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American Industrial Partners Announces Best and Final Offer for the Acquisition of SEACOR Holdings Inc.

American Industrial Partners Announces Best and Final Offer for the Acquisition of SEACOR Holdings Inc.

NEW YORK–(BUSINESS WIRE)–
American Industrial Partners (“AIP”) is reinforcing its commitment to the offer to acquire all of the outstanding common stock of SEACOR Holdings Inc. (NYSE: CKH) (“SEACOR”) at the tender offer price of $41.50 per share. AIP must make clear that $41.50 is its best and final offer and it believes that there is significant downside to shareholders if the transaction does not close on these terms.

The tender offer currently expires at 5:00 p.m. ET on Friday, March 12, 2021. As shareholders make their decision, they should be aware that:

  • The current transaction was not initiated by AIP. In fact, it resulted from a full and multi-stage auction process, comprising both strategic and financial investors. As described in the proxy, the process was initiated by SEACOR’s board of directors when it engaged an investment bank in June 2020 to assist SEACOR in assessing its strategic positioning and plan. AIP was contacted by SEACOR’s representatives in early August, not the other way around.
  • On November 18, 2020, AIP submitted a final bid of $41.00 per share, which was above its initial first round bid of $40.00 per share. In final negotiations, AIP was persuaded to increase its bid to $41.50. Given the full auction process and that AIP’s transaction was announced 13 weeks ago, it strikes AIP as unlikely in the extreme that another bidder is going to emerge offering more.
  • AIP’s offer price represents an approximately 31% premium over SEACOR’s 90-day volume weighted average price prior to announcing the take-private transaction. AIP believes if the transaction doesn’t close, SEACOR’s share price will likely return to its pre-announcement context. The fundamental overcapacity and demand headwinds facing SEACOR’s petroleum transportation end-markets are well known, evident in the trading prices of single name comparables and relevant indices, and further confirmed in the extensive due diligence AIP performed.
  • SEACOR’s board, management and all other insiders (none of whom are affiliated in any way with AIP) are all selling 100% of their equity in the context of this transaction.
  • AIP offered Charles Fabrikant and Eric Fabrikant the opportunity to “roll over” a portion or all of their equity, and the opportunity was declined. Charles Fabrikant, Seacor’s founder and longtime CEO, chose to approve this transaction and fully exit in the context of this transaction, and intends to step down from all roles with the company effective upon the closing. He would not be maintaining any further exposure to SEACOR’s equity.

In closing, AIP observes that while it of course believes that this transaction represents a good long-term investment for AIP, in its view SEACOR is a poor fit as a public company, and if the transaction doesn’t close there is significant near- and long-term risk for SEACOR’s public stockholders.

About American Industrial Partners

American Industrial Partners is an operationally oriented private equity firm that makes control investments in industrial businesses serving domestic and global markets. The firm has deep roots in the industrial economy and has been active in private equity investing since 1989. To date, American Industrial Partners has completed over 100 transactions and currently has more than $7 billion of assets under management on behalf of leading pension, endowment and financial institutions. For more information on American Industrial Partners, visit www.americanindustrial.com.

Additional Information and Where to Find It

The tender offer described in this communication commenced on December 18, 2020. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of SEACOR. On December 18, 2020, the bidders filed with the United States Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO, and SEACOR filed with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9. SEACOR’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Tender Offer Statement and the Solicitation/Recommendation Statement are available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting SEACOR. Free copies of these materials and certain other offering documents will be made available by SEACOR upon request by mail to SEACOR Holdings Inc., 2200 Eller Drive, P.O. Box 13038, Fort Lauderdale, FL 33316, attention: Investor Relations, or by phone at 1-954-523-2200, or by directing requests for such materials to the information agent for the offer named in the Tender Offer Statement. Copies of the documents filed with the SEC by SEACOR will be available free of charge under the “Investors” section of SEACOR’s internet website at seacorholdings.com. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, SEACOR files annual, quarterly and current reports, proxy statements and other information with the SEC. SEACOR’s filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

Information Agent

Michael Madalon

D.F. King & Co., Inc.

212-269-5732 / 917-294-9326

[email protected]

Investors

Innisfree M&A Incorporated

Scott Winter / Jonathan Salzberger

212-750-5833

Media

Stephen Pettibone / Mike DeGraff

Sard Verbinnen & Co.

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

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Enphase Energy and Urban Solar Partner on 719 kW Multifamily Solar Site in Florida

FREMONT, Calif., March 08, 2021 (GLOBE NEWSWIRE) — Enphase Energy, Inc. (NASDAQ: ENPH), a global energy management technology company and the world’s leading supplier of microinverter-based solar-plus-storage systems, today announced that Urban Solar has deployed a large-scale commercial solar system at the Praxis of Deerfield Beach senior living community in Deerfield Beach, Florida. Spanning nine buildings, the system is expected to produce 1,040,900 kWh of electricity in its first year of operation.

The Praxis of Deerfield Beach senior living community is owned by MRK Partners and offers apartment-style living designed for low- and fixed-income seniors. The 224-unit complex was originally built in a master meter configuration, for which the local utility required the use of a single-phase solar system. The Praxis solar array consists of 1,798 Enphase IQ 7+™ microinverters managed by nine Enphase Envoy™ communications gateway devices. The Envoy communications gateways connect Enphase Solar systems to the Enphase Enlighten™ software monitoring platform and help make per-panel energy monitoring and insights for operations and maintenance easy.

“This is the second master meter property in the MRK Partners portfolio that Urban Solar has helped bring into the future with solar energy, and Enphase Solar technology has once again proven to be the right technology for the upgrade,” said Michael Vergona, president at Urban Solar. “These master meter buildings were built in the 1980s and provide a vital source of housing for seniors with constrained budgets. A large-scale upgrade to an individually metered electrical system would have been complicated and expensive, so we were very happy to offer a solar energy alternative that helped to solve the problem.”

Enphase microinverters are subjected to a rigorous reliability and quality testing regimen with over one million cumulative hours of test cycles in heat, high humidity, salty air, and extreme cold. To further help ensure quality and durability, Enphase IQ 7+ microinverters are designed to be long-lived energy assets and do not contain complicated moving parts or easily breakable components, such as fans, and are backed by a 25-year warranty.

“The Urban Solar team has taken on some extraordinarily challenging solar projects, and I am proud that Enphase products were utilized to add value for multi-unit properties like the Praxis of Deerfield Beach,” said Dave Ranhoff, chief commercial officer at Enphase Energy. “At Enphase, we are dedicated to delivering a combination of high-quality products and an outstanding customer experience, and installation companies like Urban Solar help deliver on these commitments.”

For more information about Urban Solar and commercial solar solutions based on Enphase Energy technology, please visit the Urban Solar website at https://urbansolar.com/.

About Enphase Energy, Inc.

Enphase Energy, a global energy technology company, delivers smart, easy-to-use solutions that manage solar generation, storage and communication on one intelligent platform. The Company revolutionized the solar industry with its microinverter technology and produces a fully integrated solar-plus-storage solution. Enphase has shipped more than 32 million microinverters, and approximately 1.4 million Enphase-based systems have been deployed in more than 130 countries. For more information, visit www.enphase.com and follow the company on Facebook, LinkedIn and Twitter.

Enphase Energy, Enphase, the E logo, IQ 7+, Envoy, Enlighten, and other trademarks or service names are the trademarks of Enphase Energy, Inc. Other names are for informational purposes and may be trademarks of their respective owners.

Forward-Looking Statements

This press release may contain forward-looking statements, including statements related to the expected capabilities and performance of Enphase Energy’s technology and products, including monitoring capabilities, quality and reliability, and energy production; and our customer service and the quality of service provided by our installation partners. These forward-looking statements are based on Enphase’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of certain risks and uncertainties, including those risks described in more detail in Enphase’s most recent Annual Report on Form 10-K and other documents on file with the SEC and available on the SEC’s website at www.sec.gov. Enphase Energy undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, or changes in its expectations, except as required by law.

Contact:

Christian Zdebel
[email protected]
484-788-2384

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7eeefd99-8c2f-4ee4-a59c-a12b1d7987da



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American Industrial Partners Announces Extension of Seacor Holdings Inc. Tender Offer

American Industrial Partners Announces Extension of Seacor Holdings Inc. Tender Offer

NEW YORK–(BUSINESS WIRE)–
American Industrial Partners has announced that Safari Merger Subsidiary, Inc. (“Purchaser”), an affiliate of American Industrial Partners, has extended until 5:00 p.m. Eastern Time on Friday, March 12, 2021 the expiration time for its previously announced cash tender offer to purchase all of the outstanding shares of common stock (the “Shares”) of SEACOR Holdings Inc. (NYSE:CKH) (“SEACOR”) at a price of $41.50 per share. The tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern Time, on March 5, 2021, was extended to allow additional time to meet the minimum tender condition that shares actually delivered (excluding shares tendered pursuant to guaranteed delivery procedures) represent at least 66 2/3% of all outstanding Shares.

American Stock Transfer & Trust Company, LLC, the depository for the tender offer, has indicated that, as of the prior expiration time, a total of approximately 923,839 Shares, representing approximately 4.42% of the outstanding Shares, had been validly tendered. The amount tendered includes approximately 3,931 Shares delivered pursuant to guaranteed delivery procedures that had been validly tendered pursuant to the tender offer. Shareholders who have already tendered their Shares do not have to re-tender their Shares or take any other action as a result of the extension of the tender offer.

The tender offer is being made pursuant to the tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other offer documents) in the Tender Offer Statement on Schedule TO (together with any amendments or supplements thereto, the “Tender Offer Statement”) filed by Purchaser and its affiliates with the United States Securities and Exchange Commission on December 18, 2020, as amended.

About American Industrial Partners

American Industrial Partners is an operationally oriented private equity firm that makes control investments in industrial businesses serving domestic and global markets. The firm has deep roots in the industrial economy and has been active in private equity investing since 1989. To date, American Industrial Partners has completed over 100 transactions and currently has more than $7 billion of assets under management on behalf of leading pension, endowment and financial institutions. For more information on American Industrial Partners, visit www.americanindustrial.com.

Additional Information and Where to Find It

The tender offer described in this communication commenced on December 18, 2020. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of SEACOR. On December 18, 2020, the bidders filed with the United States Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO, and SEACOR filed with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9. SEACOR’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Tender Offer Statement and the Solicitation/Recommendation Statement are available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting SEACOR. Free copies of these materials and certain other offering documents will be made available by SEACOR upon request by mail to SEACOR Holdings Inc., 2200 Eller Drive, P.O. Box 13038, Fort Lauderdale, FL 33316, attention: Investor Relations, or by phone at 1-954-523-2200, or by directing requests for such materials to the information agent for the offer named in the Tender Offer Statement. Copies of the documents filed with the SEC by SEACOR will be available free of charge under the “Investors” section of SEACOR’s internet website at seacorholdings.com. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, SEACOR files annual, quarterly and current reports, proxy statements and other information with the SEC. SEACOR’s filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

Information Agent Contact

Michael Madalon

D.F. King & Co., Inc.

212-269-5732 / 917-294-9326

[email protected]

Investor Contact

Innisfree M&A Incorporated

Scott Winter / Jonathan Salzberger

212-750-5833

Media Contact

Stephen Pettibone / Mike DeGraff

Sard Verbinnen & Co.

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

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Pluralsight and Vista Equity Partners Amend Definitive Agreement to Increase Offer Price to $22.50 Per Share in Cash

Revised Agreement Represents “Best and Final” Offer from Vista and Provides Enhanced, Immediate and Certain Value

Vista to Commence a Tender Offer for All of Pluralsight’s Outstanding Shares

Independent Transaction Committee and Pluralsight Board of Directors Unanimously Approve Revised Agreement and Recommend that All Shareholders Tender Their Shares in Support of the Transaction

SILICON SLOPES, Utah, March 08, 2021 (GLOBE NEWSWIRE) — Pluralsight, Inc. (NASDAQ: PS) and Vista Equity Partners (“Vista”) today announced that they have entered into a revised definitive agreement under which Vista will acquire all outstanding shares of Pluralsight for $22.50 in cash through a tender offer. The offer, which represents a best and final offer, is an 11% increase from the original $20.26 per share agreement. The independent Transaction Committee and Pluralsight’s Board of Directors have each unanimously approved the revised agreement and recommend that all shareholders tender their shares in support of the transaction. As part of the revised transaction, there have also been waivers of certain payments owed under Pluralsight’s Tax Receivable Agreement (“TRA”).

Aaron Skonnard, co-founder and CEO of Pluralsight, said, “The Pluralsight Board and management team are committed to acting in the best interests of the company and all of our shareholders, and appreciate the input that we have received from shareholders throughout this process. We worked with Vista to reach a revised agreement that provides an enhanced cash premium for Pluralsight shareholders. To that end, the directors who are parties to the TRA in their individual capacities, including me, have waived our rights to receive any TRA payments in connection with the acquisition by Vista, with those amounts being added to the additional consideration being offered by Vista to achieve the $22.50 per share price. Importantly, the revised transaction maintains a structure that preserves the ability of shareholders who are not officers and who are not receiving benefits under the TRA to determine the ultimate outcome of the transaction.”

“The independent Transaction Committee and the Pluralsight Board each unanimously support this revised agreement, which provides cash consideration of $22.50 per share to our shareholders. The amended agreement we announced today provides Pluralsight shareholders with immediate and certain value for the shares that they own at an 11% premium to the original transaction price and an approximately 38% premium to the volume weighted average closing stock price for the 30 trading days prior to the initial announcement of a transaction with Vista,” said Gary Crittenden, Pluralsight’s lead independent director. “The independent Transaction Committee and the Pluralsight Board each unanimously recommend that all Pluralsight shareholders tender their shares in support of the transaction.”

“This is our best and final offer for Pluralsight,” said Monti Saroya, co-head of the Vista Flagship Fund and senior managing director at Vista. “We are pleased that we have been able to enter into this revised merger agreement with Pluralsight and look forward to closing the transaction.”

Transaction Details

Under the terms of the revised agreement, Vista will commence a tender offer on or before March 10, 2021, to acquire all outstanding shares of Pluralsight’s common stock for $22.50 in cash.

Consistent with the conditions to the acquisition initially required by the Pluralsight Board, the consummation of the tender offer will be conditioned on the participation of a majority of the shares not held by (1) parties to the TRA that are receiving benefits under the TRA in connection with the acquisition by Vista or (2) any of Pluralsight’s officers, including Aaron Skonnard.

The transaction is expected to close in the second quarter of 2021.

In light of the revised agreement, the special meeting of Pluralsight shareholders scheduled to be held on March 9, 2021, has been canceled.

Following the completion of the tender offer, Vista will acquire any shares of Pluralsight that are not tendered in the tender offer through a second-step merger and any units of Pluralsight Holdings, LLC not held by Pluralsight through a merger under Delaware law, in each case for consideration equal to the tender offer price. Upon completion of the transaction, Pluralsight will become a privately held company and shares of Pluralsight’s Class A common stock will no longer be listed on any public market.

Shareholders who would like to tender their shares or have questions about the tender offer may contact MacKenzie Partners, Inc. who will act as Information Agent for the tender offer at 1-800-322-2885 (toll-free), 212-929-5500 or by email at [email protected].

Qatalyst Partners is serving as financial advisor to Pluralsight and Wilson Sonsini Goodrich & Rosati, Professional Corporation is serving as legal counsel. For Vista, Morgan Stanley & Co. LLC is serving as financial advisor, and Kirkland & Ellis LLP is serving as legal counsel.

About Pluralsight

Pluralsight is the leading technology workforce development company that helps companies and teams build better products by developing critical skills, improving processes and gaining insights through data, and providing strategic skills consulting. Trusted by forward-thinking companies of every size in every industry, Pluralsight helps individuals and businesses transform with technology. Pluralsight Skills helps enterprises build technology skills at scale with expert-authored courses on today’s most important technologies, including cloud, artificial intelligence and machine learning, data science, and security, among others. Skills also includes tools to align skill development with business objectives, virtual instructor-led training, hands-on labs, skill assessments and one-of-a-kind analytics. Flow complements Skills by providing engineering teams with actionable data and visibility into workflow patterns to accelerate the delivery of products and services. For more information about Pluralsight (NASDAQ: PS), visit pluralsight.com.

About Vista Equity Partners

Vista is a leading global investment firm with more than $73 billion in assets under management as of September 30, 2020. The firm exclusively invests in enterprise software, data and technology-enabled organizations across private equity, permanent capital, credit and public equity strategies, bringing an approach that prioritizes creating enduring market value for the benefit of its global ecosystem of investors, companies, customers and employees. Vista’s investments are anchored by a sizable long-term capital base, experience in structuring technology-oriented transactions and proven, flexible management techniques that drive sustainable growth. Vista believes the transformative power of technology is the key to an even better future – a healthier planet, a smarter economy, a diverse and inclusive community and a broader path to prosperity. Further information is available at vistaequitypartners.com. Follow Vista on LinkedIn, @Vista Equity Partners, and on Twitter, @Vista_Equity.

Additional Information and Where to Find It

In connection with the proposed acquisition of Pluralsight Inc. (“Pluralsight”), Lake Merger Sub I, Inc. (“Merger Sub”), will commence a tender offer for all of the outstanding shares of Pluralsight. The tender offer has not commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any securities of Pluralsight. It is also not a substitute for the tender offer materials that Merger Sub will file with the Securities and Exchange Commission (the “SEC”) upon commencement of the tender offer. Following the commencement of the tender offer, Merger Sub will file tender offer materials on Schedule TO with the SEC, and Pluralsight will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BY PLURALSIGHT’S SHAREHOLDERS BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Both the tender offer materials and the solicitation/recommendation statement will be made available to Pluralsight’s shareholders free of charge. A free copy of the tender offer materials and the solicitation/recommendation statement will also be made available to Pluralsight’s shareholders by visiting Pluralsight’s website (http://investors.pluralsight.com). In addition, the tender offer materials and the solicitation/recommendation statement (and all other documents filed by Pluralsight with the SEC) will be available at free of charge on the SEC’s website (http://www.sec.gov) upon filing with the SEC. PLURALSIGHT’S SHAREHOLDERS ARE ADVISED TO READ THE TENDER OFFER MATERIALS AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED BY MERGER SUB OR PLURALSIGHT WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER. THESE MATERIALS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TENDER OFFER, MERGER SUB AND PLURALSIGHT.

Forward-Looking Statements

This communication contains forward-looking statements that involve risks and uncertainties, including statements regarding our pending acquisition by affiliates of Vista Equity Partners (the “Transaction”), including the expected timing of the closing of the transaction and considerations taken into account by our Board of Directors in approving the Transaction. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of our assumptions prove incorrect, our actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include risks associated with: the risk that the conditions to the closing of the Transaction are not satisfied, including the risk that a sufficient number of Pluralsight’s shareholders do not participate in the Transactions; potential litigation relating to the Transaction; uncertainties as to the timing of the consummation of the Transaction and the ability of each party to consummate the Transaction; risks that the Transaction disrupts the current plans and operations of Pluralsight; and the risks described in the filings that we make with the SEC from time to time, including the risks described under the headings “Risk Factors” and “Management Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K, which was filed with the SEC on February 26, 2021, and which should be read in conjunction with our financial results and forward-looking statements. Our filings with the SEC are available on the SEC filings section of the Investor Relations page of our website at http://investors.pluralsight.com. All forward-looking statements in this communication are based on information available to us as of the date of this communication, and we do not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts

For Pluralsight

Investor Relations
Mark McReynolds
[email protected]

Media
DJ Anderson
[email protected]

Joele Frank, Wilkinson Brimmer Katcher
Matthew Sherman / Jed Repko
212.355.4449

For Vista

MacKenzie Partners, Inc.
Daniel H. Burch
212-929-5748
[email protected]

Laurie Connell
212-378-7071
[email protected] 



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Exelixis Enters into Exclusive License Agreement with WuXi Biologics to Support Further Expansion of its Growing Oncology Biologics Pipeline

Exelixis Enters into Exclusive License Agreement with WuXi Biologics to Support Further Expansion of its Growing Oncology Biologics Pipeline

– Exelixis has exclusive license to panel of monoclonal antibodies against an undisclosed oncology target for biologics applications, leveraging WuXi Biologics integrated technology platforms –

– In addition to a modest upfront payment, WuXi Biologics is eligible for potential milestones and royalties on net sales of potential products –

ALAMEDA, Calif. & SHANGHAI–(BUSINESS WIRE)–
Exelixis, Inc. (Nasdaq: EXEL) and WuXi Biologics (“WuXi Bio”) (2269.HK) today announced the companies have entered into an exclusive license agreement to support the continued expansion of Exelixis’ oncology biologics pipeline. The agreement is the latest in a series of biologics-focused transactions for Exelixis as the company builds out its pipeline behind CABOMETYX® (cabozantinib), its flagship product and global oncology franchise, which received its fourth approval from the U.S. Food and Drug Administration in January.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210308005465/en/

Under the terms of the agreement, Exelixis will make a modest upfront payment to WuXi Bio in exchange for an exclusive license to a panel of monoclonal antibodies to a preclinically validated target, discovered based on WuXi Bio’s integrated technology platforms, for the development of antibody-drug conjugate, bispecific, and certain other novel tumor-targeting biologics applications. WuXi Bio will be eligible for development and commercialization milestones, as well as tiered royalties on net sales of any potential products commercialized from the panel.

“Exelixis is pursuing a broad range of targets and therapeutic modalities to maximize the potential of our biologics pipeline to help patients with cancer,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. “Our agreement with WuXi Bio enhances our growing biotherapeutics portfolio by providing an approach to a preclinically validated target that has already shown early clinical potential in cancer. We’re looking forward to building on WuXi Bio’s significant technical foundation and applying our own expertise as we bring this promising program into the Exelixis discovery organization.”

“We’re glad to support Exelixis’ growing biotherapeutics pipeline with antibodies discovered through our integrated biologics technology platforms,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. “WuXi Biologics will continue to develop globally leading next-generation technologies to accelerate and transform biologics discovery, development and manufacturing. With globally recognized technical capabilities and unparalleled capacities, we are transforming how biologics are developed in the global setting.”

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company’s history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

About Exelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune’s 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Exelixis Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ strategy to build a growing oncology biologics pipeline and the potential of such biologics pipeline to help patients with cancer; Exelixis’ immediate and potential future financial and other obligations under the collaboration and license agreement with WuXi Bio; Exelixis’ plans build on WuXi Bio’s technical foundation and apply Exelixis’ own expertise to enhance its biotherapeutics portfolio; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the continuing COVID-19 pandemic and its impact on Exelixis’ research and development operations; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationship with WuXi Bio, including WuXi Bio’s adherence to its obligations under the collaboration and license agreement and the level of WuXi Bio’s assistance to Exelixis in completing clinical trials, pursuing regulatory approvals or successfully commercializing partnered compounds in the territories where they may be approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ and WuXi Bio’s continuing compliance with applicable legal and regulatory requirements; Exelixis’ and WuXi Bio’s ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its product pipeline discussed under the caption “Risk Factors” in Exelixis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 10, 2021, and in Exelixis’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a Japanese trademark.

Exelixis

Investors Contact:

Susan Hubbard

Executive Vice President,

Public Affairs & Investor Relations

(650) 837-8194

[email protected]

Media Contact:

Hal Mackins

For Exelixis, Inc.

(415) 994-0040

[email protected]

WuXi Biologics

Investors Contact:

[email protected]

Media Contact:

[email protected]

KEYWORDS: China United States North America Asia Pacific California

INDUSTRY KEYWORDS: Biotechnology Health Genetics Pharmaceutical Oncology

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Lineage Cell Therapeutics Raises $35.9 Million From Sales of Marketable Securities Holdings and an At-the-Market Equity Offering

Lineage Cell Therapeutics Raises $35.9 Million From Sales of Marketable Securities Holdings and an At-the-Market Equity Offering

Improved Cash Position Expected to Fund Operations for More Than Two Years

CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported that it raised $11 million in new capital from sales of its holdings of marketable securities, including shares of OncoCyte Corporation (Nasdaq: OCX) and Hadasit Bio-Holdings (TASE: HDST), as well as $25 million in gross proceeds from its at-the-market (“ATM”) offering. Lineage expects its approximately $57 million of cash and cash equivalents as of March 5, 2021 to fund operations well into 2023, by which time the Company expects to have achieved value-creating clinical and product development milestones. Lineage’s strengthened balance sheet also provides it with strategic flexibility in its ongoing partnership discussions.

“During the past six months, appreciation in our share price and that of marketable securities we owned has provided us with opportunities to monetize our investments and raise additional capital through our ATM offering,” stated Brian Culley, Lineage’s CEO. “These sales underscore that Lineage has created substantial value for its shareholders over time not only by advancing our product candidates toward later-stage clinical trials, but also by making and now harvesting significant early investments in OncoCyte and Hadasit and from aggressive and prudent expense reductions we previously reported. We expect that Lineage is now funded well into 2023, by which time we expect to have reached additional significant milestones, explored new areas to deploy our technology, and moved Lineage ever closer to our goal of becoming the preeminent allogeneic cell transplant company. Our stronger balance sheet also can provide us with optionality with respect to our ongoing partnership discussions.”

Cash and cash equivalents as of December 31, 2020 were $32.6 million and reflected $5.1 million in gross proceeds from sales on the ATM (which excluded $0.3 million in cash in transit related to 2020 sales that settled in 2021) and $0.8 million in gross proceeds from sales of Hadasit shares during the fourth quarter. From January 1, 2021 through March 5, 2021, Lineage raised an additional $19.9 million in gross proceeds through the ATM offering (which included $0.3 million in cash in transit related to 2020 sales that settled in 2021), as well as $10.1 million in gross proceeds from sales of OncoCyte shares and $21,000 in gross proceeds from sales of Hadasit shares. Lineage incubated OncoCyte and funded its initial product development before spinning it out as a separate public company in January 2016. As of March 5, 2021, OncoCyte’s market capitalization was over $300 million and Lineage has realized $32.5 million in total sales of its OncoCyte shares over time. The Company continues to hold 1,122,401 shares of OncoCyte stock valued at approximately $4.2 million and 169,167 shares of Hadasit stock valued at approximately $330,000, in each case based on the closing prices of those shares on March 5, 2021. Previously, Lineage also incubated and funded the initial product development of AgeX Therapeutics (NYSE American: AGE), and subsequently spun it out as a separate public company in November 2018, ultimately raising nearly $50 million from sales of its securities. Lineage believes that its broad technology platform and intellectual property portfolio may allow it to create additional value for shareholders through the advancement of its own novel pipeline as well as through the incubation and development of other products and companies, and through strategic corporate partnerships.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy technology platform and associated in-house development and manufacturing capabilities, as well as its broad intellectual property portfolio. With its technology platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or to be administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar market opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in a fully enrolled Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in a fully enrolled Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. Lineage’s broad technology platform and intellectual property portfolio also have allowed it to create value through the incubation, spinoff, and sale of companies addressing other large market opportunities. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s expected cash burn, timing for expected achievement of milestones, and partnership discussions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance, or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR

Ioana C. Hone

([email protected])

(442) 287-8963

Solebury Trout IR

Gitanjali Jain Ogawa

([email protected])

(646) 378-2949

Russo Partners – Media Relations

Nic Johnson or David Schull

[email protected]

[email protected]

(212) 845-4242

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Science Stem Cells Biotechnology Research Pharmaceutical Oncology Health Genetics

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Rezolute Strengthens Board of Directors with Key Appointments of Leading Rare Disease Experts

Vlad Hogenhuis, M.D., MBA, and Nerissa C. Kreher, M.D., M.S., MBA, to join board of directors as Rezolute advances lead candidate, RZ358, in congenital hyperinsulinism through late-stage clinical trials

REDWOOD CITY, Calif., March 08, 2021 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), today announced the appointments of Vlad Hogenhuis, M.D., MBA, and Nerissa C. Kreher, M.D., M.S., MBA to its Board of Directors.

“We are delighted to welcome rare disease experts Dr. Hogenhuis and Dr. Kreher to our board of directors,” said Nevan Elam, chief executive officer of Rezolute. “Dr. Hogenhuis’ track record of driving growth, culture change and patient impact across global markets coupled with Dr. Kreher’s extensive biotechnology industry experience in both clinical development for rare disease therapies and medical affairs will prove invaluable as we continue to advance RZ358 through late-stage clinical trials and accelerate the growth of our company.”

Dr. Hogenhuis added, “Rezolute’s targeted therapeutic candidates have great promise for patients with serious metabolic disorders across the globe. The company’s advances in developing a monoclonal antibody designed specifically to address congenital hyperinsulinism and an orally administered plasma kallikrein inhibitor for diabetic macular edema present a truly unique opportunity for me to assist in guiding the team at this pivotal stage.”

Dr. Kreher commented, “I am especially excited to join the board at this point in Rezolute’s evolution and look forward to leveraging my experience to provide strategic support to the company as it continues to grow. I am eager to work with their experienced, ambitious team towards a common vision of advancing targeted therapies for rare, metabolic and life-threatening diseases with transformative potential for patients.”

In addition to his role at Rezolute, Dr. Hogenhuis recently served as chief operating officer at Ultragenyx in global commercial operations, business development and manufacturing of medicines for patients with rare diseases. Previously, Dr. Hogenhuis served as senior vice president and global franchise head of specialty pharmaceuticals at GlaxoSmithKline (GSK) for six years. Prior to GSK, he served in leadership positions at Merck in the U.S., China and Europe for 18 years. He also served as a National Institutes of Health fellow in medical decision making at New England Medical Centre in Boston, and as a naval lieutenant surgeon in the Royal Dutch Navy. Dr. Hogenhuis currently serves on the board of GATT Technologies B.V. and IHP Therapeutics. He earned his medical degree from the University of Leiden in the Netherlands. He received an MBA from the Wharton School of Business at The University of Pennsylvania, Philadelphia.

Dr. Kreher currently serves as chief medical officer at Entrada Therapeutics, in addition to her new role on Rezolute’s board. Previously, she held the role of chief medical officer at Tiburio Therapeutics and Avrobio. Prior to these roles, Dr. Kreher held leadership positions at Zafgen, Shire, Enobia (acquired by Alexion) and Genzyme. During her career, she has made significant contributions to several approved therapies including Strensiq and has contributed to global clinical and regulatory strategies for multiple development programs. Dr. Kreher is a board-certified pediatric endocrinologist and holds multiple degrees including her B.S. in biology from University of North Carolina at Chapel Hill, M.D. from East Carolina University, an M.S. in clinical research from Indiana University-Purdue University Indianapolis and an MBA from Northeastern University Graduate School of Business Administration.

About Rezolute, Inc.

Rezolute is advancing targeted therapies for rare, metabolic, and life-threatening diseases. Its lead product candidate, RZ358, is in Phase 2b development as a potential treatment for congenital hyperinsulinism (HI), a rare pediatric endocrine disorder. Its pipeline also includes RZ402, an orally available plasma kallikrein inhibitor in Phase 1 development as a potential treatment for diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter.

Forward-Looking Statements

This release, like many written and oral communications presented by Rezolute, Inc. and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
[email protected]

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
[email protected]



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Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One™ COVID-19 Test

MENLO PARK, Calif., March 08, 2021 (GLOBE NEWSWIRE) — Talis Biomedical Corporation (Nasdaq: TLIS), a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point-of-care, today announced that it has withdrawn its current application pursuing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Talis One™ COVID-19 test in the CLIA moderate setting, in favor of focusing on its planned EUA application in the CLIA waived setting. In late February, the FDA informed the company that it cannot ensure the comparator assay used in the primary study has sufficient sensitivity to support Talis’s EUA application.

Talis intends to initiate its previously planned clinical validation study in a point-of-care environment, with plans to submit an EUA application for the Talis One COVID-19 test in CLIA waived settings early in the second quarter of 2021. The planned clinical validation study was designed with a different comparator assay, which Talis believes will address the FDA’s concerns.

“The company’s business priority remains focused on serving health care providers and their patients in the point-of-care setting, where we continue to see the greatest need for high quality testing,” said Brian Coe, Chief Executive Officer of Talis. “Given the recent correspondence from the Agency and its stated prioritization of point-of-care platforms, we feel this course of action offers a faster path to market.”

About Talis         
Talis is dedicated to transforming diagnostic testing by developing and commercializing innovative products that are designed to enable accurate, low cost and rapid molecular testing for infectious diseases at the point-of-care, beginning with COVID-19. The company is developing Talis One, a compact, sample-to-answer, cloud-enabled, molecular diagnostic platform. Talis is headquartered in Menlo Park, California. For more information, please visit talis.bio.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “focus,” “pursue,” “will,” “intends,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to Talis’ regulatory strategy, including its intention to prioritize an EUA application for its Talis One COVID-19 test in CLIA waived settings and its ability to submit an EUA early in the second quarter of 2021; and Talis’ ability to initiate a new clinical validation study and a limit-of-detection study for its Talis One COVID-19 test in CLIA waived settings, and the timing thereof. These forward-looking statements are based upon the Company’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that the Talis One COVID-19 test that the Company is developing will be granted an EUA by the FDA; risks that the FDA may require additional information or data in connection with the Company’s EUA; risks and uncertainties associated with the costly and time-consuming development and regulatory approval process and the uncertainty of success; and those discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our prospectus dated February 11, 2021, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

Contact:

Media & Investors
Emily Faucette
[email protected]
+1.415.595.9407



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Cortexyme Announces Partnership with Parkinson Study Group and Upcoming Alzheimer’s Disease Data Presentation

Cortexyme Announces Partnership with Parkinson Study Group and Upcoming Alzheimer’s Disease Data Presentation

— Partnership with Parkinson Study Group Advisory Panel to collaborate on Parkinson’s Disease Program —

— Presentation at AD/PD™ 2021 Underscores Relevance of Cortexyme’s Approach —

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–
Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer’s and other degenerative diseases, announced that it has partnered with the Parkinson Study Group (PSG) to form an Advisory Board to leverage the group’s expertise and further develop the company’s Parkinson’s disease (PD) program. In addition, Cortexyme will present new data further demonstrating the role of Porphyromonas gingivalis(P. gingivalis) in the development of Alzheimer’s disease at AD/PD™ 2021, the 15th International Conference on Alzheimer’s & Parkinson’s Diseases, which is being held virtually March 9-14, 2021.

Hubert Fernandez, M.D., Co-Chair of the Parkinson Study Group Executive Committee and Chair of the PSG Credentialing Committee, and a member of the newly created Advisory Board, stated: “I look forward to working with my colleagues on the Advisory Board. We are collectively eager to further understand the mechanism of gingipain inhibition and its potential to improve the lives of patients suffering from Parkinson’s disease. There is a tremendous unmet medical need for PD, and the potential link between P. gingivalis and PD demands further exploration.”

Along with Fernandez, the new Cortexyme/PSG Advisory Board is comprised of expert researchers across the PD field:

  • Patrik Brundin, M.D., Ph.D., Honorary Guest to the PSG
  • Eric Macklin, Ph.D., PSG Executive Committee Member
  • Zoltan Mari, M.D., Co-Chair of the PSG Motor Features of PD Working Group
  • Andrew Siderowf, M.D., PSG Executive Committee Member

“Our partnership with the PSG demonstrates the importance of Cortexyme’s evidence to date and the potential to benefit patients suffering from Parkinson’s disease,” said Michael Detke, M.D., Ph.D., Cortexyme’s Chief Medical Officer. “We are pleased to partner with the PSG and look forward to advancing our work in Parkinson’s disease as we make progress towards improving patient outcomes.”

Mounting evidence supports the role of P. gingivalis in Parkinson’s disease, including research supporting the epidemiological link between periodontal disease and Parkinson’s disease and rodent studies demonstrating that oral P. gingivalis infectioncauses alpha-synuclein production and degeneration of dopamine-producing neurons in the substantia nigra of the brain. For further details, visit www.cortexyme.com/science.

AD/PD 2021 Presentation Furthers Link Between P. gingivalis and Neurodegeneration

Cortexyme will also present research (poster 131/abstract 1544) at AD/PD 2021 further reinforcing Cortexyme’s foundational research on P. gingivalis’ role in AD and new techniques to detect the presence of P. gingivalis in the human brain.

In the poster, scientists at the University of Auckland and Cortexyme report new techniques to determine the ultrastructural localization of the arginine-gingipain (Rgp) virulence factor secreted by P. gingivalis in the human AD brain using electron microscopy. The researchers will report on the intracellular organelles in AD brain cells that Rgp co-localizes with, providing insight for the first time on why some sub-cellular organelles in AD neurons and astrocytes are damaged.

“This research adds to the growing body of evidence that shows the presence of gingipains in the human AD brain and the validation of new electron microscopy techniques that can be leveraged for future research into sub-cellular localization of gingipains within neurons and astrocytes,” said Stephen Dominy, M.D., Cortexyme’s Co-Founder and Chief Scientific Officer.

View the abstract “Ultrastructural localization of Porphyromonas gingivalis RgpB virulence factor in the middle temporal gyrus (MTG) of the Alzheimer’s disease human brain” hereon Cortexyme’s website following the conference.

About Cortexyme

Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer’s and other degenerative diseases. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer’s disease. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

Forward-Looking Statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding the partial clinical hold and ongoing correspondence with the FDA, and its related impact on the timing and success of our clinical trials, including with respect to atuzaginstat, the double-blind, placebo-controlled randomized phase of the GAIN Trial and open-label extension phase; the timing of announcements and updates relating to our clinical trials and related data; the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds; statements about our ability to obtain, and the timing relating to, and regulatory submissions and approvals with respect to our drug product candidate. Forward-looking statements are based on Cortexyme’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

Corporate Contact:

Chris Lowe

Chief Operating Officer

Cortexyme, Inc.

[email protected]

Investor Contact:

Corey Davis, Ph.D.

LifeSci Advisors

[email protected]

(212) 915-2577

Media Contact:

Hal Mackins

For Cortexyme, Inc.

[email protected]

(415) 994-0040

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Mental Health Health Infectious Diseases Dental Pharmaceutical Biotechnology

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Industry-First Electric Vaccine Vehicle Launches to Expand Access to COVID-19 Vaccination and Testing

In response to the ongoing challenges facing vaccine distributors, segment leaders Element, Club Car, AYRO and Gallery Carts have teamed up to develop a compact, zero-emissions vehicle offering that helps make vaccines more accessible.

AUSTIN, TEXAS, March 08, 2021 (GLOBE NEWSWIRE) —
AYRO, Inc. (NASDAQ: AYRO) (“AYRO” or the “Company”), a designer and manufacturer of light-duty, short-haul, and last-mile delivery electric vehicles (EVs), today announced the launch of the Electric Vaccine Vehicle (EVV) www.vaccineEV.com , which is designed specifically to mobilize a flexible, safe and efficient means of delivering vaccines and testing to millions of people in 2021 and beyond.

Element Fleet Management Corp. (“Element”), the world’s largest pure-play automotive fleet manager will offer sales, financing solutions and vehicle management services throughout the vehicle lifecycle to EVV fleet operators. Club Car, one of the most respected names in the golf and utility vehicle industry, will provide sales and service support for the vehicles to Element and its Clients. Each company will leverage its national footprint and expertise to facilitate the deployment of EVVs and meet urgent demand.

The EVV is a self-contained, all-electric transportation solution that has been optimized to store, transport, and deliver testing and vaccines to a large population across a wide variety of environments and locations. The zero-emissions vehicle features medical-grade equipment and a made-to-order design by AYRO and mobile cart’s leader Gallery, expanding on the companies’ existing food service vehicle models. When partnered with community healthcare systems, it makes safe and rapid COVID-19 testing and vaccine distribution possible by reaching patients in need and managing demand at aggregation centers. It can traverse tight areas and help reduce wait times at central distribution locations by meeting patients at their place in line. When configured as a street-legal vehicle it can serve populations unable to get to vaccination sites because they don’t have access to transportation —including millions of high-risk older adults and low-income households.

Additional EVV benefits include:

  • Medical-Grade Equipment — Each EVV is outfitted with an ultra-low temperature freezer and refrigeration units with Bluetooth-enabled data loggers and temperature monitoring devices to virtually track and log live inside readings and pharmaceutical conditions, which follows the Centers for Disease Control & Prevention (CDC) guidelines to safely store and distribute vaccines.1 There is also on-board medical-grade storage, mobile onboard sinks, and other features designed to meet the needs of mobile healthcare providers and patients.2
  • Zero-Emissions, Zero Exhaust — The 100% electric vehicle can be moved into and operated indoors to allow medical providers to treat patients virtually anywhere without greenhouse gas (GHG) emissions or fumes.
  • No Specialized EV Charging Infrastructure Required — The EVV has a 50-mile driving range plus approximately 6-8 hours of equipment operation on a single charge (depending on EVV configuration and driving conditions), or can provide all-day operations if plugged in. Each vehicle can be charged and/or operated using a standard 110V/20amp outlet, so no EV charging infrastructure is required.
  • Compact Size — The vehicle enables more patient access, even within space-constrained locations. Each vehicle as a vaccine station takes up less than 100 square feet, allowing for easy group deployments. Vaccine administration can also happen while the patient is still inside his or her own vehicle or directly outside of the EVV for a rapid, drive-through experience.
  • Street Legal EVV Configuration— Select EVV configurations can be registered and licensed to operate at 25 MPH on city streets with posted speeds up to 35 MPH. The low-speed EV can also maneuver through car-free zones bringing essential services directly to patients that need them. Check your local regulations and ordinances as to whether the EVV may be operated legally on public streets, and if so, under what conditions.

The EVV can also be adapted for future needs—disaster relief, annual flu shot distribution, medical testing, food services and more — with clearly identifiable vehicle branding customized to convey each use case. The vehicle can also be leased rather than purchased reducing the impact to capital budgets, while also providing flexibility in the lifecycle. The EVV Roadshow is taking place across major U.S. cities in March and April www.vaccineEV.com for local governments and organizations to experience the vehicle in-person. 

“Element is pleased to bring our broad network, scalable operating platform and industry-leading strategic consulting services to support our existing and prospective clients interested in the EVV ”, said David Madrigal, Executive Vice President and Chief Commercial Officer. “We look forward to being part of the Club Car, AYRO and Gallery teams helping to bring an innovative solution to vaccine distribution.”

“This initiative allows us to tap our network of industry leading dealers to ensure the Electric Vaccine Vehicle is ready to deliver essential vaccines quickly,” said Jeff Tyminski, Vice President of Product Management and Marketing at Club Car. “Our extensive local customer support and service coverage allows us to provide the EVV solution to areas in need immediately.”

“COVID-19 testing and vaccine distribution has become a serious logistical challenge and our purpose-built EVs offer a potential solution,” said AYRO CEO Rod Keller. “Throughout the pandemic, we’ve been working with our partners to design customizable EVs for food delivery on college campuses in lieu of crowded dining halls. We quickly realized that experience designing EVs with hot and cold storage and hygiene precautions translated well to mobile vaccination vehicle design. The Electric Vaccine Vehicle can go virtually anywhere — within buildings or throughout cities and parking lots — potentially bringing millions of vaccines to patients.”

“The Electric Vaccine Vehicle is our most important and impactful customizable solution to date. The EVV overcomes a wide range of physical and logistical barriers, and will enable making vaccine distribution, testing resources and other medical services more accessible to as many people as possible,” said Dan Gallery V at Gallery Carts. “Rather than bringing the people to the medical services, we’re now bringing the medical services to the people.”

Learn more about the solution and inquire about orders at www.vaccineEV.com.

1 The CDC requires a data logger or temperature monitoring devise to consistently record live temperature readings from the inside of a refrigerator or freezer when storing all types of vaccines. Constant monitoring of vaccines at recommended temperatures is essential for maintaining the efficacy of a vaccine. Failing to do so can lead to wasted vaccines or ineffective vaccines being administered to patients. Please follow the CDC requirements for Vaccine Storage & the COVID-19 Vaccination Program found here.

2 All medical grade refrigerator and freezer units tested and certified to maintain temperatures within refrigerated or frozen ranges required by the CDC.

ABOUT ELEMENT FLEET MANAGEMENT

Element Fleet Management (TSX: EFN) is the largest pure-play automotive fleet manager in the world, providing the full range of fleet services and solutions to a growing base of loyal, world-class clients – corporates, governments and not-for-profits – across North America, Australia and New Zealand. Element enjoys proven resilient cash flow, a significant proportion of which is returned to shareholders in the form of dividends and share buybacks; a scalable operating platform that magnifies revenue growth into earnings growth; and an evolving capital-lighter business model that enhances return on equity. Element’s services address every aspect of clients’ fleet requirements, from vehicle acquisition and maintenance to accident recovery and remarketing. Clients benefit from Element’s expertise as the largest fleet solutions provider in its markets, offering unmatched economies of scale and insight used to reduce fleet operating costs and improve productivity and performance. For more information, visit www.elementfleet.com/investors.

ABOUT CLUB CAR

Club Car has been one of the most respected names in the golf industry for more than half a century. The Club Car product portfolio has grown to include much more than golf cars, now encompassing golf and commercial vehicles, multi-passenger shuttle vehicles, rough-terrain and off-road utility vehicles and street legal low-speed vehicles for commercial and consumer markets. For more information, visit www.clubcar.com.

ABOUT AYRO, INC.

Texas-based AYRO, Inc., engineers and manufactures purpose-built electric vehicles to enable sustainable fleets. With rapid, customizable deployments that meet specific buyer needs, AYRO’s agile EVs are an eco-friendly microdistribution alternative to gasoline vehicles. The AYRO 411 Club Car is the only zero-emission, light duty EV known to AYRO that can be optimized for the needs of any sustainable fleet, while the AYRO 311 EV can be configured for a variety of urban last-mile transportation needs. AYRO innovates with speed, discipline, and agility, and was founded in 2017 by entrepreneurs, investors and executives with a passion for creating sustainable urban electric vehicle solutions for micromobility. For more information, visit: www.ayro.com.

ABOUT GALLERY

With 40 years of experience as the leading manufacturer of mobile food, beverage, and merchandising carts and kiosks for use in stadiums, arenas, airports, shopping malls, and campuses, Gallery is pioneering the use of custom electric vehicles for retail and concession delivery in these environments. Based in Denver, Colorado, the family-run company has produced more than 30,000 carts for over 5,000 venues in all 50 states and worldwide. Find Gallery online at www.gallerycarts.com.

FORWARD LOOKING STATEMENTS

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would” and their opposites and similar expressions are intended to identify forward-looking statements and include the intended use of net proceeds from the registered direct offering. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: AYRO has a history of losses and has never been profitable, and AYRO expects to incur additional losses in the future and may never be profitable; the market for AYRO’s products is developing and may not develop as expected and AYRO, accordingly, may never meet its targeted production and sales goals; AYRO’s limited operating history makes evaluating its business and future prospects difficult and may increase the risk of any investment in its securities; AYRO may experience lower-than-anticipated market acceptance of its vehicles; developments in alternative technologies or improvements in the internal combustion engine may have a materially adverse effect on the demand for AYRO’s electric vehicles; the markets in which AYRO operates are highly competitive, and AYRO may not be successful in competing in these industries; AYRO relies on and intends to continue to rely on a single third-party supplier for the sub-assemblies in semi-knocked-down for all of its vehicles; AYRO may become subject to product liability claims, which could harm AYRO’s financial condition and liquidity if AYRO is not able to successfully defend or insure against such claims; increases in costs, disruption of supply or shortage of raw materials, in particular lithium-ion cells, could harm AYRO’s business; AYRO will be required to raise additional capital to fund its operations, and such capital raising may be costly or difficult to obtain and could dilute AYRO stockholders’ ownership interests, and AYRO’s long term capital requirements are subject to numerous risks; AYRO may fail to comply with environmental and safety laws and regulations; and AYRO is subject to governmental export and import controls that could impair AYRO’s ability to compete in international market due to licensing requirements and subject AYRO to liability if AYRO is not in compliance with applicable laws. A discussion of these and other factors with respect to AYRO is set forth in the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, filed by AYRO on November 6, 2020, as amended. Forward-looking statements speak only as of the date they are made and AYRO disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.


Media

Element Fleet Management

Samantha Ouimet
Vice President, Communications
416-417-1272
[email protected]

Club Car
Trent Bailey
704-430-6759
[email protected]

AYRO

Liz Crumpacker
Media Relations Contact
[email protected]

GALLERY
Holly Sprague
Media Relations Contact
[email protected]


INVESTOR RELATIONS CONTACTS:


Element Fleet Management
Michael Barrett
Vice President, Investor Relations
416-646-5698
[email protected]

AYRO
CORE IR
Joseph Delahoussaye III
Vice President of Investor Relations
516-222-2560
[email protected]