Neoleukin Therapeutics Announces Participation in Piper Sandler 32nd Annual Virtual Healthcare Conference

SEATTLE, Nov. 23, 2020 (GLOBE NEWSWIRE) — Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced that Jonathan Drachman, M.D., Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference taking place December 1-3, 2020.

The pre-recorded fireside chat will be accessible beginning at 10 a.m. Eastern Time, November 23, 2020 from the investors section of the Neoleukin website at http://investor.neoleukin.com/events. An archived replay will also be available on the company website for at least 30 days following the event.

About Neoleukin Therapeutics, Inc.

Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity using de novo protein design technology. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins.  Neoleukin’s lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to improve tolerability and activity by eliminating the alpha receptor binding interface. For more information, please visit the Neoleukin website: www.neoleukin.com.

Safe Harbor /
Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, planned development activities and timelines, use and adequacy of cash reserves and the potential benefits of the company’s product candidates and platform. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Examples of such forward-looking statements include but are not limited to statements regarding the therapeutic properties and potential of the company’s de novo protein design technology. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the company’s cash forecasts, the company’s ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, the timing and results of preclinical and clinical trials, the timing of announcements and updates relating to the company’s clinical trials and related data market conditions and further impacts of COVID-19, that could cause actual results to differ materially from what Neoleukin expects. Further information on potential risk factors that could affect Neoleukin’s business and its financial results are detailed under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Neoleukin undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts
:

Media

Julie Rathbun
206-769-9219
[email protected]

Investors

Solebury Trout
Brian Korb
646-378-2923
[email protected]



Align Technology Hosts 2020 Virtual Investor Day

Shares Vision to Bring Digital Orthodontics to the Masses Through Invisalign Doctors

  • Huge global market opportunity of 15M annual orthodontic case starts with an incremental 500 million potential through Align’s doctor-driven model and its digital platform
  • Strategic priorities drive Align’s 5-year revenue CAGR of more than 20%
  • iTero scanner installed base of more than 35K enables more than 1M scans per month and drives Invisalign adoption

SAN JOSE, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) — Align Technology, Inc. (NASDAQ: ALGN) announced that it is hosting a Virtual Investor Day today focused on the Align digital platform that is enabling doctors to deliver the benefits of digital orthodontics to more than 9 million patients and counting. Align Technology CEO Joe Hogan will share Align’s vision and strategy of successful disruptive innovation that is accelerating a wave of digital orthodontics, bringing doctor-delivered Invisalign clear aligner treatment to more people around the world.

“Align’s global Invisalign brand is vastly underpenetrated into the existing orthodontic market which we now estimate to be approximately 15 million case starts each year, 3 million more than our prior estimate, as a result of establishing and increasing our direct presence in several new markets including Brazil, Russia, Turkey, Middle East and Africa, India and Southeast Asia,” said Joe Hogan, Align Technology president and CEO. “We believe digital orthodontics is inevitable and an incremental 500 million potential consumers can benefit from Invisalign treatment. Align is well positioned to enable over 189 thousand Invisalign doctors to capture this market using our products, services and digital platform. We will continue investing in resources to drive utilization and scale the Align digital platform to meet the needs of consumers, patients, and doctors globally.”

Align’s 2020 Virtual Investor Day will highlight the company’s strategic priorities and growth drivers, including the Align digital platform, and how Invisalign treatment, iTero scanner and services, and exocad CAD/CAM software are key to unlocking the potential 500 million consumers. Align’s executive team will address the company’s many strengths and advantages including its global scale and operational expertise, sales and marketing initiatives, and its demand creation and customer segmentation strategies that are driving utilization and helping doctors convert more consumers into Invisalign patients. The company will also provide an update to its fourth quarter commentary.

“The strong momentum we experienced across the business in October has continued into November,” said John Morici, Align Technology CFO. “Similar to the third quarter, we are continuing to see a higher mix of new Invisalign cases as compared to additional aligner cases as doctors continue to ramp up their practices. We remain committed to supporting our doctors and their practices through this recovery and beyond. Our prior investments have helped drive adoption and top line growth and we are encouraged by the return on our investments. Therefore, we are adding significant investments in sales, marketing, innovation and manufacturing capacity to continue to drive momentum and penetrate the huge market opportunity. At the same time, there continues to be uncertainty around the pandemic and the global environment, and any additional lockdowns, change in consumer behavior or practice closures could impact our operations and financial results.”

To register for the 2020 Align Virtual Investor Day starting at 8:00 a.m. Eastern time today, please use the following link:

https://event.webcasts.com/starthere.jsp?ei=1398581&tp_key=8aa7c31f94

To register in advance to listen to the live Q&A session starting at 1:00 p.m. Eastern time today with the Align executive team, please use the following link to attend the Zoom webinar:

https://aligntech-us00.zoom.us/webinar/register/WN_CsIXkvgQTBu3WjYRxPovXw

After registering, you will receive a confirmation email with information about how to join the webinar.

Q&A session attendees will be able to submit written questions via the Q&A window.

Forward Looking Statement

This press release includes forward looking statements that involve a number of risks and uncertainties. Words such as “believes,” “anticipates,” “plans,” “intends,” “expects,” “seeks,” “estimates,” and similar expressions are intended to identify forward-looking statements, but other statements that are not historical facts may also be deemed to be forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the markets for Align’s products, its beliefs concerning the digital transformation of dentistry and Align’s strategic priorities, its business momentum, products and product mix, the COVID-19 pandemic and its impacts on Align’s business and results of operations, Align’s expectations for digital adoption in dentistry and the potential impact of its products in the transition, and Align’s expectations for investments in its business, including sales, marketing, development and manufacturing. Forward-looking statements relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement.

Factors that might cause such a difference include, but are not limited to:

  • the impact of the COVID-19 pandemic on the health and safety of our employees, customers, patients, and our suppliers as well as the physical and economic impacts of the various recommendations, orders and protocols issued by local and national governmental agencies in light of the evolving situation, including any reimplementation of preventative measures;
  • difficulties predicting customer and consumer purchasing behavior and changes in consumer spending habits as a result of, among other things, the COVID-prev19 pandemic, prevailing economic conditions, levels of employment, salaries and wages and consumer confidence;
  • expectations regarding the continued growth or declines of our domestic and/or international markets;
  • increasing competition from existing and new competitors;
  • rapidly evolving and groundbreaking advances that are fundamentally changing the dental industry and the way new and existing participants market and provide products and services to consumers;
  • the ability to protect our intellectual property rights;
  • continued compliance with regulatory requirements;
  • our expectations regarding sales of our intra-oral scanners domestically and internationally and our belief that technology features and functionality of the iTero scanners and exocad technology will increase adoption of Invisalign and increase sales of our intra-oral scanners;
  • the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers;
  • the possibility that the development and release of new products or enhancements to existing products do not proceed in accordance with the anticipated timeline or may themselves contain bugs or errors requiring remediation and that the market for the sale of these new or enhanced products may not develop as expected;
  • a tougher consumer demand environment in China generally, especially for manufacturers and service providers whose headquarters or primarily operations are not based in China;
  • the risks relating to our ability to sustain or increase profitability or revenue growth in future periods (or minimize declines) while controlling expenses;
  • the impact of excess or constrained capacity at our manufacturing and treat operations facilities and pressure on our internal systems and personnel;
  • the compromise of customer and/or patient data for any reason;
  • the timing of case submissions from our doctors within a quarter as well as an increased manufacturing costs per case;
  • foreign operational, political and other risks relating to our international manufacturing operations; and
  • the loss of key personnel or work stoppages.

The foregoing and other risks are detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2020 and its latest Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the SEC on October 30, 2020. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign® system, the most advanced clear aligner system in the world, iTero® intraoral scanners and services, and CAD/CAM software. Align has helped treat over 9 million patients with the Invisalign system and is driving the evolution in digital dentistry with the iTero intraoral scanner and exocad® CAD/CAM software − modernizing today’s practices by enabling enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology Zeno Group
Madelyn Homick Sarah Johnson
(408) 470-1180 (828) 551-4201

[email protected]

[email protected]



Carillon’s Credentialing Services Earns Trusted Status with SAFE Identity Bridge Certification Authority

RESTON, Va. and VIENNA, Va., Nov. 23, 2020 (GLOBE NEWSWIRE) — SAFE Identity and Carillon Information Security Inc. today announced that Carillon has achieved cross-certification with the SAFE Identity Bridge Certification Authority (SIBCA), a cryptographic infrastructure that enables individuals, organizations and online services in the healthcare sector to trust each other’s digital identities for high assurance electronic transactions.

Carillon, already a leading provider of trusted PKI identity credentials for the aerospace industry, will now have the ability to issue digital certificates that will be trusted throughout the SAFE ecosystem. This certification was achieved under the recently announced SAFE Certificate Policy, a set of technical specifications, interoperability criteria, compliance guidelines and liability rules that govern the SAFE Identity Trust Framework.

SAFE is an industry consortium and certification body focused on expanding and standardizing the use of PKI-based credentials employed for identity, confidentiality and data integrity in healthcare by enabling trust of digital credentials.

SIBCA provides the essential federated infrastructure that enables the recognition and trust of digital credentials issued by multiple identity providers and organizations. It establishes a balance across the federated SAFE ecosystem that ensures comparable levels of trust based on the underlying technology and governing requirements—a necessity for peer-to-peer interoperability and trust between its cross-certified members.

“In addition to their credential issuing services, PKI enablement tools and tangible knowledge of federated environments, Carillon brings its expertise in working with trusted and cross-certified certificates in aerospace to the SAFE Identity healthcare community,” said Kyle Neuman, managing director of SAFE Identity. “I’m learning that there are a lot of similarities between aerospace and healthcare when it comes to the digital identity space. They are both heavily regulated industries, requiring security and assurance for not only people, but also devices. We welcome Carillon and their expertise to our Bridge and look forward to their contributions to our ecosystem.”

“Individuals with credentials issued by our PKI services now can consistently and reliably use them across the SAFE ecosystem for trusted authentication, digital signatures and encryption,” said Patrick Patterson, president of Carillon. “As a result, healthcare organizations can use Carillon credentials to more quickly, cost-effectively and compliantly collaborate with their customers, partners and suppliers both within and outside of their organization, just as our aerospace and defense customers do today. As well, with our experience deploying credentials into the challenging IoT space around aircraft, we’re looking forward to working with healthcare equipment providers to bring increased security to medical devices.”

The full list of SAFE Identity Certified Credential Providers is available at https://makeidentitysafe.com/get-safe-certified-credentials/ and Carillon at https://www.carillon.ca.

About Carillon

Carillon Information Security Inc. provides a complete spectrum of identity management solutions that are designed to prevent identity theft, promote the migration from paper to electronic authentication, and avoid the loss of intellectual property. From consulting services, to validation software and managed identity services, Carillon provides the skill set and tools to help companies take control of their corporate digital credentials.

About SAFE Identity


SAFE Identity
is an industry consortium and certification body supporting the advancement of digital identity and cryptography in healthcare by enabling trust of digital credentials. SAFE maintains an interoperable identity infrastructure used to facilitate and communicate trust to relying parties. SAFE reduces risk and assures the integrity of identities and data in virtual clinical trials, medical devices and trusted data exchange in healthcare supply chains.

Media Contact

Dana Kringel
Montner Tech PR
203-226-9290
[email protected]



Feronia Inc. Announces Closing of Restructuring Transaction

VANCOUVER, British Columbia, Nov. 23, 2020 (GLOBE NEWSWIRE) — Feronia Inc. (“Feronia” or the “Company”) (TSX-V: FRN) announces that it has closed its previously announced third party sale and restructuring transaction.

As previously reported, the Company initiated debtor in possession insolvency proceedings under the Bankruptcy and Insolvency Act (Canada)(the “BIA”) on July 23, 2020 (the “NOI Proceedings”). Pursuant to an Order of the Supreme Court of British Columbia in Bankruptcy and Insolvency dated September 3, 2020, the transaction was completed pursuant to the terms of a definitive purchase agreement with Straight KKM 2 Limited, which provided for the acquisition by Feronia KNM of substantially all of the Company’s assets, including its direct and indirect equity interests in its operating subsidiary, Plantations et Huileries du Congo.

The key terms of the transaction are set forth in the press release of the Company issued on July 20, 2020, as updated in its press release dated September 10, 2020.

Following completion of the sale transaction, and the expiry of the NOI Proceedings, the Company was declared bankrupt pursuant to the BIA.

As Feronia will not meet the continued listing requirements of the TSX Venture Exchange (the “TSXV”) following completion of the transaction, Feronia intends to have its common shares voluntarily delisted from the TSXV and expects to apply to Canadian securities regulators to cease to be a reporting issuer following closing.

For further information please contact:

Larry Seruma
Executive Chairman, Feronia Inc.
[email protected]

Paul Dulieu
Director of Communications and Corporate Development, Feronia Inc.
44 (0)7554 521421
[email protected]

About Feronia Inc.

  • Feronia is an agribusiness operating in the Democratic Republic of the Congo (DRC).
  • At the heart of Feronia lies a long established palm oil business,
    PHC
    , which has three remotely located plantations;
    Lokutu
    ,
    Yaligimba
    and
    Boteka
    .
  • When Feronia acquired its palm oil business from Unilever in 2009, it had suffered from years of underinvestment and considerable disruption caused by conflict in the DRC. Our initial focus has been on rebuilding the business and resuming production to secure
    PHC’s
    future and the livelihoods of the thousands of people it employs.
  • Feronia’s plantations produce crude palm oil (CPO) and palm kernel oil (
    PKO
    ). CPO is part of the staple and traditional diet of the Congolese and, with our products sold locally in the DRC, we are well placed to help decrease reliance on imports and increase food security and quality.
  • Feronia prides itself on being the guardian of
    its
    10
    9
    year-old palm oil business and its employees, communities, and environment. We have a long term commitment to improve the living and working environment of our employees and their communities and are committed to sustainable agriculture, environmental protection and community inclusion. Feronia has in place Environmental and Social Management which is focused on implementing environmental and social best practice and improving social infrastructure.
  • Feronia is working towards certification by the Roundtable for Sustainable Palm Oil (RSPO) and is implementing
    IFC
    /World Bank standards for environmental and social sustainability. Our oil palm replanting
    programme
    is brownfield in nature – replacing old palms with new – and it has no reliance on deforestation.
  • For more information please see

    www.feronia.com

Cautionary Notes
Except for statements of historical fact contained herein, the information in this press release constitutes “forward-looking information” within the meaning of Canadian securities law. Such forward-looking information may be identified by words such as “anticipates”, “plans”, “proposes”, “estimates”, “intends”, “expects”, “believes”, “may” and “will”. There can be no assurance that such statements will prove to be accurate; actual results and future events could differ materially from such statements. Factors that could cause actual results to differ materially include, among others: risks related to foreign operations (including various political, economic and other risks and uncertainties), the interpretation and implementation of the “Loi Portant Principes Fondamentaux Relatifs A L’Agriculture”, termination or non-renewal of concession rights or expropriation of property rights, political instability and bureaucracy, limited operating history, lack of profitability, lack of infrastructure in the DRC, high inflation rates, limited availability of debt financing in the DRC, fluctuations in currency exchange rates, competition from other businesses, reliance on various factors (including local labour, importation of machinery and other key items and business relationships), the Company’s reliance on two major customers, lower productivity at the Company’s plantations, risks related to the agricultural industry (including adverse weather conditions, shifting weather patterns, and crop failure due to infestations), a shift in commodity trends and demands, vulnerability to fluctuations in the world market, the lack of availability of qualified management personnel and stock market volatility. Details of the risk factors relating to Feronia and its business are discussed under the heading “Risks and Uncertainties” in Feronia’s Management’s Discussion and Analysis for the year ended December 31, 2019, a copy of which is available on the Company’s SEDAR profile at www.sedar.com. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking information. Except as otherwise required by applicable securities statutes or regulation, the Company expressly disclaims any intent or obligation to update publicly forward-looking information, whether as a result of new information, future events or otherwise.

Neither the
TSX
Venture Exchange nor its regulation services provider (as that term is defined in the policies of the
TSX
Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.



Nightfood and Papa John’s Satisfy Late Night Cravings with Double Cheeseburger Papadias and Pickles for Two Ice Cream

TARRYTOWN, NY, Nov. 23, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Nightfood, Inc. (OTCQB: NGTF), the company pioneering the category of nighttime snacks for better sleep, today announced Nightfood’s Pickles For Two ice cream is being featured along with a Double Cheeseburger Papadia from Papa John’s in a gift pack as part of a promotional partnership.

“We’re honored to have been invited by Papa John’s to participate in this national promotion satisfying late-night cravings,” commented Nightfood CEO Sean Folkson. “We’re excited to be able to introduce our Pickles For Two, and the entire Nightfood brand, to so many new consumers.”

Nightfood ice cream was developed by leading sleep experts for nighttime snacking with ingredients for relaxation and better sleep.  A better choice for men, women, and children of all ages, Nightfood pints feature more protein, fiber, calcium, magnesium, and zinc, and less sugar, less fat, and fewer calories than regular ice cream.  

The company recently launched the Pickles For Two flavor to satisfy the two most popular pregnancy cravings: pickles and ice cream. Nightfood was named this year as the official ice cream of the American Pregnancy Association. And now, the two companies are bringing consumers the opportunity to satisfy all of their late-night pickle cravings with Pickles for Two ice cream and the Papa John’s Double Cheeseburger Papadia, which also features crunchy pickles.

In addition to Pickles For Two, Nightfood ice cream comes in many traditional flavors, including Cold Brew Decaf, Cookies n’ Dreams, Midnight Chocolate, Full Moon Vanilla, Milk & Cookie Dough, Bed and Breakfast, Cherry Eclipse, and After Dinner Mint Chip.

Papa John’s Double Cheeseburger Papadia is a fan-favorite, available for a limited time only.  It features a quarter pound of seasoned beef with crispy pickles and melty cheese baked to a toasty perfection. The Double Cheeseburger Papadia is served with Papa John’s signature burger dipping sauce for a maximum flavor experience.

As part of the promotion, influencers and other consumers were selected to receive a custom cooler, pints of Nightfood’s Pickles For Two, and of course, a Papa John’s Double Cheeseburger Papadia, delivered by their local Papa John’s location.  Nightfood ice cream is not available for consumer purchase from Papa John’s as part of this promotional partnership. 

About Nightfood Holdings:

Nightfood Holdings, Inc. (OTC: NGTF), owns Nightfood, Inc. and MJ Munchies, Inc. 

Nightfood has expanded distribution for its ice cream into major divisions of the largest supermarket chains in the United States: Kroger (Harris Teeter), Albertsons Companies (Jewel-Osco and Shaw’s and Star Markets), and H-E-B (Central Market) as well as Lowe’s Foods, Rouses Markets, and other independent retailers. 

Nightfood won the 2019 Product of the Year award in the ice cream category in a Kantar survey of over 40,000 consumers. Nightfood was also named Best New Ice Cream in the 2019 World Dairy Innovation Awards.

Nightfood has been endorsed as the Official Ice Cream of the American Pregnancy Association and is the recommended ice cream for pregnant women.  There are approximately 3,000,000 pregnant women in the United States at any given time, and ice cream is the single most-widely reported pregnancy craving.  With more calcium, magnesium, zinc, fiber, and protein, less sugar and a lower glycemic profile than regular ice cream, Nightfood has been identified as a better choice for expectant mothers.

Nightfood is not just for pregnant women.  Over 80% of Americans snack regularly at night, resulting in an estimated 700M+ nighttime snack occasions weekly, and an annual spend on night snacks of over $50 billion dollars, the majority of it on options that are understood to be both unhealthy, and disruptive to sleep quality.  

Nightfood was formulated by sleep and nutrition experts with ingredients that research suggests can support nighttime relaxation and better sleep quality.  Scientific research indicates unhealthy nighttime cravings are driven by human biology.  Willpower is also weakest at night, and stress is another contributing factor.  A majority of night snackers report feeling both guilty and out-of-control when it comes to their nighttime snacking.

Because unhealthy night snacking is believed to be biologically driven, and not a trend or a fad, management believes the category of nighttime-specific nutrition, which Nightfood is pioneering, can be a billion-dollar category. 

MJ Munchies, Inc. was formed in 2018 as a new, wholly owned subsidiary of Nightfood Holdings, Inc. to capitalize on legally compliant opportunities in the CBD and marijuana edibles and related spaces.  The Company is seeking licensing opportunities to market such products under the brand name “Half-Baked”, for which they’ve successfully secured trademark rights.  

Questions can be directed to [email protected]

Management also encourages Nightfood shareholders to connect with the Company via these methods:

E-mail: By signing up at ir.nightfood.com, investors can receive updates of filings and news releases in their inbox.

Telegram: There is now a live, interactive Telegram group which interested parties can join to reach team members and discuss Nightfood. Ask questions, learn more about the company and discuss future prospects. Join the Telegram Group Here: https://t.me/NightfoodHoldings

YouTube: The company has established a new YouTube series which will feature weekly videos with team members, insights into latest industry developments, and provide a behind the scenes look at the latest company developments.  Click here to subscribe to Nightfood’s YouTube channel.

About Papa John’s

Papa John’s International, Inc. opened its doors in 1984 with one goal in mind: BETTER INGREDIENTS. BETTER PIZZA.® Papa John’s believes that using high quality ingredients leads to superior quality pizzas. Its original dough is made of only six ingredients and is fresh, never frozen. Papa John’s tops its pizzas with real cheese made from mozzarella, pizza sauce made with vine-ripened tomatoes that go from vine to can in the same day and meat free of fillers. It was the first national pizza delivery chain to announce the removal of artificial flavors and synthetic colors from its entire food menu. Papa John’s is headquartered in Louisville, Ky. and is the world’s third largest pizza delivery company with more than 5,360 restaurants in 48 countries and territories as of September 27, 2020. For more information about the Company or to order pizza online, visit www.PapaJohns.com or download the Papa John’s mobile app for iOS or Android.

Forward-Looking Statements: 

This current press release contains “forward-looking statements,” as that term is defined in Section 27A of the United States Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future, including but not limited to, any products sold or cash flow from operations. 

Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with distribution and difficulties associated with obtaining financing on acceptable terms. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that the beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our most recent annual report for our last fiscal year, our quarterly reports, and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

Media Contact:
Tim Sullivan
[email protected]
732-816-0239

Investor Contact:
Stuart Smith
[email protected]
888-888-6444, x3

Attachment



Recce Pharmaceuticals Announces Anti-viral Patent Granted in Japan for RECCE® Anti-Infectives

SYDNEY, Australia, Nov. 23, 2020 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing new classes of synthetic anti-infectives, is pleased to announce the Japan Patent Office (JPO) has granted Patent Family 3 titled “Anti-virus Agent and Method for Treatment of Viral Infection”, furthering marketing and manufacturing monopolies to February 2037.

“Recce’s intellectual property portfolio continues to grow in-line with our business strategy and the unprecedented global infectious disease crisis before us,” said Chief Executive Officer, James Graham. “At now 31 granted patents across three wholly-owned patent families, our market-monopolies reinforce our unique opportunity among a significant-range of both bacterial and viral pathogens.”

Japan Patent Office granted claims relate to RECCE® 327 (R327) and new anti-viral formulation RECCE® 529 (R529), most notably:

  • Composition/method of manufacture of RECCE® anti-infectives
  • Use of R327 or R529 for the treatment of viruses having a lipid envelope or coat, examples being SARS-CoV-2 and coronaviruses, influenza viruses, HIV, hepatitis, Ross River and Herpes viruses
  • Administration of R327 or R529 by oral, injection, inhalation and transdermal dose applications

Japan is the second largest pharmaceutical market in the world1 with the unmet medical need from infections caused by lipid enveloped or coated viruses representing millions of potential patients Japan country alone. Patent Family 3 applications in other major pharmaceutical markets around the world are in their advanced stages of independent patent reviews.

__________________________________

1 https://www.worldatlas.com/articles/countries-with-the-biggest-global-pharmaceutical-markets-in-the-world.html

About Recce Pharmaceuticals Ltd

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

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

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

The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval.

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

Corporate Contact

James Graham
Recce Pharmaceuticals Ltd
+61 (02) 8075 4585
[email protected]

Media and Investor Relations (AU)

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

Media and Investor Relations (USA)

Meredith Sosulski, Ph.D.
LifeSci Communications
+1 929 469 3851
[email protected]



Equipment Leasing and Finance Association’s Survey of Economic Activity: Monthly Leasing and Finance Index

October New Business Volume Down 9 Percent Year-over-year, Up 6 Percent Month-to-Month, and Down Almost 6 Percent Year-to-date

WASHINGTON, Nov. 23, 2020 (GLOBE NEWSWIRE) — The Equipment Leasing and Finance Association’s (ELFA) Monthly Leasing and Finance Index (MLFI-25), which reports economic activity from 25 companies representing a cross section of the $900 billion equipment finance sector, showed their overall new business volume for October was $9.2 billion, down 9 percent year-over-year from new business volume in October 2019. Volume was up 6 percent month-to-month from $8.7 billion in September. Year-to-date, cumulative new business volume was down almost 6 percent compared to 2019.

Receivables over 30 days were 2.20 percent, up from 2.00 percent the previous month and up from 2.00 percent the same period in 2019. Charge-offs were 0.60 percent, down from 0.82 percent the previous month and up from 0.46 percent in the year-earlier period.

Credit approvals totaled 72.3 percent, down from 72.9 percent in September. Total headcount for equipment finance companies was down 4.9 percent year-over-year.

Separately, the Equipment Leasing & Finance Foundation’s Monthly Confidence Index (MCI-EFI) in November is 56.1, up from the October index of 55.0.


ELFA President and CEO Ralph Petta
said, “To the extent that member companies responding to the October MLFI-25 survey are an indicator, the equipment finance industry shows resilience in the face of a worsening health pandemic and uneven economic performance in the U.S. The labor market continues to strengthen, except for workers and their employers in the restaurant, travel, leisure and hospitality sectors, who continue to struggle. Corporate earnings in many sectors are strong, the equity markets continue to defy gravity and business confidence seems to be on the rise. Hopefully, this struggle to get back to a sense of normalcy will not be overtaken by a double dip recession caused by worsening COVID-19 outbreaks reported in some states around the nation. At the end of the day, equipment finance companies continue to do their part to help the nation get back to business by helping finance billions of dollars in equipment investment by businesses both large and small.”


Howard Shiebler, President, Crossroads Equipment Lease & Finance LLC
, said, “We focus exclusively on transportation finance, and 2020 is shaping up to be an amazing year. Freight volume and trucking market spot rates are up and corresponding demand for new and used trucks is driving our new business to record levels. We expect this trend to continue into at least the first half of 2021 and for portfolio performance and used truck and trailer prices to stay strong.”

About ELFA’s MLFI-25

The MLFI-25 is the only index that reflects capex, or the volume of commercial equipment financed in the U.S. The MLFI-25 is released globally at 8 a.m. Eastern time from Washington, D.C., each month on the day before the U.S. Department of Commerce releases the durable goods report. The MLFI-25 is a financial indicator that complements the durable goods report and other economic indexes, including the Institute for Supply Management Index, which reports economic activity in the manufacturing sector. Together with the MLFI-25 these reports provide a complete view of the status of productive assets in the U.S. economy: equipment produced, acquired and financed.

The MLFI-25 is a time series that reflects two years of business activity for the 25 companies currently participating in the survey. The latest MLFI-25, including methodology and participants, is available at www.elfaonline.org/Data/MLFI/.

MLFI-25 Methodology

ELFA produces the MLFI-25 survey to help member organizations achieve competitive advantage by providing them with leading-edge research and benchmarking information to support strategic business decision making.

The MLFI-25 is a barometer of the trends in U.S. capital equipment investment. Five components are included in the survey: new business volume (originations), aging of receivables, charge-offs, credit approval ratios, (approved vs. submitted) and headcount for the equipment finance business.

The MLFI-25 measures monthly commercial equipment lease and loan activity as reported by participating ELFA member equipment finance companies representing a cross section of the equipment finance sector, including small ticket, middle-market, large ticket, bank, captive and independent leasing and finance companies. Based on hard survey data, the responses mirror the economic activity of the broader equipment finance sector and current business conditions nationally.

About ELFA

The Equipment Leasing and Finance Association (ELFA) is the trade association that represents companies in the nearly $1 trillion equipment finance sector, which includes financial services companies and manufacturers engaged in financing capital goods. ELFA members are the driving force behind the growth in the commercial equipment finance market and contribute to capital formation in the U.S. and abroad. Its 575 members include independent and captive leasing and finance companies, banks, financial services corporations, broker/packagers and investment banks, as well as manufacturers and service providers. For more information, please visit www.elfaonline.org.

Follow ELFA:

Twitter: @ELFAonline
LinkedIn: www.linkedin.com/groups?gid=89692
Facebook: www.facebook.com/ELFApage
 
ELFA is the premier source for statistics and analyses concerning the equipment finance sector. Please visit www.elfaonline.org/Data/ for additional information.

The Equipment Leasing & Finance Foundation is a 501c3 non-profit organization that propels the equipment finance sector—and its people—forward through industry-specific knowledge, intelligence, and programs that contribute to industry innovation, individual careers, and the overall betterment of the equipment leasing and finance industry. The Foundation is funded through charitable individual and corporate donations. Learn more at www.leasefoundation.org.

Media/Press Contact: Amy Vogt, Vice President, Communications and Marketing, ELFA, 202-238-3438 or [email protected]



Aemetis Signs Distributor Agreement for Health Safety Products and Receives $24 Million Initial Purchase Order

CUPERTINO, CA, Nov. 23, 2020 (GLOBE NEWSWIRE) — via NewMediaWireAemetis, Inc. (NASDAQ: AMTX) announced today that its wholly-owned subsidiary, Aemetis Health Products, Inc., received a $24 million initial purchase order after signing a supply agreement for sanitizer alcohol and nitrile gloves with a California distributor that provides health safety products to the state of California as well as other governmental entities and large hospital chains throughout the U.S. 

“Aemetis Health Products became what we believe to be the largest production plant for sanitizer alcohol in the Western U.S. during the second quarter of 2020. We are now executing on our plan to produce and market alcohol-based health safety products including hand sanitizer, sanitizer wipes and aerosol sanitizers under the Aemetis and private label brand names,” said Eric McAfee, Chairman and CEO of Aemetis. “Our government and healthcare customers have repeatedly requested that Aemetis extend our product line to include the supply of nitrile gloves.  With more than a decade of extensive business experience in Asian markets, we believe Aemetis is well positioned to be a trusted partner of health safety product manufacturers in that region, as well as other international markets.”  

To support the supply agreement and enable the expansion of the Aemetis Health Products business, Aemetis has negotiated the general terms of a new credit facility with its existing lender, which will be used solely for our health safety product transactions.  

About Aemetis 

Headquartered in Cupertino, California, Aemetis is an advanced renewable fuel and biochemicals company focused on the acquisition, development and commercialization of innovative technologies that replace traditional petroleum-based products by the conversion of

ethanol and biodiesel plants into advanced biorefineries. Founded in 2006, Aemetis owns and operates a 65 million gallon per year ethanol production facility in California’s Central Valley near Modesto. Aemetis also owns and operates a 50 million gallon per year renewable chemical and advanced fuel production facility on the East Coast of India producing high quality distilled biodiesel and refined glycerin for customers in India and Europe. Aemetis is building a biogas anaerobic digester network and pipeline to convert dairy animal waste gas to Renewable Natural Gas (RNG) and is developing a plant to convert waste orchard wood into cellulosic ethanol.  Aemetis holds a portfolio of patents and related technology licenses for the production of renewable fuels and biochemicals. For additional information about Aemetis, please visit www.aemetis.com. 

Safe Harbor Statement 

This news release contains forward-looking statements, including statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events or other statements that are not historical facts. Forward-looking statements in this news release include, without limitation, statements relating to sales of high grade alcohol, sales of nitrile gloves under the initial purchase order, our ability to develop a retail presence, the ability of our source manufacturers to deliver nitrile gloves, the credit worthiness of our health safety product distributor, the production of alcohol by competitors in the Western United States and the ability to access funding to execute our sanitizer and health safety product business plan. Words or phrases such as “anticipates,” “may,” “will,” “should,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “showing signs,” “targets,” “will likely result,” “will continue”, “enable” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on current assumptions and predictions and are subject to numerous risks and uncertainties. Actual results or events could differ materially from those set forth or implied by such forward-looking statements and related assumptions due to certain factors, including, without limitation, competition in the ethanol, biodiesel and other industries in which we operate, commodity market risks including those that may result from current weather conditions, financial market risks, customer adoption, counter-party risks, risks associated with changes to federal policy or regulation, and other risks detailed in our reports filed with the Securities and Exchange Commission (the “SEC”), including our Annual Report on Form 10-K for the year ended December 31, 2019, and in our subsequent filings with the SEC. We are not obligated, and do not intend, to update any of these forward-looking statements at any time unless an update is required by applicable securities laws.

External Investor Relations
Contact:
 

Kirin Smith 
PCG Advisory Group 
(646) 863-6519 
[email protected] 

Company Investor Relations/ 

Media Contact: 

Todd Waltz 
(408) 213-0940 
[email protected] 



HTG Announces One-for-Fifteen Reverse Stock Split

TUCSON, Ariz., Nov. 23, 2020 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM), a life science company whose mission is to advance precision medicine, today announced that as a result of its one-for-fifteen reverse stock split which became effective at 5:00 p.m. Eastern Time on November 20, 2020, its common stock will begin trading on a split-adjusted basis on The Nasdaq Capital Market (“Nasdaq”) effective with the open of the market today, Monday, November 23, 2020. HTG’s common stock will continue to trade under the ticker symbol “HTGM.”

As a result of the reverse stock split, each fifteen pre-split shares of common stock outstanding were automatically combined and converted into one issued and outstanding share of common stock. No fractional shares of common stock were issued to any stockholders in connection with the reverse stock split. Holders of record will receive a cash payment in lieu of fractional shares.  

Stockholders of record will receive information regarding their share ownership from HTG’s transfer agent, American Stock Transfer & Trust Company, LLC (“AST”). AST can be reached at (877) 248-6417 or (718) 921-8337. 

For additional information regarding the reverse stock split, please refer to HTG’s Current Report on Form 8-K, filed with the Securities and Exchange Commission on November 19, 2020.

About HTG:
HTG is focused on NGS-based molecular profiling. The company’s proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Its mission is to empower precision medicine.

Contact:

Ashley R. Robinson
LifeSci Advisors, LLC
Phone: (617) 430-7577
Email: [email protected]



PMV Pharma Doses First Patient in Phase 1/2 Study of PC14586, a First-in-Class Precision Oncology Therapy That Targets Mutant p53

  • PC14586 targets p53 Y220C mutants to selectively reactivate p53, restoring the protein’s tumor-suppressing function
  • Phase 1/2 study is enrolling patients with advanced solid tumors that have a p53 Y220C mutation

CRANBURY, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced dosing of the first patient in its Phase 1/2 clinical trial evaluating PC14586, the company’s investigational lead compound that targets the Y220C mutant of p53. The trial will enroll up to 130 patients with advanced solid tumors that have the specific p53 Y220C variant.

“This is an important step forward in the battle against the many cancers that are driven by a p53 mutation,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “Initiating our Phase 1/2 study represents a significant milestone for PMV, as PC14586 is our first tumor-agnostic therapy to enter the clinic. By selectively binding to the p53 Y220C mutant, PC14586 is designed to reactivate the tumor suppressing function of p53. We look forward to the opportunity to address the significant unmet need for patients whose cancers have a p53 Y220C mutation as we advance PC14586 in the clinic.”

The multi-center, single-arm Phase 1/2 study will evaluate PC14586 in patients with advanced solid tumors with a p53 Y220C mutation. Phase 1 will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of PC14586. Phase 2 will determine the overall response rate and duration of response of PC14586 at a dose identified in Phase 1.

About p53

p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.  

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice created by the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with advanced solid tumors that have a p53 Y220C mutation identified by next generation sequencing. PC14586 was granted Fast Track Designation by the U.S. Food and Drug Administration in October 2020.

For information on the Phase 1/2 trial, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).

About
PMV Pharma

PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 is mutated in approximately half of all cancer. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus.  PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.

Forward-Looking
Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s future plans or expectations for PC14586, including expectations regarding the timing for patient enrollment and success of its current clinical trial for PC14586. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities and planned clinical trials, the Company’s ability to execute on its strategy and operate as an early clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company’s ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 13, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company 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

For Investors:

Winston Kung
Chief Financial Officer
[email protected]

For Media:

Mariann Caprino
[email protected]
(917) 242-1087 mobile