Veru Inc (VERU)

[Biobonic]

VERU another upcoming catalyst.

VERU-111 is a novel, proprietary, next generation, first-in-class oral selective antitubulin agent that targets and disrupts alpha and beta tubulin subunits of microtubules. In cancer cells, microtubules are critical for transport of growth factor receptors, cellular proliferation, and metastases. In preclinical effectiveness and toxicity studies, orally administered VERU-111 demonstrated significant antitumor activity against castration and novel androgen blocking agent (abiraterone or enzalutamide) resistant human prostate cancer models. Furthermore, VERU-111 had significant antitumor effects against cancers that overexpress multidrug resistant proteins, like P-glycoprotein, a common mechanism by which cancer cells become resistant to cancer drugs. At oral doses that had significant antitumor effects, VERU-111 had a favorable safety profile as it did not cause neutropenia or myelosuppression, common dose limiting side effects of other classes of commercially available antitubulins such as intravenous taxanes or intravenous vinca alkaloids.

VERU-111 has the potential to be the first FDA approved oral, selective antitubulin agent that targets and disrupts alpha and beta tubulin subunits of microtubules to treat cancer.

The current Phase 1b/2 trial has already shown safety at therapeutic dose levels.
From the latest Q CC

As for safety, VERU-111 appears to be generally well tolerated. There are no reports of neutropenia, which is the dose limiting toxicity of an IV taxane. There have been no reported complaints of neurotoxicity, a side effect that also commonly occur with IV taxanes.

The study has also demonstrated the anti-tumor activity for which VERU-111 was designed. Again from the latest CC

And even without having determined in optimal dose or a dose schedule yet, there were four men who are still ongoing in the trial with no tumor progression at 9.75 months, 8.4 months, 8.4 months, 5.6 months.

Potential Market:

In the U.S., there is a $5 billion annual market for 2nd line hormone therapies for prostate cancer and a $4.8 billion annual market for IV-given taxanes and vinca alkaloids.

The upcoming catalyst: given the current efficacy and safety profile, early in 2020, we plan to expand the clinical program of VERU-111 to a study of three additional tumor types or indications where we've had demonstrated anti-cancer activity in pre-clinical animal studies.

The planned new cancer types are metastatic pancreatic cancer, metastatic breast cancer and post-chemotherapy metastatic castration.

Metastatic pancreatic cancer is over half of the 57,000 annual diagnosed.

Breast cancer approx 271,000 are diagnosed with 6% of those being metastatic.