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Legal & regulatory executive with extensive expertise in FDA law and regulatory leadership for one of the world’s leading medical device companies

MIAMI, FL / ACCESS Newswire / September 22, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held biotechnology company focused on the development of innovative regenerative medicines, today announced the appointment of Sandra Cohen Kalter to its Strategic Advisory Group.

“This appointment represents another step toward bolstering our ability to navigate complex regulatory pathways, potentially accelerate clinical translation and unlock the full potential of our pipeline. Our Strategic Advisory Group was formed to provide strategic guidance from individuals with a diverse background of expertise to support our initiatives, and Sandra is a wonderful addition that provides valuable insight and expertise. Over the course of her career, Sandra has navigated a number of regulatory pathways, inspections and integrations which have provided her with a depth and breadth of expertise that we believe will be instrumental as we move our development plans forward,” commented Anthony Japour, Chief Executive Officer of iTolerance.

Mrs. Kalter added, “I am pleased to serve in this capacity for iTolerance and leverage my knowledge and experience from my career to help advance this important technology forward. iTolerance’s platform technology, which has the potential to eliminate the need for life-long immunosuppression, continues to demonstrate promise, and I look forward to bolstering the Company’s efforts to provide patients with a treatment option where there remains significant unmet need.”

Sandra Cohen Kalter is a seasoned senior legal executive most recently serving as Vice President & Chief Regulatory Counsel at Medtronic plc (“Medtronic”), overseeing global strategies in regulatory compliance, quality, clinical affairs and medical safety for a world-renowned medical-device leader. She has led transformative enterprise-wide initiatives, including a patient safety and quality program that delivered major reductions in FDA findings and field corrective actions.

Additional career highlights include:

• Built and managed an in-house FDA legal team that navigated 17 regulatory inspections in a single year, ensuring product continuity

• Guided due diligence and integration efforts for more than 27 acquisitions, led regulatory responses to FDA violations and high-profile media scrutiny, and helped steer approval strategies for groundbreaking devices like the Evolut TAVR system and Micra leadless pacemaker

• Previously served as FDA/Health Care Counsel at King & Spalding LLP, where she advised on complex regulatory filings and FDA panel proceedings

• Received several awards including: Service to FDLI Award, Food and Drug Law Institute, 2023; Rapaport Lifetime Achievement Award, Juvenile Diabetes Research Foundation, 2019; Medtronic Wallin Leadership Award, June 2010; Marketing Campaign Team Award, Spinal & Biologics “Just the Facts,” 2010; Medtronic Star of Excellence Award, 2009

• Member of AdvaMed (Advanced Medical Technology Association) Legal Committee and Business Case for Quality Working Group

• Co-Chair of AdvaMed Advertising and Promotion Working Group , Off-Label Working Group, and Business Case for Quality Working Group

• Board of Directors of Food and Drug Law Institute (FDLI)

• Board of Directors of Juvenile Diabetes Research Foundation (JDRF) and Corporate Recruitment Chair of JDFR One Walk

• Member of Food and Drug Law Institute Medical Devices Advisory Committee

Mrs. Kalter attended George Washington University, The National Law Center and received a Juris Doctor Degree and a Bachelor of Science in Journalism from Northwestern University.

About iTolerance, Inc.

iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islets to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
iTolerance@jtcir.com

Media Contact
Susan Roberts
T:202.779.0929
sr@roberts-communications.com

SOURCE: iTolerance, Inc.

View the original press release on ACCESS Newswire

From Hobby to Cultural Movement: Sake Day East Brings Nearly 100 Sakes, Expert-Led Tastings, and Japanese Traditions to Boston.

BOSTON, MA / ACCESS Newswire / September 22, 2025 / What began as a personal hobby has grown into a cultural movement. Emmy Award-winning WHDH Channel 7 director Marina Giordano fell in love with the art of sake years ago-and now she’s the force behind Sake Day East, New England’s largest sake festival, celebrating its 5th year this fall.

On Saturday, October 4, 2025, at 100 High Street, Boston, Marina and her team-including her sons, who help organize the festival each year-will welcome sake enthusiasts from across the country for an evening of tastings, education, and cultural celebration.

“I never imagined a hobby could grow into something that would bring people together from all over the U.S.,” Marina said. “Sake Day East is about more than tasting-it’s about learning, connecting, and appreciating an incredible tradition.”

Marina, a WSET-certified sake instructor and nationally recognized educator, travels across the U.S. sharing the craftsmanship, diversity, and cultural richness of sake. Her approachable teaching style and deep knowledge have made her a respected voice in the industry, and Sake Day East has become her platform to educate and inspire on a national scale.

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Event Highlights

• 5th Anniversary Celebration – Marking five years of growth, community, and national recognition.

• Expert-Led Tastings – Nearly 100 sakes, guided by leading sake voices.

• Rare & Premium Selections – Curated sakes from breweries across the U.S. and Japan.

• Food & Culture – Pairings, performances, and immersive experiences highlighting sake’s place in Japanese tradition.

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Event Information & Tickets

Where: 100 High Street, Boston, MA
When: Saturday, October 4, 2025 | 5:00-8:00 PM
Tickets: Available now at: https://www.eventbrite.com/e/sake-day-east-2025-tickets-1344346940889?aff=ebdssbdestsearch

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About Sake Day East

Founded in 2021 by Emmy Award-winning WHDH Channel 7 Director Marina Giordano, Sake Day East has become New England’s premier sake festival. Marina, a WSET-certified sake instructor and nationally recognized educator, created the event to inspire and grow sake appreciation across the region. With the help of her family and a growing community of enthusiasts, Sake Day East connects breweries, experts, and audiences in celebration of sake’s artistry, heritage, and cultural significance.

Contact:
Jaclyn Zukerman Delory
Publicist
Next On Scene Media
jackie@nextonscene.com

SOURCE: Sake Day East

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ORLANDO, FL / ACCESS Newswire / September 22, 2025 / RedChip Companies (“RedChip”), an international investor relations, media, and research firm, today announced that it has been engaged by Bimergen Energy Corporation [OTCQB:BESS], (“the Company” or “Bimergen”), a developer of utility-scale battery energy storage projects and an independent power provider, to lead its investor relations efforts.

“We are at a pivotal stage in our growth as we advance our 2.0 GW portfolio of battery energy storage system (BESS) projects,” stated Benjamin Tran, Bimergen Chairman and CEO. “With the surge in demand for energy storage driven by AI, electrification, and grid modernization, our projects are positioned to deliver contract-backed revenues and provide essential grid stability. Partnering with RedChip enables us to broaden our visibility among institutional and retail investors while communicating the significant long-term value we are building.”

Dave Gentry, CEO of RedChip commented, “Bimergen Energy is uniquely positioned to capitalize on one of the fastest-growing segments of the renewable energy sector. Their robust pipeline, experienced leadership team, and commitment to stable, long-term revenue streams through institutional partnerships present a compelling story for investors. We look forward to delivering Bimergen’s message to our global audience through our integrated investor relations and media platform.”

With U.S. data center power demand expected to double by 2030 and grid-scale battery storage capacity projected to grow at a 24% CAGR through the decade, Bimergen is well-positioned to capitalize on these powerful industry tailwinds.

About Bimergen Energy Corporation

Bimergen Energy Corporation [OTCQB: BESS] is a utility-scale Battery Energy Storage System (BESS) asset owner, project developer, and independent power provider focused on generating revenues from delivering critical power grid stability. The Company owns 23 development stage BESS projects with a cumulative energy capacity of approximately 2 GW. The company secures project financing and oversees construction of their energy storage projects, partnering with institutional counterparties to manage daily energy trading operations under long-term offtake agreements ensuring stable, contract-backed revenue. For more information, please visit www.bimergen.com

About RedChip Companies

RedChip Companies, an Inc. 5000 company, is an international investor relations, media, and research firm focused on microcap and small-cap companies. For 33 years, RedChip has delivered concrete, measurable results for its clients. Our newsletter, Small Stocks, Big Money™, is delivered online weekly to 60,000 investors. RedChip has developed the most comprehensive service platform in the industry for microcap and small-cap companies. These services include the following: a worldwide distribution network for its stock research; retail and institutional roadshows in major U.S. cities; outbound marketing to stock brokers, RIAs, institutions, and family offices; a digital media investor relations platform that has generated millions of unique investor views; investor webinars and group calls; a television show, Small Stocks, Big Money™, which airs weekly on Bloomberg US; TV commercials in local and national markets; corporate and product videos; website design; and traditional investor relation services, which include press release writing, development of investor presentations, quarterly conference call script writing, strategic consulting, capital raising, and more. RedChip also offers RedChat™, a proprietary AI-powered chatbot that analyzes SEC filings and corporate disclosures for all Nasdaq and NYSE-listed companies, giving investors instant, on-demand insights.

To learn more about RedChip’s products and services, please visit:

https://www.redchip.com/corporate/investor_relations

“Discovering Tomorrow’s Blue Chips Today”™

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Cautionary Note Regarding Forward-Looking Statements

This press release may include, and oral statements made from time to time by representatives of the Company may include, “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements regarding possible business combinations and the financing thereof, and related matters, as well as all other statements other than statements of historical fact included in this press release are forward-looking statements. When used in this press release, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions, as they relate to us or our management team, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, the Company’s management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in the Company’s filing with the Securities and Exchange Commission (“SEC”). All subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are qualified in their entirety by this paragraph. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s filings with the SEC. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Contacts:

Bimergen Energy Corporation
Tel: 1.855.777.0888
Email: info@bimergen.com

Dave Gentry
RedChip Companies Inc.
1-407-644-4256
BESS@redchip.com

SOURCE: RedChip Companies, Inc.

View the original press release on ACCESS Newswire

SAN FRANCISCO, CA / ACCESS Newswire / September 22, 2025 / MentalHealth.com today announced its acquisition of Therapy.ai, a move that advances artificial intelligence in mental health care. This milestone positions MentalHealth.com to deliver safe, compliant AI solutions at the intersection of technology and therapy.

A Safe Approach to AI in Mental Health

Nearly 23% of Americans face bans or proposed restrictions on AI therapy at a time when mental health needs are rising sharply worldwide¹. Concerns focus on safety, privacy, and security, along with fears AI could replace human relationships – the foundation of therapy. These challenges present the urgent need to define AI’s role in mental health care.

The world is facing a mental health crisis at an unprecedented scale, with more than one billion people affected. According to the World Health Organization, anxiety and depression alone cost the global economy an estimated $1 trillion annually, while suicide remains among the leading causes of death worldwide. In the United States, the crisis is especially severe, with declining mental health and rising rates of substance abuse, self-harm, and violence.

“Early AI models often felt like real therapy, but without human connection their effects faded – leaving people more isolated,” said Patrick Nagle, Co-Founder of MentalHealth.com. “Eliminating AI from therapy altogether is not only unreasonable, it’s irresponsible. Applied responsibly, AI expands access to knowledge, supports therapists in delivering care, and provides frameworks to help people navigate challenges. In this role, AI augments care and strengthens relationships.”

Therapy.ai will operate as a wholly owned subsidiary, managed independently from MentalHealth.com. Its services are scheduled to debut in 2026 through the MentalHealth.com App Store, offering a full spectrum of therapy solutions within a trusted marketplace of care.

This acquisition builds on MentalHealth.com’s recent milestones, including the acquisitions of MentalHelp.net and PsychGuides.com and the launch of the Mental Health Network – reinforcing its mission to develop the world’s most intelligent mental health technology.

To learn more about MentalHealth.com and its vision to support the mental health of one billion people, visit: MentalHealth.com Vision Presentation (2025)

For interviews and further information:

MentalHealth.com, LLC
Helena Georgiou
press@mentalhealth.com

¹ Legislative actions on AI in mental health care include Illinois (HB 1806), Utah (HB 452), New Jersey (A5603), California (AB 489 and AB 1064), New York (S.8484), and Pennsylvania (proposed), according to recent reports from KFF Health News and CNN (2025).

Contact Information

Helena Georgiou
pr@mentalhealth.com
1-800-834-8587

SOURCE: MentalHealth.com, LLC

View the original press release on ACCESS Newswire

NEW YORK, NY / ACCESS Newswire / September 22, 2025 / The world is drowning in conferences. COP 29, the latest UN Climate Change Summit, came and went like the 28 before it, filled with lofty promises, carefully crafted communiqués, and expenses that could fund an actual recycling plant. The headlines don’t change. The applause doesn’t change. Even the quotes have a ring of similarity. This year, UN Secretary-General António Guterres warned: “We are in the midst of a climate crisis… humanity and the planet are hurtling towards catastrophe.”

The intent is always genuine. Leaders, regulators, and negotiators want to create solutions that matter. But intent is not the same as impact. Speeches, however heartfelt, do not move plastics out of burn piles or guarantee fire safety in the materials around us. The world does not need another round of statements. It needs systems that actually work.

That is why attention is shifting toward technology. Real progress comes not from ballrooms in Geneva, Dubai, or New York, but from innovations that embed solutions into supply chains and make results undeniable. SMX (NASDAQ: SMX) has focused on that challenge. Instead of adding to the rhetoric, it has been building the tools that transform promises into proof, giving policymakers, industries, and consumers the confidence they have been waiting for.

Proof, Not Pledges

Treaties set ambition. Technology delivers it. A global resolution cannot chase down every carbon-black pellet or hold every producer accountable for fire-retardant claims that may or may not be accurate. Words on paper cannot verify what’s inside a package or whether recycling percentages are honest.

SMX offers a different kind of statement: simple-to-scan verification. Its molecular markers go into the product itself, making proof inseparable from the material. A scan at any point in the supply chain confirms origin, recycled content, and compliance. No more gray zones between marketing slogans and regulatory filings. No more guessing games about whether claims hold up under scrutiny.

That is the difference between pledges and proof. One is a promise that might never be enforced. The other is a measurable fact embedded directly into the material. SMX doesn’t wait for consensus; it delivers clarity. And that clarity is exactly what the circular economy has been missing.

Singapore Isn’t Waiting

Look at Singapore. Ninety-four percent of its plastic waste gets incinerated – a number that would paralyze most nations into defeat. But instead of running from the challenge, Singapore has leaned into it. The country is connecting with SMX, Bio-Packaging, Aegis, Sky-Pac, and A*STAR to flip its waste profile from a liability into a global model for transformation.

By embedding molecular-level proof into packaging and plastics, every bag, film, and wrapper produced can be certified at birth. This isn’t theoretical. It’s happening right now on extrusion lines and production floors. What used to be invisible is now undeniable. The technology ensures not just sustainability, but verifiable sustainability – something consumers demand, regulators require, and brands cannot fake.

ASEAN’s leadership makes this even more powerful. The region is building a blueprint for plastics circularity that can be exported across borders and industries. The lessons from Singapore aren’t confined to one island nation – they are scalable, portable, and worth billions in value creation. That is real leadership.

Proof Extends to Safety

The strength of SMX’s toolbox is that it doesn’t stop at recycling. It extends into safety, compliance, and performance. A single scan of a plastic component can prove not only that it is recycled, but also that it meets fire-retardant standards. That is a dual proof – a guarantee of safety and circularity – that no piece of legislation or global agreement could ever deliver on its own.

NAFRA’s involvement underscores the urgency. Too many tragedies have been caused by false safety claims, from buildings lined with substandard materials to consumer goods that fail when they are needed most. By working with SMX, regulators and industry groups finally have a way to close that gap. The marker inside the product does the verification automatically.

This dual proof reshapes trust. Regulators can enforce without endless inspections. Brands can prove value without risk of fraud. And consumers can use products knowing that promises have been verified, not just advertised. That is not a small improvement – it is a global standard in the making.

The Plastic Cycle Token Turns Proof Into Currency

Proof is powerful on its own, but SMX has taken it further. Through the Plastic Cycle Token (PCT), every verified unit of recycling becomes a tradable economic instrument. For the first time, compliance generates dividends – credits that can be exchanged, traded, and monetized. Suddenly, recycling isn’t a cost center. It’s a profit center.

That shift changes everything. Incineration costs shrink. Recycling margins grow. Certified recycled materials become the new premium product in the global supply chain. What used to be waste now carries balance sheet value, creating incentives for companies to participate in circularity without waiting for government subsidies.

This is where sustainability and capitalism meet. Proof has become currency, and SMX is the mint. It is not only solving one of the world’s biggest waste problems – it is building an entirely new economic framework around verified circularity.

Stop the Talk. Start the Proof

The world has endured nearly three decades of sustainability conferences, and the results are always the same. Every summit, every communiqué, every banquet is another reminder that promises without enforcement are meaningless.

History may not remember the gatherings themselves. But it will remember the turning point – Singapore’s pivot, ASEAN’s blueprint, and the company that transformed rhetoric into reality with molecular proof that cannot be ignored. That company is SMX.

Proof is no longer a dream for tomorrow. It exists today, and it is already being deployed at scale. The question is not whether the world will act. The question is how long it will continue to waste time at conferences before embracing the tools already in its hands.

About SMX

As global businesses face new and complex challenges relating to carbon neutrality and meeting new governmental and regional regulations and standards, SMX is able to offer players along the value chain access to its marking, tracking, measuring and digital platform technology to transition more successfully to a low-carbon economy.

Forward-Looking Statements

The information in this press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “will,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this press release may include, for example: successful launch and implementation of SMX’s joint projects with manufacturers and other supply chain participants of steel, rubber, plastic and other materials; changes in SMX’s strategy, future operations, financial position, estimated revenues and losses, projected costs, prospects and plans; SMX’s ability to develop and launch new products and services, including its planned Plastic Cycle Token; SMX’s ability to successfully and efficiently integrate future expansion plans and opportunities; SMX’s ability to grow its business in a cost-effective manner; SMX’s product development timeline and estimated research and development costs; the implementation, market acceptance and success of SMX’s business model; developments and projections relating to SMX’s competitors and industry; and SMX’s approach and goals with respect to technology. These forward-looking statements are based on information available as of the date of this press release, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing views as of any subsequent date, and no obligation is undertaken to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. As a result of a number of known and unknown risks and uncertainties, actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include: the ability to maintain the listing of the Company’s shares on Nasdaq; changes in applicable laws or regulations; the ability to implement business plans, forecasts, and other expectations, and identify and realize additional opportunities; the risk of downturns and the possibility of rapid change in the highly competitive industry in which SMX operates; the risk that SMX and its current and future collaborators are unable to successfully develop and commercialize SMX’s products or services, or experience significant delays in doing so; the risk that the Company may never achieve or sustain profitability; the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the risk that the Company experiences difficulties in managing its growth and expanding operations; the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations; the risk that SMX is unable to secure or protect its intellectual property; the possibility that SMX may be adversely affected by other economic, business, and/or competitive factors; and other risks and uncertainties described in SMX’s filings from time to time with the Securities and Exchange Commission.

EMAIL: info@securitymattersltd.com

SOURCE: SMX (Security Matters) Public Limited

View the original press release on ACCESS Newswire

Heirs facing stricter withdrawal deadlines may owe more to the IRS than expected.

IRVINE, CALIFORNIA / ACCESS Newswire / September 22, 2025 / The Internal Revenue Service (IRS) is reminding taxpayers that inheriting a retirement account, such as an IRA or 401(k), could come with new and often unexpected tax obligations. Changes under recent federal rules now require most non-spouse beneficiaries to withdraw inherited funds within ten years – a move that could accelerate taxable income and lead to larger IRS bills.

Financial experts say many heirs mistakenly assume inherited retirement accounts are tax-free or can be left untouched for decades. In reality, the SECURE Act and subsequent IRS guidance have tightened requirements, and failure to comply can result in costly penalties.

“Beneficiaries often don’t realize that an inherited IRA is treated very differently than one they opened themselves,” said a spokesperson for Clear Start Tax. “If you don’t take the right withdrawals on schedule, you could face both unexpected income tax and additional IRS penalties. Reviewing the rules early can save thousands.”

Clear Start Tax notes that planning ahead is especially important for retirees passing wealth to children or grandchildren. “We’re encouraging families to talk about these rules before a loved one passes,” the spokesperson added. “It’s not just about protecting the inheritance – it’s about avoiding a surprise tax bill that could wipe out much of the benefit.”

Tax professionals recommend beneficiaries carefully review IRS distribution timelines, consider strategies to spread withdrawals over multiple years, and seek professional guidance before making major decisions.

By answering a few simple questions, taxpayers can find out if they’re eligible for the IRS Fresh Start Program and take the first step toward resolving their tax debt.

About Clear Start Tax

Clear Start Tax is a trusted tax relief company dedicated to helping individuals and families resolve back taxes, navigate IRS programs, and protect themselves from enforcement actions. With a client-focused approach, the firm provides education and personalized solutions to reduce financial stress and achieve lasting tax relief.

Need Help With Back Taxes?

Click the link below:
https://clearstarttax.com/qualifytoday/
(888) 710-3533

Contact Information

Clear Start Tax
Corporate Communications Department
tech@clearstarttax.com
(949) 800-4011

SOURCE: Clear Start Tax

View the original press release on ACCESS Newswire

Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine.

MIAMI, FLORIDA / ACCESS Newswire / September 22, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of its lead oral candidate, Ketamir-2, in healthy volunteers.

The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). The primary endpoints were safety, tolerability, and PK characterization.

Key Pharmacokinetic Findings

• Dose-proportional increases in exposure (Cmax and AUC) were observed across all dose levels tested.

• Median time to maximum plasma concentration (Tmax) reached within 1-2 hours, consistent across cohorts, confirming rapid and predictable absorption.

• Terminal half-life (t½) of Ketamir-2 ranged from 2-5 hours, while its primary active metabolite, nor-Ketamir, demonstrated a longer half-life of 6.5-8.5 hours. This favorable duration of action supports convenient once-daily dosing and may contribute to sustained therapeutic benefit.

• This contrasts with oral ketamine, which is characterized by erratic absorption and a much shorter half-life, limiting its clinical use in chronic treatment. The predictable PK profile of Ketamir-2 supports convenient once-daily dosing for patients with neuropathic pain and potentially other CNS conditions.

Safety and Tolerability

• Ketamir-2 was generally safe and well tolerated across all four cohorts

• No dose-limiting toxicities or serious adverse events were observed

• Treatment-emergent adverse events were transient and resolved without intervention

• In addition to routine safety assessments, CNS effects were carefully monitored using validated tools (C-SSRS, Bowdle VAS, KSET). Across all SAD cohorts, Ketamir-2no clinically significant adverse effects observed.

Next Steps

Based on the data, MIRA is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers, to be followed by a Phase 2a trial in patients with neuropathic pain.

Management Commentary

“These first-in-human data clearly demonstrate a favorable safety profile and predictable pharmacokinetics across a wide dosing range,” said Erez Aminov, CEO of MIRA. “Importantly, the absence of the hallmark CNS side effects typically associated with ketamine, which we first observed preclinically, has now been confirmed clinically – reinforcing Ketamir-2’s differentiated profile. Given the significant unmet need for safe, effective, and non-addictive treatments for neuropathic pain, we believe Ketamir-2 is well positioned as a highly attractive development candidate, and the Company is actively exploring strategic partnering opportunities to accelerate its advancement.”

Dr. Itzchak Angel, CSA of MIRA, added: “The Phase 1 pharmacokinetic data demonstrate that Ketamir-2 is rapidly absorbed, predictably metabolized, and suitable for once-daily dosing – a major advantage compared to oral ketamine, which suffers from poor bioavailability and short half-life. Importantly, we were able to confirm in a human clinical study that Ketamir-2 continues to differentiate itself from ketamine by showing a robust safety and pharmacokinetics profile well adapted for its intended use. These findings underscore its potential as a next-generation therapeutic.”

About Ketamir-2

Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and shows no significant off-target activity across a broad receptor panel.

Preclinical studies have demonstrated:

• Neuropathic pain: Superior efficacy upon oral administration versus ketamine, pregabalin, and gabapentin in gold-standard models, without the dissociative side effects associated with ketamine.

• PTSD: In the validated Single Prolonged Stress (SPS) model, Ketamir-2 restored normalized behavior in stressed animals, reversing hallmark PTSD-like behaviors consistent with non-stressed controls. A larger follow-on PTSD study is ongoing.

• Depression: Activity in established preclinical models supports the potential of Ketamir-2 as a differentiated treatment for major depressive disorders, including treatment-resistant depression (TRD).

• Inflammatory pain (topical formulation): In animal models, a topical formulation of Ketamir-2 demonstrated pain relief equal to injected morphine, underscoring its versatility and non-opioid potential across pain indications.

The U.S. Drug Enforcement Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company’s pipeline includes oral drug candidates designed to address significant unmet medical needs in neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline.

For more information, please visit www.mirapharmaceuticals.com.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA’s management related thereto contain “forward-looking statements,” which are statements other than historical facts made pursuant to the safe harbor provisions 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 may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA’s current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA’s control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA’s potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA’s programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA’s website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

NAPERVILLE, IL / ACCESS Newswire / September 22, 2025 / Abilities Independent Community, INC (AIC) today celebrated a major milestone in its inaugural year, announcing the successful transition of its first cohort of residents into self-sufficient living. The highlight is the story of “Alex S.” (a composite resident), a 32-year-old adult with a cognitive disability who, after nine months in the intergenerational program, has achieved full financial independence and secured a permanent remote position in data management.

Alex’s journey exemplifies the core tenet of AIC: that with the right environment and mentorship, adult with disabilities can shatter the barriers of dependence. Before joining AIC, Alex relied entirely on his aging parents for daily tasks, financial management, and social integration. Following intensive coaching from the AIC team and mentorship from a 61-year-old senior resident, he mastered budgeting, advanced digital literacy, and time management.

“This isn’t about simple hand-holding; it’s about providing the keys to the kingdom of adult life,” said an AIC Program Director. “Alex’s success proves the model works: the seniors provide the wisdom and practical experience that formal institutions often lack, and the specialized training provides the contemporary skills needed for the job market.”

Measurable Change: Before and After AIC

Alex’s progress was tracked using quantifiable metrics, demonstrating the tangible shift from reliance to resourcefulness:

The Historical Real-Life Event That Demanded Independence

Alex’s journey to self-determination stands as a modern victory in the long, hard-fought battle for disability rights in America. This fight was crystallized by the “Capitol Crawl,” a powerful, real-life event that occurred on March 12, 1990.

The Capitol Crawl was a dramatic, pivotal protest organized by disability rights activists, including the group American Disabled for Public Transit (ADAPT), to push for the passage of the Americans with Disabilities Act (ADA). Approximately 60 activists, many using wheelchairs, abandoned their mobility aids and crawled up the 83 stone steps of the U.S. Capitol Building. They literally dragged themselves, using only their arms, legs, and sheer willpower, to demonstrate the profound inaccessibility of public spaces and the dignity they were denied.

This shocking and undeniable display of the physical obstacles faced by disabled Americans captured national attention and broke down political resistance. The ADA was signed into law later that year, prohibiting discrimination against individuals with disabilities in all areas of public life.

AIC’s success stories, like Alex’s, honor the legacy of the Capitol Crawl. The activists fought for access; AIC provides the application. They secured the civil right to independence; AIC delivers the educational, vocational, and residential infrastructure to make that right a reality.

Next Steps: Expansion and Replication

Inspired by the success of its first cohort, AIC is now finalizing plans for replication in a second major metropolitan area. The organization urges philanthropists and state-level housing agencies to examine its data and recognize the profound return on investment (ROI) in dignity, reduced state dependency, and restored purpose.

Disclaimer:

This feature is presented in partnership with Evrima Chicago, a digital publication and creative agency dedicated to exploring innovation, culture, and human potential. At the core of Evrima’s mission is a commitment to digital accessibility (a11y) and assistive technology, ensuring that the stories they tell and the platforms they build are inclusive and available to all.

Evrima Chicago believes that technology should be a bridge, not a barrier. This philosophy makes them a natural and powerful ally for mission-driven organizations like AIC. By leveraging their platform to amplify stories of empowerment and independence, Evrima Chicago works to support organizations that operate with the highest integrity and for the best interest of humanity. This partnership is built on a shared vision of a more accessible, equitable, and self-determined future for every member of our community.

• This is a critical opinion-based cultural analysis authored by Waa Say and reflects his personal editorial perspective. The views expressed do not represent the institutional stance of Evrima Chicago.

• This article draws from open-source information, legal filings, published interviews, and public commentary – including audio content from The Joe Rogan Experience podcast. All allegations referenced remain under investigation or unproven in a court of law.

• No conclusion of criminal liability or civil guilt is implied. Any parallels made to public figures are interpretive in nature and intended to examine systemic patterns of influence, celebrity, and accountability in American culture.

• Where relevant, satirical, rhetorical, and speculative language is used to explore public narratives and their societal impact. Readers are strongly encouraged to engage critically and examine primary sources where possible.

• This piece is protected under the First Amendment of the U.S. Constitution and published under recognized standards of opinion journalism for editorial inputs: Waasay@evrimachicago.com

• Evrima Chicago remains committed to clear distinction between fact-based reporting and individual editorial perspective.

Media PR & Contact
Duane Martin
pr@evrimachicago.com

SOURCE: AIC

View the original press release on ACCESS Newswire

SASKATOON, SK / ACCESS Newswire / September 22, 2025 / Studio 12 has been recognised with the 2025 Consumer Choice Award in the Music School category for Saskatoon. This marks the studio’s 7th consecutive recognition, celebrating its role as a leading provider of performing arts education for more than 16 years.

With three locations in Saskatoon, Studio 12 has become a trusted name in music and performing arts education. The school offers a wide range of professional classes that nurture creativity, build confidence, and provide students with the technical skills to succeed both on stage and in life.

“At Studio 12, our mission has always been to inspire and empower students through the performing arts,” says Michael Lander, Owner of Studio 12. “Receiving recognition for the 7th year in a row through the Consumer Choice Award is incredibly meaningful. It reflects the trust families place in us and the dedication of our instructors, who give their all to help students thrive.”

Building A Strong Foundation in the Arts

Studio 12’s programs are designed to meet the needs of all students, from beginners discovering their passion for music to advanced performers looking to refine their craft. The school’s professional instructors bring experience, enthusiasm, and a commitment to helping each student achieve their potential.

Through music, dance, and other performing arts, Studio 12 provides opportunities for personal growth, teamwork, and self-expression, creating an environment where students can thrive.

This year’s recognition also reflects the loyalty and confidence of Saskatoon families who continue to make Studio 12 their top choice for performing arts education.

“Beyond the classroom, we see the arts as a way to strengthen our community,” adds Lander. “Our students perform at local events, support charitable initiatives, and share their talents in ways that bring people together. That’s what makes our work so rewarding – watching students grow as performers and as contributors to the community.”

Continuing The Tradition of Excellence

As Studio 12 celebrates its 7th consecutive Consumer Choice Award, the school remains committed to providing professional, inspiring, and high-quality performing arts education across Saskatoon. With a foundation built on passion and community, Studio 12 is excited to continue shaping the next generation of musicians and performers.

To learn more about Studio 12 or to explore program offerings, visit www.s12.ca or CLICK HERE.

About Studio 12
Studio 12 is a Saskatoon-based performing arts school with three locations, providing music and performing arts classes for more than 16 years. With professional instructors and a wide range of programs, Studio 12 is dedicated to inspiring creativity, confidence, and technical excellence in students of all ages. Recognised as a 7-time Consumer Choice Award recipient, Studio 12 continues to enrich Saskatoon’s arts community. Learn more at www.s12.ca.

About Consumer Choice Award
Since 1987, Consumer Choice Award has been recognising and promoting business excellence across North America. Through a rigorous selection process, only the most outstanding businesses in each category earn this prestigious recognition. Learn more at www.ccaward.com.

Contact Information:
Sumi Saleh
Communications Manager
ssaleh@ccaward.com

SOURCE: Consumer Choice Award

View the original press release on ACCESS Newswire

SASKATOON, SK / ACCESS Newswire / September 22, 2025 / K & S Contracting Inc. has been recognised with the 2025 Consumer Choice Award in the Waterproofing and Foundation Repair category for Saskatoon. This award highlights the company’s reputation for integrity, quality workmanship, and a strong commitment to client satisfaction across Saskatchewan.

Since its founding, K & S Contracting has focused on providing reliable foundation repair and contracting solutions that homeowners can count on. With expertise spanning basement leak repairs, waterproofing, renovations, and engineering solutions, the company has established itself as a trusted partner for residential and small commercial projects.

“At K & S Contracting, we value integrity and precision in everything we do,” says the K & S Contracting team. “This recognition from the Consumer Choice Award reinforces the trust our clients place in us to keep their homes and businesses safe and secure.”

Expert Services for Lasting Results

K & S Contracting delivers a wide range of engineer-approved services designed to protect and strengthen buildings from the ground up. Their skilled team provides:

• Basement leak detection and repair

• Foundation reinforcement and waterproofing

• Contracting services for residential and small commercial properties

By combining technical expertise with customer-focused service, K & S Contracting ensures projects are completed to the highest standard, offering peace of mind to homeowners across Saskatchewan.

Recognition Rooted in Community Confidence

The Consumer Choice Award is the only organisation in North America that recognises business excellence based entirely on consumer feedback. Winners are chosen through independent research that evaluates reputation, customer satisfaction, and overall business excellence.

For K & S Contracting, being recognised as Saskatoon’s top waterproofing and foundation repair company reflects the trust built through years of consistent, high-quality work.

A Commitment to Strong Foundations

As the company celebrates its 2025 Consumer Choice Award, K & S Contracting remains committed to helping families and businesses across Saskatchewan protect what matters most. With every project, their goal is to provide dependable solutions that keep homes strong, dry, and built to last.

To learn more about K & S Contracting Inc. or to request a consultation, visit www.kscontractingsk.ca.

About K & S Contracting Inc.
K & S Contracting Inc. is a Saskatoon-based company specialising in foundation repair, waterproofing, and general contracting. Serving residential and small commercial clients across Saskatchewan, the company prides itself on integrity, precision, and customer satisfaction. From basement leak repairs to complete renovations, K & S Contracting delivers reliable solutions that ensure homes and businesses remain safe and secure. Learn more at www.kscontractingsk.ca.

About Consumer Choice Award
Since 1987, Consumer Choice Award has been recognising and promoting business excellence across North America. Through a rigorous selection process, only the most outstanding businesses in each category earn this prestigious recognition. Learn more at www.ccaward.com.

Contact Information:
Sumi Saleh
Communications Manager
ssaleh@ccaward.com

SOURCE: Consumer Choice Award

View the original press release on ACCESS Newswire