On November 14, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX) reported financial results for the third quarter ended September 30, 2019 (Press release, Leap Therapeutics, NOV 14, 2019, View Source [SID1234551301]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The body of clinical data we presented in the third quarter for both DKN-01 monotherapy and combination treatment for cancer patients continues to demonstrate impressive activity. Patients with advanced gastroesophageal junction and gastric cancer whose tumors expressed high levels of DKK1 (DKK1-high) achieved higher survival and objective response outcomes to the combination of DKN-01 and KEYTRUDA," commented Christopher K. Mirabelli, Ph.D., President and Chief Executive Officer of Leap. "DKN-01 also showed durable benefit in patients with endometrial cancer with Wnt pathway alterations, including a monotherapy complete response, highlighting the potential utility of DKN-01 for biomarker-targeted patient populations."

Dr. Mirabelli continued: "We also completed enrollment in the dose escalation phase of our clinical trial evaluating TRX518 in combination with BAVENCIO and cyclophosphamide; however, we’ve made the strategic decision to deprioritize further development of TRX518 at this time in order to focus our resources on our more advanced DKN-01 program. The safety profile observed to date was acceptable, and patients who are benefiting from treatment in the TRX518 program will continue to be treated."

DKN-01 Development Program Update

·DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented data from the KEYNOTE-731 clinical study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. Study results demonstrated that patients with DKK1-high status had improved outcomes, including longer progression free survival (PFS) independent of PD-L1 Combined Positive Scores (CPS). In ten evaluable gastroesophageal junction and gastric cancer patients who had not received prior PD-1/PD-L1 therapy, 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). Fifteen evaluable DKK1-low patients experienced 5.9 weeks PFS and 17.4 weeks OS, with a 20% DCR. PD-L1 CPS did not predict efficacy to the combination of DKN-01 plus KEYTRUDA.

· DKN-01 in GYNECOLOGICAL CANCERS: The Company presented data from the ongoing clinical study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers at the International Gynecologic Cancer Society Annual Global Meeting held in September. In the cohort of sixteen evaluable monotherapy patients with epithelial endometrial cancer (EEC) with identified Wnt signaling mutations, patients had higher response rates and demonstrated longer PFS as compared to patients without Wnt signaling mutations. Specifically, one patient had a complete response and one patient had a partial response, representing a 12.5% single agent ORR, seven patients had a best response of stable disease, and seven patients had progressive disease. In the six evaluable monotherapy EEC patients who did not have any identified Wnt signaling mutations, none had clinical benefit. Patient follow-up is continuing in this study, which has been expanded to include focused cohorts of patients with carcinosarcoma.

·DKN-01 plus OPDIVO in BILIARY TRACT CANCER: The first patients have been dosed in an investigator-initiated clinical study to evaluate DKN-01 in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab) in previously treated patients with advanced biliary tract cancer. The study is being conducted by Massachusetts General Hospital and will enroll up to 36 biliary tract cancer patients who have progressed after one or more lines of systemic therapy for advanced biliary tract cancer. The primary endpoint of the study will be ORR, to be assessed in the overall population as well as in subgroups stratified by

tumor DKK1 and PD-L1 expression. Bristol-Myers Squibb is providing OPDIVO drug supply and partial funding for the study, with Leap providing DKN-01 drug supply as well as additional partial funding.

TRX518 Development Program Update

·FURTHER DEVELOPMENT OF TRX518 HAS BEEN DEPRIORITIZED: Leap has completed enrollment in dose escalation phase of the clinical trial evaluating TRX518 in combination with cyclophosphamide chemotherapy and BAVENCIO (avelumab). However, instead of pursuing additional enrollment through the expansion cohorts in this study as initially planned, the Company has decided to reprioritize resources on the further development of the DKN-01 program. There were no safety or efficacy concerns leading to this decision, and patients who are benefitting from the combination therapy will continue to be treated in the study.

Selected Third Quarter 2019 Financial Results

Net loss was $7.9 million for the third quarter 2019, compared to $6.6 million for the same period in 2018. This increase was primarily due to the recording of a $1.8 million gain in the third quarter 2018 as a result of a change in the fair value of the warrant liability, partially offset by a decrease in research and development expense.

Research and development expenses were $5.8 million for the third quarter 2019, compared to $6.5 million for the same period in 2018. This decrease was primarily due to a decrease of $0.4 million in clinical trial costs as a result of the timing of patient enrollment and a decrease of $0.3 million in manufacturing costs related to clinical trial material manufacturing campaigns.

General and administrative expenses were $2.2 million for the third quarter 2019, compared to $2.1 million for the same period in 2018. The increase was primarily due to a $0.1 million increase in stock based compensation as a result of new stock options granted to employees and directors in 2019.

Cash, cash equivalents and marketable securities totaled $10.1 million at September 30, 2019. Research and development incentive receivables, short term, totaled approximately $752,000 at September 30, 2019.

On November 14, 2019 X-37, LLC, an artificial intelligence-enabled drug discovery company, reported that it has closed a $14.5 million Series A financing (Press release, X-37, NOV 14, 2019, View Source [SID1234551317]). The funding round was led by DCVC Bio and was joined by Alpha Intelligence Capital and Hemi Ventures. The Series A funding will be used to expand the number of drug development programs at X-37 and to advance identified drug leads through laboratory and preclinical testing, with the goal of beginning human clinical trials by 2022. X-37’s development programs encompass novel therapeutics modulating important drug targets to address unmet clinical needs, including ZAP-70 for autoimmune disease, PIM3 and SHP2 for cancer, and Factor XIIa for anticoagulation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

X-37 was cofounded by Atomwise Inc. and a team of experienced pharmaceutical developers from Velocity Pharmaceutical Development. In addition to the above development programs, the team at X-37 will identify additional high-value drug targets, generate novel drug leads against these targets using Atomwise’s world-class AI platform for structure-based drug design, and develop each of these drug programs to a medically-relevant inflection point, where it can be acquired by or partnered with a major pharmaceutical company to be brought to market.

X-37 makes use of an LLC structure permitting each drug development program to be housed in a separate virtual company under the parent LLC. This structure is tax efficient and flexible, in that it allows X-37 to divest individual drug development programs, while maintaining the parent company and team. X-37 began operation in 2018 and has already generated promising novel hit molecules against several targets of high interest to the pharmaceutical industry.

"We are thrilled with the progress we have made to date and we are looking forward to moving a set of important new drugs into development," said David Collier, M.D., CEO and cofounder of X-37. "With this financing, we have the ability to progress multiple discovery and development programs. Our investors have been a huge help in the genesis of X-37, and we look forward to working closely with them going forward."

"X-37 represents an opportunity to bring new drugs to market very quickly, for challenging targets that have repeatedly stumped pharma and are in dire need of advancement," said Abraham Heifets, CEO and Founder of Atomwise, Inc. "We’re thrilled to work alongside industry veterans who have a track record of efficiently delivering drug after drug for the past 25 years."

"We are very pleased to be investors in X-37," said Kiersten Stead of DCVC Bio. "We have watched with great excitement as Atomwise has refined its deep neural network and chemistry expertise. We identified the team of drug developers at Velocity Pharmaceutical Development as ideal partners for Atomwise because of their experience in target selection and development of drug leads beyond the initial discovery stage. The progress of the combined teams at X-37 has been superb."

Following the financing, Kiersten Stead and Antoine Blondeau of Alpha Intelligence Capital joined the Board of Directors of X-37. The founding leadership team of X-37 is comprised of industry veterans and luminaries, including: David Collier, M.D., Matthew Kerby, Ph.D., PE, James Larrick, M.D., Ph.D., Andrew Perlman, M.D., Ph.D., Anie Roche, J.D., Ph.D., and Ed Schnipper, M.D., who together have brought 17 therapies to the market addressing an even greater number of indications.

About the Investors

DCVC Bio is a Silicon Valley venture capital fund focused on deep technology ventures that lie at the nexus of artificial intelligence (AI) and biotechnology. Alpha Intelligence Capital is a global venture capital fund investing in advanced AI technology-based companies. Hemi Ventures is an early stage venture capital fund investing in the rebels that commercialize nascent technologies to revolutionize industries.

On November 14, 2019 Milestone Pharmaceuticals Inc. (Nasdaq: MIST) reported that Joseph G. Oliveto, President and Chief Executive Officer, will present at the following investor conferences (Press release, Milestone Pharmaceuticals, NOV 14, 2019, View Source [SID1234551337]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 3:20 p.m. Greenwich Mean Time (10:20 a.m. Eastern Time)
The Piper Jaffray 31st Annual Healthcare Conference in New York on Wednesday, December 4, 2019 at 3:30 p.m. Eastern Time
A live webcast of each presentation can be accessed in the News & Events section of Milestone’s website at www.milestonepharma.com. An archived replay of each webcast will be available on the same website for approximately 30 days following the presentation.

On November 14, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the quarter ended September 30, 2019 (Press release, DelMar Pharmaceuticals, NOV 14, 2019, https://ir.delmarpharma.com/news/detail/919/delmar-pharmaceuticals-announces-fiscal-first-quarter-2020-financial-results-and-recent-corporate-updates [SID1234551240]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Following a productive quarter, we continue to believe that our cash position will provide the runway to enable us to achieve topline results for two of our three patient groups in our two Phase 2 trials. We are seeing encouraging progress and look forward to sharing our upcoming update of data from two poster presentations at the Society for Neuro-Oncology Annual Meeting," commented Saiid Zarrabian, DelMar’s President and Chief Executive Officer. "In the meantime, our relocation to San Diego offers the unique opportunity to access additional professionals to help advance our programs at the appropriate time. We look forward to providing updates to all of our programs soon."

RECENT CORPORATE UPDATES

November 2019 – Announced Key Opinion Leader GBM summit at the Society for Neuro-Oncology annual meeting November 22, 2019. This event will include four members of DelMar’s recently appointed Scientific Advisory Board
September 2019 – Moved corporate headquarters to San Diego, California
August 2019 – Closed an underwritten public offering with net proceeds of approximately $6.6 million
August 2019 – Provided update on Phase 2 clinical study on first line therapy in newly-diagnosed, MGMT-unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center. At the time of the update, nine patients were assessed as having achieved complete response, seven were assessed with stable disease, and one was assessed with disease progression
July 2019 – Enrolled first patient in adjuvant (pre-temozolomide maintenance) arm of Phase 2 open label study of VAL-083 being conducted at MD Anderson Cancer Center (MDACC)
July 2019 – Provided enrollment update of Phase 2 open label study of VAL-083 in recurrent GBM patients with MGMT-unmethylated status. As of this announcement, 56 of the planned 83 patients had been enrolled in the recurrent arm of the study being conducted at MDACC
SUMMARY OF FINANCIAL RESULTS FOR FISCAL QUARTER ENDED SEPTEMBER 30, 2019

At September 30, 2019, the Company had cash and cash equivalents on hand of approximately $8.1 million. In August 2019, the Company completed an underwritten public offering for net proceeds of approximately $6.6 million. The proceeds from the August 2019 financing combined with cash and cash equivalents on hand at June 30, 2019 are expected to be sufficient to fund the Company’s planned operations into the fourth quarter of calendar year 2020.

For the quarter ended September 30, 2019, the Company reported a net loss of approximately $1.6 million, or $0.21 per share, compared to a net loss of approximately $2.0 million, or $0.88 per share, for the same period of 2018.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company’s website at: View Source

On November 14, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Scott Wolchko, President and Chief Executive Officer, will present at the Jefferies 2019 London Healthcare Conference in London on Thursday, November 21, 2019, at 4:40 p.m. GMT (Press release, Fate Therapeutics, NOV 14, 2019, View Source [SID1234551285]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following the live webcast, an archived replay will be available on the Company’s website.