Arqule Inc (ARQL) 10-K Annual Report March 2019

For the quarter ended December 31, 2018, the Company reported a net loss of $8,487,000 or $0.08 per share, compared with net loss of $7,760,000 or $0.09 per share, for the quarter ended December 31, 2017. The Company reported a net loss of $15,482,000 or $0.16 per share, for the year ended December 31, 2018, compared with a net loss of $29,203,000 or $0.39 per share, for the year ended December 31, 2017.

As of December 31, 2018, the Company had a total of approximately $99,558,000 in cash, equivalents, and marketable securities.

Key Highlights from 2018

ARQ 531, our potent and reversible dual inhibitor of both wild-type and C481S-mutant BTK. Successfully progressed recruitment in our ongoing phase 1 dose escalation trial in 2018, enrolling over 20 patients at 7 dose cohorts ranging from 5mg to 65mg QD. Data from this trial was presented at 3 major conferences (AACR, EHA, ASH) in 2018 and demonstrated a good safety profile, profound target engagement and encouraging signs of dose-dependent clinical activity in both lymphomas and C481S-mutant CLL

Miransertib, our potent and selective first-generation AKT inhibitor. Presented first-of-its kind clinical data in Proteus syndrome and PROS at the American Society of Human Genetics (ASHG), received FDA Fast Track Designation in PROS, and worked with regulators to define registrational trial designs for both indications

ARQ 751, our highly potent and selective next-generation AKT inhibitor. Progressed the phase 1 basket trial in R/R or metastatic cancer patients harboring an AKT, PI3K or PTEN mutation, identified a recommended phase 2 dose of 75mg QD and presented data at the EORTC/AACR/NCI congress in November

Derazantinib, our FGFR inhibitor, partnered with Basilea and Sinovant, in a registrational trial for intrahepatic cholangiocarcinoma. Continued the timely recruitment and transfer of clinical and other responsibilities to Sinovant and Basilea following the outlicensing to both companies in February and April of last year, respectively

Capital Structure. Strengthened our capital structure through business development activities, which included funding from our collaborators and a successful offering of our common stock which raised gross proceeds of about $70 million

Stock Index Inclusions. Added to the family of Russell 2000 Index companies in June and the NASDAQ Biotechnology Index in December

The following information was filed by Arqule Inc (ARQL) on Thursday, March 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Arqule Inc's 10-K Annual Report:

Financial - Shares Highlight
Each share of Series A Preferred converted into 1,000 shares of common stock and each associated Warrant converted into 1,000 common stock warrants upon the effectiveness on May 8, 2018 of an amendment to our restated certificate of incorporation to increase the number of authorized shares of common stock thereunder.

Other - Other Highlight
Our net cash provided by financing activities of $15.4 million in the year ended December 31, 2016, was comprised of net proceeds from our February 2016 stock offering of $15.2 million and $0.2 million from stock option exercises and employee stock plan purchases.
Other - Other Highlight
Our inability to complete our programs in a timely manner or our failure to enter into appropriate collaborative agreements could significantly increase our capital requirements and could adversely impact our liquidity.
Revenue - Product Highlight
Under Topic 606 we: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation.
Financial - Expense Highlight
2017 as compared to 2016: The $0.6 million decrease in research and development expense in 2017 was primarily due to lower labor related costs of $0.6 million and professional fees of $0.2 million, partially offset by higher outsourced clinical and product development costs for our pipeline programs of $0.3 million.
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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Arqule Inc provided additional information to their SEC Filing as exhibits

Exhibit 3.1: Articles Of Incorporation

Exhibit 10.24: Material Contract

Exhibit 10.25: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32: Section 1350 Certification

Ticker: ARQL
CIK: 1019695
Form Type: 10-K Annual Report
Accession Number: 0001144204-19-012700
Submitted to the SEC: Thu Mar 07 2019 6:17:48 AM EST
Accepted by the SEC: Thu Mar 07 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations