We expect investors to focus on CytoDyn Inc.’s (CYDY - Free Report) development plans for its promising CCR5 antagonist candidate, leronlimab (currently being developed for treating critically ill COVID-19 patients), when it reports fourth-quarter fiscal year ended May 31, 2020 earnings results.
In the last reported quarter, CytoDyn witnessed a negative earnings surprise of 66.67%
Shares of CytoDyn have skyrocketed 220% so far this year versus the industry’s decrease of 10.2%.
Let’s see how things shaped up for this announcement.
Factors to Note
CytoDyn’s portfolio is currently devoid of any approved product. As a result, the company is yet to generate revenues from product sales. The company is developing leronlimab to address the unmet medical needs in the areas of human immunodeficiency virus (HIV), cancer and immunological indications. Investors will be keen to get an update on the same during the upcoming earnings call.
In April 2020, CytoDyn submitted the clinical, and the chemistry, manufacturing and controls portions of its biologics license application (BLA) to the FDA for leronlimab in combination with the highly-active antiretroviral therapy (HAART) for addressing treatment-experienced HIV patients. In May, CytoDyn submitted all the remaining parts of its BLA.
The study and developmental activities pertaining to leronlimab are likely to have escalated operating expenses in the to-be-reported quarter.
Meanwhile, CytoDyn is evaluating leronlimab in a phase IIb/III study for treating severe and critically ill COVID-19 patients. Further, the candidate is being evaluated in a phase II study in mild-to-moderate COVID-19 patients.
Apart from these two clinical studies, CytoDyn administered leronlimab in several patients through hospitals and clinics under the Emergency Investigational New Drug (EIND) authorizations granted by the FDA.
The company recently requested the FDA to grant an expanded access, also known as “compassionate use”, for making leronlimab available to patients who are not eligible for the two ongoing studies on COVID-19.
Our proven model does not conclusively predict an earnings beat for CytoDyn this season. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of a positive surprise. But that is not the case here.
Earnings ESP: CytoDyn has an Earnings ESP of 0.00% as both the Most Accurate Estimate and the Zacks Consensus Estimate are pegged at a loss of 5 cents per share. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Zacks Rank: CytoDyn carries a Zacks Rank #2.
CytoDyn Inc Price and EPS Surprise
Stocks to Consider
Here are some stocks worth considering from the medical sector that have the right combination of elements to beat on earnings this time around:
Axovant Sciences Ltd (AXGT - Free Report) has an Earnings ESP of +13.27% and a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
Summit Therapeutics PLC (SMMT - Free Report) has an Earnings ESP of +1.72% and a Zacks Rank of 2.
BioLife Solutions Inc (BLFS - Free Report) has an Earnings ESP of +816.68% and a Zacks Rank #3. The company is scheduled to release results on May 14.
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