Santhera Provides Update on Convertible Bond Issued on 23 September 2025




Santhera Provides Update on Convertible Bond Issued on 23 September 2025

Ad hoc announcement pursuant to Art. 53 LR

Pratteln, Switzerland, September 25, 2025 – Santhera Pharmaceuticals (SIX: SANN) today provides the following update regarding its convertible bond announced on 23 September 2025:

Details:

• The conversion price has been set at CHF 13.5446, representing a 10% premium to the volume-weighted average price (VWAP) of Santhera’s shares on 23 September 2025.
• The coupon is 7%, reflecting a reduction compared with the previous bond.
• The aggregate principal amount of the convertible bond, including the exchange at parity of the prior bond, is CHF 20.132 million.

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Commission (EC), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in China by the National Medical Products Administration (NMPA) and Hong Kong by the Department of Health (DoH). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China and certain countries in Southeast Asia to Sperogenix Therapeutics. For further information, please visit www.santhera.com.

AGAMREE® is a trademark of Santhera Pharmaceuticals.

For further information please contact:

Santhera
Catherine Isted, Chief Financial Officer:

IR@santhera.com

ICR Healthcare

Santhera@icrhealthcare.com

Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

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Attachment

• 250925 Update on convertible bond_Final

Press release: Sequana Medical announces H1 2025 results and provides business update




Press release: Sequana Medical announces H1 2025 results and provides business update

Sequana Medical announces H1 2025 results and provides business update

• alfapump® US commercialisation underway; Strengthened US reimbursement with CMS approval of NTAP “top-up” reimbursement;
• On track for at least 70 US commercial alfapump implants during “Soft Launch” – “Full Launch” on track for Q2 2026
• Debt reduction of EUR 2 million through partial conversion of Kreos loan and 2025 convertible loan
• Total liquidity position of EUR 7.3 million as per 30 June 2025

Ghent, Belgium – 25 September 2025 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, announces today its business highlights and financial results for the six-month period ending 30 June 2025 and its outlook for the remainder of the year.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “This is an exciting time for Sequana Medical with the commencement of alfapump commercialisation in the United States. We have put in place the US infrastructure to support this launch, including a team of ten focused on this key activity for Sequana Medical. We are delighted with the strong interest among the US clinical and patient community for the alfapump as a breakthrough in the treatment of a condition that has been overlooked for far too long. Reimbursement is a key aspect of our commercialisation plans, and we are delighted to have received approval for the NTAP “top-up” reimbursement of up to $21,450 from CMS.

Our team is working intensively with the target sites to complete necessary approvals and contracting to enable US commercial implants to take place. We are in advanced discussions with multiple highly regarded sites and anticipate first implants early in the fourth quarter. We remain confident of our goals for both the Soft Launch and Full Launch phases.

Despite challenging market conditions, we were able to secure €13.6m of financing in the first half of the year and anticipate this, together with the anticipated proceeds from the GEM share subscription facility will extend our financing runway to at least the first quarter of 2026. We continue to explore all financing options for the Company, including direct investments into each of the alfapump® and DSR® activities which we anticipate to expand the universe of potential investors and therefore benefit all Sequana Medical shareholders.”

Highlights from H1 2025 to date

US alfapump liver program

• US Commercial:
  • US Commercialisation Underway: Following the PMA approval of the alfapump in late December 2024, the Company made the necessary preparations for US commercialization that commenced during Q3. Formal transfer to manufacturing was completed and the alfapump systems for the Soft Launch have been manufactured. The initial US team of seven individuals has been recruited and they are supported by three further European team members dedicated to the US. The Company is very pleased with the strong interest from US clinicians for alfapump as a new treatment option for their patients and discussions are underway with more than ten US hospitals to complete the necessary approvals and contracting to commence alfapump implants. Seven hospitals have completed alfapump training for hepatologists, interventional radiologists and their teams. Awareness is spreading among both the hepatology and interventional radiology communities in the US and the alfapump has been or will be imminently profiled in three podium presentations at clinical conferences.
  • US Reimbursement – NTAP: In August 2025 CMS (the Centers for Medicare and Medicaid Services), published the Final Rule for Fiscal Year 2026 Hospital Inpatient Prospective Payment System (IPPS), approving a NTAP (new technology add-on payment) for the alfapump system when performed in the hospital inpatient setting. The NTAP will be in effect from October 1, 2025 and provides “top-up” reimbursement of up to $21,450, in addition to the hospital’s Medicare Severity Diagnosis Related Group (MS-DRG) payment.
  • The Company forecasts completing at least 70 US commercial implants in eight hospitals during the “Soft Launch” (up to the end of Q1 2026), prior to commencing the “Full Launch” with approximately five additional centers opening per quarter starting Q2 2026.
• Publications & Presentations:
  • January 2025 – Publication of “The Effects of alfapump on Ascites Control and Quality of Life in Patients with Cirrhosis and Recurrent or Refractory Ascites” in the prestigious peer-reviewed journal, American Journal of Gastroenterology. The publication covered the six month data for the forty implanted patients in the pivotal cohort of the POSEIDON study, the multicenter, open-label, single arm study with a within-subject crossover design conducted in patients with cirrhosis and recurrent or refractory ascites. The authors reported that the alfapump system effectively controlled ascites, which improved quality of life^1,2. Results from the literature indicate that the overall survival of patients with the alfapump was higher than reported for standard of care (LVP)³.
  • January 2025 – The Company hosted a Key Opinion Leader (KOL) Webinar to discuss alfapump US Commercial Roll-Out following FDA approval of the alfapump system. Sequana Medical management, together with Dr Saab, Professor of Medicine and Surgery, David Geffen School of Medicine, UCLA and Dr Pagadala, Transplant Hepatologist, Methodist Dallas Medical Center, discussed i) the clinical need in recurrent and refractory ascites due to liver cirrhosis, including current treatment options, ii) the results of the alfapump POSEIDON and Patient Preference studies, and what this means for US patients and physicians, and iii) alfapump US commercial roll-out plans and market opportunity.
  • July 2025 – Publication of “Using the alfapump to control ascites enabling elective umbilical hernia repair: A case report” in the prestigious peer-reviewed journal, Hernia. The case study presented a patient from the POSEIDON study that received an alfapump for control of his ascites and subsequently underwent a robotic repair of his umbilical hernia.

Corporate

• Financing
  • Conversion outstanding indebtedness into equity. In January 2025, the Company announced the conversion of EUR 0.53 million under the Sensinnovat 2020 loan,  EUR 1.28 million under the 2024 convertible loan with various shareholders, and EUR 2.68 million under the Kreos 2022 loan into equity, reducing net debt by EUR 4.50 million. Today, the Company announced a further EUR 2.0 million reduction of net debt through the conversion into equity of EUR 1.8 million of the Kreos 2022 loan and EUR 0.2 million of the 2025 Convertible Loan.
  • EUR 4.0 million convertible loan investment and GEM Committed Share Subscription Facility of up to EUR 60 million. In March 2025, the Company announced a financing package comprising i) the granting of an unsecured subordinated convertible loan of EUR 4.0 million by certain of its major shareholders, namely Partners in Equity V B.V. and EQT Health Economics 3 Coöperatief U.A. and ii) entering into a share subscription facility agreement with GEM Global Yield LLC SCS (“GEM“), a $3.4 billion, Luxembourg based alternative investment group with offices in Paris, New York and Bahamas. Pursuant to the Facility, GEM agreed to commit, subject to certain conditions, an amount of up to EUR 20 million in cash (with Sequana Medical’s option to increase the commitment to up to EUR 60 million in cash, once the aforementioned EUR 20 million has been drawn down) (the “Capital Commitment“), within a maximum term of three years in exchange for new ordinary shares in Sequana Medical and subject to certain share lending arrangements being in place. In addition, the Company agreed with its existing debt providers to restructure several features of the Company’s debt, subject to certain conditions. The Company subsequently made subscription requests under the Subscription Share Facility in May, August and September 2025.
  • Additional EUR 6.3 million convertible loan financing. In May 2025, the Company announced that SFPIM (previously known as SFPI-FPIM) and other existing shareholders had invested a further EUR 6.3 million in the 2025 Convertible Loan announced on 18th March 2025.

Outlook for the remainder of 2025

• US alfapump liver program – US Commercialisation on Track
  • As a result of the extensive discussions with target centers, the Company anticipates significant US commercial implants in several top tier US hospitals.
  • The Company forecasts completion of at least 70 commercial implants at up to eight centers in the US before the end of Q1 2026, following which the “Full Launch” is planned to commence with the addition of approximately five new centers per quarter.
• DSR heart failure program
  • The Company continues to explore financing of DSR either as part of the Company or as a separate entity. The start of MOJAVE randomized cohort is approved by the independent DSMB, and subject to additional fundraising.

Financial review – Six months ended 30 June 2025

N.M.: Not Meaningful (percentage greater than 150%)
* Cash position only includes highly liquid cash and cash equivalents.

Condensed Consolidated Income Statement

Revenue

Revenue decreased from €0.11 million in H1 2024 to €0.00 million in H1 2025 due to the decision to terminate European commercial activities in Q1 2024 .

Cost of goods sold

Cost of goods sold decreased from €0.03 million in H1 2024 to €0.00 million in H1 2025 in line with the decrease in revenue.

Operating expenses

Total operating expenses decreased from €9.82 million in H1 2024 to €8.97 million in H1 2025 due to the measures taken to substantially reduce the cash burn.

Sales and Marketing expenses increased from €0.37 million in H1 2024 to €0.71 million in H1 2025 due to the preparation for the US alfapump commercial launch.

Clinical expenses decreased from €1.63 million in H1 2024 to €0.54 million in H1 2025, mainly as a result of lower costs related to the North American pivotal POSEIDON study of the alfapump and the decision to postpone the start of the randomized phase of the MOJAVE DSR study in the US.

Quality and Regulatory expenses decreased from €1.77 million in H1 2024 to €1.19 million in H1 2025, mainly due to the lower expenses in 2025 following the successful completion of the submission for marketing approval of the alfapump in the US and the measures taken to reduce the cash burn.

Supply chain expenses increased from €1.63 million in H1 2024 to €1.93 million in H1 2025, largely driven by the preparation for the US alfapump commercial launch.

Engineering expenses decreased from €0.98 million in H1 2024 to €0.78 million in H1 2025, largely driven by the measures taken to reduce the cash burn.

General and Administration expenses remained broadly stable at €3.44 million in H1 2024 versus €3.82 million in H1 2025.

Other income increased from €0.14 million in H1 2024 to €0.38 million in H1 2025 and includes recognized income from Belgian Research & Development (R&D) incentives with regard to incurred R&D expenses and the capitalization effect of 2025 Development costs following the application of IFRS IAS 38 para 57.

EBIT

As a result of the above, earnings before interest and taxes (EBIT) evolved from a loss of €9.59 million in H1 2024 to a loss of €8.58 million in H1 2025.

Total net finance cost

Net finance cost increased from €1.34 million in H1 2024 to €9.57 million in H1 2025, mainly resulting from the impact of the valuation of the warrants and the March 2025 loan amendments. All of these items are non-cash items.

Income tax expense

Income tax expense remained stable at €0.15 million in H1 2024 versus €0.13 million in H1 2025.

Net loss for the period

As a result of the above, the net loss increased from €11.08 million in H1 2024 to €18.28 million in H1 2025, of which the majority of the increase is due to the increase in non-cash net finance cost.

Basic losses per share (LPS)

Basic losses per share remained broadly stable at €0.34 in H1 2024 and €0.35 in H1 2025.

Condensed Consolidated Statement of Financial Position

Net debt

Net debt⁵ at 30 June 2025 decreased by €2.2 million compared to 31 December 2024, mainly as a result of the improvement of the cash position.

Working Capital

Working capital⁶ at 30 June 2025 dropped €1.83 million compared to 31 December 2024. The decrease is largely driven by measures taken to reduce cash burn.

Condensed Consolidated Statement of Cash Flows

Net cash outflow from operating activities was €9.72 million in H1 2025 compared to €12.36 million in H1 2024. The lower outflow was driven by the measures taken to further reduce the cash burn.

Cash flow from investing activities resulted in no outflow in H1 2025, compared to a net outflow of €0.03 million in H1 2024.

Cash flow from financing activities was €13.26 million in H1 2025, comprising the proceeds from the financing announced in March 2025, compared to €13.96 million in H1 2024, comprising the proceeds from the March 2024 equity placement and the Convertible Loan provided by major shareholders in February 2024.

The Company ended H1 2025 with a total liquidity position of €7.31 million (end 2024: €3.81 million).

For more information, please contact:

Sequana Medical
Investor Relations
E: IR@sequanamedical.com
T: +44 (0) 797 342 9917

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic resistant” patient population. alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.

The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. Sequana Medical has commenced US commercialisation through its specialty commercial team that will target the 90 US liver transplant centers that perform more than 90% of liver transplants. In August 2025, CMS announced that it approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting as of October 1, 2025.

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements⁷. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Safety Information:

Indication for Use: The alfapump® System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.

Contraindications: MRI Safety Information: The alfapump® System is MRI unsafe. This diagnostic procedure is contraindicated due to possible movement of the alfapump®, damage to the pump circuitry, tissue damage in the vicinity of the alfapump® and/or catheter dislocation. Hyperbaric oxygen therapy is contraindicated because the environmental conditions entailed in this therapy are out of the defined range of use for the alfapump® System.

Warnings, Risks, and Precautions: The implantation of the alfapump® may result in infection that could delay liver transplant or impact transplant listing status. Additional risks associated with implanting the alfapump® System including risk of peritoneal cavity infections/peritonitis, Coagulopathy, Small bladder capacity and/or obstructive uropathy.  The following procedures or therapies could impact the alfapump® System function: Supersonic therapy and high-frequency heat therapy, Transcutaneous Electrical Nerve Stimulation (TENS), Lithotripsy, Defibrillation, Radiation therapy, Electrocautery, or use of other implantable medical devices and wearable devices.

Adverse Events: In addition to procedure related risks the following Adverse Events may occur: pump pocket hematoma, skin erosion, infection, pump migration, catheter clogging or other catheter complications resulting in tissue damage or loss of or change in therapy, genito-urinary complications, reduced kidney function, hepatic encephalopathy, progression of liver disease, and other systemic effects.

Caution: the law restricts the sale by or on the order of a physician. Refer to package insert provided with the product for complete Instructions for Use, Contraindications, Potential Adverse Effects, Warnings and Precautions prior to using this product.

The alfapump® System is currently not approved in Canada.

DSR® therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR® therapy has not been established.

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Financial information

The condensed consolidated financial statements have been prepared in accordance with IAS 34, as adopted by the EU. The financial information included in the press release is an extract from the Condensed Consolidated Financial Statements.

The Condensed Consolidated Financial Statements for the six months ending 30 June 2025 are available on the website of Sequana Medical: https://www.sequanamedical.com/investors/financial-information/

Condensed Consolidated Income Statement

Condensed Consolidated Statement of Comprehensive Income

Condensed Consolidated Statement of Financial Position

Condensed Consolidated Statement of Cash Flows

Condensed Consolidated Statement of Changes in Equity

¹ as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)
² Data on file; statements from “The Effects of alfapump on Ascites Control and Quality of Life in Patients with Cirrhosis and Recurrent or Refractory Ascites” American Journal of Gastroenterology [January 2025]
³ a) Tan HK, James PD, Wong F. Albumin may prevent the morbidity of paracentesis-induced circulatory dysfunction in cirrhosis and refractory ascites: A pilot study. Dig Dis Sci 2016;61:3084-3092; b) Salerno F, Cammà C, Enea M, Rössle M, Wong F. Transjugular intrahepatic portosystemic shunt for refractory ascites: a meta-analysis of individual patient data. Gastroenterology 2007;133:825-834.
⁴ EBIT is defined as Revenue less Cost of goods sold and Operating Expenses, plus Other income.
⁵ Net debt is calculated by adding short-term, long-term financial and lease debt and deducting cash and cash equivalents.
⁶ The components of working capital are inventories plus trade receivables and other receivables minus trade payables (including contract liabilities) and other payables, and accrued liabilities.
⁷ Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period

Attachments

• 250925 Press Release_HY 2025 and business update_25 Sept 2025 (ENG)
• 250925 Press Release_HY 2025 and business update_ 25 Sept 2025 (NL)

Immuneering Announces Pricing of $175 Million Underwritten Public Offering of Class A Common Stock and Concurrent $25 Million Private Placement of Class A Common Stock to Sanofi




Immuneering Announces Pricing of $175 Million Underwritten Public Offering of Class A Common Stock and Concurrent $25 Million Private Placement of Class A Common Stock to Sanofi

NEW YORK, Sept. 25, 2025 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced the pricing of its underwritten public offering of 18,959,914 shares of its Class A common stock at an offering price of $9.23 per share, which is equal to the last reported sale price for Immuneering’s Class A common stock on The Nasdaq Global Market on September 24, 2025. In addition, Immuneering has granted the underwriters a 30-day option to purchase up to an additional 2,843,987 shares of Class A common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds from the public offering are expected to be approximately $175 million, before deducting underwriting discounts and commissions and offering expenses payable by Immuneering, and excluding any exercise of the underwriters’ option to purchase additional shares. In addition, Immuneering announced that Sanofi has agreed to purchase 2,708,559 shares of Immuneering’s Class A common stock, at a purchase price of $9.23 per share, in a separate private placement transaction that is expected to close concurrently with the public offering. All securities in the public offering and private placement will be offered by Immuneering. The public offering and private placement are expected to close concurrently on or about September 26, 2025, subject to customary closing conditions, and the closing of the private placement is contingent upon the closing of the public offering.

Immuneering intends to use the net proceeds of the public offering and the private placement to advance the preclinical and clinical development of its product candidates and for working capital and other general corporate purposes.

Leerink Partners and Oppenheimer & Co. are acting as the joint bookrunners for the public offering and as placement agents in connection with the private placement.

The public offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed by Immuneering with the Securities and Exchange Commission (the “SEC”) on August 13, 2025 and declared effective by the SEC on August 20, 2025. A prospectus supplement relating to the offering will be filed with the SEC. Copies of the prospectus supplement relating to the offering, when available, may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; and Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at EquityProspectus@opco.com, or by visiting the EDGAR database on the SEC’s website at www.sec.gov.

The shares being sold in the Private Placement have not been and will not be registered under the Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 jurisdiction.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the consummation of and the terms of the public offering and the private placement, the anticipated use of the net proceeds from the public offering and the private placement and the anticipated gross proceeds from the public offering and the private placement. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Actual results or developments may differ materially from those projected or implied in these forward-looking statements and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. Such statements are subject to numerous risks and uncertainties, including, but not limited to, risks associated with general economic and market conditions and the other important factors discussed under the caption “Risk Factors” in the prospectus supplement related to the offering, our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and our other filings with the SEC. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise.

Media Contact:
Carson Creehan
817-412-1096
carson.creehan@padillaco.com

Investor Contact:
Laurence Watts
619-916-7620
laurence@newstreetir.com

We have filed a registration statement (including a prospectus) and a preliminary prospectus supplement with the SEC for the offerings to which this communication relates. Before you invest, you should read the preliminary prospectus supplement and the prospectus in that registration statement and other documents we have filed with the SEC for more complete information about us and this offering. You may get these documents free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, we, the underwriter or any dealer participating in the offering will arrange to send you the preliminary prospectus supplement (or, when available, the final prospectus supplement) and the accompanying prospectus upon request to: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at EquityProspectus@opco.com.

Sapu Nano’s Sapu003 Advances to Human Clinical Testing – Transforming Everolimus Delivery with Full Bioavailability for Breast Cancer Patients




Sapu Nano’s Sapu003 Advances to Human Clinical Testing – Transforming Everolimus Delivery with Full Bioavailability for Breast Cancer Patients

Sapu003 Designed to Overcome Limitations of Afinitor^®, FDA-Approved Oral Everolimus, Delivering Full Strength of Everolimus via Intravenous Injection

AUSTRALIA, Sydney, Sept. 24, 2025 (GLOBE NEWSWIRE) — Sapu Nano, developer of Deciparticle^™, today announced it received approval from Australia’s Human Research Ethics Committee (HREC) to begin enrolling patients in a Phase 1 human clinical trial of Sapu003—an injectable form of Everolimus—for the treatment of breast cancer. Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

Everolimus is an FDA-approved drug (Afinitor^®) for various cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. In oral pill form, only about 10% of the drug is absorbed by the body, limiting its effectiveness. Using Sapu Nano’s proprietary Deciparticle™ technology, Sapu003, delivered intravenously, allows 100% of the drug to reach the bloodstream. Preclinical studies suggest this approach could be more effective than the current approach.

“We are extremely pleased to receive approval from HREC to proceed with human clinical trials,” said Sapu Nano CEO, Dr. Vuong Trieu. “Despite advances in treatment, a critical unmet need for next generation mTOR inhibitors remains. Current therapies often extend progression-free survival for less than one year and rarely deliver long-term disease control. This Phase 1 trial will allow us to determine the best dose for future studies, including a Phase 3 trial.”

Dr. Sud Agarwal, CEO, Ingenu, added: “The approval of Sapu003 to enter human trials is a landmark moment. By enabling full drug absorption through intravenous delivery, this program has the potential to achieve meaningful tumor shrinkage where oral formulations have been limited. We are proud to support Sapu Nano in advancing this therapy, potentially giving breast cancer patients better outcomes and improved quality of life.”

What This Means for Patients

Put simply, Sapu003 is a new way of giving an existing cancer drug, so it works better. By delivering it intravenously, researchers can deliver the medicine at full strength, which could make it more effective at shrinking tumors. This first trial is the starting point to see if this improved version can give breast cancer patients longer-lasting benefits and new hope.

Investor & Media Contact
Sapu Nano (US) LLC
Investor Relations
ir@sapubio.com

Sapu Nano’s Sapu003 Advances to Human Clinical Testing – Transforming Everolimus Delivery with Full Bioavailability for Breast Cancer Patients




Sapu Nano’s Sapu003 Advances to Human Clinical Testing – Transforming Everolimus Delivery with Full Bioavailability for Breast Cancer Patients

Sapu003 Designed to Overcome Limitations of Afinitor^®, FDA-Approved Oral Everolimus, Delivering Full Strength of Everolimus via Intravenous Injection

AUSTRALIA, Sydney, Sept. 24, 2025 (GLOBE NEWSWIRE) — Sapu Nano, developer of Deciparticle^™, today announced it received approval from Australia’s Human Research Ethics Committee (HREC) to begin enrolling patients in a Phase 1 human clinical trial of Sapu003—an injectable form of Everolimus—for the treatment of breast cancer. Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

Everolimus is an FDA-approved drug (Afinitor^®) for various cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. In oral pill form, only about 10% of the drug is absorbed by the body, limiting its effectiveness. Using Sapu Nano’s proprietary Deciparticle™ technology, Sapu003, delivered intravenously, allows 100% of the drug to reach the bloodstream. Preclinical studies suggest this approach could be more effective than the current approach.

“We are extremely pleased to receive approval from HREC to proceed with human clinical trials,” said Sapu Nano CEO, Dr. Vuong Trieu. “Despite advances in treatment, a critical unmet need for next generation mTOR inhibitors remains. Current therapies often extend progression-free survival for less than one year and rarely deliver long-term disease control. This Phase 1 trial will allow us to determine the best dose for future studies, including a Phase 3 trial.”

Dr. Sud Agarwal, CEO, Ingenu, added: “The approval of Sapu003 to enter human trials is a landmark moment. By enabling full drug absorption through intravenous delivery, this program has the potential to achieve meaningful tumor shrinkage where oral formulations have been limited. We are proud to support Sapu Nano in advancing this therapy, potentially giving breast cancer patients better outcomes and improved quality of life.”

What This Means for Patients

Put simply, Sapu003 is a new way of giving an existing cancer drug, so it works better. By delivering it intravenously, researchers can deliver the medicine at full strength, which could make it more effective at shrinking tumors. This first trial is the starting point to see if this improved version can give breast cancer patients longer-lasting benefits and new hope.

Investor & Media Contact
Sapu Nano (US) LLC
Investor Relations
ir@sapubio.com

Range Impact Announces $550,000 Capital Raise




Range Impact Announces $550,000 Capital Raise

Cleveland, Ohio, Sept. 24, 2025 (GLOBE NEWSWIRE) — Range Impact, Inc. (OTCQB: RNGE) (“Range Impact” or the “Company”), a public impact investing company dedicated to acquiring, reclaiming and repurposing mine sites in Appalachia, announced the closing of a $550,000 capital raise.

Capital Raise

The capital raise was comprised of a $350,000 investment by Tower IV, LLC, an investment vehicle of Joseph E. LoConti, the Company’s largest shareholder, a $100,000 investment by Edward Feighan, the Company’s Chairman of the Board, and a $100,000 investment by Michael Cavanaugh, the Company’s CEO and Board Member.

The investors entered into securities purchase agreements pursuant to which they acquired a total of 3,666,667 shares of Range Impact’s common stock at a price of $0.15 per share.

Michael Cavanaugh, Range Impact’s CEO, stated, “The additional capital investment reflects our largest shareholder’s and board’s continued confidence in our vision and strategy.” Cavanaugh added, “By aligning leadership and capital, we are strengthening our ability to accelerate the reclamation and repurposing of our land assets and unlock long-term value for our shareholders, strategic partners, and the local communities we serve.”

About Range Impact, Inc.

Headquartered in Cleveland, Ohio, Range Impact is a public company (OTC: RNGE) dedicated to improving the health and wellness of people and the planet through a novel and innovative approach to impact investing. Range Impact owns and operates several complementary operating businesses focused on developing long-term solutions to environmental, social, and health challenges, with a particular focus on acquiring, reclaiming and repurposing mine sites and other undervalued land in economically disadvantaged communities throughout Appalachia. Range Impact takes an opportunistic approach to impact investing by leveraging its competitive advantages and looking at solving old problems in new ways. Range Impact seeks to thoughtfully allocate its capital into strategic opportunities that are expected to make a positive impact on the people-planet ecosystem and generate strong investment returns for its shareholders.

Notice Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as that term is defined in Section 27(a) of the Securities Act of 1933, as amended and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Although we believe that these statements are based on reasonable assumptions, they are subject to numerous factors that could cause actual outcomes and results to be materially different from those indicated in such statements. Such factors include, among others, the inherent uncertainties associated with new projects, changes in business strategy and new lines of business. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

Range Impact, Inc.
Investor Relations
P: +1 (216) 304-6556
E: ir@rangeimpact.com
W: www.rangeimpact.com 

Verano to Report Third Quarter 2025 Financial Results on October 29, 2025




Verano to Report Third Quarter 2025 Financial Results on October 29, 2025

CHICAGO, Sept. 24, 2025 (GLOBE NEWSWIRE) — Verano Holdings Corp. (Cboe CA: VRNO) (OTCQX: VRNOF) (“Verano” or the “Company”), a leading multi-state cannabis company, today announced that it plans to release financial results for the third quarter ended September 30, 2025, before the market opens on October 29, 2025.

A conference call and webcast with analysts and investors is scheduled for October 29, 2025 at 8:30 a.m. ET / 7:30 a.m. CT to discuss the results.

• Investors and participants can register in advance for the call by visiting: https://register-conf.media-server.com/register/BI0122898845f54044bfa55206a0105ded
• After registering, instructions will be shared on how to join the call for those who wish to dial in.
• On October 29, the live webcast can be accessed via the following link: https://edge.media-server.com/mmc/p/q42h988w
• The live and archived webcast will be available on the Events and Presentations page of the Company’s investor relations website at investors.verano.com.

About Verano

Verano Holdings Corp. (Cboe CA: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on historical revenue, geographic scope and brand performance, is a vertically integrated, multi-state operator embracing a mission of saying Yes to plant progress and the bold exploration of cannabis. Verano provides a superior cannabis shopping experience in medical and adult use markets under the Zen Leaf^™ and MÜV^™ dispensary banners, including Cabbage Club^™, an innovative annual membership program offering exclusive benefits for cannabis consumers. Verano produces a comprehensive suite of high-quality, regulated cannabis products sold under its diverse portfolio of trusted consumer brands including Verano™, (the) Essence^™, MÜV^™, Savvy^™, BITS^™, Encore^™, and Avexia^™. Verano’s active operations span 13 U.S. states, comprised of 15 production facilities with over 1.1 million square feet of cultivation capacity. Learn more at Verano.com.

Contacts:

Media
Verano
Steve Mazeika
Vice President, Communications
Steve.Mazeika@verano.com
312-348-4430

Investors
Verano
Aaron Miles
Chief Investment Officer
Investors@verano.com

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans, strategies, or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Generally, such forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “future”, “scheduled”, “estimates”, “forecasts”, “projects,” “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, “will occur” or “will be achieved”. Forward-looking statements involve and are subject to assumptions and known and unknown risks, uncertainties, and other factors which may cause actual events, results, performance, or achievements of the Company to be materially different from future events, results, performance, and achievements expressed or implied by forward-looking statements herein, including, without limitation, the risk factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2024 and any subsequent quarterly reports on Form 10-Q, in each case, filed with the U.S. Securities and Exchange Commission at www.sec.gov. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information or forward-looking statements that are contained or referenced herein, except as may be required in accordance with applicable securities laws. All subsequent written and oral forward-looking information and statements attributable to the Company or persons acting on its behalf is expressly qualified in its entirety by this notice regarding forward-looking information and statements.

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