Ascentage Pharma to Present Data from Two Clinical Studies for Bcl-2 Inhibitor Lisaftoclax, Including an Oral Report, at ASH 2025




Ascentage Pharma to Present Data from Two Clinical Studies for Bcl-2 Inhibitor Lisaftoclax, Including an Oral Report, at ASH 2025

ROCKVILLE, Md. and SUZHOU, China, Nov. 03, 2025 (GLOBE NEWSWIRE) — Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that the latest results from two clinical studies of its novel drug, lisaftoclax (APG-2575), have been selected for presentations, including an oral report, at the 67th American Society of Hematology (ASH) Annual Meeting. This is the fourth consecutive year in which clinical results on lisaftoclax have been selected by the ASH Annual Meeting. This year, data from multiple clinical and preclinical studies on three of the company’s investigational drug candidates (lisaftoclax, olverembatinib, and APG-5918) have been selected for presentations at the ASH Annual Meeting.

Developed by Ascentage Pharma, lisaftoclax is an orally available Bcl-2 inhibitor. Early data from the studies have demonstrated effects on hematologic malignancies and solid tumors. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. At this year’s ASH Annual Meeting, Ascentage Pharma will present an oral report featuring the latest results from a registrational Phase II study of lisaftoclax monotherapy in patients with relapsed/refractory (R/R) CLL/SLL. Moreover, Ascentage Pharma will present a poster featuring the latest data of lisaftoclax in combination with azacitidine (AZA) in patients with newly diagnosed (ND) or prior venetoclax–exposed myeloid malignancies.

The ASH Annual Meeting is one of the largest gatherings of the international hematology community, aggregating the latest scientific research on the pathogenesis and clinical treatment of hematologic diseases. The 67th ASH Annual Meeting will take place on December 6-9, 2025, local time, both online and in-person in Orlando, Florida.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, “Lisaftoclax has demonstrated efficacy and manageable safety profiles across numerous studies to-date. Lisaftoclax is currently being evaluated in four global registrational Phase III studies. At ASH 2025, the latest clinical data supporting lisaftoclax were once again selected for presentations, including an oral report, underscoring the drug’s therapeutic potential in hematologic diseases. We are pleased that multiple studies of our key drug candidates have been selected for presentation at the ASH Annual Meeting, demonstrating Ascentage Pharma’s robust capabilities in global innovation and clinical development. We are eager to share more detailed results during the conference and will continue to accelerate our clinical development programs in order to bring more treatment options to patients as soon as possible.”

An overview of presentations featuring Ascentage Pharma’s drug candidates at ASH 2025:

Study abstracts on lisaftoclax selected for presentations at the 2025 ASH Annual Meeting are as follows: (for details on the abstracts featuring olverembatinib, please refer to a separate press release published at the same time)

Oral Presentation
Results of a registrational phase 2 study of lisaftoclax monotherapy for treatment of patients (pts) with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had failed Bruton’s tyrosine kinase inhibitors (BTKis)
Format: Oral Presentation
Abstract#: 88
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Treatment of CLL in Relapse and in Richter Transformation
Time: Saturday, December 6, 2025; 10:15 AM – 10:30 AM EST
First Author: Prof. Keshu Zhou, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China
Presenter: Prof. Keshu Zhou, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China
Highlights:
This is a pivotal registrational Phase II study (NCT05147467) in patients with CLL/SLL, with the objective response rate (ORR) as its primary endpoint. Patients in this study were refractory to, relapsed on, or intolerant of both BTK inhibitors and immunochemotherapy; or failed prior BTK inhibitors and were ineligible for immunochemotherapy.

Efficacy Results: As of July 25, 2025, among 72 evaluable patients with R/R CLL/SLL, the ORR as confirmed by the independent review committee (IRC) was 62.5%, the median progression-free survival (mPFS) was 23.89 months (with a median follow-up of 22.01 months). Among high-risk patients (those with adverse prognostic genotypes such as del(17p)/TP53 mutation, chromosomal complex karyotype, and unmutated IGHV), the treatment showed clinically meaningful deep responses. 21.8% of patients achieved minimal residual disease (MRD) negativity in peripheral blood. In the 11 evaluable patients with bone marrow MRD, 6 achieved MRD-negativity.

Safety Results: Lisaftoclax demonstrated a manageable safety profile in BTKi-pretreated patients. Frequent grade ≥3 treatment-related adverse events were hematologic toxicities that included decreased neutrophil, decreased platelet count, and anemia. No tumor-lysis syndrome (TLS) was reported and no treatment-related deaths occurred during the study.

Conclusion: Lisaftoclax monotherapy demonstrated significant and durable clinical efficacy and a manageable safety profile in patients with heavily-pretreated BTK-refractory R/R CLL/SLL, underscoring its utility as a potential new treatment option.

Poster Presentation:
Results of the APG2575AU101 study of lisaftoclax (APG-2575) combined with azacitidine (AZA) in patients with newly diagnosed (ND) or prior venetoclax–exposed myeloid malignancies
Format: Poster Presentation
Abstract#: 1641
Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster I
Time: Saturday, December 6, 2025; 5:30 PM – 7:30 PM EST
First Author: Dr. Tapan Kadia, Department of Leukemia, The University of Texas MD Anderson Cancer Center
Presenter: Dr. Tapan Kadia, Department of Leukemia, The University of Texas MD Anderson Cancer Center
Highlights:

• This is a phase I/II study (NCT04964518) designed to evaluate the safe dose and efficacy of lisaftoclax in combination with AZA in patients with ND or R/R acute myeloid leukemia (AML), mixed-phenotype acute leukemia (MPAL), chronic myelomonocytic leukemia (CMML), or higher-risk (HR) myelodysplastic syndromes (MDS). The first part of this study is the dose-escalation phase and the second part is the dose-expansion phase.
• As of July 1, 2025, a total 103 patients were enrolled, including 63 patients with AML/MPAL (of whom 56 patients had relapsed/refractory diseases) and 40 patients with HR MDS/CMML (of whom 25 patients had relapsed/refractory diseases).

Efficacy Results as of July 1, 2025:

• In the 47 evaluable patients with R/R AML/MPAL, the ORR was 40.4%, the complete response (CR) rate was 29.8% (14/47). In the 24 patients with venetoclax–exposed R/R AML/MPAL, the ORR was 29.2% (7/24), the CR rate was 20.8% (5/24).
• In the 15 evaluable patients with ND HR MDS/CMML, the ORR was 80.0%, including 6 (40.0%) patients who achieved a CR, and 6 (40.0%) who achieved a marrow CR (mCR).
• Median overall survival (OS) values for patients with R/R AML/MPAL or R/R HR MDS/CMML were 7.6 months and 11.3 months, respectively.
• The median OS of patients with ND AML/MPAL was 6.3 months and it was not reached in patients with ND HR MDS/CMML.

Safety Results: No dose-limiting toxicities (DLTs) were reported in part one for dose-escalation or part two for dose-expansion. Common grade ≥3 treatment-emergent adverse events (TEAEs) included neutropenia (41.7%), febrile neutropenia (35.0%), thrombocytopenia (26.2%), anemia (17.5%).

Conclusion: These preliminary clinical data show that the combination regimen of lisaftoclax plus AZA holds promise in overcoming venetoclax resistance, therefore potentially offering a new treatment option to patients with AML/HR MDS.

* Olverembatinib, lisaftoclax and APG-5918 are currently under investigation and have not yet been approved by the FDA in the US.

About Ascentage Pharma
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors.

The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients.

The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia ( AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the US FDA, the EMA of the EU, and China CDE.
Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition.

These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.
As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts
Investor Relations:
Hogan Wan, Head of IR and Strategy
Ascentage Pharma
Hogan.Wan@ascentage.com
+86 512 85557777

Stephanie Carrington
ICR Healthcare
AscentageIR@icrhealthcare.com
+1 (646) 277-1282

Media Relations:
Jon Yu
ICR Healthcare
AscentagePR@icrhealthcare.com
+1 (646) 677-1855

Zelluna ASA – Key information relating to subsequent offering




Zelluna ASA – Key information relating to subsequent offering

Reference is made to the stock exchange announcement made by Zelluna ASA (the “Company“) on 3 November 2025 regarding the allocation of 5,500,000 new shares in the Company in a private placement (the “Private Placement“), the allocation of 315,639 new shares in a retail offering via the PrimaryBid platform (the “PrimaryBid Offering“), and a potential subsequent repair offering of up to 800,000 new shares at the same subscription price as in the Private Placement and the PrimaryBid Offering (the “Subsequent Offering“). The Subsequent Offering will, subject to applicable securities law, be directed towards existing shareholders in the Company as of 3 November 2025, as registered in the Company’s register of shareholders with Euronext Securities Oslo on 5 November 2025, who (i) were not included in the pre-sounding phase of the Private Placement; (ii) were not allocated shares in the Private Placement, and (iii) are not resident in a jurisdiction where such offering would be unlawful or, would (in jurisdictions other than Norway) require a prospectus, filing registration or similar action.

The following key information is provided with respect to the Subsequent Offering:

Date on which the terms and conditions of the Subsequent Offering were announced: 3 November 2025

Last day including right: 3 November 2025

Ex-date: 4 November 2025

Record date: 5 November 2025

Date of approval: On or about 25 November 2025 (date of extraordinary general meeting)

Maximum number of new shares: 800,000

Subscription price: NOK 10 per share

Shall the rights be listed: No

Other information: The Subsequent Offering is subject to, inter alia, completion of the Private Placement, approval by the board of directors and an extraordinary general meeting of the Company, and the publication of a prospectus. Whether or not the Subsequent Offering will ultimately take place, will depend inter alia on the development of the price of the shares in the Company after completion of the Private Placement, and the Company reserves the right in its sole discretion to not conduct or to cancel the Subsequent Offering.

This information is published in accordance with the requirements of the Continuing Obligations for Euronext Oslo Børs.

Zelluna ASA – Mandatory notification of trade




Zelluna ASA – Mandatory notification of trade

Reference is made to the private placement (the “Private Placement“) and the retail offering through PrimaryBid (the “PrimaryBid Offering“) announced by Zelluna ASA on 3 November 2025. Please see the attached PDMR-forms related to (i) allocation of shares in the Private Placement; and (ii) share lending to facilitate settlement of tranche 1 of the Private Placement and the PrimaryBid Offering.

Attachment

• 20251104 – PDMR attachment

Aardvark Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)




Aardvark Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

SAN DIEGO, Nov. 03, 2025 (GLOBE NEWSWIRE) — Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics for the treatment of metabolic diseases, today announced that (i) on October 20, 2025, one new employee was granted an inducement award consisting of a stock option to purchase 23,602 shares of common stock, (ii) on October 28, 2025, three new employees were granted inducement awards consisting of stock options to purchase an aggregate of 49,849 shares of common stock and (iii) on November 3, 2025, one new employee was granted an inducement award consisting of a stock option to purchase 14,766 shares of common stock.

Each option was granted pursuant to the Aardvark Therapeutics, Inc. 2025 Inducement Equity Incentive Plan, and was granted as an inducement material to each employee’s employment with Aardvark in accordance with Nasdaq Listing Rule 5635(c)(4).

The exercise price of each option is equal to the closing price of Aardvark’s common stock on the date of grant, or $12.28, $12.00 and $10.39 on October 20, 2025, October 28, 2025 and November 3, 2025, respectively. Each option will vest over four years, with 25% of the total number of shares vesting on the one year anniversary of the date of commencement of such employee’s employment with Aardvark and 1/48^th of the total number of shares subject to each option vesting monthly thereafter, subject to continued employment.

About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food). Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com.

Contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
Carolyn.hawley@inizioevoke.com

Zelluna ASA – Successful private placement and retail offering




Zelluna ASA – Successful private placement and retail offering

Successful private placement and retail offering – Zelluna ASA raises NOK 58 million to advance the world’s first “off-the-shelf” TCR-NK therapy, ZI-MA4-1, into Phase I clinical trials and develop the pipeline

Strong support from existing shareholders, management and board members with extensive life science and cell therapy experience.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE’S REPUBLIC OF CHINA, SOUTH AFRICA, NEW ZEALAND, JAPAN OR THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL

Oslo, 3 November 2025: Zelluna ASA (“Zelluna” or the “Company”), a company pioneering allogeneic ‘off the shelf’ T Cell Receptor based Natural Killer (TCR-NK) cells for the treatment of cancer raises NOK 58 million to advance the world’s first MAGE-A4 targeting TCR-NK, ZI-MA4-1 into a Phase I trial to treat solid cancer patients and develop the pipeline. The Company will conduct a webcast on 4 November at 09:00 CET to present the Q3 2025 results and provide an update on the private placement. Please find the webcast presentation attached to this announcement. Link to the webcast here.

The financing is strongly supported by existing shareholders, management and board members (see below) with extensive experience within life science and cell therapy. This demonstrates the significant potential of the Zelluna TCR-NK platform and the strong belief of what this new generation of allogeneic “off the shelf” cell therapies can deliver to patients.

The completion of this financing marks a pivotal milestone in Zelluna’s journey from innovation to clinical validation. Our mission is to deliver a new generation of allogeneic “off-the-shelf” cell therapies for advanced solid cancers by combining the precision of T-cell receptors (TCRs) with the potency and safety of natural killer (NK) cells. In a market showing renewed appetite for scalable “off the shelf” cell therapies, with five major deals in the past year based on early patient data, Zelluna is now positioned with the resources to initiate its first clinical study with the world’s first MAGE-A4-targeting TCR-NK and generate data that could transform treatment for solid tumours and create significant value for the company.

“This fundraising marks a defining moment for Zelluna. It provides the resources to take our pioneering allogeneic cell therapy into patients for the first time, a step years in the making. The participation from both existing and new investors in a challenging market reflects strong confidence in Zelluna’s vision, science, and team. I want to thank our team for their relentless efforts and our investors and Board for their deep commitment to our journey. We now enter a critical phase; one that could bring meaningful impact for late-stage cancer patients amid growing industry appetite for accessible, ‘off-the-shelf’ cell therapies and a significant value inflection for the Company” said Namir Hassan, CEO, Zelluna ASA.

“This successful financing marks a significant milestone for Zelluna and reflects strong investor confidence in the company’s value proposition, shareholder value potential, and disciplined execution. The Board is grateful for the continued support from both existing and new shareholders, which strengthens Zelluna’s position as a leader in next-generation cell therapy innovation.” said Anders Tuv, Chairman of the Board of Directors, Zelluna ASA.

Reference is made to the stock exchange announcement published by the Company on 3 November 2025 regarding the launch of a private placement of new shares in the Company to raise gross proceeds of NOK 50-55 million through the issuance of new shares at an offer price of NOK 10 per share (the “Private Placement”), and the retail offering of new shares of up to the NOK equivalent of EUR 1 million via the PrimaryBid platform (the “PrimaryBid Offering”) (together with the new shares in the Private Placement, the “Offer Shares”).

The Company is pleased to announce that the Private Placement has been successfully placed, through the allocation of 5,500,000 Offer Shares at the subscription price of NOK 10 per Offer Share (the “Subscription Price”), raising gross proceeds of NOK 55 million.

Additionally, 315,639 Offer Shares were allocated at the Subscription Price in the PrimaryBid Offering, raising gross proceeds of NOK 3,156,390.

The net proceeds to the Company from the Private Placement and the PrimaryBid Offering will be used to initiate the Phase I clinical trial with ZI-MA4-1 and generate initial patient data, develop the pipeline and for general corporate purposes.

The following existing shareholders and primary insiders of the Company (the “Pre-committing Shareholders”) pre-committed to subscribe, and were allocated, Offer Shares in the Private Placement in the following amounts:

• Oxford Investors (a group of international private investors with strong track-record within the Life Science industry) for NOK 24.8 million;
• Sundt AS / Helene Sundt AS for NOK 10 million;
• Gjelsten Holding AS for NOK 5 million;
• MP Pensjon PK for NOK 5 million;
• Norda ASA for NOK 2 million;
• Ro Invest AS for NOK 1.5 million;
• Management for NOK 1.2 million, whereof;
  • Namir Hassan (CEO) for NOK 0.5 million;
• Members of the Board of Directors for NOK 1.2 million, whereof;
  • Anders Tuv (Chair of the Board, co-founder) for NOK 0.2 million;

The Offer Shares in the Private Placement were allocated in two tranches, where 3,729,774 Offer Shares were allocated in the first tranche (“Tranche 1”) and the remaining 1,770,226 Offer Shares were allocated in the second tranche (“Tranche 2”). The allocation of Offer Shares in Tranche 2 is conditional upon approval of the issuance of such shares by an extraordinary general meeting of the Company expected to be held on or about 25 November 2025 (the “EGM”).

Notification of allocation, including settlement instructions, in the Private Placement are expected to be distributed by the Manager on 4 November 2025. Settlement of Offer Shares in Tranche 1 to investors other than the Pre-committing Shareholders is expected to take place on or about 6 November 2025 on a delivery-versus-payment (DVP) basis by delivery of existing and unencumbered shares in the Company that are already listed on Euronext Oslo Børs, pursuant to a share lending agreement (the “Share Lending Agreement”) between the Company, the Manager and Radforsk. The Offer Shares allocated to the investors in Tranche 1 of the Private Placement other than the Pre-committing Shareholders will thus be tradable upon allocation. Settlement of the Offer Shares allocated to the Pre-committing Shareholders in Tranche 1 will not be made on DVP-basis. The payment date for such Offer Shares is expected on or about 6 November 2025. Delivery of such Offer Shares will occur following registration of the share capital increase pertaining to such Offer Shares in the Norwegian Register of Business Enterprises (the “NRBE”), expected on or about 10 November 2025.

The payment date for Offer Shares in Tranche 2 is expected to be on or about 27 November 2025 and delivery of such Offer Shares is expected to occur on or about 2 December 2025, subject to the share capital increase pertaining to the issuance of such Offer Shares having been registered with the NRBE. The Offer Shares in Tranche 2 and part of the Offer Shares in Tranche 1 to be delivered to Pre-committing Shareholders and/or Radforsk (as settlement of the share loan described above) will initially be delivered on a separate non-listed ISIN pending approval and publication of a listing prospectus, and the new shares to be issued in Tranche 2 and such part of the Offer Shares to be issued in Tranche 1 will thus not be listed or tradable on Euronext Oslo Børs until such prospectus has been published. All investors in the Private Placement were allocated Offer Shares in Tranche 1, except for the Pre-committing Shareholders who were allocated Offer Shares in Tranche 1 and Tranche 2.

Settlement of the Offer Shares in the PrimaryBid Offering is expected to take place on or about 6 November 2025 on a delivery-versus-payment (DVP) basis by delivery of existing and unencumbered shares in the Company that are already listed on Euronext Oslo Børs, pursuant to the Share Lending Agreement. The Offer Shares to be delivered to the investors in the PrimaryBid Offering will thus be tradable upon allocation.

To issue the Offer Shares allocated in Tranche 1 of the Private Placement and the PrimaryBid Offering, the Company’s board of directors has resolved to increase the Company’s share capital with in total NOK 4,045,413 by the issuance of 4,045,413 new shares pursuant to the board authorization to increase the Company’s share capital granted by the Company’s general meeting on 29 April 2025. Following registration of the share capital increase pertaining to the issuance of Offer Shares in Tranche 1 of the Private Placement and the PrimaryBid Offering with the NRBE, the Company will have a share capital of NOK 24,499,575 divided into 24,499,575 shares, each with a par value of NOK 1.

Completion of Tranche 2 of the Private Placement is subject to (i) completion of Tranche 1; (ii) the EGM of the Company resolving to issue the Offer Shares in Tranche 2; and (iii) the share capital increase pertaining to the issuance of the Offer Shares in Tranche 2 being registered with the NRBE.

The Private Placement and the PrimaryBid Offering implies a deviation from the pre-emptive rights of the existing shareholders of the Company under the Norwegian Public Limited Companies Act. When resolving the issuance and allocation of shares in the Private Placement and the PrimaryBid Offering, the Board considered this deviation and also the equal treatment obligations under the Norwegian Public Limited Companies Act and Norwegian Securities Trading Act. The Board is of the opinion that there are sufficient grounds to deviate from the pre-emptive rights and that the Private Placement and PrimaryBid Offering are in compliance with the equal treatment requirements. By structuring the transaction as a private placement combined with a retail offering, the Company was able to raise capital in an efficient manner, with a lower discount to the current trading price and with significantly lower completion risks compared to a rights issue, and to strengthen the Company’s shareholder base.

To mitigate the dilutive effects for the existing shareholders not participating in the Private Placement, the Company intends, subject to, inter alia, completion of the Private Placement and the PrimaryBid Offering, the necessary approvals being granted by the EGM and publication of a prospectus and certain other conditions, to carry out a subsequent repair offering of up to 800,000 new shares at the Subscription Price (the “Subsequent Offering”), directed towards existing shareholders in the Company as of 3 November 2025, as registered in the Company’s register of shareholders with Euronext Securities Oslo on 5 November 2025, and who (i) were not included in the pre-sounding phase of the Private Placement; (ii) were not allocated Offer Shares in the Private Placement, and (iii) are not resident in a jurisdiction where such offering would be unlawful or, would (in jurisdictions other than Norway) require a prospectus, filing registration or similar action. The Company will issue a separate stock exchange announcement with further details on the Subsequent Offering. The Company may decide that the Subsequent Offering will not be carried out in the event that the Company’s shares trade below the Subscription Price at adequate volumes. The Company reserves the right in its sole discretion to not conduct or to cancel the Subsequent Offering.

Advisors

DNB Carnegie, a part of DNB Bank ASA is acting as sole bookrunner for the Private Placement.

Advokatfirmaet Schjødt AS is acting as legal counsel to the Company in connection with the Private Placement.

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA
Email: namir.hassan@zelluna.com
Phone: +44 7720 687608

Hans Vassgård Eid, CFO, Zelluna ASA
Email: hans.eid@zelluna.com
Phone: +47 482 48632

About Zelluna ASA

Zelluna’s mission is to deliver transformative treatments with the capacity to cure advanced solid cancers, in a safe and cost-efficient manner, to patients on a global scale. The Company aims to do this by combining the most powerful elements of the immune system through pioneering the development of “off the shelf” T cell receptor (TCR) guided natural killer (NK) cell therapies (TCR-NK). The TCR-NK platform offers a unique mechanism of action with broad cancer detection capability to overcome the diversity of tumours and will be used “off the shelf” to overcome scaling limitations of current cell therapies. The lead program is a world’s first MAGE-A4 targeting “off the shelf” TCR-NK for the treatment of various solid cancers; a pipeline of earlier products follows. The Company is led by a management team of biotech entrepreneurs with deep experience in discovery through to clinical development of TCR and cell-based therapies including marketed products.

Important notice

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 the Norwegian Securities Trading Act.

This stock exchange announcement was published by Joachim Midttun, Financial Manager at Zelluna ASA, on 3 November 2025 at 23:50 CET.

This announcement is not and does not form a part of any offer to sell, or a solicitation of an offer to purchase, any securities of the Company. Copies of this announcement are not being made and may not be distributed or sent into any jurisdiction in which such distribution would be unlawful or would require registration or other measures.

The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any part of the offering in the United States or to conduct a public offering of securities in the United States. Any sale in the United States of the securities mentioned in this announcement will be made solely to “qualified institutional buyers” as defined in Rule 144A under the U.S. Securities Act.

In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the EU Prospectus Regulation, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State. The expression “EU Prospectus Regulation” means Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 as amended (together with any applicable implementing measures in any Member State).

In the United Kingdom, this communication is only addressed to and is only directed at Qualified Investors who (i) are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the “Order”) or (ii) are persons falling within Article 49(2)(a) to (d) of the Order (high net worth companies, unincorporated associations, etc.) (all such persons together being referred to as “Relevant Persons”). These materials are directed only at Relevant Persons and must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “strategy”, “intends”, “estimate”, “will”, “may”, “continue”, “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believe that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict, and are beyond their control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not make any guarantee that the assumptions underlying the forward-looking statements in this announcement are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this announcement or any obligation to update or revise the statements in this announcement to reflect subsequent events. You should not place undue reliance on the forward-looking statements in this announcement.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

Neither the Manager nor any of its affiliates makes any representation as to the accuracy or completeness of this announcement and none of them accepts any responsibility for the contents of this announcement or any matters referred to herein.

This announcement is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgment. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy any securities or a recommendation to buy or sell any securities of the Company. Neither the Manager nor any of its affiliates accepts any liability arising from the use of this announcement.

The distribution of this announcement and other information may be restricted by law in certain jurisdictions. Persons into whose possession this announcement or such other information should come are required to inform themselves about and to observe any such restrictions.

Attachment

• Zelluna-ASA-Q325-Presentation

FibroGen to Report Third Quarter 2025 Financial Results




FibroGen to Report Third Quarter 2025 Financial Results

SAN FRANCISCO, Nov. 03, 2025 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) will announce third quarter 2025 financial results on Monday, November 10 after market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company’s corporate and financial performance.

Conference Call and Webcast Presentation
The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

About FibroGen
FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO^TM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. 

For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@fibrogen.com

FibroGen to Report Third Quarter 2025 Financial Results




FibroGen to Report Third Quarter 2025 Financial Results

SAN FRANCISCO, Nov. 03, 2025 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) will announce third quarter 2025 financial results on Monday, November 10 after market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company’s corporate and financial performance.

Conference Call and Webcast Presentation
The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

About FibroGen
FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO^TM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. 

For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@fibrogen.com

Kura Oncology Receives Second $30 Million Development Milestone Payment in AML Menin Inhibitor Program With Kyowa Kirin




Kura Oncology Receives Second $30 Million Development Milestone Payment in AML Menin Inhibitor Program With Kyowa Kirin

– Milestone triggered by dosing of first patient in the second of two frontline AML Phase 3 clinical trials –

SAN DIEGO, Nov. 03, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the second of two KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. Kura previously announced receipt of the first $30 million milestone triggered by patient dosing in the KOMET-017 trials in October 2025. Kura has received a total of $105 million in milestone payments to date and expects to receive up to $315 million in additional, near-term milestones under the collaboration.

KOMET-017 (NCT07007312) comprises two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). Kura believes KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings.

About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the therapeutic potential of ziftomenib, the KOMET-017 trial being the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings, and anticipated near-term milestone payments under Kura’s collaboration agreement with Kyowa Kirin. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Kura Contact

Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com

Kura Oncology Receives Second $30 Million Development Milestone Payment in AML Menin Inhibitor Program With Kyowa Kirin




Kura Oncology Receives Second $30 Million Development Milestone Payment in AML Menin Inhibitor Program With Kyowa Kirin

– Milestone triggered by dosing of first patient in the second of two frontline AML Phase 3 clinical trials –

SAN DIEGO, Nov. 03, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the second of two KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. Kura previously announced receipt of the first $30 million milestone triggered by patient dosing in the KOMET-017 trials in October 2025. Kura has received a total of $105 million in milestone payments to date and expects to receive up to $315 million in additional, near-term milestones under the collaboration.

KOMET-017 (NCT07007312) comprises two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). Kura believes KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings.

About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the therapeutic potential of ziftomenib, the KOMET-017 trial being the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings, and anticipated near-term milestone payments under Kura’s collaboration agreement with Kyowa Kirin. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Kura Contact

Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com

Inspire Medical Systems, Inc. Announces Third Quarter 2025 Financial Results and Updates 2025 Outlook




Inspire Medical Systems, Inc. Announces Third Quarter 2025 Financial Results and Updates 2025 Outlook

MINNEAPOLIS, Nov. 03, 2025 (GLOBE NEWSWIRE) — Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire, or the company), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, today reported financial results for the quarter ended September 30, 2025.

Recent Business Highlights

• Generated revenue of $224.5 million in the third quarter of 2025, a 10% increase over the same quarter last year
• Achieved gross margin of 85.8% in the third quarter of 2025
• Net income was $9.9 million in the third quarter of 2025. Adjusted net income was $11.2 million
• Income per share was $0.34 in the third quarter of 2025. Adjusted diluted earnings per share was $0.38
• Generated operating cash flow of $68.5 million for the third quarter of 2025, bringing the year-to-date total to $64.5 million
• Presented Inspire V safety and efficacy data at recent industry meetings
• Completed $50 million in share repurchase

“The Inspire team had a very productive third quarter focusing on the transition to the Inspire V system while delivering very strong results globally,” said Tim Herbert, Chairman and Chief Executive Officer of Inspire Medical Systems. “Further, at recent industry meetings, we presented clinical evidence demonstrating that the Inspire V system offers enhanced performance, building on the strong foundation established by our legacy systems.”

“Patient safety is paramount, and with our Inspire V study in Singapore of 44 patients and the Limited-Market-Release study of over 100 patients in the United States, 100% of patients had a successful device implant,” continued Mr. Herbert. “Device performance was equally impressive starting with a 20% reduction in surgical procedure time, and statistically significant and clinically relevant reductions in disease severity. Recent field experience with the Inspire V system is generating very positive feedback from clinicians, and the team is making excellent progress with the U.S. launch with over 75% of centers ready to transition to Inspire V. We remain laser-focused on execution and with our strong performance and disciplined investments and cost management, we are reaffirming our full year revenue guidance of $900 to $910 million and increasing our diluted net income per share guidance to $0.90 to $1.00, up from $0.40 to $0.50 previously. I am very proud of how our team is executing and I look forward to a strong finish to the year.”

Third Quarter 2025 Financial Results

Revenue was $224.5 million for the third quarter, a 10% increase from $203.2 million in the corresponding prior year period. U.S. revenue for the quarter was $214.4 million, an increase of 9% as compared to the prior year quarter. Third quarter revenue outside the U.S. was $10.1 million, an increase of 37% as compared to the third quarter of 2024.

Gross margin was 85.8% for the third quarter of 2025 compared to 84.1% in the third quarter of 2024. The year-over-year increase was due to higher sales volume and higher Inspire V sales mix, which carries a lower cost of goods sold.

Operating expenses were $183.1 million for the third quarter of 2025, as compared to $156.5 million in the corresponding prior year period, an increase of 17%. This increase primarily reflected patient marketing expenses and general corporate costs, partially offset by a reduction in R&D. Operating expenses also included an additional $1.3 million in certain litigation-related legal expenses which do not reflect costs associated with our ongoing operations. A reconciliation table has been included at the bottom of this release.

Operating income was $9.6 million for the third quarter of 2025, as compared to $14.3 million in the prior year period.

Net income was $9.9 million for the third quarter of 2025 as compared to $18.5 million in the corresponding prior year period. Adjusted EBITDA for the third quarter of 2025 was $44.0 million as compared to $44.5 million in the corresponding prior year period. The diluted net income for the third quarter of 2025 was $0.34 per share, as compared to $0.60 per share in the prior year period. The adjusted net income for the third quarter of 2025 was $0.38 per share, as compared to $0.60 per share in the prior year period.

As of September 30, 2025, cash, cash equivalents, and investments were $410.9 million compared to $516.5 million on December 31, 2024.

Full Year 2025 Guidance

Inspire is maintaining full year 2025 revenue guidance to be in the range of $900 million to $910 million, which represents growth of 12% to 13% over full year 2024 revenue of $802.8 million.

The company is maintaining its full year 2025 gross margin guidance of 84% to 86%.

Inspire anticipates diluted net income per share guidance for the full year 2025 to be in the range of $0.90 to $1.00. This compares to the prior guidance of $0.40 to $.50 per share.

Webcast and Conference Call

Inspire’s management will host a conference call after market close today, Monday, November 3, 2025, at 5:00 p.m. Eastern Time to discuss these results and answer questions.

To access the conference call, please preregister on
https://register-conf.media-server.com/register/BIcaef92f7ac51467ca25919f83cd3e22e.
Registrants will receive confirmation with dial-in details.

A live webcast of the event can be accessed on https://edge.media-server.com/mmc/p/7um4yofb/. A replay of the webcast will be available on https://investors.inspiresleep.com starting approximately two hours after the event and archived on the site for two weeks.

About Inspire Medical Systems

Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA, EU MDR and PDMA-approved neurostimulation technology of its kind that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

For additional information about Inspire, please visit www.inspiresleep.com.

Use of Non-GAAP Financial Measures

This press release includes the non-GAAP financial measures of Adjusted net income, Adjusted earnings per share (“EPS”), Adjusted EBITDA, and Adjusted EBITDA margin, which differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”).

We define Adjusted net income as net income or loss, plus items that are not indicative of our ongoing operations. Net income is the most directly comparable GAAP financial measure to adjusted net income. Adjusted EPS is calculated as adjusted net income divided by the dilutive weighted average shares outstanding. Diluted EPS is the most directly comparable GAAP financial measure to adjusted EPS. We define Adjusted EBITDA as net income or loss, less interest income, plus interest expense, plus income tax expense, plus depreciation and amortization, plus stock-based compensation expense, plus litigation-related legal expenses and other non-operating expenses less non-operating income. Net income is the most directly comparable GAAP financial measure to Adjusted EBITDA. We define Adjusted EBITDA margin in this release as Adjusted EBITDA divided by revenue. Net income margin is the most directly comparable GAAP measure to Adjusted EBITDA margin. Reconciliations of these non-GAAP financial measures to their most directly comparable GAAP measures are included in this press release.

These non-GAAP financial measures are presented because we believe they are useful indicators of our operating performance. Management uses these measures principally as measures of our operating performance and for planning purposes, including the preparation of our annual operating plan and financial projections. We believe these measures are useful to investors as supplemental information and because they are frequently used by analysts, investors and other interested parties to evaluate companies in our industry. We also believe these non-GAAP financial measures are useful to our management and investors as a measure of comparative operating performance from period to period.

These non-GAAP financial measures should not be considered as an alternative to, or superior to, the most directly comparable GAAP financial measures, as measures of financial performance or cash flows from operations, as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and they should not be construed to imply that our future results will be unaffected by unusual or non-recurring items. In addition, Adjusted EBITDA is not intended to be a measure of cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as tax payments, capital expenditures and certain other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and cash costs to replace assets being depreciated and amortized. In evaluating our non-GAAP financial measures, you should be aware that in the future we may incur expenses that are the same as or similar to some of the adjustments in this presentation. Our presentation of non-GAAP financial measures should not be construed to imply that our future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on our GAAP results in addition to using non-GAAP financial measures on a supplemental basis. Our definition of these non-GAAP financial measures is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding full year 2025 financial outlook and our expectations regarding the launch of our Inspire V neurostimulation system, including the timeline to complete the full transition to that product. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” “guidance,” ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential,’’ ‘‘continue,’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, our history of operating losses and dependency on our Inspire therapy for revenues; commercial success and market acceptance of our Inspire therapy; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire therapy or any future products we may seek to commercialize; competitive companies, technologies and pharmaceuticals in our industry; our involvement in current or future legal disputes or regulatory proceedings; our ability to expand our indications and develop and commercialize additional products and enhancements to our Inspire therapy; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; our ability to accurately forecast customer demand for our Inspire therapy and manage our inventory; our dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire therapy in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; our ability to address quality issues that may arise with our Inspire therapy; our ability to successfully integrate any acquired business, products, or technologies; changes in global macroeconomic trends; challenges experienced by patients in obtaining prior authorization, our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire therapy; our business model and strategic plans for our products, technologies and business, including our implementation thereof; the impact of glucagon-like peptide 1 class of drugs on demand for our Inspire therapy; risks related to information technology and cybersecurity; our ability to commercialize or obtain regulatory approvals for our Inspire therapy, or the effect of delays in commercializing or obtaining regulatory approvals; and FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release can be found under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations“ in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as updated in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 to be filed with the SEC, and as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website at www.inspiresleep.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

Investor & Media Contact
Ezgi Yagci
Vice President, Investor Relations
ezgiyagci@inspiresleep.com
617-549-2443

Inspire Medical Systems, Inc.

Consolidated Statements of Operations and Comprehensive Income (unaudited)

(in thousands, except share and per share amounts)

Inspire Medical Systems, Inc.

Consolidated Balance Sheets (unaudited)

(in thousands, except share and per share amounts)

Inspire Medical Systems, Inc.

Reconciliation of Non-GAAP Financial Measures (unaudited)

(in thousands, except share and per share amounts)

Reconciliation of GAAP Net Income and Income per Share to Non-GAAP Adjusted Net Income and
Adjusted Net Income per Share

⁽¹⁾ Represents accelerated stock-based compensation expense for certain employees who are retirement eligible in accordance with the implementation of changes to the treatment of equity awards under the Inspire Medical Systems, Inc. 2018 Incentive Award Plan upon the holder’s death, disability, or retirement.

⁽²⁾ These costs represent legal-related expenses related to (a) a civil investigative demand from the Department of Justice, (b) a patent infringement suit that we filed against Nyxoah S.A. and its wholly-owned subsidiary, Nyxoah, Inc. (“Nyxoah”), and (c) a patent infringement suit brought against us by Nyxoah. These costs do not reflect costs associated with our normal ongoing operations.

⁽³⁾ Represents a non-cash impairment of a strategic investment, which does not reflect costs associated with our ongoing operations.

Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA

⁽⁴⁾ Total stock-based compensation expense.

Reconciliation of GAAP Net Income Margin and Non-GAAP Adjusted EBITDA Margin

⁽⁴⁾ Total stock-based compensation expense.

⁽⁵⁾ Net income margin is calculated as net income divided by total revenue.

⁽⁶⁾ Adjusted EBITDA margin is calculated as Adjusted EBITDA divided by total revenue.