Good morning,
we are on the verge of registering BCX-CM-J for osteoarthritis in dogs. BCX-EM for arthritis in horses has already been submitted to the European Medicines Agency. We have also published preliminary, positive results for the BCX-EM-AD product for canine atopic dermatitis.
A fortunate “three” also in the overall ranking of the prestigious Stock Exchange Company of the Year competition. And the leader title: in the categories Success in 2024 and Development Prospects.
The pace? It’s accelerating! After the “Animal Health, Nutrition & Technology Innovation” conference in Boston, we are heading to Wall Street. This time the one in Karpacz, because on 23–25 May, representatives of business and investors will meet at the foot of the Karkonosze Mountains. Bioceltix will appear on stage on Friday and Saturday.
We invite you to review the latest events from the Company’s life:
🔔 After BCX-CM-J, BCX-EM has also entered the registration pathway at the European Medicines Agency. At the end of April, we submitted an application to the EMA for a positive opinion on the authorization for marketing of the product for arthritis in horses. We are counting on a smooth process, as the BCX-EM clinical trial was completed with great success, and additional analyses confirmed that the therapeutic effect is maintained also on day 84 ±5 after administration of a single dose of the drug. In Europe alone, more than 7 million patients are waiting for us! | Read more
🔔 We have received preliminary results of the BCX-CM-AD clinical trial for atopic dermatitis in dogs. They confirmed the product’s effectiveness in the treatment of AD in the short, medium and long term. A single intravenous administration of BCX-CM-AD significantly alleviated skin lesions, which is why diagnoses conducted on day 28 clearly demonstrated the effectiveness of the investigational drug. The therapeutic effect was also maintained after 84 days from administration. The final report will be published within a few weeks and will be the last stage preceding the submission of Bioceltix’s third product to the European Medicines Agency. We intend to submit BCX-AM-AD as an extension of the use of BCX-CM-J with a new therapeutic indication. This approach opens up a number of new opportunities for us. | Read more
🔔 We are consistently building the foundation for industrial-scale production of Bioceltix’s future medicines. We are pleased to note that the project concerning the new manufacturing facility has been positively assessed by the Polish Agency for Enterprise Development under the European Funds for a Modern Economy and SMART Pathways programme. The value of the requested co-financing exceeds PLN 17 million, and the total value of eligible expenditures in this project exceeds PLN 49 million. Verification of formal regulatory criteria is ongoing. If we meet them, we will be able to sign the agreement and receive funding for the construction and launch of the facility. | Read more
🔔 We talked about all this to the international community at another conference in the “Animal Health, Nutrition & Technology Innovation” series. On 14 May in Boston, Paweł Wielgus delivered a presentation entitled “Veterinary innovation: Cutting-Edge Stem Cell-Based Therapies”, devoted, among other things, to the results of clinical trials of our products and plans for the future. It was a great opportunity to exchange information, insights and experiences with industry representatives gathered on the other side of the Atlantic. | Read more
🔔 It is quite possible that we will meet you in one of the 130 veterinary clinics located throughout Poland. This is because together with Pethelp we are encouraging participation in the free Dog and Cat Health Check. We are a partner of this year’s edition of the event, and our educational materials have been displayed in nearly 100 cities. This year we are focusing on osteoarthritis – a disease affecting as many as two-thirds of dogs over the age of 7. We suggest how to recognize its first symptoms. We have no doubt that an innovative approach to veterinary medicine goes hand in hand with prevention. Registration is ongoing. | Read more
We are setting sail for international waters:
🌎 “Just like pierogi, pets are becoming a staple in Polish households” – we read in international articles. This is true. We care for as many as 8.1 million dogs and 7.2 million cats. Poland’s role in the development of the sector is steadily growing. The industry is driven on the one hand by domestic demand and on the other by investments from major foreign players. The Vistula-side market, attractive to international business, has recorded significant M&A activity in recent years. An example? Assisi Pet Care expanded its operations in Europe by acquiring Maced, a Polish producer of dog treats, and United Petfood increased its production capacity by acquiring two plants from Cargill in Krzepice. | Read more
🌎 The animal health sector is also attracting millions – both caretakers and capital. The beginning of the year brought a series of investments in biotechnology. California-based Anivive Lifesciences raised USD 20 million from Leonid Capital Partners to commercialize a vaccine against a fungal disease occurring, among others, in dogs. According to local scientists, it has a chance to become the world’s first approved antifungal vaccine. Meanwhile, Philadelphia-based Vetigenics raised USD 6 million to develop cancer drugs for four-legged patients. The company announced positive results of studies on therapies for oral melanoma and urinary tract cancer. | Read more
🌎 The American dream cannot come true without the participation of four-legged companions. New studies show that in 2024, 94 million U.S. residents had at least one dog, up from 84 million in 2023. The results of a survey conducted by Talker Research are not surprising, according to which nearly 90% of Americans prioritize animal welfare over personal spending. In the animal world, however, costs are also rising. The industry is meanwhile being driven by Generation Z – already one in three people aged 15–29 has a four-legged friend. Among other things thanks to Gen Z, total spending on pets in the U.S. amounted to USD 152 billion last year and is expected to rise to USD 157 billion this year. | Read more
🌎 Further news concerns the medicinal product Librela® – a monoclonal antibody used in dogs for the treatment of joint pain associated with osteoarthritis. In the last newsletter, we reported that the FDA had signaled a number of adverse reactions in patients after administration of the drug. This month, a group of scientists published an additional analysis showing that dogs treated with bedinvetmab (Librela®) experienced numerous musculoskeletal adverse events (MSAERs), compared with six other drugs with the same indication. Ligament damage, polyarthritis, fractures, musculoskeletal neoplasia and septic arthritis were reported approximately nine times more often in dogs treated with Librela®. A review of 19 musculoskeletal adverse events (MSAEs) indicated a suspected causal relationship between bedinvetmab and accelerated joint destruction. The article emphasized the need for further research and close clinical monitoring of treated dogs. To date, the drug has been sold worldwide in more than 21 million doses. | Read more
🌎 Biotechnology can, however, work wonders, including extending the lives of dogs. The conventional limit of 16 years for smaller breeds and 10 years for larger dogs is being challenged by the company Loyal. Scientists have discovered that the hormone IGF-1 plays a key role in the aging process of four-legged animals – it is responsible for a dog’s growth at a young age, but can also accelerate aging of the body. A preparation that has already passed the necessary studies and is awaiting FDA approval for marketing is intended to lower the level of the hormone at the appropriate time. This may extend the lives especially of large-breed dogs, which statistically live shorter lives. | Read more
We publish even more industry news and up-to-date information on the progress of our work on LinkedIn – we invite you to follow the Bioceltix profile.
If you have suggestions regarding the newsletter content, please contact us at: newsletter@bioceltix.com.
Kind regards,
The Bioceltix Team