Market Newsdesk

TUCSON, Ariz., April 18, 2023 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a platform-based life science tools and drug discovery company, today announced the achievement of three significant drug discovery business milestones in the first quarter of 2023.

As reported in January 2023, HTG filed a patent application on December 28, 2022, which included claims directed toward specific compounds, pharmaceutical compositions and methods of treating or preventing disease by administration of the compounds for its first target and indication. These compounds were designed by the company’s advanced machine-learning medicinal chemistry platform using a target-first approach. That work has now been followed up with the first of the key first quarter 2023 milestones – in vitro demonstration of efficacy of the lead compounds both as a standalone therapy and in combination with the current standard of care. HTG considers this result a powerful demonstration of its medicinal chemistry platform.

The second key milestone achieved during the first quarter was the use of the company’s proprietary HTG EdgeSeq RNA profiling platform to biologically interrogate the lead molecules. This data, along with other primary and secondary data, was then introduced into the company’s AI-driven drug discovery engine, resulting in the creation of a second generation of molecules. The second generation of molecules have been subjected to the same in vitro experiments as the first, demonstrating improved efficacy over the first generation of molecules. These results also demonstrate the utility of the AI-driven drug discovery engine in combination with high-quality full transcriptome data.

The third milestone achieved was the use of our AI-driven drug discovery engine to design compounds using transcriptomic data as the starting point. These system-designed compounds showed highly similar characteristics to our lead compounds that were designed starting with the target. These results demonstrate the ability of HTG’s engine to design novel compounds based on transcriptomic data alone, which the company believes will open other applications of this platform, including drug repurposing.

In addition to further advancing the company’s drug discovery platform, these first quarter efforts have significantly advanced candidate molecules through lead optimization for HTG’s first oncology indication in liquid tumors, with a program in solid tumors expected to follow closely behind. This second target for the treatment of solid tumors has been selected and added to HTG’s oncology portfolio, which also includes an early pipeline in neurodegenerative diseases.

“We have made significant progress in the advancement of candidate molecules for our first target during the first quarter of 2023, using profiling study results to inform the selection and design of drug candidates, while further building our existing pipeline with additional oncology indications and neurodegenerative programs,” said Stephen A. Barat, Ph.D., SVP of Therapeutics at HTG. “We have also further advanced our drug discovery engine, enabling us to not only select molecules but to design them. We constructed our engine in a manner that allows future scalability and flexibility for integrating multiple data streams, which I believe gives us the ability to continue to evolve this unique discovery platform going forward.”

About HTG:

HTG is accelerating precision medicine from diagnosis to treatment by harnessing the power of transcriptome-wide profiling to drive translational research, novel therapeutics and clinical diagnostics across a variety of disease areas.

Building on more than a decade of pioneering innovation and partnerships with biopharma leaders and major academic institutes, HTG’s proprietary RNA platform technologies are designed to make the development of life science tools and diagnostics more effective and efficient and to unlock a differentiated and disruptive approach to transformative drug discovery. For more information visit www.htgmolecular.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, including statements regarding the potential of our AI-driven drug discovery engine, the ability of HTG’s engine to design novel compounds based on transcriptomic data and our belief that doing so will open other applications of the platform (including drug repurposing), our expected pipeline advancement, expected future scalability and flexibility in our platform, and the capabilities of our technology. Words such as “designed to,” “believe,” “anticipate,” “expect,” “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, 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 risks associated with drug discovery and development; the risk that our technologies may not provide the benefits that we expect; risks associated with our ability to develop and commercialize our products; risks associated with our ability to enter into licensing, partnering or other transactions for any candidates we discover or develop; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; and risks related to our need for additional capital. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission (SEC), including under the “Risk Factors” heading of our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

HTG Investor Contact:                        

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

BEDMINSTER, N.J., April 18, 2023 (GLOBE NEWSWIRE) — Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, announces that Marisa H. Miceli, MD, Professor of Medicine, Specializing in Fungal Infections and Transplant Diseases, Division of Infectious Diseases, Internal Medicine, at the University of Michigan and her team delivered an oral presentation earlier today at the 33^rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen discussing MAT2203’s clinical impact in treating a compassionate use patient suffering from Rhodotorula mucilaginosa (R. mucilaginosa), a rare and opportunistic invasive fungal infection.

“We are extremely pleased with the positive clinical impact that MAT2203, oral amphotericin B, had on an extremely ill patient with very limited treatment options,” said Dr. Miceli. “R. mucilaginosa infection is rare and challenging to treat, due to innate antifungal resistance requiring long-term amphotericin B treatment, which historically leads to significant nephrotoxicity. In our patient, IV-amphotericin B had to be discontinued due to electrolyte abnormalities and associated toxicities. Following transition, MAT2203 was well-tolerated, and led to a robust clinical response with no renal adverse effects, allowing for six continuous months of treatment with regular outpatient monitoring. Based on our experience, MAT2203 appears to represent a safe and well-tolerated oral treatment option that can be safely administered in the outpatient setting to patients who require long-term antifungal treatment with amphotericin B.”

Key elements of Dr. Miceli’s team presentation included:

• Rhodotorula are a genus of pigmented yeasts and represent a rare, but opportunistic and emerging threat often highly resistant to antifungal therapy. Patients can require months of consistent IV-amphotericin B therapy to clear the infection, putting them at significant risk for kidney toxicity.

• The patient was at risk of amputation of her foot where the infection was located and was generally unable to walk. The patient began treatment with liposomal IV-administered amphotericin B but developed serious kidney toxicities attributed to the use of IV-amphotericin B. As a result, treatment with IV-amphotericin B was discontinued and Dr. Miceli applied to Matinas’ Compassionate Use Expanded Access Program for treatment with MAT2203.
• The patient was admitted for monitored initiation of MAT2203 with a dosing regimen of 300mg, four times a day.
• Following initiation with MAT2203, the patient’s renal function improved and remained at baseline throughout treatment. While taking MAT2203, the patient experienced none of the electrolyte abnormalities evident while taking IV-amphotericin B.
• The patient received MAT2203 daily for six months and ended therapy in January 2023 following complete clinical resolution of the fungal infection while regaining the use of her foot.

“The outcomes observed in this compassionate use case are highly encouraging, although we recognize the data are limited,” said Theresa Matkovits, PhD, Chief Development Officer at Matinas. “This is one of several cases with successful outcomes using MAT2203 as part of our ongoing Expanded Access Program. We are in the final stages of planning a Phase 3 program for MAT2203 with the U.S. Food & Drug Administration. Our goal is to add to the growing body of evidence to fully evaluate the significant potential of MAT2203 in the treatment of invasive fungal infections and, if appropriate, support broader use of this investigational drug.”

MAT2203 is not yet licensed or approved anywhere globally.

About MAT2203

Matinas BioPharma is developing MAT2203 as a potential oral broad-spectrum treatment for invasive deadly fungal infections. Although amphotericin B is a fungicidal agent, it is currently only available through an intravenous route of administration, which is known to be associated with a number of significant safety issues such as renal toxicity and anemia due to very high circulating levels of amphotericin B. MAT2203 has the potential to overcome the significant limitations of the currently available amphotericin B products due to its targeted oral delivery, combining comparable fungicidal activity with targeted delivery resulting in a lower risk of toxicity and potentially creating the ideal antifungal agent for the treatment of invasive fungal infections.

About ECCMID

The European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) has become one of the most comprehensive and influential congresses in the field of infectious diseases and an exciting networking opportunity, bringing together more than 14,000 colleagues from all over the world. The scientific program is built by the ECCMID Programme Committee, an independent group of experts representing all disciplines related to clinical microbiology, infectious diseases, infection control and prevention, and public health.

About Matinas BioPharma

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology to maximize global clinical impact and patient access. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop novel formulations that capitalize on the unique characteristics of the LNC platform.

Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the challenges in achieving safe and effective intracellular delivery for both small molecules and larger, more complex molecules such as mRNA, DNA plasmids, antisense oligonucleotides, and vaccines. The combination of a unique mechanism of action and flexibility with formulation and route of administration (including oral) positions Matinas’ LNC technology potentially to become the preferred next-generation intracellular drug delivery vehicle with distinct advantages over both lipid nanoparticles and viral vectors.   For more information, please visit www.matinasbiopharma.com.

Forward-looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to our business activities, our strategy and plans, our collaborations with National Resilience, Inc. and BioNTech SE, the potential of our LNC platform delivery technology, and the future development of its product candidates, the Company’s ability to identify and pursue development, licensing and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as “expects,” “anticipates,” “intends,” “plans,” “could,” “believes,” “estimates” and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and the other factors listed under “Risk Factors” in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma’s product candidates are all in a development stage and are not available for sale or use.

Investor Contact

LHA Investor Relations
Jody Cain
[email protected]
310-691-7100

MARLBOROUGH, Mass., April 18, 2023 (GLOBE NEWSWIRE) — IPG Photonics Corporation (Nasdaq: IPGP) will release its first quarter 2023 financial results before the market opens on Tuesday, May 2, 2023. The Company will hold a conference call to review these results at 10:00 a.m. ET on the same day. To access the call, please dial 877-407-6184 in the United States or 201-389-0877 internationally. A live webcast of the call will also be available and archived in the investor relations section of the Company’s website at investor.ipgphotonics.com.

About IPG Photonics Corporation

IPG Photonics Corporation is the leader in high-power fiber lasers and amplifiers used primarily in materials processing and other diverse applications. The Company’s mission is to develop innovative laser solutions making the world a better place. IPG accomplishes this mission by delivering superior performance, reliability and usability at a lower total cost of ownership compared with other types of lasers and non-laser tools, allowing end users to increase productivity and decrease costs. IPG is headquartered in Marlborough, Massachusetts and has more than 30 facilities worldwide. For more information, visit www.ipgphotonics.com.

Contact:

Eugene Fedotoff
Director of Investor Relations
IPG Photonics Corporation
508-597-4713
[email protected]

MALVERN, Pa., April 18, 2023 (GLOBE NEWSWIRE) — Vishay Intertechnology, Inc., (NYSE: VSH), will release its results for the fiscal first quarter ended April 1, 2023 before the New York Stock Exchange opens on Wednesday, May 10, 2023.

A conference call to discuss Vishay’s first quarter financial results is scheduled for Wednesday, May 10, 2023 at 9:00 a.m. ET. The dial-in number for the conference call is 877-407-0989 (+1 201-389-0921, if calling from outside the United States) and the access code is 13737582.

A live audio webcast of the conference call and a PDF copy of the press release and the quarterly presentation will be accessible directly from the Investor Relations section of the Vishay website at http://ir.vishay.com.

There will be a replay of the conference call from 12:00 p.m. ET on Wednesday, May 10, 2023, through 11:59 p.m. ET on Wednesday, May 24, 2023. The telephone number for the replay is +1 877-660-6853 (+1 201-612-7415, if calling from outside the United States or Canada) and the access code is 13737582.

About Vishay

Vishay manufactures one of the world’s largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. Serving customers worldwide, Vishay is The DNA of tech.™ Vishay Intertechnology, Inc. is a Fortune 1,000 Company listed on the NYSE (VSH). More on Vishay at www.Vishay.com.

The DNA of tech

™ is a trademark of Vishay Intertechnology.

Contact:                                                   
Vishay Intertechnology, Inc.
Peter Henrici
Executive Vice President – Corporate Development
+1-610-644-1300

WALTHAM, Mass., April 18, 2023 (GLOBE NEWSWIRE) — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of XPHOZAH (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy. An Acknowledgement of Receipt letter from the FDA, confirming the resubmission is complete, is expected in mid-May. We expect that the letter will include the classification of the resubmission and the review goal date.

The NDA is supported by a comprehensive development program that included more than 1,200 patients in three Phase 3 clinical trials evaluating the safety and efficacy of XPHOZAH, all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY), as well as two additional Phase 4 open-label clinical trials (OPTIMIZE and NORMALIZE).

About XPHOZAH® (tenapanor)
XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. This novel blocking mechanism enables a one 30mg tablet twice daily dosing regimen. The most common side effect with XPHOZAH in clinical trials was diarrhea.

About Hyperphosphatemia
Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphate in the blood that is estimated to affect the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidney is the organ responsible for regulating phosphate, but when kidney function is significantly impaired, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).

About Ardelyx, Inc.

Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories. For more information, please visit https://ardelyx.com/ and connect with us on Twitter, LinkedIn and Facebook.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s current expectation it will receive confirmation from the FDA that its resubmission of the NDA for XPHOZAH is complete and the timing thereof, and Ardelyx’s current expectation that such confirmation will also include the review goal date for the NDA. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the process for regulatory approval. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx’s business in general, please refer to Ardelyx’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2023, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

Investor and Media Contacts:

Caitlin Lowie
[email protected]

Kimia Keshtbod
[email protected]

• FDA has set a target action date of December 16, 2023
• NDA supported by positive efficacy and safety data from the Phase 2 and pivotal Phase 3 trials of roflumilast foam
• If approved, roflumilast foam would be the first topical drug for seborrheic dermatitis with a new mechanism of action in over two decades

WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

“Seborrheic dermatitis has long been a disease in need of its own treatment,” said Neal Bhatia MD, Director of Clinical Dermatology at Therapeutics Clinical Research and one of the investigators for Arcutis. “Some of the biggest challenges of current treatments have not only been lack of efficacy and consequences from long-term use, but also the limitations that affect adherence, especially the inability to treat both hair- and non-hair-bearing areas. Roflumilast foam was designed to address these shortcomings, as a once-daily, steroid-free topical drug that can be used chronically anywhere on the body. Dermatologists will be excited to incorporate roflumilast foam, if approved, as a new standard of care for those living with seborrheic dermatitis.”

Roflumilast foam is an investigational once-daily, topical formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk.

Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

“The acceptance of the NDA for roflumilast foam marks a major milestone toward our goal of bringing a steroid-free, topical foam treatment option to market, addressing a significant unmet need for individuals living with seborrheic dermatitis,” said Frank Watanabe, President and CEO of Arcutis. “If approved, roflumilast foam would be the first topical drug with a new mechanism of action for this condition in over two decades, highlighting the unique formulation and deep dermatological expertise that Arcutis brings to immuno-dermatology. We look forward to continuing our work with the FDA over the coming months and are preparing commercial efforts for the anticipated approval and launch.”

The NDA is supported by positive results from Arcutis’ Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was the pivotal Phase 3, parallel group, double-blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3% in seborrheic dermatitis. The STRATUM study met its primary endpoint with an Investigator Global Assessment (IGA) Success rate of 79.5% in roflumilast foam-treated individuals compared to 58.0% (P<0.0001) in those treated with vehicle at Week 8. Improvement with roflumilast foam was seen early, with roflumilast demonstrating a statistically significant improvement compared to vehicle on IGA Success at Week 2, the first timepoint assessed. In addition, 51.3% of individuals in the roflumilast foam treated arm reached complete clearance at Week 8.

The study also demonstrated statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness). More than 60% of individuals achieved an itch response at Week 8 (62.8% roflumilast foam vs 40.6% vehicle; p=0.0001), and significant improvements in itch were reported at Week 2 and Week 4.

Roflumilast foam was well-tolerated with a favorable safety and tolerability profile. Incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). In the combined Phase 2 and Phase 3 studies, over 90% of patients who were randomized to roflumilast foam in the study completed the full eight weeks of treatment, and there were few discontinuations due to adverse events (0.9% and 2.2% in the roflumilast foam and vehicle groups, respectively). Overall, the most common adverse events occurring in ≥1% of subjects in the combined phase 2 and phase 3 study populations included nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).   

About Topical Roflumilast

Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast foam is a once-daily foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Roflumilast cream 0.3% (ZORYVE^®) is approved by the FDA for the topical treatment of plaque psoriasis in adults and adolescents.

About ZORYVE

ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION

The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

Forward-Looking Statements

Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential and timing for roflumilast foam to be approved by the FDA for the treatment of adults and adolescents with seborrheic dermatitis, the potential to use roflumilast foam over a long period of time, or chronically, the potential to use roflumilast foam anywhere on the body, including the face and scalp, and the potential for roflumilast foam to advance the standard of care in seborrheic dermatitis and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:



Media



Amanda Sheldon, Head of Corporate Communications
[email protected]

Investors



Eric McIntyre, Head of Investor Relations
[email protected]

• All 10 patients with late stage melanoma who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses and were relapse-free at their last assessment
• Results further validate predictive potential of proprietary AI technology and pave the way for advancement of EVX-03, a next-generation DNA-based personalized cancer immunotherapy, into the clinic in Q4

COPENHAGEN, Denmark, April 18, 2023 (GLOBE NEWSWIRE) — Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, today presented promising clinical data from its Phase 1/2a first-in-human study of its DNA-based personalized cancer immunotherapy, EVX-02 in combination with the checkpoint inhibitor nivolumab. Data were presented in the Late Breaking Research: Clinical Research 2 session at the 2023 AACR (American Association for Cancer Research) meeting in Orlando, Florida.

The study, in patients with resected melanoma, showed that:

• All 10 patients who received the full dosing schedule of 8 immunizations with EVX-02 were relapse-free at their last assessment
• Of these 10 patients, 9 completed the full study and were relapse-free at the 12-month end of study visit. One patient was prematurely terminated due to non-EVX-02 related adverse events (AEs), and was relapse-free at the last visit at 9 months
• The combination of EVX-02 and nivolumab was well tolerated and only mild EVX-02-associated AEs were observed
• Robust and long-lasting neoantigen-specific T-cell immune responses were confirmed in all EVX-02 completers
• The induced T-cell immune responses involved both CD4+ and CD8+ T cells

“We are extremely happy to share the positive clinical data from our Phase 1/2a EVX-02 study at AACR. We met both our primary endpoints on safety, tolerability and immunogenicity and our secondary endpoint on clinical efficacy. With all 10 patients who completed the EVX-02 treatment being relapse-free during the trial and with robust and treatment-specific immune responses, we see clear signs of a protective cancer vaccination effect,” said Per Norlén, Chief Executive Officer of Evaxion. “The EVX-02 data affirm our ability to select the right neoantigens, matched to the cancer of each patient, and provide further validation of our AI platform PIONEER^TM. They also support our plan to fast track our next-generation DNA-based personalized cancer immunotherapy, EVX-03, to the clinic in Q4.”

About the Phase 1/2a Study with EVX-02

The open-label, single-arm, multi-center Phase 1/2a study (NCT04455503) was designed to evaluate the combination of EVX-02 plus nivolumab in patients who had undergone complete surgical resection of late stage melanoma and were at high risk for recurrence. The primary objectives of the 12-month study were to assess the safety, tolerability and immunogenicity of EVX-02 plus nivolumab. In addition, the study was intended to evaluate relapse free survival. Evaxion reported initial, interim safety and immunogenicity data from the first 8 patients in the study in November 2022.

About Evaxion

Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies. Evaxion’s proprietary and scalable AI technologies decode the human immune system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline of product candidates, including three personalized cancer immunotherapies. The company is located in Hørsholm, Denmark, and is listed on the Nasdaq New York stock exchange. For more information, please visit: www.evaxion-biotech.com.

Source: Evaxion Biotech

Forward-looking statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from the worldwide COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

LEIDEN, Netherlands & CAMBRIDGE, Mass., April 18, 2023 (GLOBE NEWSWIRE) — ProQR Therapeutics NV. (Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its proprietary Axiomer® RNA editing technology platform, today announced the Annual General Meeting (AGM) of Shareholders will take place on Wednesday, May 17, 2023 at 16:00 CET (10:00am EDT) at the offices of Allen & Overy LLP, in Amsterdam, the Netherlands.

All relevant documents and information for the meeting, including the notice and agenda and explanatory notes, are or will be made available in the “Investors & Media” section of ProQR’s website (www.proqr.com) under “Financials and filings” and then “Shareholder meeting”. The documents will also be made available on the SEC’s website at www.sec.gov. Shareholders that wish to attend should register as described in the notice and agenda.

As part of the AGM, the Company highlights the following Supervisory Board updates:

• Begoña Carreño, PhD, is nominated for election to the Supervisory Board. Dr. Carreño was most recently Global Business Development & Licensing Head (BD&L) in the Ophthalmology franchise at Novartis Pharma, AG, based in Basel, Switzerland.  She has more than 20 years of pharmaceutical development and strategy leadership, having led BD&L efforts at Novartis across five different therapeutic franchises, as well as a proven track record in licensing deals and M&A. Before joining Novartis, she was the Head of External Pharmaceutical projects at Almirall (Barcelona, Spain). Dr. Carreño holds a PhD in Drug Delivery from the London School of Pharmacy (UK) and a BSc in Biochemistry from Keele University (UK).
• Theresa Heggie is nominated for election to the Supervisory Board. In light of her anticipated re-election to the Supervisory Board, Ms. Heggie departed from the Management Team at the end of October 2022, where she served as the Chief Operating Officer, after originally joining the Management Team in 2021 as the Chief Commercial Officer. Prior to ProQR, she served as Chief Executive Officer of Freeline Therapeutics. She had senior commercial and operating roles at Alnylam Pharmaceuticals as Senior Vice President, Head of CEMEA and Shire where she built the EMEA rare disease business. Earlier in her career, Ms. Heggie held increasingly senior positions in the commercial organizations at Janssen Pharmaceuticals and Baxter Healthcare. She previously served on the ProQR Supervisory Board from 2019-2021.
• Bart Filius is being nominated for re-election to the Supervisory Board. Mr. Filius has served on ProQR’s Supervisory Board since 2019. He joined Galapagos in 2014 as Chief Financial Officer and added the role of Chief Operating Officer in 2017, he was promoted to President and Chief Operating Officer in 2021. Prior to joining Galapagos, Mr. Filius held a variety of executive positions at Sanofi, where he was Vice President, Chief Financial Officer Europe, Country manager for The Netherlands and Vice President for Mergers & Acquisitions. Prior to joining Sanofi, Mr. Filius was a strategy consultant at Arthur D. Little. Mr. Filius has an MBA degree from INSEAD and a bachelor’s degree in business from Nyenrode University.
• Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners, has indicated his planned rotation off the ProQR Supervisory Board at the upcoming AGM. He has served on ProQR’s Supervisory Board since 2014.

About Axiomer^®

ProQR is pioneering a next-generation RNA base editing technology called Axiomer^®, which could potentially yield a new class of medicines for diverse types of diseases. Axiomer^® “Editing Oligonucleotides”, or EONs, mediate single nucleotide changes to RNA in a highly specific and targeted way using molecular machinery that is present in human cells called ADAR (Adenosine Deaminase Acting on RNA). Axiomer^® EONs are designed to recruit and direct endogenously expressed ADARs to change an Adenosine (A) to an Inosine (I) in the RNA – an Inosine is translated as a Guanosine (G) – correcting an RNA with a disease-causing mutation back to a normal (wild type) RNA, modulating protein expression, or altering a protein so that it will have a new function that helps prevent or treat disease.

About ProQR

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA therapies. ProQR is pioneering a next-generation RNA technology called Axiomer^®, which uses a cell’s own editing machinery called ADAR to make specific single nucleotide edits in RNA to reverse a mutation or modulate protein expression and could potentially yield a new class of medicines for both rare and prevalent diseases with unmet need. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.

Learn more about ProQR at www.proqr.com.

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Such forward-looking statements include, but are not limited to, statements regarding our business, technology, strategy, our Axiomer platform, and our product candidates and their therapeutic potential. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and clinical trials and other development activities by us and our collaborative partners; the likelihood of our preclinical and clinical programs being initiated and executed on timelines provided and reliance on our contract research organizations and predictability of timely enrollment of subjects and patients to advance our clinical trials and maintain their own operations; our reliance on contract manufacturers to supply materials for research and development and the risk of supply interruption from a contract manufacturer; the potential for future data to alter initial and preliminary results of early-stage clinical trials; the unpredictability of the duration and results of the regulatory review of applications or clearances that are necessary to initiate and continue to advance and progress our clinical programs; the ability to secure, maintain and realize the intended benefits of collaborations with partners, including the collaboration with Lilly; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated in research and development; and general business, operational, financial and accounting risks, and risks related to litigation and disputes with third parties. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

For ProQR Therapeutics N.V.

Investor contact:

Sarah Kiely
ProQR Therapeutics N.V.
T: +1 617 599 6228
[email protected]
or
Hans Vitzthum
LifeSci Advisors
T: +1 617 430 7578
[email protected]

Media contact:

Robert Stanislaro
FTI Consulting
T: +1 212 850 5657
[email protected]

SAN DIEGO, April 18, 2023 (GLOBE NEWSWIRE) — Beam Global, (Nasdaq: BEEM, BEEMW), the leading provider of innovative sustainable products and technologies for electric vehicle (EV) charging, energy storage, energy security and outdoor media, announced a leading global automotive brand has placed an order for EV ARC™ solar-powered EV charging systems.

“Receiving an order from a global, name-brand, automotive manufacturer is both a further validation of our products’ capabilities and a continued indication of the mainstream adoption of our technology,” said Beam Global CEO Desmond Wheatley. “While we cannot disclose the specifics of this order, we can confirm that it comes from one of the world’s top auto manufacturers and that we believe it bodes well for the adoption, sustainability and further development of our products.”

Solar-powered EV ARC™ electric vehicle charging infrastructure products are rapidly deployed, at scale, with no digging, no construction and no electrical work. Off-grid and 100% solar-powered, EV ARC™ systems generate and store their own clean electricity in batteries and deliver that energy to any quality brand charger the customer chooses. The EV charger is pre-installed on the EV ARC™ at the Beam Global factory and arrives at the customer site ready to charge EVs. The optional Emergency Power Panel can serve communities and first responders with 120V and 240V electric outlets in grid outages or in case of an emergency.

For more information on purchasing Beam EV ARC™ ready-to-deploy sustainable EV charging solutions please contact The Beam Team at 858-799-4583 or [email protected].

About Beam Global

Beam Global is a clean technology leader providing innovative, sustainable products and technologies for electric vehicle (EV) charging, energy storage, energy security and outdoor media. Core platforms include Beam EV ARC™ and Solar Tree® sustainable EV charging systems, Beam AllCell™ high-performance energy storage solutions, energy resiliency and disaster preparedness products and a deep patent library.

Beam EV ARC™ EV charging infrastructure systems support any quality brand EV charging service equipment, and Beam AllCell™ battery solutions power micro-mobility, terrestrial EVs, aviation, maritime and recreational vehicles as well as stationery and energy-security platforms.

Beam develops, patents, designs, engineers and manufactures unique and advanced clean mobility solutions that protect the environment, save customers time and money, empower communities and keep people moving. Based in San Diego and Chicago, the company produces Made-in-America products with the mission to Lead the World to Clean Mobility. Beam Global is listed on Nasdaq under the symbols BEEM and BEEMW. For more information visit BeamForAll.com, LinkedIn, YouTube and Twitter.

Forward-Looking Statements

This Beam Global Press Release may contain forward-looking statements. All statements in this Press Release other than statements of historical facts are forward-looking statements. Forward-looking statements are generally accompanied by terms or phrases such as “estimate,” “project,” “predict,” “believe,” “expect,” “anticipate,” “target,” “plan,” “intend,” “seek,” “goal,” “will,” “should,” “may,” or other words and similar expressions that convey the uncertainty of future events or results.

Media Contact:

Next PR
+1 813-526-1195
[email protected]

Investor Relations:

Core IR
+1 516-222-2560
[email protected]

A video accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/3ac7a449-da31-4026-a9a8-de3982e80bd0