CFOR 8-K
CapForce Inc. (CFOR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
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FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
April 14, 2020
Date of Report (date of earliest event reported)
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OpGen, Inc.
(Exact name of Registrant as specified in its charter)
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Delaware (State or other jurisdiction of incorporation or organization) |
001-37367 (Commission File Number) |
06-1614015 (I.R.S. Employer |
708 Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
(Address of principal executive offices)(Zip code)
(240) 813-1260
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
_________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[_] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[_] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[_] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock | OPGN | The Nasdaq Capital Market |
| Common Stock Warrants (IPO) | OPGNW | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [_]
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Item 2.02 Results of Operations and Financial Condition.
On April 14, 2020, OpGen, Inc. (the “Company”) issued a press release announcing preliminary financial results for the quarter ended March 31, 2020. The full text of such press release is furnished as Exhibit 99.1 to this report.
Item 7.01 Regulation FD Disclosure.
On April 14, 2020, the Company updated its corporate presentation, which it made available on its website. A copy of the presentation is furnished as Exhibit 99.2 to this report.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press Release, dated April 14, 2020.
99.2 Investor Presentation, dated April 14, 2020.
The information included herein and in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Date: April 14, 2020 | OpGen, Inc. | |||||
| By: |
/s/ Timothy C. Dec | |||||
| Name: | Timothy C. Dec | |||||
| Title: | Chief Financial Officer | |||||
Exhibit 99.1
OpGen
Announces Preliminary Unaudited Revenue and Cash Position for First Quarter 2020
and Provides Business Update
- Total Revenue for Q1 2020 was approximately $617,000 (excluding first quarter 2020 Curetis Revenue)
- Balance sheet strengthened significantly with $13.9 million cash raised in Q1 2020
- OpGen and Curetis successfully completed business combination effective April 1, 2020
GAITHERSBURG, Md., April 14, 2020 -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that total revenue for the first quarter of 2020 was approximately $617,000 down from $1.0 million in the first quarter of 2019, excluding revenues from the Curetis businesses, which was acquired upon closing of the business combination on April 1, 2020. Cash as of March 31, 2020 was approximately $11.5 million, up significantly from the $2.7 million as of December 31, 2019.
The company also announced accomplishment of the following key milestones, including key business milestones achieved by Curetis and Ares Genetics in the first quarter of 2020:
| • | Successful completion of the business combination between Curetis and OpGen on April 1, 2020. At the closing, William E. Rhodes III, the former chairman of the Supervisory Board of Curetis N.V., was appointed chairman of the board of OpGen, and Oliver Schacht, PhD, the former Chief Executive Officer of Curetis N.V., was appointed the President and Chief Executive Officer of OpGen and to the board of directors; |
| • | The newly formed board of directors of OpGen now also includes Evan Jones, former Chairman and CEO of OpGen, Don Elsey, Mario Crovetto and Prabhavathi Fernandes, PhD; |
| • | OpGen significantly improved its working capital position in the first quarter of 2020 through the sale of approximately 2.8 million shares of common stock for gross proceeds of $5.8 million of sales under the company’s ATM program and the sale of approximately 4.1 million shares of common stock for gross proceeds of $8.1 million from the exercise of warrants from the company’s public offering in October 2019; |
| • | OpGen expects that its submission to the U.S. Food and Drug Administration (“FDA”) for clearance of the Acuitas® AMR Gene Panel (Isolates) for the detection of antimicrobial resistance genes in bacterial isolates is nearing completion. OpGen has responded, and is continuing to respond, to the FDA’s additional information requests and now anticipates approaching a clearance decision for the Acuitas® AMR Gene Panel for isolates. Exact timing is unknown as a result of the COVID-19 pandemic; |
| • | Clinical trial enrollment was active during the first quarter of 2020 at all nine participating sites for the Acuitas® AMR Gene Panel (Urine) test. Testing and the trial have been suspended due to hospital actions to focus resources on the COVID-19 pandemic; |
| • | OpGen successfully achieved the first year final milestone in this collaboration with the New York State Department of Health and ILÚM Health Solutions, LLC, a wholly-owned subsidiary of Merck’s Healthcare Services and Solutions, to develop a state-of-the-art research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. In response to the COVID-19 emergency in New York State, testing under the program has been put on hold by the Wadsworth Center and participating hospitals; |
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| • | Acuitas Lighthouse® was utilized in a research study conducted by the Mayo Clinic to predict phenotypic resistance and antimicrobial susceptibility among clinical isolates, with findings published in Diagnostic Microbiology & Infectious Disease; |
| • | Curetis, Ares Genetics, and BGI announced a partnership around BGI’s CoV-2 test kit commercialization in Europe; Curetis has begun selling the BGI CoV-2 product via its distribution network in EMEA during Q1 2020; and |
| • | Curetis and Quaphaco entered into an exclusive three-year distribution partnership for the Unyvero product line in Vietnam; the contract includes minimum commitments by Quaphaco totaling approximately $ 2.1 million over the initial three-year term. |
OpGen revenue during the first quarter of 2020 can be attributed to Acuitas® AMR Gene Panel and Acuitas Lighthouse® revenue, which was approximately $254,000, while revenues from the company’s rapid FISH products decreased to $363,000. The company expects to provide full first quarter 2020 financial results during its first quarter 2020 earnings call in early May of this year.
Oliver Schacht, President and CEO of OpGen commented, “In light of the unprecedented crisis situation with COVID-19, we were pleased with the robust first quarter 2020 initial results. We have been humbled and extremely encouraged by the dedication and hard work put in place by all our employees globally during these extraordinary times. Going forward and once this crisis is behind us, we anticipate dynamic growth in our business trajectory following the expected near-term FDA clearance decision of our Acuitas® AMR Gene Panel. We also expect the CoV-2 test kit sales in Europe to continue contributing to our top-line revenue in Q2 of 2020.”
Schacht continued, “Now operating as one combined company, OpGen with its group companies Curetis and Ares Genetics boast strong proprietary assets for developing and commercializing innovative, data-driven solutions in infectious disease diagnostics, and we look forward to the continued integration of our businesses over the coming weeks and months.”
The preliminary financial results are estimates prior to the completion of OpGen’s financial closing procedures and review procedures by its external auditors and therefore may be subject to adjustment when the actual results are available.
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.
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Forward-Looking Statements
This press release includes statements regarding the pursuit of FDA clearance for the Acuitas® AMR Gene Panel for use with bacterial isolates, the integration of OpGen with its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, and activities related to the company’s products and services. 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 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:
Joe Green
Edison Group
[email protected]
Exhibit 99.2
OpGen Corporate Overview April 2020
FORWARD LOOKING STATEMENTS DISCLAIMER 2 ©2020 OpGen, Inc. This presentation contains forward - looking statements that are subject to many risks and uncertainties. These statements, among other things, relate to our business strategy, goals and expectations concerning our products, future operations, prospects, plans and objectives of management. The words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict ,” “project,” “will” and similar terms and phrases are used to identify forward - looking statements in this presentation. These statements and other statements regarding our future plans constitute “forward - looking statements” within the meaning of Section 27A of the Securitie s Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are intended to qualify for the saf e harbor from liability established by the Private Securities Litigation Reform Act of 1955. Such statements are subject to ri sks and uncertainties that are often difficult to predict, are beyond OpGen’s control, and that may cause results to differ materially from expectations. Factors that could cause results to differ materially from those described include, but are not limited to, our ability to su cce ssfully, timely and cost - effectively develop, seek and obtain regulatory clearance for and commercialize our product and service offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected synergies from ou r business combination transaction with Curetis GmbH, the successful integration of our company with the operations and business of Curetis GmbH and its subsidiaries and the implementation of the combined company’s strategic and business goals and objectives, the ability to comply with the complexities of operating a global business, the success of our commercialization efforts, the eff ect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the mos t 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 expectatio ns as of the date of this presentation and speak only as of the date of this presentation. We undertake no obligation to publicl y u pdate or revise any forward - looking statement, whether as a result of new information, future events or otherwise.
OPGEN AND CURETIS COMPLETE BUSINESS COMBINATION 3 ©2020 OpGen, Inc.
OPGEN AND ITS GROUP COMPANIES: STRIVING TO INNOVATE MOLECULAR MICROBIOLOGY 4 Fast Comprehensive AI - Powered AMR Prediction & Bioinformatics Rapid Pathogen Detection For Life Threatening Infections Broad Pathogen & Antimicrobial Resistance (AMR) Marker Coverage Smart Easy Sample - To - Answer Platforms ©2020 OpGen, Inc.
COMBINED COMPANY’S PORTFOLIO: SYNERGISTIC PRODUCTS & CAPABILITIES Unyvero Platform & Syndromic Tests Acuitas Tests & Acuitas Lighthouse Direct sales in U.S., European and China distribution with partners; 18 distributors covering 43 countries; CoV - 2 test kit distribution in EMEA Unyvero FDA - cleared platform and lower respiratory tract infection (LRT & LRT BAL) as well as 5 CE IVD tests; Unyvero A30 RQ platform in development Acuitas AMR Gene Panel tests in clinical trials (Urine) and pending FDA clearance (isolates) to improve antibiotic decision making; Lighthouse® knowledge base deployed for public health use Global Commercial Presence Ares Genetics NGS & Bioinformatics Ares Technology for AI - powered AMR Prediction combining ARESdb with NGS; Strategic Partnerships with globally leading IVD & pharma companies ©2020 OpGen, Inc. 5
STRATEGIC RATIONALE AND BENEFITS Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection Proprietary molecular diagnostic tests and platforms Premier AI - powered bioinformatics solutions for multi - drug resistance diagnostics Global commercial channel capabilities & partners Financial leverage, operational synergies, and positive growth - driven business outlook ©2020 OpGen, Inc. 6
U.S. And European Markets With ~10 Million Hospitalized Patients Annually Addressed Through Hospital - Focused Sales Channels COMBINED COMPANY TO ADDRESS UNMET CLINICAL NEEDS AND LARGE AVAILABLE MARKET OPPORTUNITIES The current Unyvero portfolio and pipeline of cartridges according to management estimates target about 10 million patients annually in EU and U.S. with additional upside in Asia / Pacific and ROW markets ∼ 10M cases per year ©2020 OpGen, Inc. 7
STRATEGIC RATIONALE AND BENEFITS ©2020 OpGen, Inc. Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection Proprietary molecular diagnostic tests and platforms Premier AI - powered bioinformatics solutions for multi - drug resistance diagnostics Global commercial channel capabilities & partners Financial leverage, operational synergies, and positive growth - driven business outlook 8
Innovating Molecular Microbiology Through Proprietary Platforms And Content SAMPLE - TO - ANSWER HIGH - THROUGHPUT TESTING CAPABILITIES * Unyvero A30 RQ Analyzer in development, latest design concept; final product may differ Striving for Molecular Microbiology Innovation MDx Platforms MDx Content Low - to High - Plex PCR Broad Range of Sample Types Proprietary PCR & NGS Applications Based on Leading AI - Powered AMR Knowledgebases Unyvero A50 High - Plex PCR Unyvero A30 RQ* Low - to Mid - Plex PCR ©2020 OpGen, Inc. **Pending 510(k), not for diagnostic use. † ** 9 ARESdb MDx Content & NGS Applications
BROAD UNYVERO CARTRIDGE PORTFOLIO 10 HPN / LRT BAL* Hospitalized Pneumonia / Lower Respiratory Tract Infections ITI Implant & Tissue Infection IAI Intra - Abdominal Infection BCU Blood Culture UTI Urinary Tract Infection ©2020 OpGen, Inc. * Unyvero LRT / LRT BAL are FDA cleared – all other products CE IVD marked
Cartridge Indication area Number of targets Sample types Clearance status HPN** Severe cases of Pneumonia 48 targets****, pathogens (29) and antibiotic resistance markers (19) Sputum, broncho - alveolar lavage, tracheal aspirate CE - IVD marked Singapore (HAS) Thailand Malaysia LRT & LRT BAL Lower Respiratory Tract Infections LRT (LRT BAL): 46 (47) targets****, pathogens 36 (37) and antibiotic resistance markers 10 (10) LRT: Tracheal aspirates LRT BAL: Bronchoalveolar Lavage (BAL) LRT: FDA cleared (4/2018) LRT BAL: FDA cleared (12/2019) ITI Severe cases of Implant and Tissue Infections 102 targets, pathogens (85) and antibiotic resistance markers (17) Sonication fluid, swabs, striche, tissue, pus, aspirate/exudate, etc. CE - IVD marked BCU*** Bloodstream infections 103 targets, pathogens (86) and antibiotic resistance markers (17) Positively flagged blood cultures CE - IVD marked Singapore (HAS) Thailand IAI Severe Intra - Abdominal Infections 130 targets, pathogens (105), toxins (3) and antibiotic resistance markers (22) Paracentesis fluids, biliary fluids, peritoneal fluids, drainage fluids, retroperitoneal fluids, pus, swabs, samples from positively flagged blood culture bottles inoculated with other fluids than blood (IAI fluids such as ascites) CE - IVD marked UTI Severe cases of U rinary Tract Infections 103 targets, pathogens (88) and antibiotic resistance markers (15) Midstream urine, suprapubic aspiration, tissue CE - IVD marked UNIQUE AND DIFFERENTIATED SYNDROMIC PANELS 11 **HPN: Hospitalized Pneumonia ***BCU: Blood Culture Application ****Difference between HPN and LRT (BAL) due to different rep ort ing requirements between CE - IVD and U.S. FDA - cleared products ©2020 OpGen, Inc.
CURRENT U.S. PRODUCT OFFERINGS: UNYVERO LRT & LRT BAL 12 Providing Clear Direction • FDA - cleared, sample - to - answer, in less than 5 hours with just about 2 min hands - on time • Direct from native specimen, FDA - cleared for bronchoalveolar lavage fluids and tracheal aspirates • Multiplex PCR with array detection • Detects the most clinically relevant pathogens (incl. atypicals ) and antibiotic resistance markers associated with lower respiratory tract infections including pneumonia • Broadest carbapenemase resistance coverage • The only FDA - cleared LRT panel that detects Pneumocystis jirovecii • Critical information for life - saving treatment decisions ©2020 OpGen, Inc.
CURRENT U.S. PRODUCT OFFERINGS: ACUITAS AMR GENE PANEL* 13 IDENTIFIES Up to 47 Resistance Genes, Spanning 9 Antibiotic Classes TESTS Directly from Urine (in clinical trials) or Isolated Colonies (FDA Clearance Decision Pending), Sample - to - Answer Multiplex PCR from Bacterial Isolates (or Native Urine Specimen) in under 3 hours SEMI - QUANTITATIVELY DETECTS MOST DEADLY SUPERBUGS E. coli, K. pneumoniae, P. mirabilis, P. aeruginosa, E. faecalis * For Research Use Only. Not for use in diagnostic procedures. ©2020 OpGen, Inc. Available For RUO in Outbreak Monitoring and Epidemiology Settings (FDA Clearance Decision Pending) – And In Clinical Trials for cUTI
UNYVERO A30 RQ RAPID SAMPLE - TO - ANSWER TESTING PLATFORM IN DEVELOPMENT 14 ©2020 OpGen, Inc. Key Design Features • Fully integrated, closed, sample - to - answer MDx platform • Universal real - time PCR technology for low - to mid - plex testing • Flexible cartridge fluidics for numerous chemistries and assay formats • Fast turn - around time of 45 - 90 minutes • Light - weight, stackable benchtop design with small footprint • Modular and scalable from 1 to 8 cartridge slots • Designed for ease - of - use and flexible deployment in labs and near - patient settings • Attractive COGS for instruments and reagents Development Status • First multiplex PCR successfully demonstrated on functional prototypes • Manufacturing aspects fully specified and in development or implementation phase • Curetis aims at having Unyvero A30 RQ platform ready for partnering in 2020 Platform Available For Partnering To Rapidly Create Menu Of Tests And Commercial Channel(s)
STRATEGIC RATIONALE AND BENEFITS ©2020 OpGen, Inc. Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection Proprietary molecular diagnostic tests and platforms Premier AI - powered bioinformatics solutions for multi - drug resistance diagnostics Global commercial channel capabilities & partners Financial leverage, operational synergies, and positive growth - driven business outlook 15
16 ARES GENETICS & ARESdb * ©2020 OpGen, Inc. Bioinformatics Powerhouse With Industry - Leading Proprietary AI - Powered AMR Knowledgebase for Molecular Microbiology Global ARESdb Database • Unique Knowledgebase on Antibiotic Resistance Markers building on SIEMENS Microbiology Strain Collection • Demonstrated up to > 99% Accuracy for Antibiotic Susceptibility Prediction in evaluation studies • Based on > 50,000 Pathogens and associated Resistance Data for > 100 Antibiotics First RUO applications launched through NGS service laboratory and cloud platform Partners and customers include globally leading IVD & pharma companies † In development; For Research Use Only. Not for use in diagnostic procedures.
Cloud - based bioinformatics platform powers our ability to trace AMR in real - time with the potential to change the landscape of clinical infectious disease management and improve outcomes for patients ACUITAS LIGHTHOUSE®: DIAGNOSTICS DATA MANAGEMENT PLATFORM FOR ANTIBIOTIC RESISTANT PATHOGENS * Rapid Molecular Antibiotic Resistance Prediction * In development; For Research Use Only. Not for use in diagnostic procedures. 17 Successfully Met All Development Milestones Under 1 st Year Contract - Potential State - Wide AMR Surveillance Network ©2020 OpGen, Inc.
STRATEGIC RATIONALE AND BENEFITS Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection Proprietary molecular diagnostic tests and platforms Premier AI - powered bioinformatics solutions for multi - drug resistance diagnostics Global commercial channel capabilities & partners Financial leverage, operational synergies, and positive growth - driven business outlook^^ 18 ©2020 OpGen, Inc.
Leveraging Synergies From Our Now Combined Commercial Team Structures DUAL COMMERCIAL MODEL Expanding global c ommercial r each though direct sales in U.S. and via global distributors > Direct sales in the U.S. > European distribution through Menarini Diagnostics > China distribution through Beijing Clear Biotech > 18 distributors covering 43 countries in EU, ME, LATAM, and Asia > EMEA distribution and sales of BGI’s CoV - 2 test kits Direct Partners ©2020 OpGen, Inc. ▪ Multiple products to same hospital call points via same sales channel to drive synergies and cost efficiencies 19
Currently 11 EU Countries – Option To Expand Relationship To Further EMEA Markets And Additional Product Lines PAN EUROPEAN DISTRIBUTION VIA MENARINI Menarini Diagnostics & Curetis Collaboration ( since Q1 - 2019) > Covers entire Unyvero A50 product line > Initial countries: BE, CH, DE, ES, FR, IT, LU, NL, PT, UK, GR > Option to expand relationship to further EMEA countries Menarini Diagnostics Other Distributors ©2020 OpGen, Inc. 20
STRATEGIC RATIONALE AND BENEFITS ©2020 OpGen, Inc. Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection Proprietary molecular diagnostic tests and platforms Premier AI - powered bioinformatics solutions for multi - drug resistance diagnostics Global commercial channel capabilities & partners Financial leverage, operational synergies, and positive growth - driven business outlook 21
FINANCIAL CONSIDERATIONS • Proforma Revenue : • FY2018 revenues of $4.5 • FY2019 revenues of $6.0 million • No revenue guidance for 2020 at this time due to COVID - 19 situation • Cash Position : • March 31, 2020 - $11.5 million • Cash raised via ATM and Warrant exercises YTD 2020 - $14.3 million • Current available ATM gross capacity - $9.3 million • Warrants outstanding – 864k @ avg. exercise price $2.16 – gross available proceeds $1.9 million • Cash Burn – estimated to be approximately $4.5 - $5.5 million per quarter • Capital Structure - Shares outstanding : • Common Stock – 14,746,076 • Warrants – 1,040,107 (864,000 warrants avg. exercise price $2.16) • Convertible – 426,680 • Equity Awards – 158,525 • Fully Diluted Shares Outstanding - 16,371,388 22 ©2020 OpGen, Inc.
FINANCIAL CONSIDERATIONS • Other Key Items • 15,000 sq. ft. FDA registered R&D/ Manufacturing facility in Maryland • 16,000 sq. ft. FDA registered Manufacturing facility in Germany • 15 Acuitas AMR Gene panel system placements • ~ 170 Unyvero Analyzer placements globally (of which ~35 in the U.S.) • Employee count : • Approximately 110 global employees: • ~57 R&D • ~20 Manufacturing, QM /QA / QC & RA • ~18 Sales and Marketing • ~15 General and Administration 23 ©2020 OpGen, Inc.
NEW OPGEN INC. EXECUTIVE LEADERSHIP TEAM AND BOARD Combined Team Has Decades Of Experience In Precision Medicine, Molecular Diagnostics And Capital Markets Chief Executive Officer: Oliver Schacht, Ph.D. Chief Financial Officer: Timothy (Tim) C. Dec Chief Operating Officer: Johannes (Jan) Bacher Board Members: William (Bill) Rhodes (Chairman) Evan Jones Mario Crovetto Don Elsey Prabhavathi Fernandes, Ph.D . Oliver Schacht, PhD (CEO) 24 ©2020 OpGen, Inc.
UPCOMING MILESTONES, NEWSFLOW & CATALYSTS Unyvero & Acuitas ® Rapid Molecular Tests • FDA clearance decision Acuitas ® AMR Gene Panel (isolates) • USA commercial updates on Unyvero LRT / LRT BAL adoption for bacterial co - infections in COVID - 19 ICU patients • Portfolio news on various SARS - CoV - 2 test related programs across OpGen Group • Acuitas ® AMR Gene Panel (urine) clinical trial enrolment completion • FDA submission Acuitas ® AMR Gene Panel for cUTI • Unyvero A30 RQ partnering deal(s) • China NMPA approval and launch for Unyvero HPN test Ares Genetics • Completion of global IVD corporation technology evaluation and R&D program • Further partnering / licensing deal(s) • Publication of clinical data validating ARESdb for NGS - based antibiotic susceptibility testing 25 ©2020 OpGen, Inc.
CONTACT INFO 26 OpGen Inc. (Global HQ) 708 Quince Orchard Road Gaithersburg, MD 20878 USA P +1 301.869.9683 [email protected] Curetis GmbH Max - Eyth - Str. 42 71088 Holzgerlingen Germany P +49 (0)7031 49195 - 10 [email protected] ©2020 OpGen, Inc. Ares Genetics GmbH Karl - Farkas - Gasse 18 1030 Wien Austria P +43 (0)1 361 8880 10 contact@ares - genetics.com
Thank You ! 27 ©2020 OpGen, Inc .