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Canada Aviation and Space Museum to Include Draganfly Drone Technology in Canada Day Event Celebrations

Draganfly technology will be featured in the
Canada
Aviation and Space Museum’s “Drone Zone”.

Los Angeles, CA., June 28, 2023 (GLOBE NEWSWIRE) — Draganfly Inc. (NASDAQ: DPRO) (CSE: DPRO) (FSE: 3U8A) (“Draganfly” or the “Company”), an award-winning, industry-leading drone solutions and systems developer, is proud to announce their inclusion in the Canada Day celebrations at the Canada Aviation and Space Museum in Ottawa, Ontario on, July 1, 2023.

The Canada Aviation and Space Museum has one of the most extensive aviation collections in Canada. Its collection consists of over 130 aircraft and artifacts, focusing on the history of Canadian aviation and its global impact.

“It is an honor for Draganfly to be recognized as a pioneer in the aviation industry and to have our latest technology on display alongside other great Canadian aerospace companies at the Canada Aviation and Space Museum,” said Cameron Chell, President, and CEO of Draganfly.

Visitors to the Canadian Achievements Drone Zone exhibit will see Draganfly’s latest cutting-edge drone technology, the Heavy Lift Drone and Commander 3 XL.

Draganfly’s Heavy Lift Drone is a versatile, industrial, multirotor unmanned aerial vehicle (UAV) designed to lift more and fly further. Capable of automated missions and manual flight operations, Draganfly’s heavy-duty, robust UAV has a payload lift capacity of 67 pounds and up to 55 minutes of flight time.

Draganfly’s Commander 3 XL Drone is a high-endurance, weather-resistant, multirotor UAV designed for easy assembly and rapid deployment. The “Swiss Army Knife” of drones can drop and winch-down systems to transport up to 22lb of payload. It performs extremely well in light rain and snow.

About Draganfly

Draganfly Inc. (NASDAQ: DPRO; CSE: DPRO; FSE: 3U8A) is the creator of quality, cutting-edge drone solutions, software, and AI systems that revolutionize how organizations can do business and service their stakeholders. Recognized as being at the forefront of technology for over 24 years, Draganfly is an award-winning industry leader serving the public safety, agriculture, industrial inspections, security, mapping, and surveying markets. Draganfly is a company driven by passion, ingenuity, and the need to provide efficient solutions and first-class services to its customers around the world with the goal of saving time, money, and lives.

For more information on Draganfly, please visit us at www.draganfly.com.
For additional investor information, visit https://www.thecse.com/en/listings/technology/draganfly-inc, https://www.nasdaq.com/market-activity/stocks/dpro, or https://www.boerse-frankfurt.de/equity/draganfly-inc-1.

Media Contact
Arian Hopkins
email: [email protected]

Company Contact
Email: [email protected]



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ZyVersa Therapeutics Announces Publication in Clinical Immunology Demonstrating Association Between Renal NLRP3 Inflammasome Activation and Lupus Nephritis Disease Activity

  • Lupus Nephritis (“LN”) is characterized by inflammation in the kidney, protein leakage into the urine (“proteinuria”), and progressive kidney damage
  • NLRP3 inflammasomes were extensively activated in the kidneys of LN patients, with higher levels of activation in patients with more severe forms of the disease
  • Inflammasome activation was positively correlated with clinicopathological indices of LN
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation

WESTON, Fla., June 28, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Clinical Immunology, demonstrating the role of inflammasome NLRP3 activation in lupus nephritis.

In the paper titled, “Renal NLRP3 Inflammasome activation is associated with disease activity in lupus nephritis,” the authors evaluated renal biopsy tissue of patients with biopsy proven LN in comparison to control tissue. Data demonstrated that renal NLRP3 inflammasome activation positively correlated with LN severity and clinicopathological indices of LN. Following are key findings reported in the paper:

  • Expression patterns of NLRP3, ASC, caspase-1, IL-1β, and IL-18 in the glomeruli and tubulointerstitum of LN patients were significantly higher in LN patients versus controls
  • Levels of NLRP3, ASC, caspase-1, IL-1β, and IL-18 were higher in patients with proliferative (more severe) LN than in patients with non-proliferative LN
  • Levels of NLRP3, ASC, caspase-1, IL-1β, and IL-18 were positively correlated with several clinicopathological indices, including, proteinuria, renal pathological activity indices, and systemic lupus erythematosus disease activity index (SLEDAI) scores

The authors stated, “We comprehensively evaluated the activation patterns of the NLRP3 inflammasome pathway in the renal tissues of LN patients. NLRP3 was extensively activated in various renal intrinsic cells and infiltrating cells, and was closely associated with disease activity, which needs further explorations.” To read the article, Click Here.

“The research published in the Journal of Clinical Immunology demonstrated that renal NLRP3 inflammasome activation is associated with lupus nephritis disease activity, providing support for inflammasome inhibition as a promising treatment for LN. Unlike NLRP3 inhibitors, which only inhibit formation of the NLRP3 inflammasome to block initiation of the inflammatory cascade, Inflammasome ASC inhibitor IC 100 inhibits formation of multiple types of inflammasomes, and it uniquely inhibits ASC specks to block perpetuation of damaging inflammation,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:

Karen Cashmere
Chief Commercial Officer
[email protected]
786-251-9641

Media Contacts

Tiberend Strategic Advisors, Inc.

Casey McDonald
[email protected]
646-577-8520

Dave Schemelia
[email protected]
609-468-9325



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Long-term Clinical Study Demonstrates Disease Modifying Effects of ANAVEX®2-73 (blarcamesine) for Rett Syndrome

NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that long-term clinical study results from the U.S. ANAVEX®2-73-RS-001 (NCT03758924) study demonstrate disease modifying effect of ANAVEX®2-73 (blarcamesine) for adult patients with Rett syndrome.

Usually, symptomatic therapies treat the symptoms of the disease but do not address the underlying cause of the disease. Disease-modifying therapies target the underlying cause of the disease.

ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) which, data suggest, is pivotal to restoring cellular homeostasis and promoting neuroplasticity.1

In the U.S. ANAVEX®2-73-RS-001 trial, of all 25 patients who both started and completed the randomized, double-blind, placebo-controlled study, 24 patients voluntarily enrolled in the 12-week open label extension (OLE) study, receiving once daily oral liquid ANAVEX®2-73 (blarcamesine) formulation for further evaluation of long-term safety, tolerability, and effectiveness of ANAVEX®2-73 (blarcamesine) in patients with Rett syndrome. The 12-week extension study was subsequently further extended to 36 weeks.

The effect of ANAVEX®2-73 (blarcamesine) in the double-blind part of the U.S. ANAVEX®2-73-RS-001 study was maintained in the open label 12-week extension study. Results from pharmacometric modeling of the full clinical data (i.e., from baseline of the double-blind study to the end of the open label extension study) indicates that the data are best characterized by a combined symptomatic and disease modifying drug effect model. Meaning that ANAVEX®2-73 (blarcamesine) exhibited both symptomatic and disease modifying effects in the treatment of Rett syndrome in a clinical setting.

Patients assigned first to ANAVEX®2-73 (blarcamesine) in the double-blind part of the study and who continued on ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) study had a statistically significant (p = 0.01147) reduction in disease severity when compared with patients assigned first to placebo in the double-blind part of the study and who then received ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) part of the study – a criterion for classification as a disease modifying agent.

Continued improvement from the drug, as measured with the Rett Syndrome Behavior Questionnaire (RSBQ) total score,2 was observed from the start of the double-blind study to the end of the open label extension part for patients continuing on ANAVEX®2-73 (blarcamesine). Patients previously on placebo, who switched to ANAVEX®2-73 (blarcamesine) in the OLE part of the study experienced improvement during the OLE part.

Additionally, disease progression, which is defined as change in Rett syndrome disease severity with time, was also reduced with long-term treatment with ANAVEX®2-73 (blarcamesine).

Patients assigned first to ANAVEX®2-73 (blarcamesine) in the double-blind part of the study and who continued on ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) study had a statistically significant (p = 0.01752) reduction in disease progression when compared with patients assigned first to placebo in the double-blind part of the study and who then received ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) part of the study – a criterion for classifying a drug as a disease modifying agent.

Patients assigned to ANAVEX®2-73 (blarcamesine) at the start of the double-blind study experienced more benefit of drug effect than could be explained by symptomatic benefit alone – hence, ANAVEX®2-73 (blarcamesine) exhibited both symptomatic and disease modifying effect.

The reduction in annual rate of disease progression for those patients, who continued on ANAVEX®2-73 (blarcamesine) was over 3-fold greater, relative to those who switched from placebo to ANAVEX®2-73 (blarcamesine): Ratio of reduction in annual rate of disease progression = 3.17 (Reduced disease progression rate [Double-blind Part/ OLE — ANAVEX®2-73/ ANAVEX®2-73] = -1.383/year; Reduced disease progression rate [Double-blind Part/ OLE — Placebo/ ANAVEX®2-73] = -0.4357/year).

Anavex plans to submit the data for publication in a peer-reviewed medical journal.

ANAVEX®2-73 (blarcamesine) has previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.

“We believe these promising long-term clinical results in adult patients with Rett syndrome provides further support of the beneficial effect of ANAVEX®2-73 (blarcamesine) for patients with Rett syndrome,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Rett syndrome is a devastating, non-inherited genetic post-natal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life. We are looking forward to the upcoming read-out of the ANAVEX®2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett syndrome clinical trial in pediatric patients with Rett syndrome.”

About Rett Syndrome

Rett syndrome is a rare, non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat and even breathe easily. The hallmark of Rett syndrome is near constant repetitive hand movements while awake. It is characterized by normal early growth and development (6 to 18 months) followed by a slowing of development, loss of purposeful use of the hands, distinctive hand movements, slowed brain and head growth, problems with walking, seizures and intellectual disability. There is currently no cure for Rett syndrome and treatment of the disorder is symptomatic. Management of symptoms is done through a multidisciplinary approach utilizing medication for motor difficulties, breathing irregularities and control of seizures through anticonvulsant drugs. Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups and occurs worldwide in approximately one in every 10,000 to 15,000 live female births.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and recently a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the company on Twitter,Facebook, Instagram, and LinkedIn.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: [email protected]

Investors:

Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: [email protected]

1 Advances in Experimental Medicine and Biology Volume 964 (2017) Sigma Receptors: Their Role in Disease and as Therapeutic Targets.
2 Rett Syndrome Behavior Questionnaire (RSBQ) total score is key primary endpoint in the completed multi-center, double-blind clinical EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 (NCT04304482) in pediatric patients with Rett syndrome. Topline results from this study are expected in the second half of this year.



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Zai Lab Announces NDA Acceptance of Repotrectinib for Patients with ROS1-positive NSCLC by China’s NMPA

SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).

“We are pleased to obtain the NMPA’s acceptance of our NDA for repotrectinib, which further supports repotrectinib as a potential best-in-class treatment for patients with ROS1-positive NSCLC in China. There is a significant unmet need for these patients given the limited durability of benefit, the emergence of resistance to approved therapies and eventual tumor progression,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “We look forward to collaborating with the NMPA during the review process in a joint effort to bring this important medicine to patients in need as soon as possible.”

In May 2023, the Center for Drug Evaluation (CDE) of China’s NMPA granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

About Repotrectinib

Repotrectinib is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of advanced solid tumors, including NSCLC. Patients with tumor harboring ROS1 and NTRK gene fusions treated with approved targeted therapies often develop resistance mutations, limiting binding of these drugs to their target, eventually leading to tumor progression. Repotrectinib is uniquely designed to improve durability of benefit and overcome resistance mutations. Zai Lab and Turning Point Therapeutics, Inc. (Turning Point Therapeutics, acquired by Bristol Myers Squibb) are studying repotrectinib in TRIDENT-1, a registrational Phase 1/2 study in adults, and CARE, a Phase 1/2 study in pediatric patients. Repotrectinib has shown robust antitumor activity and durable responses among TKI-naïve and pre-treated patients. Zai Lab is enrolling patients in the registrational TRIDENT-1 study in Greater China (Mainland China, Hong Kong, Taiwan, and Macau), while Turning Point Therapeutics is enrolling patients in other regions of the world.

Repotrectinib has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration in: ROS1-positive metastatic NSCLC patients who have not been treated with a ROS1 TKI; ROS1-positive metastatic NSCLC patients who have previously been treated with a ROS1 TKI and who have not received prior platinum-based chemotherapy; and patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK TKIs, with or without prior chemotherapy, and have not had satisfactory alternative treatments. Additionally, repotrectinib was previously granted four Fast-Track designations in ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve; ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive advanced NSCLC patients pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy; and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have not had satisfactory alternative treatments. Repotrectinib was also granted an Orphan Drug designation in 2017.

Repotrectinib has been granted three Breakthrough Therapy Designations from the CDE of China’s NMPA in ROS1-positive metastatic NSCLC patients who have not been treated with a ROS1 TKI; ROS1-positive metastatic NSCLC patients who have previously been treated with a ROS1 TKI and who have not received prior platinum-based chemotherapy; and ROS1-positive metastatic NSCLC patients who have previously been treated with a ROS1 TKI and one prior line of platinum-based chemotherapy.

Zai Lab has an exclusive license agreement with Turning Point Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb, to develop and commercialize repotrectinib in Greater China.

About Non-Small Cell Lung Cancer in China

Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 871,000 new cases and 767,000 deaths of lung cancer in China in 2022, respectively.1 NSCLC accounts for approximately 85% of lung cancer, and approximately 70% of NSCLC is locally advanced or metastatic at initial diagnosis. In China, ROS1 rearrangements occur in 2-3% of patients with advanced NSCLC.

1
Changfa Xia, et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants
.

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious diseases, and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.

For additional information about Zai Lab, including our products, business activities and partnerships, research, and other events or developments, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

Zai Lab Forward-Looking Statements

This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing repotrectinib in the Greater China region and the potential efficacy and safety of repotrectinib. It should be noted that Priority Review is not a guarantee of approval. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact, nor are they guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and results of operations, and (6) risks related to doing business in China, and (7) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov.

For more information, please contact:

Investor Relations:

Christine Chiou / Lina Zhang
+1 (917) 886-6929 / +86 136 8257 6943
[email protected] / [email protected]

Media:

Shaun Maccoun / Xiaoyu Chen
+1 (415) 317-7255 / +86 185 0015 5011
[email protected] / [email protected]

Zai Lab Limited 



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Amesite Announces V6.3, with Streamlined, AI-First Infrastructure to Enable Customization and Scale for Its Enterprise Customers

DETROIT, June 28, 2023 (GLOBE NEWSWIRE) — Amesite Inc. (NASDAQ: AMST), a leading artificial intelligence software company offering a cloud-based learning platform for education, business, and government markets, announces today that V6.3 will be available to its Customers on July 10, 2023.

“We are thrilled to announce the roll out of our latest update – V6.3 – utilizing a streamlined, AI-first infrastructure. Our enterprise customers are in a phase of rapid expansion, and they need reliable solutions that support their growth,” said Amesite Founder & CEO, Dr. Ann Marie Sastry. “Our AI-driven platform features can now be delivered with even greater scalability and affordability, along with greater degrees of customization, to meet our Customers’ needs.”

By implementing Azure’s cloud solutions, Amesite has enhanced its platform’s efficiency and ensured secure authentication with Azure AD B2C. The incorporation of Azure’s latest database technology enables Amesite to deliver services faster and improve user experiences. The centralization of Amesite’s innovation deployments allows rapid access to new features such as games and other AI offerings. This significant update reaffirms Amesite’s dedication to addressing our customers’ ever-evolving needs and delivering an unrivaled user experience.

Amesite’s V6.3 includes upgraded cybersecurity with centralized security measures and updates to fortify protection against cyber threats. Enhanced visibility achieved through centralized monitoring allows proactive identification of vulnerabilities, paired with the ability to rapidly deploy security patches across all tenants. In addition, Amesite’s scalable customer support facilitates frictionless resource allocation to manage Customer inquiries and onboarding efficiently. Amesite is committed to best-in-class cybersecurity and has created a free cybersecurity white paper available for download by the public here.

By partnering with Amesite, organizations can navigate the complexity of infrastructure configurations and leverage its seamless integration with popular identity solutions, databases, storage systems, and AI tools. Possible infrastructure configurations can easily number into the thousands with only a few selections of formats and tools, so customizability is essential. As a Consulting Partner, Amesite helps its Customers execute a well-thought-out strategy to integrate learning solutions effectively. A detailed breakdown can be accessed here and a free integration white paper is available for download by the public here.

About Amesite Inc.

Amesite delivers its scalable, customizable, white-labeled online learning platform to universities, businesses, museums, and government agencies, enabling them to deliver outstanding digital learning. Amesite provides a single system that combines eCommerce, instruction, engagement, analytics, and administration using best-in-class infrastructure to serve multi-billion-dollar online learning markets. For more information, visit www.amesite.io.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning the Company, the Company’s planned online machine learning platform, the Company’s business plans, any future commercialization of the Company’s online learning solutions, potential customers, business objectives and other matters. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement. Risks facing the Company and its planned platform are set forth in the Company’s filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

Christine Petraglia

TraDigital IR

(917) 633-8980

[email protected]



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InflaRx Appoints Dr. Camilla Chong as Chief Medical Officer

  • Camilla Chong, M.D., joins the team with 25 years of experience in the global pharmaceutical industry in drug development
  • Dr. Chong to lead clinical development of InflaRx’s portfolio of C5a/C5aR inhibitors

JENA, Germany, June 28, 2023 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company commercializing and developing anti-inflammatory therapeutics that target the complement system, today announced the appointment of Dr. Camilla Chong as Chief Medical Officer (CMO) of InflaRx, effective July 1, 2023. Dr. Chong is a medical doctor with extensive experience in the pharmaceutical industry, including leadership roles in clinical development, medical affairs and overseeing the launch of new drugs across multiple geographies. She will be responsible for all clinical developments related to InflaRx’s portfolio as she joins the C-suite of the company.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “We are excited to welcome Camilla to our team. She is a highly accomplished executive who brings a wealth of expertise in drug development. At InflaRx, she will lead our clinical development activities. Besides managing our ongoing clinical trials, she will also drive the strategy for future clinical development programs of the company including those for vilobelimab and INF904. She will be a great addition to our team as we bring our first product to market and advance our development programs.”

Dr. Camilla Chong commented: “I am thrilled to be joining InflaRx at this transformative stage for the Company following the recent Emergency Use Authorization by the FDA and the ongoing commercial launch of Gohibic (vilobelimab). I believe that our innovative anti-C5a / anti-C5aR programs have the potential to be truly life-changing for patients with acute inflammatory conditions as well as many chronic immunologic diseases. I very much look forward to advancing our clinical programs with the goal of providing patients suffering from these diseases with improved treatments that can truly impact their quality of life.“

Dr. Chong is a medical doctor with 25 years of experience in the global pharmaceutical industry. She has successfully led clinical development, medical affairs, clinical operations, regulatory and pharmacovigilance teams and has managed global clinical development programs. She has extensive experience in the launch of many new medicines in multiple geographies. She joins InflaRx from Kyowa Kirin Corporation, where she was Vice President & Global Medical Affairs Therapy Area Head – Immunology. Her previous senior management roles have spanned multiple therapeutic areas, including cardiology, immunology, respiratory, dermatology and orphan diseases at Pfizer, GlaxoSmithKline and Teva. Dr. Chong received her MD from the Royal Free Hospital School of Medicine, University College London, UK. She holds a Diploma in Pharmaceutical Medicine and is a Member of the Faculty of Pharmaceutical Medicine (MFPM).

About InflaRx

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, “InflaRx”).

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a / C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de.

Contacts:

InflaRx N.V.

Email: [email protected]

MC Services AG

Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email: [email protected]
Europe: +49 89-210 2280
U.S.: +1-339-832-0752

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 “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ability to commercialize and the receptiveness of Gohibic (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for and clinical utility of Gohibic (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; the timing, progress and results of clinical trials of our product candidates, and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our BLA submission for Gohibic (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or Gohibic (vilobelimab) for any indication; whether the FDA, the EMA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product Gohibic (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the Securities Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. 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.



Posted on

SIGNA Sports United N.V. Reports H1 FY23 Results

SIGNA Sports United N.V. Reports H1 FY23 Results

Strategic realignment and cost initiatives of up to €100 million implemented

H1 FY23 net revenue of €441 million, YoY reported change of -2%

Subdued demand and market overstock weighing on financial results and liquidity

  • Active Customers of 6.1 million, representing a decrease of (-15)% YoY
  • Net Revenue of €441 million in H1 FY23 down (-2)% YoY, Q2 FY23 Net revenue decreased (-23)% YoY
  • Gross profit of €117 million in H1 FY23 and €44 million in Q2 FY23
  • Adj. EBITDA decreased to (€97) million in H1 FY23 and (€59) million in Q2 FY23
  • Secured €150 million commitment from major indirect shareholder to fund the operations of the business into FY25

BERLIN–(BUSINESS WIRE)–
SIGNA Sports United N.V. (“SSU” or the “Company”), a NYSE-listed specialist sports e-commerce company with businesses in bike, tennis, outdoor, and teamsports, today issued a trading update for the second quarter of fiscal year 2023 ended March 31, 2023 and H1 FY2023. Q2 FY23 includes full contribution of businesses acquired in FY22, WiggleCRC and Tennis Express (acquisitions closed on December 14 and December 31, 2021, respectively).

The operating environment in the first half of FY23 was a continuation of the disruptions introduced in Q4 of FY22. Although economic indicators across core markets have begun to improve slightly since the beginning of the year but demand remains below FY22 levels and pre-pandemic levels. On the supply side, stock levels across the industry remain severely elevated as market participants aim to clear excess inventory, resulting in a meaningful compression of gross margins and negative cash flows.

Stephan Zoll, CEO of SSU, said, “The first half of our fiscal year has been marked by challenging conditions across the sports retail industry. While macro headwinds and oversupply in the market have pressured our financial results, we have remained focused on positioning our business for success as operating conditions normalize. In response to the demand outlook in the near-term, we have conducted a comprehensive strategic repositioning of the business with the aim of enabling a return to profitable growth and positive cash flow. In addition, I am pleased to welcome key hires across our Bike and Tennis segments with the experience and industry insight needed to deliver the next chapter of SSU’s growth story. Though our results in H1 FY23 have suffered as the market navigates another period of disruption, I am confident that the worst distortions are behind us and we remain fully aligned behind our renewed operating approach with a clear course toward long-term value creation.”

H1 FY23 Consolidated Financial Summary and Key Operating Metrics

Q2 Q2 YoY H1 H1 YoY
EUR in millions FY22 FY23 Growth FY22 FY23 Growth
Key Financials
Net Revenue

€255

€195

(23.5%)

€449

€441

(1.7%)
Gross Profit

€92

€44

(52.4%)

€163

€117

(28.4%)
% Margin

36.1%

22.5%

(1,364)bps

36.3%

26.4%

(988)bps
Adj. EBITDA

(€15)

(€59)

NM

(€26)

(€97)

NM
% Margin

(5.9%)

(30.3%)

NM

(5.7%)

(22.0%)

NM
Operating Performance
LTM Active Customers

7.1

6.1

(14.7%)

7.1

6.1

(14.7%)
Total Visits

76.6

56.5

(26.2%)

131.8

119.4

(9.4%)
Net Orders

2.1

1.5

(27.3%)

3.6

3.5

(3.1%)
Net AOV

€103.1

€105.7

2.5%

€100.1

€104.6

4.4%
 

Note: Financials inclusive of Tennis Express from 1 Jan 2022 and inclusive of WiggleWCRC from 15 Dec 2021. Please refer to Non-IFRS Financial Measures section for further detail regarding disclosed metrics. “NM” defined as not meaningful.

Alex Johnstone, the Company’s CFO, said, “As we anticipated heading into the fiscal year, current operating conditions have severely weighed on our topline growth and profitability. Looking towards the second half of the year, we anticipate the lingering effects of excess stock in the market to challenge margins but believe the worst of the market disruptions were already incurred in H1. In addition, the cost measures put in place, in tandem with our renewed commercial and operating framework, will drive meaningful cost efficiencies in the coming quarters and support returning the business to Adj. EBITDA profitability. While the operating environment remains turbulent, we have taken critical steps to protect our liquidity position with an incremental €150 million commitment from our major indirect shareholder to support the business through to cash flow generation in a normalized market backdrop.”

H1 FY23 Business Highlights / Commentary

  • Business Update
    • Began implementation of updated commercial and operational framework and targeted cost initiatives designed to promote long-term stability including:

      • Prioritization of core, profitable markets while scaling back international partnerships

      • Consolidation of logistics footprint to reduce redundancy

      • Targeted stock management and cancellation of inbound orders; clean order book for FY24 to maximize flexibility as operating conditions shifting rapidly and trimming of SKU count to reduce operational complexity

      • Reduction in force across employee base to allow for benefits of operating leverage

      • Cross-selling of Owned Brands and prioritization of Owned Brand portfolio given higher unit economics

  • Roadmap outlined to achieve approximately 100M EUR of run-rate EBITDA savings by FY25

  • Strengthening of liquidity position with 150M EUR equity commitment to fund the operational and investment requirements of the business into FY25

  • Key Performance Indicators (KPIs)
  • (-15%) YoY decline in Active Customers vs. +143% pre-Covid (Q2 FY19) on a reported basis to 6.1 million Active Customers in H1 FY2023, led by acquisitions at the time and focused marketing spend to drive conversion

  • (-26%) YoY decline in visits for Q2 FY23 and (-9%) YoY for H1 FY23 due as demand has contracted sharply on a year-over-year basis

  • Net Orders decreased by (-27%) YoY in Q2 and (-3%) YoY in H1 FY23 driven by the traffic decrease, in challenging operating environment

  • 2% YoY Net AOV increase in Q2 FY23 and 4% YoY for H1 FY23 a result of improved product mix in H1 FY23 following severe shortage of full-bike stock in FY22

  • Q2 FY23 Core KPIs remain meaningfully above pre-pandemic levels with PF growth vs. pre-Covid (Q2 FY19) in Active Customers (+18%), conversion (+84 bps) and AOV (+7%)

  • Financial Update
  • (-1.7%) YoY Net revenue decline in H1 FY23, Q2 FY23 YoY decline of (-23%) as consumer sentiment continued to lag pre-pandemic levels. Though supply chain pressures eased in H1 FY23, market oversupply and tightening macroeconomic conditions have weakened consumer demand, particularly in non-core markets

  • Gross margin contraction of (-1,364bps) YoY in Q2 FY23 and (-988bps) YoY in H1 FY23 a result of targeted inventory management to counteract the severe oversupply across the market and right-size stock position for level of market demand

  • Significant cash outflows in H1 FY23 driven primarily by weakened operating performance as well as elevated payables resulting from meaningful stock inbounds at YE FY22

  • On June 26, 2023, obtained €150 million hard financing commitment from SIGNA Holding GmbH to fund the Company’s operational and investment requirements into FY25

Outlook & Guidance

Management announces FY23 guidance to reflect ongoing market dislocation and sustained demand contraction into H2 FY23 before any potential improvement anticipated in FY24.

  • FY23 Guidance
  • Net revenue: (9)% – (11)% YoY decline

  • Adjusted EBITDA margin: (16)% – (18)%

  • Free cash flow: (€250) – (€270) million

In line with expectations going into FY23, SSU performance has been severely impacted by macroeconomic headwinds and market overstock. Management anticipates a continuation of challenging operating conditions into H2 FY23 with some improvement expected by management in Q4.

As the Company looks beyond the near-term turbulence, Management reiterates its conviction that the measures enacted as part of the strategic realignment process provide the business with a clear pathway to profitable long-term growth as conditions allow. The financial impact anticipated from our renewed approach include:

  • Changes in our commercial model that will result in lower sales, but at a higher contribution

  • Focus on lean operating processes to accelerate cost savings from FY24; on track with various cost reduction measures

  • Transaction synergies to start accruing from FY24 along with IT re-platforming, logistics consolidation, seeking procurement benefits

With near-term market disruption putting strain on suppliers and retailers across the sports retail industry, the Company anticipates opportunities for inorganic growth in the coming quarters. With a market leading position, SSU is closely monitoring the M&A pipeline with a continued focus on accretive M&A to broaden reach and enhance our Owned Brand portfolio. The Company continues to believe in the strength of the underlying global trends of health and fitness, e-mobility and e-commerce and is committed to delivering long-term value with a differentiated proposition.

Conference Call Information

SSU’s management will host a conference call today at 8:30 a.m. Eastern Time to discuss the results. Interested parties will be able to access the conference call by dialling 1-855-979-6654 (in the United States) or +1-646-664-1960 (outside of the United States), along with access code 424915. The conference call will be simulcast and archived on SSU’s website at https://investor.signa-sportsunited.com/.

Non-IFRS Financial Measures

The press release includes certain non-IFRS financial measures (including on a forward-looking basis). These non-IFRS measures are an addition, and not a substitute for or superior to, measures of financial performance prepared in accordance with IFRS and should not be considered as an alternative to net income, operating income or any other performance measures derived in accordance with IFRS. Please see for our definitions of our non-IFRS measures below.

SSU believes that these non-IFRS measures of financial results (including on a forward-looking basis) provide useful supplemental information to investors about SSU. SSU’s management uses forward-looking non-IFRS measures to evaluate SSU’s projected financials and operating performance. However, there are a number of limitations related to the use of these non-IFRS measures and their nearest IFRS equivalents, including that they exclude significant expenses that are required by IFRS to be recorded in SSU’s financial measures. In addition, other companies may calculate non-IFRS measures differently, or may use other measures to calculate their financial performance, and therefore, SSU’s non-IFRS measures may not be directly comparable to similarly titled measures of other companies. Additionally, to the extent that forward looking non-IFRS financial measures are provided, they are presented on a non-IFRS basis without reconciliations of such forward-looking non-IFRS measures due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations.

Totals have been calculated on the basis of non-rounded euro amounts and may differ from a calculation based on the reported million euro amounts.

Liquidity

In addition to the €130 million hard financing commitment which SIGNA Sports United N.V. (the “Company”) received from SIGNA Holding GmbH (“SIGNA Holding”), an affiliate of the Company’s largest shareholder SIGNA International Sports Holding GmbH (“SISH”) on February 6, 2023 SIGNA Holding and the Company have entered into an additional equity commitment letter on June 26, 2023 with commitments by SIGNA Holding to provide the Company with additional liquidity of €150 million until September 30, 2025. The parties shall mutually agree on detailed financing terms substantially on the basis of the outstanding and newly issued convertible bonds, subject to amendments to the terms. The Company is confident the €150 million of liquidity commitments will be sufficient to fund its operational and investment related funding requirements into FY25.

The current market conditions have, and continue to, weigh heavily on our financial results and liquidity position. Additional factors may further accelerate our need for additional financing, including if revenues are lower than expected, or if our costs and expenses on a go-forward basis are higher than expected or if we are unable to extend loan repayment terms on loans maturingwithin the next 12 months; furthermore, our operating plan may change as a result of many factors, including those currently unknown to us, and we may need to seek additional funds sooner than planned, in each case, through public or private equity, debt financings or other sources. Notwithstanding the hard financing commitments obtained from SIGNA Holding, the Company is working to extend the terms or refinance its revolving credit facility of € 100 million which falls due in May 2024. A failure to extend the terms or refinance the Company’s existing revolving credit facility by May 2024 could have a material adverse effect on our business, financial condition, results of operations and prospects, raise substantial doubt about the Company’s continuation as a going concern and ultimately cause our business to fail and liquidate with little or no return to investors.

Forward-Looking Statements

These forward-looking statements include, but are not limited to, statements regarding future events, the estimated or anticipated future results and benefits of SSU following the business combination, future opportunities for SSU, future planned products and services, business strategy and plans, objectives of management for future operations of SSU, market size and growth opportunities, competitive position, technological and market trends, and other statements that are not historical facts. Forward-looking statements are generally accompanied by words such as believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “could,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” “suggests,” “targets,” “projects,” “forecast” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are based upon estimates and forecasts and reflect the views, assumptions, expectations, and opinions of the Company, which are all subject to change due to various factors including, without limitation, changes in general economic conditions as a result of the war in Ukraine, significant inflation, higher financing costs, an increase in energy costs, a negative consumer sentiment and COVID-19. Any such estimates, assumptions, expectations, forecasts, views or opinions, whether or not identified in this document, should be regarded as indicative, preliminary and for illustrative purposes only and should not be relied upon as being necessarily indicative of future results.

Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors. The forward-looking statements in this press release may include, without limitations, statements about:

  • our liquidity and losses from operations and projected cash flows and related impact on our ability to continue as a going concern;

  • our future financial condition and operating results;

  • our ability to remain in compliance with financial covenants under our financing arrangements;

  • our ability to extend, renew or refinance our existing debt;

  • our growth, expansion and acquisition prospects and strategies, the success of such strategies, and the benefits we believe can be derived from such strategies;

  • our ability to effectively manage our inventory and inventory reserves;

  • impairments of our goodwill or other intangible assets;

  • changes in consumer spending patterns and overall levels of consumer spending;

  • our ability to further upgrade our information technology systems and infrastructure, including our accounting processes and functions, and other risks associated with the systems that operate our online retail operations;

  • our ability to continue to remedy weaknesses in our internal controls;

  • costs as a result of operating as a public company;

  • our assumptions regarding interest rates and inflation;

  • changes affecting currency exchange rates;

  • continuing business disruptions arising from the on-going war in Ukraine and in the aftermath of the coronavirus pandemic;

  • our financial condition and ability to obtain financing in the future to implement our business strategy and fund capital expenditures, acquisitions and other general corporate activities;

  • estimated future capital expenditures needed to preserve our capital base;

  • changes in general economic conditions in the Federal Republic of Germany (“Germany”), and the European Union and the Unites States of America, including changes in the unemployment rate, the level of energy and consumer prices, wage levels, etc.;

  • the further development of online sports markets, in particular the levels of acceptance of internet retailing;

  • our behavior on mobile devices and our ability to attract mobile internet traffic and convert such traffic into purchases of our goods;

  • our ability to offer our customers an inspirational and attractive online purchasing experience;

  • demographic changes, in particular with respect to Germany;

  • changes in our competitive environment and in our competition level;

  • the occurrence of accidents, terrorist attacks, natural disasters, fires, environmental damage, or systemic delivery failures;

  • our inability to attract and retain qualified personnel, consultants and collaborators;

  • political changes;

  • changes in laws and regulations;

  • our expectations relating to dividend payments and forecasts of our ability to make such payments; and

  • other factors discussed in “Item 3. Key Information — D. Risk Factors” in our 20-F filing as of February 7, 2023 and Exhibit 99.4 in our 6-K filing as of June 28, 2023.

Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in “Item 3. Key Information—D. Risk Factors” in our 20-F filing as of February 7, 2023 and Exhibit 99.4 in our 6-K filing as of June 28, 2023 and our ability to continue as a going concern. Accordingly, you should not rely on these forward-looking statements, which speak only as of the date of this press release. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC after the date of this press release.

In addition, statements such as “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this press release. And while we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and you are cautioned not to rely unduly on these statements.

Although we believe the expectations reflected in the forward-looking statements were reasonable at the time made, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should carefully consider the cautionary statements contained or referred to in this section in connection with the forward-looking statements contained in this press release and any subsequent written or oral forward-looking statements that may be issued by us or persons acting on our behalf.

Definitions

Gross Profit: Net revenues less cost of materials adjusted to exclude extraordinary write-offs.

Active Customers: Customers with one or more purchases within the last 12 months, irrespective of cancellations or returns.

Total Visits: Number of visits including mobile and website. Cut-off at 30 minutes of inactivity and at date change. Not cut off at channel change during session.

Net Orders: Orders post cancellations and full returns.

Net AOV: Total online revenue (excluding sales partners) divided by net orders (post cancellations and full returns).

About SIGNA Sports United:

SIGNA Sports United (SSU) is a NYSE-listed specialist sports e-commerce company with headquarters in Berlin. It has businesses operating within bike, tennis, outdoor, and team sports. SSU has more than 80 online sites and partners with 500 shops serving over 6 million customers worldwide. It includes Tennis-Point, WiggleCRC, Fahrrad.de, Bikester, Probikeshop, Campz, Addnature, TennisPro and Outfitter.

Further information: www.signa-sportsunited.com.

 

Reconciliations

(in EUR millions)

H1

 

H1

FY22

 

FY23
 
Net Loss

(€196.4)

 

(€180.5)
Income tax expense / benefit

€8.0

 

€3.0
Earnings before tax (EBT)

(€204.4)

 

(€183.5)
Interest

€2.6

 

(€13.1)
Depreciation and amortization

(€21.5)

 

(€27.6)
EBITDA

(€185.4)

 

(€142.8)
 
Impairment loss

–

 

€0.2
Other net finance (income) / costs

(€10.8)

 

€0.3
Result from investments accounted for at equity

€0.6

 

€0.8

 

 

 
Total EBITDA Adjustments

€169.8

 

€44.5
Transaction related charges

€0.7

 

–
Reorganization and restructuring costs

€126.9

 

€30.0
Consulting fees

€31.3

 

€13.2
Share-based compensation

€9.1

 

€3.2
Other items not directly related to current operations

€1.8

 

(€1.9)
Adj. EBITDA

(€25.8)

 

(€96.9)
 

Unaudited interim condensed consolidated statements of operations

(in EUR millions)

H1

H1

YoY

2022

2023

Growth
 
Net Revenue

€449.1

€441.4

(1.7%)
 
Own Work Capitalized

2.2

2.3

5.2%
Other Operating Income

2.6

5.5

NM
Total Revenue and Other Income

€453.9

€449.3

(1.0%)
 
Cost of Materials

(286.0)

(324.7)

13.5%
Personnel Expense

(61.8)

(76.1)

23.2%
Other Operating Expenses

(131.9)

(145.4)

10.2%
EBITDA Adjustments

(169.8)

(44.5)

(73.8%)
Depreciation & Amortization

(21.5)

(27.9)

29.5%
Operating Loss

(€217.1)

(€169.3)

(22.0%)
 
Share of results of associates

(0.6)

(0.8)

27.7%
Finance income

17.0

6.8

(60.3%)
Finance costs

(3.6)

(20.2)

NM
Pre-Tax Income

(€204.4)

(€183.5)

(10.2%)
 
Income Taxes

8.0

3.0

(62.8%)
Result from continuing operations

(€196.4)

(€180.5)

(8.1%)

 

Unaudited interim condensed consolidated statements of financial position

(in EUR millions)
H1 H1
FY22 FY23
 
Non-current assets
Intangible assets

€935.2

€674.5
Property, plant and equipment and right of use

137.7

176.5
Equity accounted investees

0.0

0.0
Other non-current financial assets

3.3

9.2
Accrued expenses (non-current)

–

0.0
Current assets
Inventories

313.7

257.4
Trade receivables

25.3

28.2
Income tax receivables

0.4

0.4
Other current financial assets

15.9

17.2
Other current assets

47.7

50.1
Cash and cash equivalents

68.6

35.4
Total assets

€1,547.7

€1,248.9
Owners net investment

972.2

441.6
Total equity

€972.2

€441.6
Non-current liabilities
Non-current provisions

4.1

2.6
Non-current financial liabilities

105.5

469.5
Non-current trade payables

12.3

–
Other non-current liabilities

3.6

11.5
Deferred taxes

57.8

37.0
Current liabilities
Current income tax liabilities

0.9

1.0
Current provisions

2.7

3.3
Trade payables

153.3

164.3
Other current financial liabilities

154.9

44.8
Other current liabilities

75.0

62.9
Contract liabilities

5.5

10.3
Total liabilities

€575.5

€807.2
Total equity and liabilities

€1,547.7

€1,248.9
 

Unaudited interim condensed consolidated statements of cash flows

(in EUR millions)
H1 H1
FY22 FY23
 
NET CASH FLOW FROM OPERATING ACTIVITIES
Loss before taxes from continuing operations

(€204.4)

(€183.5)
Loss before taxes from discontinued operations

(€5.3)

€0.5
Loss before taxes for the total operations

(€209.7)

(€183.0)
Adjustments to reconcile losses before taxes to net cash from operating activities
Depreciation, amortization and impairment

€21.5

€27.9
(Income) loss from investments accounted for using the equity method

€0.6

€0.8
Net finance costs (income)

(€13.4)

€13.4
Equity-based compensation expense

€10.0

€3.0
Other non-cash income and expenses

(€1.7)

(€1.5)
Listing expenses (IFRS 2 service charge)

€121.9

–
Change in other non-current assets

€3.0

(€0.5)
Change in other non-current liabilities

€5.6

€4.8
Change in:
Inventories

(€44.7)

€39.7
Trade receivables

€3.3

(€3.2)
Other current financial assets

€5.6

€3.4
Other current assets

(€5.3)

€1.2
Current provisions

(€2.2)

€2.3
Trade payables

€0.6

(€30.6)
Other current financial liabilities

€0.0

(€1.7)
Other current liabilities

(€44.3)

(€12.7)
Contract liabilities

(€0.9)

€1.1
Cash flow used in continuing operating activities

(€144.7)

(€136.2)
Cash flow used in discontinued operating activities, net

(€3.3)

€1.1
Net cash flow used in operating activities

(€148.0)

(€135.1)
 
NET CASH FLOW FROM INVESTING ACTIVITIES
Purchase of intangible assets and property, plant and equipment

(€20.4)

(€16.7)
Acquisition of subsidiaries, net of cash acquired

(€169.9)

–
Cash flow used in continuing investing activities

(€190.2)

(€16.7)
Cash flow used in discontinued investing activities, net

(€0.3)

(€0.0)
Net cash flow used in investing activities

(€190.6)

(€16.7)
 
NET CASH FLOW FROM FINANCING ACTIVITIES
Proceeds from capital contributions

€402.7

–
Proceeds from the issue of convertible loans

–

100.0
Repayments of financial liabilities to related parties

–

(0.0)
Proceeds from financial liabilities to related parties

–

62.0
Proceeds from financial liabilities to financial institutions

26.1

0.4
Repayment of financial liabilities to financial institutions

(77.5)

(0.8)
Transaction costs related to the lisiting

(€10.3)

–
Proceeds from the recapitalization

23.6

–
Acquisition of NCI

–

(1.2)
Repayment of other loans

(0.7)

–
Payments for lease liabilities

(6.2)

(8.4)
Interest paid

(1.2)

(6.9)
Cash flow from continuing financing activities

€356.6

€145.1
Cash flow used in discontinued financing activities, net

(€0.2)

(€0.4)
Net cash flow from financing activities

€356.4

€144.6
 
Effect of exchange rate changes on cash and cash equivalents

–

(0.4)
 
Net increase (decrease) in cash and cash equivalents

€17.8

(€7.5)

 

SSU Investor Contact

Jeremy Nelle

[email protected]

+1 203 546 0154

SSU Media Contact

Jeremy Nelle

[email protected]

+1 203 546 0154

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Complete Solaria Announces Promotion of Arnaud Lepert to Chief Operating Officer

Complete Solaria Announces Promotion of Arnaud Lepert to Chief Operating Officer

FREMONT, Calif.–(BUSINESS WIRE)–Complete Solaria, Inc. (“Complete Solaria” or the “Company”), a leading solar technology, services, and installation company, is pleased to announce the promotion of Arnaud Lepert to Chief Operating Officer, effective June 26, 2023. Mr. Lepert will oversee all Systems and Modules operations and functions for the company.

“Arnaud comes from the semiconductor industry, which has the highest standards for quality, efficiency, and disciplined manufacturing,” said T.J. Rodgers, Chairman of the Board. “I have placed people with similar expertise into companies like Enphase and Enovix, and as a result they took off. I expect Arnaud will have that kind of impact here.”

Mr. Lepert was most recently SVP, Product and Technology at Solaria. Prior to joining Solaria, Mr. Lepert served as Chief Product Officer for Energy Everywhere where he led the development of innovative perovskite-based solar cells. Mr. Lepert previously worked at Coherent, serving as the general manager of the high power optically pumped semiconductor laser business unit where he grew this technology from the lab to a market leading position. His career includes tenures in the semiconductor industry working for Applied Materials, STMicroelectronics and Maxim Integrated leading R&D and engineering teams focused on CMOS and BiCMOS process development. Mr. Lepert earned an M.S. in Electrical Engineering at Telecom Paris, and B.S. in Materials Science at Ecole Polytechnique.

About Complete Solaria

Complete Solaria is a solar company with unique technology and an end-to-end customer offering, which is expected to include financing, project fulfilment, and customer service, allowing it to sell more products across more markets and enable more options for customers wishing to make the switch to a more energy-efficient lifestyle. To learn more, visit: https://www.completesolaria.com.

Investor Relations – Complete Solaria

Sioban Hickie, ICR, Inc.

[email protected]

Public Relations – Complete Solaria

Doug Donsky, ICR, Inc.

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Other Energy Utilities Sustainability Environment Alternative Energy Energy Environmental Health Green Technology

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Redwire Announces Follow-On Contract to Develop Additional Roll-Out Solar Arrays for the International Space Station

Redwire Announces Follow-On Contract to Develop Additional Roll-Out Solar Arrays for the International Space Station

Development of two additional Roll-Out Solar Arrays announced following the successful deployment of the sixth Redwire-built array on the space station.

JACKSONVILLE, Fla.–(BUSINESS WIRE)–
Redwire Corporation (NYSE: RDW), a leader in space infrastructure for the next generation space economy, announced today that it has been awarded a follow-on contract from Boeing to develop two additional Roll-Out Solar Arrays (IROSA) for the International Space Station (ISS).

The IROSAs augment the space station’s power supply to support critical research and space operations. This award is a follow-on to Redwire’s contract to deliver six IROSAs, which were developed in partnership with Boeing’s Spectrolab and delivered to NASA under contract with Boeing, NASA’s prime contractor for space station operations.

“We are proud of the successful deployment of six IROSAs on the ISS to date, making it the gold standard for large-scale power generation with proven flight heritage. The continuation of the program with the award of an additional two IROSAs, bringing the total to eight arrays, is a testament to the excellence and dedication of our team and the coordination amongst our suppliers and partners,” said Peter Cannito, Redwire Chairman and CEO.

“The six IROSAs installed on the ISS are innovative examples to support further utilization with technologies and systems that were not envisioned when the ISS was designed and built,” said John Mulholland, Boeing vice president and program manager for the ISS. “It is a tribute to the performance of the design, build, and operational teams that NASA has contracted for two additional arrays to complete the upgrade to the full eight-array set.”

Since 2021, a total of six Redwire-built arrays have been developed, delivered, and deployed on the ISS, augmenting its critical power supply. Each wing provides an additional 20+ kW of power once deployed, and all eight IROSA wings combined will provide more than 160 kW for over 10 years.

Redwire has continued to advance ROSA technology to power other spaceflight platforms and ambitious missions with reliable and stable power solutions. Redwire is currently building ROSA for the Power and Propulsion Element for NASA’s Gateway program, a part of the agency’s Artemis program, and Astrobotic’s Lunar Vertical Solar Array program, which aims to provide sustainable power on the lunar surface. Along with its previous success on the ISS, ROSA technology powered NASA’s DART spacecraft to impact asteroid Dimorphos, successfully altering the asteroid’s orbit in September 2022.

About Redwire

Redwire Corporation (NYSE: RDW) is a global leader in mission critical space solutions and high reliability components for the next generation space economy, with valuable intellectual property for solar power generation, in-space 3D printing and manufacturing, avionics, critical components, sensors, digital engineering and space-based biotechnology. We combine decades of flight heritage with an agile and innovative culture. Our “Heritage plus Innovation” strategy enables us to combine proven performance with new, innovative capabilities to provide our customers with the building blocks for the present and future of space infrastructure. For more information, please visit redwirespace.com.

Media Contact:

Emily Devine

[email protected]

305-632-9137

OR

Investors:

[email protected]

904-425-1431

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INDUSTRY KEYWORDS: Aerospace Manufacturing Alternative Energy Other Science Energy Other Manufacturing Science

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Sarissa Capital Urges Alkermes Shareholders to Vote “FOR” Sarah Schlesinger and “WITHHOLD” Incumbent Director Richard Gaynor

Sarissa Capital Urges Alkermes Shareholders to Vote “FOR” Sarah Schlesinger and “WITHHOLD” Incumbent Director Richard Gaynor

Independent proxy advisory firm ISS also recommends voting “FOR” Sarah Schlesinger and “WITHHOLD” Richard Gaynor

Sarissa believes adding Sarah Schlesinger to the Alkermes board can unlock shareholder value and help Alkermes achieve its true potential

GREENWICH, Conn.–(BUSINESS WIRE)–
Sarissa Capital Management LP (“Sarissa”) today released the following letter to shareholders of Alkermes plc (NASDAQ: ALKS):

June 28, 2023

Dear Fellow Alkermes Shareholders:

For over 30 years and over $150 million in compensation, Chairman and CEO Richard Pops has presided over massive destruction of shareholder value at Alkermes, including managing to operate a $1 billion revenue-generating company (nearly one third of which is cost-free royalty income) at a perpetual loss with limited oversight by the board and no accountability to shareholders.

Shareholder pressure, including from Sarissa, has only incrementally moved the company in the right direction the last few years. We believe true change will not occur without a strong shareholder presence on the board. Despite Alkermes’ process to refresh the board (a process which we believe was run by Pops), it remains a board largely seemingly devoted to Pops, without shareholder perspectives, and with incumbent directors who have superfluous skill sets. If shareholders are not added to the board, we fear that Pops will continue to run the company as he pleases and never address its fundamental issues.

The board steadfastly refuses to add our nominees, including Sarah Schlesinger, who the Nom-Gov committee at Alkermes previously acknowledged would be a qualified board candidate and who ISS recommended that shareholders vote “FOR”. Sarah has extensive expertise in biopharmaceutical R&D and experience serving on the boards of several biopharmaceutical companies, including ARIAD Pharmaceuticals and The Medicines Company, where she helped create meaningful shareholder value.

Shareholders face an important decision at the upcoming Alkermes annual shareholder meeting. We need to send a strong message to Chairman and CEO Pops that we will not accept a reversion to the status quo of prolonged underperformance.

We urge our fellow Alkermes shareholders to vote the BLUE universal proxy card “FOR” Sarah Schlesinger to provide much needed oversight and accountability at Alkermes and vote “WITHHOLD” on Richard Gaynor (a cancer specialist whose skills will be unnecessary after the spin of the cancer business in a few months).

Thank you for your continued support.

Sarissa Capital Management LP

For additional information please visit our website at upgradealkermes.com.

#UpgradeAlkermes

If you have any questions regarding your BLUE universal proxy card or need assistance in executing your proxy card, please contact:

D.F. King & Co., Inc.

Shareholders call Toll-Free: (866) 207-3648

All Others Call: (212) 493-6952

Email: [email protected]

Your vote at Alkermes’ Annual General Meeting of Shareholders on June 29, 2023 is very important. We urge all shareholders to vote “FOR” the election of the Sarissa Nominees, “AGAINST” the compensation of the Company’s named executive officers, and “FOR” all other proposals in our proxy statement.

You can vote in one of three easy ways: by internet at www.cesvote.com, by telephone at 1-888-693-8683 or by mail using the BLUE universal proxy card and postage-paid envelope sent to you.

If you vote by internet or telephone, you will be required to provide the unique control number printed on your BLUE universal proxy card.

Additional Information

Sarissa Capital Management LP (“Sarissa Capital”), together with other participants, filed a definitive proxy statement and an accompanying BLUE universal proxy card with the SEC on June 2, 2023, in connection with the solicitation of shareholders of the Company for the 2023 annual general meeting of shareholders (the “Annual Meeting”). Shareholders are advised to read the definitive proxy statement and other documents related to the Annual Meeting as they contain important information.

The definitive proxy statement and other relevant documents are available at no charge on the SEC’s website at www.sec.gov. The definitive proxy statement and other relevant documents filed by Sarissa Capital are also available at no charge at www.upgradealkermes.com or by directing a request to Sarissa Capital’s proxy solicitor, D.F. King & Co., Inc., 48 Wall Street, New York, New York 10005 (Shareholders can call toll-free: (866) 207-3648).

Dayna Packes

Sarissa Capital Management LP

[email protected]

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