SeeThruEquity Issues Update on CytoDyn Inc. (CYDY)

NEW YORK, NY / ACCESSWIRE / July 18, 2016 / SeeThruEquity, the leading independent equity research firm focused on smallcap and microcap public companies, today announced it has issued an update on CytoDyn Inc. (OTCQB: CYDY) with a price target of $3.40.

The report is available here: CYDY Update Note. 

CytoDyn Inc. (OTCQB: CYDY, “CytoDyn”) is engaged in the development of humanized monoclonal antibodies for the treatment of Human Immunodeficiency Virus (HIV), and other diseases. CytoDyn’s lead drug candidate is PRO-140, a viral entry inhibitor which seeks to block HIV from entering a cell by binding to a molecule called CCR5. CytoDyn has a Phase 3 clinical trial underway with PRO-140 for HIV in combination with Highly Active Anti-Retroviral Therapy (HAART). The company also recently initiated a Phase 3 trial of PRO-140 for long-term monotherapy as a replacement for HAART for patients who have completed initial antiretroviral therapy (ART). If approved, PRO-140 would be the first, self-administered, injectable antibody therapy for HIV. In our view, whether approved as a combination therapy or first line therapy, PRO-140 has the potential to be a significant advancement in the treatment of HIV, which could dramatically improve the quality of life for HIV patients while sharply lowering toxicity, offering fewer side-effects, and lowering costs versus existing treatments.

Investment Highlights

Positive Clinical Developments

CytoDyn held an update conference call with investors on July 13, 2016, during which the company announced several key developments on the clinical front. These included an important outcome from its conversations with the FDA regarding its ongoing Phase 3 clinical trial for PRO-140 in combination therapy with HAART, which allows for an accelerated and less costly completion of the trial, as well as the introduction of a new clinical pathway for PRO-140 with the potential for breakthrough and orphan drug designations. Finally, while no specific timing was provided, the company reiterated that achieving an uplisting to the NASDAQ or NYSE Market was a high priority for the company.

FDA allows CYDY to trim patient enrollment pool to 150

In a significant development for what is likely CytoDyn’s best chance for an approval of PRO-140, the FDA allowed the company to reduce its enrollment pool by half in its ongoing Phase 3 pivotal study of PRO-140 as a 2nd line combination therapy with HAART. This should allow CytoDyn to accelerate the timeline for the trial. It will also reduce costs given that fewer patients will be participating in the 25-week trial, which has a primary endpoint of viral load reduction from baseline and secondary endpoints of tolerating repeat subcutaneous injections with no serious adverse events related to PRO-140 over 24 weeks. If approved, the potential market opportunity for PRO-140 for 2nd line combination therapy with HAART is estimated to be approximately $5 billion per year.

CYDY identifies new potential pathway for acute HIV

A key takeaway for us from CYDY’s investor update was that management believes it has identified a new potential pathway for PRO-140, which has the potential for breakthrough status and may qualify for an orphan drug designation. The pathway involves initiating PRO-140 therapy for treatment-naïve HIV patients in the two week “danger period” while they wait for the results of a genotype test that enables physicians to select the best medication for patients. For these two weeks the patient has no available drugs, making HIV an acute condition. CYDY expects to file an application for a Phase 2b clinical study with the FDA within a week’s time, and we are eager to learn more about the size and scope of this this opportunity.

Maintaining price target of $3.40

We are maintaining our price target for CYDY at this time. We continue to see CYDY as a speculative biotechnology company with a bold goal of transforming the quality of life for HIV patients in the United States.

Please review important disclosures at www.seethruequity.com. 

About CytoDyn Inc.

CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in man and is currently in Phase 3. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several weeks of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV indications where CCR5 and its ligand CCL5 may be involved. www.cytodyn.com.

About SeeThruEquity

Since its founding in 2011, SeeThruEquity has been committed to its core mission: providing impactful, high quality research on underfollowed smallcap and microcap equities. SeeThruEquity has pioneered an innovative business model for equity research that is not paid for and is unbiased. SeeThruEquity is the host of acclaimed investor conferences that are the ultimate event for publicly traded companies with market capitalizations less than $1 billion.

SeeThruEquity is approved to contribute its research reports and estimates to Thomson One Analytics (First Call), the leading estimates platform on Wall Street, as well as Capital IQ and FactSet. SeeThruEquity maintains one of the industry’s most extensive databases of opt-in institutional and high net worth investors. The firm is headquartered in Midtown Manhattan in New York City.
For more information visit www.seethruequity.com.

Contact:

SeeThruEquity
info@seethruequity.com

SOURCE: SeeThruEquity

ReleaseID: 442497