On December 17, 2019, CytoDyn Inc. (OTCQB: CYDY) announced that they have entered into a Commercialization and License Agreement (CLA) and a related Supply Agreement to commercialize leronlimab (PRO 140) in the U.S. for the treatment of HIV.
Under the terms of the CLA, CytoDyn will maintain responsibility for the development and FDA approval of leronlimab for all HIV-related and other indications, while Vyera has been granted an exclusive license to market and distribute leronlimab in the U.S. for the treatment of HIV. In exchange for such exclusive license, Vyera has agreed to pay upfront and regulatory and sales-based milestone payments of up to $87.5 million, as well as a royalty of 50 percent on net sales. Vyera also agreed to make an investment in CytoDyn of $4 million in the form of registered CytoDyn common stock.
It is anticipated that these agreements will enable CytoDyn to leverage Vyera’s well-established commercial infrastructure and highly-experienced sales team for the launch and commercialization of leronlimab and provide Vyera with a complimentary and novel product to bolster its pipeline of therapies for the treatment of infectious diseases.
“This agreement helps complete the strategic objective to further establish CytoDyn as a leader in efforts to enhance the lives of patients through target-specific medicine,” said Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer. “Vyera’s focus on developing therapies for patients living with serious and neglected diseases make them an ideal partner for this collaboration. We are excited to work with Vyera to leverage their platforms and capabilities to potentially offer a more effective treatment option for this HIV population.”
Averill L. Powers, Chief Executive Officer of Phoenixus AG, Vyera’s parent company, noted: “Vyera’s collaboration with CytoDyn demonstrates our commitment to address the needs of significant patient populations across our group companies generally and, in particular, a new level of our commitment to supporting patients living with HIV.”
On December 19, 2019, H.C. Wainwright analyst Yi Chen raised CytoDyn’s price target to $1.50 from $1.00 after the company entered into a commercialization and license agreement with Vyera Pharmaceuticals. Though the upfront payment is limited, the 50% royalty should provide CytoDyn with sufficient cash inflow for operations once leronlimab sales start to ramp up, Chen tells investors in a research note. The analyst reiterates a Buy rating on the shares.