BioCardia issues letter to shareholders

BioCardia issues the following letter to shareholders: “BioCardia completed 2023 with three active clinical programs of its autologous and allogeneic cell therapies to treat heart disease, with a focus on ischemic heart failure of reduced ejection fraction. We expect to report clinical data from each of these programs in 2024. In coming months, we will provide a more detailed update on our therapeutic pipeline including expected timelines for data readouts and regulatory milestones. Today, I am writing to share a brief update on our business development activities related to our Biotherapeutic Delivery Partnering, BDP, business and our Morph Access Innovations business… In BDP, our team provides support for pre-clinical and clinical stage programs to enable and enhance our partner’s biotherapeutic development efforts. Efforts include review and preparation of protocols, sharing of strategic and regulatory insights, and providing technical input on strategies for handling and delivering biologic agents. We provide protocols and data collection templates as well as catheter products and technologies that are available today. We perform training for staff and physicians and support procedures using our biotherapeutic delivery systems. We believe that BioCardia having more opportunities to participate meaningfully in new high-value therapies through BDP is in our shareholders’ interests and outweighs concerns with respect to enabling competitive therapeutic programs. We have two new biotherapeutic delivery partnerships we anticipate finalizing soon based on terms agreed upon in December 2023. Both potential partners have extensive positive large animal experience with our delivery systems, as do a number of additional potential partners. We have the ability to fully support several of these partners, sharing our knowledge, experience and technology to help advance their efforts. We have also been active in partnering discussions for our Morph products for markets where our products and technologies enable high value therapies beyond biotherapeutic intervention… Our BDP and Morph partnering efforts are enhanced by both the performance of our offerings in our clinical programs and our extensive intellectual property portfolio. We have had recent patent issuances in Japan and EU that are in our partner’s interests… The coming year offers the potential for catalysts that could dramatically improve our prospects, timetable, and attractiveness as a business, both from our therapeutic programs themselves and from the technologies we have developed to advance these therapeutic programs”