Background and motives
Chronic and acute degenerative diseases are a major global health challenge affecting hundreds of millions of people around the world. The diseases cause both significant reduction in life expectancy and quality of life for affected patients and result in extensive socio-economic costs. Fluicell is a Swedish innovation-driven life science company that develops new therapies and techniques to be able to offer treatment alternatives to these, currently difficult-to-treat or incurable diseases. Fluicell is active in regenerative medicine and human tissue-based screening models for drug development in several therapeutic areas that are on the WHO's top-ten list of diseases that threaten longevity and quality of life. These include type 1 diabetes, cardiovascular disease and kidney disease. The key to Fluicell's growth strategy is the company's platform for tissue production, Nexocyte™, which includes Biopixlar®, the company's technology for high-resolution 3D-Bioprinting. The Nexocyte platform forms the basis for Fluicell's operations in both regenerative medicine and human screening products. Fluicell's development program in regenerative medicine aims to create tissue-based therapies that bring about significant improvements in both longevity and quality of life for patients with serious disease, with the long-term goal of being able to provide curative treatments.
The company's product pipeline consists of a pharmaceutical product for the treatment of type 1 diabetes as well as two human screening products in cardiac safety pharmacology and for kidney disease. The product candidates are based on detailed bioprinted tissues, generated using Fluicell's tissue production platform Nexocyte which is based on Biopixlar®, the company's technology for high resolution Bioprinting. Fluicell also has the following research technology platforms aimed at biological and biomedical research and drug development: BioPen®, Biozone 6® and Dynaflow® Resolve.
Fluicell's flagship program in type 1 diabetes aims to create a treatment solution that restores the body's normal function and capacity to regulate blood sugar levels through a unique therapy concept based on bioprinted cell clusters (mimicking the composition and function of human pancreatic islets) with the ability to regulate both high and low blood sugar. The therapeutic concept is thus a cell-based transplantation tool intended to be transplanted into the patient's body to replace damaged pancreatic islets. Fluicell's long-term goal is to create a curative solution that enables patients with type 1 diabetes to live a life without insulin injections and blood sugar monitoring.
The purpose of the Rights Issue is primarily to accelerate development of the Company's drug candidate in the disease area of type 1 diabetes. Additional investments are also being made to advance product development of cardiac tissue models for drug screening as well as counter-scaling and further development of the Company's tissue production platform.
Development target 2024
Objectives in the development of tissue-based products for the treatment of type 1 diabetes
- Insulin and glucagon release optimization (Q2 2024)
- Confirmed in vivo tolerability (Q1-Q2 2024)
- Viability lead optimization (Q3 2024)
- Initial discussion with EMA regarding further in vivo studies (Q1 2024)
- Confirmed in vivo efficacy (Q4 2024)
Goals within the development of human cardiac safety models
- Presentation of initial model (Q1 2024)
- Model validation with example substances (Q3 2024)
- Model scaled for secondary screening (Q3/Q4, 2024)
Company-related and financial goals
- Submission of 2–3 new patent applications (Q3 2024)
- Submission of 2-4 research grant applications focusing on screening models, tissue development, and automation (Q2-Q4 2024)
- Initiation of commercial partnership regarding type 1 diabetes or commencement of collaboration agreements within a new therapy area (Q4, 2024)
- Initiation of 1-2 collaboration agreements regarding the development of screening product (Q4 2024)
CEO Carolina Trkulja speaks
"With tissue-based type 1 diabetes therapy in the in vivo phase and collaboration on human cardiac tissue models for drug development with a top ten pharmaceutical company, we are well-positioned for success."
Serious chronic diseases linked to tissue damage pose a significant challenge for today's healthcare system, affecting millions of individuals worldwide, resulting in a high number of premature deaths and extensive socio-economic costs. Fluicell has a unique opportunity to create tissue-based therapeutic solutions that can completely change how we treat these diseases. With our patented platform Nexocyte, we have the ability to develop tissue-based solutions for regenerative medicine and drug development with an unmatched level of precision in the market.
Nexocyte combines Fluicell's award-winning bioprinting technology with our expertise in tissue design, biomaterials, and stem cell technology, based on years of research. With this platform, we have the opportunity to provide revolutionary products targeted towards rapidly growing markets estimated to reach a value of $155 billion by around 2030. With a development program for tissue-based type 1 diabetes therapy in the in vivo phase and collaboration on human cardiac tissue models for drug development with a top ten pharmaceutical company, we are well-positioned for success.
Carolina Trkulja, CEO Fluicell
The utilization of emission proceeds
In case of full subscription in the Rights Issue, the Company will receive an initial net liquidity of approximately 22.2 million SEK (after issuance costs). The net proceeds are intended to be allocated for the following purposes, in priority order:
- Mandatory repayment of bridge loans (approximately 8 percent)
- Development of tissue-based therapies for the treatment of type 1 diabetes (approximately 42 percent)
- Optimization and validation of tissue model for heart toxicity (approximately 11 percent)
- Platform optimization and production scaling (approximately 10 percent)
- Administrative expenses and working capital (approximately 29 percent)
In the event that all subscription options of series TO5 and TO6 issued in the Rights Issue are exercised for the subscription of shares, the Company will receive an additional net liquidity of approximately 23.3–45.7 million SEK, intended to be allocated for the following purposes, in priority order:
- Development of tissue-based therapies for the treatment of type 1 diabetes (approximately 42 percent)
- Optimization and validation of tissue model for heart toxicity (approximately 11 percent)
- Platform optimization and production scaling (approximately 10 percent)
- Administrative expenses and working capital (approximately 29 percent)
The offering in brief:
Offering & emission volume
The rights issue comprises a maximum of 27,218,405 units corresponding to a maximum of 272,184,050 shares, a maximum of 136,092,025 warrants of series TO5 and a maximum of 136,092,025 warrants of series TO6 (the "Rights Issue"). In case of full subscription in the Rights Issue, approximately SEK 30 million will be added to Fluicell before issue costs. Upon full utilization of the maximum number of warrants of series TO5 and TO6 respectively, Fluicell will receive a maximum of approximately SEK 47.6 million before issue costs.
The right to subscribe for units
Those who are registered in the share register maintained by Euroclear Sweden AB on the record date of January 11, 2024, have the preferential right to subscribe for units in the Rights Issue.
Terms
One (1) existing share in the Company held on the record date entitles to one (1) unit right. One (1) unit right entitles to the subscription of one (1) unit consisting of ten (10) new shares, five (5) series TO5 subscription options, and five (5) series TO6 subscription options.
Subscription price
The subscription price is 1.10 SEK per unit, equivalent to 0.11 SEK per share and a market value of approximately 3 million SEK before the Offering. No brokerage fee is charged.
Subscription period
The subscription period in the Rights Issue runs from January 15 to January 29, 2024.
Subscription options
The subscription options will be listed for trading on First North after the Rights Issue has been registered with the Swedish Companies Registration Office. The complete terms of the series TO5 and TO6 subscription options are available further down on the page.
Subscription commitments and underwriting
Fluicell has received subscription commitments of approximately SEK 0.46 million, corresponding to approximately 1.54 percent of the Rights Issue. The Company has also received underwriting commitments of approximately SEK 24.0 million, corresponding to approximately 80.19 percent of the Rights Issue, of which approximately SEK 14.5 million, corresponding to approximately 48.46 percent, constitute a bottom guarantee, and approximately SEK 9.5 million, corresponding to approximately 31.73 percent, constitute a top guarantee. The underwriting commitments can only be invoked in case of undersubscription in the Offering. In total, the Rights Issue is thus covered by subscription commitments and underwriting commitments totaling approximately SEK 24.5 million, corresponding to approximately 81.73 percent of the Rights Issue. Neither subscription commitments nor underwriting commitments are secured by bank guarantees, escrow, pledges, or similar arrangements, hence there is a risk that the commitments, in whole or in part, will not be fulfilled.
Timeline
- January 9, 2024: Last day of trading in Fluicell's share including the right to receive unit rights
- January 10, 2024: First day of trading excluding the right to receive unit rights
- January 11, 2024: Record date
- January 15 – January 29, 2024: Subscription period for the Rights Issue
- January 15 – January 24, 2024: Trading of unit rights
- January 15 – February 14, 2024: Trading of BTU (Paid Subscribed Unit)
- January 31, 2024: Announcement of the outcome of the Rights Issue.
Presentations and articles
- January 16: Intervju with CEO Carolina Trkulja (BioStock)
- January 18: Companypresentation BioStock
- January 19: Fluicell's emission to accelerate the development of diabetes treatment (BioStock)
- January 22: Intervju with CEO Carolina Trkulja (Stockpicker)