CLINUVEL to advance novel pharmaceutical formulations in preclinical program




CLINUVEL to advance novel pharmaceutical formulations in preclinical program

Next generation sustained-release formulations for a variety of peptides

Executive summary

• first biocompatible pharmaceutical formulations progress to preclinical models
• new sustained-release drug delivery platforms for peptides, melanocortins
• aim to predict drug release kinetics from new formulations
• liquid formulation allows flexible dosing through adjusting injection volumes
• perseverance during 10 years of in-house research

MELBOURNE, Australia, Sept. 28, 2025 (GLOBE NEWSWIRE) — CLINUVEL today announced that it is advancing new sustained-release liquid drug formulations in a preclinical program evaluating various drug release profiles. A decade of investment in fundamental research & development in CLINUVEL’s fully-owned Singaporean laboratories (VALLAURIX) has provided positive, consistent results demonstrating the potential for depot formulations to extend the duration of release of peptide drugs.

Investment in novel drug delivery systems

CLINUVEL’s formulation development has sought to lengthen the duration of time that peptides are detectable in blood levels and arrive at predictable kinetics – optimising patient exposure to active pharmaceutical ingredients while minimising dosing to achieve therapeutic effects. The advantage of the chosen biocompatible formulations under review is to facilitate flexible dosing by adjusting the injection volume for delivery of peptides to infants, children and adults according to body weight.

If the technology is confirmed in vivo, the new depot formulations would serve as a platform for the delivery of various peptides, with an initial focus on melanocortins.

The preclinical program for the first formulations is expected to complete in the second half of 2026.

Commentary

“It has been challenging to realise the journey from drug delivery concepts to effective formulations containing the right drug loading, but recent reproducible in vitro results at VALLAURIX have given us confidence to pursue the preclinical program,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.

“We have selected multiple drug product candidates for preclinical evaluation, after which decisions on manufacturing of the products for human evaluation can be made. Perseverance seems to have been justified by current results of an adaptable platform that can be tailored for different release profiles and clinical needs.

“We have progressed research in a cost-effective manner, with an approach that may provide substantial options for drug delivery in general.”

About CLINUVEL PHARMACEUTICALS LIMITED

CLINUVEL (ASX: CUV; ADR LEVEL I: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives.

CLINUVEL’s lead therapy, SCENESSE^® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to https://www.clinuvel.com.

Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD.

Head of Investor Relations

Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD

Investor Enquiries

https://www.clinuvel.com/investors/contact-us

Forward-Looking Statements

This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. All statements other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “foresee,” “intend,” “likely,” “may,” “objective,” “potential,” “plan,” “predict,” “project,” “seek,” “should,” “will” and similar words or phrases and their negatives. Forward-looking statements reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products; competition for our products, especially SCENESSE^® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA^®, NEURACTHEL^® or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE^®, CYACÊLLE, PRÉNUMBRA^®, NEURACTHEL^® or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran’s Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology, cosmetic and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2025 Annual Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.

Contact:
Tel: +61 3 9660 4900
Fax: +61 3 9660 4909
Email: mail@clinuvel.com

“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China




“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China

TOKYO and CAMBRIDGE, Mass., Sept. 28, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI^®” (brand name in China: “乐意保^®”, generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China.

In January 2024, LEQEMBI was approved for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in China. After 18 months of a dosing regimen of 10 mg/kg once every two weeks during initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued.

AD is a progressive, relentless disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. It is caused by a continuous underlying neurotoxic process that begins before amyloid plaque accumulation and continues after plaque removal.^1,2,3,4 The data show that Aβ protofibrils^* and tau tangles play roles in the neurodegeneration process,^2,3 and LEQEMBI is the only approved therapy that fights AD in two ways — targeting both amyloid plaque and protofibrils, which can impact tau downstream.

Eisai estimates that, as of 2024, there were 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to increase with the aging of the population.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In China, Eisai distributes the product and conducts information provision activities through specialized Medical Representatives.

References

1. Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer’s disease at Clinical Trials on Alzheimer’s Disease (CTAD) conference. Available at: https://www.eisai.co.jp/news/2022/news202285.html
2. Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer’s disease. Mol Psychiatry. 2021;26(10):5481-5503.
3. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
4. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
5. van Dyck. C, et al. Lecanemab in Early Alzheimer’s Disease. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2212948. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

Larimar Therapeutics Announces Conference Call on the Nomlabofusp Program for the Treatment of Friedreich’s Ataxia




Larimar Therapeutics Announces Conference Call on the Nomlabofusp Program for the Treatment of Friedreich’s Ataxia

Conference call and webcast on Monday, September 29, 2025 at 8:00 am EDT

BALA CYNWYD, Pa., Sept. 28, 2025 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the Company will host a conference call and webcast to discuss updates for the Company’s nomlabofusp clinical development program including data from the ongoing long-term open label study for the treatment of Friedreich’s ataxia on Monday, September 29, 2025 at 8:00 am EDT.

Conference Call and Webcast Details
To access the webcast on Monday, September 29, 2025 at 8:00 am EDT, please visit this link to the event. To participate by phone, please dial 1-877-407-9716 (domestic) or 1-201-493-6779 (international) and refer to conference ID 13756144 or click on this link and request a return call. Following the live event, an archived webcast will be available on the “Events & Presentations” page of the Larimar website.

About Larimar Therapeutics
Larimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Larimar’s lead compound, nomlabofusp, is being developed as a potential treatment for Friedreich’s ataxia. Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds. For more information, please visit: https://larimartx.com.

Forward-Looking Statements
This press release contains forward-looking statements that are based on Larimar’s management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including but not limited to statements regarding Larimar’s ability to develop and commercialize nomlabofusp and any other planned product candidates, Larimar’s planned research and development efforts, including the timing of its nomlabofusp clinical trials, interactions and filings with the FDA, expectations regarding potential for accelerated approval or accelerated access and time to market and overall development plans and other matters regarding Larimar’s business strategies, ability to raise capital, use of capital, results of operations and financial position, and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others, the success, cost and timing of Larimar’s product development activities, nonclinical studies and clinical trials, including nomlabofusp clinical milestones and continued interactions with the FDA; that preliminary clinical trial results may differ from final clinical trial results, that earlier non-clinical and clinical data and testing of nomlabofusp may not be predictive of the results or success of later clinical trials, and assessments; that the FDA may not ultimately agree with Larimar’s nomlabofusp development strategy; the potential impact of public health crises on Larimar’s future clinical trials, manufacturing, regulatory, nonclinical study timelines and operations, and general economic conditions; Larimar’s ability and the ability of third-party manufacturers Larimar engages, to optimize and scale nomlabofusp’s manufacturing process; Larimar’s ability to obtain regulatory approvals for nomlabofusp and future product candidates; Larimar’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators, and to successfully commercialize any approved product candidates; Larimar’s ability to raise the necessary capital to conduct its product development activities; and other risks described in the filings made by Larimar with the Securities and Exchange Commission (SEC), including but not limited to Larimar’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. These forward-looking statements are based on a combination of facts and factors currently known by Larimar and its projections of the future, about which it cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent Larimar’s management’s views only as of the date hereof. Larimar undertakes no obligation to update any forward-looking statements for any reason, except as required by law.

Investor Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
(212) 915-2569

Company Contact:
Michael Celano
Chief Financial Officer
mcelano@larimartx.com
(484) 414-2715

MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab




MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab

• VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16
• Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary analysis and a treatment policy strategy to test the robustness of the results: difference between the two methods relates to the statistical handling of intercurrent events
• In the combined VELA program, patients treated with sonelokimab experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001)
• In VELA-1, sonelokimab achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001)
• In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053)
• The pre-specified treatment policy strategy provides for the analysis of data irrespective of intercurrent events; using this analysis, a statistically significant HiSCR75 at week 16 in VELA-1 and VELA-2 was achieved with sonelokimab (35% and 36%, respectively) vs placebo (18% and 26%, respectively); clinically meaningful and statistically significant benefit was also observed for all key secondary endpoints (Table 2)
• Sonelokimab continued to show a favourable safety profile with no new safety signals detected, including an absence of key events of interest such as suicidal ideation and behavior
• VELA progresses to its pre-specified week 52 readout and the Company will now seek to confirm the path to registration in HS with the appropriate regulatory authorities
• Other clinical studies with sonelokimab, including the Phase 3 VELA-TEEN trial in adolescent HS, the Phase 3 IZAR program and the Phase 2 P-OLARIS trial in psoriatic arthritis (PsA), the Phase 2 LEDA trial in palmoplantar pustulosis (PPP), and the Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA), continue as planned and are expected to support a catalyst-rich roadmap
• The Company will hold a webcast on Monday, September 29 at 2pm CET / 8am EDT (link below)

ZUG, Switzerland, September 28, 2025 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced the week 16 results of the Phase 3 VELA-1 and VELA-2 trials of its registrational global program in patients with moderate-to-severe hidradenitis suppurativa (HS).

The VELA program used the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. Key secondary endpoints included the percentage of participants achieving HiSCR50 and the percentage of patients achieving a Dermatology Quality of Life Index (DLQI) total score reduction of >4 (minimal clinically important difference), among participants with a baseline DLQI >4, as well as other scores that reflect the evolving needs of HS patients, treating physicians and regulators. These included the percentage of participants achieving at least a 55% reduction in the International HS Severity Scoring System (IHS4-55), the percentage of participants achieving at least a 3 point improvement from baseline in the worst pain Numerical Rating Scale (NRS) among participants with a baseline score of at least 3 points, and the change from baseline in the HS-specific Quality of Life score (HiSQOL). A total of 838 patients were enrolled across both trials. The trials were identical in design comparing a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at week 16. From week 16, all patients receive the 120mg dose of sonelokimab through to 48 weeks, with a last assessment at week 52, followed by an open-label extension for up to two years. The Phase 3 program used a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS. The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. Data in this press release is presented using the aforementioned analysis strategies, as indicated throughout. The baseline characteristics for VELA-1 and VELA-2 are shown in Table 1.

TABLE 1

In the combined Phase 3 VELA program, all endpoints reached statistical significance with p-values below 0.001, including lesion counts and patient reported outcomes (PROs), as per Table 2. Sonelokimab demonstrated the expected profile of response over time, with statistically significant HiSCR75 for both studies achieved as early as week 4 (Table 3). A preliminary analysis suggests that responses continue to improve beyond week 16 and that placebo patients crossing over at week 16 achieve similar responses to those originally randomized to the sonelokimab 120mg arm, as of week 20 (pre-specified analysis, data not shown).

Using the treatment policy strategy as per protocol, both VELA-1 and VELA-2 showed a statistically significant increase in the percentage of participants achieving HiSCR75 at week 16 and provided a clinically meaningful benefit (Table 2). Response rates for sonelokimab 120mg were consistent between the two trials, with 34.8% and 35.9% of patients in VELA-1 and VELA-2 achieving HiSCR75 at week 16, respectively. The placebo response rate in VELA-1 of 17.5% at week 16 was within the historical Phase 3 range of 13% to 18%. The placebo response rate in VELA-2 of 25.6% at week 16 was higher than expected.

Both VELA-1 and VELA-2 achieved statistical significance for all key secondary endpoints (Table 2). This includes other lesion count based endpoints (HiSCR50 and IHS4-55). It also includes relevant PROs in HS. Around 30% of patients experienced a marked reduction of pain, as measured by an at least 3-point improvement in the worst pain NRS, in both VELA-1 and VELA-2 (p≤0.002). Sonelokimab showed a significant improvement of HiSQOL score at week 16 (p<0.001), which was consistent between VELA-1 and VELA-2. Almost 60% of patients achieved a meaningful (4 points or more) improvement of DLQI, an approximately 20 percentage-point benefit over placebo (p≤0.001).

Overall, the week 16 endpoint results using the treatment policy strategy were as follows:

TABLE 2

Note 1: ITT, pre-specified treatment policy strategy
Note 2: Across the VELA program all deltas to placebo vary between treatment policy and composite strategy by less than 1.5 percentage points (HiSQOL varies by less than 0.5 points)
Note 3: For VELA-1 and VELA-2, using composite strategy, all primary and key secondary endpoints achieved p<0.025 except for VELA-2 primary endpoint (HiSCR75, p=0.053); control for multiple testing was only performed within the composite strategy testing for VELA-1 and VELA-2 individually. Statistical significance refers to analyses where p<0.05, in both multiplicity and non-multiplicity controlled strategies
Note 4: “Pain NRS 3pt “ refers to Worst Pain NRS reduction of at least 3 points; “CFB” refers to mean change from baseline; “MCID” refers to minimally clinically important difference which reflects a reduction of at least 4 points in the score

The percentage of participants achieving HS Clinical Response (HiSCR) 75 at different timepoints was as follows:

TABLE 3

Note 1: ITT, pre-specified treatment policy strategy (time points other than week 16 were pre-specified Other secondary endpoints)
Note 2: Multiplicity control was only applied for testing of the primary and key secondary endpoints at week 16 by composite strategy in VELA-1 and VELA-2 individually. Statistical significance refers to analyses where p<0.05, in both multiplicity and non-multiplicity controlled strategies

The safety profile of sonelokimab was consistent with previously reported studies with no new safety signals observed. This includes the absence of new signals in key events of interest with IL-17A and F therapies: Suicidal Ideation and Behavior, hepatic events, IBD and non-infectious diarrhea, MACE and Eczema and Dermatitis (Table 4).

TABLE 4

1 Most frequent TEAEs excluding safety topics of interest (as presented separately in this table) and one TEAEs to maintain blinding of the ongoing VELA studies 2 AESI, events in adjudication; 3 AESI; 4 there were three cases of oesophageal candida and two cases of oropharyngeal candida on SLK; 5 PTs eczema and dermatitis; 6 Reported adverse events, 7 Hepatic events (all hepatic AEs and laboratory investigations in adjudication to possible DILI); 8 Events in adjudication

Overall, the Company believes that sonelokimab continues to show a favorable safety profile, with no new safety signals detected and a competitive outlook. The VELA program is conducted using a convenient sub-cutaneous dosing scheme with 1ml volume delivered every other week to week 6 in the induction phase (4 injections), and monthly from week 8 for maintenance, with no up-titration. This profile is matched by improvements of HS lesions, including draining tunnels, as well as in all key Patient Reported Outcomes (PROs), such as quality-of-life and pain scores, that are meaningful for HS patients and their treating physicians.

   
Prof. Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: “We are encouraged by the results of VELA-1, which follow the expected performance of sonelokimab in all the important metrics for patients and treating physicians. The higher-than-expected placebo response rate in VELA-2 is disappointing but we are encouraged by the consistent performance of sonelokimab arms across all endpoints in both studies. We are pleased to see a favorable safety profile consistent with previous studies, with no new safety signals. We believe that this, together with the convenient dosing, the efficacy data in the lesion-based metrics and the patient reported outcomes, shows the potential for a promising profile of sonelokimab in HS. Patients with HS are in desperate need of new treatment options and we remain committed to our path forward in HS.”

These interim results will now be discussed with the appropriate regulators, including the analytical strategies considering the higher-than-expected placebo response rate in VELA-2 at week 16 and path to submission of a Biologics License Application.

The Company continues to progress with the development of its Nanobody^® sonelokimab across a portfolio of indications, including:

• Q4 2025: Primary endpoint readout of the Phase 2 LEDA trial in PPP
• Q1 2026: Primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA
• Q2 2026: 52 weeks data of the VELA-1 and VELA-2 trials in HS
• H1 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS
• H1 2026: Primary endpoint readout of Phase 3 IZAR program in PsA

The Company will hold a webcast on Monday 29th of September at 2pm CET / 8am EDT. Link to the webcast, a replay of it and the presentation document will be made available at https://ir.moonlaketx.com.

Sonelokimab is not yet approved for use in any indication.

-Ends-

About MoonLake Immunotherapeutics

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody^® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com.

About Nanobodies^®

Nanobodies^® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies^® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations.

The terms Nanobody^® and Nanobodies^® are trademarks of Ablynx, a Sanofi company.

About Sonelokimab

Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody^® consisting of three variable regions of heavy-chain-only antibodies domains (VHHs) covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.

Sonelokimab is being assessed in two lead indications, hidradenitis suppurative (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmo-plantar pustulosis (PPP) and axial spondyloarthritis (axSpA).

For adults with HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected.

Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS.

For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody^® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected.

Sonelokimab is also being assessed in the Phase 2 LEDA trial, which is ongoing for PPP, a debilitating inflammatory skin condition affecting a significant number of patients.

Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS trial for active axSpA. The trial features an innovative design complementing traditional clinical outcomes with cellular imaging techniques.

Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).

In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203).

About the VELA program

The Phase 3 VELA program has enrolled over 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody^® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials will also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. Data in this press release is presented using the aforementioned analysis strategies, as indicated throughout. Further details are available under NCT06411379 and NCT06411899 at ClinicalTrials.gov.

About the VELA-TEEN trial

The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-40 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at ClinicalTrials.gov.

About Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the US indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity.

About the IZAR Program

IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at ClinicalTrials.gov.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology.

About the S-OLARIS trial

S-OLARIS is an open-label Phase 2 proof-of-concept trial aiming to investigate sonelokimab 60mg administered subcutaneously in approximately 25 patients with active axial spondylarthritis (axSpA). The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also includes an exploratory peripheral blood and tissue biomarker program.

About Axial Spondyloarthritis

Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies.

About the LEDA Trial

The LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls.

The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively.

About Palmoplantar Pustulosis

Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology.

Cautionary Statement Regarding Forward Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: trial design, plans for and timing of clinical trials; whether the regulatory agencies agree that the two statistical strategies, when reviewed together, provide substantial evidence of efficacy in the VELA program, recognizing that under the composite strategy, VELA-2 failed to show a statistically significant improvement over placebo at week 16 on the primary endpoint; enrollment for clinical trials, including the VELA-TEEN trial and the IZAR program; the efficacy and safety of sonelokimab for the treatment of adult HS, adolescent HS, PPP, PsA and axSpA, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs; the anticipated timing of the results from those studies and trials, and potential market opportunities for sonelokimab and MoonLake’s anticipated cash position. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.

Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that interim data in the VELA trials are not consistent with the final 52-week data, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates and reliance on third parties to conduct and support its preclinical studies and clinical trials and the other risks described in or incorporated by reference into MoonLake’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.

Contacts:

MoonLake Immunotherapeutics Media & Investors Relations

Carla Bretes, Director IR & External Communications

ir@moonlaketx.com

ICR Healthcare

Mary-Jane Elliott, Namrata Taak, Ashley Tapp

Tel: +44 (0) 20 3709 5700

MoonLake@ICRHealthcare.com

Acoramidis Begins to Reduce Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Patients with ATTR-CM




Acoramidis Begins to Reduce Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Patients with ATTR-CM

– By Month 1, numerically fewer cumulative events were observed with acoramidis compared to placebo

– Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH through Month 30 versus placebo with a 49% hazard reduction (p<0.0001)

– The difference in cumulative events increased progressively with results at Month 30 showing 53 events were avoided per 100 treated participants (95% CI:29–79)

PALO ALTO, Calif., Sept. 28, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, presented data from the ATTRibute-CM study showing that acoramidis reduced cumulative cardiovascular outcomes, including cardiovascular mortality (CVM) or recurrent cardiovascular-related hospitalizations (CVH), within the first month of treatment in patients with ATTR-CM. These data were presented in a Late Breaking Clinical Trials Oral Presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2025 and simultaneously published in Journal of the American College of Cardiology. Acoramidis is a selective, small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

“Acoramidis demonstrated early and sustained clinical efficacy on the totality of cumulative cardiovascular outcomes, where accrued events start to numerically diverge within the first month of treatment,” said Ahmad Masri, M.D., M.S. of Oregon Health & Science University. “As a practicing cardiologist, these findings are incredibly meaningful because it draws attention to the time-sensitive nature of transthyretin amyloidosis diagnosis and treatment initiation, where a safe and effective treatment such as acoramidis can potentially have an early effect on reducing patients’ risk of cardiovascular hospitalizations and events.”

Details from the late breaking oral presentation, Effect of Acoramidis on Recurrent and Cumulative Cardiovascular Outcomes in ATTR-CM: Exploratory Analysis from ATTRibute-CM, presented by Dr. Masri included:

• At Month 1, numerically fewer cumulative events were observed with acoramidis compared to placebo
• Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH through Month 30 versus placebo with a 49% hazard reduction (p<0.0001)
• The difference in cumulative events increased progressively with results at Month 30 showing 53 events were avoided per 100 treated participants (95% CI:29–79)
• In addition to the late breaking oral presentation, a simultaneous publication in Journal of the American College of Cardiology, with the same title as the presentation, noted the same details and also concluded that at Month 42, CVM was reduced with continuous acoramidis versus placebo-to-acoramidis with a hazard reduction of 45% (p=0.0011)

In addition to the late breaking oral presentation and simultaneous publication of the cumulative cardiovascular outcomes data from ATTRibute-CM, one oral presentation and three poster sessions were shared on the open-label extension data from ATTRibute-CM and real-world evidence. These findings included:

• Continuous Acoramidis Treatment Significantly Reduced Risk of All-cause Mortality and Cardiovascular-related Hospitalization at Month 42, in Patients with Wild-type And Variant Transthyretin Amyloidosis Cardiomyopathy, shared in an oral presentation by Lily Stern, M.D. of Cedars-Sinai Heart Institute
  • At Month 42, continuous acoramidis was associated with lower risk of all-cause mortality (ACM), first CVH, and ACM/first CVH vs placebo to acoramidis switch in both wild-type ATTR-CM and variant ATTR-CM, highlighting the importance of early and continuous acoramidis regardless of TTR genotype
• Acoramidis Mitigates the Rise in NT-proBNP Levels Observed with Placebo in Patients with Variant Transthyretin Amyloid Cardiomyopathy: Results from ATTRibute-CM, presented in a poster session by Nitasha Sarswat, M.D. of UChicago Medicine
  • In the variant ATTR-CM subpopulation from ATTRibute-CM, acoramidis consistently mitigated the rise in N-terminal pro-B-type natriuretic peptide (NT-proBNP) observed in the placebo variant group, with effects starting at Month 3, and continuing through Month 30. Considering the higher risk posed by variant ATTR-CM, these findings are especially relevant in addressing the distinct medical needs of the variant ATTR-CM patient population
• Effect of Acoramidis on Cardiac Conduction Abnormalities in Transthyretin Amyloid Cardiomyopathy, presented in a poster session by Brett W. Sperry, M.D. of Saint Luke’s Health System
  • In ATTRibute-CM, acoramidis treatment was associated with numerically lower percentages of participants with worsening, prolonged PR or QRS intervals at Month 24 and Month 30, compared with placebo. These observations are consistent with the slowing of ATTR-CM disease progression previously reported with acoramidis
• State-Level Differences in Incidence of Transthyretin Amyloid Cardiomyopathy in United States Veterans Persist After Introduction of Disease-Modifying Therapy, presented in a poster session by Sandesh Dev, M.D. of Arizona State University
  • The incidence of ATTR-CM in the U.S. Veteran population increased nationally in the setting of available treatment, possibly due to improved awareness in most states

Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and the UK Medicines and Healthcare Products Regulatory Agency with all labels specifying near-complete stabilization of TTR.

More data on the benefit of Attruby for ATTR-CM patients is planned for future medical meetings.

About Attruby™ (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio
BridgeBio Pharma (BridgeBio; NASDAQ:BBIO) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible.  For more information visit bridgebio.com and follow us on LinkedIn, Twitter, Facebook, Instagram, and YouTube.

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “potential,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements regarding the potential of acoramidis to have an early effect on reducing patients’ risk of cardiovascular hospitalizations and events, the timing of future data disclosures, and BridgeBio’s ongoing development pipeline, reflect BridgeBio’s current views about its plans, intentions, expectations, and strategies, which are based on the information currently available to BridgeBio and on assumptions it has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies as reflected in or suggested by these forward-looking statements are reasonable, it can give no assurance that such plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to: the risks associated with BridgeBio’s dependence on third parties for development; regulatory authorities requiring additional studies or data to support the continued or expanded commercialization of acoramidis; whether data and results meet regulatory requirements or are sufficient for continued development, review, or approval; and whether other regulatory agencies agree with BridgeBio’s strategies or data interpretations. These risks also include impacts from global health emergencies, such as delays in regulatory reviews and other activities, manufacturing and supply chain interruptions, adverse effects on healthcare systems, and disruption of the global economy; and the impacts of macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing inflation rates, and fluctuating interest rates on BridgeBio’s operations and expectations. Additional risks are described in the Risk Factors section of BridgeBio’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other filings with the U.S. Securities and Exchange Commission. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio’s management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these statements. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

BridgeBio Media Contact:
Bubba Murarka, Executive Vice President, Corporate Development
contact@bridgebio.com  
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
ir@bridgebio.com

Palisade Bio Announces Adjournment of Special Meeting of Stockholders Due to Lack of Quorum




Palisade Bio Announces Adjournment of Special Meeting of Stockholders Due to Lack of Quorum

Carlsbad, CA, Sept. 26, 2025 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a clinical-stage biopharmaceutical company advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that the Company’s special meeting of stockholders held on September 26, 2025 at 10:00 a.m. Pacific Time was convened and adjourned, without any business being conducted, due to lack of the required quorum.

A quorum consists of one-third of the outstanding shares of the Company’s common stock entitled to vote at the special meeting. There were fewer than one-third of outstanding shares of the Company’s common stock entitled to vote present, either in person or by proxy at this meeting. The special meeting of stockholders therefore had no quorum and the meeting was adjourned to allow additional time for the Company’s stockholders to vote on the proposals set forth in the Company’s definitive proxy statement filed with the United States Securities and Exchange Commission (the “SEC”) on August 18, 2025 (the “Proxy Statement”). The special meeting of stockholders will reconvene at 10:00 a.m. Pacific Time on Friday, October 10, 2025 in virtual format at www.proxydocs.com/PALI.

During the adjournment, the Company continues to solicit votes from its stockholders with respect to the proposals set forth in the Proxy Statement. As set forth in the Proxy Statement, the Company has engaged a proxy solicitor, Mediant Communications Inc. to assist management with obtaining adequate votes to achieve the required quorum of at least one-third of the outstanding shares entitled to vote.

Only stockholders of record, as of the record date, July 28, 2025 are entitled to and are being requested to vote. At the time the special meeting was adjourned, proxies had been submitted by stockholders representing approximately 29.68% of the shares of the Company’s common stock outstanding and entitled to vote at the special meeting. Proxies previously submitted in respect of the special meeting will be voted at the adjourned special meeting unless properly revoked, and stockholders who have previously submitted a proxy or otherwise voted need not take any action.

The Company encourages all stockholders of record on July 28, 2025, whom have not yet voted, to do so by October 9, 2025 at 11:59 p.m. Pacific Time. Stockholders who have any questions or require any assistance with completing a proxy or voting instruction form or who do not have the required materials, may contact Mediant Communications Inc.; Toll-free: 1-888-715-3034, Monday through Friday, 9 a.m. to 6 p.m. Eastern Time.

About Palisade Bio
Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com

Oculis Publishes Notification of Transactions by Person Discharging Managerial Responsibilities




Oculis Publishes Notification of Transactions by Person Discharging Managerial Responsibilities

ZUG, Switzerland, Sept. 26, 2025 (GLOBE NEWSWIRE) — The attached notification relates to trades entered into by a PDMR of the Company pursuant to a 10b5-1 trading plan, in accordance with Rule 10b5-1(c)(1) of the Securities Exchange Act of 1934, as amended.

Attachment

• pdmr-notification-r-sherif-sales-sep 2025