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| Statement |
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| Furthermore, we continue to see revenue growth opportunities for our Unyvero products and Ares Genetics services globally and especially here in the U.S., including, in particular, with respect to our distribution partnership for our Unyvero products with Fisher Healthcare that we entered into during the second quarter |
| The C-Series instruments have been optimized to improve manufacturability, serviceability and should extend the lifetime of key moving parts inside these instruments |
| During the second quarter, we continued to see traction across all our platforms and we have seen several successful recent commercial contract plannings |
| As we mentioned earlier, we continue to make strong headway on the commercial front, which could not be supported without dedication from our team |
| During the second quarter, we also signed contracts for two new Unyvero system placements with one of our Acuitas customers, demonstrating scientific potential of our product lines |
| Taken together, in recent weeks, we have signed commercial contracts totaling potential annualized revenue volume of up to $1.5 million, adding to our topline revenue growth potential |
| We expect to see traction and momentum building for our Unyvero sales in the U.S |
| As mentioned previously, we believe there is an attractive opportunity to partner with the Chinese organization familiar with the markets to possibly license or otherwise monetize the A30 platform |
| We are excited to have their direction in this exciting stage of the business |
| Under a commercial contract with that healthcare network, we would expect annual testing volumes to initially be in the range of 1,000 to 2,000 samples per year with further medium-term growth potential |
| The latest milestone deliverables support users and treatment decision-making, adding options to allow for mobile and cloud-based data access and harnessing the power of next-generation sequencing strain analysis |
| First half of 2023 revenue of approximately $1.65 million grew by approximately 15%, compared to revenue of approximately $1.44 million in the first half of 2022 |
| A recently signed agreement and purchase order confirms significant six-figure dollar revenue for the first full year from that U.S |
| Thus, we are starting to see some upselling and cross-selling opportunities across our entire portfolio of IVD and ROU offerings in AMR |
| During the quarter, we have successfully completed the vendor setup of OpGen on the Fisher Healthcare Systems, have held an introductory all-hands training session for their entire U.S |
| This will also lower the manufacturing cost of A30 instruments |
| We anticipate growing our revenue base across the Unyvero, Acuitas and Ares product lines in the U.S., intend to continue working with our international distribution partners in Europe, as well as our current and potential future partners in China for Unyvero A50 and A30, respectively |
| OpGen continues to emphasize commercialization opportunities to leverage our current platform and further nurture existing partnerships |
| On the Ares isolate sequencing services front, we have also seen progress in Q2 |
| Beyond a total of up to $1.5 million in FIND contracted funding to-date, additional non-dilutive financing opportunities remain a strategic priority for OpGen |
| Since the end of the second quarter, we have pursued options to improve our cash position or mitigate a liquidity shortfall |
| This increase in 2023 was primarily due to the revenue generated from the FIND collaboration project, but also included Unyvero product sales, revenue we received under our Acuitas AMR Gene Panel commercial contracts, as well as Ares related service revenues |
| Thank you all for your continued support and for participating in this afternoon’s call |
| On the IP front, OpGen’s subsidiary, Ares Genetics, successfully defended a key patent that was being contested in Europe |
| As shown year-to-date, we look to complement these opportunities with equity funding that will expand our collaboration potential and could allow us to partner with organizations like FIND, BARDA, the European Union and other funding bodies |
| For the coming quarters, we expect to see a growing number of commercial accounts being signed in the U.S |
| Following the successful completion of data readout from our successful Unyvero UTI clinical trial, OpGen submitted a de novo classification request with the FDA seeking marketing authorization |
| We have also recently signed several new contracts with customers for further Unyvero system placements here in the U.S., including a strategic account with a global diagnostics corporate customer for Unyvero pneumonia and blood culture reference testing, a multiyear contract with a hospital from a larger network of hospitals across the Western U.S |
| Thank you very much |
| Together with Fisher and the information from their CRM system and customer data, we have already identified several hundred high priority leads across the U.S |
| Statement |
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| Nevertheless, there is substantial doubt about OpGen’s ability to continue as a going concern |
| Otherwise, non-dilutive funding would not likely materialize |
| If we are unable to successfully identify and execute on any of these alternatives, the company will have insufficient cash to continue operating beyond September 2023 |
| Such risks and uncertainties include, but are not limited to OpGen’s ability to continue to finance its business and operations, the results of alternatives to mitigate the company’s cash position, including restructuring or refinancing its debt, seeking additional capital, reducing business activities, strategic transactions and other measures, including obtaining relief under applicable bankruptcy laws |
| For the first half of 2023, we saw a decrease of approximately 6% in operating expenses from $12.6 million in the first six months of 2022 to $11.9 million in the comparable period this year |
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