MannKind Shares FUROSCIX® Business Updates




MannKind Shares FUROSCIX® Business Updates

• FDA approves FUROSCIX^® for use in pediatric patients weighing 43kg or above
• USPTO issues five patents for FUROSCIX ReadyFlow^™ Autoinjector

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD) today announced two business updates—approval of the FUROSCIX^® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage FUROSCIX ReadyFlow^™ Autoinjector, which is currently under review by the U.S. FDA.

FUROSCIX Expanded Treatment Options for Appropriate Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX^® (furosemide) On-body Infusor, expanding the indication of this product to include pediatric patients weighing 43 kg or more. FUROSCIX was previously approved for the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults. This additional approval fulfills all post-marketing requirements outlined in the original approval letter under the Pediatric Research Equity Act.

“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation.

Five New U.S. Patents Provide Protection to FUROSCIX ReadyFlow Autoinjector
The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect the FUROSCIX ReadyFlow Autoinjector. These patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment potentially through 2040, further reinforcing MannKind’s intellectual property position around this innovative drug-device combination. The patents would be listed in the FDA’s Orange Book, if the FUROSCIX ReadyFlow Autoinjector is approved by the FDA.

The newly issued patents complement previously issued patents supporting FUROSCIX and the FUROSCIX ReadyFlow Autoinjector, creating a robust IP portfolio that is designed to protect the formulation and delivery approach for years to come.

FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds
MannKind recently announced that the FDA accepted for review its sNDA for the FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with CHF or CKD. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

If approved, the FUROSCIX ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/mL) in under 10 seconds, providing a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved in 2022 for the treatment of edema in adult patients with chronic heart failure and, in 2025, for adult patients with chronic kidney disease in 2025.

“FUROSCIX ReadyFlow Autoinjector has the potential to redefine how patients manage fluid overload episodes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “By delivering an IV-equivalent diuretic dose in seconds from the comfort of home, this innovation, if approved, could significantly reduce hospital visits, improve quality of life, and lower healthcare costs—creating meaningful value for patients, providers, and payers alike.”

About FUROSCIX
FUROSCIX^® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.

IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives. 

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO₂, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Please see the full Prescribing Information (https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf) and Instructions for Use (https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf).

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements about a potential regulatory action date, statements regarding the potential duration of patent protection and statements regarding the potential benefits of the administration of furosemide via an autoinjector for providers, patients and payors. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining marketing approval, the risk that we may be unable to protect our proprietary rights as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

FUROSCIX is a registered trademark of scPharmaceuticals, a wholly owned subsidiary of MannKind Corporation.

MANNKIND is a registered trademark of MannKind Corporation.

CONTACT: MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(781) 301-6869
ir@mnkd.com

BillionToOne to Participate in the 44th Annual J.P. Morgan Healthcare Conference




BillionToOne to Participate in the 44th Annual J.P. Morgan Healthcare Conference

MENLO PARK, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) — BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced that Company management will participate in the 44^th Annual J.P. Morgan Healthcare Conference.

Management will present from 9:45am to 10:25am Pacific Time on Monday, January 12^th, 2026.

A live and archived webcast will be available on the “Events & Presentations” page of BillionToOne’s investor relations website at https://investors.billiontoone.com/news-events/events-presentations.

About BillionToOne

Headquartered in Menlo Park, California, BillionToOne is a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company’s patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, visit www.billiontoone.com.

Investor Contact
ir@billiontoone.com

Media Contact
billiontoone@moxiegrouppr.com

Vaccinex, Inc. Announces $60 million Agreement to Finance a Phase 2b clinical trial of pepinemab to treat Alzheimer’s Disease




Vaccinex, Inc. Announces $60 million Agreement to Finance a Phase 2b clinical trial of pepinemab to treat Alzheimer’s Disease

ROCHESTER, N.Y., Dec. 23, 2025 (GLOBE NEWSWIRE) — Vaccinex, Inc. (VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) by inhibiting semaphorin 4D (SEMA4D) induced pathology in brain, today announced that it has entered into a $60 million revenue sharing agreement with Pepinemab Development Venture, LP (PDV) to continue advancing development of its pepinemab anti-SEMA4D antibody in an enlarged phase 2b clinical trial for treatment of AD. PDV LP is an investment entity established by FCMI, an existing Vaccinex investor. Albert Friedberg is Chairman of FCMI and of the Vaccinex Board. The agreements provide that, in exchange for the commitment of funding, PDV will receive 50% of future economic proceeds received by Vaccinex from a development partner or licensee of pepinemab related to neurological indications and 25% related to other indications.

This agreement follows on promising data previously reported from studies in animal disease models and in the early stage SIGNAL-AD phase 1/2a clinical trial indicating that treatment with pepinemab antibody (1) blocks crosstalk between reactive astrocytes and microglia that amplifies glial reactivity leading to inflammation and glial scars; (2) preserves vascular integrity in brain; and (3) downregulates expression of AD disease-related proteins in cerebral spinal fluid (CSF) including SNAP25 associated with synaptic loss and GAP-43 that promotes tau spreading and accumulation. In addition, data from a randomized Phase 2 study in Huntington’s disease (HD, n=179) as well as the completed SIGNAL-AD phase 1/2a study in Mild Cognitive Impairment (MCI) and mild AD (n=50) suggest that pepinemab was well-tolerated and that treatment early in disease has favorable effects on biomarkers related to disease progression and appears to slow cognitive decline.

More recently, a large group of investigators led by Dr. Philip De Jager, Professor of Neurology and Chief, Division of Neuroimmunology at Columbia University Medical Center, identified a genetic signature associated with a unique subset of astrocytes termed Ast10 whose representation in brain correlates with cognitive decline in Alzheimer’s. Importantly, the SEMA4D-PLXNB1 signaling pathway was identified as a top ligand-receptor pair that strongly regulates Ast10 representation in brain. Based on information shared by Dr. De Jager and colleagues, we were able to determine that pepinemab treatment (1) reduced representation of Ast10 cells in brain, and (2) that this appears to be associated with slowing of cognitive decline relative to the placebo controls. Results were reported at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference in San Diego, December 3, 2025. We believe that the combination of biological, clinical and genetic evidence for the important role of the SEMA4D-PLXNB1 signaling pathway in AD progression is a compelling reason to continue development of pepinemab as a potentially novel and effective therapeutic for AD.

About Vaccinex Inc. 

Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases including Alzheimer’s and Huntington’s disease through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers a chain of pathogenic events downstream of astrocyte reactivity that drive disease progression in both AD and HD.

Forward Looking Statements

To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about the Company’s plans, expectations and objectives with respect to the results and timing of clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington’s and Alzheimer’s disease and other indications, the expected timeline for publication and disclosure of trial results, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “planned,” “anticipate,” “estimate,” “intend,” “hypothesis,” “potential,” “suggest,” “advance,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of the Company’s research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, the risks related to the Company’s dependence on its lead product candidate pepinemab, the ability to leverage its ActivMAb® platform, the impact of the COVID-19 pandemic, and other matters that could affect the Company’s development plans or the commercial potential of its product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in the Company’s periodic reports and its most recent year end Annual Report on Form 10-K.

Investor Contact
Elizabeth Evans, PhD
Chief Operating Officer, Vaccinex, Inc.
(585) 271-2700
eevans@vaccinex.com

Join Jupiter Neurosciences’ Exclusive Live Investor Webinar and Q&A Session on January 6




Join Jupiter Neurosciences’ Exclusive Live Investor Webinar and Q&A Session on January 6

Jupiter, Florida, Dec. 23, 2025 (GLOBE NEWSWIRE) — Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter” or the “Company”), a clinical-stage pharmaceutical company developing JOTROL^™, a patented resveratrol-based platform, is pleased to invite investors to a webinar on January 6, 2026, at 4:15 p.m. ET.

The exclusive event, hosted by RedChip Companies, will feature Jupiter Neuroscience Chairman and CEO Chister Rosén who will provide investors with an overview of Jupiter Neurosciences’ scientific platform, clinical development plans, and commercial strategy heading into 2026. Rosén will discuss the Company’s lead asset, JOTROL^™, including its differentiated bioavailability profile and upcoming Phase 2a clinical trial in Parkinson’s disease, as well as the broader therapeutic potential across neuroinflammatory and rare disease indications. The presentation will also outline Jupiter’s dual-path approach, highlighting the launch and early commercialization of its Nugevia^™ longevity product line, the rationale for leveraging the same clinically validated technology across pharmaceutical and consumer markets, and how recent financing initiatives support disciplined execution across both pathways.

A live Q&A session will follow the presentation.

To register for the free webinar, please visit: https://www.redchip.com/webinar/JUNS/86401333631

Questions can be pre-submitted to JUNS@redchip.com or online during the live event.

About Jupiter Neurosciences, Inc.

Jupiter Neurosciences is a clinical-stage pharmaceutical company pursuing a dual-path strategy to address neuroinflammation and promote healthy aging. The Company is advancing a therapeutic pipeline targeting central nervous system (CNS) disorders and rare diseases, while also expanding into the consumer longevity market with its Nugevia product line. Both efforts are powered by JOTROL^™, Jupiter’s proprietary, enhanced resveratrol formulation that has demonstrated significantly improved bioavailability. Nugevia brings clinical-grade science to the supplement space, supporting mental clarity, skin health, and mitochondrial function. The Company’s prescription pipeline is focused broadly on CNS disorders, presently with a Phase IIa in Parkinson’s disease, including indications such as Alzheimer’s Disease, Mucopolysaccharidoses Type I, Friedreich’s Ataxia, and MELAS. More information may be found on the Company’s website www.jupiterneurosciences.com.

About JOTROL

Resveratrol is one of the world’s most extensively researched molecules. Thorough evaluation has shown that for the compound to be effective, it requires a high C-Max (~300 ng/ml of resveratrol in plasma), achievable only with doses exceeding 3 grams using earlier resveratrol products. Poor bioavailability has been a well-documented issue with resveratrol. Doses over 2 grams have been associated with severe gastrointestinal (GI) side effects, which have prevented the compound from receiving regulatory approval for any indication.

Jupiter Neurosciences (JUNS) conducted a Phase I study demonstrating that JOTROL^™ achieves over nine times higher bioavailability compared to resveratrol used in earlier clinical trials (e.g., Turner et al., MCI/Early Alzheimer’s Disease trial, and Yui et al., Friedreich’s Ataxia trial). The results of this Phase I study, which will be cross-referenced in all upcoming JOTROL^™ trials, were published in the Journal of Alzheimer’s Disease and AAPS Open in February 2022. JUNS is now advancing JOTROL^™ toward a Phase IIa trial in Parkinson’s Disease.

In addition to its therapeutic applications, JOTROL^™ serves as the foundation for Jupiter’s Nugevia consumer supplement line. By leveraging the same clinically validated delivery technology, Nugevia introduces pharmaceutical-grade bioavailability into the wellness space, offering targeted support for cognitive health, skin vitality, and cellular energy.

About Nugevia

Nugevia^™ is Jupiter Neurosciences’ premium longevity and performance supplement line powered by the same patented JOTROL^™ micellar delivery technology advancing through clinical trials for CNS disorders. Built on pharmaceutical-grade science, each formulation features synergistic, highly bioavailable active ingredients designed to target key pillars of healthy aging, including cognitive resilience (MND), mitochondrial energy and recovery (PWR), and cellular skin vitality (GLO).

Unlike conventional supplements that often struggle with poor absorption and inconsistent results, Nugevia^™ products are rooted in peer-reviewed clinical data, developed under pharmaceutical standards, and informed by strategic research collaborations with leading institutions including Harvard, Georgetown, MIT’s Picower Institute, and the University of Miami. More information is available at www.nugevia.com.

FORWARD-LOOKING STATEMENTS

Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations, including the Company’s ability to generate revenues from the sale of JOTROL products to consumers through the DTC model. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to read the risk factors contained in the Company’s final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company’s securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.

Contact:

IR@jupiterneurosciences.com

JUNS@redchip.com

CooperCompanies Appoints Walter M Rosebrough, Jr. to its Board of Directors




CooperCompanies Appoints Walter M Rosebrough, Jr. to its Board of Directors

Enters into Cooperation Agreement with Browning West

SAN RAMON, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) — CooperCompanies (Nasdaq: COO), a leading medical device company, announced today that the Company’s Board of Directors (the “Board”) has appointed Walter (Walt) M Rosebrough, Jr. as an independent director, effective as of January 3, 2026. In connection with this appointment, the Company also has entered into a cooperation agreement (the “Cooperation Agreement”) with Browning West, LP. (“Browning West”). Mr. Rosebrough will join the Board’s Corporate Governance & Nominating Committee. The Board has also agreed that, by the end of 2026, it shall provide due and serious consideration for Mr. Rosebrough to be appointed Chair of the Board. In addition, the Board will identify and appoint a new independent director with medical technology experience, with the mutual agreement of Browning West.

Mr. Rosebrough currently serves as CEO Emeritus and Senior Advisor of STERIS plc (NYSE: STE), a global medical device business focused on infection prevention products and services. During his tenure as CEO of STERIS from 2007 to 2021, STERIS’s stock generated a 10-fold total return or an 18% annualized return compared with a 10% annualized return for the S&P 500, and the company’s market capitalization increased by over $20 billion. His career also includes nearly two decades at Hill-Rom Holdings, Inc., where he held senior executive positions, including President and CEO of Support Systems International and President and CEO of Hill-Rom. Mr. Rosebrough currently serves as Independent Chair on the Board of Varex Imaging (NASDAQ: VREX).

“We are pleased to welcome Walt to our Board,” said Colleen Jay, Incoming Chair of the Board of CooperCompanies. “He brings decades of leadership experience in the medical device manufacturing and healthcare industries, and his proven track record delivering sustainable growth will support our strategic vision and ongoing focus of delivering long-term value for shareholders.”

“Cooper has significant long-term potential, and we are pleased to have aligned on a constructive path forward with the Cooper Board,” said Usman S. Nabi, Co-Founder and Chief Investment Officer of Browning West. “We believe Walt’s appointment along with the Company’s commitment to additional Board refreshment position Cooper to drive the critical initiatives required to unlock sustained long-term value for all shareholders.”

Browning West has agreed to certain customary standstill and voting commitments in connection with the Cooperation Agreement and will support the Board’s full slate of directors at the 2026 Annual Meeting of Stockholders. The Cooperation Agreement will be filed by the Company with the U.S. Securities and Exchange Commission (“SEC”) as an exhibit to the Current Report on Form 8-K.

About CooperCompanies
CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical. CooperVision is a trusted leader in the contact lens industry, helping to improve the way people see each day. CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most. Headquartered in San Ramon, CA, CooperCompanies has a workforce of more than 15,000, sells products in over 130 countries, and positively impacts over fifty million lives each year. For more information, please visit www.coopercos.com.

About Browning West, LP
Browning West is an independent investment partnership based in Los Angeles, California. The partnership employs a concentrated, long-term and fundamental approach to investing and focuses primarily on investments in North America and Western Europe. Founded in 2019, Browning West seeks to identify and invest in a limited number of high-quality businesses and to hold these investments for multiple years. Backed by a select group of leading foundations, family offices, and university endowments, our unique capital base allows us to focus on long-term value creation at our portfolio companies.

Forward-Looking Statements
This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Statements relating to the Company’s potential transactions, capital allocation priorities, share repurchase program, efforts to enhance long-term shareholder value, plans, strategies, future actions, and other statements of which are other than statements of historical fact, are forward-looking. Forward-looking statements necessarily depend on assumptions, data, or methods that may be incorrect or imprecise and are subject to risks and uncertainties. Statements regarding future events and performance and contain words such as “expects” and similar words or phrases. A wide range of factors could materially affect future developments, including, but not limited to, uncertainties related to market conditions and other factors set forth in our other filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K. These risks and uncertainties may cause actual future results or actions to be materially different than those expressed in such forward-looking statements. We do not intend, or undertake any duty, to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:
Kim Duncan
Vice President, Investor Relations and Risk Management
925-460-3663
ir@cooperco.com

Profound Medical Corp. Closes $36 Million Registered Direct Offering; Expects to Complete Subsequent Private Placement On or Before December 30th




Profound Medical Corp. Closes $36 Million Registered Direct Offering; Expects to Complete Subsequent Private Placement On or Before December 30th

Financing included participation by healthcare-dedicated investors alongside existing shareholders

TORONTO, Dec. 23, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) today announced the closing of its previously announced registered direct offering of 5,142,870 common shares at a purchase price of $7.00 per share, for gross proceeds of approximately $36 million before fees and expenses.

The registered direct offering was structured as a straightforward equity investment with no warrant coverage and was led by healthcare-dedicated investors alongside existing shareholders.

Gross proceeds to the Company from the registered direct offering were approximately $36 million, before deducting placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for expansion of its sales and marketing, working capital, research and development, strategic transactions and general corporate purposes.

Konik Capital Partners, LLC, a division of T.R. Winston and Company, LLC, acted as the exclusive placement agent for the offering.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-291516) which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 4, 2025. The offering was made only by means of a prospectus supplement and accompanying base prospectus which form a part of the effective shelf registration statement. A prospectus supplement and the accompanying base prospectus relating to the offering was filed with the SEC and is available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained from Konik Capital Partners, 7 World Trade Center, 46th Floor, New York, NY, or by email at capmarkets@konikcapitalpartners.com.

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

In addition to the registered direct offering, the Company intends to complete a private placement (the “Private Placement”) to certain Canadian purchasers on a private placement basis. The closing of the Private Placement is expected to occur on or prior to December 30, 2025 and is subject to the Company receiving all necessary approvals, including the conditional approval from the Toronto Stock Exchange. No securities will be sold under the Private Placement to United States purchasers and this press release is not an offer to sell or the solicitation of an offer to buy such securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered under the Private Placement have not been, nor will they be, registered under the U.S. Securities Act, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.
Profound is commercializing TULSA-PRO^®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve^®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, statements relating to the Company’s anticipated use of proceeds, expected cash runway and the closing of the offering. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including the planned Private Placement. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound’s Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849

Cassava Announces Agreement to Settle Securities Class Action Litigation




Cassava Announces Agreement to Settle Securities Class Action Litigation

AUSTIN, Texas, Dec. 23, 2025 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced that it has reached a definitive agreement to resolve the previously disclosed consolidated securities class action litigation pending in the United States District Court for the Western District of Texas Austin Division (In re Cassava Sciences, Inc. Securities Litigation, No. 1:21-cv-00751-DAE) (the “Consolidated Securities Action”). This lawsuit was originally filed in 2021.

Under the agreement, Cassava will pay $31.25 million to achieve a complete settlement and release of all claims and causes of action that have been or could be asserted by the plaintiffs and the plaintiff class, which is defined as all purchasers or acquirers of Company common stock or call options on Company common stock or sellers of put options on Company common stock between September 14, 2020 and October 12, 2023 (subject to certain exclusions). The court will decide whether later-filed securities class action litigation should be consolidated into the Consolidated Securities Action. The settlement is not an admission of fault or wrongdoing by the Company.

Cassava fully reserved a loss contingency of $31.25 million in the second quarter of 2025 relating to the Consolidated Securities Action.

“We are pleased to announce that we have reached an agreement to resolve our most significant, legacy litigation,” said Rick Barry, President and Chief Executive Officer of Cassava. “With this agreement, we can dedicate our attention and resources to the continued development of simufilam as a potential treatment for TSC-related epilepsy.”

About Simufilam

Simufilam is a proprietary, investigational oral small molecule believed to modulate activity of the filamin A protein, which regulates diverse aspects of neuronal development¹.

About Cassava Sciences, Inc.

Cassava Sciences, Inc. (NASDAQ: SAVA), is a biotechnology company focused on developing novel, investigational treatments, including simufilam, for central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and potentially other indications. Simufilam is a proprietary, investigational oral small molecule believed to modulate activity of the filamin A protein, which regulates diverse aspects of neuronal development¹. The Company is planning a Phase 2 proof-of-concept study to evaluate simufilam in patients with TSC-related epilepsy, collaborating closely with the TSC Alliance and key opinion leaders. The program is based on a method of treatment patent issued in 2025 and in-licensed from Yale University. Cassava is based in Austin, Texas.

For more information, please visit: https://www.CassavaSciences.com

References:

1. Zhang L, Bartley CM, Gong X, Hsieh, LS.; LinTV, Feliciano DM, Bordey A. “MEK-ERK1/2-Dependent FLNA Overexpression Promotes Abnormal Dendritic Patterning in Tuberous Sclerosis Independent of mTOR. Neuron (2014) 84 (1), 78-91.  DOI: 10.1016/j.neuron.2014.09.009

For More Information Contact:
Investors
Sandya von der Weid
svonderweid@lifesciadvisors.com

Company
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@CassavaSciences.com
IR@cassavasciences.com

Cautionary Note Regarding Forward-Looking Statements:

This news release contains forward-looking statements that may include but are not limited to statements regarding: the potential resolution of certain securities litigation and our loss contingency estimates related thereto, plans to conduct clinical studies with simufilam, our plans to conduct additional preclinical studies of simufilam relating to seizures in TSC, the potential for simufilam as a treatment for TSC-related epilepsy and other potential indications, the timing of anticipated milestones, the timing of payment of an estimated loss contingency related to the settlement of the Consolidated Securities Action, recorded in second quarter 2025, and expected cash balances and cash use in future periods. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, ”pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning.

Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to advance preclinical and clinical studies related to TSC-related epilepsy, and other potential indications, the ability to successfully carry out the Company’s obligations under the Yale License Agreement, the ability to initiate an initial proof-of-concept study of simufilam in TSC-related epilepsy, and other risks inherent in drug discovery and development or specific to Cassava Sciences, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the period ended September 30, 2025, and subsequent reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC’s website at www.sec.gov.

All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.

Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.

CancerVax Reviews Major Scientific and Strategic Milestones Achieved in 2025




CancerVax Reviews Major Scientific and Strategic Milestones Achieved in 2025

Year-End Recap Highlights Breakthrough Discoveries, Platform Advancements, and Strengthened Scientific Leadership

Lehi, Utah, Dec. 23, 2025 (GLOBE NEWSWIRE) — Lehi, Utah, December 23, 2025 – CancerVax, Inc., the developer of a breakthrough Universal Cancer Treatment Platform that uses the body’s immune system to treat cancer, today released a year-end summary highlighting significant advancements made throughout 2025. These achievements mark a transformative period in the Company’s development as it accelerates its mission to create safe, targeted, and broadly adaptable cancer treatments.

Throughout 2025, CancerVax achieved substantial scientific progress, expanded its leadership and intellectual property portfolio, and advanced the development of its AI-engineered “Smart mRNA” and nanoparticle delivery technologies. These accomplishments position the Company for a strong 2026 as it moves toward in-vivo studies and continued platform expansion.

Key Accomplishments Since January 2025

Strengthened Scientific Leadership– Appointed a world-class biotech executive as Chief Scientific Advisor to guide platform development and strategic execution (see source).

Engineered Precision Cell-Targeting Nanoparticles– Developed ligand-conjugated lipid nanoparticles capable of identifying cancer-specific biomarkers. Validated selective uptake into cancerous cells while avoiding healthy cells. Demonstrated functionality of dual-key targeting architecture (Marker1 + Marker2), (see source).

Expanded Platform Capability to Aggressive Liver Cancers– Initiated research programs targeting hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), (see source).

Breakthrough: Cancer Cells Successfully Disguised as Pathogens– Achieved proof-of-principle demonstrating cancer cells can be disguised as common pathogens to trigger immune attack (see source).

Filed Foundational PCT Patent Application– Submitted non-provisional PCT application protecting the universal cancer immunotherapy platform (see source).

Advanced Smart mRNA Activation Technology– Confirmed Smart mRNA remains inactive in healthy human liver cells and Smart mRNA only activates inside cancer cells, reducing off-target toxicity (see source).

Strong cancer cell uptake and Smart mRNA activation-  Recent In-vitro studies showed strong uptake of cell-targeting nanoparticles by cancer cells and strong activation of Smart mRNAs inside cancer cells, providing confidence in moving forward with animal testing (see source).

Platform Momentum and Path Toward 2026

As the Company plans for 2026, major milestones expected include: 1) Integration of nanoparticles with Smart mRNA to form full therapeutic nanoparticles. 2) Complete pre-IND animal studies to determine toxicity and efficacy in pancreatic and liver cancers. 3) Expand scientific collaborations and future IND groundwork.

CEO Statement

“Our progress in 2025 represents a turning point in the development of our universal cancer immunotherapy platform,” said Byron Elton, CEO of CancerVax. “This year, we shifted from theoretical possibility to validated scientific evidence. Our breakthroughs bring us significantly closer to delivering cancer treatments that are more precise, more accessible, and more humane.”

To learn more about the CancerVax platform, please watch the Short Explainer Video at https://cancervax.com/explainer

About CancerVax

CancerVax is a pre-clinical biotech company developing a novel Universal Cancer Treatment platform that will be customizable, as an injection, to treat many types of cancer. Our innovative approach DETECTS, MARKS, and KILLS only cancer cells. By making cancer cells look like well-immunized common diseases, such as measles or chickenpox, we intend to use the body’s natural immune system to easily kill the cancer cells. We look forward to the day when treating cancer will be as simple as getting a shot — a better way to fight cancer. To learn more, please visit www.CancerVax.com

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside our control. Our actual results and financial condition may differ materially from those in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this release is based only on information currently available to us and speaks only as of the date it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

Press Contact:
CancerVax, Inc.
Tel: (805) 356-1810
communications@CancerVax.com

CancerVax Reviews Major Scientific and Strategic Milestones Achieved in 2025




CancerVax Reviews Major Scientific and Strategic Milestones Achieved in 2025

Year-End Recap Highlights Breakthrough Discoveries, Platform Advancements, and Strengthened Scientific Leadership

Lehi, Utah, Dec. 23, 2025 (GLOBE NEWSWIRE) — Lehi, Utah, December 23, 2025 – CancerVax, Inc., the developer of a breakthrough Universal Cancer Treatment Platform that uses the body’s immune system to treat cancer, today released a year-end summary highlighting significant advancements made throughout 2025. These achievements mark a transformative period in the Company’s development as it accelerates its mission to create safe, targeted, and broadly adaptable cancer treatments.

Throughout 2025, CancerVax achieved substantial scientific progress, expanded its leadership and intellectual property portfolio, and advanced the development of its AI-engineered “Smart mRNA” and nanoparticle delivery technologies. These accomplishments position the Company for a strong 2026 as it moves toward in-vivo studies and continued platform expansion.

Key Accomplishments Since January 2025

Strengthened Scientific Leadership– Appointed a world-class biotech executive as Chief Scientific Advisor to guide platform development and strategic execution (see source).

Engineered Precision Cell-Targeting Nanoparticles– Developed ligand-conjugated lipid nanoparticles capable of identifying cancer-specific biomarkers. Validated selective uptake into cancerous cells while avoiding healthy cells. Demonstrated functionality of dual-key targeting architecture (Marker1 + Marker2), (see source).

Expanded Platform Capability to Aggressive Liver Cancers– Initiated research programs targeting hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), (see source).

Breakthrough: Cancer Cells Successfully Disguised as Pathogens– Achieved proof-of-principle demonstrating cancer cells can be disguised as common pathogens to trigger immune attack (see source).

Filed Foundational PCT Patent Application– Submitted non-provisional PCT application protecting the universal cancer immunotherapy platform (see source).

Advanced Smart mRNA Activation Technology– Confirmed Smart mRNA remains inactive in healthy human liver cells and Smart mRNA only activates inside cancer cells, reducing off-target toxicity (see source).

Strong cancer cell uptake and Smart mRNA activation-  Recent In-vitro studies showed strong uptake of cell-targeting nanoparticles by cancer cells and strong activation of Smart mRNAs inside cancer cells, providing confidence in moving forward with animal testing (see source).

Platform Momentum and Path Toward 2026

As the Company plans for 2026, major milestones expected include: 1) Integration of nanoparticles with Smart mRNA to form full therapeutic nanoparticles. 2) Complete pre-IND animal studies to determine toxicity and efficacy in pancreatic and liver cancers. 3) Expand scientific collaborations and future IND groundwork.

CEO Statement

“Our progress in 2025 represents a turning point in the development of our universal cancer immunotherapy platform,” said Byron Elton, CEO of CancerVax. “This year, we shifted from theoretical possibility to validated scientific evidence. Our breakthroughs bring us significantly closer to delivering cancer treatments that are more precise, more accessible, and more humane.”

To learn more about the CancerVax platform, please watch the Short Explainer Video at https://cancervax.com/explainer

About CancerVax

CancerVax is a pre-clinical biotech company developing a novel Universal Cancer Treatment platform that will be customizable, as an injection, to treat many types of cancer. Our innovative approach DETECTS, MARKS, and KILLS only cancer cells. By making cancer cells look like well-immunized common diseases, such as measles or chickenpox, we intend to use the body’s natural immune system to easily kill the cancer cells. We look forward to the day when treating cancer will be as simple as getting a shot — a better way to fight cancer. To learn more, please visit www.CancerVax.com

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside our control. Our actual results and financial condition may differ materially from those in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this release is based only on information currently available to us and speaks only as of the date it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

Press Contact:
CancerVax, Inc.
Tel: (805) 356-1810
communications@CancerVax.com