Virometix Announces Completion of Enrollment in Phase I Trial of V-212 — a Fully Synthetic, Serotype-Independent Vaccine Candidate Against Streptococcus Pneumoniae




Virometix Announces Completion of Enrollment in Phase I Trial of V-212 — a Fully Synthetic, Serotype-Independent Vaccine Candidate Against Streptococcus Pneumoniae

SCHLIEREN, Switzerland–(BUSINESS WIRE)–Virometix AG, a Swiss clinical-stage biotechnology company pioneering fully synthetic vaccines, today announced that it has successfully completed enrollment in the Phase I clinical trial of V-212, a peptide-based, serotype-independent vaccine candidate targeting Streptococcus pneumoniae infections.

“Completing enrollment in this Phase I trial marks a significant milestone for V-212,” said Anna Sumeray, CEO of Virometix. “This fully synthetic, serotype-independent vaccine candidate is designed to advance our mission of delivering scalable, safe, and broad-spectrum protection against pneumococcal disease, while addressing the current limitations of existing PCV approaches. Through our collaboration with CEVAC, we are well-positioned to deliver high-quality Phase I data, with topline results anticipated in the first quarter of 2026.”

Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC, added, “We are proud to collaborate with Virometix on this first-in-human study of V-212. Pneumococcal infections remain a major global health challenge, underscoring the urgent need for next-generation vaccines with broader and more durable protection. V-212’s fully synthetic, serotype-independent approach is highly innovative, and we look forward to advancing the clinical evaluation of this important candidate.”

About Virometix and the V-212 Program

Virometix develops structure-based, fully synthetic nanoparticle vaccines designed to elicit targeted, robust, and durable immune responses. Its proprietary Synthetic Virus-Like Particle (SVLP) platform employs conformational synthetic peptide mimetics displayed on self-assembling lipopeptidic nanoparticles that include built-in adjuvant elements, including T-helper epitopes and Toll-like receptor (TLR) ligands—eliminating dependence on biological components and simplifying manufacturing.

V-212, the lead pneumococcal vaccine candidate, is specifically engineered as a serotype-independent, peptide-based immunogen. Multiple conserved antigenic epitopes from key Streptococcus pneumoniae surface proteins are synthesized and conjugated to SVLP nanoparticles, aiming to induce broad immunity across diverse serotypes—addressing the limitations of current conjugate vaccines.

Preclinical studies have demonstrated robust, long-lasting immunogenicity in mouse and rabbit models. V-212 prevented lethal sepsis in a serotype 3 challenge, inhibited bacterial dissemination into blood, and reduced pulmonary burden. It also conferred protection against serotype 8 infections. Moreover, antisera elicited by V-212 recognized multiple pneumococcal serotypes, including non-PCV-13 types, underscoring its serotype-independent potential.

Phase I Trial Design and Enrollment Highlights

• Study ID: NCT06975319 (VMX-SPN-212-001)
• Design: A randomized, double-blind, placebo-controlled, first-in-human, Phase I trial in healthy adult volunteers.
• Participants: A total of 60 healthy subjects aged 18–45 years have been enrolled.
• Collaboration: The trial is being conducted in collaboration with CEVAC (Centre for Vaccinology) at Ghent University Hospital, a leading European clinical trial unit with extensive expertise in vaccine development.
• Dosing Regimen: Subjects receive three intramuscular injections of either V-212 or placebo, across low, medium, and high dose groups to assess safety, tolerability, and immunogenicity.
• Primary Objective: Evaluate safety and tolerability across dose levels.
• Secondary Objective: Assess immunogenicity to identify an optimal dose for subsequent studies.
• Next Milestone: Topline safety and immunogenicity data are expected in Q1 2026. 

About Virometix

Virometix AG is a privately held Swiss biotechnology company developing a new generation of fully synthetic vaccines to generate targeted and protective immune responses against infectious diseases and cancer. There is a considerable medical need for vaccines to combat infectious as well as a number of chronic human diseases, including cancer. Rational molecular design, chemical synthesis and Virometix’ proprietary “Synthetic Virus-Like Particle” platform technology allow for the rapid production and optimization of vaccine candidates with the potential to demonstrate superior properties in terms of safety, efficacy, ease and cost of manufacturing and stability. Learn more at www.virometix.com

Forward-Looking Statements

This release contains forward-looking statements regarding the clinical development of V-212. Trial outcomes, timelines, and future steps involve inherent risks and uncertainties.

Contacts

Media & Investor Contact
For further inquiries, please contact:

Virometix AG

Wagistrasse 14

8952 Schlieren, Switzerland

+41 43 433 86 60

Email: press@virometix.com

Veracyte Announces that Decipher-Enabled Biomarker Predicts Hormone Therapy Benefit in Men with Recurrent Prostate Cancer




Veracyte Announces that Decipher-Enabled Biomarker Predicts Hormone Therapy Benefit in Men with Recurrent Prostate Cancer

Findings from the first prospective validation trial for biomarker presented at ASTRO 2025

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$VYCT #ASTRO25—Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, announced that new data from the prospective, randomized integral biomarker BALANCE trial (NCT03371719) finds that the PAM50 molecular signature predicts which patients with recurrent prostate cancer benefit from hormone therapy with apalutamide in addition to salvage radiation therapy. The prostate PAM50 biomarker is currently available for Research Use Only on the Decipher GRID (Genomic Resource for Intelligent Discovery) research tool.

The new findings were shared today by Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University, in a podium presentation at ASTRO 2025, the annual meeting of the American Society for Radiation Oncology, being held in San Francisco.

“Our findings mark the first time, to my knowledge, that a predictive biomarker has been validated in a prospective, biomarker-driven, randomized trial in non-metastatic prostate cancer,” said Dr. Spratt. “Thus, this is an unprecedented advancement for patients who can be more-precisely selected to receive hormone therapy or forego the treatment and the potential side effects.”

For the study, 295 men with recurrent, non-metastatic prostate cancer following prostate-removal surgery were randomly assigned to salvage radiation therapy with a placebo or apalutamide for 6 months. The PAM50 biomarker was a key stratification variable to ensure each arm had a similar proportion of luminal B and non-luminal B subtypes. They were followed for a median of 5 years during which they were evaluated for biochemical failure, which is a rise in levels of prostate-specific antigen (PSA) post treatment—an early sign of salvage therapy failure. Among the 127 men with luminal B molecular subtype tumors (as determined by the PAM50 signature), 72% of those taking apalutamide did not experience biochemical failure, as compared to the 54% rate in the placebo group [HR 0.45 (80% CI 0.29-0.68), p=0.0062]. In the non-luminal B subset, there was no difference between those taking apalutamide versus placebo (70% vs 71%) [HR 0.95 (80% CI 0.65-1.41), p=0.44].

“These results from NRG GU006 represent the highest level of evidence to support routine biomarker testing in recurrent prostate cancer patients planned to receive secondary radiotherapy,” Dr. Spratt added. “With such a strong difference in the metastasis-free survival response to hormone therapy between luminal B and non-luminal-B tumors, the use of the predictive PAM50 biomarker is a game changer to help personalize treatment for men with recurrent prostate cancer beyond merely prognostic tools.”

The PAM50 signature is the third biomarker—assessed through the whole-transcriptome-based Decipher platform—that a major study has shown predicts benefit from hormone therapy, radiation therapy or chemotherapy. Another trial—PREDICT-RT—recently completed enrollment two years early and is evaluating the Decipher Prostate test’s ability to predict benefit of combined hormone therapy (ADT and apalutamide) concurrent with radiation in patients with high-risk prostate cancer at initial diagnosis.

“Prostate cancer, like all cancers, is a disease of the genome,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “Our Decipher GRID tool uniquely enables researchers to better pinpoint adverse molecular features that are associated with poor outcomes. This can ultimately lead to more-personalized care for each patient based on their tumor’s unique molecular make-up. We are proud to partner with the world’s leading prostate cancer researchers to help uncover insights that can change the trajectory of care for each individual patient and also help deliver the next generation of prostate cancer diagnostics.”

The BALANCE trial results are among 9 Decipher-focused abstracts being presented at the ASTRO 2025 conference. More information can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve “Level I” evidence status and inclusion in the risk-stratification table in the most recent NCCN^® Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com or follow us on LinkedIn or X (Twitter).

About Decipher GRID

The Decipher GRID database includes more than 250,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found here.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to our statements regarding the use of the predictive PAM50 biomarker to help personalize treatment for men with recurrent prostate cancer beyond merely prognostic tools and the belief that this is a game changer, and expectations that our Decipher GRID tool uniquely enables researchers to better pinpoint adverse molecular features that are associated with poor outcomes; that this can ultimately lead to more-personalized care for each patient based on their tumor’s unique molecular make-up; and that this can help uncover insights that can change the trajectory of care for each individual patient and also help deliver the next generation of prostate cancer diagnostics. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” “ultimately,” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to the potential impact the Veracyte Diagnostics Platform can have on scientific advancements in cancer and, in turn, patient care. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on February 28, 2025. Copies of these documents, when available, may be found in the Investors section of our website at https://investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

Veracyte, the Veracyte logo, and Decipher are registered trademarks of Veracyte, Inc., and its subsidiaries in the U.S. and selected countries.

* National Comprehensive Cancer Network. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Contacts

Investors:
Shayla Gorman

investors@veracyte.com
619-393-1545

Media:
Karen Possemato

media@veracyte.com

New Data from HELIOS-B Phase 3 Study Demonstrate Lower Rates of Gastrointestinal Events in ATTR-CM Patients Treated with Vutrisiran




New Data from HELIOS-B Phase 3 Study Demonstrate Lower Rates of Gastrointestinal Events in ATTR-CM Patients Treated with Vutrisiran

− Treatment with Vutrisiran Led to 37- 49% Lower Rates of Gastrointestinal Events, a Multisystem Manifestation of ATTR-CM, Across Multiple Treatment Groups, Compared to Placebo –

− Additional Analyses Reinforce Vutrisiran’s Safety and Efficacy Profile as a Monotherapy and Illustrate Consistent Benefit from Treatment with Vutrisiran Across a Range of Patients’ Baseline Health Status and Quality of Life –

− Findings Presented at the Heart Failure Society of America Annual Scientific Meeting 2025 Highlight the Impact of Vutrisiran which Delivers Rapid Knockdown of Transthyretin –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced results from new analyses of the HELIOS-B Phase 3 study of AMVUTTRA^® (vutrisiran), an RNAi therapeutic approved for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. Data from a post hoc analysis of the HELIOS-B study, which assessed whether treatment with vutrisiran was associated with a reduction in gastrointestinal (GI) adverse events in patients with ATTR-CM, compared to placebo, were presented during a late-breaking session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025 in Minneapolis, Minnesota. The analysis showed that treatment with vutrisiran was associated with a lower rate of GI events across the overall, vutrisiran monotherapy, and baseline tafamidis treatment groups, compared to placebo, a trend that was consistent in patients living with both the wild-type and hereditary forms of the disease.

Patients with ATTR-CM often experience disease manifestations beyond the heart including GI events such as diarrhea, abdominal pain and discomfort, constipation, nausea, and vomiting. In the analysis, a 42% lower rate of GI events was observed in patients treated with vutrisiran in the overall population, compared to placebo. Consistent results were also observed across the vutrisiran monotherapy group and in patients treated with tafamidis at baseline. In the vutrisiran monotherapy group, a 37% lower rate of GI events was observed, compared to placebo. In the baseline tafamidis group, a 49% lower rate of GI events was observed, compared to placebo. When looking specifically at individual GI symptoms known to significantly impact quality of life (QOL), including diarrhea, nausea, and vomiting, reductions of greater than 50% were observed across all three study populations: the overall population, the vutrisiran monotherapy population, and the population of patients treated with tafamidis at baseline. This corresponded to rate ratios (RR) for diarrhea of 0.46, 0.48, and 0.44; for nausea of 0.35, 0.17, and 0.48; and for vomiting of 0.16, 0.25, and 0.00, respectively. The lower rate of GI events in patients treated with vutrisiran, compared to placebo, was observed as early as three months and was consistent across hereditary and wild-type patients throughout the double-blind period. These findings suggest a potential treatment effect in all study populations assessed.

“As a multisystem disease, it is well-known that ATTR-CM impacts more than just the heart,” said Marcus Urey, M.D., Associate Professor, University of California San Diego Health. “For patients living with both hereditary and wild-type forms of the disease, gastrointestinal complications such as diarrhea, abdominal pain, constipation, nausea, and vomiting are a part of their journey with ATTR-CM, with some of these symptoms often significantly impacting their quality of life. As a physician who sees the multisystem impact of this disease every day, I am encouraged by these findings which underscore vutrisiran’s differentiated clinical profile and its potential to address the multisystem nature of this disease.”

A second post hoc analysis of the HELIOS-B study presented at the HFSA Annual Scientific Meeting assessed the efficacy and safety of vutrisiran as a monotherapy by censoring patients who initiated tafamidis during the double-blind period at investigator discretion. This analysis was designed to isolate the effect of vutrisiran treatment alone, without the potential confounding influence of additional therapy. Tafamidis initiation occurred in 21.5% of monotherapy patients, with a median time to initiation of approximately 12 months. In this censored monotherapy population, patients treated with vutrisiran demonstrated a statistically significant 32% reduction in the risk of the primary composite endpoint of all-cause mortality and recurrent cardiovascular events through 36 months, compared to patients who received placebo (hazard ratio [HR] 0.68; 95% confidence interval [CI]: 0.49–0.95; p=0.022). These results were consistent with the primary monotherapy analysis of the study which included patients who later initiated tafamidis (HR 0.67; 95% CI: 0.49–0.93; p=0.016). Moreover, within the censored population, outcomes for the secondary endpoints and safety findings were consistent with the results of the primary analysis. These results reinforce the findings from the powered monotherapy subgroup and provide further evidence of vutrisiran’s efficacy and safety as a standalone first-line therapy, without the confounding effects of additional treatments.

“The new HELIOS-B analyses presented at the HFSA Annual Scientific Meeting build on AMVUTTRA’s differentiated first-line profile,” said John Vest, M.D., Senior Vice President, TTR Global Clinical Lead, Alnylam. “We understand that gastrointestinal symptoms place a significant burden on patients, thus I’m encouraged to observe a reduction in these events in as early as three months after initiation of treatment. These findings, taken together with further evidence of AMVUTTRA’s strong monotherapy profile, underscore its potential to deliver meaningful impact as a first-line treatment for patients living with this rapidly progressive multisystem disease.”

A third post hoc analysis of the HELIOS-B study evaluated outcomes by baseline Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score, and demonstrated that treatment with vutrisiran resulted in consistent benefits in survival, cardiovascular outcomes, functional capacity, quality of life, cardiac biomarkers, and reduced GI adverse events, regardless of baseline health status.

Data from the HELIOS-B study supported the recent approvals of AMVUTTRA for the treatment of the cardiomyopathy of wild-type or hereditary ATTR-CM in adults in the United States (US), Brazil, European Union (EU), Japan, United Arab Emirates (UAE) and United Kingdom (UK). Collectively, AMVUTTRA has more than 8,000 patient-years of experience worldwide and is the first RNAi therapeutic approved for the treatment of both the cardiomyopathy manifestations of ATTR amyloidosis and the polyneuropathy manifestations of hereditary transthyretin-mediated amyloidosis (hATTR) in adults.

For additional information on Alnylam’s presentations at the HFSA Annual Scientific Meeting 2025, please visit Capella.

Indications and Important Safety Information

Indications Approved by the U.S. FDA

AMVUTTRA^® (vutrisiran) is indicated for the treatment of the:

• cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits.
• polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.

Important Safety Information

Reduced Serum Vitamin A Levels and Recommended Supplementation

AMVUTTRA treatment leads to a decrease in serum vitamin A levels.

Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking AMVUTTRA. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with AMVUTTRA, as serum vitamin A levels do not reflect the total vitamin A in the body.

Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).

Adverse Reactions

In a study of patients with hATTR-PN, the most common adverse reactions that occurred in patients treated with AMVUTTRA were pain in extremity (15%), arthralgia (11%), dyspnea (7%), and vitamin A decreased (7%).

In a study of patients with ATTR-CM, no new safety issues were identified.

For additional information about AMVUTTRA, please see the full U.S. Prescribing Information (revised March 2025)

About AMVUTTRA

AMVUTTRA^® (vutrisiran) is an RNAi therapeutic that delivers rapid knockdown of transthyretin (TTR), addressing the underlying cause of transthyretin (ATTR) amyloidosis. It is marketed in more than 15 countries for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults and it is also approved for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults in the US, EU, UK, Brazil, Japan, and UAE. In a clinical study, AMVUTTRA rapidly knocked down TTR in as early as six weeks and decreased TTR levels by 87% with two and a half years of treatment. Administered quarterly via subcutaneous injection, AMVUTTRA is the first and only RNAi therapeutic approved for the treatment of both the cardiomyopathy manifestations of ATTR amyloidosis and the polyneuropathy manifestations of hereditary transthyretin-mediated amyloidosis (hATTR).

About ATTR

Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by misfolded transthyretin (TTR) proteins, which accumulate as amyloid deposits in various parts of the body, including the nerves, heart, and gastrointestinal tract. Patients may present with polyneuropathy, cardiomyopathy, or both manifestations of disease. There are two different forms of ATTR – hereditary ATTR (hATTR), which is caused by a TTR gene variant and affects approximately 50,000 people worldwide, and wild-type ATTR (wtATTR), which occurs without a TTR gene variant and impacts an estimated 200,000 – 300,000 people worldwide.^1-4

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today.⁵ Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine.⁶ By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made.⁵ This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P⁵x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.

Alnylam Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, Alnylam’s expectations regarding the safety and efficacy of vutrisiran as a treatment for ATTR-CM, including vutrisiran’s potential to deliver meaningful impact for ATTR-CM patients; vutrisiran’s potential as a standalone first-line treatment for ATTR-CM; the consistent benefit of treatment with vutrisiran across a range of patients’ baseline health status and quality of life; vutrisiran’s potential to address the multisystem nature of ATTR-CM; and Alnylam’s ability to execute on its “Alnylam P⁵x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to Alnylam’s ability to successfully execute on its “Alnylam P⁵x25” strategy; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; successfully launching, marketing and selling Alnylam’s approved products globally; delays, interruptions or failures in the manufacture and supply of Alnylam’s product candidates or its marketed products; obtaining, maintaining and protecting intellectual property; Alnylam’s ability to manage its growth and operating expenses through disciplined investment in operations and its ability to achieve a self-sustainable financial profile in the future; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products; the outcome of litigation; the potential risk of future government investigations; and unexpected expenditures; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s 2024 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam’s subsequent Quarterly Reports on Form 10-Q, and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing Alnylam’s views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

References

¹ Hawkins PN, Ando Y, Dispenzeri A, et al. Ann Med. 2015;47(8):625-638.

² Gertz MA. Am J Manag Care. 2017;23(7):S107-S112.

³ Conceicao I, Gonzalez-Duarte A, Obici L, et al. J Peripher Nerv Syst. 2016;21:5-9.

⁴ Ando Y, Coelho T, Berk JL, et al. Orphanet J Rare Dis. 2013;8:31.

⁵ Elbashir SM, Harborth J, Lendeckel W, et al. Nature. 2001;411(6836):494-498.

⁶ Zamore P. Cell. 2006;127(5):1083-1086.

Contacts

Alnylam Pharmaceuticals, Inc.

Christine Akinc  

(Investors and Media)

+1-617-682-4340

Josh Brodsky

(Investors)

+1-617-551-8276

Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025




Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025

More than 45 abstracts, including five late-breaking presentations and recognition in Presidential Symposium, showcase impact of approved medicines and potential of next-generation pipeline

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany. Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer’s core scientific modalities and key tumor areas.

“At ESMO, Pfizer is demonstrating how earlier interventions with our innovative medicines have the potential to deliver greater impact to even more patients,” said Jeff Legos, Chief Oncology Officer, Pfizer. “The survival benefits we’re seeing across certain cancer types reinforce our commitment to accelerating innovative medicines that bring new hope to patients everywhere, while pipeline data highlight the next wave of potential breakthroughs that could transform care for even more people living with cancer.”

Pfizer will share highlights from its leading Oncology portfolio at ESMO, including:

• In a Presidential Symposium, unprecedented survival results from the Phase 3 EV-303 trial (KEYNOTE-905) evaluating PADCEV^® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), plus KEYTRUDA^® (pembrolizumab)* in patients with muscle-invasive bladder cancer who are ineligible for or declined cisplatin-based chemotherapy, showing potential to redefine standard of care in these patients (Presentation #LBA2)
• Final overall survival results from the Phase 3 EMBARK trial evaluating XTANDI^® (enzalutamide)** in combination with leuprolide and as monotherapy in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence, highlighting the benefit of XTANDI in this earlier line of treatment (Presentation #LBA87)
• Updated overall survival data from the Phase 2 PHAROS study of BRAFTOVI^® (encorafenib) plus MEKTOVI^® (binimetinib)*** in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC), reinforcing this combination as a potential key treatment option for these patients (Presentation #1849MO)

Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here.

* Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV^® and KEYTRUDA^® in patients with previously untreated metastatic urothelial cancer.

** XTANDI^® is jointly developed and commercialized by Pfizer and Astellas in the United States.

*** The PHAROS trial is conducted with support from Pierre Fabre.

**** Led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP) with Astellas funding

***** Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant.

****** The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company.

Prescribing Information for Pfizer Medicines

Please see full Prescribing Information, including BOXED WARNING, for PADCEV^® (enfortumab vedotin).

Please see full Prescribing Information for XTANDI^® (enzalutamide).

Please see full Prescribing Information for BRAFTOVI^® (encorafenib).

Please see full Prescribing Information for MEKTOVI^® (binimetinib).

Please see full Prescribing Information for IBRANCE^® (palbociclib) tablets and IBRANCE^® (palbociclib) capsules.

About Pfizer Oncology

At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of September 25, 2025. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer Oncology, Pfizer’s Oncology portfolio of marketed and investigational therapies, including combinations, and an investigational therapy for a cancer-related condition; expectations for our product pipeline, in-line products and product candidates, including their potential benefits, clinical trial results and other developing data; potential breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Contacts

Media Contact: PfizerMediaRelations@Pfizer.com

Investor Contact: IR@Pfizer.com

Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed




Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed

KUOPIO, Finland–(BUSINESS WIRE)–#hiven–Marginum announces a significant milestone as its flagship device, HIVEN^®, is cleared for the CE mark. The underlying MDR certification signifies an important regulatory milestone.

Marginum, a Finnish medical technology company, made rapid strides in validating the aspirate tissue monitoring (ATM) technique and received the MDR certificate at a record-breaking speed, just over 4.5 years. Marginum’s team successfully developed a breakthrough class IIb medical device that addresses an unmet clinical need to accurately detect tumorous tissue during surgery, without compromising existing workflows.

New era of precision in cancer surgery

HIVEN^® is a novel device for assisting in intraoperative margin assessment that provides near real-time feedback to support surgeons in achieving a safer and more complete tumour resection. By providing surgical teams with immediate insight into the tumour margins while resecting, the device aims to improve patient outcomes and reduce the likelihood of reoperations. HIVEN^® is designed to detect fluorescent cancer tissue from aspirated tissue during surgery without disrupting standard workflow.

“Achieving clearance for the CE mark is a pivotal step in bringing the HIVEN^® into clinical practice and improving outcomes for patients in Europe. This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations,” says Juho Leskinen, CTO and co-founder of Marginum.

Clinical Benefits & Indications

The aspirate tissue monitoring technology aims to overcome surgical challenges that may damage healthy tissues and leave tumour cells undetected. Incomplete removal, damage to healthy tissues, and reoperations exacerbate patient suffering, compromised standard of care, and long-term complications – all directly escalating healthcare costs.

Critical structures like blood vessels often create blind spots – behind corners and tissue ridges – where cancerous tissue can be difficult to detect. The HIVEN^® aspirate tissue monitoring device addresses this challenge by allowing resected tissue to be transported directly for fluorescence analysis. This provides surgeons with more comprehensive information about the surgical site.

“In glioma surgery, our ability to distinguish tumour from healthier tissues is limited by anatomical constraints, blood and compromised visibility, particularly in deep-seated areas. We wanted HIVEN^® to provide critical feedback beyond sensory limitations; you can consider it a sixth sense for tumour detection,” comments docent Antti-Pekka Elomaa MD PhD, a consultant neurosurgeon and one of Marginum co-founders.

The HIVEN^® is approved for fluorescence-guided neurosurgery of high-grade gliomas, where precise margin identification is critical. HIVEN^® enhances surgical accuracy by enabling objective tissue detection in hard-to-reach areas and simplifying the procedure workflow.

About Marginum:

Marginum, a leading innovator in fluorescence-guided oncological surgery, is a medical technology company developing fluorescence-based tissue detection systems. HIVEN^® by Marginum enables safe and efficient monitoring of tumour tissues during cancer surgery. www.marginum.com

Contacts

Media contact:
Samu Lehtonen, CEO & Co-Founder

Email: samu.lehtonen@marginum.com
Mobile: +358405797890

https://www.marginum.com

Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)




Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)

The collaboration will seek to foster the adoption of appropriate protocols and pathways for the integration of ENBUMYST™ (bumetanide nasal spray) into clinical care with the goal of reducing readmissions, improving fluid management and enhancing outcomes through the novel delivery of diuretic therapy.

HENDERSON, Nev.–(BUSINESS WIRE)–#chf–Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, today announced a strategic collaboration with U.S. Heart and Vascular® (USHV), the nation’s premier cardiovascular management services organization, seeking to enable earlier intervention and enhance outcomes for heart failure patients. Corstasis and USHV will co-develop, and seek to optimize, value-based care pathways for the outpatient treatment of fluid overload in patients with congestive heart failure, liver disease and chronic kidney disease with ENBUMYST™ (bumetanide nasal spray).

“ENBUMYST was developed with the goal of giving providers a new, self-administered outpatient option,” said Brian Kolski M.D., Chief Medical Officer of Corstasis Therapeutics. “Our collaboration with USHV reflects a shared commitment to health system innovation, value-based care delivery and patient-centered outcomes.”

The collaboration between Corstasis and USHV will seek to:

• Develop and validate protocols and clinical workflows that are consistent with approved labeling and enable adoption of early intervention via nasal spray diuresis when clinically indicated

• Develop associated provider and staff training to ensure seamless integration of this important new intervention into clinical care

• Capture outcomes and healthcare economic data to support payer engagement and future reimbursement strategies

“At USHV, we are continuously seeking new tools that empower our affiliated physicians and deliver measurable value to patients and payers,” said Emily Rash, Chief Value-Based Care Officer, USHV. “We believe an outpatient-friendly alternative represents a meaningful step forward in ambulatory heart failure care and we’re proud to work with Corstasis to bring this innovation into practice.”

The U.S. Food and Drug Administration (FDA) recently approved ENBUMYST for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults.

This effort is intended to put Corstasis and USHV at the forefront of improving outpatient heart failure management, with the goal of enabling the option of earlier intervention, reduced escalation of care and a more cost-effective path to euvolemia. Fluid overload associated with CHF, liver disease and chronic kidney disease is responsible for driving millions of hospitalizations and readmissions annually.

About ENBUMYST

ENBUMYST is a nasal spray loop diuretic indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ENBUMYST™ (BUMETANIDE NASAL SPRAY).

INDICATION

ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

IMPORTANT SAFETY INFORMATION

ENBUMYST is contraindicated in patients with anuria, who are in hepatic coma and have a history of hypersensitivity to bumetanide.

ENBUMYST is a diuretic that may cause fluid, electrolyte, and metabolic abnormalities. Excessive fluid loss can lead to dehydration, decreased blood volume, and increased risk of blood clots. Abnormalities may include changes in blood electrolytes, nitrogen, glucose, and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses or who do not get enough electrolytes by mouth.

If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide.

Although unlikely at the recommended doses, the potential for ototoxicity must be considered a risk of intravenous therapy, at high doses, repeated frequently in the face of renal excretory function impairment.

Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause.

Advise lactating women treated with ENBUMYST to monitor their infants for excessive urine output, dehydration, and lethargy.

Most common adverse reactions are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease).

These are not all of the possible side effects of ENBUMYST. To report suspected adverse reactions, contact Corstasis Therapeutics at 1-877-300-5339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for ENBUMYST.

About Corstasis Therapeutics

Corstasis Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on transforming the treatment of fluid overload in patients with heart failure, liver disease, and kidney disease. Its lead asset, ENBUMYST™ (bumetanide nasal spray), was approved by the FDA on September 12, 2025 and is designed to offer rapid, reliable diuresis outside the hospital setting. For more information, please visit www.corstasis.com.

About U.S. Heart and Vascular (USHV)

Formed in 2021 in Nashville, TN, US Heart and Vascular is a physician-led management platform enabling independent cardiologists to expand patient access, improve outcomes, and reduce costs to the healthcare system. USHV builds collaborative partnerships with best-in-class cardiovascular practices, providing non-clinical management solutions and resources that allow practices to expand access to compassionate and comprehensive care, improve patient outcomes, and strategically reduce costs to the healthcare system. Currently investing in practices across five states, USHV is actively seeking new partnerships with quality cardiovascular practices and entrepreneurial physicians across the U.S. Visit https://usheartandvascular.com/.

Contacts

Media Contacts:
Ben Esque, CEO

Corstasis Therapeutics Inc.

Phone: 702-541-9222

Email: Info@corstasis.com

Carrie Moore, VP Communications

U.S. Heart & Vascular

Email: carrie.moore@usheartandvascular.com

ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test




ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test

SAN DIEGO–(BUSINESS WIRE)–#5hmC—ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received a United Kingdom Conformity Assessed (UKCA) marking for its Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test. Part of the UK’s independent product safety framework following its departure from the European Union, this designation confirms compliance with UK medical device regulations and is a prerequisite for selling products in the UK. The company’s Avantect Pancreatic Cancer Test received the same certification in July 2025.

The Avantect Multi-Cancer Detection Test is a simple blood test designed to screen for several types of cancer simultaneously in asymptomatic, generally healthy persons. It targets some of the deadliest cancers by analyzing both the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) and genomic features in circulating cell-free DNA. Unlike conventional methods, ClearNote Health’s 5hmC-based approach measures changes in active biology, offering a highly specific signal of early cancer development and identifying the likely tissue of tumor origin.

This test was one of only two assays recently selected for the critical Vanguard Study funded by the National Cancer Institute, part of the National Institutes of Health, following a thorough evaluation of 23 emerging multi-cancer detection technologies. The Vanguard Study implemented a stringent, multi-stage selection process to evaluate multi-cancer detection assays based on sensitivity, specificity, tissue of origin prediction accuracy, and assay failure rates. Key selection criteria included early-stage detection performance for at least three cancer types. The study includes nine geographically diverse clinical trial hubs and will enroll up to 24,000 total participants to assess the implementation of multi-cancer detection testing.

The Avantect Ovarian Cancer Test was designed to aid in earlier diagnosis of cancer in women at elevated risk, particularly those with inherited genetic mutations, such as BRCA1 and BRCA2, Lynch syndrome, or a strong family history of ovarian, breast, uterine, or colorectal cancer, as well as other significant risk factors. The test uses ClearNote Health’s underlying Virtuoso™ epigenomics platform to measure the presence or absence of an abnormal signal associated with ovarian cancer in cell-free DNA.

“By achieving UKCA markings for all three of our Avantect cancer tests, ClearNote Health is well poised to deliver on our mission of helping to eradicate the deadliest forms of cancer through early detection,” said Dave Mullarkey, CEO at ClearNote Health. “These regulatory milestones are a testament to the dedication of our cross-functional team as we expand into new international markets and bring our innovative, life-saving technology to more patients worldwide.”

For more information on the Avantect cancer tests, please visit www.avantect.com.

About ClearNote Health

ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company’s patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. Its highly sensitive, noninvasive Avantect® pancreatic and ovarian diagnostic tests may identify cancers in high-risk patient populations earlier than conventional approaches, when patients may be more likely to benefit from treatment. ClearNote Health’s headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn.

ClearNote Health, the ClearNote Health logo, and Avantect are registered trademarks of ClearNote Health.

Contacts

Media Contact
Andrew Noble

415-722-2129

andrew@bioscribe.com

SFI Health™ EMEA Announces Exclusive License Agreement with Curasense BV for Equazen® in the Netherlands and Belgium




SFI Health™ EMEA Announces Exclusive License Agreement with Curasense BV for Equazen® in the Netherlands and Belgium

– Partner Curasense will market Equazen^® products featuring a clinically researched combination of essential fatty acids across pharmacies, healthcare stores and online pharmacies.

LUGANO, Switzerland–(BUSINESS WIRE)–#GLAsupplements–SFI Health™ EMEA, the regional entity of SFI Health™, a global leader in natural healthcare, and Curasense BV (Curasense), a Belgian company specializing in the distribution and development of high-quality nutraceuticals and health products, are excited to announce that they have entered into an exclusive licensing agreement for Equazen^® food supplements in the Netherlands and Belgium.

Under the terms of the agreement, Curasense will hold exclusive rights to distribute, promote, market, and sell Equazen^® products within the licensed territories. Curasense will begin commercial activities following a transition period from SFI Health™’s previous licensee.

Together, Belgium and the Netherlands count over 6,500 pharmacies, alongside a strong presence of health stores — from 800 independents in Belgium to 2,000 outlets in the Netherlands. With well-established pharmacy and retail networks, plus growing online demand, the agreement positions the brand for strong visibility and reach across both markets.

Matthew Brabazon, GM of SFI Health™ EMEA commented: “We are very pleased to collaborate with Curasense, a company with extensive experience in the healthcare sector and a strong reputation among healthcare professionals and consumers. This partnership marks an important step in strengthening the Equazen^® brand, as we leverage Curasense BV’s expertise in bringing advanced scientifically naturally sourced health solutions to market. Together, we are committed to expand Equazen^®’s distribution and market share, establishing it as a reference point for brain health and cognitive wellness.”

Mr. Jelle D’Helft, CEO of Curasense, added: “We are thrilled to formalize our strategic partnership with SFI Health™ EMEA for the Equazen® brand in the Netherlands and Belgium. For Curasense, this agreement is a natural extension of our mission to deliver evidence-based health solutions that make a real impact. Equazen^®’s clinically supported formulations align closely with our vision and reflect our ambition to bridge conventional and complementary medicine. This collaboration will accelerate access to innovative, science-backed products for children, adolescents, and adults—while setting new benchmarks in the nutraceutical industry.”

The brain health supplement sector is emerging as one of the most dynamic segments within the global food supplements market. In Europe, it is expected to grow at a CAGR of 12.5% from 2023 to 2030, supported by increasing consumers’ focus on sustaining normal cognitive function and mental health.

Equazen^® is currently present in several EMEA markets, including Spain, Portugal, the United Kingdom, Switzerland, Poland, the Czech Republic, Slovakia, the Nordics, and the Baltics, with SFI Health™ aiming to broaden its reach into new markets to unlock its full sales potential and capitalize on the growing momentum in the brain food supplements sector.

About SFI Health™

SFI Health™ is a global leader in natural healthcare, specialized in the design, development and commercialization of clinically researched products in the areas of microbiome, cognition and wellbeing.

Guided by the belief in the healing potential of natural products, SFI Health™ combines a rigorous pharma-based approach with the benefits of naturally sourced solutions.

An extensive network of trusted business partners enables the company, headquartered in Australia, to market its own brands, reaching consumers in over 50 countries. The EMEA SFI Health™ regional office in Lugano, Switzerland, manages commercial operations across Europe, Middle East and Africa.

SFI Health™ is committed to fostering confidence in natural healthcare by sharing state-of-the-art research, technical expertise and comprehensive sales & marketing resources with consumers, healthcare professionals and partners worldwide.

For more information go to sfihealth.com or follow us SFI Health on LinkedIn.

About Curasense

Curasense BV is a Belgian company specializing in the distribution and development of high-quality nutraceuticals and health products. Building on more than 20 years of experience in the healthcare sector, Curasense delivers Health through Nature, Science and Innovation, addressing key needs like cognitive function, inflammation management, and overall vitality.

The company’s approach combines a strong foundation in scientific substantiation and strict compliance with European regulations, ensuring proven quality and effectiveness.

Through close collaboration with international partners and healthcare professionals, consumers gain access to our innovative products.

Based in Heist-op-den-Berg (Antwerp), Curasense serves both the Belgian and Dutch markets and continues to expand its ambition of making advanced health solutions available across Europe and beyond.

For more info go to curasense.com/ or follow us Curasense on LinkedIn.

About Equazen^®

Equazen^® is a science-based globally branded food supplement designed and studied to help nourish, enhance, and support the human brain’s potential across all life stages.

Each product of the Equazen^® range contains a balanced unique combination of essential fatty acids (Omega 3 and Omega 6), which has been clinically proven for more than 20 years to assist with learning capabilities, concentration and healthy brain development.

Equazen^® is available in multiple pharmaceutical formats and sizes to support optimal cognitive functions from infants to teenagers.

Currently marketed in 30 countries globally, Equazen^® is widely recommended by healthcare professionals and trusted by families for the last 25 years.

Equazen^® aims to advance human health naturally, delivering expertly formulated products that empower individuals to reach their cognitive potential.

For more info visit www.equazen.com

Contacts

For more information
SFI Health™ EMEA Contact
Elisabetta Bianchi

e-mail address: elisabetta.bianchi@sfihealth.com

Curasense BV Contact
Jelle D’Helft

e-mail address: jelle@curasense.be

KalVista Prices Upsized Offering of $125.0 Million of 3.250% Convertible Senior Notes Due 2031




KalVista Prices Upsized Offering of $125.0 Million of 3.250% Convertible Senior Notes Due 2031

FRAMINGHAM, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (“KalVista”) (NASDAQ: KALV), announced today the pricing of its offering of $125.0 million aggregate principal amount of 3.250% Convertible Senior Notes due 2031 (the “notes”) in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The aggregate principal amount of the offering was increased from the previously announced offering size of $110.0 million. KalVista also granted the initial purchasers of the notes an option to purchase, for settlement within a 13-day period from, and including, the date on which the notes are first issued, up to an additional $18.75 million aggregate principal amount of notes. The sale of the notes is expected to close on September 29, 2025, subject to customary closing conditions.

The notes will be senior, unsecured obligations of KalVista, and will bear interest at a rate of 3.250% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2026. The notes will mature on October 1, 2031, unless earlier converted, repurchased or redeemed in accordance with the terms of the notes. Prior to 5:00 p.m., New York City time, on the business day immediately preceding July 31, 2031, the notes will be convertible at the option of holders of the notes only upon satisfaction of certain conditions and during certain periods, and thereafter, the notes will be convertible at the option of holders at any time until 5:00 p.m., New York City time, on the second scheduled trading day immediately preceding the maturity date, regardless of whether such conditions have been met. Upon conversion, the notes may be settled in shares of KalVista’s common stock, cash or a combination of cash and shares of KalVista’s common stock, at the election of KalVista. The initial conversion rate is 59.4919 shares of KalVista’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $16.81 per share of KalVista’s common stock, representing an approximate 30.0% premium based on the last reported sale price of KalVista’s common stock on The Nasdaq Global Market on September 24, 2025 of $12.93 per share). The initial conversion rate will be subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest. Prior to October 5, 2028, the notes will not be redeemable. On or after October 5, 2028, and prior to July 1, 2031, KalVista may redeem for cash all or part of the notes, at its option, subject to a partial redemption limitation, if the last reported sale price of KalVista’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which KalVista provides notice of redemption.

Holders of the notes will have the right to require KalVista to repurchase for cash all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of a fundamental change (as defined in the indenture relating to the notes). KalVista will also be required to increase, in certain circumstances, the conversion rate for holders who convert their notes in connection with certain fundamental changes occurring prior to the maturity date or convert their notes called (or deemed called) for redemption following the delivery by KalVista of a notice of redemption.

KalVista estimates that the net proceeds from the offering will be approximately $120.8 million (or approximately $139.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discount and estimated offering expenses payable by KalVista.

KalVista expects to use the net proceeds from the offering for working capital and other general corporate purposes, including the commercialization of EKTERLY. KalVista may also use a portion of the net proceeds from the offering for investments in and acquisitions of other companies, products or technologies in the future. However, KalVista has no commitments or specific plans with respect to any such investments in and acquisitions of other companies, products or technologies at this time.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities (including the shares of KalVista’s common stock, if any, into which the notes are convertible) and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. Any offers of the notes were made only by means of a private offering memorandum.

The offering is being made to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The notes and any shares of KalVista’s common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties, including, without limitation, statements regarding the timing and closing of KalVista’s offering of the notes and expected use of net proceeds from the offering. Statements containing words such as “could,” “believe,” “expect,” “intend,” “will,” or similar expressions constitute forward-looking statements. Factors that may contribute to such differences include, but are not limited to, risks related to whether KalVista will close the offering of the notes, the expected use of the net proceeds from the offering, which could change as a result of market conditions or for other reasons, prevailing market and other general economic, industry or political conditions in the United States or internationally, and whether KalVista will be able to satisfy the conditions required to close the sale of the notes. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. For information about other potential factors that could affect KalVista’s business and financial results, please review the “Risk Factors” described in KalVista’s Annual Report on Form 10-K for the year ended April 30, 2025 filed with the Securities and Exchange Commission (the “SEC”) on July 10, 2025 and in KalVista’s other filings with the SEC. Except as may be required by law, KalVista does not intend, and undertakes no duty, to update this information to reflect future events or circumstances.

Contacts

Investors:

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Media:

Molly Cameron

Director, Corporate Communications

(857) 356-0164

molly.cameron@kalvista.com

PepGen Announces Pricing of $100 Million Public Offering




PepGen Announces Pricing of $100 Million Public Offering

BOSTON–(BUSINESS WIRE)–PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the pricing of an underwritten offering of 31,250,000 shares of its common stock at a price to the public of $3.20 per share. The aggregate gross proceeds to PepGen from this offering are expected to be $100 million, before deducting underwriting discounts and commissions and offering expenses payable by PepGen. The offering is expected to close on or about September 26, 2025, subject to customary closing conditions. In addition, PepGen has granted the underwriters a 30-day option to purchase up to 4,687,500 additional shares of common stock at the public offering price, less the underwriting discount.

Leerink Partners and Stifel are acting as joint bookrunning managers for the offering.

PepGen currently intends to use the net proceeds from this offering to fund its ongoing research and clinical development efforts, including the FREEDOM-DM1 and FREEDOM2-DM1 clinical trials, as well as for working capital and other general corporate purposes.

The securities are being offered pursuant to a registration statement on Form S-3 that was previously filed with, and subsequently declared effective on July 8, 2024, by the Securities and Exchange Commission (“SEC”). A final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC, and are or will be available on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, telephone: (415) 364‐2720 or by emailing syndprospectus@stifel.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About PepGen

PepGen Inc. is a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, the Company is generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

Forward Looking Statements

This press release contains forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in this press release are based on PepGen’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties related to completion of the offering on the anticipated terms, or at all, include, but are not limited to, market conditions and the satisfaction of customary closing conditions related to the offering. Additional risks concerning PepGen’s programs and operations are described in our most recent annual report on Form 10-K and quarterly report on Form 10-Q that are filed with the SEC. PepGen explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contacts

Investor Contact
Laurence Watts

New Street Investor Relations

laurence@newstreetir.com