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REJIMUS Expands In 21 CFR Part 11 Software Validation Services for CPG Supply Chains

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REJIMUS empowers FDA-regulated businesses throughout the GPG supply-chain to more quickly audit, validate, document and maintain electronic systems – including AI-enabled workflows – within their existing quality and compliance programs subject to regulations under 21 CFR Part 11.

NORTH RICHLAND HILLS, Texas, Aug. 26, 2026 /PRNewswire-PRWeb/ — REJIMUS, Inc., a preeminent regulatory management consultancy and SaaS provider serving FDA-regulated consumer-product industries in the US, today announced the expansion of its 21 CFR Part 11 Software Validation Services.

“Food, supplement, cosmetic and OTC companies are adopting cloud systems and AI at the same speed as the rest of the market, but many do not have software validation expertise in-house or even know it is required,” said Brandon M. Griffin, CEO of REJIMUS, Inc.

The offering helps food and beverage, dietary supplement, cosmetic and over-the-counter (OTC) drug companies implement and maintain Part 11 compliance over their computerized systems, AI integrated workflows, and electronic record keeping practices to ensure such systems operate in compliance for their intended use throughout the operational life-cycle.

Electronic quality management systems, manufacturing execution systems, standalone document-control systems, laboratory information management systems, analytical equipment-attached software, enterprise resource planning tools, electronic batch and production records, electronic complaint handling, supplier-management systems, controlled spreadsheets, electronic-signature tools and AI-enabled/integrated software are now commonplace in regulated operations. 21 CFR Part 11 establishes controls for applicable electronic record keeping and electronic signatures, and under FDA’s current guidance, it generally applies when records required by an FDA statute are maintained electronically in lieu of paper, when companies rely on electronic records to perform regulated activities, when designated records are submitted electronically to FDA, or when electronic signatures replace required handwritten signatures. Not every computer system or electronic record is automatically subject to Part 11, and such determination can be made quickly in an Electronic System Gap Assessment.

Validation decisions and scope should be based on a justified, documented assessment of intended use, inclusive of product quality and safety, regulatory obligations, and the accuracy, integrity, availability and authenticity of required records and signatures. REJIMUS does not presume that every use of artificial intelligence is subject to Part 11, therefore, AI utilization is evaluated case by case as part of the underlying computerized system and regulated workflows. The assessment from REJIMUS considers whether AI creates, modifies, summarizes, classifies, recommends, reviews, approves, retains or transmits information that the company relies upon as a required record or to perform a regulated quality or compliance activity.

While most established Part 11 Validation service providers in the US, publicly center their costly services on companies in the pharmaceutical, biotechnology, and medical-device sectors, REJIMUS offers a notably more efficient and cost-effective alternative for consumer-product businesses in the foods, dietary supplements, cosmetics and OTC drugs sectors that are subject to the same regulations.

“Food, supplement, cosmetic and OTC companies are adopting cloud systems and AI at the same speed as the rest of the market, but many do not have software validation expertise in-house or know it is required,” said Brandon M. Griffin, CEO of REJIMUS, Inc. “AI can help quality and regulatory teams work faster, but speed cannot replace evidence, governance and accountability,” Griffin said. “Our role is to determine where the gaps are quickly, where AI sits in the regulated process, what controls and testing are proportionate to the risk, and how human oversight, vendor monitoring and change control can keep the system operating as intended.”

REJIMUS combines specialized Part 11 validation leadership with quality and regulated-operations expertise to address cGMP Quality Systems wholistically with an efficient compliance mindset. This is inclusive of SOP development, facility and supplier auditing, FDA inspection preparation, and most notably in the complete resolution and close out of of FDA Form 483’s and Warning Letters. That distinction matters because AI-enabled functions can and are introducing new risks that are different from conventional deterministic software. A human reviewer does not eliminate the need to understand and control the system when its output materially supports a regulated decision.

Services are scaled to the system, intended use and risk and may include:

Part 11 gap assessments; system, data-integrity and AI-use risk assessments; validation planning; and remediation roadmapsPart 11 auditing; user and functional requirements; supplier assessments; configuration, security, access-control, audit-trail and electronic-signature reviewsPart 11 validations; writing and executing of test protocols and scripts; IQ, OQ, PQ and user-acceptance testing, as applicable, inclusive of requirements traceability, deviations and Part 11 validation summary reportsExisting-system remediation; for data-migration validation, governing SOPs, staff training and change control, full and partial re-validations and ongoing lifecycle support

Part 11 Software Validation services from REJIMUS are available for new implementations, existing or legacy platforms, cloud and software-as-a-service systems, significant software upgrades, integrations, data migrations, inspection readiness and remediation following audit or FDA inspections. Learn more or request an assessment: www.rejimus.com/software-validation/

Media Contact

Brandon Griffin, REJIMUS, Inc., 1 6822671203, info@rejimus.com, www.rejimus.com

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SOURCE REJIMUS, Inc.

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From homegrown startup to biggest PH IPO: Mynt banners growth story at world’s biggest fintech stage

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SINGAPORE, Nov. 13, 2026 /PRNewswire/ — For the fourth consecutive year, Philippine fintech leader GCash is returning to the Singapore Fintech Festival (SFF) 2026 following its historic $966-million (₱60.9-billion) initial public offering (IPO).

Now a publicly listed company, GCash parent Mynt brings the Philippine fintech industry’s growth story to the global stage, demonstrating how homegrown innovation can expand financial inclusion and make financial services more accessible to millions of Filipinos.

For GCash, this reflects how a technology designed around people’s everyday needs can help transform the financial landscape in the Philippines and even abroad.

Key leaders of the Philippines’ leading finance super app will join panel sessions, sharing insights and experiences that have shaped the growth of GCash and the broader Philippine fintech landscape. Participating leaders include Tony Isidro, President and CEO of Fuse Financing, Inc., the lending arm of GCash, Winsley Bangit, the Head of New Businesses at Mynt, the parent company of GCash, and Michelle Fernandez, GCash Head of Corporate Sustainability and Communications.

Mynt’s IPO, the biggest in Philippine corporate history, marks an important milestone for the country’s capital market. It creates an opportunity for more Filipinos, including first-time investors, to participate in the growth of a homegrown tech company through the public markets.

“Digital financial access should not be a privilege reserved for a limited few. Technology can help make financial services more inclusive, accessible, relevant, and responsive to the realities of everyday Filipinos,” Mynt President and CEO Martha Sazon shared.

Isidro, for his part, will speak at the Global SME Forum Roundtable where he will discuss how digital ecosystems can translate customer and transaction activity into accessible, scalable credit products

Bangit will also join a fireside chat with the Securities and Exchange Commission to discuss emerging trends in investing. The session will highlight how progressive regulation, meaningful industry collaboration, and fintech innovation are unlocking greater access to instruments like bonds, funds, and stocks for more Filipinos, making diverse investing more affordable while strengthening consumer protection.

Meanwhile, Fernandez will take part in the “Sustainability-Linked Finance for MSMEs” panel to discuss GCash initiatives that promote sustainable practices among MSMEs. One of these is Project Sirius MSME Scorecard, which makes sustainability reporting more straightforward, and helps MSMEs qualify for sustainability-linked financing.

GCash will showcase Filipino fintech innovations at its booth at the Singapore Expo Hall 2, featuring demonstrations of key app services and AI-powered technologies that enhance security, service and financial education.

SFF, the largest gathering of fintech players, will take place on November 18 to 20 at the Singapore Expo, with the theme “The Coming Rewiring of the Financial System: New Risks. New Rules. New Growth.” The event will bring together leading fintech companies, investors, payment network operators, central banks, government representatives, and other industry stakeholders.

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SOURCE Mynt

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TuHURA Biosciences Reports Third Quarter 2026 Financial Results and Provides a Corporate Update

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TAMPA, Fla., Nov. 13, 2026 /PRNewswire/ — TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today reported financial results for the Company’s third quarter ended September 30, 2026, and provided a corporate update. 

“We continue to make significant progress across each of our programs. In October, we shared our first look at data from our open-label front line study of IFx-2.0 with Keytruda® in patients with deep-seated metastatic Merkel cell carcinoma, which showed durable, major objective anti-tumor responses in the first three patients with all responses ongoing for more than six months,” said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. “Working collaboratively with the FDA, we received clearance to begin our Phase 1b study of TBS-2025, our VISTA-inhibiting antibody, in relapsed/refractory mutNPM1 acute myeloid leukemia (AML), a molecularly defined subset of AML where the presence of VISTA on leukemic cells is associated with poor response to therapy and survival.”

Dr. Bianco continued, “We will have a strong presence again this year at the upcoming American Society of Hematology (ASH) Annual Meeting in December with 3 poster presentations highlighting our Delta Opioid Receptor (DOR) technology. The ASH scientific review committee recognized the importance of our discoveries of the central role the DOR plays in controlling proliferation, recruitment and immunosuppressive capabilities of MDSCs, the body’s main cell type for suppressing immune responses leading to acquired resistance to cancer immunotherapies.”

“With meaningful progress having been made in each of our programs, we believe we are well positioned to deliver on several transformational potential milestones. Having continuing access to a $50mm credit facility from our largest shareholder has allowed us to fund operations in a non-dilutive manner benefiting shareholders as we continue driving towards these value-creating events,” Dr. Bianco concluded.

Third Quarter and Recent Corporate Highlights:

Announced three poster presentations at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 12-15, 2026, in New Orleans. The posters highlight research on the role of the Delta Opioid Receptor (DOR) in controlling the immunosuppressive capabilities of myeloid-derived suppressor cells (MDSCs), and the data underscore the potential therapeutic breadth of DOR technology across MDSCs, T regs and M2 macrophages.Provided a first look at data from its open-label study of IFx-2.0 as an adjunctive therapy to Keytruda® in first line treatment of patients with deep seated metastatic Merkel Cell Carcinoma. Preliminary results demonstrated major objective partial responses in each of the first 3 patients, constituting major objective tumor responses, which are ongoing for more than six months.Received a new U.S. Patent broadening coverage for its VISTA Inhibitor, TBS-2025. The patent extends coverage to include bispecific/multi-specific antibodies across all classes of human antibodies as well as coverage for methods of treatment that extend beyond cancer, expanding into new treatment areas like autoimmune disease and infection. The patent term extends to 2042, prior to any potential patent term adjustment and/or regulatory patent term extension.Received key U.S. patent for its groundbreaking Delta Opioid Receptor (DOR) Antibody Drug Conjugate (ADC) technology. The patent discloses uses beyond ADCs, including autologous or allogeneic adoptive cellular immunotherapies like CAR-T, Tregs or TIL cell therapies. The term of the patent runs through 2043 before any patent term extension.Well funded to achieve clinical goals. The Parkview loan facility contributed $5.6 million in non-dilutive financing during the quarter ended September 30, 2026. This facility allows the Company to operationally proceed on all fronts while maintaining shareholder value. This facility also allows the Company to focus exclusively on operational goals.Received FDA “Study May Proceed” notice and IND clearance for the evaluation of its VISTA-Inhibiting Antibody in molecularly defined subsets of AML and other blood-related cancers. The IND allows the Company to examine TBS-2025 in a Phase 1b study evaluating the safety and potential efficacy of monotherapy at different doses in patients with relapsed/refractory (r/r) mutNPM1 AML who have failed to respond to or relapsed after Menin inhibitor therapy. If TBS-2025 results in encouraging response rates during the dose-optimization stage of the study, the Company will explore with the FDA the potential expansion of the trial in consideration for the opportunity for accelerated approval.

Currently Anticipated Milestones by Program

IFx-2.0 (Innate Immune Agonist)

2H 2026: Expect to receive orphan drug designation in MCC1H2027: Expect preliminary results from front-line study IFX-2.0 with Keytruda®  when administered by CT or ultrasound-guided techniques to metastatic deep seated MCC2H 2027: Expect to complete enrollment in the Company’s Phase 3 registrational front-line study of IFx-2.0 as adjunctive therapy to Keytruda® in advanced or metastatic MCC

TBS-2025 (VISTA inhibiting mAb)

2H 2026: Expect to initiate a Phase 1b/2 trial of TBS-2025 VISTA inhibiting antibody in mutNPM1 r/r AML1H 2027: Expect to receive orphan drug designation in AML1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML

MDSC Inhibitors (Bi-specific ADCs)

2H 2026: Presentations at ASH2H 2026: Initiation of ADC in vivo POC studies

Summary of Financial Results for the Third Quarter 2026
Cash and cash equivalents of $1.9 million at September 30, 2026. The Company received $9.2 million in gross proceeds as of September 30, 2026, on the Parkview credit facility.  

Research and development expenses were $3.7 million and $5.0 million for the 3 months ended September 30, 2026, and 2025, respectively. The decrease of $1.3 million was due to lower manufacturing costs, which are expected to resume in the next quarter with the start of the TBS-2025 clinical trial material manufacturing campaign. 

General and administrative (G&A) expenses were $2.0 million and $1.6 million for the 3 months ended September 30, 2026, and 2025, respectively. The increase of $0.4 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.

Net cash outflows from operating activities were ($18.1) million and ($22.1) million for the 9 months ended September 30, 2026, and 2025, respectively.

Net cash flows from financing activities were $16.5 million and $13.4 million for the 9 months ended September 30, 2026, and 2025, respectively.

Total common shares outstanding were approximately 65.8 million at September 30, 2026.

About TuHURA Biosciences, Inc. 
TuHURA Biosciences, Inc. (NASDAQ: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.

TuHURA’s lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.

In addition to its innate immune agonist product candidates, TuHURA is developing TBS-2025, its VISTA-inhibiting mAb in a Phase 1b clinical trial in patients with mutNPM1 r/r AML, a molecularly defined subgroup that represents approximately 35% of patients with AML. TuHURA is also leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting Myeloid-Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain “forward-looking statements” within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely,” or the negative or plural of these words or similar expressions. Our statements in this press release regarding our ongoing research programs and studies are an example of such forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include, among others, the risk that funds available under the Company’s credit facility may be insufficient to fund the Company’s operations and development programs to the extent anticipated; risks associated with conducting the ongoing Phase 3 trial for IFx.20; the risks associated with continuing the development of TBS-2025 and our DOR technologies and our planned Phase 1b trial for TBS-2025; risks related to patient enrollment, trial design, data outcomes and regulatory interactions; uncertainty regarding the timing and likelihood of milestones and regulatory approvals; and the other risks described from time to time in detail in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 31, 2026, and TuHURA’s other reports and filings with the SEC from time to time, which are available on TuHURA’s website and at www.sec.gov. 

The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

Investor Contact: 
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com

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SOURCE TuHURA Biosciences, Inc.

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Autech Parking Solutions Rebrands to Expand Global Presence in Automated Parking

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SEOUL, South Korea, Nov. 13, 2026 /PRNewswire/ — Autech Parking Solutions, a leading South Korean provider of automated parking systems formerly known as Autech-Otis Parking Systems, has rebranded to strengthen its position as a premier global provider of sophisticated parking solutions.

Founded in 1978, the company brings nearly five decades of expertise to the automated parking industry. To date, Autech Parking Solutions has delivered over 150,000 parking spaces across more than 2,000 project sites, establishing itself as a market leader in South Korea’s automated parking maintenance sector. Beyond its domestic success, the company supplies advanced systems to international clients in Israel, Vietnam, India, Indonesia, and China.

Building on its proven global capabilities, Autech Parking Solutions is reinforcing its commitment as a customer-focused provider, specializing in custom-designed parking systems tailored for challenging and non-standard spaces.

Its diverse product portfolio includes palletless fork-type and comb-type conveyor systems—which transfer vehicles smoothly without the need for pallets—alongside its advanced XY (chess-type) parking system, engineered to maximize spatial efficiency. These solutions offer ideal alternatives for buildings with unconventional structural layouts or sites with severe space constraints.

To further enhance property value, the company offers acoustic solutions designed to minimize noise and vibration—significantly improving comfort in residential buildings—as well as EV charging systems that integrate seamlessly into automated parking infrastructure. Furthermore, Autech Parking Solutions is currently piloting a robotic parking system in South Korea as part of its ongoing investment in next-generation parking automation technologies.

Company name : AUTECH PARKING SOLUTIONS CO.LTDContact person : Overseas Business Division(E) mail : SangHyun.Song@atps.co.kr Website : https://www.atps.co.kr/en/main/Address : 6FL., Ire Bldg, 57 Seonyudong 3-ro, Yeongdeungpo-gu, Seoul, South Korea

View original content:https://www.prnewswire.co.uk/news-releases/autech-parking-solutions-rebrands-to-expand-global-presence-in-automated-parking-302938931.html

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