Leap Therapeutics Announces Q1 2024 Financial Results

Leap Therapeutics, Inc., a biotechnology company dedicated to developing targeted and immuno-oncology therapeutics, headquartered in Cambridge, Massachusetts, recently announced its financial outcomes for the first quarter ending March 31, 2024. The company has been making significant strides in its clinical studies and financing activities.

Key Achievements:
1. $40 Million Private Financing: Leap Therapeutics completed a $40 million private placement with the involvement of Gilead Sciences, Samsara BioCapital, 683 Capital Partners, Laurion Capital Management, and Rock Springs Capital.
2. Clinical Data Presentation: The company shared results from Part A of its Phase 2 DeFianCe study, evaluating DKN-01 combined with bevacizumab and chemotherapy for patients with advanced colorectal cancer, during the 2024 ASCO Gastrointestinal Cancers Symposium.
3. Expanded Enrollment: The randomized controlled Part B of the DeFianCe study has been expanded from 130 to 180 patients to enhance the statistical power for left-sided colorectal cancer cases, with enrollment expected to conclude by late Q3 or early Q4 2024.
4. DisTinGuish Study Progress: Leap completed enrollment for Part C of the Phase 2 DisTinGuish study, which evaluates DKN-01 in combination with tislelizumab and chemotherapy for advanced gastroesophageal junction and gastric cancer. The first data from this study is anticipated in the second half of 2024 or early 2025.

CEO Douglas E. Onsi expressed gratitude for the robust support from investors, emphasizing that the financing extends Leap’s cash runway into the second quarter of 2026. This financial support will aid in the expansion of the DeFianCe CRC study, maturation of data in the DisTinGuish GEJ/gastric cancer study, and the production of Phase 3 clinical trial material.

Business and Development Updates:
- Private Placement Details: Leap issued 12,660,993 shares of common stock at $2.82 per share and pre-funded warrants for 1,523,404 shares at $2.819 per share in a private placement, yielding approximately $40 million. This financing, alongside existing cash reserves, will support operations and capital expenditures through mid-2026.
- DeFianCe Study Insights: Data from Part A of the study showed a 30% overall response rate (ORR) and a 93% disease control rate (DCR) among evaluable patients. Those with left-sided tumors exhibited enhanced activity, with a 33% ORR and 100% DCR.
- DisTinGuish Study Completion: The randomized Part C of the study included 170 patients with advanced gastroesophageal adenocarcinoma. The primary endpoint is progression-free survival (PFS), with secondary objectives focused on overall survival (OS) and ORR.

Financial Highlights for Q1 2024:
- Net Loss Reduction: The net loss for the first quarter of 2024 was $13.8 million, a significant decrease from $41.9 million in Q1 2023, primarily due to the absence of $29.6 million in-process research and development expenses from the Flame merger in 2023.
- R&D Expenditure: Research and development expenses dropped to $11.3 million from $38.9 million. The reduction was mainly due to the prior year’s Flame merger expenses, alongside decreased manufacturing and consulting costs, offset by increased clinical trial costs and payroll expenses.
- Administrative Costs: General and administrative expenses slightly decreased to $3.5 million from $3.8 million, attributed to lowered professional fees.

As of March 31, 2024, Leap had cash and cash equivalents of $54.9 million, excluding the net proceeds from the recent private placement.

Leap Therapeutics remains dedicated to advancing its pipeline, particularly with its lead candidate, DKN-01, and looks forward to achieving significant clinical milestones in the coming year.

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