On August 13, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, reported financial results for the quarter ended 30 June 2019 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, AUG 13, 2019, View Source [SID1234538833]).
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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "ASLAN made significant progress through the second quarter of this year, highlighted by our agreement with K-MASTER investigating varlitinib in metastatic gastric cancer patients, updated results from the ongoing clinical program studying ASLAN003 in AML, as well as results from our ASLAN004 single ascending dose study supporting differentiation versus other IL4/IL13 receptor inhibitors. Based on this exciting new data, we amended the agreement with CSL Limited to include full global rights to develop, manufacture, and commercialise this first in class therapeutic antibody for atopic dermatitis and other indications. Looking forward to the remainder of the year, we await topline data from our pivotal TreeTopp trial as second line treatment for biliary tract cancer, in the fourth quarter."
Second quarter 2019 and recent business highlights
Clinical development Varlitinib
Signed an agreement with the Korean Cancer Diagnosis & Treatment Enterprise (K-MASTER) to investigate varlitinib in a phase 1b/2 multi-centre umbrella study to evaluate the safety and efficacy of varlitinib in combination with weekly paclitaxel as a second-line treatment in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients. The open label, multi-centre study will recruit approximately 400 patients, divided between four experimental arms and a common control arm based on biomarker profiling.
ASLAN003
The first part of a phase 2 clinical trial with ASLAN003 in patients with advanced relapsed/refractory acute myeloid leukaemia (AML) was fully recruited and four doses of ASLAN003 (100mg QD, 200mg QD, 100mg BID and 200mg BID) have been tested as monotherapy. Significant reductions in peripheral blood blast cells of up to 98% and fast onset of blast cell reduction were observed in a number of patients. ASLAN003 has been well-tolerated in AML patients with only one patient out of 24 experiencing febrile neutropenia and tumor lysis syndrome, which were classified as drug-related serious adverse events. ASLAN is now evaluating next steps in the development of ASLAN003.
ASLAN004
Completed a single ascending dose (SAD) study testing ASLAN004 in healthy volunteers and announced the updated data from the second part of the study that tested a subcutaneous formulation of ASLAN004. The results from the single ascending dose study confirmed ASLAN004’s favourable tolerability profile, complete inhibition of downstream mediators and potential for monthly dosing.
Amended license agreement with CSL Limited (CSL) so that ASLAN has full global rights to develop, manufacture and commercialise ASLAN004 in all indications. The amended agreement replaces the licensing agreement ASLAN and CSL signed in May 2014. Under the terms of the amended agreement,
ASLAN will make a first payment of US$30 million to CSL upon commencement of a phase 3 study of ASLAN004. CSL is also eligible to receive up to US$95 million of regulatory milestones, US$655 million of sales milestones and tiered royalties on net sales between mid-single digits and 10%.
Corporate updates
Elected Andrew Howden as non-executive Chairman of the Board. Dr Carl Firth, who has held the positions of Chairman and CEO since founding the company in 2010, will continue to serve as CEO and as a Director. This planned separation of the Chairman and CEO roles was conducted to align to best corporate governance practices.
Anticipated upcoming milestones
Presentation of new phase 1 data for varlitinib in combination with mFOLFIRI chemotherapy in advanced solid tumours at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019 in late September.
Initiation of a multiple ascending dose trial for ASLAN004 in patients with moderate to severe atopic dermatitis in the second half of 2019.
Topline global pivotal trial (TreeTopp) data on varlitinib as second line treatment for biliary tract cancer in the fourth quarter of 2019.
Second quarter 2019 financial results
Cash used in operations for the quarter ended 30 June 2019 was US$6.5 million compared to US$10.0 million in the same period in 2018.
Research and development (R&D) expense was US$5.3 million and general and administrative (G&A) expense was US$1.9 million for the second quarter of 2019, compared to US$8.3 million and US$3.1 million, respectively, in the same period in 2018. The decrease in R&D expense was due to the completion of clinical studies and lower manufacturing expenses. The decrease in G&A expense in the period resulted from the restructuring implemented in January 2019.
Net loss for the second quarter of 2019 was US$7.9 million compared to a net loss of US$11.0 million for the second quarter of 2018.
Cash, cash equivalents and short-term investments totaled US$15.1 million as of 30 June 2019 compared to US$28.9 million as of 31 December 2018. Weighted average shares outstanding for the second quarter of 2019 was 160.2 million compared to 147.9 million for the second quarter of 2018. One American Depositary Share is the equivalent of five ordinary shares.