Centre For Probe Development & Commercialization

A Canadian manufacturer of radiopharmaceuticals is building a new site in Ontario after netting a major investment. AtomVie Global Radiopharma, which launched and secured a $40 million Series A in the latter half of last year, is currently building a new 64,000-square-foot manufacturing facility in the city of Hamilton in Ontario, Canada. The company’s origins can be traced back to 2008, with the Centres of Excellence for Commercialization and Research (CECR) program, AtomVie CEO Bruno Paquin said, in an interview with Endpoints News. The program, run by the Canadian government, was aimed at commercializing academic research and resulted in the Hamilton-based Center for Probe Development and Commercialization (CPDC), aimed at bringing radiopharmaceuticals to Ontario. The CPDC started offering contract manufacturing services which quickly grew, Paquin said, and in 2020, he became the CEO. However, CDPC was then based on the campus of McMaster University in Hamilton, and the space became too small, so Paquin decided to create a spinoff company. In 2021, AtomVie was incorporated with the manufacturer and officially launched in August of 2022, eventually closing on a $40 million Series A. However, Paquin said, the company was still operating in a 15,000 square-foot space at McMaster University and was “scattered” over four different buildings. Paquin said the space at McMaster University is limited in terms of growth, and there were other factors, such as the electrical and HVAC systems, that were not controlled by the company. “There was several drivers for us to go out, seek that money and build the facility. One of them was that the demand was way over what we could offer in the current facility. The second is that the current facility (at) McMaster University is very good, but it’s limited in terms of infrastructure, and it’s very limited in terms of growth for space,” Paquin said. AtomVie’s new space is located near Hamilton’s airport and about 50 miles from the US border. The shell of the facility is already built, and Paquin said the buildout of the interior will start soon. The new build will allow the manufacturer to attract more clients who have commercial needs in the radiopharmaceutical space and allow it to handle around 30 products, Paquin said. The facility’s exact cost was not disclosed, but Paquin said the funding for the facility’s buildout all came from private investment in the US, and no funding came from the Canadian government. AtomVie, which currently has 110 employees, plans to increase its headcount to 200 by 2027. The facility’s full build-out is expected to be finished in the second half of 2024, with Paquin estimating that production will start in 2025.

- Entered into exclusive agreement with Intelligent Fingerprinting Ltd. (IFP) for screening technology focused on drugs of abuse towards a prospective acquisition - - Completed collection and analysis in a study with coincidental sampling of oral fluid and blood to evaluate the time-course of glucose in oral fluids - - Company to host conference call & webcast today at 4:30 p.m. ET - NEW YORK, Aug. 31, 2022 (GLOBE NEWSWIRE) -- GBS Inc. (Nasdaq: GBS), a life sciences company developing non-invasive, real-time monitoring and diagnostic testing for patients and their primary health practitioners at point of care, today announced its preliminary financial results for the fourth financial quarter and full-year ended June 30, 2022 and provided a business update. Management will host a webcast and conference call at 4:30 p.m. ET today. “Over the course of the last fiscal year we have successfully advanced our novel saliva Glucose Biosensor into an ongoing comparative study at the Diabetes Research Institute of Sutter Health’s Mills-Peninsula Medical Center (MPMC) in San Mateo, California,” stated Dr. Steven Boyages, Interim Chief Executive Officer of GBS. “In addition to having secured additional manufacturing capacity at the University of Newcastle, our recent clinical study enrolling 40 adults with type 2 diabetes and over 1,400 samples will allow GBS to move into the final design and verification phase of the Glucose Biosensor development. Concurrently, and perhaps most notably, our strong relationship with Intelligent Fingerprinting has the potential to greatly increase our capabilities as we look to expand and enhance our product portfolio. We continue our thorough due diligence process and remain on track to update the market in the near term.” Fourth Quarter and Full Year Highlights, Recent Operational Developments Strategic Partnerships & Pipeline Development Entered into an exclusive agreement with Intelligent Fingerprinting Ltd. (IFP) for the rights to acquire the company including its point of care fingerprint sweat-based drug screening technology focused on opioids and drugs of abuse. This agreement forms the precursor for a proposed acquisition of IFP that, if consummated, would allow GBS to expand its portfolio with a rapid non-invasive diagnostic solution outside of saliva, while also accelerating revenue growth through an expanded portfolio of tests.Completed sample collection and analysis in a study of coincident sampling of oral fluid and blood to evaluate the time-course of glucose and intended to support clinical validation of the Saliva Glucose Biosensor and to solidify the direction of further development and subsequent clinical studies. The results from this study are encouraging and broadly in line with expectations with the blood: salivary glucose concentrations consistent with previous studies. GBS is now proceeding with the next phase of the glucose biosensor development program, including two key parallel clinical studies. In the first study, GBS will apply the results of our recent study to focus on eliminating the variables affecting glucose levels in saliva and in the sample collection method, and in the second study, GBS will move forward with a patient study involving saliva on the Glucose Biosensor test strip to assess accuracy and reproducibility. Commercial Development In the early part of the last fiscal year, GBS reorganized its leadership team to accelerate product development and manufacturing. Specifically, the Board of Directors appointed Professor Steven Boyages, PhD, Chairman of the Board of GBS, to the additional position of Interim Chief Executive Officer, effective October 29, 2021. An endocrinologist with extensive experience in research and clinical science and a Clinical Professor of the Sydney Medical School at The University of Sydney, Dr. Boyages is also a seasoned healthcare executive who has led complex, large organizations across the healthcare industry.In June, GBS selected a site with the University of Newcastle in Australia for construction and operation of a new, state-of-the-art, proprietary biosensor manufacturing facility and will begin construction before the end of the year. Management Also in June, GBS hired Peter Passaris as Director of Operations. Peter has 18 years of experience in manufacturing and enterprise industries. He began his career as a Chemical Engineer, R&D, eventually moving into technical sales and operations. Most recently, Mr. Passaris served as Sales and Operations Manager at Ecolab, where he led a high performing sales team of engineers/sales reps and technicians. He will be responsible for managing the Newcastle SRA and product development.On March 19, 2022, Tom Parmakellis resigned as a member of the Board of Directors for reasons unrelated to the company’s operations. In connection with Mr. Parmakellis’ resignation, and to strengthen our Board’s operations, existing, independent board members were appointed to specific committee governance roles. Specifically, George Margelis was appointed to serve on the Audit Committee; Christopher Towers was appointed to serve on the Compensation Committee; and Lawrence Fisher was appointed to serve on the Nominating Committee. Anticipated Events and Targeted Milestones for the Coming Fiscal Year •Prospective Acquisition of Intelligent Fingerprinting Ltd. •Full results of comparative study of coincident sampling of oral fluid and blood to evaluate the time-course of glucose and inform the downstream clinical strategy and product development. •Advancement into the final design and verification phase of the Glucose Biosensor development, involving two key parallel clinical studies. 1.Applying the results of our recent blood:glucose study to focus on eliminating the variables affecting glucose levels in saliva and in the sample collection method; and 2.A patient study involving saliva on the Glucose Biosensor test strip to assess accuracy and reproducibility. Both studies will further improve saliva collection protocols and fine-tune the biosensor performance as we head towards finalizing our product design and moving it from Research and Development to Manufacturing. •Completion of algorithm, middle wear and application development with the University of Newcastle in Australia. •Expansion of biosensor development to include additional analytes in the product portfolio in point of care testing using saliva. Full Year Ended June 30, 2022, Financial Results As of June 30, 2022, the Company’s cash, cash equivalents and marketable securities totaled approximately $8.2 million, compared to approximately $12.6 million on June 30, 2021. This change was primarily due to expenses incurred on regulatory and development and operational activities to progress on its regulatory and development milestones For the year ended, June 30, 2022, the Company had a preliminary net loss of $8.4 million or $0.57 per share compared to a net loss of $7.3 million or $0.68 per share for same period last year. This increase in loss is primarily due to more government support income last year as a result of qualifying research & development expenditure in that period and an increase in general and administration expenses due to expansion in operational activities in order to progress on its regulatory and development milestones. Government support income was $.44 million and $2.0 million for the year ended June 30, 2022 and 2021 respectively. This change was primarily due to GBS Inc.’s subsidiary companies receiving COVID-19 related government support in the previous financial year which was discontinued in April 2021 and qualifying research & development expenditure for research & development government subsidies. Since our IPO, GBS has brought forward expenditure on key resources and commercial partners’ activities to advance projects towards commercialization. The major categories include: Research, Development & Commercialization for the full fiscal year 2022 of $3.8 million compared to the year prior of $3.8 million.Employee Benefits Expense for the full fiscal year 2022 of $2.3 million compared to the year prior of $1.9 million. GBS is of the view that based on the current operating plan and financial resources, its cash, cash equivalents and marketable securities at June 30, 2022, will be sufficient to cover expenses and capital requirements into the second half of 2023. This cash runway forecast does not include a potential exercise of the glucose North American license option agreement or additional funds that would be required for the operation of IFP, after a potential consummation of the proposed merger. Webcast Information: Title:GBS Inc. Fourth Quarter and Full Year 2022 Financial Results Conference Call & Webcast Date:Wednesday, August 31, 2022 Time:4:30 p.m. ET Conference Call Details:Toll-Free: 877-407-3982International: 201-493-6780Conference ID: 13731215 The conference call will be webcast live from the Company’s website and will be available via the following links: Webcast:Webcast Registration Linkhttps://investors.gbs.inc/news-and-events/investor-calendar The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website at https://gbs.inc/ Forward-Looking Statements: Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, GBS Inc.’s ability to consummate the proposed transaction described in this press release, develop and commercialize its diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although GBS Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. GBS Inc. has attempted to identify forward-looking statements by terminology, including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in GBS’s public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. GBS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. GBS Inc. GBS Inc. is a life sciences company developing non-invasive, real-time monitoring and diagnostic tests for patients and their primary health practitioners at point of care. With the world-first Biosensor Platform, GBS Inc. is developing and launching diagnostic tests urgently needed to help people living with diabetes. For more information, please visit https://gbs.inc/ Company Contact:Alex Arzeno – Vice President of IR & CommunicationsGBS, Inc.Investor.Relations@gbs.inc Investor Contact:Tim McCarthy – Managing DirectorLifeSci Advisors, LLCTim@LifeSciAdvisors.com GBS, INC.PRELIMINARY CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(UNAUDITED)(Amounts in $) Year Ended June 30, 2022 2021 Revenue: Other income: Government support income$437,146 $1,980,484 Total revenue 437,146 1,980,484 Operating expenses: General and administrative expenses 4,920,103 3,359,065 Development and regulatory approval expenses 3,853,919 3,835,703 Prospectus and capital raising expenses - 359,198 Total operating expenses 8,774,022 7,553,966 Loss from operations (8,336,876) (5,573,482) Other income (expense): Interest expense (7,539) (1,093,608)Loss from unconsolidated equity method investment - (135,692)Realized foreign exchange loss (3,987) (271,225)Interest income 14,426 13,806 Total other income (expense) 2,900 (1,486,719)Net loss (8,333,976) (7,060,201)Net loss attributable to non-controlling interest (27,925) (22,915)Net loss attributable to GBS Inc.$(8,306,051) $(7,037,286)Other comprehensive loss, net of tax: Foreign currency translation loss$(126,875) $(297,309)Total other comprehensive loss (126,875) (297,309)Comprehensive loss (8,460,851) (7,357,510)Comprehensive loss attributable to non-controlling interest (27,925) (22,915)Comprehensive loss attributable to GBS Inc.$(8,432,926) $(7,334,595) Net loss per share, basic and diluted$(0.57) $(0.68)Weighted average shares outstanding, basic and diluted 14,665,263 10,414,886 GBS, INC.PRELIMINARY CONSOLIDATED BALANCE SHEETS(Unaudited)(Amounts in $) June 30, 2022 June 30, 2021ASSETS Current assets: Cash and cash equivalents$8,238,301 $12,573,685 Grant receivable, current portion 1,529,882 2,098,884 Research and development tax incentive receivable 353,048 1,025,455 Other current assets 746,761 2,509,017 Total current assets 10,867,992 18,207,041 Long-term grant receivable 1,092,773 3,148,328 Construction in progress 391,408 - Other non-current assets - 504,000 TOTAL ASSETS$12,352,173 $21,859,369 LIABILITIES AND SHAREHOLDERS' EQUITYCurrent liabilities: Accounts payable and accrued expenses$1,625,089 $1,467,968 Related party payables - 13,323 Current portion of deferred grant income 2,836,582 2,098,884 Current employee benefit liabilities 201,332 102,475 Total current liabilities 4,663,003 3,682,650 Employee benefit liabilities 50,626 21,770 Long-term deferred grant income 1,092,773 3,148,328 Total liabilities 5,806,402 6,852,748 Commitments and contingencies (Note 10) Shareholders' equity: Preferred stock, $0.01 par value, 10,000,000 shares authorized, 0 and 1,300,000 shares issued and outstanding at June 30, 2022 and June 30, 2021, respectively - 13,000 Common stock, $0.01 par value, 100,000,000 shares authorized, 14,889,904 and 13,582,122 shares issued and outstanding at June 30, 2022 and June 30, 2021, respectively 148,899 135,821 Additional paid-in capital 38,440,011 38,440,089 Accumulated deficit (31,175,853) (22,869,803)Accumulated other comprehensive loss (788,135) (661,260)Total consolidated GBS Inc. equity 6,624,922 15,057,847 Non-controlling interest (79,151) (51,226)Total shareholders' equity 6,545,771 15,006,621 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$12,352,173 $21,859,369

BOSTON, July 20, 2022 /PRNewswire/ -- Insulin pumps offer several prominent benefits over other insulin delivery methods. Insulin pumps can reduce the need for insulin injections and can also deliver doses with a precision unmatched by other options. Allowing users to set up pre-determined delivery schedules can be helpful for preventing hyperglycemic events should users forget to administer insulin or for helping parents manage their child's glucose levels. So why are insulin pumps so rarely used today, as compared to other insulin delivery methods? Continue Reading Insulin pump revenue by type. Source: IDTechEx - “Diabetes Management Technologies 2022-2032: Markets, Players, and Forecasts” (PRNewsfoto/IDTechEx) The primary reason is the cost. Insulin pumps are extremely expensive, with a single unit worth several thousand dollars due to the range of sensors required to ensure precise insulin delivery. This does not even account for the disposable equipment required: a traditional insulin infusion pump needs catheters, batteries, adhesives, and several other components that need to be replaced regularly, further adding to the costs. In the face of more affordable insulin delivery options, insulin pumps have struggled to justify their price. This has seen less-than-stellar volume uptake for insulin pumps, with a study finding a pump uptake rate of only 6.2% among adults with diabetes in the UK in 2021. However, this could all be set to change due to two key developments in the industry: the development of more affordable patch pumps and the gradual move towards fully automated diabetes management in the form of full closed-loop and artificial pancreas systems, which have caused rising interest in the previously largely stagnant insulin pump industry. The IDTechEx report, "Diabetes Management Technologies 2022-2032: Markets, Players, and Forecasts", details the insulin pump market and its interactions with the wider diabetes management device industry. Patch pumps: More affordable, more convenient Traditional insulin pumps can be priced between US$2000-US$8000 per unit, with further supplies requiring around US$1000-US$2000 per year. While the long lifetimes of these pumps (of 4 – 8 years) do translate to a reduced annual price, the fact remains that this high upfront cost is a major barrier to customers. Despite their ability to mitigate risks of hyperglycemia, this high cost also discourages reimbursement policies outside specific patient groups. Encouraging patient uptake would require pump developments to either offer patients with significant improvements to their quality of life or to notably reduce unit cost. This latter approach is taken by patch pumps, wherein all the required components are encapsulated in a single disposable unit. Patch pumps are typically deployed as a single disposable pod and can be controlled using a connected transmitter device. Patch pumps are much more affordable than traditional insulin pumps, with each pump being priced between US$20–US$50. However, patch pumps also have a much shorter lifetime than infusion pumps, with each pump typically lasting between 1–5 days. The patch pump industry has grown rapidly over the last few years, and growth is expected to continue over the next 10 years. The low unit cost is believed to be a particularly attractive characteristic to consumers; each pod is sufficiently affordable even without reimbursement support. Despite their lower unit costs, patch pumps may not necessarily lower patient expenses as compared to traditional infusion pumps: the need for constant replacement of patch pumps may actually result in higher annual costs, depending on pump model and usage. Despite this, consumers have continued to show significant interest in these patch pump options. Automating diabetes management: Full closed-loop systems The goal of the diabetes management industry has long been to automate the process of managing diabetes completely. Perhaps the most promising method for achieving this thus far has been the development of closed-loop systems. In a closed-loop system, an insulin delivery device is paired with a glucose monitoring device. This allows blood glucose to be measured and used by software to inform insulin dosing autonomously, without requiring patient intervention. Insulin pumps are the ideal insulin delivery system for such a system, as they are already able to deliver insulin autonomously (albeit in small doses and often according to pre-set schedules) and only require suitable algorithms to be developed for autonomous insulin delivery to be carried out. The recent rise to the prominence of continuous glucose monitors (CGMs) has brought closed loop into the spotlight. CGMs can act as the requisite glucose monitoring component for closed-loop insulin delivery; these devices can collect and deliver blood glucose data frequently and remotely to mobile data, a feat unachievable by previous test strip methods. CGMs have continued to develop over the years, with accuracies now approaching that of test strips. The interest in developing closed-loop systems has sparked a flurry of partnerships between the insulin pump and CGM manufacturers, with CGM leader Dexcom having partnered with a host of insulin pump manufacturers such as Insulet and Tandem Diabetes Care. Today, Medtronic leads the pack with their 780G system: this "advanced hybrid closed-loop" system allows Medtronic pumps to receive data from connected Medtronic CGMs and modulate their insulin delivery autonomously. However, insulin delivery amounts are restricted, and human input is required for larger insulin doses; the requirement of human approval classes this as a "hybrid" rather than a "full" closed-loop system. Commercialization of full closed-loop systems is expected to drive the insulin pump industry significantly; in addition to the greater convenience and peace of mind these systems can offer, the improved patient outcomes will likely encourage further reimbursement policies. However, reaching full closed-loop is difficult: any mistakes of the system can potentially lead to death, and so the progress towards full closed-loop is slow in no small part due to stringent regulatory policy requirements. Regardless, promising advancements in hybrid closed-loop automation demonstrated by the insulin pump industry over the last few years are causes for optimism. These developments promise major changes in the insulin pump industry over the coming years, and the highly interconnected nature of the diabetes management device market will thus result in significant "knock-on" effects on various other markets across the entire industry. The IDTechEx report, "Diabetes Management Technologies 2022-2032: Markets, Players, and Forecasts", discusses the outlook of the insulin pump industry and its effects on the wider ecosystem in detail, summarizing our findings in 10-year market forecasts. For more information on this report, please visit or for the full portfolio of Healthcare research available from IDTechEx, please visit . About IDTechEx IDTechEx guides your strategic business decisions through its Research, Subscription and Consultancy products, helping you profit from emerging technologies. For more information, contact [email protected] or visit . Images download: Media Contact: Natalie Fifield Digital Marketing Manager [email protected] +44(0)1223 812300 Social Media Links: Twitter: LinkedIn: Facebook: Photo: Logo: SOURCE IDTechEx