Cytodyn Inc (CYDY) recently announced it was going to move forward with a Breakthrough Therapy Designation (BTD) in January 2020.  It also announced preliminary clinical trial results for its humanized monocolonal antibody leronlimab (PRO 140).  The CEO stated “Due to these very promising clinical data, we feel that the 98% inhibition of metastasis shown by our animal studies may soon become a reality for many cancer patients throughout the world. We are cautiously optimistic and believe we have enough results in an unmet medical need population to justify filing for Breakthrough Therapy Designation in January 2020.”

CYDY’s mouse model for mTNBC shows a 98% reduction in tumor metastasis.  The first patients in the study are seeing a confirmation of the mouse data.  The CEO of IncellDX, said that “the first patient that has been dosed for 11 weeks demonstrated sustained undetectable levels of Circulating Tumor Cells (CTCs) and a reduction of cancer-associated macrophage like cells (CAMLs).” The reason measuring CTC’s are so important is because the patients that have CTC’s lower than 5 tend to survive much longer than the patients that don’t have these low levels. This survival benefit is what the FDA would look at in approving the drug. 

Cytodyn’s second patient enrolled in the metastatic Triple Negative Breast Cancer (mTNBC) study was an emergency IND.  According to Proactive Investors video update this is the CEO’s mother in law who had been lethargic for close to 2 years and is moving around and cooking again.  Dr. Patterson stated the Stage 4 patient had metastasis of the liver, lung, and brain and just after 3 weeks the scans showed “demonstrated shrinkage of the tumors at both timepoints following the first leronlimab injection, reduction in brain edema, and remarkable disappearance of several metastatic spots and no new spots .”  The other patient using leronlimab is the first patient enrolled in CytoDyn Phase 1b/2 for mTNBC patient.  The drug clearly had a benefit for her and has kept her CTC’s at zero for over 14 weeks now and has apparently (according to the results of CTC) completely eliminated the metastasis. Her tumor also shrunk more than 20%.

The company has also just enrolled patient number 3 and 4 and is filing BTD this month.

BTD is worth a lot if we examine the case study of Immunomedics (IMMU).  The company has a $4.2 billion market capitalization and is essentially going after the same indication of mTNBC but one company’s market is more lucrative than the others.   IMMU estimates their patient population is 22,000 patients while CYDY is going after a patient population close to 170,000 patients.  CYDY clearly has a bigger market potential.  The other discriminating factor is the time to approval.  IMMU just filed its BLA a couple of weeks ago which is the last step before approval and CYDY is planning on filing its BLA in the coming weeks.  So on the surface they are tied but actually CYDY’s drug PRO 140 is looking to be approved as an HIV drug which has much higher standards of approval than a life threatening cancer drug.  As a cancer drug PRO 140’s chances should be even higher.  IMMU’s drug has to be used in combination with chemotherapy so comparing toxicity is not fair but what is fair is that PRO 140 has been used long term by some patients with HIV and these patients have experienced hardly any side effects.  When looking at the overall picture the scales seem to tip toward CYDY because they have a relatively safe drug (over 840 patients with zero drug related serious adverse event) that works well in HIV, they are at basically the same point in the approval process, and they have a much larger patient population to treat.  The only issue is that despite all these advantages the market cap of CYDY is only $0.42 billion versus the $4.2 billion market cap of IMMU.

Investment Summary

There is clearly a race to treat mTNBC patients and the top contenders are CYDY and IMMU.  Each of these companies is taking a novel approach to treating the disease.The time between BLA filings should be no more than a month.  BLA approval seem to be a given for both companies.  CYDY made it very clear with their intentions to file a BTD.  The clear winner in market size is CYDY with its enormous patient population.  IMMU is better capitalized but CYDY has 8 other cancer indications in the pipeline if mTNBC is approved.  CYDY could easily follow in the footsteps of Merck (MRK) and Bristol- Meyers Squibb (BMY) with multiple indications in cancer.  There is a huge disparity in market capitalization between the two leaders in mTNBC.  The analysis suggests that CYDY is extremely undervalued.  As more cancer news arrives we believe this disparity will resolve itself in short order.  The wild card in this horse race is Gilead (GILD) because they didn’t buy CYDY when they had the chance and if their drug gains marketing approval for monotherapy it could put a serious dent into GILD’s dominant HIV franchise (  Investors will want to keep an eye on this developing story.