Market Newsdesk

• Approval granted
  by h
  ealth authority for t
  he intravenous (IV) formulation of ibrexafungerp
  to
  enter Phase
  1
  ; dosing
  in healthy volunteers
  to
  start
  in the first quarter of 2021

• New interim analysis of the data from the Phase 3 studies of
  ibrexafungerp in
  refractory invasive fungal infections (FURI and CARES) expected in the first quarter of 2021;
  additional 43 patients
  will double the existing dataset of
  41
  cases
  already
  analyzed

• Analysis of the
  CARES
  study will provide the first
  clinical trial data
  of an investigational treatment against
  infections caused by Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC

JERSEY CITY, N.J., Dec. 10, 2020 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced significant progress on the ibrexafungerp IV formulation and provided an update on its ongoing Phase 3 studies in the hospital setting.

(1)  L
iposomal
IV formulation of ibrexafungerp entering Phase 1 study

SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. SCYNEXIS has been granted approvals from the health authority and ethics committee, with dosing anticipated to start in the first quarter of 2021.

(2)  New interim analysis of
Phase 3
FURI and CARES
open-label
studies expected in the first quarter of 2021
,
doubl
ing
the existing dataset
of patient cases

SCYNEXIS has collected data for another 43 patients who have completed treatment in the FURI and CARES open-label studies, and a Data Review Committee (DRC) of independent experts is assessing the efficacy of oral ibrexafungerp in this combined third interim analysis. The FURI study is evaluating oral ibrexafungerp as a salvage treatment in patients with a variety of difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to, intolerant of current standards of care, or require a non-azole oral step-down therapy for treatment of azole-resistant species. The CARES study is focused on hospitalized patients with invasive candidiasis caused by the multidrug-resistant Candida auris organism, which is associated with high mortality. Similar to interim analyses of data previously reported, SCYNEXIS plans to report results on this new group of patients in the first quarter of 2021, bringing the total data set to 84 patients from FURI and CARES. Each study is designed to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

“As we prepare for our first commercial launch of oral ibrexafungerp in the community setting in 2021, we are also excited about advancing ibrexafungerp for patients with serious and life-threatening infections in the hospital setting,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “The analysis of our CARES study will provide the first clinical trial data of an investigational treatment against Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC. When approved, ibrexafungerp would represent the first new antifungal class in over 20 years and, with the advancement of our IV formulation, ibrexafungerp could become the first new class offering the flexibility of both IV and oral formulations in over 40 years.”

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. Our lead candidate, ibrexafungerp (formerly known as SCY-078), is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, in late stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients. The SCYNEXIS team has deep expertise in anti-infective drug development and marketing, which can be leveraged to advance ibrexafungerp from clinical development to commercialization. For more information, visit www.scynexis.com.

Forward Looking Statement

Statements contained in this press release regarding expected future events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding SCYNEXIS’s expected timing of dosing of volunteers and patients and reporting of interim analyses. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS’s ability to successfully obtain regulatory approval to commence dosing of ibrexafungerp; SCYNEXIS’s need for additional capital resources; and SCYNEXIS’s reliance on third parties to conduct SCYNEXIS’s clinical studies. These and other risks are described more fully in SCYNEXIS’s filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Form 10-Q under the caption “Risk Factors” and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT

: 

Investor Relations

Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
[email protected]

Media Relations

Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
[email protected]

BOSTON, Dec. 10, 2020 (GLOBE NEWSWIRE) — X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel therapies targeting diseases resulting from dysfunction of the CXCR4 pathway, today announced that it has received Rare Pediatric Disease (RPD) Designation from the U.S. Food and Drug Administration (FDA) for its lead asset, mavorixafor, for the treatment of WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor is currently being investigated in a global pivotal Phase 3 clinical trial, 4WHIM, for the treatment of WHIM syndrome in patients who are 12 years of age and older.

“WHIM is a congenital disease that affects individuals of all ages. Children, in particular, have been shown to experience serious or life-threatening bacterial infections that can require hospitalizations. There are currently no treatments available that address the underlying genetic cause of WHIM,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. “The RPD designation reinforces the clear unmet need for a disease modifying therapy in both pediatric and adult patient populations.”

RPD designations are granted by the FDA for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals between birth and 18 years of age. Under the RPD program, a sponsor who receives an approval for a drug for a “rare pediatric disease” and a Fast Track designation may qualify for a voucher that can be redeemed to receive a priority review by the FDA for any subsequent marketing application for a different product. Such a voucher is transferrable and may be sold.

Mavorixafor had previously been granted Fast Track Designation and Breakthrough Therapy Designation by the FDA, as well as Orphan Drug status by the FDA and the European Commission (EC), for the treatment of WHIM syndrome in adults.

About Mavorixafor in WHIM Syndrome

WHIM syndrome is a rare, inherited, primary immunodeficiency disease caused by gain-of-function mutations in the chemokine receptor CXCR4, resulting in a reduced mobilization and trafficking of white blood cells from the bone marrow. The company estimates there to be more than 3,500 diagnosed and undiagnosed WHIM patients in the U.S. As a first-in-class, small-molecule antagonist of chemokine receptor CXCR4, mavorixafor is designed to address the underlying cause of WHIM directly. The candidate is currently being developed as a once-daily oral therapy in the Phase 3 4WHIM trial, a 52-week, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety and efficacy of mavorixafor in genetically confirmed WHIM patients. The trial is anticipated to enroll up to 28 subjects in approximately 20 countries, followed by an open-label extension trial. Phase 3 results are expected in 2022.

About X4 Pharmaceuticals

X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company and a leader in the discovery and development of novel therapies for the treatment of diseases resulting from dysfunction of the CXCR4 pathway, with a focus on rare diseases and those with limited treatment options. The company’s lead candidate, mavorixafor, is a first-in-class, small molecule antagonist of chemokine receptor CXCR4 being developed as a once-daily oral therapy. X4 believes that inhibition of the CXCR4 receptor creates the potential for mavorixafor to provide therapeutic benefit across a wide variety of diseases, including primary immunodeficiencies and certain types of cancer. The efficacy and safety of mavorixafor, dosed once daily, is currently being evaluated in a global Phase 3 clinical trial in patients with WHIM syndrome, and in two Phase 1b clinical trials – in combination with ibrutinib in patients with Waldenstrom macroglobulinemia, and as monotherapy in patients with severe congenital neutropenia (SCN). X4 is continuing to leverage its insights into CXCR4 biology at its corporate headquarters in Boston, Massachusetts and at its research facility in Vienna, Austria, and is developing additional product candidates. For more information, please visit www.x4pharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” or other similar terms or expressions that concern X4’s expectations, strategy, plans or intentions. Forward-looking statements include, without limitation, statements regarding the clinical development of mavorixafor and X4’s other product candidates or programs, and the potential benefits resulting from a Rare Pediatric Disease designation. Any forward-looking statements in this press release are based on management’s current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, the risks and uncertainties described in the section entitled “Risk Factors” in X4’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

Investors and Media:

Daniel Ferry
Managing Director
LifeSci Advisors
[email protected]
+1 (617) 430-7576

Mónica Rouco Molina
Senior Account Executive
LifeSci Communications
[email protected]
+1 (929) 469-3850

• Merger accelerates transformation to profitability, with estimated annual
  ized
  cost synergies of
  $15M
  beginning
  FY
  2022 

• A
  ytu a
  dds
  Neos’ established, multi-brand ADHD portfolio, enhancing Aytu’s footprint in pediatrics and expanding its presence in adjacent specialty care segments

• Opportunity to leverage and further enhance Neos RxConnect, a best-in-class patient support program, for Aytu’s product portfolio
  of
  best-in-class prescription therapeutics and consumer health products

• Companies to host joint conference call today at
  8
  :30
  a
  m ET
  

ENGLEWOOD, Colo. and GRAND PRAIRIE, Texas, Dec. 10, 2020 (GLOBE NEWSWIRE) — Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, and Neos Therapeutics, Inc. (NASDAQ: NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that they have entered into a definitive merger agreement pursuant to which Neos will merge with a wholly owned subsidiary of Aytu in an all-stock transaction.

Transaction Details

Upon the effectiveness of the merger (the “Merger”), Neos stockholders will be entitled to receive 0.1088 shares of common stock of Aytu for each share of Neos common stock held, after taking into account the one-for-ten reverse split of Aytu’s common stock that was effected on December 8, 2020. The transaction will result in Neos stockholders owning approximately 30% of the fully diluted common shares of Aytu. The all-stock transaction is valued, on a fully diluted basis, at approximately $44.9 million based on the 10-day volume weighted average price of Aytu stock for the period ended December 9, 2020.

The boards of directors of both companies have approved the transaction.

Strategic Rationale and
Financial
Benefits of the Transaction

The combined entity will have an increased footprint in the prescription pediatric market, an established, growing multi-brand ADHD portfolio addressing the $8.5 billion ADHD market and significant combined revenue scale. For the 12-month period ending September 30, 2020, Neos generated $57.0 million in revenues. On a combined pro-forma basis for this same period, Aytu and Neos’ aggregate net revenue is over $100 million. In addition, this Merger facilitates operational and commercial synergies that can be harnessed to accelerate the path to profitability for the combined entity, with estimated annualized cost synergies of approximately $15.0 million beginning fiscal year 2022.

“This is a truly transformative transaction, elevating the newly combined company to a $100 million revenue, leading specialty pharmaceutical company positioned for what we expect to be an accelerated path to profitability, continued revenue growth and further business diversification,” said Josh Disbrow, Chief Executive Officer of Aytu BioScience. “The combination of Neos with the Aytu business further increases our footprint in an attractive pediatric medicine market, following our acquisition of the Cerecor pediatric Rx assets late last year. This transaction is an excellent strategic fit with our market expansion plans and we believe creates strong stockholder value.”

Mr. Disbrow continued, “This transaction increases Aytu’s addressable market, adding the large and growing ADHD market, with 75.1 million scripts written annually. Importantly, and despite the impact of COVID-19 on this market, Neos’ ADHD product growth significantly outpaced the overall ADHD market in the third quarter of 2020, with Adzenys XR-ODT prescriptions growing by 9.9 percent and Cotempla XR-ODT prescriptions growing by 6.5 percent. Expanding into ADHD with Neos is the ideal embodiment of Aytu’s strategy to build a portfolio of best-in-class prescription therapeutics and consumer health products competing in large markets.”

Neos’ Chief Executive Officer, Jerry McLaughlin, stated, “I firmly believe Aytu BioScience is the right partner to continue the exceptional work our team has done to build the ADHD franchise into what it is today and to continue the development of NT0502 for the treatment of sialorrhea. By leveraging the respective commercial infrastructure of Neos and Aytu, including complementary sales call points and our best-in-class patient support program, Neos RxConnect, we expect continued growth of the product portfolio. After a thorough evaluation of strategic alternatives, the Board of Directors of Neos believes that this merger represents the highest-potential value creation opportunity for Neos stockholders.”

Additional Information

The combined company will be led by Josh Disbrow, Chief Executive Officer of Aytu and will be headquartered in Englewood, Colorado. The board of the combined company will consist of six members designated by Aytu and two members designated by Neos, including Neos Chief Executive Officer and Director Jerry McLaughlin and Neos Director Beth Hecht.

The Merger is currently expected to close by the second quarter of 2021, subject to certain approvals by both Aytu and Neos stockholders and the satisfaction of other customary closing conditions.

As part of the transaction, Aytu has agreed to provide Neos with access to up to $5.0 million cash for working capital needs for the period prior to the closing of the Merger. In addition, upon closing of the Merger, $15.0 million in principal of Neos’s existing senior secured debt facility with affiliates of Deerfield Management will be repaid, and Deerfield has agreed to allow the remaining debt under the facility to remain outstanding with the combined company following the Merger. Indebtedness under Neos’s existing ABL agreement with Encina Business Credit will also remain outstanding.

Cowen is acting as the exclusive financial advisor to Aytu, and Dorsey & Whitney LLP is acting as its legal counsel. MTS Health Partners LP is acting as the exclusive financial advisor to Neos, and Goodwin Procter LLP is acting as its legal counsel.

Conference Call Information

Aytu and Neos will jointly host a live conference call at 8:30 am ET today.

The conference call can be accessed by dialing:
877-407-9124 (toll-free)
201-689-8584 (international)

The webcast will be accessible live and archived at the following link: https://www.webcaster4.com/Webcast/Page/2142/39104 and on Aytu BioScience’s website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 39104.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. Aytu currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”), (ii) ZolpiMist®, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) Cefaclor, a second-generation cephalosporin antibiotic suspension; (ii) Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iii) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test and rapid antigen test. These tests are used separately in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu recently licensed worldwide rights to develop the Healight™ technology platform. Healight is an investigational medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.

Aytu operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. (“Innovus”), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men’s and women’s health and vitality. Innovus commercializes numerous novel consumer health products competing in large healthcare categories including diabetes, men’s health, sexual wellness, respiratory health, and general wellness. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company’s proprietary Beyond Human® marketing and sales platform.

Aytu’s strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about Aytu’s consumer healthcare products.

About Neos Therapeutics

Neos Therapeutics, Inc. is a commercial-stage pharmaceutical company developing and manufacturing central nervous system (CNS)-focused products. Neos markets Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING), all for the treatment of ADHD. Neos also has a development candidate, NT0502, for the treatment of sialorrhea in patients with neurological conditions. Additional information about Neos is available at www.neostx.com.

Additional Information about the Proposed Merger Transaction and Where to Find It

This press release relates to the proposed merger transaction pursuant to the terms of the Agreement and Plan of Merger, dated as of December 10, 2020, by and among Neos Therapeutics, Inc. (“Neos”), Aytu Bioscience Inc. (“Aytu”), and Neutron Merger Sub, Inc. In connection with the proposed merger transaction, Aytu expects to file with the United States Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 that will include a joint proxy statement of Aytu and Neos that also constitutes a prospectus of Aytu, which joint proxy statement/prospectus will be mailed or otherwise disseminated to Aytu stockholders and Neos stockholders when it becomes available. Aytu and Neos also plan to file other relevant documents with the SEC regarding the proposed merger transaction.

INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER TRANSACTION.

You may obtain a free copy of the joint proxy statement/prospectus and other relevant documents (if and when they become available) filed by Aytu or Neos with the SEC at the SEC’s website at www.sec.gov. Copies of the documents filed by Aytu with the SEC will be available free of charge on Aytu’s website at www.aytubio.com or by contacting Aytu’s Investor Relations at [email protected]. Copies of the documents filed by Neos with the SEC will be available free of charge on Neos’ website at www. investors.neostx.com or by contacting Neos’ Investor Relations at (972) 408-1300.

Certain Information Regarding Participants

Aytu and Neos and their respective directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed merger transaction. You can find information about Aytu’s executive officers and directors in Aytu’s definitive proxy statement filed with the SEC on March 4, 2020 in connection with Aytu’s 2020 annual meeting of stockholders. You can find information about Neos’ executive officers and directors in Neos’ definitive proxy statement filed with the SEC on April 21, 2020 in connection with Neos’ 2020 annual meeting of stockholders. Additional information regarding the interests of such potential participants will be included in the joint proxy statement/prospectus and other relevant documents filed with the SEC if and when they become available. You may obtain free copies of these documents from Aytu or Neos using the sources indicated above.

No Offer or Solicitation

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor a solicitation of any vote or approval with respect to the proposed merger transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”) and otherwise in accordance with applicable law.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ”may,” ”will,” ”should,” ”forecast,” ”could,” ”expect,” ”suggest,” ”believe,” ”estimate,” ”continue,” ”anticipate,” ”intend,” ”plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the expected timetable for completing the proposed transaction, the results, effects, benefits and synergies of the proposed transaction, future opportunities for the combined company, future financial performance and condition, guidance and any other statements regarding Aytu’s or Neos’ future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: failure to obtain the required votes of Neos’ shareholders or Aytu’s shareholders to approve the transaction and related matters, the risk that a condition to closing of the proposed transaction may not be satisfied, that either party may terminate the merger agreement or that the closing of the proposed transaction might be delayed or not occur at all, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the transaction, the diversion of management time on transaction-related issues, the ultimate timing, outcome and results of integrating the operations of Aytu and Neos, the effects of the business combination of Aytu and Neos, including the combined company’s future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, regulatory approval of the transaction, risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of the combined company’s product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of the combined company’s ongoing and future clinical trials, the anticipated designs of the combined company’s future clinical trials, anticipated future regulatory submissions and events, the combined company’s anticipated future cash position and future events under current and potential future collaboration. We also refer you to (i) the risks described in ”Risk Factors” in Part I, Item 1A of Aytu’s Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission and (ii) the Risk Factors set forth in Neos’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and in the other filings Neos makes with the SEC from time to time.

Contact for Investors:

James Carbonara
Hayden IR
(646) 755-7412
[email protected]

---

¹ Based on unaudited combined pro-forma net revenues for the two companies for the twelve-month period ending September 30, 2020

• IRB Approval Includes Both the Ergonomix2 Diamond Implant and Mia Tools

SANTA BARBARA, Calif., Dec. 10, 2020 (GLOBE NEWSWIRE) — Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced it recently received Institutional Review Board (IRB) approval to initiate a patient series in Costa Rica to study its Motiva Mia^® system for minimally invasive augmentation, which includes the Motiva Ergonomix2 Diamond^® breast implant, and has completed the procedure in the first 21 patients in the study.

“Motiva Mia is truly disruptive to traditional breast aesthetics,” said Dr. Charles Randquist, an internationally recognized plastic surgeon. “Minimally invasive breast enhancement should define a more balanced approach in aesthetics: an augmentation that is considerably more subtle in its sizing and approach and is performed without general anesthesia through a very small incision with a quick recovery and less pain.”

“The aesthetic results we achieved for these patients exceed today’s standards in plastic surgery,” said Dr. Alexandre Munhoz, professor of plastic surgery at the University of São Paulo School of Medicine. “These are highly natural, sophisticated outcomes that represent the future of our profession. Just as important as the innovations in the Motiva Ergonomix2 Diamond implant are the tools that make a minimally invasive procedure possible. The innovations and interactions of the implants and tools in Motiva Mia allow for new standards that will change both perceptions and the demand for breast aesthetics.”

“Based on our experience, Motiva Mia enables minimally invasive breast enhancement procedures that address many of the concerns that women have had about traditional breast augmentation surgery,” said Establishment Labs’ founder and chief executive officer, Juan José Chacón-Quirós. “Our third-party commissioned market research suggests that the number of women globally who would consider a minimally invasive procedure could be as many as 1.9 million annually. With Motiva Mia, our intention is to make breast aesthetics far more accessible than it has ever been.

“It is important to note that we received IRB approval for the Motiva Mia system, which includes both the Ergonomix2 Diamond implant as well as all our proprietary tools that make the minimally invasive procedure possible,” Chacón-Quirós continued. “The successful completion of our patient series is an integral part of bringing Motiva Mia to market on an accelerated timeline.”

The Motiva Mia system is designed to offer a minimally invasive breast enhancement procedure in less time and with faster recovery than a traditional breast surgery procedure. The first procedures as part of the Company’s initial cases were performed in Asia beginning in late 2019. In the Costa Rica patient series, Dr. Manuel Chacón and Dr. Pablo Solís serve as lead plastic surgeons. In addition to this patient series in Costa Rica, the Company also has IRB approval to conduct a separate patient series in Thailand, which it expects to commence in the first quarter of 2021.

The Motiva Mia

^®

system is currently not approved for commercial distribution. Motiva Implants

^®

are undergoing clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.

About Establishment Labs


Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in more than 80 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina® 3D Simulation System and other products and services. Please visit our website for additional information at www.establishmentlabs.com.

Forward-Looking Statements


This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “would,” “may” or other similar expressions in this press release, and includes statements related our ability to commercialize the Motiva Mia^® system for minimally invasive augmentation including the Motiva Ergonomix2 Diamond^® breast implant. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the Company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results may differ from our expectations, and those differences may be material. Factors that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the Company’s annual report on Form 10-K filed on March 16, 2020, quarterly reports on Form 10-Q, and other filings made by the Company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

Investor/Media Contact: 
David K. Erickson
949-447-6671
[email protected]

LAS VEGAS, Dec. 10, 2020 (GLOBE NEWSWIRE) — Asia Broadband Inc. (OTC : AABB), through its wholly owned subsidiary Asia Metals Inc., announced today that the Company has received a purchase proposal for the mineral property and mining operations facilities in the Guerrero Gold Belt, Mexico, from Joint Venture Partner (JVP), Qiangda Investments & Economics Co. Ltd. (QIEC). AABB held a special meeting in Mexico City on December 9, 2020, to discuss the details of the purchase proposal regarding GGB assets. AABB recently conducted a pre-feasibility study assessment of the GGB property and facilities, which was utilized as a basis for the discussions in the special meeting. A follow-up meeting with the JVP is scheduled for Monday, December 14, 2020, to discuss AABB’s decision with respect to the proposal and the Company’s strategic plans going forward.

QIEC is a holding company and facilitating subsidiary of an Asian conglomerate. Its operational objective is to secure physical gold supplies for it affiliates’ manufacturing demand and to build an investment hedge that mitigates the risk of instabilities caused by fluctuations in markets and world economic conditions. In 2018, QIEC signed an agreement committing $34 million allocated over a 3-year period to earn-in a maximum 40% equity interest in the Company. The investment funds were dedicated to the expansion of the Company’s gold production and property exploration operations in Guerrero, Mexico. To date per the agreement, QIEC has disbursed $24 million and earned a 28% interest in the Company. AABB jointly operates a management committee with representatives of QIEC to oversee, approve and direct budgeting, capital expenditures and decision-making regarding operational processes and expenditures.

Asia Broadband Inc. (OTC : AABB), through its wholly owned subsidiary Asia Metals Inc., is a resource company focused on the production, supply and sale of precious and base metals, primarily to Asian markets. The Company utilizes its specific geographic expertise, experience and extensive industry contacts to facilitate its innovative distribution process from the production and supply of precious and base metals in Guerrero, Mexico, to our client sales networks in Asia. This vertical integration approach to sales transactions is the unique strength of Asia Broadband and differentiates the Company to its shareholders.

Contact the Company at:

Email:          Website:  Phone:	[email protected] www.asiametalsinc.com 702-866-9054
Parkin Investor Relations Kevin Parkin

Forward-Looking Statements are contained in this press release within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the Asia Broadband Inc.’s (the “Company”) expected current beliefs about the Company’s business, which are subject to uncertainty and change. The operations and results of the Company could materially differ from what is expressed or implied by the statements made above when industry, regulatory, market and competitive circumstances change. Further information about these risks can be found in the annual and quarterly disclosures the Company has published on the OTC Markets website. The Company is under no obligation to update or alter its forward-looking statements as future circumstances, events and information may change.

Multi-system order for ESI^® Geode^™ HDI via drilling system to support leading technology in HDI PCB manufacturing

PORTLAND, Ore., Dec. 10, 2020 (GLOBE NEWSWIRE) — MKS Instruments, Inc. (NASDAQ: MKSI), a global provider of technologies that enable advanced processes and improve productivity, today announced it has received an order for multiple ESI^® Geode™ HDI via drilling systems in Taiwan from a major technology leader in the HDI PCB manufacturing market.

“The market is embracing the economic advantages that the latest MKS developments have to offer,” said John Williams, Vice President and General Manager of MKS’ Equipment and Solutions division. “Our Geode HDI via drilling system meets the needs of high-volume HDI PCB manufacturing, while helping customers secure a technological advantage for current and future product requirements.”

This multi-unit order will support the customer’s existing manufacturing and future technological development through the use of leading-edge via drilling technology. Since its release to the market, the Geode HDI via drilling system has introduced HDI manufacturers to the performance advantages that ESI technology has provided to Flex PCB manufacturers for decades. The Geode platform has seen strong traction amongst the industry’s top players since its recent introduction to the market.

Developed by MKS’ Equipment & Solutions Division, already a market leader in flex PCB laser drilling solutions, the Geode system is optimized to process the rigid HDI PCBs and package substrates widely used in consumer electronics, such as smartphones and other handheld devices. Building on MKS’ technology leadership in laser processing for flexible printed circuits, Geode’s new laser technology and control capabilities deliver breakthrough performance. Its superior throughput, refined power control and small system footprint meet the needs of high-volume PCB manufacturers and technology leaders.

About MKS Instruments
MKS Instruments, Inc. is a global provider of instruments, systems, subsystems and process control solutions that measure, monitor, deliver, analyze, power and control critical parameters of advanced manufacturing processes to improve process performance and productivity for our customers. Our products are derived from our core competencies in pressure measurement and control, flow measurement and control, gas and vapor delivery, gas composition analysis, electronic control technology, reactive gas generation and delivery, power generation and delivery, vacuum technology, lasers, photonics, optics, precision motion control, vibration control and laser-based manufacturing systems solutions. We also provide services relating to the maintenance and repair of our products, installation services and training. Our primary served markets include semiconductor, industrial technologies, life and health sciences, research and defense. Additional information can be found at www.mksinst.com.

About
the
ESI
Brand
ESI^® is a brand within the MKS Instruments Equipment & Solutions Division. The ESI portfolio consists of laser-based micro manufacturing systems and component test systems that are used worldwide by manufacturers in the electronics industry to process the materials and components that are an integral part of the electronic devices and systems in use today. Leveraging over 40 years of laser-material interaction expertise and applied laser technology, ESI solutions enable customers to optimize production by providing more control, greater application flexibility and more precise processing of a wide range of materials. The result is higher production quality, increased throughput and higher back-end yields at a lower total cost-of-ownership. Additional information can be found at www.esi.com.

Electro Scientific Industries and ESI are registered trademarks of MKS Instruments, Inc. All other trade names referenced are the service marks, trademarks or registered trademarks of their respective companies.

MKS
Contact:

Dale Paulin
Marketing Operations Manager
Phone: 503-671-5510
Email: [email protected]

CAMBRIDGE, Mass., Dec. 10, 2020 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections, today announced that it has initiated dosing in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD) in its dose-ranging Phase 2a clinical trial of SPR720, Spero’s oral antimicrobial agent in development for the treatment of NTM-PD.

“The initiation of this trial is a significant milestone for the program, and we look forward to the trial producing important data that will further inform our development pathway for SPR720 in NTM-PD,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “The lack of approved, oral options for the treatment of NTM-PD presents a significant unmet need for patients and we believe SPR720 has the potential to offer a new treatment option.”

The Phase 2a clinical trial is a multi-center, partially blinded, placebo-controlled proof-of-concept clinical trial of SPR720 that will enroll approximately 90 treatment-inexperienced patients with NTM-PD due to Mycobacterium avium complex (MAC).  Patients will be randomized to receive either 500 mg or 1,000 mg of oral SPR720 once daily, placebo, or standard- of-care (SOC), consisting of a macrolide and ethambutol, plus the option of adding a rifamycin.  The objectives of the trial are to evaluate the plasma pharmacokinetics, safety, tolerability, and microbiological response of SPR720 compared with placebo and SOC over 28 days of treatment, with the inclusion of the SOC arm to assess and ensure assay sensitivity for the trial design.

“A significant unmet medical need exists for safe and effective treatments for patients with NTM pulmonary disease. We have very few antibiotics to combat these highly drug resistant organisms, and we essentially lack any approved therapies for first-line therapy against pulmonary NTM,” said Dr. Kevin Winthrop, the trial’s Principal Investigator and Professor of Infectious Disease and Public Health at Oregon Health and Science University. “Oral SPR720 shows potential to benefit patients with NTM pulmonary disease and we are excited to have initiated this novel Phase 2a trial to assess SPR720 in patients with early onset pulmonary disease.”

The Phase 2a clinical trial is supported by data from its first-in-human Phase 1 clinical trial of SPR720 in healthy volunteers and pharmacokinetic/pharmacodynamic (PK/PD) data that was presented at Infectious Disease Society of America (IDSA) IDWeek 2020. That data suggested that predicted therapeutic exposures could be attained with a 500 – 1,000 mg once daily oral dose. Spero expects to report top-line data from the Phase 2a clinical trial in the first half of 2022.

About SPR720

SPR720 represents a novel class of antibacterial agents that target enzymes essential for bacterial DNA replication. SPR720 was acquired from Vertex Pharmaceuticals and is currently under development by Spero as an oral therapy for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare chronic orphan disease.  NTM are ubiquitous environmental pathogens that can cause progressive lung damage and respiratory failure, particularly in patients with compromised immune systems or underlying pulmonary disorders. Although rare, the incidence of NTM pulmonary disease is increasing worldwide. Treatment of NTM pulmonary disease requires prolonged therapy (continuing for approximately 12 to 24 months) with a combination of drugs approved for other infections and is frequently complicated by tolerability and/or toxicity issues. There are currently no oral antibiotics specifically approved for use to treat NTM pulmonary disease. Thus, if successfully developed, SPR720 has the potential to address an important unmet need as the first oral antibiotic approved for the treatment of this debilitating disease.  Under Spero’s collaboration with the Bill and Melinda Gates Medical Research Institute, SPR720 will also be developed for the treatment of Mycobacterium tuberculosis (Mtb) infections in select economically disadvantaged countries. Tuberculosis is a priority pathogen as defined by the World Health Organization with it being one of the top ten causes of death worldwide, and a situation where resistance is increasing, and current treatment approaches are not optimal.

Spero believes that its intellectual property portfolio for SPR720 will provide protection globally, including in the United States and Europe, through 2033. SPR720 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of nontuberculous mycobacterial (NTM) infection. It has also been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for the treatment of lung infections caused by non-tuberculous mycobacteria and lung infections caused by Mycobacterium tuberculosis (Mtb), which offers an additional five-year extension of Hatch-Waxman Act exclusivity. The FDA accepted Spero’s investigational new drug application (IND) for SPR720 in August 2020 and SPR720 was awarded Fast Track designation for the treatment of adult patients with NTM pulmonary disease by the FDA in September 2020.

SPR720 Research Support

Research reported in this publication was partially supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, under Award Number R44AI131749. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Spero Therapeutics
Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug-resistant (MDR) bacterial infections and rare diseases.

Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP.

Spero is also advancing SPR720, its novel oral therapy product candidate being developed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.

Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR Gram-negative infections in the hospital setting.

For more information, visit https://sperotherapeutics.com.

Forward-Looking Statements

This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the initiation, timing and submission to the FDA of a NDA for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; expected broad access across payer channels for tebipenem HBr; the expected pricing of tebipenem HBr and the anticipated shift from IV to oral administration; the design, initiation, timing, progress and results of Spero’s preclinical studies and clinical trials and its research and development programs, including the commencement of Spero’s planned Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment and its renal impairment study of SPR206; management’s assessment of the results of such preclinical studies and clinical trials; the direct and indirect impact of the pandemic caused by an outbreak of a new strain of coronavirus on Spero’s business and operations, including manufacturing, research and development costs, clinical trials, regulatory processes and employee expenses; and Spero’s cash forecast and anticipated expenses, anticipated payments under Spero’s agreement with Everest Medicines, potential payments under Spero’s agreement with BARDA, the sufficiency of its cash resources and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Spero’s ability to timely complete related Phase 1 trials for its planned NDA submission for tebipenem HBr, taking into account the possible effects of the COVID-19 pandemic; Spero’s need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero’s reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to develop and commercialize Spero’s product candidates, if approved; the potential impact of the COVID-19 pandemic; Spero’s ability to retain key personnel and to manage its growth; whether Spero will satisfy all of the pre-conditions to receipt of the development milestone payment under its agreement with Everest Medicines; whether BARDA elects to exercise its second option under Spero’s agreement with BARDA; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero’s views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero’s views as of any date subsequent to the date of this press release.

Spero Investor and Media Contact:
Sharon Klahre
Vice President, Investor Relations
857-242-1547
[email protected]

DENVER, Dec. 10, 2020 (GLOBE NEWSWIRE) — The Identity Defined Security Alliance (IDSA), an industry alliance that helps organizations leverage existing cybersecurity investments to establish a stronger security posture, today announced the appointment of its 2021/2022 Executive Advisory Board (EAB), as well as the expansion of its Customer Advisory Board (CAB). The EAB is composed of eight elected industry leaders, now including Atos and BeyondTrust, who provide oversight and organizational direction for executing the mission, goals, policies, and programs of the IDSA.

IDSA Executive Advisory Board members:

• Atos – Allen Moffett, Global IAM Program Lead and CTO
• BeyondTrust – Morey Haber, CTO and CISO
• CyberArk – Adam Bosnian, EVP Global Business Development
• Okta – Stephen Lee, VP Technical Strategy and Partnerships
• Optiv – Julie Talbot-Hubbard, SVP Cyber Protection and Identity
• Ping Identity – Aubrey Turner, Executive Advisor
• SailPoint – Lori Robinson, Senior Director of Product and Market Strategy
• VMware – Doris Yang, Senior Director of Product Management

“The pandemic has created a fundamental change in how organizations conduct business — with both a significant shift to remote work, and an increase in online transactions. This has put a spotlight on identity security and the risks associated with inadequate processes and technologies,” said Julie Talbot-Hubbard, senior vice president of cyber protection and identity for Optiv. “CISOs need to consider identity a major pillar of their security strategies. In the coming year, the IDSA and its members will continue to collaborate on forward-thinking, identity-centric security best practices while addressing current issues like Zero Trust and the expanded remote workforce. Specialized IDSA technical working groups will also explore emerging areas including customer identity and access management, artificial intelligence, and DevSecOps.”

The IDSA CAB, which provides a user perspective and guidance on the vision, mission, and work of the IDSA has also expanded. Scott Breece, VP and CISO of Community Health Systems, has joined the group of thought leaders and advocates for identity-centric security approaches.

IDSA Customer Advisory Board members:

• Eric Anderson, Director, Enterprise Security, Adobe
• Scott Breece, VP and CISO, Community Health Systems
• James Carder, CSO and VP of Labs, LogRhythm
• Carlos Garcia, Senior Principal Architect, Office of CIO, Optum
• Den Jones, Senior Director of Enterprise Security, Cisco
• Tom Malta, Head of Identity and Access Management, Navy Federal Credit Union
• Clint Maples, CISO, Robert Half
• Narendra Patlolla, Director, Corporate Technology and Security, Red Ventures

Key 2020 IDSA Research and Guidance

• 
  Identity Defined Security Outcomes and Approaches
  – A newly expanded library designed to help organizations make sense of the complex identity and security landscape by focusing on desired outcomes and how they can be achieved. The Library also maps to the NIST Cybersecurity 1.1 Framework and special publications, including 800-207 Zero Trust Architecture, and 800-63 Digital Identity Guidelines, providing identity-centric implementation guidance to address NIST recommendations.
• 
  How Forward-Thinking Enterprises Are Preventing Breaches
  – A research report which found identity-related breaches to be ubiquitous, with 79% having had an identity-related breach within the past two years.
• 
  Securing the Remote Workforce Through Identity-Centric Security
  – Guidance on addressing a variety of remote work challenges associated with stay-at-home orders tied to the pandemic.

About the Identity Defined Security Alliance

The IDSA is a group of identity and security vendors, solution providers, and practitioners that acts as an independent source of thought leadership, expertise, and practical guidance on identity centric approaches to security for technology professionals. The IDSA is a nonprofit that facilitates community collaboration to help organizations reduce risk by providing education, best practices, and resources.

Follow the IDSA

Join the Community: https://forum.idsalliance.org/
Twitter: www.twitter.com/idsalliance
LinkedIn: www.linkedin.com/company/identity-defined-security-alliance/
Blog: https://www.idsalliance.org/blog/

Contacts
Industry Contact:
Identity Defined Security Alliance
Julie Smith, 303-324-3159
[email protected]

SAN DIEGO, Dec. 10, 2020 (GLOBE NEWSWIRE) —
KULR Technology Group, Inc. (OTCQB: KULR) (the “Company” or “KULR”), a leading developer of next-generation thermal management technologies, today highlights a report conducted by the Naval Surface Warfare Center Carderock Division (NSWCCD) on the Company’s battery safety technology. The report confirms that KULR’s thermal management solutions can prevent cell-to-cell propagation. These findings mirror test results from other government and private test authorities such as NASA, which co-developed KULR’s core thermal technology.

The NSWCCD report, titled, “Emerging Energy Storage Technologies,” studied energy storage applications in consumer electronics, along with the safety concerns they pose. The newly public report, commissioned and released by the Consumer Product Safety Commission, states that:

“Incorporating a vaporizing heat sink from KULR could lead to significant mass savings and … was capable of preventing cell-to-cell propagations. … [battery] packs assembled and tested at NSWCCD with the KULR material (the Thermal Runaway Shield or “TRS”) were found to be highly effective at resisting cell-to-cell propagation when a trigger cell was externally heated to failure. Meanwhile, identical cells with identical configuration but no TRS underwent a complete cell-to-cell propagation under the same test conditions.”

Conditions such as extreme heat, bumping and jostling, short circuit, constant high-demand use, or physical damage can cause a single battery cell in a multi-cell pack to fail. When this happens, the fire and heat of that single failure often trigger failure in neighboring cells. This causes a dangerous chain reaction that causes high energy fires and explosions. According to the NSWCCD report, it is these types of runaway or propagation risks that KULR’s solutions are capable of preventing.

In addition to supporting the effectiveness of the KULR safety product(s) in lithium-ion battery packs, the report highlights storage alternatives to lithium-ion batteries such as solid state or lithium metal configurations.

The report states:

“The overall conclusion from the authors of this report is that LiB [lithium-ion batteries] are likely to maintain if not increase application in consumer electronics. For this reason, the safety of these devices may have to be engineered through secondary technologies…”

“This report is highly significant for two reasons,” said Michael Mo, CEO of KULR. “First, it shows that lithium-ion batteries will not be replaced anytime soon, which makes preventing cell-to-cell propagation fires the holy grail of battery safety. Second, the results again confirm that our design solution efficiently prevents battery packs from blowing up, which has major implications across various multi-billion-dollar market verticals.”

Bob Richard, president of Hazmat Safety Consulting, remarked, “There is a real need to improve lithium battery safety. Multiple government agencies are focused on technologies that can reduce the likelihood of battery fires in transport (e.g. aircraft cargo compartments), for energy storage, vehicle applications, and consumer electronics. The test results on KULR’s thermal management solution are quite remarkable and very encouraging.”

KULR recently announced research and design partnerships with a number of commercial partners, including Drako Motors, the super-EV; a separate Tier-1 automaker; a major power tool manufacturer; a large medical device manufacturer; a shipping container maker; and defense and aerospace agreements.

The KULR suite of thermal management and battery safety solutions have been deployed in space. In July 2020, a KULR thermal solution was part of the Mars Rover mission; another KULR product has been in use aboard the International Space Station since 2019.

About KULR Technology Group, Inc.


KULR Technology Group, Inc. (OTCQB: KULR) develops, manufactures and licenses next-generation carbon fiber thermal management technologies for batteries and electronic systems. Leveraging the company’s roots in developing breakthrough cooling solutions for NASA space missions and backed by a strong intellectual property portfolio, KULR enables leading aerospace, electronics, energy storage, 5G infrastructure, and electric vehicle manufacturers to make their products cooler, lighter and safer for the consumer. For more information, please visit www.kulrtechnology.com.

Safe Harbor Statement


This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. This release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our Form 10-K filed on May 14, 2020. Forward-looking statements include statements regarding our expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. All forecasts are provided by management in this release are based on information available at this time and management expects that internal projections and expectations may change over time. In addition, the forecasts are entirely on management’s best estimate of our future financial performance given our current contracts, current backlog of opportunities and conversations with new and existing customers about our products and services. We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

Media Contact:	Investor Relations:
Derek Newton	KULR Technology Group, Inc.
Head, Media Relations	Main: (888) 367-5559
Main: (786) 499-8998	[email protected]
[email protected]

FALLS CHURCH, Va., Dec. 10, 2020 (GLOBE NEWSWIRE) — PAE (NASDAQ: PAE, PAEWW), a global leader in delivering smart solutions to the U.S. government and its allies, was awarded a single-award indefinite delivery, indefinite quantity contract with a ceiling value of $98 million to provide electronic warfare operations training and infrastructure maintenance support for the U.S. Air Forces in Europe & Air Forces Africa. PAE was also awarded a five-year, €46 million new task order on the contract to operate and maintain USAFE-AFAFRICA’s electronic warfare range systems infrastructure in Germany and provide mobile training operations throughout Europe and Africa.

PAE President and CEO John Heller said the company’s past technical experience was key to winning the awards.

“PAE has built a unique set of skills and knowledge from decades supporting essential Air Force national security initiatives,” Heller said. “We believe that expertise and our dedication to continuous improvement practices gives PAE a competitive advantage with training and technical operations support services work, including this opportunity to support electronic warfare training missions for USAFE-AFAFRICA at locations throughout Europe and Africa.”

The awards further PAE’s strategy of expanding innovation and technology integration services for U.S. government customers, adding to a 65-year history providing world class technical support services for critical national security missions. The contract vehicle has a five-year period of performance with future task orders anticipated for sites in the United Kingdom and Italy.

About PAE

For 65 years, PAE has tackled the world’s toughest challenges to deliver agile and steadfast solutions to the U.S. government and its allies. With a global workforce of about 20,000 on all seven continents and in approximately 60 countries, PAE delivers a broad range of operational support services to meet the critical needs of our clients. Our headquarters is in Falls Church, Virginia. Find us online at pae.com, on Facebook, Twitter and LinkedIn.

Forward-Looking Statements

This press release may contain a number of “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about PAE’s possible or assumed future results of operations, financial results, backlog, estimation of resources for contracts, risks related to IDIQ contracts, strategy for and management of growth, needs for additional capital, risks related to U.S. government contracting generally, including congressional approval of appropriations, and bid protests. These forward-looking statements are based on PAE’s management’s current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events.

These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside PAE’s management’s control, that could cause actual results to differ materially from the results discussed in the forward-looking statements.

Forward-looking statements included in this release speak only as of the date of this release. PAE does not undertake any obligation to update its forward-looking statements to reflect events or circumstances after the date of this release except as may be required by the federal securities laws.

For media inquiries regarding PAE, contact:

Terrence Nowlin
Senior Communications Manager
PAE
703-656-7423
[email protected]

For investor inquiries regarding PAE, contact:

Mark Zindler
Vice President, Investor Relations
PAE
703-717-6017
[email protected]