Market Newsdesk

ROCKAWAY, NJ, May 04, 2021 (GLOBE NEWSWIRE) — — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the U.S. Department of Veterans Affairs is starting an investigator-initiated study of the use of gammaCore Sapphire^TM non-invasive vagus nerve stimulation (nVNS) for the treatment of post-traumatic headache (PTH). PTH accounts for approximately 4% of all symptomatic headache disorders¹ and is one of the most common consequences of mild traumatic brain injury (mTBI),^2,3 also known as concussion. Estimates suggest that 69 million people per year experience a traumatic brain injury (TBI) worldwide.⁴ In addition, patients with PTH commonly suffer from comorbidities such as anxiety and depression,⁵ both of which are among the leading causes of disability worldwide.⁶

The study (GAP-PTH) is a randomized, multi-center, double-blind, parallel, sham-controlled trial enrolling up to 100 veterans and directed by the Veterans Health Administration’s Headache Center of Excellence (HCoE) at the West Haven VA Medical Center in West Haven, CT. PTH is a critical area of concern for the VA and it is estimated that more than 350,000 service members have headaches resulting from TBIs sustained in combat. PTH in veterans is most often caused by the kind of TBIs experienced during combat, including blast wave injuries

“PTH is one of the most common presentations among veterans who come to our VA Headache Centers of Excellence around the United States. Last year the Veterans Health Administration was caring for more than 140,000 veterans diagnosed with headache related to head trauma,” commented Dr. Jason Sico, National Director of the VA Headache Centers of Excellence Program and Associate Professor of Neurology (Headache Medicine and Vascular Neurology) and Internal Medicine (General Medicine) Yale School of Medicine.

“We have been using gammaCore nVNS successfully in veterans suffering from cluster headache and migraine at our center,” commented Dr. Emmanuelle Schindler, Medical Director of the HCoE at VA Connecticut Healthcare System, Assistant Professor of Neurology at Yale School of Medicine, and primary investigator of the GAP-PTH study. “This will be among the first Randomized Controlled Trials (RCTs) for PTH and we look forward to demonstrating how gammaCore nVNS can help our veterans with PTH.”

“We appreciate the opportunity to work with Dr. Schindler, Dr. Sico and their team to evaluate the potential of gammaCore as an acute and/or preventive option for PTH” said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore is being used across the Department of Veterans Affairs and Department of Defense for both cluster and migraine headache and we believe that the same mechanisms of action that support the efficacy of gammaCore in primary headaches could also provide relief to our servicemen, servicewomen, and veterans suffering from post-traumatic headache.”

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCore

^TM

gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

• gammaCore is contraindicated for patients with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric patients (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat post-traumatic headache or traumatic brain injury and related disorders and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

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¹ Seifert, T. D. & Evans, R. W. Posttraumatic headache: a review. Curr. Pain Headache Rep. 14, 292–298 (2010).
² Nampiaparampil, D. E. Prevalence of chronic pain after traumatic brain injury: a systematic review. JAMA. 300, 711–719 (2008).
³ Mullally, W. J. Concussion. Am. J. Med. 130, 885–892 (2017).
⁴ Dewan, M. C. et al. Estimating the global incidence of traumatic brain injury. J. Neurosurg. 27, 1–18 (2018)
⁵ Minen, M. T., Boubour, A., Walia, H. & Barr, W. Post-concussive syndrome: a focus on post- traumatic headache and related cognitive, psychiatric, and sleep issues. Curr. Neurol. Neurosci. Rep. 16, 100 (2016). A review that details the clinical characteristics and associated comorbidities of PTH.
⁶ GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the global burden of disease study 2015. Lancet. 388, 1545–1602 (2016).

Investors:
Rich Cockrell
CG Capital
404-736-3838
[email protected]

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
[email protected]

REDWOOD CITY, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance, today announced positive topline results from its first-in-human Phase 1a clinical study of RZ402, the Company’s investigational oral plasma kallikrein inhibitor (PKI), for the treatment of diabetic macular edema (DME). Single dose oral administration of RZ402 resulted in plasma concentrations that substantially exceeded target pharmacologically active drug levels, demonstrating the potential for once daily dosing, and supporting the advancement of developmental activities toward Phase 2, including a Phase 1b multiple-ascending dose study. RZ402 was generally safe and well-tolerated at all doses tested, without dose-limiting toxicities.

“We’re in need of new treatments in the clinical care of patients with diabetic eye diseases,” said Robert B. Bhisitkul, M.D., Ph.D., Professor of Ophthalmology and Retinal Specialist at the University of California San Francisco School of Medicine’s Department of Ophthalmology, and member of Rezolute’s Scientific Advisory Board. “Pioneering research has strongly implicated the kallikrein-kinin system in the development of diabetic retinopathy and macular edema. A novel plasma kallikrein inhibitor has potential to give patients with diabetic macular edema an alternative therapeutic option. Oral delivery would provide the possibility of earlier treatment intervention and enable a patient-controlled regimen with advantages in comfort, convenience, and continuous drug levels in the retinal microvasculature. I look forward to the continued development of RZ402 for patients at risk of losing their sight from DME.”

RZ402-101 is a first-in-human Phase 1a, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult volunteers. The study objectives were to characterize the safety profile and pharmacokinetics of RZ402 administered as single oral doses. The study enrolled 30 subjects in three planned sequential dose-level cohorts of 25 mg, 100 mg, and 250 mg. Within each ten-subject dose cohort, subjects were randomized 8:2 to receive either RZ402 oral solution or matched placebo. After receiving single doses, participants remained in the clinic for seven days for serial pharmacokinetic and safety assessments, before completing two outpatient follow-up visits at study days 14 and 30. Dose advancement proceeded following blinded reviews of safety and pharmacokinetic data from the preceding cohort(s).

Single doses of RZ402 resulted in dose-dependent increases in systemic exposure. Plasma concentrations of RZ402 exceeded the 3.5 ng/mL target concentration that was pharmacologically active in animal models of DME for a 24-hour period after receipt of the 25 mg starting dose, and by > 20 and > 5-fold at maximum concentration and 24 hours after dosing, respectively, at the highest dose tested. Across this dose and exposure range, there were no serious adverse events, adverse drug reactions, or discontinuations due to adverse events, and no imbalance of adverse events between the treatment and placebo control groups. Similarly, regular laboratory, hemodynamic, cardiac, and ophthalmologic safety examinations were unremarkable.

“We are excited to share these encouraging results from the first clinical trial of the systemic delivery of an oral plasma kallikrein inhibitor for the treatment of DME. Given that DME is a consequence of diseased microvascular at the back of the eye, we believe that systemic exposure may be crucial in treating the disease,” said Brian Roberts, M.D., Rezolute’s Senior Vice President and Head of Clinical Development. “It is noteworthy that a single oral dose of RZ402 safely, durably, and substantially exceeded target blood concentrations that have been shown in animal models of DME to reduce retinal inflammation and fluid leakage, the physiological hallmarks of this microvascular disease. These results support the advancement of RZ402 into a Phase 1b multiple ascending dose study, which we expect to initiate in the third quarter of this year.”

About RZ402 and the contact activation kallikrein-kinin system

The contact-activation kallikrein-kinin system promotes increased vascular permeability and inflammation via key downstream mediators, including bradykinin, and activation of the intrinsic pathway of coagulation. Pathophysiologic upregulation of this system has been linked to a variety of diseases which are characterized by vascular dysfunction, including diabetic macular edema.

RZ402 is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME). By inhibiting the formation of kallikrein, RZ402 is designed to block downstream bradykinin production and the pro-inflammatory, pro-coagulant, and fluid-leakage contact-activation cascade.

About Diabetic Macular Edema (DME)

Diabetic retinopathy (DR) affects approximately one third of adults with diabetes and is the leading cause of vision loss in the working age population. DME is a severe vision-threatening complication of DR characterized by swelling of the retina and thickening of the macula, the part of the eye that is responsible for high-resolution vision. Anti-vascular growth factor (anti-VEGF) injections into the eye are the current standard of care for DME, requiring continued administration over long periods of time to preserve vision. Due to their invasive route of administration and occasional serious side effects, there is a tendency to delay treatment until later in the disease course, and long-term compliance with eye injection regimens can be difficult for patients. Coupled with inadequate responsiveness in some patients, this leads to overall undertreatment and suboptimal vision outcomes in DME patients.

About Rezolute, Inc.

Rezolute is advancing novel therapies for diseases caused by chronic glucose imbalance. The Company’s lead clinical asset, RZ358, is in Phase 2b development for treatment of congenital hyperinsulinism (CHI), a rare pediatric endocrine disorder. The Company is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter.

Forward-Looking Statements

This release, like many written and oral communications presented by Rezolute, Inc. and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.

Media Contact

[email protected]

Investor Contact

[email protected]

MENLO PARK, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Talis Biomedical Corporation (“TLIS”), a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point-of-care, today announced that it will release financial results for the first quarter after market close on Tuesday, May 11, 2021. Talis will host a conference call, beginning at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) to discuss financial and operational results.

Interested parties may access the live call via telephone by dialing 833-715-1329 for participants in the U.S. or Canada and 430-775-1933 for international callers, using conference ID 7657867. A live and archived webcast of the event can be accessed via the News & Events page of the investor section of Talis Biomedical’s website at www.talis.bio.

About Talis Biomedical

Talis is dedicated to transforming diagnostic testing by developing and commercializing innovative products that are designed to enable accurate, low cost and rapid molecular testing for infectious diseases at the point-of-care, beginning with COVID-19. The company is developing Talis One, a compact, sample-to-answer, cloud-enabled, molecular diagnostic platform. Talis is headquartered in Menlo Park, California. For more information, please visit talis.bio.

Contact

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

BOSTON, May 04, 2021 (GLOBE NEWSWIRE) — Block & Leviton is investigating whether Ubiquiti Inc. (NYSE: UI) committed violations of securities fraud, and investors who have lost money should contact the firm to learn more about how they might recover those losses. For more details, visit https://www.blockleviton.com/cases/ui.

What is this all about?

On March 30, 2021, Krebs on Security reported that a whistleblower has claimed that Ubiquiti’s January 11, 2021 data breach was “catastrophic,” and much more serious than the company previously let on. The report claims Ubiquiti hid a “massive” breach that put customer data and device security at risk. We are investigating whether Ubiquiti lied or misrepresented to investors the severity of the data breach when the Company announced it in January.

Who is eligible?

On this news, the Ubiquiti share price dropped from its March 30, 2021 open of $375.30 to an April 1, 2021 close of just $289.15 per share, representing a two day drop of approximately 23%. Investors who have lost money on their Ubiquiti investment – – whether or not they have sold that investment – – are potentially eligible and should contact Block & Leviton to learn more.

What is Block & Leviton doing?

Block & Leviton is considering filing a securities class action lawsuit to attempt to recover losses on behalf of investors who have lost money.

What should I do next?

If you’ve lost money on your investment, you should contact Block & Leviton to learn more via our case website, by email at [email protected], or by phone at (617) 398-5600.

Why should I contact Block & Leviton?

Many law firms have issued releases about this matter; many of those firms do not actually litigate securities class actions. Block & Leviton is a law firm that actually litigates cases. We are dedicated to obtaining significant recoveries on behalf of defrauded investors through active litigation in the federal courts across the country. Many of the nation’s top institutional investors hire us to represent their interests. You can learn more about us at our website, www.blockleviton.com, or call (617) 398-5600 or email [email protected] with any questions.

This notice may constitute attorney advertising.

CONTACT:
BLOCK & LEVITON LLP
260 Franklin St., Suite 1860
Boston, MA 02110
Phone: (617) 398-5600
Email: [email protected]
SOURCE: Block & Leviton LLP
www.blockleviton.com

CALGARY, Alberta, May 04, 2021 (GLOBE NEWSWIRE) — Boulder Energy Ltd. (“Boulder” or the “Company”) has engaged National Bank Financial Inc. (“NBF”) as Financial Advisor and Raymond James Ltd. (“Raymond James”) as Co-Financial Advisor to initiate a process (the “Strategic Review”) to identify, examine and consider all strategic and financial alternatives available to the Company, including a sale of the Company’s assets, with the ultimate view of enhancing stakeholder value.

Strategic Review

The Strategic Review is intended to explore a comprehensive range of strategic and transaction alternatives, including, but not limited to, a sale of the Company, investment in, merger or other business combination, a recapitalization or refinancing, a sale of all or a portion of the Company’s assets, or any combination thereof, among all other alternatives to improve the Company’s financial position and maximize value.

Overview of Boulder

Boulder Energy Ltd. is a private oil and natural gas producer with high-working-interest operations in the multi-zone Belly River play at Brazeau in the Alberta Deep Basin. Key highlights include:

• 44 degree API light sweet oil with top tier operating netbacks;
• ~100% owned and operated infrastructure;
• More than 165,000 net acres of land controlled;
• Inventory of high-quality prospective drilling locations for oil; and
• Successful enhanced oil recovery (EOR) schemes with minimal capital required to increase and expand gas injection programs.

The Company provides a stable, low-decline production base, with average daily production net to Boulder in March 2021 of approximately 2,860 boe/d, consisting of approximately 1,928 bbls/d of oil and natural gas liquids and 5,594 mcf/d of natural gas.

Net operating income for calendar 2020 totaled approximately $16.7 million. The Company estimates Q1 2021 net operating income to be approximately $7.0 million, or $28.0 million annualized.

A downloadable, non-confidential summary of opportunity will be posted to Boulder’s website when available – see www.boulderenergy.ca.

Advisor Contacts

For access to marketing materials and a Confidentiality Agreement (“CA”) please contact NBF or Raymond James. More detailed confidential information and process timeline will be provided to any party executing a CA.

Offers relating to this transaction will be accepted until 12:00pm MST on May 27, 2021.

National Bank Financial Inc.

Chris Muldoon
Managing Director, Investment Banking
Phone: (403) 290-5105
Email: [email protected]

Raymond James Ltd.

Dion Degrand
Managing Director, Head of Canadian Oil & Gas Investment Banking
Phone: (403) 509-0517
Email: [email protected]

TORONTO, May 04, 2021 (GLOBE NEWSWIRE) — BlueCat, the Adaptive DNS Company™, today announced the latest release of its flagship product, BlueCat Integrity. Integrity 9.3, which allows enterprises to better manage their DNS, DHCP, and IP Address Management (DDI), now includes new functionality that allows customers to better leverage these critical services to optimize their increasingly complex networks, more quickly adopt automation and deliver on hybrid cloud initiatives.

“We continue to provide our global customers, who rely on DNS as a critical service, the ability to support network resilience, cybersecurity, and automation requirements, as well as the ability to better meet their current goals around cloud adoption and business transformation,” said Martin McNealis, BlueCat’s Chief Product Officer.

BlueCat’s Integrity 9.3 release enables the enterprise to:

• Better manage complex networks. Two thirds (66%) of network teams struggle to support strategic business initiatives using decentralized, legacy DNS infrastructures. Network complexity is compounded by private and overlapping address space, distributed deployment environments, M&A activity, and more. Using Integrity 9.3, customers can now centrally document and navigate these complex relationships across their cloud, on-prem and virtualized networks.
• Ramp up automation. More than half (56%) of IT managers admit their teams are overwhelmed by DNS tickets and service requests, stalling innovation across the organization. BlueCat customers can now use Integrity 9.3 to ramp up their automation efforts and provision at scale that ensures consistency and reduce human error.
• Improve visibility and compliance. Nearly two-thirds (63%) of network teams do not have central visibility or control over their DDI audit data. This visibility gap introduces security risks and data compliance challenges. With Integrity 9.3, customers gain even more control with improvements in capturing, maintaining, and exporting system and DNS data. Not only can Integrity 9.3 customers capture both query and response for all DNS resolution, the system level data can all be tracked as well. This data can be integrated with an external security instance and event management platform (SIEM) or data lake, enabling compliance with all audit and retention policies.

“With the incredible pace of innovation in our networking environment today, Integrity 9.3’s tracking of overlapping space gives us the visibility and control we need to meet our ever-more demanding SLAs,” said a BlueCat customer, who manages IT at a medical services provider. Another BlueCat customer, a global telecommunications company, praised the release, saying, “in our dynamic network today, we need the ability to zero-touch provision new services anywhere. Integrity 9.3 provides us the capability to do so with the core tools we use today.”

For a complete list of new features included in the Integrity 9.3 release, please visit this information page.

About BlueCat

BlueCat is the Adaptive DNS™ company. The company’s mission is to help the world’s largest organizations thrive on network complexity, from the edge to the core. To do this, BlueCat re-imagined DNS. The result – Adaptive DNS™ – is a dynamic, open, secure, scalable, and automated resource that supports the most challenging digital transformation initiatives, like adoption of hybrid cloud and rapid application development. Learn more at www.bluecatnetworks.com.

Contact:
[email protected]
#: 416 966 3428

VANCOUVER, British Columbia, May 04, 2021 (GLOBE NEWSWIRE) — Treatment.com International Inc. (CSE: TRUE), a disruptive healthcare technology company that is harnessing the power of AI to help Canadians improve their health has developed the most sophisticated medical AI engine to “think like a doctor”.

The Company enlisted a team of leading doctors and engineers around the world to train its AI to process information and provide insights in the same way a doctor would. Its exclusive technology was developed from the ground up by doctors, and as a result, its ability to absorb unique and complex health information and reason like a doctor to provide an accurate assessment is unparalleled.

Treatment.com, led by its Chief Medical Officer, Dr. Kevin Peterson, assembled a team of 40 doctors to build a global library of medical knowledge specifically designed to train the AI. The AI was tested by a top 10 North American medical school, and it was so effective that the university is using it to test and train future doctors.

“I have been practicing and teaching medicine for over 35 years, and I am particularly excited by the ability of our AI to perform complex medical reasoning. The software can support and empower all of us in making better health decisions,” said Dr. Peterson.

“The applications of the technology are boundless. By understanding disease in the same way that a doctor was taught, the AI provides a medical perspective that can improve consumer health decisions or support doctors in their everyday clinical decisions. By improving everyone’s access to medical knowledge, we can promote prevention, provide earlier identification of medical problems, enhance access to medical care, and support treatments that can improve the lives of billions of people.”

The first product to use this ground-breaking resource will be Treatment.com’s Cara mobile application. Providing a symptom-based assessment for consumers, Cara is designed to assess the context of a medical problem, and to collect and track personalized information that can help a consumer make better health decisions. Cara is scheduled to be released summer 2021.

About Treatment.com

Treatment.com is a disruptive healthcare technology company that is harnessing the power of AI to help Canadians improve their health through personalized recommendations and insights. Based in Vancouver, the company spent the last five years working with a team of world-class doctors, engineers, mathematicians, and AI specialists to develop a complex AI engine that leverages the most robust, personalized data to generate highly predictive and accurate insights. Treatment.com is the parent company of Cara. This summer, Cara will be empowering Canadians to take control of their health with the launch of an innovative mobile app powered by this exclusive AI engine.

For more investor information on Treatment.com please visithttps://treatment.com/investors/.

Forward Looking Statement

This news release contains forward-looking statements relating to the future operations of Treatment.com, International, Inc. (Treatment) and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Treatment, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from Treatment’s expectations include other risks detailed from time to time in the filings made by Treatment with securities regulators.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of Treatment. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and Treatment will only update or revise publicly the included forward-looking statements as expressly required by Canadian securities law.

For more information:

Investor Contact: [email protected]

Highlights:

• More than 99.9% effective against full suite of ESKAPE pathogens, within hours of exposure to RECCE
  
  ^®
  
  327 (R327) in independent bacterial efficacy studies
• R327 remains effective against hypermutated ESKAPE superbugs, including multi-drug resistant (MDR) forms, a current market challenge of all existing antibiotics
• On-track to be the only company developing an efficacious anti-infective against ESKAPE pathogens globally
  

SYDNEY, Australia, May 04, 2021 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX:RCE) (FSE:R9Q) (Company), the Company developing new classes of synthetic anti-infectives, is pleased to announce RECCE^® 327 (R327) has demonstrated bactericidal activity against all six antibiotic resistant ESKAPE pathogens, including drug resistant mutations (superbugs) as well as two additional World Health Organization (WHO) priority pathogens list.

“We are encouraged by the data from this study and will continue to explore the potential of RECCE^® 327 to treat hospital-acquired infections,” said Recce Pharmaceuticals CEO James Graham. “Antimicrobial resistance is one of the most urgent threats to global public health with the suite of ESKAPE pathogens posing a significant threat due to their virulence and rapid development of drug-resistance. Additionally, with R327 effective against two more priority pathogens listed by the WHO, we believe this reinforces the potential of R327 to treat some of the greatest threats to human health.”

These antibiotic resistant bacteria acronymically dubbed ‘ESKAPE’ due to their propensity of ‘escaping’ the biocidal action of antibiotics, are collectively responsible for over 720,000 hospital acquired (nosocomial) infections in the United States alone each year.¹ The ESKAPE pathogens include both Gram-positive and Gram-negative bacteria; Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species.

The study was conducted by an independent contract research organization to assess the in-vitro efficacy of R327 against all ESKAPE pathogen bacterial strains. R327 is a broad-spectrum synthetic anti-infective that has potential to address the urgent global health threat posed by antibiotic resistant superbugs and emerging viral pathogens.

Graphics accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/a3b15bb1-79c7-44fd-b457-734d4e2fa7d0

https://www.globenewswire.com/NewsRoom/AttachmentNg/a695f826-f4e3-4061-bea3-d0ae89a8d31f

ESKAPE pathogens are responsible for 42.2% of blood infections,² around 50 million infections each year, resulting in one in five deaths in the community or one in three deaths in hospitals³ and are associated with higher lengths of stay, cost of care, and mortality compared with non-ESKAPE pathogens.²

The dilution method of R327 used in these studies slightly increased the minimum inhibitory concentration (MIC) across the wide range of Gram-positive, Gram-negative and superbug forms of bacteria. The slight variation (+/-) between one experiment to the next is likely due to small variance in the sensitivity of the instruments used in detection. The dilution of R327 that showed efficacy against K. pneumonia (CRE) is higher than previous findings though still well within the therapeutic window dosing range.

Additionally, R327 was shown to be effective against the WHO global priority pathogens carbapenem-resistant Escherichia coli (E. coli CRE) and multi-drug resistant Neisseria gonorrhoeae⁴ (N. gonorrhea MDR). These bacteria are listed on the WHO’s list of priority pathogens as those for which new antibiotics are urgently needed in addition to ESKAPE pathogens.

A graphic accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/08edf798-57a0-4634-8bb3-593db59a0b48

The minimum inhibitory concentration (MIC), or the lowest concentration of a drug that prevents visible growth of a bacterium or bacteria, was first determined to define the test concentrations for the time-kill study. The time-kill study was performed to determine the bacterial killing effect of R327 at a total of five concentrations, ranging from 0.5X to 8X the MIC and to measure killing kinetics of treatment with R327 against each strain.

Time-kill curves of R327 at various concentrations against strains of ESKAPE pathogens. In the time kill assay, each R327 dilution was tested in duplicate with the average plot shown.

The bactericidal activity of R327 demonstrated a three-log or 99.9% reduction in the number of colony forming units (CFUs) over 24 hours against all six strains at various concentrations and times.

Additional time kill concentration studies are underway with drug-resistant bacterial and are expected to be in-line with existing MIC/Time Kill. Data is expected in around a month and as pivotal inclusion in a Whitepaper/Abstract for presentation at the World Microbe Forum (20-24 June 2021) ⁵.

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation of New Classes of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.

Recce’s anti-infective pipeline is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE^® 327, RECCE^® 435, and RECCE^® 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.

Patented lead candidate RECCE^® 327 has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. Recce’s new antibiotic compound, RECCE^® 435, has been formulated for oral use.

The FDA has awarded RECCE^® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE^® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate in development.

Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE^® technologies targeting synergistic, unmet medical needs.

Chief Executive Officer


James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
[email protected]

Media and Investor Relations (AU)


Andrew Geddes
CityPR
+61 (02) 9267 4511
[email protected]

Media and Investor Relations (USA)


Meredith Sosulski, PhD
LifeSci Communications
+1 929 469 3851
[email protected]

¹ 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4871955/#:~:text=The%20ESKAPE%20pathogens%20(Enterococcus%20faecium,nosocomial%20infections%20throughout%20the%20world.
²https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902016/
³https://www.sensium.co.uk/news/lancet-publication-finds-one-in-five-deaths-due-to-sepsis/
⁴https://www.pharmacologydiscoveryservices.com/catalogmanagement/viewitem/Neisseria-gonorrhoeae-MDR-WHO-L-CCUG-57598-MIC/612505
⁵https://www.worldmicrobeforum.org/ 

SOUTH SAN FRANCISCO, Calif. and HANOVER, Md., May 04, 2021 (GLOBE NEWSWIRE) — In recognition of World Sickle Cell Day, which falls on June 19, 2021, Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) and the Sickle Cell Disease Association of America, Inc. (SCDAA) today launched “Lift Every Voice to Shine the Light on Sickle Cell” – a contest that will feature original spoken word pieces to raise awareness of sickle cell disease (SCD). The contest, which aims to elevate the voices and experiences of people living with SCD and their caregivers, is presented by Sickle Cell Speaks, GBT’s SCD education campaign that highlights authentic stories of those living with SCD to dispel misconceptions about the disease.

“People with sickle cell disease possess an incredibly rich and diverse array of creative abilities, often used to express the physical and emotional burden of living with this complex and devastating disease,” said Beverley Francis-Gibson, M.A., president and CEO of the SCDAA. “Celebrating these voices is critical as we work to overcome the legacy of stigma and misinformation that have a direct impact on health outcomes. We are proud to partner with GBT to shine the light on the challenges that SCD warriors face with strength and resilience.”

Spoken word poetry is an art form rooted in traditions of storytelling to convey compelling messages and personal experiences. People living with SCD and their caregivers are invited to sign up to submit videos of themselves performing original spoken word pieces about their experience with SCD. To learn more about the contest details and how to submit a video, please email [email protected] or visit www.facebook.com/SickleCellSpeaks. Participants must sign up by May 24, 2021, and be U.S. residents. For each eligible submission received, GBT will donate $100 to the SCDAA, up to a total donation of $5,000. The contest winner will be featured in a GBT event at the SCDAA Annual Convention in October 2021. “Shine the Light on Sickle Cell” is a collaboration between SiNERGe and SCDAA.

“GBT is proud to partner with SCDAA to recognize the many inspiring voices within the sickle cell community who have rallied for progress in the face of tremendous health and societal challenges over the last year,” said Jung E. Choi, chief business and strategy officer, and head of patient advocacy and government affairs at GBT. “People with SCD suffer from a terrible, life-threatening disease that is made worse by being subjected to racial bias. We reiterate our commitment to shining a brighter light on the inequities these patients encounter and will continue working with all our partners to ensure access to the high-quality care patients deserve.”

Performances by the spoken word contest winner and finalists will be featured in a virtual event on Friday, June 18, 2021, at 4:00 p.m. PT and Saturday, June 19, 2021, at 12:00 p.m. PT on the Sickle Cell Speaks Facebook and Instagram pages. The event will be hosted and feature performances by three SCD advocates who are passionate about using spoken word to educate and inspire change:

• Charly Richard, musician and writer
• DeMitrious Wyant, musician and entrepreneur
• Candis St. John, nurse and poet

About Sickle Cell Disease

Sickle cell disease (SCD) affects an estimated 100,000 people in the United States,¹ an estimated 52,000 people in Europe,² and millions of people throughout the world, particularly among those whose ancestors are from sub-Saharan Africa.¹ It also affects people of Hispanic, South Asian, Southern European, and Middle Eastern ancestry.¹ SCD is a lifelong inherited blood disorder that impacts hemoglobin, a protein carried by red blood cells that delivers oxygen to tissues and organs throughout the body.³ Due to a genetic mutation, people with SCD form abnormal hemoglobin known as sickle hemoglobin. Through a process called hemoglobin polymerization, red blood cells become sickled – deoxygenated, crescent-shaped, and rigid.^3-5 The sickling process causes hemolytic anemia (low hemoglobin due to red blood cell destruction) and blockages in capillaries and small blood vessels, which impede the flow of blood and oxygen throughout the body. The diminished oxygen delivery to tissues and organs can lead to life-threatening complications, including stroke and irreversible organ damage.^4-7

About SCDAA

Sickle Cell Disease Association of America (SCDAA) advocates for people affected by sickle cell conditions and empowers community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure. The association and more than 50 member organizations support sickle cell research, public and professional health education and patient and community services. Visit www.sicklecelldisease.org.

About Global Blood Therapeutics

Global Blood Therapeutics (GBT) is a biopharmaceutical company dedicated to the discovery, development, and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta^® (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of red blood cell sickling in SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a P-selectin inhibitor in development to address pain crises associated with the disease, and GBT021601 (GBT601), the company’s next-generation hemoglobin S polymerization inhibitor. In addition, GBT’s drug discovery teams are working on new targets to develop the next wave of treatments for SCD. To learn more, please visit www.gbt.com and follow the company on Twitter @GBT_news.

References

1. Centers for Disease Control and Prevention website. Sickle Cell Disease (SCD). https://www.cdc.gov/ncbddd/sicklecell/data.html. Accessed June 3, 2019.
2. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3182125. Accessed June 12, 2020.
3. National Heart, Lung, and Blood Institute website. Sickle Cell Disease. https://www.nhlbi.nih.gov/health-topics/sickle-cell-disease. Accessed August 5, 2019.
4. Rees DC, et al. Lancet. 2010;376(9757):2018-2031.
5. Kato GJ, et al. Nat Rev Dis Primers. 2018;4:18010.
6. Kato GJ, et al. J Clin Invest. 2017;127(3):750-760. 
7. Caboot JB, et al. Paediatr Respir Rev. 2014;15(1):17-23.

GBT Contact Information:

Steven Immergut
650-410-3258
[email protected]

SCDAA Contact Information:

Emma Day
[email protected]

Kyri Jacobs
[email protected]