Small Company That Could Change the Way HIV is Treated

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Analyst Coverage: CytoDyn Inc. (OTCQB: CYDY)

 

Summary:

 

CytoDyn (OTCQB: CYDY) is a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses.  CytoDyn’s lead product candidate, PRO 140, has the potential to drive groundbreaking advancements in developing the next generation of HIV treatments.

 

CytoDyn Inc. has a current market capitalization of $91.5 million with 98.9 million shares outstanding. Its average daily trading volume is 222,589 shares.

 

 

Financial Highlights (Q2 2016):

Revenue: –

Gross Profit: –

Net Income: -5.3 million

Cash and Cash Equivalents: 3.3 million

Long Term Debt: –

 

Recent News and Analysis:

On February 23^rd, CytoDyn announced that it submitted a Phase 3 protocol for a monotherapy trial, along with the Topline Report for its Phase 2b monotherapy trial to the FDA  The company expects to enlist Amarex Clinical Research, its principal CRO, to conduct the study.

On January 28^th, the company announced that 11 patients have achieved full virologic suppression in the Phase 2b extension study evaluating long-term suppression of HIV replication by PRO 140 monotherapy.

On January 22^nd, CytoDyn filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a treatment for HIV-1 Infection in Treatment-Experienced Patients with Virologic Failure.

 

Conclusions:

Investing in companies during clinical trials carries significant of headline risk.  There is a possibility that the company could receive fast track approval that could accelerate the process or the trail could fail to achieve its targeted end points.

The adjunct therapy trial for PRO 140 is expected to be completed shortly with a submission of the results to the FDA by the end of the fiscal year and if successful, commercialization to commence in 2017.  The monotherapy trial for PRO 140 is expected to begin during the first half of the fiscal year with a submission to the FDA by the end of 2017.   The addressable market for the adjunct therapy is estimated by the company to be a $5 billion market and the monotherapy market is a roughly $11 billion market.  If we were to give the company a 25% chance of success in addressing just 5% of the addressable markets and discount it by 15% for 2 years would still have a $150 million value which would be more than 50% higher than the current market value for CYDY.

Sources:

1. http://ir.cytodyn.com/
2. http://ir.cytodyn.com/all-sec-filings/content/0001193125-16-426510/0001193125-16-426510.pdf
3. http://ir.cytodyn.com/press-releases/detail/224/cytodyn-initiates-phase-3-monotherapy-trial-for-hiv-patients
4. http://ir.cytodyn.com/press-releases/detail/223/cytodyn-reports-full-virologic-suppression-in-eleven-hiv
5. http://ir.cytodyn.com/press-releases/detail/222/cytodyn-files-request-for-breakthrough-therapy-designation
6. http://ir.cytodyn.com/press-releases/detail/220/cytodyn-announces-hiv-patients-approaching-17-months-of
7. http://ir.cytodyn.com/press-releases/detail/221/cytodyn-appoints-denis-r-burger-ph-d-as-chief-science
8. http://ir.cytodyn.com/press-releases/detail/219/cytodyn-files-for-orphan-drug-designation-for-use-of-pro
9. http://ir.cytodyn.com/press-releases/detail/218/fda-clears-cytodyn-for-relaxed-entry-criteria-for-its
10. http://ir.cytodyn.com/press-releases/detail/217/cytodyn-receives-fda-clearance-for-its-first-non-hiv
11. https://finance.yahoo.com/q;_ylt=ApWtAhTMKHiNWB3WEsBA962M87cF?uhb=uhb2&fr=uh3_finance_vert_gs_ctrl2_e&type=2button&s=CYDY
12. http://content.equisolve.net/cytodyn/media/a142a8575db88331c0585a336ca2ebfd.pdf

 

 

 

 

 

 

 

 

 

 

 

 

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