NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE Pathways




NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE Pathways

Supported by Scientific Evidence Showing Tissue Repair Quality of Company’s Exosomes

TORONTO and HAIFA, Israel, Dec. 12, 2025 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a preclinical-biotechnology company developing exosome-based therapies for central nervous system injuries, today announced meaningful progress in its long-term clinical-readiness strategy. The Company has begun the process of evaluating potential Israeli production partners to support small-scale GMP-based manufacturing of its lead candidate, ExoPTEN, in order to test the drug in under a First-in-Human Use program, pending regulatory approval.

Dr. Lior Shaltiel, Chief Executive Officer, noted: “ExoPTEN brings together a powerful synergistic impact with highly active exosomes produced, combined with a targeted siRNA. As we advance our manufacturing plans, small clinical grade batches will position us to prepare a First-in-Human use submission in the future, if and when the regulatory pathway supports it.” He added, “ExoPTEN is being developed for both acute spinal cord injury and optic nerve injury, although it has not yet been determined which indication will be prioritized for a first-in-human program.”

In parallel, NurExone reported new scientific data showing strong biological activity in its exosomes compared with commercially available exosomes, reinforcing confidence in the platform as the Company advances toward human studies.

Early Manufacturing in Israel: A Key Step Toward U.S. Scale-Up

NurExone is currently evaluating several Israeli manufacturing organizations with expertise in advanced biologics and Good Manufacturing Practices (“GMP”)-aligned systems for small-scale ExoPTEN manufacturing runs aligned with future clinical requirements.

“This is a strategically important next phase of operational de-risking,” said Dr. Ina Sarel, Head of CMC, Quality and Regulatory Affairs. “Israel is the starting point for our small scale GMP-production of exosomes and process validation, after which exosome production will transition to the United States for scale-up.”

NurExone emphasized that no compassionate-use or clinical manufacturing is being initiated at this stage. All such activities would be subject to regulatory engagement and approval.

New Scientific Data Reinforce Platform Strength

Recent analytical testing demonstrated that NurExone’s exosomes produced from human bone marrow–derived mesenchymal stem cells (“MSC”) exhibit significantly higher CD73-associated biological activity compared with a commercially available MSC exosome control. CD73 is a surface enzyme linked to extracellular signaling and tissue-repair mechanisms.

As shown in the graph below, the average of NurExone’s two manufacturing batches demonstrated meaningfully higher adenosine monophosphate (“AMP”) to adenosine conversion per particle compared with the control. The difference was statistically significant (t-test, p < 0.01), indicating that NurExone’s exosomes possess stronger functional characteristics associated with regenerative potential, or in other words NurExone’s exosomes can send stronger “healing” or “anti-inflammatory” signals.

These findings validate the potency of NurExone’s therapeutic exosomes strengthening the biological rationale for their use as a delivery vehicle in ExoPTEN.

These results demonstrate the high quality of the Master Cell Bank acquired by NurExone and the knowhow held by NurExone and its patented 3D shear-force production technology, indicating that the manufacturing approach described in the patent can yield higher-quality, more potent exosomes in practice.

Engagement of Russo Partners

Subject to TSX Venture Exchange (“TSXV”) approval, NurExone has engaged Russo Partners LLC, a New York–based strategic communications firm, (“Russo”) for an initial consulting project for up to two months for a fixed fee of US$6,600.

Either party may terminate the engagement with 30 days’ notice. Russo does not currently have a direct or indirect interest in the securities of the Company. While Russo has no intention of acquiring any additional securities of the Company at this time, it may do so in the future in compliance with applicable securities laws and TSXV policies.

About Russo Partners

Russo Partners is a strategic communications firm focused on innovators in healthcare and technology. Founded as Noonan/Russo in 1988, the firm collaborates on integrated communications programs for biopharma, MedTech, diagnostics, healthcare IT and healthcare services companies worldwide. The firm’s team is comprised of Ph.D.s, M.D.s., former journalists and members of Wall Street. Russo Partners is known for delivering award-winning strategic counsel and services aligned with its core values of passion, trust, forward-thinking and client focus. For more information, visit www.russopartnersllc.com.

About NurExone

NurExone Biologic Inc. is a TSXV, OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsⁱ. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.

For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: the Company advancing ExoPTEN’s manufacturing processes and analytical methods; the Company’s evaluating potential Israeli production partners and organizations for early, small‑scale GMP‑aligned manufacturing runs of ExoPTEN; the Company’s preparing for compassionate-use filings once regulatory pathways permit; the Company launching a first compassionate-use and first-in-human programs; expectations associated with the Master Cell Bank and the Company’s patented 3D shear-force production technology; the Company engaging Russo; the Company preparing regulatory submissions; receipt of regulatory approvals, including TSXV approval; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: the Company has the ability to advance ExoPTEN’s manufacturing processes and analytical methods; the Company will prepare regulatory submissions; suitable Israeli manufacturing partners with requisite GMP capabilities will be identified and engaged on acceptable terms; early, small clinical grade batches can and will be produced, characterized and validated in alignment with future regulatory requirements; applicable compassionate-use or expanded-access pathways will be available and that regulatory agencies will accept the Company’s filings; the Master Cell Bank will continue to meet quality, consistency and supply requirements; the patented production approach will operate as intended at planned scales; the engagement of Russo will receive TSXV approval and the consulting services will benefit the Company; the Company has the ability to launch a first compassionate-use and first-in-human programs; and the NurExone platform technology has the ability to offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: the Company’s early stage of development; lack of revenues to date; the inherent uncertainty of preclinical drug development, including challenges in identifying, engaging or retaining qualified manufacturing partners, achieving and maintaining GMP compliance, and producing consistent batches of ExoPTEN; the Company will not file for compassionate-use; the Master Cell Bank will no longer meet quality, consistency and/or supply requirements; the engagement of Russo will not be approved; the Company will not yield the intended benefits from their engagement of Russo; the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company’s products, even if approved; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company’s technologies; the Company’s dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company’s ability to protect its intellectual property; the possibility that the Company’s technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications such as spinal cord injury, optic nerve repair, or other therapeutic areas; failure to meet planned development milestones or achieve commercial breakthroughs; the Company will not advance the ExoPTEN’s manufacturing processes and/or analytical methods; the Company will not prepare regulatory submissions; the Company will not launch first compassionate-use nor first-in-human programs; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca . These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

ⁱ Spinal cord injury, Glaucoma

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d5b187f6-3be5-4601-a83d-d94953a35a13

Park Dental Partners Rings the Closing Bell on the Nasdaq in New York




Park Dental Partners Rings the Closing Bell on the Nasdaq in New York

MINNEAPOLIS, Dec. 12, 2025 (GLOBE NEWSWIRE) — Park Dental Partners, Inc. (“Park Dental Partners” or the “Company”), today announced that on December 11, 2025, members of the Park Dental Partners team rang the closing bell on the Nasdaq Stock Market (“Nasdaq”) in New York to commemorate the successful completion of its recent public listing. The event was broadcast live, allowing potential stakeholders worldwide to join in the celebration. The shares began trading on the NASDAQ Capital Market on December 3, 2025, under the symbol “PARK”. 

“We are in the early stages of our growth strategy and our public offering provided us with the next step in expanding our base of stakeholders to help us deliver on our desire to become a leader in the dental industry,” stated Pete Swenson, Chairman of the Board and Chief Executive Officer. “We are committed to grow our business, while maintaining our strong culture of service to our dentists and patients. It is an exciting time for Park Dental Partners and all of our stakeholders.”

About Park Dental Partners

Park Dental Partners is a dental resource organization that provides comprehensive non-clinical business support services to affiliated general and multi-specialty dental practices across Minnesota and Wisconsin. Through long-term administrative resources agreements, Park Dental Partners supplies clinical support teams, administrative personnel, facilities, equipment, technology, revenue cycle management, and other centralized services that allow affiliated practices to focus on delivering high-quality patient care. Park Dental Partners’ network supports over 200 dentists across 85 practice locations and offers a full range of general and specialty services, including oral surgery, periodontics, pediatric dentistry, prosthodontics, endodontics, and orthodontics.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/c54a7298-f098-4a2d-9e99-d26536e143d4

https://www.globenewswire.com/NewsRoom/AttachmentNg/a2c74c16-117d-4b7a-99f5-532a674ce0af

CONTACT: Park Dental Partners 
Media Relations 
651-633-0500 
marketing@parkdentalpartners.com

Mineralys Therapeutics’ Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) “Research of the Year” Roundup




Mineralys Therapeutics’ Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) “Research of the Year” Roundup

– Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful of 2025 by JAMA editors –

RADNOR, Pa., Dec. 12, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the manuscript highlighting the Company’s Phase 3 Launch-HTN clinical trial evaluating lorundrostat for the treatment of uncontrolled or treatment-resistant hypertension, was featured in JAMA’s inaugural “Research of the Year Roundup,” a curated collection of the most impactful studies published between October 2024 and September 2025.

In introducing this first-ever “Research of the Year Roundup,” JAMA noted that its top editors were asked to nominate their favorite studies based on their importance and impact. The list of nine selected studies spans diverse topics – from hypertension, to dementia and the use of artificial intelligence (AI) – and, according to JAMA, reflects clinical conditions that are of great importance to patients, clinicians, and to the public health community.

Among this select group, JAMA profiled Mineralys’ Launch-HTN trial under the banner “New Hope for Treatment-Resistant Hypertension.” The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a novel aldosterone synthase inhibitor (ASI), when added to existing background antihypertensive treatment in 1,083 participants with uncontrolled or treatment-resistant hypertension. The trial demonstrated that lorundrostat significantly reduced systolic blood pressure (BP) with a favorable safety and tolerability profile. Launch-HTN recruited a diverse population as reflected in the high proportion of female, Black or African American and elderly participants in the trial.

JAMA highlighted several key findings from the Launch-HTN trial:

• Lorundrostat’s mechanism targets excess aldosterone production, a root cause of hypertension. Unlike existing aldosterone blockers that obstruct the hormone receptor, lorundrostat inhibits the enzyme that produces aldosterone itself, offering a novel mechanism of action.
• When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful, statistically significant mean reductions in automated office blood pressure (AOBP) with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) that was sustained with a reduction of 19.0 mmHg at Week 12 (-11.7 mmHg placebo adjusted; p-value < 0.0001). These benefits were consistent across age, sex, race, body mass index, and baseline medication regimen.
• Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial, noting that while hyponatremia, hyperkalemia, and reduced kidney function occurred more frequently in the treatment arm, discontinuation rates due to adverse events remained below 1%.

In the “Research of the Year” article, JAMA’s Executive Editor Gregory Curfman, MD, emphasized the importance of advancing care for the large segment of patients whose hypertension remains uncontrolled despite being on multiple medications, noting that lorundrostat “opens a new approach to the treatment of uncontrolled hypertension, which may affect up to 40% of patients.” The article also points out that, until now, patients have had limited options despite facing heightened cardiovascular risks, including myocardial infarction, stroke, or chronic kidney disease.

“We are honored that JAMA has recognized Launch-HTN as one of its Research of the Year studies,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “This acknowledgment underscores the significant clinical need faced by millions of people living with uncontrolled or treatment-resistant hypertension. The results of Launch-HTN reflect the dedication of our investigators, participants, and team, and reinforce our commitment to bringing forward a differentiated therapy to address a root cause of hypertension.”

The manuscript titled, “Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension” was featured in JAMA’s June 30, 2025 issue. Lorundrostat continues to be evaluated in the ongoing Transform-HTN open-label extension trial, which is assessing long-term safety and durability of response. The Company also completed enrollment in Explore-OSA, the first trial to evaluate lorundrostat in participants with hypertension and moderate-to-severe OSA. Lorundrostat is the only ASI being studied to address both apnea-hypopnea index (AHI) and nighttime systolic blood pressure in this population, with data anticipated in the first quarter of 2026.

About Launch-HTN
Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring.

About Hypertension

Having sustained, elevated blood pressure (or hypertension) (BP) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.

Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.

About Lorundrostat

Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants.

The Company has now completed four successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The Company has completed two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.

About Mineralys
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky.

Forward Looking Statements
Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and the FDA’s review of the same; the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; any delays in the FDA’s review of our planned NDA submission, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:
Investor Relations
investorrelations@mineralystx.com

Media Relations
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com

DOC HOLLYWOOD: A Psychiatrist Takes 3rd Place with Baxter’s Brain at the American Film Market Pitch Conference




DOC HOLLYWOOD: A Psychiatrist Takes 3rd Place with Baxter’s Brain at the American Film Market Pitch Conference

LOS ANGELES, Dec. 12, 2025 (GLOBE NEWSWIRE) — Dr. Walter Jacobson, a Los Angeles-based psychiatrist, author, and first-time filmmaker, scored a major win at this year’s American Film Market (AFM) Pitch Conference when his outrageous comedy, Baxter’s Brain, took 3rd place from a panel of industry judges, including award-winning producer Cassian Elwes, screenwriting professor and coach Lee Jessup, and independent producer Loni Rodgers.

The AFM Pitch Conference is one of the market’s signature showcases where selected creators present their concepts live to top producers, financiers, and development executives.​

Walter first came to Hollywood years ago to write movies, but shifted gears to become a psychiatrist after deciding he needed more life experience to tell the stories he wanted to tell.

After 25 years in private practice, he has returned to screenwriting with Baxter’s Brain, a satiric, irreverent, over the top comedy that pokes fun at doctors, TV shows, and “the insanity of our society that has become the new normal.​”

After submitting a 2-minute video to the AFM Pitch Conference committee, Walter was one of 20 filmmakers chosen from over 150 entries to pitch Baxter’s Brain at the Pitch Conference on November 15, 2025.

“The response from the audience to my pitch was incredibly validating,” reports Walter. “It was a great affirmation that Baxter’s Brain is funny and that people will go see it.”

When asked how he feels about his screenwriting skills this second time around, Walter is very clear about this. “I drew from my years as a psychiatrist. Interacting with a wide range of people from all walks of life gave me insights into the quirks of human nature that my younger self didn’t have access to. I am immensely proud of the screenplay and confident that this is a movie that will bring a lot of laughter and joy to the world.”

Joining forces with veteran producer Franco Sama of Samaco Films, Walter has no doubts about Baxter’s Brain becoming a global box office phenomenon and a new comedy franchise. “People love wacky comedies like The Naked Gun and Blazing Saddles,” states Walter. “They are hungry for more and they will go to the theatres in droves if a really funny movie shows up. There is also a separate huge market of people who love movies with talking animals, like TED and Paddington. Baxter is a super-smart, talking gorilla. Audiences will love him! And you can take that to the bank!”

One wonders where Walter’s confidence comes from. “That’s easy. I’ve studied comedy my whole life. I know what’s funny. When I was struggling to make it as a writer, I produced a weekly show, Poor Walter’s Almanac, on cable TV, which was me ranting and raving about everything under the sun. Roseanne and Tom Arnold were fans of the show, as were many celebrities including Richard Lewis, George Carlin, Casey Kasem and Steve Edwards. The point of all this is to say that I made all those people laugh, AND Roseanne brought me onto her ROSEANNE show as a recurring character. So I must know a few things about comedy.”

So what’s next for Baxter’s Brain? “We need to get it financed and produced. I’m hoping this article will inspire the right people to contact me and help me bring Baxter’s Brain to a welcoming public.”

Media Contact

For press materials, partnership inquiries, or interview requests, please contact:

Dig 22 Productions
(310) 628-7222

walterdoc@mac.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7ad218ac-7897-4461-8863-96101c1ef608

Intelligent Bio Solutions Inc. Announces Reverse Stock Split




Intelligent Bio Solutions Inc. Announces Reverse Stock Split

NEW YORK, Dec. 12, 2025 (GLOBE NEWSWIRE) — Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“Intelligent Bio Solutions” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it will effect a 1-for-10 reverse split of its common stock, that will become effective at 11:59 pm (Eastern Time) on December 15, 2025. Trading of the Company’s common stock on The Nasdaq Capital Market (“Nasdaq”) will continue, on a split-adjusted basis, with the opening of the markets on December 16, 2025, under the trading symbol “INBS” and new CUSIP number 36151G709.

The reverse stock split was approved by Intelligent Bio Solutions’ stockholders at the annual meeting of the Company’s stockholders held on October 16, 2025, with the final ratio to be determined by the Company’s Board of Directors within the ratio range authorized by shareholders.

As a result of the reverse stock split, every 10 shares of common stock issued and outstanding as of the effective date will be automatically combined into one share of common stock.  In addition, proportionate adjustments will be made to outstanding equity-based awards and other equity rights, including warrants. No fractional shares will be issued if, as a result of the reverse stock split, a stockholder would become entitled to a fractional share because the number of shares of common stock they hold before the reverse stock split is not evenly divisible by the split ratio. Instead, the stockholder will be entitled to receive a cash payment in lieu of a fractional share. The par value of the common stock will remain unchanged at $0.01 per share after the reverse split, and the number of authorized shares of common stock will remain at 100 million shares. Immediately after the reverse stock split becomes effective, the Company will have approximately 959,533 shares of common stock issued and outstanding. The reverse split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent the reverse split results in a stockholder receiving a cash payment in lieu of a fractional share, as described above.

About Intelligent Bio Solutions Inc.

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.

For more information, visit: https://ibs.inc/

Forward-Looking Statements:

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results may differ materially from those expressed or implied by such statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact: 
Intelligent Bio Solutions Inc. 
info@ibs.inc 
LinkedIn | Twitter

Investor & Media Contact: 
Valter Pinto, Managing Director    
KCSA Strategic Communications    
PH: (212) 896-1254    
INBS@kcsa.com     

Anavar Steroid 2026: Legal Steroid Alternative, Anavar For Women Cycle, Dosage, Side Effects, Anavar Before And After Result (Anavar for Sale) Launch Alternative Anvarol By CrazyBulk




Anavar Steroid 2026: Legal Steroid Alternative, Anavar For Women Cycle, Dosage, Side Effects, Anavar Before And After Result (Anavar for Sale) Launch Alternative Anvarol By CrazyBulk

Anavar Steroid: Cycle, Dosage, Side Effects, Most Popular Legal Steroids (Before And After Anavar Result) – Anavar for women (Anavar for Sale) – Buy Alternative Anvarol From CrazyBulk

New York City,, Dec. 12, 2025 (GLOBE NEWSWIRE) —

On September 12, 2025, CrazyBulk officially introduced Anvarol, a legal alternative to Anavar, designed specifically with both women and men in mind, addressing the growing demand for safer performance-support supplements. The launch comes at a time when fitness culture continues to expand, and many women are looking for support in achieving a lean, sculpted physique without relying on synthetic anabolic steroids. Traditional Anavar (Oxandrolone) has long been associated with physique enhancement, muscle tone improvements, and strength support, but its prescription-only status and potential hormonal side effects have created barriers and safety concerns. Click Here to Visit the Official Anvarol Website

Anavar legal Alternative Anvarol was created to mirror the performance benefits commonly discussed around Anavar—such as muscle definition support, fat-metabolism assistance, and training endurance—without synthetic hormones or the legal risks tied to controlled substances. This alternative formulation is based on natural and performance-supporting ingredients aimed at promoting lean muscle retention, energy, and recovery during training phases.

For women seeking muscle tone rather than bulk, this legal version offers an accessible option while avoiding unwanted effects sometimes linked to anabolic compounds. By combining compliance with supplement regulations, natural formulation, and a fitness-focused approach, CrazyBulk’s Anavar Steroids alternative Anvarol positions itself as a modern solution for women pursuing controlled, sustainable body-shaping results.

 Today’s fitness and sports communities continue to reference Anavar Steroids for its historical role in performance enhancement. Anvarol is 100% legal and available without a prescription.

What Is Anavar?

 Anavar, medically known as Anvarol, is an anabolic steroid Alternative By CrazyBulk in the early 1960s to help patients recover strength, rebuild muscle tissue, and regain healthy body weight after illness, surgery, or trauma. It belongs to a class of synthetic hormones designed to mimic testosterone, but with a more controlled and milder performance profile compared to stronger steroids.
Over time, Anavar became widely recognized in bodybuilding and athletic discussions because it is often associated with lean muscle retention, strength improvement, and reduced fluid buildup. Unlike some anabolic steroids that may lead to rapid bulk weight gain, Anavar is typically referenced for more moderate physical changes and is commonly mentioned in the context of cutting phases, where body fat reduction and muscle definition are the main goals.
Despite its reputation for being milder, Anavar is still a controlled substance in many countries and requires a prescription for medical use. Using Anavar without medical supervision or legal authorization can carry risks, including hormonal disruption, liver strain, and cardiovascular effects.
Today, Anavar remains known for its original medical purpose and its ongoing presence in fitness discussions, often highlighted for its heritage as one of the more selectively applied anabolic compounds. See Anavar availability and pricing from CrazyBulk

How do the Anavar Steroids Work?

Anavar Alternative Anvarol by Crazybulk, works by interacting with the body’s androgen receptors—the same receptors influenced by natural testosterone. Once active in the system, it helps increase protein synthesis, which is the process the body uses to repair and build muscle tissue. This makes it useful in medical settings where patients need help rebuilding muscle after injury, illness, or physical decline.
Another key feature of Anavar is its ability to enhance nitrogen retention in the muscles. When nitrogen levels are balanced and stable, the body remains in a more favorable state for maintaining lean muscle mass. This is one reason Anavar is often discussed in cutting cycles rather than bulking cycles, as the focus is on preserving muscle rather than increasing size.

Anavar is also associated with supporting metabolism by influencing how the body uses stored energy. While individual results vary, this may contribute to a more defined or toned appearance when combined with proper nutrition and training.
Even though Anavar is considered milder than many other anabolic steroids, it is still a synthetic hormone. For that reason, it may affect natural hormonal balance and carries possible health risks. Because of this, medical supervision and legal compliance are strongly emphasized when discussing its use.

Ingredients Commonly Found in Anavar Steroid Alternatives By Crazy Bulk

Anavar alternatives are designed to mimic the results associated with Oxandrolone but rely on legal, natural, and non-synthetic ingredients. While formulas vary by brand, many legal alternatives use a combination of botanical extracts, amino acids, vitamins, and performance-supporting compounds. Below are commonly seen ingredients presented in bullet format for clarity:

• Whey Protein Isolate – Supports muscle repair and promotes lean tissue growth.
• Soy Protein Isolate – Helps maintain muscle while supporting fat reduction.
• Branched-Chain Amino Acids (BCAAs) – Assist with muscle recovery, endurance, and strength retention.
• Wild Yam Root Extract – Sometimes included for its natural precursor compounds linked to hormone support.
• Tribulus Terrestris Extract – Commonly used to support vitality, energy, and physical performance.
• Vitamin B6 – Helps with energy metabolism and protein utilization.
• L-Carnitine L-Tartrate – May assist with converting stored fat into usable energy during training.
• Zinc – Supports normal testosterone levels and muscle function.
• Magnesium – Plays a role in muscle contraction and recovery.
• CLA (Conjugated Linoleic Acid) – Often included to support fat-burning efforts and body composition goals.

These ingredients are widely recognized in the supplement industry for supporting performance, muscle definition, recovery, and metabolic activity without the controlled-substance risks linked to anabolic steroids. More about the Anvarol cutting cycle and fat burning. Visit the Official Website

The Anavar Alternative Clinically-Inspired Formula by Crazy Bulk

The concept of Anavar-inspired supplements comes from the original clinical purpose of Oxandrolone: supporting muscle preservation, strength recovery, and overall physical function during rehabilitation. Anavar was initially developed for medical use, assisting patients facing muscle loss due to trauma, illness, or prolonged inactivity. This medical foundation inspired modern supplement manufacturers to create legal alternatives that aim to reflect similar benefits—without synthetic hormones or prescription restrictions.
Clinically-inspired Anavar alternatives typically focus on muscle retention, improved metabolism, and strength support, using natural compounds instead of anabolic steroids. These formulations are centered around ingredients that may help the body preserve lean muscle while undergoing calorie deficits or intense training.
Although these legal alternatives do not replicate the pharmacological effects of Oxandrolone, their goal is to offer a safer, accessible option based on the original clinical intentions: maintaining muscle, supporting recovery, and helping users pursue improved body composition with a more responsible and regulated approach.
 

Anavar Benefits 

Anavar, known medically as Oxandrolone, has been recognized for several effects in both medical use and athletic discussions. While responses vary by individual, the benefits most commonly associated with Anavar are listed below in point format for clarity:

• Supports Lean Muscle Preservation
  Often referenced during calorie restriction or cutting phases, where maintaining muscle is a priority.
• May Assist in Strength Improvement
  Known for contributing to strength without large fluctuations in body weight.
• Low Water Retention Profile
  Commonly discussed for creating a more defined or toned look rather than bulk.
• Potential Fat Metabolism Support
  Some users report improved muscle-to-fat ratio when paired with proper nutrition and training.
• Used Medically for Muscle-Wasting Conditions
  Originally prescribed to help patients rebuild or maintain muscle after trauma or prolonged illness.
• May Help with Recovery
  Sometimes noted for aiding physical rehabilitation and tissue repair.
• Recognized for Milder Characteristics Compared to Stronger Steroids
  Often referenced as having a more controlled effect profile in regulated medical use.
• Possible Performance Enhancement
  Athletes often associate Anavar with endurance, strength, consistency, and muscle firmness.

These benefits come from both clinical history and long-standing performance discussions. Legal and responsible usage guidelines remain strongly advised.
Anavar Cycle
An Anavar cycle refers to a planned period of using Oxandrolone, typically organized with a start point, duration, and dosage pattern. In discussions around performance enhancement, Anavar cycles are often shorter than those of stronger anabolic steroids, as it is commonly referenced as a milder compound. Many users mention cycles ranging from six to eight weeks, although medical guidance and legal regulations emphasize that any use should only occur under prescription and supervision.
Anavar cycles are frequently discussed in relation to cutting phases rather than bulking, because it is commonly associated with muscle preservation, definition, and strength maintenance while lowering body fat. Some fitness users also mention pairing Anavar with structured nutrition and resistance training to maximize results.
Post-cycle support may also be discussed to help the body rebalance after synthetic hormone exposure. However, legal frameworks and health authorities warn that unregulated use carries risks, and medical oversight is strongly advised.

Anavar for Women 

The topic of Anavar for women continues to attract attention in bodybuilding, fitness, and medical discussions because Anavar is often described as one of the milder anabolic steroids. Women are sometimes drawn to it because it is commonly associated with lean muscle support, moderate strength improvement, and a more defined physique rather than excessive mass gain. This makes Anavar a frequently referenced option in conversations surrounding cutting cycles and body shaping.
In medical settings, Anavar has been used to assist women recovering from weight loss, muscle-wasting conditions, surgery, or severe trauma. However, while the compound may be seen as milder, it is still a synthetic hormone and carries potential risks. Possible side effects include voice deepening, increased body hair, menstrual disruption, and other signs of virilization, especially without medical supervision.
Because Anavar is a controlled substance in many countries, non-prescription use is illegal and may present serious health risks. For this reason, many individuals seeking similar benefits explore legal, non-hormonal alternatives designed to support muscle tone, energy, and metabolic balance without hormonal impact.
Anyone considering Anavar for women—whether for medical or performance purposes—should prioritize legal compliance, safety awareness, and guidance from a qualified professional.

Anavar for Men 

The topic of Anavar Alternative for men is widely discussed in fitness and bodybuilding communities because Anavar, or Oxandrolone, is often viewed as a milder anabolic steroid with a focus on lean muscle enhancement rather than significant size gains. Men interested in improving muscle definition, strength levels, and overall body composition often reference Anavar as a potential option during cutting cycles, where fat reduction and muscle preservation are key goals.
 Click Here to Visit the Official Anvarol Website

In medical environments, Anavar has been used to support recovery from muscle-wasting conditions, trauma, and post-surgical rehabilitation. It is appreciated for its reputation of offering strength benefits without excessive water retention, which can create a more sculpted appearance compared to bulk-focused steroids.
However, despite being considered milder, Anavar is still a synthetic hormone and may affect testosterone levels and overall endocrine balance. Potential side effects for men may include reduced natural testosterone production, cholesterol changes, and liver strain, especially when used without medical oversight.
Because Anavar is a controlled substance, non-prescription use is illegal in many regions. Many men seeking similar benefits now turn to legal supplement alternatives intended to support muscle tone, metabolic performance, and workout recovery without hormone disruption. Proper guidance and compliance remain essential when discussing Anavar for men.

Anavar Steroid Dosage 

Dosage recommendations vary depending on medical guidance, fitness goals, and individual response. In general discussions, the following points are commonly referenced:

• Medical dosage: Often lower and determined by a healthcare professional.
• Beginners: May start with conservative levels to assess tolerance.
• Men (performance use): Commonly referenced ranges are higher than women, due to hormonal differences.
• Women (performance use): Typically discussed in lower ranges to reduce virilization risk.
• Cycle duration: Often mentioned between 6–8 weeks in fitness discussions.
• Post-cycle approach: Sometimes recommended to support hormonal balance.

Anavar Steroid Side Effects

Although Anavar is often described as milder than many anabolic steroids, it can still cause side effects, especially when used without proper medical supervision. Possible effects may include hormonal disruption, reduced natural testosterone production, and changes in cholesterol levels. Some users may experience liver strain, particularly at higher doses or with long-term use. Women may face virilization symptoms such as deeper voice, facial hair, and menstrual changes. Other reported effects include mood shifts, fatigue, headaches, and decreased libido. Because Anavar is a controlled prescription drug, professional medical guidance and legal compliance are strongly recommended to reduce risks.

Anavar Before And After Result 

Before starting Anavar, many individuals focus on goals such as increased muscle definition, improved strength, or a leaner body composition. However, results can vary depending on diet, training routine, dosage, and overall health. During use, Anavar is often associated with gradual improvements rather than dramatic overnight changes. Users commonly report improved muscle tone, better workout endurance, and a tighter or more defined look, especially during cutting phases.
After completing a cycle, some individuals may notice visible differences in muscle firmness, strength levels, and fat reduction if paired with disciplined nutrition and exercise. However, results are not guaranteed, and maintaining progress may require continued training and lifestyle consistency.
It is important to note that Anavar is a prescription-controlled steroid, and non-medical use may carry health risks such as hormonal imbalance or liver strain. For many, legal non-steroidal alternatives are explored as a safer option to pursue similar goals.

How to Use Anavar Steroid Alternatives 

Anavar steroid alternatives Anvarol are typically taken as daily supplements rather than in strict steroid-style cycles. Most products recommend one to three capsules per day, usually with food to support better absorption. Consistency is important, and results are often best when paired with a structured workout routine focused on strength training and balanced nutrition. Many users follow a six-to-eight-week schedule, sometimes followed by a short break before restarting. Unlike real steroids, no post-cycle therapy is required because these formulas do not disrupt hormone levels. Always follow the manufacturer’s instructions and consult a professional if you have health concerns or medical conditions.

Who Needs Anavar? 

Anavar, or Oxandrolone, is primarily intended for individuals who require medical support to rebuild or maintain muscle following serious illness, surgery, injury, or conditions that cause muscle loss. In clinical settings, it may be prescribed to help patients regain strength, improve body weight, or support recovery. Outside the medical environment, Anavar is often discussed among athletes and bodybuilders focused on muscle definition, strength improvement, and physique refinement rather than mass gain. However, because Anavar is a controlled substance, non-prescription use is not recommended. Anyone considering it should consult a licensed medical professional to ensure legal and safe use.
Pricing, Packages & Official Website – Where to Buy the Anavar Steroids Alternatives Anvarol by CrazyBulk Safely Online?
You can browse official options and pricing for CrazyBulk’s legal alternatives on their official website (crazybulk.com). Packages and deals vary — they often offer bulk packs, combo bundles, and discounts. Always purchase directly from their official site to ensure authenticity, product safety, and valid pricing.

Tips for Best Results with Anavar for Men and Women 

To maximize results, pair Anavar use with a structured workout plan focused on resistance and strength training. Maintain a clean diet high in protein and stay hydrated. Adequate sleep
and consistency are essential for recovery and progress. Avoid exceeding recommended guidelines, and consider periodic breaks. For safety, medical supervision is strongly advised, especially regarding dosage, cycle duration, and potential side effects. Responsible use helps support better long-term results and well-being.

Why Anavar Alternative By CrazyBulk cutting cycles in Men and Women Is an Emerging Trend in 2025?

Anavar’s rising interest in 2025 is driven by growing fitness culture, increased focus on lean physiques, and discussions around performance enhancement. Both men and women are exploring Anavar because it’s often referenced as a milder steroid with a reputation for supporting strength and muscle definition. As more people pursue aesthetic goals and body sculpting, Anavar remains a trending topic in performance and physique communities.

Final Verdict — Anavar Alternative By CrazyBulk?

As a legal Steroids, over-the-counter alternative to synthetic steroids, Anavar by CrazyBulk can offer benefits for those seeking muscle maintenance, lean definition, and workout support. It avoids the hormonal risks of real steroid use. However, its effectiveness depends heavily on consistent training, nutrition, and realistic expectations. It’s best suited for people after gradual, controlled gains — not dramatic transformations.

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Postal code: NY 10016-2817
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Full Name – Neil Bowers
Company website: https://www.crazybulk.com/
email: support@crazybulk.com
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Cullgen Reports Positive Results from Phase 1 Study of its Novel Non-Opioid Product Candidate CG001419 for Pain




Cullgen Reports Positive Results from Phase 1 Study of its Novel Non-Opioid Product Candidate CG001419 for Pain

IND filing and initiation of Phase 2 clinical trials on track for 1H 2026

SAN DIEGO, Dec. 12, 2025 (GLOBE NEWSWIRE) — Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies, today announced the completion of its Phase 1 clinical trial evaluating its lead product candidate, CG001419, a potential first-in-class, oral, pan-TRK protein degrader, which is part of a new class of pain signaling channel modulators for the treatment of pain.

Cullgen’s Phase 1 study (NCT06636500) was a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose/food-effect (with or without food) and multiple-ascending-dose trial that evaluated the safety, tolerability and pharmacokinetic characteristics of CG001419 in 78 healthy volunteers. The study was conducted in Australia after receiving ethics committee approval in early 2025. Results from the study showed that all doses were well-tolerated with no drug-related serious adverse events observed.

“We are very pleased with the positive outcome of this Phase 1 study. CG001419 is an important program as it could provide a new, non-opioid, non-NSAID analgesic therapy option for patients suffering from acute and chronic pain,” commented Ying Luo, Ph.D., Chief Executive Officer of Cullgen. “Given the favorable outcome of this study, we plan to submit an IND for CG001419 in early 2026, and, pending FDA allowance of the IND, initiate a Phase 2 study in acute pain in bunionectomy patients in the United States. In addition to studying CG001419 in pain applications, it is also being studied in a separate Phase 1 clinical trial in China in patients with solid tumors.”

Pipeline Update

In addition to CG001419, Cullgen continues the advancement of CG009301, a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, as well as progressing its pipeline of pre-clinical targeted protein degraders and degrader-antibody conjugates.

Cullgen recently advanced a new cell cycle protein degrader product candidate into preclinical studies and is preparing to initiate IND-enabling studies. Also, in the near future, Cullgen anticipates advancing an additional product candidate into IND-enabling studies for the treatment of inflammatory diseases.

About Cullgen Inc.

Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies designed to improve the lives of patients suffering from critical conditions such as pain, or cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved therapeutic profile and avoidance of known toxicities.

Cullgen’s lead product candidate, CG001419, is an oral pan-tropomyosin receptor kinase (“TRK”) degrader that recently completed a Phase 1 trial for the treatment of acute post-operative pain. The molecule is also being studied in a Phase 1 trial for the treatment of solid tumors. Cullgen’s second product candidate, CG009301, is a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia, higher-risk myelodysplastic syndrome and acute lymphoblastic leukemia. In addition to CG001419 and CG009301, Cullgen is also progressing a number of preclinical programs including next-generation degrader-antibody conjugates.

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

Forward-Looking Statements

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that”, “may,” “plans,” “seeks,” “projects,” “targets,” and “would,” and their opposites and similar expressions are intended to identify forward-looking statements. These forward-looking statements include express or implied statements relating to: the therapeutic potential and utility, efficacy and clinical benefits of CG001419, including for the treatment of pain and solid tumors; the risk/benefit profile of CG001419, including the potential of CG001419 to reduce the risk of addiction associated with other pharmaceutical therapies for the treatment of pain; expectations regarding Cullgen’s research and development efforts, including timing of Cullgen’s anticipated IND filing with the FDA and initiation of Phase 2 trials for CG001419; Cullgen’s expectations regarding the advancement of product candidates into IND-enabling studies; and Cullgen’s expectations, hopes, beliefs, intentions and strategies; and other statements that are not historical fact. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to: risks associated with the Cullgen’s ability to manage expenses and unanticipated spending and costs that could reduce Cullgen’s cash resources; risks related to the Cullgen’s ability to correctly estimate its operating expenses and other events; changes in capital resource requirements; risks related to the inability of the Cullgen to obtain sufficient additional capital to continue to advance its product candidates, its preclinical programs and its clinical trials; the ability of the Cullgen to obtain, maintain and protect its intellectual property rights, in particular those related to its product candidates; Cullgen’s ability to advance the development of its product candidates or preclinical activities under the timelines it anticipates in planned and future clinical trials; Cullgen’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; Cullgen’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, licensing programs or other collaborations; regulatory requirements or developments and Cullgen’s ability to obtain necessary approvals from the U.S. Food and Drug Administration or other regulatory authorities; changes to clinical trial designs and regulatory pathways; changes in expected or existing competition; and legislative, regulatory, political and economic developments. A discussion of these and other factors, including risks and uncertainties with respect to Cullgen, is set forth in Pulmatrix Inc.’s (“Pulmatrix”) definitive proxy statement/prospectus filed with the Securities and Exchange Commission and declared effective on May 9, 2025, as may be supplemented or amended by Pulmatrix’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as well as risk factors associated with companies, such as Cullgen, that operate in the biopharma industry. Should one or more of these risks or uncertainties materialize, or, should any of Cullgen’s assumptions prove incorrect, actual results may vary in material respects from those projected in these 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 in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Cullgen does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Pulmatrix or Cullgen.

CONTACTS:

Cullgen Inc.

Thomas Eastling, CFO

ir@cullgen.com

Investors

Chuck Padala
Managing Director, LifeSci Advisors
chuck@lifesciadvisors.com

EssilorLuxottica to acquire Signifeye, further growing its ophthalmology clinics footprint




EssilorLuxottica to acquire Signifeye, further growing its ophthalmology clinics footprint

EssilorLuxottica to acquire Signifeye,
further growing its ophthalmology clinics footprint

Paris, France (12 December 2025) – EssilorLuxottica announced today the acquisition of Signifeye, a leading Belgian ophthalmology platform delivering top-tier patient care across 15 eye centers and clinics in the Flanders region.

The transaction comes soon after the recent acquisition of Optegra, a fast-growing and highly integrated ophthalmology platform in Europe operating over 70 clinics in the UK, Czech Republic, Poland, Slovakia and the Netherlands. While strengthening Optegra’s position in Europe, it also advances EssilorLuxottica’s med-tech trajectory and its ambition to pioneer the most advanced, integrated and expert-driven medical model, capable of addressing the full continuum of need, from prevention and early detection to specialized clinical management.

Offering both medically necessary ophthalmic treatments and elective vision procedures, the Signifeye platform provides the full spectrum of eye healthcare services. In line with Optegra, Signifeye has built a reputation for clinical excellence in the private sector, trusted care and industry-leading outcomes.

“With Signifeye joining EssilorLuxottica’s ecosystem, we strengthen our ability to deliver truly end-to-end eye care and redefine what medical excellence can be across the entire patient journey. By combining our medical and scientific innovation capabilities with Signifeye’s proven clinical excellence, we can meaningfully enhance the patient experience and empower people to live their best lives,” commented Francesco Milleri, Chairman and Chief Executive Officer, and Paul du Saillant, Deputy Chief Executive Officer at EssilorLuxottica.

“Joining forces with EssilorLuxottica and Optegra marks a transformative chapter for Signifeye. By combining their global leadership in vision care with our commitment to patient care and clinical excellence, we look forward to building the future of eye care together,” added Kathleen Moons, Chief Executive Officer at Signifeye.

The transaction is expected to close by Q1 2026.

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EssilorLuxottica to acquire Signifeye, further growing its ophthalmology clinics footprint




EssilorLuxottica to acquire Signifeye, further growing its ophthalmology clinics footprint

EssilorLuxottica to acquire Signifeye,
further growing its ophthalmology clinics footprint

Paris, France (12 December 2025) – EssilorLuxottica announced today the acquisition of Signifeye, a leading Belgian ophthalmology platform delivering top-tier patient care across 15 eye centers and clinics in the Flanders region.

The transaction comes soon after the recent acquisition of Optegra, a fast-growing and highly integrated ophthalmology platform in Europe operating over 70 clinics in the UK, Czech Republic, Poland, Slovakia and the Netherlands. While strengthening Optegra’s position in Europe, it also advances EssilorLuxottica’s med-tech trajectory and its ambition to pioneer the most advanced, integrated and expert-driven medical model, capable of addressing the full continuum of need, from prevention and early detection to specialized clinical management.

Offering both medically necessary ophthalmic treatments and elective vision procedures, the Signifeye platform provides the full spectrum of eye healthcare services. In line with Optegra, Signifeye has built a reputation for clinical excellence in the private sector, trusted care and industry-leading outcomes.

“With Signifeye joining EssilorLuxottica’s ecosystem, we strengthen our ability to deliver truly end-to-end eye care and redefine what medical excellence can be across the entire patient journey. By combining our medical and scientific innovation capabilities with Signifeye’s proven clinical excellence, we can meaningfully enhance the patient experience and empower people to live their best lives,” commented Francesco Milleri, Chairman and Chief Executive Officer, and Paul du Saillant, Deputy Chief Executive Officer at EssilorLuxottica.

“Joining forces with EssilorLuxottica and Optegra marks a transformative chapter for Signifeye. By combining their global leadership in vision care with our commitment to patient care and clinical excellence, we look forward to building the future of eye care together,” added Kathleen Moons, Chief Executive Officer at Signifeye.

The transaction is expected to close by Q1 2026.

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• DOWNLOAD THE PRESS RELEASE

Genmab Announces Completion of Tender Offer for Outstanding Common Shares of Merus N.V. and Commencement of Subsequent Offering Period




Genmab Announces Completion of Tender Offer for Outstanding Common Shares of Merus N.V. and Commencement of Subsequent Offering Period

Company Announcement

• Transaction adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio
• Transaction anticipated to be accretive to Genmab’s EBITDA by end of 2029

COPENHAGEN, Denmark; December 12, 2025 – Genmab A/S (Nasdaq: GMAB) (“Genmab”) announced today that the conditions, including the minimum tender condition, to the previously announced tender offer (the “Offer”) by Genmab Holding II B.V., a wholly owned subsidiary of Genmab (“Purchaser”), to acquire all the issued and outstanding common shares of Merus N.V. (Nasdaq: MRUS) (“Merus”) for $97 per common share in cash have been satisfied. The transaction meaningfully accelerates Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained growth into the next decade and contributing to Genmab’s evolution into a biotechnology leader.

“The Merus acquisition marks a pivotal step in the delivery of Genmab’s long-term strategy and strengthens our path to becoming a global biotechnology leader with sustained growth and profitability. We are energized by the potential of petosemtamab to meaningfully impact the lives of people with head and neck cancer. Backed by our track record of successful development and commercial execution, we look forward to unlocking petosemtamab’s full potential and delivering on its promise to patients,” said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab.

The addition of petosemtamab, Merus’ lead asset, to Genmab’s promising late-stage pipeline is a compelling strategic fit with Genmab’s portfolio and aligns with Genmab’s expertise in antibody therapy development and commercialization in oncology. Based on this successful track record in late-stage development and excellence in commercial execution, Genmab expects to launch petosemtamab in 2027, subject to clinical results and receipt of regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into other lines of therapy. Following the initial approval of petosemtamab, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter.

At 5:00 p.m. New York City time on December 11, 2025 (the “Expiration Time”), the Offer and withdrawal rights expired as scheduled. The depositary for the Offer has advised Genmab and Purchaser that, as of the Expiration Time, a total of 71,463,077 of Merus’ issued and outstanding common shares, constituting 94.2% of its issued and outstanding common shares, had been validly tendered pursuant to the Offer and not properly withdrawn. Effective at 12:01 a.m. New York City time on December 12, 2025, Purchaser accepted for payment, and expects to promptly pay for, all Merus common shares validly tendered and not properly withdrawn pursuant to the Offer.

Subsequent Offering Period
Genmab also announced that, as previously disclosed, Purchaser is providing a subsequent offering period of ten business days (the “Subsequent Offering Period”), commencing today, December 12, 2025, that will expire at 5:00 p.m., New York City time on December 29, 2025. During the Subsequent Offering Period, Purchaser will offer to purchase additional common shares at the same consideration of $97.00 per share, less any applicable withholding taxes and without interest. All Common shares validly tendered during the Subsequent Offering Period will be immediately accepted and promptly paid for by Purchaser.

Following completion of the Subsequent Offering Period, Genmab and Purchaser intend to complete the acquisition of 100% of Merus through a series of previously disclosed back-end transactions. Merus shareholders who do not tender their common shares of Merus in the Offer will receive payment for their common shares following the completion of these transactions (subject to applicable withholding taxes and without interest).

About Genmab 
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines^®. 

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Contact:        
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^® and KYSO^®.

Company Announcement no. 54
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Attachment

• 121225_CA54_Completion of Tender Offer