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OpGen Reports Third Quarter 2020 Financial Results and Provides Business Update

  • 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 40th 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 )

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QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test That Can Accurately Analyze Over 30 Samples Per Hour

QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test That Can Accurately Analyze Over 30 Samples Per Hour

  • QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with Ellume, is an important step towards decentralized mass screening by processing samples in 2–15 minutes
  • Digital results for dozens of samples per hour and the ability to process antibody tests in parallel, setting new standards in scalability and flexibility
  • Test submitted to FDA for Emergency Use Authorization for US, CE-IVD marking for European Union and other markets expected by year’s end

HILDEN, Germany & GERMANTOWN, Md.–(BUSINESS WIRE)–
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) has started commercialization of a portable digital test in the United States that can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care (POC) claim will be added and EUA amended later this year.

The QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, sets new standards in scalability, validation and flexibility by processing more than 30 swab samples per hour, providing digital test results that do not require subjective interpretation, and allowing antibody tests to run simultaneously with antigen tests. This flexibility will be particularly valuable when vaccines are introduced.

QIAGEN has begun marketing and distributing QIAreach™ SARS-CoV-2 Antigen Test in the United States after applying for FDA emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for European Union and other markets is expected as early as by the end of the year.

“As existing approaches often lack scalability and accuracy, antigen testing is playing an increasingly important role in national testing strategies as a complementary tool to PCR, the gold-standard for detecting active COVID-19 infections,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “QIAreach SARS-CoV Antigen is a fast, digital and easy to use test that makes use of sensitive nanoparticle technology from Ellume. In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation. And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”

Please find the full press release here

###

QIAGEN

Investor Relations

e-mail: [email protected]

John Gilardi

+49 2103 29 11711

Phoebe Loh

+49 2103 29 11457


Public Relations

e-mail: [email protected]


Thomas Theuringer

+49 2103 29 11826

Robert Reitze

+49 2103 29 11676

KEYWORDS: Maryland Switzerland United States Austria North America Europe Germany

INDUSTRY KEYWORDS: Medical Devices Health Infectious Diseases Research Science Biotechnology

MEDIA:

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Resonant to Present at the Virtual Fall Investor Summit

GOLETA, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) — Resonant Inc. (NASDAQ: RESN), a leader in transforming the way radio frequency, or RF, front-ends are being designed and delivered for mobile handset and wireless devices, today announced that management will present at the Virtual Fall Investor Summit, hosted by Investor Summit Group and taking place November 16-18, 2020.

George B. Holmes, Chairman and Chief Executive Officer of Resonant, is scheduled to participate in one-on-one meetings throughout the event and will host a virtual presentation as follows:

Virtual Fall Investor Summit        

Date: Monday, November 16, 2020
Time: 3:30 p.m. Eastern time (12:30 p.m. Pacific time)
Webcast: https://www.webcaster4.com/Webcast/Page/2038/38523

A live audio webcast and archive of the summit presentation will be available using the webcast link above. For more information on the Investor Summit Group Virtual Fall Summit or to schedule a one-on-one meeting, please contact the Company’s investor relations contact or your Investor Summit Group representative.

About Resonant Inc.

Resonant (NASDAQ: RESN) is transforming the market for RF front-ends (RFFE) by disrupting the RFFE supply chain through the delivery of solutions that leverage our Infinite Synthesized Network (ISN) software tools platform, capitalize on the breadth of our IP portfolio, and are delivered through our services offerings. In a market that is critically constrained by limited designers, tools and capacity, Resonant addresses these critical problems by providing customers with ever increasing design efficiency, reduced time to market and lower unit costs. Customers leverage Resonant’s disruptive capabilities to design cutting edge filters and modules, while capitalizing on the added stability of a diverse supply chain through Resonant’s fabless ecosystem-the first of its kind. Working with Resonant, customers enhance the connectivity of current mobile devices, while preparing for the demands of emerging 5G applications.

To learn more about Resonant, view the series of videos published on its website that explain Resonant’s technologies and market positioning:

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

Resonant uses its website (https://www.resonant.com) and LinkedIn page (https://www.linkedin.com/company/resonant-inc-/) as channels of distribution of information about its products, its planned financial and other announcements, its attendance at upcoming investor and industry conferences, and other matters. Such information may be deemed material information, and Resonant may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor the company’s website and its social media accounts in addition to following the company’s press releases, SEC filings, public conference calls, and webcasts.

About Resonant’s ISN
®
Technology

Resonant can create designs for difficult bands, modules and other complex RF Front End requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. ISN is a suite of proprietary mathematical methods, software design tools and network synthesis techniques that enable us to explore a much larger set of possible design solutions that regularly incorporate our proprietary technology. We then quickly deliver design simulations to our customers, which they manufacture or have manufactured by one of our foundry partners. These improved solutions still use Surface Acoustic Wave (SAW) or Temperature Compensated Surface Acoustic Wave (TC-SAW) manufacturing methods and perform as well as those using higher cost manufacturing methods such as Bulk Acoustic Wave (BAW). Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is seamless because its models speak the “fab language” of basic material properties and dimensions.

Investor Relations Contact:

Greg Falesnik or Brooks Hamilton
MZ Group – MZ North America
(949) 546-6326
[email protected]

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Yelp to Participate in the RBC Capital Markets Global Technology, Internet, Media and Telecommunications Conference

Yelp to Participate in the RBC Capital Markets Global Technology, Internet, Media and Telecommunications Conference

SAN FRANCISCO–(BUSINESS WIRE)–
Yelp Inc. (NYSE: YELP), the company that connects people with great local businesses, today announced that management will present at the RBC Capital Markets Global Technology, Internet, Media and Telecommunications Conference on Wednesday, November 18, 2020 at 1:00 p.m. Pacific Time.

The live and archived webcasts of the presentation will be available on the company’s investor relations website at www.yelp-ir.com.

About Yelp

Yelp Inc. (www.yelp.com) connects people with great local businesses. With unmatched local business information, photos, and review content, Yelp provides a one-stop local platform for consumers to discover, connect, and transact with local businesses of all sizes by making it easy to request a quote, join a waitlist, and make a reservation, appointment, or purchase. Yelp was founded in San Francisco in July 2004.

Yelp Inc.

Kate Krieger

Investor Relations

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Social Media Restaurant/Bar Marketing Data Management Communications Technology Mobile/Wireless Retail

MEDIA:

Logo
Logo
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Alector to Present at the Stifel 2020 Virtual Healthcare Conference

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]

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Pulse Biosciences to Participate in Upcoming Investor Conferences

Pulse Biosciences to Participate in Upcoming Investor Conferences

HAYWARD, Calif.–(BUSINESS WIRE)–
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced plans to participate in three upcoming virtual investor conferences.

Management is scheduled to present at the Stifel Healthcare Conference on Tuesday, November 17, 2020 at 4:00pm ET.

Management is scheduled to present at the Stephens Annual Investment Conference on Thursday, November 19, 2020 at 4:00pm ET.

Management is also scheduled to participate in the Piper Sandler Healthcare Conference hosting one-on-one meetings Tuesday, December 1, 2020. A presentation webcast will be available in advance of the event on Monday, November 23, 2020 at 10:00am ET.

Interested parties may access a live and recorded webcast from all conferences on the “Investors” section of the Company’s website at www.pulsebiosciences.com.

About Pulse Biosciences®

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. If cleared, the CellFX® System will be the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology, such as the ability to non-thermally clear cells while sparing non-cellular tissue, to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across a spectrum of clinical applications. To learn more please visit www.pulsebiosciences.com.

Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Investors:

Pulse Biosciences

Sandra Gardiner, EVP and CFO

510.241.1077

[email protected]

or

Gilmartin Group

Philip Trip Taylor

415.937.5406

[email protected]

Media:

Tosk Communications

Nadine D. Tosk

504.453.8344

[email protected] or

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Medical Devices Health

MEDIA:

Posted on

CTG to Participate at Upcoming Virtual Investor Conferences

BUFFALO, N.Y., Nov. 11, 2020 (GLOBE NEWSWIRE) — CTG (NASDAQ: CTG), a leading provider of information technology (IT) solutions and services in North America and Western Europe, today announced that management will be available to meet with participating investors at the following virtual investor conferences.

The
Benchmark Discovery One-on-One Conference

Participation Date: Wednesday, November 18, 2020

The Sidoti Virtual Microcap Conference

Participation Date: Thursday, November 19, 2020
Webcast: A replay of the presentation will be available at investors.ctg.com

Portfolio managers and analysts can request a virtual meeting with the Company by contacting their sales representative at the respective hosting firms.

About CTG

CTG has established a reputation for responsiveness and reliability—traits that our clients say set us apart—since our founding in 1966. Today, we provide comprehensive information, technology, and business solutions that address critical challenges for clients in high-growth industries in North America and Western Europe. Backed by a proven track record of reliable delivery, CTG fosters long-term client relationships and trust, which allows us to develop strategic insights that maximize client investments in solutions and competitive advantage. CTG has operations in North America, South America, Western Europe, and India. The Company regularly posts news and other important information online at www.ctg.com.

Investors and Media:

John M. Laubacker, Chief Financial Officer
(716) 887-7368

Posted on

Salarius Pharmaceuticals Reports Business Highlights and Third Quarter 2020 Financial Results

Conference Call and Live Audio Webcast Scheduled for Today, November 11, 2020, at 4:30 p.m. ET

HOUSTON, Nov. 11, 2020 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for children and adults with pediatric cancers, solid tumors and other cancers, today reported its corporate and financial results for the third quarter ended September 30, 2020.

Recent Business and Corporate Events:

  • Ewing sarcoma Phase 1/2 clinical trial is completing dose escalation to establish maximum tolerated dose (MTD) and is expected to advance into Phase 2 dose-expansion in Q1 2021
  • Ewing sarcoma clinical trial expansion phase expanded to include patients with Ewing-related sarcomas such as myxoid liposarcoma, desmoplastic small round cell tumors and other sarcomas with similar biology to Ewing sarcoma
     º Ewing sarcoma and Ewing-related sarcomas represent rare cancers affecting both children and adults where there is a high unmet need for additional treatment options

Financial Highlights:

  • Total cash and cash equivalents of $9.6 million as of September 30, 2020 due in part to $6.2 million gross proceeds in an underwritten public offering closed August 3, 2020
  • Three-month period ended September 30, 2020 net loss per common share – basic and diluted – of $0.10, compared to $0.73 for the same period ended September 30, 2019

“The events of the third quarter of 2020 affirm the company’s growth strategy and demonstrate the potential of seclidemstat as a treatment for cancers with high unmet need,” said David Arthur, President and CEO of Salarius. “Our lead clinical program in Ewing sarcoma continues to advance, and we expect to reach the maximum tolerated dose (MTD) in the Phase 1 portion of the clinical trial and, as planned, begin the Phase 2 dose-expansion portion of the trial in Q1 2021.  This is an important milestone as it allows us to establish the recommended Phase 2 dosing regimen for the trial and begin treating a broader group of patients with Ewing and Ewing-related sarcomas.”

Mr. Arthur continued, “Ewing sarcoma and advanced solid tumors (AST) remain our most advanced development programs, but we believe seclidemstat offers the opportunity to address numerous cancers where additional treatment options are needed.  In this regard, we recently expanded the dose-expansion phase of the Ewing sarcoma clinical trial to include several additional sarcomas.  This decision was based on preclinical data and early clinical data observations from the ongoing clinical trials that suggest seclidemstat may demonstrate drug activity and have applicability in other sarcomas that have a similar gene arrangement to Ewing sarcoma, known as Ewing-related sarcomas.  Among those observations, Salarius previously disclosed that a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions, which generally represent a patient’s largest measurable tumors.”

Ewing Sarcoma Clinical Trial Expanded
On July 29, 2020, Salarius announced the expansion of its ongoing Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma to include additional select sarcomas that share a similar biology to Ewing sarcoma, also known as Ewing-related sarcomas.  Sarcomas of interest include myxoid liposarcoma, desmoplastic small round cell tumors and other sarcomas that harbor similar FET family gene rearrangements to Ewing sarcoma.

These Ewing-related sarcomas were chosen based on their underlying biology as well as preclinical data and early clinical observations involving seclidemstat that suggest the drug may demonstrate activity and may have applicability in several sarcomas that share key characteristics of Ewing sarcoma.  As Salarius previously disclosed, a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions.  Target lesions generally represent a patient’s largest measurable tumors.  However, at eight weeks, an increase in non-target lesions resulted in an overall patient classification of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

The amendment to the ongoing clinical trial will allow up to 30 patients with Ewing-related sarcomas to enroll in the trial’s upcoming dose-expansion phase, which is in addition to the 20 Ewing sarcoma patients also planned to be treated in the dose-expansion phase. 

Additional Clinical Trials to Expand Development Program
Mr. Arthur concluded, “In addition, in the third quarter we continued preparatory work on two additional clinical trials and look forward to announcing the initiation of these trials soon.  These additional clinical trials support our growth strategy focused on maximizing the market potential of seclidemstat.”  

Three-
Month Financial Results:
For the three-month period ended September 30, 2020, Salarius’ reported net loss was $1.7 million, or $0.10 per basic and diluted share, compared to a net loss of $2.6 million, or $0.73 per basic and diluted share for the same period in 2019.  The loss before other income for the three-month period ended September 30, 2020 decreased by $2.0 million compared to the same time span last year, primarily due to a $2.2 million decrease in general and administrative expenses which more than offset the increase of $0.7 million in research and development expenses. Increased research and development costs resulted from increased clinical trial expenses and drug manufacturing costs. The decrease in general and administrative costs resulted from the absence of costs related to Salarius’ one-time transformation into a public company during 2019 which did not reoccur in the current period.

As of September 30, 2020, total cash, cash equivalents and restricted cash were $9.6 million, compared to $3.7 million at year-end 2019. Increases in cash balances result from the Company’s public offerings of stock in the first quarter and third quarter 2020.  The Company expects its cash and cash equivalents to fund its operations into the third quarter of 2021.

$6.2 Million Underwritten Public Offering

On August 3, 2020, Salarius completed an underwritten public offering with total gross proceeds of approximately $6.2 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering and ongoing non-dilutive financial support from the Cancer Prevention Institute of Texas (CPRIT) to fund the expansion of the Ewing sarcoma clinical trial and ongoing company operations.

Conference Call Information:

Salarius Pharmaceuticals will host a conference call and live audio webcast on Wednesday, November 11, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the third quarter 2020.  Interested participants and investors may access the conference call by dialing either:

  • (833) 423-0481 (U.S.)
  • (918) 922-2375 (international)
  • Conference ID: 1277839

An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website http://investors.salariuspharma.com/.  An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on November 11, 2020.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients that need them the most.  Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma, for which it has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study in advanced solid tumors, including prostate, breast, and ovarian cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also the recipient of an $18.7 million Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT).  For more information, please visit salariuspharma.com or follow the Company on Twitter and LinkedIn.

Forward-Looking Statements 

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements, other than statements of historical facts, included in this press release are forward-looking statements.  These forward-looking statements may be identified by terms such as “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” “developing,” and similar terms or expressions or the negative thereof.  Examples of such statements include, but are not limited to, statements relating to the following: Salarius’ growth strategy; the value of seclidemstat as a potential treatment for Ewing sarcoma and other cancers; the status and anticipated progress and milestones of Salarius’ clinical trials in advanced solid tumors and Ewing sarcoma including statements related to when Salarius will reach the maximum tolerated dose in the Phase 1 portion of the study and when Salarius will begin the Phase 2 expansion portion of any study; the expansion of Salarius’ clinical trials to include Ewing-related sarcomas; Salarius’ belief as to being well-capitalized; statements related to Salarius’ ability to obtain or the availability of any additional amount from the CPRIT award; the anticipated use of proceeds from Salarius’ recent public offering to advance and expand the seclidemstat development pipeline; Salarius’ goal to maximize the potential of seclidemstat; Salarius’ developing seclidemstat for several cancers with high unmet medical need; and Salarius plans to announce two additional clinical trials. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements.  You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements.  These risks and uncertainties include, but are not limited to, the following: the sufficiency of Salarius’ capital resources; the ability of, and need for, Salarius to raise additional capital to meet Salarius’ business operational needs and to achieve its business objectives and strategy; Salarius’ ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of Salarius to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in Salarius’ quarterly report on Form 10-Q for the quarter ended June 30, 2020 and in Salarius’ annual report on Form 10-K for the year ended December 31, 2019.  The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date.  Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

Contact


Tiberend Strategic Advisors, Inc.


Maureen McEnroe, CFA/Miriam Miller (investors)
(212) 375-2664 / 2694
[email protected]
[email protected]
Johanna Bennett (media)
(212) 375-2686 
[email protected]

SALARIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

  September 30,

2020 		  December 31,

2019
       
Assets      
Current assets:      
Cash and cash equivalents $ 9,557,813     $ 3,738,900  
Grants receivable from CPRIT 3,212,678     —  
Prepaid expenses and other current assets 1,148,667     955,899  
Total current assets 13,919,158     4,694,799  
Property and equipment, net 15,635     25,016  
Goodwill 8,865,909     8,865,909  
Other assets 262,509     308,674  
Total assets $ 23,063,211     $ 13,894,398  
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $ 1,195,063     $ 1,790,966  
Accrued expenses and other current liabilities 448,862     160,783  
Note payable 761,096     502,332  
Deferred revenue —     541,701  
Warrant liability 52,224     317,762  
Total liabilities 2,457,245     3,313,544  
       
Commitments and contingencies (Note 6)      
       
Stockholders’ equity:      
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; 0 issued and outstanding —     —  
Common stock, $0.0001 par value; 100,000,000 shares authorized; 19,821,716 and 4,519,533 shares issued at September 30, 2020 and December 31, 2019, and 19,818,912 and 4,511,174 shares outstanding at September 30, 2020 and December 31, 2019, respectively 1,981     451  
Additional paid-in capital 38,265,391     22,657,103  
Accumulated deficit (17,661,406 )   (12,076,700 )
Total stockholders’ equity 20,605,966     10,580,854  
Total liabilities and stockholders’ equity $ 23,063,211     $ 13,894,398  

SALARIUS PHARMACEUTICALS, INC.

 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

  Three Months Ended

September 30 
       
  2020   2019
Revenue:      
Grant revenue $ 1,378,239     $ 874,949  
Operating expenses:      
Research and development 1,803,682     1,140,909  
General and administrative 1,333,062     3,494,205  
Total operating expenses 3,136,744     4,635,114  
Loss before other income (expense) (1,758,505 )   (3,760,165 )
Change in fair value of warrant liability 45,103     1,130,848  
Government grants and other income —     —  
Interest income (expense), net (3,230 )   (752 )
Loss from continuing operations (1,716,632 )   (2,630,069 )
Income from discontinued operations —     2,348  
Net loss $ (1,716,632 )   $ (2,627,721 )
       
Loss per common share — basic and diluted $ (0.10 )   $ (0.73 )
Weighted-average number of common shares outstanding — basic and diluted 17,968,664     3,605,913  

Posted on

Getty Realty Corp. Appoints Brian Dickman as New Chief Financial Officer

Getty Realty Corp. Appoints Brian Dickman as New Chief Financial Officer

JERICHO, N.Y.–(BUSINESS WIRE)–Getty Realty Corp. (NYSE: GTY) announced today that Brian R. Dickman has been appointed Executive Vice President, Chief Financial Officer and Treasurer, effective December 14, 2020. Mr. Dickman will succeed Danion Fielding, who previously announced his intention to resign for personal reasons. Mr. Fielding will stay on as Chief Financial Officer through December 11, 2020.

“I am pleased to welcome Brian to our leadership team,” said Christopher J. Constant, Getty’s President and Chief Executive Officer. “Brian is a seasoned executive with extensive real estate experience and a track record of demonstrated leadership capabilities, which makes him an excellent addition to the Getty team.” Mr. Constant continued, “On behalf of our entire Company, I want to thank Danion for his service to Getty. We have truly valued his leadership and contributions. We wish Danion much success in his future endeavors. I anticipate a smooth transition of the CFO position and expect no disruption to the continued execution of our strategic plans.”

Mr. Dickman brings more than 15 years of REIT experience to Getty, including nearly seven years as a public company executive. Mr. Dickman is joining Getty from his current role as Executive Vice President and Chief Financial Officer of Seritage Growth Properties (NYSE:SRG). Prior to joining Seritage, Mr. Dickman was Chief Financial Officer at Agree Realty (NYSE: ADC), where he was responsible for all corporate finance, capital markets, accounting, financial reporting, treasury and investor relations activities. Prior to that role, he was a real estate investment banker covering public REITs and other real estate companies beginning at Lehman Brothers in 2005.

About Getty Realty Corp.

Getty Realty Corp. is the leading publicly traded real estate investment trust in the United States specializing in the ownership, leasing and financing of convenience store and gasoline station properties. As of September 30, 2020, the Company owned 896 properties and leased 58 properties from third-party landlords in 35 states across the United States and Washington, D.C.

Investor Relations

(516) 478-5418

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: REIT Retail Commercial Building & Real Estate Construction & Property Convenience Store

MEDIA:

Posted on

GMS to Present at the Stephens Annual Investment Conference

GMS to Present at the Stephens Annual Investment Conference

TUCKER, Ga.–(BUSINESS WIRE)–
GMS Inc. (NYSE: GMS), a leading North American specialty distributor of interior building products is scheduled to present at the Stephens Annual Investment Conference on Tuesday, November 17, 2020 at 11:00 Eastern Time.

The presentation will be webcast live on the Investors section of the Company’s website at www.gms.com. Following the webcast, an archived replay will be available for approximately 90 days.

About GMS:

Founded in 1971, GMS operates a network of more than 260 distribution centers across the United States and Canada. GMS’s extensive product offering of wallboard, suspended ceilings systems, or ceilings, and complementary construction products is designed to provide a comprehensive one-stop-shop for our core customer, the interior contractor who installs these products in commercial and residential buildings.

For more information about GMS, please visit www.gms.com.

Investor Relations:

Leslie Kratcoski

770-723-3306

[email protected]

Media Relations:

770-723-3378

[email protected]

KEYWORDS: United States North America Georgia

INDUSTRY KEYWORDS: Residential Building & Real Estate Commercial Building & Real Estate Construction & Property Interior Design

MEDIA:

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