Item 7.01 Regulation FD Disclosure. On August 25, 2026, draft copies of three posters submitted by Generate Biomedicines, Inc. (the “Company”) and accepted for presentation at the European Respiratory Society Congress 2026 (“ERS”), scheduled for September 5-9, 2026, were inadvertently made publicly available via the ERS website prior to the expiration of the applicable embargo, which the Company b…
Filed Aug 26, 2026Accepted Aug 25, 2026, 7:28 PM EDTCIK 2100782Accession 0001193125-26-365556
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On August 25, 2026, draft copies of three posters submitted by Generate Biomedicines, Inc. (the “Company”) and accepted for presentation at the European Respiratory Society Congress 2026 (“ERS”), scheduled for September 5-9, 2026, were inadvertently made publicly available via the ERS website prior to the expiration of the applicable embargo, which the Company believed would run until 6:01 p.m., Eastern time, on September 7, 2026. The draft posters include results of ongoing clinical trials sponsored by the Company and are entitled:
• “GB-0895, a next-generation anti-TSLP mAb, demonstrates durable pharmacologic activity supporting a single subcutaneous injection every 6 months for asthma patients”;
• “SOLAIRIA-1 & SOLAIRIA-2: Two Phase 3 randomized, double-blind, placebo-controlled studies of GB-0895, a long-acting anti-TSLP antibody, in severe uncontrolled asthma”; and
• “GB-0895, a High-Affinity Anti-TSLP Antibody, Demonstrates Potent and Sustained Pharmacological Activity in Adults with COPD.”
As a precautionary measure, the Company is providing the final posters attached hereto as Exhibit 99.1, which include the information that was furnished to ERS.
The information included under Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Filed exhibits (1)
EX-99.1 (by filename) ck0002100782-ex99_1.htm
EX-99.1
2
ck0002100782-ex99_1.htm
EX-99.1
EX-99.1
Exhibit 99.1
GB-0895, a next-generation anti-TSLP mAb, demonstrates durable pharmacologic activity supporting a single subcutaneous injection every 6 months for asthma patients. Dave Singh1, Kapil Mayawala2, Victoria Szenes2, Andreas Eich3, Brian Leaker4, Philipp Badorrek5, Stanislav Ignatenko6, Sacha Prashad2, Stephanie Straley2, Antonios Aliprantis7, Lovely Goyal2, Alex Synder2, Oliver Kornmann3 Affiliations: 1University of Manchester, Manchester University NHS Foundation Trust, M13 9WL, UK; 2Generate Biomedicines Inc., Somerville, MA 02143, USA; 3IKF Pneumologie Clinical Research Center Respiratory Diseases, Frankfurt, 60596, Germany; 4Queen Anne Street Medical Centre, W1T 6AH, UK; 5Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, 30625, Germany; 6Charité Research Organisation GmbH, Berlin, 10117, Germany; 7Pioneering Medicines, Cambridge, MA 02141, USA Background & Aims of Study Thymic Stromal Lymphopoietin (TSLP), an alarmin, drives inflammatory responses in the airways and is a validated therapeutic target in severe asthma. Generate:Biomedicines developed GB-0895, a next-generation human monoclona…