PROSPECTUS SUMMARY
This summary highlights certain information about us, this offering and information appearing elsewhere in this prospectus and in the documents we
incorporate by reference. This summary is not complete and does not contain all of the information that you should consider before investing in our securities. To fully understand this offering and its consequences to you, you should read this
entire prospectus carefully, including the information referred to under the heading Risk Factors in this prospectus beginning on page 5, and the financial statements and other information incorporated by reference in this prospectus
when making an investment decision. This is only a summary and may not contain all the information that is important to you. You should carefully read both this prospectus and any accompanying prospectus supplement, including the information
incorporated by reference therein, and any other offering materials, together with the additional information described under the heading Where You Can Find More Information.
About Us
We are a late-stage biotechnology company
focused on the clinical development and potential commercialization of leronlimab (PRO 140), a CCR5 antagonist to treat HIV infection, with the potential for multiple therapeutic indications.
We believe leronlimab shows promise as a powerful antiviral agent with the advantage of fewer side effects, lower toxicity and less frequent dosing
requirements, as compared to daily drug therapies currently in use for the treatment of HIV. The leronlimab antibody belongs to a class of HIV therapies known as entry inhibitors that block HIV from entering into and infecting certain cells.
Leronlimab blocks HIV from entering a cell by binding to a molecule called CCR5, a normal cell surface receptor protein to which certain strains of HIV, referred to as R5 strains, attach as part of HIVs entry into a cell.
Leronlimab is a monoclonal antibody, and through several short-term clinical trials, it has demonstrated efficacy without issues relating to toxicity, side
effects or drug resistance. Moreover, these trials suggest that leronlimab does not affect the normal function of the CCR5 co-receptor for HIV. Instead, leronlimab binds to a precise site on CCR5 that R5
strains of HIV use to enter the cell and, in doing so, inhibits the ability of these strains of HIV to infect the cell without affecting the cells normal function. We believe that the R5 strains of HIV currently represent approximately 70% of
all HIV infections in the U.S. As a result, we believe leronlimab represents a distinct class of CCR5 inhibitors with advantageous virological and immunological properties and may provide a unique tool to treat HIV infected patients.
The preclinical and clinical development of leronlimab was led by Progenics Pharmaceuticals, Inc. (Progenics) through 2011. We acquired the asset
from Progenics in October 2012. In February 2018, we announced we had met the primary endpoint in its Phase 3 trial for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients, and filed the non-clinical portion of our Biologics License Application (BLA) on March 18, 2019. We filed with the U.S. Food and Drug Administration (FDA) the Clinical, along with the Chemistry,
Manufacturing, and Controls (CMC) portions of the BLA in April and May of 2020. In July 2020, we received a Refusal to File letter from the FDA regarding the BLA filing requesting additional information. In August and September 2020, the
FDA provided written responses to our questions and met telephonically with key personnel and our clinical research organization concerning our BLA for this HIV combination therapy to expedite the resubmission of our BLA filing for this indication.
We expect to resubmit our BLA filing in the first half of calendar year 2021.
In addition, we intend to advance our clinical trials and seek approval for
leronlimab as a potential therapeutic benefit for COVID-19 patients, and to advance our clinical trials to evaluate the safety and efficacy of leronlimab as a treatment for HIV, and as a treatment for various
forms of cancers.
Corporate Information
CytoDyn
Inc. is a Delaware corporation with its principal business office at 1111 Main Street, Suite 660, Vancouver, Washington 98660. Our website can be found at www.cytodyn.com. We do not intend to incorporate any contents from our website into
this prospectus. Effective August 27, 2015, we completed a reincorporation from Colorado to Delaware. Effective November 16, 2018, we implemented a holding company reorganization, as a result of which, we became the successor issuer and
reporting company to the former CytoDyn Inc. (now our wholly owned subsidiary, CytoDyn Operations Inc.).
Convertible Note Transaction
On November 10, 2020, the Company issued a secured convertible promissory note with a two-year maturity and a
principal balance of $28.5 million (the Note) to the selling stockholder, an accredited investor (the Convertible Note Transaction). The convertible note was issued with an original issue discount of $3.4 million
and debt issuance costs of $0.1 million. Interest accrues on the outstanding balance of the Note at 10% per annum. Upon the occurrence of an Event of Default, interest accrues at the lesser of 22% per annum or the maximum rate permitted by
applicable law. In addition, upon any Event of Default, the selling stockholder may accelerate the outstanding balance payable under the Note, which will increase automatically upon such acceleration by 15%, 10% or 5%, depending on the nature of the
Event of Default. All capitalized terms used herein and not otherwise defined shall have the same meaning as set forth in the Conversion Note Transaction documents filed as an exhibit to the current report on Form
8-K filed with the SEC on November 16, 2020.