AI Earnings Predictions for Bicycle Therapeutics plc (BCYC)

EX-99.1

2 tm2628394d1_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Bicycle Therapeutics Reports Recent Business Progress and Third Quarter 2026 Financial Results

Nuzefatide pevedotin granted FDA Orphan Drug Designation for the treatment of pancreatic cancer; further updates expected in 2027

Initiation of the first company-sponsored radioligand

clinical trial for BT1702, an MT1-MMP- targeting Bicycle® Radioconjugate, expected in 2H 2027

Cash and cash equivalents of $469.9 million as of September 30, 2026, with expected cash runway into 2030

CAMBRIDGE, England & BOSTON, October 29, 2026 - Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the third quarter ended September 30, 2026, and provided recent corporate updates.

“We are pleased with the continued progress made across our pipeline during the third quarter, as we advance nuzefatide pevedotin in the Phase 2 clinical trial in patients with recurrent pancreatic ductal adenocarcinoma and build our emerging pipeline of next-generation radioligands. We believe the FDA’s Orphan Drug Designation for nuzefatide in pancreatic cancer further supports our development strategy and underscores the significant unmet need in this patient population,” said Bicycle CEO Kevin Lee, Ph.D. “We remain focused on disciplined execution across our prioritized programs and believe our growing clinical data continue to demonstrate the potential of Bicycle® molecules to deliver highly targeted therapies with differentiated benefit/risk profiles. We look forward to advancing our pipeline and reaching important clinical milestones for nuzefatide and initiating our first company-sponsored radioligand clinical trial for BT1702 in the second half of 2027.”

Third Quarter 2026 and Recent Events

·Nuzefatide pevedotin (nuzefatide), a potentially first-in-class EphA2 targeting Bicycle® Drug Conjugate (BDC®), was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. In September 2026, the FDA granted nuzefatide ODD for the treatment of pancreatic cancer. The designation is granted to investigational therapies intended to treat rare diseases affecting fewer than 200,000 patients in the United States. The designation provides development incentives, including eligibility for tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon regulatory approval.

Bicycle Therapeutics is actively enrolling patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent pancreatic ductal adenocarcinoma (PDAC) and expects to provide further updates in 2027.

·Bicycle Therapeutics continues to optimize its Bicycle® Radioconjugate (BRC®) molecules and advance its emerging radioligand pipeline, with initiation of the first company-sponsored radioligand clinical trial for BT1702, an MT1-MMP-targeting BRC®, expected in the second half of 2027.

·Zelenectide pevedotin is a BDC® molecule targeting Nectin-4, a well-validated tumor antigen. Bicycle Therapeutics converted the Duravelo-2 trial to a randomized Phase 2 trial in May 2026 and deprioritized the program for internal development. The company expects to report Duravelo-2 survival data from the randomized Phase 2 trial in previously untreated patients with metastatic urothelial cancer (mUC) in the second half of 2027.

Third Quarter 2026 Financial Results

·Cash and cash equivalents were $469.9 million as of September 30, 2026, compared to $628.1 million as of December 31, 2025. The decrease in cash and cash equivalents is primarily due to cash used in operations, including cash payments for clinical program activities.

·Collaboration revenue was $34.1 million for the three months ended September 30, 2026, compared to $11.7 million for the three months ended September 30, 2025. The increase in collaboration revenue was primarily due to the recognition of all remaining revenue under Bicycle Therapeutics’ collaboration with Bayer Consumer Care AG upon termination of the underlying collaboration agreement.

·Research and development (R&D) expenses were $33.4 million for the three months ended September 30, 2026, compared to $58.4 million for the three months ended September 30, 2025. The decrease in expense of $25.0 million was primarily due to decreased clinical program expenses for zelenectide, decreased personnel-related costs and share-based compensation due to our workforce reductions announced in August 2025 and March 2026, as well as decreased discovery, platform and other expenses, offset by lower research and development incentives associated with the corresponding decrease in qualifying research and development expenses period over period.

·General and

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