Frequently Asked Questions
When will Lobe start communicating with investors?
Thank you for visiting Lobe's website. In July of last year, Lobe held its annual general meeting with all interested investors and elected its current Board of Directors. During this AGM, an entirely new Board and management team were appointed. Dr. Sancilio, a major shareholder of Lobe, became the new CEO and Board Chairman. After an orientation period, Dr. Sancilio and the new Board began planning for the Company's future. Although it wasn't well communicated, Lobe had a rich science base and quickly moved to expedite patents on some of its important discoveries. We also hired a professional social media manager who organized a communications campaign, starting with a complete overhaul of our website. The new site went live on 2/7/25 and we have just started to focus on communication to inform investors and potential investors about our exciting company and programs.
How does our L-130 product candidate
compare to Cybin's CYB003?
L-130 is a conjugated form of psilocin, while CYB003 is a deuterated form of psilocin. Lobe has achieved something unique by stabilizing the active metabolite of psilocybin (a prodrug found in some mushrooms), which is psilocin. Psilocin is typically unstable and cannot be used as an active drug. By synthesizing dozens of combinations of psilocin with other materials, we discovered that combining psilocin with Mucic acid forms a stable new material. This salt of a weak acid and weak base is called Conjugated Psilocin (CP) or L-130. It has shown to be stable for over two years and can be used as a pharmaceutical ingredient. Additionally, it has demonstrated high bioavailability and safety in clinical trial with healthy volunteers. We have filed numerous patents to protect this novel material and two patents have been issued.
CYB003 is a deuterated form of psilocin where certain hydrogen atoms are replaced with deuterium, a heavier isotope of hydrogen. Some claim that this form has enhanced stability, but the actual data supporting this has not been made public.
Lobe now has a superior form of a highly active drug candidate and is developing it to treat several unmet medical needs, including those being investigated with CYB003, but without using isotopes, which are not typically used in the pharmaceutical industry as therapeutics.
Will Lobe use the 505(b)(2) route to bring L-130 to market after completing trials for CCH?
The 505(b)(2) pathway is widely used by many applicants, if not most, for seeking market approval from the FDA. This pathway allows applicants to reference existing data from other companies that is pertinent to their product. For instance, with L-130, our new psilocin conjugate, we can leverage numerous high-quality publications that provide safety data for psilocybin or psilocin. By combining this existing data with our own research, we can build a compelling case for the safety of psilocin, regardless of the method of ingestion.
To readdress the question regarding Lobe's utilization of this pathway, we can confidently state that we plan to use this approach if we conclude that it will expedite approval.
How long until investors will see Altemia ® MF generating revenue?
Launching a new product like Altemia ® Medical Food (MF) involves securing reimbursement pathways from insurers and other third-party payers. Unfortunately, the process for medical food lacks clear guidelines. Each state has its own rules, requiring separate applications for reimbursement approval in 2025. Meanwhile, we are collaborating with several Sickle Cell Disease (SCD) research clinics to gather additional data on the benefits of Altemia ® MF and its impact on this debilitating disease.