SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM




SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

Ghent – Belgium, Nov. 20, 2025 (GLOBE NEWSWIRE) — SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

PRESS RELEASE
REGULATED INFORMATION – INSIDE INFORMATION
20 November 2025, 6:00 pm CET

Ghent, Belgium, 20 November 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 that it issued a subscription request notice in accordance with the terms of the share subscription facility agreement (the “Facility“) entered into on 17 March 2025 between the Company and GEM Global Yield LLC SCS (“GEM“). Under the terms of the Facility, GEM has agreed, subject to certain conditions, to commit an amount of up to EUR 20 million in cash (with the Company’s option to increase the commitment to up to EUR 60 million in cash, once the aforementioned EUR 20 million has been drawn down), within a maximum term of three years, in exchange for new shares in the Company and subject to certain share lending arrangements being in place. For more information about the Facility, reference is made to the Company’s press release dated 18 March 2025 (which can be accessed here).

The new subscription request notice is expected to be settled into new shares on or around 22 December 2025. The number of new shares the Company has requested GEM to subscribe for amounts to up to 1,995,014 shares in the Company (the “Draw Down Amount“). The issue price of the relevant new shares to be issued will be equal to 90% of the average volume weighted average price (VWAP) of the Company’s shares during a forward-looking pricing period and will be subject to certain corrections. Following the aforementioned pricing period, GEM will have to subscribe for a number of new shares ranging between a minimum of 50% and a maximum of 150% of the Draw Down Amount (subject to certain adjustments as set out in the Facility).

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. In Sequana Medical’s POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfapump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life1,2.

Sequana Medical has commenced US commercialisation through a small specialty salesforce initially targeting US liver transplant centers – 90 of these centers perform more than 90% of US liver transplants annually. CMS has 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 requirements3. 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: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.

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.


1 Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
2 As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

3 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

SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM




SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

Ghent – Belgium, Nov. 20, 2025 (GLOBE NEWSWIRE) — SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM

PRESS RELEASE
REGULATED INFORMATION – INSIDE INFORMATION
20 November 2025, 6:00 pm CET

Ghent, Belgium, 20 November 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 that it issued a subscription request notice in accordance with the terms of the share subscription facility agreement (the “Facility“) entered into on 17 March 2025 between the Company and GEM Global Yield LLC SCS (“GEM“). Under the terms of the Facility, GEM has agreed, subject to certain conditions, to commit an amount of up to EUR 20 million in cash (with the Company’s option to increase the commitment to up to EUR 60 million in cash, once the aforementioned EUR 20 million has been drawn down), within a maximum term of three years, in exchange for new shares in the Company and subject to certain share lending arrangements being in place. For more information about the Facility, reference is made to the Company’s press release dated 18 March 2025 (which can be accessed here).

The new subscription request notice is expected to be settled into new shares on or around 22 December 2025. The number of new shares the Company has requested GEM to subscribe for amounts to up to 1,995,014 shares in the Company (the “Draw Down Amount“). The issue price of the relevant new shares to be issued will be equal to 90% of the average volume weighted average price (VWAP) of the Company’s shares during a forward-looking pricing period and will be subject to certain corrections. Following the aforementioned pricing period, GEM will have to subscribe for a number of new shares ranging between a minimum of 50% and a maximum of 150% of the Draw Down Amount (subject to certain adjustments as set out in the Facility).

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. In Sequana Medical’s POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfapump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life1,2.

Sequana Medical has commenced US commercialisation through a small specialty salesforce initially targeting US liver transplant centers – 90 of these centers perform more than 90% of US liver transplants annually. CMS has 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 requirements3. 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: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.

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.


1 Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
2 As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

3 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

GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market

GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market




GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market

Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland); November 20, 2025 – GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces that the Company’s voluntary delisting of American Depositary Shares (“ADSs”) representing its ordinary shares from The Nasdaq Global Select Market (“Nasdaq”) has become effective. Each ADS represents one ordinary share of the Company. The Company has also filed a Form 15F with the Securities and Exchange Commission (“SEC”) to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), in respect of the ADSs and the ordinary shares. The Company expects that the deregistration of the ADSs under the Exchange Act will become effective 90 days after the filing of the Form 15F.

Information for ADS Holders

The Bank of New York Mellon serves as depositary (the “Depositary”) for the Company’s ADS facility. Each ADS represents one ordinary share. GENFIT intends to terminate the Deposit Agreement, dated March 26, 2019, among the Company, the Depositary and owners and holders of ADSs (the “Deposit Agreement”) on or about February 6, 2026. As a result, the existing facility will be terminated effective at 5:00 PM (Eastern Time) on February 5, 2026.

Under the terms of the Deposit Agreement, ADS holders will have until February 9, 2026 to surrender ADSs for delivery of the underlying ordinary shares. If they surrender ADSs for delivery of the underlying ordinary shares, they must pay a cancellation fee of up to $0.05 per ADS and a cable fee of $17.50. In order to exchange ADSs for the Company’s ordinary shares, ADS holders should instruct their brokers to surrender ADSs to The Bank of New York Mellon (DTC No. 2504). In connection with this surrender, brokers should include ongoing ordinary share delivery instructions in the comments field within DTC, including information such as the name and BIC of the appropriate local bank/broker and/or appropriate delivery code, beneficiary name and account number. U.S. brokers holding ADSs on behalf of their clients, can reach out to DRSettlements@BNYMellon.com for questions regarding the conversion and settlement process.

Subsequent to February 9, 2026, the Depositary may elect to sell the underlying ordinary shares. If the Depositary has sold such shares, holders of ADSs must surrender such securities in order to obtain payment of the sale proceeds of the underlying ordinary shares, net of the expenses of sale, any applicable U.S. or local taxes or government charges and a cancellation fee of up to $0.05 per ADS.

To surrender American Depositary Receipts (“ADRs”), the address of the Depositary is: The Bank of New York Mellon, 240 Greenwich Street, New York, New York 10286, Attention: Depositary Receipt Administration. Registered or overnight mail is the suggested method of delivering ADRs to the Depositary. For Settlement specific inquiries, please contact DRSettlements@BNYMellon.com.

Investors may still present ADSs to The Bank of New York Mellon. Investors will receive either the underlying ordinary shares (if those have not yet been sold by the Depositary) or the cash received by the Depositary received upon sale of underlying ordinary shares, net of fees, if those underlying ordinary shares were sold. For more information, investors should contact DRSettlements@BNYMellon.com.

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades.

Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow.

GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.1  

Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis).

GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about the Company’s expectation that the deregistration of the ADSs under the Exchange Act will become effective 90 days after the filing of the Form 15F. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025 or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors
Tel : + 33 3 20 16 40 00 | investors@genfit.com

GENFIT | Press relations

Stephanie BOYER | Tel : + 33 3 20 16 40 00 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com


1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®

Attachment

GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market

GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market




GENFIT announces effectiveness of voluntary delisting of American Depositary Shares from Nasdaq Stock Market

Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland); November 20, 2025 – GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces that the Company’s voluntary delisting of American Depositary Shares (“ADSs”) representing its ordinary shares from The Nasdaq Global Select Market (“Nasdaq”) has become effective. Each ADS represents one ordinary share of the Company. The Company has also filed a Form 15F with the Securities and Exchange Commission (“SEC”) to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), in respect of the ADSs and the ordinary shares. The Company expects that the deregistration of the ADSs under the Exchange Act will become effective 90 days after the filing of the Form 15F.

Information for ADS Holders

The Bank of New York Mellon serves as depositary (the “Depositary”) for the Company’s ADS facility. Each ADS represents one ordinary share. GENFIT intends to terminate the Deposit Agreement, dated March 26, 2019, among the Company, the Depositary and owners and holders of ADSs (the “Deposit Agreement”) on or about February 6, 2026. As a result, the existing facility will be terminated effective at 5:00 PM (Eastern Time) on February 5, 2026.

Under the terms of the Deposit Agreement, ADS holders will have until February 9, 2026 to surrender ADSs for delivery of the underlying ordinary shares. If they surrender ADSs for delivery of the underlying ordinary shares, they must pay a cancellation fee of up to $0.05 per ADS and a cable fee of $17.50. In order to exchange ADSs for the Company’s ordinary shares, ADS holders should instruct their brokers to surrender ADSs to The Bank of New York Mellon (DTC No. 2504). In connection with this surrender, brokers should include ongoing ordinary share delivery instructions in the comments field within DTC, including information such as the name and BIC of the appropriate local bank/broker and/or appropriate delivery code, beneficiary name and account number. U.S. brokers holding ADSs on behalf of their clients, can reach out to DRSettlements@BNYMellon.com for questions regarding the conversion and settlement process.

Subsequent to February 9, 2026, the Depositary may elect to sell the underlying ordinary shares. If the Depositary has sold such shares, holders of ADSs must surrender such securities in order to obtain payment of the sale proceeds of the underlying ordinary shares, net of the expenses of sale, any applicable U.S. or local taxes or government charges and a cancellation fee of up to $0.05 per ADS.

To surrender American Depositary Receipts (“ADRs”), the address of the Depositary is: The Bank of New York Mellon, 240 Greenwich Street, New York, New York 10286, Attention: Depositary Receipt Administration. Registered or overnight mail is the suggested method of delivering ADRs to the Depositary. For Settlement specific inquiries, please contact DRSettlements@BNYMellon.com.

Investors may still present ADSs to The Bank of New York Mellon. Investors will receive either the underlying ordinary shares (if those have not yet been sold by the Depositary) or the cash received by the Depositary received upon sale of underlying ordinary shares, net of fees, if those underlying ordinary shares were sold. For more information, investors should contact DRSettlements@BNYMellon.com.

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades.

Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow.

GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.1  

Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis).

GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about the Company’s expectation that the deregistration of the ADSs under the Exchange Act will become effective 90 days after the filing of the Form 15F. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025 or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors
Tel : + 33 3 20 16 40 00 | investors@genfit.com

GENFIT | Press relations

Stephanie BOYER | Tel : + 33 3 20 16 40 00 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com


1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®

Attachment

MiNK Therapeutics Announces New Data Showing MiNK-215 Drives Potent Anti-Tumor Activity in Treatment-resistant Solid Tumors

MiNK Therapeutics Announces New Data Showing MiNK-215 Drives Potent Anti-Tumor Activity in Treatment-resistant Solid Tumors




MiNK Therapeutics Announces New Data Showing MiNK-215 Drives Potent Anti-Tumor Activity in Treatment-resistant Solid Tumors

  • MiNK-215, an IL-15 armoured FAP-targeting CAR-iNKT, targets and clears tumor-protective FAP+ fibroblasts to allow immune cells to infiltrate and kills cancer cells
  • Activates multiple immune pathways to generate potent, lasting anti-tumor activity in lung and MSS colorectal cancer models

NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced the publication of new preclinical data for MiNK-215, a novel, next-generation FAP-targeting, IL-15–enhanced CAR-iNKT therapy. The manuscript, titled The allogeneic FAP-CAR-IL15 iNKT therapy MiNK-215 remodels the tumor stroma to enhance antitumor immunity”, is now available on Cancer Immunology Research website here.

MiNK-215 is engineered to eliminate FAP-positive cancer-associated fibroblasts (CAFs)—the cells that build the dense, immunosuppressive stroma blocking immune infiltration in solid tumors and contributing heavily to immunotherapy failure. Using MiNK’s proprietary allogeneic platform, MiNK-215 also secretes IL-15 to enhance persistence, immune activation, and durability.

Key Findings: MiNK-215 tackles the two fundamental barriers: the physical stroma that blocks immune entry and the dysfunctional immune circuitry inside the tumor. Specifically,

  • Dismantles the protective stromal barrier and selectively eliminates FAP+ cancer-associated fibroblasts, clearing the path for robust immune infiltration.
  • Reprograms the immune landscape in preclinical models of refractory lung and MSS colon cancer liver metastases, MiNK-215:
    • Remodeled the tumor microenvironment
    • Activated dendritic cells and antigen-presentation pathways
    • Re-polarized macrophages to pro-inflammatory, cancer killing state
    • Enabled deep infiltration of tumor-specific T cells

As an “off-the-shelf” therapy, MiNK-215 can be manufactured at scale and delivered on demand—offering a new therapeutic strategy for patients with solid tumors that have long been unresponsive to checkpoint inhibitors and other immune-based treatments.

“The findings published today underscore the real potential of MiNK-215 to reshape how we treat solid tumors that have resisted immunotherapy for decades. By dismantling the fibroblast barriers that shield these cancers and activating multiple arms of the immune system, MiNK-215 goes beyond traditional checkpoint approaches. As an allogeneic, off-the-shelf therapy, it represents a meaningful step toward delivering scalable, immediate immune engagement for patients who currently have few effective options,” said Jennifer Buell, PhD, President and CEO of MiNK Therapeutics.

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse.

Its lead candidate, AgenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments.

About MiNK-215
MiNK-215 is engineered to eliminate FAP-positive cancer-associated fibroblasts (CAFs)—the cells that build the dense, immunosuppressive stroma blocking immune infiltration in solid tumors and contributing heavily to immunotherapy failure. Using MiNK’s proprietary allogeneic platform, MiNK-215 also secretes IL-15 to enhance persistence, immune activation, and durability.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for AgenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law.

Contacts

Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com
Source: MiNK Therapeutics

MiNK Therapeutics Announces New Data Showing MiNK-215 Drives Potent Anti-Tumor Activity in Treatment-resistant Solid Tumors

MiNK Therapeutics Announces New Data Showing MiNK-215 Drives Potent Anti-Tumor Activity in Treatment-resistant Solid Tumors




MiNK Therapeutics Announces New Data Showing MiNK-215 Drives Potent Anti-Tumor Activity in Treatment-resistant Solid Tumors

  • MiNK-215, an IL-15 armoured FAP-targeting CAR-iNKT, targets and clears tumor-protective FAP+ fibroblasts to allow immune cells to infiltrate and kills cancer cells
  • Activates multiple immune pathways to generate potent, lasting anti-tumor activity in lung and MSS colorectal cancer models

NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced the publication of new preclinical data for MiNK-215, a novel, next-generation FAP-targeting, IL-15–enhanced CAR-iNKT therapy. The manuscript, titled The allogeneic FAP-CAR-IL15 iNKT therapy MiNK-215 remodels the tumor stroma to enhance antitumor immunity”, is now available on Cancer Immunology Research website here.

MiNK-215 is engineered to eliminate FAP-positive cancer-associated fibroblasts (CAFs)—the cells that build the dense, immunosuppressive stroma blocking immune infiltration in solid tumors and contributing heavily to immunotherapy failure. Using MiNK’s proprietary allogeneic platform, MiNK-215 also secretes IL-15 to enhance persistence, immune activation, and durability.

Key Findings: MiNK-215 tackles the two fundamental barriers: the physical stroma that blocks immune entry and the dysfunctional immune circuitry inside the tumor. Specifically,

  • Dismantles the protective stromal barrier and selectively eliminates FAP+ cancer-associated fibroblasts, clearing the path for robust immune infiltration.
  • Reprograms the immune landscape in preclinical models of refractory lung and MSS colon cancer liver metastases, MiNK-215:
    • Remodeled the tumor microenvironment
    • Activated dendritic cells and antigen-presentation pathways
    • Re-polarized macrophages to pro-inflammatory, cancer killing state
    • Enabled deep infiltration of tumor-specific T cells

As an “off-the-shelf” therapy, MiNK-215 can be manufactured at scale and delivered on demand—offering a new therapeutic strategy for patients with solid tumors that have long been unresponsive to checkpoint inhibitors and other immune-based treatments.

“The findings published today underscore the real potential of MiNK-215 to reshape how we treat solid tumors that have resisted immunotherapy for decades. By dismantling the fibroblast barriers that shield these cancers and activating multiple arms of the immune system, MiNK-215 goes beyond traditional checkpoint approaches. As an allogeneic, off-the-shelf therapy, it represents a meaningful step toward delivering scalable, immediate immune engagement for patients who currently have few effective options,” said Jennifer Buell, PhD, President and CEO of MiNK Therapeutics.

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse.

Its lead candidate, AgenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments.

About MiNK-215
MiNK-215 is engineered to eliminate FAP-positive cancer-associated fibroblasts (CAFs)—the cells that build the dense, immunosuppressive stroma blocking immune infiltration in solid tumors and contributing heavily to immunotherapy failure. Using MiNK’s proprietary allogeneic platform, MiNK-215 also secretes IL-15 to enhance persistence, immune activation, and durability.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for AgenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law.

Contacts

Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com
Source: MiNK Therapeutics

Channel Medsystems Appoints Robert Brown, MBA, CPA, as Chief Financial Officer

Channel Medsystems Appoints Robert Brown, MBA, CPA, as Chief Financial Officer




Channel Medsystems Appoints Robert Brown, MBA, CPA, as Chief Financial Officer

BERKELEY, Calif., Nov. 20, 2025 (GLOBE NEWSWIRE) — Channel Medsystems, Inc., a privately held company dedicated to advancing women’s health with innovative solutions, announced today the appointment of Robert Brown, MBA, CPA, as Chief Financial Officer.

Mr. Brown is a seasoned financial executive with deep expertise in strategic finance, operations, and growth planning for healthcare and medtech organizations. As an MBA and CPA, he brings the combination of strong financial acumen, regulatory rigor, and business leadership needed to guide high-growth companies in regulated industries.

Before joining Channel, Mr. Brown held senior financial roles across medtech and life sciences firms, where he built scalable financial infrastructure, led fundraising and M&A efforts, and aligned financial operations with commercialization goals.

“We’re thrilled to bring Robert on board,” said Nelson Whistance, President and Chief Executive Officer of Channel Medsystems. “His credentials and track record in financial leadership will be invaluable as we scale our operations and expand access to the Cerene® Cryotherapy Device.”

“I am honored to join Channel Medsystems at such a transformative moment,” said Robert Brown, MBA, CPA. “I believe deeply in Channel Medsystems’ mission to transform women’s healthcare. I look forward to supporting growth, strengthening financial operations, and helping advance broader access to safe and effective therapies.”

With Mr. Brown’s appointment, Channel Medsystems strengthens its executive team’s financial leadership to support sustained growth and strategic execution.

About Channel Medsystems
Channel Medsystems is a privately held company dedicated to transforming women’s healthcare globally through the development and commercialization of its flagship product, the Cerene® Cryotherapy Device. Cerene is a non-hormonal, incision-free treatment designed to provide safe, effective, and convenient therapy for women suffering from heavy menstrual bleeding (HMB) and dysmenorrhea. Offering a modern alternative to invasive surgery or long-term medications, Channel Medsystems is committed to improving patient outcomes, broadening access, and empowering women with greater control over their care.

For more information, visit cerene.com and follow us on LinkedIn.

Media Contact:
Tara Murphy
Vice President, Marketing
Channel Medsystems
tmurphy@cerene.com                                                                                                 
215-620-3004

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/65a78797-c385-4a5c-913b-5b17216e8d81

Channel Medsystems Appoints Robert Brown, MBA, CPA, as Chief Financial Officer

Channel Medsystems Appoints Robert Brown, MBA, CPA, as Chief Financial Officer




Channel Medsystems Appoints Robert Brown, MBA, CPA, as Chief Financial Officer

BERKELEY, Calif., Nov. 20, 2025 (GLOBE NEWSWIRE) — Channel Medsystems, Inc., a privately held company dedicated to advancing women’s health with innovative solutions, announced today the appointment of Robert Brown, MBA, CPA, as Chief Financial Officer.

Mr. Brown is a seasoned financial executive with deep expertise in strategic finance, operations, and growth planning for healthcare and medtech organizations. As an MBA and CPA, he brings the combination of strong financial acumen, regulatory rigor, and business leadership needed to guide high-growth companies in regulated industries.

Before joining Channel, Mr. Brown held senior financial roles across medtech and life sciences firms, where he built scalable financial infrastructure, led fundraising and M&A efforts, and aligned financial operations with commercialization goals.

“We’re thrilled to bring Robert on board,” said Nelson Whistance, President and Chief Executive Officer of Channel Medsystems. “His credentials and track record in financial leadership will be invaluable as we scale our operations and expand access to the Cerene® Cryotherapy Device.”

“I am honored to join Channel Medsystems at such a transformative moment,” said Robert Brown, MBA, CPA. “I believe deeply in Channel Medsystems’ mission to transform women’s healthcare. I look forward to supporting growth, strengthening financial operations, and helping advance broader access to safe and effective therapies.”

With Mr. Brown’s appointment, Channel Medsystems strengthens its executive team’s financial leadership to support sustained growth and strategic execution.

About Channel Medsystems
Channel Medsystems is a privately held company dedicated to transforming women’s healthcare globally through the development and commercialization of its flagship product, the Cerene® Cryotherapy Device. Cerene is a non-hormonal, incision-free treatment designed to provide safe, effective, and convenient therapy for women suffering from heavy menstrual bleeding (HMB) and dysmenorrhea. Offering a modern alternative to invasive surgery or long-term medications, Channel Medsystems is committed to improving patient outcomes, broadening access, and empowering women with greater control over their care.

For more information, visit cerene.com and follow us on LinkedIn.

Media Contact:
Tara Murphy
Vice President, Marketing
Channel Medsystems
tmurphy@cerene.com                                                                                                 
215-620-3004

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/65a78797-c385-4a5c-913b-5b17216e8d81

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review




Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

New release introduces unparalleled digital medical history and clinical intake capabilities, supporting hospitals, employers, individuals, families, and health insurers—and opens limited Showcase Partner slots for a forthcoming national TV appearance.

Aliso Viejo, CA, Nov. 20, 2025 (GLOBE NEWSWIRE) — Galacxia Inc., creator of the Life Backup Plan Interoperable Lifecare Platform, today announces a new version featuring a first-of-its-kind, comprehensive, standardized digital health patient workflow. The enhancement helps clinicians, hospitals, employers, individuals, families, caregivers, and health insurers collect robust medical and lifestyle information quickly. This improves safety, reduces delays, and strengthens decision-making across the entire care continuum.

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

Sandy Eulitt, founder and CEO of Galacxia Inc., works on the Life Backup Plan Interoperable Lifecare(TM) digital health platform.

The release coincides with Medicare Open Enrollment Season (October 15 through December 7) and the annual period when employers, hospitals, and health insurers finalize their benefit offerings for the coming year.

A comprehensive intake workflow that helps clinicians diagnose faster

Organizing the vital details clinicians most rely on: medications, surgical, family, and medical history, allergies, and symptoms, Life Backup Plan integrates with EHR systems, reducing healthcare workload and simplifying access to essential patient information.

“While recently recovering from cervical spine surgery, I used Life Backup Plan to check on me, medication tracking, and symptom monitoring.” reflected Sandy Eulitt, founder and CEO of Galacxia Inc. “Managing a post-operative infection, with numerous clinical visits, home health care, wound care, supply orders, medication changes, and nearly two emergency room visits, this new version extrapolates my personal experience into a clinically aligned system which gives providers the tools they need to deliver more connected care.”

Hospitals will benefit significantly from the enhancement. Through comprehensive post-discharge monitoring and reduced information gaps, Life Backup Plan helps organizations lower readmissions, strengthen JCAHO performance, improve care coordination, and reduce CMS penalties associated with preventable readmissions.

Clinician-approved approach to interoperability

“From a clinical operations standpoint, Life Backup Plan addresses a longstanding gap in healthcare: patient-driven interoperability,” said Dr. Allison Lamont, Chief Medical Officer of Life Backup Plan. “By aligning the platform with the standard intake information physicians rely upon, it improves the accuracy of clinical data, supports safer decision-making, and reduces inefficiencies across the system. It’s a practical, scalable solution that strengthens both care quality and continuity.”

Support for seniors, caregivers, and families—without limiting the platform’s reach

“In my work helping seniors choose Medicare coverage, I see how overwhelmed people of all ages feel—not because they lack ability, but because the healthcare system is so fragmented,” said Meredith Skurkey, a Medicare Advantage specialist. “Life Backup Plan is the first tool I’ve seen that brings medications, history, safety tools, and vital documents together in one secure, easy-to-use platform. It gives my clients clarity, confidence, and peace of mind—and helps them stay healthier and independent longer.”

Health insurance adjacent benefits

The platform reduces absenteeism and employee distraction by identifying and responding to illnesses and emergencies earlier. It also supports workers who care for aging parents or young children, resulting in improved productivity and fewer health and/or safety related disruptions.

Universal health and safety tool

Although the timing coincides with Open Enrollment, the platform remains universally beneficial for people of all ages. It supports anyone who may be by themselves at any time, including individuals living alone, outdoor enthusiasts, travelers, women, singles, and parents who want reassurance that their children arrived home safely. Whether someone is hanging Christmas lights, moving boxes, showering while home alone, or navigating safety risks that disproportionately affect women, the app provides a reliable safety net during falls, safety concerns, or medical emergencies.

Business Today Showcase Partner opportunity

Life Backup Plan will be featured in a “Maximizing the Healthcare Journey” segment on Business Today with Bill and Giuliana Rancic. The segment tapes in January, 2026, with the episode airing in March 2026. Galacxia Inc. is announcing a Showcase Partner Program for organizations that would like to be filmed on site and featured during the broadcast. Partners may also appear in short-form video reels, podcast content, social media, and related media packages. Interested organizations should contact Sandy Eulitt.

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

Official Business Today with Bill and Giuliana Rancic promotional artwork, provided for use in advance of the Life Backup Plan feature segment.

About Life Backup Plan by Galacxia, Inc

Life Backup Plan is a first-of-its-kind, interoperable digital health and safety platform built around the Five M’s of Health and Safety™: Monitoring, Medicine, Metrics, Money, and Membership. The platform provides early detection and rapid response for both illness and emergencies through intelligent check-ins, symptom tracking, medication logs, and passive alert escalation. These capabilities lower healthcare costs by identifying issues sooner, improving diagnostic speed, and enabling earlier intervention before complications develop. For emergent or non-emergent medical interaction, Life Backup Plan centralizes digital medical history, clinical intake data, allergies, family and surgical history, risk factors, and other essential health information in one secure, patient-managed system. This gives first responders, healthcare workers, and care teams immediate access to accurate, organized data that strengthens decision-making and improves care coordination across hospitals, outpatient care, home-based care, and recovery settings. Designed for people of all ages and lifestyles, Life Backup Plan supports individuals, families, aging in place, caregiving, disability support, post-discharge monitoring, women’s safety, dating and travel safety, outdoor recreation, and domestic violence and human trafficking prevention. The platform delivers health-insurance–adjacent benefits for employers by reducing absenteeism, minimizing avoidable health events, and supporting employees who care for aging parents or young children. Its comprehensive design helps hospitals, employers, insurers, and public agencies reduce preventable complications, lower costs, and improve safety, independence, and continuity of care for the people they serve.

Press inquiries

Life Backup Plan by Galacxia, Inc
https://www.lifebackupplan.com
Sandy Eulitt
founder@lifebackupplan.com
8588480860
49 El Prado Lane, Oceanside, CA 92058

A video accompanying this announcement is available at: https://www.youtube.com/embed/eNg74k-t2l4

 

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review




Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

New release introduces unparalleled digital medical history and clinical intake capabilities, supporting hospitals, employers, individuals, families, and health insurers—and opens limited Showcase Partner slots for a forthcoming national TV appearance.

Aliso Viejo, CA, Nov. 20, 2025 (GLOBE NEWSWIRE) — Galacxia Inc., creator of the Life Backup Plan Interoperable Lifecare Platform, today announces a new version featuring a first-of-its-kind, comprehensive, standardized digital health patient workflow. The enhancement helps clinicians, hospitals, employers, individuals, families, caregivers, and health insurers collect robust medical and lifestyle information quickly. This improves safety, reduces delays, and strengthens decision-making across the entire care continuum.

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

Sandy Eulitt, founder and CEO of Galacxia Inc., works on the Life Backup Plan Interoperable Lifecare(TM) digital health platform.

The release coincides with Medicare Open Enrollment Season (October 15 through December 7) and the annual period when employers, hospitals, and health insurers finalize their benefit offerings for the coming year.

A comprehensive intake workflow that helps clinicians diagnose faster

Organizing the vital details clinicians most rely on: medications, surgical, family, and medical history, allergies, and symptoms, Life Backup Plan integrates with EHR systems, reducing healthcare workload and simplifying access to essential patient information.

“While recently recovering from cervical spine surgery, I used Life Backup Plan to check on me, medication tracking, and symptom monitoring.” reflected Sandy Eulitt, founder and CEO of Galacxia Inc. “Managing a post-operative infection, with numerous clinical visits, home health care, wound care, supply orders, medication changes, and nearly two emergency room visits, this new version extrapolates my personal experience into a clinically aligned system which gives providers the tools they need to deliver more connected care.”

Hospitals will benefit significantly from the enhancement. Through comprehensive post-discharge monitoring and reduced information gaps, Life Backup Plan helps organizations lower readmissions, strengthen JCAHO performance, improve care coordination, and reduce CMS penalties associated with preventable readmissions.

Clinician-approved approach to interoperability

“From a clinical operations standpoint, Life Backup Plan addresses a longstanding gap in healthcare: patient-driven interoperability,” said Dr. Allison Lamont, Chief Medical Officer of Life Backup Plan. “By aligning the platform with the standard intake information physicians rely upon, it improves the accuracy of clinical data, supports safer decision-making, and reduces inefficiencies across the system. It’s a practical, scalable solution that strengthens both care quality and continuity.”

Support for seniors, caregivers, and families—without limiting the platform’s reach

“In my work helping seniors choose Medicare coverage, I see how overwhelmed people of all ages feel—not because they lack ability, but because the healthcare system is so fragmented,” said Meredith Skurkey, a Medicare Advantage specialist. “Life Backup Plan is the first tool I’ve seen that brings medications, history, safety tools, and vital documents together in one secure, easy-to-use platform. It gives my clients clarity, confidence, and peace of mind—and helps them stay healthier and independent longer.”

Health insurance adjacent benefits

The platform reduces absenteeism and employee distraction by identifying and responding to illnesses and emergencies earlier. It also supports workers who care for aging parents or young children, resulting in improved productivity and fewer health and/or safety related disruptions.

Universal health and safety tool

Although the timing coincides with Open Enrollment, the platform remains universally beneficial for people of all ages. It supports anyone who may be by themselves at any time, including individuals living alone, outdoor enthusiasts, travelers, women, singles, and parents who want reassurance that their children arrived home safely. Whether someone is hanging Christmas lights, moving boxes, showering while home alone, or navigating safety risks that disproportionately affect women, the app provides a reliable safety net during falls, safety concerns, or medical emergencies.

Business Today Showcase Partner opportunity

Life Backup Plan will be featured in a “Maximizing the Healthcare Journey” segment on Business Today with Bill and Giuliana Rancic. The segment tapes in January, 2026, with the episode airing in March 2026. Galacxia Inc. is announcing a Showcase Partner Program for organizations that would like to be filmed on site and featured during the broadcast. Partners may also appear in short-form video reels, podcast content, social media, and related media packages. Interested organizations should contact Sandy Eulitt.

Life Backup Plan Rolls Out New Version During Medicare Open Enrollment Season and Employer Benefits Review

Official Business Today with Bill and Giuliana Rancic promotional artwork, provided for use in advance of the Life Backup Plan feature segment.

About Life Backup Plan by Galacxia, Inc

Life Backup Plan is a first-of-its-kind, interoperable digital health and safety platform built around the Five M’s of Health and Safety™: Monitoring, Medicine, Metrics, Money, and Membership. The platform provides early detection and rapid response for both illness and emergencies through intelligent check-ins, symptom tracking, medication logs, and passive alert escalation. These capabilities lower healthcare costs by identifying issues sooner, improving diagnostic speed, and enabling earlier intervention before complications develop. For emergent or non-emergent medical interaction, Life Backup Plan centralizes digital medical history, clinical intake data, allergies, family and surgical history, risk factors, and other essential health information in one secure, patient-managed system. This gives first responders, healthcare workers, and care teams immediate access to accurate, organized data that strengthens decision-making and improves care coordination across hospitals, outpatient care, home-based care, and recovery settings. Designed for people of all ages and lifestyles, Life Backup Plan supports individuals, families, aging in place, caregiving, disability support, post-discharge monitoring, women’s safety, dating and travel safety, outdoor recreation, and domestic violence and human trafficking prevention. The platform delivers health-insurance–adjacent benefits for employers by reducing absenteeism, minimizing avoidable health events, and supporting employees who care for aging parents or young children. Its comprehensive design helps hospitals, employers, insurers, and public agencies reduce preventable complications, lower costs, and improve safety, independence, and continuity of care for the people they serve.

Press inquiries

Life Backup Plan by Galacxia, Inc
https://www.lifebackupplan.com
Sandy Eulitt
founder@lifebackupplan.com
8588480860
49 El Prado Lane, Oceanside, CA 92058

A video accompanying this announcement is available at: https://www.youtube.com/embed/eNg74k-t2l4