We are an exempted company with limited liability incorporated under the laws of the Cayman Islands, whose principal place of business is in Switzerland. As a holding company with no operations, we conduct all of our operations through our subsidiaries in Switzerland and to a lesser extent, Hong Kong SAR (“HK SAR”), the People’s Republic of China (“PRC”) and Australia. (Incorporated in the Cayman Islands)

We are a biotechnology company spearheading the development of oral (specifically, sublingual) delivery of peptides and proteins.

Many of the more effective drugs to treat diabetes and obesity are “biologics”, the vast majority of which currently have to be injected. For example, although insulin was discovered almost 100 years ago, there has, to date, not been any commercially viable solution to administer insulin without the need for injection.

Consistent with this, the delivery of peptides or proteins, such as insulin, in a non-invasive way (i.e. without needles or injections) is a very challenging endeavor from a scientific and technical perspective.

Since our inception, we have focused on developing an alternative approach, known as sublingual delivery. The sublingual area lies under the tongue and is lined by a thin layer of cells which has a rich supply of blood vessels. Sublingual delivery has been successfully used commercially for many years to deliver a variety of so-called small molecule drugs, such as glyceryl trinitrate and ondansetron, which can readily penetrate this layer of cells to rapidly enter the blood stream. We hypothesized that we could similarly exploit the unique nature of the sublingual area to effectively deliver peptides and proteins, and this subsequently became the focus of our research. The main peptide used to improve the technology was exenatide, which was the first commercial glucagon-like peptide (GLP-1) receptor protein product and is routinely used to treat type 2 diabetes.

During our first series of studies with exenatide, the sublingual dose required was almost 200 times the injectable dose to achieve a similar effect. After 2 to 3 years of extensive development, we were able to reduce this ratio to 5 to 10, and we now have a “platform” of formulations (the “BioLingus Platform”) and expertise on how formulations should be designed for better performance.

During the course of our research and testing of various peptides and proteins across several different disease indications, it has become clear to us that there are two areas for our technology with significant commercial potential: (1) Metabolic disease, in particular, diabetes and obesity and related metabolic disorders such as NASH (nonalcoholic steatohepatitis) and (2) Immunology (mainly allergy and auto-immune disorders)

Our lead product candidate, Liraglutide Sublingual, being evaluated in a Phase Ib and Phase IIa together. The phase Ib/IIa is a “dose-finding study”: the goal is – as the name says – to find an optimal dose range in humans; this is a relatively short study, which lasts 6-9 months. The trial began in late April 2023, when the first patient was successfully enrolled and dosed, and is taking place at the Clinical Trials Centre of the Chinese University of Hong Kong. In total, 15 patients will be enrolled in the trial, which is being conducted as a single ascending dose study of sublingual liraglutide in patients with type 2 diabetes, with the main endpoints related to safety, tolerability and preliminary efficacy. As of May 29, 2023, 1 of 15 patients had been enrolled.

 *Note: Net loss is for the fiscal year that ended April 30, 2023. The company has no product revenues.

(Note: BioLingus (Cayman) Ltd. postponed its IPO as of Feb. 12, 2024. Background: BioLingus filed an F-1/A dated Nov. 9, 2023, in which it cut its IPO’s size to 360,000 shares – down sharply from 3.0 million shares initially – and raised its assumed IPO price to $20.00 – up from its initial price range of $15.00 to $16.00  – to raise $7.2 million. Background: BioLingus filed its F-1 on June 30, 2023, and disclosed terms for its IPO: 3.0 million shares at $15.00 to $16.00 to raise $47.0 million.)