Market Newsdesk

HOLLYWOOD, Fla., July 27, 2023 (GLOBE NEWSWIRE) — NV5 Global, Inc. (the “Company” or “NV5”) (Nasdaq: NVEE), a provider of technology, conformity assessment, and consulting solutions, announced today that it has been awarded a $16 million contract by the New York City Department of Environmental Protection to provide construction management services for the Bronx River Combined Sewer Overflow Reduction project.

“NV5 offers a broad array of engineering and technical services to assist our clients with meeting their ESG and sustainable infrastructure goals,” said Dickerson Wright, PE, Chairman & CEO of NV5. “NV5 has been a pioneer in sustainable infrastructure, including contributing to the Institute for Sustainable Infrastructure’s ENVISION rating system, and we are pleased to assist the City with this important infrastructure improvement.”

Under this contract, NV5 will perform resident engineering, not at risk construction management, and engineering support services for the installation of a parallel relief sewer constructed by microtunneling. The new sewer and associated regulator chamber will direct flow away from combined sewer overflow outlets along the Bronx River towards the Hunts Point Wastewater Resource Recovery Facility. This will support the New York City Department of Environmental Protection’s mission “to enrich the environment and protect public health for all New Yorkers by providing high quality drinking water, managing wastewater and stormwater, and reducing air, noise, and hazardous materials pollution.”

About NV5

NV5 Global, Inc. (NASDAQ: NVEE) is a provider of technology, conformity assessment, and consulting solutions for public and private sector clients supporting utility, infrastructure, and building assets and systems. The Company primarily focuses on six business verticals: utility services, infrastructure engineering, testing, inspection & consulting, buildings & technology, environmental health sciences, and geospatial services. NV5 operates out of more than 100 offices nationwide and abroad. For additional information, please visit the Company’s website at www.NV5.com. Also visit the Company on Twitter, LinkedIn, Facebook, and Vimeo.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. The Company cautions that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements contained in this news release. Such factors include: (a) changes in demand from the local and state government and private clients that we serve; (b) general economic conditions, nationally and globally, and their effect on the market for our services; (c) competitive pressures and trends in our industry and our ability to successfully compete with our competitors; (d) changes in laws, regulations, or policies; and (e) the “Risk Factors” set forth in the Company’s most recent SEC filings. All forward-looking statements are based on information available to the Company on the date hereof, and the Company assumes no obligation to update such statements, except as required by law.

Investor Relations Contact

NV5 Global, Inc.
Jack Cochran
Vice President, Marketing & Investor Relations
Tel: +1-954-637-8048
Email: [email protected]

Source: NV5 Global, Inc.

GOLDEN, Colo., July 27, 2023 (GLOBE NEWSWIRE) — SHF Holdings, Inc., d/b/a/ Safe Harbor Financial (“Safe Harbor” or the “Company”) (NASDAQ: SHFS), a leader in facilitating banking, payments, and financial services to the regulated cannabis industry, announced today that the Company has increased its lending and deposit relationship with a tier one multi-state operator (“MSO”) by originating three new loans for affiliates of the MSO in the aggregate amount of $4,282,000. The loans were secured by retail assets in three additional limited-license markets in which the MSO operates.

“Our ongoing relationship with this top-performing multi-state operator demonstrates the steady credit origination and placement activity were are continuing to secure for companies operating in the legal cannabis industry,” Sundie Seefried, Chief Executive Officer at Safe Harbor Financial commented. “These new loans further diversify our collateral portfolio, and afford us the opportunity to open deposit accounts for the MSO’s operating entities in three new markets.”

The Company had previously announced in May that it had originated four commercial real estate-backed loans for subsidiaries of the tier-one MSO. The approximate amount for the loans was approximately $5.5 million aggregate and are secured by a first deed of trust on four retail dispensary locations in a key limited-license state. The Company also announced an expanded relationship with the tier-one MSO in June through the origination of an additional first lien-secured loan in the approximate amount of $2.9 million on a cultivation facility located in a major adult-use cannabis market. The current loans are in accordance with the same lending commitment as previous loans provided to the MSO, offering the same market-leading terms–including a fixed interest rate, five-year term and a 25-year amortization period–for permanent financing of the MSO’s critical assets.

About Safe Harbor

Safe Harbor is among the first service providers to offer compliance, monitoring and validation services to financial institutions, providing traditional banking services to cannabis, hemp, CBD, and ancillary operators, making communities safer, driving growth in local economies, and fostering long-term partnerships. Currently managing approximately 1000 cannabis-related relationships, Safe Harbor, through its financial institution clients, implements high standards of accountability, transparency, monitoring, reporting and risk mitigation measures while meeting Bank Secrecy Act obligations in line with FinCEN guidance on cannabis-related businesses. Over the past eight years, Safe Harbor has facilitated more than $18 billion in deposit transactions for businesses with operations spanning over 40 states and US territories with regulated cannabis markets. For more information, visit www.shfinancial.org.

Forward-Looking Statements

Certain statements contained in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements may include, but are not limited to, statements with respect to trends in the cannabis industry, including proposed changes in U.S and state laws, rules, regulations and guidance relating to Safe Harbor’s services; Safe Harbor’s growth prospects and Safe Harbor’s market size; Safe Harbor’s projected financial and operational performance, including relative to its competitors; performance of the loans referenced in this release or otherwise; product and service offerings Safe Harbor may introduce in the future; Safe Harbor’s ability to maintain financial institution contractual relationships; the impact of recent volatility in the capital markets, which may adversely affect the price of the Company’s securities; the outcome of any legal proceedings that may be instituted against Safe Harbor; other statements regarding Safe Harbor’s expectations, hopes, beliefs, intentions or strategies regarding the future; and the other risk factors discussed in Safe Harbor’s filings from time to time with the Securities and Exchange Commission. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “outlook,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject, are subject to risks and uncertainties. These forward-looking statements involve a number of risks and uncertainties (some of which are beyond the control of Safe Harbor), and other assumptions, that may cause the actual results or performance to be materially different from those expressed or implied by these forward-looking statements.

Contact Information

NEW YORK and SINGAPORE, July 27, 2023 (GLOBE NEWSWIRE) — Stronghold Digital Mining, Inc. (NASDAQ: SDIG) (“Stronghold”), a vertically integrated Bitcoin mining company, and Canaan Inc. (NASDAQ: CAN) (“Canaan”), a leading high-performance computing solutions provider, today jointly announced an agreement whereby Stronghold has purchased from Canaan 2,000 new, latest-generation A1346 Bitcoin miners for a total purchase price of approximately $3 million. The miners are expected to be delivered during the third quarter of 2023 for use at Stronghold’s wholly-owned Panther Creek Facility. Stronghold has also amended and expanded its existing hosting agreement with Cantaloupe Digital LLC, a subsidiary of Canaan, with the addition of 2,000 A1346 miners under the same terms as those of the previously announced Bitcoin Mining Agreement dated April 27, 2023.

“We are very excited to expand our relationship with Canaan through the purchase of the A1346 miners, their most efficient Bitcoin miners,” said Greg Beard, Chairman and Chief Executive Officer of Stronghold. “These miners are among our best performers in our air-cooled StrongBox containers and provide an attractive value proposition given the combination of high hash rate, energy efficiency, and price point. The purchase of these miners further demonstrates our extreme focus on capital efficiency.”

“As we have demonstrated in 2023, we believe that our approach to acquiring Bitcoin miners is differentiated from our peers. We are able to fund the purchase of the 2,000 A1346 out of our currently available cash on hand. Additionally, the expansion of our hosting agreement allows us to further retain exposure to Bitcoin mining economics and power upside, consistent with our vertically integrated business model. This compares favorably versus our peers that are announcing large miner orders that we believe will require, in some cases, substantial future equity offerings,” said Mr. Beard. “Similar to our miner purchases earlier in the year, we believe that the cash flow uplift from this expansion will allow us to recover our entire investment in less than one year based on current hash price, forward power prices, and 95% assumed miner uptime.”

Nangeng Zhang, Chairman and Chief Executive Officer of Canaan, commented, “We are delighted to continue and upgrade our existing collaboration with Stronghold. At Canaan, our focus has always been on delivering products that embody advanced technology, outstanding performance, exceptional quality, and high maintainability. Beyond our products, we are committed to elevating value for our clients through unparalleled service, striving to maximize their capital efficiency to the utmost. Our dedication has distinguished us with world-class service, flexible win-win solutions, and unwavering long-term support. We are proud of the trust that Stronghold has placed in our brand, and we sincerely value our continuing collaboration.”

About Stronghold Digital Mining, Inc.

Stronghold is a vertically integrated Bitcoin mining company with an emphasis on environmentally beneficial operations. Stronghold houses its miners at its wholly owned and operated Scrubgrass Plant and Panther Creek Plant, both of which are low-cost, environmentally beneficial coal refuse power generation facilities in Pennsylvania.

About Canaan

Established in 2013, Canaan Inc. (NASDAQ: CAN), is a technology company focusing on ASIC high-performance computing chip design, chip research and development, computing equipment production, and software services. Canaan’s vision is “super computing is what we do, social enrichment is why we do it.” Canaan has extensive experience in chip design and streamlined production in the ASIC field. In 2013, under the leadership of Mr. Nangeng Zhang, founder and CEO, Canaan’s founding team shipped to its customers the world’s first batch of mining machines incorporating ASIC technology in Bitcoin’s history under the brand name, Avalon. In 2018, Canaan released the world’s first RISC-V architecture commercial edge AI chip. In 2019, Canaan completed its initial public offering on the Nasdaq Global Market. To learn more about Canaan, please visit https://www.canaan.io/.

Forward Looking Statements of Stronghold:

Certain statements contained in this press release, including guidance, constitute “forward-looking statements.” within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements because they contain words such as “believes,” “expects,” “may,” “will,” “should,” “seeks,” “approximately,” “intends,” “plans,” “estimates” or “anticipates” or the negative of these words and phrases or similar words or phrases which are predictions of or indicate future events or trends and which do not relate solely to historical matters. Forward-looking statements and the business prospects of Stronghold are subject to a number of risks and uncertainties that may cause Stronghold’s actual results in future periods to differ materially from the forward-looking statements. These risks and uncertainties include, among other things: the hybrid nature of our business model, which is highly dependent on the price of Bitcoin; our dependence on the level of demand and financial performance of the crypto asset industry; our ability to manage growth, business, financial results and results of operations; uncertainty regarding our evolving business model; our ability to retain management and key personnel and the integration of new management; our ability to raise capital to fund business growth; our ability to maintain sufficient liquidity to fund operations, growth and acquisitions; our substantial indebtedness and its effect on our results of operations and our financial condition; uncertainty regarding the outcomes of any investigations or proceedings; our ability to enter into purchase agreements, acquisitions and financing transactions; public health crises, epidemics, and pandemics such as the coronavirus pandemic; our ability to procure crypto asset mining equipment, including from foreign-based suppliers; our ability to maintain our relationships with our third party brokers and our dependence on their performance; our ability to procure crypto asset mining equipment; developments and changes in laws and regulations, including increased regulation of the crypto asset industry through legislative action and revised rules and standards applied by The Financial Crimes Enforcement Network under the authority of the U.S. Bank Secrecy Act and the Investment Company Act; the future acceptance and/or widespread use of, and demand for, Bitcoin and other crypto assets; our ability to respond to price fluctuations and rapidly changing technology; our ability to operate our coal refuse power generation facilities as planned; our ability to remain listed on a stock exchange and maintain an active trading market; our ability to avail ourselves of tax credits for the clean-up of coal refuse piles; and legislative or regulatory changes, and liability under, or any future inability to comply with, existing or future energy regulations or requirements. More information on these risks and other potential factors that could affect our financial results is included in our filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of our Annual Report on Form 10-K filed on April 3, 2023. Any forward-looking statement or guidance speaks only as of the date as of which such statement is made, and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements or guidance, whether because of new information, future events, or otherwise.

Safe Harbor Statement of Canaan

This announcement contains forward−looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward−looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as Canaan Inc.’s strategic and operational plans, contain forward−looking statements. Canaan Inc. may also make written or oral forward−looking statements in its periodic reports to the U.S. Securities and Exchange Commission (“SEC”) on Forms 20−F and 6−K, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Canaan Inc.’s beliefs and expectations, are forward−looking statements. Forward−looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward−looking statement, including but not limited to the following: the Company’s goals and strategies; the Company’s future business development, financial condition and results of operations; the expected growth of the Bitcoin industry and the price of Bitcoin; the Company’s expectations regarding demand for and market acceptance of its products, especially its Bitcoin mining machines; the Company’s expectations regarding maintaining and strengthening its relationships with production partners and customers; the Company’s investment plans and strategies, fluctuations in the Company’s quarterly operating results; competition in its industry; and relevant government policies and regulations relating to the Company and cryptocurrency. Further information regarding these and other risks is included in the Company’s filings with the SEC, including its registration statement on Form F−1, as amended, and its annual reports on Form 20−F, as amended. All information provided in this press release and in the attachments is as of the date of this press release, and Canaan Inc. does not undertake any obligation to update any forward−looking statement, except as required under applicable law.

Contacts:

Stronghold Digital Mining, Inc.

Investor Contact:
Matt Glover or Alex Kovtun
Gateway Group, Inc.
[email protected]
1-949-574-3860

Media Contact:
[email protected]

Canaan Inc.

Ms. Xi Zhang
[email protected]
Media Contact:
ICR, LLC.
Robin Yang
[email protected]

SAN DIEGO, July 27, 2023 (GLOBE NEWSWIRE) — Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced progress with its latest clinical device performance study, evaluating the device function and safety of its NaviCap™ targeted oral delivery platform.

“In this study evaluating twelve subjects to date, the NaviCap device accurately identified entry into the colon, triggered release of its non-drug payload, and achieved distribution throughout the colon in all subjects,” said Sharat Singh, PhD, Head of Research at Biora Therapeutics. “Importantly, we observed no early or late deployments,” continued Dr. Singh.

The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release its payload.   

“We are continuing to see excellent device performance in human studies with the NaviCap platform, following similar results in three previous functional studies in both healthy volunteers and patients with active ulcerative colitis,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “With more than 40 study participants receiving over 70 NaviCap devices to date, the combined results build confidence as we proceed toward an IND application in the third quarter of this year for our BT-600 program for treatment of ulcerative colitis,” continued Dr. Kelman.

Biora’s BT-603 clinical device performance study was designed to evaluate the safety and tolerability of its phase 1-ready NaviCap device and the device’s localization and delivery function in healthy volunteers. During the study, NaviCap devices filled with a saline solution that included radioisotopes were ingested orally by healthy volunteers. Scintigraphic imaging was used to indicate device localization and payload delivery to the lower GI tract. No drug was administered as part of this study.

Sequential scintigraphic images of NaviCap delivery in a BT-603 study subject can be viewed on the company’s website.

About the NaviCap™ Targeted Oral Delivery Platform and BT-600  
Biora’s NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.   

The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl.   

Biora’s BT-600 program consists of a unique, liquid formulation of tofacitinib delivered to the colon via the NaviCap device, for the treatment of ulcerative colitis. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and demonstrated the device’s ability to function in both fasted and fed states, making it potentially the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. A device function study in participants with active ulcerative colitis (UC) also demonstrated successful device performance in active UC patients. The company plans to submit an Investigational New Drug (IND) application to begin a Phase 1 study with its BT-600 program during the second half of 2023.   

About Biora Therapeutics

Biora Therapeutics is the biotech company that is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives.

Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.

Safe Harbor Statement or Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development and clinical efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,”  “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future filings and initiate clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding  opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC. 

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. 

Investor Contact

Chuck Padala
Managing Director, LifeSci Advisors
[email protected]
(646) 627-8390

Media Contact

[email protected]

MONTREAL, July 27, 2023 (GLOBE NEWSWIRE) — TFI International Inc. (NYSE and TSX: TFII), a North American leader in the transportation and logistics industry, today announced that Sébastien Martel will join its Board of Directors, effective July 31, 2023.

Mr. Martel is the Chief Financial Officer of BRP Inc. (“BRP”, TSX: DOO; Nasdaq: DOOO), a global leader in the design, manufacturing, and distribution of recreational vehicles and powersports. He has been with BRP for nearly 20 years, serving as CFO since 2014. A registered CPA, Mr. Martel holds a Bachelor degree in Accountancy from McGill University.

“We are thrilled to welcome Sébastien to our Board and view his leadership qualities and contributions to BRP’s growth as valuable attributes,” stated Alain Bédard, Chairman, President and Chief Executive Officer of TFI International. “We eagerly anticipate drawing from Sébastien’s expertise and business acumen that will benefit our company as we continually strive to further enhance shareholder value.”

ABOUT TFI INTERNATIONAL

TFI International Inc. is a North American leader in the transportation and logistics industry, operating across the United States and Canada through its subsidiaries. TFI International creates value for shareholders by identifying strategic acquisitions and managing a growing network of wholly-owned operating subsidiaries. Under the TFI International umbrella, companies benefit from financial and operational resources to build their businesses and increase their efficiency. TFI International companies service the following segments:

• Package and Courier;
• Less-Than-Truckload;
• Truckload;
• Logistics.

TFI International Inc. is publicly traded on the New York Stock Exchange and the Toronto Stock Exchange under the symbol TFII. For more information, visit www.tfiintl.com.

For further information:

Alain Bédard
Chairman, President and CEO
TFI International Inc.
647-729-4079
[email protected]

Preliminary data suggest a chlamydia, gonorrhea and trichomonas (CT/NG/TV) multiplex test is feasible on a molecular point-of-care (POC) test system with time to result in less than 30 minutes

Ability to effectively lyse challenging fungal pathogens, including Candida, in under four minutes on Talis One

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system positions Company to develop POC vaginal infection panel

REDWOOD CITY, Calif., July 27, 2023 (GLOBE NEWSWIRE) — Talis Biomedical Corporation (Nasdaq: TLIS) today announced new data supporting the development of its planned CT/NG/TV and vaginal infection panels. Results from these studies, presented in poster sessions at the 2023 IDSOG Annual Meeting in Denver, Colorado, support Talis Biomedical’s mission to advance health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care.

“The COVID-19 pandemic accelerated the development of numerous molecular point-of-care platforms to bring rapid respiratory testing closer to patients. Unfortunately, very few are designed to effectively address the needs of women’s and sexual health,” said Rob Kelley, chief executive officer at Talis Biomedical. “The ability to lyse difficult targets and to purify and concentrate nucleic acids to deliver lab quality results in less than 30 minutes is what we believe will set the Talis One system apart from current platforms. These data presented at IDSOG give us confidence we are on the path to developing viable and differentiated CT/NG/TV and vaginal infection tests that can be performed at the point of care, before a patient leaves the doctor’s office.”

Data Highlights from Talis Biomedical Presentations at IDSOG Annual Meeting July 27-29, 2023:

Feasibility and preliminary performance of development-stage CT/NG/TV test for Talis One



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system

A series of analytical studies were conducted to characterize preliminary analytical sensitivity, exclusivity, inclusivity and clinical performance of a development-stage CT/NG/TV test as part of Talis Biomedical’s planned test menu.

To determine preliminary analytical sensitivity of its sample-to-answer test in development to detect CT/NG/TV in less than 30 minutes, company scientists co-spiked 20 self-collected vaginal swabs and 7 male urine samples with live CT serovar D, NG 19424, and TV G3 for testing on the Talis One system. In females, CT and TV were detected in 19/20 contrived vaginal swab samples at concentrations of 1 IFU/mL and 5 cells/mL, respectively. NG was detected in 20/20 vaginal swabs at a concentration of 50 CFU/mL. In males, CT, NG, and TV were detected in 7/7 urine samples at concentrations of 1.5 IFU/mL, 50 CFU/mL, and 5 cells/mL, respectively.

To characterize exclusivity, closely related target organisms tested at 1E6 units/mL or 1E5 genome copies/mL were not detected by the Talis One development-stage CT, NG, or TV assays. Conversely, the assays were inclusive of all strains and serovars.

Preliminary clinical performance of the Talis One development-stage CT/NG/TV test was assessed using residual clinical samples initially tested by widely used, on-market molecular tests that require up to 90 minutes to generate a result. In neat male urine, positive percent agreement (PPA) was 100% for CT, NG and TV. Negative percent agreement (NPA) was 100% for CT and NG, and 98% for TV. In female vaginal swabs where only positive samples were tested, PPA was 100% for CT and NG, and 90% for TV.

“As we approach this new era of STI testing, it is encouraging to see a development-stage point-of-care CT/NG/TV assay achieve clinical performance that is comparable to widely used on-market tests being run at central laboratories,” said Glenn Harnett, M.D., chief executive officer at No Resistance, a clinical trial site management organization and former chief medical officer at American Family Care. “Access to STI test results during a single patient visit will allow providers to make more informed treatment decisions, reduce the use of unnecessary antibiotics, and provide an opportunity for more directed and meaningful patient education.”

On-cartridge bead beating differentiates Talis One lysis for future development of vaginal panel

Talis Biomedical conducted a series of analytical studies to test different mechanical lysis conditions on the Talis One system to determine the feasibility of nucleic acid recovery from difficult-to-lyse fungal pathogens.

Company scientists performed initial experiments to determine lysis efficiency with and without beads added to the Talis One’s on-cartridge mechanical (stir bar containing) lysis chamber. The lysis conditions were evaluated and selected using intact Candida albicans as a model pathogen. With stir bar mixing alone, target nucleic acids were only detected 100% of the time (3/3) at 1000 CFU/mL. When beads (bead-beating) were added to the stir bar containing lysis chamber on the Talis One cartridge, target nucleic acids were detected 100% of the time (6/6) at concentrations as low as 125 CFU/mL, delivering an 8-fold increase in lysis efficiency. The lysis time was as short as 4 minutes.

Additional experiments performed to further challenge the Talis One system included using contrived specimens of five different Candida species diluted in a DNA/RNA transport and storage medium at concentrations of 100,000, 10,000 and 1000 CFU/ml. The contrived specimens were lysed using the Talis One’s bead beating, mechanical lysis system. On bench detection was demonstrated down to the lowest concentration tested (1000 CFU/ml in 3/3 replicates) for all five Candida species.

These studies demonstrate that incorporating mechanical lysis on the Talis One system led to lysing fungal cells and releasing target nucleic acids for detection at a concentration level that is comparable to the limits of detection (LODs) of three on-market vulvovaginal candidiasis in vitro diagnostic (IVD) tests. Based on these positive early results, Talis Biomedical may be able to achieve these LODs while having a turnaround time that is approximately 30-90 minutes faster.

“The availability of accurate and reliable point-of-care testing for vaginitis will be invaluable in the women’s healthcare space. More than 30 percent of women of all ages suffer from symptoms of a vaginal infection and often receive deferred treatment with delays in diagnosis,” said Annelise Skor Swigert, M.D., FACOG, medical director, Premier Ob/Gyn of Minnesota. “I believe access to immediate and definitive testing results would clearly have an instant impact on care for these patients.”

Talis Biomedical plans to perform additional testing at lower concentrations to determine the effectiveness of lysing each fungal pathogen for amplification and detection. LODs will be confirmed once a fully developed vulvovaginal candidiasis assay is integrated on the Talis One test cartridge.

About the Talis One System

The Talis One system is a compact, sample-to-answer molecular testing platform designed to enable rapid, highly accurate point-of care infectious disease testing in non-laboratory settings. The Talis One test cartridge is a fully self-contained, closed device that includes all the necessary reagents to perform a Talis One test. When loaded into the Talis One instrument, each cartridge fully automates sample lysis, nucleic acid extraction and purification, isothermal amplification, and target detection. The Talis One test system is not authorized, cleared, or approved by the FDA and is not available for sale.

About Talis Biomedical

Talis Biomedical is dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care. The Company plans to develop and commercialize innovative products on its sample-to-answer Talis One^® system to enable accurate, low cost, and rapid molecular testing. For more information, visit talisbio.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “would,” “should,” “believe,” “expect,” “anticipate,” “could,” “estimate,” “continue,” “predict,” “potential,” “forecast,” “project,” “plan,” “intend” or similar expressions, or other words that convey uncertainty of future events or outcomes can be used to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the potential clinical performance of assays on the Talis One system, or results of additional research and development studies. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others, the performance of future Company products, the Company’s development pipeline, results of additional research and development studies
and
other risks and uncertainties that are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Talis Biomedical assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

Contact

Media & Investors
Emily Faucette
[email protected]
415-595-9407