceutical company developing therapies for central nervous system cancers. Its investigational programs include intranasal NEO100 and oral NEO212. NEO212 has completed Phase 1 dose escalation and is advancing toward Phase 2 development. NeOnc exclusively licenses a worldwide portfolio of issued patents and pending applications from the University of Southern California related to NEO100, NEO212 and other drug candidates and delivery approaches.

For more information, visit https://neonc.com. 

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the Company’s clinical development programs and the clinical potential of NEO100. Forward-looking statements in this release also include statements regarding the clinical potential of NEO212 and the planned presentation of data at the Society for Neuro-Oncology Annual Meeting. These statements reflect current expectations and involve risks and uncertainties. NEO100 is investigational and has not been approved by any regulatory authority; future studies may not demonstrate safety or efficacy; clinical development remains subject to applicable clinical, regulatory and institutional requirements; and no regulatory pathway or marketing approval is assured. NEO212 is also investigational and has not been approved by any regulatory authority. Actual results may differ materially. Readers should consider the risk factors described in the Company’s most recent filings with the Securities and Exchange Commission. These statements speak only as of the date of this release.

The Company undertakes no obligation to update forward-looking statements except as required by law.

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

Contacts

Company Contact:
info@neonc.com 

Investor Contact:
Jon Nugent
Jon Nugent Communications
jon@jonnugent.com 
205-566-3026

This press release was published by a CLEAR® Verified individual.

Independent laboratory results advance first commercial waste-to-methanol module toward Portugal deployment

HOUSTON, Nov. 02, 2026 (GLOBE NEWSWIRE) — HyOrc Corporation (OTCQB: HYOR) announced independent laboratory results from its first commercial module, demonstrating exceptionally low nitrogen dilution in refuse-derived fuel (RDF) syngas.

Prewel Laboratories measured 39.88% carbon monoxide, 35.55% hydrogen and 0.76% nitrogen after gasification and gas cleaning, before water-gas shift reaction, membrane separation and stoichiometric conditioning for methanol synthesis.

“Nitrogen is the number I’d look at,” said Reginald Fubara, CEO. “Air contains approximately 78% nitrogen, which conventional air-blown gasification carries into syngas. Our equipment produced just 0.76% nitrogen, alongside 75.43% combined hydrogen and carbon monoxide. That’s a significant achievement.”

Low nitrogen dilution can improve downstream efficiency and reduce equipment requirements.

HyOrc’s earlier pilot system (1 TPD RDF to 300 litres methanol daily) operated extensively before undergoing a structured 60-day monitoring and data-validation programme, including instrumentation upgrades to meet Bureau Veritas verification requirements. Bureau Veritas conducted three days of continuous on-site monitoring in April 2026, reporting satisfactory results with no non-conformities. Building on sustained pilot-scale methanol production, these latest results demonstrate the performance of HyOrc’s first commercial gasification module ahead of long-term operating validation in Portugal.

Portugal Deployment

The gasifier, tar-scrubbing and filtration systems are built. Final integration and factory testing are targeted for early December, followed by shipment to Portuguese JV partner MO.RE.DA. Oils, Lda., near Porto.

HyOrc has revised its deployment timetable to accommodate final equipment integration, factory testing and international shipping logistics, with initial methanol production in Portugal now targeted for Q1 2027.

“Our pilot system has already demonstrated sustained methanol production from waste,” said Mr Fubara. “We are now bringing that experience into our first commercial installation in Portugal, where the focus will be on demonstrating reliable, sustained production under everyday operating conditions.”

The initial module targets 3 tonnes of RDF daily, yielding approximately 1 tonne of methanol. A planned 35-tonne RDF expansion targeting 8 tonnes of methanol daily has an approved €6,706,550 non-repayable COMPETE 2030 STEP grant.

About HyOrc

HyOrc Corporation (OTCQB: HYOR) develops modular waste-to-methanol and power-generation technologies.

Website: www.hyorc.com Press Contact: comms@hyorc.com

Forward-Looking Statements

This release contains forward-looking statements concerning deployment, financing, commissioning, production and expansion. Actual results may differ due to funding, manufacturing, logistics, regulatory and operational risks. HyOrc undertakes no obligation to update these statements except as required by law.