On February 23, 2018 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Leap Therapeutics, FEB 23, 2018, View Source;p=RssLanding&cat=news&id=2334290 [SID1234524139]). Leap additionally announced that its Annual Meeting of Stockholders will be held on Thursday, May 3, 2018, at 11:00 a.m., Eastern Time, at the offices of Morgan, Lewis & Bockius LLP, One Federal Street, Boston, Massachusetts 02110.

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"We had a very successful 2017 at Leap, our first year as a public company. We have advanced clinical development of both of our innovative cancer programs to explore novel combinations with immunotherapies and chemotherapies and have laid the foundation for a data-rich 2018," said Christopher K. Mirabelli, Ph.D., Chief Executive Officer of Leap. "We additionally strengthened our balance sheet to continue to grow the company and further advance our pipeline."

2017 Accomplishments

DKN-01

Announced parallel development strategy to evaluate DKN-01 in patients with documented alterations of the Wnt signaling pathway and to evaluate DKN-01 as a combination immunotherapy.
Wnt Signaling Studies
Initiated a Phase 2 clinical trial evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced endometrioid gynecologic malignancies. The study will enroll approximately 50% of patients with Wnt signaling abnormalities.
Announced an investigator-sponsored clinical trial, DIAL-1, in patients with advanced hepatocellular carcinoma (HCC) with activated Wnt signaling at the University Medical Center of the Johannes Gutenberg-University Mainz in Germany.
Immunotherapy Studies:
Enrolled first patient in combination study evaluating DKN-01 with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with esophagogastric cancer.
Announced an immunotherapy collaboration, DINAMIC, with the European Organisation for Research and Treatment of Cancer (EORTC). The cooperative group sponsored clinical trial will evaluate DKN-01 in combination with atezolizumab (TECENTRIQ) +/- paclitaxel in advanced esophagogastric malignancies and DKN-01 + atezolizumab in advanced biliary tract cancers at EORTC centers across Europe.
Presented proof of concept clinical data of DKN-01 in combination with chemotherapy in patients with advanced biliary tract or esophagogastric cancers at major medical conferences including the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium. The data included encouraging overall response and disease control rates, progression-free survival data, and biomarker data.
TRX518:

Fully enrolled the monotherapy cohorts of the 003 repeat-dose clinical trial evaluating TRX518 in patients with advanced solid tumors.
Presented interim data from the repeat-dose monotherapy study, including robust disease control and signs of pharmacodynamic activity including CD8+ T cell activation.
Initiated combination cohorts of study 003 evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or Opdivo (nivolumab), anti-PD-1 therapies marketed by Merck (known as MSD outside the United States and Canada) or Bristol-Myers Squibb, respectively.
Business:

Completed $18M private-placement financing with participation from Eli Lilly and Company and other existing and new investors.
Completed a clinical collaboration agreement with Merck for the study of the combination of DKN-01 and KEYTRUDA (pembrolizumab).
2018 Objectives

DKN-01 Program Objectives

Present interim data from clinical trial evaluating DKN-01 and KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer.
Present interim data from the Phase 2 clinical trial evaluating DKN-01 ± paclitaxel in patients with advanced gynecologic cancers enriched for patients with Wnt pathway alterations.
Present final data from the combination study of DKN-01 with gemcitabine and cisplatin in advanced biliary tract cancers.
Enroll first patient in the DIAL-1 clinical trial.
Enroll first patient in the DINAMIC clinical trial.
TRX518 Program Objectives

Present interim data from study of TRX518 in combination with gemcitabine chemotherapy, KEYTRUDA (pembrolizumab), or Opdivo (nivolumab).
Present TRX518 clinical biomarker data from monotherapy studies.
Selected Year-End and Fourth Quarter 2017 Financial Results

Net loss was $29.7 million for the year ended December 31, 2017, compared to $25.6 million for the year ended December 31, 2016. Net loss was $6.6 million for the fourth quarter of 2017, compared to $5.7 million for the same period in 2016.

Research and development expenses were $22.5 million for the full year 2017, compared to $23.3 million for the same period in 2016. This decrease was primarily due to reduced manufacturing expenses of our clinical product candidates. Research and development expenses were $4.4 million for the fourth quarter of 2017, compared to $7.4 million for the same period in 2016.

General and administrative expenses were $9.8 million for the full year 2017, compared to $4.0 million for the same period in 2016. This increase was primarily due to increased personnel, stock-based compensation, and expenses related to operating as a public company. General and administrative expenses were $2.1 million for the fourth quarter of 2017, compared to $0.5 million for the same period in 2016.

Cash, cash equivalents and marketable securities totaled $25.7 million at December 31, 2017. Research and development incentive receivables totaled $1.7 million.

Annual Meeting of Stockholders

The Annual Meeting of Stockholders will be held on Thursday, May 3, 2018, at 11:00 a.m., Eastern Time, at the offices of Morgan, Lewis & Bockius LLP, One Federal Street, Boston, Massachusetts 02110. The record date for the Annual Meeting of Stockholders is March 28, 2018. Leap expects to mail its definitive proxy statement to all stockholders of record in the first week of April.

Rule 14a-8 Stockholder Proposal Deadline

The 2018 Annual Meeting date represents Leap’s first Annual Meeting of Stockholders. As a result, pursuant to Rule 14a-8 under the Securities Exchange Act of 1934, as amended, the deadline for the receipt of any stockholder proposals submitted pursuant to Rule 14a-8 for inclusion in Leap’s proxy materials for the 2018 Annual Meeting, is required to be a reasonable time before the Company begins to print and mail the proxy materials. Taking into consideration the time and process for addressing any deficiencies in proposals that may be submitted, the Company has determined that close of business on March 9, 2018 should be the deadline for receipt of proposals pursuant to Rule 14a-8. Such proposals should be delivered to: Leap Therapeutics, 47 Thorndike Street, Suite B1-1, Cambridge, Massachusetts 02141, Attention: Corporate Secretary. Leap recommends that such proposals be sent by certified mail, return receipt requested. Such proposals also will need to comply with the rules of the Securities and Exchange Commission regarding the inclusion of stockholder proposals in Leap’s proxy materials and may be omitted if not in compliance with applicable requirements.

Bylaws Advance Notice Deadline for Stockholder Proposals and Nominations

For stockholder proposals not submitted pursuant to Rule 14a-8 and stockholder nominations of directors, the stockholder must give timely notice thereof in writing and in accordance with the requirements set forth in the Company’s bylaws to the Company’s Secretary no later than 5:00 p.m., Eastern Time on March 9, 2018 at the address noted above.