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Investigational New Drug (IND) application submitted to U.S. Food and Drug Administration (FDA) for ELX-02 for the treatment of Alport syndrome with nonsense mutations

Rebound in average UPCR 3-months post treatment provides further evidence that proteinuria remission in one out of three patients was drug related

All 3 Alport patients (100% response rate) treated with ELX-02 had biopsy confirmed disease regression, suggesting clinical benefit likely with longer treatment duration

Significant strategic interest in ZKN-013 following FDA approval to start Phase 1 single ascending dose (SAD) trial

WATERTOWN, Mass., Sept. 07, 2023 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today provided an update on the continued advancement of ELX-02 for the treatment of Alport syndrome with nonsense mutations, including additional positive results from its Phase 2 clinical study evaluating ELX-02, as well as an update on ZKN-013.

Alport syndrome is a rare genetic kidney disorder caused by mutations in COL4A3/4/5 genes, characterized by podocyte injury and impaired kidney filter function leading to proteinuria.

“We have shared the results of our Phase 2 study with several key opinion leaders and key stakeholders within the Alport syndrome community. They have expressed uniform and overwhelming strong support for the potential of ELX-02 to treat this devasting indication and the need to advance into a pivotal study,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx.

IND Submitted to U.S. FDA for Alport Syndrome

Based on the encouraging clinical results to date, Eloxx has submitted an IND application with the U.S. FDA for ELX-02 for the treatment of Alport syndrome with nonsense mutations. Allowance of the IND will allow for the inclusion of U.S.-based sites in the planned pivotal trial.

Biopsy Results from ELX-02 Phase 2 Alport Trial Support Protein Restoration

All three patients (100% response rate) treated with ELX-02 in its proof-of-concept Phase 2 open-label clinical trial (NCT05448755) showed an improvement in podocyte foot process effacement, a hallmark of proteinuric kidney diseases like Alport syndrome. Electron microscopy images of biopsy samples showed an improvement in the glomerular basement membrane and a re-attachment of podocyte foot processes in all treated patients. This confirms protein restoration and the disease modifying effect of ELX-02 and potential for improvement in proteinuria with longer duration of treatment. Podocytes are specialized cells that bind to the glomerular basement membrane and form finger-like extensions called foot processes that enable efficient ultrafiltration. Podocyte injury leads to the effacement (loss) of podocyte foot processes and proteinuria in nearly all cases of Alport syndrome. Eloxx previously announced achievement of remission in one patient

Eloxx is announcing today 3 month post treatment results. The increase in UPCR following withdrawal of therapy confirms likely on-treatment remission in one out of three patients, providing additional evidence of drug activity.

*Patient who achieved remission.

Strategic Interest in ZKN-013

As we previously announced, the FDA has cleared the company to begin a SAD trial in healthy volunteers for ZKN-013 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) and junctional epidermolysis bullosa (JEB).

Eloxx has since received significant strategic interest in ZKN-013, which the company is actively pursuing. Should these discussions lead to a transaction, it will allow Eloxx to remain focused on fully maximizing the potential of ELX-02 in rare kidney diseases and continue funded discovery efforts on our TURBO-ZM platform.

About Eloxx Pharmaceutical

Eloxx Pharmaceuticals, Inc. is engaged in the science of ribosome modulation, leveraging its innovative TURBO-ZM™ chemistry technology platform in an effort to develop novel Ribosome Modulating Agents (RMAs) and its library of Eukaryotic Ribosome Selective Glycosides (ERSGs). Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ELX-02 for the treatment of CF patients with nonsense mutations. In addition, ELX-02 has also been granted Orphan Drug Designation for the treatment of CF patients with nonsense mutations by the FDA and orphan medicinal product designation by the European Commission. ELX-02 is in clinical development, focusing on cystic fibrosis (US Trial NCT04135495, EU/IL Trial NCT04126473). Eloxx also has preclinical programs focused on select rare diseases, including inherited diseases, cancer caused by nonsense mutations, kidney diseases, including autosomal dominant polycystic kidney disease, as well as rare ocular genetic disorders.

For more information, please visit www.eloxxpharma.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of present and historical facts contained in this press release, including without limitation, the expected timing of trials of our product candidates and the potential of our product candidate to treat nonsense mutations are forward-looking statements. Forward-looking statements can be identified by the words “aim,” “may,” “will,” “would,” “should,” “expect,” “explore,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections based on information currently available to us. Forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and actual results or outcomes may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to progress any product candidates in preclinical or clinical trials; the uncertainty of clinical trial results and the fact that positive results from preclinical studies are not always indicative of positive clinical results; the scope, rate and progress of our preclinical studies and clinical trials and other research and development activities; the competition for patient enrollment from drug candidates in development; the impact of the global COVID-19 pandemic on our clinical trials, operations, vendors, suppliers, and employees; our ability to obtain the capital necessary to fund our operations; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain financial in the future through product licensing, public or private equity or debt financing or otherwise; general business conditions, regulatory environment, competition and market for our products; and business ability and judgment of personnel, and the availability of qualified personnel and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, as any such factors may be updated from time to time in our other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the “Financials & Filings” page of our website at https://investors.eloxxpharma.com/financials-filings.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact

Investors
John Woolford
[email protected]
443.213.0506

Media
Laureen Cassidy
[email protected]

SOURCE: Eloxx Pharmaceuticals, Inc. 

Quincy, MA, Sept. 07, 2023 (GLOBE NEWSWIRE) — Stran & Company, Inc. (“Stran” or the “Company”) (NASDAQ: SWAG) (NASDAQ: SWAGW), a leading outsourced marketing solutions provider that leverages its promotional products and loyalty incentive expertise, today announced that it has launched a new loyalty program for a client that has received more than 22,000 orders in the first week of the redemption period, generating more than $2 million in sales.

Stran’s client, an online sports and entertainment company, invests in both customer acquisition and retention initiatives that Stran supports through a combination of physical and experiential rewards designed to drive behavior. The loyalty program rewards are offered to the client’s consumers in the form of products that can be redeemed online. The program is an example of one of several such programs based on Stran’s e-commerce loyalty program platform, which supports all aspects of client and consumer engagement from product ideation, production, technology, logistics, inventory management, fulfillment, and reporting to ensure a seamless experience for both the client and their consumers.

The maximum number of orders from this program will be approximately 45,000, for total maximum sales of approximately $4 million.

“We are thrilled to see the volume of redemptions that took place in the initial week of our engagement, as it speaks to the effectiveness of both the overarching loyalty strategy as well as the specific offering to the client’s consumer base,” stated Andy Shape, CEO of Stran. “Our creative, merchandising, sourcing, production, and logistics capabilities are helping our client to retain their customers. This is an example of one of several loyalty and incentive-based initiatives that we offer to assist our clients with the goal of driving customer retention.  Moreover, given the results so far from this program, we look forward to rolling out similar programs with this client in the future as we continue to expand our relationship.”

About Stran

Over the past 27 years, Stran has grown to become a leader in the promotional products industry, specializing in complex marketing programs to help recognize the value of promotional products, branded merchandise, and loyalty incentive programs as a tool to drive awareness, build brands and impact sales. Stran is the chosen promotional programs manager of many Fortune 500 companies, across a variety of industries, to execute their promotional marketing, loyalty and incentive, sponsorship activation, recruitment, retention, and wellness campaigns. Stran provides world-class customer service and utilizes cutting-edge technology, including efficient ordering and logistics technology to provide order processing, warehousing and fulfillment functions. The Company’s mission is to develop long-term relationships with its clients, enabling them to connect with both their customers and employees in order to build lasting brand loyalty. Additional information about the Company is available at: www.stran.com.

Forward Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s periodic reports which are filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Contacts:

Investor Relations Contact

Crescendo Communications, LLC
Tel: (212) 671-1021
[email protected]

Press Contact

Howie Turkenkopf
[email protected]

SAN JOSE, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) — Synaptics Incorporated (Nasdaq: SYNA) today reiterated its previous guidance for the first quarter of fiscal 2024 that was issued on August 3, 2023.

As previously announced, the company will host a Financial Analyst & Investor Day today at The Yale Club in New York City from 2:00pm to 5:00pm ET.

At the event, the company will discuss its long-term strategy, product portfolio and growth opportunities in the IoT markets. Presentations will be made by the following members of the executive team followed by a live Q&A session:

• Michael Hurlston – President and Chief Executive Officer
• Dean Butler – Chief Financial Officer
• Venkat Kodavati – General Manager, Wireless Products
• Vikram Gupta – General Manager, IoT Processors
• Saleel Awsare – General Manager, Enterprise and Mobile

We invite all interested parties to participate in the live webcast, which can be accessed at Investor Day 2023. (https://edge.media-server.com/mmc/p/e6nnz47v). Further, a copy of the presentation material will be available immediately prior to the event. A replay of the event will be available for approximately one year on the Investor Relations section of the company’s website at https://investor.synaptics.com/.

Business Outlook

For the first quarter of fiscal 2024, the company expects:

*Projected Non-GAAP gross margin excludes $17.0 million of intangible asset amortization and $1.0 million of share-based compensation.

**Projected Non-GAAP operating expense excludes $29.0 million to $31.0 million of share-based compensation, $7.0 million to $10.0 million restructuring costs, and $6.0 million of intangible asset amortization.

About Synaptics Incorporated:

Synaptics (Nasdaq: SYNA) is changing the way humans engage with connected devices and data, engineering exceptional experiences throughout the home, at work, in the car, and on the go. Synaptics is the partner of choice for the world’s most innovative intelligent system providers who are integrating multiple experiential technologies into platforms that make our digital lives more productive, insightful, secure, and enjoyable. These customers are combining Synaptics’ differentiated technologies in touch, display, and biometrics with a new generation of advanced connectivity and AI-enhanced video, vision, audio, speech, and security processing. Follow Synaptics on LinkedIn, Twitter, and Facebook, or visit synaptics.com.

Synaptics and the Synaptics logo are trademarks of Synaptics in the United States and/or other countries. All other marks are the property of their respective owners.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to the safe harbors created under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. Forward-looking statements give our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business, and can be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements may include words such as “expect,” “anticipate,” “intend,” “believe,” “estimate,” “plan,” “target,” “strategy,” “continue,” “may,” “will,” “should,” variations of such words, or other words and terms of similar meaning. All forward-looking statements reflect our best judgment and are based on several factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Such factors include, but are not limited to, the risk that our business, results of operations and financial condition and prospects may be materially and adversely affected by the temporary reduction in demand for our products resulting from accumulated inventories held by our customers and channel partners; the risks as identified in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” sections of our most recent Annual Report on Form 10-K; and other risks as identified from time to time in our Securities and Exchange Commission reports. Forward-looking statements are based on information available to us on the date hereof, and we do not have, and expressly disclaim, any obligation to publicly release any updates or any changes in our expectations, or any change in events, conditions, or circumstances on which any forward-looking statement is based. Our actual results and the timing of certain events could differ materially from the forward-looking statements. These forward-looking statements do not reflect the potential impact of any mergers, acquisitions, or other business combinations that had not been completed as of the date of this release.

For further information, please contact:

Munjal Shah
Synaptics
+1-408-518-7639
[email protected]

FARMINGTON HILLS, Mich., Sept. 07, 2023 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that it will present clinical data on APX3330 and Nyxol^® at the 41st Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) to take place September 8th – 11th, in Vienna, Austria. In addition, Bindu Manne, Head of Market Development and Commercialization at Ocuphire, will deliver a corporate presentation at the MODLive! Conference to take place September 8th – 10th, in Nashville, TN.

About Ocuphire Pharma

Ocuphire Pharma, Inc. is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders.

Ocuphire’s lead retinal product candidate, APX3330, is a first-in-class small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1a and NF-kB. Inhibiting REF-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. Through inhibition of Ref-1, APX3330 normalizes the levels of VEGF to physiologic levels, unlike biologics that abolish the VEGF levels required for normal function. APX3330 is an oral tablet administered twice per day for the treatment of diabetic retinopathy (“DR”) and diabetic macular edema (“DME”). A Phase 2 study in subjects with DR or DME has recently completed, and an End-of-Phase 2 meeting is confirmed with the FDA in Q4 2023.

DR affects approximately 10 million people with diabetes and is projected to impact 14.6 million Americans by 2050. DR is classified as Non-Proliferative Diabetic Retinopathy (“NPDR”), the early stage of the disease in which symptoms may be mild or nonexistent or Proliferative Diabetic Retinopathy (“PDR”) which is the more advanced stage of diabetic eye disease that can be highly symptomatic with loss of vision. Approximately 80% of DR patients have NPDR that will progress to PDR if left untreated. Despite the risk for visual loss associated with this disease, over 90% of NPDR patients currently receive no course of treatment apart from observation by their eye care specialist until they develop sight-threatening complications. This is due to the burdensome and frequent eye injections currently required with currently approved therapies for this disease. APX3330 as an oral tablet has the potential to be an early, non-invasive treatment for the 8 million NPDR patients in the US. Treatment with APX3330 is expected to delay or prevent progression of NPDR, thereby reducing the need for expensive intravitreal injections with anti-VEGF therapies and reducing the likelihood of vision loss due to DR.

Ocuphire has also in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330. The unique dual mechanism of action of these Ref-1 inhibitors of reducing angiogenesis and inflammation could potentially be beneficial in treating other retinal diseases such as age-related macular degeneration (“AMD”), and geographic atrophy (“GA”). Ocuphire is currently evaluating local delivery routes in addition to the systemic (oral) route as part of its pipeline expansion in retinal therapies.

Ocuphire has a partnership with Viatris, Inc. to develop and commercialize Nyxol^® eye drops as a preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by uniquely blocking the alpha-1 receptors found only on the iris dilator muscle without affecting the ciliary muscle. Nyxol has been studied in a total of 12 clinical trials across three indications, including single-use for reversal of pharmacologically-induced mydriasis (“RM”), and once-daily for treatment of presbyopia and dim light (night) vision disturbances (“DLD”), pending regulatory approvals. Nyxol’s NDA under the 505(b)(2) pathway for the first indication, RM, has been accepted with a PDUFA date assigned of September 28, 2023. Nyxol is currently in Phase 3 for presbyopia and DLD.

For more information, visit www.ocuphire.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. Such statements include, but are not limited to, statements concerning the End-of-Phase 2 meeting with the FDA to confirm Phase 3 registration endpoints and study parameters, and the potential receipt of regulatory approval for Nyxol for the treatment of RM. These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) risks that the Nyxol partnership may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates; (x) the success and timing of commercialization of any of Ocuphire’s product candidates, and (xi) the maintenance of Ocuphire’s intellectual property rights. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

IRVING, Texas, Sept. 07, 2023 (GLOBE NEWSWIRE) — Exela Technologies, Inc. (“Exela” or “the Company”) (NASDAQ: XELA, XELAP), a leader in business processing automation (“BPA”) announced today that the Company signed a new customer for its Marketing Execution solution (“XME”). Exela’s customer, a large regional healthcare provider, was using multiple vendors for print, promotional products and branded apparel leading to inefficiencies and escalating costs. The customer also experienced operational issues with reporting, inventory control, and invoicing. Exela’s XME solution will provide real-time reporting, inventory management, and print-on-demand enabling the elimination of over-inventoried items, reducing the cost of carry on their books and eliminating obsolete materials that needed to be discarded. The TCV of the contract is estimated at $7.5 million and will be included in the ITPS segment which generated $765 million of revenue in 2022. 

“The rich features of the XME solution greatly enhances productivity, reduces waste and adds a level of personalization. Additionally, our XME solution will provide cost savings of over 15% while also improving processes,” noted Ken Bechard, President, Integrated Communications Solutions, Exela Technologies.

For more Exela news, commentary, and industry perspectives, visit: 

https://investors.exelatech.com/


And please follow us on social:

Twitter: 

https://twitter.com/exelatech


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Instagram: https://www.instagram.com/exelatechnologies

The information posted on the Company’s website and/or via its social media accounts may be deemed material to investors. Accordingly, investors, media and others interested in the Company should monitor the Company’s website and its social media accounts in addition to the Company’s press releases, SEC filings and public conference calls and webcasts.

About Exela Technologies

Exela is a business process automation (BPA) leader, leveraging a global footprint and proprietary technology to provide digital transformation solutions that improve efficiency, quality, and productivity. With decades of experience operating mission-critical processes, Exela serves a growing roster of more than 4,000 customers throughout 50 countries, including over 60% of the Fortune^® 100. With foundational technologies spanning information management, workflow automation, and integrated communications, Exela’s software and services include multi-industry solution suites addressing finance & accounting, human capital management, facilities optimization, and legal management, as well as industry-specific solutions for banking, healthcare, insurance, and the public sector. Exela is a leader in workflow automation, attended and unattended cognitive automation, digital mailrooms, print communications, and payment processing, with deployments across the globe. Through cloud-enabled platforms, built on a configurable stack of automation modules, and approximately 15,500 employees operating in 21 countries, Exela rapidly deploys integrated technology and operations as an end-to-end digital journey partner.

Forward-Looking Statements
Certain statements included in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding our industry, future events, estimated or anticipated future results and benefits, future opportunities for Exela, and other statements that are not historical facts. These statements are based on the current expectations of Exela management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties, including without limitation those discussed under the heading “Risk Factors” in Exela’s Annual Report and other securities filings. In addition, forward-looking statements provide Exela’s expectations, plans or forecasts of future events and views as of the date of this communication. Exela anticipates that subsequent events and developments will cause Exela’s assessments to change. These forward-looking statements should not be relied upon as representing Exela’s assessments as of any date subsequent to the date of this press release.

Investor and/or Media Contacts:

Vincent Kondaveeti
E: [email protected]

Mary Beth Benjamin
E: [email protected]

SUNNYVALE, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) — GSI Technology, Inc. (Nasdaq: GSIT), developer of the Gemini^® Associative Processing Unit (APU) for AI and high-performance parallel computing (HPPC) and a leading provider of high-performance memory solutions for the networking, telecommunications, and military markets, today announced that Didier Lasserre, Vice President of Sales and Investor Relations will participate in the 16^th Annual “Main Event” Conference to be held on October 3 – 5, 2023 at the Luxe Sunset Boulevard Hotel in Los Angeles.

Mr. Lasserre will host a group presentation on Tuesday, October 3 at 3:00-3:25 PM PST in Track 4 and hold one-on-one meetings on Tuesday, October 3 and Wednesday, October 4.

For more information about registering or to schedule a meeting with the Company, please visit the LD Micro conference website https://www.meetmax.com/sched/event_98269/conference_home.html.

ABOUT GSI TECHNOLOGY

Founded in 1995, GSI Technology, Inc. is a leading provider of semiconductor memory solutions. The Company recently launched radiation-hardened memory products for extreme environments in space and the Gemini^® Associative Processing Unit (APU). This memory-centric design delivers significant performance advantages for diverse AI applications. The Gemini APU architecture removes the I/O bottleneck between the processors and memory arrays by performing massive parallel searches directly in the memory array where data is stored. The novel architecture delivers performance-over-power ratio improvements compared to CPU, GPU, and DRAM for applications like image detection, speech recognition, e-commerce recommendation systems, and more. Gemini is an ideal solution for edge applications with a scalable format, small footprint, and low power consumption where rapid, accurate responses are critical. For more information, please visit www.gsitechnology.com.

Contacts:

Investor Relations

Hayden IR
Kim Rogers
385-831-7337
[email protected]

Media Relations

Finn Partners for GSI Technology
Ricca Silverio
(415) 348-2724
[email protected]

Company

GSI Technology, Inc.
Douglas M. Schirle
Chief Financial Officer
408-331-9802

Boca Raton, FL, Sept. 07, 2023 (GLOBE NEWSWIRE) — INmune Bio (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that harness a patient’s immune system to fight disease, announced today that RJ Tesi, MD, Chief Executive Officer, and David Moss, Chief Financial Officer, will participate in two September 2023 conferences.

Baird Global Healthcare Conference 2023

Dr Tesi and Mr. Moss will be available for one-on-one meetings throughout the conference.

The conference is being held September 12 -13, 2023 at the InterContinental New York Barclay.  To register for the conference, click here:

H.C. Wainwright 25^th Annual Global Investment Conference

Dr Tesi and Mr. Moss will be available for one-on-one meetings throughout the conference. To request a meeting and to register for the conference, click here.

The conference is being held on September 11 – 13, 2023 at the Lotte New York Palace Hotel.

About INmune Bio Inc.

INmune
 
Bio
 
Inc
.
 is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.

Forward Looking Statements

Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:
David Moss, CFO (858) 964-3720
[email protected]

Investor Contact:
Jason Nelson
Core IR
(516) 842-9614 x-823