Market Newsdesk

November 12, 2020 7:03 am

BELLUS Health Reports Third Quarter 2020 Financial Results and Business Highlights

BELLUS Health Reports Third Quarter 2020 Financial Results and Business Highlights

– Following a recent FDA meeting, the Phase 2bSOOTHE trial in refractory chronic cough patients remains on track to initiate in Q4 2020 –

– The Phase 2 BLUEPRINT trial in chronic pruritus associated with atopic dermatitis remains on track to initiate in Q4 2020 –

– Recently completed $40M offering of shares provides extended cash runway to end of 2022 –

LAVAL, Quebec–(BUSINESS WIRE)–
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today reported its financial and operating results for the third quarter ended September 30, 2020.

“We are pleased with the progress we have made over the last few months, completing key steps required to advance our development plans for BLU-5937,” said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. “Back in September, we announced the trial design of our Phase 2b SOOTHE trial for the treatment of refractory chronic cough, refining our clinical strategy for BLU-5937 based on learnings from the Phase 2 RELIEF trial. Following a meeting with the FDA this month, we remain on track to initiate the SOOTHE trial in the fourth quarter of 2020. In addition, we continue to believe that BLU-5937’s mechanism may have broad applicability as a potential treatment for many additional hypersensitization-related conditions, and are looking forward to initiating the Phase 2 BLUEPRINT trial in patients with chronic pruritus associated with atopic dermatitis also in the fourth quarter of 2020.”

Mr. Bellini added, “Following our recent offering of our common shares in October, we believe that BELLUS Health is well-positioned financially to deliver on our important upcoming milestones.”

PROGRAM AND CORPORATE HIGHLIGHTS

Completed a US$40.3 million offering.

In October 2020, BELLUS Health completed an offering of its common shares, resulting in gross proceeds to the Company of US$40.3 million.
The Company’s cash, cash equivalent and short-term investments as of September 30, 2020, together with the net proceeds of the October offering (after deducting underwriting discounts and commissions and estimated offering expenses), amounted to US$107 million.

Expects to initiate the Phase 2b SOOTHE clinical trial of BLU-5937 enriched for higher cough count patients in the fourth quarter of 2020.

Following a Type C meeting with the U.S. Food and Drug Administration (“FDA”) on November 6^th, the Company is proceeding with its planned Phase SOOTHE 2b trial in patients with refractory chronic cough (“RCC”). The trial design was announced in September 2020.
Topline results from the SOOTHE trial are expected in the second half of 2021.

Announced topline results from the Phase 2 RELIEF clinical trial of BLU-5937 in patients with RCC in July 2020.

On track to initiate the Phase 2 BLUEPRINT clinical trial of BLU-5937 in patients with chronic pruritus associated with atopic dermatitis (“AD”) in the fourth quarter of 2020.

Topline results from BLUEPRINT, a Phase 2 proof-of-concept clinical trial evaluating the efficacy and safety of BLU-5937 in chronic pruritus associated with AD, are expected in 2021.

FINANCIAL RESULTS

Cash Position: As of September 30, 2020, the Company had available cash, cash equivalents and short-term investments totaling US$70.0 million, compared to US$90.0 million at December 31, 2019. The Company’s cash position as of September 30, 2020, together with the net proceeds of the October offering (after deducting underwriting discounts and commissions and estimated offering expenses), amounted to US$107 million.

Net Loss: For the third quarter ended September 30, 2020, net loss amounted to US$5.7 million (US$0.09 per share), compared to US$6.5 million (US$0.14 per share) for the same period in 2019.

Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to US$5.8 million for the third quarter ended September 30, 2020, compared to US$5.6 million for the same period in 2019. The Company expects these expenses to continue to increase in subsequent quarters as it pursues the development of BLU-5937, for which it plans to initiate in the fourth quarter of 2020 two clinical trials, SOOTHE, a Phase 2b trial in RCC, and BLUEPRINT, a Phase 2 trial in chronic pruritus associated with AD.

General and Administrative Expenses: General and administrative expenses amounted to US$0.5 million for the third quarter ended September 30, 2020, compared to US$1.7 million for the same period in 2019. The decrease is mainly due to a stock-based compensation net recovery related to the Company’s liability classified deferred share unit plan due to BELLUS Health’s stock price decrease in July 2020.

Net Finance Income: Net finance income amounted to US$0.5 million for the third quarter ended September 30, 2020, compared to US$0.7 million for the same period in 2019. The decrease is mainly attributable to a lower foreign exchange gain that arose from the translation of the Company’s net monetary assets denominated in Canadian dollars during the quarter.

The Company’s full unaudited condensed consolidated interim financial statements and accompanying management’s discussion and analysis for the three and nine-month periods ended September 30, 2020 will be available shortly on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

About BLU-5937

BLU-5937, a highly selective P2X3 antagonist – (>1500 fold) – is in development for chronic cough, chronic pruritus and other hypersensitization-related disorders.

The P2X3 receptor in the cough reflex pathway, which is implicated in chronic cough, is a rational target for treating chronic cough, and it has been evaluated in multiple clinical trials with different P2X3 antagonists. The Company believes that its highly selective P2X3 antagonist has the potential to reduce coughing in patients with chronic cough while limiting impact on taste function.

In addition to chronic cough and chronic pruritus, BLU-5937 may also have broad applicability across other afferent hypersensitization-related disorders, enabling the Company to consider developing a pipeline of therapies using its P2X3 platform. BELLUS Health is exploring how P2X3 activation can contribute to irritation and pain, and whether inhibition of P2X3 receptors can help treat these afferent hypersensitization-related disorders.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders. The Company’s product candidate, BLU-5937, is being developed for the treatment of chronic cough and chronic pruritus.

Chronic cough, the lead indication for BLU-5937, is a cough lasting more than eight weeks and is associated with significant adverse physical, social and psychosocial effects on health and quality of life. It is estimated that approximately 26 million adults in the United States suffer from chronic cough with approximately 3 million having refractory chronic cough lasting for more than a year and approximately 6 million having refractory chronic cough lasting more than 8 weeks and under one year. There is no specific therapy approved for refractory chronic cough and current treatment options are limited.

Chronic pruritus, commonly known as chronic itch, is an irritating sensation that leads to scratching, and persists for longer than six weeks, which can be debilitating and has a significant impact on quality-of-life. It is a hallmark of many dermatologic disorders, including AD. It is estimated that chronic pruritus associated with AD affects more than 16.9 million adults in the United States.

Forward-Looking Statements

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute “forward-looking statements” within the meaning of Canadian securities legislation and regulations, the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as “expects,” “anticipates,” “believes,” “intends,” “estimates,” “potential,” “possible,” “projects,” “plans,” and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health’s control. Such statements include, but are not limited to, the potential of BLU-5937 to successfully treat chronic cough, chronic pruritus and other hypersensitization-related disorders, BELLUS Health’s expectations related to its preclinical studies and clinical trials, including the design and timing of its Phase 2b clinical trial of BLU-5937 in refractory chronic cough and its Phase 2 clinical trial of BLU-5937 in chronic pruritus associated with AD, including the timing and outcome of interactions with regulatory agencies, the potential activity and tolerability profile, selectivity, potency and other characteristics of BLU-5937, including as compared to other competitor candidates, the commercial potential of BLU-5937, including with respect to patient population, pricing and labeling, BELLUS Health’s financial position, and the potential applicability of BLU-5937 and BELLUS Health’s P2X3 platform to treat other disorders. Risk factors that may affect BELLUS Health’s future results include but are not limited to: the benefits and impact on label of its enrichment strategy, estimates and projections regarding the size and opportunity of the addressable refractory chronic cough market for BLU-5937, the ability to expand and develop its project pipeline, the ability to obtain adequate financing, the ability of BELLUS Health to maintain its rights to intellectual property and obtain adequate protection of future products through such intellectual property, the impact of general economic conditions, general conditions in the pharmaceutical industry, the impact of the COVID-19 pandemic on BELLUS Health’s operations, plans and prospects, including to the initiation and completion of clinical trials in a timely manner or at all, changes in the regulatory environment in the jurisdictions in which BELLUS Health does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights , achievement of forecasted preclinical study and clinical trial milestones, reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937 and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health’s product candidate’s development process and its market size and commercial value are dependent upon a number of factors. Moreover, BELLUS Health’s growth and future prospects are mainly dependent on the successful development, patient tolerability, regulatory approval, commercialization and market acceptance of its product candidate BLU-5937 and other products. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health’s public filings with the Canadian securities regulatory authorities, including, but not limited to, its Annual Information Form, and the United States Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 40-F, for further risk factors that might affect BELLUS Health and its business.

SUMMARY OF FINANCIAL RESULTS

	Three months ended September 30, 2020		Three months ended September 30, 2019
	(in thousands of dollars, except per share data)
Revenues	US$	3	US$	7
Research and development expenses, net		(5,796)		(5,600)
General and administrative expenses		(456)		(1,666)
Net finance income		540		739
Net loss for the period	US$	(5,709)	US$	(6,520)
Basic and diluted loss per share	US$	(0.09)	US$	(0.14)

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005341/en/

Danny Matthews

Director, Investor Relations and Communications

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Health Managed Care Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

Logo

November 12, 2020 7:03 am

BIONIK Laboratories Announces Fiscal 2021 Q2 Financial Results

BIONIK Laboratories Announces Fiscal 2021 Q2 Financial Results

TORONTO & BOSTON–(BUSINESS WIRE)–BIONIK Laboratories Corp.(OTCQB: BNKL), a robotics company focused on providing rehabilitation and assistive technology solutions to individuals with neurological and mobility challenges from hospital to home, today announced financial results for its second quarter of fiscal year 2021, ending September 30, 2020.

Financial highlights for the second quarter of fiscal 2021 and recent weeks include:

● Reported sales have increased by 3.8%, compared to the prior-year quarter.

● Gross margins for the quarter were $222,334 or 76% on the sale of InMotion robots, Connect and Pulse, compared to $198,484 or 70% in the prior-year quarter.

● An existing robotic device customer purchased and subscribed to InMotion Connect™ and deployed the service in 22 of its hospitals across 13 states.

● During the COVID-19 pandemic, the Company continued to ship InMotion robots to customers in the U.S.

Corporate highlights for the second quarter of fiscal 2021 and recent weeks include:

● Following its launch on June 25, 2020, the Company deployed InMotion Connect™, a cloud-based data analytics solution, which combines real-time robot data with deep expertise of BIONIK’s clinical specialists to partner with each clinic, promoting robot utilization, supporting clinician engagement, and enhancing patient care by providing contextual and relevant data to reach hospital clinicians and management teams when it matters the most. The Company continues to customize the solution by developing new functionalities including smart actions to improve the decision process.

● In October 2020, the Company placed an InMotion Connect™ solution at another strategic account, for evaluation and possible sales across that account’s hospital network.

Management Commentary

Commenting on the quarter, Dr. Eric Dusseux, BIONIK’s Chief Executive Officer, said, “Following the launch of InMotion Connect™, we are seeing good traction in targeting the critical needs around improving technology adoption and utilization at each rehabilitation clinic we serve. Through this new platform, we can ensure that the state-of-the-art rehabilitation methods are effectively in use across the hospital networks. We sold and deployed, during the second quarter of fiscal year 2021, InMotion Connect™ solutions within 22 hospitals across 13 states in the U.S. and look forward to our customers’ continued and long-term use of the many solutions InMotion Connect™ offers. We have already seen the impact at many of our client sites, showing the benefit and ROI to our customers, the clinicians, the hospital management and the headquarter teams. Feedback received to-date suggests that these teams are seeing improved performance and most importantly, are now more confident in the process to increase their internal objectives and are moving to share transparently the metrics for these newly increased targets within their organization. Our R&D team is focused on continuing its work to improve the InMotion Connect™ solution, expanding the functionalities and including smart actions to better support the decision making and management process at our client’s sites. With the COVID-19 pandemic, we are continuing to operate under a modified plan to reduce costs and otherwise address the effects on our business caused by COVID-19.”

BIONIK continues to expect to achieve the following milestones during fiscal year 2021:

● Continue to expand sales channels in North America and abroad.

● Further develop InMotion Connect™ solutions to serve clinical rehabilitation providers.

● Work with our commercial outsourced manufacturing partner to enhance effectiveness in order to support the expected increase in product demand and introduction of new products.

● Increase sales of data solutions, service contracts and warranties.

Financial Results:

Sales for quarter ended September 30, 2020 were $292,381, compared with $281,691 for the quarter ended September 30, 2019. The increase reflects the sale of one InMotion robot sold during the COVID-19 pandemic quarter ended September 30, 2020 compared to two InMotion robots in the prior-year quarter, and 22 InMotion Connect™ solutions, including hardware and subscriptions, following the InMotion Connect™ launch at the end of June 2020. In addition, deferred revenue, comprised of training to be provided and extended warranties, decreased to $526,250 at September 30, 2020 from $616,063 at March 31, 2020. The Company believes that extended warranties and training are important to growing parts of its business.

Gross margin for the quarter ended September 30, 2020 was $222,334, or 76%, on the sale of InMotion robots, Connect and Pulse, compared to $198,484, or 70%, for the quarter ended September 30, 2019.

The Company reported a comprehensive loss for the quarter ended September 30, 2020 of $(1,627,622), or a loss per share of $(0.32), compared with a comprehensive loss of $(3,382,684), or a loss per share of $(0.87), for the quarter ended September 30, 2019. The decrease in the loss is due to a reduction of employees by 30% between March 31, 2020 and September 30, 2020 primarily due to completion of engineering projects connected with the development of InMotion Connect™. BIONIK had cash and cash equivalents of $1,350,627 as of September 30, 2020, compared to $2,269,747 as of March 31, 2020. The Company’s working capital deficit at September 30, 2020 was $2,306,282 compared to a working capital surplus of $626,923 as of March 31, 2020. The working capital deficit at September 30, 2019 is due to convertible loans received by the Company during the six months being recorded as current liabilities rather than in equity when the loans are converted.

About BIONIK Laboratories Corp.

BIONIK Laboratories is a robotics company focused on providing rehabilitation and mobility solutions to individuals with neurological and mobility challenges from hospital to home. The Company has a portfolio of products focused on upper and lower extremity rehabilitation for stroke and other mobility-impaired patients, including three products on the market and two products in varying stages of development.

For more information, please visit www.BIONIKlabs.com and connect with us on Twitter, LinkedIn, and Facebook.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “should,” “would,” “will,” “could,” “scheduled,” “expect,” “anticipate,” “estimate,” “possible,” “believe,” “intend,” “seek,” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of robotic rehabilitation products and other Company products, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, pipeline of potential sales, capital structure or other financial items, (iii) the Company’s future financial performance, (iv) the market and projected market for our existing and planned products and (v) the assumptions underlying or relating to any statement described in points (i), (ii), (iii) or (iv) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances, and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions, and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the inability to meet listing standards to uplist to a national stock exchange, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the impact on the Company’s business as a result of the Covid-19 pandemic, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, volatility in the price of the Company’s raw materials, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company does not undertake to update these forward-looking statements.

Bionik Laboratories Corp. Condensed Consolidated Interim Balance Sheets (unaudited) (Amounts expressed in US Dollars)
	As at			As at
	September 30, 2020			March 31, 2020
	$			$ (Audited)
Assets
Current
Cash and cash equivalents		1,350,627			2,269,747
Accounts receivable		657,615			846,964
Prepaid expenses and other receivables		1,671,298			1,632,555
Inventories		890,321			1,059,462
Due from related parties		19,151			17,840
Total Current Assets		4,589,012			5,826,568
Equipment		119,913			154,144
Technology and other assets		1,402,916			1,449,924
Goodwill		11,085,984			11,085,984
Total Assets		17,197,825			18,516,620

Liabilities and Shareholders’ Equity
Current
Accounts Payable		529,618			857,093
Accrued liabilities		1,616,625			1,647,656
PPP Loan		459,912			–
Convertible Loans		3,762,889			2,078,833
Deferred revenue – Contract Liabilities		526,250			616,063
Total Current Liabilities		6,895,294			5,199,645
Shareholders’ Equity
Preferred Stock, par value $0.001; Authorized 10,000,000 (March 31, 2020 – 10,000,000) Special Voting Preferred Stock, par value $0.001; Authorized; Issued and outstanding – 1 (March 31, 2020 – 1)		–			–
Common Shares, par value $0.001; Authorized – 500,000,000; (March 31, 2020 – 500,000,000) Issued and outstanding 5,009,151 and 117,683 Exchangeable Shares (March 31, 2020 – 5,009,151 and -117,683)
		5,126			5,126
Additional paid in capital		85,263,824			84,643,570
Deficit		(75,008,568	)		(71,373,870	)
Accumulated other comprehensive income		42,149			42,149
Total Shareholders’ Equity		10,302,531			13,316,975
Total Liabilities and Shareholders’ Equity		17,197,825			18,516,620

Bionik Laboratories Corp. Condensed Consolidated Interim Statements of Operations and Comprehensive Loss For the three and six month periods ended September 30, 2020 and 2019 (unaudited) (Amounts expressed in U.S. Dollars)
	Three months ended			Six months ended September 30, 2020			Three months ended			Six months ended September 30, 2019
	September 30, 2020			Six months ended September 30, 2020			September 30, 2019			Six months ended September 30, 2019
		$			$			$			$
Sales		292,381			550,289			281,691			1,072,070
Cost of Sales		70,047			132,602			83,207			419,292
Gross Margin		222,334			417,687			198,484			652,778

Operating expenses
Sales and marketing		244,262			467,447			584,775			1,168,507
Research and development		410,507			763,770			886,060			1,702,583
General and administrative		858,410			1,986,920			1,199,938			2,041,631
Share-based compensation expense		212,939			620,254			638,219			925,976
Amortization		23,504			47,008			69,314			138,628
Depreciation		16,119			34,231			27,059			51,029
Total operating expenses		1,765,741			3,919,630			3,405,365			6,028,354

Other (income) expenses
Other expense		111,408			186,383			170,739			185,035
Other income		(46,178	)		(83,790	)		–			–
Foreign exchange		18,985			30,162			5,064			(57,283	)
Total other expenses (income)		84,215			132,755			175,803			127,752
Net (loss) and comprehensive (loss) for the period		(1,627,622	)		(3,634,698	)		(3,382,684	)		(5,503,328	)

Loss per share – basic and diluted		(0.32	)		(0.71	)		(0.87	)		(1.42	)
Weighted average number of shares outstanding – basic and diluted		5,126,834			5,126,834			3,872,428			3,865,573

Bionik Laboratories Corp. Condensed Consolidated Interim Statements of Cash Flows For the six month periods ended September 30, 2020 and 2019 (unaudited) (Amounts expressed in U.S. Dollars)
	Six months ended			Six months ended
	September 30, 2020 $			September 30, 2019 $
Operating activities
Net loss for the period		(3,634,698	)		(5,503,328	)
Adjustment for items not affecting cash
Depreciation		34,231			51,029
Amortization		47,008			138,628
Interest expense		181,481			167,877
Share based compensation expense		620,254			925,976
		(2,751,724	)		(4,219,818	)
Changes in non-cash working capital items
Accounts receivable		189,349			1,041,848
Prepaid expenses and other receivables		(38,743	)		(837,145	)
Due from related parties		(1,311	)		(347	)
Inventories		169,141			(631,376	)
Accounts payable		(327,475	)		285,315
Accrued liabilities		(31,031	)		(512,068	)
Deferred revenue		(89,813	)		122,821
Net cash (used in) operating activities		(2,881,607	)		(4,750,770	)
Investing activities
Acquisition of equipment		–			(91.141	)
Net cash (used in) investing activities		–			(91,141	)
Financing activities
Proceeds from convertible loans		1,502,575			9,070,000
Proceeds from PPP Loan		459,912			–
Repayment of term loan		–			(500,000	)
Proceeds from term loan		–			500,000
Net cash provided by financing activities		1,962,487			9,070,000
Net increase in cash and cash equivalents for the period		(919,120	)		4,228,089
Cash and cash equivalents, beginning of the period		2,269,747			446,779
Cash and cash equivalents, end of the period		1,350,627			4,674,868

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005302/en/

Media contact:

Matthew Bretzius

FischTank PR

[email protected]

KEYWORDS: United States North America Canada Massachusetts

INDUSTRY KEYWORDS: Data Management Health Technology Mobile/Wireless Software General Health Internet

MEDIA:

November 12, 2020 7:03 am

GFG Identifies New High-Grade Gold Target and Provides Drilling Update at the Pen Gold Project, West of Timmins, ON

SASKATOON, Saskatchewan, Nov. 12, 2020 (GLOBE NEWSWIRE) — GFG Resources Inc. (TSX-V: GFG) (OTCQB: GFGSF) (“GFG” or the “Company”) has identified a new high-grade gold target with grab samples of up to 65.90 grams of gold per tonne (“g/t Au”) from a recent prospecting program at its 100% owned, district-scale, Pen Gold Project (the “Project”). In addition to its surface exploration program, the Company is well advanced on its Phase 2 drill program at the Project. To date, the Company has completed 5,200 metres of the 8,500 metre drill program and expects to complete the program in December 2020. Following the Phase 2 drill program, the Company will resume drilling with a plan to drill 4-5,000 metres in the first quarter of 2021.

The new gold target, the R66 Prospect, is located 2.3 kilometres southeast of the Slate Rock Prospect where the Company has been actively drilling (See Figure 1). The R66 target and area was highlighted as a high priority target during the Company’s regional structural interpretation when it consolidated the Project in 2018. The R66 surface showing consists of a pair of northeast-trending quartz veins with trace to one percent pyrite and chalcopyrite within sericite-carbonate altered, highly strained mafic to intermediate volcanic rocks. Grab samples of the vein and adjacent wall rocks returned values that include 7.57, 28.60, 52.10 and 65.90 g/t Au (See Table 1).

The R66 target area is highly attractive as it is located along a northeast-structural corridor in direct proximity to a major first and second order structural intersection. Also relevant is the presence of broad intrusion-hosted mineralization at the Slate Rock target and Timiskaming conglomerates hosting anomalous gold mineralization immediately to the north. The veins are sub-parallel to the strain fabric and exposed intermittently over a strike length of 25 metres in a low-lying area in the central part of the west block of the Project. The area has had limited historical surface exploration or drilling, and the Company intends to conduct additional surface stripping and sampling to advance the R66 Prospect to a drill-ready stage by the first quarter of 2021.

Brian Skanderbeg, President and CEO commented, “The R66 Prospect results are the highest grade surface samples to have been recorded on the western portion of the property and demonstrate the opportunity to make new gold discoveries at the Project. The high-grade results demand further attention and we will advance this prospect to a drill ready stage in the coming months with an objective to drill test the target in the first quarter of 2021.

“Our expanded Phase 2 2020 drill program is progressing well with 15 holes completed to date at several targets including four holes at our new Nib discovery. We are optimistic we will be able to provide initial assay results in the near term and consistent news flow over the next several quarters.”

Table 1: Grab Sample Highlights from the R66 Prospect:

Sample Number	Au g/t	Prospecting Description
1133487	65.90	50cm wide grey quartz vein; 1% blebby chalcopyrite
1133483	52.10	Grey quartz vein; 1% blebby chalcopyrite
27549	28.60	60% vein; 40% wallrock; trace chalcopyrite
1133484	23.50	100% grey quartz vein; 1% chalcopyrite
28294	9.24	40cm wide quartz vein; trace chalcopyrite
1133479	8.46	30cm wide gossanous quartz vein
1133485	7.57	Sheared mafic-interm volcanic; trace pyrite
1133482	6.36	Massive grey quartz vein; no visible sulphides
27550	3.77	Quartz vein in sericite-ankerite schist
28293	2.77	4cm quartz vein in chlorite altered mafic volcanic
1133486	1.26	Quartz vein boudin

Drilling Update

The Company has made significant progress on its Phase 2 8,500 metre drill program (See news release: “GFG Begins 8,500 Metre Drill Program Focused on High-Grade Gold Targets at the Pen Gold Project, West of Timmins, ON”). Since August 30, the Company has completed 15 holes (5,200 metres) at several targets including Nib, HGM, North Sewell, Boundary and Broadway prospects. The Company anticipates completing the 8,500 metre drill program by the end of December and will resume drilling early in the first quarter of 2021 with an additional 4-5,000 metre program.

The Company has experienced significant delays in receiving assay results due to lab processing times. However, the Company does anticipate receiving initial assay results for the Phase II drill program during the coming weeks and will provide updates as they become available.

The Project is located approximately 40 kilometres west of the prolific Timmins Gold District in Ontario. The contiguous land package, one of the largest in the region, consists of approximately 475 square kilometres and is situated between Newmont’s Borden Gold Mine and Pan American Silver’s Timmins West Mine. The Project covers an approximately 50-kilometre-long section of Archean greenstone that contains the interpreted western extension of the Porcupine-Destor Fault Zone within the same geological setting that hosts most of the gold deposits found in the Timmins Gold Camp.

Figure 1: Plan Map of Priority Drill Targets at the Pen Gold Project

Figure 2: Plan Map of Priority Targets in the West Block of the Pen Gold Project

About GFG Resources Inc.

GFG Resources is a North American precious metals exploration company focused on district scale gold projects in tier one mining jurisdictions, Ontario and Wyoming. In Ontario, the Company owns 100% of the Pen and Dore gold projects, two large and highly prospective gold properties west of the prolific gold district of Timmins, Ontario, Canada. The Pen and the Dore gold projects have similar geological settings that host most of the gold deposits found in the Timmins Gold Camp which have produced over 70 million ounces of gold. The Company also owns 100% of the Rattlesnake Hills Gold Project, a district scale gold exploration project located approximately 100 kilometres southwest of Casper, Wyoming, U.S. The geologic setting, alteration and mineralization seen in the Rattlesnake Hills are similar to other gold deposits of the Rocky Mountain alkaline province which, collectively, have produced over 50 million ounces of gold.

For further information, please contact:

Brian Skanderbeg, President & CEO
Phone: (306) 931-0930
or
Marc Lepage, Vice President, Business Development
Phone: (306) 931-0930
Email: [email protected]
Website: www.gfgresources.com

Stay Connected with Us

Twitter: @GFGResources
LinkedIn: https://www.linkedin.com/company/gfgresources/
Facebook: https://www.facebook.com/GFGResourcesInc/

Qualified Persons

Brian Skanderbeg, P.Geo. and M.Sc., President and CEO, is the Qualified Person for the information contained in this press release and is a Qualified Person within the meaning of National Instrument 43-101. Mr. Skanderbeg has reviewed the sampling and QA/QC procedures and results thereof as verification of the sampling data disclosed above and has approved the information contained in this news release.

Sampling and Quality Control

Surface rock and drill core samples are being analyzed for gold by Activation Laboratories Ltd. in Timmins, Ontario using a 50-gram aliquot, Pb collection fire assay and an Atomic Absorption Spectrometry finish (Package 1A2-50). Samples assaying above 5 ppm Au are re-run using a gravimetric finish (Package 1A3-50). Selected samples will also be submitted for multi-element analysis using a four-acid digestion and an ICP-MS finish (Package MA250) at Bureau Veritas Laboratories in Vancouver, British Columbia. Quality control and assurance measures include the monitoring of results for inserted certified reference materials coarse blanks and preparation duplicates.

Sampling protocols, quality control and assurance measures and geochemical results related to historic till, rock grab, and drill core samples quoted in this news release have not been verified by the Qualified Person and therefore must be regarded as estimates. Any historic mineral resources quoted in this release and accompanying maps are not compliant with National Instrument 43-101-and are only considered to be an indication of overall prospectivity of the region.

CAUTION REGARDING FORWARD-LOOKING INFORMATION

All statements, other than statements of historical fact, contained in this news release constitute “forward-looking information” within the meaning of applicable Canadian securities laws and “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 (referred to herein as “forward-looking statements”). Forward-looking statements include, but are not limited to, the future price of gold, success of exploration activities and metallurgical test work, permitting time lines, currency exchange rate fluctuations, requirements for additional capital, government regulation of exploration work, environmental risks, unanticipated reclamation expenses, title disputes or claims and limitations on insurance coverage. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate” or “believes”, or the negative connotation thereof or variations of such words and phrases or state that certain actions, events or results, “may”, “could”, “would”, “will”, “might” or “will be taken”, “occur” or “be achieved” or the negative connotation thereof.

All forward-looking statements are based on various assumptions, including, without limitation, the expectations and beliefs of management, the assumed long-term price of gold, that the Company will receive required permits and access to surface rights, that the Company can access financing, appropriate equipment and sufficient labour, and that the political environment within Canada and the United States will continue to support the development of mining projects in Canada and the United States. In addition, the similarity or proximity of other gold deposits to the Rattlesnake Hill Gold Project, the Pen Gold Project and the Dore Gold Project is not necessary indicative of the geological setting, alteration and mineralization of the Rattlesnake Hills Gold Project, the Pen Gold Project and the Dore Gold Project.

Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of GFG to be materially different from those expressed or implied by such forward-looking statements, including but not limited to: actual results of current exploration activities; environmental risks; future prices of gold; operating risks; accidents, labour issues and other risks of the mining industry; delays in obtaining government approvals or financing; and other risks and uncertainties. These risks and uncertainties are not, and should not be construed as being, exhaustive.

Although GFG has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. In addition, forward-looking statements are provided solely for the purpose of providing information about management’s current expectations and plans and allowing investors and others to get a better understanding of our operating environment. Accordingly, readers should not place undue reliance on forward-looking statements.

Forward-looking statements in this news release are made as of the date hereof and GFG assumes no obligation to update any forward-looking statements, except as required by applicable laws.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/bac1315b-6465-4de1-961f-9fe6bb1248f0

https://www.globenewswire.com/NewsRoom/AttachmentNg/400bee79-fd33-427b-a520-caf0526df1f5

November 12, 2020 7:03 am

ADC Therapeutics Reports Third Quarter 2020 Financial Results and Provides Recent Business Highlights

ADC Therapeutics Reports Third Quarter 2020 Financial Results and Provides Recent Business Highlights

– Submitted BLA for lead program, Lonca, for treatment of relapsed or refractory DLBCL on September 21, 2020

– Commercial launch activities on track for potential U.S. launch of Lonca in mid-2021

– Initiated Phase 3 confirmatory trial of Lonca in combination with rituximab in second-line DLBCL

– Strong balance sheet with $494 million in cash and cash equivalents as of September 30, 2020 after completing an upsized follow-on public offering in September 2020

– Company to host conference call today at 8:30 a.m. ET

LAUSANNE, Switzerland–(BUSINESS WIRE)–
ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights.

“The third quarter was one of tremendous execution as we prepare for the U.S. launch of our first drug, Lonca, for the treatment of relapsed or refractory diffuse large B-cell lymphoma,” said Chris Martin, Chief Executive Officer of ADC Therapeutics. “We have submitted our Biologics License Application to the U.S. Food and Drug Administration and are now working diligently to prepare for a planned commercial launch in mid-2021, including U.S. organizational build-out, the establishment of U.S. operations to ensure distribution, access and reimbursement of Lonca, and significant appropriate physician engagement. In addition to our commercial preparations, we are expanding our Lonca development activities, having initiated our Phase 3 LOTIS 5 clinical trial evaluating Lonca in combination with rituximab as a second-line therapy in DLBCL and are preparing to initiate our Phase 2 trial of Lonca in follicular lymphoma next year.”

Dr. Martin continued, “Across our Cami programs, we have now enrolled more than half of the 100-patient pivotal Phase 2 trial in Hodgkin lymphoma and continue to see promising preliminary data from our Phase 1b trial in solid tumors that show robust immune activity following treatment, as well as recently published preclinical data highlighting the anti-tumor activity of CD25-targeted antibody drug conjugates. With these promising data, we expanded our Phase 1b trial to evaluate Cami in combination with pembrolizumab to better understand its potential as both a monotherapy and in combination and have dosed the first patient in the combination arm. To support these exciting developments and ensure continued growth across our pipeline, we completed an upsized public offering in September. With these additional funds, we look forward to continuing to deliver on our vision to bring transformative therapies to cancer patients as quickly and effectively as possible.”

Recent Clinical and Business Highlights:

Submitted a BLA to the FDA for Lonca for treatment of relapsed or refractory DLBCL: On September 21, 2020, the Company announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Lonca for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The submission is based on data from LOTIS 2, a pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior systemic therapy.

Opened Phase 3 LOTIS 5 clinical trial of Lonca in combination with rituximab for enrollment: This Phase 3 confirmatory trial will evaluate the efficacy of Lonca in combination with rituximab in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The trial will evaluate the safety and efficacy of Lonca in combination with rituximab versus standard immunochemotherapy, and the primary endpoint will be progression-free survival. LOTIS 5 is designed to fulfill the Company’s post-marketing requirement to the FDA for full approval, if accelerated approval is received for relapsed or refractory DLBCL, and is intended to support a supplemental Biologics License Application (sBLA) for Lonca as a second-line therapy for patients with DLBCL who have relapsed or refractory disease following at least one multi-agent systemic treatment regimen.

Actively enrolling patients in the pivotal Phase 2 portion of LOTIS 3 clinical trial of Lonca in combination with ibrutinib: Enrollment continues in the pivotal Phase 2 portion of LOTIS 3, a 161-patient Phase 1/2 clinical trial of Lonca in combination with ibrutinib, which is being evaluated in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL). The first patient was dosed in the pivotal Phase 2 portion of this trial in July 2020.

Planning to initiate a pivotal Phase 2 clinical trial of Lonca in follicular lymphoma (FL) in H1 2021: The Company continues to consider rapid expansion opportunities for Lonca across other non-Hodgkin lymphoma indications. Following consultation with the FDA, the Company plans to initiate a pivotal Phase 2 trial to evaluate the safety and efficacy of Lonca in patients with relapsed or refractory FL.

Dosed first patient in Phase 1b clinical trial of Cami in combination with pembrolizumab for treatment of solid tumors: Earlier this month, the Company announced that the first patient was dosed with Cami in combination with pembrolizumab, a checkpoint inhibitor, in an ongoing Phase 1b trial in patients with selected advanced solid tumors. Based on preclinical data and initial pharmacodynamic data from the Phase 1b monotherapy trial, the Company has expanded the Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab in select solid tumors. Pharmacokinetic and biomarker data from the Phase 1b trial were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, and preclinical data were published in the Journal for ImmunoTherapy of Cancer.

Announced multiple abstracts accepted for presentation at ASH: The Company announced earlier in November that six clinical abstracts and two preclinical abstracts have been accepted for presentation at the 62^nd American Society of Hematology (ASH) Annual Meeting, including an oral presentation of Cami Phase 2 data in Hodgkin lymphoma (HL) and poster presentations of Lonca subgroup data from the pivotal Phase 2 LOTIS 2 trial in relapsed or refractory DLBCL and the Phase 1b pivotal trial of Lonca combined with ibrutinib in relapsed or refractory DLBCL and MCL.

Amended 2013 collaboration and license agreement with Genmab for Cami: In October 2020, the Company and Genmab agreed to amend their original 2013 agreement to allow the Company to continue the development and commercialization of Cami. Under the amendment, Genmab agreed, among other things, to convert its economic interest into a mid-to-high single-digit royalty on net sales.

Completed upsized public offering: In September 2020, the Company completed an upsized public offering of 6,000,000 common shares at a price of $34.00 per share. Gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, were approximately $204 million.

Anticipated Upcoming Milestones:

FDA feedback on BLA submission for Lonca for the treatment of patients with relapsed or refractory DLBCL.
Initiation of a pivotal Phase 2 trial of Lonca in relapsed refractory FL in the first half of 2021.
Reporting of interim results from the pivotal Phase 2 trial of Cami in HL in the first half of 2021.
Potential FDA approval and launch of Lonca in mid-2021.

Third Quarter 2020 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $494.4 million as of September 30, 2020, compared to $115.6 million as of December 31, 2019.

Research and Development (R&D) Expenses

R&D expenses were $32.2 million for the quarter ended September 30, 2020, compared to $30.5 million for the same quarter in 2019. The increase was primarily due to increased share-based compensation expense.

General and Administrative (G&A) Expenses

G&A expenses were $20.3 million for the quarter ended September 30, 2020, compared to $2.3 million for the same quarter in 2019. The increase was primarily due to an increased number of Commercial employees, increased costs due to new commercial activities and increased share-based compensation expense.

Net Loss and Adjusted Net Loss

Net loss was $20.3 million, or a net loss of $0.29 per basic and diluted share, for the quarter ended September 30, 2020, compared to $31.3 million, or a net loss of $0.62 per basic and diluted share, for the same quarter in 2019. The net loss for the quarter ended September 30, 2020 includes a $33.9 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from June 30, 2020. In addition, net loss included share-based compensation expense of $11.0 million for the quarter ended September 30, 2020, compared to $0.2 million for the same quarter in 2019.

Adjusted net loss was $41.3 million, or an adjusted net loss of $0.58 per basic and diluted share, for the quarter ended September 30, 2020, compared to $31.1 million, or an adjusted net loss of $0.62 per basic and diluted share, for the same quarter in 2019. The increase in adjusted net loss was primarily driven by higher employee headcount across the organization and costs associated with the build out of the Company’s commercial organization in preparation for the anticipated launch of Lonca in 2021.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2020 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the call, please dial +41 225 675632 (international) or (833) 249-8403 (U.S.). A live webcast of the presentation will be available on the Investors section of the ADC Therapeutics website at www.ir.adctherapeutics.com. The archived webcast will be available after the completion of the event.

About ADC Therapeutics

ADC Therapeutics SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company’s lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. In September 2020, ADC Therapeutics submitted a Biologics License Application to the U.S. Food and Drug Administration seeking accelerated approval for Lonca for the treatment of patients with relapsed or refractory DLBCL. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86.5% ORR in HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

Use of Non-IFRS Financial Measures

In addition to financial information prepared in accordance with IFRS, this document also contains certain non-IFRS financial measures based on management’s view of performance including:

Adjusted net loss
Adjusted net loss per share

Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-IFRS measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. When preparing these supplemental non-IFRS measures, management typically excludes certain IFRS items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these IFRS items to be normal, recurring cash or non-cash operating expenses; however, these items may not meet the IFRS definition of unusual or non-recurring items. Since non-IFRS financial measures do not have standardized definitions and meanings, they may differ from the non-IFRS financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other IFRS financial measures.

The following items are excluded from adjusted net loss and adjusted net loss per share:

Shared-Based Compensation Expense: We exclude share-based compensation from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy.

Certain Other Items: We exclude certain other significant items that may occur occasionally and are not normal, recurring operating expenses, cash or non-cash, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature and generally represent items that, either as a result of their nature or significance, management would not anticipate occurring as part of our normal business on a regular basis. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of derivatives, and the effective interest expense, associated with the Convertible Credit Facility with Deerfield, as well as transaction costs associated with debt or equity issuances that are expensed pursuant to IFRS.

See the attached Reconciliation of IFRS Measures to Non-IFRS Measures for explanations of the amounts excluded and included to arrive at the non-IFRS financial measures for the three- and nine-month periods ended September 30, 2020 and 2019.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

ADC Therapeutics SA Condensed Consolidated Interim Statement of Operations (Unaudited) (in KUSDexcept for share and per share data)

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2020		2019		2020		2019
Contract revenue	–		–		–		2,340

Operating expense
Research and development	(32,155	)	(30,541	)	(93,480	)	(77,113	)
General and administrative	(20,273	)	(2,302	)	(47,782	)	(8,894	)
Total operating expense	(52,428	)	(32,843	)	(141,262	)	(86,007	)
Loss from operations	(52,428	)	(32,843	)	(141,262	)	(83,667	)

Other income (expense)
Other income	145		1,433		423		1,433
Convertible loans, derivatives, change in fair value income (expense)	33,868		–		(45,393	)	–
Convertible loans, first tranche, derivative, transaction costs	–		–		(1,571	)	–
Financial income	163		729		732		2,035
Financial expense	(1,940	)	(32	)	(2,879	)	(105	)
Exchange differences	(139	)	(360	)	(210	)	(428	)
Total other income (expense)	32,097		1,770		(48,898	)	2,935
Loss before taxes	(20,331	)	(31,073	)	(190,160	)	(80,732	)
Income tax benefit (expense)	3		(268	)	(201	)	(467	)
Net loss	(20,328	)	(31,341	)	(190,361	)	(81,199	)

Net loss attributable to:
Owners of the parent	(20,328	)	(31,341	)	(190,361	)	(81,199	)

Net loss per share, basic and diluted	(0.29	)	(0.62	)	(3.09	)	(1.68	)

ADC Therapeutics SA Condensed Consolidated Interim Balance Sheet (Unaudited) (in KUSD)

	September 30,		December 31,
	2020		2019
ASSETS
Current assets
Cash and cash equivalents	494,416		115,551
Other current assets	12,003		7,055
Total current assets	506,419		122,606
Non-current assets
Property, plant and equipment	1,502		1,376
Right-of-use assets	3,402		4,898
Intangible assets	9,814		8,434
Other long-term assets	389		368
Total non-current assets	15,107		15,076
Total assets	521,526		137,682

LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities
Accounts payable	6,146		3,329
Other current liabilities	22,633		15,430
Lease liabilities, short-term	1,051		1,132
Current income tax payable	91		52
Convertible loans, short-term	2,642		–
Total current liabilities	32,563		19,943
Non-current liabilities
Convertible loans, long-term	33,788		–
Convertible loans, derivatives	73,190		–
Lease liabilities, long-term	2,605		3,899
Defined benefit pension liabilities	3,113		2,684
Other non-current liabilities	208		–
Total non-current liabilities	112,904		6,583
Total liabilities	145,467		26,526

Equity attributable to owners of the parent
Share capital	6,314		4,361
Share premium	981,032		549,922
Treasury shares	(4	)	(100	)
Other reserves	27,642		5,473
Cumulative translation adjustment	5		69
Accumulated losses	(638,930	)	(448,569	)
Total equity attributable to owners of the parent	376,059		111,156
Total liabilities and equity	521,526		137,682

ADC Therapeutics SA Reconciliation of IFRS Measures to Non-IFRS Measures (Unaudited) (in KUSDexcept for share and per share data)

	Three months ended September 30,				Nine months ended September 30,
in KUSD (except for share and per share data)	2020		2019		2020		2019
Net loss	(20,328	)	(31,341	)	(190,361	)	(81,199	)
Adjustments:
Share-based compensation expense (i)	10,988		216		27,512		356
Convertible loans, derivatives, change in fair value (income) expense (ii)	(33,868	)	–		45,393		–
Convertible loans, first tranche, derivative, transaction costs (iii)	–		–		1,571		–
Effective interest expense (iv)	1,913		–		2,781		–
Adjusted net loss	(41,295	)	(31,125	)	(113,104	)	(80,843	)

Net loss per share, basic and diluted	(0.29	)	(0.62	)	(3.09	)	(1.68	)
Adjustment to net loss per share, basic and diluted	(0.29	)	–		1.25		0.01
Adjusted net loss per share, basic and diluted	(0.58	)	(0.62	)	(1.84	)	(1.67	)
Weighted average shares outstanding, basic and diluted	70,914,300		50,626,246		61,613,177		48,448,085

(i) Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted and is recognized over the vesting period of the award by a charge to the income statement and a corresponding increase in other reserves within equity. These accounting entries have no cash impact.

(ii) Change in the fair value of the convertible loan derivatives results from the valuation at the end of each accounting period of the derivatives associated with the convertible loans, as explained in note 11 “Convertible notes” to the unaudited condensed consolidated interim financial statements. There are several inputs to these valuations, but those most likely to provoke significant changes in the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. Any change in the estimated probability of the regulatory approval of Lonca would directly affect the valuation related to the second tranche. These accounting entries have no cash impact.

(iii) The transaction costs allocated to the convertible loan first tranche derivative represent actual costs. These are not expected to recur on an ongoing basis.

(iv) Effective interest expense relates to the increase in the value of our convertible loan in accordance with the effective interest method. As the initial value of the loan is recorded net of the value of the embedded derivative, the increase in the loan value necessary to attain the amount necessary to fund the cash outflows of interest payments, repayment of capital and exit fee is considerably higher than the payments of interest at coupon rate and of the exit fee.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005282/en/

Investors

Amanda Hamilton

ADC Therapeutics

[email protected]

Tel.: +1 917-288-7023

EU Media

Alexandre Müller

Dynamics Group

[email protected]

Tel: +41 (0) 43 268 3231

USA Media

Annie Starr

6 Degrees

[email protected]

Tel.: +1 973-415-8838

KEYWORDS: Europe Switzerland United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

Logo

November 12, 2020 7:03 am

LGI Homes Continues Expansion in Las Vegas

New Community Offers Lineup of Never-Before-Seen Floor Plans

LAS VEGAS, Nov. 12, 2020 (GLOBE NEWSWIRE) — LGI Hom e s, Inc. (NASDAQ: LGIH) today announced the opening of its newest community in the Las Vegas market, La Ma d re, presenting a lineup of never-before-seen floor plans in a prime Las Vegas location.

Located off I-15, LGI homebuyers at La Madre are conveniently positioned less than twenty minutes away from the excitement of the downtown Las Vegas strip, while still being able to enjoy the peacefulness of a serene, family-friendly neighborhood.

“We are overjoyed to show customers that they can truly have it all,” said Ron Christian, vice president of sales for LGI Homes. “At La Madre, we build brand-new, high-quality homes at an affordable price and in a great location.”

With the construction of five single-family one- and two-story floor plans, La Madre by LGI Homes will have a place for everyone to call home. These new homes range from approximately 1,280 square feet to 2,200 square feet and feature premier upgrades such as open-concept floor plans, covered back patios, walk-in closets and much more. As part of LGI Homes’ Comple t eHome™ package, other features included at no extra cost include granite countertops, energy-efficient Whirlpool® appliances, tall kitchen cabinets with crown molding, Wi-Fi-enabled garage door openers and enhanced front yard landscaping.

Within this quiet neighborhood, residents are presented with a variety of community amenities that can be enjoyed for years to come. Homeowners and guests can gather at the community picnic tables or barbeque grill to share meals and memories alike. Along the walking trails, children will enjoy hours of endless play at La Madre’s community playground.

New homes for sale within this community start in the $290s. To accommodate homebuyers during this time, the La Madre information center is open for tours by appointment only and is in compliance with Centers for Disease Control and Prevention and local safety guidelines. To schedule a tour or learn more, interested homebuyers are encouraged to call (866) 874-9531 ext 521.

About LGI Homes, Inc.

Headquartered in The Woodlands, Texas, LGI Homes, Inc. engages in the design, construction and sale of homes in Texas, Arizona, Florida, Georgia, New Mexico, Colorado, North Carolina, South Carolina, Washington, Tennessee, Minnesota, Oklahoma, Alabama, California, Oregon, Nevada, West Virginia and Virginia. Recently recognized as the 10th largest residential builder in America, based on units closed, the Company has a notable legacy of more than 17 years of homebuilding operations, over which time it has closed more than 40,000 homes. For more information about the Company and its new home developments, please visit the Company’s website at www.LGIHomes.com.

MEDIA CONTACT:
Rachel Eaton
(281) 362-8998 ext. 2560

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/e3957fbd-01d4-4a20-83a5-2ab4c5b00ef1

November 12, 2020 7:03 am

Organicell Provides Update on Its COVID-19 Clinical Trial Using ZofinTM

Organicell Provides Update on Its COVID-19 Clinical Trial Using Zofin^TM

Anticipates Phase I/II trial completion by end of year
Anticipates Phase IIb trial to begin in Q1 2021
Seeks to retain a global contract research organization (“CRO”)

MIAMI–(BUSINESS WIRE)–
Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today provided an update on its Phase I/II clinical trial for treatment of COVID-19 using Organicell’s proprietary therapeutic, Zofin™, which is currently underway as well as an update on its expanded access protocol for outpatients with COVID-19.

The Company’s current Phase I/II clinical trial which commenced on September 8, 2020, is a randomized, double-blinded, placebo-controlled phase I/II trial designed to investigate its proprietary therapeutic, Zofin™, as a potential treatment for moderate to severe acute respiratory syndrome (SARS) related to COVID-19. To date, several patients have been enrolled, dosed and treated at Larkin Hospital in Miami, Florida. Organicell expects to finish enrollment and complete the trial by December 31, 2020. It is the Company’s intention, subject to favorable results, careful data analysis, discussion with and approvals from the FDA, to begin a Phase IIb confirmatory trial as early as the first quarter of 2021.

In September 2020, Organicell announced that the FDA granted it an expanded access protocol. This protocol allows Organicell to provide Zofin™ to a certain amount of mild to moderate COVID-19 patients in both outpatient and inpatient settings.

In connection with its planned Phase IIb confirmatory trial, the Company is negotiating an agreement with a nationally known CRO to support the needed services related to running its clinical trials. The Company expects this agreement to be finalized in the coming days.

“We’re very pleased in the progress we are making in our clinical trials,” said Albert Mitrani, Chief Executive Officer of Organicell. “Our planned CRO partnership is intended to support our efforts to efficiently and expeditiously conduct our clinical trial programs which, if successful, may ultimately afford a potentially effective treatment for patients suffering from the effects of COVID-19.”

About Organicell Regenerative Medicine, Inc.:

Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of nanoparticles to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Maria Ines Mitrani, Chief Science Officer. To learn more, please visit https://organicell.com/.

About Zofin^TM:

Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

Forward-Looking Statements

Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as “will,” “believes,” “expects,” “potential” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Company’s periodic reports that are filed with the SEC and available on the SEC’s website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005278/en/

Jeffrey Freedman

RooneyPartners

646-432-0191

[email protected]

KEYWORDS: United States North America Florida

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Health FDA Infectious Diseases Clinical Trials

MEDIA:

Logo

November 12, 2020 7:03 am

Discovery Reports 138 g/t AgEq over 139 m in South Corridor at Cordero

TORONTO, Nov. 12, 2020 (GLOBE NEWSWIRE) — Discovery Metals Corp. (TSX-V: DSV, OTCQX: DSVMF) (“Discovery” or the “Company”) is pleased to announce results from seven diamond drill holes targeting bulk-tonnage mineralization in the South Corridor at its flagship Cordero project (“Cordero” or “the Project”) located in Chihuahua State, Mexico. The South Corridor has seen significantly less drilling than the North Corridor and will be a key area of focus for the remainder of the 55,000 metre (“m”) Phase 1 drill program. The goal of this drill program is to delineate a high-margin silver project with size and scaleability.

Highlight intercepts include:

Hole C20-34
8
:
1
39.1
m averaging 1
38
grams per tonne silver equivalent (“g/t
AgEq
¹”) from 196.2 m (47 g/t Ag, 0.07 g/t gold (“Au”), 0.6% lead (“Pb”) and 1.6% zinc (“Zn”)) including 19.0 m averaging 357 g/t AgEq¹ (112 g/t Ag, 0.17 g/t Au, 1.8% Pb, 4.0% Zn)

Hole C20-35
3
:
26.6
m averaging
108
g/t AgEq
¹ from 99.5 m (56 g/t Ag, 0.09 g/t Au, 0.4% Pb and 0.7% Zn) and 29.6 m averaging 119 g/t AgEq¹ from 278.1 m (52 g/t Ag, 0.07 g/t Au, 0.8% Pb, 0.8% Zn)
Hole C20-35
9
:
62.2
m averaging
86
g/t AgEq
¹ from 149.0 m (38 g/t Ag, 0.07 g/t Au, 0.4% Pb and 0.7% Zn)

Taj Singh, President and CEO, states: “Our drill targeting approach in the South Corridor is guided by ongoing iterations of our internal model in order to identify areas that are classified as waste due to a lack of drilling. Considering all seven holes in this release intercepted broad zones of mineralization in such areas bodes well for the conversion of waste to ore in this part of the deposit. This obviously has positive implications for not only increasing the size of the pit-constrained resource but also for reducing the overall strip ratio of the deposit and clearly demonstrates that we continue to add value through the drill bit through our proactive and focused exploration approach.”

DRILL RESULTS

:

The seven holes in this release were drilled along approximately 700 m of strike extent of the South Corridor and were designed to in-fill significant gaps in previous drilling. All holes intercepted broad zones of galena and sphalerite mineralization in disseminations, veinlets and stockworks predominantly hosted in dacite and sedimentary rock.

The highlight hole in this release was C20-348, drilled in the central part of the South Corridor. C20-348 intercepted multiple broad zones of higher-grade mineralization including an intercept of 139.1 m averaging 138 g/t AgEq from 196.2 m (47 g/t Ag, 0.07 g/t Au, 0.6% Pb and 1.6% Zn) including 19.0 m averaging 357 g/t AgEq¹ (112 g/t Ag, 0.17 g/t Au, 1.8% Pb, 4.0% Zn). The remaining holes were drilled up to 250 m to the southwest and up to 450 m to the northeast of C20-348. Drill hole locations for all holes are shown in Figure 1 (see links below) and detailed drill highlights are provided in the table below.

Hole ID	From (m)	To (m)	Width (m)	Ag (g/t)	Au (g/t)	Pb (%)	Zn (%)	AgEq ¹ (g/t)
C20-348	77.6	148.8	71.2	18	0.06	0.2	0.7	59
including	144.0	144.8	0.8	495	0.42	7.2	3.1	913
and	196.2	335.3	139.1	47	0.07	0.6	1.6	138
including	273.2	276.1	2.9	471	0.21	4.2	3.8	793
& including	292.5	311.5	19.0	112	0.17	1.8	4.0	357
and	388.0	420.2	32.3	44	0.08	0.7	1.3	127

C20-353	99.5	126.1	26.6	56	0.09	0.4	0.7	108
including	118.7	119.7	1.0	849	0.37	4.5	5.8	1,281
and	207.1	226.5	19.4	41	0.06	0.5	1.2	115
and	278.1	307.7	29.6	52	0.07	0.8	0.8	119

C20-355	4.5	63.3	58.9	29	0.06	0.4	0.4	66
and	64.6	156.7	92.1	27	0.05	0.2	0.4	56
and	288.7	321.0	32.4	72	0.07	0.3	0.1	95

C20-356	122.8	161.2	38.4	36	0.04	0.6	0.7	90
and	380.5	414.1	33.6	25	0.03	0.3	0.6	65

C20-359	107.1	141.0	33.9	30	0.07	0.5	0.6	79
and	149.0	211.2	62.2	38	0.07	0.4	0.7	86
including	195.7	197.3	1.6	530	0.42	2.5	3.5	800
and	228.2	231.5	3.3	152	0.71	2.2	6.9	572
including	228.2	229.0	0.8	236	0.27	5.7	9.2	840

C20-363	268.4	325.5	57.1	18	0.01	0.2	1.0	69

C20-364	366.7	424.3	57.6	19	0.03	0.3	0.7	61

¹
All results in this news release are rounded. Assays are uncut and undiluted. Widths are drilled widths, not true widths, as a full interpretation of the actual orientation of mineralization is not complete.
Intervals
were chosen
based on a 2
0
g/t
AgEq
cutoff with no more than
10
m of dilution
.
AgEq
calculations are used as the basis for total metal content calculations given Ag is the dominant metal constituent as a percentage of
AgEq
value in approximately 70% of the Company’s mineralized intercepts.
AgEq
calculations for reported drill results are based on USD $16.50/oz Ag, $1,350/oz Au, $0.85/
lb
Pb, $1.00/
lb
Zn. The calculations assume 100% metallurgical recovery and are indicative of gross in-situ metal value at the indicated metal prices. Refer to
Technical Notes
below for metallurgical recoveries assumed in the 2018 PEA completed on Cordero.

PHASE 1 DRILL PROGRAM UPDATE:

The Company has completed 39,950 m (105 holes) as part of its expanded 55,000 m Phase 1 drill program. Assays from 27 holes are pending. There are currently four drill rigs operational on site. Additional drill rigs may be added when the Company is confident that the health and safety risks related to COVID-19 can be managed effectively.

Drilling is focused on two key concepts: (1) targeting of bulk-tonnage mineralization within and to the east and northeast of both mineralized corridors; and (2) testing of the width, grade and continuity of extensive high-grade vein systems that transect the deposit.

Supporting maps and sections, drill hole locations and full assay results can be found at the following link: https://dsvmetals.com/site/assets/files/5407/20201112_dsv_nrm.pdf

A PDF of this release with supporting maps and sections included as appendices can be found at the following link: https://dsvmetals.com/site/assets/files/5407/20201112_dsv_nr.pdf

About Discovery

Discovery’s flagship project is its 100%-owned Cordero silver project in Chihuahua State, Mexico. Our drill results to date show that Cordero is developing all the attributes of a tier 1 project – grade, scale, significant organic growth opportunities and well located in one of Mexico’s premier mining belts. The project is supported by an industry leading balance sheet with over C$80 million of cash allocated for aggressive exploration, resource expansion and future development.

Sample analysis and QA/QC Program

True widths of reported drill intercepts have not been determined. Assays are uncut except where indicated. All core assays are from HQ drill core unless stated otherwise. Drill core is logged and sampled in a secure core storage facility located at the project site 40km north of the city of Parral. Core samples from the program are cut in half, using a diamond cutting saw, and are sent to ALS Geochemistry-Mexico for preparation in Chihuahua City, Mexico, and subsequently pulps are sent to ALS Vancouver, Canada, which is an accredited mineral analysis laboratory, for analysis. All samples are prepared using a method whereby the entire sample is crushed to 70% passing -2mm, a split of 250g is taken and pulverized to better than 85% passing 75 microns. Samples are analyzed for gold using standard Fire Assay-AAS techniques (Au-AA24) from a 50g pulp. Over limits are analyzed by fire assay and gravimetric finish. Samples are also analyzed using thirty three-element inductively coupled plasma method (“ME-ICP61”). Over limit sample values are re-assayed for: (1) values of zinc > 1%; (2) values of lead > 1%; and (3) values of silver > 100 g/t. Samples are re-assayed using the ME-OG62 (high-grade material ICP-AES) analytical package. For values of silver greater than 1,500 g/t, samples are re-assayed using the Ag-CON01 analytical method, a standard 30 g fire assay with gravimetric finish. Certified standards and blanks are routinely inserted into all sample shipments to ensure integrity of the assay process. Selected samples are chosen for duplicate assay from the coarse reject and pulps of the original sample. No QAQC issues were noted with the results reported herein.

Qualified

Person

Gernot Wober, P.Geo, VP Exploration, Discovery Metals Corp., is the Company’s designated Qualified Person for this news release within the meaning of National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101”) and has reviewed and validated that the information contained in this news release is accurate.

On Behalf of the Board of Directors,

Taj Singh, M.Eng, P.Eng, CPA,

President, Chief Executive Officer and Director

For further information contact:

Forbes Gemmell, CFA

VP Corporate Development & Investor Relations
[email protected]

TECHNICAL

NOTES

&

FORWARD-LOOKING

STATEMENTS

:

The most recent technical report for the Cordero Project is the 2018 Preliminary Economic Assessment (PEA) authored by M3 Engineering and Technology Corp and includes the most recent resource estimate, completed by Independent Mining Consultants, Inc. It is available on Discovery’s website and on SEDAR under Levon Resources Ltd, a wholly owned subsidiary of Discovery. The PEA assumes metallurgical recoveries of 89% for Ag, 84% for Pb, 72% for Zn and 40% for Au.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release is not for distribution to United States newswire services or for dissemination in the United States.

This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful, including any of the securities in the United States of America. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “1933 Act”) or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.

Cautionary Note Regarding Forward-Looking Statements

This news release may include forward-looking statements that are subject to inherent risks and uncertainties. All statements within this news release, other than statements of historical fact, are to be considered forward looking. Although Discovery believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those described in forward-looking statements. Factors that could cause actual results to differ materially from those described in forward-looking statements include fluctuations in market prices, including metal prices, continued availability of capital and financing, and general economic, market or business conditions. There can be no assurances that such statements will prove accurate and, therefore, readers are advised to rely on their own evaluation of such uncertainties. There can be no assurance that the Private Placement will close on the announced terms. Discovery does not assume any obligation to update any forward-looking statements except as required under applicable laws.

November 12, 2020 7:03 am

Exicure, Inc. Reports Third Quarter 2020 Financial Results and Corporate Progress

Exicure, Inc. Reports Third Quarter 2020 Financial Results and Corporate Progress

CHICAGO & CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today reported financial results for the quarter and nine months ended September 30, 2020 and provided an update on corporate progress.

“Exicure has seen growth and clinical and pre-clinical advancement during the third quarter of this year,” said Dr. David Giljohann, Exicure’s Chief Executive Officer. “During the third quarter of 2020, Exicure hosted a virtual KOL event where we presented promising interim results from our ongoing Phase 1b/2 clinical trial of cavrotolimod (AST-008) and we announced that our poster on the safety and preliminary efficacy of intertumoral cavrotolimod (AST-008) in combination with pembrolizumab in the Phase 1b stage was accepted for presentation at the 2020 SITC Annual Meeting. We also entered into a $25.0 million senior secured term loan during the third quarter of 2020 which extends our cash runway into 2022,” concluded Dr. Giljohann.

Exicure’s candidate, XCUR-FXN

Despite the ongoing COVID-19 pandemic, the Company’s laboratories have continued operations with limited impact on our research and development activities.
The Company remains on track to initiate IND-enabling studies for Friedreich’s ataxia in the fourth quarter of this year.

Exicure announced promising interim results from ongoing Phase 1b/2 clinical trial of cavrotolimod (AST-008) in September 2020

Confirmed overall response rate (ORR) of 21% in the dose-escalation stage across all doses, confirmed ORR 33% at the highest dose cohort and recommended Phase 2 dose.
Target tumor shrinkage was observed in 37% of patients.
Preliminary data show activity in patients with melanoma, Merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (CSCC).
Phase 2 arms in both MCC and CSCC are currently recruiting.

Cavrotolimod (AST-008) Phase 1b/2 clinical trial is open and actively enrolling patients

In the second quarter of 2020, the Company began enrolling patients in the Phase 2 dose expansion phase of its Phase 1/2 clinical trial of intra-tumoral cavrotolimod (AST-008) in combination with approved checkpoint inhibitors pembrolizumab or cemiplimab, for the treatment of patients with advanced or metastatic MCC or CSCC.
Currently, 14 clinical trial sites are open for enrollment and 7 additional sites are pending activation; the Company expects to open up to 25 sites for the Phase 2 stage of the clinical trial.
We continue to monitor the impact that COVID-19 may be having on patient enrollment and safety, site initiation, and study integrity. We have put in place and continue to maintain a variety of measures to mitigate the effects of COVID-19 and our top priority is to maintain patient safety and clinical trial continuity. During the third quarter of 2020, we have observed delays in our enrollment plans for the Phase 2 dose expansion phase of this clinical trial. The effects of the COVID-19 pandemic or its impact may have contributed to such delays. As a result, we have taken additional measures to increase the enrollment of patients, including frequent interaction with our clinical trial sites currently open as well as increasing the number of clinical trial sites that potentially are activated for this clinical trial so that we may continue to enroll patients as planned. However, these delays have caused us to lengthen our clinical development timeline for cavrotolimod (AST-008) and we now expect to report ORR results in the first half of 2022 rather than by year-end 2021 as previously guided.

Third Quarter Financial Results, Financial Guidance and Recent Developments

Cash Position: Cash, cash equivalents, and short-term investments were $94.1 million as of September 30, 2020 compared to $85.8 million as of June 30, 2020, and the increase is attributed to the borrowing of the first tranche ($17.5 million) of the $25.0 million senior secured term loan with MidCap Financial Trust (MidCap), as agent, and Silicon Valley Bank (SVB).

Research and Development (R&D) Expenses: Research and development expenses were $9.1 million for the quarter ended September 30, 2020, as compared to $4.2 million for the quarter ended September 30, 2019. The Company continues to increase staffing in the R&D function, increasing headcount from 26 at September 30, 2019 to 48 at September 30, 2020 and the associated increase in hiring, in addition to growth in cavrotolimod (AST-008) clinical trial activities, has driven the Company’s increase in R&D costs. The associated increases in platform and discovery-related costs reflected increased preclinical R&D activities associated with the Company’s collaboration with AbbVie Inc. (AbbVie), increased costs related to XCUR-FXN, as well as other preclinical discovery work in neurology and ophthalmology.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.4 million for the quarter ended September 30, 2020, as compared with $2.2 million for the quarter ended September 30, 2019.

Net Loss: The Company had a net loss of $8.8 million for the quarter ended September 30, 2020 compared to a net loss of $5.8 million for the quarter ended September 30, 2019 reflecting a higher net loss of $3.0 million. This increase in net loss was driven principally by the increases in R&D expenses and G&A expenses discussed above, partially offset by the recognition of $2.4 million of revenue associated with our collaboration with AbbVie.

Cash Runway Guidance: The Company believes that, based on its current operating plans and estimates of future expenses, as of the date of this press release, its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

Response to COVID-19: With the global spread of the ongoing COVID-19 pandemic in 2020, we have been closely monitoring developments and have taken active measures to protect the health of our employees and their families, our communities, as well as our clinical trial investigators, patients and caregivers. We continue to carefully manage laboratory staffing and take other appropriate managerial actions to maintain progress on our preclinical and collaboration programs. We also continue to work closely with our third-party manufacturers and other partners to manage our supply chain activities and will take such action as we believe appropriate with our clinical operations to maintain patient safety and clinical trial continuity.

Resignation of Director: On November 10, 2020, Helen S. Kim resigned as a Class II director of our Board of Directors, or the Board, as well as from the Nominating and Corporate Governance Committee of the Board, effective immediately. Ms. Kim’s decision to resign was not the result of any disagreement between Ms. Kim and our Company, management, the Board or any committee thereof, on any matter relating to our operations, policies or practices. We thank Ms. Kim for her six years of service on the Board.

About Exicure, Inc.

Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for neurology, immuno-oncology, inflammatory diseases and other genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure is in preclinical development of XCUR-FXN an SNA–based therapeutic candidate, for the treatment of Friedreich’s ataxia (FA). Exicure’s therapeutic candidate cavrotolimod (AST-008) is in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Exicure is based in Chicago, IL and in Cambridge, MA.

For more information, visit Exicure’s website at www.exicuretx.com.

Exicure Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical fact could be deemed forward looking including, but not limited to, statements regarding the anticipated and potential impact of the COVID-19 pandemic and its impact and effects on the company’s business and operations, including the conduct of and timeline for its ongoing Phase 1b/2 clinical trial for cavrotolimod (AST-008); the company’s plans, initiatives and expectations in light of and in response to the COVID-19 pandemic; the company’s expectations regarding its ability to adapt its business to the evolving COVID-19 pandemic, mitigate its impacts on the business and maintain business continuity; the design, timing and results of its Phase 1b/2 clinical trial of cavrotolimod (AST-008) including patient enrollment expectations and opening of additional clinical trial sites; the initiation, timing and results of its other preclinical studies and clinical trials, including XCUR-FXN; the potential of the company’s SNA technology to provide therapeutic benefit to target diseases, including its ability to address the genetic challenges posed by Friedreich’s ataxia and other neurological conditions; the potential of the company’s collaborations and R&D efforts; the company’s ability to advance its clinical and pre-clinical pipelines; the company’s expectations with respect to its continued growth; and the company’s anticipated extended cash runway. The forward-looking statements in this press release speak only as of the date of this press release, and the company undertakes no obligation to update these forward-looking statements. Forward-looking statements are based on management’s current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risks that the ongoing COVID-19 pandemic or its impact or effects may disrupt the company’s business and/or the global healthcare system more severely than it has to date or more severely than anticipated, which may have the effect of impacting or delaying the company’s ongoing Phase 1b/2 clinical trial; unexpected costs, charges or expenses that reduce the company’s capital resources; the company’s preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the cost, timing and results of clinical trials; that many drug candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; regulatory developments; risks that preliminary results from clinical trials are not necessarily predictive of future clinical trial results; and the ability of the company to protect its intellectual property rights. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by the company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the company undertakes no duty to update this information, except as required by law. In addition, the COVID-19 pandemic and the associated containment efforts have had and continue to have a serious adverse impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts have only partially mitigated the consequences. The extent and duration of the impact on the company’s business and operations is highly uncertain, and that impact includes effects on its clinical trial operations, timelines and supply chain. Factors that will influence the impact on the company’s business and operations include the duration and extent of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The COVID-19 pandemic or its impact or effects could have a material adverse impact on the company’s business, operations and financial results for an extended period of time.

EXICURE, INC. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data)

	September 30, 2020		December 31, 2019

ASSETS
Current assets:
Cash and cash equivalents……………………………………………………………………………	$	31,459	$	48,460
Short-term investments………………………………………………………………………………..	62,621		62,326
Accounts receivable…………………………………………………………………………………….	59		16
Unbilled revenue receivable…………………………………………………………………………	6		19
Prepaid expenses and other assets…………………………………………………………………	2,684		1,955
Total current assets………………………………………………………………………………………..	96,829		112,776
Property and equipment, net……………………………………………………………………………	4,269		2,099
Right-of-use asset………………………………………………………………………………………….	8,768		356
Other noncurrent assets…………………………………………………………………………………..	1,414		32
Total assets………………………………………………………………………………………	$	111,280	$	115,263
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current portion of long-term debt………………………………………………………………….	$	—	$	4,965
Accounts payable………………………………………………………………………………………..	2,006		1,814
Accrued expenses and other current liabilities………………………………………………..	2,124		2,435
Deferred revenue, current…………………………………………………………………………….	8,479		21,873
Total current liabilities…………………………………………………………………………………..	12,609		31,087
Long-term debt, net………………………………………………………………………………………..	16,500		—
Common stock warrant liability, noncurrent……………………………………………………..	—		414
Deferred revenue, noncurrent………………………………………………………………………….	—		2,956
Lease liability, noncurrent	8,087		59
Other noncurrent liabilities……………………………………………………………………………..	656		—
Total liabilities…………………………………………………………………………………	$	37,852	$	34,516

Stockholders’ equity:
Common stock, $0.0001 par value per share; 200,000,000 shares authorized,
87,228,586 issued and outstanding, September 30, 2020; 86,069,263
issued and outstanding, December 31, 2019…………………………………………	9		9
Additional paid-in capital……………………………………………………………………………….	166,499		162,062
Accumulated other comprehensive income (loss)………………………………………………	200		(27)
Accumulated deficit……………………………………………………………………………………….	(93,280)		(81,297)
Total stockholders’ equity…………………………………………………………………..	73,428		80,747
Total liabilities and stockholders’ equity……………………………………………..	$	111,280	$	115,263

EXICURE, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data)

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Revenue:
Collaboration revenue………………………………………………………………………..	$	2,443	$	527	$	16,473	$	986
Total revenue……………………………………………………………………	2,443		527		16,473		986
Operating expenses:
Research and development expense………………………………………………………………………..	9,139		4,245		22,222		11,073
General and administrative expense………………………………………………………………………..	2,424		2,228		7,227		6,421
Total operating expenses……………………………………………………………………	11,563		6,473		29,449		17,494
Operating loss……………………………………………………………………………	(9,120)		(5,946)		(12,976)		(16,508)
Other income (expense), net:
Dividend income………………………………………………………………………..	2		228		45		415
Interest income………………………………………………………………………..	205		1		832		3
Interest expense………………………………………………………………………..	(27)		(203)		(155)		(589)
Other income (expense), net………………………………………………………………………..	118		104		271		357
Total other income (expense), net……………………………………………………………………	298		130		993		186
Net loss……………………………………………………………………………	$	(8,822)	$	(5,816)	$	(11,983)	$	(16,322)

Basic and diluted loss per common share……………………………………………………………………………	$	(0.10)	$	(0.09)	$	(0.14)	$	(0.32)
Weighted-average basic and diluted common shares outstanding……………………………………………………………………………	87,227,136		64,651,040		87,160,520		51,200,072

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005225/en/

Media:

Karen Sharma

MacDougall

781-235-3060

[email protected]

Investors:

Thomas Hoffmann

Solebury Trout

+1-646-378-2931

[email protected]

KEYWORDS: Illinois Massachusetts United States North America

INDUSTRY KEYWORDS: Research Genetics Clinical Trials Biotechnology Health Pharmaceutical Other Science Science Oncology

MEDIA:

Logo

November 12, 2020 7:03 am

First American Docutech Announces New Integration With Encompassby Ellie Mae

First American Docutech Announces New Integration With Encompass^{by Ellie Mae}

—Lenders can now implement dynamic document generation and eClosing faster—

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–First American Docutech^®, the leading provider of document, eSign, eClose and digital to print fulfillment technology, and a member of the First American family of companies, today announced a new streamlined integration with Encompass^®loan origination software by Ellie Mae^®. With the integration, Encompass lenders can accelerate their closing process by easily implementing First American Docutech’s suite of digital mortgage and closing solutions. The integration seamlessly updates key disclosure tracking fields, and automatically delivers documents into Encompass.

“Lenders of all sizes are focusing on digitizing as much of their loan process as possible to optimize the borrower experience, maximize loan production, and reduce costs,” said Amy Brandt, president, First American Docutech. “For smaller lenders though, it’s been challenging to compete with the larger financial institutions on a level technology playing field. Now, through a new integration with Encompass, lenders can easily implement our suite of solutions with very limited effort, enabling them to digitize their process from point-of-sale origination through closing, and on to secondary market delivery.”

Ellie Mae, now a part of Intercontinental Exchange, Inc. (NYSE: ICE), is a leading cloud-based loan origination platform provider for the mortgage industry. Lenders across the U.S. trust Ellie Mae’s Encompass loan origination system to help them originate more loans, lower costs and reduce time to close. The combination of Encompass with First American Docutech provides lenders with higher efficiencies towards enabling an end-to-end digital mortgage experience.

“We are thrilled to expand our digital solution suite integration within Encompass,” said Brandt. “As a long-time Ellie Mae partner and market leader in dynamic document generation and eClosing, we recognized the need to provide lenders with more options and the ability to choose the right solution at the right time based on their unique strategy. This new integration model was designed with small- to medium-sized lenders in mind to give them the ability to close more loans, faster and deliver a superior customer experience.”

About First American Docutech

First American Docutech, a part of the First American family of companies, provides an end-to-end integrated digital mortgage experience that enables lenders to accelerate the real estate closing process. The company digitizes and streamlines the creation, delivery, execution and perfection of mortgage documents. First American Docutech sets the standard in providing market-proven technology and unrivaled customer service to the financial industry. For more information, visit the company’s website at www.firstam.com/docutech or follow them on LinkedIn or Twitter (@Docutech).

About First American

First American Financial Corporation (NYSE: FAF) is a leading provider of title insurance, settlement services and risk solutions for real estate transactions that traces its heritage back to 1889. First American also provides title plant management services; title and other real property records and images; valuation products and services; home warranty products; property and casualty insurance; banking, trust and wealth management services; and other related products and services. With total revenue of $6.2 billion in 2019, the company offers its products and services directly and through its agents throughout the United States and abroad. In 2020, First American was named to the Fortune 100 Best Companies to Work For^® list for the fifth consecutive year. More information about the company can be found at www.firstam.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005181/en/

Media Contact:

Marcus Ginnaty

Corporate Communications

First American Financial Corporation

(714) 250-3298

KEYWORDS: Arizona United States North America

INDUSTRY KEYWORDS: Professional Services Technology Residential Building & Real Estate Software Finance Construction & Property Banking

MEDIA:

Logo

November 12, 2020 7:03 am

eCommerce Transactions Will Soar During Holiday Shopping Season as Pandemic Leads to More Lockdowns, per New Data from ACI Worldwide

eCommerce Transactions Will Soar During Holiday Shopping Season as Pandemic Leads to More Lockdowns, per New Data from ACI Worldwide

As consumers prepare for holiday shopping season, concern over lockdowns drives early shopping with a 53 percent increase in the retail sector in October 2019 vs. 2020

NAPLES, Fla.–(BUSINESS WIRE)–
New benchmark data from ACI Worldwide (NASDAQ: ACIW), a leading global provider of real-time digital payment software and solutions, revealed a 23 percent increase in global eCommerce transactions in October 2020 compared to October 2019. This increase was driven by the retail, gaming, DIY and digital sectors as consumers prepare for further lockdowns. In addition, the data, based on hundreds of millions of eCommerce transactions from global merchants, showed a projected 25 percent increase in volume of transactions for all sectors combined (including those impacted by the pandemic, such as airline and ticketing) in Q4 2020 compared to Q4 2019.

ACI’s data also showed that the second wave of COVID-19 lockdowns in the EMEA region has already resulted in a more than 100 percent increase in eCommerce transactions in the retail sector from November 1-4, 2020.

“With the U.K. already in another lockdown and the U.S. potentially heading toward one, we’re seeing consumers prepare to hunker down for the holidays and get their shopping done earlier than ever,” said Debbie Guerra, executive vice president, ACI Worldwide. “Related, merchants are offering deals earlier, which has also driven increases in transaction volumes in October compared to the same time last year. We’re expecting this trend to continue as we move further into the holiday season.”

ACI’s data from October 2020 showed a slight increase to 4.1 percent in the value of fraud attempts compared to the same period in 2019 as genuine consumers continue to outpace fraudulent consumers.

The gaming sector continued to see record levels of transactions, with a 90 percent increase in October 2020 compared to 2019. Sectors that continue to see a decline in transactions include travel (33%) and ticketing (79%).

“Lockdowns have led many consumers to cancel any plans to travel—such as holiday getaway vacations—or attend large group gatherings, leading to an even greater decline in airline and ticketing compared to the previous year,” Guerra concluded.

Key Findings:

eCommerce purchasing trends:

Sectors that continue to experience major increases in purchases in October include gaming (90% increase) and retail (53% increase).
Sectors that continue to experience major decreases in purchases in October include travel (33% decrease) and ticketing (79% decrease).
The average ticket price of genuine purchases dropped by $21 in 2020 compared to 2019, driven by declines within the airline and ticketing sectors, which yield higher ticket prices on average.

Fraud trends:

Transactional value of fraud attempts increased 0.4 percent in October, driven by purchases of electronics, with buy online, pick-up in-store (BOPIS) being the channel of choice for fraudsters.
The average ticket price for fraud attempts decreased by $9 in the period January through October 2020, compared to the same period in 2019.
Non-fraud chargebacks* increased by 10 percent in October 2020 compared to October 2019; this has been declining compared to March-June 2020. Reasons include the following:
- Backlog of processing returns since employees have been unable to work due to stay at home restrictions, and safety concerns around opening boxes due to COVID-19
- Call centers were not staffed for several days in March to answer incoming customer calls
- Shipment delays
- Product back order

*Chargebacks often take approximately 45 days to process.

About ACI Worldwide

ACI Worldwide powers digital payments for more than 6,000 organizations around the world. More than 1,000 of the largest financial institutions and intermediaries, as well as thousands of global merchants, rely on ACI to execute $14 trillion each day in payments and securities. In addition, myriad organizations utilize our bill presentment and payment services. Through our comprehensive suite of software solutions delivered on customers’ premises, through the public cloud or through ACI’s private cloud, we provide real-time payment capabilities and enable the industry’s most complete omni-channel payments experience.

© Copyright ACI Worldwide, Inc. 2020

ACI, ACI Worldwide, ACI Payments, Inc., ACI Pay, Speedpay and all ACI product/solution names are trademarks or registered trademarks of ACI Worldwide, Inc., or one of its subsidiaries, in the United States, other countries or both. Other parties’ trademarks referenced are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005159/en/

Dan Ring

[email protected]

781-370-3600

Nidhi Alberti

[email protected]

781-370-3600

KEYWORDS: Florida Massachusetts United States North America

INDUSTRY KEYWORDS: Professional Services Data Management Technology Other Technology Software Finance Banking

MEDIA:

Logo