At least a bit better than others.
I too bought it for the drug pipeline...
Below is a summary I put together:
Veru is focused on developing and commercializing novel medicines for the prostate cancer continuum of care and urology specialty pharmaceuticals.
Am not a medical expert, this is mostly copy and paste, if there are errors let me know.
It is estimated by the American Cancer Society that in 2020 there will be about 191,930 men with newly diagnosed prostate cancer which is a 10% increase from 2019. There will be an estimated 33,330 deaths from prostate cancer in 2020, a 13% increase from 2018.
Upon detection, much occurs. Determine stage, size, etc. Assess individual to determine if anything should be done. If so,
Surgery is a common choice to try to cure prostate cancer if it is not thought to have spread outside the prostate gland.
The main type of surgery for prostate cancer is a radical prostatectomy.
If that fails, then comes hormone therapy, androgen deprivation therapy (ADT).
According to the published scientific report, about 12% to 25% of men who have metastatic castration-resistant prostate cancer and who have been started on a novel androgen blocking agent will not respond at all to this therapy. And about 75% of men will initially respond to the treatment with an androgen blocking agent, but their tumor will start progressing in about 9 to 15 months.
At this point, just to be very, very clear, there are no drugs approved for patients that fail ADT and fail one of these androgen blocking agents. (VERU CC)
This is when the urologist lets the patient know, he has done all he can and refers the patient to medical oncologist.
The oncologist administers the chemotherapy, taxanes, etc.
This market segment
According to Accuvia, oral drugs, abiraterone, enzalutamide for advanced prostate cancer had over $6 billion in 2018 global annual sales. Men who have failed these novel blocking agents or the patients that VERU-111 is currently targeting, which we estimate represents a $4.5 billion annual global market.
So essentially by 1 year, the majority of these men will have tumor progression and will be ready for the next therapy by VERU-111 to control their advancing prostate cancer. This pre-chemotherapy space in men who have failed in ADT and a novel androgen blocking agent is currently the fastest growing unmet medical need segment in advanced prostate cancer.
VERU-111 I think has got a tremendous competitive advantage, because we are a cytotoxic therapy without some of the side effects of the cytotoxic therapy.
At the medical oncologist:
Taxanes are cytotoxic therapies, they work, but you have the dose-limiting neutropenia, febrile neutropenia, sepsis, neurotoxicity meaning they can’t feel their fingers and toes and other side effects, hypersensitivity you have to get an IV, you have to sit in an IV chair, you have to be pre-medicated with prednisone.
VERU-111 currently in a Phase 1b clinical trial. Determining therapeutic dosage levels. VERU-111 has good bioavailability.
As historically reported from the literature, men with metastatic castration-resistant and androgen blocking agent resistant prostate cancer have a median of 3.7 months before their CT and/or bone scan evidence of new cancer progression. This is called imaging based progression-free survival.
Some of the results from the still ongoing Phase 1b for VERU-111.
Even without having determined an optimal dose or a dose schedule yet, there are 4 men who are still ongoing in the trial with no tumor progression at 12, 10.4, 10.4 and 7.6 months. All of these men have experienced PSA reductions from peak or base values, another 6 men have progressed to 4.2 months. The patients still in the trial of 12 months has had a PSA reduction of 63% from peak and had two of its cancerous lymph node shrink as measured by an initial follow-up CT scan and confirmed by another follow-up CT scan 3 months later. We also have another patient who at the time of enrollment had progressing prostate cancer bone metastases now showing improvements of these bone metastases based on a bone scan following treatment with VERU-111.
The drug is not tailored to just mCRPC, there are plans to: We will initiate new open-label Phase 2 clinical studies in other indications and tumor types.
They have other drugs in their pipeline, this one is their star.
Their drugs markets potential:
Annual global market:
VERU-111 $4.5 Billion for mCRPC
VERU-100 $2.6 Billion
Zuclomiphene annual revenue of $600 million
Share Outstanding: 66 million.
