−Removed: We are a blank check company incorporated on April 21, 2021 as an exempted company in the Cayman Islands and formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses, which we refer to throughout this Report as our initial business combination.
−Removed: To date, our efforts have been limited to organizational activities related to our initial public offering and our search for a suitable target for a potential business combination.
−Removed: We have generated no operating revenues to date and we do not expect that we will generate operating revenues until we consummate our initial business combination.
−Removed: While we may pursue an initial business combination with a company in any business, industry, sector or geographic location, we are concentrating our efforts on pursuing an acquisition opportunity in the transportation, supply chain and logistics industry in any stage of the target’s corporate evolution.
−Removed: Traditional and next-generation supply chain solutions, physical or digital, are driving essential changes across end markets as business leaders around the world navigate unprecedented supply chain disruption caused by the COVID-19 pandemic.
−Removed: We seek to capitalize on our management team’s extensive experience in our target sectors, along with their valuable networks of seasoned venture capital and private equity investors, veteran operational partners and others to identify these unique acquisition opportunities.
−Removed: Our management team has a distinguished history of accomplishments across a broad spectrum of subsectors within the transportation, supply chain, and logistics industry, growing businesses into industry-leading enterprises by structurally improving their strategic position, growth trajectory and profitability.
−Removed: Our board of directors also has a significant track record in our target sectors and expertise in corporate strategy, technological innovation and operational enhancement.
−Removed: Their knowledge enhances the management team’s perspective as we evaluate potential initial business combinations and we expect will support the target’s management after completing an initial business combination, to the extent they remain on our board following the completion of our initial business combination.
−Removed: Initial Public Offering
−Removed: On November 8, 2021, we consummated our initial public offering of 34,500,000 units.
−Removed: Each unit consists of one Class A ordinary share of the Company, par value $0.0001 per share, and one-half of one redeemable warrant of the Company, with each whole warrant entitling the holder thereof to purchase one Class A ordinary share for $11.50 per share.
−Removed: The units were sold at a price of $10.00 per unit, generating gross proceeds to the Company of $345,000,000.
−Removed: Prior to the closing of our initial public offering, the underwriters for our initial public offering exercised their over-allotment option in full.
−Removed: Simultaneously with the closing of our initial public offering, we completed the private sale of an aggregate of 1,450,000 units (1,300,000 units to our sponsor and 150,000 units to Cantor) at a purchase price of $10.00 per unit, generating gross proceeds to the Company of $14,500,000.
−Removed: A total of $351,900,000, comprised of the proceeds from the initial public offering after offering expenses and a portion of the proceeds of the sale of the private placement units, was placed in the trust account maintained by Continental, acting as trustee.
−Removed: Exempted companies are Cayman Islands companies wishing to conduct business outside the Cayman Islands and, as such, are exempted from complying with certain provisions of the Companies Law.
−Removed: As an exempted company, we have applied for and received a tax exemption undertaking from the Cayman Islands government that, in accordance with section 6 of the Tax Concessions Law (2018 Revision) of the Cayman Islands, for a period of 20 years from the date of the undertaking, No law which is enacted in the Cayman Islands imposing any tax to be levied on profits, income, gains or appreciations shall apply to us or our operations and, in addition, that no tax to be levied on profits, income, gains or appreciations or which is in the nature of estate duty or inheritance tax shall be payable (i) on or in respect of our shares, debentures or other obligations or (ii) by way of the withholding in whole or in part of a payment of dividend or other distribution of income or capital by us to our shareholders or a payment of principal or interest or other sums due under a debenture or other obligation of us.
−Removed: Conversion of Founder Shares
−Removed: On January 30, 2023, our sponsor elected to convert all of the Class B ordinary shares issued to it in a private placement prior to our initial public offering into Class A ordinary shares of the Company on a one-for-one basis.
−Removed: As a result, all 11,983,333 of our
−Removed: then outstanding Class B ordinary shares were cancelled and 11,983,333 of our Class A ordinary shares were issued to our sponsor.
−Removed: Our sponsor agreed that all of the terms and conditions applicable to the founder shares set forth in the Letter Agreement, dated November 3, 2021, by and among the Company, its officers, its directors and the sponsor, shall continue to apply to the Class A ordinary shares that the founder shares converted into, including the voting agreement, transfer restrictions and waiver of any right, title, interest or claim of any kind to the trust account or any monies or other assets held therein.
−Removed: Extension Amendment
−Removed: On February 3, 2023, we held an extraordinary general meeting of shareholders for the purpose of considering and voting on a proposal to amend our amended and restated memorandum and articles of association to extend the date by which we must consummate our initial business combination from February 8, 2023 to December 15, 2023.
−Removed: The Extension Amendment was approved by a special resolution of our shareholders and took effect upon such approval.
−Removed: If our initial business combination is not consummated by December 15, 2023 (or by the end of any Extension Period if we further extend the period of time to consummate a business combination), then our existence will terminate, and we will distribute all amounts in the trust account.
−Removed: In connection with the EGM, shareholders holding 32,116,947 public shares exercised their right to redeem their shares for a pro rata portion of the funds in our trust account.
−Removed: As a result, approximately $333 million (approximately $10.38 per public share) was removed from the trust account to pay such holders.
−Removed: As of March 15, 2023, approximately $25 million remained in the trust account and there were 2,383,053 public shares outstanding.
−Removed: Our Management Team
−Removed: Our management team is led by Richard N.
−Removed: Peretz, our Executive Chairman, Hooman Yazhari, our Vice Chairman, Ben Baldanza, our Chief Executive Officer, and Jeff Rogers, our President, Chief Financial Officer and Secretary.
−Removed: The team has significant operational and transactional experience, primarily in the transportation, mobility and supply chain management industries.
−Removed: We believe our management team has complementary skills and deep operational experience relevant to our target industries with a strong history of working productively and creatively with stakeholders and labor groups, which represent a prominent and sustainable competitive advantage.
−Removed: Enriching this differentiated characteristic is management’s well-connected network, extending from leadership of the largest industrial and transportation enterprises to founders at early-stage technology ventures across our target markets as well as consultants, private equity and venture capital firms, and more.
−Removed: Our team is a flat, consensus-driven organization with a focus on seeking business combination opportunities that we hope will meaningfully benefit from accessing capital via the public market and more importantly, have the potential to become a world-class, industry leading organization with help from the wide-ranging set of competencies of our officers and directors.
−Removed: Industry Opportunity
−Removed: The COVID-19 pandemic has significantly challenged the resilience of global supply chains, putting a signification portion of global companies’ earnings and cash flows at risk.
−Removed: We believe that the pandemic has highlighted the urgency and significance of supply chain innovations, as company executives seek to instill flexibility into their logistics networks and deliver productivity improvements.
−Removed: We believe companies must recognize the fundamental shifts in how customers spend and how transportation and logistics infrastructures should operate differently to meet customer expectations and foster trust and loyalty.
−Removed: The global logistics industry was worth $5.819 trillion in 2020 and is projected to grow at a 4.7% compound annual growth rate from 2020 to 2024 according to Transport Intelligence.
−Removed: 1 Multiple macroeconomic trends, such as the globalization of trade, acceleration of e-commerce adoption, rise of Internet-of-Things (IoT) enabled devices, focus on energy efficiency/carbon footprint and emergence of specialty outsourced transportation and logistics providers, are expected to be the driving force of market growth for logistics services providers.
−Removed: The e-commerce industry relies on exceptionally competent logistics services to manage its supply chains and meet its consumer promises.
−Removed: Since the onset of the COVID-19 pandemic, widespread stay-at-home orders and concerns over the virus compressed 10 years of adoption of e-commerce into three months, according to McKinsey.
−Removed: The impact of this acceleration is significant to both business-to-business (B2B) and business-to-consumer (B2C) enterprises.
−Removed: As companies prepare for this structural uplift and large influx of online traffic, new technologies and operation innovations are strategically imperative for navigating fulfillment challenges and associated reverse logistics volume.
−Removed: 1 Converted to USD from €5.275 trillion at a rate of 1:1.1031 as of March 24, 2022.
−Removed: As global supply chains become increasingly integrated, innovations around logistics automation, big data analytics, and network optimization have gained traction across the industry.
−Removed: Interoperability is playing an increasingly critical role for service providers today.
−Removed: We believe that companies view digital interoperability, through data analytics and information exchanges, as the key enabler of the next-generation supply chain.
−Removed: We believe logistics of tomorrow will heavily rely upon artificial intelligence, autonomous systems, and digitalization to help connect and coordinate for improved visibility, productivity, and predictability.
−Removed: We also believe logistics management via multi-modal transport requires handovers between stakeholders and numerous document exchanges.
−Removed: As global trade volume grows, we anticipate that demand for faster processing and communication across electronic interfaces will follow.
−Removed: We believe that digitally-enabled supply chains can provide real-time tracking of shipments, delivery time prediction, and much higher automation-enabled throughput.
−Removed: In order to remain competitive, we believe transportation service providers must embrace and adopt digital transformation to deliver expected business results.
−Removed: We source our potential combination opportunities by proactively approaching our extensive network of contacts, including private equity and venture capital sponsors, executives of public and private companies, merger and acquisition advisory firms, investment banks, capital markets desks, lenders and other financial intermediaries.
−Removed: We believe the prior operational and investment experience of our team gives us a competitive advantage when accessing potential initial business combination opportunities.
−Removed: Collectively, our management team and directors have extensive experience in the following areas:
−Removed: ● Broad experience in both the public and private companies over the last three decades providing guidance on managing a wide range of challenges, including strategy, operations, finance, marketing and regulatory affairs.
−Removed: ● Established networks across the global transportation, supply chain and logistics sectors providing a deep sourcing network and due diligence acumen.
−Removed: ● Extensive operating and investing experience and a strong track record of creating shareholder value, with clear focus on operations and organizational alignment with management for progressive growth.
−Removed: ● Scaling companies with compelling competitive moats and unit economics models through organic and acquisition-based strategic investments.
−Removed: ● Ability to attract, assess and develop talented, high performing and resilient management teams, with an emphasis on mentoring and values-based leadership, excellence and integrity.
−Removed: Following the completion of our initial public offering, we began the process of communicating with the network of relationships of our management team and their affiliates to articulate the parameters for our search for a potential initial business combination target and began the process of pursuing and reviewing potential opportunities.
−Removed: Our Acquisition Criteria
−Removed: Consistent with our business strategy, we identified the following general criteria and guidelines that we believe are important in evaluating prospective targets for our acquisition opportunities.
−Removed: We use these criteria and guidelines in evaluating initial business combination opportunities, but we may decide to enter into our acquisition with a target business that does not meet any or all of these criteria and guidelines.
−Removed: ● Asset or Non-Asset Based Companies :
−Removed: Innovative companies with unique assets or intellectual property, disruptive platforms and product offerings, will be at the forefront of our evaluation process.
−Removed: Our management team and our board have extensive operational, commercial and transactional experience with technology-driven companies in our target sectors, and we use these skills to identify market leaders;
−Removed: ● Defensible Forward Looking Business Model :
−Removed: Companies exposed to attractive trends in an emerging space that will continue to evolve in a post-COVID world, with differentiated technology aimed at solving critical challenges in their areas of focus, efficiency, customer experience and sustainability;
−Removed: ● Scalable Business with Opportunity to Produce Attractive Financial Returns :
−Removed: Marketability to support significant growth while also driving margin expansion through technological or operational advancements;
−Removed: ● Significant Opportunity for Near-and Long-Term Growth :
−Removed: Fundamentally sound business that is underperforming its full potential and can benefit from applications and use of modern technology and tools, which can be leveraged in novel and transformative ways;
−Removed: ● Capable and Creative Management Team .
−Removed: Qualified leadership team that is open to mentorship, with a demonstrated track record of driving organic revenue growth and margin improvement;
−Removed: ● Partnership Approach :
−Removed: Companies that will benefit from our management team’s knowledge of industry dynamics, proven collection of operational strategies and tools, access to capital and relationships with key players in target industries and ability to rapidly scale businesses;
−Removed: ● Value Proposition as a Public Company :
−Removed: Companies that will benefit from being publicly traded and having access to the public capital markets, enhancing its ability to pursue accretive acquisitions, high- return capital projects, and/or strengthen its balance sheet.
−Removed: These criteria are not intended to be exhaustive.
−Removed: Any evaluation relating to the merits of a particular initial business combination may be based, to the extent relevant, on these general guidelines as well as other considerations, factors and criteria that our management team may deem relevant.
−Removed: In the event that we decide to enter into our initial business combination with a target business that does not meet any or all of the above criteria and guidelines, we intend to disclose that the target business does not meet the above criteria in our shareholder communications related to our initial business combination, which, as discussed in our prospectus dated November 3, 2021, would be in the form of proxy solicitation or tender offer materials that we would file with the SEC.
−Removed: Our Acquisition Process
−Removed: In evaluating a prospective target business, we conduct a comprehensive due diligence review.
−Removed: That due diligence review may include, among other things, financial statement analysis, document reviews, meetings with the target’s management and other employees, consultations with relevant industry experts, competitors, customers and suppliers, as well as a review of additional information that we will seek to obtain as part of our analysis of a target company.
−Removed: We are not prohibited from pursuing an initial business combination with a business that is affiliated with our sponsor or a member of our management team.
−Removed: In the event we seek to complete our initial business combination with a business that is affiliated with our sponsor or a member of our management team, we, or a committee of independent and disinterested directors, intend to obtain an opinion from an independent investment banking firm that is a member of the Financial Industry Regulatory Authority (“FINRA”) or an independent accounting firm that our initial business combination is fair to our company from a financial point of view.
−Removed: We are not required to obtain such an opinion in any other context.
−Removed: Certain of our directors and officers presently have, and any of them in the future may have additional, fiduciary or contractual obligations to other entities, pursuant to which such officer or director is or will be required to present a business combination opportunity to such entities.
−Removed: Initial Business Combination
−Removed: So long as our securities are then listed on the Nasdaq, our initial business combination must occur with one or more target businesses that together have an aggregate fair market value of at least 80% of the net assets held in the trust account (excluding the deferred underwriting commissions and taxes payable on the interest earned on the trust account) at the time of signing a definitive agreement in connection with our initial business combination.
−Removed: Our board of directors intends to make the determination as to fair market value of our initial business combination.
−Removed: While we consider it unlikely that our board of directors will not be able to make an independent determination of the fair market value of a target business or businesses, it may be unable to do so if the board of directors is less familiar or experienced with the target business, there is a significant amount of uncertainty as to the value of the target’s assets or prospects, including if such target is at an early stage of development, operations or growth, or if the anticipated transaction involves a complex financial analysis or other specialized skills and the board of directors determines that outside expertise would be helpful or necessary in conducting such analysis.
−Removed: If our board of directors is unable to independently determine the fair market value of the target business or businesses, we intend to obtain an opinion from an independent investment banking firm that is a member of FINRA or an independent accounting firm with respect to the satisfaction of such criteria.
−Removed: Unless such opinion includes material information regarding the valuation of a target business or the consideration to be provided, it is not anticipated that copies of such opinion would be distributed to our shareholders.
−Removed: However, if required under applicable law, any proxy statement that we deliver
−Removed: to shareholders and file with the SEC in connection with a proposed transaction will include such opinion.
−Removed: We have also agreed not to enter into a definitive agreement regarding an initial business combination without the prior consent of our sponsor.
−Removed: Additionally, pursuant to Nasdaq rules, any initial business combination must be approved by a majority of our independent directors.
−Removed: We anticipate structuring our initial business combination so that the post-business combination company in which our public shareholders own shares will own or acquire 100% of the equity interests or assets of the target business or businesses.
−Removed: We may, however, structure our initial business combination such that the post-business combination company owns or acquires less than 100% of such interests or assets of the target business in order to meet certain objectives of the target management team or shareholders or for other reasons, but we will only complete such business combination if the post-business combination company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise acquires a controlling interest in the target sufficient for it not to be required to register as an investment company under the Investment Company Act of 1940, as amended, which we refer to as the Investment Company Act.
−Removed: Even if the post-business combination company owns or acquires 50% or more of the voting securities of the target, our shareholders prior to the business combination may collectively own a minority interest in the post-business combination company, depending on valuations ascribed to the target and us in the business combination.
−Removed: For example, we could pursue a transaction in which we issue a substantial number of new shares in exchange for all of the outstanding capital stock, shares or other equity interests of a target.
−Removed: In this case, we would acquire a 100% controlling interest in the target.
−Removed: However, as a result of the issuance of a substantial number of new shares, our shareholders immediately prior to our initial business combination could own less than a majority of our outstanding shares subsequent to our initial business combination.
−Removed: If less than 100% of the equity interests or assets of a target business or businesses are owned or acquired by the post-business combination company, the portion of such business or businesses that is owned or acquired is what will be valued for purposes of the 80% of net assets test.
−Removed: If the business combination involves more than one target business, the 80% of net assets test will be based on the aggregate value of all of the target businesses.
−Removed: If our securities are not then listed on the Nasdaq for whatever reason, we would no longer be required to meet the foregoing 80% of net assets test.
−Removed: The time required to select and evaluate a target business and to structure and complete our initial business combination, and the costs associated with this process, are not currently ascertainable with any degree of certainty.
−Removed: Any costs incurred with respect to the identification and evaluation of a prospective target business with which our initial business combination is not ultimately completed will result in our incurring losses and will reduce the funds we can use to complete another business combination.
−Removed: Status as a Public Company
−Removed: We believe our structure makes us an attractive business combination partner to target businesses.
−Removed: As an existing public company, we offer a target business an alternative to the traditional initial public offering through a merger or other business combination with us.
−Removed: In a business combination transaction with us, the owners of the target business may, for example, exchange their shares of stock, shares or other equity interests in the target business for our Class A ordinary shares (or shares of a new holding company) or for a combination of our Class A ordinary shares and cash, allowing us to tailor the consideration to the specific needs of the sellers.
−Removed: Although there are various costs and obligations associated with being a public company, we believe target businesses will find this method a more expeditious and cost-effective method to becoming a public company than the typical initial public offering.
−Removed: The typical initial public offering process takes a significantly longer period of time than the typical business combination transaction process, and there are significant expenses in the initial public offering process, including underwriting discounts and commissions, that may not be present to the same extent in connection with a business combination with us.
−Removed: Furthermore, once a proposed business combination is completed, the target business will have effectively become public, whereas an initial public offering is always subject to the underwriters’ ability to complete the offering, as well as general market conditions, which could delay or prevent the offering from occurring or have negative valuation consequences.
−Removed: Once public, we believe the target business would then have greater access to capital, an additional means of providing management incentives consistent with shareholders’ interests and the ability to use its shares as currency for acquisitions.
−Removed: Being a public company can offer further benefits by enhancing a company’s profile among potential new customers and vendors and aid in attracting talented employees.
−Removed: While we believe that our structure and our management team’s backgrounds make us an attractive business partner, some potential target businesses may view our status as a blank check company, such as our lack of an operating history and our ability to seek shareholder approval of any proposed initial business combination, negatively.
−Removed: We are an “emerging growth company”, as defined in Section 2(a) of the Securities Act, as modified by the JOBS Act.
−Removed: As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
−Removed: If some investors find our securities less attractive as a result, there may be a less active trading market for our securities and the prices of our securities may be more volatile.
−Removed: In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.
−Removed: In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
−Removed: We intend to take advantage of the benefits of this extended transition period.
−Removed: We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our Class A ordinary shares that are held by non-affiliates equals or exceeds $700 million as of the last business day of the preceding second fiscal quarter, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
−Removed: Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.
−Removed: Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
−Removed: We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our ordinary shares held by non-affiliates exceeds $250 million as of the last business day of that year’s second fiscal quarter, or (2) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our ordinary shares held by non-affiliates equals or exceeds $700 million as of the last business day of that year’s second fiscal quarter.
−Removed: Until the completion of our initial business combination, only holders of our founder shares will have the right to vote on the appointment of directors.
−Removed: As a result, the Nasdaq will consider us to be a “controlled company” within the meaning of the Nasdaq corporate governance standards.
−Removed: Under the Nasdaq corporate governance standards, a company of which more than 50% of the voting power is held by an individual, group or another company is a “controlled company” and may elect not to comply with certain corporate governance requirements.
−Removed: We have not utilized these exemptions and have complied with the corporate governance requirements of the Nasdaq, subject to applicable phase-in rules.
−Removed: However, if we determine in the future to utilize some or all of these exemptions, our shareholders will not have the same protections afforded to shareholders of companies that are subject to all of the Nasdaq corporate governance requirements.
−Removed: Financial Position
−Removed: With funds available for a business combination in the amount of approximately $25 million (after payment of the expenses of our initial public offering and $14,700,000 of deferred underwriting commissions and the removal of approximately $333 million from our trust account to pay shareholders who exercised their right to redeem their shares in connection with the Extension Amendment), we offer a target business a variety of options such as creating a liquidity event for its owners, providing capital for the potential growth and expansion of its operations or strengthening its balance sheet by reducing its debt ratio.
−Removed: Because we are able to complete our initial business combination using our cash, debt or equity securities, or a combination of the foregoing, we have the flexibility to use the most efficient combination that will allow us to tailor the consideration to be paid to the target business to fit its needs and desires.
−Removed: However, we have not taken any steps to secure third-party financing and there can be no assurance it will be available to us.
−Removed: Effecting Our Initial Business Combination
−Removed: We are not presently engaged in, and we will not engage in, any operations for an indefinite period of time following our initial public offering.
−Removed: We intend to effectuate our initial business combination using cash from the proceeds of our initial public offering and the sale of the placement units, our equity, debt or a combination of these as the consideration to be paid in our initial business combination.
−Removed: We may seek to complete our initial business combination with a company or business that may be financially
−Removed: unstable or in its early stages of development or growth, which would subject us to the numerous risks inherent in such companies and businesses.
−Removed: If not all of the funds released from the trust account are used for payment of the consideration in connection with our initial business combination or used for redemptions of our Class A ordinary shares, we may apply the balance of the cash released to us from the trust account for general corporate purposes, including for maintenance or expansion of operations of the post-transaction company, the payment of principal or interest due on indebtedness incurred in completing our initial business combination, to fund the purchase of other companies or for working capital.
−Removed: We may seek to raise additional funds through a private offering of debt or equity securities in connection with the completion of our initial business combination (which may include a specified future issuance), and we may effectuate our initial business combination using the proceeds of such offering rather than using the amounts held in the trust account.
−Removed: In addition, we intend to target businesses larger than we could acquire with the net proceeds of our initial public offering and the sale of the placement units, and in such circumstance we will be required to seek additional financing to complete such proposed initial business combination.
−Removed: Subject to compliance with applicable securities laws, we would expect to complete such financing only simultaneously with the completion of our initial business combination.
−Removed: In the case of an initial business combination funded with assets other than the trust account assets, our proxy materials or tender offer documents disclosing the initial business combination would disclose the terms of the financing and, only if required by law, we would seek shareholder approval of such financing.
−Removed: There are no prohibitions on our ability to raise funds privately, including pursuant to any specified future issuance, or through loans in connection with our initial business combination.
−Removed: At this time, we are not a party to any arrangement or understanding with any third party with respect to raising any additional funds through the sale of securities or otherwise.
−Removed: We have not engaged or retained any agent or other representative to identify or locate any suitable acquisition candidate, to conduct any research or take any measures, directly or indirectly, to locate or contact a target business, other than our officers and directors.
−Removed: Accordingly, there is no current basis for investors in our initial public offering to evaluate the possible merits or risks of the target business with which we may ultimately complete our initial business combination.
−Removed: Although our management will assess the risks inherent in a particular target business with which we may combine, we cannot assure you that this assessment will result in our identifying all risks that a target business may encounter.
−Removed: Furthermore, some of those risks may be outside of our control, meaning that we can do nothing to control or reduce the chances that those risks will adversely affect a target business.
−Removed: Sources of Target Businesses
−Removed: We utilize the network and industry experience of our management team in seeking an initial business combination and employing our acquisition strategy.
−Removed: Over the course of their careers, the members of our management team and their affiliates have developed a broad network of contacts and corporate relationships that we believe serves as a robust source of acquisition opportunities and a competitive strength.
−Removed: This network has been developed through our management team’s:
−Removed: ● extensive experience in sourcing, structuring, acquiring, operating, integrating, developing, growing, financing and selling businesses;
−Removed: ● significant experience in providing financial advice across a range of sectors, setting and changing strategies and identifying, monitoring and recruiting world-class talent;
−Removed: ● deep relationships with sellers, financing providers and target management teams;
−Removed: ● experience negotiating transactions favorable to investors;
−Removed: ● experience in executing transactions in a broad range of sectors under varying economic and financial market conditions;
−Removed: ● significant experience in analyzing company fundamentals and producing proprietary asset management research.
−Removed: In addition, target business candidates may be brought to our attention by various unaffiliated sources, including investment market participants, private equity groups, investment banking firms, consultants, accounting firms and large business enterprises.
−Removed: Target businesses may be brought to our attention by such unaffiliated sources as a result of being solicited by us through calls or mailings.
−Removed: These sources may also introduce us to target businesses in which they think we may be interested on an unsolicited basis, since some of these sources will have read our prospectus and know what types of businesses we are targeting.
−Removed: Our officers and directors, as well as their affiliates, may also bring to our attention target business candidates that they become aware of through their business contacts as a result of formal or informal inquiries or discussions they may have, as well as attending trade shows or conventions.
−Removed: In addition, we may receive a number of proprietary deal flow opportunities that would not otherwise necessarily be available to us as a result of the business relationships of our officers and directors.
−Removed: While we do not presently anticipate engaging the services of professional firms or other individuals that specialize in business acquisitions on any formal basis, we may engage these firms or other individuals in the future, in which event we may pay a finder’s fee, consulting fee or other compensation to be determined in an arm’s length negotiation based on the terms of the transaction.
−Removed: We will engage a finder only to the extent our management determines that the use of a finder may bring opportunities to us that may not otherwise be available to us or if finders approach us on an unsolicited basis with a potential transaction that our management determines is in our best interest to pursue.
−Removed: Payment of finder’s fees is customarily tied to completion of a transaction, in which case any such fee will be paid out of the funds held in the trust account.
−Removed: There will be no finder’s fees, reimbursements or cash payments made by us to our sponsor, our management team or their respective affiliates, for services rendered to us prior to or in connection with the completion of our initial business combination, other than the following payments, none of which have been or will be made from the portion of the proceeds of our initial public offering and the sale of placement units, in each case held in the trust account, prior to the completion of our initial business combination:
−Removed: ● the repayment of a promissory note in an aggregate principal amount of up to $300,000 made to us by our sponsor to cover offering-related and organizational expenses;
−Removed: ● payments of $10,000 per month to an affiliate of our sponsor for office space and administrative and support services;
−Removed: ● reimbursement for any out-of-pocket expenses related to identifying, investigating, negotiating and completing an initial business combination;
−Removed: ● repayment of loans in the future may be, made by our sponsor or an affiliate of our sponsor to finance transaction costs in connection with an initial business combination.
−Removed: Up to $1,500,000 of such loans may be convertible into units of the post-business combination entity at a price of $10.00 per unit at the option of the lender.
−Removed: The units would be identical to the placement units.
−Removed: Except for the foregoing, the terms of such additional loans, if any, have not been determined and no written agreements exist with respect to such loans.
−Removed: In addition, some of our officers and directors may enter into employment or consulting agreements with the post-transaction company following our initial business combination.
−Removed: The presence or absence of any such fees or arrangements will not be used as a criterion in our selection process of an acquisition candidate.
−Removed: We are not prohibited from pursuing an initial business combination with a company that is affiliated with our sponsor or a member of our management team.
−Removed: In the event we seek to complete our initial business combination with a company that is affiliated with our sponsor or a member of our management team, we, or a committee of independent and disinterested directors, will obtain an opinion from an independent investment banking firm that is a member of FINRA or an independent accounting firm that such initial business combination is fair to our company from a financial point of view.
−Removed: We are not required to obtain such an opinion in any other context.
−Removed: Each of our officers and directors presently has, and any of them in the future may have, additional fiduciary or contractual obligations to other entities, including entities that are affiliates of our sponsor, and due to such fiduciary or contractual obligations such officer or director may be required to present a business combination opportunity to such entity.
−Removed: Our management team is also not prohibited from sponsoring, investing or otherwise becoming involved with, any other special purpose acquisition companies, including in connection with their initial business combinations, prior to us completing our initial business combination.
−Removed: A special purpose acquisition company sponsored by an affiliate of our sponsor or with certain members of our management team also serving on its management team could pursue a business combination opportunity in the same or similar businesses or industries as us, the pursuit of which could create an actual or potential conflict of interest relating to what would otherwise be an opportunity for us.
−Removed: Accordingly, if any of our officers or directors becomes aware of a business combination opportunity which is suitable for an entity to
−Removed: which he or she has then-current fiduciary or contractual obligations, then, subject to their fiduciary duties under Cayman Islands law, he or she will honor his or her fiduciary or contractual obligations to present such business combination opportunity to such entity.
−Removed: Evaluation of a Target Business and Structuring of Our Initial Business Combination
−Removed: In evaluating a prospective target business, we conduct an extensive due diligence review which may encompass, as applicable and among other things, meetings with incumbent management and employees, document reviews, interviews of customers and suppliers and a review of financial and other information about the target and its industry.
−Removed: We also utilize our management team’s operational and capital planning experience.
−Removed: If we determine to move forward with a particular target, we will proceed to structure and negotiate the terms of the business combination transaction.
−Removed: The time required to select and evaluate a target business and to structure and complete our initial business combination, and the costs associated with this process, are not currently ascertainable with any degree of certainty.
−Removed: Any costs incurred with respect to the identification and evaluation of, and negotiation with, a prospective target business with which our initial business combination is not ultimately completed will result in our incurring losses and will reduce the funds we can use to complete another business combination.
−Removed: The company will not pay any consulting fees to members of our management team, or their respective affiliates, for services rendered to or in connection with our initial business combination.
−Removed: We have also agreed not to enter into a definitive agreement regarding an initial business combination without the prior consent of our sponsor.
−Removed: See “Our Acquisition Criteria,” “Our Acquisition Process” and “Initial Business Combination” for additional information regarding the contemplated evaluation of a target business and structuring of our initial business combination.
−Removed: Lack of Business Diversification
−Removed: For an indefinite period of time after the completion of our initial business combination, the prospects for our success may depend entirely on the future performance of a single business.
−Removed: Unlike other entities that have the resources to complete business combinations with multiple entities in one or several industries, it is probable that we will not have the resources to diversify our operations and mitigate the risks of being in a single line of business.
−Removed: By completing our initial business combination with only a single entity, our lack of diversification may:
−Removed: ● subject us to negative economic, competitive and regulatory developments, any or all of which may have a substantial adverse impact on the particular industry in which we operate after our initial business combination;
−Removed: ● cause us to depend on the marketing and sale of a single product or limited number of products or services.
−Removed: Limited Ability to Evaluate the Target’s Management Team
−Removed: Although we closely scrutinize the management of a prospective target business when evaluating the desirability of effecting our initial business combination with that business, our assessment of the target business’s management may not prove to be correct.
−Removed: In addition, the future management may not have the necessary skills, qualifications or abilities to manage a public company.
−Removed: The determination as to whether any of the members of our management team will remain with the combined company will be made at the time of our initial business combination as any future roles cannot be stated with certainty.
−Removed: While it is possible that one or more of our directors will remain associated in some capacity with us following our initial business combination, it is unlikely that any of them will devote their full efforts to our affairs subsequent to our initial business combination.
−Removed: Moreover, we cannot assure you that members of our management team will have significant experience or knowledge relating to the operations of the particular target business.
−Removed: We cannot assure you that any of our key personnel will remain in senior management or advisory positions with the combined company.
−Removed: The determination as to whether any of our key personnel will remain with the combined company will be made at the time of our initial business combination.
−Removed: Following an initial business combination, we may seek to recruit additional managers to supplement the incumbent management of the target business.
−Removed: We cannot assure you that we will have the ability to recruit additional managers, or that additional managers will have the requisite skills, knowledge or experience necessary to enhance the incumbent management.
−Removed: Shareholders May Not Have the Ability to Approve Our Initial Business Combination
−Removed: We may conduct redemptions without a shareholder vote pursuant to the tender offer rules of the SEC subject to the provisions of our amended and restated memorandum and articles of association.
−Removed: However, we will seek shareholder approval if it is required by applicable law or stock exchange listing requirement, or we may decide to seek shareholder approval for business or other reasons.
−Removed: Under the Nasdaq listing rules, shareholder approval would typically be required for our initial business combination if, for example:
−Removed: ● we issue ordinary shares that will be equal to or in excess of 20% of the number of our ordinary shares then-outstanding (other than in a public offering);
−Removed: ● any of our directors, officers or substantial security holder (as defined by the Nasdaq rules) has a 5% or greater interest, directly or indirectly, in the target business or assets to be acquired or otherwise and the present or potential issuance of ordinary shares could result in an increase in issued and outstanding ordinary shares or voting power of 1% or more (or 5% or more if the related party involved is classified as such solely because such person is a substantial security holder);
−Removed: ● the issuance or potential issuance of ordinary shares will result in our undergoing a change of control.
−Removed: The decision as to whether we will seek shareholder approval of a proposed business combination in those instances in which shareholder approval is not required by law will be made by us, solely in our discretion, and will be based on business and legal reasons, which include a variety of factors, including, but not limited to:
−Removed: ● the timing of the transaction, including in the event we determine shareholder approval would require additional time and there is either not enough time to seek shareholder approval or doing so would place the company at a disadvantage in the transaction or result in other additional burdens on the company;
−Removed: ● the expected cost of holding a shareholder vote;
−Removed: ● the risk that the shareholders would fail to approve the proposed business combination;
−Removed: ● other time and budget constraints of the company;
−Removed: ● additional legal complexities of a proposed business combination that would be time-consuming and burdensome to present to shareholders.
−Removed: Permitted Purchases and Other Transactions with Respect to Our Securities
−Removed: If we seek shareholder approval of our initial business combination and we do not conduct redemptions in connection with our initial business combination pursuant to the tender offer rules, our sponsor, management team, advisors or their respective affiliates may purchase public shares or warrants in privately negotiated transactions or in the open market either prior to or following the completion of our initial business combination.
−Removed: Additionally, at any time at or prior to our initial business combination, subject to applicable securities laws (including with respect to material nonpublic information), our sponsor, management team, advisors or their respective affiliates may enter into transactions with investors and others to provide them with incentives to acquire public shares, vote their public shares in favor of our initial business combination or not redeem their public shares.
−Removed: However, they have no current commitments, plans or intentions to engage in such transactions and have not formulated any terms or conditions for any such transactions.
−Removed: None of the funds in the trust account will be used to purchase public shares or warrants in such transactions.
−Removed: If they engage in such transactions, they will be restricted from making any such purchases when they are in possession of any material non-public information not disclosed to the seller or if such purchases are prohibited by Regulation M under the Exchange Act.
−Removed: In the event that our sponsor, management team, advisors or their respective affiliates purchase shares in privately negotiated transactions from public shareholders who have already elected to exercise their redemption rights or submitted a proxy to vote against our initial business combination, such selling shareholders would be required to revoke their prior elections to redeem their shares and any proxy to vote against our initial business combination.
−Removed: We do not currently anticipate that such purchases, if any, would constitute a tender offer subject to the tender offer rules under the Exchange Act or a going-private transaction subject to the going-private rules under the Exchange Act;
−Removed: however, if the purchasers determine at the time of any such purchases that the purchases are subject to such rules, the purchasers will be required to comply with such rules.
−Removed: The purpose of any such transaction could be to (i) vote in favor of the business combination and thereby increase the likelihood of obtaining shareholder approval of the business combination, (ii) reduce the number of public warrants outstanding or vote such warrants on any matters submitted to the warrant holders for approval in connection with our initial business combination or (iii) satisfy a closing condition in an agreement with a target that requires us to have a minimum net worth or a certain amount of cash at the closing of our initial business combination, where it appears that such requirement would otherwise not be met.
−Removed: Any such purchases of our securities may result in the completion of our initial business combination that may not otherwise have been possible.
−Removed: In addition, if such purchases are made, the public “float” of our Class A ordinary shares or public warrants may be reduced and the number of beneficial holders of our securities may be reduced, which may make it difficult to maintain or obtain the quotation, listing or trading of our securities on a national securities exchange.
−Removed: Our sponsor, management team and/or their respective affiliates may identify the shareholders with whom our sponsor, management team or their respective affiliates may pursue privately negotiated transactions by either the shareholders contacting us directly or by our receipt of redemption requests submitted by shareholders (in the case of Class A ordinary shares) following our mailing of tender offer or proxy materials in connection with our initial business combination.
−Removed: To the extent that our sponsor, management team, advisors or their respective affiliates enter into a private transaction, they would identify and contact only potential selling or redeeming shareholders who have expressed their election to redeem their shares for a pro rata share of the trust account or vote against our initial business combination, whether or not such shareholder has already submitted a proxy with respect to our initial business combination but only if such shares have not already been voted at the general meeting related to our initial business combination.
−Removed: Our sponsor, management team, advisors or their respective affiliates will select which shareholders to purchase shares from based on the negotiated price and number of shares and any other factors that they may deem relevant, and are restricted from purchasing shares if such purchases do not comply with Regulation M under the Exchange Act and the other federal securities laws.
−Removed: Our sponsor, management team and their respective affiliates are restricted from making purchases of shares if the purchases would violate Section 9(a)(2) or Rule 10b-5 of the Exchange Act.
−Removed: We expect any such purchases would be reported by such person pursuant to Section 13 and Section 16 of the Exchange Act to the extent such purchasers are subject to such reporting requirements.
−Removed: Redemption Rights for Public Shareholders upon Completion of Our Initial Business Combination
−Removed: We will provide our public shareholders with the opportunity to redeem all or a portion of their Class A ordinary shares upon the completion of our initial business combination at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account calculated as of two business days prior to the consummation of the initial business combination, including interest earned on the funds held in the trust account and not previously released to us to pay our taxes, if any, divided by the number of then-outstanding public shares, subject to the limitations described herein.
−Removed: The amount in the trust account is initially anticipated to be $10.20 per public share.
−Removed: The per-share amount we will distribute to investors who properly redeem their shares will not be reduced by the deferred underwriting commissions we will pay to the underwriters.
−Removed: The redemption rights will include the requirement that a beneficial holder must identify itself in order to validly redeem its shares.
−Removed: There will be no redemption rights upon the completion of our initial business combination with respect to our warrants.
−Removed: Further, we will not proceed with redeeming our public shares, even if a public shareholder has properly elected to redeem its shares, if a business combination does not close.
−Removed: Our initial shareholders and each member of our management team have entered into an agreement with us, pursuant to which they have agreed to waive their redemption rights with respect to any founder shares and public shares held by them in connection with (i) the completion of our initial business combination and (ii) a shareholder vote to approve an amendment to our amended and restated memorandum and articles of association (A) that would modify the substance or timing of our obligation to provide holders of our Class A ordinary shares the right to have their shares redeemed in connection with our initial business combination or to redeem 100% of our public shares if we do not complete our initial business combination by December 15, 2023 or (B) with respect to any other provision relating to the rights of holders of our Class A ordinary shares.
−Removed: Limitations on Redemptions
−Removed: Our amended and restated memorandum and articles of association provides that in no event will we redeem our public shares in an amount that would cause our net tangible assets to be less than $5,000,001 either prior to or upon consummation of an initial business combination (so that we do not then become subject to the SEC’s “penny stock” rules).
−Removed: However, the proposed business combination may require:
−Removed: (i) cash consideration to be paid to the target or its owners, (ii) cash to be transferred to the target for working capital or other general corporate purposes or (iii) the retention of cash to satisfy other conditions in accordance with the terms of the proposed business combination.
−Removed: In the event the aggregate cash consideration we would be required to pay for all Class A ordinary shares that are validly submitted for redemption plus any amount required to satisfy cash conditions pursuant to the terms of the proposed business combination exceed the aggregate amount of cash available to us, we will not complete the business combination or redeem any shares, and all Class A ordinary shares submitted for redemption will be returned to the holders thereof.
−Removed: In addition, if accepting all properly submitted redemption requests in connection with an amendment we seek to make to our amended and restated memorandum and articles of association would cause our net tangible assets to be less than $5,000,001, we would not proceed with the amendment or the related redemption of our public shares at such time.
−Removed: Manner of Conducting Redemptions
−Removed: We will provide our public shareholders with the opportunity to redeem all or a portion of their Class A ordinary shares upon the completion of our initial business combination either (i) in connection with a general meeting called to approve the business combination or (ii) by means of a tender offer.
−Removed: The decision as to whether we will seek shareholder approval of a proposed business combination or conduct a tender offer will be made by us, solely in our discretion, and will be based on a variety of factors such as the timing of the transaction and whether the terms of the transaction would require us to seek shareholder approval under applicable law or stock exchange listing requirement.
−Removed: Asset acquisitions and share purchases would not typically require shareholder approval, while direct mergers with our company and any transactions where we issue more than 20% of our outstanding ordinary shares or seek to amend our amended and restated memorandum and articles of association would typically require shareholder approval.
−Removed: We intend to conduct redemptions in connection with a shareholder vote unless shareholder approval is not required by applicable law or stock exchange listing requirement or we choose to conduct redemptions pursuant to the tender offer rules of the SEC.
−Removed: So long as we obtain and maintain a listing for our securities on the Nasdaq, we will be required to comply with the Nasdaq rules.
−Removed: If we hold a shareholder vote to approve our initial business combination, we will, pursuant to our amended and restated memorandum and articles of association:
−Removed: conduct the redemptions in conjunction with a proxy solicitation pursuant to Regulation 14A of the Exchange Act, which regulates the solicitation of proxies, and not pursuant to the tender offer rules;
−Removed: and file proxy materials with the SEC.
−Removed: In the event that we seek shareholder approval of our initial business combination, we will distribute proxy materials and, in connection therewith, provide our public shareholders with the redemption rights described above upon completion of the initial business combination.
−Removed: If we seek shareholder approval, we will complete our initial business combination only if we obtain the approval of an ordinary resolution under Cayman Islands law, which requires the affirmative vote of a majority of the shareholders who attend and who vote at a quorate general meeting of the company.
−Removed: In such case, our initial shareholders and each member of our management team have agreed to vote their founder shares, public shares, and placement shares in favor of our initial business combination.
−Removed: As a result, in addition to shares held by our initial shareholders and members of our management team, no affirmative votes from public shareholders would be required to approve our initial business combination because our initial shareholders own 13,283,333 shares in the aggregate (including 11,983,333 founder shares which were converted into Class A ordinary shares and 1,300,000 placement shares), which number exceeds the 7,183,194 votes (representing a majority of our 14,366,386 issued and outstanding shares) needed to approve the initial business combination.
−Removed: Our initial shareholders and Cantor own an aggregate of 13,433,333 shares, or 93.5% of our issued and outstanding shares, including 11,983,333 founder shares which were converted into Class A ordinary shares and 1,300,000 placement shares held by our initial shareholders and 150,000 placement shares held by Cantor.
−Removed: Each public shareholder may elect to redeem their public shares irrespective of whether they vote for or against the proposed transaction or vote at all.
−Removed: In addition, our initial shareholders and each member of our management team have entered into an agreement with us, pursuant to which they have agreed to waive their redemption rights with respect to any founder shares and public shares held by them in connection with (i) the completion of an initial business combination, and (ii) a shareholder vote to approve an amendment to our amended and restated memorandum and articles of association (A) that would modify the substance or timing of our obligation to provide holders of our Class A ordinary shares the right
−Removed: to have their shares redeemed in connection with our initial business combination or to redeem 100% of our public shares if we do not complete our initial business combination by December 15, 2023 or (B) with respect to any other provision relating to the rights of holders of our Class A ordinary shares.
−Removed: If we conduct redemptions pursuant to the tender offer rules of the SEC, we will, pursuant to our amended and restated memorandum and articles of association:
−Removed: ● conduct the redemptions pursuant to Rule 13e-4 and Regulation 14E of the Exchange Act, which regulate issuer tender offers;
−Removed: ● file tender offer documents with the SEC prior to completing our initial business combination which contain substantially the same financial and other information about the initial business combination and the redemption rights as is required under Regulation 14A of the Exchange Act, which regulates the solicitation of proxies.
−Removed: Upon the public announcement of our initial business combination, if we elect to conduct redemptions pursuant to the tender offer rules, we and our sponsor will terminate any plan established in accordance with Rule 10b5-1 to purchase our Class A ordinary shares in the open market, in order to comply with Rule 14e-5 under the Exchange Act.
−Removed: In the event we conduct redemptions pursuant to the tender offer rules, our offer to redeem will remain open for at least 20 business days, in accordance with Rule 14e-1(a) under the Exchange Act, and we will not be permitted to complete our initial business combination until the expiration of the tender offer period.
−Removed: In addition, the tender offer will be conditioned on public shareholders not tendering more than the number of public shares we are permitted to redeem.
−Removed: If public shareholders tender more shares than we have offered to purchase, we will withdraw the tender offer and not complete such initial business combination.
−Removed: Limitation on Redemption upon Completion of Our Initial Business Combination if we Seek Shareholder Approval
−Removed: If we seek shareholder approval of our initial business combination and we do not conduct redemptions in connection with our initial business combination pursuant to the tender offer rules, our amended and restated memorandum and articles of association provides that a public shareholder, together with any affiliate of such shareholder or any other person with whom such shareholder is acting in concert or as a “group” (as defined under Section 13 of the Exchange Act), will be restricted from redeeming its shares with respect to more than an aggregate of 15% of the shares sold in our initial public offering, which we refer to as “Excess Shares”, without our prior consent.
−Removed: We believe this restriction will discourage shareholders from accumulating large blocks of shares, and subsequent attempts by such holders to use their ability to exercise their redemption rights against a proposed business combination as a means to force us, our sponsor or our management team to purchase their shares at a significant premium to the then-current market price or on other undesirable terms.
−Removed: Absent this provision, a public shareholder holding more than an aggregate of 15% of the shares sold in our initial public offering could threaten to exercise its redemption rights if such holder’s shares are not purchased by us, our sponsor or our management team at a premium to the then-current market price or on other undesirable terms.
−Removed: By limiting our shareholders’ ability to redeem no more than 15% of the shares sold in our initial public offering without our prior consent, we believe we will limit the ability of a small group of shareholders to unreasonably attempt to block our ability to complete our initial business combination, particularly in connection with a business combination with a target that requires as a closing condition that we have a minimum net worth or a certain amount of cash.
−Removed: However, we would not be restricting our shareholders’ ability to vote all of their shares (including Excess Shares) for or against our initial business combination.
−Removed: Tendering Share Certificates in Connection with a Tender Offer or Redemption Rights
−Removed: Public shareholders seeking to exercise their redemption rights, whether they are record holders or hold their shares in “street name”, will be required to either tender their certificates (if any) to our transfer agent prior to the date set forth in the proxy solicitation or tender offer materials, as applicable, mailed to such holders, or to deliver their shares to the transfer agent electronically using The DWAC System, at the holder’s option, in each case up to two business days prior to the initially scheduled vote to approve the business combination.
−Removed: The proxy solicitation or tender offer materials, as applicable, that we will furnish to holders of our public shares in connection with our initial business combination will indicate the applicable delivery requirements, which will include the requirement that a beneficial holder must identify itself in order to validly redeem its shares.
−Removed: Accordingly, a public shareholder would have from the time we send out our tender offer materials until the close of the tender offer period, or up to two business days prior to the initially scheduled vote on the proposal to approve the business combination if we distribute proxy materials, as applicable, to
−Removed: tender its shares if it wishes to seek to exercise its redemption rights.
−Removed: Given the relatively short period in which to exercise redemption rights, it is advisable for shareholders to use electronic delivery of their public shares.
−Removed: There is a nominal cost associated with the above-referenced tendering process and the act of certificating the shares or delivering them through the DWAC System.
−Removed: The transfer agent will typically charge the tendering broker a fee of approximately $80.00 and it would be up to the broker whether or not to pass this cost on to the redeeming holder.
−Removed: However, this fee would be incurred regardless of whether or not we require holders seeking to exercise redemption rights to tender their shares.
−Removed: The need to deliver shares is a requirement of exercising redemption rights regardless of the timing of when such delivery must be effectuated.
−Removed: The foregoing is different from the procedures used by many blank check companies.
−Removed: In order to perfect redemption rights in connection with their business combinations, many blank check companies would distribute proxy materials for the shareholders’ vote on an initial business combination, and a holder could simply vote against a proposed business combination and check a box on the proxy card indicating such holder was seeking to exercise his or her redemption rights.
−Removed: After the business combination was approved, the company would contact such shareholder to arrange for him or her to deliver his or her certificate to verify ownership.
−Removed: As a result, the shareholder then had an “option window” after the completion of the business combination during which he or she could monitor the price of the company’s shares in the market.
−Removed: If the price rose above the redemption price, he or she could sell his or her shares in the open market before actually delivering his or her shares to the company for cancellation.
−Removed: As a result, the redemption rights, to which shareholders were aware they needed to commit before the general meeting, would become “option” rights surviving past the completion of the business combination until the redeeming holder delivered its certificate.
−Removed: The requirement for physical or electronic delivery prior to the meeting ensures that a redeeming shareholder’s election to redeem is irrevocable once the business combination is approved.
−Removed: Any request to redeem such shares, once made, may be withdrawn at any time up to two business days prior to the initially scheduled vote on the proposal to approve the business combination, unless otherwise agreed to by us.
−Removed: Furthermore, if a holder of a public share delivered its certificate in connection with an election of redemption rights and subsequently decides prior to the applicable date not to elect to exercise such rights, such holder may simply request that the transfer agent return the certificate (physically or electronically).
−Removed: It is anticipated that the funds to be distributed to holders of our public shares electing to redeem their shares will be distributed promptly after the completion of our initial business combination.
−Removed: If our initial business combination is not approved or completed for any reason, then our public shareholders who elected to exercise their redemption rights would not be entitled to redeem their shares for the applicable pro rata share of the trust account.
−Removed: In such case, we will promptly return any certificates delivered by public holders who elected to redeem their shares.
−Removed: If our initial proposed business combination is not completed, we may continue to try to complete a business combination with a different target by December 15, 2023 (or until the end of any Extension Period).
−Removed: Redemption of Public Shares and Liquidation If No Initial Business Combination
−Removed: Our amended and restated memorandum and articles of association provides that we will have until December 15, 2023 (or until the end of any Extension Period) to consummate an initial business combination.
−Removed: If we have not consummated an initial business combination by December 15, 2023 or by the end of any Extension Period, we will:
−Removed: (i) cease all operations except for the purpose of winding up;
−Removed: (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the public shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account, including interest earned on the funds held in the trust account and not previously released to us to pay our taxes, if any (less up to $100,000 of interest to pay dissolution expenses), divided by the number of the then-outstanding public shares, which redemption will completely extinguish public shareholders’ rights as shareholders (including the right to receive further liquidation distributions, if any);
−Removed: and (iii) as promptly as reasonably possible following such redemption, subject to the approval of our remaining shareholders and our board of directors, liquidate and dissolve, subject in each case to our obligations under Cayman Islands law to provide for claims of creditors and the requirements of other applicable law.
−Removed: There will be no redemption rights or liquidating distributions with respect to our warrants, which will expire worthless if we fail to consummate an initial business combination by December 15, 2023 or by the end of any Extension Period.
−Removed: Our amended and restated memorandum and articles of association provides that, if we wind up for any other reason prior to the consummation of our initial business combination, we will follow the foregoing procedures with respect to the liquidation of the trust account as promptly as reasonably possible but not more than ten business days thereafter, subject to applicable Cayman Islands law.
−Removed: Our initial shareholders and each member of our management team have entered into an agreement with us, pursuant to which they have agreed to waive their rights to liquidating distributions from the trust account with respect to any founder shares and placement shares (but will retain such rights for any public shares) they hold if we fail to consummate an initial business combination by December 15, 2023 or by the end of any Extension Period (although the initial shareholders, and each member of our management team will be entitled to liquidating distributions from the trust account with respect to any public shares they hold if we fail to complete our initial business combination within the prescribed time frame).
−Removed: Our initial shareholders and each member of our management team have agreed, pursuant to a written agreement with us, that they will not propose any amendment to our amended and restated memorandum and articles of association (A) that would modify the substance or timing of our obligation to provide holders of our Class A ordinary shares the right to have their shares redeemed in connection with our initial business combination or to redeem 100% of our public shares if we do not complete our initial business combination by December 15, 2023 or by the end of any Extension Period or (B) with respect to any other provision relating to the rights of holders of our Class A ordinary shares, unless we provide our public shareholders with the opportunity to redeem their public shares upon approval of any such amendment at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account, including interest earned on the funds held in the trust account and not previously released to us to pay our taxes, if any, divided by the number of the then-outstanding public shares.
−Removed: However, we may not redeem our public shares in an amount that would cause our net tangible assets to be less than $5,000,001 either prior to or upon consummation of an initial business combination (so that we do not then become subject to the SEC’s “penny stock” rules).
−Removed: If this optional redemption right is exercised with respect to an excessive number of public shares such that we cannot satisfy the net tangible asset requirement, we would not proceed with the amendment or the related redemption of our public shares at such time.
−Removed: This redemption right shall apply in the event of the approval of any such amendment, whether proposed by our initial shareholders, any member of our management team or any other person.
−Removed: We expect that all costs and expenses associated with implementing our plan of dissolution, as well as payments to any creditors, will be funded from cash held outside of the trust account of $129,186, together with up to $100,000 of funds from the trust account available to us to pay dissolution expenses, although we cannot assure you that there will be sufficient funds for such purpose.
−Removed: If we were to expend all of the net proceeds of our initial public offering and the sale of the placement units, other than the proceeds deposited in the trust account, and without taking into account interest, if any, earned on the trust account, the per-share redemption amount received by shareholders upon our dissolution would be $10.20.
−Removed: The proceeds deposited in the trust account could, however, become subject to the claims of our creditors which would have higher priority than the claims of our public shareholders.
−Removed: We cannot assure you that the actual per-share redemption amount received by shareholders will not be less than $10.20.
−Removed: While we intend to pay such amounts, if any, we cannot assure you that we will have funds sufficient to pay or provide for all creditors’ claims.
−Removed: Although we seek to have all vendors, service providers, prospective target businesses and other entities with which we do business execute agreements with us waiving any right, title, interest or claim of any kind in or to any monies held in the trust account for the benefit of our public shareholders, there is no guarantee that such parties will execute such agreements or, even if such parties execute such agreements, that such parties would be prevented from bringing claims against the trust account for, among other things, fraudulent inducement, breach of fiduciary responsibility or other similar claims, as well as claims challenging the enforceability of the waiver, in each case in order to gain an advantage with respect to a claim against our assets, including the funds held in the trust account.
−Removed: If any third-party refuses to execute an agreement waiving such claims to the monies held in the trust account, our management will perform an analysis of the alternatives available to it and will only enter into an agreement with a third-party that has not executed a waiver if management believes that such third-party’s engagement would be significantly more beneficial to us than any alternative.
−Removed: Examples of possible instances where we may engage a third-party that refuses to execute a waiver include the engagement of a third-party consultant whose particular expertise or skills are believed by management to be significantly superior to those of other consultants that would agree to execute a waiver or in cases where management is unable to find a service provider willing to execute a waiver.
−Removed: In addition, the underwriters of our initial public offering and our independent registered public accounting firm have not executed agreements with us waiving such claims to the monies held in the trust account.
−Removed: Further, there is no guarantee that such entities will agree to waive any claims they may have in the future as a result of, or arising out of, any negotiations, contracts or agreements with us and will not seek recourse against the trust account for any reason.
−Removed: In order to protect the amounts held in the trust account, our sponsor has agreed that it will be liable to us if and to the extent any claims by (A) a third-party for services rendered or products sold to us (other than our independent registered public accounting firm), or (B) a prospective target business with which we have discussed entering into a transaction agreement, reduce the amounts in the trust account to below the lesser of (i) $10.20 per public share and (ii) the actual amount per public share held in the trust account as of the date of the liquidation of the trust account if less than $10.20 per public share due to reductions in the value of the trust assets, in each case net of the interest that may be
−Removed: withdrawn to pay our tax obligations, provided that such liability will not apply to any claims by a third-party or prospective target business that executed a waiver of any and all rights to seek access to the trust account nor will it apply to any claims under our indemnity of the underwriters of our initial public offering against certain liabilities, including liabilities under the Securities Act.
−Removed: In the event that an executed waiver is deemed to be unenforceable against a third-party, our sponsor will not be responsible to the extent of any liability for such third-party claims.
−Removed: However, we have not asked our sponsor to reserve for such indemnification obligations, nor have we independently verified whether our sponsor has sufficient funds to satisfy its indemnity obligations and we believe that our sponsor’s only assets are securities of our company.
−Removed: Therefore, we cannot assure you that our sponsor would be able to satisfy those obligations.
−Removed: None of our officers, directors or other affiliates will indemnify us for claims by third parties including, without limitation, claims by vendors and prospective target businesses.
−Removed: Recourse against us and our sponsor will be limited as noted herein;
−Removed: there will not be any recourse against any of our affiliates other than sponsor as noted herein.
−Removed: In the event that the proceeds in the trust account are reduced below the lesser of (i) $10.20 per public share and (ii) the actual amount per public share held in the trust account as of the date of the liquidation of the trust account if less than $10.20 per public share due to reductions in the value of the trust assets, in each case net of the amount of interest which may be withdrawn to pay our tax obligations, and our sponsor asserts that it is unable to satisfy its indemnification obligations or that it has no indemnification obligations related to a particular claim, our independent directors would determine whether to take legal action against our sponsor to enforce its indemnification obligations.
−Removed: While we currently expect that our independent directors would take legal action on our behalf against our sponsor to enforce its indemnification obligations to us, it is possible that our independent directors in exercising their business judgment may choose not to do so in any particular instance.
−Removed: Accordingly, we cannot assure you that due to claims of creditors the actual value of the per-share redemption price will not be less than $10.20 per public share.
−Removed: We seek to reduce the possibility that our sponsor will have to indemnify the trust account due to claims of creditors by endeavoring to have all vendors, service providers, prospective target businesses or other entities with which we do business execute agreements with us waiving any right, title, interest or claim of any kind in or to monies held in the trust account.
−Removed: However, there is no guarantee that such parties will execute such agreements or, even if such parties execute such agreements, that such parties would be prevented from bringing claims against the trust account for, among other things, fraudulent inducement, breach of fiduciary responsibility or other similar claims, as well as claims challenging the enforceability of the waiver, in each case in order to gain an advantage with respect to a claim against our assets, including the funds held in the trust account.
−Removed: Our sponsor will also not be liable as to any claims under our indemnity of the underwriters of our initial public offering against certain liabilities, including liabilities under the Securities Act.
−Removed: We have access to up to $129,186 following our initial public offering and the sale of the placement units with which to pay any such potential claims (including costs and expenses incurred in connection with our liquidation, currently estimated to be no more than approximately $100,000).
−Removed: In the event that we liquidate, and it is subsequently determined that the reserve for claims and liabilities is insufficient, shareholders who received funds from our trust account could be liable for claims made by creditors, however such liability will not be greater than the amount of funds from our trust account received by any such shareholder.
−Removed: If we file a bankruptcy or winding-up petition or an involuntary bankruptcy or winding-up petition is filed against us that is not dismissed, the proceeds held in the trust account could be subject to applicable bankruptcy or insolvency law and may be included in our bankruptcy or insolvency estate and subject to the claims of third parties with priority over the claims of our shareholders.
−Removed: To the extent any bankruptcy or insolvency claims deplete the trust account, we cannot assure you we will be able to return $10.20 per public share to our public shareholders.
−Removed: Additionally, if we file a bankruptcy or winding-up petition or an involuntary bankruptcy or winding-up petition is filed against us that is not dismissed, any distributions received by shareholders could be viewed under applicable debtor/creditor and/or bankruptcy or insolvency laws as either a “preferential transfer” or a “fraudulent conveyance.” As a result, a bankruptcy or insolvency court could seek to recover some, or all amounts received by our shareholders.
−Removed: Furthermore, our board of directors may be viewed as having breached its fiduciary duty to our creditors and/or may have acted in bad faith, and thereby exposing itself and our company to claims of punitive damages, by paying public shareholders from the trust account prior to addressing the claims of creditors.
−Removed: We cannot assure you that claims will not be brought against us for these reasons.
−Removed: Our public shareholders are entitled to receive funds from the trust account only (i) in the event of the redemption of our public shares if we do not complete our initial business combination by December 15, 2023 or by the end of any Extension Period, (ii) in connection with a shareholder vote to amend our amended and restated memorandum and articles of association (A) to modify the substance or timing of our obligation to provide holders of our Class A ordinary shares the right to have their shares redeemed in connection with our initial business combination or to redeem 100% of our public shares if we do not complete our initial business combination by December 15, 2023 or by the end of any Extension Period or (B) with respect to any other provision relating to the rights of holders of our Class A ordinary shares, or (iii) if they redeem their respective shares for cash upon the completion of the initial business combination.
−Removed: Public shareholders who redeem their Class A ordinary shares in connection with a shareholder vote
−Removed: described in clause (ii) in the preceding sentence shall not be entitled to funds from the trust account upon the subsequent completion of an initial business combination or liquidation if we have not consummated an initial business combination by December 15, 2023 or by the end of any Extension Period with respect to such Class A ordinary shares so redeemed.
−Removed: In no other circumstances will a shareholder have any right or interest of any kind to or in the trust account.
−Removed: In the event we seek shareholder approval in connection with our initial business combination, a shareholder’s voting in connection with the business combination alone will not result in a shareholder’s redeeming its shares to us for an applicable pro rata share of the trust account.
−Removed: Such shareholder must have also exercised its redemption rights described above.
−Removed: These provisions of our amended and restated memorandum and articles of association, like all provisions of our amended and restated memorandum and articles of association, may be amended with a shareholder vote.
−Removed: In identifying, evaluating and selecting a target business for our initial business combination, we may encounter intense competition from other entities having a business objective similar to ours, including other blank check companies.
−Removed: Many of these entities are well established and have extensive experience identifying and effecting business combinations directly or through affiliates.
−Removed: Moreover, many of these competitors possess financial, technical, human and other resources greater than ours.
−Removed: Our ability to acquire larger target businesses will be limited by our available financial resources.
−Removed: This inherent limitation gives others an advantage in pursuing the acquisition of a target business.
−Removed: Furthermore, our obligation to pay cash in connection with our public shareholders who exercise their redemption rights may reduce the resources available to us for our initial business combination and our outstanding warrants, and the future dilution they potentially represent, may not be viewed favorably by certain target businesses.
−Removed: Either of these factors may place us at a competitive disadvantage in successfully negotiating an initial business combination.
−Removed: Human Capital Management
−Removed: We currently have three officers.
−Removed: These individuals are not obligated to devote any specific number of hours to our matters but they intend to devote as much of their time as they deem necessary to our affairs until we have completed our initial business combination.
−Removed: The amount of time our officers devote in any time period varies based on the stage of the business combination process we are in.
−Removed: We do not intend to have any full-time employees prior to the completion of our initial business combination.
−Removed: Periodic Reporting and Financial Information
−Removed: We have registered our units, Class A ordinary shares and warrants under the Exchange Act and have reporting obligations, including the requirement that we file annual, quarterly and current reports with the SEC.
−Removed: In accordance with the requirements of the Exchange Act, our annual reports will contain financial statements audited and reported on by our independent registered public accountants.
−Removed: We will provide shareholders with audited financial statements of the prospective target business as part of the proxy solicitation or tender offer materials, as applicable, sent to shareholders.
−Removed: These financial statements may be required to be prepared in accordance with, or reconciled to, GAAP, or IFRS, depending on the circumstances, and the historical financial statements may be required to be audited in accordance with the standards of the PCAOB.
−Removed: These financial statement requirements may limit the pool of potential target businesses we may acquire because some targets may be unable to provide such statements in time for us to disclose such statements in accordance with federal proxy rules and complete our initial business combination within the prescribed time frame.
−Removed: We cannot assure you that any particular target business identified by us as a potential acquisition candidate will have financial statements prepared in accordance with the requirements outlined above, or that the potential target business will be able to prepare its financial statements in accordance with the requirements outlined above.
−Removed: To the extent that these requirements cannot be met, we may not be able to acquire the proposed target business.
−Removed: While this may limit the pool of potential acquisition candidates, we do not believe that this limitation will be material.
−Removed: We evaluated our internal control procedures for the fiscal year ending December 31, 2022 as required by the Sarbanes-Oxley Act and determined that we should not be deemed to be a large accelerated filer or an accelerated filer and continue to qualify as an emerging growth company.
−Removed: Therefore, we are not required to comply with the independent registered public accounting firm attestation requirement on our internal control over financial reporting.
−Removed: A target business may not be in compliance with the provisions of the Sarbanes-Oxley Act regarding adequacy of their internal controls.
−Removed: The development of the internal controls of any such entity to achieve compliance with the Sarbanes-Oxley Act may increase the time and costs necessary to complete any such acquisition.
−Removed: We have filed a Registration Statement on Form 8-A with the SEC to voluntarily register our securities under Section 12 of the Exchange Act.
−Removed: As a result, we will be subject to the rules and regulations promulgated under the Exchange Act.
−Removed: We have no current intention of filing a Form 15 to suspend our reporting or other obligations under the Exchange Act prior or subsequent to the consummation of our initial business combination.
−Removed: We are a Cayman Islands exempted company.
−Removed: Exempted companies are Cayman Islands companies conducting business mainly outside the Cayman Islands and, as such, are exempted from complying with certain provisions of the Companies Act.
−Removed: As an exempted company, we applied for and received a tax exemption undertaking from the Cayman Islands government that, in accordance with Section 6 of the Tax Concessions Act (2018 Revision) of the Cayman Islands, for a period of 30 years from the date of the undertaking, no law which is enacted in the Cayman Islands imposing any tax to be levied on profits, income, gains or appreciations will apply to us or our operations and, in addition, that no tax to be levied on profits, income, gains or appreciations or which is in the nature of estate duty or inheritance tax will be payable (i) on or in respect of our shares, debentures or other obligations or (ii) by way of the withholding in whole or in part of a payment of dividend or other distribution of income or capital by us to our shareholders or a payment of principal or interest or other sums due under a debenture or other obligation of us.
−Removed: We are an “emerging growth company”, as defined in Section 2(a) of the Securities Act, as modified by the JOBS Act.
−Removed: As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
−Removed: If some investors find our securities less attractive as a result, there may be a less active trading market for our securities and the prices of our securities may be more volatile.
−Removed: In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.
−Removed: In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
−Removed: We intend to take advantage of the benefits of this extended transition period.
−Removed: We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our Class A ordinary shares that are held by non-affiliates equals or exceeds $700 million as of the last business day of the preceding second fiscal quarter, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
−Removed: Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.
−Removed: Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
−Removed: We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our ordinary shares held by non-affiliates exceeds $250 million as of the last business day of that year’s second fiscal quarter, or (2) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our ordinary shares held by non-affiliates equals or exceeds $700 million as of the last business day of that year’s second fiscal quarter.
+Added: are a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic
+Added: T lymphocytes (“CD8+ CTLs” or “CTLs”), to develop off-the-shelf, precision T cell therapies for the treatment
+Added: of infectious diseases, cancers, and neurological disorders, with the aim of addressing the significant unmet needs of large patient
+Added: We believe that sustainability and commercial success in the forthcoming era of medicine will rely on ensuring patient accessibility
+Added: through advanced science, innovative business models and engagement across the development lifecycle and healthcare system.
+Added: to be the first biotechnology company offering commercially attractive, economically viable, and cost-effective personalized T cell therapies.
+Added: believe our allogeneic, precision T cell technology platform, ExacTcell TM , represents a significant scientific breakthrough
+Added: that has the potential to produce a new class of off-the-shelf – manufactured and stored for immediate use – drugs with diverse applications
+Added: spanning virology, oncology, and neurology.
+Added: ExacTcell is a set of processes and methodologies to develop, enrich, and expand single human
+Added: leukocyte antigen (“HLA”) restricted CTL therapies with proactively selected, precisely defined targets.
+Added: HLA molecules are
+Added: proteins that play an important role in the immune system’s ability to recognize “self” versus “foreign.”
+Added: There are numerous HLA types that vary from person to person.
+Added: CD8+ CTLs, also known as killer T cells, are white blood cells that are
+Added: part of the immune system and destroy infected, malignant, or otherwise damaged cells.
+Added: We are focused on using ExacTcell to develop allogeneic
+Added: therapeutics, meaning therapeutics that are intended to be infused in patients other than the original donor.
+Added: therapies are based on carefully selected, naturally occurring CTLs that are designed to recognize targets of interest from the body’s
+Added: native T cell receptor pool, unlike genetically engineered T cell therapies.
+Added: CD8+ CTLs in ExacTcell-based products target multiple and
+Added: distinct antigens, with the aim to circumvent the impact of mutations in viruses and cancer cells, which can render existing treatments
+Added: ExacTcell is designed to maximize the immunologic specificity of our products in order to eliminate malignant and virally
+Added: infected cells while allowing healthy cells to remain intact.
+Added: We believe this high degree of specificity has the potential to significantly
+Added: reduce the chances of cross-reactivity or adverse impact on healthy cells.
+Added: Our confidence in ExacTcell is reflected in our development
+Added: pipeline, which has been carefully tailored to address the unmet needs of large patient populations grappling with life-threatening viral
+Added: diseases, both viral and non-viral induced cancers, and neurological disorders such as multiple sclerosis.
+Added: first clinical product of ExacTcell, TVGN 489, is being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised
+Added: and the high-risk elderly, with potential applications in both treatment and prevention of chronic lingering
+Added: symptoms of the disease (“Long COVID”).
+Added: Viruses, including COVID-19, hijack cellular machinery to transform infected cells
+Added: into virus production plants.
+Added: Elimination of infected cells is necessary to allow them to be replaced by healthy, uninfected counterparts.
+Added: TVGN 489 consists of CTLs that are designed to be active against multiple precise, well defined, and well characterized targets spread
+Added: across the SARS-CoV-2 genome.
+Added: The product progressed from pre-discovery to the clinic in less than 18 months, and in January 2023, we
+Added: completed the Phase 1 proof-of-concept clinical trial of TVGN 489 for the treatment of ambulatory, high-risk adult COVID-19 patients.
+Added: No dose-limiting toxicities or significant treatment-related adverse events were observed in the treatment arm.
+Added: Secondary endpoints showing
+Added: a rapid reduction of viral load and that infusion of TVGN 489 did not prevent development of the patients’ own T cell-related (cellular)
+Added: or antibody-related (humoral) anti-COVID-19 immunity were also met.
+Added: None of the patients reported progression of infection, reinfection,
+Added: or the development of Long COVID during the six-month follow-up period.
+Added: These clinical observations were mirrored by laboratory evidence
+Added: of the persistence of TVGN 489 cells for at least six months after treatment.
+Added: We hope to launch a pivotal trial of TVGN 489 in COVID-19
+Added: patients with B cell malignancies as soon as late 2024, with studies of other highly vulnerable populations thereafter.
+Added: TVGN 489 is also
+Added: in preclinical development for treatment and prevention of Long COVID.
+Added: to February 14, 2024, Semper Paratus Acquisition Corporation (“Semper Paratus”) was a special purpose acquisition
+Added: company formed for the purpose of effecting a merger, stock purchase, reorganization or similar acquisition or business combination
+Added: with one or more businesses.
+Added: On February 14, 2024 (the “Closing Date”), Semper Paratus completed the previously
+Added: announced business combination pursuant to that certain Agreement and Plan of Merger by and among Semper Paratus, Semper Merger Sub,
+Added: Inc., a Delaware corporation and a wholly owned subsidiary of Semper Paratus (“Merger Sub”), SSVK Associates, LLC,
+Added: Semper Paratus’s sponsor (the “Sponsor”), in its capacity as purchaser representative, Tevogen Bio Inc, a Delaware
+Added: corporation (“Tevogen Bio”), and Dr.
+Added: Ryan Saadi, in his capacity as seller representative (the “Merger
+Added: contemplated by the Merger Agreement, on the Closing Date, Merger Sub merged with and into Tevogen Bio, with Tevogen Bio being the surviving
+Added: company and a wholly owned subsidiary of Semper Paratus (the “Merger,” and together with the other transactions contemplated
+Added: by the Merger Agreement, the “Business Combination”).
+Added: In connection with the closing of the Business Combination, we changed
+Added: our name from “Semper Paratus Acquisition Corporation” to “Tevogen Bio Holdings Inc.” As of the open of trading
+Added: on February 15, 2024, our common stock and public warrants began trading on The Nasdaq Stock Market LLC (“Nasdaq”) as “TVGN”
+Added: and “TVGNW,” respectively.
+Added: are leveraging our understanding of immunotherapy and our ExacTcell platform to discover, validate, and build a proprietary pipeline
+Added: of T cell therapies with diverse targets in infectious disease, cancer, and neurological disorders.
+Added: The figure below details our pipeline
+Added: of product candidates and their targets:
+Added: 1 clinical trials are designed in part to generate proof of concept data and safety-related data on tolerability and side effects.
+Added: pivotal trial is a trial designed to generate data sufficient to support the filing of an application for regulatory approval.
+Added: pivotal trial may not necessarily be denoted as a Phase 3 clinical trial, and instead may be a Phase 2 or Phase 2/3 clinical trial.
+Added: We believe that Phase 2, Phase 2/3, or Phase 3 clinical trials may serve as pivotal trials for TVGN 489.
+Added: completed Phase 1 clinical trial of TVGN 489 was specifically conducted in ambulatory, high-risk adult patients with acute cases
+Added: believe that the data from our completed Phase 1 clinical trial should be sufficient to serve as the basis for one or more later
+Added: stage, potentially pivotal trials in acute COVID-19 patients with B-cell cancer immune suppression, other B cell immune suppressed
+Added: acute COVID-19 patients without a B cell cancer indication, and for Long COVID prevention and treatment.
+Added: We cannot be certain whether
+Added: we will be permitted to move from a Phase 1 trial directly to a pivotal trial covering any specific target population until FDA reviews
+Added: and concurs with or rejects our proposed plans, and FDA may require us to conduct further trials to generate additional safety and
+Added: efficacy data prior to approval.
+Added: collected in the completed Phase 1 trial of TVGN 489 includes and in all future trials of TVGN 489 is expected to include information
+Added: regarding the incidence of Long COVID in patients treated with TVGN 489 versus untreated patients or those treated with alternate
+Added: goal is to have a positive impact on patients’ health and treatment equity by developing and commercializing personalized cell
+Added: therapies to treat infectious disease, cancer, and neurological disease.
+Added: Key elements of our strategy to advance toward this goal include
+Added: the following:
+Added: the clinical development of TVGN 489 for the treatment of COVID-19 and Long COVID .
+Added: We completed a Phase 1 proof-of-concept
+Added: trial of TVGN 489 for the treatment of high-risk ambulatory adult COVID-19 patients in January 2023 and hope to launch a pivotal
+Added: trial in COVID-19 patients with B cell malignancies as soon as late 2024.
+Added: TVGN 489 is also in development for other highly vulnerable
+Added: COVID-19 patients and sufferers of Long COVID.
+Added: We will undertake a Long COVID genetic predisposition trial early in the second quarter
+Added: of 2024 in part to generate information needed to expeditiously conduct a Long Covid treatment trial that we expect to be launched
+Added: in approximately the first quarter of 2025.
+Added: our ExacTcell platform to develop therapies for additional indications .
+Added: In addition to TVGN 489, we are leveraging our ExacTcell
+Added: platform to advance product candidates in virology, oncology, and neurology.
+Added: Preclinical investigation is underway with product candidates
+Added: for the treatment of Epstein-Barr virus-associated lymphomas, multiple sclerosis, and several other viral and cancer targets.
+Added: manufacturing capabilities, including through acquisitions .
+Added: We will need to develop manufacturing capabilities for clinical
+Added: and, if approved, commercial supply of our cell therapy products.
+Added: Our efforts to develop manufacturing capability are currently focused
+Added: on acquiring existing manufacturing facilities or constructing one or more new manufacturing facilities, including through collaboration
+Added: with a potential facility development partner, and we have identified a potential clinical manufacturing facility for use.
+Added: strategic alliances and collaborating with partners to augment our capabilities .
+Added: We may pursue strategic alliances with other
+Added: biopharmaceutical companies with well-established presences in the specialties we aim to target for our indications.
+Added: This may include
+Added: co-marketing, co-promotion, and co-development relationships, or a partnership with a diagnostics company to help improve availability
+Added: of rapid HLA testing.
+Added: We also intend to explore options to work with partners to augment the study and treatment of patients and
+Added: the impact of our product candidates, including medical professionals, healthcare professional networks, pharmacy benefit managers,
+Added: insurance companies, and artificial intelligence companies.
+Added: ExacTcell Platform
+Added: ExacTcell platform and our therapies harness one of nature’s own approaches to eradicating cancer and other diseases:
+Added: the cytotoxic
+Added: or killer T cell.
+Added: We believe that our patented ExacTcell precision allogeneic T cell development platform has the potential to be a broadly
+Added: applicable approach for developing convenient and reasonably priced cellular immunotherapies for the treatment of acute viral infections,
+Added: long-term consequences of viral infections such as Long COVID, viral- and non-viral-induced cancers, and certain neurological disorders.
+Added: focuses on the selection and expansion of naturally occurring, genetically unmodified CD8+ CTLs to target multiple, distinct, preselected
+Added: antigens present only on virus-infected or malignant cells and to kill those cells.
+Added: We believe that by relying on CD8+ CTLs, ExacTcell
+Added: has the potential to produce an entirely new class of drugs that could present numerous benefits over existing platforms.
+Added: to other approaches, ExacTcell enables a single, specific HLA molecule to be targeted in a clinical product and the specific target peptides
+Added: to be known with certainty and precision.
+Added: HLA molecules are proteins present on the cell surface that play an important role in the immune
+Added: system’s ability to recognize “self” versus “foreign.” Specifically, HLA molecules present foreign antigens
+Added: to T cells for eradication.
+Added: There are numerous HLA types that vary from person to person.
+Added: T cells are white blood cells that play a vital role in the immune system’s defense against diseases, including viruses and cancer.
+Added: Most CTLs, including those developed with ExacTcell, express T cell receptors (“TCRs”), which are surface proteins that provide
+Added: each T cell with its unique immune specificity to recognize and react against specific foreign antigenic peptides of infected or malignant
+Added: These foreign antigenic peptides are presented in conjunction with an HLA molecule.
+Added: The CTLs destroy their infected or malignant
+Added: cell targets by inducing them to undergo apoptosis, or programmed cell death, by releasing cytolytic granules that produce pores in the
+Added: target cell’s membrane.
+Added: CTLs also possess a protein that spans the entirety of the cell membrane, known as Cluster Differentiation
+Added: 8 (which makes them CD8+), that aids in the reaction.
+Added: CD8+ T cells work in conjunction with HLA-class I molecules, and CD4+ T cells work
+Added: in conjunction with HLA-class II molecules.
+Added: available cell-based immunotherapy approaches include genetically unmodified T cells applied to the treatment of viruses early after
+Added: transplant and genetically modified chimeric antigen receptor (“CAR”) T cells used to treat a selected subset of malignancies.
+Added: We believe that to date, cellular therapy has not been harnessed to its full potential for clinical application.
+Added: We believe that our
+Added: proprietary approach will allow T cell products to be generated with a much higher target-specific CD8+ content and better-defined target
+Added: specificity than existing commercially available approaches.
+Added: Contrasted with our approach, the genetically unmodified T cells used after
+Added: hematopoietic stem cell transplantation for the treatment of viral infections have used large viral proteins, pools of peptides, or infected
+Added: cells to stimulate CTLs.
+Added: These broader targets may stimulate both CD4+ and CD8+ T cell responses, resulting in more heterogeneous T cell
+Added: products with little information regarding the specific peptide targets recognized by the T cells.
+Added: By stimulating with only carefully
+Added: defined smaller peptides that are selected to bind to a single HLA-class I molecule, our approach elicits a high degree of target-specific
+Added: CD8+ responses, which we believe may result in improved outcomes as compared to these other approaches.
+Added: Knowing the specific peptide
+Added: targets also allows rapid identification of the impact of mutations on our CTL products.
+Added: to the targeted nature of the cells ExacTcell can produce, we also believe we may be able to avoid some of the unwanted corollary effects
+Added: observed in other T cell immunotherapies.
+Added: For example, we believe products developed through ExacTcell could potentially avoid the high
+Added: incidence of adverse events, some life-threatening, such as cytokine release syndrome and neurotoxicity, that have been observed with
+Added: autologous and allogeneic CAR-T platforms.
+Added: Autologous cell therapies are derived from a donor’s own cells, as contrasted with allogenic
+Added: therapies such as ours, where cells are from third party donors.
+Added: order to select candidate peptides for ExacTcell products, we rely on a combination of computer-facilitated prediction of the ability
+Added: of specific peptide candidates to bind to specific HLA molecules and published scientific research.
+Added: Once candidates are selected, we
+Added: use tetramer staining to assess whether T cells recognize the target peptides and assess cytotoxicity against individual peptide-pulsed
+Added: and non-pulsed targets.
+Added: This allows us to rapidly and proactively select multiple, precise, candidate T cell targets and then quickly
+Added: experimentally confirm them for use.
+Added: Through our Tevogen.ai artificial intelligence initiative, we are exploring ways to deploy artificial
+Added: intelligence-powered target detection to further accelerate our product development pace, either internally or in collaboration with
+Added: leading entities in the field of artificial intelligence.
+Added: illustrated in the figure below, we begin the ExacTcell process by collecting cells from a healthy donor.
+Added: T cells from the donor are
+Added: exposed to the preselected targeted peptides and through a repetitive process of selection and expansion.
+Added: CD8+ CTLs specific for the
+Added: targeted, antigenic peptides become the major cellular component of the final product.
+Added: The expansion of the antigen specific CTLs is
+Added: extensive enough to produce over 100, and up to hundreds, of doses from a single donor.
+Added: Those doses can then be used to treat hundreds
+Added: of patients who share the same HLA type.
+Added: stands in contrast with both autologous and allogeneic CAR-T platforms, which target antigens present on both healthy and diseased cells
+Added: and require genetic modification of the T cells.
+Added: In autologous CAR-T approaches, the quantity and health of desired T cells in patient
+Added: blood samples used to manufacture the CAR-T product have been among the largest obstacles for T cell therapies to date.
+Added: is due to the chemotherapy treatments the patients have already received.
+Added: Some existing CAR-T therapies may take weeks to manufacture,
+Added: may require patients to receive pre-infusion lymphodepleting ( i.e.
+Added: , immunosuppressing) chemotherapy as part of a lengthy preparation
+Added: process, and be hospitalized in many cases during the CAR-T cell infusion or afterwards due to the frequency of side effects from the
+Added: therapy such as cytokine release syndrome.
+Added: These treatments may also require lifelong monitoring for the development and treatment of
+Added: infections due to eradication of normal parts of the immune system along with the cancer.
+Added: recently, in November of 2023, FDA announced that it had “received reports of T-cell malignancies, including chimeric antigen receptor
+Added: positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.” These
+Added: secondary malignancies resulted in hospitalization and death in a small subset of patients.
+Added: On January 19, 2024, FDA required a class-wide
+Added: black box warning be added to the label of these CAR T products regarding this risk.
+Added: FDA also underscored that the benefits of CAR-T
+Added: therapies continue to outweigh their risks but recommended lifelong monitoring of this potential side effect.
+Added: Currently approved autologous
+Added: CAR-T platforms utilize the patient’s own T cells to manufacture their products.
+Added: These cells have previously been exposed to cancer
+Added: therapy and are genetically altered and subsequently expanded.
+Added: contrast, CTLs generated using the ExacTcell platform come from a healthy donor with a normal immune system.
+Added: ExacTcell CTLs are not genetically
+Added: altered in the manufacturing process and although they expand during manufacture, this is the expected response of a T-lymphocyte when
+Added: encountering its target antigen.
+Added: The genetic modifications necessary to make CAR-T cells, which may be associated with the recent reports
+Added: of T-cell malignancies, are not utilized in the manufacture of our products made on the ExacTcell platform.
+Added: Moreover, secondary malignancies
+Added: have not been described in the unmodified T cell products given to hundreds of post-transplant patients.
+Added: Although our ExacTcell products
+Added: are not designed to be genetically modified, they are still in the early stages of testing, and only limited human and laboratory study
+Added: data are available regarding the risk profiles of our products.
+Added: Allogeneic CAR-T approaches are in early-stage development, but concerns
+Added: exist regarding side effects similar to autologous CAR-T, and additionally, the development of graft versus host disease with allogeneic
+Added: CAR-T products, both of which we believe will be of lower risk with our platform.
+Added: of doses per donor can be obtained using the ExacTcell approach, which is expected to facilitate off-the-shelf use and the ability to
+Added: administer doses within hours of diagnosis in the case of treatments against viruses where rapid therapeutic intervention is crucial.
+Added: Use of TVGN 489, for example, is expected to begin with a confirmatory COVID-19 test and rapid HLA typing for which results would be
+Added: available in six to eight hours, allowing selection of the proper product based on HLA type.
+Added: After confirmation of HLA type, thawing
+Added: takes minutes, and cells are infused within ten minutes of thawing.
+Added: convenience of “off-the-shelf” – manufactured and stored for immediate use – therapy has the potential to offer timely and
+Added: cost-efficient therapeutics by potentially eliminating the need for specialized medical facilities, unlike existing platforms.
+Added: products in which the active CD8+ T cell components are present at high concentrations, we believe relatively small volumes will be required,
+Added: allowing our therapies to be easily and promptly delivered in the ambulatory setting as a very brief intravenous administration such
+Added: as in a physician’s office.
+Added: are working to further advance ExacTcell with a new, proprietary T cell receptor-engineered process (“TCR-T”), which we believe
+Added: may substantially increase the number of doses that can be produced from a single donor.
+Added: Available technology can be used to allow us
+Added: to interrogate over a thousand individual T cells to determine which one kills peptide-pulsed targets fastest or kills the most in a
+Added: given timeframe.
+Added: This highest performing T cell can then be isolated, and its T cell receptor sequenced, allowing us to make an artificial
+Added: TCR gene that can be introduced into CD8+ T cells collected from healthy donors.
+Added: We believe this could allow at least a several-fold
+Added: increase in the number of desired CTLs as compared to our current approach.
+Added: We expect efforts to produce second generation products based
+Added: on this process may begin shortly after and if initial regulatory approval of the first-generation product is obtained.
+Added: First Product Candidate
+Added: first product candidate, TVGN 489, is an off-the-shelf, allogeneic cytotoxic CD8+ T cell therapy designed to fill a critical gap in COVID-19
+Added: therapeutic solutions for the immunocompromised and the high-risk elderly, with potential applications in both treatment and prevention
+Added: of Long COVID.
+Added: Treatment for these groups represents an area of unmet or incompletely met need which we believe TVGN 489 can significantly
+Added: We rapidly progressed TVGN 489 from pre-discovery to the clinic in only 18 months.
+Added: TVGN 489 cells are derived from healthy donors
+Added: who recovered from a prior COVID-19 infection, and TVGN 489 is active against multiple, precise targets spread across the SARS-CoV-2
+Added: January 2023, we completed a Phase 1 proof-of-concept trial of TVGN 489 for the treatment of ambulatory high-risk adult COVID-19 patients.
+Added: No dose-limiting toxicities or significant TVGN 489-related adverse events were observed in this trial at any of the four dosing levels
+Added: Secondary endpoints showing a rapid reduction of COVID-19 viral load and to show that infusion of TVGN 489 did not prevent development
+Added: of the patient’s own T cell-related (cellular) and antibody-related (humoral) anti-COVID-19 immunity were also met.
+Added: none of the patients in the treatment arm reported progression of infection, reinfection, or the development of Long COVID during the
+Added: six-month follow-up period.
+Added: The TVGN 489 in the Phase 1 trial was formulated to match patients expressing HLA-A*02:01, the most common
+Added: HLA type in the population.
+Added: believe TVGN 489 has the potential to be less susceptible to viral mutation than monoclonal antibodies, less susceptible to drug resistance
+Added: than antivirals, and to rapidly be able to overcome any increased immune evasion of current and emerging SARS-CoV-2 variants.
+Added: believe ExacTcell can enable us to deliver products faster, at a greater scale, and at lower cost than future competing cell therapies,
+Added: Despite selection of T cell targets in 2020, the HLA-A*02:01 TVGN 489 product has maintained a high degree of activity through
+Added: the full range of studied delta and subsequent omicron variants.
+Added: In contrast, most monoclonal antibodies were withdrawn from the market
+Added: for lack of efficacy related to the emergence of new variants, providing what we believe to be evidence of decreased susceptibility of
+Added: TVGN 489 to viral mutation.
+Added: In addition, knowing the precise peptide targets of our therapy helps allow rapid assessment regarding their
+Added: preservation or loss as soon as new variants are sequenced.
+Added: We check emerging COVID-19 variants against TVGN 489 targets on an ongoing
+Added: caused by the SARS-CoV-2 virus, has killed millions and infected hundreds of millions since its emergence in late 2019.
+Added: Groups currently
+Added: most at risk for poor outcomes due to COVID-19 are immunocompromised individuals unable to mount an adequate immune response, such as
+Added: those with immune system cancers, immunodeficiency disorders, transplant recipients, patients with immune-mediated disorders requiring
+Added: immunosuppressive therapy, or high doses of corticosteroids, the elderly and the unvaccinated.
+Added: For example, recent data shows that the
+Added: majority of COVID-19 deaths occur in people over the age of 65.
+Added: The risk of severe illness from COVID-19 for an individual tends to escalate
+Added: with an increase in their number of underlying medical conditions.
+Added: In addition to the acute impacts of infection, a significant portion
+Added: of those who have been infected by COVID-19 in the past develop more chronic and potentially debilitating symptoms afterwards, a condition
+Added: termed Long COVID.
+Added: Of US adults, 17.6% had experienced symptoms of Long COVID, according to the Centers for Disease Control and Prevention’s
+Added: (“CDC’s”) household pulse survey taken from January 9 through February 5, 2024.
+Added: As of October 2023, 5% of all adults
+Added: were still experiencing symptoms of Long COVID, according to a USA FACTS review of U.S.
+Added: Census Bureau data.
+Added: Despite the availability
+Added: of vaccines and emergence of initial therapeutics, significant gaps and shortcomings in treatment remain both for vulnerable patients
+Added: experiencing an acute infection and for Long Covid sufferers for whom there are no treatment options approved for the indication or its
+Added: underlying causes.
+Added: other viruses that have RNA as their genetic material, SARS-CoV-2 is constantly evolving through random mutations.
+Added: New mutations can
+Added: potentially increase or decrease infectiousness and virulence.
+Added: In addition, mutations can increase the virus’ ability to evade
+Added: adaptive immune responses from past SARS-CoV-2 infection or vaccination.
+Added: New variants of the SARS-CoV-2 virus continue to emerge, and
+Added: many people continue to be adversely affected by COVID-19, particularly those at the highest risk and sufferers of Long COVID.
+Added: a growing body of scientific data suggests new immune-evasive variants are more likely to arise in immunocompromised patients because
+Added: they are less able to eradicate the virus.
+Added: The longer duration of infection within the host affords the virus more opportunity to mutate
+Added: so as to evade the immune system.
+Added: of May 2023, about 103 million cumulative confirmed COVID-19 cases were reported in the United States alone.
+Added: While there has been a decrease
+Added: in the number of confirmed and reported cases, this is a multifactorial issue due in part to a decrease in testing by younger or healthier
+Added: individuals, reliance on home tests, the results of which are often not reported, expiration of federal funding for testing, and the
+Added: CDC’s discontinuation of collection of testing data.
+Added: However, a large number of Americans remain highly vulnerable to COVID-19
+Added: infection, including immunocompromised and elderly patients.
+Added: For example, the rate of hospitalization in cancer patients with COVID-19
+Added: infection remains high, specifically for those under active chemotherapy or immunosuppression.
+Added: There is therefore a high unmet need to
+Added: have an effective treatment available for these populations.
+Added: Classic herd immunity leading to eradication of COVID-19 is unlikely, much
+Added: as is the case for influenza, respiratory syncytial virus (RSV), and other endemic respiratory viruses.
+Added: This contrasts with smallpox,
+Added: for example, where both natural infection and vaccination eliminated virus transmission.
+Added: SARS-CoV-2 infection and vaccination produce
+Added: a steadily waning natural and vaccine-induced immunity, respectively, but do not eliminate transmission.
+Added: Although the number of daily
+Added: reported cases and deaths has declined, the emergence of more transmissible variants has led to spikes in cases and mortality, and variants
+Added: are expected to continue to evolve over time.
+Added: current COVID-19 landscape is also characterized by continued vaccine hesitancy among a significant portion of the population, unequal
+Added: access to vaccines and treatment, lack of response in some immunocompromised and other high-risk groups, and breakthrough cases among
+Added: the vaccinated due in part to increased immune evasion by current and emerging variants and the relatively short duration of protection
+Added: by booster shots.
+Added: We expect these circumstances to continue, which could adversely impact long-term community-level protective immunity.
+Added: In addition, we believe that the expiration of the U.S.
+Added: federal Public Health Emergency and U.S.
+Added: government funding for COVID-19 testing,
+Added: and treatment could lead to higher pricing for diagnostics and therapeutics.
+Added: two anti-viral agents, Nirmatrelvir/Ritonavir (Paxlovid) and Remdesivir, have been FDA-approved for the treatment of COVID-19.
+Added: Paxlovid is indicated for treatment in individuals at high risk for viral progression, neither drug has been specifically authorized
+Added: for use in immunocompromised patients, creating a need for the development of novel therapies in this area.
+Added: Both drugs also present challenges
+Added: for subsets of patients.
+Added: Paxlovid is associated with many drug-drug interactions, resulting in the need to temporarily stop ongoing medications
+Added: or seek alternative therapy and thereby making it difficult for some patients to take.
+Added: This is especially true for patients on multiple
+Added: medications, which is often true of high-risk patients requiring anti-COVID-19 treatment.
+Added: Paxlovid is also known to be associated with
+Added: COVID-19 rebound, which has been calculated as high as 21% in ambulatory patients, according to a study published in the Annals of Internal
+Added: Medicine in November 2023.
+Added: Although the rate of rebound in high-risk subgroups is less well-documented, we anticipate it may be as high
+Added: or higher in this group.
+Added: Paxlovid also must be started within five days of symptom development to be effective.
+Added: Remdesivir must be given
+Added: within seven days and is only available in intravenous form, requiring three daily infusions in a treatment center.
+Added: Remdesivir has also
+Added: been associated with liver enzyme abnormalities and gastrointestinal side effects.
+Added: Monoclonal antibodies to the viral spike protein were
+Added: introduced early in the pandemic for treatment of COVID-19, but typically have been rendered ineffective over time as the virus continues
+Added: No therapies have been approved to treat the underlying causes of the symptoms of Long COVID, and significant research is
+Added: ongoing to determine why some patients fully recover while others develop long-term complications.
+Added: Advantages of TVGN 489
+Added: the ongoing spread of COVID-19 and its effects and continued gaps in treatment, there is a clear need for alternatives to current therapeutic
+Added: options for COVID-19.
+Added: We believe TVGN 489 has been shown to be less susceptible to viral mutations than monoclonal antibodies and thus
+Added: able to overcome the increased immune evasion of current and emerging COVID-19 variants.
+Added: We also believe TVGN 489 has the potential to
+Added: be less susceptible to drug resistance than antivirals.
+Added: As contrasted with existing therapies, TVGN 489 is designed to recognize multiple
+Added: specific target peptides from distinct COVID-19 proteins, versus one or two targets typically derived only from the spike protein.
+Added: other viral therapies buy time for natural immunity to emerge and definitively control the virus, TVGN 489 provides natural immunity
+Added: directly and immediately to patients.
+Added: 489’s targets have also persisted in studied COVID-19 variants.
+Added: We have observed TVGN 489’s targets to be generally retained,
+Added: in nearly all cases at greater than a 95% level of retention, in the genome of all of the isolates of SARS-CoV-2 variants that we have
+Added: studied to date.
+Added: This is in significant contrast with the target loss of anti-spike monoclonal antibody therapies, which led to the withdrawal
+Added: of emergency use authorizations (“EUAs”) that had been granted during the now-expired COVID-19 National Public Health Emergency.
+Added: For example, the EUA for AbCellera Biologics’ and Eli Lilly’s bamlanivimab administered alone, which was granted in November
+Added: 2020, was revoked in April 2021 due to a sustained increase in viral variants that were not sensitive to this product.
+Added: variants have demonstrated how this virus is able to escape our immune system through mutation.
+Added: However, we believe our proprietary approach
+Added: to manufacturing TVGN 489 may allow us to monitor the sequences of emerging variants and, if necessary, to proactively adjust or fine
+Added: tune our products to ensure that they continue to recognize and treat current and future variants of this and other viruses.
+Added: with our approach, if a product contains T cells that recognize and target seven different peptides and one is lost through mutation,
+Added: that peptide can be dropped from future product batches.
+Added: Similarly, if the mutation generates a new peptide target, that target can be
+Added: added to future batches.
+Added: However, making these types of changes to TVGN 489 may require additional regulatory approvals, and there is
+Added: no guarantee that we will receive such approvals.
+Added: 489 is also designed to be fast acting, as the cells are fully mature and crafted to be primed to act as soon as they find their way
+Added: to infected cells.
+Added: All patients in the interventional arm of our Phase 1 clinical trial noted improved symptoms within two to three days,
+Added: which is shorter than the average noted by patients in the observational arm, and 83% of patients in the interventional arm had negative
+Added: nasal swab polymerase chain reaction tests within 14 days.
+Added: The consistency of the resolution was suggestive of a treatment effect and
+Added: the observed period is in contrast to a range of up to 90 days in the general population.
+Added: This observed consistency and rapidity of nasal
+Added: swab COVID-19 resolution was in a population where five individuals were on active immunosuppression for cancer and one for lupus at
+Added: the time of COVID-19 infection.
+Added: Two patients on the trial went on to stem cell transplantation, an immunosuppressive procedure, within
+Added: a month of treatment.
+Added: Neither experienced COVID-19 reactivation, which we believe further attests to the rapid acting nature of this
+Added: When immunocompromised patients get sick from COVID-19, their current treatment regimens for existing conditions are often stopped.
+Added: For oncology patients, this can be especially disruptive or even harmful.
+Added: Given TVGN 489’s design and these results, we believe
+Added: TVGN 489 may allow immunocompromised patients to recover and be able to return to their pre-COVID-19 treatment regimen with minimal delays.
+Added: of TVGN 489 and Mechanism of Action
+Added: 489 cells are sourced from healthy donors who have recovered from a previous COVID-19 infection.
+Added: These donor cells are subsequently expanded
+Added: by 600-fold or more by restimulating them toward specific peptide targets.
+Added: This is accomplished by exposing them to antigen-presenting
+Added: cells and selectively isolating the T cells that recognize the specific targets.
+Added: TVGN 489 is formulated to precisely target multiple
+Added: peptide targets spread across the SARS-CoV-2 genome, rather than focusing solely on the mutation-susceptible spike protein, which is
+Added: the primary target of most vaccines and monoclonal antibodies.
+Added: Upon completion of the manufacturing process, the cells are frozen and
+Added: stored for future intravenous infusion.
+Added: Administration
+Added: of TVGN 489 infuses the body with killer T cells that have been designed to attack COVID-19 infected cells.
+Added: These highly purified, multi-target
+Added: CD8+ CTLs are intended to bind to and eliminate infected cells expressing the targeted peptides against which the CTLs were manufactured.
+Added: Peptides are presented in conjunction with the HLA molecule and the CTLs eradicate diseased cells expressing these viral or malignant
+Added: To be clinically effective, a T cell therapy must be compatible with the patient’s specific HLA type.
+Added: Therefore, a panel
+Added: of HLA-specific CTL products is necessary to broadly cover and treat the population.
+Added: In our next clinical trial of TVGN 489, we expect
+Added: to treat patients with the six most common HLA types, which we believe would represent between 60% and 65% of the COVID-19 infected population.
+Added: We plan to continue expansion into additional HLA types until we are confident that between 90% and 95% of the population could be treated
+Added: based on our research.
+Added: believe that once bound to infected cells, TVGN 489 cells then destroy the infected cells through formation of an immunological synapse
+Added: between the killer cell and target and the release of cytotoxic granules from TVGN 489 into the target.
+Added: These both produce pores in the
+Added: target cell’s membrane and also trigger a process known as apoptosis, or programmed cell death, which is built into all our cells.
+Added: Then, once the infected cells die, new, healthy cells are able to grow in their place.
+Added: and Preclinical Data
+Added: approach to identifying CTL targets starts with computer-based prediction and then tests candidate peptides functionally with T cells.
+Added: We use a technique known as tetramer staining to assess whether T cells recognized these target peptides, assessed cytotoxicity against
+Added: individual peptide-pulsed and non-pulsed targets, and selected final peptides for use in TVGN 489 on that basis.
+Added: conducted multiple in-vitro studies of TVGN 489 in preparation for filing the investigational new drug application (“IND”)
+Added: with FDA and observed strong antiviral activity against SARS-CoV-2 in these laboratory studies.
+Added: In preclinical studies, we observed that
+Added: TVGN 489 cells kill target cells that are exposed to SARS-CoV-2 peptides, but not cells that are not exposed to those peptides.
+Added: is illustrated in the figure below, which shows the percentage of cells killed over a four-hour period when targets were pulsed with
+Added: the peptides and when they were not, with the x-axis showing the lysis rates based on the ratio of CTLs to target cells.
+Added: Identification
+Added: of appropriate COVID-19 peptide targets for additional HLA molecules remains ongoing, and we plan to continue this testing until we are
+Added: confident that between 90% and 95% of the COVID-19 infected population could be treated based on our research.
+Added: Development for COVID-19 Patients
+Added: permitted our IND for TVGN 489 to proceed in May 2021, and we began enrolling patients in the Phase 1 proof-of-concept trial of TVGN
+Added: 489 for the treatment of high-risk ambulatory adult COVID-19 patients in October 2021.
+Added: Patients in the trial were newly diagnosed with
+Added: COVID-19 and were deemed to be at high risk for complications due to the presence of one or more underlying medical conditions defined
+Added: as high risk by the CDC, including among others cancer, hypertension, obesity, diabetes, cardiovascular disease, and old age.
+Added: which was conducted at Thomas Jefferson University Hospital in Philadelphia, was completed in January 2023.
+Added: trial included two arms, with 12 patients in the treatment, or interventional, arm and 18 patients in the observational arm.
+Added: to the interventional arm versus the observational arm was based on each patient’s HLA type.
+Added: Patients expressing HLA-A*02:01, the
+Added: most common HLA type in the population, matched the CTLs and were enrolled in the interventional arm.
+Added: Patients in the treatment arm had
+Added: been infected with either the delta variant or one of three omicron variants of COVID-19.
+Added: Patients on the interventional arm had a higher
+Added: median number of comorbid conditions, a higher incidence of immune compromise, and a higher number of patients who were unvaccinated
+Added: or failed to respond to vaccination versus patients on the observational arm.
+Added: patient in the treatment arm received a single intravenous infusion of TVGN 489 within four days of diagnosis.
+Added: Analysis of COVID-19 viral
+Added: load showed that the patients were early in their COVID-19 disease course.
+Added: Patients were treated with TVGN 489 at one of four dose levels:
+Added: 1 x 10 5 /kg;
+Added: 3 x 10 5 /kg;
+Added: 1 x 10 6 /kg;
+Added: or 3 x 10 6 /kg.
+Added: These dose levels were chosen based on
+Added: data regarding antiviral T cell therapy in hematopoietic transplant patients involving the administration of similar cell numbers.
+Added: patients were enrolled at each dosing level with the option to enroll three more if a significant side effect was observed.
+Added: level concluded with three patients rather than six and the treatment arm concluded with a total of 12 patients rather than 24, primarily
+Added: due to the absence of appreciable toxicities across all dose levels.
+Added: The comparative arm, which was designed to end enrollment when treatment
+Added: arm enrollment was completed, concluded with 18 patients, appreciably less than what would have occurred if the treatment group required
+Added: additional enrollment.
+Added: Observational arm patients received standard of care treatment, including monoclonal antibodies.
+Added: Interventional
+Added: arm patients were monitored in the hospital for four days before being discharged and then were observed daily at home for ten additional
+Added: days and again at the one, two, three, and six-month anniversary of the initial infusion.
+Added: Observational arm patients were monitored at
+Added: home over the same interval.
+Added: primary endpoints of the trial, which were safety-related, were met.
+Added: No dose-limiting toxicities or significant adverse events related
+Added: to TVGN 489, including acute infusion reactions, cytokine release syndrome, neurotoxicity, or instances of graft versus host disease,
+Added: were observed in any patient at any dose level of our Phase 1 trial of TVGN 489.
+Added: endpoints showing a rapid reduction of COVID-19 viral load and showing that infusion of TVGN 489 did not prevent development of the patient’s
+Added: own T cell-related (cellular) and antibody-related (humoral) anti-COVID-19 immunity were also met.
+Added: In other words, observations indicate
+Added: that TVGN 489 did not prevent the body from responding to the infection and generating its own CTLs and antibodies to COVID-19.
+Added: treatment arm patients reported returning to their baseline level of health without COVID-19 symptoms within 14 days of treatment.
+Added: such patients also reported symptom improvement within two to three days of treatment, which corresponded with a decrease in the COVID-19
+Added: viral load on PCR testing in the majority of patients.
+Added: None of the patients who participated in the trial reported progression of their
+Added: COVID-19 infection and none developed COVID-19 or Long COVID during the six-month follow-up period.
+Added: These clinical observations were
+Added: mirrored by laboratory evidence of the persistence of infused TVGN 489 cells for at least six months after treatment.
+Added: of infused therapeutic cells remains a significant issue in the T cell therapy space, leading to challenges in controlling viral infections,
+Added: preventing viral recurrence, and managing cancer relapse.
+Added: The shorter the CTLs persist in the recipient, the less opportunity they have
+Added: to perform their intended therapeutic tasks.
+Added: Genetic differences between donor and recipient in allogeneic cell products and new genes
+Added: introduced into autologous products can be recognized by the patient’s immune system, which can encourage elimination of the administered
+Added: This is one of the reasons why lymphodepleting therapy is commonly administered prior to CAR-T treatments.
+Added: Maximizing the percentage
+Added: of CTLs in the products is also useful as the CTLs may receive re-stimulation from the virus infecting the patient and have a better
+Added: ability to protect themselves against elimination by the patient’s immune system.
+Added: Most studies of genetically unmodified CTLs have
+Added: suggested that they are eliminated within weeks, with three months, in highly immune-suppressed hematopoietic blood and marrow transplant
+Added: (“HSCT”) patients, being the longest that they typically are reported to persist.
+Added: The highly immune-suppressed nature of
+Added: the HSCT patient group is thought to allow for longer than typical persistence.
+Added: our Phase 1 clinical trial for TVGN 489, following infusion, peripheral blood of five patients was collected at various timepoints throughout
+Added: the six-month follow-up period.
+Added: These samples were sent to Adaptive Biotechnologies (“Adaptive”) to evaluate the persistence
+Added: of infused TVGN 489 in the patients following treatment, and Adaptive conducted analyses by sequencing protein chains of TCRs in the
+Added: As seen in the figure below, Adaptive’s data showed persistence of T cells present in the TVGN 489 product but absent
+Added: from the recipients prior to administration of TVGN 489.
+Added: This subset of CTLs was found in all samples tested, including at the final
+Added: study assessment at six months.
+Added: The TCRs used to recognize TVGN 489’s peptides were also shown to be largely distinct from person
+Added: to person, making it highly unlikely that the cells from later timepoints derive from anything other than the product in these five different
+Added: Taken together, we believe this data shows the persistence of TVGN 489 cells six months after administration.
+Added: 489 COVID-19 Reactive CD8+ T Cells Detected Throughout the Six-Month Follow Up Period
+Added: and persistence of allogeneic T cells has been associated with disease control in many settings.
+Added: Whether the prolonged persistence of
+Added: the CTLs used in this study is of benefit in the treatment of COVID-19, Long COVID, or alternate future viral or oncologic targets for
+Added: these CTLs merits further examination.
+Added: However, the evidence of their prolonged persistence provides us with encouragement for future
+Added: applications of the ExacTcell platform, particularly in oncology.
+Added: believe based on precedential industry examples, including in areas with high unmet needs or strong early phase clinical trial results,
+Added: that we may be able to commence pivotal trials of TVGN 489 on the basis of the results of our completed Phase 1 trial.
+Added: A pivotal trial
+Added: is a trial designed to generate data sufficient to support the filing of an application for regulatory approval.
+Added: Although the clinical
+Added: trial process usually includes three phases, a pivotal trial may not necessarily be denoted as a Phase 3 clinical trial, and instead
+Added: may be a Phase 2 or Phase 2/3 clinical trial.
+Added: As soon as late 2024, we hope to begin a pivotal trial of TVGN 489 for the treatment of
+Added: COVID-19 in select vulnerable populations with humoral immune suppression due to B cell malignancy or the treatment thereof.
+Added: with hematological malignancies continue to experience higher rates of hospitalization and death as compared to the general population
+Added: and those with solid tumors.
+Added: Increased mortality, hospitalization, and incidence of Long COVID are higher in patients with B cell malignancies
+Added: due to inadequate vaccination response and the immunosuppressive consequences of treatment received for B cell cancers.
+Added: While the major
+Added: acute outcomes of patients with hematological malignancies and COVID-19 have improved with increasing experience, delays in cancer treatment
+Added: due to the infection are increasingly recognized as a long-term impact of COVID-19 in this population.
+Added: Whereas treatment arm patients
+Added: in our Phase 1 proof-of-concept clinical trial all had a single HLA type, we expect to treat patients in this pivotal trial who have
+Added: any of the six most common HLA types, which we believe would represent between 60% and 65% of the population.
+Added: The primary endpoint of
+Added: this trial is planned to be reduced risk of hospitalization, with secondary endpoints relating to pace of viral load reduction, duration
+Added: of hospitalization, intensive care unit admissions, hours on supplemental oxygen, mortality, COVID-19 recurrence, Long COVID diagnosis,
+Added: and interruption in cancer treatment associated with COVID-19.
+Added: At this stage, however, we cannot be certain whether we will be permitted
+Added: to move from a Phase 1 trial directly to a pivotal trial until FDA reviews and concurs with or rejects our proposed plans, and FDA may
+Added: require us to conduct further trials to generate additional safety and efficacy data.
+Added: development of TVGN 489 continues, we may also seek FDA’s regenerative medicine advanced therapy (“RMAT”) designation
+Added: for TVGN 489, which as explained in “Regulatory Environment – Expedited Development and Review Programs” below, is intended
+Added: to facilitate efficient development and expedited review.
+Added: Target Patient Populations and Indications for TVGN 489
+Added: target patient populations for TVGN 489 that we are prioritizing include the treatment of COVID-19 in B cell immune suppressed acute
+Added: COVID-19 patients without a B cell cancer indication, elderly and infirm acute COVID-19 patients, and Long COVID sufferers.
+Added: above, these patients are among those with the greatest need for effective treatment.
+Added: We believe that the safety and the clinical benefit
+Added: data from our completed Phase 1 clinical trial in ambulatory, high-risk adult patients should be sufficient to serve as the basis for
+Added: later-stage and potentially pivotal trials in these patient groups as well as for the prevention of Long COVID.
+Added: However, whether such
+Added: trials may serve as pivotal trials, the phase of these trials, and the dose level to be selected in each trial remains subject to discussions
+Added: with and agreement by FDA.
+Added: also intend to develop TVGN 489 for the treatment of acute COVID-19 in patients on T cell suppressing drugs, including solid organ transplant
+Added: The suppression of these patients’ immune systems may make them more susceptible to developing graft versus host disease.
+Added: Based on data analyzed from hundreds of bone marrow transplant patients receiving T cell therapies showing almost no incidence of graft
+Added: versus host disease, we believe it unlikely that patients on T cell suppressing drugs would develop graft versus host disease as a result
+Added: of treatment with TVGN 489.
+Added: However, we believe the possibility nonetheless merits an additional safety study in this target population
+Added: prior to moving forward with later stage clinical development.
+Added: In addition, higher doses may also be required for efficacy in these patients
+Added: as compared to other patients, as T cell suppressing drugs may reduce the impact of TVGN 489, requiring more cells to produce comparable
+Added: studies have detected persistent viral spike and nucleocapsid proteins in some Long COVID patients, suggesting a persistent viral reservoir
+Added: in those patients.
+Added: If that is correct, we believe that TVGN 489 may circumvent Long COVID by preventing such a reservoir from being established
+Added: or by minimizing its size.
+Added: No treated patients in our Phase 1 proof-of-concept trial developed Long COVID.
+Added: We expect considerable additional
+Added: information on Long COVID prevention to be obtained from our planned acute COVID-19 treatment trials in which patients treated with TVGN
+Added: 489 are expected to be compared to patients receiving standard of care treatment.
+Added: We believe that the comparative data with respect to
+Added: patients in these trial arms going on to develop Long COVID should provide sufficient information to obviate a separate Phase 1 Long
+Added: COVID prevention trial, and that the significant unmet need for treatment in vulnerable patients as well as the efficacy data in preventing
+Added: Long COVID generated in these studies will lend further support for a streamlined development pathway.
+Added: However, we cannot be certain
+Added: whether FDA will require us to conduct a separate prevention trial until FDA reviews and concurs with or rejects our proposed plans.
+Added: is also beginning to identify Long COVID biomarkers in preparation for Long COVID treatment trials.
+Added: We believe that certain individuals
+Added: may be genetically predisposed to Long COVID, in that the HLA types of Long COVID patients may be skewed toward some HLA types and away
+Added: However, very limited Long COVID-related HLA typing information has been published to date.
+Added: We therefore plan to launch
+Added: a non-therapeutic blood draw study in the second quarter of 2024 to assess whether the Long COVID population generally reflects
+Added: or is skewed towards or away from certain HLA types and to determine the optimal HLA types to target in a therapeutic trial of TVGN 489
+Added: for the treatment of Long COVID.
+Added: This will allow us to develop CTLs for the HLA types most commonly found in Long COVID.
+Added: Following the
+Added: results of that study, we plan to begin a clinical trial in Long COVID treatment in approximately the fourth quarter of 2024.
+Added: symptoms will also be explored for an association with the viral reservoir in advance of this trial.
+Added: Additional studies in vulnerable
+Added: populations are expected to follow.
+Added: Discovery Programs, Product Candidates and Indications
+Added: addition to TVGN 489, we have several product candidates under early-stage development in virology, neurology, and oncology using our
+Added: ExacTcell platform technology.
+Added: We are developing Epstein-Barr virus (“EBV”) specific CTLs for potential use in multiple sclerosis
+Added: (“MS”) and EBV-associated lymphomas.
+Added: Our TVGN 601 is being developed for MS, and our TVGN 930 is being developed for EBV-associated
+Added: EBV is a common virus that infects over 90% of the world’s adult population, according to the World Health Organization
+Added: (the “WHO”), and is mainly transmitted through saliva, but also through other body fluids such as blood and semen.
+Added: the leading cause of infectious mononucleosis, and infects B-cells, a type of immune cell.
+Added: Recent studies have suggested a potential
+Added: link between infection with EBV and later onset of inflammation that causes MS, and EBV infection can lead to a variety of cancers and
+Added: cancer-like disorders, including lymphomas, nasopharyngeal cancers, Post-Transplant Lymphoproliferative Disorder, and others.
+Added: widespread nature of EBV and the serious health problems it can cause, investigative work is underway to identify effective peptide targets
+Added: for this virus to further the development of TVGN 601 and TVGN 930.
+Added: Investigative work is also underway to develop product candidates
+Added: targeted at human papilloma virus (“HPV”)-related diseases, including TVGN 920 in cervical cancer and TVGN 960 in oropharyngeal
+Added: cancer, which is a type of mouth and throat cancer.
+Added: Cervical cancer and oropharyngeal cancer are both commonly caused by HPV.
+Added: to the WHO, HPV is responsible for 99% of cervical cancers.
+Added: Mouth and throat cancers are more diverse, but the WHO estimates that about
+Added: 70% of oropharyngeal cancers are due to HPV.
+Added: Although a vaccine for HPV exists, the National Cancer Institute estimates that as of 2021,
+Added: only 58.5% of adolescents between the ages of 13 and 15 had received the recommended doses, estimated vaccination among older populations
+Added: is lower, and the COVID pandemic has shown that significant portions of the population will avoid vaccination.
+Added: We believe that as with
+Added: other viral infections, the availability of both a preventative strategy and a treatment strategy is important to reduce incidence and
+Added: impact of disease and is investigating peptide candidates for HPV to further the development of TVGN 920 and TVGN 960.
+Added: believe that our ExacTcell approach also presents a novel and highly specific technique to combating cancers with T cell therapy.
+Added: CAR-T or Bispecific T-cell Engager (BiTE) antibody approaches, which recruit a heterogeneous group of T cells to the tumor, our approach
+Added: would instead focus a highly purified population of CTLs on the tumor, which we believe may provide more potential to accomplish the
+Added: task of eradicating the cancer.
+Added: Cancer cells may not always express an ideal T cell target on their own.
+Added: However, it is possible to coat
+Added: a cancer cell with a well-recognized target peptide using monoclonal antibodies or liposomes.
+Added: We believe this would allow our target
+Added: specific CTLs to then attack the cancer cells.
+Added: We also believe that our approach has the potential to eventually bring the benefits of
+Added: cell therapies to first-line options in oncology, as well as to create products that may overcome current limitations of checkpoint inhibitors.
+Added: cells can lose their ability to fight viruses and tumors in prolonged infections and cancer in a state called T cell exhaustion that
+Added: is characterized by the presence of certain biomarkers.
+Added: Expression of these markers, which include PD-1, PDL-1, and LAG-3, has been observed
+Added: to be low level to absent in TVGN 489 cells.
+Added: Moreover, TVGN 489 cells are functionally tested after generation, and have been observed
+Added: to remain strongly cytolytic at very low ratios of CTLs to target cells, which shows that they are not displaying the functional limitations
+Added: associated with T cell exhaustion.
+Added: Manufacturing
+Added: relied on a Clinical Trial Services and Materials Agreement with Thomas Jefferson University for the manufacture of TVGN 489 for our
+Added: Phase 1 proof-of-concept trial.
+Added: However, we will need to develop manufacturing capabilities for clinical and, if approved, commercial
+Added: supply of our cell therapy products.
+Added: Our efforts to develop manufacturing capability are currently focused on acquiring existing manufacturing
+Added: facilities or constructing one or more new manufacturing facilities, including through collaboration with a potential facility development
+Added: Commercialization Plans
+Added: approved, we plan to globally commercialize TVGN 489 and our other product candidates aimed at serving a large patient population suffering
+Added: from infectious diseases, cancer, and multiple sclerosis.
+Added: Our commercial and market access team has been diligently working alongside
+Added: our research and development team and external experts to better understand market dynamics, identify segments with high unmet needs,
+Added: map the patient journey, understand the competition within each segment, and identify opportunities for our product candidates.
+Added: team continues to offer input in portfolio planning and target prioritization for our research pipeline.
+Added: We are also proactive in identifying
+Added: potential collaboration and service partners, including distribution partners for our sophisticated, cryopreserved cell therapy products
+Added: like TVGN 489.
+Added: As part of our company’s mission of patient centricity, we aim to collaborate with all stakeholders, including patients,
+Added: healthcare professionals, sales channel partners, public and private payers, and service providers.
+Added: Essential commercial capabilities,
+Added: such as market analytics, pricing, and commercial operations functions, are continuously being developed as we progress toward the later-stage
+Added: development of TVGN 489.
+Added: October 2023, we announced Tevogen.ai, a new early-stage initiative focused on harnessing the potential of artificial intelligence to
+Added: expedite drug development, optimize laboratory processes and clinical trials, unravel complex biological data, improve patient outcomes,
+Added: and pass on related savings to patients.
+Added: We intend to assemble a team of research scientists, physicians, data scientists, and artificial
+Added: intelligence and machine learning engineers to help accomplish these goals by leveraging tools and techniques that might include large,
+Added: curated data sets, algorithmic models, pattern recognition, data analyses, automation, and artificial intelligence-powered software such
+Added: As an initial part of this initiative, we are specifically exploring ways to deploy artificial intelligence-powered target
+Added: detection to further accelerate our product development pace, either internally or in collaboration with leading entities in the field
+Added: of artificial intelligence.
+Added: We also intend to explore the potential use of artificial intelligence to power tools that could anticipate
+Added: potential adverse reactions and efficacy concerns for and identify patients who would be most likely to respond to an investigational
+Added: The ability to search the human genome for specific peptide sequences might, for example, eliminate some peptide targets simplifying
+Added: the peptide screening/selection process.
+Added: We have filed patents for algorithms to be trained against a curated dataset to predict immunologically
+Added: active HLA-peptide complexes and additionally to predict T-cell receptor engagement tied to specific HLA-peptide complexes.
+Added: History and Team
+Added: were incorporated as a Cayman Islands exempted company in April 2021, and Tevogen Bio was established in June 2020 as a Delaware corporation.
+Added: Our senior leadership team is composed of eminent scientists and accomplished biopharmaceutical leaders.
+Added: The team brings together diverse
+Added: experience across the entire life sciences spectrum, including biotechnology, pharmaceuticals, hospitals, public and private insurance,
+Added: education, and health policy.
+Added: Additionally, our team holds substantial expertise in drug development, global product launches, and commercialization
+Added: and ensuring patient access across a range of therapeutic areas.
+Added: biotechnology industry, and in particular the cell therapy sector, are characterized by the rapid evolution of technologies and understanding
+Added: of disease etiology, and strong pursuit and defense of intellectual property.
+Added: We believe that our approach, strategy, scientific development
+Added: capabilities, know-how, access to global experts, and experience provide us with competitive advantages.
+Added: However, we expect future competition
+Added: in some of the indications we are targeting and from existing or emerging pharmaceutical and biotechnology companies as well as possibly
+Added: from governmental agencies, academic institutions, and public and private research institutions, among others.
+Added: Some of our competitors,
+Added: either alone or through collaborations, have greater financial resources and expertise in research and development, conducting clinical
+Added: trials, manufacturing, obtaining regulatory approvals, and marketing approved products than we do.
+Added: Smaller or early-stage companies may
+Added: also prove to be competitors, particularly through collaborative arrangements with large and established companies.
+Added: Entities in the biotechnology
+Added: industry also compete with us in recruiting and retaining qualified scientific, clinical, and management personnel and may compete with
+Added: us in establishing clinical trial sites and enrolling patients in clinical trials as well as in acquiring technologies complementary
+Added: to, or necessary for, our programs.
+Added: As a result, our competitors may discover, develop, license, or commercialize products before or
+Added: more successfully than we do.
+Added: 489 is being developed to fill the critical gaps that exist in COVID-19 therapeutics for the immunocompromised and the high-risk elderly.
+Added: No treatments are specifically approved for immunocompromised patients as of the date of this Annual Report, and clinical trial data
+Added: of currently approved treatments in immunocompromised patients is limited.
+Added: The National Institutes of Health’s (“NIH”)
+Added: COVID-19 Treatment Guidelines Panel, a group of clinical experts that has developed guidance on COVID-19 care (the “NIH Panel Guidelines”),
+Added: currently recommends prompt treatment of COVID-19 in non-hospitalized immunocompromised patients with antiviral drugs, but acknowledges
+Added: the limitations of these drugs and related research in such patients.
+Added: Two antivirals are currently FDA-approved for COVID-19 treatment:
+Added: Gilead Science’s Veklury ® (Remdesivir) for the treatment of mild-to-moderate COVID-19 in hospitalized or non-hospitalized
+Added: adults who are at high risk for progression to severe COVID-19, and Pfizer’s Paxlovid (Nirmatrelvir/Ritonavir tablets) for the
+Added: treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19.
+Added: The NIH Panel Guidelines highlight
+Added: the limitation of the insights that clinical trials conducted for Remdesivir and for Nirmatrelvir/Ritonavir tablets in broader populations
+Added: can provide with respect to immunocompromised patients, as each trial enrolled only limited numbers of such patients.
+Added: For example, a
+Added: retrospective study examining the use of Nirmatrelvir/Ritonavir tablets in vulnerable individuals with COVID-19 included only 13.2% highly
+Added: immunocompromised and 10.6% moderately immunocompromised patients with cancer, with cancer type and type immunosuppressive medications
+Added: not otherwise specified.
+Added: Although the NIH Panel Guidelines acknowledge observation in retrospective studies of “some potential
+Added: benefits” of the use of Paxlovid for patients with “various immunocompromising conditions,” they also note that because
+Added: the pivotal trial of Nirmatrelvir/Ritonavir tablets did not enroll many immunocompromised participants, “efficacy ...
+Added: was not established
+Added: for this population.” Based on our target product profile, therefore, we anticipate that these products may not be direct competitors
+Added: in our target patient population.
+Added: Moreover, we believe that TVGN 489’s anticipated single outpatient infusion may be easier to
+Added: administer than Veklury’s multiple infusions over a number of days.
+Added: Additionally, Paxlovid requires daily doses, has a significant
+Added: number of drug interaction issues, as discussed in “COVID-19 Background” and noted by the NIH Panel Guidelines, and has experienced
+Added: numerous patient reports of disease relapse or rebound, which in each case we do not anticipate for TVGN 489 based on its design and
+Added: our Phase 1 proof of concept trial results.
+Added: We do expect that these products may present direct competition in high-risk elderly patients,
+Added: but we are initially targeting immunocompromised indications.
+Added: antibodies have also previously been considered promising as an effective therapeutic option for COVID-19, including in immunocompromised
+Added: patients, and several had been granted EUAs.
+Added: However, these treatments have had their EUAs revoked by FDA due to lack of efficacy stemming
+Added: from viral mutations.
+Added: For example, AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a monoclonal antibody pair
+Added: that previously had an EUA granted on December 8, 2021, for preventive use in immunocompromised patients, was undermined by viral mutations,
+Added: resulting in the revocation of its EUA in January 2023, only 13 months later.
+Added: Evushield had previously been associated with a reduced
+Added: risk of mortality in ancestral strains of COVID-19, but the results of a trial reported in February 2024 showed that Evushield failed
+Added: to impact patient clinical status or increase viral clearance in hospitalized COVID-19 patients.
+Added: This finding was thought to be due at
+Added: least in part to evasion of the therapy by newer COVID-19 variants, highlighting the difficulty of applying monoclonal antibody treatments
+Added: to COVID-19 therapy.
+Added: There are nonetheless ongoing efforts to develop additional anti-COVID monoclonal antibodies for treatment and prevention
+Added: of Covid-19 infection.
+Added: For example, in January 2024, Invivyd applied to FDA for EUA of its product, VYD222, a broadly neutralizing monoclonal
+Added: antibody used for COVID-19 prevention in immunocompromised individuals.
+Added: While this product has shown in vitro activity against a currently
+Added: circulating variant, JN.1, it may remain vulnerable to novel viral mutations.
+Added: Antibodies, unlike T-cells, recognize intact molecules.
+Added: Consequently, even remote mutations, not directly where the antibodies bind, may alter how the target molecule folds and its overall
+Added: shape and therefore prevent antibody binding.
+Added: T-cells, in contrast, recognize small peptide breakdown products of proteins and are only
+Added: affected if the mutation is directly within the target peptide.
+Added: Although it is possible that the epitope targeted by VYD 222 and others
+Added: like it will remain more durable, this remains to be seen.
+Added: broadly, known companies developing virus-specific T cell therapies include Atara Biotherapeutics (“Atara Bio”), whose Ebvallo
+Added: (tabelecleucel) has received approval in Europe for treating a rare hematologic cancer caused by EBV.
+Added: AlloVir, Inc.
+Added: (“AlloVir”) is another company developing
+Added: allogeneic T cell therapies for viral diseases.
+Added: Neither Atara Bio nor AlloVir has an active development program for the treatment of
+Added: AlloVir conducted a Phase 1b trial of an allogeneic, partially HLA-matched product candidate in COVID-19 and reported results
+Added: of the trial in 2021 but has not continued clinical development.
+Added: One patient in the trial experienced a recurrence of the disease and
+Added: died four weeks after treatment.
+Added: Atara Bio announced in November 2023 that the Phase 2 trial of its T cell therapy, ATA 188, targeting
+Added: EBV-infected B cells and plasma cells in progressive forms of multiple sclerosis, failed to meet efficacy or biomarker endpoints.
+Added: initially treated with placebo in this trial later received ATA 188, which we believe may have made it more challenging to discern a
+Added: difference between the study arms.
+Added: ATA 188 targets only three latent EBV proteins, whereas our CTL peptide targets are selected from
+Added: all proteins expressed at the appropriate point in the viral life cycle, whether unique to that point in the viral life cycle or not.
+Added: This approach provides far more immunologic targets and thus more opportunities for viral control.
+Added: In addition, ATA 188 is generated
+Added: against targets restricted by several HLA alleles, which is likely to reduce the functional dose of drug targeting any one HLA allele,
+Added: as contrasted with CTLs developed with ExacTcell, which are generated against a single HLA specificity and therefore allow a more precise
+Added: understanding and control of dosage.
+Added: anticipate that we may face competition as new therapies enter the market and advanced technologies become available from time to time.
+Added: We expect that any treatments which we develop and commercialize will need to compete on, among other things, efficacy, safety, convenience
+Added: of administration and delivery, and price.
+Added: Commercialization of any treatments we develop will be affected by the level of competition
+Added: from original and biosimilars products and the availability of reimbursement from government and other third-party payors.
+Added: ability to commercialize our proprietary cell products could be significantly and adversely affected if our competitors develop and commercialize
+Added: products that are more effective, have a better safety profile, are more convenient or are less expensive than our products.
+Added: Our competitors
+Added: also may obtain relevant regulatory approvals for their products more rapidly than we may be able to obtain approval for ours, which
+Added: could result in our competitors obtaining a head start and establishing a frontrunner position before we are ready to commercialize.
+Added: If we are not able to compete effectively against our existing and potential competitors, our business, financial condition, results
+Added: of operations and growth prospects may be materially and adversely affected.
+Added: commercial success depends in part on our ability to obtain and maintain patent and other proprietary protection for our products and
+Added: methods, preserve the confidentiality of our trade secrets, operate without infringing, misappropriating, or otherwise violating the
+Added: valid, enforceable proprietary rights of others, and prevent others from infringing, misappropriating, or otherwise violating our proprietary
+Added: We rely on a combination of patents, patent applications, and trade secrets to establish and protect our intellectual property
+Added: Our ability to stop third parties from making, using, selling, offering to sell, or importing our products without the right
+Added: to do so may depend on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.
+Added: continue to build our intellectual property portfolio and seek to protect our proprietary position by, among other things, filing patent
+Added: applications.
+Added: Our patent estate includes patents and patent applications with claims relating to our product candidates, methods of use,
+Added: and methods of preparing the product candidates.
+Added: As of March 15, 2024, our U.S.
+Added: intellectual property portfolio includes three U.S.
+Added: relating to TVGN 489 for the treatment of COVID-19, nine pending U.S.
+Added: patent applications, including two patent applications relating
+Added: to the treatment of COVID-19, five relating to the treatment of other viruses or cancer, and two related to artificial intelligence-driven
+Added: T cell target identification and receptor engagement, as well as eleven ex-U.S.
+Added: patent applications, including applications in Australia,
+Added: Canada, Europe, Japan, Qatar, and United Arab Emirates directed at viral specific T cells, methods of treating and preventing viral infections,
+Added: and methods for developing CD3+CD+ cells against multiple viral epitopes for the treatment of viral infections, which have anticipated
+Added: expiration dates through July 29, 2042.
+Added: the United States, our three issued utility patents, all of which will expire on December 9, 2040, are U.S.
+Added: 11,191,827 covering
+Added: methods of treating COVID-19 infection using COVID-19 peptide specific CTLs, U.S.
+Added: 11,207,401 covering COVID-19 peptide-specific
+Added: CTLs, and U.S.
+Added: 11,219,684 covering methods of manufacturing COVID-19 peptide specific CTLs.
+Added: A pending utility patent application
+Added: in the United States directed at viral specific T cells and methods of treating and preventing viral infections has an anticipated expiration
+Added: of December 9, 2041.
+Added: addition, we have applied for registered trademark protection for “Tevogen Bio” (and design) as well as “ExacTcell”
+Added: with the U.S.
+Added: Patent and Trademark Office (the “USPTO”).
+Added: determine strategy for claim scope for our patent applications on a case-by-case basis, taking into account advice of counsel and our
+Added: business model and needs.
+Added: We file patents containing claims for protection of useful applications of our proprietary technologies and
+Added: any product candidates, including new applications or uses we discover for existing technologies and product candidates, based on our
+Added: assessment of their strategic value.
+Added: We continuously reassess the number and type of patent applications, as well as our pending and
+Added: issued patent claims, to ensure maximum coverage and value are obtained for our processes and compositions, given existing patent office
+Added: rules and regulations.
+Added: Capital Resources
+Added: success depends on our ability to attract and retain highly qualified management and personnel.
+Added: As of April 26, 2024, we had 17 full-time
+Added: and no part-time employees.
+Added: We value a work culture that encourages employees, contractors, and vendors to contribute their unique and
+Added: diverse perspectives, to harness optimism and creativity, and to be ready to learn and develop solutions towards a common and greater
+Added: purpose of developing accessible immunotherapies.
+Added: Our work culture is centered around four “CORE” values:
+Added: Curiosity, Optimism,
+Added: Respect, and Equality.
+Added: We believe it is essential and necessary that these values are instilled and maintained in each of our employees
+Added: to foster a collaborative culture.
+Added: At our current size, ensuring this culture is primarily achieved through the recruitment process.
+Added: Talent recruitment at our current stage is setting the foundation for further company growth.
+Added: When attracting talent, we ensure that
+Added: every job description mentions our core values, and the importance of these values in achieving our mission.
+Added: Beyond evaluating experience,
+Added: job applicants are also evaluated based on their values and passions.
+Added: We believe it is necessary that each employee represents our four
+Added: As our employee numbers increase, we plan to create more defined programs to further enhance our company culture and retention
+Added: of personnel.
+Added: Regulation and Product Approval
+Added: the United States, biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the “FDCA”),
+Added: and the Public Health Service Act (the “PHSA”), and other federal, state, and local statutes and regulations.
+Added: Both the FDCA
+Added: and PHSA and their corresponding regulations govern, among other things, the research, development, clinical trials, testing, manufacturing,
+Added: quality control, safety, purity and potency (efficacy), labeling, packaging, storage, record keeping, distribution, reporting, marketing,
+Added: promotion, advertising, post-approval monitoring, and post-approval reporting involving biological products.
+Added: Along with third-party contractors,
+Added: we will be required to navigate the various preclinical and clinical regulatory obligations and the commercial approval requirements
+Added: of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our product
+Added: The processes for obtaining regulatory approvals in the United States, along with subsequent compliance with applicable laws
+Added: and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.
+Added: policies may change and additional government regulations may be enacted that could prevent or delay further development or regulatory
+Added: approval of any product candidates, product or manufacturing changes, additional disease indications or label changes.
+Added: We cannot predict
+Added: the likelihood, nature or extent of government regulation that might arise from future legislative or administrative action.
+Added: and Approval for Licensing Biologics in the United States
+Added: the United States, FDA regulates our current product candidates as biological products, or biologics, under the FDCA, the PHSA, and associated
+Added: implementing regulations.
+Added: Biologics, like other drugs, are used for the diagnosis, cure, mitigation, treatment, or prevention of disease
+Added: In contrast to low molecular weight drugs, which have a well-defined structure and can be thoroughly characterized, biologics
+Added: are generally derived from living material (human, animal, or microorganism), are complex in structure, and thus are usually not fully
+Added: characterized.
+Added: are also subject to other federal, state, and local statutes and regulations.
+Added: The failure to comply with applicable statutory and regulatory
+Added: requirements at any time during the product development process, approval process, or after approval may subject a sponsor or applicant
+Added: to administrative or judicial enforcement actions.
+Added: These actions could include the suspension or termination of clinical trials by FDA,
+Added: FDA’s refusal to approve pending applications or supplemental applications, withdrawal of an approval, issuance of warning or untitled
+Added: letters, product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions,
+Added: fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought
+Added: by FDA, the Department of Justice (“DOJ”), and other governmental entities.
+Added: applicant seeking approval to market and distribute a biologic in the United States must typically undertake the following:
+Added: of non-clinical laboratory tests and studies performed in accordance with FDA’s good laboratory practice (“GLP”)
+Added: labeling and distribution of investigational drugs in compliance with FDA’s current good manufacturing practice (“cGMP”)
+Added: requirements;
+Added: to FDA of an IND, which must become effective before clinical trials may begin and must be updated annually and when significant
+Added: changes are made;
+Added: by an independent institutional review board (“IRB”) for each clinical site before each clinical trial may be initiated;
+Added: of adequate and well-controlled human clinical trials in accordance with FDA’s Good Clinical Practices (“GCP”)
+Added: to establish the safety, purity, and potency of the proposed biological product candidate for its intended purpose;
+Added: completion of all pivotal clinical trials, preparation of and submission to FDA of a Biologics License Application (“BLA”)
+Added: requesting marketing approval, which includes providing sufficient evidence to establish the efficacy, safety, purity, and potency
+Added: of the proposed biological product for its intended use, including from results of nonclinical testing and clinical trials;
+Added: completion of an FDA advisory committee review, when appropriate, as may be requested by FDA to assist with its review;
+Added: completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or certain components
+Added: thereof, are produced to assess compliance with cGMP and data integrity requirements to assure that the facilities, methods, and
+Added: controls are adequate to preserve the biological product’s identity, strength, quality, and purity and, if applicable, FDA’s
+Added: good tissue practice (“GTP”) requirements for human cellular and tissue products;
+Added: completion of FDA inspections of selected clinical investigation sites to assure compliance with GCP requirements and the integrity
+Added: of the clinical data;
+Added: completion of an FDA sponsor GCP inspection, often conducted at the applicant’s headquarters facility;
+Added: of user fees (unless there is a waiver, exemption, or reduction) under the Prescription Drug User Fee Act (“PDUFA”) for
+Added: the relevant year;
+Added: review and approval of the BLA to permit commercial marketing of the licensed biologic for particular indications for use in the
+Added: United States;
+Added: with post-approval requirements, including the potential requirements to implement a Risk Evaluation and Mitigation Strategy (“REMS”),
+Added: to report adverse events and biological product deviations, and to complete any post-approval studies;
+Added: of any post-approval clinical studies required by FDA, such as confirmatory trials or pediatric studies.
+Added: time to time, legislation is drafted, introduced, and passed in Congress that could significantly change the statutory provisions governing
+Added: the testing, approval, manufacturing, and marketing of biological products regulated by FDA.
+Added: In addition to new legislation, FDA regulations,
+Added: guidance documents, and policies are often revised or interpreted by the agency in ways that may significantly affect the regulation
+Added: of biological products in the United States.
+Added: It is impossible to predict whether further legislative changes will be enacted or whether
+Added: FDA regulations, guidance, policies, or interpretations will change, and the effects of any such changes.
+Added: and Clinical Development
+Added: an applicant can begin testing the potential product candidate in human subjects, the applicant must first conduct preclinical studies.
+Added: Preclinical studies may include laboratory evaluations of product chemistry, toxicity, and formulation, as well as in vitro and animal
+Added: studies to assess the potential safety and activity of the drug for initial testing in humans and to establish a rationale for therapeutic
+Added: Preclinical studies are subject to federal regulations and requirements, including GLP regulations, which govern the conduct of
+Added: animal studies designed to test a product’s safety.
+Added: None of our preclinical studies to date have been animal studies.
+Added: of an applicant’s preclinical studies are submitted to FDA as part of an IND.
+Added: IND is a request for authorization from FDA to administer an investigational new drug product to humans.
+Added: An IND is an exemption from
+Added: the FDCA that allows an unapproved drug to be shipped in interstate commerce for use in a clinical trial.
+Added: Such authorization must be
+Added: secured prior to interstate shipment and administration of a biological drug that is not subject of an approved BLA.
+Added: In support of an
+Added: IND, applicants must submit a protocol for each clinical trial, which details, among other things, the objectives of the trial, the parameters
+Added: to be used in monitoring safety and the effectiveness criteria to be evaluated.
+Added: A separate submission to the existing IND must be made
+Added: for each successive clinical trial conducted during product development and for any subsequent protocol amendments.
+Added: clinical trials may not begin until an IND is effective.
+Added: The IND automatically becomes effective 30 days after receipt by FDA, unless
+Added: FDA raises safety concerns or questions about the proposed clinical trial within the 30-day time period.
+Added: In such a case, FDA may place
+Added: the IND on clinical hold and the IND sponsor must resolve any of FDA’s outstanding concerns or questions before the clinical trial
+Added: Submission of an IND therefore may or may not result in regulatory authorization to begin a clinical trial.
+Added: may also place a clinical hold or partial clinical hold on a clinical trial following commencement of the trial under an IND.
+Added: hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation.
+Added: clinical hold is a delay or suspension of only part of the clinical work requested under the IND.
+Added: For example, under a partial clinical
+Added: hold, FDA may instruct a sponsor not to enroll any new patients into a study, but permit the previously enrolled patients to continue
+Added: in the study.
+Added: No more than 30 days after imposition of a clinical hold or partial clinical hold, FDA will provide the sponsor a written
+Added: explanation of the basis for the hold.
+Added: Following issuance of a clinical hold or partial clinical hold, an investigation may only resume
+Added: after FDA has notified the sponsor that the investigation may proceed.
+Added: FDA will base that determination on information provided by the
+Added: sponsor addressing the deficiencies previously cited or otherwise satisfying FDA that the investigation can proceed.
+Added: trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
+Added: accordance with GCP regulations, which include the requirement that all research subjects provide their informed consent for their participation
+Added: in any clinical trial.
+Added: If a sponsor chooses to conduct a foreign clinical study under an IND, all FDA IND requirements must be met unless
+Added: When the foreign clinical study is not conducted under an IND, the sponsor must ensure that the study complies with GCP regulations
+Added: in order to use the study as support for an IND or application for marketing approval, including review and approval by an IRB and informed
+Added: consent from subjects.
+Added: an independent IRB for all sites participating in a clinical trial must review and approve the plan for any clinical trial and its informed
+Added: consent form before the clinical trial begins at each site, and must monitor the trial until completed.
+Added: Regulatory authorities, the IRB,
+Added: or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to
+Added: an unacceptable health risk or that the trial is unlikely to meet its stated objectives.
+Added: trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety
+Added: monitoring board (“DSMB”).
+Added: DSMBs review unblinded study data at pre-specified times during the course of the study.
+Added: DSMB determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy, the DSMB
+Added: can make a recommendation to the sponsor to modify or stop the trial.
+Added: grounds for a sponsor’s decision to suspend or terminate a study may be made based on evolving business objectives or competitive
+Added: purposes of BLA approval, clinical trials are typically conducted in the following sequential phases:
+Added: The investigational product is initially introduced into a small group of healthy human
+Added: subjects or patients with the target disease or condition.
+Added: These trials are designed to test
+Added: the safety, dosage tolerance, absorption, metabolism and distribution of the investigational
+Added: product in humans and the side effects associated with increasing doses.
+Added: These trials may
+Added: also yield early evidence of effectiveness.
+Added: The investigational product is administered to a slightly larger patient population with
+Added: a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, and
+Added: dosing schedule and to identify possible adverse side effects and safety risks.
+Added: Phase 2 clinical trials may be conducted to obtain information prior to beginning larger
+Added: and more expensive Phase 3 clinical trials.
+Added: The investigational product is administered to an expanded patient population to further
+Added: evaluate dosage, to provide statistically significant evidence of clinical efficacy and to
+Added: further test for safety, generally at multiple geographically dispersed clinical trial sites.
+Added: These clinical trials are intended to generate sufficient data to statistically demonstrate
+Added: the efficacy and safety of the product, to establish the overall risk/benefit ratio of the
+Added: investigational product, and to provide an adequate basis for product approval by FDA.
+Added: phases may overlap or be combined.
+Added: In some cases, FDA may require, or companies may voluntarily pursue, additional clinical trials after
+Added: a product is approved to gain more information about the product, referred to as Phase 4 trials.
+Added: Such post-approval trials are conducted following initial approval, often to develop additional data and information relating to the
+Added: use of the product in new indications.
+Added: reports detailing the results of the clinical trials must be submitted at least annually to FDA.
+Added: In addition, IND safety reports must
+Added: be submitted to FDA for any of the following:
+Added: serious and unexpected suspected adverse reactions in study subjects;
+Added: findings from epidemiological
+Added: studies, pooled analysis of multiple studies, animal or in vitro testing, or other clinical studies, whether or not conducted under an
+Added: IND, and whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug;
+Added: and any clinically important
+Added: increase in the rate of a serious suspected adverse reaction over such rate listed in the protocol or investigator brochure.
+Added: sponsor’s planned clinical trials may not be completed successfully within any specified period, or at all.
+Added: Furthermore, FDA or
+Added: the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects
+Added: are being exposed to an unacceptable health risk.
+Added: Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution,
+Added: or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the
+Added: drug has been associated with unexpected serious harm to patients.
+Added: FDA will typically inspect one or more clinical sites to assure compliance
+Added: with GCP and the integrity of the clinical data submitted.
+Added: clinical development, the sponsor often refines the indication and endpoints on which the BLA will be based.
+Added: For endpoints based on patient-reported
+Added: outcomes (“PROs”), the process typically is an iterative one.
+Added: FDA has issued guidance on the framework it uses to evaluate
+Added: PRO instruments.
+Added: Although the agency may offer advice on optimizing PRO instruments during the clinical development process, FDA usually
+Added: reserves final judgment until it reviews the BLA.
+Added: with clinical trials, companies often complete additional animal studies, and develop additional information about the chemistry and
+Added: physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with
+Added: The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things,
+Added: must develop methods for testing the identity, strength, quality, purity and potency of the final drug.
+Added: Additionally, appropriate packaging
+Added: must be selected and tested, and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable
+Added: deterioration over its shelf life.
+Added: Submission and Review
+Added: successful completion of all required clinical testing in accordance with all applicable regulatory requirements, an applicant may submit
+Added: a BLA requesting licensing to market the biologic for one or more indications in the United States.
+Added: The BLA must include the results
+Added: of nonclinical studies and clinical trials;
+Added: detailed information on the product’s chemistry, manufacture, controls;
+Added: Under the PDUFA, a BLA submission is subject to an application user fee, unless a waiver, reduction, or exemption applies.
+Added: will initially review the BLA for completeness before accepting it for filing.
+Added: Under FDA’s procedures, the agency has 60 days from
+Added: its receipt of a BLA to determine whether the application will be accepted for filing and substantive review.
+Added: If the agency determines
+Added: that the application does not meet this initial threshold standard, FDA may refuse to file the application and request additional information,
+Added: in which case the application must be resubmitted with the requested information and review of the application delayed.
+Added: the BLA is accepted for filing, FDA reviews the BLA to determine, among other things, whether a product is safe, pure, and potent and
+Added: if the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued
+Added: identity, strength, quality, safety, purity, and potency.
+Added: To ensure cGMP, GLP, GCP, GTP, and other regulatory compliance, an applicant
+Added: must incur significant expenditure of time, money, and effort in the areas of training, record keeping, production and quality control.
+Added: In addition, FDA expects that all data be reliable and accurate, and requires sponsors to implement meaningful and effective strategies
+Added: to manage data integrity risks.
+Added: Data integrity is an important component of the sponsor’s responsibility to ensure the safety,
+Added: efficacy and quality of its product or products.
+Added: cellular products, FDA will not approve the product if the manufacturer is not in compliance with the GTPs, to the extent applicable.
+Added: GTPs are FDA regulations and guidance documents that govern the methods used in, and the facilities and controls used for, the manufacture
+Added: of human cells, tissue, and cellular and tissue-based products (“HCT/Ps”), which are human cells or tissue intended for implantation,
+Added: transplant, infusion, or transfer into a human recipient.
+Added: The primary intent of the GTP requirements is to ensure that cell and tissue-based
+Added: products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease.
+Added: FDA regulations
+Added: also specify how HCT/P establishments must register and list their HCT/Ps with FDA and how they must evaluate donors through screening
+Added: and testing, where applicable.
+Added: FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies
+Added: in the submission and often will request additional testing or information.
+Added: Notwithstanding the submission of any requested additional
+Added: information, FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
+Added: performance goals and policies implemented by FDA under the PDUFA generally provide for FDA action on an original BLA within 10 months
+Added: of filing, which (as discussed above) typically occurs within 60 days of submission, but that deadline is extended in certain circumstances.
+Added: Furthermore, the review process is often significantly extended by FDA’s requests for additional information or clarification.
+Added: may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee.
+Added: Typically, an advisory committee consists of a panel that includes clinicians and other experts who will review, evaluate, and provide
+Added: a recommendation as to whether the application should be approved and, if so, under what conditions.
+Added: FDA is not bound by the recommendations
+Added: of an advisory committee, but it considers such recommendations carefully when making decisions and usually has followed such recommendations.
+Added: FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its components will
+Added: be produced, FDA may issue an approval letter or a Complete Response Letter (“CRL”).
+Added: An approval letter authorizes commercial marketing of the biologic with specific prescribing information for specific indications.
+Added: CRL will describe all of the deficiencies that FDA has identified in the BLA, except that where FDA determines that the data supporting
+Added: the application are inadequate to support approval, FDA may issue the CRL without first conducting required inspections, testing submitted
+Added: product lots and/or reviewing proposed labeling.
+Added: If and when the deficiencies have been addressed to FDA’s satisfaction in a resubmission
+Added: of the BLA, FDA will issue an approval letter.
+Added: In issuing the CRL, FDA may recommend actions that the applicant might take to place the
+Added: BLA in condition for approval, including requests for additional data, information, or clarification.
+Added: FDA may delay or refuse approval
+Added: of a BLA if applicable regulatory criteria are not satisfied, and may require additional testing or information and/or require new clinical
+Added: Even with submission of this additional information, FDA ultimately may decide that the application does not satisfy the regulatory
+Added: criteria for approval.
+Added: the approval process, FDA will determine whether a REMS is necessary to help ensure the benefits outweigh the risks of the biologic.
+Added: A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued
+Added: access to such medicines by managing their safe use, and could include medication guides, physician communication plans or elements to
+Added: assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
+Added: If FDA concludes that
+Added: a REMS is needed, the BLA sponsor must submit a proposed REMS and FDA will not approve the BLA without a REMS that the agency has determined
+Added: is acceptable.
+Added: FDA approves a product, it may limit the approved indications for use for the product, or require that contraindications, warnings, or
+Added: precautions be included in the product labeling.
+Added: FDA may also require that post-approval studies, including Phase
+Added: 4 clinical trials, be conducted to further assess the drug’s safety after approval.
+Added: FDA may prevent or limit further marketing
+Added: of a product based on the results of post-market studies or surveillance programs.
+Added: may also require testing and surveillance programs to monitor the product after commercialization.
+Added: For biologics, such testing may include
+Added: official lot release, which requires the manufacturer to perform certain tests on each lot of the product before it is released for distribution.
+Added: The manufacturer then typically must submit samples of each lot of product to FDA, together with a release protocol showing a summary
+Added: of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot.
+Added: perform certain confirmatory tests on lots of some products itself, before releasing the lots for distribution by the manufacturer.
+Added: general, an approved BLA only allows the sponsor to market the biologic as approved, without modification.
+Added: If, for example, a sponsor
+Added: modifies an approved T cell product to target different peptides or in our case to target another HLA type, the sponsor would be required
+Added: to either file a supplemental BLA with FDA or receive FDA approval for a comparability protocol in order to implement this change into
+Added: the final product.
+Added: may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after
+Added: the product reaches the marketplace.
+Added: Post-Approval
+Added: products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by FDA, including,
+Added: among other things, requirements relating to recordkeeping, periodic reporting, reporting of certain deviations and adverse experiences,
+Added: product sampling and distribution, and advertising and promotion of the product.
+Added: After approval, many types of changes to the approved
+Added: product, such as adding new indications, manufacturing changes and additional labeling claims, are often subject to further testing requirements
+Added: and FDA review and approval, depending on the nature of the post-approval change.
+Added: There also are continuing user fee requirements, under
+Added: which FDA assesses an annual program fee for each product identified in an approved BLA.
+Added: Biologic manufacturers and their third-party
+Added: contractors are required to register their facilities with FDA and certain state agencies.
+Added: These facilities are subject to routine and
+Added: periodic unannounced inspections by FDA and certain state agencies for compliance with cGMP, post-marketing safety reporting and data
+Added: integrity requirements, which impose certain procedural and documentation requirements to assure quality of manufacturing and product.
+Added: FDA has increasingly observed cGMP violations involving data integrity during site inspections and is a significant focus of its oversight.
+Added: Requirements with respect to data integrity include, among other things, controls ensuring complete and secure data;
+Added: activities documented
+Added: at the time of performance;
+Added: audit trail functionality;
+Added: authorized access and limitations;
+Added: validated computer systems;
+Added: and review of records
+Added: for accuracy, completeness, and compliance with established standards.
+Added: Post-approval
+Added: changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require FDA approval
+Added: before being implemented.
+Added: FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting
+Added: requirements upon the sponsor and any third-party manufacturers that the sponsor may use.
+Added: Accordingly, manufacturers must continue to
+Added: expend time, money, and effort in the area of production and quality control to maintain compliance with cGMP, data integrity, pharmacovigilance,
+Added: and other aspects of regulatory compliance.
+Added: may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product
+Added: reaches the market.
+Added: Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity
+Added: or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved
+Added: labeling to add new safety information;
+Added: imposition of post-approval studies to assess new safety risks;
+Added: or imposition of distribution
+Added: or other restrictions under a REMS.
+Added: Other potential consequences include, for example:
+Added: on the marketing or manufacturing of a product, complete withdrawal of the product from the market, or product recalls;
+Added: warning or untitled letters, or holds on post-approval clinical studies;
+Added: of FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;
+Added: seizure or detention, or refusal of FDA to permit the import or export of products;
+Added: injunctions and consent decrees, including the imposition of civil or criminal penalties.
+Added: strictly regulates the marketing, labeling, advertising, and promotion of prescription drug products placed on the market.
+Added: can make only those claims relating to safety and efficacy, purity and potency that are approved by FDA and in accordance with the provisions
+Added: of the approved labeling.
+Added: FDA’s regulation includes, among other things, standards and regulations for direct-to-consumer advertising,
+Added: communications regarding unapproved uses, industry-sponsored scientific and educational activities and promotional activities involving
+Added: the Internet and social media.
+Added: Promotional claims relating to a product’s safety or effectiveness are prohibited before the drug
+Added: After approval, a product generally may not be promoted for uses that are not approved by FDA, as reflected in the product’s
+Added: prescribing information.
+Added: In the United States, healthcare professionals are generally permitted to prescribe drugs for such uses not
+Added: described in the drug’s labeling, known as off-label uses, because FDA does not regulate the practice of medicine.
+Added: regulations impose rigorous restrictions on manufacturers’ communications and prohibit the promotion of off-label uses.
+Added: be permissible, under very specific, narrow conditions, for a manufacturer to engage in non-promotional, non-misleading communication
+Added: regarding off-label information, such as distributing scientific or medical journal information.
+Added: a company is found to have promoted off-label uses, it may become subject to adverse public relations and administrative and judicial
+Added: enforcement by FDA, the DOJ, or the Office of the Inspector General of the Department of Health and Human Services (“HHS”),
+Added: as well as other federal and state authorities.
+Added: This could subject a company to a range of penalties that could have a significant commercial
+Added: impact, including civil, administrative, and criminal fines, penalties, and agreements that materially restrict the manner in which a
+Added: company promotes or distributes products.
+Added: The federal government has levied large civil, administrative, and criminal fines and penalties
+Added: against companies for alleged improper promotion, and has also requested that companies enter into Corporate
+Added: Integrity Agreements and Consent Decrees of Permanent Injunction under which specified promotional conduct is changed or curtailed.
+Added: distribution of prescription drugs and biologics are subject to the Drug Supply Chain Security Act (“DSCSA”), which requires
+Added: manufacturers and other stakeholders to comply with product identification, tracing, verification, detection and response, notification,
+Added: and licensing requirements.
+Added: In addition, the Prescription Drug Marketing Act and its implementing regulations and state laws limit the
+Added: distribution of prescription pharmaceutical product samples, and the DSCSA imposes requirements to ensure accountability in distribution
+Added: and to identify and remove prescription drug and biological products that may be counterfeit, stolen, contaminated, or otherwise harmful
+Added: from the market.
+Added: Development and Review Programs
+Added: offers a number of expedited development and review programs for qualifying product candidates.
+Added: The fast-track program is intended to
+Added: expedite or facilitate the process for reviewing new products that meet certain criteria.
+Added: Specifically, new products are eligible for
+Added: fast-track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential
+Added: to address unmet medical needs for the disease or condition.
+Added: A product intended to treat a serious or life-threatening disease or condition
+Added: may also be eligible for breakthrough therapy designation to expedite its development and review.
+Added: Any marketing application for a biologic
+Added: submitted to FDA for approval, including a product with a fast-track designation and/or breakthrough therapy designation, may be eligible
+Added: for other types of FDA programs intended to expedite FDA review and approval process, such as priority review and accelerated approval.
+Added: FDA also may grant accelerated approval to certain products studied for their safety and effectiveness in treating serious or life-threatening
+Added: diseases or conditions.
+Added: RMAT designation, which we are currently planning to seek for some of our therapies, is intended to facilitate an efficient development
+Added: program for, and expedite review of, any drug that meets the following criteria:
+Added: (1) the drug is a cell therapy, therapeutic tissue engineering
+Added: product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions;
+Added: drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition;
+Added: and (3) preliminary clinical
+Added: evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition.
+Added: Like breakthrough
+Added: therapy designation, RMAT designation provides potential benefits that include more frequent meetings with FDA to discuss the development
+Added: plan for the product candidate and eligibility for rolling review and priority review.
+Added: Products granted RMAT designation may also be
+Added: eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical
+Added: benefit, or reliance upon data obtained from a meaningful number of sites (including through expansion to additional sites) so as to
+Added: remove any likelihood of site-specific or investigator-specific bias on the evidence of effectiveness.
+Added: Once approved, when appropriate,
+Added: FDA can permit fulfillment of post-approval requirements for RMATs receiving accelerated approval through the submission of clinical
+Added: evidence, clinical studies, patient registries, or other sources of real-world evidence such as electronic health records;
+Added: collection of larger confirmatory datasets;
+Added: or through post-approval monitoring of all patients treated with the therapy prior to approval.
+Added: track designation, breakthrough therapy designation, priority review, accelerated approval, and RMAT designation do not change the standards
+Added: for approval but may expedite the development or approval process.
+Added: Term Restoration and Marketing Exclusivity
+Added: approval, owners of relevant drug or biological product patents may apply for up to a five year term patent extension to restore a portion
+Added: of patent term lost during product development and FDA review of a BLA if approval of the application is the first permitted commercial
+Added: marketing or use of a drug or biologic containing the active ingredient under the Drug Price Competition and Patent Term Restoration
+Added: Act of 1984, referred to as the Hatch-Waxman Act.
+Added: The allowable patent term extension is
+Added: calculated as one-half of the product’s testing phase, which is the time between the effective date of an IND and initial BLA submission,
+Added: and all of the approval phase, which is the time between BLA submission and approval, up to a maximum of five years.
+Added: The time can be
+Added: shortened if FDA determines that the applicant did not pursue approval with due diligence.
+Added: The total patent term after the extension
+Added: may not exceed 14 years from the date of FDA approval of the product.
+Added: Only one patent claiming each approved product is eligible for
+Added: restoration and the patent holder must apply for restoration within 60 days of approval, even if the product cannot be commercially marketed
+Added: at that time.
+Added: The USPTO, in consultation with FDA, reviews and approves the application for patent term restoration.
+Added: patents that might expire during the BLA application phase, the patent owner may request an interim patent extension.
+Added: An interim patent
+Added: extension increases the patent term by one year and may be renewed up to four times.
+Added: For each interim patent extension granted, the post-approval
+Added: patent extension is reduced by one year.
+Added: The director of the USPTO must determine that approval of the product candidate covered by the
+Added: patent for which a patent extension is being sought is likely.
+Added: Interim patent extensions are not available for a product candidate for
+Added: which a BLA has not been submitted.
+Added: and Marketing Exclusivities
+Added: Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval
+Added: pathway for biological product candidates shown to be highly similar to or interchangeable with an FDA licensed biological product.
+Added: biological product on which another biological product candidate’s BLA relies to establish biosimilarity is known as a reference
+Added: Biosimilarity sufficient to reference a prior FDA-approved product requires that there be no differences in conditions of use,
+Added: route of administration, dosage form and strength, and no clinically meaningful differences between the biological product candidate
+Added: and the reference product in terms of safety, purity, and potency.
+Added: Biosimilarity must be shown through analytical trials, animal trials
+Added: and at least one clinical trial, unless the Secretary of HHS waives a required element.
+Added: A biosimilar product candidate may be deemed
+Added: interchangeable with a prior approved product if it meets the higher hurdle of demonstrating that it can be expected to produce the same
+Added: clinical results as the reference product and, for products administered multiple times, the biological product candidate and the reference
+Added: biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative
+Added: to exclusive use of the reference biologic.
+Added: Complexities associated with the larger, and often more complex, structures of biologics,
+Added: as well as the process by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval
+Added: pathway that are still being resolved by FDA.
+Added: reference biologic is granted 12 years of exclusivity from the time of first licensure of the reference product, and no application for
+Added: a biosimilar can be submitted for four years from the date of licensure of the reference product.
+Added: The first biological product candidate
+Added: submitted under the abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity
+Added: against a finding of interchangeability for other biologics for the same condition of use for the lesser of (i) one year after first
+Added: commercial marketing of the first interchangeable biosimilar, (ii) 18 months after the first interchangeable biosimilar is approved if
+Added: there is no patent challenge, (iii) 18 months after resolution of a lawsuit over the patents of the reference biologic in favor of the
+Added: first interchangeable biosimilar applicant, or (iv) 42 months after the first interchangeable biosimilar’s application has been
+Added: approved if a patent lawsuit is ongoing within the 42 month period.
+Added: At this time, it is unclear whether products deemed “interchangeable”
+Added: by FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy laws and regulations.
+Added: Pricing, and Reimbursement
+Added: ability to successfully commercialize any products for which we receive regulatory approval for commercial sale will depend, in part,
+Added: on the extent to which third-party payors provide coverage and establish adequate reimbursement levels for such products, and significant
+Added: uncertainty exists as to the coverage and reimbursement status of any products for which may we obtain regulatory approval.
+Added: In the United
+Added: States, third-party payors include federal and state health care programs, private managed care providers, health insurers and other
+Added: organizations.
+Added: The process for determining whether a third-party payor will provide coverage for a product may be separate from the process
+Added: for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the product.
+Added: payors may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the FDA-approved
+Added: products for a particular indication.
+Added: Third-party payors are increasingly challenging the price, examining the medical necessity, and
+Added: reviewing the cost-effectiveness of medical products, therapies, and services, in addition to questioning their safety and efficacy.
+Added: We may need to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our
+Added: products, in addition to the costs required to obtain FDA approvals.
+Added: Our product candidates may not be considered medically necessary
+Added: or cost-effective.
+Added: A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will
+Added: Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide
+Added: coverage for the product.
+Added: Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to
+Added: realize an appropriate return on our investment in product development.
+Added: marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if the government and
+Added: third-party payors fail to provide adequate coverage and reimbursement.
+Added: In addition, emphasis on managed care in the United States has
+Added: increased and we expect will continue to increase the pressure on healthcare pricing.
+Added: Coverage policies and third-party reimbursement
+Added: rates may change at any time.
+Added: Even if favorable coverage and reimbursement status is attained for one or more products for which we receive
+Added: regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
+Added: Healthcare Laws and Compliance Requirements
+Added: we currently do not have any commercialized products, our current and future business operations may be subject to additional healthcare
+Added: regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our
+Added: Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security,
+Added: price reporting and physician sunshine laws.
+Added: Some of our pre-commercial activities are subject to some of these laws.
+Added: federal Anti-Kickback Statute makes it illegal for any person or entity, including
+Added: a prescription drug manufacturer or a party acting on its behalf to knowingly and willfully, directly or indirectly, solicit, receive,
+Added: offer, or pay any remuneration in cash or in kind that is intended to induce or reward the referral of business, including the purchase,
+Added: order, or lease of any item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.
+Added: The term “remuneration” has been broadly interpreted to include anything of value.
+Added: The Anti-Kickback
+Added: Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary
+Added: managers and beneficiaries on the other.
+Added: there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions
+Added: and safe harbors are drawn narrowly.
+Added: Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases
+Added: or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.
+Added: Failure to meet all of the requirements
+Added: of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback
+Added: Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts
+Added: and circumstances.
+Added: Several courts have found that the Anti-Kickback Statute may be
+Added: violated if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare program business.
+Added: addition, liability may be established without actual knowledge of the statute or specific intent to violate it.
+Added: Violations of this law
+Added: are punishable by up to ten years in prison, and can also result in criminal fines, civil money penalties and exclusion from participation
+Added: in federal healthcare programs.
+Added: a claim including items or services resulting from a violation of the federal Anti-Kickback
+Added: Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
+Added: federal civil False Claims Act prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented,
+Added: a false or fraudulent claim for payment of government funds or knowingly making, using, or causing to be made or used, a false record
+Added: or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing,
+Added: or concealing an obligation to pay money to the federal government.
+Added: Persons and entities can be held liable under these laws if they
+Added: are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding
+Added: information to customers or promoting a product off-label.
+Added: Many pharmaceutical and other healthcare companies have been investigated
+Added: and have reached substantial financial settlements with the federal government under the civil False Claims Act for a variety of alleged
+Added: improper marketing activities, including:
+Added: providing free product to customers with the expectation that the customers would bill federal
+Added: programs for the product;
+Added: providing sham consulting fees, grants, free travel and other benefits to physicians to induce them to prescribe
+Added: the company’s products;
+Added: and inflating prices reported to private price publication services, which are used to set drug payment
+Added: rates under government healthcare programs.
+Added: Penalties for federal civil False Claims Act violations may include up to three times the
+Added: actual damages sustained by the government, plus mandatory civil penalties of between $13,508 and $27,018 for each separate false claim,
+Added: and the potential for exclusion from participation in federal healthcare programs.
+Added: In addition, although the federal False Claims Act
+Added: is a civil statute, False Claims Act violations may also implicate various federal criminal statutes.
+Added: healthcare fraud provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) prohibit knowingly and willfully
+Added: executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third- party payors, knowingly
+Added: and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare
+Added: offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious
+Added: or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
+Added: Like the federal Anti-Kickback
+Added: Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed
+Added: states have analogous laws and regulations, such as:
+Added: state anti-kickback and false claims laws that may apply to sales or marketing arrangements
+Added: and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;
+Added: that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant
+Added: compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to certain healthcare providers;
+Added: laws that require drug manufacturers to report information related to clinical trials or information related to payments and other transfers
+Added: of value to physicians and other healthcare providers or marketing expenditures;
+Added: laws that restrict the ability of manufacturers to offer
+Added: co-pay support to patients for certain prescription drugs;
+Added: and laws and local ordinances that require identification or licensing of
+Added: sales representatives.
+Added: as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations,
+Added: mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common healthcare transactions,
+Added: as well as standards relating to the privacy and security of individually identifiable health information, which require the adoption
+Added: of administrative, physical and technical safeguards to protect such information.
+Added: Among other things, HITECH makes HIPAA’s security
+Added: standards directly applicable to business associates, defined as independent contractors or agents of covered entities that create, receive,
+Added: or obtain protected health information in connection with providing a service for or on behalf of a covered entity.
+Added: HITECH also increased
+Added: the civil and criminal penalties that may be imposed against covered entities and business associates, and gave state attorneys general
+Added: new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s
+Added: fees and costs associated with pursuing federal civil actions.
+Added: In addition, certain state laws govern the privacy and security of health
+Added: information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant
+Added: ways and may not have the same effect, thus complicating compliance efforts.
+Added: Failure to comply with these laws, where applicable, can
+Added: result in the imposition of significant civil and/or criminal penalties.
+Added: federal Physician Payment Sunshine Act, implemented as the Open
+Added: Payments Program, requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare,
+Added: Medicaid or the Children’s Health Insurance Program (with certain exceptions)
+Added: to report annually to CMS information related to direct or indirect payments and other transfers of value to physicians and teaching
+Added: hospitals (and certain other practitioners as of 2022), as well as ownership and investment interests held in the company by physicians
+Added: and their immediate family members.
+Added: we intend to commercialize products that could be reimbursed under a federal health care program and other governmental healthcare programs,
+Added: we intend to develop a comprehensive compliance program that establishes internal control to facilitate adherence to the rules and program
+Added: requirements to which we will or may become subject.
+Added: Although the development and implementation of compliance programs designed to establish
+Added: internal control and facilitate compliance can mitigate the risk of investigation, prosecution, and penalties assessed for violations
+Added: of these laws, the risks cannot be entirely eliminated.
+Added: our operations are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject
+Added: to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, contractual
+Added: damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring of our operations, exclusion from
+Added: participation in federal and state healthcare programs and individual imprisonment, any of which could adversely affect our ability to
+Added: operate our business and our financial results.
+Added: the United States and some foreign jurisdictions, there have been, and continue to be, legislative and regulatory changes and proposed
+Added: changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval
+Added: activities, and affect the ability to profitably sell product candidates for which marketing approval is obtained.
+Added: Among policy makers
+Added: and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated
+Added: goals of containing healthcare costs, improving quality and/or expanding access.
+Added: In the United States, the pharmaceutical industry has
+Added: been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
+Added: example, the Affordable Care Act (“ACA”)
+Added: substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S.
+Added: pharmaceutical industry.
+Added: The ACA contains provisions that may reduce the profitability of drug products through increased rebates for
+Added: drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain
+Added: Medicare Part D beneficiaries, and annual fees based on
+Added: pharmaceutical companies’ share of sales to federal health care programs.
+Added: The ACA made several changes to the Medicaid
+Added: Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid
+Added: The ACA also expanded the universe of Medicaid utilization subject to drug rebates by requiring pharmaceutical manufacturers
+Added: to pay rebates on Medicaid managed care utilization and by enlarging the population potentially eligible for Medicaid drug benefits.
+Added: have been judicial challenges to certain aspects of the ACA, as well as efforts by Congress to modify, and by agencies to alter the implementation
+Added: of, certain aspects of the ACA.
+Added: For example, Congress eliminated the tax penalty for failure to comply with the ACA’s individual
+Added: mandate to carry health insurance.
+Added: Further, the Bipartisan Budget Act of 2018, among other things, amended the ACA to increase from 50
+Added: percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare
+Added: Part D to close the coverage gap in most Medicare drug plans, commonly referred to as the donut
+Added: hole (this existing coverage gap program will be sunset by the Inflation Reduction Act beginning in 2025 and replaced with a new manufacturer
+Added: discount program).
+Added: is possible that the ACA, as currently enacted or as may be amended in the future, as well as other healthcare reform measures, including
+Added: those that may be adopted in the future, may result in more rigorous coverage criteria, and less favorable payment methodologies, or
+Added: other downward pressure on coverage and payment and the price that we receive for any approved product.
+Added: Any reduction in reimbursement
+Added: or restriction on coverage under Medicare or other federal health care programs may result in a similar reduction or restriction by private
+Added: legislative changes have been proposed and adopted in the U.S.
+Added: since the ACA was enacted.
+Added: For example, the Inflation Reduction Act introduces
+Added: several changes to the Medicare Part D benefit, including
+Added: a limit on annual out-of-pocket costs and a change in manufacturer liability under the program which could negatively affect the profitability
+Added: of our product candidates.
+Added: The IRA sunsets the current Part D coverage gap discount program starting
+Added: in 2025 and replaces it with a new manufacturer discount program.
+Added: Failure to pay a discount under this new program will be subject to
+Added: a civil monetary penalty.
+Added: In addition, the IRA establishes a Medicare Part
+Added: B inflation rebate scheme effective January 2023 and a Medicare Part
+Added: D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the price of a Part
+Added: B or Part D drug increases faster than the pace of inflation.
+Added: Failure to timely pay a Part
+Added: B or D inflation rebate is subject to a civil monetary penalty.
+Added: The IRA also creates a drug price negotiation
+Added: program under which the prices for Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar
+Added: competition will be capped by reference to, among other things, a specified non-federal average manufacturer price starting in 2026.
+Added: Failure to comply with requirements under the drug price negotiation program is subject to an excise tax and/or a civil monetary penalty.
+Added: Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs with respect to
+Added: the government health benefit programs and otherwise.
+Added: The IRA or other legislative changes could impact the market conditions for our
+Added: product candidates.
+Added: general, there has been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their commercial
+Added: products, which has resulted in several Congressional inquiries and proposed and enacted
+Added: federal and state legislation designed to, among other things, bring more transparency to drug product pricing, review the relationship
+Added: between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
+Added: state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological
+Added: product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing
+Added: cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
+Added: may also be subject to federal, state, national and international laws and regulations governing the privacy and security of health-related
+Added: and other personal data we collect and maintain (e.g., Section 5 of the Federal Trade Commission Act, the California
+Added: Privacy Rights Act, and the EU’s General Data Protection Regulation (the “GDPR”)).
+Added: The GDPR, for example, imposes restrictions
+Added: on the processing (e.g., collection, use, or disclosure) of personal data in the EU and also imposes strict restrictions on the transfer
+Added: of personal data out of the EU to the United States.
+Added: These laws and regulations are evolving and subject to interpretation and may impose
+Added: limitations on our activities or otherwise adversely affect our business.
+Added: In addition, state laws govern the privacy and security of
+Added: health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect,
+Added: thus complicating compliance efforts.
+Added: we or our third party partners fail to comply or are alleged to have failed to comply with these or other applicable data protection
+Added: and privacy laws and regulations, or if we were to experience a data breach involving personal data, we could be subject to government
+Added: enforcement actions or private lawsuits.
+Added: Any associated claims, inquiries, or investigations or other government actions could lead to
+Added: unfavorable outcomes that have a material impact on our business including through significant penalties or fines, monetary judgments
+Added: or settlements including criminal and civil liability for us and our officers and directors, increased compliance costs, delays or impediments
+Added: in the development of new products, negative publicity, increased operating costs, diversion of management time and attention, or other
+Added: remedies that harm our business, including orders that we modify or cease existing business practices.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.