1 The EIC Accelerator Project

EIC Accelerator Program Overview

The EIC Accelerator is a flagship funding program of the European Innovation Council, designed to support innovative startups and small to medium-sized enterprises (SMEs) in their growth and development phases. It focuses on high-risk, high-impact innovations with the potential to create new markets or disrupt existing ones in Europe and beyond. The program targets breakthrough technologies and deep tech innovations that require substantial funding and strategic support to scale.

Funding Structure

The EIC Accelerator provides a unique funding model combining grants and equity investments:

• Grants: Up to €2.5 million can be awarded to cover activities such as demonstration, testing, prototyping, and other innovation development expenses. This funding aims to bring the innovation closer to market readiness.
• Equity Investments: The program offers equity support of up to €15 million until 2024, which will adjust to up to €10 million starting in 2025. This component is designed to help leverage additional private investments and support the scaling of operations.

Purpose in the European DeepTech and Startup Ecosystem

The EIC Accelerator plays a crucial role in nurturing the European DeepTech and startup ecosystem by:

• Bridging Funding Gaps: Addressing the financial challenges faced by startups, particularly those working on high-risk, high-reward projects.
• Fostering Innovation: Encouraging the development of groundbreaking technologies that have the potential to create new industries or disrupt existing ones.
• Enhancing Competitiveness: Supporting companies that can enhance Europe's competitive edge in the global market.

Role in Scaling and Private Sector Funding

The EIC Accelerator assists companies in scaling and securing private sector investments by:

• Providing Credibility: EIC support acts as a quality stamp, increasing the credibility of the companies and making them more attractive to private investors.
• Facilitating Networking: Offering access to a network of investors, industry leaders, and potential partners.
• Strategic Support: Supplying mentorship and strategic business advice to ensure growth and market entry success.

GEDEA BIOTECH AB and the pHyph Project

Company Overview: GEDEA BIOTECH AB, based in Sweden, is a winner of the EIC Accelerator, recognized for its innovative healthcare solutions.

Project pHyph: This project focuses on developing a pioneering dual-action over-the-counter (OTC) tablet designed for the treatment and prevention of bacterial and fungal vaginitis. The pHyph tablet aims to offer an effective, non-prescription alternative for managing these common and often recurrent conditions.

Technology Basics and Background

• Dual-action Mechanism: The pHyph tablet combines two therapeutic actions to address both bacterial and fungal infections, providing a comprehensive solution for vaginitis.
• Innovation in Treatment: Traditionally, separate treatments are required for bacterial and fungal infections. The pHyph tablet simplifies this by combining treatment modalities, potentially improving patient compliance and outcomes.
• Market Impact: As a non-prescription solution, pHyph has the potential to significantly impact the market by providing accessible and efficient treatment options, reducing the need for medical consultations and prescriptions.

Strategic Goals: With the support of the EIC Accelerator, GEDEA BIOTECH AB aims to further develop and scale the pHyph project, positioning it as a leading solution in women's health and expanding its reach in the market.

For more information, visit gedeabiotech.com.

2 The Funding Rounds

Since receiving the EIC Accelerator funding on November 8, 2023, Gedea Biotech AB has secured additional financing to support the development and commercialization of their antibiotic-free treatment for vaginal infections, pHyph.

Funding Rounds:

October 2024: Gedea Biotech conducted a rights issue, initially aiming to raise SEK 24.3 million. Due to high interest from both existing and new investors, the issue was oversubscribed by 54%, leading to an additional directed issue of SEK 13 million. In total, the company raised SEK 34.8 million (approximately €3 million or $3.2 million) after issue costs. (gedeabiotech.com)

Investor Information:

The October 2024 funding round attracted both existing shareholders and new investors, including family offices and high-net-worth individuals with experience in the life sciences sector. Specific names of these investors have not been publicly disclosed. (gedeabiotech.com)

Company Valuation:

As of now, specific valuation figures for Gedea Biotech following these funding rounds have not been publicly disclosed.

These financial milestones have provided Gedea Biotech with a runway exceeding 24 months, enabling the company to finalize the CE marking process for pHyph, transfer the technology to commercial-scale production, and advance partnership efforts for development and commercialization. (gedeabiotech.com)

3 The Press Releases

Since receiving EIC Accelerator funding on November 8, 2023, Gedea Biotech AB has issued several press releases detailing significant developments:

1. Approval for NEFERTITI-2 Clinical Study (November 8, 2023): Gedea Biotech received approval from the Swedish Medical Product Agency and Ethics Committee to initiate the pivotal NEFERTITI-2 clinical study. This randomized, partly-blinded study aims to confirm the safety and efficacy of pHyph in treating and preventing bacterial vaginosis (BV) recurrence. Patient recruitment was set to begin across five Swedish clinics. Previous studies indicated that pHyph's cure rate for BV aligns with existing antibiotics but offers a superior safety profile without causing secondary candida infections or high recurrence rates associated with antibiotic treatments. (news.cision.com)

2. Oversubscribed Rights Issue (November 15, 2023): The company announced the successful completion of an oversubscribed rights issue, raising €1.5 million (16.5 million SEK). The funds are designated to:

• Initiate patient recruitment for the approved registration CL3-2 study.
• Obtain data from the CL4 study to establish pHyph's proof-of-concept for treating vaginal fungal infections.
• Conduct microbiome analysis from the CL3 study.

This financial boost supports the advancement of pHyph as an antibiotic-free treatment for vaginal infections. (news.cision.com)

3. Completion of EpHect Clinical Trial (February 8, 2024): Gedea Biotech completed patient enrollment for the EpHect study, which evaluates the safety and efficacy of pHyph in treating vulvovaginal candidiasis (VVC). All 26 participants commenced treatment, with results anticipated in the second quarter of 2024. VVC affects approximately 75% of women during their lifetime, and current treatments often lead to concerns about resistance. The EpHect study aims to provide an effective, antibiotic-free alternative. (news.cision.com)

4. EIC Accelerator Grant Awarded (February 29, 2024): The European Innovation Council (EIC) selected Gedea Biotech for a €2.5 million EIC Accelerator grant to further develop and commercialize pHyph. This funding will expedite pHyph's development, bringing the antibiotic-free treatment for vaginal infections to patients sooner. The EIC Accelerator is highly competitive, with only 42 out of 1,083 applicants (~4%) selected in the November 2023 cutoff. (news.cision.com)

5. Appointment of New CFO (April 25, 2024): Per-Ola Forsberg was appointed as the new Chief Financial Officer (CFO) of Gedea Biotech. With over 25 years of experience in the life science industry, Forsberg has held CFO positions at several companies, including Pharmiva AB, WntResearch AB, and Probi AB. His expertise is expected to strengthen Gedea's financial and business development strategies. (gedeabiotech.com)

6. Oversubscribed Share Issue (November 6, 2024): Gedea Biotech conducted a rights issue of SEK 24.3 million in October, which was oversubscribed by 54%, leading to a total of SEK 34.8 million after issue costs. This funding supports the finalization of the CE marking process for pHyph, technology transfer to commercial-scale production, and partnership efforts for development and commercialization. (gedeabiotech.com)

7. Team Expansion and Award Recognition (December 3, 2024): The company strengthened its team by hiring Anna-Karin Areskog as QA Director, focusing on CE marking and commercial-scale production of pHyph. Additionally, Gedea Biotech received the Arvind Hundal Scale-up Award at the Nordic Mentor Network for Entrepreneurship (NOME) annual meeting, recognizing the company's inspirational growth. (gedeabiotech.com)

These developments highlight Gedea Biotech's progress in advancing pHyph, securing funding, expanding its team, and receiving industry recognition since obtaining EIC Accelerator funding.

4 The Technology Advancements

As of April 15, 2025, Gedea Biotech AB has made significant strides since receiving EIC Accelerator funding on November 8, 2023.

Technology Advancements:

In September 2023, prior to the EIC funding, Gedea Biotech was granted a European patent for the formulation of its vaginal pHyph tablet, which is designed to treat and prevent bacterial and fungal vaginitis. This patent strengthens their intellectual property portfolio and extends protection until 2040. (gedeabiotech.com)

Scaling and Development Phase:

Following the EIC funding, Gedea Biotech successfully completed a rights issue in October 2024, raising SEK 34.8 million. This capital is being utilized to finalize the CE marking process under the Medical Device Regulation (MDR) for European approval of pHyph. Additionally, the company is initiating activities to transfer their technology to commercial-scale production and advancing partnership efforts for the development and commercialization of pHyph. (gedeabiotech.com)

Market Demonstration:

While Gedea Biotech has conducted clinical trials demonstrating the efficacy and safety of pHyph, the product has not yet been introduced to the market. The company is currently in the process of obtaining CE marking, which is a prerequisite for market entry in Europe. (gedeabiotech.com)

Patents and Publications:

Since the EIC funding, there have been no publicly disclosed new patents, scientific studies, clinical trials, or whitepapers from Gedea Biotech. The most recent patent was granted in September 2023, prior to the funding. (gedeabiotech.com)

In summary, Gedea Biotech AB is actively progressing towards scaling their pHyph technology and entering the European market, with ongoing efforts to secure necessary regulatory approvals and establish commercial partnerships.

5 The Partnerships and Customers

Since receiving EIC Accelerator funding on November 8, 2023, Gedea Biotech AB has not publicly announced any new partnerships or customer acquisitions. However, the company has made significant strides in strengthening its financial position and advancing its product development.

In October 2024, Gedea Biotech conducted a rights issue that was oversubscribed by 54%, raising a total of SEK 34.8 million (approximately €3 million or $3.2 million). This funding, combined with the earlier €2.5 million grant from the Horizon 2020 EIC program, has provided the company with a financial runway exceeding 24 months. These resources are being utilized to finalize the CE marking process for pHyph, their antibiotic-free vaginal tablet for treating bacterial vaginosis, and to initiate technology transfer to commercial-scale production. Additionally, Gedea is actively seeking partnerships for the development and commercialization of pHyph. (gedeabiotech.com)

While specific new partnerships or customer relationships have not been disclosed, the strengthened financial position and ongoing efforts to secure partnerships are expected to enhance Gedea Biotech's market position. The successful CE marking and commercialization of pHyph will enable the company to offer a novel treatment option for bacterial vaginosis, potentially capturing a significant share of the market.

Furthermore, the additional funding supports technology advancements and scaling efforts, facilitating the transition to commercial-scale production and ensuring the company is well-prepared to meet market demand upon product approval.

6 The Hiring and Company Growth

Since receiving the EIC Accelerator funding on November 8, 2023, Gedea Biotech AB has made notable strides in team expansion and organizational development.

Current Headcount and Team Size: As of April 2025, specific details regarding Gedea Biotech's total headcount and team size are not publicly disclosed. However, available information indicates a team of approximately 12 employees. (edgein.io)

Recent Hiring and Team Growth: In December 2024, Gedea Biotech appointed Anna-Karin Areskog as the Quality Assurance (QA) Director. Anna-Karin had been collaborating with the company as a consultant since April 2023 and transitioned to a permanent role to focus on obtaining CE marking for pHyph and initiating its commercial-scale production. (gedeabiotech.com)

Additionally, the company welcomed Emilia Lahtinen as an industrial Ph.D. student in 2022. Emilia's research centers on understanding the impact of antibiotic and antibiotic-free treatments on the vaginal microbiome and the risk of recurrence in bacterial vaginosis. (gedeabiotech.com)

Current Hiring Status: As of April 2025, there is no publicly available information indicating that Gedea Biotech is actively recruiting for new positions.

Impact of New Team Members: The addition of experienced professionals like Anna-Karin Areskog and the collaboration with researchers such as Emilia Lahtinen are pivotal for Gedea Biotech's future. Anna-Karin's expertise in quality assurance is instrumental in navigating regulatory processes and scaling up production, while Emilia's research contributes valuable insights into treatment efficacy and safety. Together, they enhance the company's capacity to bring pHyph to market and address unmet needs in women's health.

Changes in Management or Founding Team: There have been no reported major changes in Gedea Biotech's management or founding team since November 2023.

In summary, Gedea Biotech has strategically expanded its team with key hires and collaborations, positioning the company for successful product development and commercialization following the EIC Accelerator funding.

7 The Media Features and Publications

Since receiving EIC Accelerator funding on November 8, 2023, Gedea Biotech AB has been featured in several media outlets and has actively participated in various events. Below is a summary of their media coverage and activities:

Media Features and Publications:

• Announcement of the €2.5M EIC Accelerator grant for the development and commercialization of pHyph. (news.cision.com)
• Completion of an important clinical trial on vaginal fungal infection. (news.cision.com)
• Raising 1.5 MEUR (16.5 MSEK) in an oversubscribed rights issue to initiate and accelerate clinical trial activities. (news.cision.com)

Content from Publications:

• The €2.5M EIC Accelerator grant will accelerate the development of pHyph, an antibiotic-free treatment for vaginal infections, bringing this treatment earlier to patients in need. (news.cision.com)
• The completion of the EpHect study, which aims to confirm the safety and efficacy of pHyph in treating vaginal yeast infections, included 26 patients, all of whom have commenced treatment. Results are expected in the second quarter of 2024. (news.cision.com)
• The oversubscribed rights issue raised 1.5 MEUR (16.5 MSEK) to initiate patient recruitment in the recently approved registration CL3-2 study and to perform microbiome analysis from the CL3 study. (news.cision.com)

Podcasts or Interviews:

No specific podcasts or interviews featuring the Gedea Biotech team since November 8, 2023, were identified in the available sources.

Conferences, Fairs, and Events:

Specific details regarding Gedea Biotech's participation in conferences, fairs, presentations, or other events since November 8, 2023, are not available in the provided sources.

For the most current information on Gedea Biotech's activities, including media appearances and event participation, it is recommended to visit their official website or contact the company directly.