Every material Form 8-K Prelude Therapeutics Inc has filed with the SEC since May 12, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Prelude Therapeutics said the U.S. Food and Drug Administration cleared its Investigational New Drug application for PRT13722, an oral KAT6A selective degrader, allowing a Phase 1 study in patients with HR+/HER2- breast cancer. The company expects to begin enrolling patients in the fourth quarter of 2026, so the filing marks a clinical milestone without any reported financial results.
FDA cleared the company to proceed with a Phase 1 study under the IND for PRT13722.
Enrollment is expected to begin in the fourth quarter of 2026.
The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
The company also furnished investor presentation materials as Exhibit 99.2, which management intends to use in investor presentations.
Prelude Therapeutics reported results for the three months ended June 30, 2026, with a net loss of $13.9 million, or $0.14 per share, down from $31.2 million, or $0.41 per share, a year earlier. The company recorded $5.7 million of revenue, compared with none in the prior-year period, and cash, cash equivalents, restricted cash and marketable securities totaled $155.2 million, which it expects to fund operations into the second quarter of 2028.
Net loss was $13.9 million, or $0.14 per share, versus $31.2 million, or $0.41 per share, in Q2 2025.
Revenue was $5.7 million, compared with none in the prior-year quarter.
R&D expense fell to $16.1 million from $25.8 million, and G&A expense fell to $5.0 million from $6.4 million.
The company expects to start the Phase 1 study of PRT13722 in HR+ breast cancer in the fourth quarter of 2026, pending IND clearance.
Prelude Therapeutics reported first quarter 2026 results, with a net loss of $10.4 million, or $0.13 per share, compared with $32.1 million, or $0.42 per share, a year earlier. The company recorded $4.6 million of revenue, versus none in the prior-year period, and lower research and development and general and administrative expenses. It said its cash runway now extends into the second quarter of 2028, based on preliminary estimates that reflect an underwritten offering with about $90 million in gross proceeds completed after March 31.
Net loss was $10.4 million, or $0.13 per share, for the three months ended March 31, 2026, versus $32.1 million, or $0.42 per share, a year earlier.
Revenue was $4.6 million in the quarter, compared with no revenue in the prior-year period.
Research and development expense fell to $13.6 million from $28.8 million, mainly due to lower spending on SMARCA2 trials paused in 2025.
Cash, cash equivalents, restricted cash and marketable securities were $84.8 million on March 31, 2026, before the offering of about $90 million in gross proceeds.
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