Market Newsdesk

MALVERN, Pa., Nov. 11, 2020 (GLOBE NEWSWIRE) — TELA Bio, Inc. (“TELA”) (Nasdaq: TELA), a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today reported financial results for the third quarter ended September 30, 2020. 

Recent Highlights

• Reported revenue of $5.3 million for the third quarter of 2020, increasing 34% over the third quarter of 2019
   
• Presented additional data from the BRAVO post-market study, further demonstrating a low incidence of surgical site infections and occurrences and an initial two-year hernia recurrence rate of zero
   
• Strategically added to commercial sales team and continued to educate surgeons through TELA LIVE virtual programs

“I am pleased with our strong third quarter results and proud of our team in continuing to execute and deliver to our customers and patients despite the ongoing challenges associated with the current pandemic,” said Antony Koblish, co-founder, President and Chief Executive Officer of TELA Bio. “While we are encouraged by the healthy rebound we saw in hernia procedures in the third quarter, there continues to be uncertainty in light of the increased number of daily COVID-19 cases in certain regions of the country. However, we remain cautiously optimistic and prepared as a team to meet the challenges of these dynamic times and adapt our commercial plan to ensure that we can continue to support our customers and advance our mission of improving patient care and outcomes.”

Third Quarter 2020 Financial Results

Revenue was $5.3 million for the third quarter of 2020, an increase of 34% compared to the prior year period. Despite strong quarterly revenue, revenue growth in the third quarter was impacted by lower than expected procedural volumes as a result of hospitals and patients deferring elective procedures and other factors related to the COVID-19 pandemic.

Gross profit was $3.3 million for the third quarter of 2020, or 62% of revenue, compared to $2.6 million, or 66% of revenue, in the same period in 2019. The decrease in gross margin was due to the increase in the charge for excess and obsolete inventory adjustments as a percentage of revenue.

Operating expenses were $10.2 million in the third quarter of 2020, compared to $6.5 million in the same period in 2019. The increase was due to the expansion of our commercialization activities, increased outside development expenses and increased costs associated with operating as a public company, which were partially offset by lower travel and consulting expenses resulting from the cost containment actions taken in response to the COVID-19 pandemic.

Loss from operations was $6.9 million in the third quarter of 2020, compared to a loss from operations of $3.9 million in the same period in 2019.

Net loss was $7.7 million in the third quarter of 2020, compared to a net loss of $4.7 million in the same period in 2019.

Total cash and cash equivalents at September 30, 2020 were $81.5 million.

Financial Outlook

There is considerable uncertainty and lack of visibility regarding the Company’s near-term revenue growth prospects and product development plans due to the rapidly evolving environment resulting from the COVID-19 pandemic. The COVID-19 pandemic is a highly fluid situation, and it is not currently possible for the Company to reasonably estimate the impact that it may have on financial and operating results.  Accordingly, TELA Bio will not be providing 2020 financial guidance. 

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Wednesday, November 11, 2020, at 4:30 PM ET.

To participate in the call, please dial (855) 548-1219 (domestic) or (409) 217-8881 (international) and provide conference ID 1670209. The live webcast will be available on the Events & Presentations page of the Investors section of TELA’s website.

About TELA Bio, Inc.

TELA Bio, Inc. is a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction. TELA’s products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA’s portfolio is supported by quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over other commercially available products.

Caution Regarding Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of TELA’s management. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: the impact to our business of the ongoing COVID-19 pandemic, including but not limited to any impact on our ability to market our products, demand for our products due to deferral of procedures using our products or disruption in our supply chain, our ability to achieve or sustain profitability, our ability to gain market acceptance for our products and to accurately forecast and meet customer demand, our ability to compete successfully, our ability to enhance our product offerings, development and manufacturing problems, capacity constraints or delays in production of our products, maintenance of coverage and adequate reimbursement for procedures using our products, product defects or failures. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and TELA assumes no obligation to updates to our forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

TELA Bio Contact

Stuart Henderson
Vice President, Corporate Development and Investor Relations
TELA Bio, Inc.
484-320-2930

Investor Contact
Greg Chodaczek
347-620-7010 
[email protected]

TELA Bio, Inc.

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

	September 30,				December 31,
	2020				2019
Assets
Current assets:
Cash and cash equivalents	$	81,467			$	45,302
Short-term investments		—				9,285
Accounts receivable, net		2,640				2,836
Inventory		4,042				4,603
Prepaid expenses and other assets		867				2,308
Total current assets		89,016				64,334
Property and equipment, net		652				677
Intangible assets, net		2,683				2,911
Total assets	$	92,351			$	67,922
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	976			$	3,171
Accrued expenses and other current liabilities		4,369				3,542
Total current liabilities		5,345				6,713
Long‑term debt with related party		30,673				30,243
Other long‑term liabilities		—				4
Total liabilities		36,018				36,960
Stockholders’ equity:
Preferred stock; $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding		—				—
Common stock; $0.001 par value: 200,000,000 shares authorized; 14,432,472 and 11,406,976 shares issued and 14,432,220 and 11,406,221 shares outstanding at September 30, 2020 and December 31, 2019, respectively		14				11
Additional paid-in capital		245,199				198,829
Accumulated other comprehensive loss		(17	)			(19	)
Accumulated deficit		(188,863	)			(167,859	)
Total stockholders’ equity		56,333				30,962
Total liabilities and stockholders’ equity	$	92,351			$	67,922

TELA Bio, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

	Three months ended								Nine months ended
	September 30,								September 30,
	2020				2019				2020				2019
Revenue	$	5,313			$	3,973			$	12,546			$	10,582
Cost of revenue (excluding amortization of intangible assets)		1,950				1,293				4,746				4,045
Amortization of intangible assets		76				76				228				228
Gross profit		3,287				2,604				7,572				6,309
Operating expenses:
Sales and marketing		6,342				4,736				15,734				12,678
General and administrative		2,607				1,208				7,274				3,737
Research and development		1,201				516				3,092				3,230
Total operating expenses		10,150				6,460				26,100				19,645
Loss from operations		(6,863	)			(3,856	)			(18,528	)			(13,336	)
Other (expense) income:
Interest expense		(898	)			(899	)			(2,661	)			(2,725	)
Change in fair value of preferred stock warrant liability		—				34				—				(4	)
Other income		58				55				185				172
Total other (expense) income		(840	)			(810	)			(2,476	)			(2,557	)
Net loss		(7,703	)			(4,666	)			(21,004	)			(15,893	)
Accretion of redeemable convertible preferred stock to redemption value		—				(2,058	)			—				(6,843	)
Net loss attributable to common stockholders	$	(7,703	)		$	(6,724	)		$	(21,004	)		$	(22,736	)
Net loss per common share, basic and diluted	$	(0.53	)		$	(22.58	)		$	(1.69	)		$	(76.62	)
Weighted average common shares outstanding, basic and diluted		14,421,990				297,750				12,431,257				296,743
Comprehensive loss:
Net loss	$	(7,703	)		$	(4,666	)		$	(21,004	)		$	(15,893	)
Foreign currency translation adjustment		(29	)			1				2				(2	)
Comprehensive loss	$	(7,732	)		$	(4,665	)		$	(21,002	)		$	(15,895	)

TORONTO, Nov. 11, 2020 (GLOBE NEWSWIRE) — ECN Capital Corp. (TSX: ECN) (“ECN Capital” or the “Company”) today reported financial results for the three-month period ended September 30, 2020.

For the three-month period ended September 30, 2020, ECN Capital reported Adjusted netincomeapplicable to common shareholders from continuing operations of $23.3 million or $0.10 per share (basic) versus $17.0 million or $0.07 per share (basic) for the previous three-month period ended June 30, 2020 and $18.2 million or $0.08 per share (basic) for the same period last year.

“ECN’s strong Q3 earnings of $0.10, reflects ongoing strength in each of our businesses, which was apparent before Covid-19 and has continued in its face.”, said Steven Hudson, CEO of ECN Capital Corp. “We are reiterating guidance for 2020 at $0.31-$0.33, which is 15-22% above 2019 and given our performance confidently reiterating our guidance for 2021 at $0.44 – $0.53. I am very pleased with the resiliency of each of our businesses and look forward updating everyone at our Investor Day on February 4, 2021”

Originations for the three-month period ended September 30, 2020 were $842 million versus $676 million in the previous three-month period and $639 million for the same period last year.

Total Earning Assets
Manage
d
and Advis
ory as at September 30, 2020 were $32.2 billion, versus $33.3 billion as at June 30, 2020 and $32.6 billion at September 30, 2019.

Adjusted
EBITDA for the three-month period ended September 30, 2020 was $38.9 million versus $31.3 million for the previous three-month period and $34.0 million for the same period last year.

Operating Expenses for the three-month period ended September 30, 2020 were $30.6 million versus $29.9 million reported for the previous three-month period and $29.3 million for the same period last year.

Net Income
(loss)
attributable to common shareholders for the three-month period ended September 30, 2020 was $5.6 million versus ($1.8) million for the previous three-month period and $2.4 million for the same period last year.

Dividends Declared

The Company’s Board of Directors has authorized and declared a quarterly dividend of $0.025 per outstanding common share to be paid on December 31, 2020 to shareholders of record at the close of business on December 15, 2020. These dividends are designated to be eligible dividends for purposes of section 89(1) of the Income Tax Act (Canada).

The Company’s Board of Directors declared the following dividends on ECN Capital’s preferred shares:

• A quarterly dividend of $0.40625 per outstanding Cumulative 5-Year Rate Reset Preferred Share, Series A (TSX: ECN.PR.A) payable on December 31, 2020 to shareholders of record on the close of business on December 15, 2020. These dividends are designated to be eligible dividends for purposes of section 89(1) of the Income Tax Act (Canada).
• A quarterly dividend of $0.390625 per outstanding Cumulative 5-Year Rate Reset Preferred Share, Series C (TSX: ECN.PR.C) payable on December 31, 2020 to shareholders of record on the close of business on December 15, 2020. These dividends are designated to be eligible dividends for purposes of section 89(1) of the Income Tax Act (Canada).

Webcast

The Company will host its analyst briefing to discuss these results commencing at 5:30 PM (ET) on Wednesday, November 11, 2020. The call can be accessed as follows:

Webcast	http://services.choruscall.ca/links/ecncapitalcorp20201111.html
Toll-free dial in	North America 1-800-319-8560 International 1-604-638-5345 Passcode 47234#
Presentation slides	http://ecncapitalcorp.com/investors/presentations

The webcast will be available until December 11, 2020. A recording of the conference call may also be accessed until February 11, 2021 by dialing 1-800-319-6413 and entering the passcode 5576#.

Non-IFRS Measures

The Company’s interim unaudited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and the accounting policies we adopted in accordance with IFRS.

The Company believes that certain Non-IFRS Measures can be useful to investors because they provide a means by which investors can evaluate the Company’s underlying key drivers and operating performance of the business, exclusive of certain adjustments and activities that investors may consider to be unrelated to the underlying economic performance of the business of a given period. Throughout this Press Release, management used a number of terms and ratios which do not have a standardized meaning under IFRS and are unlikely to be comparable to similar measures presented by other organizations. A full description of these measures can be found in the Management Discussion & Analysis that accompanies the financial statements for the three and nine-month periods ended September 30, 2020.

ECN Capital’s Management Discussion and Analysis as at and for the three and nine-month periods ended September 30, 2020 has been filed on SEDAR (www.sedar.com) and is available under the investor section of the Company’s website (www.ecncapitalcorp.com).

About ECN Capital Corp.

With managed and advised assets of US$32 billion, ECN Capital Corp. (TSX: ECN) is a leading provider of business services to North American based banks, credit unions, life insurance companies, pension funds and investment funds (collectively our “Partners”). ECN Capital originates, manages and advises on credit assets on behalf of its Partners, specifically unsecured loan portfolios, secured loan portfolios and credit card portfolios. Our Partners are seeking high quality assets to match with their deposits or other liabilities. These services are offered through three operating businesses: Service Finance, Triad Financial Services and The Kessler Group.

Contact

John Wimsatt
647-649-4634
[email protected]

Forward-looking Statements

This release includes forward-looking statements regarding ECN Capital and its business. Such statements are based on the current expectations and views of future events of ECN Capital’s management. In some cases the forward-looking statements can be identified by words or phrases such as “may”, “will”, “expect”, “plan”, “anticipate”, “intend”, “potential”, “estimate”, “believe” or the negative of these terms, or other similar expressions intended to identify forward-looking statements. Forward-looking statements in this press release include those relating to
the future financial and operating performance of ECN Capital, the strategic advantages, business plans and future opportunities of ECN Capital and the ability of ECN Capital to access adequate funding sources, identify and execute on acquisition opportunities and transition t
o an asset management business.
The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting ECN Capital, including risks regarding the equipment finance industry, economic factors, and many other factors bey
ond the control of ECN Capital.
No forward-looking statement can be guaranteed. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information.
A discussion of the material risks and assumptions associated with this outlook can be fou
nd in ECN Capital’s
September
30
,
20
20
MD&A and
201
9
AIF Di
sclosure Document dated March
26
,
20
20
which
ha
ve
been filed on SEDAR and can be accessed at
www.sedar.com
.
Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and ECN Capital does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

• OpGen takes strategic steps to expand the Unyvero platform and product pipeline, to focus on the pending Acuitas AMR Gene Panel (isolates) FDA clearance and expects to invest significantly in bioinformatics
• OpGen subsidiary Ares Genetics received notification of exercise of option to negotiate for a potential future license by its IVD Partner
• OpGen
  has
  discontinue
  d
  Acuitas AMR Gene Panel (urine) clinical trial and
  will
  discontinue FISH product line globally by mid-2021
• Total Revenue for Q3 2020 was approximately $1.
  1
  million dollars
• Maintained strong balance sheet with $10.
  5
  million cash as of September 30, 2020

Conference call to be held at 4:30 p.m. Eastern Time today

GAITHERSBURG, Md., Nov. 11, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported today its financial and operating results for the three and nine months ended September 30, 2020 and provided a business update. Total OpGen revenue for the third quarter of 2020 was approximately $1.1 million, up from $0.6 million in the third quarter of 2019. The financial results for the three months ended September 30, 2020 reflect the consummation of our business combination with Curetis GmbH on April 1, 2020. OpGen’s cash as of September 30, 2020 was approximately $10.5 million. The company has access to an additional $6.4 million under its expanded ATM program and has 594,000 warrants outstanding at an average exercise price of $2.16. In addition, the Company continues to have access to an additional €5.0 million tranche of non-dilutive debt financing for COVID-19 related R&D programs from the European Investment Bank.

As previously reported, OpGen announced details regarding a strategic reprioritization of its product portfolio, platform pipeline and priorities going forward. This reprioritization was based on feedback from extensive market research, a customer survey of 150 stakeholders in the decision making on new diagnostic platforms, and key-opinion-leader interviews conducted by an independent market research firm over the past two quarters. Following a review of this research, OpGen and its board decided to consolidate the company’s product portfolio on its proprietary Unyvero platform and unique bioinformatics capabilities. As a result of this change in priority, the company anticipates the following key impacts:

• Product portfolio going forward is centered around rapid, molecular diagnostic platform offerings and increased focus on value added bioinformatics solutions, including Ares Genetics’ next generation sequencing-based and artificial intelligence powered AMR and AST prediction capabilities.
• Following the successful completion of the three phases of the partnered R&D program as announced in the during our second quarter 2020 earnings call, Ares Genetics has recently received formal notification from its undisclosed global leading IVD corporation partner that they have exercised their option to exclusively negotiate with Ares Genetics the scope and terms of a potential exclusive license or other arrangement with Ares to Ares Genetics’ technology in the field of human clinical diagnostics in the coming months.
• Platform consolidation to realize significant operational synergies and cost savings over time as fewer products and platforms would need to be maintained from a regulatory, quality management and logistics and service standpoint.
• Unyvero platform and product portfolio to be expanded beyond lower respiratory tract infections such as pneumonia (LRT / LRT BAL) to include complicated urinary tract infections (cUTI) and invasive joint infections (IJI) in the U.S. with clinical trials for future FDA submission and clearance anticipated to start in 2021. Similar products in both clinical indication areas using the same sample types have already been successfully developed and CE-IVD marked and are commercially available in Europe and other markets.
• Recent notification from the FDA has indicated that the agency plans to continue prioritizing emergency use authorization (EUA) requests for diagnostic products intended to address the COVID-19 pandemic for at least the remainder of the year, which will impact the statutory review periods for ongoing submissions. During this time, the FDA plans to provide monthly updates regarding the ongoing impact of such prioritization of EUAs on our Acuitas AMR Gene Panel for Isolates submission. Despite such impact, OpGen has remained in open and ongoing dialogue with the FDA regarding the status of the Acuitas AMR Gene Panel for Isolates submission since our October 2020 formal response to the FDA’s Additional Information (AI) requests. If the Acuitas AMR Gene Panel for Isolates is cleared by the FDA, OpGen anticipates swift commercial launch in the U.S. in the following months.
• Legacy FISH products business including Quick FISH^® and PNA FISH^® to be discontinued by mid-2021 in Europe, the U.S. and rest of world with last production lots to be manufactured in early 2021. All customers in the U.S. and distributors in Europe have been informed of the discontinuation and OpGen expects last stocking orders to come in by year-end with several orders already received.
• Acuitas AMR Gene Panel (urine) clinical trial has been discontinued and all clinical trial sites have been notified as focus shifts to Unyvero platform for complicated UTI indication as well as additional future applications.

Oliver Schacht, President and CEO of OpGen commented, “Reprioritization efforts including the consolidation of our product portfolio highlights our focus on rapid, molecular diagnostic offerings and bioinformatics as we look to 2021 and beyond. Additionally, the discontinuation of the Acuitas AMR Gene Panel (urine) clinical trial and the Legacy FISH products business will result in significant operational synergies and cost savings for OpGen. We believe this shift will create meaningful, long term shareholder value for our investors, partners and healthcare provides alike as we continue to establish ourselves as industry leaders in molecular diagnostics and bioinformatics space.”

Third
Quarter
and
Nine Month
2020
F
inancial Results

• Total revenue for the third quarter of 2020 was approximately $1.1 million, up from $0.6 million in the third quarter of 2019. Total revenue for the nine months ended September 30, 2020 was $2.9 million, compared with $2.7 million for the nine months ended September 30, 2019;
• Operating expenses for the third quarter of 2020 were $7.2 million, compared with $4.1 million in the third quarter of 2019. Operating expenses for the nine months ended September 30, 2020 were $19.6 million, compared with $12.4 million for the nine months ended September 30, 2019;
• The net loss for the third quarter of 2020 was $7.7 million or $0.40 per share, compared with $3.5 million or $3.95 per share in the third quarter of 2019. The net loss for the nine months ended September 30, 2020 was $19.1 million or $1.36 per share, compared with a net loss of $9.9 million or $13.32 per share for the nine months ended September 30, 2019; and
• Cash and cash equivalents were $10.5 million as of September 30, 2020.

The company also announced accomplishment of the following key milestones in the third quarter of 2020 and year to date:

• OpGen’s subsidiary Curetis GmbH obtained CE mark certification in the European Union for its own SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus that causes COVID-19.
• OpGen announced that subsidiary Ares Genetics GmbH won the Austrian national digitization award and was also nominated for the 40^th Austrian Innovation Award for its artificial intelligence powered, next-generation sequencing based molecular antibiotic susceptibility test marketed under the brand name ARESupa – Universal Pathogenome Assay.
• OpGen’s subsidiary Curetis GmbH was awarded EUR 350 thousand in non-dilutive grant funding in a collaboration project with InfectoGnostics campus at Jena University Hospital.
• OpGen announced the award of a German Federal Government grant to its subsidiary, Curetis GmbH, and collaborators Carpegen GmbH and the Clinic for Small Animal Internal Medicine of the LMU Ludwig-Maximilians University to collaborate on a project focused on travel related and enteric diseases in small animals.
• OpGen’s subsidiary Ares Genetics GmbH in collaboration with researchers from the Johns Hopkins University School of Medicine, announced the publishing of a peer-reviewed study on modifiable risk factors for the emergence of ceftolozane-tazobactam resistance in P. aeruginosa in the journal Clinical Infectious Diseases.
• OpGen announced the release of a new peer-reviewed publication that demonstrates the clinical utility of the Unyvero LRT panel and its potential impact on antibiotic use in hospitalized patients with suspected pneumonia compared to treatment directed based on microbiological culture results.
• OpGen successfully completed its study collaboration with Karolinska Institutet on bacterial co-infections in COVID-19 pneumonia patients and data on the Unyvero HPN Panel was presented by the Karolinska investigators at ECCVID 2020.
• OpGen significantly improved its working capital position in the third quarter of 2020 through the sale of approximately 1.8 million shares of common stock under the company’s ATM program and the exercise of warrants from the October 2019 financing for gross proceeds of $4.3 million during the third quarter. During the nine months ended September 30, 2020, the Company sold approximately 11.4 million shares of common stock under the company’s ATM program and upon exercise of warrants from the October 2019 offering for gross proceeds of $24.4 million.
• The German Federal Ministry for Economic Affairs and Energy (BMWi) concluded its investigation of the OpGen business combination with Curetis with regards to its impact on the public order and security of the Federal Republic of Germany as well as national healthcare interests in the light of the current COVID-19 pandemic. No further action is expected from the Federal government on this matter.

Mr. Schacht commented, “I am pleased with our third quarter financial results and am encouraged by the exciting business updates that were issued this quarter including the CE mark certification for our SARS-CoV-2 Kit, notable awards and grants, peer-reviewed publications and the submission of our formal response letter to the FDA, which upon continued positive interactions with the FDA, makes us believe there should be a near-term clearance decision once the COVID-19 related FDA delays allow the agency to respond. In addition to the business and pipeline progress achieved this quarter, we are excited to provide further details about our reprioritization strategy aimed at creating both near-term and long-term growth potential for the company. As we wrap up 2020 OpGen is in a strong position to achieve pipeline and growth targets in the years ahead and I look forward to the company’s continued successes.”

Conference Call Information

OpGen’s management will host a conference call today, November 11 at 4:30 p.m. ET to discuss the third quarter financial results and other business activities, as well as answer questions. Dial-in information is below:

Dial-in Information

U.S. Dial-in Number: +1 (877) 705 6003
International Dial-in Number: +1 (201) 493 6725
Webcast: http://public.viavid.com/index.php?id=142176
Conference ID: 13712431

Following the conclusion of the conference call, a replay will be available through November 25, 2020. The live, listen-only webcast of the conference call may also be accessed by visiting the Investors section of the Company’s website at www.opgen.com. A replay of the webcast will be available following the conclusion of the call and will be archived on the Company’s website for 90 days. Replay access information is below:

Replay Information

U.S. Dial-in Number: +1 (844) 512 2921
International Dial-in Number: +1 (412) 317 6671
Replay PIN: 13712431

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas^® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

For more information, please visit www.opgen.com.

Forward-Looking Statements

This press release includes statements regarding OpGen’s third quarter 2020 results, the company’s strategic portfolio and product pipeline priorities, the ongoing integration of OpGen with its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, and the impact of COVID-19 on the company and general market conditions. These statements and other statements regarding OpGen’s future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:

Oliver Schacht
President and CEO
[email protected]

OpGen Press Contact:

Matthew Bretzius 
FischTank Marketing and PR
[email protected]

OpGen Investor Contact:

Megan Paul
Edison Group 
[email protected]

OpGen, Inc.
Consolidated Balance Sheets
(unaudited)
	September 30, 2020				December 31, 2019
Assets
Current assets
Cash and cash equivalents	$	10,488,072			$	2,708,223
Accounts receivable, net		423,432				567,811
Inventory, net		2,975,060				473,030
Note receivable		—				2,521,479
Prepaid expenses and other current assets		1,072,364				396,760
Total current assets		14,958,928				6,667,303
Property and equipment, net		3,370,847				130,759
Finance lease right-of-use assets, net		571,329				958,590
Operating lease right-of-use assets		1,373,418				1,043,537
Goodwill		8,057,894				600,814
Intangible assets, net		16,071,680				817,550
Other noncurrent assets		300,744				203,271
Total assets	$	44,704,840			$	10,421,824
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	1,240,351			$	1,056,035
Accrued compensation and benefits		2,003,002				855,994
Accrued liabilities		2,664,581				1,046,661
Deferred revenue		51,622				9,808
Short-term notes payable		1,156,517				373,599
Short-term finance lease liabilities		348,000				579,030
Short-term operating lease liabilities		1,142,435				1,017,414
Total current liabilities		8,606,508				4,938,541
Note payable		18,159,433				329,456
Deriviative liabilities		74,239				—
Long-term finance lease liabilities		76,701				313,263
Long-term operating lease liabilities		554,295				547,225
Other long term liabilites		154,716				–
Total liabilities		27,625,892				6,128,485
Commitments
Stockholders’ equity
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at September 30, 2020 and December 31, 2019, respectively		—				—
Common stock, $0.01 par value; 50,000,000 shares authorized; 19,799,348 and 5,582,280 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively		197,993				55,823
Additional paid-in capital		208,892,463				178,779,814
Accumulated deficit		(193,625,510	)			(174,524,983	)
Accumulated other comprehensive income/(loss)		1,614,002				(17,315	)
Total stockholders’ equity		17,078,948				4,293,339
Total liabilities and stockholders’ equity	$	44,704,840			$	10,421,824

OpGen, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Revenue
Product sales	$	601,562			$	573,035			$	1,569,799			$	1,597,505
Laboratory services		112,892				185				138,884			$	5,435
Collaboration revenue		342,311				75,000				1,153,400				1,075,000
Total revenue		1,056,765				648,220				2,862,083				2,677,940
Operating expenses
Cost of products sold		1,350,296				262,373				2,340,766				681,568
Cost of services		159,794				196,184				550,115				592,647
Research and development		2,433,553				1,139,369				6,630,134				4,069,335
General and administrative		2,356,413				1,560,706				6,549,432				4,901,136
Sales and marketing		932,671				376,955				2,258,980				1,142,755
Transaction costs		—				538,061				470,322				538,061
Impairment of intangible assets		—				—				750,596				—
Impairment of right-of-use asset		—				—				—				520,759
Total operating expenses		7,232,727				4,073,648				19,550,345				12,446,261
Operating loss		(6,175,962	)			(3,425,428	)			(16,688,262	)			(9,768,321	)
Other (expense) income
Interest and other income/(expense)		19,965				1,043				101,644				(8,213	)
Interest expense		(1,183,927	)			(49,099	)			(2,267,085	)			(142,672	)
Foreign currency transaction losses		(501,168	)			(8,954	)			(794,832	)			(9,426	)
Change in fair value of derivative financial instruments		165,497				—				548,008				67
Total other expense		(1,499,633	)			(57,010	)			(2,412,265	)			(160,244	)
Loss before income taxes		(7,675,595	)			(3,482,438	)			(19,100,527	)			(9,928,565	)
Provision for income taxes		—				—				—				—
Net loss	$	(7,675,595	)		$	(3,482,438	)		$	(19,100,527	)		$	(9,928,565	)
Net loss per common share – basic and diluted	$	(0.40	)		$	(3.95	)		$	(1.36	)		$	(13.32	)
Weighted average shares outstanding – basic and diluted		19,116,864				882,280				14,016,896				745,471
Net loss	$	(7,675,595	)		$	(3,482,438	)		$	(19,100,527	)		$	(9,928,565	)
Other comprehensive income – foreign currency translation		1,266,901				7,298				1,631,317				5,174
Comprehensive loss	$	(6,408,694	)		$	(3,475,140	)		$	(17,469,210	)		$	(9,923,391	)

SOUTH SAN FRANCISCO, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) — Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that Sabah Oney, Ph.D., chief business officer of Alector, will participate in a fireside chat at the Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020, at 4:40 p.m. ET.

A live webcast of the fireside chat will be available on the “Events & Presentations” page within the Investors section of the Alector website at http://investors.alector.com. A replay will be available on the Alector website for 30 days following the event.

About Alector
Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company’s immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. This scientific approach is also the basis for the Company’s immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

Contacts
Media:
Erica Jefferson
Vice President, Communications and Public Affairs
Alector, Inc.
301-928-4650
[email protected]

1AB
Dan Budwick
973-271-6085
[email protected]

or

Investors:
Alector, Inc.
[email protected]