SiccaNova Therapeutics Co., Ltd. (Headquarters: Tsukuba City, Ibaraki Prefecture, CEO: Keni Nii, hereinafter referred to as "the Company") is pleased to announce the completion of a Series A round through a third-party allocation of shares, raising a total of 1.25 billion yen.

The Company will use the funds raised to accelerate preparations for the clinical development of its M3 receptor positive allosteric modulator, "XF8302," in the field of xerostomia (dry mouth). Simultaneously, the Company will strengthen its manufacturing and quality control, non-clinical research, regulatory affairs, and development systems, while continuing to explore therapeutic possibilities in related areas, including dry eye.


◆Funding Overview◆
Total Funding: 1.25 billion yen (Series A)
Funding Method: Third-party capital increase
Subscribers: Tohoku University Venture Partners Co., Ltd., JIC Venture Growth Investments Co., Ltd., MPower Partners (WPower Fund I), Red capital Co., Ltd., 77 Capital Co., Ltd., Joyo Capital Partners Co., Ltd.

◆Main Uses of Funds◆
• Preparation for clinical development of XF8302 in the field of xerostomia (dry mouth)
• Promotion of manufacturing and quality control, non-clinical research, and regulatory compliance
• Strengthening of research and development and business promotion systems

〈About XF8302〉
XF8302 is an oral small molecule compound under development as a positive allosteric modulator (M3 PAM) of the muscarinic M3 receptor. It has the characteristic of enhancing receptor activation by acetylcholine in the body, and aims to become a new treatment option for symptoms associated with decreased exocrine gland function.
We are currently preparing for clinical development in the field of xerostomia. Furthermore, based on the properties of XF8302, we are also conducting exploratory research in related areas, including dry eye.


— Comment from the President & CEO —

We are deeply grateful for the continued support from our existing investors, as well as for the positive evaluation of our business and the potential of XF8302 by new investors, which has enabled us to complete our Series A funding round.
Xerostomia associated with Sjögren's syndrome affects various aspects of patients' daily lives, including eating, talking, and sleeping. While muscarinic receptor agonists, which appeared about 20 years ago, remain an important treatment option, some patients find it difficult to continue adequate treatment due to side effects such as sweating and gastrointestinal symptoms.
XF8302 is an M3 receptor positive allosteric modulator that enhances the activation of M3 receptors by acetylcholine in the body. Through a novel mechanism of action different from conventional muscarinic receptor agonists, we aim to achieve a better balance between saliva secretion promotion and tolerability.
This funding will allow us to move to the next stage of clinically verifying the potential of XF8302 in patients with Sjögren's syndrome. We aim to accelerate development with the goal of delivering a new drug to this area, where no new treatment options have long been available.


— Comments from Investors —

◆New Investor◆

【JIC Venture Growth Investments Co., Ltd.】
Life Science Professional, Venture Capitalist, Yoshiharu Uruno

　Dry mouth is not simply a symptom of a dry mouth; it causes various serious health problems. While several treatment methods, including pharmaceuticals, exist, there is a need for more effective and safer treatments.
　SiccaNova Therapeutics is advancing the clinical development of a drug candidate compound with a novel mechanism of action. Through clinical trials, we will accelerate its social implementation as a medicine, and together with stakeholders, we will support the development so that a new treatment option can be provided as soon as possible to those suffering from dry mouth symptoms.


【MPower Partners (WPower Fund I)】
General Partner: Miwa Seki / Principal: Ye Xia

Addressing women's unmet medical needs. That is the primary reason we decided to invest in SiccaNova Therapeutics.
The new drug being developed by the company will initially target Sjögren's syndrome. While over 90% of patients are women, dryness symptoms in women are often dismissed as age-related or menopausal changes, and many women go undiagnosed. As a result, both the actual number of patients and the disease burden have long been underestimated. For middle-aged and older women, dryness is a persistent source of distress in every aspect of daily life, from eating, speaking, and sleeping to sexual activity. Yet, it has still not been treated as a "disease that needs treatment." We believe that presenting a new solution to this structurally overlooked area is extremely significant.
This new drug, "Low Molecular Weight M3 PAM Oral Formulation," is a highly unique asset that leverages the physiological mechanism of saliva secretion to simultaneously maximize efficacy and reduce side effects. Early clinical trials have shown favorable efficacy and tolerability, and it is expected to significantly improve the quality of life (QOL) of patients who are not satisfied with existing treatments.
WPower Fund, which places women's well-being at the core of its investment theme, expects this investment to accelerate the acquisition of a clinical proof-of-concept (PoC) in Japan and development in the United States. In the future, we will fully support the growth of the business together with SiccaNova, so that its value can reach a wider range of patients, including those with dry mouth and xerostomia in the elderly.

[Red Capital Co., Ltd.]
Representative Director & Managing Partner, Maiko Katadae

Dry mouth and dry eye significantly impact patients' QOL, yet existing treatments are insufficient, creating a strong need for new treatment options in this disease area. SiccaNova Therapeutics is working to realize innovative treatments for dryness-related diseases through a novel drug discovery approach called M3 PAM, which selectively enhances the function of M3 receptors and stimulates the body's natural secretory functions. Building on the results of their accumulated research and development, we expect further progress in future clinical development. Red Capital will continue to provide full support to ensure that this new treatment option reaches patients as quickly as possible.


[77 Capital Co., Ltd.]
President and CEO, Masanori Muranushi

Amidst changing and diversifying population structures and lifestyles, dryness-related diseases such as dry mouth and dry eyes are on the rise. SiccaNova Therapeutics, in collaboration with Tohoku University, is developing innovative therapeutic drugs using an unprecedented approach to meet the high demand for safe and highly effective treatments. Our company aims to contribute to the realization of a sustainable society by providing new value, such as a significant improvement in quality of life, through treatment with new drugs, and we will work together toward social implementation.


[Joyo Capital Partners Co., Ltd.]
Mr. Masataka Iida, Chief Research Officer, Fund Division

Sicca-related diseases, which significantly reduce quality of life (QOL), represent a huge unmet medical need with limited effective treatments. SiccaNova is steadily advancing an innovative pipeline to address this challenge, leveraging its unique pharmacological approach and robust academic network. We deeply sympathize with the efforts of CEO Nii and his high-quality team, and have decided to make this investment. We will support SiccaNova so that their treatments reach patients worldwide as quickly as possible.


◆Existing Investor◆

[Tohoku University Venture Partners Co., Ltd.]
Mr. Fumihiro Nakamori, Senior Vice President, Investment Department

We are very pleased to make an additional investment in SiccaNova, which has made remarkable progress in strengthening its management structure and building a system for domestic clinical trials since our previous investment.
XF8302, developed by SiccaNova, is a novel candidate for the treatment of xerostomia (dry mouth) with a unique mechanism of action. It is an extremely promising small molecule compound that has already demonstrated safety and some pharmacological effects in clinical trials. Because it is a small molecule compound, it is highly accessible and affordable, and we are confident that it will be a groundbreaking treatment that will significantly improve the Quality of Life (QoL) of many patients.


— About SiccaNova Therapeutics Co., Ltd. —

SiccaNova Therapeutics Co., Ltd. is a drug discovery venture aiming to provide new treatment options for symptoms associated with exocrine gland dysfunction, including xerostomia. Focusing on the M3 receptor positive allosteric modulator XF8302, we are promoting research and development of pharmaceuticals that contribute to improving patients' QoL.

Company Name: SiccaNova Therapeutics Co., Ltd.
English Name: SiccaNova Therapeutics Co., Ltd.
Address: 2-5-1 Azuma, Tsukuba City, Ibaraki Prefecture 305-0031, Japan
Established: February 2022
Representative: Keni Nii, Representative Director & CEO
Website: https://www.siccanova.com

Inquiries regarding this matter:

SiccaNova Therapeutics Co., Ltd.
E-mail: info@siccanova.com
Website: https://www.siccanova.com