Crinetics: Earlier Data Release Bodes Well For Upcoming Data (NASDAQ:CRNX)

Crinetics Pharmaceuticals (NASDAQ:CRNX) just released initial data from its phase 2 open-label study using its drug Atumelnant [CRN04894] for the treatment of patients with congenital adrenal hyperplasia. The data released from 4 patients was released earlier than the expected embargo date for the presentation of data, which is expected to take place at ENDO between June 1st – 4th of 2024. Despite such data being released, this doesn’t mean that there isn’t another catalyst relating to this program that investors can’t capitalize on. That’s because, as I said before, this was only the release of 4 initial patients at the time of submission. The newly released data at the ENDO 2024 medical conference is going to include data from 6 patients in cohort 1 and then other patients in cohort 2.

It is not guaranteed, but possible that the other cohorts with higher dosing could result in superior efficacy. Besides this catalyst to still look forward to, there are two others for consideration. The first of which would be the New Drug Application [NDA] submission of Paltusotine for the treatment of patients with Acromegaly, expected in the 2nd half of 2024. It has been able to even make progress on the development of this very same drug for the treatment of patients with Carcinoid Syndrome. Having said that, another catalyst would be the initiation of a phase 3 study for this specific program by the end of 2024. With Several catalysts on the way, plus the advancement of two different drug molecules in its pipeline, I believe that investors could benefit with any potential gains made.

Atumelnant Is An Additional Drug In Pipeline With Massive Potential

A good thing about Crinetics Pharmaceuticals is that it is not only relying on the development of Paltusotine for Acromegaly or Carcinoid Syndrome. It has another drug it is advancing in the pipeline, known as Atumelnant [CRN04894]. This specific drug is being developed to treat patients with Congenital Adrenal Hyperplasia. These patients are being treated with Atumelnant in a phase 2 open-label study. Congenital Adrenal Hyperplasia [CAH] is a disorder where a genetic change causes the inability of the adrenal gland to develop hormones. That’s because the adrenal gland itself is responsible for generating hormones as follows:

• Cortisol
• Mineralocorticoids [like aldosterone]
• Androgens [like testosterone]

In patients with CAH, the adrenal gland lacks sufficient enzymes to be able to produce these needed hormones.

The phase 2 open-label study enrolled a total of 10 patients with classical CAH who were on a stable dose of GC replacement for at least 6 months. They were given once-daily oral Atumelnant for 12-weeks. As I stated above, data was released earlier than the intended embargo date of the presentation expected at the upcoming ENDO 2024 conference. However, the data released was only for the first 4 patients in cohort 1. Plus, these patients only received the dose of 80 mg once-daily oral Atumelnant for 12-weeks. Despite this low dose being given, patients were able to experience reductions in two key biomarkers of disease, which were A4 and 17-OHP. When high levels of these biomarkers are present, it said that patients may have CAH. Thus, the goal is to reduce both of these measures. Having said that, reduction of each of these throughout the study as follows:

• A4 reduction ranging from 74% to 99%
• 17-OHP reduction ranting from 68% to >99%

The bottom-line is that 80 mg once-daily of Atumelnant was able to achieve a rapid and sustained suppression of both of these biomarkers. If this data has been released and will be presented at the upcoming medical conference, then what catalyst could be left for investors here? Well, this data only deals with a portion of the patients in cohort 1. The other 6 patients in cohort 1, along with additional patients in cohort 2, will be released at the upcoming ENDO 2024. Specifically, a late-breaking poster presentation show will be released on June 3rd 2024 at 12:00 to 1:30 p.m. ET.

Financials

According to the 10-Q SEC Filing, Crinetics Pharmaceuticals had cash, cash equivalents and investments of $901 million as of March 31st of 2024. The reason for the cash on hand is that it was able to complete a private placement agreement, which helped it to raise approximately $350 million. It has plenty of cash for a long period of time, especially to get through several of the catalysts I noted above. It believes that its cash on hand will be sufficient to funds its operations into 2028. Its cash burn is roughly $54.1 million per quarter.

Risks To Business

There are several risks that investors should be aware of before investing in Crinetics Pharmaceuticals. The first risk to consider would be with respect to the recently released data of 4 patients from the phase 2 open-label study, using Atumelnant for the treatment of patients with CAH. Even though the first 4 patients in cohort 1 saw rapid and sustained reductions of A4 and 17-OHP throughout the study, there is no guarantee that the same will be seen in the other 6 patients in the very same cohort. In addition, there is no way of knowing if giving a higher dose results in superior data compared to the 80 mg once-daily dose.

A second risk to consider would be with respect to the NDA of Paltusotine to the FDA for the treatment of patients with Acromegaly. Even if the submission is achieved, there is no guarantee that the agency will expect the application for starters. Nor, that the company will ultimately end up being successful in receiving FDA approval of this drug for the treatment of this patient population.

A third risk to consider would be in terms of the ongoing talks with the FDA. It is the intention of the company to advance the use of Paltusotine for the treatment of patients with Carcinoid Syndrome in a phase 3 study. However, there is no assurance that the agency will allow it to move forward to such late-stage testing. Despite the fact that Crinetics reported positive topline results from an open-label phase 2 study using this drug to treat these patients, there is the possibility of the FDA now allowing a late-stage study so quickly.

Conclusion

Crinetics Pharmaceuticals has done well to advance the use of Atumelnant for the treatment of patients with CAH. This is evidenced above with the rapid and sustained reductions of A4 and 17-OHP achieved only using 80 mg once-daily dose of drug. Where is the potential? Well, it remains to be seen if the other 6 patients in cohort 1 given the same dose achieve a similar outcome. Plus, it will be important to see if higher dosing yields an even better reduction in terms of both of these biomarkers. This biotech has built a pipeline full of several drugs targeting different drugs. Having said that, its value is not only being derived off of Atumelnant for CAH. This brings about two other catalysts relating to the development of Paltusotine for the treatment of patients with Acromegaly and Carcinoid Syndrome. Speaking of which, both of these other catalysts are also anticipated before the end of 2024.