2023-09-12 08:41:35 ET
Summary
- Results from the phase 2b CAHmelia-203 clinical trial, which is using tildacerfont for the treatment of patients with classic congenital adrenal hyperplasia, expected in the 2nd half of 2023.
- Results from the CAHptain study, using tildacerfont for the treatment of patients with classic congenital adrenal hyperplasia, expected in 2nd half of 2023.
- The congenital adrenal hyperplasia market is projected to grow to $884 million by 2032.
- Positive interim results released from phase 2 proof-of-concept study, using tildacerfont for the treatment of patients with polycystic ovary syndrome; final results to be released at upcoming medical meeting 2023.
Spruce Biosciences (SPRB) has made great progress in advancing the use of its phase 2b CAHmelia-203 clinical trial, which is using tildacerfont for the treatment of patients with classic congenital adrenal hyperplasia [CAH]. This trial, CAHmelia-203 is expected to have results released from it in the 2nd half of 2023. This is going to be a big catalyst for investors to look forward to. This isn't the only readout for this adults CAH program, it has another study known as CAHmelia-204, which is expected to have results released from it in the 2nd half of 2024. Then, there is another catalyst for investors to look forward to in the 2nd half of 2023, which would be topline results from certain cohorts from the phase 2 CAHptain study, which is using tildacerfont for pediatric patients with CAH. Just in case the CAH indication doesn't pan out, it announced proof of concept data from the phase 2 POWER study , using tildacerfont for the treatment of patients with polycystic ovary syndrome [PCOS]. It was stated that final results from this proof-of-concept study would be released at an upcoming medical conference.
Congenital Adrenal Hyperplasia Treatment Program Provides Multiple Shots On Goal
The thing about Spruce Biosciences is that it has multiple catalysts, which are expected to come out of its congenital adrenal hyperplasia [CAH] program. A major issue with CAH is that it causes a major defect in the adrenal glands , which are responsible for creating hormones. However, the adrenal glands in these patients is faulty and is unable to produce one or more of three hormones in the body. Such hormones the adrenal gland needs to produce are as follows: Androgen, Cortisol and aldosterone. The congenital adrenal hyperplasia market is projected to grow to $884 million by 2032 . Another thing to note is that there are two main types of CAH, which are classic and nonclassic. As I noted above, are two adult studies using tildacerfont for the treatment of patients with CAH. One phase 2 study, known as CAHmeila-2023, is using tildacerfont to reduce an excessive amount of adrenal androgens. On the other hand, the other phase 2 study known as CAHmelia-204, is evaluating the use of tildacerfont to see if it can be able to help patients reduce glucocorticoid usage. The thing to know about these studies is that they are not looking to replace current treatments for CAH, but to be used in addition to them. This programs brings about several catalyst opportunities as I highlighted in the beginning above, which were two data readouts expected in the 2nd half of 2023 and then one data readout expected in the 2nd half of 2024. Why should investors look closely into this CAH program using tildacerfont? It is because there have been no meaningful improvements in CAH for 50 years. Thus, if Spruce can get tildacerfont to the finish line [regulatory approvals], then it will be in very good shape moving forward.
Financials
According to the 10-Q SEC Filing , Spruce Biosciences had cash, cash equivalents and investments of $120.5 million as of June 30, 2023. The reason for the cash on hand is because of a securities purchase agreement that was made in February of 2023, whereby it raised a total of $53.6 million . This private placement agreement was made with both new and existing investors of this company. It believes that the cash on hand will be enough to fund its operations into the 1st half of 2025. Management may decide not to raise cash immediately, but barring positive data readouts in the 2nd half of 2023, I believe that it won't hesitate to do so.
Risks To Business
There are several risks that investors should be aware of before investing in Spruce Biosciences. The first risk to consider would be the use of tildacerfont, which is being developed for the treatment of patients with CAH. As I stated above, there are three particular studies being done using this drug for the treatment of this patient population. These three studies are as follows: CAHmelia-203 study, CAHmelia-204 study and the CAHptain study [pediatric CAH patients].
There is no guarantee that the results to be released from each of these studies will end up being successful. Not only that, but a failure in one of the first of three studies, may signify a reduced chance of success for all the other remaining CAH studies. A second risk to consider would be with respect to the interim results that were released from the phase 2 proof-of-concept POWER study, which used tildacerfont for the treatment of women with polycystic ovary syndrome [PCOS]. There is no assurance that the final results to be released at an upcoming medical meeting in 2023 will end up being positive.
Conclusion
Spruce Biosciences has made great progress in being able to advance the use of tildacerfont for the treatment of patients with CAH. It is said that the congenital adrenal hyperplasia market is projected to grow to $884 million by 2032. As I stated above, there are two readouts which are expected in the short-term in the 2nd half of 2023 and then the other expected in the 2nd half of 2024. This company already reported positive results from its phase 2 proof-of-concept study using tildacerfont for the treatment of patients with PCOS. Even though this interim data has already been released for this mid-stage study, it is expected that final results will be released at an upcoming medical meeting in 2023. With proof of concept established using tildacerfont in treating patients with PCOS and CAH, plus several catalysts expected before the end of 2023, I believe that investors might be able to capitalize on any gains made.
For further details see:
Spruce Biosciences: H2 2023 Data Could Be A Game Changer For CAH Treatment