Accolade Announces Upcoming Investor Events

SEATTLE, May 08, 2023 (GLOBE NEWSWIRE) — Accolade, Inc. (NASDAQ: ACCD), a healthcare provider that serves millions of members, today announced that it will be presenting at the following upcoming investor events. A webcast and replay of each event will be available at ir.accolade.com.

  • Monday, May 8 at 1:00 pm PT. Accolade’s Capital Markets Day at the Wynn Las Vegas
  • Tuesday, May 9 at 3:40 pm PT. BofA Securities Health Care Conference 2023 at the Encore Hotel in Las Vegas

About Accolade, Inc.

Accolade (Nasdaq: ACCD) is a Personalized Healthcare company that provides millions of people and their families with exceptional healthcare experiences so they can live their healthiest lives. Accolade’s employer, health plan, and consumer solutions combine virtual primary care and mental health, expert medical opinion, and best-in-class care navigation. These offerings are built on a platform that is engineered to care through predictive engagement of population health needs, proactive care that improves outcomes and cost savings, and by addressing barriers to access and continuity of care. Accolade consistently receives consumer satisfaction ratings of over 90%. For more information, visit accolade.com. Follow us on LinkedInTwitter, Instagram and Facebook.

Investor Contact:

Todd Friedman, Investor Relations, [email protected]

Source: Accolade



Aprea Therapeutics Appoints Gabriela Gruia, M.D. to Board of Directors

DOYLESTOWN, Pa., May 08, 2023 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical stage biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, today announced the appointment of Gabriela Gruia, M.D. to its Board of Directors, effective as of May 5, 2023. Dr. Gruia joins Aprea with over 25 years of clinical, regulatory and life science leadership experience.

“We are honored to welcome Dr. Gruia to the Aprea Board of Directors, where her deep experience and accomplishments in drug development and regulatory affairs will be of immense importance in advancing and expanding our pipeline of synthetic lethality inhibitors,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “Dr. Gruia’s proven skills in executing successful drug development strategies will provide valuable support to our growing pipeline, as we look ahead to upcoming milestones, including continued advancement of our lead candidate, ATRN-119, currently in a Phase 1/2a monotherapy trial for the treatment of cancers with DDR mutations.”

Dr. Gruia currently serves as Principal at Gabriela Gruia Consulting, LLC, which she founded in January 2021. She also serves as an Independent Board Director at Tessa Therapeutics, TScan Therapeutics, and Molecular Templates. Prior to her time as a consultant, Dr. Gruia served as the Chief Development Officer at Ichnos Sciences Inc. where she led clinical development activities. Prior to that, she was Senior Vice President and Head of Drug Regulatory Affairs for Novartis Oncology, where she led an oncology regulatory affairs organization which oversaw worldwide regulatory submissions and approvals of twelve molecular oncological entities, and over 100 sNDAs and MAAs. Previously, Dr. Gruia held leadership roles in research and development at Novartis, Pfizer, Pharmacia, Aventis and Rhone Poulenc. Dr. Gruia received her M.D. from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from Rene Huguenin/Curie Institute Cancer Center in Paris, France. She received her training in oncology and hematology from Rene Descartes University in Paris, France.

“I am thrilled to join Aprea at this pivotal moment in the company’s growth. I was impressed by Aprea’s approach to cancer therapy using synthetic lethality, and I look forward to applying my expertise in R&D and regulatory affairs to help grow this promising pipeline of synthetic lethality inhibitors, and poise the company for success with regulatory agencies,” said Dr. Gruia. “I share Aprea’s mission and commitment to addressing unmet medical needs for patients suffering from cancers.”

About Aprea Therapeutics, Inc.

Aprea Therapeutics, Inc. is a clinical stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on developing and commercializing novel synthetic lethality-based cancer therapeutics targeting a critical pathway and some of the most central targets in DDR and cancer progression. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor being developed for solid tumor indications. Our WEE1 inhibitor is being advanced to IND submission. For more information, please visit the company website at www.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

Forward Looking Statement

Certain information contained in this press release includes “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, related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.

Source: Aprea Therapeutics, Inc.

Investors and Media:

[email protected]
212-600-1902



Cabot Corporation Board Increases Dividend

Cabot Corporation Board Increases Dividend

BOSTON–(BUSINESS WIRE)–
On Friday, May 5, 2023, the Board of Directors of Cabot Corporation (NYSE: CBT) declared a quarterly dividend of $0.40 per share, an increase of 8% compared to the current quarterly dividend, on all outstanding shares of the Corporation’s common stock. The dividend is payable on June 9, 2023, to stockholders of record at the close of business on May 26, 2023.

“For over 50 years, we have consistently paid dividends, which reinforces our commitment to return capital to our shareholders,” said Sean Keohane, President and Chief Executive Officer of Cabot Corporation. “The dividend increase, our sixth in the last eight years, reflects our positive long-term view and the Board’s confidence in our ability to generate strong cash flows to fund high-growth investments and return cash to shareholders through a competitive dividend.”

On an annualized basis, the new dividend rate is $1.60 per share versus $1.48 per share, previously.

About Cabot Corporation

Cabot Corporation (NYSE: CBT) is a global specialty chemicals and performance materials company, headquartered in Boston, Massachusetts. The company is a leading provider of reinforcing carbons, specialty carbons, battery materials, engineered elastomer composites, inkjet colorants, masterbatches and conductive compounds, fumed metal oxides, and aerogel. For more information on Cabot, please visit the company’s website at: http://www.cabotcorp.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Statements in the press release regarding Cabot’s business that are not historical facts, including statements concerning our expectation about our ability to generate cash flow to fund growth investments and return cash to shareholders through a competitive dividend are forward looking statements. Forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward looking statements, see “Risk Factors” in the Company’s Annual Report on Form 10-K.

Steve Delahunt

Investor Relations

(617) 342-6255

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Machine Tools, Metalworking & Metallurgy Engineering Chemicals/Plastics Technology Other Technology Manufacturing

MEDIA:

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STRATA Skin Sciences to Participate in Inaugural EF Hutton Global Conference

HORSHAM, Pa., May 08, 2023 (GLOBE NEWSWIRE) — STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced the company will participate in the Inaugural EF Hutton Global Conference at The Plaza Hotel in New York City from May 10-11, 2023.

Management will participate in one-on-one meetings. To arrange a meeting with management, please contact your EF Hutton representative.

About STRATA Skin Sciences, Inc.

STRATA Skin Sciences is a medical technology company dedicated to developing, commercializing and marketing innovative products for the in-office treatment of various dermatologic conditions such as psoriasis, vitiligo, and acne. Its products include the XTRAC® excimer laser, VTRAC® lamp systems, and the TheraClear®X Acne Therapy System.

STRATA is proud to offer these exciting technologies in the U.S. through its unique Partnership Program. STRATA’s popular partnership approach includes a fee per treatment cost structure versus an equipment purchase, installation and use of the device, on-site training for practice personnel, service and maintenance of the equipment, dedicated account and customer service associates, and co-op advertising support to help raise awareness and promote the program within the practice.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
[email protected]



1ST DETECT SECURES SIGNIFICANT PURCHASE ORDER FOR CHECKPOINT SECURITY

AUSTIN, Texas, May 08, 2023 (GLOBE NEWSWIRE) — Astrotech Corporation (NASDAQ: ASTC) announced today that its 1st Detect subsidiary has received a 17 unit order for its TRACER 1000™ explosives trace detector (ETD). The systems will be deployed in Europe with deliveries scheduled to be fulfilled over the remainder of this calendar year. We expect this sale will expand 1st Detect’s footprint to 22 sites across 14 countries in Europe and Asia.

“We’re excited to extend our reach into more checkpoints throughout the world. Based on our near-zero false alarm rate, we believe that the TRACER 1000 improves checkpoint efficiency and passenger throughput by reducing the need for time-consuming and invasive secondary screenings that costs airports millions in lost merchandise and food sales,” said Thomas B. Pickens III, Chairman and Chief Executive Officer of 1st Detect.

The Astrotech Mass Spectrometer Technology™ (AMS Technology) powers the breakthrough TRACER 1000, the first certified ETD to use mass spectrometry. The TRACER 1000 is a rugged, fast, small, and easy to use mass spectrometer with near-zero false alarms. The TRACER 1000 is the only mass spectrometry-based ETD to have received European Civil Aviation Conference (ECAC) certification for both checkpoint and cargo security.

About Astrotech Corporation

Astrotech (Nasdaq: ASTC) is a mass spectrometry company that launches, manages, and commercializes scalable companies based on its innovative core technology through its wholly-owned subsidiaries. 1st Detect develops, manufactures, and sells trace detectors for use in the security and detection market. AgLAB develops and sells chemical analyzers for use in the agriculture market. BreathTech is developing a breath analysis tool to screen for volatile organic compounds that could indicate bodily infections and critical conditions. Astrotech is headquartered in Austin, Texas. For information, please visit www.astrotechcorp.com.

Forward
-Looking Statements

This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be
materially different from the forward-looking statement. These factors include, but are not limited to,
the adverse impact of recent inflationary pressures, including significant increases in fuel costs, global economic conditions and events related to these conditions, including the ongoing war in Ukraine and the COVID-19 pandemic
, the Company’s use of proceeds from the common stock offerings, whether we can successfully complete the development of our new products and proprietary technologies, whether we can obtain the FDA and other regulatory approvals required to market our products under development in the United States or abroad, whether the market will accept our products and services and whether we are successful in identifying, completing and integrating acquisitions, as well as other risk factors and business considerations described in the Company’s Securities and Exchange Commission filings including the Company’s most recent Annual Report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. Although the Company believes the expectations reflected in its forward-looking statements are reasonable and are based on reasonable assumptions, no assurance can be given that these assumptions are accurate or that any of these expectations will be achieved (in full or at all) or will prove to have been correct. Moreover, such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the Company, which may cause actual results to differ materially from those implied or expressed by the forward-looking statements. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company assumes no obligation to correct or update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.



Company Contact: Jaime Hinojosa, Chief Financial Officer, Astrotech Corporation, (512) 485-9530

Turtle Beach Appoints William Wyatt, the Founder and CIO of The Donerail Group, to the Company’s Board of Directors, Effective Immediately

Turtle Beach Appoints William Wyatt, the Founder and CIO of The Donerail Group, to the Company’s Board of Directors, Effective Immediately

Delivers on Commitment to Appointing a Shareholder Representative

Board Forms Value Enhancement Committee to Review a Broad Range of Strategic Opportunities

WHITE PLAINS, N.Y.–(BUSINESS WIRE)–
Turtle Beach Corporation (Nasdaq: HEAR, the “Company”), one of the world’s leading gaming accessory brands, today announced the appointment of William Wyatt to the Company’s Board of Directors (the “Board”), effective immediately.

In addition, the Board announced that it has formed a Value Enhancement Committee (the “Committee”) to review and assess a broad range of opportunities to maximize value for shareholders, including potential strategic transactions.

“There is strong progress underway at Turtle Beach, as evidenced by the Company’s improved 2023 revenue and adjusted EBITDA guidance,” said Terry Jimenez, Chairman of the Board at Turtle Beach. “I believe that the addition of Will as a shareholder representative with a sound understanding of our business after years of investing in the Company, along with being a key part of our newly created Value Enhancement Committee, will further extend our momentum of value creation for shareholders.”

Board Appointment

Mr. Wyatt is the Founder and Chief Investment Officer of The Donerail Group, a value-driven investment firm and one of the largest shareholders of Turtle Beach. He has over 15 years of financial services industry experience, having served as both an institutional investor and investment banker advising and investing in companies in the retail and consumer sectors. Prior to Donerail, he was a Portfolio Manager at Starboard Value LP, a New York-based investment adviser, where he served as the Head of Event Driven Investments. Mr. Wyatt also served in a variety of investment, advisory and leadership roles at Empyrean Capital, Magnetar Capital and Goldman Sachs.

“We are pleased to welcome Will to the Turtle Beach Board,” said Julia Sze, Chair of the Nominating and Governance Committee. “In addition to his perspective as one of the Company’s larger independent shareholders, Will brings capital markets acumen and significant M&A experience to the Board, and he has a strong track record developing successful financial strategies. Will and his team at Donerail have dedicated significant time over the last two years to understanding Turtle Beach’s business, and we look forward to leveraging his insights as we continue taking action to enhance value for Turtle Beach shareholders.”

“Turtle Beach has tremendous financial upside potential, and I am excited to join the Board at such an important time,” said Mr. Wyatt. “I am pleased with the recent governance actions that the Board has taken, in line with feedback that I, and many of my fellow shareholders, have provided. Looking ahead, I am committed to working with the significantly refreshed Board to unlock the substantial shareholder value that exists at Turtle Beach.”

Mr. Wyatt’s appointment fulfills the Board’s recently announced commitment to appoint a shareholder representative. In accordance with the Company’s bylaws, to accommodate the addition of Mr. Wyatt to the Board, the Board has temporarily expanded the size of the Board to ten members. The Board intends to later reduce the size of the Board as of the 2023 Annual Meeting of Stockholders, which the Board believes will facilitate management of an efficient board size given that Mr. Stark and Mr. Keitel have informed the Board of their intention not to stand for re-election at the 2023 annual meeting, as previously disclosed.

Formation of Value Enhancement Committee

The Value Enhancement Committee will review a broad range of opportunities to maximize value for shareholders, including potential strategic transactions. Mr. Jimenez will serve as Chair of the Committee with Mr. Wyatt and Dr. Andrew Wolfe, all of whom are independent directors, joining as members of the Committee.

The Committee will be focused on both short- and long-term revenue, profit and cash flow optimization and capital allocation, and will also explore a range of potential strategic paths to maximize value for shareholders. The Committee is moving forward with purpose and will be guided by our commitment to act in the best interests of all shareholders.

The Company notes that there can be no assurances that the review will result in a transaction or announcement of any kind. Turtle Beach does not intend to comment further regarding the review unless or until it is determined that further disclosure is appropriate or required by law.

Dechert LLP and Vinson & Elkins L.L.P. are serving as legal advisors to the Company.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking information and statements within the meaning of the federal securities laws. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding assumptions, projections, expectations, targets, intentions or beliefs about future events. Statements containing the words “may”, “could”, “would”, “should”, “believe”, “expect”, “anticipate”, “plan”, “estimate”, “target”, “goal”, “project”, “intend” and similar expressions, or the negatives thereof, constitute forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which could cause actual results to differ materially from those contained in any forward-looking statement. Forward-looking statements are based on management’s current beliefs and expectations, as well as assumptions made by, and information currently available to, management.

While the Company believes that its expectations are based upon reasonable assumptions, there can be no assurances that its goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect actual results and may cause results to differ materially from those expressed in forward-looking statements made by the Company or on its behalf. Some of these factors include, but are not limited to, risks related to logistic and supply chain challenges, the substantial uncertainties inherent in the acceptance of existing and future products, the difficulty of commercializing and protecting new technology, the impact of competitive products and pricing, general business and economic conditions, risks associated with the expansion of our business, including the integration of any businesses we acquire and the integration of such businesses within our internal control over financial reporting and operations, our indebtedness, the Company’s liquidity, and other factors discussed in our public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and the Company’s other periodic reports filed with the SEC. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, the Company is under no obligation to publicly update or revise any forward-looking statement after the date of this release whether as a result of new information, future developments or otherwise.

Important Additional Information

The Company, its directors and certain of its executive officers are participants in the solicitation of proxies from the Company’s shareholders in connection with the Annual Meeting. The Company intends to file a definitive proxy statement and a WHITE proxy card with the SEC in connection with any such solicitation of proxies from the Company’s shareholders. SHAREHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ SUCH PROXY STATEMENT, ACCOMPANYING WHITE PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION. The Company’s definitive proxy statement for the 2022 Annual Meeting of Shareholders contains information regarding the direct and indirect interests, by security holdings or otherwise, of the Company’s directors and executive officers in the Company’s securities. Information regarding subsequent changes to their holdings of the Company’s securities can be found in the SEC filings on Forms 3, 4 and 5, which are available on the Company’s website at https://corp.turtlebeach.com/ or through the SEC’s website at www.sec.gov. Information can also be found in the Company’s other SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2022. Updated information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in the definitive proxy statement and other materials to be filed with the SEC in connection with the Annual Meeting. Shareholders will be able to obtain the definitive proxy statement, any amendments or supplements to the proxy statement and other documents filed by the Company with the SEC at no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge on the Company’s website at https://corp.turtlebeach.com/.

About Turtle Beach Corporation

Turtle Beach Corporation (corp.turtlebeach.com) is one of the world’s leading gaming accessory providers. The Company’s namesake Turtle Beach brand (www.turtlebeach.com) is known for designing best-selling gaming headsets, top-rated game controllers, and groundbreaking gaming simulation accessories. Innovation, first-to-market features, a broad range of products for all types of gamers, and top-rated customer support have made Turtle Beach a fan-favorite brand and the market leader in console gaming audio for over a decade. Turtle Beach’s ROCCAT brand (www.roccat.com) combines detail-loving German innovation with a genuine passion for designing the best PC gaming products, including award-winning keyboards, mice, headsets, mousepads, and other PC accessories. Turtle Beach’s shares are traded on the Nasdaq Exchange under the symbol: HEAR.

Media Information:

Joele Frank, Wilkinson Brimmer Katcher

Jed Repko / Nick Lamplough / Arielle Rothstein

212.355.4449

Investor Information:

Cody Slach or Alex Thompson

Gateway Investor Relations

949.574.3860

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Entertainment Consumer Electronics Technology Audio/Video Mobile/Wireless Electronic Games Casino/Gaming

MEDIA:

Natera Announces New Publication from I-SPY2 Trial Reinforcing Clinical Utility of Signatera™ for Breast Cancer Patients in the Neoadjuvant Setting

Natera Announces New Publication from I-SPY2 Trial Reinforcing Clinical Utility of Signatera™ for Breast Cancer Patients in the Neoadjuvant Setting

Study with 283 patients, >1,000 plasma samples, and longest follow-up exceeding 5 years demonstrates how ctDNA monitoring can help inform treatment decisions in HR+/HER2- and TNBC patients

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the publication of a new paper1 in Cancer Cell from the I-SPY2 trial, highlighting the prognostic and predictive utility of Natera’s personalized and tumor-informed, molecular residual disease (MRD) test, Signatera, in locally advanced breast cancer patients receiving neoadjuvant chemotherapy (NAC, treatment before surgery).

Up to 50% of newly diagnosed breast cancer patients receive NAC.2 While patients with locally advanced breast cancer can benefit from NAC, response rates tend to be lower among HER2-negative breast cancers, which represent the majority of cases. Such patients are therefore in need of a reliable biomarker predictive of treatment benefit. This study focused on evaluating circulating tumor DNA (ctDNA) dynamics during NAC as a tool to assess response and predict patient outcomes, with the hypothesis that treatment protocols may be tailored to optimize efficacy and reduce exposure to the toxicity of ineffective therapies.

The publication reports on an expanded cohort of 283 patients and 1,024 plasma samples from the I-SPY2 study. Plasma samples were collected at four time points: pretreatment (T0), 3 weeks after initiation of treatment (T1), 12 weeks between paclitaxel-based and anthracycline (AC) NAC regimens (T2), and after NAC before surgery (T3).

Key findings include:

  • ctDNA-positivity before, during, and after NAC was significantly associated with inferior distant recurrence-free survival (DRFS) in both subtypes (p=0.02 to p<0.0001); and in the 9% of TNBC patients who tested ctDNA-negative pretreatment, zero DRFS events were observed with a median follow-up of 3.12 years.

  • Early ctDNA clearance at 3 weeks of NAC was a significant predictor of response, as determined by pathologic complete response (pCR) or residual cancer burden (RCB) in TNBC (p=0.0002).

  • ctDNA-negativity after NAC was significantly associated with improved DRFS, even in patients with extensive residual cancer burden at surgery (p<0.0001), indicating that ctDNA status may be more prognostic than pCR status.

“Neoadjuvant chemotherapy is a powerful tool to optimize treatment of breast cancer. As we introduce new therapies, we need optimal tools to predict complete response,” said Laura Esserman, MD, MBA, and Laura van ‘t Veer, PhD, professors at the University of California, San Francisco, and co-authors of the paper. “This latest publication from the ISPY-2 study builds upon our previous findings that tumor-informed ctDNA monitoring has the potential to improve the prediction of response to NAC, and with more data, may allow non-invasive assays to replace core biopsies.”

“I-SPY2 provides compelling evidence to support the role of ctDNA in predicting the likelihood of benefit from neoadjuvant chemotherapy for HER2-negative breast cancer,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “The data support the use of Signatera to improve risk stratification and potentially guide escalation or de-escalation of systemic therapy in the neoadjuvant treatment setting.”

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

References

  1. Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high-risk early-stage HER2-negative breast cancer receiving neoadjuvant chemotherapy. Cancer Cell. 2023.

  2. Riedel F, Hoffmann AS, Moderow M, et al. Time trends of neoadjuvant chemotherapy for early breast cancer. Int J Cancer. 2020;147(11):3049–3058.

 

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, [email protected]

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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OSI Systems to Present at Oppenheimer 18th Annual Industrial Growth Conference

OSI Systems to Present at Oppenheimer 18th Annual Industrial Growth Conference

HAWTHORNE, Calif.–(BUSINESS WIRE)–OSI Systems, Inc. (NASDAQ: OSIS), today announced that it will be presenting at the Oppenheimer 18th Annual Industrial Growth Conference on Monday, May 8, 2023 at 1:30 PM ET.

To listen to the live web cast of the presentation, please visit the investor relations section of the OSI Systems website.

About OSI Systems, Inc.

OSI Systems, Inc. is a vertically integrated designer and manufacturer of specialized electronic systems and components for critical applications in the homeland security, healthcare, defense and aerospace industries. We combine more than 40 years of electronics engineering and manufacturing experience with offices and production facilities in more than a dozen countries to implement a strategy of expansion into selective end product markets. For more information on OSI Systems, Inc. or any of its subsidiary companies, visit www.osi-systems.com. News Filter: OSIS-G

OSI Systems, Inc.

Ajay Vashishat

Vice President, Business Development

310-349-2237

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Health Engineering Health Technology Technology Apps/Applications Aerospace Manufacturing Security

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Vontier to Participate in Upcoming Investor Events

Vontier to Participate in Upcoming Investor Events

RALEIGH, N.C.–(BUSINESS WIRE)–
Vontier Corporation (NYSE: VNT), a leading global provider of critical technologies and solutions to connect, manage and scale the mobility ecosystem, today announced that President and Chief Executive Officer Mark Morelli, and Senior Vice President and Chief Financial Officer Anshooman Aga, will participate in a fireside chat at the Goldman Sachs Industrial and Materials Conference on Wednesday, May 10th at 1:10 p.m. Eastern Time and will be hosting one-on-one meetings with investors.

Additionally, CFO Anshooman Aga will be hosting one-on-one meetings with investors at the following conferences:

  • Wolfe Research 16th Annual Global Transportation & Industrials Conference on Tuesday, May 23.

  • KeyBanc Capital Markets 2023 Industrials & Basic Materials Conference on Wednesday, May 31.

Vontier’s formal presentation during the Goldman Sachs event will be webcast live and can be accessed on the Investor Relations, “Events & Presentations” section of Vontier’s website, at www.vontier.com. A replay will be available, shortly after the presentations conclude.

ABOUT VONTIER

Vontier (NYSE: VNT) is a global industrial technology company uniting critical mobility and multi-energy technologies and solutions to meet the needs of a rapidly evolving, more connected mobility ecosystem. Leveraging leading market positions, decades of domain expertise and unparalleled portfolio breadth, Vontier enables the way the world moves – delivering smart, safe and sustainable solutions to our customers and the planet. Vontier has a culture of continuous improvement built upon the foundation of the Vontier Business System and embraced by over 8,500 colleagues worldwide. Additional information about Vontier is available on the Company’s website at www.vontier.com.

Ryan Edelman

Vice President, Investor Relations

Vontier Corporation

+1 (984) 238-1929

[email protected]

KEYWORDS: North Carolina United States North America

INDUSTRY KEYWORDS: EV/Electric Vehicles Fleet Management Data Management IOT (Internet of Things) Alternative Vehicles/Fuels Technology Autonomous Driving/Vehicles Automotive Environment Green Technology Automotive Manufacturing Manufacturing

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MAIA Biotechnology Reports First Quarter 2023 Financial Results and Provides Corporate Update

MAIA Biotechnology Reports First Quarter 2023 Financial Results and Provides Corporate Update

  • Reported positive topline data from the completed Part A safety lead-in of the THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer (NSCLC) and commenced recruitment in Part B randomized efficacy/dose selection

  • Outlined preliminary safety data from Part A survival safety data from THIO-101 with first two enrolled patients alive after approximately 10 and 9 months post treatment initiation, respectively

  • Reported strong efficacy of THIO in liver in vivo cancer models; study showed THIO with complete and durable responses in Hepatocellular Carcinoma (HCC), the dominant histology of primary liver cancer (90%),

  • Raised approximately $5.75 million in gross proceeds from public offering of 2,555,500 shares of common stock at a public offering price of $2.25 per share

CHICAGO–(BUSINESS WIRE)–MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today reported financial results for the first quarter ended March 31, 2023, and provided a corporate update.

“We are thrilled with the advancement of the THIO-101 trial, inclusive of reporting the positive topline data and preliminary survival data from the completed Part A safety lead-in of our ongoing phase 2 trial,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “The clinical activity seen with THIO thus far, in addition to its favorable safety and efficacy profiles, puts us one step closer to our goal of treating NSCLC and liver cancer. Additionally, we are proud to have strengthened our balance sheet by completing the follow-on offering. As we progress through the year, we look forward to our plan to share the safety data from Part B randomized efficacy/dose selection and receive IND clearance in the U.S.”

Corporate Highlights

Reported positive topline data from the completed Part A safety lead-in of the THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer (NSCLC) and commenced recruitment in Part B randomized efficacy/dose selection: Topline data from Part A demonstrated that MAIA’s telomere-targeting agent, THIO, administered in sequential combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab), were generally well-tolerated.

Reported preliminary survival data in Part A of THIO-101 Phase 2 trial for Non-Small Cell Lung Cancer: As of April 2023, the first two patients enrolled in Part A continued to be alive, approximately 10 and 9 months, respectively, from treatment initiation. Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of therapy, respectively, after previously failing treatment with an immune checkpoint inhibitor.

Reported strong efficacy of THIO in liver in vivo cancer models: Study showed THIO with complete and durable responses in Hepatocellular Carcinoma (HCC), which is the dominant histology in primary liver cancer (90%). When combined with immunotherapy checkpoint inhibitor (CPI), the duration of response was further potentiated. Administration of THIO alone and in combination with CPI generated anti-cancer immune memory. Upon rechallenge with two times more cancer cells and no additional treatment, tumor growth was completely prevented.

Closed common stock public offering: Raised gross proceeds of approximately $5.75 million, before deducting underwriting discounts and offering expenses, in a public offering of 2,555,500 shares of common stock at a public offering price of $2.25 per share.

First Quarter 2023 Financial Results

Cash Position: The Company had cash totaling approximately $7.6 million as of March 31, 2023, compared to $10.9 million in cash as of March 31, 2022. The amount as of March 31, 2023 does not include the net proceeds from the public offering of shares of common stock received subsequent to quarter end.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.2 million for the quarter ended March 31, 2023, compared to approximately $2.1 million for quarter ended March 31, 2022. The increase was primarily related to an increase in payroll and bonus expenses of approximately $0.46 million related to the increased headcount of additional research and development employees offset by a decrease in Clinical and Scientific research fees of approximately $0.23 million due less THIO-101 trial start-up fees, and a decrease in consulting and other fees of approximately $0.12 million. R&D expenses included approximately $0.3 million and $0.3 million of non-cash stock compensation expense in the first quarter of 2023 and 2022, respectively.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.0 million for the quarter ended March 31, 2023, compared to approximately $1.4 million for the quarter ended March 31, 2022. The increase for the quarter was primarily due to approximate increases in payroll and bonus expenses of $0.3 million, an increase of approximately $0.6 million of other expenses related to the costs of operating as a public company, offset by a decrease in stock-based compensation of approximately $0.2 million and professional fees of approximately $0.1 million. G&A expenses included approximately $0.3 million and $0.4 million of non-cash stock compensation expense in the quarters ended March 31, 2023, and 2022, respectively.

Other Income (Expense): Other income was approximately $0.07 million for the quarter ended March 31, 2023, and other expense for the quarter ended March 31, 2022 was approximately $0.03 million. The increase was primarily related to increases in the Australia research and development incentives of approximately $0.02 million and a gain on the change in the fair value of the warrant liability of approximately $0.02 million, offset by increases to interest expense of approximately $0.005 million.

Net Income (Loss): Net loss was approximately $4.1 million for the quarter ended March 31, 2023, as compared to net loss of approximately $3.9 million for the quarter ended March 31, 2022.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

MAIA Biotechnology

Joseph McGuire

Chief Financial Officer

[email protected]

904-228-2603

ICR Westwicke

Stephanie Carrington

[email protected]

646-277-1282

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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