CYDY stock continues to attract buyers after the company reported on December 17, 2019, that it entered into a license agreement to commercialize leronlimab.
Back on December 17, 2019, CytoDyn Inc. (OTC.QB: 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.”
On December 23, 2019, CytoDyn Inc. (OTC.QB: CYDY) announced continued promising clinical responses from its metastatic triple-negative breast (mTNBC) Phase1b/2 trial and its trial investigating leronlimab for the treatment of metastatic breast cancer (MBC).
Further data from the first mTNBC cancer patient continues to show no detectable circulating tumor cells (CTC) or putative metastatic tumor cells in the peripheral blood and additional reductions in CCR5 expression on cancer-associated cells at 11 weeks of treatment with leronlimab. Additional data in an emergency IND protocol involving one MBC patient demonstrated shrinkage of tumor (via MRI) after three weeks of treatment with leronlimab.
“In the first patient, we’re encouraged to see that after 11 weeks these additional data provide further preliminary evidence of efficacy, as demonstrated by sustained undetectable levels of CTCs and a reduction of cancer-associated macrophage like cells (CAMLs),” said Bruce Patterson, M.D., Chief Executive Officer of IncellDx. “Thus far, the data have been consistent with previous studies evaluating leronlimab as a long-term therapy for HIV+ patients, with no serious adverse effects reported in the mTNBC trial.”
CytoDyn’s second patient enrolled is a stage 4 MBC patient. The metastasis progressed to the liver, lung and brain. This patient was enrolled through an emergency IND. The patient was on Herceptin and Perjita for over 1.5 years. Herceptin is known to stop working after about 12 months, while Perjita is effective for approximately 1.5 years. This patient received her first injection of leronlimab on November 25, with one 700 mg dose each week.
Regarding the second patient, Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated: “It is very exciting to see ongoing results that demonstrate leronlimab’s potential as a therapeutic option to treat patients with mTNBC and MBC with HER2+ condition. This second patient was enrolled in an emergency IND.”
Added Dr. Patterson, “The results from two subsequent scans of the metastatic lesions for this second patient demonstrated shrinkage of the tumors at both timepoints following the first leronlimab injection, reduction in brain edema, and remarkably, disappearance of several metastatic tumors.”
Dr. Pourhassan continued, “Due to these very promising clinical data, we feel that the 98% inhibition of metastasis shown by our animal studies may soon become a reality for many cancer patients throughout the world. We are cautiously optimistic and believe we have enough results in an unmet medical need population to justify filing for Breakthrough Therapy Designation in January 2020.”
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.