Filed by Talaris Therapeutics, Inc.
pursuant to Rule 425 under the
Securities Act of 1933, as amended
and deemed filed under Rule 14a-12 under the
Securities Exchange Act of 1934, as amended
Subject Company: Talaris Therapeutics, Inc.
Filers Commission File Number: 001-40384
Date: August 28, 2023
This filing relates to
the proposed transaction pursuant to the terms of that certain Agreement and Plan of Merger, dated as of June 22, 2023, among Talaris Therapeutics, a Delaware corporation (Talaris), Tourmaline Bio, Inc., a Delaware corporation
(Tourmaline), and Terrain Merger Sub, Inc. (Merger Sub), a direct, wholly owned subsidiary of Talaris (the Merger Agreement), pursuant to which, and subject to the satisfaction or waiver of the conditions set
forth in the Merger Agreement, Merger Sub will merge with and into Tourmaline, with Tourmaline surviving as a wholly owned subsidiary of Talaris.
On
August 28, 2023, Toumaline published the following communication:
Tourmaline Bio Announces FDA Clearance of Investigational New
Drug (IND) Application for TOUR006, an anti-IL-6 antibody with a differentiated profile for the treatment of thyroid eye disease (TED)
Phase 2b trial of TOUR006 is expected to report top-line clinical data in the first half of 2025
NEW YORK August 28, 2023 Tourmaline Bio, Inc. (Tourmaline), a late-stage clinical biotechnology company developing transformative medicines
to dramatically improve the lives of patients with life-altering immune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of Tourmalines IND application for TOUR006.
TOUR006 is a fully-human, anti-IL-6 antibody with differentiated properties
including high binding affinity to IL-6 and a naturally long half-life. TED, also known as Graves ophthalmopathy, is an autoimmune disease characterized by inflammation and disfigurement around the eye,
which can be sight-threatening in severe cases. Off-label use of IL-6 pathway inhibitors in TED has resulted in reduced inflammation and
eye-bulging and has been shown to impact key biomarkers such as levels of pathogenic autoantibodies.
We are
excited to advance TOUR006 into late-stage development in TED. We believe TOUR006 could be an ideal treatment option for patients suffering from TED, in light of its anti-inflammatory mechanism of action, established tolerability profile, attractive
dosing schedule, and convenient subcutaneous administration, said Sandeep Kulkarni, MD, Chief Executive Officer of Tourmaline. We anticipate top-line data from this trial in the first half of 2025
and expect to further expand the development of TOUR006 into atherosclerotic cardiovascular disease (ASCVD) and other indications. We are also looking forward to the expected closing of our merger with Talaris Therapeutics and listing on Nasdaq in
the fourth quarter of 2023.
The planned Phase 2b trial of TOUR006 in TED is expected to evaluate 20mg and 50mg doses against placebo given by a
subcutaneous injection every eight weeks. The approximately 81 participants planned to be enrolled (27 in each arm) will be moderate to severe TED patients who are in the active phase of disease. The primary endpoint for this trial will be proptosis
response, or reduction of abnormal eye protrusion, measured at week 20.
About Tourmaline Bio, Inc.
Tourmaline Bio is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of
patients with life-altering immune diseases. Tourmalines lead program, TOUR006, is an anti-IL-6 antibody that exhibits differentiated properties including high
binding affinity to IL-6 and a naturally long half-life. To date, TOUR006 has been studied in over 400 autoimmune patients across six clinical trials. Tourmaline plans to develop TOUR006 in thyroid eye disease
(TED) and atherosclerotic cardiovascular disease (ASCVD) as its first two indications, with additional indications under consideration. In June 2023, Tourmaline announced it had entered into a definitive agreement with Talaris Therapeutics under
which Tourmaline is expected to combine with Talaris. The combined company will operate under Tourmalines name and be led by Tourmalines current management team, focused on advancing the development of TOUR006.