Market Newsdesk

Fort Lauderdale, Florida, Jan. 19, 2022 (GLOBE NEWSWIRE) — Splash Beverage Group, Inc. (NYSE American: SBEV) (“Splash” or the “Company”), a portfolio company of leading beverage brands, today announced it has received authorization to sell its Pulpoloco Sangria line in 187 of Ralph’s Grocery stores.   Ralph’s Grocery, a division of The Kroger Company, is a market share leader with 187 stores across Southern California.

“This is another significant milestone for Splash and a meaningful step in our strategy to expand into major supermarket chains,” said Robert Nistico, Splash Beverage Group’s Chairman and CEO.  “After a successful test run, Ralph’s authorized all three SKU’s of Pulpoloco white, rosé and classic red.  Ralph’s already carries Splash’s Copa di Vino varietals, which were added in early summer of 2021, and now all 3 Pulpoloco varietals. We believe this is a strong affirmation that consumers are catching on to the unique product lines that Splash distributes and bodes well for future expansion.”

Ralph’s Grocery is owned by The Kroger Company, one of the world’s largest food retailers with 2750 grocery retail stores under a variety of banner names.

“AB One’s coverage includes Southern California, and Ralph’s confidence in them as an elite service provider in beverage distribution was a key element in our obtaining this authorization,” Nistico said. 

Follow Splash Beverage Group on Twitter: www.twitter.com/SplashBev

About Splash Beverage Group, Inc.

Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wine by the glass, SALT flavored tequilas, Pulpoloco sangria, and TapouT performance hydration and recovery drink. Splash’s strategy is to rapidly develop early stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution. 

For more information, visit:
www.SplashBeverageGroup.com
www.copadivino.com
www.drinksalttequila.com
www.pulpo-loco.com
www.tapoutdrinks.com

Forward-Looking Statement

This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results and, consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements and factors that may cause such differences include, without limitation, the risks disclosed in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2021, and in the Company’s other filings with the SEC. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Except as required by law, the Company disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this press release.

Contact Information:

Splash Beverage Group
[email protected]
954-745-5815

Attachments

• $SBEV – Splash Beverage Group’s Pulpoloco Brand Receives Authorization for 187 Ralph’s Grocery Stores
• $SBEV – Splash Beverage Group’s Pulpoloco Brand Receives Authorization for 187 Ralph’s Grocery Stores

SOUTH SAN FRANCISCO, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) — CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for CX-904, an EGFRxCD3 T-cell-engaging bispecific antibody being co-developed by CytomX and Amgen.

“The impressive innovation of CX-904’s design and its advancement into the clinical setting underscores our commitment to destroying cancer differently. The CX-904 IND also marks the sixth therapeutic candidate and the third treatment modality overall to enter the clinic from our versatile and tunable Probody platform, reinforcing our leadership in the field of conditional activation of biologic therapeutics,” said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. “Our masked Probody T-cell engagers are designed to harness the power of this highly potent modality. We are eager to initiate the Phase 1 dose-escalation study for CX-904 as the leading edge of our broad efforts to bring conditionally activated bispecifics to patients with advanced solid tumors.”

T-cell-engaging bispecific antibodies have tremendous potential for the treatment of solid tumors by directing T cells against tumor antigens, including the epidermal growth factor receptor (EGFR). However, the extraordinarily high potency of these agents can narrow their therapeutic window significantly when their target is present on normal tissues. CX-904 is a conditionally activated T-cell bispecific antibody designed to bind to both EGFR on cancer cells and to the CD3 receptor on T cells selectively in the tumor microenvironment. In preclinical studies, CytomX’s conditionally activated Probody EGFRxCD3 bispecific therapeutics demonstrated potent anti-tumor activity and strong improvement in safety versus EGFRxCD3 bispecifics without Probody masking.¹

About CytomX Therapeutics, Inc.

CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments and successfully leverage therapeutic targets that were once thought to be inaccessible. CytomX’s robust and differentiated pipeline includes the wholly-owned praluzatamab ravtansine (CX-2009), an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD166, and CX-2029, an investigational conditionally activated ADC directed toward CD71 co-developed with AbbVie. These two programs are currently being evaluated in Phase 2 studies, targeting a variety of late-stage, difficult-to-treat cancer types, including breast cancer for praluzatamab ravtansine, and squamous non-small cell lung cancer, and head and neck squamous cell carcinoma for CX-2029. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, and our wholly-owned conditionally activated anti-PD-L1 antibody, pacmilimab (CX-072), as well as the Amgen-partnered CX-904, a conditionally activated T-cell-engaging bispecific antibody against the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells. In addition, CytomX has a diverse preclinical portfolio and strategic collaborations with other leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and Twitter.

CytomX Therapeutics Forward-Looking Statements

This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-904, the potential benefits or applications of CytomX’s Probody platform technology, CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288, pacmilimab, and CX-904, and the timing of the commencement of clinical trials, initial data, investigational new drug applications and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; CytomX’s clinical trial product candidates, including CX-904, are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288, pacmilimab, and CX-904; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; and possible regulatory developments in the United States and foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading “Risk Factors” included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on November 4, 2021. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.

Probody is a U.S. registered trademark of CytomX Therapeutics, Inc.

Reference:

1. Boustany L, La Porte S, Wong L, et al. EGFR-CD3 Bispecific Probody™ Therapeutic Induces Tumor Regressions and Increases Maximum Tolerated Dose > 60 fold in Preclinical Studies. Poster presented at: AACR-NCI-EORTC International Conference on Molecular Targets; 2017 Oct. 26-30; Philadelphia, PA.

https://cytomx.com/wp-content/uploads/CytomX-PbTCB_AACR_NCI_EORTC_2017_FINAL.pdf

Investor Contact:

Chau Cheng, PhD MBA
VP, Investor Relations & Corp. Communications
[email protected]
Direct: (650) 273-4999

Media Contact:

Bret Coons
Director, Corporate Communications
[email protected]
Direct: (650) 528 2929

BOSTON, Jan. 19, 2022 (GLOBE NEWSWIRE) — X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel CXCR4-targeted small molecule therapeutics to benefit people with diseases of the immune system, today announced that management will participate in a fireside chat at B. Riley Securities Oncology Investor Conference on Friday, January 28, 2022.

Details are as follows:

Conference: B. Riley Securities Oncology Investor Conference
Format: Fireside Chat
Date: Friday, January 28, 2022
Time: 1:00 PM ET
Presentation Webcast Link

A live webcast of the fireside chat from the B. Riley Securities Oncology Investor Conference will be available on the investors section of the X4 Pharmaceuticals’ website at www.x4pharma.com. After the live webcast, the event will remain archived on the X4 Pharmaceuticals’ website for at least 30 days.

About X4 Pharmaceuticals

X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company leading the discovery and development of novel therapies for people with immune system dysfunction. The company’s lead candidate is mavorixafor, a first-in-class, small molecule antagonist of chemokine receptor CXCR4 that is being developed as a once-daily oral therapy. Due to mavorixafor’s ability to antagonize CXCR4 and improve the healthy maturation and trafficking of white blood cells, X4 believes that mavorixafor has the potential to provide therapeutic benefit across a wide variety of diseases, including primary immunodeficiencies (PIDs) and certain types of cancer. Mavorixafor has already demonstrated clinical potential in a Phase 2 trial in people with WHIM syndrome, a rare PID. Its efficacy and safety continue to be evaluated in a global Phase 3 clinical trial in WHIM (fully enrolled) and in two Phase 1b clinical trials – one, as monotherapy in people with Severe Congenital Neutropenia (SCN) and other chronic neutropenia conditions, and another in combination with ibrutinib in people with Waldenström’s macroglobulinemia, a rare B-cell lymphoma. 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, to discover and develop additional product candidates. For more information, please visit www.x4pharma.com.

Contacts:

Glenn Schulman, PharmD, MPH (corporate)

VP, Investor Relations & Corporate Communications
[email protected]
(203) 494-7411

Daniel Ferry (investors)

Managing Director, LifeSci Advisors
[email protected]
(617) 430-7576

Mónica Rouco Molina (media)

Senior Account Executive, LifeSci Communications
[email protected] 

FUZHOU, China, Jan. 19, 2022 (GLOBE NEWSWIRE) — E-Home Household Service Holdings Limited (Nasdaq: EJH) (the “Company” or “E-Home”), a provider of integrated household services in China, today announced that the Company has set up a cleaning robot equipment leasing department in the cleaning service sector, highlighting to promote the growth of the Company’s cleaning service business.

The specific measures reveal in the cleaning robot equipment leasing department include:

• Import the high-tech cleaning robot equipment from Japan and the United States
• Improve market share and reduce labor cost of cleaning service business by the robot equipment
• Achieve multiple simultaneous use of the robot equipment by leasing the robot equipment to small and medium-sized enterprises
• Achieve an integration effect between robot equipment and cleaning service industry
• Use capital investment to improve the profitability of the robot equipment leasing business
• By robot equipment leasing business, E-Home access the cutting-edge technology of cleaning robot equipment, to improve its technological innovation ability
• Combine real lecturers and virtual lecturers by the metaverse technology, to provide the online training for the cleaning staff from time to time
• Establish a cleaning robot equipment technology docking group to ensure that traditional cleaning industry can improve profitability through technological innovation

Mr. Wenshan Xie, Chairman and CEO of E-Home, commented: “At present, with the improvement of office and home environment requirements, cleaning business is increasing year by year. However, the profits of most traditional cleaning companies are dragged down by cleaning equipment, labor costs, and outdoor personnel risks. Based on this, the Company decided at the recent 2022 business strategy meeting to set up a cleaning robot equipment leasing department. The new business segment will greatly reduce the operating cost of the cleaning department of the Company and improve the profit margin. In addition, with the support of high-tech robot equipment, it will also bring customers a brand new consumption experience, encourage and guide them to spread good corporate reputation information, so as to obtain a continuous competitive advantage in the industry. The new business is expected to contribute approximately $15 million in revenue and approximately $3 million in net income to the Company in 2022.”

Mr. Xie continued: “In this special period, this new project shows our determination to actively develop new businesses segment, and our innovation ability to flexibly respond to the market competition pressures. We believe that our strong technological innovation capabilities and diversified service strategies will drive our business to significant growth. At the same time, we look forward to offering customers more solutions in the future and further expanding our marketing channels.”

About E-Home Household Service Holdings Limited

E-Home Household Service Holdings Limited is a household service company based in Fuzhou, China. The Company, through its website and WeChat platform “e家快服”, provides integrated household services, including appliance installation and maintenance, housekeeping services, and Internet based home and senior care. For more information, visit the Company’s website at http://www.ej111.com/ir.html. 

Forward-Looking Statements

All statements other than statements of historical fact in this announcement are forward-looking statements in nature within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions are intended to identify such forward-looking statements. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to consider risk factors, including those described in the Company’s filings with the SEC, that may affect the Company’s future results.
All forward-looking statements attributable to the Company and its subsidiaries or persons acting on their behalf are expressly qualified in their entirety by these risk factors.

Contact Person : Dong Cao

Cell Number: +86 13502048965

Email: [email protected]

SAN DIEGO, Jan. 19, 2022 (GLOBE NEWSWIRE) — Genasys Inc. (NASDAQ: GNSS), the global leader in critical communications systems and solutions that help protect and keep people safe, today announced a $1.97 million public safety mass notification and emergency warning systems contract from the City of Berkeley, CA. Last year, Alameda County, CA, in which Berkeley is located, entered into a multi-year software services and evacuation management contract with Genasys’ Zonehaven.

“Berkeley and other communities are enhancing safety for residents and visitors by implementing fully integrated software and hardware emergency alerting and evacuation solutions,” said Richard Danforth, Chief Executive Officer, Genasys Inc. “The award from the city includes installing a network of our outdoor Integrated Mass Notification Systems (IMNS) that broadcast audible voice notifications with exceptional clarity and area coverage.

“In addition to satellite connectivity, solar power and battery backup, the IMNS installations will be activated and controlled as a network, or individually, with Genasys Emergency Management (GEM) software,” added Mr. Danforth. “Annual recurring software and system maintenance fees are also included in the multi-year contract.”

“The Genasys network will deliver city-wide or hyperlocal fire, flooding, tsunami, earthquake, and other public safety threat alerts to our 125,000+ citizens,” said Keith May, Assistant Fire Chief and Public Information Officer, Berkeley Fire Department. “IPAWS compatibility, remote activation and control, and the ability to continue operating in the event power or telecommunications infrastructure goes down are among the advantages of the Genasys system. Genasys speaker arrays and the Zonehaven evacuation management platform are important additions to the City’s emergency services resources.”

Genasys provides the only critical communications platform that unifies software, geo-data analytics, multiple sensor inputs, and multichannel alerting that includes industry leading voice speaker arrays.

About Genasys Inc.

Genasys^® is a global provider of critical communications systems and solutions that help protect and keep people safe. Genasys provides a multichannel approach to deliver geo-targeted alerts, notifications, instructions and information before, during and after public safety threats and critical business events. The Company’s unified critical communications platform includes Genasys Emergency Management (GEM) software-as-a-service, Integrated Mass Notification Systems (IMNS), Zonehaven™ emergency evacuation resources, National Emergency Warning Systems (NEWS), LRAD^® long-range voice broadcast systems, and more.

Genasys systems are in service in more than 100 countries in a range of diverse applications, including public safety, emergency warning, mass notification, critical event management, defense, law enforcement, homeland security, and other applications. For more information, visit genasys.com.

Forward-Looking Statements

Except for historical information contained herein, the matters discussed are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on these statements. We base these statements on particular assumptions that we have made in light of our industry experience, the stage of product and market development as well as our perception of historical trends, current market conditions, current economic data, expected future developments and other factors that we believe are appropriate under the circumstances. These statements involve risks and uncertainties that could cause actual results to differ materially from those suggested in the forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties, including without limitation the business impact of health crises or outbreaks of disease, such as epidemics or pandemics and how they may affect our supply chain, and other risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. Risks and uncertainties are identified and discussed in our filings with the Securities and Exchange Commission. These forward-looking statements are based on information and management’s expectations as of the date hereof. Future results may differ materially from our current expectations. For more information regarding other potential risks and uncertainties, see the “Risk Factors” section of the Company’s Form 10-K for the fiscal year ended September 30, 2021. Genasys Inc. disclaims any intent or obligation to update those forward-looking statements, except as otherwise specifically stated.

Investor Relations Contact

Kimberly Rogers
Hayden IR

[email protected]

Company to Review Recently Announced $5 Billion of Offtake Contracts for SAF and RD

CUPERTINO, CA , Jan. 19, 2022 (GLOBE NEWSWIRE) — via NewMediaWire – Aemetis, Inc. (NASDAQ: AMTX), a renewable natural gas and renewable fuels company focused on negative carbon intensity products, announced that Chairman and CEO Eric McAfee will provide an overview of the Aemetis Dairy RNG, Aviation Fuel, Renewable Diesel, Ethanol and Carbon Sequestration businesses at the 27th Annual Credit Suisse Energy Summit which will be held at the Grand Hyatt Vail in Vail, Colorado on February 28, 2022.   

McAfee will present on the topic “$5 billion of New Contracts for Aemetis Carbon Zero Renewable Fuels: Sustainable Aviation Fuel, Renewable Diesel, Dairy RNG, Ethanol, Biodiesel, CO2 Sequestration.” 

The Aemetis Carbon Zero, 90 million gallons per year, renewable jet/diesel fuel plant is currently completing engineering and permitting for the 125-acre Riverbank, California site.

“Aemetis has recently announced $2 billion of sustainable aviation fuel contracts with Delta Air Lines and American Airlines, with seven signed MOU’s for additional contracts with members of the oneworld Alliance,” stated McAfee. “In addition, we signed a $3.1 billion supply contract with a large travel stop company to provide renewable diesel to California locations.”

McAfee noted, “These final, signed contracts provide 100% of the LCFS, RFS, Blender’s Tax Credit and fuel value to Aemetis as the producer of the renewable fuel, and the aviation fuel is being supplied at a price premium over petroleum jet fuel.”  

Aemetis is also constructing a 52-site Dairy Renewable Natural Gas project near Modesto, California. Phase 1 of the RNG project with two dairy digesters and a 4 mile pipeline is completed and operational. Phase 2 of the project is under construction, including a biogas upgrading facility to produce RNG, a PG&E utility gas pipeline interconnect, 15 additional dairy digesters, and 32 miles of pipeline.

The Aemetis Biogas Central Dairy Digester project has already obtained a negative 426 (-426) carbon intensity rating from the California Air Resources Board (CARB) for biogas produced by Phase I.  

When fully built out, the planned 52 dairy digesters in the Aemetis biogas project are expected to capture more than 1.4 million MMBtu of dairy methane and reduce greenhouse gas emissions equivalent to an estimated 5.2 million metric tonnes of CO2 each year, equal to removing the emissions from approximately 1.1 million cars per year.  

The Aemetis Biogas dairy RNG project, energy efficiency upgrades to the Aemetis Keyes biofuels plant, and the Aemetis Renewable Jet/Diesel project include $57 million of grant funding and other support from the US Department of Agriculture, the US Forest Service, the California Energy Commission, the California Department of Food and Agriculture, CAEATFA, and Pacific Gas and Electric’s energy efficiency program.

About Aemetis

Aemetis has a mission to transform renewable energy with below zero carbon intensity transportation fuels. Aemetis has launched the Carbon Zero production process to decarbonize the transportation sector using today’s infrastructure. 

Aemetis Carbon Zero products include zero carbon fuels that can “drop in” to be used in airplane, truck, and ship fleets. Aemetis low-carbon fuels have substantially reduced carbon intensity compared to standard petroleum fossil-based fuels across their lifecycle. 

Headquartered in Cupertino, California, Aemetis is a renewable natural gas, renewable fuel and biochemicals company focused on the acquisition, development and commercialization of innovative technologies that replace petroleum-based products and reduce greenhouse gas emissions.  Founded in 2006, Aemetis has completed Phase 1 and is expanding a California biogas digester network and pipeline system to convert dairy waste gas into Renewable Natural Gas. Aemetis owns and operates a 65 million gallon per year ethanol production facility in California’s Central Valley near Modesto that supplies about 80 dairies with animal feed. Aemetis also owns and operates a 50 million gallon per year production facility on the East Coast of India producing high quality distilled biodiesel and refined glycerin for customers in India and Europe.  Aemetis is developing the Carbon Zero sustainable aviation fuel (SAF) and renewable diesel fuel biorefineries in California to utilize distillers corn oil and other renewable oils to produce low carbon intensity renewable jet and diesel fuel using cellulosic hydrogen from waste orchard and forest wood, while pre-extracting cellulosic sugars from the waste wood to be processed into high value cellulosic ethanol at the Keyes plant. Aemetis holds a portfolio of patents and exclusive technology licenses to produce 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 the development and construction of the carbon sequestration facilities, biogas lagoon digesters, biogas cleanup and compression unit, construction and operation of the biogas pipeline, our compliance with governmental programs, and our ability to access markets and funding to execute our business plan.  Words or phrases such as “anticipates,” “may,” “will,” “should,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “showing signs,” “targets,” “view,” “will likely result,” “will continue” 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, including our Annual Report on Form 10-K for the year ended December 31, 2020 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]

ATLANTA, Jan. 19, 2022 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading healthcare and human services provider to the federal government, will release its financial results for the fiscal first quarter ended December 31, 2021 on January 31, 2022 after the market closes. DLH will then host a conference call for the investment community at 10:00 a.m. Eastern Time on February 1, 2022 during which members of senior management will make a brief presentation focused on the financial results and operating trends. A question-and-answer session will follow. 

Interested parties may listen to the conference call by dialing 888-347-5290 or 412-317-5256. Presentation materials will also be posted on the Investor Relations section of the DLH website prior to the commencement of the conference call. A digital recording of the conference call will be available for replay two hours after the completion of the call and can be accessed on the DLH Investor Relations website or by dialing 877-344-7529 and entering the conference ID 8200479.

About DLH


DLH (NASDAQ:DLHC) delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit http://www.DLHcorp.com.

INVESTOR RELATIONS

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

 

Systemic bioavailability of JAK inhibitor (tofacitinib) and S1P receptor modulator (fingolimod) in topical formulation substantially lower compared to oral equivalents

Mean C

_max

of tofacitinib 50-fold and 1500-fold lower at Day 1 and 14 of study compared to the lowest commercially available oral alternative

Findings from Phase 1b safety portion of study support trial continuation

Topline Phase 2a results expected in Q1 2022

BRIDGEWATER, N.J., Jan. 19, 2022 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that it has completed the Phase 1b portion of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) (Study VY2021-01). FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD. FMX114 has the potential to be the first topical combination product for the treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor modulation mode of action.

The objective of the Phase 1b portion of the study was to evaluate the preliminary clinical safety, dermal tolerance and pharmacokinetics of FMX114 and vehicle gels when topically applied for up to 2 weeks to individual qualifying atopic dermatitis lesions. The study planned to enroll up to 6 subjects with mild to moderate atopic dermatitis in this Phase 1b safety portion. However, based on the data obtained from the first two completing subjects, the Human Research Ethics Committee (HREC) in Australia overseeing the study agreed to reduce the enrollment number to 4 subjects with mild to moderate atopic dermatitis.

At the study baseline visit, each subject had two AD lesions of comparable severity and extent based on the Atopic Dermatitis Severity Index (ADSI) scoring assessment and qualifying lesions were randomized to either FMX114 or vehicle gel treatment. Adverse events, clinical laboratory results and local dermal tolerance data was collected throughout subject participation in the study. Pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate were evaluated based on blood/plasma concentration data obtained from highly sensitive and validated bioanalytical methods.

Both FMX114 and vehicle gel treatments were generally well-tolerated, and no serious adverse events were recorded during study conduct. Pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate are summarized below:

• The mean plasma C_max of tofacitinib calculated on treatment day 1 and day 14 were approximately 50-fold and 1500-fold lower, respectively, when compared to the equivalent data for the lowest commercially available adult oral dose of tofacitinib (XELJANZ 5mg BD).¹
  • The mean plasma C_max of tofacitinib was determined to be 0.914 ng/ml and 0.0220 ng/ml on treatment day 1 and 14 respectively (assay Lower Limit of Quantification [LLOQ]: 0.01ng/ml).
  • Systemic drug accumulation of tofacitinib was negligible over the dosing period, with an accumulation ratio calculation based on C_max of 0.03. In samples obtained one week after the end of treatment, tofacitinib was not quantifiable (<0.01ng/ml).
• The pharmacokinetics of fingolimod and active metabolite, fingolimod 1-phosphate could not be determined as all whole blood concentrations were below the assay LLOQ (0.08ng/ml for both analytes). The mean whole blood C_max for fingolimod and fingolimod 1-phosphate for the adult oral dose of fingolimod (GILENYA 0.5mg QD) is 3.7ng/ml and 1.8ng/ml respectively at steady state.²

Dr. Iain Stuart, Chief Scientific Officer of VYNE, stated, “FMX114 was designed to deliver both active drugs efficiently to the skin while minimizing their respective systemic exposures. We are encouraged by the results from the Phase 1b portion of study VY2021-01 and look forward to announcing top-line Phase 2a results later this quarter.”

About Study VY2021-01 (ClinicalTrials.gov Identifier: NCT04927572)

The Phase 1b/2a study is a randomized, double-blinded trial designed to compare the safety and efficacy of FMX114 gel with vehicle gel. The study is expected to enroll up to 31 subjects, with each subject serving as their own control. The enrollment criteria specifies that subjects must have two comparable target AD lesions for treatment upon entry. Participants will have FMX114 gel applied to one of these lesions and vehicle gel to the other. Up to six subjects will be initially treated twice daily with FMX114 and vehicle for up to two weeks to evaluate preliminary safety of FMX114 and the pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate. A further 25 subjects will receive FMX114, and vehicle treatment applied twice daily for four weeks in a double-blinded phase of the study to further evaluate safety, pharmacokinetics and efficacy. After completion of this phase, these subjects may continue into a two-week open-label treatment phase and will be able to apply the active drug to both lesions. The trial is being conducted in Australia in subjects with mild-to-moderate atopic dermatitis (clinicaltrials.gov link) in two segments:

1. XELJANZ/XELJANZ XR/XELJANZ Oral Solution US Prescription Information, December 2021
2. Clinical Pharmacokinetics of Fingolimod, Clin Pharmacokinet 2012;51(1):15-28]

About FMX114

FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD by developing a distinct combination of tofacitinib (a Janus kinase inhibitor) aimed at reducing inflammation by inhibiting cytokine release from inflammatory cells) and fingolimod (a Sphingosine 1-phosphate receptor modulator) which approaches the reduction of inflammation by inhibiting migration of inflammatory cells, and in addition may also directly support skin barrier recovery. FMX114 has the potential to be the first topical combination product for the treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor modulation mode of action.

About Atopic Dermatitis

Atopic dermatitis (AD) is a chronic, severe form of eczema that is characterized by the appearance of dry, red, and itchy skin. AD most commonly affects the cheeks, arms, and legs. Flare ups often occur and symptoms can worsen leading to more-intense itching and worsening of disease. AD flares are triggered by stress, temperature changes, sweat, various skin irritants, and allergies. AD can have a wide-ranging impact on quality of life and there is a substantial monetary burden from direct and indirect costs to this patient population. While AD occurs most often in childhood, it can develop at any point in a person’s lifetime and affects approximately 30 million people in the U.S. alone. Approximately 22 million of those diagnosed are on treatment, with 19 million registering mild to moderate disease.  According to Symphony Health data, there were over 7 million prescriptions written in 2019 alone for the treatment of AD.

About VYNE Therapeutics Inc.

VYNE’s mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company’s unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential treatment of major immuno-inflammatory conditions and rare skin diseases.

For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

Investor Relations:

John Fraunces
LifeSci Advisors, LLC
917-355-2395
[email protected]

Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
[email protected]

Cautionary Statement Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s product candidate, FMX114, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the outcome and cost of preclinical and clinical trials for current and future product candidates; determination by the FDA that results from VYNE’s preclinical and clinical trials are not sufficient to support registration or marketing approval of product candidates; adverse events associated with the development and commercialization of FMX114 and VYNE’s other product candidates; the COVID-19 pandemic and its impact on our business operations and liquidity, including our ability to progress a preclinical or clinical trial; the size of the atopic dermatitis market; the potential patient base and commercial potential of FMX114 or any of VYNE’s other product candidates; risks of potential litigation by third-parties regarding infringement of third-party intellectual property; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the markets in which we compete; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

NASHVILLE, Tenn., Jan. 19, 2022 (GLOBE NEWSWIRE) — SmileDirectClub, Inc. (Nasdaq: SDC), the next generation oral care company with the first medtech platform for teeth straightening, today announced the expansion of its award-winning whitening product line with its new Fast-Dissolving Whitening Strips.

The new convenient and easy to use Fast-Dissolving Whitening Strips are the ideal whitening treatment for those who want results fast, without the mess of traditional whitening strips. With a short wear time – just once a day for 15 minutes – the Fast-Dissolving Whitening Strips are perfect for those who suffer from painful sensitivity caused by other longer-wear whitening strips. In just seven days, the new Strips can whiten teeth up to nine shades* in half the wear time when compared to 30-minute-wear strips.

SmileDirectClub is pleased to partner with Peloton star trainer Tunde Oyeneyin to help promote this exciting new launch and highlight the convenience of this innovative and highly effective whitening product. Like SmileDirectClub, Oyeneyin believes that a great smile has a transformational power to boost your self-confidence, making her an ideal partner for this launch. Throughout the partnership, Tunde will share how she incorporates the new Fast-Dissolving Whitening Strips into her self-care routine and how they have positively impacted her confidence.

“With the introduction of the Fast-Dissolving Whitening Strips, SmileDirectClub is revolutionizing the way we look at whitening teeth,” said Amy Keith, General Manager of Global Oral Care at SmileDirectClub. “The new Strips allow customers to customize their teeth whitening journey by applying them anywhere, anytime, making teeth whitening convenient and accessible no matter where or when you choose to whiten.”

The SmileDirectClub Fast-Dissolving Whitening Strips are available as a one-week ($30) or two-week ($45) treatment, available now on Shop.SmileDirectClub.com and Amazon and will be launching in over 4,600 Walmart locations in late February as well as other major retailers across North America later in Q1. The Fast-Dissolving Whitening Strips complement SmileDirectClub’s existing best-in-class product offerings, including a portfolio of top-selling whitening products as well as the recently released Water Flossers.

According to recent research, a majority of those surveyed believe having a whiter smile would boost their self-confidence. Additionally, almost half (40%) of individuals want to focus on their oral care – teeth whitening, cleaning, straightening – as a means of improving their overall health in 2022.**

SmileDirectClub is the only clear aligner brand that offers customers an end-to-end solution to keep teeth straighter, brighter and cleaner. Since its launch, SmileDirectClub has become one of the fastest-growing health technology companies and continues to be the leading telehealth platform for orthodontia.

About SmileDirectClub 
SmileDirectClub, Inc. (“SmileDirectClub”) is an oral care company and creator of the first medtech platform for teeth straightening. Through its cutting-edge telehealth technology and vertically integrated model, SmileDirectClub is revolutionizing the oral care industry. SmileDirectClub’s mission is to democratize access to a smile each and every person loves by making it affordable and convenient for everyone. SmileDirectClub is headquartered in Nashville, Tennessee and operates in the U.S., Canada, Australia, New Zealand, United Kingdom, Ireland, Hong Kong, Singapore, Spain, France and Mexico. For more information, please visit SmileDirectClub.com.

Contact: SmileDirectClub Media Relations: [email protected] 

* Maximum results when used as directed. Results may vary.  
** Source: Pollfish Survey, n=1,000 US Consumers, 16+ years old with representative market mix of gender, ethnicity, age group, HH income, and geographic location.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/589fe684-5e64-498e-9c86-670be3199eb3

https://www.globenewswire.com/NewsRoom/AttachmentNg/35e463be-86f0-4ed8-9da5-cc5fa3aadd1a

 

GUILFORD, Conn. and MINNEAPOLIS, Jan. 19, 2022 (GLOBE NEWSWIRE) — Hyperfine, Inc. (Nasdaq: HYPR) (“Hyperfine”), creator of the first U.S. Food and Drug Administration (“FDA”) cleared portable magnetic resonance imaging (“MRI”)™ device, Swoop®, is proud to announce that M Health Fairview is deploying a Swoop system in the emergency room (ER), intensive care unit (ICU) and post anesthesia environments at M Health Fairview University of Minnesota Medical Center. The hospital is the first in the state of Minnesota, and one of the first in the country, to offer this technology to its patients.

“Forward thinking academic institutions like University of Minnesota are leading the charge adopting new, robust technologies in support of advancing research and improving the care continuum,” said Dr. Khan Siddiqui, MD, Chief Medical Officer and Chief Strategy Officer, for Hyperfine. “Swoop was designed to address the complex issues these institutions face by eliminating long wait times and minimizing difficulties with transporting patients, all while improving staff workflow and reducing costs.”

Swoop’s portable design and easy-to-use interface make it accessible for use in hospitals, clinics, and other settings outside of the conventional MRI suite. Instead of requiring a team of three to four nurses to transport a critically ill patient to an MRI room on a different floor, the Swoop system can be wheeled straight to a patient’s bed. The Swoop system is also a fraction of the cost of a traditional MRI unit, which helps hospitals and patients save valuable time and financial resources.

Swoop® was designed to enable rapid diagnoses and treatment for every patient regardless of income, resources, or location, pushing the boundaries of conventional imaging technology and expanding patient access to life-saving care. In as little as 30 seconds after a Swoop scan, advanced artificial intelligence applications analyze and return annotated, segmented brain images, providing clinicians with quantitative markers for decision support and immediate feedback for diagnostic insight.

“Patient safety and advancing the standard of care for our patient are of the highest priority for M Health Fairview,” said Dr. Clark Chen, MD, PhD, M Health Fairview neurosurgeon, Lyle French Chair in Neurosurgery and the head of the University of Minnesota Medical School Department of Neurosurgery. “We have invested in a trial of the Hyperfine’s Swoop system because we believe that the technology enhances patient safety and represents the next stage of how artificial intelligence can redefine the future of patient care.”

Through deep learning and artificial intelligence-aided image reconstruction, Swoop is able to assess brain tissue in real-time which provides physicians the ability to make quick and informed clinical decisions for patients. Swoop results are displayed on a tablet and deliver crisp, clear T1, T2, FLAIR, and DWI (with ADC map) tissue contrasts within minutes before uploading the scans to local PACS (Picture Archive and Communications System).

The device also has a lower field strength than standard MRI systems which greatly enhances patient safety and shortens the time required for each MRI. These features allow clinicians to quickly scan, diagnose and treat patients within crowded healthcare environments like ERs, ORs, and ICUs. The device also eliminates the need for comprehensive metal detection, allowing for parents of pediatric patients to stay bedside while their children get life-saving scans.

To date, the Hyperfine Swoop Portable MRI System™ has been deployed at Yale New Haven Hospital, University of California Irvine Medical Center, Ohio State University Wexner Medical Center, and the University of Illinois at Chicago’s Surgical Innovation Training Lab.

For more information about the Hyperfine Swoop Portable MRI System, please visit http://www.hyperfine.io.

About Hyperfine and the Swoop Portable MR Imaging System

Hyperfine, Inc. is the groundbreaking medical device company that created Swoop, the world’s first FDA-cleared portable MRI system. Hyperfine designed Swoop to enable rapid diagnoses and treatment for every patient regardless of income, resources, or location, pushing the boundaries of conventional imaging technology and expanding patient access to life-saving care. The Swoop Portable MR Imaging System produces high-quality images at a lower magnetic field strength, allowing clinicians to quickly scan, diagnose, and treat patients in various clinical settings. Swoop can be wheeled directly to the patient’s bedside, plugged into a standard electrical wall outlet, and controlled by a tablet. Designed as a complementary system to conventional MRIs at a fraction of the cost, Swoop captures images in minutes, providing critical decision-making capabilities in emergency departments (ED), operating rooms (OR) outside the sterile field, and intensive care units (ICU), among others.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Hyperfine’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about the benefits of Hyperfine’s products and services, their impact on the future of patient care, and M Health Fairview’s use of the Swoop system. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of Hyperfine’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of Hyperfine product development and commercialization activities, including the degree that Swoop is accepted and used by healthcare professionals; the impact of COVID-19 on Hyperfine’s business; the inability to maintain the listing of Hyperfine’s Class A common stock on the Nasdaq following the recently completed business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and Hyperfine’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of Hyperfine to raise financing in the future; the inability of Hyperfine to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of Hyperfine to identify, in-license or acquire additional technology; the inability of Hyperfine to maintain its existing or future license, manufacturing, supply and distribution agreements; the inability of Hyperfine to compete with other companies currently marketing or engaged in the development of products and services that Hyperfine is currently marketing or developing; the size and growth potential of the markets for Hyperfine’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of Hyperfine’s products and services and reimbursement for medical procedures conducted using Hyperfine’s products and services; Hyperfine’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; Hyperfine’s financial performance; and other risks and uncertainties indicated from time to time in Hyperfine’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. Hyperfine cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Hyperfine does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Media Contacts


Emily Barnes
APCO Worldwide
[email protected] 

Aimee Jordan
M Health Fairview
[email protected]