PfCSP mRNA-LNP(Acuitas Therapeutics)

CAMBRIDGE, Mass., Aug. 25, 2022 (GLOBE NEWSWIRE) --Arbor Biotechnologies, Inc. a biotechnology company discovering and developing the next generation of genetic medicines, today announced that it has entered into an agreement with Acuitas Therapeutics, a leader in the development of lipid nanoparticles (LNP). As part of the agreement, the companies will combine the optimized delivery of Acuitas' highly validated LNP technology with Arbor’s differentiated, proprietary CRISPR gene editing technology designed for use in vivo in patients with rare liver diseases. “We are building a robust, proprietary portfolio of genomic medicines, beginning with severe liver diseases, for which LNPs are known to provide an optimal delivery approach with their ability to efficiently target hepatocytes, limit off target toxicity and have minimal immunogenicity. We are looking forward to working with Acuitas, a leading global developer of clinically-validated LNP technology,” said Devyn Smith, Ph.D., CEO, Arbor Biotechnologies. “Importantly, we believe this partnership accelerates our path to the clinic, with an ability to leverage established and scalable manufacturing.” Commented Dr. Thomas Madden, President & CEO of Acuitas Therapeutics: “We are excited to collaborate with Arbor on the development of novel genomic medicines for patients who currently have few, if any, therapeutic options. Arbor’s commitment to addressing this unmet clinical need resonates with Acuitas. We look forward to supporting their advance into the clinic.” About Arbor Biotechnologies Arbor Biotechnologies is a next-generation gene editing company focused on discovering and developing potentially curative genomic medicines. Founded by Feng Zhang, David Walt, David Scott, and Winston Yan, our proprietary discovery engine is focused on discovering genetic editing capabilities spanning knockdowns to whole gene insertions, which has enabled us to generate the most extensive toolbox of proprietary genomic editors in the industry to date. Leveraging our wholly-owned nucleases as the chassis for genetic modification, we can work backward from disease pathology to choose the optimal editing approach that specifically addresses the underlying cause of disease, resulting in a potentially curative medicine for a wider range of genetic disorders. As Arbor continues to advance its pipeline toward the clinic with an initial focus in liver and CNS disease, the Company has also secured several partnerships around gene editing and ex vivo cell therapy programs to broaden the reach of its novel nuclease technology. For more information, visit arbor.bio. About Acuitas Therapeutics Founded in February 2009, Vancouver-based Acuitas Therapeutics ( ) is a private biotechnology company that specializes in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles. The company partners with pharmaceutical and biotechnology companies, as well as non-governmental organizations and academic institutes to advance nucleic acid therapeutics into clinical trials and to the marketplace. The team works with partners to develop new therapies to address unmet clinical needs based on its internationally recognized capabilities in delivery technology. Acuitas Therapeutics has agreements in place with several partners to use its proprietary lipid nanotechnology in the development of COVID-19 vaccines. These include Pfizer/BioNTech for COMIRNATY®, which has received full approval in the U.S. and Canada and is authorized for Emergency Use in Europe, the UK and many other countries. The Acuitas team is currently working on therapeutics focused on addressing cancer, HIV/AIDS, tuberculosis, malaria, rabies, and other serious diseases. Contacts Media Amy Bonanno, Solebury Trout abonanno@soleburytrout.com 914-450-0349 Investor Relations Alexandra Roy, Solebury Trout aroy@soleburytrout.com 617-221-9197

Total Q2 2022 revenues of $1.0 million with product sales a key growth driverFirst two commercial customer contracts for Acuitas AMR Gene Panel signed in June and July 2022Requested additional 180-day period to regain compliance with Nasdaq minimum bid price ruleManagement conference call scheduled for August 11th, 2022, at 4:30 p.m. EDT ROCKVILLE, Md., Aug. 11, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported its second quarter 2022 financial and operating results. Management will host an investor call to discuss quarterly results and provide a business update. Oliver Schacht, President & CEO of OpGen, commented, “We are pleased with the progress we’ve made in the first half of 2022, which includes signing two commercial contracts for our Acuitas AMR Gene Panel with two major U.S. hospitals. Additionally, we have added a fourth trial site and continued enrollment towards our 1,500th patient sample for the clinical trial for Unyvero Urinary Tract Infection (UTI) Panel. We anticipate completing the enrollment and expect final data read out in the second half of this year towards an FDA submission.” Dr. Schacht continued, “Overall we are tracking well against our R&D milestones and continue to progress on the commercial front with significant growth in direct product sales year over year. We look forward to continuing to update on our progress and continue the fight against antimicrobial resistance.” Second Quarter and First Half 2022 Financial Results of OpGen, Inc. Total revenue for the second quarter of 2022 was approximately $1.0 million, compared with approximately $0.8 million in the second quarter of 2021. Total revenue for the first half of 2022 was approximately $1.4 million, as compared to approximately $1.6 million for the first half of 2021. Operating expenses for the second quarter of 2022 were approximately $6.2 million, compared with approximately $7.0 million in the second quarter of 2021. Operating expenses for the first half of 2022 were approximately $12.6 million, compared with approximately $14.0 million in the first half of 2021.The net loss available to common stockholders for the second quarter of 2022 was approximately $5.8 million, or $0.13 per share, compared with approximately $7.1 million, or $0.19 per share, in the second quarter of 2021. The net loss available to common stockholders for the first half of 2022 was approximately $12.6 million, or $0.27 per share, compared with approximately $21.9 million, or $0.65 per share, in the first half of 2021.Cash and cash equivalents were approximately $16.6 million as of June 30, 2022, compared with $36.1 million as of December 31, 2021. In the reporting quarter and year to date, the Company reached the following key milestones: OpGen signed its first two commercial customer contracts for the Acuitas AMR Gene Panel in June and July 2022 with a major 1,000+ bed teaching hospital in the Northeast and a renowned 400+ bed children’s hospital in the MidwestOpGen subsidiary Ares Genetics extended its collaboration agreement with Sandoz until 2025, to drive cutting-edge digital solutions in the global fight against antimicrobial resistance (AMR)OpGen subsidiary Ares Genetics also commercially launched new sequencing and analysis services globally, which includes ARESid and ARESiss ExpressOpGen announced interim analysis results from its clinical trial for Unyvero UTI Panel and added a fourth trial siteOpGen to date has enrolled over 1,300 patient samples in the clinical trial for Unyvero UTI Panel and is on track towards the enrollment goal of 1,500 prospective patient samplesOpGen subsidiary Curetis and Leader Life Sciences entered into a Unyvero distribution partnership within the United Arab Emirates and Qatar for a total value of approximately $1 million in revenue during the initial three-year termOpGen subsidiary Curetis and Keis Group entered into a three-year exclusive Unyvero distribution partnership in Kosovo based on Keis’ successfully won tender for Unyvero productsOpGen and Menarini expanded their distribution agreement to increase the annual minimum revenue commitment by Menarini in the next two years, in addition to the sale of around 70 installed Unyvero systems across nine European countries at residual fair market value from OpGen’s subsidiary Curetis to MenariniOpGen announced publication of results from a major prospective, multi center, randomized and interventional clinical study using Unyvero Hospitalized Pneumonia (HPN) Panel in The Lancet Respiratory Medicine that demonstrated Unyvero decreases the duration of inappropriate antibiotic therapy in hospitalized patients with pneumoniaOpGen announced publication of results of Unyvero HPN Panel for detection of bacterial respiratory tract pathogens from serial specimens collected from hospitalized COVID-19 patients at Karolinska University Hospital (Sweden), confirming the ability of Unyvero in detecting potential pneumonia pathogens earlier than cultureOpGen commenced a new At The Market (ATM) sales facility for up to approximately $10.7 million, pursuant to which the Company may sell, from time to time, in an “at the market” offering shares of its common stock. While no shares were sold under this new ATM in H1 2022, in July and August to date the Company has sold approximately 1.7 million new shares of its common stock for gross proceeds of approximately $1 million.OpGen requested an additional 180-day period from Nasdaq to regain compliance with the $1.00 minimum bid price rule and expects their decision by the end of August. In terms of fiscal 2022 guidance, OpGen expects: U.S. direct product sales of Unyvero and Acuitas are anticipated to contribute to growthContinuous increase in its European and international distribution business for Unyvero productsExpand Ares Genetics strategic collaborations and partnerships and launch U.S. Next Generation Sequencing lab services in Q3 2022Overall, 2022 revenue growth of approximately 25% year over year from the products and services business globally Conference Call Information OpGen’s management will host a conference call today, August 11th at 4:30 p.m. EDT, to go over the second quarter and first half of 2022 financial results and business activities, as well as answer analyst questions. Dial-in InformationU.S. Dial-in Number: +1-877-704-4453International Dial-in Number: +1-201-389-0920Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1556114&tp_key=e1546ec0f5Conference ID: 13730742 Following the conclusion of the conference call, a replay will be available through August 25th, 2022. 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 InformationU.S. Dial-in Number: +1-844-512-2921International Dial-in Number: +1-412-317-6671Replay PIN: 13730742 About OpGen, Inc. OpGen, Inc. (Rockville, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our 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 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 the second quarter and first half 2022 financials of OpGen and the current business of OpGen. 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, the success of our commercialization efforts, 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 fact that we may not effectively use proceeds from recent financings, the continued realization of expected benefits of our business combination transaction with Curetis GmbH, the continued impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, our ability to satisfy debt obligations under our loan with the European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, 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, Inc.Consolidated Balance Sheets(unaudited) June 30, 2022 December 31, 2021Assets Current assets Cash and cash equivalents $16,586,577 $36,080,392 Accounts receivable, net 738,148 1,172,396 Inventory, net 1,196,956 1,239,456 Prepaid expenses and other current assets 1,687,564 1,250,331 Total current assets 20,209,245 39,742,575 Property and equipment, net 3,209,311 4,011,748 Finance lease right-of-use assets, net 19,660 90,467 Operating lease right-of-use assets 1,582,325 1,814,396 Goodwill 6,884,915 7,453,007 Intangible assets, net 12,969,215 14,530,209 Strategic inventory 3,492,602 3,472,337 Other noncurrent assets 441,320 551,794 Total assets $ 48,808,593 $ 71,666,533 Liabilities and Stockholders’ Equity Current liabilities Accounts payable $731,845 $1,307,081 Accrued compensation and benefits 1,575,299 1,621,788 Accrued liabilities 788,153 1,965,845 Current maturities of long-term debt 10,887,469 14,519,113 Short-term finance lease liabilities 16,731 43,150 Short-term operating lease liabilities 394,027 459,792 Total current liabilities 14,393,524 19,916,769 Long-term debt, net 4,024,413 7,176,251 Derivative liabilities 175,498 228,589 Long-term finance lease liabilities 1,962 3,644 Long-term operating lease liabilities 2,721,233 2,977,402 Other long-term liabilities 130,983 146,798 Total liabilities 21,447,613 30,449,453 Stockholders' equity Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at June 30, 2022 and December 31, 2021, respectively — — Common stock, $0.01 par value; 100,000,000 shares authorized; 46,623,618 and 46,450,250 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively 466,237 464,503 Additional paid-in capital 276,205,778 275,708,490 Accumulated deficit (248,185,670) (235,541,539)Accumulated other comprehensive (loss)/income (1,125,365) 585,626 Total stockholders’ equity 27,360,980 41,217,080 Total liabilities and stockholders’ equity $ 48,808,593 $ 71,666,533 OpGen, Inc.Consolidated Statements of Operations and Comprehensive Loss(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Revenue Product sales $889,271 $307,804 $1,255,323 $835,383 Laboratory services 20,570 266,784 63,499 450,849 Collaboration revenue 57,364 237,027 118,128 355,099 Total revenue 967,205 811,615 1,436,950 1,641,331 Operating expenses Cost of products sold 646,389 342,580 938,386 896,634 Cost of services 15,650 137,934 46,212 242,918 Research and development, net 2,273,756 2,859,590 4,590,197 5,673,081 General and administrative 2,134,266 2,692,255 4,759,319 5,355,912 Sales and marketing 1,169,349 802,549 2,220,781 1,701,801 Impairment of right-of-use asset — 115,218 — 170,714 Total operating expenses 6,239,410 6,950,126 12,554,895 14,041,060 Operating loss (5,272,205) (6,138,511) (11,117,945) (12,399,729)Other expense Gain on extinguishment of debt — 259,353 — 259,353 Warrant inducement expense — — — (7,755,541)Interest and other income, net 13,851 4,702 16,972 9,627 Interest expense (779,912) (1,198,169) (2,049,493) (2,363,151)Foreign currency transaction gains/(losses) 271,967 (915) 470,707 426,700 Change in fair value of derivative financial instruments (74,116) (13,021) 35,628 (114,411)Total other expense (568,210) (948,050) (1,526,186) (9,537,423)Loss before income taxes (5,840,415) (7,086,561) (12,644,131) (21,937,152)Provision for income taxes — — — — Net loss $ (5,840,415) $ (7,086,561) $ (12,644,131) $ (21,937,152)Net loss available to common stockholders $ (5,840,415) $ (7,086,561) $ (12,644,131) $ (21,937,152)Basic and diluted net loss per share attributable to common stockholders $ (0.13) $ (0.19) $ (0.27) $ (0.65)Weighted average shares outstanding - basic and diluted 46,574,512 38,268,293 46,529,718 33,900,964 Net loss $(5,840,415) $(7,086,561) $(12,644,131) $(21,937,152)Other comprehensive loss - foreign currency translation (1,227,142) 529,651 (1,710,991) (548,828)Comprehensive loss $ (7,067,557) $ (6,556,910) $ (14,355,122) $ (22,485,980) OpGen:Oliver SchachtPresident and CEOInvestorRelations@opgen.com OpGen Press Contact:Matthew Bretzius FischTank Marketing and PR matt@fischtankpr.com OpGen Investor Contact:Alyssa FactorEdison Groupafactor@edisongroup.com