Human Stem Cell Institute, HSCI PJSC (MOEX: ISKJ), a Russian biotech holding, published its consolidated performance statement for 2022 in accordance with International Financial Reporting Standards (IFRS) on May 2, 2023.
Main events of the year affecting the valuation of HSCI
RBT
The first stage of clinical trials of TetraFluBET, the new quadrivalent influenza vaccine, has been completed. The trial conducted on 25 volunteers showed the vaccine to be safe, with no significant side effects.
HSCI and RBT together build a platform for the development of candidate antiviral vaccines based on surface recombinant proteins and spherical adjuvant particles. In preclinical studies, the platform showed a high safety profile and the required level of immunogenicity and protection. Previously, the Betuvax-Cov-2 coronavirus vaccine was developed on this platform.
Betuvax
Phase 1 and 2 clinical trials of the Betuvax-Cov-2 vaccine for the prevention of coronavirus have been completed. The results obtained confirm the high immunogenicity, safety and good tolerability of the new recombinant vaccine.
Currently, documents are being prepared for submission to the Russian Ministry of Health for the beginning of the third phase of clinical trials for the SARS CoV-2 and quadrivalent influenza vaccines. At the same time, materials are being prepared for agreements for the contract production of vaccines.
The company received a grant from the Innovation Promotion Fund under the Start-1 competition. The grant is allocated for the development, effectiveness research and implementation of the Betuvax-Cov-2 coronavirus vaccine in the form of an intranasal spray.
In December 2022, HSCI and the Rostec’s Nacimbio Pharmaceutical Holding signed an agreement to conduct clinical trials, produce and market a jointly developed combination vaccine for the prevention of influenza and coronavirus infection. The largest part of preclinical studies of the drug took place in August 2022, showing compliance with international requirements in terms of safety, immunogenicity and protection.
In 2022, an application was submitted, and in April 2023, a patent was received for a hybrid gene consisting of the Sars-Cov-2 surface protein S RBD receptor, S14P5 and S21P2 epitopes, Fc fragment, for the production of a recombinant antigen and its use in a combination coronavirus vaccine.
Nextgen
In November 2022, the HSCI’s Nextgen biotech company successfully completed preclinical studies of a gene therapy drug for the treatment of interstitial cystitis (painful bladder syndrome). According to the preclinical study results, intramuscular administration of the drug had a therapeutic effect on the experimental pathology indicators.
Nextgen is conducting clinical trials of Neovasculgen for the treatment of diabetic foot syndrome (DFS). The phase 2 trial is currently underway at 8 clinical sites, and 87% of the required patient population have been enrolled.
The company has prepared and submitted a dossier to obtain a permit to conduct a clinical trial for the treatment of interstitial cystitis from the Russian Ministry of Health.
In October 2022, the Moscow Interdepartmental Commission decided to include the Neovasculgen gene therapy drug for the treatment of lower limb ischemia in the Moscow compulsory medical insurance program. Now Moscow’s healthcare facilities will be compensated for its purchase from the Federal Compulsory Medical Insurance Fund. This will significantly expand the market for the drug.
Genetico
In accordance with Decree of the Government of the Russian Federation No. 2026 of November 24, 2021 “On Unregistered In Vitro Diagnostic Medical Devices”, effective since March 1, 2022, Genetico submitted for registration its own non-invasive prenatal test (NIPT) kit. After being registered under this law, the test kit can be used in medical practice. The practice of using unregistered diagnostic tests is known internationally as Laboratory Developed Test (LDT). In accordance with this regulation, Genetico can register a number of medical devices of its own development.
Under a co-development agreement with SweetGen, Genetico began joint development of gene therapy drugs for the treatment of rare (orphan) diseases. Over the next two years, the company plans to conduct the necessary research to obtain 2 or 3 candidate drugs with a confirmed mechanism of action, ready for further preclinical and clinical trials.
In 2022, Genetico was actively preparing for an initial public offering (IPO). This offering was successfully completed on April 25, 2023.
Histograft
A contract production site has been re-equipped, reducing the production cycle time by 70% and increasing production capacity by 5 times.
The process of preparing a registration dossier for the project’s second product, a gene-activated material based on xenogeneic bone matrix (XenoBone), has begun.
A prototype of a medical accessory indicated for use with gene-activated materials has been developed.
A US patent has been received for the personalized gene-activated material (3D-bone) technology.
Post-marketing clinical studies have begun.
Gemabank
In 2022, Gemabank expanded its cryostorage capacity to 30,000 samples.
A bond-secured loan has been granted in the amount of RUB 200 million for a period of 4.5 years.
A co-development agreement to develop drugs for the treatment of blood diseases using hematopoietic stem cells has been signed. The Drug Discovery and Proof-of-Concept are currently underway.
For the consolidated financial statements of PJSC HSCI and its subsidiaries for 2022 under IFRS, visit the Company’s corporate website, the “Investors” section (Financial Statements / IFRS Reports): https://artgen.ru/investors/raskrytie-informaczii/msfo/