Market Newsdesk

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of First American Financial Corporation (“First American” or the “Company”) (NYSE: FAF).   Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether First American and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action]

On May 24, 2019, KrebsOnSecurity reported that First American’s website “leaked hundreds of millions of documents related to mortgage deals going back to 2003.”  The records included bank account numbers and statements, mortgage and tax records, Social Security numbers, wire transaction receipts, and driver’s license images-all of which “were available without authentication to anyone with a Web browser.”  Approximately 885 million records were exposed. 

On this news, First American’s stock price fell $3.31 per share, or 6%, to close at $49.52 per share on May 27, 2019. 

Then, on October 22, 2020, after the market closed, First American disclosed receipt of a Wells Notice from the U.S. Securities and Exchange Commission (“SEC”), regarding a preliminary determination to file an enforcement action against the Company related to the security breach.  Specifically, the SEC questioned the adequacy of the Company’s disclosures at the time of the incident and the adequacy of its disclosure controls. 

On this news, First American’s stock price fell $4.83 per share, or 9.36%, to close at $46.75 per share on October 22, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980

BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) — MicroEJ, a leader in trusted virtual execution environments for cost effective SoC/MCU/MPU, today announced support for the QNX^® Neutrino^® RTOS, a microkernel real-time operating system from BlackBerry QNX. The QNX operating system is widely used in life and safety-critical systems for vehicles, medical devices, industrial controls, rail, robotics and aerospace & defense. With reliability being the essence of both partners, this collaboration empowers mission-critical device manufacturers with first-class safety, reduced R&D costs and faster time to production.

MICROEJ VEE standard micro-virtualization (less than 50Kb) completes the high performance and enhanced kernel-level security in the QNX RTOS by offering a closed and hermetic sandbox, which isolates and decouples certified software modules from less critical ones. This virtualized and modular architecture greatly eases system certification and ensures that best-effort code won’t be able to interact with the device critical functions.

In addition, binary software modules developed for MicroEJ VEE can be ported on any QNX supported hardware with no modification, resulting in reduced development costs, a scalable binary software foundation, and reduced software architecture complexity. Through its unique true binary code simulation on virtual devices, the combination of MicroEJ and BlackBerry QNX technologies addresses the number one embedded system issue: time-to-market for mission-critical and life-critical devices in markets such as medical, automotive, and industrial automation.

MICROEJ VEE supports QNX^® Neutrino^® RTOS v6.x and v7.x (including new features such as ASLR) for any available microcontroller, microprocessor, or systems-on-chip based on the latest ARMv8 architecture such as Cortex-R52, Cortex-M33, Cortex-M23 and legacy ones such as ARMv5.

“Reliability, which is based on both safety and security paradigms, has always been our first and foremost priority, considering the sensitive nature of the millions of embedded devices powered by MicroEJ on the field today,” declares Fred Rivard, MicroEJ’s CEO. “With BlackBerry QNX technology, MicroEJ offers the best cost-effective process for mission-critical devices’ makers, allowing utmost levels of safety, and up to 70% time-to-market improvement, which is absolutely crucial due to the accelerating race to innovation today.”

“
We’re thrilled
to expand
our
collaboration with MicroEJ
. We
both
share
a
passion for innovation and reliability
and look forward to helping
mission-critical device manufacturer
s
expedite their IoT projects without sacrificing safety
or
security
,
” said Grant Courville, VP, Products and Strategy, BlackBerry QNX.

About MicroEJ

MicroEJ is a software vendor of cost-driven solutions for embedded and IoT devices. We are focused on providing device manufacturers with secure products in markets where software applications require high performance, compact size, energy efficiency, and cost-effective development.

Today more than 120+ companies in the world with currently over 37 million products sold, have already chosen MicroEJ to design electronic product applications in a large variety of industries, including smart home, wearables, healthcare, industrial automation, retail, telecommunications, smart city, building automation, transportation, etc.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/14926c47-e88a-4748-baec-89e9c3de42f9

For more info: www.microej.com
Media Contact: [email protected]

SCOTTSDALE, AZ, Nov. 12, 2020 (GLOBE NEWSWIRE) — AMMO, Inc. (OTCQB: POWW) (“AMMO” or the “Company”), a premier American ammunition and munition components manufacturer and technology leader, is pleased to provide guidance for its 3^rd quarter for the 2021 Fiscal Year. 

The Company has updated its guidance for the 3rd quarter of fiscal year 2021 to approximately $15.0 million in revenue. AMMO’s 3^rd quarter guidance represents an estimated 435% year-over-year increase compared to $2.8 million in revenue for the third quarter of fiscal 2020 and a 25% increase in revenue when compared to $12 million in the 2nd quarter of fiscal 2021.

“Our team continues to work diligently to meet existing domestic consumer demand as export opportunities start to open up again in the post-COVID international market. These efforts have kept us on track to increase our positive adjusted EBITDA in the fiscal 3rd quarter as we maintain our focus on driving sales for our higher margin product offerings,” said Fred Wagenhals, AMMO’s CEO.

About AMMO, Inc.

AMMO was founded in 2016 with a vision to change, innovate and invigorate the complacent munitions industry. The Company designs and manufactures products for a variety of markets, including law enforcement, military, hunting, sport shooting and self-defense. AMMO promotes its company branded munitions, its patented STREAK™ Visual Ammunition, /stelTH/™ subsonic munitions, and O.W.L. Technologies^®. The Company’s corporate offices are headquartered in Scottsdale, Arizona. Manufacturing operations are based in both northern Arizona and Manitowoc, Wisconsin. For more information please visit: www.ammoinc.com.

Forward Looking Statements

This document contains certain “forward-looking statements”. All statements other than statements of historical fact are “forward-looking statements” for purposes of federal and state securities laws, including, but not limited to, any projections of earnings, revenue or other financial items; any statements of the plans, strategies, goals and objectives of management for future operations; any statements concerning proposed new products and services or developments thereof; any statements regarding future economic conditions or performance; any statements or belief; and any statements of assumptions underlying any of the foregoing.

Forward looking statements may include the words “may,” “could,” “estimate,” “intend,” “continue,” “believe,” “expect” or “anticipate” or other similar words, or the negative thereof. These forward-looking statements present our estimates and assumptions only as of the date of this report. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the dates on which they are made. We do not undertake to update forward-looking statements to reflect the impact of circumstances or events that arise after the dates they are made. You should, however, consult further disclosures and risk factors we include in Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Reports filed on Form 8-K.

Investor Contact:

Rob Wiley, CFO
AMMO, Inc.
Phone: (480) 947-0001
[email protected]

Salt Lake City Utah, Nov. 12, 2020 (GLOBE NEWSWIRE) — Cambridge University Medical School Study Finds Rapid Medical Tourniquet More Conducive For Civilian Every Day Carry

Rapid Medical is pleased to share the Cambridge University Medical School findings of a study recently conducted in June of 2020 on the efficacy of commercial tourniquet designs for extremity hemorrhage control compared to a military-approved tourniquet. This study, which includes the Rapid Medical Tourniquet, clearly evaluates the Rapid Medical Tourniquet’s competency without bias.

“This study plainly states what we here at Rapid Medical have known for years; the Rapid Tourniquet is FAST and easy to apply while also being one of the most effective tourniquets to successfully stop arterial bleeding available. The Rapid Tourniquet is simple, lightweight, easy to apply to adults, children, and pets. No other tourniquet is as adaptable, making it the obvious choice for civilian carry, including families.” Stated Clint Chamberlain, Retired Army Captain, Veteran SLCPD Officer, Chief Operating Officer of Rapid Medical.

The study, conducted by nine emergency medicine residents, evaluated four different tourniquet designs.

Gen 7 Combat Application Tourniquet (CAT7; control) Stretch Wrap and Tuck Tourniquet (SWAT-T)
Gen 2 Rapid Application Tourniquet System (RATS)

Tourni-Key (TK)

Popliteal artery flow cessation was determined using a ZONARE ZS3 ultrasound. The steady-state maximal generated force was measured for 30 seconds with a thin-film force sensor.

Success rates for distal arterial flow cessation were: 89% CAT7
67% SWAT-T
89% RATS

78% TK (H 0.89; P = .83)

Mean (SD) application times were:
10.4 (SD = 1.7) seconds CAT7
23.1 (SD = 9.0) seconds SWAT-T
11.1 (SD = 3.8) seconds RATS
20.0 (SD = 7.1) seconds TK
(F 9.71; P <.001).

Steady state maximal forces were: 29.9 (SD = 1.2) N CAT7
23.4 (SD = 0.8) N SWAT-T
33.0 (SD = 1.3) N RATS
and 41.9 (SD = 1.3) N TK.

Conclusion: All commercial TQ systems were non-inferior to the military-approved CAT7. Mean application times were less than 30 seconds for all four designs. The size of these commercial TQs may make them more conducive to lay- provider EDC, thereby increasing community resiliency and improving the response to high-threat events. The study can be accessed here: The Efficacy of Novel Commercial Tourniquet Designs for Extremity Hemorrhage Control: Implications for Spontaneous Responder Every Day Carry.

  

About Rapid Medical 

The Rapid Tourniquet was developed to be used in real-life situations, under stress,including low-light/night. It is the only tourniquet on the market that works on adults, children, and pets. Unlike traditional tourniquets, there’s no threading, locks, or other complex procedures, just wrap around the limb and cleat off. The Rapid tourniquet is simple and easy-to-use, even one-handed. It is the fastest tourniquet available and can be rapidly and effectively implemented in military, law enforcement as well as civilian emergency medicine as a life-saving tool. Rapid Medical is Veteran owned and operated. To Learn more visit rapidtq.com

For more information please contact Sara Liberte [email protected] 412.400.3978

Attachments

• SLP_8800
• Rapid_Cambridge_PR

Sara Liberte
MyMedic
412-400-3978
[email protected]

KNOXVILLE, TN, Nov. 12, 2020 (GLOBE NEWSWIRE) — Provectus (OTCQB: PVCT) today announced that data from the Company’s ongoing Phase 1b/2 study of autolytic cancer immunotherapy PV-10, an injectable formulation of Provectus’ proprietary small molecule rose bengal disodium (RBD), in combination with KEYTRUDA^® (pembrolizumab) for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade (CB) will be presented at Melanoma Bridge 2020, to be held online from December 3-5, 2020.

The abstract accepted for oral presentation is entitled “Response for combination of PV-10 autolytic immunotherapy and immune checkpoint blockade in checkpoint-refractory patients.”

Intralesional (IL) (aka intratumoral) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death and induce tumor-specific reactivity in circulating T cells.^1,2,3 This IL PV-10-induced functional T cell response may be enhanced and boosted in combination with CB.⁴ In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response.

About the Phase 1b/2 Combination Therapy Trial (NCT02557321)

A first expansion cohort of the Phase 1b portion of the study began enrolling patients with metastatic cutaneous melanoma who were CB-refractory in December 2018. This CB-Refractory Cohort extended an exploratory group of refractory patients enrolled into the study’s main cohort that primarily enrolled CB-naïve patients. Patients with at least one injectable lesion and who were candidates for KEYTRUDA were eligible. Eligible subjects received the combination treatment of PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., over a period of up to 12 weeks), followed by only KEYTRUDA every three weeks for up to 24 months. The protocol allows for additional cycles of PV-10 beyond the fifth cycle for patients with additional injectable disease. The primary endpoint for the Phase 1b trial was safety and tolerability. ORR and progression-free survival were key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter).

About Rose Bengal Disodium

RBD is 4,5,6,7-tetrachloro-2′,4′,5′,7′-tetraiodofluorescein disodium, a halogenated xanthene and Provectus’ proprietary lead molecule. Provectus’ current Good Manufacturing Practices (cGMP) RBD is a proprietary pharmaceutical-grade drug substance produced by the Company’s quality-by-design (QbD) manufacturing process to exacting regulatory standards that avoids the formation of uncontrolled impurities currently present in commercial-grade rose bengal. Provectus’ RBD and cGMP RBD manufacturing process are protected by composition of matter and manufacturing patents as well as trade secrets.

An IL formulation (i.e., by direct injection) of cGMP RBD drug substance, cGMP PV-10, is being developed as an autolytic immunotherapy drug product for solid tumor cancers. By targeting tumor cell lysosomes, RBD treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells, including a T cell mediated immune response against treatment refractory and immunologically cold tumors.^1,2,3 Adaptive immunity can be enhanced by combining CB with RBD.⁴ IL PV-10 is undergoing clinical study for relapsed and refractory adult solid tumor cancers, such skin and liver cancers.

IL PV-10 is also undergoing preclinical study for relapsed and refractory pediatric solid tumor cancers, such as neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.^5,6

A topical formulation of cGMP RBD drug substance, PH-10^®, is being developed as a clinical-stage immuno-dermatology drug product for inflammatory dermatoses, such as atopic dermatitis and psoriasis. RBD can modulate multiple interleukin and interferon pathways and key cytokine disease drivers.⁷

Oral formulations of cGMP RBD are undergoing preclinical study for relapsed and refractory pediatric blood cancers, such as acute lymphocytic leukemia and acute myelomonocytic leukemia.^8,9

Oral formulations of cGMP RBD are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk adult solid tumor cancers, such as head and neck, breast, pancreatic, liver, and colorectal cancers.

Different formulations of cGMP RBD are also undergoing preclinical study as potential treatments for multi-drug resistant (MDR) bacteria, such as Gram-negative bacteria.

Tumor Cell Lysosomes as the Seminal Cancer Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.¹⁰ Cancer progression and metastasis are associated with lysosomal compartment changes^11,12, which are closely correlated (among other things) with invasive growth, angiogenesis, and drug resistance¹³.

RBD selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus^1,14, external collaborators⁵, and other researchers^15,16,17 have independently shown that RBD triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via RBD: RBD-induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine hepatocellular carcinoma (HCC) cells can be viewed in this Provectus video of the process (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames, with a duration of approximately one hour). Exposure to RBD triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video of the process, with a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators in neuroblastoma cells to show that lysosomes are disrupted upon exposure to RBD.⁵

Tumor Autolytic Death via RBD: RBD causes acute autolytic destruction of injected tumors (via autolytic cell death), mediating the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens; release of these signaling factors may initiate an immunologic cascade where local response by the innate immune system may facilitate systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Mediated immune signaling pathways may include an effect on STING, which plays an important role in innate immunity.⁹

Orphan Drug Designations (ODDs)

ODD status has been granted to RBD by the U.S. Food and Drug Administration for metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Intellectual Property (IP)

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which cGMP RBD and related halogenated xanthenes are produced, avoiding the formation of previously unknown impurities that exist in commercial-grade rose bengal in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of RBD and CB (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035; US patent application numbers include 20200138942.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entirely- and wholly-owned family of small molecules called halogenated xanthenes. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.

References

1. Wachter et al. Functional Imaging of Photosensitizers using Multiphoton Microscopy. Proceedings of SPIE 4620, 143, 2002.

2. Liu et al. Intralesional rose bengal in melanoma elicits tumor immunity via activation of dendritic cells by the release of high mobility group box 1. Oncotarget 7, 37893, 2016.

3. Qin et al. Colon cancer cell treatment with rose bengal generates a protective immune response via immunogenic cell death. Cell Death and Disease 8, e2584, 2017.

4. Liu et al. T cell mediated immunity after combination therapy with intralesional PV-10 and blockade of the PD-1/PD-L1 pathway in a murine melanoma model. PLoS One 13, e0196033, 2018.

5. Swift et al. Potent in vitro and xenograft antitumor activity of a novel agent, PV-10, against relapsed and refractory neuroblastoma. OncoTargets and Therapy 12, 1293, 2019.

6. Swift et al. In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors. 2018 ASCO Annual Meeting, J Clin Oncol 36, 2018 (suppl; abstr 10557).

7. Krueger et al. Immune Modulation by Topical PH-10 Aqueous Hydrogel (Rose Bengal Disodium) in Psoriasis Lesions. Psoriasis Gene to Clinic, 8^th International Congress, Br J Dermatol 177.

8. Swift et al. In Vitro Activity and Target Modulation of PV-10 Against Relapsed and Refractory Pediatric Leukemia. 2018 ASH Annual Meeting, Blood 132, 2018 (suppl; abstr 5207).

9. Thakur et al. Association of heat shock proteins as chaperone for STING: A potential link in a key immune activation mechanism revealed by the novel anti-cancer agent PV-10. 2020 AACR VAM II, (abstr 5393).

10. Piao et al. Targeting the lysosome in cancer. Annals of the New York Academy of Sciences. 2016; 1371(1): 45.

11. Nishimura et al. Malignant Transformation Alters Intracellular Trafficking of Lysosomal Cathespin D in Human Breast Epithelial Cells. Pathology Oncology Research. 1998; 4(4): 283.

12. Gocheva et al. Distinct roles for cysteine cathepsin genes in multistage tumorigenesis. Genes & Development. 2006; 20(5): 543.

13. Fehrenbacher et al. Lysosomes as Targets for Cancer Therapy. Cancer Research. 2005; 65 (8): 2993.

14. Wachter et al. Imaging Photosensitizer Distribution and Pharmacology using Multiphoton Microscopy. Proceedings of SPIE 4622, 112, 2002.

15. Koevary. Selective toxicity of rose Bengal to ovarian cancer cells in vitro. International Journal of Physiology, Pathophysiology and Pharmacology 4(2), 99, 2012.

16. Zamani et al. Rose Bengal suppresses gastric cancer cell proliferation via apoptosis and inhibits nitric oxide formation in macrophages. Journal of Immunotoxicology, 11(4), 367, 2014.

17. Luciana et al. Rose Bengal Acetate photodynamic therapy-induced autophagy. Cancer Biology & Therapy, 10:10, 1048, 2010.

Trademarks

PV-10^® and PH-10^® are registered trademarks of Provectus, Knoxville, Tennessee, U.S.A.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Kenilworth, New Jersey, U.S.A.

FORWARD-LOOKING STATEMENTS:

The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in


Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019


and


Provectus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2020


.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

Publication


Explores


the Beneficial Effects of


Apabetalone on the Immune Cells of Diabetic Patients

Event


Reminder: Multiple


Presentations


on


Apabetalone


to be made during the American Heart Association Scientific Sessions


– November 13-17

CALGARY, Alberta, Nov. 12, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX:RVX) announced today the recent publication of an article titled: “BET protein inhibitor apabetalone (RVX-208) suppresses pro-inflammatory hyper-activation of monocytes from patients with cardiovascular disease and type 2 diabetes”, in the high-impact, peer-reviewed Clinical Epigenetics.

The publication can be viewed using the following LINK. As previously announced, additional information related to this study, and others on apabetalone, will be presented in an oral presentation at the 2020 American Heart Association (AHA) Scientific Sessions (see details below).

“Building on our previous work, this study shows apabetalone treatment works directly on immune cells that contribute to cardiovascular disease and has great potential to reduce cardiovascular risk in diabetes and chronic kidney disease patients,” said Dr. Ewelina Kulikowski, Senior Vice President, Research & Development at Resverlogix, and a corresponding author of the paper. “In addition, during the coming AHA meeting, we look forward to presenting additional BETonMACE findings including how apabetalone may prove beneficial in preventing SARS-CoV-2 viral entry in human cell lines.”

P
ublication
Highlights
include:

• Immune cells taken directly from diabetes and cardiovascular disease patients have an activated state of inflammation compared to the cells of matched control patients
• When immune cells are activated by inflammation, it can trigger a cascade of events leading to vascular damage and disease
• A
  pabetalone treatment dampens the response of immune cells to inflammation, preventing them from activating unnecessarily, and reversing damaging disease processes
• These findings may help explain apabetalone’s beneficial effect on cardiovascular outcomes, as observed in BETonMACE

Publication
Background and Conclusions:

Activation of immune cells is an important process in the development of atherosclerosis and contributes to cardiovascular risk. The findings published in this article highlight the central role of BET proteins in driving the expression of disease risk factors in patients with diabetes and cardiovascular disease. Apabetalone treatment, acting at the epigenetic level, can reduce the activation of disease-promoting cells, helping us better understand how BET inhibitors reduce cardiovascular and chronic kidney disease risk in type 2 diabetes patients.

Event Reminder –
AHA Scientific Sessions, November 13-17, 2020

Through participation at leading industry events, including the AHA Scientific Sessions, the Company continues to highlight apabetalone and its ability to regulate multiple biological pathways that underlie chronic disease, as well as presenting new research related to COVID-19. Further details of the presentations are outlined below, and the posters may be found HERE, when available.

• Oral Presentation: BET Protein Inhibitor Apabetalone Suppresses Inflammatory Hyperactivation of Monocytes from Patients with Cardiovascular Disease and Type 2 Diabetes
  • Presentation will discuss the important role of macrophage hyperactivation in driving CVD in diabetic patients and demonstrate apabetalone’s reduction of maladaptive gene expression in these cells
• Poster Presentation: Apabetalone (RVX-208) Reduces ACE2 Expression in Human Cell Culture Systems, Which Could Attenuate SARS-CoV-2 Viral Entry
  • New data will be presented showing apabetalone treatment reduces expression of the angiotensin converting enzyme 2 (ACE2) receptor that is essential for SARS-CoV-2 viral entry, in human cell lines
• Poster Presentation:
  Reduction in the Risk of Major Adverse Cardiovascular Events
  w
  ith
  Apabetalone
  , a BET Protein Inhibitor, in Patients
  w
  ith Recent Acute Coronary Syndrome and Type 2 Diabetes According to Insulin Treatment: Analysis of the
  BETonMACE
  Trial
  • A new post-hoc analysis of BETonMACE will be presented examining the risk of major adverse cardiovascular events (MACE) events to enrolled patients according to their concomitant insulin treatment

A
bout Resverlogix

Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.

BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.

Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).

Follow us on:

• Twitter: @Resverlogix_RVX
• LinkedIn: https://www.linkedin.com/company/resverlogix-corp-/

For further information please contact:

Investor Relations
Email: [email protected]
Phone: 403-254-9252
Or visit our website: www.resverlogix.com

This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”,
“forecasts” and other similar expressions. In particular, this news release includes forward looking information relat
ed
to
multiple presentations on
apabetalone
being made at the AHA Scientific Sessions meeting and
the potential role of
apabetalone
in the treatment of
patients with
high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis,
neurodegenerative disease,
Fabry disease, peripheral artery disease and other orphan diseases
. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

MARIETTA, Ga., Nov. 12, 2020 (GLOBE NEWSWIRE) — MiMedx Group, Inc. (Nasdaq: MDXG) (“MiMedx” or the “Company”), an industry leader in advanced wound care and a therapeutic biologics company, today announced that Timothy R. Wright, MiMedx Chief Executive Officer, and Peter M. Carlson, MiMedx Chief Financial Officer, will present at the Canaccord Genuity Virtual MedTech & Diagnostics Forum on Thursday, November 19, 2020, beginning at 9:30 am, Eastern Time.

A live webcast of the presentation will be available on the Events page of the Investors section of the Company’s website or through the conference site by using the link below.

Date: Thursday, November 19, 2020
Time: 9:30 AM ET
Webcast: https://wsw.com/webcast/canaccord44/mdxg/2454624 

A replay of the webcast will be available for approximately 45 days on the Company’s website at www.mimedx.com following the conclusion of the presentation.

About MiMedx

MiMedx^® is an industry leader in advanced wound care and a therapeutic biologics company developing and distributing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION^® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied more than two million allografts, through both direct and consignment shipments. For additional information, please visit www.mimedx.com.

Contact

Hilary Dixon
Investor Relations & Corporate Communications
770.651.9066
[email protected]

 

‘S-HERTOGENBOSCH, the Netherlands, Nov. 12, 2020 (GLOBE NEWSWIRE) — Enphase Energy, Inc. (NASDAQ: ENPH), a global energy management technology company and the world’s leading supplier of microinverter-based solar-plus-storage systems, today announced a strategic partnership with DMEGC Solar Energy, a vertically integrated manufacturer of solar photovoltaic (PV) products from poly silicon to modules, to develop high-efficiency Enphase Energized™ AC modules (ACM) for the European residential solar market. These ACMs are currently available in France and the Netherlands.

The Mono PERC Black Enphase Energized ACM in Europe features Enphase IQ 7™ and IQ 7+™ microinverters. Incorporating advanced mono PERC half-cut cell technology, the DMEGC Black ACM produces outstanding yields due to power classes of up to 340 Wp and efficiencies of up to 20.15%. The ACM also offers best-in-class quality manufacturing according to international quality standards and 100% EL testing performed twice during production. The Mono PERC DMEGC ACM enables installers to be more competitive through improved capital management, reduced labor costs, improved SKU management with accelerated design, and faster installation times. 

“We see a promising future for our partnership with Enphase Energy in European countries, particular in countries like France and the Netherlands, where quality, innovation and aesthetics are key for residential PV solutions,” said Erik Das, sales director at DMEGC Solar Europe. “Enphase Energized AC modules offer remote monitoring, rapid shutdown, quality design, and simple installation. Their lower maintenance costs and high safety features are much appreciated in our competitive solar markets.”

The seventh-generation Enphase IQ™ microinverter system leverages Enphase’s unique software-defined architecture and semiconductor integration for excellent reliability and economies of scale. Enphase microinverters are subjected to a rigorous reliability and quality testing regimen with more than an aggregated one million hours of cumulative power-on testing to ensure exceptional performance under heat, high humidity, salty air, and extreme cold. The Company’s microinverters are designed to be long-lived energy assets and are backed by a 25-year limited warranty.

“Our experience with installing the DMEGC ACM has been very positive, as we have benefitted from the product’s fewer components and ease of installation,” said Janneke vd. Kerkhoff, owner at Goforsunpower, the Netherlands. “We are pleased to know the ACM is powered by Enphase microinverters, which are designed to be safe, reliable and future-proof.”

Enphase Energized AC modules from DMEGC Solar Energy work seamlessly with Enphase IQ accessory products: the lighter two-wire Enphase Q Cable™, Enphase Envoy-S™ gateway and Enphase Envoy-S metered gateway with split core current transformers (CTs) for production and consumption monitoring. Solar installers who select the Mono PERC ACM can monitor their solar fleets remotely using the powerful cloud-based Enphase Enlighten™ monitoring system, and rely on the Enphase support team to deliver an outstanding customer experience.

“Our partnership with DMEGC Solar Energy is another validation of the high-efficiency AC module concept and Enphase microinverter technology for the European solar market,” said Dave Ranhoff, chief commercial officer at Enphase Energy. “We are pleased to join forces with such a high-quality AC module manufacturer in Europe, where Enphase microinverters continue to have broad appeal for both solar installers and homeowners.”

For more information about the Enphase Energized AC Modules from DMEGC, visit the Enphase Energy website.

About Enphase Energy, Inc.

Enphase Energy, a global energy technology company, delivers smart, easy-to-use solutions that connect solar generation, storage and management on one intelligent platform. The Company revolutionized solar with its microinverter technology and produces the world’s only truly integrated solar plus storage solution. Enphase has shipped more than 30 million microinverters, and approximately 1.3 million Enphase-based systems have been deployed in more than130 countries. For more information, visit www.enphase.com/de and follow the company on Facebook, LinkedIn and Twitter.

Enphase Energy®, the Enphase logo, Enphase Energized, IQ, IQ 7+, Q Cable, Envoy-S, Enlighten, and other trademarks or service names are the trademarks of Enphase Energy, Inc. Other names are for informational purposes and may be trademarks of their respective owners.

Forward-Looking Statements


This press release may contain forward-looking statements, including statements related to the expected performance and advantages of Enphase Energy’s technology and products, including quality, safety, reliability, lower costs, the ease of installation and being “future-proof”; the capabilities of its customer service teams; anticipated product adoption; and the capabilities and performance of its partners’ products and services. These forward-looking statements are based on Enphase’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of certain risks and uncertainties including those risks described in more detail in Enphase’s most recent Annual Report on Form 10-K and other documents on file with the SEC and available on the SEC’s website at www.sec.gov. Enphase Energy undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations, except as required by law.

Enphase
Energy
Contact:

Robert Gruijters
Marketing Director, EMEA
[email protected]
Telephone: +31-6-82390633 

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Credit Acceptance Corporation (“Credit Acceptance” or the “Company”) (NASDAQ: CACC).   Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Credit and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action]

On August 13, 2020, Credit Acceptance disclosed that on August 11, 2020, the Company had received subpoenas from the Attorney General of the State of Maryland and from the Attorney General of the State of New Jersey.  Describing the subpoenas as “substantively identical” to one another, Credit Acceptance advised investors that the subpoenas both “relat[ed] to the Company’s repossession and sale policies and procedures” and “the Company’s origination and collection policies and procedures.”  Taken together with previously disclosed subpoenas received in March 2016 and April 2020, Credit Acceptance advised investors that the inquiries it faced now related to its operations in 39 states. 

On this news, Credit Acceptance’s stock price fell $19.05 per share, or 3.84%, over the following two trading sessions, closing at $476.78 per share on August 17, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980

VANCOUVER, British Columbia, Nov. 12, 2020 (GLOBE NEWSWIRE) — Sabina Gold & Silver Corp (SBB.T/SGSVF.OTCQX), (“Sabina” or the “Company”) is pleased to report that the detail engineering contract has been awarded and work has commenced on the Goose Mine at its 100%-owned Back River Gold Project (“Back River” or the “Project”) in Nunavut, Canada.

After comprehensive evaluation of various construction delivery methods for the Process Plant at Goose, Sabina believes that a modified Engineering, Procurement, Construction Management (“EPCM”) method offers the greatest efficiency, flexibility and risk mitigation for development of the Goose Project.

This delivery model includes completion of detail engineering in a reimbursable cost model for engineering and procurement directly sourcing major process equipment, and pursuit of a fixed price construction bid.

Detail engineering will provide definitive material requirements per AACE class II standards (up to 70% project definition) and will result in development of procurement packages and delivery of issued for construction drawings. This approach de-risks the engineering aspect, better defines the execution plan and provides greater certainty of procurement and construction costs. With these details in hand, Sabina will solicit fixed price construction bids for the plant, including performance guarantees.

CONSULTANTS

Sabina has engaged Sacré-Davey Engineering Inc. (“SD”) to complete the detail engineering scope for the process plant and experienced Arctic builders, CGT Industrial (“CGT”) to review and evaluate the detailed design’s constructability and operability. The CGT team is also assisting in developing a construction execution plan.

SD has extensive experience ranging from feasibility studies and concepts to detailed design, system integration, and construction. They have executed projects across many industries, including mining, oil & gas, and forestry, among others.

CGT is a northern Arctic constructor with proven experience in the mining industry with a successful track record of involvement in projects that includes Pretivm’s Brucejack gold mine, Dominion Diamond’s Ekati and Diavik Diamond mines and Yukon Zinc’s Wolverine mine.

Both detailed engineering and the constructability and operations review have begun and are expected to be completed during Q1, 2021.

“We are pleased to be working with Sacre Davey and CGT on these initiatives,” said Bruce McLeod, President & CEO. “Both firms have significant experience which we believe aligns with Sabina’s approach to this Project. We also believe that given the global supply chain volatility due to the COVID-19 pandemic, this revised delivery approach bodes well for delivering more certainty around project costs and deliverables. We look forward to reporting further on our pre-development activities as they progress.”

OTHER KEY INITIATIVES

Sabina had selected FLSmidth (“FLS”) as the equipment manufacturer and FLS is actively working on their line-up of equipment and a definitive pricing model with a performance guarantee for the plant. FLS will also be engaged in commissioning support and critical spares management. This continued engagement with FLS will provide Sabina with more certainty for the phases of the Project throughout detailed engineering, commissioning, optimization, and training.

Sabina is also reaching out to power plant technology providers to support the design and development of construction drawings for a ~15MW power plant. Sabina expects this contract will be awarded before the end of the year.  

Sabina has engaged DT Engineering to design the Port Facility fuel farm and fuel distribution process. The objective is to receive, store and dispense 40 Million liters at the Port Facility area and at the Goose site.

Sabina consultants are also working on the design of various water diversion structures designed to mitigate seasonal flow, site wide road networks, waste dump designs and site wide water balance calculations.

In 2019 Sabina obtained a third-party logistics review for Project construction.  As part of the process, Sabina engaged various vessel operators to do a logistics review while finalizing plans for the material consolidation points for the Project, the Port Facility receiving schedule and offloading requirements. The inaugural winter ice road in 2018/19 provided the experience required to develop a robust logistics and procurement execution plan to support the Project’s material requirements.  The opportunity enabled Sabina to conduct winter ice road time studies and road management plans.  All these initiatives have been carried forward and will be incorporated into the updated Project execution plan. 

Sabina Gold & Silver Corp.

Sabina Gold & Silver Corp. is well-financed and is an emerging precious metals company with district scale, advanced, high grade gold assets in one of the world’s newest, politically stable mining jurisdictions: Nunavut, Canada.

Sabina released a Feasibility Study on its 100% owned Back River Gold Project which presents a project that has been designed on a fit-for purpose basis, with the potential to produce ~200,000 ounces a year for ~11 years with a rapid payback of 2.9 years (see “Technical Report for the Initial Project Feasibility Study on the Back River Gold Property, Nunavut, Canada” dated October 28, 2015).

The Project received its final Project Certificate on December 19, 2017. The Project received its Type A Water License on November 14, 2018 and its listing to enable deposition of tailings on Schedule 2 of the Metals and Diamond Mining Effluent Regulations on June 25, 2020. The Company is now in receipt of all major authorizations for construction and operations.

In addition to Back River, Sabina also owns a significant silver royalty on Glencore’s Hackett River Project. The silver royalty on Hackett River’s silver production is comprised of 22.5% of the first 190 million ounces produced and 12.5% of all silver produced thereafter.

For further information please contact:

Nicole Hoeller, Vice-President, Communications: 1 888 648-4218
[email protected]

Forward Looking Information

This news release contains “forward-looking information” within the meaning of applicable securities laws (the “forward-looking statements”), including our belief as to the extent, results and timing of and various studies relating to engineering studies, infrastructure improvement activities, exploration results and permitting and licensing outcomes. These forward-looking statements are made as of the date of this news release. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the future circumstances, outcomes or results anticipated in or implied by such forward-looking statements will occur or that plans, intentions or expectations upon which the forward-looking statements are based will occur. While we have based these forward-looking statements on our expectations about future events as at the date that such statements were prepared, the statements are not a guarantee that such future events will occur and are subject to risks, uncertainties, assumptions and other factors which could cause events or outcomes to differ materially from those expressed or implied by such forward-looking statements. Such factors and assumptions include, among others, the effects of general economic conditions, commodity prices, changing foreign exchange rates and actions by government and regulatory authorities and misjudgments in the course of preparing forward-looking statements. In addition, there are known and unknown risk factors which could cause our actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements. Known risk factors include risks associated with exploration and project development; the need for additional financing; the calculation of mineral resources and reserves; operational risks associated with mining and mineral processing; fluctuations in metal prices; title matters; government regulation; obtaining and renewing necessary licenses and permits; environmental liability and insurance; reliance on key personnel; the potential for conflicts of interest among certain of our officers or directors; the absence of dividends; currency fluctuations; labour disputes; competition; dilution; the volatility of the our common share price and volume; future sales of shares by existing shareholders; and other risks and uncertainties, including those relating to the Back River Project and general risks associated with the mineral exploration and development industry described in our Annual Information Form, financial statements and MD&A for the fiscal period ended December 31, 2019 filed with the Canadian Securities Administrators and available at www.sedar.com. Although we have attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. We are under no obligation to update or alter any forward-looking statements except as required under applicable securities laws. This news release has been authorized by the undersigned on behalf of Sabina Gold & Silver Corp.

Bruce McLeod, President & CEO
Suite 1800 – Two Bentall Centre
555 Burrard Street
Vancouver, BC V7X 1M7
Tel 604 998-4175 Fax 604 998-1051
http://www.sabinagoldsilver.com