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More than 60% average improvement in clitoral blood flow observed with both dose-combinations

• Statistical significance achieved with new high dose-combination despite small sample size
• Results validate dose selection and de-risk pivotal trial in US and Europe clinical
  development program

Amsterdam, the Netherlands, March 27 November 2026 – Freya Pharma Solutions, a pharmaceutical company specializing in innovative therapies for women diagnosed with Female Sexual Disorders (FSD), today announced highly compelling positive results from its Phase II Clitoral Doppler Duplex Ultrasound (CDU) study evaluating the Lybrido™ combination of testosterone and sildenafil in women with Female Sexual Interest/Arousal Disorder (FSIAD). The study successfully achieved its primary endpoint, demonstrating objective physiological evidence of arousal response to combination therapy and confirming optimal dose selection for the continuation of the clinical program.

This investigator-initiated study, conducted at Chaim Sheba Medical Center and led by Principal Investigator Prof. Cobi Reisman (urologist, sexologist) and Co-Investigator Dr. Anna Padoa (gynecologist), evaluated two dose-combinations of Lybrido™ in premenopausal women diagnosed with acquired generalized FSIAD. The study utilized standardized Clitoral Doppler Duplex Ultrasound to quantify clitoral blood flow parameters, a key biomarker of genital arousal.

Study Highlights and Clinical Relevance
The study results demonstrate compelling objective evidence of Lybrido™’s dual mechanism of action:

• First-time achievement: This marks the first time objective biomarker data have been measured with the high dose-combination (Testosterone 1.0 mg + Sildenafil 100 mg) in women with FSIAD, representing a significant milestone in female sexual health research.
• Robust efficacy signal: Both dose-combinations showed more than 60% average improvement in Peak Systolic Velocity (PSV), the primary measure of clitoral blood flow.
• Statistical significance: The high-dose combination (Testosterone 1.0 mg + Sildenafil 100 mg) achieved statistical significance (p=0.008), demonstrating a clear and consistent physiological arousal response despite the relatively small sample size.
• Mechanism validation: Results are entirely consistent with Lybrido™’s known mechanism of action regarding the phosphodiesterase 5 (PDE5) inhibition’s enhancement of genital blood flow.
• Dose confirmation: The study successfully validates the dose selection for upcoming study/studies, substantially reducing development risk.

Nicole Hijnen, Chief Executive Officer of Arletta Pharma Solutions, said: “These results represent a watershed moment for Arletta Pharma’s clinical development program. For the first time, we have objective biomarker evidence demonstrating that our high-dose Lybrido™ formulation produces statistically significant physiological arousal responses in women with FSIAD, even with a small sample size. This study confirms our dose selection and validates our approach. Combined with our
expanding patent portfolio and constructive FDA dialogue, we are well-positioned to move forward with our clinical development program.”

Prof. Cobi Reisman, MD, PhD, FECSM, ECPS, Principal Investigator, commented: “The CDU study results offer physiological evidence suggesting that combination therapy with sublingual testosterone and oral sildenafil may produce notable improvements in clitoral blood flow, which can serve as an indicator of genital arousal capacity. The fact that statistical significance was reached with the high dose-combination, even with a relatively small sample size, points to a
potentially consistent treatment effect. The alignment of these objective findings with previously reported improvements in patient-reported outcomes adds to the growing evidence for this therapeutic approach and its possible role in addressing an important unmet need.”

Study Design and Results
The randomized, open-label Phase II dose-response study enrolled 16 premenopausal women with acquired generalized FSIAD. Participants were randomized to receive either the standard dose-combination or the high dose-combination of Testosterone + Sildenafil. The primary outcome measure was change from baseline in Peak Systolic Velocity (PSV) of clitoral blood flow measured by Clitoral Doppler Duplex Ultrasound.

Conclusions: Results Conform to Expectation

The study’s conclusions confirm the therapeutic hypothesis and support advancement of the clinical program:

• More than 60% average improvement in clitoral blood flow (PSV) with both dose-combinations
• Statistical significance achieved for the high dose-combination
• Demonstrates objective physiological arousal response to combination therapy
• Consistent with mechanism of action (Testosterone + PDE5 inhibition)
• Confirms dose selection for pivotal program

Earlier studies have already demonstrated that combination therapy is required to achieve the desired therapeutic effect. Previous research by van der Made, Bloemers et al. (2009) established that testosterone enhances the effect of PDE-5 inhibitors on genital blood flow in women with Hypoactive Sexual Desire Disorder (HSDD), with combination therapy showing significantly superior results compared to either component alone (p<0.03)[1].

Potential US Phase II Study to Complement Clinical Development Program
In parallel with the planned pivotal study in Europe, Arletta Pharma is evaluating the initiation of a smaller Phase II study in the United States, focusing on the highest Lybrido™ dose-combination identified in the CDU study (1.0 mg Testosterone / 100 mg Sildenafil). Depending on timing and resources, these two studies may be initiated sequentially or in overlapping fashion, with the US Phase II trial designed to further characterize the efficacy and safety profile of the high-dose regimen in the target population of women suffering from FSIAD. Together, the pivotal program and the potential US Phase II study are intended to maximize the clinical and strategic value of Lybrido™’s development, supporting optimal value creation for patients and stakeholders.

About Female Sexual Interest/Arousal Disorder (FSIAD)
Among female sexual disorders (FSD), low sexual desire and arousal consistently represent the most common issues affecting women, often leading to clinically significant distress, dissatisfaction in intimate relationships, and profoundly impacting emotional well-being and quality of life.

Female Sexual Interest/Arousal Disorder (FSIAD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), is characterized by persistent reductions in both sexual interest and/or arousal. FSIAD is diagnosed when symptoms persist for a minimum of six months and cause clinically significant distress.

FSIAD represents the clustering of Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, which are listed in the World Health Organization’s International Classification of Diseases, 11th Revision (ICD-11) under Code HA00/HA01.0. An estimated 8% of adult women meet diagnostic criteria for FSIAD, representing approximately 250 million women worldwide, an enormous unmet medical need.

About Lybrido™
Lybrido™ is an investigational on-demand, dual-action therapy designed to address both the psychological and physiological components of Female Sexual Interest/Arousal Disorder (FSIAD) and Hypoactive Sexual Desire Disorder (HSDD). The treatment consists of a novel dual-route, dual-release, fixed dose-combination tablet with a testosterone coating for sublingual administration and an inner-core component containing the PDE5 inhibitor sildenafil.

Lybrido™’s proprietary delayed-immediate-release formulation ensures that peak plasma concentration of sildenafil coincides with the window of increased sexual motivation induced by sublingually administered testosterone. This synchronized dual mechanism enables increased genital arousal through enhanced responsivity to sexual stimuli, with effects lasting 3 to 6 hours after intake. The on-demand administration provides women with control over their treatment.

To date, Lybrido™ has been investigated in 20 Phase I and Phase IIa trials, plus large-scale Phase IIb trials conducted across 17 US research sites, establishing a substantial safety and efficacy database. The therapy addresses both central sexual motivation (desire) and peripheral genital arousal, representing a differentiated mechanism of action compared to currently available treatments.

About Arletta Pharma Solutions
Arletta Pharma Solutions is a pharmaceutical company, previously known as Freya Pharma Solutions, focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon more than fifteen years of rigorous scientific research. The company’s core asset under development is Lybrido™, designed to address FSIAD/HSDD through an innovative on-demand dual-action mechanism that targets both psychological and physiological components of female
sexual dysfunction.

Based in Amsterdam, The Netherlands, Arletta Pharma Solutions aims to offer patients a convenient, personalized on-demand solution for this recognized unmet medical need affecting millions of women worldwide. The company’s name, derived from a rare butterfly species, symbolizes transformation, beauty, and freedom, concepts that resonate deeply with women’s healthcare and the company’s mission to empower women to take control of their sexual health.

References
[1] van der Made F, Bloemers J, et al. (2009). The influence of testosterone combined with a PDE5-inhibitor on cognitive, affective, and physiological sexual functioning in women suffering from sexual dysfunction. Journal of Sexual Medicine, 6(3), 429-439. https://doi.org/10.1111/j.1743-6109.2008.01142.x

For further information please contact:
Arletta Pharma Solutions, Amsterdam
Marcel Wijma, Chief Business Officer
E: marcel@arlettapharmasolutions.com

For media:
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
E: lmelens@lifespring.nl

This press release contains forward-looking statements regarding Arletta Pharma Solutions’ clinical development plans, regulatory strategy, and commercial potential. Actual results may differ materially from those projected. Lybrido™ is an investigational product that has not been approved by any regulatory authority.

Attachment

• Press Release Arletta CDU Study Results_FINAL

• New name reflects company’s transformation as it advances toward the final phase of Lybrido™’s clinical development
• The Arletta butterfly symbolism underscores commitment to women’s health and lifecycle transitions
• CDU Phase II study ongoing with preliminary data expected near-term; ALETTA pivotal study positioned for launch pending financing completion
• Company leverages fifteen years of research in Female Sexual Disorders

Amsterdam, the Netherlands, 27 November 2025 – Freya Pharma Solutions, Freya Pharma Solutions, a pharmaceutical company specializing in innovative therapies for women diagnosed with Female Sexual Disorders (FSD), today announced it will rebrand as Arletta Pharma Solutions, effective December 1, 2025. The new name, derived from a rare butterfly species, symbolizes the company’s transformation as it progresses toward pivotal clinical milestones and its strategic objectives of securing regulatory approval.

“Like a caterpillar emerging as a butterfly, this name change marks the beginning of our company’s final phase,” said CEO Nicole Hijnen, Chief Executive Officer of Arletta Pharma Solutions. “This rebranding comes at the optimal moment in our evolution—as we advance our clinical programs and prepare to deliver on our founding mission to address a significant unmet medical need affecting millions of women worldwide.”

The Butterfly: A Universal Symbol in Women’s Healthcare

The name Arletta, inspired by a rare butterfly species, carries profound significance for women’s medical care. The butterfly symbolizes transformation, change, beauty, and freedom—concepts that resonate deeply throughout women’s healthcare. Internationally, the term “butterfly” appears frequently in medical contexts related to women’s health, from anatomical structures to diagnostic indicators, reflecting the transformative nature of women’s life stages.

Throughout their lives, women undergo remarkable transformations—puberty, reproductive years, perimenopause, and postmenopause—each representing a metamorphosis that requires specialized medical attention and understanding. Arletta Pharma’s focus on developing innovative therapies for Female Sexual Interest/Arousal Disorder (FSIAD) acknowledges these unique transitions and the need for targeted therapeutic solutions that respect the complexity of female sexual health.

Clinical Programs Advancing

Arletta Pharma’s Clitoral Doppler Duplex Ultrasonography (CDU) Phase II study is currently ongoing at Chaim Sheba Medical Center, evaluating two testosterone-sildenafil dose-combinations in 16 premenopausal women with acquired generalized FSIAD. Led by Prof. Cobi Reisman and Dr. Anna Padoa, the study utilizes clitoral doppler duplex ultrasound imaging to quantify clitoral blood flow parameters, with preliminary data expected in the near term. Additionally, the company is finalizing preparations for the ALETTA pivotal study across 20 European research sites in five countries, with enrollment positioned to commence in the foreseeable future pending completion of financing arrangements—a critical milestone toward regulatory approval in Europe.

Building on Fifteen Years of Scientific Foundation

Arletta Pharma Solutions (formerly Freya Pharma Solutions) is developing Lybrido™, an innovative on-demand dual-action therapy for FSIAD and Hypoactive Sexual Desire Disorder (HSDD), building upon fifteen years of research. Lybrido™ features a novel dual-route, dual-release tablet with a testosterone coating for sublingual administration and a sildenafil (PDE-5 inhibitor) inner core. The delayed-immediate-release matrix synchronizes peak plasma concentration of sildenafil with the testosterone-induced window of increased sexual motivation, enhancing genital arousal through increased responsivity to sexual stimuli. Effects last 3 to 6 hours after intake. To date, Lybrido™ has been investigated in 20 Phase I and Phase IIa trials, plus large-scale Phase IIb trials across 17 US research sites.

About Female Sexual Disorders

Low sexual desire is the most common female sexual disorder (FSD), often causing clinically significant distress, dissatisfaction in intimate relationships, and profoundly impacting emotional well-being. Female Sexual Interest/Arousal Disorder (FSIAD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), combines persistent reductions in sexual interest and/or arousal lasting six months while causing clinically significant distress. FSIAD represents the clustering of Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, listed in the World Health Organization’s International Classification of Diseases, 11th Revision (ICD-11) under Code HA00/HA01.0.

About Arletta Pharma Solutions

Arletta Pharma Solutions (formerly Freya Pharma Solutions) is a pharmaceutical company focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon fifteen years of solid research. The company’s core asset under development is Lybrido™, designed to address FSIAD/HSDD through an innovative on-demand dual-action mechanism. Based in Amsterdam, The Netherlands, Arletta Pharma Solutions aims to offer patients a convenient, personalized on-demand solution for this recognized unmet medical need.

For further information please contact:

Arletta Pharma Solutions, Amsterdam

Marcel Wijma, Chief Business Officer
marcel@arlettapharmasolutions.com

For media

LifeSpring Life Sciences Communication, Amsterdam

Leon Melens

T: +31 6 538 16 427
E: lmelens@lifespring.nl

Arletta Pharma Solutions Announces Launch of Phase II Clinical Dose-Response Study testing its Lybrido^TM Concept Targeting Female Sexual Dysfunction

• Study evaluates Lybrido™’s Dual-Action therapy for Female Sexual Dysfunction
• Innovative clitoral blood flow measurement technique aims to objectively quantify treatment efficacy of two dose-combinations
• ALETTA Pivotal Study prepared for Late 2025 launch in Europe amid significant unmet medical need

Amsterdam, the Netherlands, 4 August 2025 – Arletta Pharma Solutions, a pharmaceutical company specializing in innovative therapies for women diagnosed with Female Sexual Disorders (FSD), today announced the initation of a Phase II clinical study evaluating its Lybrido^TM concept. The study will investigate two dose-combinations of testosterone and sildenafil, assessing their effects on female sexual response through physiological measurements of genital blood flow parameters.

This investigator-initiated clinical study, designed and led by Principal Investigator Prof. Cobi Reisman, (urologist, sexologist), and Co-Investigator Dr. Anna Padoa (gynecologist), will be conducted at the Chaim Sheba Medical Center. The study aims to assess objective physiological measurements of arousal response in premenopausal women diagnosed with acquired generalized Female Sexual Interest/Arousal Disorder (FSIAD) following treatment with combined sublingual testosterone and oral sildenafil therapy. Clitoral blood flow parameters – a key biomarker of genital arousal – will be quantified using standardized Clitoral Doppler Duplex Ultrasound imaging.

Prof. Cobi Reisman, MD, PhD, FCESM,ECPS said:

“Combination therapy of sublingual testosterone and oral sildenafil is reported as a potentially effective and safe treatment option for premenopausal women with FSIAD. We are very interested in this promising treatment modality, and aim to better understand the mechanisms behind the clinical observations reported sofar. Sexual function is frequently measured with validated and standardized questionnaires to determine the subjective sexual response, whereas objective measures warrant physical measurement. In this regard, clitoral vascularization is reported as a relevant physiological indicator of the female genital arousal response. In our study we will use Clitoral Doppler Duplex Ultrasound which is a promising technique to assess clitoral blood flow in women.”

Dr. Jan van der Mooren, Chief Medical Officer at Arletta Pharma Solutions commented:

“The combination of sublingual testosterone and oral sildenafil being studied by Prof. Reisman and Dr. Padoa closely mirrors the mechanism of action of Lybrido^TM, our investigational product for women diagnosed with FSIAD. This research aligns with Arletta Pharma’s commitment to advancing science in this field, and we’re proud to support a study that could deepen our understanding of Lybrido^TM’s therapeutic potential. Concurrently, Arletta Pharma Solutions is finalizing preparations for the ALETTA clinical study – a pivotal clinical  study as part of Lybrido™’s European clinical development program. Enrollment is slated to begin in late 2025 across 20 European research sites in five countries.”

About Female Sexual Disorders

Among female sexual disorders (FSD), representing a significant health concern, low sexual desire consistently is reported as the most common issue affecting women. This widespread challenge often leads to clinically significant distress, dissatisfaction in intimate relationships, profoundly impacting emotional well-being and social connections.

In the Diagnostic and Statistical Manual of Mental Disorders, 5^th Edition (DSM-5), Female Sexual Interest/Arousal Disorder (FSIAD) combines persistent reductions in both sexual interest and/or arousal, requiring symptoms to persist for six months, while causing clinically significant distress. Clinicians diagnose FSIAD through specific symptom thresholds and further categorize it by severity (mild, moderate, or severe) and subtype: lifelong versus acquired, and generalized versus situational presentations. FSIAD is the clustering of Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder; listed in the World Health Organization’s International Classification of Diseases, 11^th Revision (ICD-11) under Code 17 HA00/HA01.0 Hypoactive Sexual Desire Dysfunction and Female Sexual Arousal Dysfunction (https://icd.who.int/).

About LybridoTM

A total of 20 phase I and phase IIa trials, and large-scale phase IIb trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat FSIAD, LybridoTM and LybridosTM. LybridoTM increases central sexual motivation and physiological sexual responses, such as swelling of genitals and lubrication. The therapy can be taken ‘on-demand’ and helps to increase central sexual motivation from 3 to 6 hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-immediate-release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingually administered testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.

About Arletta Pharma Solutions

Arletta Pharma Solutions is a pharmaceutical company, focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon fifteen years of solid research. The company’s core asset under development is LybridoTM, designed to address FSIAD/HSDD. Based in Amsterdam, The Netherlands, Arletta Pharma Solutions aims to offer patients a convenient, personalized ‘on-demand’ solution for this recognized unmet medical need.

For further information please contact:

Arletta Pharma Solutions, Amsterdam

Marcel Wijma, Chief Business Officer

marcel@arlettapharmasolutions.com

For media

LifeSpring Life Sciences Communication, Amsterdam

Leon Melens

T: +31 6 538 16 427
E: lmelens@lifespring.nl