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Takeda to Acquire Nimbus Therapeutics’ Highly Selective, Allosteric TYK2 Inhibitor to Address Multiple Immune-Mediated Diseases

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Nimbus Therapeutics has entered into a definitive agreement for Takeda to acquire its subsidiary, Nimbus Lakshmi, Inc., along with the TYK2 inhibitor NDI-034858. The deal includes $4 billion upfront and up to $2 billion in milestone payments. NDI-034858 is being developed for autoimmune diseases, showing promising Phase 2b results in psoriasis. The acquisition is set to close in the first half of 2023, pending antitrust reviews.

Positive
  • Acquisition value of $4 billion upfront plus $2 billion in milestone payments indicates strong confidence in NDI-034858's potential.
  • NDI-034858 demonstrated effective Phase 2b results, achieving the primary endpoint of PASI-75 in psoriasis patients.
Negative
  • The closing of the transaction depends on regulatory reviews, which may introduce uncertainties.
  • Takeda will bear the full risks related to future development and commercialization of NDI-034858.

- Nimbus to receive $4 billion in upfront cash, and up to $2 billion in commercial milestone payments -

- NDI-034858 has potential best-in-class profile among new therapeutic class of selective allosteric TYK2 inhibitors for immune-mediated diseases -

BOSTON--(BUSINESS WIRE)-- Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858. NDI-034858 is an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis.

“Nimbus’ allosteric TYK2 inhibitor has the potential to be a best-in-class medicine in multiple disease areas, and we are confident that Takeda’s commitment and capabilities will enable NDI-034858 to reach its full value to patients,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “The proposed acquisition highlights Nimbus’ ability to discover and develop high-value investigational medicines leveraging our computational structure-based drug design and development engine. We will continue to advance other exciting target programs in our R&D pipeline — including our selective HPK1 inhibitor, currently in a Phase 1/2 study in patients with solid tumors — as we have done since our founding in 2009.”

Under the terms of the agreement, Takeda will pay Nimbus Therapeutics $4 billion upfront, and sales-based milestone payments up to $2 billion. The transaction is expected to be finalized in the first half of 2023. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Nimbus Therapeutics will retain ownership of its other research and development subsidiaries. Takeda will be solely responsible for future development and commercialization of NDI-034858 and other TYK2 inhibitors.

J.P. Morgan Securities LLC is acting as exclusive financial advisor to Nimbus Therapeutics and Goodwin Procter LLP is serving as its legal advisor.

About NDI-034858

NDI-034858 is an allosteric TYK2 inhibitor discovered and developed by Nimbus Therapeutics that is being evaluated for the treatment of multiple autoimmune diseases. In preclinical studies, NDI-034858 has demonstrated exceptional functional selectivity and wide therapeutic margins. In Phase 1 studies, NDI-034858 showed a good tolerability profile, a dose-dependent trend in exploratory clinical activity and a pharmacokinetic profile allowing for once-daily solid oral dosing. Results from Nimbus’ Phase 2b clinical trial in patients with moderate-to-severe plaque psoriasis demonstrated a significantly greater proportion of patients in the study achieving the primary endpoint of PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo after twelve weeks of treatment. Data from this trial will be presented at an upcoming medical conference. In addition to psoriasis, NDI-034858 is in an ongoing Phase 2b trial in active psoriatic arthritis (NCT05153148).

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. Nimbus combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes clinical-stage programs targeting TYK2 and HPK1 (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, inflammatory and autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, MA. To learn more about Nimbus, please visit www.nimbustx.com.

Media

Chris Railey, +1 (617) 834-0936

Ten Bridge Communications

chris@tenbridgecommunications.com

Source: Nimbus Therapeutics

FAQ

What is the significance of the Takeda and Nimbus Therapeutics acquisition?

Takeda's acquisition of Nimbus Therapeutics, particularly its TYK2 inhibitor NDI-034858, is significant as it reflects a strategic move to enhance its portfolio in autoimmune disease treatments.

How much will Takeda pay for Nimbus Lakshmi, Inc.?

Takeda will pay Nimbus Therapeutics $4 billion upfront and up to $2 billion in commercial milestone payments.

What are the expected outcomes of NDI-034858?

NDI-034858 is expected to be a best-in-class treatment for autoimmune diseases, with promising Phase 2b clinical trial results in psoriasis.

When is the acquisition of Nimbus Therapeutics expected to close?

The acquisition is expected to be finalized in the first half of 2023, subject to antitrust review.

What are the risks associated with the NDI-034858 development?

Risks include reliance on Takeda for future development and commercialization, as well as uncertainties related to regulatory reviews.

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