EX-99.1 2 artl_ex991.htm PRESS RELEASE artl_ex991.htm

EXHIBIT 99.1

 

 

ARTELO BIOSCIENCES REPORTS FIRST QUARTER FISCAL YEAR 2020

FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

 

LA JOLLA, CA – January 14, 2020 – Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that modulate the endocannabinoid system, today reported financial and operating results for the first quarter of its fiscal year ended November 30, 2019.

 

The Company continues to advance its clinical and pre-clinical pipeline which consists of three therapeutic candidates for cancer-related anorexia, cancer, and PTSD. During the quarter, the Company held a positive meeting with the U.K. Medicines and Healthcare Products Regulatory Agency on the initiation of a Phase 1b/2a study with ART27.13, successfully manufactured drug substance at scale, and increased its public profile. In particular, a pre-clinical study published in October 2019 demonstrated that the Company’s Fatty Acid Binding Protein 5 (FABP5) inhibitor can increase the cytotoxic and tumor suppressive effects in prostate cancer cells when coadministered with taxanes. “Artelo Biosciences is well positioned to reach a number of meaningful milestones in 2020, including the initiation of a clinical study with ART27.13 by mid-year,” stated Gregory D. Gorgas, Chief Executive Officer. “Given these and other developments, we plan to pursue strategic discussions with potential partners about each of our programs.”

  

First Quarter FY2020 Corporate Highlights

    

 

·Successfully manufactured drug substance material and selected a contract research organization for our upcoming Phase 1b/2a study of ART27.13 for the treatment of anorexia and weight loss associated with cancer.

 

 

 

 

·Concluded a productive meeting with The U.K. Medicines and Healthcare Products Regulatory Agency to discuss our upcoming Phase 1b/2a study of ART27.13.

 

 

 

 

·Published positive pre-clinical data on ART26.12, our FABP5 inhibitor program, under development in collaboration with The Research Foundation of the State University of New York Stony Brook, in The Prostate October 2019 issue. Study identified combinations of taxanes and FABP5 inhibitors which resulted in complete prostate cell death at lower concentrations when compared to docetaxel or cabazitaxel alone.

 

 

 

 

·Artelo conducted research studies featured in the Nature Medicine September 2019 issue. Nature Medicine recognized the importance the Company’s research findings and highlighted the scarcity of data on CBD as well the limited availability of quality clinical research identifying the dose of CBD useful to treat certain diseases and conditions.

 

 

 

 

·Presented the Company at multiple, well-attended investment conferences in New York and London.
   

 
 
 
 

 

Financial Highlights

 

 

·Operating expenses for the three months ended November 30, 2019 were $1,336,448 compared to $556,903 for the same period in 2018. The Company’s operating expenses were primarily related to ongoing regulatory filing requirements, research and development contracts and general and administrative expenses.

 

 

 

 

·Net loss was approximately $1,306,361, or $0.39 per basic and $0.40 per diluted share for the quarter ended November 30, 2019 compared to a net loss of $556,903, or $0.32 per basic and diluted share for the quarter ended November 30, 2018. Net loss for the first quarter ended November 30, 2019 included a gain of $29,501 related to the change in the fair value of derivative liabilities. As of November 30, 2019, derivative liabilities amount to $0.

 

 

 

 

·As of November 30, 2019, the Company had approximately $3,374,683 in cash, compared to $4,423,965 as of August 31, 2019.

 

About Artelo Biosciences

 

Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics targeting the endocannabinoid system and related pathways. Artelo is rapidly advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio.

 

Forward Looking Statements

 

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

 

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws.

 

Investor Relations Contact:

Crescendo Communications, LLC

Tel: 212-671-1020

Email: ARTL@crescendo-ir.com

 

 
 
 
 

 

ARTELO BIOSCIENCES, INC.

Consolidated Balance Sheets

(Unaudited)

 

 

 

November 30,

 

 

August 31,

 

 

 

2019

 

 

2019

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

Cash and cash equivalents

 

$3,374,683

 

 

$4,423,965

 

Prepaid expenses

 

 

86,133

 

 

 

8,336

 

Deposits

 

 

1,500

 

 

 

1,500

 

Other receivable

 

 

45,587

 

 

 

8,787

 

Total Current Assets

 

 

3,507,903

 

 

 

4,442,588

 

Equipment, net of accumulated depreciation of $886 and $792, respectively

 

 

598

 

 

 

721

 

Intangible asset

 

 

2,039,417

 

 

 

2,039,417

 

TOTAL ASSETS

 

 

5,547,918

 

 

 

6,482,726

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$574,530

 

 

$348,863

 

Due to related parties

 

 

10,024

 

 

 

3,732

 

Derivative liability

 

 

-

 

 

 

29,501

 

Stock payable

 

 

-

 

 

 

639,417

 

Total Current Liabilities

 

 

584,554

 

 

 

1,021,513

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Preferred Stock, par value $0.001, 6,250,000 shares authorized, 0 and 0 shares issued and outstanding, respectively

 

 

-

 

 

 

-

 

Common Stock, par value $0.001, 18,750,000 shares authorized, 3,426,276 and 3,353,616 shares issued and outstanding, respectively

 

 

3,426

 

 

 

3,354

 

Additional paid-in capital

 

 

11,070,517

 

 

 

10,278,421

 

Accumulated deficit

 

 

(6,117,117)

 

 

(4,810,756)

Accumulated other comprehensive loss

 

 

6,538

 

 

 

(9,806)

Total Stockholders’ Equity

 

 

4,963,364

 

 

 

5,461,213

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUIITY

 

$5,547,918

 

 

$6,482,726

 

   

 
 
 
 

 

ARTELO BIOSCIENCES, INC.

Consolidated Statements of Operations

(Unaudited)

 

 

 

Three months ended

 

 

 

November 30,

 

 

 

2019

 

 

2018

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

General and administrative

 

$403,159

 

 

$205,501

 

Professional fees

 

 

266,227

 

 

 

167,293

 

Research and development

 

 

666,938

 

 

 

184,039

 

Depreciation

 

 

124

 

 

 

70

 

Total Operating Expenses

 

 

1,336,448

 

 

 

556,903

 

 

 

 

 

 

 

 

 

 

Loss from Operations

 

 

(1,336,448)

 

 

(556,903)

 

 

 

 

 

 

 

 

 

OTHER INCOME (EXPENSE)

 

 

 

 

 

 

 

 

Other income

 

 

586

 

 

 

-

 

Change in fair value of derivative liabilities

 

 

29,501

 

 

 

-

 

Total other income

 

 

30,087

 

 

 

-

 

NET LOSS

 

 

(1,306,361)

 

$(556,903)

OTHER COMPREHENSIVE INCOME (LOSS)

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

16,344

 

 

 

4,888

 

Total Other Comprehensive Income (Loss)

 

 

16,344

 

 

 

4,888

 

TOTAL COMPREHENSIVE LOSS

 

$(1,290,017)

 

$(552,015)

Basic Loss per Common Share

 

$(0.39)

 

$(0.32)

Diluted Loss per Common Share

 

$(0.40)

 

$(0.32)

 

 

 

 

 

 

 

 

 

Basic Weighted Average Common Shares Outstanding

 

 

3,361,601

 

 

 

1,754,494

 

Diluted Weighted Average Common Shares Outstanding

 

 

3,379,000

 

 

 

1,754,494

 

  

 
 
 
 

 

ARTELO BIOSCIENCES, INC.

Consolidated Statements of Stockholders’ Equity (Deficit)

(Unaudited)

 

 

 

 

 

 

Additional

 

 

 

 

 

Accumulated

Other

 

 

 

 

 

 

Common stock

 

 

paid-in

 

 

Accumulated

 

 

Comprehensive

 

 

 

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Deficit

 

 

Income (loss)

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, August 31, 2019

 

 

3,353,616

 

 

$3,354

 

 

$10,278,421

 

 

$(4,810,756)

 

$(9,806)

 

$5,461,213

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issuance costs

 

 

-

 

 

 

-

 

 

 

(15,151)

 

 

-

 

 

 

-

 

 

 

(15,151)

Common shares issued for services - officers

 

 

-

 

 

 

-

 

 

 

13,000

 

 

 

-

 

 

 

-

 

 

 

13,000

 

Common shares issued for acquisition of license

 

 

61,297

 

 

 

61

 

 

 

539,356

 

 

 

-

 

 

 

-

 

 

 

539,417

 

Common shares issued for settlement of debt

 

 

11,363

 

 

 

11

 

 

 

99,989

 

 

 

-

 

 

 

-

 

 

 

100,000

 

Refund for fractional stock

 

 

-

 

 

 

-

 

 

 

(117)

 

 

-

 

 

 

-

 

 

 

(117)

Stock option expense

 

 

-

 

 

 

-

 

 

 

155,019

 

 

 

-

 

 

 

-

 

 

 

155,019

 

Net loss for the period

 

 

 

 

 

 

-

 

 

 

 

 

 

 

(1,306,361)

 

 

-

 

 

 

(1,306,361)

Foreign currency translation adjustments

 

 

 

 

 

 

-

 

 

 

 

 

 

 

-

 

 

 

16,344

 

 

 

16,344

 

Balance, November 30, 2019

 

 

3,426,276

 

 

 

3,426

 

 

 

11,070,517

 

 

 

(6,117,117)

 

 

6,538

 

 

 

4,963,364

 

 

 

 

 

 

Additional

 

 

 

 

Accumulated

Other

 

 

 

 

 

Common stock

 

 

paid-in

 

 

Accumulated

 

 

Comprehensive

 

 

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Deficit

 

 

Income (loss)

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, August 31, 2018

 

 

1,750,268

 

 

$1,750

 

 

$2,514,136

 

 

$(2,638,580)

 

$(12,280)

 

$(134,974)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common shares issued for cash

 

 

29,300

 

 

 

29

 

 

 

170,745

 

 

 

-

 

 

 

-

 

 

 

170,774

 

Common shares issued for services - officers

 

 

 

 

 

 

-

 

 

 

13,000

 

 

 

-

 

 

 

-

 

 

 

13,000

 

Stock option granted for services

 

 

 

 

 

 

-

 

 

 

28,051

 

 

 

-

 

 

 

-

 

 

 

28,051

 

Net loss for the period

 

 

 

 

 

 

-

 

 

 

 

 

 

 

(556,903)

 

 

-

 

 

 

(556,903)

Foreign currency translation adjustments

 

 

 

 

 

 

-

 

 

 

 

 

 

 

-

 

 

 

4,888

 

 

 

4,888

 

Balance, November 30, 2018

 

 

1,779,568

 

 

 

1,779

 

 

 

2,725,932

 

 

 

(3,195,483)

 

 

(7,392)

 

 

(475,164)

 

 
 
 
 

 

ARTELO BIOSCIENCES, INC.

Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Three months ended

 

 

 

November 30,

 

 

 

2019

 

 

2018

 

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

Net loss

 

$(1,306,361)

 

$(556,903)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Stock based compensation

 

 

168,019

 

 

 

41,051

 

Depreciation

 

 

124

 

 

 

70

 

Change in fair value of derivative liabilities

 

 

(29,501)

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses

 

 

(77,797)

 

 

(9,462)

Other receivable

 

 

(36,800)

 

 

18,665

 

Accounts payable and accrued liabilities

 

 

230,667

 

 

 

105,427

 

Net cash used in operating activities

 

 

(1,051,649)

 

 

(401,152)

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

Issuance of common shares for cash

 

 

-

 

 

 

170,774

 

Common stock issuance costs

 

 

(15,151)

 

 

-

 

Refund for fractional stock

 

 

(117)

 

 

-

 

Advance from related parties

 

 

4,334

 

 

 

3,686

 

Repayments to related parties

 

 

(3,040)

 

 

(558)

Net cash provided by financing activities

 

 

(13,974)

 

 

173,902

 

 

 

 

 

 

 

 

 

 

Effects on changes in foreign exchange rate

 

 

16,341

 

 

 

4,900

 

 

 

 

 

 

 

 

 

 

Net decrease in cash and cash equivalents

 

 

(1,049,282)

 

 

(222,350)

Cash and cash equivalents - beginning of period

 

 

4,423,965

 

 

 

337,424

 

Cash and cash equivalents - end of period

 

$3,374,683

 

 

$115,074

 

 

 

 

 

 

 

 

 

 

Supplemental Cash Flow

 

 

 

 

 

 

 

 

Cash paid for interest

 

$-

 

 

$-

 

Cash paid for income taxes

 

$-

 

 

$-

 

 

 

 

 

 

 

 

 

 

Non-cash financing and investing activities:

 

 

 

 

 

 

 

 

Common shares issued for acquisition of license offset against stock payable

 

$539,417

 

 

 

 

 

Common shares issued for settlement of stock payable

 

$100,000

 

 

$-