Prevail Therapeutics sold for $1.04 billion

Eli Lilly to acquire Prevail Therapeutics for up to $26.50 per share in cash

Eli Lilly (LLY) and Prevail Therapeutics (PRVL) announced a definitive agreement for Lilly to acquire Prevail for $22.50 per share in cash payable at closing plus one non-tradable contingent value right, or CVR, worth up to $4.00 per share in cash, for a total consideration of up to $26.50 per share in cash, or or an aggregate of approximately $1.04B.

Prevail sold for more than $1 billion

The CVR is payable upon the first regulatory approval of a product from Prevail’s pipeline as set forth in more detail below.

Prevail is a biotechnology company developing potentially disease-modifying AAV9-based gene therapies for patients with neurodegenerative diseases.

The acquisition will establish a new modality for drug discovery and development at Lilly, extending Lilly’s research efforts through the creation of a gene therapy program that will be anchored by Prevail’s portfolio of clinical-stage and preclinical neuroscience assets.

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Prevail’s lead gene therapies in clinical development are PR001 for patients with Parkinson’s disease with GBA1 mutations and neuronopathic Gaucher disease and PR006 for patients with frontotemporal dementia with GRN mutations.

Prevail’s preclinical pipeline includes PR004 for patients with specific synucleinopathies, as well as potential gene therapies for Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis and other neurodegenerative disorders.

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Under the terms of the agreement, Lilly will commence a tender offer to acquire all outstanding shares of Prevail Therapeutics Inc. for a purchase price of $22.50 per share in cash payable at closing plus one non-tradeable CVR.

The CVR entitles Prevail stockholders to up to an additional $4.00 per share in cash payable upon the first regulatory approval for commercial sale of a Prevail product in one of the following countries: United States, Japan, United Kingdom, Germany, France, Italy or Spain.

To achieve the full value of the CVR, such regulatory approval must occur by December 31, 2024.

If such regulatory approval occurs after December 31, 2024, the value of the CVR will be reduced by approximately 8.3c per month until December 1, 2028.

There can be no assurance any payments will be made with respect to the CVR. The transaction is not subject to any financing condition and is expected to close in Q1 of 2021, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of Prevail’s common stock.

Following the successful closing of the tender offer, Lilly will acquire any shares of Prevail that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.

The purchase price payable at closing represents a premium of approximately 117% to the 60-day volume-weighted average trading price of Prevail’s common stock ended on December 14, the last trading day before the announcement of the transaction.

Prevail’s board of directors unanimously recommends that Prevail’s stockholders tender their shares in the tender offer.

Additionally, certain Prevail stockholders, beneficially owning approximately 51% of Prevail’s outstanding common stock, have agreed to tender their shares in the tender offer.

Upon closing, the impact of this transaction will be reflected in Lilly’s 2021 financial results according to Generally Accepted Accounting Principles.

There will be no change required to Lilly’s 2021 financial guidance being issued for research and development expense or non-GAAP earnings per share as a result of this transaction.

Prevail Therapeutics (PRVL) last traded at $22.67, up 81%.

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Nektar Therapeutics is in focus

Nektar presents new clinical, preclinical data from immuno-oncology pipeline

Nektar Therapeutics (NKTR) announced the presentation of five clinical and preclinical data abstracts focused on its immuno-oncology portfolio at the 2019 Society for Immunotherapy of Cancer Annual Meeting.

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New clinical results from the PIVOT-02 Phase 1/2 study were shared in an oral presentation titled, “Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the Phase 1/2 PIVOT-02 Study” during the Combination Phase 1-2 Clinical Trials Session on Saturday, November 9th.

Additional preclinical data presented at the annual meeting highlighted NKTR-255, an IL-15 agonist discovered by Nektar.

The presentations demonstrated that NKTR-255 enhanced activity of antibody-dependent cellular cytotoxicity against tumor cells in vitro, and that it also enhanced in vivo efficacy of ADCC-inducing antibodies in models of human solid tumors.

NKTR-255 is designed to engage the IL-15 pathway to stimulate and expand natural killer cells and promote the survival and expansion of memory CD8+ T cells without inducing suppressive regulatory T cells.

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NKTR-255 is currently being evaluated in a Phase 1/2 clinical trial in patients with either relapsed or refractory Non-Hodgkin’s lymphoma or multiple myeloma.

“The data presented at this year’s SITC meeting continue to showcase the potential of our I-O portfolio, most notably our key IL-2 pathway program, bempeg, and our new IL-15 pathway program, NKTR-255,” said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar.

“The 18-month follow-up data presentation for the Stage IV melanoma patients in our PIVOT-02 study reinforces the promise of BEMPEG and NIVO to work synergistically to achieve a deepening of response over time, while maintaining a favorable safety and tolerability profile. We’re pleased that at this 18 month timepoint, 85% of patients who achieved responses have ongoing responses and median PFS has not yet been reached.”

Separately, Nektar Therapeutics (NKTR) announced updated results from the first-in-human Phase 1a study of NKTR-358, a novel T regulatory cell stimulator in development for the treatment of autoimmune and other chronic inflammatory conditions.

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The data, which were presented at the 2019 Annual Meeting of the American College of Rheumatology in Atlanta, show that treatment with NKTR-358 led to a marked and selective dose-dependent expansion in the numbers and proliferative capacity of FoxP3+CD25bright Treg cells, and a measurable activation of Treg cells.

These data are a continuation of initial results reported at 2019 Annual European Congress of Rheumatology in June 2019.

NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of immune-regulating Treg cells.

NKTR-358 works by targeting the interleukin-2 receptor complex to stimulate the proliferation and activation of Treg cells.

NKTR-358 was discovered by Nektar and is being co-developed and commercialized in partnership with Eli Lilly (LLY).

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“We’re pleased to report that final results from our first-in-human Phase 1a study continue to support the positive safety and tolerability profile of NKTR-358, while reinforcing its selective and measurable impact on the numbers, expansion and activation of regulatory T cells or Tregs,” said Brian Kotzin, M.D., senior VP, Clinical Development and NKTR-358 Program Lead at Nektar.

“Autoimmune and inflammatory diseases are marked by an imbalance in the body’s self-tolerance and self-regulatory immune pathways, and the ability of NKTR-358 to expand functional Tregs could help restore normal balance.

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