INVO Fertility Announces Intent to Acquire Indiana-Based Fertility Clinic “Family Beginnings”




INVO Fertility Announces Intent to Acquire Indiana-Based Fertility Clinic “Family Beginnings”

Acquisition advances INVO’s national expansion strategy, enhances its clinical capabilities, and broadens access to innovative fertility care across the Midwest

SARASOTA, Fla. and INDIANAPOLIS, Nov. 28, 2025 (GLOBE NEWSWIRE) — INVO Fertility, Inc. (Nasdaq: IVF) (“INVO” or the “Company”), a healthcare fertility company focused on the establishment, acquisition, and operation of fertility clinics and related businesses and technologies, today announced its intent to acquire Family Beginnings, P.C., a respected fertility clinic serving patients across Indiana and the broader Midwest. The planned acquisition marks INVO’s second acquisition after its purchase of Wisconsin Fertility Institute in 2023 and reflects the Company’s multi-pronged strategic initiative to build a nationwide network of fertility centers capable of reaching underserved markets and meeting rising patient demand.

“Family Beginnings has long been recognized for its exceptional standards of care, and we are thrilled to welcome Dr. James Donahue and his talented team into the INVO family,” said Steve Shum, CEO of INVO. “From our earliest conversations, it was clear that we share a common philosophy centered on compassionate, patient-first treatment. Equally as exciting, Dr. Donahue was an early adopter and remains a strong advocate of our innovative INVOcell technology. Our intravaginal culture (“IVC”) solution is well integrated into his practice and is one of the several treatment options offered to patients. Teaming up with Dr. Donahue and the Family Beginnings team is an important step in pursuit of our strategic growth efforts, and we look forward to supporting their continued success as we expand our presence across the Midwest.”

Founded in the late 1990s, Family Beginnings has served thousands of patients across Indiana and surrounding states. Known for its personalized care model and strong success rates, the clinic offers a full suite of reproductive services, including the following:

• In vitro fertilization (IVF);
• INVOcell (IVC);
• Intrauterine insemination (IUI);
• Third-party reproduction services;
• Fertility preservation;
• Advanced diagnostic testing; and
• Comprehensive patient education and support programs

“We are excited to join forces with INVO Fertility,” said James Donahue M.D., HCLD and founder of Family Beginnings. “Our teams share a deep commitment to helping individuals and families achieve their dreams of parenthood. By partnering with INVO, we will be able to broaden our offerings, introduce new and innovative treatment options, and ensure that even more patients benefit from the high level of care we’ve always provided. This collaboration marks the beginning of an exciting new chapter for our clinic and our patients.”

With this acquisition, INVO plans to enhance the Family Beginnings clinic by:

• Introducing expanded treatment options;
• Investing in clinic infrastructure and technology, improving workflow efficiencies;
• Integrating digital patient engagement tools for streamlined communication and care coordination; and
• Leveraging INVO’s national network to provide patients with broader access to resources, support programs, and clinical expertise.

“This acquisition is a natural fit with our mission to make fertility care more accessible and patient-centered,” concluded Shum. “Strategic acquisitions like this are a core component of our growth plan, as they allow us to accelerate expansion while integrating proven teams and clinical infrastructure. Having executed a term sheet with Dr. Donahue over a month ago, we are well along in completing final agreements and expect to close the transaction in the near-term.”

The acquisition remains subject to completion of customary due diligence by INVO and the negotiation and entry into definitive purchase agreements between INVO and Family Beginnings. The definitive agreements are also expected to include customary covenants, closing conditions, any required regulatory approvals, indemnification provisions and termination rights. There can be no assurances that INVO will enter into a definitive agreement or complete the acquisition.

About INVO Fertility

We are a healthcare services fertility company dedicated to expanding access to assisted reproductive technology (“ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring, and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell^® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of INVOcell to third-party owned and operated fertility clinics. INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman’s body. The IVC procedure provides patients with a more connected, intimate, and affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly more effective treatment than intrauterine insemination. For more information, please visit invofertility.com.

Safe Harbor Statement

This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential acquisition of Family Beginnings, the terms and conditions of any such potential acquisition, whether such acquisition will occur on the terms set forth in the non-binding term sheet, if at all, and the impact of the acquisition on INVO’s current and future product offerings, business, and financial results and condition. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements , including but not limited to the risks that INVO and Family Beginnings will not be able to negotiate and enter into a definitive purchase agreement for the Family Beginnings business on terms set forth in the non-binding term sheet or at all, regulatory and other risks associated with INVO’s ability to complete such an acquisition even if a definitive purchase agreement is executed, and, if it occurs, other risks and uncertainties associated with the integration of the Family Beginnings business and whether INVO will achieve its desired or expected business, operational, and financial outcomes from the acquisition. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events, or otherwise.

For more information, please contact:

INVO Fertility, Inc.
Steve Shum, CEO
978-878-9505
sshum@invofertility.com

Investor Contact
Lytham Partners, LLC
Robert Blum
602-889-9700
INVO@lythampartners.com

Pasithea Therapeutics Announces Pricing of $60 Million Public Offering of Common Stock




Pasithea Therapeutics Announces Pricing of $60 Million Public Offering of Common Stock

• Extends cash runway through at least the first half of 2028
• Led by Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management

MIAMI, Nov. 28, 2025 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), today announced the pricing of a public offering of 80,000,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.75 per share of common stock (or per pre-funded warrant in lieu thereof). The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about December 1, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $60 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company’s cash position following the closing will extend its cash runway through at least the first half of 2028. Such corporate purposes include, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-291611) originally filed with the Securities and Exchange Commission (“SEC”) on November 18, 2025, as amended on November 26, 2025, and declared effective on November 28, 2025. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

This press release does 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About Pasithea Therapeutics Corp.

Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in advanced cancer patients (NCT06299839), and a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NCT06961565). 

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the ability of the Company to consummate the public offering, the satisfaction of the closing conditions of the public offering and the use of proceeds therefrom, the Company’s cash runway after the closing of the public offering, the Company’s ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company’s ongoing Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth and financing opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings made with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Contact

Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com

NurExone Biologic Inc. Announces Third Quarter 2025 Financial Results and Provides Corporate Update




NurExone Biologic Inc. Announces Third Quarter 2025 Financial Results and Provides Corporate Update

TORONTO and HAIFA, Israel, Nov. 28, 2025 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a preclinical-stage biotechnology company pioneering exosome-based therapies for central nervous system injuries, is pleased to announce its financial results for the third quarter ended September 30, 2025 (“Q3 2025”) and provided a corporate update on recent achievements and upcoming milestones.

The Company’s unaudited condensed interim consolidated financial statements for the nine months ended September 30, 2025, and accompanying management’s discussion and analysis, can be accessed by visiting the Company’s website at www.nurexone.com and its SEDAR+ profile at www.sedarplus.ca.

Recent Corporate Highlights and Business Updates Following Q3 2025

• Acceleration and Full Exercise of 2023 and 2024 Warrants
  
  On October 8, 2025, the Company accelerated the expiry of 8.2 million warrants issued in 2023 and 2024 after meeting the prescribed acceleration thresholds. All warrants were exercised before the accelerated expiry date, November 7, 2025, resulting in total gross proceeds of approximately C$3.2 million, which will support general corporate and working capital needs as further discussed in the Company’s press release, dated November 12, 2025.

• Reproducible Dose-Dependent Vision Recovery in Glaucoma Model
  
  Also on October 8, 2025, NurExone announced new preclinical data demonstrating consistent, dose-dependent vision recovery in its glaucoma and optic nerve injury model. Repeated studies showed that higher doses of ExoPTEN reliably restored retinal function to near-baseline STR-ERG levels and significantly improved retinal ganglion cell survival compared to controls. The reproducibility of these results further reinforces the biological rationale for ExoPTEN as a therapy for optic nerve regeneration.

• Strengthening Global Scientific Leadership in Therapeutic Exosomes
  
  NurExone enhanced its global scientific visibility through invited presentations at leading exosome and regenerative-medicine meetings, including the Precision EV Forum 2025 in Cambridge, U.K. Moreover, Dr. Lior Shaltiel has been invited to speak and serve as a panelist at the upcoming Cell and Gene Therapy International Europe conference in Berlin in December.

• Recognition in Prestigious Global Award Competitions
  
  On November 12, 2025, the Company announced it was named a finalist in two respected international programs: the Falling Walls Science Breakthroughs (Berlin, November 2025) and the Prix Galien Bridges Awards (Stockholm, December 2025). These recognitions highlight the innovative nature of the Company’s regenerative-medicine approach.

• Upcoming Investor Webinar: “Investing in the Future of Exosome Therapeutics”
  
  NurExone will host an investor webinar on December 10, 2025, at 10:00 AM EST to discuss recent achievements, U.S. biomanufacturing expansion, and strategic priorities for 2026. Register here.

Key Business Highlights

• C$1.4 Million Raised Through Private Placements
  
  On August 20, 2025, the Company completed a non-brokered private placement of 1,258,072 units (each, an “August 2025 Unit”) at a price of C$0.62 per August 2025 Unit, raising gross proceeds of approximately C$0.8 million (the “August 2025 Offering”). Each August 2025 Unit consisted of (i) one common share in the capital of the Company (each, a “Common Share”), and (ii) one-half of one Common Share purchase warrant (each, an “August 2025 Warrant”). Each August 2025 Warrant entitles the holder thereof to purchase one Common Share at a price of C$0.80 per Common Share for a period of 36 months.

  On September 11, 2025, the Company completed a non-brokered private placement of 930,376 units (each, a “September 2025 Unit”) at a price of C$0.68 per September 2025 Unit, raising gross proceeds of approximately C$0.6 million (the “September 2025 Offering”). Each September 2025 Unit consisted of (i) one Common Share, and (ii) one-half of one Common Share purchase warrant (each, a “September 2025 Warrant”). Each September 2025 Warrant entitles the holder thereof to purchase one Common Share at a price of C$0.88 per Common Share for a period of 36 months.

  The proceeds from the August and September 2025 Offerings will be used primarily for working capital, and also to support general corporate purposes and clinical development activities.

• Patents Grants in the U.S. and Israel Strengthen Intellectual Property and Manufacturing Position
  
  NurExone strengthened its intellectual property and manufacturing foundation during Q3 2025 with a U.S. Notice of Allowance covering its proprietary exosome production process and a corresponding patent grant in Israel for the same priority family. These protections reinforce the Company’s long-term manufacturing strategy, building on the recent acquisition of a GMP-grade Master Cell Bank and supporting the development of a reliable, scalable supply chain for future clinical and commercial use.

  On September 8, 2025, the Company received a Notice of Allowance from the U.S. Patent and Trademark Office for its proprietary exosome manufacturing process, covering its 3D scaffold and shear-stress–based bioreactor system. The patent was granted on November 11, 2025.

  On September 11, 2025, the Israel Patent Office granted the Company’s patent entitled “Production of Extracellular Vesicles from Stem Cells”, aligned with the U.S. Notice of Allowance for the same priority family.

• Incentive Offer Secured for U.S. Manufacturing Facility
  
  On September 16, 2025, NurExone announced plans to establish its first U.S. commercial exosome production facility in Indianapolis, Indiana, through its subsidiary Exo-Top Inc. The Company secured an incentive offer of up to US$0.26 million to support the expansion. The planned GMP-compliant facility will serve as Exo-Top Inc.’s U.S. manufacturing base for exosomes used in NurExone’s therapeutic programs and business-to-business opportunities in regenerative aesthetics.

• Dose-Dependent Motor Recovery in Acute Spinal Cord Injury Model
  
  In Q3 2025, NurExone advanced its acute spinal cord injury program with new preclinical data showing clear, dose-dependent improvements in motor recovery using the CatWalk XT gait analysis system. In this study, 100% of animals receiving the higher ExoPTEN dose regained measurable walking ability in both hind limbs, compared with minimal recovery in the untreated control group.

• Strengthening U.S. Biomanufacturing Presence through ARMI/BioFabUSA
  
  During Q3 2025, NurExone joined the ARMI/BioFabUSA BioFab Startup Lab, gaining access to a leading U.S. ecosystem dedicated to next-generation biomanufacturing technologies.

• Grant of RSUs

  Effective November 27, 2025, the Company granted an aggregate of 1,450,000 restricted share units (“RSUs”) to various consultants and officers of the Company pursuant to the Company’s omnibus equity incentive plan (the “Omnibus Plan”). Each RSU vest on the first anniversary of the commencement date and entitles the holder to one Common Share upon vesting, subject to the terms of the Omnibus Plan.

• Stock Options Grant

  Effective November 27, 2025, the Company granted an aggregate of 271,700 stock options (“Options”) to various employees and consultants of the Company pursuant to the Omnibus Plan. Each Option is exercisable in one Common Share at the closing price of the Common Shares listed on the TSX Venture Exchange (the “TSXV”) based on the last trading day immediately prior to this press release, plus 5% resulting in an exercise price of C$0.75. 260,000 Options shall vest over twenty-four months, such that 50% of the Options shall vest on the first anniversary of the vesting commencement date. An additional 12.5% of the Options shall vest on the end of each subsequent 3-month period thereafter until the second anniversary of the commencement date, provided that the grantee continues to be an eligible participant pursuant to the Omnibus Plan. The remaining 11,700 Options shall vest upon completion of a three-month period from the commencement date, subject to the grantee’s fulfillment of the services described in the engagement agreement. Each Option expires ten years from the date of grant.

Third Quarter 2025 Financial Results

• Research and Development (“R&D”) Expenses
  
  Net R&D expenses were US$0.70 million in Q3 2025, compared to US$0.50 million in Q3 2024. The increase of US$0.20 million was primarily due to US$0.12 million from higher headcount and employee stock-based compensation, US$0.06 million in higher service provider costs and related stock-based compensation, and US$0.02 million in materials and other costs.

• General and Administrative (“G&A”) Expenses
  
  G&A expenses were US$0.76 million in Q3 2025, compared to US$0.78 million in Q3 2024. The decrease was mainly driven by lower service provider costs.

• Net Financial Income
  
  Net financial income was US$0.01 million in Q3 2025, compared to US$0.04 million in Q3 2024.

• Net Loss
  
  The net loss for Q3 2025 was US$1.47 million, compared to US$1.25 million in Q3 2024.

Management Commentary

“During this quarter, we strengthened our platform with new patent approvals in the U.S. and Israel, continued progress in our preclinical programs, and increased scientific visibility through invited presentations at leading international meetings. These developments further support our long-term strategy as we prepare ExoPTEN for first-in-human evaluation,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone.

“In Q3 2025, we executed our operating plan with discipline, supported by strengthened working capital from the August and September Offerings. Our spending remained aligned with expectations as we continued to invest in advancing ExoPTEN and building the Company’s operational capabilities,” said Eran Ovadya, Chief Financial Officer of NurExone.

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotechnology company developing regenerative exosome-based therapies for central nervous system injuries. Its lead candidate, ExoPTEN, has shown compelling preclinical data supporting clinical potential in acute spinal cord and optic nerve injury, both multi-billion-dollar markets. Key regulatory milestones, including Orphan Drug Designation from the FDA and EMA, are paving the way towards clinical trials in the U.S. and Europe. NurExone has established Exo-Top Inc., a U.S. subsidiary, to produce and supply GMP-compliant exosomes for self-use, regenerative aesthetics and other indications as part of its commercial 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 use of proceeds and benefits from the warrant exercises and Offerings; the expected benefits of being selected as a finalist and the opportunities that it may yield; establishing a commercial exosome manufacturing facility in Indiana and the expected benefits thereof; the ability to secure and maintain intellectual property rights in the United States, and Israel; the anticipated impact of scientific presentations and increased visibility on the Company’s growth and investor engagement; the anticipated benefits of the RSU and Option grants in attracting, retaining, and incentivizing key personnel; the Company continuing to advance ExoPTEN and their therapeutic pipeline towards clinical readiness; 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 market demand for exosome-based therapies will continue to grow; ExoPTEN will yield the benefits outlined herein; the Company will yield benefits from its patent grants; being selected as a finalist will yield the benefits and opportunities outlined herein; the Company will continue to yield benefits from its U.S. manufacturing facility; the use of proceeds from the warrant exercises and Offerings will be utilized as set out herein; the warrant exercises will have the benefits on the Company as set out herein; the Company will continue to secure necessary financing and incentives; the Company will continue to receive necessary regulatory approvals; the Company will continue to advance ExoPTEN and their therapeutic pipeline towards clinical readiness; the RSU and Option grants will help with retention and performance of key personnel; the Company will continue to have the ability to grant and issue equity-based awards under its Omnibus Plan; the vesting of RSUs and Options will occur as contemplated herein; 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 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 Company will not continue to yield benefits from its U.S. manufacturing facility; the Company will not yield benefits from its patent grants; 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; ExoPTEN will not yield the benefits outlined herein; being selected as a finalist will not yield the benefits and/or opportunities outlined herein; the use of proceeds from the warrant exercises and Offerings will not be utilized as set out herein; the warrant exercises will not have the benefits on the Company as set out herein; the grants of RSUs and Options will not achieve their intended benefits; the Company will not have the ability to continue grant equity-based incentive awards pursuant to its Omnibus Plan; the vesting of RSUs and Options will not occur as outlined herein; the Company will be unable to continue to advance ExoPTEN and/or their therapeutic pipeline towards clinical readiness; 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

PacBio to Participate in the Piper Sandler 37th Annual Healthcare Conference




PacBio to Participate in the Piper Sandler 37th Annual Healthcare Conference

MENLO PARK, Calif., Nov. 28, 2025 (GLOBE NEWSWIRE) — PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, announced today that management will participate in a fireside chat at Piper Sandler’s 37th Annual Healthcare Conference on Wednesday, December 3, 2025, at 11:30 AM ET in New York, NY.

A live webcast of the event can be accessed at the company’s investors page at investor.pacificbiosciences.com. A replay of the webcast will be available for at least 30 days following the event.

About PacBio

PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our products and technologies, which include our HiFi long-read sequencing, address solutions across a broad set of research applications including human germline sequencing, plant and animal sciences, infectious disease and microbiology, oncology, and other emerging applications. For more information, please visit www.pacb.com and follow @PacBio.

PacBio products are provided for Research Use Only. Not for use in diagnostic procedures.

Contacts

Investors:
ir@pacb.com

Media:
pr@pacb.com

Cuprina Holdings (Cayman) Limited Announces Receipt of Nasdaq Notification Letter Regarding Minimum Bid Price Deficiency




Cuprina Holdings (Cayman) Limited Announces Receipt of Nasdaq Notification Letter Regarding Minimum Bid Price Deficiency

SINGAPORE, Nov. 28, 2025 (GLOBE NEWSWIRE) — Cuprina Holdings (Cayman) Limited (Nasdaq: CUPR) (“Cuprina” or “the Company”), a biomedical company developing and marketing products for the chronic wounds, infertility, and cosmeceuticals sectors, today announced it has received a letter of noncompliance from The Nasdaq Stock Market LLC (“Nasdaq”), dated November 26, 2025, notifying the Company that based on Cuprina’s closing bid price for the last 30 consecutive business days, the Company no longer meets the continued listing requirement of Nasdaq, under Nasdaq Listing Rules 5550(a)(2), to maintain a minimum bid price of $1 per share.

However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days in which to regain compliance. If at any time during this 180-day period the closing bid price of the Company’s security is at least $1 for a minimum of ten consecutive business days, Nasdaq will provide Cuprina with written confirmation of compliance and this matter will be closed.

In the event the Company does not regain compliance, Cuprina may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Cuprina meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to Nasdaq that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that its securities will be subject to delisting.

The Nasdaq notification letter does not result in the immediate delisting of the Company’s ordinary shares, and the shares will continue to trade uninterrupted under the symbol “CUPR.” 

Cuprina is currently evaluating options to regain compliance and intends to timely regain compliance with Nasdaq’s continued listing requirement. Although Cuprina will use all reasonable efforts to achieve compliance with Rule 5550(a)(2), there can be no assurance that the Company will be able to regain compliance with that rule or will otherwise be in compliance with other Nasdaq continued listing requirement.

About Cuprina Holdings (Cayman) Limited

We are a Singapore-based biomedical and biotechnology company that is dedicated to the development and commercialization of innovative products for the management of chronic wounds, as well as operating in the health and beauty sectors. Our expertise in biomedical research allows us to identify and utilize materials derived from natural sources to develop wound care products in the form of medical devices which meet international standards. For more information, please visit https:// www.cuprina.com. 

FORWARD-LOOKING STATEMENTS

Certain statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the “Risk Factors” section of the preliminary prospectus filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Any forward-looking statements contained in this press release speak only as of the date hereof, and Cuprina Holdings (Cayman) Limited specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Cuprina Holdings (Cayman) Limited Investor Contact
Investor Relations
c/o Blk 1090 Lower Delta Road #06-08
Singapore 169201
+65 8512 7275
Email: ir@cuprina.com.sg

Investor Relations Inquiries:
Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5^th Floor
New York, New York 10036
Office: (646) 893-5835
Email: info@skylineccg.com

Spero Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)




Spero Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

CAMBRIDGE, Mass., Nov. 28, 2025 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that on November 3, 2025, the Compensation Committee of Spero’s Board of Directors approved the grant of an aggregate of 90,000 restricted stock unit awards (RSUs) to one new employee under the Spero Therapeutics, Inc. 2019 Inducement Equity Incentive Plan, as amended (2019 Inducement Plan). The RSUs are being granted as an inducement material to Spero’s new employee in accordance with Nasdaq Listing Rule 5635(c)(4).

The 2019 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Spero (or following a bona fide period of non-employment), as a material inducement for such individuals entering into employment with Spero, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The RSUs will vest in four equal annual installments beginning on December 1, 2025, subject to the employees‘ continued employment with Spero on such vesting dates. The RSUs are subject to the terms and conditions of the 2019 Inducement Plan and an RSU agreement covering the grant.

About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com.

Investor Relations Contact:
Shai Biran, PhD
Spero Therapeutics
IR@Sperotherapeutics.com

Media Inquiries:
media@sperotherapeutics.com

Hydreight Technologies Acquires 5% Equity Stake in Perfect Scripts, LLC, with Option to Increase up to 40%, and Establishes Strategic Partnership




Hydreight Technologies Acquires 5% Equity Stake in Perfect Scripts, LLC, with Option to Increase up to 40%, and Establishes Strategic Partnership

Not for distribution to United States newswire services or for dissemination in the United States.

VANCOUVER, British Columbia, Nov. 28, 2025 (GLOBE NEWSWIRE) — Hydreight Technologies Inc. (TSXV: NURS)(OTCQB: HYDTF)(FSE: SO6),(“Hydreight” or the “Company”), a North American, fully integrated, mobile clinical network of nurses, doctors, and pharmacy distribution, is pleased to announce that, further to its news releases dated July 14, 2025 and September 2, 2025, it has closed (the “Closing”) the previously announced transaction with Perfect Scripts LLC (“Perfect Scripts”), an arm’s length limited liability company based in Texas, in respect of a strategic partnership.

On Closing: (a) Hydreight acquired an initial 5% membership interest in Perfect Scripts in consideration for 2,250,000 common shares in the capital of Hydreight (the “Hydreight Compensation Shares”), with each Hydreight Compensation Share issued at a deemed price of CAD$2.30 per share, (b) Hydreight and Perfect Scripts agreed to partner to start a 503B pharmacy in the United States, (c) Hydreight will receive the lowest pricing for all products sold or made available by Perfect Scripts or its subsidiaries, and (d) Hydreight has been granted a right to (i) maintain its pro rata interest in the outstanding membership interests of Perfect Scripts (the “Pro-Rata Investment Right”), and (ii) acquire up to an aggregate 40% interest in the outstanding membership interests of Perfect Scripts (the “Up to 40% Option”), subject to certain conditions (collectively, the “Transaction”).

In connection with the Closing, Hydreight and Perfect Scripts amended the definitive agreement dated September 1, 2025 in respect of the Transaction to set restrictions on the number of common shares of Hydreight (each a “Hydreight Share”) issuable in connection with any exercise of the Pro-Rata Investment Right and the Up to 40% Option, whereby Hydreight agreed: (a) not to issue more than 12,000,000 Hydreight Shares to Perfect Scripts in total (not including the Hydreight Compensation Shares) and (b) not to issue Hydreight Shares to Perfect Scripts, if after such issuance, Perfect Scripts would own more than 9.9% of the issued and outstanding Hydreight Shares at any time.

The Company paid a cash finder’s fee of $258,750, representing 5% of the deemed value of the Transaction, to a finder in connection with the Transaction.

The Hydreight Compensation Shares (i) vest in 25% increments every 1.5 months and will be fully vested on the date that is 6 months following the date of issuance, and (ii) are subject to a restriction on sale pursuant to which Perfect Scripts may sell a maximum number of Hydreight Compensation Shares as is equal to 5% of the five day average daily trading volume of the common shares of Hydreight on the TSX Venture Exchange for the immediately prior five trading days.

The Hydreight Compensation Shares have been issued under prospectus exemptions pursuant to National Instrument 45-106 – Prospectus Exemptions of the Canadian Securities Administrators and in reliance upon exemptions from U.S. federal and state registration requirements and are subject to a statutory hold period of four months in accordance with applicable Canadian securities laws and other hold periods in accordance with applicable U.S. securities laws and will bear legends to this effect.

Perfect Scripts LLC is the parent company of PerfectRx LLC, PerfectionRx LLC, and PerfectRx, and owns:

• Its proprietary technology, PerfectOS.
• PerfectRx LLC is a 503A retail dispensing pharmacy based in Iowa with a large pharmacy and data analytics team. PerfectionRx LLC operates out of a 30,000 sq ft licensed pharmacy and distribution center in Florida.
• PerfectRx is a nationally licensed, HIPAA-compliant mail-order pharmacy operating in all 50 states, capable of shipping brand-name, 503A, and 503B compounded medications directly to patients.
• Using its proprietary PerfectOS platform, the company offers digital prescription intake, automated accuracy checks, and real-time inventory and shipping integration.
• PerfectRx currently can process over 150,000 prescriptions per day, with scalable infrastructure to handle demand surges.

Shane Madden, CEO of Hydreight, commented: “This strategic deal locks in a rock-solid pillar for Hydreight’s next stage of growth. By controlling production, distribution, and pricing for key pharmaceuticals, we’re boosting our pharmacy margins, securing a consistent supply chain, and deepening our defensibility with true vertical integration. It’s real barriers to entry, more margin, and stronger economics for every partner and licensee on our platform. The addition of a 50-state 503A pharmacy puts us firmly in the driver’s seat on patient-specific meds with full compliance. Bottom line: this is more margin, more protection, and more upside — the kind of infrastructure that expands our product lineup and positions Hydreight for a stronger valuation multiple. It’s another big step forward in our mission to transform access to modern healthcare. As per Forbes, It forecasts the U.S. compounding pharmacy sector at $6.31 billion in 2024, projected to reach $10.76 billion by 2033.”

Brandon Rainone, Founder and Managing Member of Perfect Scripts, said: “We’re very happy to be partnering with Hydreight and VSDHOne. Hydreight offers a unique and comprehensive legal and technology framework that we believe represents the future of personal care—and the only truly compliant way to access pharmaceutical products.”

The Company also announces that, further to its news release dated September 8, 2025, it has elected not to proceed with the proposed acquisition of the Dynamic IV Therapy Support AI Agent from Auxano One LLC and the parties have terminated the letter of intent dated September 5, 2025 in respect of this proposed transaction.

About Perfect Scripts LLC

Perfect Scripts LLC is the parent entity of PerfectRx LLC, PerfectionRx LLC and PerfectRx and holds all key assets, including Perfect Scripts’ proprietary technology. PerfectRx LLC is a 503A retail dispensing licensed pharmacy operating in Iowa that employs a large pharmacy team and key data analysts for Perfect Scripts. PerfectionRx LLC is a licensed pharmacy headquartered in Florida with a 30,000 sq ft distribution center. Additionally, PerfectRx will also soon be opening a new location in the Dallas-Fort Worth metropolitan area in 2025 to provide even greater capacity.

PerfectRx is a nationally licensed, HIPAA-compliant mail order pharmacy operating in all 50 states with multiple distribution centers with the ability to ship directly to patients any medication, including brand and 503A and 503B compounded versions. Perfect RX specializes in comprehensive pharmacy services—including prescription filling, compounding, and health-related solutions—on a national scale. Our proprietary software, PerfectOS, enables seamless digital prescription intake, automated accuracy checks, and real-time inventory and shipping data integration. PerfectRx currently can process and fulfill over 150,000 prescriptions per day, with the capacity to rapidly scale for surges.

High-volume precision: Our automation systems ensure quality, reduce errors, and handle fluctuating demand seamlessly.

Compliant & secure: As a HIPAA-compliant operation, we maintain robust safeguards around patient data and transaction privacy.

Nationwide licensing: Serving patients coast to coast, we solve the geographic coverage challenge often faced by single-state players.

The securities of the Company have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”) or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an available exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there by any sale of the securities referenced in this press release, in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On behalf of the Board of Directors

Shane Madden
Director and Chief Executive Officer
Hydreight Technologies Inc.

Hydreight Technologies Inc Ranked Number 77 Fastest-Growing Company in North America on the 2025 Deloitte Technology Fast 500™

Contact
Email: ir@hydreight.com; Telephone: 1 (702) 970-8112

About Hydreight Technologies Inc. 
Hydreight Technologies Inc is building one of the largest mobile clinic networks in the United States. Its proprietary, fully integrated platform hosts a network of over 2500 nurses, over 100 doctors and a pharmacy network across 50 states. The platform includes a built-in, easy-to-use suite of fully integrated tools for accounting, documentation, sales, inventory, booking, and managing patient data, which enables licensed healthcare professionals to provide services directly to patients at home, office or hotel. Hydreight is bridging the gap between provider compliance and patient convenience, empowering nurses, med spa technicians, and other licensed healthcare professionals. The Hydreight platform allows healthcare professionals to deliver services independently, on their own terms, or to add mobile services to existing location-based operations. Hydreight has a 503B pharmacy network servicing all 50 states and is closely affiliated with a U.S. certified e-script and telemedicine provider network.

About VSDHOne – Direct to Consumer Platform 
Developed in partnership with Victory Square Technologies (CSE: VST) (OTC: VSQTF) (FWB: 6F6), Hydreight launched the VSDHOne (Read as VSDH-One) platform. VSDHOne simplifies the entry challenges for companies and medi-spa businesses to enter the online healthcare space compliantly. This platform will help all businesses to launch a direct-to-consumer healthcare brand in a matter of days in all 50 states. Compliant offerings include: GLP-1s (semaglutide, tirzepatide), peptides, personalized healthcare treatments, sermorelin, testosterone replacement therapy (TRT), hair loss, skincare, sexual health and more. Hydreight invested in technology, legal and infrastructure to launch this platform. The VSDHOne platform offers a complete, end-to-end solution for businesses looking to launch direct-to-consumer healthcare brands. From compliance and telemedicine technology to nationwide doctor and pharmacy networks, VSDHOne provides all the tools needed for a seamless entry into the online healthcare space. The platform is designed to significantly reduce the time and costs associated with launching such services, making it possible for businesses to go live in days instead of months.

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

Cautionary Statement Regarding Forward Looking Information

This news release contains forward looking information or statements within the meaning of applicable securities laws, which may include, without limitation, the business prospects of the Company and Perfect Scripts, the perceived benefits of the Transaction and a strategic partnership between the Company and Perfect Scripts, any potential exercise of the Pro-Rata Investment Right and the Up to 40% Option and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward looking information or statements. Although the Company believes the expectations expressed in such forward-looking information or statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking information or statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, the ability to achieve its goals, expected costs and timelines to achieve the Company’s goals, that general business and economic conditions will not change in a material adverse manner, and that financing will be available if and when needed and on reasonable terms. Such forward looking information or statements reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties included in documents filed under the Company’s profile on SEDAR+ at www.sedarplus.ca. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive, and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking information or statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, failure to compete effectively with competitors, failure to maintain or obtain all necessary permits, approvals and authorizations, failure to comply with applicable laws, including environmental laws, risks relating to unanticipated operational difficulties. The Company does not undertake to update forward looking statements or forward-looking information, except as required by law. All information contained in this news release regarding Perfect Scripts and its subsidiaries was provided by its management team and Hydreight and its directors and officers have relied on Perfect Scripts for such information.

Boehringer Ingelheim announces appointment to Board of Managing Directors




Boehringer Ingelheim announces appointment to Board of Managing Directors

• Harsha Deshmukh has been appointed a member of the Board of Managing Directors with responsibility for IT and Global Business Services effective 1 February 2026 

Boehringer Ingelheim announced today that the Shareholders’ Committee has appointed Harsha Deshmukh to the Board of Managing Directors. Effective 1 February 2026, Harsha Deshmukh will lead the IT and Global Business Services functions focusing on digital transformation and driving the further development of business services at the company. IT and Global Business Services, which so far were part of the Group Functions Division, will be set up as a separate Board Division. 

Commenting on the appointment, Hubertus von Baumbach, Chairman of the Boehringer Shareholders’ Committee said: “We warmly welcome Harsha Deshmukh. With his extensive experience in fostering innovation, he will help drive our journey of transformation – a transformation in the interest of patients. We know that in this process of continuous improvement we can rely on the proven skills, the contributions and the high commitment of each individual in our organization.” 

Chairman of the Board of Managing Directors Shashank Deshpande added: “I am excited to welcome Harsha to Boehringer Ingelheim. His appointment strengthens our capabilities in the important segments of IT and services, two areas that are critical elements to underpin our future growth.” 

Harsha Deshmukh will join Boehringer Ingelheim from Infineon Technologies AG in Munich, where he most recently was Executive Vice President & Chief Information Officer. He holds degrees in Electronics, Human Resources and Global Management from the University of Mumbai, Babson College and INSEAD. 

Harsha Deshmukh 

Diploma Engineering and Industrial Electronics, MBA Human Resources Management (University of Mumbai), Global Management (Babson College and INSEAD) 

Professional milestones 

2021 – present Executive Vice President & Chief Information Officer, Infineon Technologies AG, Munich, Germany 

2009 – 2021 Senior Vice President Information Technology, Infineon Technologies AG, Munich, Germany 

2001 – 2009 Director of Supply Chain Applications, Infineon Technologies, Munich, Germany 

1999 – 2001 Senior Consultant Advanced Planning Systems, Siemens Information Management Systems, Mumbai, India 

1989 – 1999 Manager Manufacturing Automation, Mukand Ltd., Mumbai, India 

About Boehringer Ingelheim 

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Attachment

• Harsha Deshmukh

Profound Medical to Launch AI-Powered BPH Module, Present New TULSA-PRO® Clinical Data, at RSNA and SUO Meetings




Profound Medical to Launch AI-Powered BPH Module, Present New TULSA-PRO® Clinical Data, at RSNA and SUO Meetings

New BPH module and clinical data reinforce the TULSA Procedure™’s versatility in prostate disease, superior patient benefits, and potential for mainstream adoption

TORONTO, Nov. 28, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, announced today the upcoming launch of its TULSA-AI^® Volume Reduction module for optimizing the treatment of patients with benign prostatic hyperplasia (“BPH”), or enlarged prostate, at the Radiological Society of North America (“RSNA”) meeting taking place in Chicago, Nov. 30-Dec. 4.

BPH is a non-cancerous enlargement of the prostate gland due to an overgrowth of prostate cells. It is a common condition as men age, often impeding the flow of urine and creating significant lower urinary tract symptoms (LUTS). Current BPH treatment with transurethral resection of the prostate (TURP) is largely unchanged over the past 100 years. Many alternative treatment methods have been investigated aiming to improve the patient experience and reduce the rates of complications such as bleeding, erectile dysfunction, loss of ejaculation, and the need to stay in the hospital overnight for one, two or more days.

The TULSA Procedure™, performed using Profound’s TULSA-PRO^® system, is the only incision-free procedure for prostate cancer, BPH, and patients who have both prostate cancer and BPH. With the TULSA-AI Volume Reduction module, physicians can efficiently and easily stack multiple prostate cases in one day, using the same device hardware, clinical support staff and reimbursement codes. The TULSA Procedure’s clinical flexibility – along with real-world data demonstrating significantly reduced risk of loss of sexual function and incontinence, and CAPTAIN perioperative data demonstrating the TULSA Procedure’s superiority to Robotic Prostatectomy in blood loss, length of stay, post-op pain and recovery time – is fueling strong demand for the incision-free procedure from both patients and healthcare providers.

“We’re confident to launch the TULSA-AI Volume Reduction module for BPH, following a successful pilot trial earlier this year,” said Profound CEO and Chairman, Arun Menawat. “The use of AI to streamline the workflow and reduce procedure times is a significant advance that makes using TULSA-PRO for treating enlarged prostate just as efficient as other modern procedures, but with the advanced benefits of precision and customization to any prostate shape or size. We expect the reduced procedure times will increase adoption of the TULSA Procedure and triple Profound’s total available market in prostate disease to about 600,000 patients annually.”

The Company will also present new data on TULSA-PRO for prostate cancer at both RSNA and the Society for Urologic Oncology (“SUO”) in Pheonix, Dec. 2-5.

RSNA EVENT DETAILS

• RSNA attendees can find Profound at Booth #3153, South Hall A, for demonstrations of the newly launched TULSA-AI Volume Reduction module, along with case studies and feature upgrades from the pilot launch.

Special Sessions and Presentations

• “CAPTAIN Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA) Versus Robotic Radical Prostatectomy,” Dr. Pejman Ghanouni from Stanford; Monday, Dec. 1^st at 12:15 p.m. CST, in the Learning Center.
• “Discover TULSA-PRO: AI-powered MRI-guided Precision Prostate Ablation,” Dr. Daniel Costa from the MD Anderson Cancer Center, and Dr. Joseph Busch from The Busch Center; Tuesday, Dec. 2^nd at 11:30 a.m. CST, in the Innovation Theatre, Booth 3316, South Hall A.
• “MR-guided transurethral ultrasound ablation (TULSA): single center outcomes in 160 patients with organ-confined prostate cancer,” Dr. Joseph Busch from the Busch Center; Tuesday, Dec. 2^nd at 1:30 p.m. CST, in Room E352.

On-demand Educational Presentations, Learning Center

• “Transurethral Ultrasound Ablation (TULSA) for Prostate Cancer: Comprehensive Overview and Experience from a High-Volume Center,” Dr. Raveen Rajamohan and Dr. Begovic of University of Texas Southwestern.
• “MRI-Guided Transurethral Ultrasound Ablation for Prostate Cancer: A Comprehensive Manual to mpMRI-Based Evaluation and Pitfall Avoidance,” Dr. Enis Yilmaz, formerly of the National Institutes of Health (NIH).
• “TULSA for Prostate Cancer: MRI-based Pre-treatment Planning and Post-Treatment Assessment – an Emerging Alternative in the Focal Therapy Spectrum,” Dr. Satoru Takahashi of Sapporo Hokuyu Hospital in Japan.

SUO EVENT DETAILS

• SUO attendees can learn more about how the TULSA Procedure is being applied across the prostate disease spectrum at the Profound Medical Booth.

Presentation

• “Randomized Controlled Trial evaluating MRI-Guided Transurethral Ultrasound Ablation (TULSA) Versus Robotic Prostatectomy,” Dr. Geoffrey Sonn from Stanford; Friday, Dec. 5^th from 2:30-3:30 MST.

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, any express or implied statements or guidance regarding current or future financial performance; the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma; and the success of Profound’s commercialization strategy and activities for TULSA-PRO^®. 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 Profound, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition, statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and Profound’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management’s expected ranges. 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

Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195

TG Therapeutics to Participate in the 8th Annual Evercore Healthcare Conference




TG Therapeutics to Participate in the 8th Annual Evercore Healthcare Conference

Fireside chat scheduled for Tuesday, December 2, 2025 at 12:30 PM ET

NEW YORK, Nov. 28, 2025 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the 8^th Annual Evercore Healthcare Conference, which is taking place from December 2 – 4, 2025. The fireside chat is scheduled to take place on Tuesday, December 2, 2025, at 12:30 PM ET.

A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events.

ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI^® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.

BRIUMVI^® is a registered trademark of TG Therapeutics, Inc.

CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations 
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6