Leap Therapeutics Reports Second Quarter 2019 Financial Results

CAMBRIDGE, Mass., Aug. 9, 2019 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported financial results for the second quarter ended June 30, 2019.

"We recently presented positive data from our clinical study of DKN-01 plus KEYTRUDA which demonstrated higher survival and objective response outcomes in patients with advanced gastroesophageal junction and gastric cancer whose tumors expressed high levels of DKK1 (DKK1-high). As we have seen with the single agent partial responses in patients with endometrial cancer, DKN-01's activity continues to be impressive in biomarker-targeted patient populations," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we have enrolled our first patients in the triple chemoimmunotherapy study of TRX518 in combination with BAVENCIO and cyclophosphamide."

Recent Developments

    --  DKN-01 CLINICAL INVESTIGATOR WEBCAST: On August 6, 2019, Leap hosted a
        DKN-01 program update webcast with Samuel J. Klempner, MD, Assistant
        Professor, Massachusetts General Hospital Cancer Center and Harvard
        Medical School, and Rebecca C. Arend, MD, Assistant Professor and
        Associate Scientist, Gynecologic Oncology Clinic, UAB Comprehensive
        Cancer Center Experimental Therapeutics Program. A replay of the webcast
        and the presentation slides are available under "Events & Presentations"
        in the Investor section of Leap's website,

    --  DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented data from the
        KEYNOTE-731 clinical study evaluating DKN-01 in combination with
        KEYTRUDA in patients with advanced esophagogastric cancer. In
        gastroesophageal junction and gastric cancer patients who had not
        received prior PD-1/PD-L1 therapy, the combination of DKN-01 plus
        KEYTRUDA demonstrated improved outcomes in patients whose tumors are
        DKK1-high. DKK1-high patients experienced 22.1 weeks median progression
        free survival (PFS) and 31.6 weeks median overall survival (OS), with a
        50% overall response rate (ORR) and 80% disease control rate (DCR) in
        ten evaluable patients. DKK1-low patients experienced 5.9 weeks PFS and
        17.4 weeks OS, with a 20% DCR in fifteen evaluable patients. PD-L1
        Combined Positive Scores (CPS) did not predict efficacy to the
        combination of DKN-01 plus KEYTRUDA. In multi-variate analysis,
        DKK1-high status correlated with longer PFS independent of PD-L1 CPS.

    --  DKN-01 in GYNECOLOGICAL CANCERS: The clinical study of DKN-01 as a
        monotherapy and in combination with paclitaxel in patients with advanced
        gynecological cancers has been expanded to include focused cohorts of
        patients with carcinosarcoma. Overall, ninety-six patients have been
        enrolled in the study, and enrollment is ongoing. Additional response
        and biomarker data will be available in September at the International
        Gynecologic Cancer Society Annual Global Meeting.

    --  TRX518 TRIPLE COMBINATION THERAPY: Leap enrolled the first patients in
        the clinical trial evaluating TRX518 in combination with
        cyclophosphamide chemotherapy and BAVENCIO. Dose escalation in the study
        is ongoing.
    --  $21 MILLION EQUITY COMMITMENT FACILITY: Leap entered into purchase
        agreements with Lincoln Park Capital Fund, LLC (LPC) pursuant to which
        Leap sold $1 million in common stock and has the option, but not the
        obligation, to sell to LPC up to an additional $20 million in shares of
        common stock in tranches over a twenty-four month period. The price of
        shares sold will be based on the market prices prevailing at the time of
        each sale to LPC. There is no upper limit as to the price per share that
        LPC may pay for future stock issuances under the agreement, and Leap
        will control the timing and amount of any future sales.

Selected Second Quarter 2019 Financial Results

Net loss was $8.4 million for the second quarter 2019, compared to $7.4 million for the same period in 2018. This increase was primarily due to an increase in clinical development expense and the recording of a loss in the second quarter 2018 as a result of a decrease in the fair value of the warrant liability.

Research and development expenses were $6.1 million for the second quarter 2019, compared to $4.2 million for the same period in 2018. This increase was primarily due to an increase in clinical trial expenses associated with an increase in patient enrollment and an increase in consulting fees and payroll expenses, partially offset by a decrease in manufacturing costs related to clinical trial material.

General and administrative expenses were $2.3 million for the second quarter 2019, compared to $2.6 million for the same period in 2018. This decrease was primarily due to a decrease in legal, audit and consulting fees.

Cash, cash equivalents and marketable securities totaled $15.7 million at June 30, 2019. Research and development incentive receivables, current and long term, totaled approximately $1.0 million at June 30, 2019. Subsequent to the end of the quarter, Leap announced the commitment facility with LPC and sold $1.0 million in common stock.

About Leap Therapeutics

Leap Therapeutics (NASDAQ: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap's second clinical candidate, TRX518, is a humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in advanced solid tumor studies. For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.


This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements regarding Leap's expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the ability to complete a financing or form business development relationships to fund our expenses; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics' periodic filings with the SEC, including Leap Therapeutics' Annual Report on Form 10-K for the fiscal year ended December 31, 2018 that Leap filed with the SEC on April 1, 2019. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

KEYTRUDA(®) is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. BAVENCIO(®) is a registered trademark of Merck KGaA, Darmstadt, Germany, and is marketed under a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, USA.


Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.

Argot Partners
Investor Relations
Heather Savelle

              Leap Therapeutics, Inc.

         Condensed Consolidated Statements of Operations

         (in thousands, except share and per share amounts)


                                                                                                                                         Three Months Ended June 30,        Six Months Ended June 30,

                                                                                                                                                                2019                              2018                    2019                     2018

     Operating expenses:

            Research and development                                                                              $6,136                             $4,234                           $12,926                  $8,465

            General and administrative                                                                             2,325                              2,603                             4,330                   4,716

            Total operating expenses                                                                               8,461                              6,837                            17,256                  13,181

     Loss from operations                                                                                                                            (8,461)                          (6,837)                 (17,256)                (13,181)

     Interest income                                                                                                                                     119                               122                       201                      199

     Interest expense                                                                                                                                    (9)                              (8)                     (16)                    (14)

     Australian research and development incentives                                                                                                       61                               243                       136                      889

     Foreign currency losses                                                                                                                            (76)                            (222)                     (34)                   (366)

     Change in fair value of warrant liability                                                                                                                                          (662)                                          (5,513)

     Net loss                                                                                                                                          (8,366)                          (7,364)                 (16,969)                (17,986)

     Dividend attributable to down round feature of warrants                                                                                               0                                                      (359)

     Net loss attributable to common stockholders                                                                                                   $(8,366)                         $(7,364)                $(17,328)               $(17,986)

     Net loss per share - basic and diluted                                                                                                          $(0.37)                          $(0.50)                  $(0.82)                 $(1.32)

     Weighted average common shares outstanding - basic and diluted                                                                               22,906,025                        14,691,890                21,081,869               13,576,850

                Leap Therapeutics, Inc.

            Condensed Consolidated Balance Sheets

         (in thousands, except share and per share amounts)

            June 30,               
        December 31,

                                                                                                                                                                                                     2019                              2018



     Current assets:

           Cash and cash equivalents                                                                                                                                                       $15,747                           $16,284

           Research and development incentive receivable                                                                                                                                       836                               836

           Prepaid expenses and other current assets                                                                                                                                           211                               202

                       Total current assets                                                                                                                                                 16,794                            17,322

     Property and equipment, net                                                                                                                                                               161                                86

     Right of use asset, net                                                                                                                                                                 1,398

     Research and development incentive receivable, net of current portion                                                                                                                     135

     Deferred tax assets                                                                                                                                                                       124                               124

     Other assets                                                                                                                                                                            1,525                             1,542

                      Total assets                                                                                                                                                         $20,137                           $19,074

                Liabilities and Stockholders' Equity

     Current liabilities:

              Accounts payable                                                                                                                   $5,325                                $3,579

              Accrued expenses                                                                                                                    2,474                                 2,872

              Lease liability - current portion                                                                                                     657

              Total current liabilities                                                                                                           8,456                                 6,451

     Non current liabilities:

              Warrant liability                                                                                                                                                        3,448

              Lease liability, net of current portion                                                                                                  742

              Total liabilities                                                                                                                   9,198                                 9,899

     Stockholders' equity:

                                 Common stock, $0.001 par value; 100,000,000 shares authorized as                                                                                        23                                15

                                 of June 30, 2019 and December 31, 2018, 22,949,064 and 14,703,159

                                 issued and outstanding as of March 31, 2019 and December 31, 2018,

              Additional paid-in capital                                                                                                        189,831                               162,393

              Accumulated other comprehensive income                                                                                                  322                                   302

              Accumulated deficit                                                                                                             (179,237)                             (153,535)

              Total stockholders' equity                                                                                                         10,939                                 9,175

              Total liabilities and stockholders' equity                                                                                              $20,137                               $19,074

                 Leap Therapeutics, Inc.

          Condensed Consolidated Statements of Cash Flows

                 (in thousands)

                                                                                                                                          Six Months Ended June 30,

                                                                                                                                                               2019            2018


                 Cash used in operating activities                                                                                               $(14,051)       $(11,531)

                 Cash used in investing activities                                                                                                   (100)

                 Cash provided by financing activities                                                                                              13,582           16,013

                 Effect of exchange rate changes on cash and cash equivalents                                                                           32              262

                 Net increase (decrease) in cash and cash equivalents                                                                                (537)           4,744

      Cash and cash equivalents at beginning of period                                                                                                16,284           25,737

      Cash and cash equivalents at end of period                                                                                                     $15,747          $30,481

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SOURCE Leap Therapeutics, Inc.