Market Newsdesk

–
PDUFA goal date of
March 21,
2021
–

–
Filing
based on positive
data from RHAPSODY
, which
achieved its primary 
and all major secondary endpoints
–

–
Rilonacept BLA for CAPS transferred
to Kiniksa
from Regeneron
–

HAMILTON, Bermuda, Nov. 23, 2020 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for rilonacept in recurrent pericarditis. The FDA granted priority review to the application and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 21, 2021. Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. The FDA granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for the treatment of pericarditis in 2020.

The regulatory submission was based on positive data from RHAPSODY, a pivotal Phase 3 trial of rilonacept in recurrent pericarditis. RHAPSODY met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept treatment in the trial improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. RHAPSODY data were recently published in The New England Journal of Medicine simultaneously with a late-breaking scientific presentation at the American Heart Association’s Scientific Sessions 2020.

“We are thrilled to receive the FDA’s acceptance of the sBLA submission for rilonacept in recurrent pericarditis with priority review, said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “Rilonacept has the potential to become the first FDA-approved therapy for this painful and debilitating autoinflammatory disease. We are committed to bringing this potential treatment option to patients as soon as possible.”

Rilonacept was discovered and developed by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) under the brand name ARCALYST^®. Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1α and IL-1β, including recurrent pericarditis. Based on positive RHAPSODY data, the Biologic License Application (BLA) for CAPS transferred to Kiniksa. If approved by the FDA for recurrent pericarditis, Kiniksa will take responsibility for sales and distribution of rilonacept for all the approved indications in the United States and evenly split profits with Regeneron, as described in the Rilonacept License Agreement.

Kiniksa is obligated to pay regulatory milestones to Regeneron of up to an aggregate of $27.5 million through the time of a potential approval of rilonacept in recurrent pericarditis, of which $7.5 million is expected to be paid in the fourth quarter of 2020.

Kiniksa continues to prepare for the potential commercial launch of rilonacept in recurrent pericarditis. The company has been generating evidence on disease burden, building disease awareness with payers, physicians, and advocacy groups, and establishing core capabilities such as distribution, patient services and data management.

About RHAPSODY

RHAPSODY is the global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis. Eligible patients presented at screening with at least a third pericarditis episode, defined as at least 1 day with pericarditis pain of ≥ 4 on the 11-point Numerical Rating Scale (NRS) and a C-reactive protein (CRP) value ≥ 1 mg/dL within the 7-day period prior to first study drug administration. Patients could be receiving concomitant nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or oral corticosteroid treatment in any combination. The study was comprised of 4 periods: a screening period; a single-blind run-in period during which patients received a loading dose of rilonacept 320 mg injected subcutaneously (SC) followed by 160 mg SC weekly while background pericarditis medications were tapered and discontinued; a double-blind, placebo-controlled randomized withdrawal period during which clinical responders to rilonacept were randomized 1:1 and received 160 mg SC weekly rilonacept or placebo; and a long-term extension treatment period with up to 24 months of open-label rilonacept 160 mg SC weekly. The primary efficacy endpoint was time-to-first pericarditis-recurrence in the randomized withdrawal period. The Clinical Endpoint Committee adjudicated all suspected pericarditis recurrences for inclusion in the primary efficacy endpoint analysis. Kiniksa will continue to follow patients in the long-term extension treatment period for up to 24 months. The co-principal investigators are Dr. Allan Klein of Cleveland Clinic and Dr. Massimo Imazio of the University of Torino, Italy. For more information, refer to ClinicalTrials.gov Identifier: NCT03737110.

About Recurrent Pericarditis

Recurrent pericarditis is a painful and debilitating autoinflammatory cardiovascular disease that typically presents with chest pain and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. Patients with pericarditis are deemed recurrent if they have an additional episode after a symptom-free period of 4-6 weeks, and chronic if symptoms from any one episode last longer than three months. Recurrent pericarditis symptoms impair qualify of life, limit physical activities, and lead to frequent emergency department visits and hospitalizations. There are currently no FDA-approved treatments for recurrent pericarditis.

About
the
Rilonacept
License Agreement with Regeneron

In 2017, Regeneron granted Kiniksa an exclusive license to develop and commercialize rilonacept worldwide, aside from Israel, Egypt, Turkey and select countries in the Middle East and North Africa. In the United States and Japan, Kiniksa’s license is initially for all indications other than those involving local administration to the eye or ear, oncology, deficiency of the interleukin1 receptor antagonist (DIRA) and CAPS. If Kiniksa is successful in receiving marketing approval for rilonacept in the United States for a new indication, the scope of the license granted to Kiniksa will automatically expand to include DIRA, if approved, and CAPS in the United States and Japan, and Kiniksa will assume the sales and distribution of rilonacept in these additional indications. Outside the United States and Japan, Kiniksa’s license is for all indications other than local application to the eye or ear, oncology, CAPS, DIRA and certain periodic fever syndromes. Kiniksa made an upfront payment of $5.0 million to Regeneron and is obligated to make regulatory milestone payments of up to $27.5 million in the aggregate. Thereafter, Kiniksa and Regeneron will evenly split profits on sales of rilonacept after deducting certain commercialization expenses subject to specified limits.

About Rilonacept

Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks IL-1α and IL-1β signaling. Rilonacept was discovered and developed by Regeneron and is approved by the FDA under the brand name ARCALYST^® for the treatment of CAPS, specifically Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. Rilonacept for the treatment of DIRA is currently under FDA review following the submission of an sBLA in June 2020. Rilonacept in recurrent pericarditis is an investigational drug. The FDA granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for the treatment of pericarditis in 2020.

Important information about ARCALYST® (rilonacept) Injection

IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections.

Patients should not receive a live vaccine while taking ARCALYST. It is recommended that prior to initiation of therapy with ARCALYST patients receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine. In the initial development program for ARCALYST, six serious adverse reactions were reported by four patients: Mycobacterium intracellular infection, gastrointestinal bleeding and colitis, sinusitis and bronchitis and Streptococcus pneumoniae meningitis. The most commonly reported adverse reactions associated with ARCALYST were injection site reaction and upper respiratory tract infection. Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted. Treatment with immunosuppressants, including ARCALYST, may result in an increase in risk of malignancies. Hypersensitivity reactions associated with ARCALYST administration in clinical studies have been rare. If a hypersensitivity reaction occurs, administration of ARCALYST should be discontinued and appropriate therapy initiated.

About Kiniksa

Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s clinical-stage product candidates, rilonacept, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation. These pipeline assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit www.kiniksa.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our belief that rilonacept has the potential to become the first FDA-approved therapy for recurrent pericarditis; our urgency in bringing this potential treatment option to patients suffering from recurrent pericarditis; our expectation regarding the timing of payments to Regeneron in connection with regulatory milestones; and our belief that all of our product candidates offer the potential for differentiation.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: impact of additional data from us or other companies; potential undesirable side effects caused by rilonacept; our potential inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; the potential for applicable regulatory authorities to delay or deny approval of the sBLA for rilonacept in recurrent pericarditis; our potential inability to demonstrate that the clinical data integrity and quality of the biologic manufacturing processes and facilities are sufficient for the FDA to approve rilonacept in recurrent pericarditis; our reliance on third parties to manufacture our product candidates, including our reliance on Regeneron to manufacture the clinical and commercial supply of rilonacept; the potential impact of the COVID-19 pandemic and measures taken in response to the pandemic; and changes in our operating plan and funding requirements.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 5, 2020 and our other reports subsequently filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

ARCALYST^® is a registered trademark of Regeneron Pharmaceuticals, Inc.

Every Second Counts!™

Kiniksa Investor and Media Contact

Mark Ragosa
(781) 430-8289 
[email protected]

ATLANTA, Nov. 23, 2020 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading healthcare and human services provider to the federal government, will release its financial results for the fiscal fourth quarter ended September 30, 2020 on December 7, 2020 before the market opens. DLH will then host a conference call for the investment community that same morning, December 7, at 11:00 a.m. Eastern Time, during which members of senior management will make a brief presentation focused on the financial results and operating trends. A question-and-answer session will follow. 

Interested parties may listen to the conference call by dialing 888-347-5290 or 412-317-5256.  Presentation materials will also be posted on the Investor Relations section of the DLH website prior to the commencement of the conference call.  A digital recording of the conference call will be available for replay two hours after the completion of the call and can be accessed on the DLH Investor Relations website or by dialing 877-344-7529 and entering the conference ID 10149431.   

About DLH


DLH (NASDAQ:DLHC) serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company’s seven core competencies include secure data analytics, clinical trials and laboratory services, case management, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,200 employees serving numerous government agencies. For more information, visit the corporate website at www.dlhcorp.com. 

INVESTOR RELATIONS

Contact: Chris Witty
Phone: 646-438-9385
Email: [email protected]

SUNNYVALE, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — Real-Time Innovations (RTI), the largest software framework provider for smart machines and real-world systems, will be exhibiting and presenting at the first Virtual Interservice/Industry Training, Simulation and Education Conference (vI/ITSEC), the world’s largest modeling simulation and training (MS&T) event taking place November 30 – December 4. Equipped with a virtual booth, RTI will demonstrate how Connext® DDS integrates distributed simulation assets and data together in a secure, high-performance, scalable environment. RTI Connext DDS is the leading connectivity framework for the MS&T industry and is deployed in simulation environments across the globe.

Being held virtually for the first time, the annual I/ITSEC conference showcases MS&T technologies for the exchange of information among industry, military, and educational communities. RTI’s team of experts will be showcasing how the company works with the MS&T community to drive the communications foundation from real deployed systems into Live, Virtual, and Constructive (LVC) solutions.

In addition to exhibiting, RTI Lead Field Application Engineer, Rob Proctor and Field Application Engineer Manager, John Breitenbach will present on, “Securing Real-Time Distributed LVC Simulations at Scale with Data Distribution Service™ (DDS),” where attendees will learn how DDS can ease integration, while also delivering National Security Agency (NSA)-tested security for real-time systems. The tutorial session will also showcase:

• How to use Connext DDS Secure in real-world Hardware-In-Loop (HIL) systems that already communicate over DDS to distributed LVC Simulations
• How to integrate DDS with existing simulation-based standards, an area where DDS can add a broad suite of Qualities of Service (QoS) to help tune performance and scalability, while also providing robust security
• Recent user experiences that offer an overview of deployed systems using Connext DDS in simulators today

Additional details on the event can be found below.

Event Details

What: vIITSEC 2020
When: November 30 – December 4, 2020
Where: Virtual Booth

Read more about RTI’s work in the Modeling, Simulation and Training (MS&T) market here: rti.com/mst

About RTI

Real-Time Innovations (RTI) is the largest software framework provider for smart machines and real-world systems. The company’s RTI Connext^® product enables intelligent architecture by sharing information in real time, making large applications work together as one.

With over 1,500 deployments, RTI software runs the largest power plants in North America, connects perception to control in vehicles, coordinates combat management on US Navy ships, drives a new generation of medical robotics, controls hyperloop and flying cars, and provides 24/7 medical intelligence for hospital patients and emergency victims.

RTI is the best in the world at connecting intelligent, distributed systems. These systems improve medical care, make our roads safer, improve energy use, and protect our freedom.

RTI is the leading vendor of products compliant with the Object Management Group^® (OMG) Data Distribution Service™ (DDS) standard. RTI is privately held and headquartered in Sunnyvale, California with regional headquarters in Spain and Singapore.

Media Contact:


Madeline Kalicka
Karbo Communications for RTI
240-427-896
[email protected]

Cameron Emery
Director of Corporate Communications, RTI
[email protected] 

FORT MYERS, Fla., Nov. 23, 2020 (GLOBE NEWSWIRE) — Alico, Inc. (“Alico” or the “Company”) (Nasdaq: ALCO) today announced that the Company will release financials results for the fourth quarter and full year ended September 30, 2020, on Tuesday, December 8, 2020, before the market open.

The Company will host a conference call to discuss its financial results on December 8, 2020, at 8:30 am Eastern Time. Interested parties may join the conference call by dialing (877) 407-0792 in the United States and (201) 689-8263 from outside of the United States. A telephone replay will be available approximately two hours after the call concludes and will be available through Tuesday, December 22, 2020. Listeners in the United States can dial (844) 512-2921 and International listeners can dial (412) 317-6671. The passcode for the playback is 13713528.

There also will be a simultaneous, live webcast available online in the Investor Relations section of the Company’s website at ir.alicoinc.com. The webcast will be archived for 30 days.

About
Alico

Alico, Inc. primarily operates two divisions: Alico Citrus, one of the nation’s largest citrus producers, and Alico Water Resources and Other Operations, a leading water storage and environmental services division. Learn more about Alico (Nasdaq: “ALCO”) at www.alicoinc.com.

Investor
Contact
:

Investor Relations
(646) 277-1254
[email protected] 

Richard Rallo
Senior Vice President and Chief Financial Officer
(239) 226-2000
[email protected] 

• U.S. Phase 1 trial patient enrollment to begin in the first half of 2021
• China Phase 1 trial enrollment ongoing
• Key regulatory milestone achieved to enable further study of product candidate for patients with HR+ HER 2- metastatic breast cancer and other tumors

NEWTOWN, Pa., Nov. 23, 2020 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the filing of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for ON 123300, the Company’s proprietary, differentiated, first-in-class multi-kinase inhibitor. The IND seeks permission to begin a Phase 1 trial with ON 123300 in relapsed/refractory advanced cancer including patients with HR+ HER 2- metastatic breast cancer with resistance to approved second-generation CDK4/6 inhibitors.

“We believe that ON 123300, based on its novel mechanism of action, presents an innovative approach to study advanced cancers including in HR+ HER 2- metastatic breast cancer that is or has become resistant to commercial CDK4/6 inhibitors. We are delighted to have filed our IND on schedule, and look forward to enrolling patients in the U.S. to complement the ongoing Phase 1 dose-escalation study underway in China by our partner HanX Biopharmaceuticals,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “The HanX Phase 1 ON 123300 study, which began in September 2020, has enrolled three patients to date and is expected to continue to enroll patients with advanced relapsed/refractory cancer at two sites until the recommended Phase 2 dose is identified. We believe that data from these two studies will generate important information to inform anticipated later-stage studies.”

As currently envisioned, the Phase 1 trial in the U.S. will assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily or higher for consecutive 28-day cycles. The Phase 1 trial is planned for patients with relapsed/refractory advanced cancer, including but not limited to patients with HR+ HER 2- metastatic breast cancer with clinical resistance to the approved second-generation CDK4/6 inhibitors. Once the recommended Phase 2 dose is established, the Company’s plan is to enroll additional HR+ HER 2- postmenopausal metastatic breast cancer patients refractory to approved second-generation CDK4/6 inhibitors, as well as patients diagnosed with advanced non-Hodgkin’s lymphoma with a special interest in mantle cell lymphoma.

This trial design in the U.S. differs from the study in China because HanX is dosing patients daily for 21 days. Notably, of the three currently approved CDK4/6 inhibitors, two are approved for dosing in 21-day cycles and one is approved for dosing in a 28-day cycle. All three are blockbuster drugs marketed by well-known pharmaceutical companies, and all of these approved therapies require concomitant treatment with an aromatase inhibitor.

“Beyond metastatic breast cancer, we believe that ON 123300 may present an innovative approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma based on preclinical studies suggesting ON 123300 crosses the blood-brain barrier,” added Richard Woodman, M.D, Chief Medical Officer.

Commenting on the expected timetable and next steps with this program, Dr. Fruchtman added: “Once the FDA approves our IND, we will seek Institutional Review Board approval at the site where this Phase 1 trial will be conducted. We   anticipate the first patient to be enrolled during the first half of 2021. With the ON 123300 program advancing, investigator-sponsored trials underway with our pipeline product rigosertib, and an active business development campaign to evaluate additional compounds, we look forward to an expanding portfolio of novel therapeutics for large, underserved oncology indications.”

About ON 123300

Onconova’s lead pipeline product is the novel small molecule ON 123300, a proprietary, first-in-class multi-kinase inhibitor targeting tumor-driving kinases including CDK4/6 and ARK5. ON 123300 is reported to simultaneously inhibit both cell cycle and cellular energy metabolism through CDK4/6 and ARK5, respectively, and in vitro has been shown to be cytotoxic to cancer cells (killing the cancer cells) rather than just cytostatic (inhibiting the growth of cancer cells), which is how the currently commercial CDK inhibitors are reported to work. With its differentiated mechanism of action, ON 123300 may present an innovative approach for treating solid tumors and hematologic malignancies that are refractory to or have become resistant to other CDK4/6 inhibitors.

Based on experiments in preclinical models, ON 123300 exhibits single-agent cytotoxicity, may have utility for certain types of cancers including breast cancer and non-Hodgkin’s lymphoma, and may also have utility for mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a biopharmaceutical company focused on discovering and developing novel products to treat cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is currently in a dose-escalation and expansion Phase 1 trial in China, and an IND has been filed in the U.S. Onconova’s product candidate oral rigosertib is currently in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ lung adenocarcinoma in combination with nivolumab. Preclinical work with rigosertib in COVID-19 is ongoing as well. Although some preclinical experiments with rigosertib in cellular models demonstrated marked inhibition of SARS-CoV-2 replication, we do not anticipate conducting clinical trials with rigosertib in COVID-19 without securing additional funding. For more information, please visit www.onconova.com.

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, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova 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. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova 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.

C
ontact information

Company Contact:

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:

LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
[email protected] 

WALL, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) — BIO-key International, Inc. (NASDAQ: BKYI), an innovative provider of identity and access management (IAM) solutions powered by biometrics, today announced that it has partnered with Prominic.NET, an owner and operator of data centers serving businesses running on HCL Digital Solutions (formerly IBM Collaboration) products, to deploy BIO-key’s PortalGuard IAM solution to a U.S. DoD agency. PortalGuard will provide enhanced user access security to the agency’s enterprise applications and data via secure smart card authentication.

BIO-key implemented its PortalGuard IAM solution on the enterprise-grade HCL Domino-based environment to support application access requirements for the DoD agency’s mission-critical environment. PortalGuard is being used as a Security Assertion Markup Language (SAML) Identity Provider to provide Single Sign-On (SSO) capabilities for the load-balanced environment. PortalGuard is also being used to configure support for Personal Identity Verification (PIV) credential smart card authentication that enables access to application data. In addition, PortalGuard provided a split login experience where users without a PIV credential smart card could still login manually using traditional two-factor authentication methods, showcasing the solution’s flexibility in supporting different user types and access conditions.

“We are proud and excited to be selected for this important DoD application environment,” stated Mark Cochran, President of BIO-key – PortalGuard. “PortalGuard delivers a complete IAM solution for both on-premises and SaaS offerings that give customers the flexibility to choose based on their application security needs and Time to Value expectations. The combination of single-sign-on and multifactor authentication capabilities allows PortalGuard to provide a higher level of configurable security to protect our customer’s critical systems and data.”

About BIO-key International, Inc.
(


www.bio-key.com


)

BIO-key is revolutionizing authentication with biometric solutions that enable convenient and secure access to devices, information, applications, and high-value transactions. BIO-key’s software and hardware finger scanning solutions offer secure, user-friendly, and attractively-priced alternatives to passwords, PINs, tokens, and security cards, enabling enterprises and consumers to secure their networks and devices as well as their information in the cloud.

BIO-key Safe Harbor Statement

All statements contained in this press release other than statements of historical facts are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 (the “Act”). The words “estimate,” “project,” “intends,” “expects,” “anticipates,” “believes” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are made based on management’s beliefs, as well as assumptions made by, and information currently available to, management pursuant to the “safe-harbor” provisions of the Act. These statements are not guarantees of future performance or events and are subject to risks and uncertainties that may cause actual results to differ materially from those included within or implied by such forward-looking statements. These risks and uncertainties include, without limitation, our history of losses and limited revenue; our ability to raise additional capital; our ability to protect our intellectual property; changes in business conditions; changes in our sales strategy and product development plans; changes in the marketplace; continued services of our executive management team; security breaches; competition in the biometric technology industry; market acceptance of biometric products generally and our products under development; our ability to execute and deliver on contracts in Africa; our ability to expand into Asia, Africa and other foreign markets; our ability to integrate the operations and personnel of PistolStar into our business; the duration and severity of the current coronavirus COVID-19 pandemic and its effect on our business operations, sales cycles, personnel, and the geographic markets in which we operate; delays in the development of products and statements of assumption underlying any of the foregoing as well as other factors set forth under the caption see “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and other filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date made. Except as required by law, the Company undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise. Additionally, there may be other factors of which the Company is not currently aware that may affect matters discussed in forward-looking statements and may also cause actual results to differ materially from those discussed. In particular, the consequences of the coronavirus outbreak to economic conditions and the industry in general and the financial position and operating results of our company in particular have been material, are changing rapidly, and cannot be predicted.

Investor & Media Contacts

William Jones, David Collins
Catalyst IR
212-924-9800
[email protected]