OSE Immunotherapeutics Reports 2019 Financial Results and Provides Business Update Expectations for Potential Impact of COVID-19 on the Company’s Clinical Development Activities
Strong clinical progress in lead assets Tedopi®, OSE-127 and BI 765063Bispecific antibody platform BiCKI®: First project selected, cytokine IL-7 to be paired with anti-PD-1 €5 million milestone payment from Servier accelerated and now expected by the start of a Phase 2 with OSE-127 in Sjögren’s syndrome FY 2019 turnover of €26 million2019 year-end cash position of €25.8 millionExpected €3 million research tax credit and Servier milestone to provide funding until Q1 2021NANTES, France, March 26, 2020 (GLOBE NEWSWIRE) — OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today reported its consolidated annual financial results for 2019 and provided an update on key achievements, as well as the company’s outlook for its agonist and antagonist immunotherapies for cancers and autoimmune diseases.Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, said: “The current COVID-19 situation is a major public health concern and also an important factor impacting our ongoing and upcoming clinical trials. Health agencies and expert groups have said in the past few days that the continuation of clinical trials in hospitals would be very disrupted due to the mobilization of medical teams, containment and the potential risks associated with the epidemic of COVID-19 for fragile patients. Our short-term priority is to do our part to ensure healthcare systems have the resources to fight COVID-19 and to reduce the demands on healthcare professionals, while safeguarding patients currently taking part in our clinical trials.“OSE Immunotherapeutics made significant clinical progress with our lead assets in immuno-oncology and auto-immune diseases in 2019 and early 2020.“In 2019, our drug candidates being developed with partners Boehringer Ingelheim and Servier generated €25 million in milestone payments and both achieved key clinical milestones: initiation of the ongoing Phase 1 trial of myeloid checkpoint inhibitor BI 765063 in advanced solid tumors and completion of Phase 1 trial of anti-IL-7 receptor antagonist OSE-127 with positive results. Based on these results, two Phase 2 studies with OSE-127 are planned to start in 2020. Furthermore, a recent amendment to our license option agreement with Servier on OSE-127 confirms our partner’s commitment and strong belief in the potential of the product.“In 2020, we plan to continue the company’s value creation by advancing our clinical and preclinical programs while adapting our organization to the COVID-19 crisis. In line with our business model, we will continue to secure financial resources to invest in R&D to discover and develop novel therapeutics for patients. In particular, the milestone payment associated with the recently-amended agreement with Servier on OSE-127 will reinforce our cash position and flexibility to progress on our development strategy. With these considerations in mind, we have provided expectations for the impact that COVID-19 could have on our clinical programs, given the current assessment of the situation. We continue to monitor the situation and will provide updates on any changes in timelines as they arise.”2019 KEY ACHIEVEMENTSMajor clinical progress with four differentiated therapeutic programs in immuno-oncology and autoimmune diseasesTedopi®, a combination of 10 neoepitopes intended to induce specific T-lymphocyte activation, is OSE Immunotherapeutics’ most advanced drug candidate and is currently in a Phase 3 pivotal clinical trial, called Atalante 1, to treat non-small cell lung cancer (NSCLC) following failure of immune checkpoint inhibitor treatment (PD-1/PD-L1). Due to the COVID-19 outbreak situation and associated considerations of the safety of trial participants, compliance with good clinical practice (GCP), and risks to trial integrity during the COVID-19 pandemic following the specific guidelines of regulatory agencies, OSE Immunotherapeutics is reviewing the potential impact of this outbreak on the Atalante 1 trial. The Company will provide an update on the status of this review and on the results of the trial’s pre-defined step 1 as soon as possible in the coming next weeks.Tedopi® also is in Phase 2 development in combination with Opdivo® (nivolumab) in patients with pancreatic cancer, called TEDOPaM, a trial sponsored by the GERCOR cooperative group in oncology and supported by Bristol Myers Squibb. Patients screening and accrual in the TEDOPaM study are expected to be impacted by the COVID-19 situation in the coming months.The Company will maintain an open dialogue with updates to these and other trials as more clarity arises on the overall impact this public health crisis has on expected timelines.Tedopi®’s intellectual property in immuno-oncology in HLA-A2 positive patients has been further strengthened and extended by notice of allowance in Japan and in the U.S. for a new patent family related to Tedopi® for use in the treatment of brain metastasis originating from cancers, including NSCLC. It was also strengthened by issuance in Japan of a new patent family protecting the product’s method for inducing early T-lymphocyte memory response for use in the treatment of cancer.A new licensing deal was signed with Chong Kun Dang (CKD) Pharmaceutical Corporation for potential registration and commercialization of Tedopi® in South Korea. Financial terms of the contract include both upfront and short-term milestone payments of €1.2 million with total milestone payments of €4.3 million, as well as royalties on sales and transfer price in the high twenties percentage.OSE Immunotherapeutics and HalioDx, an immuno-oncology diagnostic company, have initiated a collaboration to conduct a translational investigation of immune biomarkers as part of the ongoing Phase 3 clinical trial of Tedopi® in NSCLC patients. This investigation is focused on identifying potential immune biomarkers in NSCLC. Based on the data generated, the collaboration aims at defining the profile of responder patients to Tedopi® treatment in advanced lung cancer.BI 765063 (formerly OSE-172), a myeloid checkpoint inhibitor and SIRPα antagonist, being developed in partnership with Boehringer Ingelheim, is in Phase 1 trial in advanced solid tumors.The first patient was enrolled and dosed in June 2019 in the first-in-human Phase 1 trial, a dose finding study of BI 765063 administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091. The trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumors. The trial is expected to be impacted by the COVID-19 situation with regard to the screening and accrual of new patients in Q2 2020. Further updates will be made when availableOSE Immunotherapeutics received a €5.4 million payment from Bpifrance triggered by the successful completion of development milestones related to its collaborative program, called EFFI-CLIN, focused on evaluating BI 765063.OSE-127 is a monoclonal antibody antagonist of the interleukin-7 receptor (IL-7R) being developed in partnership with Servier.The United States Patent and Trademark Office (USPTO) issued a first notice of allowance for a patent application covering OSE-127 and protecting the product until at least 2035. This new patent validates the product’s novel and differentiated mechanism of action as the only full-antagonist of IL-7R in clinical development, a target which has been shown to induce a powerful antagonistic effect on effector T-lymphocytes responsible for causing autoimmune pathologies.The Phase 1 clinical study of OSE-127 was completed end of 2019 with positive results showing a good safety and tolerability profile for the product. All pharmacokinetic and pharmacodynamic parameters were consistent and demonstrated a dose-proportionality across the several dose-levels up to 10 mg/kg. Based on these positive data, two Phase 2 trials are planned to start in 2020: in ulcerative colitis (OSE sponsored) and Sjögren’s syndrome (Servier sponsored).In March 2020, OSE Immunotherapeutics and Servier signed an amendment to the two-step global licensing option agreement for OSE-127. Under this amendment, both companies have agreed to modify the provisions regarding the potential exercise of the option, amending step 2 of the option agreement, making OSE eligible to receive a €5 million milestone payment from Servier upon the enrollment of the first patient in the Phase 2a clinical study in Sjögren’s syndrome and the remaining €15 million payment upon exercise of an option at the completion of both Phase 2 clinical trials, and in priority upon completion of the Phase 2a clinical study in Sjögren’s syndrome. The previous version of the agreement had the full €20 million milestone payment due upon completion of Phase 2 clinical study in ulcerative colitis. The initiation of both Phase 2 clinical trials planned in 2020 is subject to the evolution of the COVID-19 situation and will take place once all preparatory steps are achieved and once hospitals and healthcare professionals are able to ensure safe practices during clinical research and patients’ care.FR104, a monoclonal antibody antagonist of CD28, is a Phase-2 ready asset with potential to be developed in either autoimmune disease or in transplantation.The Canadian Intellectual Property Office granted a patent that covers the product and its therapeutic applications in T-lymphocyte-mediated autoimmune diseases, chronic inflammatory diseases and graft applications. At the same time, the USPTO issued a notice of allowance providing additional protection covering the use of FR104 in the treatment of T-lymphocyte-mediated chronic inflammatory diseases. Therapeutic applications of FR104 are thus covered through 2031.A dynamic partnership business model based on innovative products to generate revenues to broaden R&D programsOSE Immunotherapeutics received €25 million in milestone payments during H1 2019 (€10 million payment from Servier upon exercise of first of two steps of a global licensing option agreement for OSE-127; €15 million in payments from Boehringer Ingelheim upon Clinical Trial Authorization and first dosing of a patient in the Phase 1 clinical trial of BI 765063).OSE Immunotherapeutics is evaluating the best options for continuing sustainable development of FR104, a Phase 2-ready asset, in autoimmune diseases or in transplantation, including worldwide partnering opportunities. Furthermore, the Company is exploring global partnership opportunities for Tedopi®, currently in Phase 3 in NSCLC and in Phase 2 in pancreatic cancer.Research & DevelopmentFocused on novel target discovery to generate innovative agonists or antagonists of the immune response, the Company is pursuing advancement of new innovative research programs.The Company disclosed its novel bispecific checkpoint inhibitor (BiCKI®) platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. BiCKI® represents the second generation of PD-(L)1 inhibitors that have been used to increase antitumor efficacy in hard to treat cancers by addressing untapped immune evasion mechanisms. The first cytokine selected to be paired with the anti-PD-1 in the bispecific antibody is Interleukin-7 (IL-7), which has been shown to improve immune functions and cancer immunotherapy efficacy.A new research collaboration agreement was concluded with premier cancer research hospital Léon Bérard Cancer Center in Lyon, France, to use artificial intelligence-based bioanalysis and bioinformatics to analyze gene expression in the human tumor microenvironment and the composition of tumor infiltrates. The findings from this collaboration will be used for the selection and validation of innovative targets for early development of new drug candidates from the platform of bispecific fusion proteins targeting PD-1 and innovative targets (BiCKI).OSE Immunotherapeutics’ “DC-Target” project was selected by the French National Research Agency to be awarded a grant of up to €800,000 as part of the “AAPG 2019” call for proposals. This research program, coordinated by the Léon Bérard Cancer Center, aims to identify new targets of therapeutic interest expressed by myeloid cells through in-depth characterization of the role of each cell by single cell RNAseq (scRNAseq – Cellenion) and gene editing.Early 2020, the Company signed a drug development collaboration with innovative deep technology French start-up MAbSilico to use artificial intelligence-based solution for the development of monoclonal antibodies, including novel bispecific antibodies (BiCKI® platform).GovernanceNicolas Poirier, Ph.D., Chief Scientific Officer of OSE Immunotherapeutics, was additionally appointed as Director, representing the employee shareholders.Walter Flamenbaum resigned from the Company’s Board of Directors on February 19, 2020.2019 RESULTSA meeting of the Board of Directors of OSE Immunotherapeutics was held on March 26, 2020 according to the ordinance n° 2020-321. Following the opinion of the Audit Committee, the Board approved the annual and consolidated financial statements prepared under IFRS at 31 December 2019.The key figures of the 2019 consolidated annual results are reported below (and presented in the attached tables):As of December 31, 2019, the Company’s available cash* amounted to €25.8 million, giving financial visibility until Q1 2021, taking into account €3 million from research tax credit and an additional planned milestone payment of €5 million from Servier, following amendment to the global license option agreement on OSE-127, and expected at the start of a Phase 2 in Sjögren’s syndrome.During 2019, additional cash influx of €25 million has been generated by milestone payments related to partnerships (€15 million from Boehringer Ingelheim upon CTA for the Phase 1 trial with BI 765063 and upcoming first patient dosed and €10 million from Servier upon exercising of the first option under the two-step option within global license agreement). Moreover, the Company received a €5.4 million payment from Bpifrance triggered by the successful completion of development milestones related to its collaborative program EFFI-CLIN, program focused on evaluating BI 765063.This available cash will enable the Company to finance its clinical development costs and R&D costs on earlier stage products until Q1 2021 at least. If there are significant delays or clinical trial holds as a result of COVID-19, our cash runway will be extended beyond the current Q1 2021 projection, given that the bulk of our expenses are mainly related to clinical development expenditures.The turnover amounted to €26 million due to the milestone payments from the collaboration agreement with Boehringer Ingelheim and Servier. During 2019, the Company recorded a consolidated operating loss of (€1.5) million.Current operating expenses were €27.4 million (€19.5 million in 2018) of which 81% related to R&D. Among R&D expenses of €21.6 million, 85% are dedicated to the Company’s ongoing clinical projects, in line with the broadening and progress of its pipeline.*Available cash and cash equivalents and current financial assetsAbout OSE Immunotherapeutics
OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPα monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under a two-step licensing option agreement. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; two independent Phase 2 studies planned in ulcerative colitis (OSE sponsor) and Sjögren’s syndrome (Servier sponsor) to start in 2020, subject to the evolution of the COVID-19 situation.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedIn
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.
(1) Warrants and free shares awards granted in 2019 and valuated for 1 511 K€
(2) Mainly explained by:
– Decrease of trade receivable for 1 506 K€
– Decrease of other current assets for 1 864 K€
– Increase of trade accounts payable for 363 K€
– Increase of social and tax payable for 493 K€
– Increase of other debts for 4 237 K€
(3) Explained by IFRS16 application, which corresponds to reimbursement of lease debt for 251 K€
Aidéo Technologies Launches Free Use of AI-Powered Automated CPT and Diagnosis Coding During the US Response to COVID-19
MELBOURNE, Fla., April 01, 2020 (GLOBE NEWSWIRE) — Aidéo Technologies – a leader in AI-enabled automation technology for the healthcare industry – announced today that it will allow healthcare organizations and revenue cycle management companies to utilize its AI enabled medical coding engine Gemini AutoCode™ free of charge in response to COVID-19.
COVID-19 has disrupted the global revenue cycle management workforce and created challenges for organizations lacking a secure infrastructure to allow employees to work from home while under shelter-in-place mandates. As a by-product, physician practice and hospital revenue are negatively impacted.There is a growing concern over security of US patient data as many companies cannot meet security requirements in a work from home environment. “Aidéo Technologies wants to help the US Healthcare Delivery System remain financially viable during this national crisis,” said Rob Gontarek, the President and CEO of Aidéo Technologies. “We are making our technology platform available at no cost for the duration of the crisis to affected providers and revenue cycle management companies. Organizations can gain immediate access to a secure solution to the disruption in the global workforce.” The business continuity of medical groups and hospitals can be maintained using the machine learning models for medical coding through Gemini AutoCode™.Gemini AutoCode™ uses AI, a proprietary Natural Language Processing engine, and machine learning to interpret structured and unstructured clinical data. The application assigns the appropriate procedure and diagnosis codes, with no human intervention required. Gemini AutoCode™ easily integrates with electronic medical records and can accurately interpret and code over forty-thousand clinical encounters per hour.It is expected that COVID-19 will have a lasting impact on the US Healthcare Delivery System and the machine learning of Gemini AutoCode™ will offer relief to entities impacted by the crisis. For more information, please visit www.aideo-tech.com/howcanwehelp?About Aidéo Technologies
Aidéo Technologies (www.aideo-tech.com) provides software automation tools using artificial intelligence, robotics, and machine learning to the healthcare industry. Established in 2009, the company has development centers in Melbourne, Florida, and Silicon Valley. Aidéo is a portfolio company of Avtar Investments (www.avtarinvestments.com), a private family office investment firm focused on disruptive technology in healthcare.Contact:
Senior Director, Client Service
2nd Gen AMD EPYC™ Processors Power New IBM Cloud Bare Metal Servers
SANTA CLARA, Calif., April 01, 2020 (GLOBE NEWSWIRE) — Today, AMD announced that IBM Cloud is enhancing its global infrastructure with 2nd Gen AMD EPYC™ processors to power its latest bare metal servers. With the addition of the AMD EPYC 7642 processor to its cloud portfolio, IBM is engineered to deliver increased computing performance in its bare metal offerings. Available now, these new bare metal servers are the first 2nd Gen AMD EPYC™ based offering from IBM Cloud and are focused on the computing power and performance required to accelerate modern workloads like data analytics, electronic design automation, artificial intelligence and virtualized and containerized workloads.
“2nd Gen AMD EPYC processors deliver where it counts for cloud providers, providing the cores, scalability and throughput for critical workloads,” said Forrest Norrod, senior vice president and general manager, Data Center and Embedded Solutions, AMD. “We are extremely excited to extend the advantages of 2nd Gen AMD EPYC processors to new bare metal offerings at IBM Cloud, helping customers tackle today’s compute-intensive workloads.”“We are thrilled to launch new IBM Cloud offerings powered by the 2nd Gen AMD EPYC CPUs,” says Satinder Sethi, GM, IBM Cloud Infrastructure Services. “With these new processors, we can offer IBM Cloud clients greater choice and flexibility to select the platform that is best suited to meet the needs of today’s most demanding workloads. We look forward to continuing to deliver new innovations and value to our clients in the future.”The AMD EPYC 7642 based, dual socket bare metal server offering at IBM Cloud includes:96 CPU cores per platformBase clock frequency of 2.3GHz with a Max Boost up to 3.3GHzi8 memory channels per socket for superior memory bandwidthUp to 4TB memory configuration supportUp to 24 local storage drivesOS choices of RHEL, CentOS, Ubuntu, MS ServerMonthly, pay-as-you-use billingOrderable via the global IBM Cloud Catalogue, API, or CLIThe bare metal servers are being made available in IBM Data Centers across the North America, Europe, and Asia Pacific regions. The AMD EPYC 7642 based servers can be ordered via the IBM Cloud global catalogue portal, API or CLI and consumed in a monthly pay-as-you-use model. Visit IBM Cloud to start building a bare metal server configuration with 2nd Gen AMD EPYC processors.Supporting ResourcesLearn more about IBM Cloud Bare Metal ServersRead more at the IBM BlogLearn more about the AMD 2nd Gen EPYCTM ProcessorBecome a fan of AMD on FacebookFollow AMD on TwitterAbout AMD
For more than 50 years AMD has driven innovation in high-performance computing, graphics and visualization technologies ― the building blocks for gaming, immersive platforms and the datacenter. Hundreds of millions of consumers, leading Fortune 500 businesses and cutting-edge scientific research facilities around the world rely on AMD technology daily to improve how they live, work and play. AMD employees around the world are focused on building great products that push the boundaries of what is possible. For more information about how AMD is enabling today and inspiring tomorrow, visit the AMD (NASDAQ: AMD) website, blog, Facebook and Twitter pages.AMD, the AMD Arrow logo, EPYC, and combinations thereof, are trademarks of Advanced Micro Devices, Inc. Other names are for informational purposes only and may be trademarks of their respective owners.i Max boost for AMD EPYC processors is the maximum frequency achievable by any single core on the processor under normal operating conditions for server systems. EPYC-18
(512) 602-8950 Laura Graves
AMD Investor Relations
Predictive Oncology Reports 2019 Full-year Financial Results
MINNEAPOLIS, April 01, 2020 (GLOBE NEWSWIRE) — Predictive Oncology Inc. (NASDAQ: POAI) (“Predictive Oncology” or “the Company”), a knowledge-driven company focused on applying artificial intelligence (“AI”) to personalized medicine and drug discovery, today reported financial results for its full year ended December 31, 2019, as well as select corporate highlights.Q4 HighlightsSecured $15.0 Million equity line with Oasis Capital, LLCNew subsidiary Helomics reached milestone sequencing tumor cases in partnership with UPMC MageeSubsidiary Skyline Medical completed largest STREAMWAY™ System order to a single hospital in the Company’s historyLaunched CancerQuest 2020 initiative, with ovarian cancer initial targetFull-Year 2019 Results – 2019 vs. 2018Revenues were $1.4 million, flat year on year relative to $1.4 million in 2018Net loss was $19.7 million versus $10.1 million in 2018, owing in part to Helomics merger expenses, goodwill impairment, and other extraneous expenses related to the transaction.Bob Myers, CFO of Predictive Oncology, stated, “2019 was not without its challenges for the entire healthcare technology industry, yet we continued to execute on our business model, making a synergistic acquisition and shoring up our balance sheet via a new $15.0 million equity line from Oasis Capital. Our STREAMWAY line has maintained strong disposable product sales and we continue to sell the STREAMWAY System.”“We continue to be very excited about the revenue and monetization prospects for our precision medicine business, which will allow us to be at the forefront of developing the artificial intelligence required to combat a variety of ailments, as well as our revolutionary STREAMWAY clinical waste disposal products,” stated Dr. Carl Schwartz, CEO and Director. “We will continue to execute upon our comprehensive strategy to deliver long-term profitable growth and innovation while concentrating our efforts and resources on our recently acquired Helomics business.”“Building on the successes in 2019, we have recently announced the launch of our CancerQuest 2020 initiative, and we expect Helomics’ first AI-driven predictive model of ovarian cancer to be ready for initial commercialization in revenue generating projects with Pharma in Q2-2020,” Dr. Schwartz added. “Furthermore, we have signed a Letter of Intent to acquire Quantitative Medicine, a biomedical analytics and computational biology company. Against this backdrop, we believe that Predictive Oncology will continue to be a pioneer within the fields of biomarker discovery and precision therapies going forward.”FULL-YEAR 2019 RESULTSRevenues were $1.4 million, consistent with 2018. Revenues in both years were primarily driven through the sale of Predictive Oncology’s proprietary STREAMWAY units, of which 43 units and 41 units were sold, respectively, in each of 2019 and 2018. Gross margins remained strong, declining slightly to 62% in 2019, from 71% in 2018, largely due to the increase in costs following the consolidation of the Helomics acquisition on April 4, 2019. However, exclusive of Helomics, the cost of sales related to the sale of STREAMWAY products was comparable on a year-on-year basis.Net losses for 2019 totaled $19.7 million versus $10.1 million in 2018. General & administrative expenses rose 111% to nearly $9.8 million in 2019 as a result of extraneous expenses and initial costs related to the Helomics merger. In addition, Predictive Oncology recognized a credit loss of $1.0 million in notes receivable from CytoBioscience (now operating as InventaBioTech). Operational expenses also rose to $3.0 million, compared to $1.8 million in 2018. Net loss in 2019 reflected impairment charges of $8.1 million on goodwill related to the Helomics merger and $0.8 million on intangibles, versus no impairment charges in 2018.Separately, the Company benefited from a gain of $6.1 million as a result of the revaluation of the equity method investment recorded post the initial 25% purchase of Helomics, following the merger and consolidation of Helomics effective April 4, 2019. Predictive Oncology also incurred other expenses of $4.0 million in 2019 compared to only $441,000 in 2018, primarily due to an increase in interest expense, payment penalties, amortization of original issue discounts and a loss on debt extinguishment related to our notes payable.OUTLOOKGoing forward, management intends to focus its resources on the Helomics and TumorGenesis divisions and the Company’s primary mission of applying artificial intelligence to precision medicine, drug discovery and the mediums used to replace rats and mice in preliminary cancer studies. Predictive Oncology had previously reported in December 2019 that it had received several indications of interest for the possible acquisition of its Skyline Medical division (which owns and markets the Company’s proprietary STREAMWAY System) no further action has resulted from these indications, and today management reaffirms that it is focusing the majority of its resources on maximizing opportunities within the Company’s precision medicine business.About Predictive Oncology Inc.Predictive Oncology (Nasdaq: POAI) operates through three segments (Domestic, International and Helomics), which contain four subsidiaries; Helomics, TumorGenesis, Skyline Medical and Skyline Europe. Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. Helomics’ CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy. In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor™, patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary bioinformatics platform to provide a tailored solution to its clients’ specific needs. Predictive Oncology’s TumorGenesis subsidiary is developing a new rapid approach to growing tumors in the laboratory, which essentially “fools” cancer cells into thinking they are still growing inside a patient. Its proprietary Oncology Discovery Technology Platform kits will assist researchers and clinicians to identify which cancer cells bind to specific biomarkers. Once the biomarkers are identified they can be used in TumorGenesis’ Oncology Capture Technology Platforms which isolate and help categorize an individual patient’s heterogeneous tumor samples to enable the development of patient specific treatment options. Helomics and TumorGenesis are focused on ovarian cancer. Predictive Oncology’s Skyline Medical division markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. The company has achieved sales in five of the seven continents through both direct sales and distributor partners. For more information, please visit www.predictive-oncology.com.Forward-looking StatementsPortions of the narrative set for this this document that are not statements of historical or current facts are forward-looking statements, in particular, the commercial outlook provided above. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors.These factors include, in addition to those mentioned elsewhere herein:
We may not be able to continue operating without additional financing;Current negative operating cash flows;The terms of any further financing, which may be highly dilutive and may include onerous terms;Risks related to the 2019 merger with Helomics including; 1) significant goodwill could result in further impairment; 2) possible failure to realize anticipated benefits of the merger; 3) costs associated with the merger may be higher than expected; 4) the merger may result in the disruption of our existing businesses; and 5) distraction of management and diversion of resources;Risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns;Risks related to the transaction with Quantitative Medicine including: 1) completion of the transaction; 2) possible failure to realize anticipated benefits of the merger; 3) costs associated with the merger may be higher than expected; 4) the merger may result in the disruption of our existing businesses; and 5) distraction of management and diversion of resources;Risk that we will be unable to complete the transaction with InventaBio Tech;Risk that we will be unable to protect our intellectual property or claims that we are infringing on others’ intellectual property;The impact of competition;Acquisition and maintenance of any necessary regulatory clearances applicable to applications of our technology;Inability to attract or retain qualified senior management personnel, including sales and marketing personnel;Risk that we never become profitable if our product is not accepted by potential customers;Possible impact of government regulation and scrutiny;Unexpected costs and operating deficits, and lower than expected sales and revenues, if any;Adverse results of any legal proceedings;The volatility of our operating results and financial condition, and,Other specific risks that may be alluded to in this report.Contact:
Predictive Oncology, Inc.
Consolidated Balance Sheets
Predictive Oncology, Inc.
Consolidated Statements of Operations
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