On March 16, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Pulse Biosciences, MAR 16, 2020, View Source [SID1234555610]).

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Recent Highlights

Nano-Pulse Stimulation (NPS) technology was highlighted in three clinical study presentations demonstrating its high clearance rates of benign skin lesions at the Annual Meeting of the American Society for Dermatologic Surgery.

Presented data from a study evaluating the clinical and histologic response of NPS technology in treating challenging cases of nodular Basal Cell Carcinoma at the International Master Course on Aging Skin World Congress.

Completed enrollment in the Company’s CellFX Warts Pivotal Study.

Obtained ISO-13485:2016 Quality System Management Certification to begin preparations for international commercialization of the CellFX System.

Appointed industry veteran Sandra Gardiner as Executive Vice President and Chief Financial Officer.

Announced Board approval to pursue a rights offering seeking to raise $30 million in net proceeds.

Following receipt of a Not Substantially Equivalent Letter from the U.S. Food and Drug Administration (FDA) on its previous 510(k) submission the Company remains engaged with the FDA to determine the regulatory path forward for the CellFX System. The Company recently requested a formal Q-submission meeting with FDA to discuss requirements for a new 510(k) submission and based on recent communication, expects the meeting to take place in May.

"I am proud of our continued work to develop NPS technology across multiple clinical applications. We’ve developed a novel and proprietary platform, the CellFX System, that implements a novel utilization-based business model to align incentives between physicians, patients and Pulse Biosciences. Our top priority remains FDA clearance for use of the CellFX System in aesthetic dermatology," said Darrin Uecker, President and CEO of Pulse Biosciences. "After recent developments and collaboration with FDA, we are refocused on generating and providing additional data that will support a new 510(k) submission for what we believe will be a general dermatologic indication. Our confidence in the technology continues to grow and we remain excited about the potential of our system."

Financial Update

Cash, cash equivalents and investments totaled $25.4 million as of December 31, 2019, compared to $34.5 million as of September 30, 2019. Cash used in the fourth quarter totaled $9.1 million. Cash use for the full year ended December 31, 2019 totaled $34.2 million.

Operating expenses for the three months ended December 31, 2019 were $13.9 million, compared to $9.1 million for the prior year period. Operating expenses for the full year ended December 31, 2019 were $48.0 million compared to $38.0 million for the full year ended December 31, 2018. The increase in operating expenses was driven by the expansion of operational infrastructure including marketing and sales functions as well as the expansion of the research and development teams and clinical trial costs.

Net loss for the fourth quarter ended December 31, 2019 was $13.8 million compared to $9.0 million for the fourth quarter ended December 31, 2018. Net loss for the full year ended December 31, 2019 was $47.0 million compared to $37.5 million for the full year ended December 31, 2018.

On March 16, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported fourth quarter and full year 2019 financial results (Press release, Oncternal Therapeutics, MAR 16, 2020, View Source [SID1234555609]).

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"We are very pleased with recent clinical results from our pipeline of novel cancer treatments for patients with critical unmet medical need," said James Breitmeyer, M.D., Ph.D., President and CEO, Oncternal. "We have seen encouraging results in all four of our clinical indications, including mantle cell lymphoma ("MCL"), Ewing sarcoma, breast cancer and chronic lymphocytic leukemia ("CLL"). We look forward to steadily advancing these programs in 2020 and expect to have multiple data updates throughout the year. Preclinical work is also identifying additional clinical targets for our existing product candidates and for our ROR1 CAR-T program."

Recent Highlights

In March 2020, we announced an interim clinical data update for cirmtuzumab, a ROR1-targeted monoclonal antibody, in combination with ibrutinib in patients with relapsed/refractory MCL enrolled in our ongoing Phase 1/2 clinical trial, including a 50% complete response ("CR") rate and an 83% best objective response (CR or partial response) rate ("ORR"). This CR rate improved meaningfully from our previously reported CR rate of 33%.

In February 2020, we presented ROR1 CAR-T preclinical data at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. ROR1 CAR-T cell therapy demonstrated expansion, persistence and anti-tumor activity in an animal model of human leukemia. This research is being conducted by our collaborators at the University of California San Diego (UC San Diego) under a grant from the California Institute of Regenerative Medicine ("CIRM").

In December 2019, we presented at the San Antonio Breast Cancer Symposium clinical data from an ongoing, investigator-sponsored Phase 1 clinical study of cirmtuzumab in combination with paclitaxel in patients with HER2-negative, metastatic or locally advanced unresectable breast cancer, including an ORR of 57%.

In December 2019, we opened for enrollment a Phase 1 expansion cohort of our ongoing clinical trial evaluating TK216, a first-in-class, targeted, investigational small-molecule inhibitor of the E26 transformation-specific ("ETS") family of oncoproteins, in patients with relapsed/refractory Ewing sarcoma.

In December 2019, we presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting a clinical data update from our ongoing Phase 1/2 clinical study of cirmtuzumab in combination with ibrutinib in patients with MCL or CLL, including a best ORR of 85% and progression-free survival of 100% in patients with CLL.

In November 2019, we presented at the Connective Tissue Oncology Society Annual Meeting interim clinical data from our ongoing Phase 1 clinical trial evaluating TK216 in patients with relapsed/refractory Ewing sarcoma, including a deep and sustained clinical response reported for a patient who received a TK216 dose regimen that was subsequently selected as a recommended Phase 2 dose.

In October 2019, we announced the opening of a Phase 1b expansion cohort of our clinical trial of cirmtuzumab in combination with ibrutinib in patients with MCL.

Expected Upcoming Milestones

Cirmtuzumab program

Clinical data update for patients with MCL, including for over 15 patients in the ongoing Phase 1/2 study – in mid-2020

Clinical data update for patients with CLL, including 12-month follow-up for 34 patients in the ongoing Phase 1/2 study – in mid-2020

Clinical data update for patients with HER2-negative breast cancer in the ongoing Phase 1b study – in the second half of 2020

IND-enabling data in additional indications – in mid-2020

TK216 program

Clinical data for 7-12 patients with Ewing sarcoma enrolled in the Phase 1 expansion cohort – in the second half of 2020

IND-enabling data in additional ETS-driven tumors – in the second half of 2020

ROR1 CAR-T program

First-in-human dosing in China – in the fourth quarter of 2020

Fourth Quarter and Full Year 2019 Financial Results

Our grant revenue was $0.7 million for the fourth quarter ended December 31, 2019. Our grant revenue is derived from a subaward under a grant from CIRM to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL. For the full year 2019, grant revenue was $2.4 million.

Our total operating expenses for the fourth quarter ended December 31, 2019 were $4.9 million. Research and development expenses for the quarter totaled $2.6 million, and general and administrative expenses for the quarter totaled $2.3 million. Net loss for the fourth quarter was $4.2 million, or a loss of $0.27 per share, basic and diluted. For the full year 2019, total operating expenses were $35.5 million, which included a one-time non-cash charge for acquired in-process research and development expenses of $18.1 million that was recorded in connection with the closing of our merger in June 2019. Net loss for the full year 2019 was $34.2 million, or a loss of $3.31 per share, basic and diluted.

As of December 31, 2019, we had $20.1 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into the third quarter of 2020. As of December 31, 2019, we had approximately 15.4 million shares of common stock outstanding.

Management Webcast

As previously announced, Oncternal will host a webcast today, March 16, 2020, at 4:30 p.m. ET (1:30 p.m. PT). The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On March 16, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the full year ended December 31, 2019 (Press release, Mustang Bio, MAR 16, 2020, View Source [SID1234555608]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are delighted by Mustang’s numerous accomplishments in 2019. We started off the year by executing a worldwide license agreement with Nationwide Children’s Hospital to develop MB-108, oncolytic virus C134, for the treatment of glioblastoma multiforme. In April, we announced the exciting New England Journal of Medicine publication of positive Phase 1/2 data from our partner, St. Jude Children’s Research Hospital ("St. Jude"), which demonstrated the curative potential of MB-107, a lentiviral gene therapy for X-linked severe combined immunodeficiency ("XSCID"), also known as bubble boy disease. We plan to transfer the MB-107 Investigational New Drug ("IND") application from St. Jude to Mustang shortly. In August, the FDA accepted our first IND application to initiate a multi-center Phase 1/2 clinical trial of MB-102 (CD123-targeted CAR T cell therapy) in acute myeloid leukemia ("AML"), blastic plasmacytoid dendritic cell neoplasm ("BPDCN") and high-risk myelodysplastic syndrome. We look forward to dosing our first patient soon, using MB-102 processed at our own cell processing facility."

Dr. Litchman continued, "In 2019, we were also pleased that the FDA granted prestigious designations to our drug candidates, including the Regenerative Medicine Advanced Therapy ("RMAT") designation to MB-107 and Orphan Drug Designations to MB-108 for the treatment of malignant glioma and to MB-102 for the treatment of AML. In addition, several Phase 1 trials were initiated with our collaborators during the year, including the MB-104 (CS1-targeted CAR T cell therapy) trial at City of Hope for multiple myeloma, the MB-105 (PSCA-targeted CAR T cell therapy) trial at City of Hope for the treatment of prostate cancer, the MB-103 (HER2-targeted CAR T cell therapy) trial at City of Hope for the treatment of glioblastoma multiforme and of HER2-positive breast cancer with brain metastases, the MB-101 (IL13Rα2-targeted CAR T cell therapy) trial at City of Hope in combination with checkpoint inhibitors for the treatment of recurrent malignant glioma, and the MB-108, oncolytic virus C134, trial for the treatment of glioblastoma multiforme at the University of Alabama at Birmingham."

Dr. Litchman concluded, "Mustang raised a total of $69 million throughout 2019, which enables us to continue to advance our gene and CAR T cell therapy programs. We look forward to maintaining this positive momentum through 2020, including several important data readouts anticipated in the second half of the year."

Financial Results:

·As of December 31, 2019, Mustang’s cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash totaled $62.4 million, compared to $73.3 million as of September 30, 2019, and $34.6 million as of December 31, 2018, a decrease of $10.9 million for the fourth quarter and an increase of $27.8 million year-to-date.
·Research and development expenses were $30.0 million for the year ended December 31, 2019. This compares to $21.1 million for 2018. Non-cash, stock-based compensation expenses included in research and development were $0.9 million for the year ended December 31, 2019, compared to $3.4 million for 2018.
·Research and development expenses from license acquisitions totaled $6.3 million for the year ended December 31, 2019, compared to $3.4 million for 2018. Non-cash, stock-based compensation expenses included in research and development – licenses acquired were $4.9 million for the year ended December 31, 2019, compared to $2.1 million for 2018.

·General and administrative expenses were $9.6 million for the year ended December 31, 2019. This compares to $6.8 million for 2018. Non-cash, stock-based compensation expenses included in general and administrative expenses were $3.4 million for the year ended December 31, 2019, compared to $1.5 million for 2018.
·Net loss attributable to common stockholders was $46.4 million, or $1.29 per share, for the year ended December 31, 2019, compared to a net loss attributable to common stockholders of $30.7 million, or $1.14 per share, for 2018.

2019 and Recent Corporate Highlights:

·In February 2019, Mustang announced that it entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital to develop oncolytic virus C134 (MB-108) for the treatment of glioblastoma multiforme. Mustang intends to combine the oncolytic virus with MB-101 (IL13Rα2-specific CAR T cell therapy) to potentially enhance efficacy in treating glioblastoma multiforme.
·In April 2019, Mustang announced that it had entered into a $20 million debt financing agreement with Horizon Technology Finance Corporation. Fifteen million of the $20 million loan was funded upon closing. The remaining $5 million may be funded upon Mustang’s achievement of certain predetermined milestones. In connection with the debt financing, Mustang issued Horizon warrants to purchase up to 288,184 shares of its common stock at an exercise price of $3.47 per share.
·Also in April 2019, the New England Journal of Medicine published St. Jude data from a Phase 1/2 clinical trial of MB-107, a lentiviral gene therapy, for the treatment of newly diagnosed infants under two years old with XSCID. Data demonstrated that the lentiviral gene therapy achieved normalization of T-cell numbers in all eight newly diagnosed infants to date and that disseminated infections resolved completely in all affected infants. Seven of the eight infants treated have developed normal IgM levels to date. Four of those seven infants have discontinued monthly infusions of intravenous immunoglobulin (IVIG) therapy to date. Three of those four infants who discontinued monthly IVIG infusions have responded to vaccines to date.
·In May 2019, Mustang completed an underwritten public offering, including the full exercise of the over-allotment option by the underwriters, that raised gross proceeds of $31.6 million, excluding underwriting discounts, commissions and other offering-related expenses.
·In May 2019, Mustang announced that City of Hope began enrolling patients with relapsed or treatment-resistant multiple myeloma in an innovative CS1-targeted CAR T cell therapy (MB-104) trial.
·Also in May 2019, the FDA granted Orphan Drug Designation to MB-108 (oncolytic virus C134) for the treatment of malignant glioma, a type of brain cancer with a median survival of less than 18 months.
·In July 2019, the FDA granted Orphan Drug Designation to MB-102 (CD123-targeted CAR T cell therapy) for the treatment of AML.
·In August 2019, Mustang announced that the FDA approved its IND application to initiate a multi-center Phase 1/2 clinical trial of MB-102 in AML, BPDCN and high-risk myelodysplastic syndrome.
·In August 2019, MB-107 was granted the RMAT designation by the FDA.
·Also in August 2019, Mustang entered into a license agreement with CSL Behring for the Cytegrity stable producer cell line, which will be used to produce the viral vector for the MB-107 lentiviral gene therapy program.
·Additionally in August 2019, the California Institute for Regenerative Medicine (CIRM) granted City of Hope $9.28 million to fund an ongoing Phase 1 clinical trial of MB-103 (HER2-targeted CAR T cell therapy) for the treatment of HER2-positive breast cancer with brain metastases.
·In September 2019, Mustang announced that City of Hope opened and initiated patient treatments in a Phase 1 clinical trial of MB-105 (PSCA-targeted CAR T cell therapy) for the treatment of prostate cancer.
·In October 2019, Mustang announced that City of Hope received $4.1 million in grant awards to initiate a clinical trial of MB-101 (IL13Rα2-targeted CAR T cell therapy) in combination with nivolumab (commercial name: Opdivo) and ipilimumab (commercial name: Yervoy) in patients with recurrent malignant glioma. The trial, which is now enrolling patients, is the first human study to combine IL13Rα2-targeted CAR T cell therapy with checkpoint inhibitors, as well as the first to locally deliver CAR T cells with combination treatment with systemic nivolumab treatment.

·Also in October 2019, Mustang announced that the first patient was dosed in a Phase 1 clinical trial to determine the safety and efficacy of MB-108 (oncolytic virus C134), an attenuated herpes simplex virus type 1, in recurrent glioblastoma multiforme.
·Updated Phase 1/2 clinical data for MB-107 were selected for oral and poster presentations at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting, which was held in December 2019. Data demonstrated that MB-107 preceded by low-dose busulfan conditioning continued to be well tolerated and resulted in the development of a functional immune system both in newly diagnosed infants with XSCID, as well as in older patients with XSCID who had received prior hematopoietic stem cell transplantation (HSCT). Also, the enhanced transduction procedure demonstrated more rapid recovery of NK cells and more rapid improvement in chronic norovirus infections vis-à-vis the original transduction procedure in older patients with XSCID who had received prior HSCT.
·Also at the 61st ASH (Free ASH Whitepaper) Annual Meeting, Mustang’s collaborator Fred Hutchinson Cancer Research Center ("Fred Hutch") presented a poster about the design of the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 (CD20-targeted CAR T cell therapy) for high-risk B-cell non-Hodgkin lymphomas.
·In February 2020, Mustang announced that the first subject treated with the optimized MB-106 (CD20-targeted, autologous CAR T cell therapy) manufacturing process, developed in collaboration between Mustang Bio and Fred Hutch, achieved a complete response at the lowest starting dose in an ongoing Phase 1/2 clinical trial. The trial is evaluating the safety and efficacy of MB-106 in subjects with relapsed or refractory B-cell non-Hodgkin lymphomas.

On March 16, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Leap Therapeutics, MAR 16, 2020, View Source [SID1234555606]).

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Leap Highlights:

·Entered into an exclusive option and licence agreement with BeiGene, Ltd. for the clinical development and commercialization of DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in Asia (excluding Japan), Australia, and New Zealand
·Completed a $27 million equity financing with BeiGene, Perceptive Advisors, and a lead institutional investor
·Presented final data from its Phase 1/2 clinical trial of DKN-01 plus Keytruda (pembrolizumab) in patients with advanced or recurrent esophagogastric cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Gastrointestinal Cancers Symposium
·Presented updated data from its Phase 2 clinical trial of DKN-01 as monotherapy and in combination with paclitaxel chemotherapy in patients with advanced gynecological malignancies at the 2019 International Gynecologic Cancer Society Annual Global Meeting and at the Society of Gynecologic Oncology 50th Annual Meeting on Women’s Cancer
·Announced investigator-initiated study of DKN-01 in patients with DKK1+ advanced prostate cancer
·Announced investigator-initiated study of DKN-01 plus Opdivo (nivolumab) in patients with advanced biliary tract cancer that is partially supported by Bristol-Myers Squibb
·Announced investigator-initiated study of DKN-01 plus Tecentriq (atezolizumab) in patients with advanced esophagogastric cancer that is funded by Roche

"We ended 2019 having made significant progress in the clinical development of DKN-01 as both a monotherapy and in combination with other therapies as a treatment for cancer. We’ve generated an abundance of data that continues to demonstrate DKN-01’s activity against multiple difficult-to-treat tumor types," said Christopher K. Mirabelli, Ph.D., President and Chief Executive Officer of Leap. "We’ve carried this momentum into the new year, having achieved our top corporate goal of securing a strategic partner for development of DKN-01 in the Asia-Pacific region. We look forward to working with BeiGene to bring DKN-01 to patients in this geographic area where the incidence of esophagogastric cancer is highly prevalent and to develop DKN-01 in combination with tizlelizumab, their anti-PD-1 antibody."

Business Update

·Leap and BeiGene Sign Exclusive Option and License Agreement for DKN-01 – Leap and BeiGene announced an exclusive option and license agreement for the clinical development and commercialization of DKN-01. Under the terms of the agreement, Leap will receive an upfront cash payment of $3 million from BeiGene in exchange for granting BeiGene an option to an exclusive license to develop and commercialize DKN-01 in Asia (excluding Japan), Australia, and New Zealand, and will be eligible to receive an additional payment from BeiGene upon BeiGene’s exercise of the option following initial proof-of-concept studies. Leap will retain exclusive rights for the development, manufacturing, and commercialization of DKN-01 for the rest of the world. Additionally, Leap is eligible to receive payments from BeiGene based upon the achievement of certain development, regulatory, and sales milestones for a total deal value of up to $132 million, together with tiered royalties on any product sales of DKN-01 in the licensed territory.

·Leap Completes $27 Million Equity Financing with BeiGene, Perceptive Advisors and another institutional investor – In connection with the licensing agreement with BeiGene, Leap has also entered into a securities purchase agreement to issue and sell in a private placement 1,421,801 shares of Series A mandatorily convertible preferred stock to a lead institutional investor and 1,137,442 shares of Series B mandatorily convertible preferred stock to BeiGene and Perceptive Advisors. On March 5, 2020, the Leap stockholders approved the conversion of the Series A preferred stock into a pre-funded warrant to purchase 14,413,902 shares of common stock and the conversion of the Series B preferred stock into 11,531,133 shares of common stock. Each investor also received a warrant to purchase an equal number of shares at an exercise price of $2.11 per share.

DKN-01 Clinical Update

DKN-01 is a humanized monoclonal antibody targeting the DKK1 protein, a Wnt pathway modulator. DKN-01, as a single agent, has achieved partial responses in three different cancer indications. In combination with immune checkpoint inhibitors and with chemotherapy, DKN-01 has achieved overall response rates and survival data that is greater than the historical benchmarks, particularly in biomarker targeted patient populations.

·ESOPHAGOGASTRIC CANCER (EGC): Leap completed a multi-part Phase 1/2 clinical study of DKN-01 as a monotherapy and in combination with paclitaxel or KEYTRUDA (pembrolizumab) in advanced EGC. Two DKN-01 monotherapy patients experienced partial responses (PRs) by central imaging assessment, one of whom had previously been treated with prior immunotherapies, including an anti-PD-L1 antibody, was on therapy for one year. Six additional monotherapy patients were determined to have had a best response of stable disease (SD). The combination of DKN-01 and pembrolizumab in gastroesophageal junction cancer (GEJ) and gastric cancer (GC) patients demonstrated improved outcomes in DKK1-high patients and who had not previously been treated with PD-1/PD-L1 therapy. DKK1-high patients experienced over 22 weeks median progression-free survival (PFS) and nearly 32 weeks overall survival (OS), with a 50% overall response rate (ORR) and 80% disease control rate (DCR) in ten evaluable patients. DKK1-low patients experienced nearly 6 weeks median PFS and over 17 weeks OS, with a 20% DCR in 15 evaluable patients.

As part of the collaboration with BeiGene, Leap plans to study the combination of DKN-01 and BeiGene’s anti-PD-1 antibody, tislelizumab and will evaluate approximately 40 DKK1-high patients with second-line GC or GEJ. In addition, Leap plans to evaluate the combination of DKN-01 with tislelizumab and chemotherapy in approximately 20 patients with first-line GC/GEJ. These clinical trials are expected to initiate in the first half of 2020.

·GYNECOLOGICAL CANCERS: The ongoing Phase 2 clinical study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers has recently completed patient enrollment. As of September 2019, twenty-two patients who had previously received one to ten lines of therapy have been enrolled to receive DKN-01 monotherapy. In the cohort of sixteen monotherapy patients with epithelial endometrial cancer with identified Wnt signaling mutations, one patient had a complete response and one patient had a partial response, seven patients had a best response of SD, and seven patients had progressive disease. Patient follow-up is continuing in this study, which has been expanded to include focused cohorts of patients with carcinosarcoma.

In light of the global emergency of the new coronavirus, COVID-19, the Society of Gynecologic Oncology will not conduct its 2020 Annual Meeting on Women’s Cancer, previously scheduled for March 28-31, 2020, in Toronto, Canada. Leap is currently awaiting additional information about the oral presentation that was to be made at the conference and evaluating other data presentation opportunities for the study in gynecologic cancers.

Selected Year-End and Fourth Quarter 2019 Financial Results

Net loss was $32.9 million for the year ended December 31, 2019, compared to $23.1 million for the year ended December 31, 2018. This increase was primarily due to increased research and development expenses and a change in warrant liability accounting.

Research and development expenses were $24.4 million for the full year 2019, compared to $21.8 million for the same period in 2018. This increase was primarily due to increased full-year clinical trial costs due to increased patient enrollment, payroll and stock-based compensation expense, offset by reduced manufacturing expenses of our clinical product candidates and consulting expenses. Research and development expenses were $5.7 million for the fourth quarter of 2019, compared to $6.9 million for the same period in 2018. This decrease was primarily due to reduced clinical trial costs in the fourth quarter of 2019 resulting from the maturing of our clinical trials and from lower manufacturing and consulting expenses.

General and administrative expenses were $9.1 million for the full year 2019, compared to $8.9 million for the same period in 2018. General and administrative expenses were $2.6 million for the fourth quarter of 2019, compared to $2.1 million for the same period in 2018. These increases were due to increases in performance-based and stock-based compensation expense.

Cash, cash equivalents and marketable securities totaled $3.9 million at December 31, 2019. Research and development incentive receivables totaled $0.2 million. Subsequent to the financial year end, Leap completed a $27.0 million private placement and received $3.0 million from the agreement with BeiGene.

On March 16, 2020 Helix BioPharma Corp. (TSX: "HBP"), a an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported its financial results for the fiscal second quarter ended January 31, 2020 (Press release, Helix BioPharma, MAR 16, 2020, View Source [SID1234555605]).

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OVERVIEW
The Company reported a consolidated net loss and total comprehensive loss, including non-controlling interest of $2,255,000 ($0.02 loss per common share) and $4,466,000 ($0.04 loss per common share), respectively for the three and six-month period ended January 31, 2020. For the three and six-month periods ended January 31, 2019, consolidated net loss and total comprehensive loss including non-controlling interest totalled $1,908,000 ($0.02 loss per common share) and $3,287,000 ($0.03 loss per common share), respectively.

To-date in fiscal 2020, the Company has raised gross proceeds totaling approximately $16,000,000 and as a result, no longer faces a working capital deficiency. In addition, the Company during the fiscal year, to-date has divested a 49% percent stake in its Polish subsidiary and is working on divesting the remaining 51% before the end of the Company’s fiscal 2020 year-end while retaining licensing agreements for future royalties and milestones payments.

The Company has also been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising additional capital to further advance the Company’s clinical development programs and to qualify for a NASDAQ listing.

Patient enrollment and screening commenced on the LDOS006 Phase Ib/II clinical study in the U.S. for the treatment of patients with previously treated advanced pancreatic cancer. Two patients have been enrolled to-date. The Phase Ib portion of the study involves three dose escalating cohorts enrolling a total of nine (9) patients. The Phase II portion of the study will enroll an additional eleven (11) patients depending on meeting safety and efficacy criteria. The Company’s other clinical studies for non-small cell lung cancer are in the following stages of development.

LDOS001 clinical study has completed enrollment and the Company is working on finalizing data for reporting while LDOS003 is in the last cohort of the study’s dose escalation phase. Research and development L-DOS47 research and development expenses for the three and six-month periods ended January 31, 2020 totalled $1,332,000 and $2,453,000, respectively (January 31, 2019-$788,000 and $1,649,000, respectively).

L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., the LDOS003 Phase II clinical study in Poland and the Ukraine and the Company’s newly approved LDOS006 Phase Ib/II clinical study in the U.S. The increase in L-DOS47 expenditures in Q2 fiscal 2020 when compared to Q2 fiscal 2019 reflects an increase of approximately $350,000 in L-DOS47 manufacturing activity to produce additional drug substance in addition to increased spend of approximately $295,000 in the Company’s newly launched pancreatic clinical study in the U.S.

The Company commenced enrollment in the new pancreatic clinical study in December 2019. For the six-month period ending Q2 2020 when compared to the six-moth period ended Q2 2019 the increase in spending mainly reflects the increase in cost associated with the commencement of the new pancreatic clinical trial in the U.S. Preclinical V-DOS47 research and development expenses for the three and six-month periods ended January 31, 2020 and 201 totalled $69,000 and $180,000, respectively (January 31, 2019-$102,000 and $232,000, respectively).

The Company’s wholly owned subsidiary in Poland has a grant funding agreement with the Polish National Centre for Research and Development ("PNCRD") for research and development expenditures associated with V-DOS47. In the three and sixmonth period ended January 31, 2020, the Company’s Polish subsidiary received grant funding of $132,000 and $159,000, respectively (January 31, 2019-$87,000 and $222,000, respectively), from the PNCRD. CAR-T research and development expenses for both the three and six-month periods ended January 31, 2020 totalled $nil, respectively (January 31, 2019-$333,000, respectively). The Company’s collaboration with ProMab Biotechnologies Inc. has been impacted by the Coronavirus pandemic and as such certain planned activities have been deferred. Trademark and patent related expenses for the three and six-month periods ended January 31, 2020 totalled $85,000 and $238,000, respectively (January 31, 2019-$43,000 and $68,000, respectively). The Company continues to ensure it adequately protects its intellectual property. Stock based compensation expense for the three and six-month periods ended January 31, 2020 totalled $40,000 and $79,000, respectively (January 31, 2019-$nil and $nil, respectively). The amount represents the expense associated with the vesting of stock options that were granted in May 2019, over their vesting period. Operating, general and administration Operating, general and administration expenses for the three and six-month periods ended January 31, 2020 totalled $654,000 and $1,363,000, respectively ($533,000 and $906,000 respectively for the three and six-month periods ended January 31, 2019). The increase is mainly the result of higher expenses associated with various third-party advisor services such as investor and media relations, legal, business development activities and investment banking services. The Company has been in discussion with various advisory groups as it pursues a listing on a recognized U.S. stock exchange, like the Nasdaq.

LIQUIDITY AND CAPITAL RESOURCES
The Company reported a consolidated net loss and total comprehensive loss including non-controlling interest of $2,255,000 for the three-month period ended January 31, 2020 (January 31, 2019-$1,908,000) and $4,466,000 for the six-month period ended January 31, 2020 (January 31, 2019-$3,287,000). As at January 31, 2020 the Company had working capital of $873,000, shareholders’ equity of $1,088,000 and a deficit of $175,938,000. As at July 31, 2019 the Company had a working capital deficiency of $3,534,000, shareholders’ deficiency of $3,281,000 and a deficit of $171,531,000.

The Company experienced a working capital deficiency for several fiscal quarters, until August 21, 2019 when the Company closed a private placement financing for gross proceeds of $7,000,005 which included a disposition of a 25% stake in the Company’s Polish subsidiary. Subsequent to the August 21, 2019 private placement and as of March 12, 2020, the Company raised an additional $9.000,000. To-date in fiscal 2020 the Company has raised a total of $16,000,000.

As previously disclosed, the Company intends to fully divest its remaining 51.0% interest in its Polish subsidiary to raise additional capital to further fund the Company’s clinical development programs for future royalties and milestone payments.

In addition, the Company has been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising additional capital to qualify the Company for a listing on a U.S. stock exchange such as NASDAQ in order to further advance the Company’s clinical development programs.

The Company’s cash reserves of $2,094,000 as at January 31, 2020 in addition to the subsequent private placement the Company closed on March 12, 2020 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, and nor are they sufficient to see planned research and development initiatives through to completion. Though the funds raised have materially assisted the Company in dealing with its working capital deficiency, additional funds are required to advance the Company’s clinical and preclinical programs and deal with working capital requirements To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its development needs. 4

The Company’s condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three and six-month periods ending January 31, 2020 and 2019 and the condensed unaudited interim consolidated statement of cash flows for the six-month periods ending January 31, 2020 and 2019 are summarized below:
Consolidated Statements of Net Loss and Comprehensive Loss Consolidated Statements of Cash Flows (thousand $, except for per share data) (thousand $) 2020 2019 2020 2019 2020 2019

The Company’s condensed unaudited interim consolidated financial statements and management’s discussion and analysis will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website.