−Removed: are a recently organized blank check company incorporated on October 19, 2021 as a Delaware corporation formed for the purpose of effecting
−Removed: a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or other similar business combination with one or
−Removed: more businesses, which we refer to throughout this report as our initial business combination.
−Removed: Public Offering
−Removed: February 7, 2022, we consummated our initial public offering of an aggregate of 13,225,000 units, including full exercise of the underwriters’
−Removed: over-allotment option, at $10.00 per unit.
−Removed: The gross proceeds of the offering were $132.25 million.
−Removed: Simultaneously with the consummation
−Removed: of the initial public offering, we consummated the private placement of 754,000 units to the sponsor, which amount included 69,000 private
−Removed: placement units purchased by the sponsor in connection with the underwriters’ exercise of their overallotment option in full, at
−Removed: a price of $10.00 per private placement unit, generating gross proceeds of approximately $7.54 million.
−Removed: the closing of the Initial Public Offering on February 7, 2022, an amount of $139,790,000 from the net proceeds of the sale of the Units
−Removed: in the Initial Public Offering and the Private Placement was placed in the Trust Account.
−Removed: This resulted in an overfunding of the Trust
−Removed: Account of $4,895,000.
−Removed: As such, subsequent to the initial funding of the Trust Account, $2,000,000 was transferred to the Company’s
−Removed: operating cash account and $2,895,000 was used to pay offering costs.
−Removed: Except with respect to interest earned on the funds held in the
−Removed: Trust Account that may be released to us to pay our taxes (less up to $100,000 interest to pay dissolution expenses), the funds held
−Removed: in the Trust Account will not be released from the Trust Account until the earliest of (a) the completion of our initial business combination,
−Removed: (b) the redemption of any public shares properly submitted in connection with a stockholder vote to amend our certificate of incorporation
−Removed: (A) to modify the substance or timing of our obligation to allow redemption in connection with our initial business combination or certain
−Removed: amendments to our charter prior thereto or to redeem 100% of our public shares if we do not complete our initial business combination
−Removed: within 12 months from the consummation of our initial public offering or up to February 7, 2024 if we extend the period of time to consummate
−Removed: a business combination, at our election by separate one month extensions, subject to satisfaction of certain conditions, including the
−Removed: deposit of approximately $77,000 for each one month extension, into the Trust Account or (ii) with respect to any other provision relating
−Removed: to stockholders’ rights or pre-initial business combination activity, and (c) the redemption of our public shares if we are unable
−Removed: to complete our initial business combination within 12 months from the consummation of our initial public offering or up to February
−Removed: 7, 2024 if we extend the period of time to consummate a business combination, at our election by separate one month extensions, subject
−Removed: to satisfaction of certain conditions, including the deposit of approximately $77,000 for each one month extension, into the Trust Account,
−Removed: subject to applicable law.
−Removed: Agreement with Conduit Pharmaceuticals Limited
−Removed: following description of the Merger Agreement and related agreements does not purport to describe all of the terms thereof and is qualified
−Removed: in its entirety by reference to the complete text of the Merger Agreement and related agreements.
−Removed: Our stockholders and other interested
−Removed: parties are urged to read such agreements in their entirety.
−Removed: November 8, 2022, we entered into an agreement and plan of merger (together with an amendment entered into on January 27, 2023, the “Merger
−Removed: Agreement”) with Conduit Pharmaceuticals Limited, a Cayman Islands exempted company (“Conduit”) and Conduit Merger
−Removed: Sub, Inc., a Cayman Islands exempted company and our wholly owned subsidiary.
−Removed: If the Merger Agreement is approved by our stockholders
−Removed: and the transactions under the Merger Agreement are consummated, Merger Sub will merge with and into Conduit, with Conduit surviving
−Removed: the merger as our wholly owned subsidiary (the “Merger”).
−Removed: Upon the closing of the Merger, it is anticipated that we will
−Removed: change our name to “Conduit Pharmaceuticals Inc.” Our board of directors has (i) approved and declared advisable the Merger
−Removed: Agreement, the related ancillary agreements thereto and the transactions contemplated thereby and (ii) resolved to recommend approval
−Removed: of the Merger Agreement and related transactions by our stockholders.
−Removed: to the Merger Agreement, the outstanding ordinary shares (including the shares issued upon conversion of all outstanding convertible
−Removed: debt, which conversion shall have occurred prior to the consummation of the Merger Agreement) of Conduit will be converted into an aggregate
−Removed: of 65,000,000 shares of our newly issued common stock, with each such outstanding Conduit ordinary share (including the ordinary shares
−Removed: issued upon conversion of all outstanding convertible debt, which conversion shall have occurred prior to the consummation of the Merger
−Removed: Agreement) converted into newly issued shares of our common stock on a pro rata basis.
−Removed: connection with the transactions contemplated by the Merger Agreement, we entered into a subscription agreement (the “Subscription
−Removed: Agreement”) with an investor.
−Removed: Pursuant to the Subscription Agreement, the investor has agreed to purchase $27 million (the “Private
−Removed: Placement”) units of our securities, with each unit consisting of (i) one share of common stock and (ii) one warrant to purchase
−Removed: one share of common stock, for a purchase price of $10.00 per unit.
−Removed: The Subscription Agreement contains registration rights, pursuant
−Removed: to which within 15 business days after the closing, we will use reasonable best efforts to file with the U.S.
−Removed: Securities and Exchange
−Removed: Commission (the “SEC”) a registration statement registering the resale of the shares of common stock included in the units
−Removed: and issued and issuable upon exercise of the warrants.
−Removed: The closing of the Private Placement is conditioned on, among other things, the
−Removed: closing of the Conduit Business Combination.
−Removed: 2023 Extension
−Removed: we were required to complete our initial business combination transaction by 12 months from the consummation of our initial public
−Removed: offering or up to 18 months if we extended the period of time to consummate a business combination in accordance with our
−Removed: Certificate of Incorporation (“Business Combination Period”).
−Removed: On January 26, 2023, at a special meeting of our stockholders, our stockholders approved a proposal
−Removed: to amend our certificate of incorporation to allow us to extend, at our election, the date by which we have to consummate a business
−Removed: combination up to 12 times, each such extension for an additional one month period, from February 7, 2023, to February 7, 2024.
−Removed: stockholders also approved a related proposal to amend the trust agreement allowing us to deposit into the Trust Account, for each
−Removed: one-month extension, one-third of 1% of the funds remaining in the Trust Account following the redemptions made in connection with
−Removed: the approval of the extension proposal at the special meeting.
−Removed: At the special meeting our stockholders also approved a proposal to
−Removed: amend our certificate of incorporation to expand the methods that we may employ to not become subject to the “penny
−Removed: stock” rules of the SEC.
−Removed: connection with such proposals, our public stockholders had the right to redeem their shares for cash equal to their pro rata share of
−Removed: the aggregate amount on deposit in the Trust Account as of two days prior to such stockholder vote.
−Removed: Our public stockholders holding 11,037,272
−Removed: shares of Class A common stock (out of a total of 13,979,000 shares of Class A common stock) exercised their right to redeem such shares
−Removed: at a redemption price of approximately $10.33 per share.
−Removed: Approximately $114 million in cash was removed from the Trust Account to pay
−Removed: such stockholders and, accordingly, after giving effect to such redemptions, the balance in the Trust Account was approximately $23 million.
−Removed: a result of the approval of such proposals, we agreed to deposit into the trust account one-third of 1% of the funds then on deposit
−Removed: in the trust account for each month of the extension period, resulting in a monthly contribution of approximately $0.035 per share that
−Removed: was not redeemed in connection with the Special Meeting (approximately $77,000 in the aggregate per month), or an aggregate of $924,000
−Removed: (the “Maximum Contribution”) if the date we have to consummate a business combination is extended 12 times, each assuming
−Removed: no interest is earned on the funds in the trust account.
−Removed: Thesis and Strategy
−Removed: date, our efforts have been limited to organizational activities, as well as activities related to our initial public offering and investigating
−Removed: potential business combinations.
−Removed: As of the date of this report, we anticipate that we will consummate the Merger Agreement.
−Removed: have entered into the Merger Agreement with Conduit, in the event we are unable to consummate the Conduit Business Combination, we will
−Removed: continue to pursue another business combination.
−Removed: While we may pursue an initial business combination target in any stage of our corporate
−Removed: evolution or in any industry or sector, we intend to focus our search on identifying businesses in the real estate industry, including
−Removed: construction, homebuilding, real estate owners and operators, arrangers of financing, insurance, and other services for real estate,
−Removed: and adjacent businesses and technologies targeting the real estate space, which we may refer to as “Proptech” businesses.
−Removed: We define Proptech businesses broadly as those applying innovative digital technologies and technology-enhanced services and solutions
−Removed: to the identification, design, development, construction, operation, underwriting, acquisition, leasing, financing, management and disposition
−Removed: of real estate properties.
−Removed: Leveraging our sponsor’s management team and directors’ deep and global real estate expertise
−Removed: and extensive network of relationships, we intend to identify innovative companies that have the potential to disrupt different aspects
−Removed: of the real estate industry or related industries and to transform how stakeholders relate to real estate in the future.
−Removed: These stakeholders
−Removed: include brokers, investors, lenders, operators, municipalities, service providers, owners, residents and tenants.
−Removed: Our sponsor and management
−Removed: team have a proven track record in identifying opportunities in the real estate industry that have generated attractive risk-adjusted
−Removed: business strategy is to identify and complete our initial business combination with a company that complements the experience of our
−Removed: management team and that can benefit from their and our sponsor’s operational expertise.
−Removed: Our selection process will leverage our
−Removed: management teams’ broad and deep relationship network, unique industry experiences and proven deal sourcing capabilities to access
−Removed: a broad spectrum of differentiated opportunities.
−Removed: The businesses we seek to acquire offer innovative software, hardware, products, operations
−Removed: or services that are technologically equipped to improve property ownership;
−Removed: property financing;
−Removed: property transactions;
−Removed: property valuation;
−Removed: property operations;
−Removed: property management;
−Removed: property insurance;
−Removed: real estate asset management and investment management;
−Removed: construction and development.
−Removed: Our management team will seek to leverage their access to proprietary deal flow, sourcing capabilities
−Removed: and network of industry contacts to generate business combination opportunities.
−Removed: with this strategy, we have identified the following general criteria and guidelines that we believe are important in evaluating prospective
−Removed: We will use these criteria and guidelines in evaluating acquisition opportunities, but we may decide to enter into our initial
−Removed: business combination with a target business that does not meet these criteria and guidelines.
−Removed: We will seek to focus our search on identifying transformative, technology-driven businesses targeting the real estate
−Removed: sector that can benefit from the leading brand, operational expertise and global network of our sponsor and management team in the
−Removed: real estate industry.
−Removed: Our management team has developed significant experience at Presidio Property Trust, Inc.
−Removed: in evaluating transaction
−Removed: candidates across many stages of the real estate investment and business life cycles, and we will seek to capitalize on that multifaceted
−Removed: expertise in sourcing and assessing potential business combination targets.
−Removed: We intend to focus our efforts on identifying one or more later-stage businesses that we believe have significant potential
−Removed: for attractive risk-adjusted returns for shareholders, weighing potential growth opportunities and operational improvements in the
−Removed: target business against any identified downside risks.
−Removed: We will seek to acquire one or more businesses that have the potential for significant revenue and earnings growth
−Removed: through a combination of organic growth, potential to leverage competitive advantages and innovation through our expertise and scale
−Removed: as a vertically integrated real estate platform.
−Removed: From Presidio Property, Inc.’s Proven Platform.
−Removed: We intend to acquire one or more businesses that we believe will benefit
−Removed: from Presidio Property, Inc.’s differentiated industry network, brand and proprietary value-creation capabilities in order
−Removed: to improve financial performance and business planning.
−Removed: We will seek to acquire one or more businesses that demonstrate advantages when compared to their competitors, including
−Removed: the potential to disrupt the market through technology driven transformation, defensible proprietary technology, strong adoption
−Removed: rates, and low or manageable risks of technological obsolescence.
−Removed: We will seek to invest in one or more businesses that have proven management teams with a compelling strategy of selling
−Removed: their product and recruiting talent.
−Removed: from Being a Public Company.
−Removed: We intend to invest in one or more businesses that will benefit from being publicly listed and can
−Removed: effectively utilize the broader access to capital and the public profile to grow and accelerate shareholder value creation.
−Removed: criteria are not intended to be exhaustive.
−Removed: Any evaluation relating to the merits of a particular initial business combination may be
−Removed: based, to the extent relevant, on these general guidelines as well as other considerations, factors and criteria that our management
−Removed: 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
−Removed: the above criteria and guidelines, we will disclose that the target business does not meet the above criteria in our shareholder communications
−Removed: related to our initial business combination, which would be in the form of tender offer documents or proxy solicitation materials that
−Removed: we would file with the SEC.
−Removed: the event the Conduit Business Combination is not consummated, we intend to capitalize on the following competitive advantages in our
−Removed: pursuit of a target company or companies:
−Removed: of an Experienced Management Team .
−Removed: believe our management team will provide us with a significant pipeline of opportunities from which to evaluate potential business
−Removed: combinations.
−Removed: Our management team provides a combination of a proprietary sourcing network and deep industry, mergers and acquisition,
−Removed: and capital markets expertise.
−Removed: management team is led by our Chief Executive Officer (“CEO”) Jack K.
−Removed: Heilbron, who has over 40 years of experience in real
−Removed: estate due diligence, mergers and acquisitions, and real estate management.
−Removed: He has previously served as a director of an investment company
−Removed: registered under the Investment Company Act of 1940.
−Removed: We believe that his business acumen and experience, which demonstrate his ability
−Removed: to identify opportunities and enhance value, will help facilitate our business acquisition strategy.
−Removed: Chief Financial Officer (“CFO”), Adam Sragovicz, has over 25 years of experience in treasury and investment analysis, equity
−Removed: and debt management, strategic risk and reward analysis as well as portfolio management.
−Removed: We believe that Mr.
−Removed: Sragovicz brings a unique
−Removed: background to oversee the Company’s accounting and financial reporting matters through a wealth of experience in SEC reporting,
−Removed: finance, accounting, and building and integrating internal control structures in high growth environments which will provide accurate
−Removed: and reliable financial and operations reporting and internal control structures for successfully acquired domestic and international
−Removed: acquisition targets.
−Removed: Bentzen, our Chief Accounting Officer (“CAO”), brings over 18 years of professional experience in accounting and finance
−Removed: for both public and private companies, including seven years of experience in SEC reporting, control processing experience at publicly
−Removed: traded companies].
−Removed: We believe that Mr.
−Removed: Bentzen’s expertise in financial reporting will prove invaluable in evaluating acquisition
−Removed: targets and ensuring a smooth business combination process.
−Removed: to established and proven solution .
−Removed: We believe the business relationships with our sponsor’s corporate parent, Presidio
−Removed: Property Trust, Inc., will provide significant value enhancement to acquisition targets from both daily human capital management
−Removed: and cost efficiency perspectives.
−Removed: Deal Sourcing Network .
−Removed: We believe the strong track record of our management team will provide access to quality initial business
−Removed: combination partners.
−Removed: In addition, through our management team, we believe we have contacts and sources from which to generate acquisition
−Removed: opportunities and possibly seek complementary follow-on business arrangements.
−Removed: These contacts and sources include those in private
−Removed: and public companies, private equity and venture capital funds, investment bankers, attorneys and accountants.
−Removed: as a Publicly Listed Acquisition Company .
−Removed: We believe our structure will make us an attractive business combination partner
−Removed: to prospective target businesses.
−Removed: As a publicly listed company, we will offer a target business an alternative to the traditional
−Removed: initial public offering process.
−Removed: We believe that some target businesses will favor this alternative, which we believe is less expensive,
−Removed: while offering greater certainty of execution, than the traditional initial public offering process.
−Removed: During an initial public offering,
−Removed: there are typically underwriting fees and marketing expenses, which would be costlier than a business combination with us.
−Removed: once a proposed business combination is approved by our stockholders (if applicable) and the transaction is consummated, the target
−Removed: business will have effectively become public, whereas an initial public offering is always subject to the underwriter’s ability
−Removed: to complete the offering, as well as general market conditions that could prevent the offering from occurring.
−Removed: Once public, we believe
−Removed: our target business would have greater access to capital and additional means of creating management incentives that are better aligned
−Removed: with stockholders’ interests than it would as a private company.
−Removed: Brings Deal Flow and Extensive Understanding of Capital Markets and Public Market Investors.
−Removed: We will be supported by A.G.P.
−Removed: and its team of investment banking professionals, each of whom have meaningful transaction experience, including corporate finance,
−Removed: mergers and acquisitions, equity and debt capital markets, strategic consulting, and operations.
−Removed: has developed an extensive
−Removed: network of contacts and corporate relationships which we believe will provide us with an important source of initial business combination
−Removed: opportunities as well as assistance with potential future financing needs.
−Removed: is a leading advisor to public company boards of
−Removed: directors and executives, including technology companies, on matters of public markets capital raising, corporate strategy, and M&A.
−Removed: We believe that the significant knowhow of A.G.P.
−Removed: will allow us to effectively gauge target companies that possess a readiness for
−Removed: being public, as well as to support their executives in the process of going public.
−Removed: we may acquire a business or businesses in any industry, in the event the Conduit Business Combination is not consummated, our focus
−Removed: will be on companies in the real estate industry, including construction, homebuilding, real estate owners and operators, arrangers of
−Removed: financing, insurance, and other services for real estate, and adjacent businesses and technologies targeting the real estate space, which
−Removed: we may refer to as “Proptech” businesses.
−Removed: We believe that our target industry is attractive for a number of reasons, including
−Removed: the following:
−Removed: Addressable Market .
−Removed: Real estate investment represents a significant segment of the global economy.
−Removed: Global real estate was worth over
−Removed: $280 trillion (by asset value), larger than equity, debt, or gold (combined), and more than 3.5 times the total global gross domestic
−Removed: product in 2017, according to Savills Inc.
−Removed: According to Forbes, real estate contributed $3.5 trillion to the U.S.
−Removed: gross domestic product
−Removed: Within the real estate industry, Proptech businesses have a large addressable market targeting landlords, tenants, developers,
−Removed: operators, managers, brokers, investors, lenders, architects, engineers, and general contractors.
−Removed: We believe the acquisition of one or
−Removed: more Proptech businesses can serve as a platform for expansion, both organically and through further acquisitions.
−Removed: Technology Trends .
−Removed: Real estate has traditionally been a human capital and resource-intensive sector, but technology has become a
−Removed: strategic imperative as owners seek ways to increase the efficiency of their assets.
−Removed: We believe new technologies that create efficiencies
−Removed: in the value chain will reduce transaction costs and improve information flow.
−Removed: Innovation is being driven by increased rates of technology
−Removed: adoption, provided by both incumbent firms and disruptive new entrants that are building vertical solutions and new consumer-facing technologies
−Removed: for the real estate industry.
−Removed: Examples of innovative technology trends driving technological transformation in the real estate sector
−Removed: artificial intelligence and machine learning, data and analytics, cloud technologies, the Internet of Things, virtual and augmented
−Removed: reality, financial and mortgage technologies, 5G, automation and robotics, 3D printing, and modular construction.
−Removed: Digital transformation
−Removed: has also enabled new business models including iBuying, co-working, flexible warehousing, and crowdfunding.
−Removed: Market Growth .
−Removed: Over the last two decades, Proptech has evolved from tools and platforms that facilitated enhanced information transparency
−Removed: to more robust and innovative technologies that can drive meaningful operational efficiencies and safety enhancements.
−Removed: The total global
−Removed: investment in Proptech businesses has grown at a pace substantially above the rate of inflation in the recent past, with approximately
−Removed: $66 billion invested in Proptech since 2010, of which approximately $63 billion has been invested since 2015 and approximately $43 billion
−Removed: We expect this growth to continue over the years to come, given the increased rates of technology adoption we are seeing
−Removed: in the real estate industry.
−Removed: Universe of Potential Targets .
−Removed: We currently intend to focus our investment effort broadly across Proptech businesses, although we
−Removed: may pursue an acquisition opportunity in any industry or geographic region.
−Removed: We believe that our investment and operating expertise in
−Removed: the real estate industry and across multiple asset classes and geographies will offer us a large, addressable universe of potential targets.
−Removed: The diversity of the target universe and the number of largely uncorrelated sub-sectors maximizes the likelihood that our management
−Removed: team will identify and execute an attractive transaction.
−Removed: with our strategy, we have identified the following general criteria and guidelines that we believe are important in evaluating prospective
−Removed: target businesses.
−Removed: In the event that the Conduit Business Combination is not consummated, we will use these criteria and guidelines in
−Removed: evaluating acquisition opportunities, but we may decide to enter into our initial business combination with a target business that does
−Removed: not meet these criteria and guidelines.
−Removed: We intend to focus on companies that provide value-added services that we believe:
−Removed: market leadership positions in their respective products and services;
−Removed: an attractive risk profile, including revenues under long-term contracts and/or a strong backlog of business;
−Removed: attractive organic and inorganic growth opportunities which may be accelerated with our expertise and/or access to a public listing;
−Removed: benefit from an improved capital structure or streamlined ownership structure;
−Removed: benefit from a relationship with a public company;
−Removed: an attractive risk-adjusted return for our stockholders.
−Removed: intend to seek targets with an aggregate combined enterprise value of approximately $300 million to $1.2 billion, based upon widely accepted
−Removed: valuation standards and methodologies.
−Removed: We believe targeting companies in this “middle market” will provide the greatest number
−Removed: of opportunities for investment.
−Removed: criteria are not intended to be exhaustive.
−Removed: Any evaluation relating to the merits of a particular initial business combination may be
−Removed: based, to the extent relevant, on these general guidelines as well as other considerations, factors and criteria that from time to time
−Removed: our management may deem relevant.
−Removed: In evaluating a prospective target business, we expect to conduct a thorough due diligence review that
−Removed: will encompass, among other things, meetings with incumbent management and employees, document reviews and inspection of facilities,
−Removed: as applicable, as well as a review of financial and other information that will be made available to us.
−Removed: Business Combination
−Removed: rules require that we must complete one or more business combinations having an aggregate fair market value of at least 80% of the value
−Removed: of the assets held in the Trust Account at the time of our signing a definitive agreement in connection with our initial business combination.
−Removed: Our board of directors will make the determination as to the fair market value of our initial business combination.
−Removed: If our board of directors
−Removed: is not able to independently determine the fair market value of our initial business combination, or if we are considering an initial
−Removed: business combination with an entity that is affiliated with A.G.P., our sponsor, directors or officers, we will obtain an opinion from
−Removed: an independent investment banking firm or another independent entity that commonly renders valuation opinions with respect to the satisfaction
−Removed: of such criteria.
−Removed: While we consider it unlikely that our board of directors will not be able to make an independent determination of
−Removed: the fair market value of our initial business combination, it may be unable to do so if it is less familiar or experienced with the business
−Removed: of a particular target or if there is a significant amount of uncertainty as to the value of a target’s assets or prospects.
−Removed: Additionally,
−Removed: pursuant to Nasdaq rules, any initial business combination must be approved by a majority of our independent directors.
−Removed: are not prohibited from consummating an initial business combination with an entity that is affiliated with A.G.P., our sponsor, officers
−Removed: or directors, provided, however, that, pursuant to our certificate of incorporation, if we do, we, or a committee of our independent
−Removed: directors, must obtain an opinion from an independent investment banking firm or another independent entity that commonly renders valuation
−Removed: opinions that our initial business combination is fair to our company from a financial point of view.
−Removed: anticipate structuring our initial business combination so that the post-transaction company in which our public stockholders own shares
−Removed: will own or acquire 100% of the equity interests or assets of the target business or businesses.
−Removed: We may, however, structure our initial
−Removed: business combination such that the post-transaction company owns or acquires less than 100% of such interests or assets of the target
−Removed: business in order to meet certain objectives of the prior owners of the target business, the target management team or stockholders or
−Removed: for other reasons, but we will only complete such business combination if the post-transaction company owns or acquires 50% or more of
−Removed: the outstanding voting securities of the target or otherwise acquires a controlling interest in the target sufficient for it not to be
−Removed: required to register as an investment company under the Investment Company Act of 1940, as amended (the “Investment Company Act”).
−Removed: Even if the post-transaction company owns or acquires 50% or more of the voting securities of the target, our stockholders prior to the
−Removed: business combination may collectively own a minority interest in the post-transaction company, depending on valuations ascribed to the
−Removed: target and us in the business combination transaction.
−Removed: For example, we could pursue a transaction in which we issue a substantial number
−Removed: 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
−Removed: acquire a 100% controlling interest in the target.
−Removed: However, as a result of the issuance of a substantial number of new shares, our stockholders
−Removed: immediately prior to our initial business combination could own less than a majority of our issued and outstanding shares subsequent
−Removed: to our initial business combination.
−Removed: If less than 100% of the equity interests or assets of a target business or businesses are owned
−Removed: or acquired by the post-transaction company, the portion of such business or businesses that is owned or acquired is what will be valued
−Removed: for purposes of the 80% fair market value test.
−Removed: If the business combination involves more than one target business, the 80% fair market
−Removed: value test will be based on the aggregate value of all of the target businesses and we will treat the target businesses together as our
−Removed: initial business combination for purposes of a tender offer or for seeking stockholder approval, as applicable.
−Removed: the extent we effect our initial business combination with a company or business that may be financially unstable or in its early stages
−Removed: of development or growth, we may be affected by numerous risks inherent in such company or business.
−Removed: Although our management will endeavor
−Removed: to evaluate the risks inherent in a particular target business, we cannot assure you that we will properly ascertain or assess all significant
−Removed: risk factors.
−Removed: evaluating a prospective target business, we expect to conduct a thorough due diligence review which will encompass, among other things,
−Removed: meetings with incumbent management and employees, document reviews, inspection of facilities, as well as a review of financial, operational,
−Removed: legal and other information which will be made available to us.
−Removed: time required to select and evaluate a target business and to structure and complete our initial business combination, and the costs
−Removed: associated with this process, are not currently ascertainable with any degree of certainty.
−Removed: Any costs incurred with respect to the identification
−Removed: and evaluation of a prospective target business with which our initial business combination is not ultimately completed will result in
−Removed: our incurring losses and will reduce the funds we can use to complete another business combination.
−Removed: Further, our sponsor’s corporate
−Removed: parent, Presidio Property Trust, Inc., is not formally constrained in any way from pursuing acquisitions or business combinations that
−Removed: could be suitable transactions for us.
−Removed: While we do not believe it is likely that Presidio Property Trust, Inc., will compete against
−Removed: us for suitable acquisition targets based upon our management’s understanding of Presidio Property Trust, Inc.’s current
−Removed: business model, it is possible that a potential business combination could arise that would be suitable for us and Presidio Property
−Removed: Trust, Inc., giving rise to a conflict of interest.
−Removed: If such a circumstance were to occur, we anticipate that our board of directors would
−Removed: recuse any conflicted members of our management from taking any role in the consideration of such a transaction and, to the extent necessary,
−Removed: retain appropriate qualified, non-conflicted personnel to advise us in accordance with the provisions of our certificate of incorporation
−Removed: relating to transactions with affiliates.
−Removed: Such an eventuality could increase the costs associated with evaluating a target business.
−Removed: Our board of directors has established a code of ethics that includes a conflict of interest policy intended to ensure timely disclosure
−Removed: and avoidance of activities and relationships that conflict with the interests of the Company.
−Removed: Business Combination Process
−Removed: evaluating prospective business combinations, we expect to conduct a thorough due diligence review process that will encompass, among
−Removed: other things, meetings with incumbent management and employees, document reviews and inspection of facilities, as applicable, as well
−Removed: as a review of financial and other information that will be made available to us.
−Removed: are not prohibited from pursuing an initial business combination with a company that is affiliated with our sponsor, Murphy Canyon Acquisition
−Removed: Sponsor, LLC, its corporate parent, Presidio Property Trust, Inc., or any of our officers or directors.
−Removed: In the event we seek to complete
−Removed: our initial business combination with a company that is affiliated with our sponsor, its corporate parent, or any of our officers or
−Removed: directors, we, or a committee of independent directors, will obtain an opinion from an independent investment banking firm which is a
−Removed: member of FINRA or an independent accounting firm that our initial business combination is fair to our company from a financial point
−Removed: of our management team will directly or indirectly own founder shares and/or private placement units and, accordingly, may have a conflict
−Removed: of interest in determining whether a particular target business is an appropriate business with which to effectuate our initial business
−Removed: Further, each of our officers and directors may have a conflict of interest with respect to evaluating a particular business
−Removed: combination if the retention or resignation of any such officers and directors were to be included by a target business as a condition
−Removed: to any agreement with respect to our initial business combination.
−Removed: However, subject to any pre-existing contractual or fiduciary obligations,
−Removed: our sponsor and officers and directors will offer all suitable business combination opportunities within the real estate industry (and
−Removed: other related sectors, as discussed elsewhere in this annual report) to us before any other person or company until we have entered into
−Removed: a definitive agreement regarding our initial business combination or we have failed to complete our initial business combination by February
−Removed: of our officers are employed by our sponsor’s corporate parent, Presidio Property Trust, Inc.
−Removed: Our sponsor is continuously made
−Removed: aware of potential business opportunities, one or more of which we may desire to pursue for an initial business combination.
−Removed: Canyon Acquisition Sponsor, LLC, Presidio Property Trust, Inc., and each of our officers and directors presently have, and any of them
−Removed: in the future may have additional, fiduciary or contractual obligations to other entities pursuant to which such officer or director
−Removed: is or will be required to present a business combination opportunity.
−Removed: Accordingly, if any of our officers or directors becomes aware
−Removed: of a business combination opportunity which is suitable for an entity to which he or she has then-current fiduciary or contractual obligations,
−Removed: he or she will honor his or her fiduciary or contractual obligations to present such business combination opportunity to such other entity.
−Removed: We do not believe, however, that any fiduciary duties or contractual obligations of our sponsor, its corporate parent, and our officers
−Removed: or directors will materially affect our ability to complete our initial business combination.
−Removed: Our certificate of incorporation provides
−Removed: that we renounce our interest in any corporate opportunity offered to any director or officer unless such opportunity is expressly offered
−Removed: to such person solely in his or her capacity as a director or officer of our company and such opportunity is one we are legally and contractually
−Removed: permitted to undertake and would otherwise be reasonable for us to pursue, and to the extent the director or officer is permitted to
−Removed: refer that opportunity to us without violating another legal obligation.
−Removed: of Potential Initial Business Combination Targets
−Removed: believe the industry experience and business relationships of our sponsor’s corporate parent, Presidio Property Trust, Inc., will
−Removed: allow for a wide range of evaluation of targets for our business combination.
−Removed: Our sponsor’s corporate parent, with many decades
−Removed: of experience in the real estate industry and related industries, should be able to assist with accessing, and the vetting of, quality
−Removed: While we are an entirely separate company from Presidio Property Trust, Inc., with a fully independent Board except for Jack
−Removed: Heilbron and Adam Sragovicz, (and no overlapping officers aside from our CEO, Jack K.
−Removed: Heilbron, our CFO, Adam Sragovicz, and our CAO,
−Removed: Ed Bentzen), we expect to benefit from our sponsor’s corporate parent’s position in the industry.
−Removed: network has provided our management team with a flow of referrals that have resulted in numerous transactions.
−Removed: In the event that the
−Removed: Conduit Business Combination is not consummated, we believe that the network of contacts and relationships of our management team will
−Removed: provide us with an important source of acquisition opportunities.
−Removed: In addition, we anticipate that target business candidates will be
−Removed: brought to our attention from various unaffiliated sources, including investment market participants, private equity groups, investment
−Removed: banks, consultants, accounting firms and large business enterprises.
−Removed: of our management team and our independent directors directly or indirectly own founder shares and/or placement units following our initial
−Removed: public offering and, accordingly, may have a conflict of interest in determining whether a particular target business is an appropriate
−Removed: business with which to effectuate our initial business combination.
−Removed: Further, each of our officers and directors may have a conflict of
−Removed: interest with respect to evaluating a particular business combination if the retention or resignation of any such officers and directors
−Removed: was included by a target business as a condition to any agreement with respect to our initial business combination.
−Removed: addition, each of our officers and directors presently has, and any of them in the future may have additional, fiduciary or contractual
−Removed: obligations to other entities pursuant to which such officer or director is or will be required to present a business combination opportunity
−Removed: to such entity.
−Removed: As discussed above, however, we do not believe that the fiduciary duties or contractual obligations of our officers or
−Removed: directors will materially affect our ability to complete our initial business combination.
−Removed: certificate of incorporation provides that we renounce our interest in any corporate opportunity offered to any director or officer unless
−Removed: such opportunity is expressly offered to such person solely in his or her capacity as a director or officer of our company and such opportunity
−Removed: is one we are legally and contractually permitted to undertake and would otherwise be reasonable for us to pursue, and to the extent
−Removed: the director or officer is permitted to refer that opportunity to us without violating another legal obligation.
−Removed: as a Public Company
−Removed: believe our structure will make us an attractive business combination partner to target businesses.
−Removed: As a public company, we offer a target
−Removed: business an alternative to the traditional initial public offering through a merger or other business combination with us.
−Removed: an initial business combination, we believe the target business would have greater access to capital and additional means of creating
−Removed: management incentives that are better aligned with stockholders’ interests than it would as a private company.
−Removed: A target business
−Removed: can further benefit by augmenting its profile among potential new customers and vendors and aid in attracting talented employees.
−Removed: a business combination transaction with us, the owners of the target business may, for example, exchange their shares of stock in the
−Removed: target business for our shares of Class A common stock (or shares of a new holding company) or for a combination of our shares of Class
−Removed: A common stock and cash, allowing us to tailor the consideration to the specific needs of the sellers.
−Removed: there are various costs and obligations associated with being a public company, we believe target businesses will find this method a
−Removed: more expeditious and cost effective method to becoming a public company than the typical initial public offering.
−Removed: The typical initial
−Removed: public offering process takes a significantly longer period of time than the typical business combination transaction process, and there
−Removed: are significant expenses in the initial public offering process, including underwriting discounts and commissions, marketing and road
−Removed: show efforts that may not be present to the same extent in connection with an initial business combination with us.
−Removed: once a proposed initial business combination is completed, the target business will have effectively become public, whereas an initial
−Removed: public offering is always subject to the underwriters’ ability to complete the offering, as well as general market conditions,
−Removed: which could delay or prevent the offering from occurring or could have negative valuation consequences.
−Removed: Following an initial business
−Removed: combination, we believe the target business would then have greater access to capital and an additional means of providing management
−Removed: incentives consistent with stockholders’ interests and the ability to use its shares as currency for acquisitions.
−Removed: Being a public
−Removed: company can offer further benefits by augmenting a company’s profile among potential new customers and vendors and aid in attracting
−Removed: talented employees.
−Removed: we believe that our structure and our management team’s backgrounds make us an attractive business partner, some potential target
−Removed: businesses may view our status as a blank check company, such as our lack of an operating history and our ability to seek stockholder
−Removed: approval of any proposed initial business combination, negatively.
−Removed: are an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended, or the “Securities
−Removed: Act”, as modified by the JOBS Act.
−Removed: As such, we are eligible to take advantage of certain exemptions from various reporting requirements
−Removed: that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not
−Removed: being required to comply with the independent registered public accounting firm attestation requirements of Section 404 of the Sarbanes-Oxley
−Removed: Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from
−Removed: the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments
−Removed: not previously approved.
−Removed: If some investors find our securities less attractive as a result, there may be a less active trading market
−Removed: for our securities and the prices of our securities may be more volatile.
−Removed: addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended
−Removed: transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.
−Removed: words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise
−Removed: apply to private companies.
−Removed: We intend to take advantage of the benefits of this extended transition period.
−Removed: will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of
−Removed: the completion of our initial public offering, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which
−Removed: we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds
−Removed: $700 million as of the prior June 30 th , and (2) the date on which we have issued more than $1.0 billion in non-convertible
−Removed: debt securities during the prior three-year period.
−Removed: Additionally,
−Removed: we are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K.
−Removed: Smaller reporting companies may take
−Removed: 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 common stock held
−Removed: by non-affiliates exceeds $250 million as of the end of the prior June 30 th , or (2) our annual revenues exceeded $100 million
−Removed: during such completed fiscal year and the market value of our common stock held by non-affiliates exceeds $700 million as of the prior
−Removed: funds available for an initial business combination in the amount of approximately $23 million after payment of $4,628,750 of deferred
−Removed: underwriting fees, we offer a target business a variety of options such as creating a liquidity event for its owners, providing capital
−Removed: for the potential growth and expansion of its operations or strengthening its balance sheet by reducing its debt or leverage ratio.
−Removed: we are able to complete our initial business combination using our cash, debt or equity securities, or a combination of the foregoing,
−Removed: we have the flexibility to use the most efficient combination that will allow us to tailor the consideration to be paid to the target
−Removed: 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
−Removed: it will be available to us.
−Removed: Our Initial Business Combination
−Removed: are not presently engaged in, and we will not engage in, any operations for an indefinite period of time following our initial public
−Removed: We intend to effectuate our initial business combination using cash from the proceeds of the offering and the sale of the placement
−Removed: units, the proceeds of the sale of our shares in connection with our initial business combination (pursuant to backstop agreements we
−Removed: may enter into), shares issued to the owners of the target, debt issued to bank or other lenders or the owners of the target, or a combination
−Removed: of the foregoing.
−Removed: We may seek to complete our initial business combination with a company or business that may be financially unstable
−Removed: or in its early stages of development or growth, which would subject us to the numerous risks inherent in such companies and businesses.
−Removed: our initial business combination is paid for using equity or debt securities, or not all of the funds released from the Trust Account
−Removed: are used for payment of the consideration in connection with our initial business combination or used for redemptions of our Class A
−Removed: common stock, we may apply the balance of the cash released to us from the Trust Account for general corporate purposes, including for
−Removed: maintenance or expansion of operations of the post-transaction company, the payment of principal or interest due on indebtedness incurred
−Removed: in completing our initial business combination, to fund the purchase of other companies or for working capital.
−Removed: in the case of the Conduit Business Combination, we may seek to raise additional funds through a private offering of debt or equity securities
−Removed: in connection with the completion of our initial business combination, and we may effectuate our initial business combination using the
−Removed: proceeds of such offering rather than using the amounts held in the Trust Account.
−Removed: In addition, we intend to target businesses larger
−Removed: than we could acquire with the net proceeds of our initial public offering and the sale of the placement units, and may as a result be
−Removed: required to seek additional financing to complete such proposed initial business combination.
−Removed: Subject to compliance with applicable securities
−Removed: laws, we would expect to complete such financing only simultaneously with the completion of our initial business combination.
−Removed: case of an initial business combination funded with assets other than the Trust Account assets, our proxy materials or tender offer documents
−Removed: disclosing the initial business combination would disclose the terms of the financing and, only if required by applicable law or stock
−Removed: exchange requirements, we would seek stockholder approval of such financing.
−Removed: There are no prohibitions on our ability to raise funds
−Removed: privately, or through loans in connection with our initial business combination.
−Removed: At this time, we are not a party to any arrangement
−Removed: or understanding with any third party with respect to raising any additional funds through the sale of securities or otherwise.
−Removed: of a Target Business and Structuring of our Initial Business Combination
−Removed: rules require that we must complete one or more business combinations having an aggregate fair market value of at least 80% of the value
−Removed: of the assets held in the Trust Account at the time of our signing a definitive agreement in connection with our initial business combination.
−Removed: The fair market value of our initial business combination will be determined by our board of directors based upon one or more standards
−Removed: generally accepted by the financial community, such as discounted cash flow valuation, a valuation based on trading multiples of comparable
−Removed: public businesses or a valuation based on the financial metrics of M&A transactions of comparable businesses.
−Removed: If our board of directors
−Removed: is not able to independently determine the fair market value of our initial business combination, or if we are considering an initial
−Removed: business combination with an entity that is affiliated with A.G.P., our sponsor, directors or officers, we will obtain an opinion from
−Removed: an independent investment banking firm or another independent entity that commonly renders valuation opinions with respect to the satisfaction
−Removed: of such criteria.
−Removed: While we consider it unlikely that our board of directors will not be able to make an independent determination of
−Removed: the fair market value of our initial business combination, it may be unable to do so if it is less familiar or experienced with the business
−Removed: of a particular target or if there is a significant amount of uncertainty as to the value of a target’s assets or prospects.
−Removed: do not intend to purchase multiple businesses in unrelated industries in conjunction with our initial business combination.
−Removed: this requirement, our management will virtually have unrestricted flexibility in identifying and selecting one or more prospective target
−Removed: businesses, although we will not be permitted to effectuate our initial business combination with another blank check company or a similar
−Removed: company with nominal operations.
−Removed: any case, we will only complete an initial business combination in which we own or acquire 50% or more of the outstanding voting securities
−Removed: of the target or otherwise acquire a controlling interest in the target sufficient for it not to be required to register as an investment
−Removed: company under the Investment Company Act.
−Removed: If we own or acquire less than 100% of the equity interests or assets of a target business
−Removed: or businesses, the portion of such business or businesses that are owned or acquired by the post-transaction company is what will be
−Removed: taken into account for purposes of Nasdaq’s 80% fair market value test.
−Removed: There is no basis for investors to evaluate the possible
−Removed: merits or risks of any target business with which we may ultimately complete our initial business combination.
−Removed: the extent we effect our initial business combination with a company or business that may be financially unstable or in its early stages
−Removed: of development or growth we may be affected by numerous risks inherent in such company or business.
−Removed: Although our management will endeavor
−Removed: to evaluate the risks inherent in a particular target business, we cannot assure you that we will properly ascertain or assess all significant
−Removed: risk factors.
−Removed: evaluating a prospective business target, we expect to conduct a thorough due diligence review, which may encompass, among other things,
−Removed: meetings with incumbent management and employees, document reviews, interviews of customers and suppliers, inspection of facilities,
−Removed: as well as a review of financial and other information that will be made available to us.
−Removed: time required to select and evaluate a target business and to structure and complete our initial business combination, and the costs
−Removed: associated with this process, are not currently ascertainable with any degree of certainty.
−Removed: Any costs incurred with respect to the identification
−Removed: and evaluation of a prospective target business with which our initial business combination is not ultimately completed will result in
−Removed: our incurring losses and will reduce the funds we can use to complete another business combination.
−Removed: of Business Diversification
−Removed: an indefinite period of time after the completion of our initial business combination, the prospects for our success may depend entirely
−Removed: on the future performance of a single business.
−Removed: Unlike other entities that have the resources to complete business combinations with
−Removed: multiple entities in one or several industries, it is probable that we will not have the resources to diversify our operations and mitigate
−Removed: the risks of being in a single line of business.
−Removed: In addition, we intend to focus our search for an initial business combination in a
−Removed: single industry.
−Removed: By completing our initial business combination with only a single entity, our lack of diversification may:
−Removed: us to negative economic, competitive and regulatory developments, any or all of which may
−Removed: have a substantial adverse impact on the particular industry in which we operate after our
−Removed: initial business combination, and
−Removed: us to depend on the marketing and sale of a single product or limited number of products or services.
−Removed: Ability to Evaluate the Target’s Management Team
−Removed: we intend to closely scrutinize the management of a prospective target business when evaluating the desirability of effecting our initial
−Removed: business combination with that business, our assessment of the target business’ management may not prove to be correct.
−Removed: the future management may not have the necessary skills, qualifications or abilities to manage a public company.
−Removed: Furthermore, the future
−Removed: role of members of our management team, if any, in the target business cannot presently be stated with any certainty.
−Removed: The determination
−Removed: 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
−Removed: business combination.
−Removed: While it is possible that one or more of our directors will remain associated in some capacity with us following
−Removed: our initial business combination, it is unlikely that any of them will devote their full efforts to our affairs subsequent to our initial
−Removed: business combination.
−Removed: Moreover, we cannot assure you that members of our management team will have significant experience or knowledge
−Removed: relating to the operations of the particular target business.
−Removed: cannot assure you that any of our key personnel will remain in senior management or advisory positions with the combined company.
−Removed: 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
−Removed: 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
−Removed: skills, knowledge or experience necessary to enhance the incumbent management.
−Removed: May Not Have the Ability to Approve Our Initial Business Combination
−Removed: may conduct redemptions without a stockholder vote pursuant to the tender offer rules of the SEC.
−Removed: However, we will seek stockholder approval
−Removed: of the Conduit Business Combination and, if the Conduit Business Combination is not consummated, of any future proposed initial business
−Removed: combination if it is required by applicable law or applicable stock exchange listing requirements, or we may decide to seek stockholder
−Removed: approval for business or other legal reasons.
−Removed: Presented in the table below is a graphic explanation of the types of initial business
−Removed: combinations we may consider and whether stockholder approval is currently required under Delaware law for each such transaction.
−Removed: of Transaction
−Removed: of stock of target not involving a merger with the company
−Removed: of target into a subsidiary of the company
−Removed: of the company with a target
−Removed: Nasdaq’s listing rules, stockholder approval would be required for our initial business combination if, for example:
−Removed: issue shares of Class A common stock that will be equal to or in excess of 20% of the number of shares of our Class A common stock
−Removed: then outstanding (other than in a public offering);
−Removed: of our directors, officers or substantial stockholders (as defined by Nasdaq rules) has a 5% or greater interest (or such persons
−Removed: collectively have a 10% or greater interest), directly or indirectly, in the target business or assets to be acquired or otherwise
−Removed: and the present or potential issuance of common stock could result in an increase in outstanding common stock or voting power of
−Removed: issuance or potential issuance of common stock will result in our undergoing a change of control.
−Removed: Purchases of our Securities
−Removed: we seek stockholder approval of our initial business combination and we do not conduct redemptions in connection with our initial business
−Removed: combination pursuant to the tender offer rules, our sponsor, initial stockholders, directors, officers, advisors or their affiliates
−Removed: may purchase public shares or public warrants in privately negotiated transactions or in the open market either prior to or following
−Removed: the completion of our initial business combination.
−Removed: There is no limit on the number of shares our initial stockholders, directors, officers
−Removed: or their affiliates may purchase in such transactions, subject to compliance with applicable law and Nasdaq rules.
−Removed: However, they have
−Removed: no current commitments, plans or intentions to engage in such transactions and have not formulated any terms or conditions for any such
−Removed: transactions.
−Removed: If they engage in such transactions, they will not make any such purchases when they are in possession of any material
−Removed: nonpublic information not disclosed to the seller or if such purchases are prohibited by Regulation M under the Exchange Act.
−Removed: currently anticipate that such purchases, if any, would constitute a tender offer subject to the tender offer rules under the Exchange
−Removed: Act or a going-private transaction subject to the going-private rules under the Exchange Act;
−Removed: however, if the purchasers determine at
−Removed: the time of any such purchases that the purchases are subject to such rules, the purchasers will comply with such rules.
−Removed: Any such purchases
−Removed: will be reported pursuant to Section 13 and Section 16 of the Exchange Act to the extent such purchasers are subject to such reporting
+Added: September 22, 2023, a merger transaction between Conduit Pharmaceuticals Limited (“Old Conduit”), Murphy Canyon Acquisition
+Added: Corp (“MURF”) and Conduit Merger Sub, Inc., a Cayman Islands exempted company and a wholly owned subsidiary of MURF (“Merger
+Added: Sub”), was completed pursuant to the Agreement and Plan of Merger, dated November 8, 2022, as amended, (the “Merger Agreement”).
+Added: Pursuant to the terms of the Merger Agreement, at the closing, (i) Merger Sub merged with and into Old Conduit, with Old Conduit surviving
+Added: the merger as a wholly-owned subsidiary of MURF, and (ii) MURF changed its name from Murphy Canyon Acquisition Corp.
+Added: to Conduit Pharmaceuticals
+Added: (hereafter referred to, collectively with is subsidiaries as “Conduit”, the “Company”,
+Added: “we”, “us” or “our”, unless the context otherwise requires).
+Added: The common stock of the Company
+Added: commenced trading on The Nasdaq Global Market under the symbol “CDT” on September 25, 2023, and the Company’s warrants
+Added: commenced trading on The Nasdaq Capital Market under the symbol “CDTTW” on September 25, 2023 .
+Added: has developed a unique business model that allows it to act as a conduit to bring clinical assets from pharmaceutical companies and
+Added: develop new treatments for patients.
+Added: Our novel approach addresses unmet medical needs and lengthens the intellectual property for our
+Added: existing assets through cutting-edge solid-form technology and then commercializing these products with life science
+Added: are led by highly experienced pharmaceutical executives:
+Added: Freda Lewis-Hall, former Chief Medical Officer of Pfizer Inc., the Chair
+Added: of our Board of Directors, and Dr.
+Added: David Tapolczay, former Chief Executive Officer of the United Kingdom-based medical research charity
+Added: LifeArc, our Chief Executive Officer.
+Added: Our management team includes active senior clinicians who have an extensive understanding of the
+Added: pharmaceuticals market, which supports our strategy of developing clinical assets in a cost-efficient manner while focusing on therapeutic
+Added: efficacy and patient safety.
+Added: We believe that we can leverage the capabilities of our Cambridge laboratory facility and highly experienced team of solid-form experts to
+Added: extend or develop proprietary solid-form intellectual property for our existing and future clinical assets.
+Added: Our own intellectual property
+Added: portfolio comprises a 20-year patent pending solid-form compound, the AZD1656 Cocrystal (a HK-4 Glucokinase Activator), targeting a wide
+Added: range of autoimmune diseases.
+Added: Our pipeline research includes a number of compounds that serve as promising alternatives to existing clinical
+Added: assets currently marketed and sold by large pharmaceutical companies, which we have identified as having an opportunity to develop further intellectual property positions through solid-form technology.
+Added: connection with the funding and development of clinical assets, we evaluate and select the specific molecules to be developed and collaborate
+Added: with external contract research organizations (“CROs”) and Key Opinion Leaders (“KOLs”) to run clinical trials
+Added: that are managed, funded, and overseen by us.
+Added: We intend to leverage our comprehensive clinical and scientific expertise in order to facilitate
+Added: development of clinical assets through Phase II trials in an efficient manner by using CROs and third-party service providers.
+Added: also collaborate closely with disease specific KOLs to collectively assess and determine the most appropriate indications for all our
+Added: current and forthcoming assets.
+Added: believe that successful Phase II trials of the clinical assets in our pipeline will increase the value of our assets.
+Added: There is no assurance
+Added: that any clinical trials on the assets owned or licensed by us will be successful, however, following a successful Phase II clinical
+Added: trial, we would look to licensing opportunities with large biotech or pharmaceutical companies, typically for up-front milestone payments
+Added: and royalty income streams for the life of the asset patent.
+Added: We anticipate using any future royalty income stream to develop our asset
+Added: portfolio in combination with other potential sources of financing, including debt or equity financing.
+Added: of our proprietary owned patented clinical assets, we have an exclusive relationship and partnership with St George Street Capital
+Added: (“St George Street”), a biomedical charity based in the United Kingdom.
+Added: We have the option to fund 100% of the
+Added: development of clinical assets that were initially licensed to St George Street by AstraZeneca PLC (AZN.L)
+Added: (“AstraZeneca”).
+Added: AstraZeneca has conducted initial pre-clinical and, in some instances, clinical trials on these assets,
+Added: but has decided to license them for further development.
+Added: At present, the Company has not definitely determined whether to fund any of projects through St George Street,
+Added: although its ability to choose to remains at the present time.
+Added: Subject to the terms of the Global Funding Agreement and the project funding
+Added: agreements (described in further detail below), either we or St George Street may seek funding for projects from third parties.
+Added: addition to our patent pending solid-form compound targeting a wide range of autoimmune diseases, two assets which were licensed from
+Added: AstraZeneca to St George Street that may be developed by us include AZD5904 (a Myeloperoxidase Inhibitor) targeting idiopathic male
+Added: infertility and AZD1656 (a Glucokinase Activator) targeting autoimmune diseases or immunodeficient conditions including uveitis, premature
+Added: labor, renal transplant rejection, and Hashimoto’s thyroiditis.
+Added: the clinical assets have undergone initial pre-clinical and clinical testing conducted by AstraZeneca, we are able to use the safety
+Added: data generated in these clinical trials to assess which clinical assets to further develop and for which indications.
+Added: Through this relationship,
+Added: there are considerable active pharmaceutical ingredients (“APIs”) that were manufactured by AstraZeneca in conducting its clinical
+Added: trials available.
+Added: As a result, Conduit does not have to develop the API, which is often a time consuming and expensive process, and the
+Added: API already produced was subject to rigorous quality control measures.
+Added: Conduit is well positioned, and intends, to pursue additional relationships and/or partnerships with third parties for the licensing
+Added: of further assets which are currently deprioritized.
+Added: We plan to focus our efforts on developing clinical assets to address diseases that
+Added: impact a large population where there is no present treatment or the present treatment, carries significant unwanted side effects.
+Added: Initial Pipeline:
+Added: HK-4 Glucokinase Activator Cocrystal, AZD1656 and AZD5904
+Added: wholly own the intellectual property and the rights to further develop the solid-form patent pending Cocrystals of AZD1656 (AZD1656 Cocrystal
+Added: WO2023084313 - Patent Expires 02/09/2042) which we intend to target a wide range of autoimmune diseases.
+Added: our agreements, we have the exclusive rights to fund the development of clinical assets, AZD1656 and AZD5904, which are licensed to St
+Added: George Street by AstraZeneca, in five indications.
+Added: has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials conducted by AstraZeneca since 2008
+Added: and 19 of which were conducted in the U.S.
+Added: Additional information about those clinical trials is available at the U.S.
+Added: National Library
+Added: of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or otherwise accessible through such website
+Added: is not part of this Annual Report).
+Added: has undergone testing in five Phase I clinical trials conducted by AstraZeneca, one of which was conducted in the U.S.
+Added: While a significant
+Added: amount of clinical trial data has already been generated for both AZD1656 and AZD5904, some of this data was generated outside of the
+Added: and accordingly may not be accepted by the FDA.
+Added: In the event that such data is not accepted by the FDA, additional clinical trials
+Added: may be required, which would result in additional costs and time to develop these clinical assets.
+Added: initial development plan is to conduct a Phase II clinical trial on the selected AZD1656 Cocrystal (which we wholly own the intellectual
+Added: property rights to), that we believe has the potential to treat a wide range of autoimmune diseases.
+Added: Should we choose to develop AZD1656
+Added: or AZD5904, that development would be subject to the terms of the Global Funding Agreement, described in more detail below.
+Added: We anticipate
+Added: developing our Initial Pipeline (which has already undergone pre-clinical and clinical trials) through the Phase II stage and then monetizing
+Added: such clinical assets through a license, royalty, or other transaction at this stage.
+Added: At this time, we do not expect that we will commercialize
+Added: any clinical assets or seek marketing approval from the FDA (or similar organizations) as we intend to enter into agreements with third
+Added: parties following Phase II clinical trials for each such clinical asset that would provide that such third party would pursue the further
+Added: development, commercialization, and marketing of such assets.
+Added: enable us to monetize our clinical assets, we, in partnership with CROs and KOLs, intend to conduct additional clinical trials on our
+Added: clinical assets in order to generate clinical data to support the further development of our clinical assets beyond the Phase II stage.
+Added: In the event successful clinical trial data is generated for a clinical asset with a particular indication, at that point, we will seek
+Added: to enter into a license, royalty, or other transaction with a third party whereby the third party would continue to pursue the development
+Added: of the clinical asset in Phase III clinical trials.
+Added: There is no assurance that any clinical trials on the assets owned or licensed by
+Added: us will be successful.
+Added: intend to use the income received from licensing clinical assets in our pipeline to fund the development of additional clinical assets,
+Added: which will allow us to use the existing income stream from clinical assets that have been licensed to fund our on-going operations, including
+Added: the development and commercialization of additional clinical assets, without having to rely solely on debt and/or equity financing.
+Added: Development Strategy
+Added: strategy is to generate value through the development of new medicines, or clinical assets, for patients where our research indicates
+Added: that there are not effective pharmaceutical treatments available or such existing pharmaceutical treatments are not adequate due to,
+Added: among other things, cost of such pharmaceuticals and side effects.
+Added: We are working to develop new medicines in diseases where competitive
+Added: treatments carry a high incidence of unacceptable side effects resulting in tolerability and compliance issues.
+Added: We aim to extend and
+Added: develop solid-form intellectual property on assets which are licensed from pharmaceutical companies or generated within our facility
+Added: in Cambridge, UK.
+Added: We believe that our Cambridge facility positions us at the nexus of scientific advancement, providing an environment
+Added: to drive cutting-edge research and development initiatives.
+Added: is evidence that promising solid-form candidates can supersede original pharmaceutical products.
+Added: We are currently in the process of developing
+Added: new solid-form intellectual property on clinical assets which we believe will serve as promising alternatives for existing products on
+Added: We believe that our expertise and utilization of solid-form technology can potentially enhance the efficacy, bioavailability,
+Added: solubility and delivery of existing products on the market.
+Added: Once a candidate has been identified and patented, we will fund and conduct
+Added: clinical trials through CROs.
+Added: previously indicated, our strategy also involves establishing strategic collaborations with globally recognized KOLs.
+Added: collaborate closely with disease specific KOLs to collectively assess and determine the most appropriate indications for all our
+Added: current and forthcoming assets.
+Added: This approach ensures that the selection of indications aligns with the KOLs’ insights, in
+Added: addition to our internal expertise, optimizing the development and success of Conduit’s diverse portfolio.
+Added: unique relationships allow us to bypass certain traditional hurdles for the development of clinical assets.
+Added: Through relationships with
+Added: St George Street, and we anticipate, subsequently with AstraZeneca, our Initial Pipeline has already undergone initial pre-clinical,
+Added: and, in some instances, clinical testing conducted by AstraZeneca, this enables us to use the safety data generated in the prior trials
+Added: in order to assess which assets to continue to develop.
+Added: We regularly assess our asset portfolio to identify potential risks and take
+Added: steps to mitigate those risks, such as the repurposing of assets, which reduces development costs and timelines, as the clinical asset
+Added: has already undergone safety and toxicity testing in humans, as well as extending the remaining patent life by up to 20 years on all
+Added: assets which are licensed.
+Added: prior preclinical and clinical studies conducted by AstraZeneca allow us to reduce the costs, expenses, and time in the development of
+Added: these assets by allowing us to continue the Phase Ib or Phase II stage, rather than the preclinical or Phase I stage, even if we are
+Added: investigating the assets for a new indication.
+Added: For example, if a clinical asset was subject to a Phase I trial, such clinical asset may
+Added: be advanced to a Phase II trial even if the clinical asset is being investigated for a different indication.
+Added: In addition, we have access
+Added: to API manufactured by AstraZeneca and as a result, should we use their formulation, we do not have to develop a route of manufacture
+Added: for the API, which is time consuming and expensive.
+Added: Funding Agreement – St George Street
+Added: and St George Street entered into an Exclusive Funding Agreement on March 26, 2021 (the “Global Funding Agreement”), pursuant
+Added: to which St George Street granted us the exclusive first right to provide to St George Street, or procure the provision of, all funding
+Added: for the performance of a drug discovery and/or development project in consideration for a share of the net revenue in respect of such
+Added: and St George Street currently have entered into five project funding agreements, which are subject to the terms of the Global Funding
+Added: Agreement, to develop certain clinical assets that have been licensed to St George Street by AstraZeneca.
+Added: The project funding agreements
+Added: for use in renal transplant,
+Added: for use in pre-term labor,
+Added: for use in Hashimoto’s thyroiditis,
+Added: for use in uveitis, and
+Added: for use in idiopathic male infertility.
+Added: present, the Company has not determined whether to fund any of these projects, although its ability to choose to remains at the present
+Added: Subject to the terms of the Global Funding Agreement and the project funding agreements, either we or St George Street may seek
+Added: funding for projects from third parties.
+Added: may be additional opportunities for us to partner with St George Street to fund the development of additional clinical assets in the
+Added: future, licensed from Astra Zeneca.
+Added: we choose to fund these projects through St.
+Added: George Street (“SGSC”), we are entitled to receive 100% of the Net Receipts (as defined in the
+Added: relevant project funding agreement) under each of the project funding agreements.
+Added: to its terms, the Global Funding Agreement remains effective in respect of each project until the expiration of the right of a party
+Added: to receive a share of the Net Revenue (as defined in the Global Funding Agreement) pursuant to the Global Funding Agreement.
+Added: Under certain
+Added: circumstances, St George Street may terminate a project (i) in the event of a material or persistent breach of the Global Funding Agreement
+Added: by us, subject to a cure period if the breach is capable of remedy, or (ii) in the event St George Street decides to cease development
+Added: of a project.
+Added: If an event of force majeure occurs and continues for a designated period of time, the innocent party may terminate the
+Added: Global Funding Agreement after a notice period.
+Added: party may terminate a project if a voluntary arrangement is proposed or approved or an administration order is made, or a receiver or
+Added: administrative receiver is appointed of any of the other party’s assets or undertakings or a winding-up resolution or petition
+Added: is passed (otherwise than for the purpose of solvent reconstruction or amalgamation, in particular with respect to any reorganization
+Added: of the structure of that party) or if any circumstances arise which entitle a court or a creditor to appoint a receiver, administrative
+Added: receiver or administrator or make a winding-up order or similar or equivalent action is taken against or by that other party by reason
+Added: of its insolvency or in consequence of debt.
+Added: Generally, each project funding agreement may be terminated by us if at any time St George
+Added: Street ceases the conduct of development or commercialization of the relevant products in accordance with the relevant development plan
+Added: for a designated period of time, provided that the termination is only effective with respect to the specified project and the Global
+Added: Funding Agreement continues in effect for all other projects.
+Added: They may also be terminated by either party upon written notice to other
+Added: party if the other party materially breaches the project funding agreement and does not fully cure the breach to the non-breaching party’s
+Added: satisfaction within 90 days.
+Added: Global Funding Agreement also contains customary representations and warranties.
+Added: Each party also agreed to keep secret and confidential
+Added: certain confidential information of the other party.
+Added: foregoing summary does not purport to be a complete description of all of the provisions of the Global Funding Agreement and related
+Added: project funding agreements and is qualified by reference to the full text of the Global Funding Agreement and the project funding agreements,
+Added: which are filed as exhibits to this Annual Report, and which are incorporated by reference in their entirety.
+Added: Agreement – St George Street and AstraZeneca
+Added: August 2019, St George Street entered into a license agreement with AstraZeneca (the “AZ License Agreement”), pursuant to
+Added: which AstraZeneca granted an exclusive worldwide license to St George Street, under certain AstraZeneca patents and know-how, to exploit
+Added: the pharmaceutical compounds known individually and together as AZD5904 (Myeloperoxidase Inhibitor) and AZD1656 (Glucokinase Activator).
+Added: The AZ License Agreement also included any additional compounds to be developed by St George Street and any product that is comprised
+Added: of or contains any such licensed compound pertaining to the field of idiopathic male infertility for the licensed compound AZD5904 and
+Added: in the field of renal transplant for the licensed compound for AZD1656.
+Added: the AZ License Agreement, for a period of 60 days following AstraZeneca’s receipt of a proof of concept study for any licensed
+Added: compound, AstraZeneca retains an exclusive right of first negotiation to transfer all development, commercialization, or other ongoing
+Added: planned activities related to such licensed compound, to AstraZeneca or any of its affiliates, and to undertake future exploitation of
+Added: such licensed compound.
+Added: Subject to the foregoing negotiation right, St George Street has the right and obligation to develop each licensed
+Added: compound at its sole cost and expense in accordance with the development plan set forth in the AZ License Agreement, and the right to
+Added: grant sublicenses to its affiliates and other persons with respect to each licensed compound.
+Added: Any sublicense shall be consistent with,
+Added: and expressly made subject and subordinate to, the terms and conditions of the AZ License Agreement, and St George Street shall cause
+Added: each sublicensee to comply with the applicable terms and conditions of the AZ License Agreement.
+Added: The development plan for each licensed
+Added: compound shall be managed by a joint coordination committee consisting of representatives from each party to the agreement.
+Added: George Street is required to pay AstraZeneca a share of any revenue payable to St George Street by any sublicensee according to the relevant
+Added: sublicense (the “Sublicense Revenue”), which shall be calculated based on the amounts payable to St George Street by the
+Added: sublicensee gross of tax, and shall include any upfront, milestone, or royalty payments payable.
+Added: The percentage of Sublicense Revenue
+Added: payable to AstraZeneca is 60% for Sublicense Revenue that is less than $10 million;
+Added: 50% for Sublicense Revenue that is equal to or greater
+Added: than $10 million but less than $15 million;
+Added: and 40% for Sublicense Revenue that is equal to or greater than $15 million.
+Added: term of the AstraZeneca License Agreement commences on the effective date of that agreement and, unless earlier terminated in accordance
+Added: therewith, continues until the date of expiration of the last royalty term for the last licensed product.
+Added: Following the expiration (but
+Added: not earlier termination) of the royalty term for a licensed product in a country, the license grant set forth in this agreement shall
+Added: become non-exclusive, fully-paid, and irrevocable for such licensed product.
+Added: AZ Agreement is terminable by either party if the other party is in material breach of the agreement, and such breach has not cured the
+Added: breach 90 days of notice (or 10 days of notice with respect to a payment breach).
+Added: may immediately terminate the agreement, including the rights of any sublicensees, upon written notice if St George Street or any of
+Added: its affiliates or sublicensees, anywhere in the territory, institutes, prosecutes or otherwise participates in any claim, demand, action
+Added: or cause of action for declaratory relief, damages or any other remedy or for an enjoinment, injunction or any other equitable remedy
+Added: alleging that any claim in an AstraZeneca patent is invalid, unenforceable or otherwise not patentable or would not be infringed by St
+Added: George Street’s activities absent the rights and licenses granted under the agreement.
+Added: AstraZeneca may also terminate the agreement
+Added: upon 30 days’ prior written notice if St George Street ceases development of all licensed compounds and all licensed products and
+Added: a licensed product is not being commercialized in the territory by or on behalf of St George Street.
+Added: George Street may terminate its activities under the agreement for convenience, on a project-by-project basis, upon reasonable notice
+Added: to AstraZeneca.
+Added: St George Street may also cease its activities under any development plan of a licensed compound if the joint commercialization
+Added: committee determines that it is inappropriate to continue such plan for scientific, safety, or for ethical reasons, or that a licensed
+Added: product no longer meets an unmet medical need.
+Added: 2020, St George Street and AstraZeneca entered into an amendment to the AZ License Agreement to add Covid-19 to the field for
+Added: licensed compound AZD1656.
+Added: St George Street and AstraZeneca entered into a second amendment and a third amendment to the AZ License
+Added: The second amendment, dated April 9, 2020, to the AZ
+Added: License Agreement added Schedule 1.36(a) to the AZ License Agreement, which describes additional terms and conditions that apply
+Added: only to the parties with respect to Covid-19 for the licensed compound AZD1656.
+Added: The third amendment, dated April 27, 2021, added
+Added: Hashimoto’s thyroiditis, uveitis, preterm labor, and Covid-19 to the field for AZD1656 and added Schedule 1.42(a) to the AZ
+Added: License Agreement, which describes additional terms and conditions that apply to the parties (i) only with respect to
+Added: Hashimoto’s thyroiditis, uveitis, and preterm labor for the licensed compound AZD1656, and (ii) with respect to all other
+Added: indications and Licensed Compounds (as defined in the AZ License Agreement) as set forth in the AZ License Agreement, except with
+Added: respect to Covid-19 for AZD1656, for which Schedule 1.36(a) of the AZ License Agreement applies.
+Added: The terms and conditions contained
+Added: in the second and third amendments to the AZ License Agreement also set forth the obligations and responsibilities of the parties
+Added: regarding supply of study drugs, conducting studies, and other matters.
+Added: Biotechnology Industry
+Added: global biotechnology industry comprises a large range of companies engaged in diverse activities, such as biopharmaceutical development.
+Added: The industry companies also span across a wide spectrum of operational models.
+Added: Some small, dedicated biotechnology companies are research
+Added: and development (“R&D”) intensive and operate primarily with venture capital, grants, initial public offerings and collaborative
+Added: Conversely, large, diversified companies hold significant in-house R&D resources and well-established production, commercialization,
+Added: and distribution processes.
+Added: believes that the global biotechnology market was valued at $1.55 trillion in 2023 and is projected to grow at a compound annual growth
+Added: rate (“CAGR”) of 13.96% from 2024 to 2030.
+Added: The market is driven by strong government support through initiatives aimed at
+Added: the modernization of regulatory framework, improvements in approval processes and reimbursement policies, as well as standardization
+Added: of clinical studies.
+Added: investor confidence has fallen during the period, which served to somewhat subdue revenue growth.
+Added: However, global investment in R&D
+Added: has grown strongly and consistently in recent years, with much of this funding funneled into medical biotechnology development, aimed
+Added: at providing better care for the aging global population, thus bolstering industry revenue.
+Added: Pharmaceutical Industry
+Added: the previous five years, pharmaceutical companies have benefited from an aging population in developed economies and a growing middle
+Added: class in emerging economies.
+Added: Many companies have also tapped into regional demand for pharmaceuticals that may differ from developed
+Added: markets and have expanded their global presence to tap into regional market needs.
+Added: cliffs have continued to hamper industry revenue during the current period.
+Added: When drugs lose patent exclusivity, the market is inundated
+Added: with low-cost generic drugs.
+Added: As manufacturers contend with more price-based competition from generics, many operators respond by lowering
+Added: their R&D expenditures, which limits the industry’s drug pipelines.
+Added: Additionally, many governments and health insurance organizations
+Added: have reduced their drug reimbursements to control healthcare costs, such as implementing incentives for patients to use generic drugs.
+Added: forward, revenue is forecast to grow an annualized 3.2% to $1.3 trillion over the next five years amid an anticipated persistence of
+Added: global demand for industry products.
+Added: Initial Pipeline:
+Added: AZD1656 and AZD5904
+Added: wholly own the intellectual property and the rights to further develop the solid-form patent pending Cocrystals of AZD1656 (AZD1656 Cocrystal
+Added: WO2023084313 - Patent Expires 02/09/2042) which we intend to target a wide range of autoimmune diseases.
+Added: we currently have the exclusive rights to develop clinical assets, AZD1656 and AZD5904, which are licensed
+Added: to St George Street by AstraZeneca, in five indications.
+Added: to our relationship with St George Street, we intend to leverage the data generated from these historical trials in order to investigate
+Added: the efficacy and safety to AZD1656 to potentially treat HT, uveitis, preterm labor, and renal transplant patients, and the efficacy and
+Added: safety of AZD5904 to treat IMI.
+Added: AZD1656 has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials
+Added: conducted by AstraZeneca since 2008 and 19 of which were conducted in the U.S.
+Added: Additional information about those clinical trials is
+Added: available at the U.S.
+Added: National Library of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or
+Added: otherwise accessible through such website is not part of this Annual Report).
+Added: AZD5904 has undergone testing in five Phase I clinical
+Added: trials conducted by AstraZeneca, one of which was conducted in the U.S.
+Added: While a significant amount of clinical trial data has already
+Added: been generated for both AZD1656 and AZD5904, some of this data was generated outside of the U.S.
+Added: and accordingly may not be accepted
+Added: In the event that such data is not accepted by the FDA, additional clinical trials may be required, which would result in
+Added: additional costs and time to develop these clinical assets.
+Added: table below sets forth the pre-clinical or clinical trials that have been conducted by or at the direction of AstraZeneca to date on
+Added: the particular clinical asset.
+Added: All of these pre-clinical or clinical trials were conducted by AstraZeneca prior to AstraZeneca entering
+Added: into its license agreement with St George Street.
+Added: None of the pre-clinical or clinical trials that have taken place to date were conducted
+Added: by or at the direction of the Company.
+Added: of Development
+Added: Phase I and Phase II
+Added: United States
+Added: Transplant Patients with Type II Diabetes
+Added: Phase I and Phase II
+Added: Male Infertility
+Added: United States
+Added: following table sets forth the current asset development stage for each of AZD1656 and AZD5904 for the indications noted below.
+Added: at Their Present Stage of Readiness (1)
+Added: Stage of Development to be Conducted by Conduit
+Added: Exit Stage for Monetization (3)
+Added: Thyroiditis & Grave’s Disease
+Added: completion of Phase II
+Added: Male Infertility
+Added: completion of Phase II
+Added: completion of Phase II
+Added: completion of Phase II
+Added: completion of Phase II
+Added: that the asset is considered ready for this Phase.
+Added: For example, if an asset is listed under Phase II, this means that the asset has
+Added: already completed Phase I trials and is therefore considered Phase II ready.
+Added: do not intend to provide additional funding to develop AZD1656 for Covid-19.
+Added: However, we are entitled to a portion of the revenues
+Added: in the event that AZD1656 is further developed by St George Street (or another third party) and is monetized, whether through a
+Added: sale, license agreement, or otherwise.
+Added: the stage at which we currently anticipate that we will seek to monetize such assets through a license, royalty, or other transaction
+Added: with a third party, who would then seek to continue the development of such clinical asset until its potential commercialization
+Added: after Phase III clinical trials were completed.
+Added: There is no assurance that we will be able to monetize such assets by entering into
+Added: a license, royalty, or other transaction with a third party.
+Added: In addition, there is no assurance that any of the clinical assets licensed
+Added: or owned by us will successfully complete Phase II or Phase III clinical trials or obtain regulatory approvals, or that such assets
+Added: will be monetized or commercialized.
+Added: was subject to Phase I and Phase IIa clinical trials consisting of 23 studies in 526 subjects, 446 of whom were dosed with AZD1656.
+Added: than for the intended effect of lowering glucose, there were no difference identified between the AZD1656-treated and placebo-treated
+Added: subjects relating to adverse events.
+Added: All of cases where low glucose levels were identified were managed by the patients and resolved.
+Added: Based on these clinical trials, no safety signals were identified regarding vital signs, safety laboratory values or electrocardiogram
+Added: No deaths occurred in any studies with healthy volunteers or patients.
+Added: AZD1656 was also subject to Phase II clinical trials consisting
+Added: of two studies where AZD1656 was given to patients with Type 2 Diabetes Mellitus for four months or longer.
+Added: In total, there were 754
+Added: randomized patients, 516 of whom were exposed to AZD1656 (316 men and 200 women).
+Added: There were no clinically important differences in the
+Added: adverse effects profile between the AZD1656 treatment group and the AZD1656 placebo group and there were no deaths in either of the Phase
+Added: The efficacy of AZD1656 as a potential treatment for diabetes was also assessed during the Phase II clinical trials, including
+Added: whether the efficacy was statistically significant.
+Added: Clinically relevant and statistically significant reductions in HbA1c were seen after
+Added: however, the initial improvement in glucose control deteriorated over time and the change in HbA1c levels after four months
+Added: were not statistically different than the placebo.
+Added: This decreasing efficacy over time was seen in both Phase II studies.
+Added: was subject to five Phase I clinical studies, with a total of 1181 subjects being exposed to AZD5904.
+Added: Single doses of up to 1200 mg and
+Added: multiple doses of up to 325 mg for up to three times per day for 21 days have been administered as an oral solution in the completed
+Added: clinical studies.
+Added: In addition, single doses of up to 1400 mg and multiple doses of up to 600 mg for 10 days have been administered as
+Added: an “extended release” formulation.
+Added: The data from these studies did not identify any expected adverse drug reactions for AZD5904
+Added: and no adverse effects were reported as related to AZD5904.
+Added: In addition, the data revealed no clinically significant changes in blood
+Added: pressure or pulse rate related to AZD5904 and electrocardiogram data was within the physiological range for the population studied.
+Added: effect of AZD5904 on human myeloperoxidase, which we refer to as MPO, activity was evaluated by determination in an ex vivo assay of
+Added: MPO activity in plasma.
+Added: The correlation between MPO activity and plasma concentrations was assessed for single and multiple doses of
+Added: A relationship between plasma concentrations of AZD5904 and MPO activity was demonstrated, which indicates that AZD5904 may
+Added: be an effective inhibitor of MPO activity in humans.
+Added: However, Phase I trials do not assess statistical significance so additional Phase
+Added: II trials are necessary to determine if the inhibition of MPO activity as a result of AZD5904 is statistically significant.
+Added: in Autoimmune Diseases
+Added: diseases refers to a broad group of diseases and conditions that arise from an abnormal immune response to a functioning body part.
+Added: example, autoimmune diseases may arise from an abnormal immune response of major organs (i.e., the heart, kidneys, bladder, liver, lungs,
+Added: and skin), glands (i.e., the adrenal gland, pancreas, thyroid, or reproductive organs), digestive system, and tissue (i.e., blood, connective
+Added: tissue, muscle, eyes, ears, or vascular system).
+Added: Management believes that there are over 80 types of autoimmune diseases that have been
+Added: identified, including lupus, celiac disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
+Added: diseases are often difficult to diagnose and often the cause of the disease is not known.
+Added: is estimated by the American Autoimmune Related Diseases Association (“AARDA”) that as many as 50 million Americans are living
+Added: with an autoimmune disease – at a cost of $86 billion a year and there is presently no totally effective treatment known to management.
+Added: The currently available treatments for autoimmune diseases include non-steroidal anti-inflammatory drugs (“NSAIDS”) or immune
+Added: suppressants.
+Added: These treatments often improve the symptoms but ultimately do not cure the disease and often involve side effects.
+Added: is a highly specific glucokinase activator;
+Added: originally developed by AstraZeneca for use in diabetes mellitus.
+Added: It has now been tested
+Added: in over 1,000 patients with both type I and II diabetes and no significant safety concerns have been raised.
+Added: It was most recently
+Added: tested in the ARCADIA Phase II trial in diabetic patients hospitalized with Covid-19 on the basis of new research into
+Added: immunometabolic modulation.
+Added: We believe that AZD1656 may be used to activate a patient’s own immune system in order to limit
+Added: harmful inflation.
+Added: We have identified several autoimmune diseases, which reflects good market potential, with a high level of need
+Added: that may be treatable using AZD1656.
+Added: We believe that our clinical assets have the potential to treat numerous autoimmune diseases.
+Added: We intend to initially focus on the indications below in order to maximize the commercial potential of our clinical
+Added: Hashimoto’s Thyroiditis Disease
+Added: Thyroiditis (“HT”) is an autoimmune disease involving the improper functioning of the thyroid.
+Added: HT is an autoimmune disease
+Added: driven by T cells, which are one of the types of white blood cells, where the immune system attacks the thyroid gland.
+Added: believes that HT is the most prevalent autoimmune thyroid disease worldwide and anticipates that the prevalence of HT will continue to
+Added: increase due to rising obesity and the rising prevalence of other autoimmune disorders that made patients more susceptible to HT.
+Added: current treatment for HT involves hormone replacement therapy with levothyroxine.
+Added: However, determining the appropriate dose for each
+Added: individual is complex with the individual needing to continue hormone replacement therapy for the rest of his or her life while still
+Added: suffering with some symptoms of HT.
+Added: Under the current treatment, the patient is monitored by measuring Thyroid-Stimulating Hormone levels
+Added: In addition, this difficulty in titrating the appropriate dose of levothyroxine leads to a high burden of medical
+Added: appointments and the risk of development of comorbidities, including cardiovascular disease.
+Added: believes that the global thyroid gland disorders treatment market was valued at $2.23 billion in 2021 and is set to grow from $2.37 billion
+Added: in 2023 to $2.95 billion by 2030, at a CAGR of 3.17% during the forecast period (2023-2030).
+Added: was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to
+Added: its potential to treat type 2 diabetes.
+Added: As of the date hereof, no preclinical or clinical trials have been conducted on the use of AZD1656
+Added: intend to conduct further trials on AZD1656 relating to HT.
+Added: We plan to conduct further research on AZD1656 to investigate if AZD1656
+Added: is a treatment option for HT, including investigating any negative side effects in the use of AZD1656 as compared to the currently available
+Added: treatment options for HT.
+Added: We, in connection with a CRO, have prepared clinical trial protocols for the use of AZD1656 in HT in a Phase
+Added: II clinical trial:
+Added: a Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AZD1656 in patients
+Added: with HT with an anticipated enrollment of 200 patients.
+Added: Pharmaceutical
+Added: companies typically find market entry for HT clinical assets challenging due to the manufacturing complexities and careful consideration
+Added: of manufacturing product, which are usually patented or trade secrets of companies.
+Added: Due to its relationship with St George Street, we
+Added: have sufficient API to conduct Phase II clinical trials on AZD1656 for the treatment of HT.
+Added: There can be no assurances that the clinical
+Added: trials that we intend to conduct on AZD1656 to treat HT will be successful.
+Added: is an autoimmune disease of the eye that refers to a number of intraocular inflammatory conditions and involves the swelling of the uvea,
+Added: the colored portion of the eyes.
+Added: Management believes that in the U.S.
+Added: uveitis causes an estimated approximately 30,000 new cases of blindness
+Added: per year and may be the third leading cause of blindness worldwide.
+Added: 3 Unlike other leading causes of blindness, uveitis is
+Added: particularly prevalent in younger working-age people.
+Added: Uveitis has a prevalence of around 40-100 per 100,000 persons, and can be subdivided
+Added: into specific conditions, so it qualifies as a rare disease.
+Added: 4 We believe that a treatment for non-infectious uveitis would
+Added: be eligible for orphan drug designation, which provides for market exclusivity of 10 years in the European Union and seven years in the
+Added: United States.
+Added: The global uveitis market size was valued at $456 million in 2022 and is estimated to reach $837 million by 2030, growing
+Added: at a CAGR of 4.8% during the forecast period (2023-2030).
+Added: “Epidemiology
+Added: of uveitis in a US population-based study,” by Marta Mora Gonzalez, Marisee Masis Solano, Travis C.
+Added: Porco, Catherine E.
+Added: Acharya, Shan C.
+Added: Lin, and Matilda F.
+Added: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5904090/)
+Added: “Epidemiology
+Added: and risk factors in non-infectious uveitis:
+Added: a systemic review,” by Katherine A.
+Added: and Anne-Marie Lobo-Chan (Link:
+Added: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8461013/ ).
+Added: which can cause elevated intraocular pressures and cataracts, are often used to manage uveitis.
+Added: Most patients develop elevated intraocular
+Added: pressures and/or cataracts after long-term treatment with steroids and may have to switch therapies or the disease may become resistant
+Added: to steroid treatment.
+Added: Biological drugs have been developed but these are expensive and not always effective as many patients still go
+Added: blind every year.
+Added: was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to
+Added: its potential to treat type 2 diabetes.
+Added: As of December 31, 2023, no preclinical or clinical trials have been conducted on the use of
+Added: AZD1656 to treat uveitis.
+Added: We, in connection with a CRO, have prepared clinical trial protocols relating to the use of AZD1656 in uveitis
+Added: in a Phase II clinical trial:
+Added: a Phase II, double-blind, placebo-controlled study to evaluate the efficacy and safety of ADZ1656 in patients
+Added: with non-infectious uveitis with an anticipated enrollment of 120 patients.
+Added: We intend to conduct further trials on AZD1656 in order to
+Added: investigate if AZD1656 is an option to treat uveitis without the side effects involved in the current treatment using steroids.
+Added: can be no assurances that the clinical trials that we intend to conduct on AZD1656 to treat uveitis will be successful.
+Added: Transplant Failure
+Added: transplant failure occurs when a patient’s body rejects a kidney transplant and involves the gradual decrease in kidney function
+Added: that starts following a kidney transplant surgery and often results in organ failure.
+Added: According to the United Network for Organ Sharing,
+Added: there are around 93,000 patients waiting for a kidney transplant in the U.S.
+Added: The United Network for Organ Sharing reports that the prevalence
+Added: of chronic kidney disease is rising due to other conditions, such as diabetes, and as a result of an aging population.
+Added: The Organ Procurement
+Added: & Transplantation Network reported that during 2023, over 46,000 individuals received an organ transplant and all-time volume records
+Added: were set for kidney transplants of 27,329.
+Added: 6 Management believe that the global kidney transplant market is estimated to be
+Added: valued at $5.8 billion in 2021 and is expected to register a CAGR of 4.2% through to 2033.
+Added: current treatment for renal transplant failure involves using immunosuppressives to suppress the patient’s immune system, which
+Added: has numerous side effects including high blood pressure, weight gain, diabetes, dyslipidemia and some cancers.
+Added: Malignancy, which refers
+Added: to uncontrolled growth and division of abnormal cells, is one of the most common causes of death in kidney transplant recipients.
+Added: Immunosuppressives
+Added: are a major contributing factor to malignancy.
+Added: was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to
+Added: its potential to impact on renal transplant patients with type 2 diabetes.
+Added: We believe that AZD1656 may facilitate the immune system in
+Added: tolerating or accepting the transplanted kidney.
+Added: We intend to conduct Phase II studies on AZD1656 to investigate if AZD1656 decreases
+Added: the rejection in kidney transplant patients.
+Added: We are currently working with a CRO to prepare protocols for clinical trials to investigate
+Added: the use of AZD1656 to reduce the rejection in kidney transplant patients.
+Added: There can be no assurances that the clinical trials that we
+Added: intend to conduct on AZD1656 to treat renal transplant patients will be successful.
+Added: labor refers to labor that begins before 37 weeks of pregnancy.
+Added: Preterm labor may result in premature birth and the earlier the
+Added: premature birth happens, the greater the of health risks for the baby.
+Added: According to an article published in PubMed, globally, 14.84
+Added: million babies were preterm births.
+Added: 8 Preterm labor is a condition that may result in the death of the baby and/or the
+Added: There is no effective treatment for preterm labor that is known to us.
+Added: Management believes that approximately 60,000 babies
+Added: per year in the U.K.
+Added: according to the Mums and Midwives Awareness Academy and approximately 380,000 per year in the U.S.
+Added: preterm according to the Preeclampsia Foundation.
+Added: Globally, prematurity is the leading cause of death in children under the age of
+Added: five years, and preterm labor rates are increasing.
+Added: For example, according to the Centers for Disease Control and Prevention, in the
+Added: U.S., the preterm labor rate rose for the fifth straight year in 2019.
+Added: For 2021, the preterm labor rate in the U.S.
+Added: approximately 10.5%.
+Added: According to the World Health Organization, the rates of preterm labor by country range from approximately 5%
+Added: to approximately 18%.
+Added: Management believe that the global preterm birth prevention and management market size is estimated to stand
+Added: at $1.70 billion in 2024.
+Added: As both developed and developing countries embrace therapeutics for preventing and managing preterm birth,
+Added: the market is expected to exceed a valuation of $4.49 billion by 2034, registering a CAGR of 10.2%.
+Added: Preterm labor results in
+Added: increases costs, both higher costs of labor and neonatal care, and often results in additional medical care during the child’s
+Added: lifetime for those that are born prematurely.
+Added: Accordingly, the reduction in preterm labor would have a significant health and
+Added: economic impact.
+Added: https://optn.transplant.hrsa.gov/news/continued-increase-in-organ-donation-drives-new-records-in-2023-
+Added: new-milestones-exceeded/
+Added: https://pubmed.ncbi.nlm.nih.gov/36964535/
+Added: was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to
+Added: its potential to treat type 2 diabetes.
+Added: As of the date hereof, no preclinical or clinical trials have been conducted on the use of AZD1656
+Added: to treat preterm labor.
+Added: Specially, we intend to conduct a Phase II study on the use of AZD1656 to assist in maintaining pregnancy beyond
+Added: in connection with a CRO, have prepared clinical trial protocols relating to the use of AZD1656 in preterm labor in a Phase II clinical
+Added: a multicenter, randomized, double-bind, placebo-controlled Phase II clinical trial evaluating the efficacy and safety of AZD1656
+Added: in the prevent of preterm labor with an anticipated enrollment of 200 patients.
+Added: In the event that AZD1656 is shown to be able to effectively
+Added: treat preterm labor (of which there can be no assurance), AZD1656 could potentially maintain a pregnancy for longer, reduce the number
+Added: of babies that are born prematurely and reduce the costs associated with preterm labor.
+Added: There can be no assurances that the clinical
+Added: trials that we intend to conduct on AZD1656 to treat preterm labor will be successful.
+Added: drugs for preterm labor are only used for about 24-48 hours once a woman is already in labor, so that the patients can be treated with
+Added: corticosteroids to promote the functioning of the baby’s lungs.
+Added: These drugs are unable to sustain a pregnancy beyond this and are
+Added: not safe to be used for prolonged periods.
+Added: We believe that, in the event that AZD1656 is shown to be able to effectively treat preterm
+Added: labor (of which there can be no assurance), AZD1656 could potentially maintain a pregnancy for longer, reduce the number of babies that
+Added: are born prematurely and reduce the costs associated with preterm labor.
+Added: in Infectious Diseases – Covid-19 and Long Covid
+Added: is a disease caused by a virus named SARS-CoV-2, which refers to severe acute respiratory syndrome coronavirus 2, and is a strain of
+Added: the coronavirus, which is a respiratory illness.
+Added: We continue to have an economic interest in AZD1656 for treatment of Covid-19 and have
+Added: included AZD1656 for the treatment of Covid-19 in our pipeline.
+Added: However, at this time, we do not intend to provide additional funding
+Added: to develop AZD1656 for Covid-19.
+Added: However, we are entitled to a portion of the revenues in the event that AZD1656 is further developed
+Added: by St George Street or other third parties and is monetized, whether through a sale, license agreement, or otherwise.
+Added: While we do not
+Added: intend to further fund the research and development of the use of AZD1656 in Covid, we retain an economic interest in the clinical asset
+Added: and if such asset is further developed through funding provided by other third parties, then we may be entitled to receive compensation
+Added: from those development activities conducted by third parties.
+Added: There can be no assurances that AZD1656 will be further developed or commercialized
+Added: for the treatment of Covid-19 or Long Covid.
+Added: in Idiopathic Male Infertility
+Added: Male Infertility (“IMI”) is defined as failure of a couple to conceive after one year of regular sexual intercourse where
+Added: the physical examination and endocrine laboratory testing of the male are normal, but semen analysis reveals sperm abnormalities.
+Added: Approximately
+Added: 15% of couples globally, or 48.5 million couples globally, are infertile and that 30% of infertility cases can be attributed solely to
+Added: the female, 30% can be attributed solely to the male, 30% can be attributed to a combination of both partners, and 10% of cases have
+Added: an unknown cause.
+Added: 8 According to the National Library of Medicine, male infertility accounts for 30% of infertility cases and
+Added: its prevalence in the general population approximately ranges between 9 and 15%.
+Added: 9 Our management believes that male sperm
+Added: counts have declined in Western men and will continue to decline due, in part, to increasing rates of diseases such as obesity and diabetes
+Added: that can reduce fertility.
+Added: affects families worldwide and is inherent in problems of reproduction.
+Added: Currently, there are no specific treatments for male infertility,
+Added: and we are not aware of any other company that is developing a treatment for male infertility.
+Added: There are no approved pharmacotherapies
+Added: for idiopathic male infertility.
+Added: Lifestyle medicine and unproven supplements are often used.
+Added: Intracytoplasmic sperm injection, a form
+Added: of in vitro fertilization, is the only treatment currently available for male infertility.
+Added: This process is not a treatment of male infertility
+Added: but rather is an alternative means of fertilizing the egg.
+Added: In vitro fertilization places a significant burden on the woman as it requires
+Added: the induction of egg production and harvesting of eggs.
+Added: In vitro fertilization is costly and time consuming and has modest success rates.
+Added: Management believes that the male infertility market size is expected to grow from $3.72 billion in 2023 to $4.42 billion by 2028, at
+Added: a CAGR of 3.54% during the period 2023-2028.
+Added: unique view on male infertility around the globe,” by Ashok Agarwal, Aditi Mulgund, Alaa Hamada, and Michelle Renee Chyatte
+Added: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424520/).
+Added: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10057583/#B1-jcm-12-02366
+Added: sperm are unable to successfully fertilize eggs due to factors including impaired motility, impaired ability to penetrate and/or DNA
+Added: damaged sperm that is unable to form a viable fetus.
+Added: Our development pipeline for AZD5904 includes a potent, irreversible inhibitor of
+Added: human myeloperoxidase, which we refer to as MPO, that has the potential to treat idiopathic male infertility.
+Added: was investigated by AstraZeneca for the treatment of idiopathic male infertility in Phase I trials, which confirmed the suitability to
+Added: progress to Phase II trials.
+Added: While AZD5904 is Phase II ready, our management intends to conduct a Phase Ib “proof of mechanism”
+Added: trial to verify AZD5904 has the intended biological effect in semen (as well as in blood) prior to commencing a Phase II trial for the
+Added: use of AZD5904 to treat idiopathic male infertility.
+Added: Specifically, our management intends to conduct the Phase Ib study in order to see
+Added: if the trial will provide evidence that AZD5904 has its intended effect of inhibiting myeloperoxidase and reduce oxidative stress in
+Added: We believe that AZD5904 has the potential to be used to create a tablet that could treat IMI and would be the first drug developed
+Added: to directly treat IMI.
+Added: We, in connection with a CRO, have prepared clinical trial protocols relating to the use of AZD5904 to treat IMI
+Added: in a Phase Ib clinical trial:
+Added: a Phase Ib, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety,
+Added: tolerability and preliminary efficacy of AZD5904 in adult men with IMI with an anticipated enrollment of 60 patients, and a Phase II
+Added: clinical trial:
+Added: a Phase II, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of AZD5904
+Added: in the treatment of IMI with an anticipated enrollment of 200 patients.
+Added: There can be no assurances that the clinical trials that we intend
+Added: to conduct on AZD5904 to treat idiopathic male infertility will be successful.
+Added: Clinical Assets
+Added: part of our strategic planning process, we intend to explore the efficacy of using AZD1656 to treat other diseases.
+Added: Specifically, we
+Added: intend to conduct research on whether AZD1656 may be effective treating other autoimmune diseases, include systemic lupus erythematosus,
+Added: ANCA vasculitis, rheumatoid arthritis, multiple sclerosis, motor neuron disease, and amyotrophic lateral sclerosis.
+Added: As part of our strategic
+Added: planning process, we intend to explore the efficacy of using AZD1656 to treat other diseases.
+Added: We also plan to further develop the co-crystals
+Added: that we own from our prior development work on AZD1656, including to research the ability of the co-crystals developed from AZD1656 to
+Added: treat psoriasis, Crohn’s disease, lupus, sarcoidosis, diabetic wound healing, idiopathic pulmonary fibrosis, and nonalcoholic steatohepatitis.
+Added: In addition, we currently intend to explore the use of AZD5904 for the treatment of glioma.
+Added: Due to our on-going relationship with St
+Added: George Street, from time to time, there may be additional clinical assets that we are able to partner with St George Street to develop.
+Added: We expect to seek to develop other clinical assets and determine based on pre-clinical and clinical data which clinical assets in order
+Added: to determine which assets in our pipeline to continue to develop.
+Added: Accordingly, we believe that our management team will be able to effectively
+Added: allocate resources to the development of clinical assets that we believe show the most promise.
+Added: However, there can be no guarantee that
+Added: the clinical trials conducted by us of our clinical assets will be successful.
+Added: If we are unable to commercialize our clinical assets
+Added: or experience significant delays in doing so, our business will be materially harmed.
+Added: Manufacturing
+Added: do not currently own or operate any facilities to formulate, manufacture, test, store, package, or distribute any of the clinical assets
+Added: that we are developing or may seek to develop and do not currently have the capabilities to conduct such activities.
+Added: We currently plan
+Added: to rely on third parties to manufacture, store, and test the clinical assets that we seek to develop, including material manufactured
+Added: originally by AstraZeneca.
+Added: We will depend on third-party suppliers and manufacturing organizations for all our required raw materials
+Added: and drug substance and to formulate, manufacture, test, store, package, and distribute clinical trial quantities of clinical assets that
+Added: we may seek to develop.
+Added: We plan to continue to use third-party suppliers and manufacturing organizations and we anticipate expanding
+Added: our network of third-party suppliers and manufacturing organizations as our operations expand.
+Added: have internal personnel and utilize consultants with extensive technical, manufacturing, analytical, and quality experience to oversee
+Added: our contract manufacturing and testing activities.
+Added: Manufacturing is subject to extensive regulations that impose procedural and documentation
+Added: requirements, including, but not limited to, record-keeping, manufacturing processes and controls, personnel, quality control, and quality
+Added: Our systems, procedures, and contractors are required to be in compliance with these regulations and are assessed through
+Added: regular monitoring and formal audits.
+Added: and Development
+Added: research and development activities have included developing co-crystals of AZD1656 to increase patent life.
+Added: Some of this work was completed
+Added: by third-party CROs but all intellectual property is retained by us.
+Added: The successful completion of clinical trials increases the value
+Added: of clinical assets and may lead to the commercialization and/or licensing of such assets to other pharmaceutical companies.
+Added: no assurance that any clinical trials on the assets owned or licensed by us will be successful or any assurance our co-crystal development
+Added: will be successful.
+Added: do not intend to further fund the research and development of the use of AZD1656 in Covid;
+Added: however, we retain an economic interest in
+Added: the clinical asset and if such asset is further developed through funding provided by other third parties, then we may be entitled to
+Added: receive compensation from those development activities conducted by third parties due to its economic interest in AZD1656 in Covid.
+Added: and Marketing
+Added: do not currently have marketing, sales, or distribution capabilities.
+Added: In order to commercialize any clinical asset that is approved for
+Added: commercial sale, we must either develop our own sales, marketing, and distribution infrastructure or collaborate with third parties that
+Added: have such commercial infrastructure and relevant marketing and sales experience.
+Added: We anticipate relying on licensing, co-sale, co-promotion,
+Added: and distribution agreements with strategic partners for the commercialization of our products.
+Added: We do not currently anticipate that we
+Added: would develop our own internal sales force organization.
+Added: operate in the highly competitive pharmaceutical and biotechnology industry.
+Added: Our competitors may include public and private companies,
+Added: universities, governmental agencies, and other research organizations actively engaged in the research and development of clinical assets
+Added: and biopharmaceutical products.
+Added: Our competitors may have greater financial, technical, and human resources than we currently have and/or
+Added: may be better equipped to develop, manufacture, and market their products.
+Added: Our competitors may be developing clinical assets for products
+Added: for similar indications.
+Added: However, we believe that we have an unprecedented advantage in novelty.
+Added: As discussed above, AZD1656 is an activator
+Added: (not an inhibitor) of a metabolic process.
+Added: We anticipate that the number of companies seeking to develop clinical assets, biopharmaceutical
+Added: products, and therapies will continue to increase.
+Added: As a result, the competition we face may also increase.
+Added: However, both in the treatment
+Added: of autoimmune disease and idiopathic male infertility the competition is currently expected to come in years, even if biopharmaceutical
+Added: products that we develop and/or commercialize were not to compete with products of our competitors based on the product efficacy, safety,
+Added: ease of use, price, demonstrated cost-effectiveness, marketing effectiveness, service, reputation, and access to technical information.
+Added: However, we believe that our ability to focus on clinical assets that have been deprioritized by larger pharmaceutical companies is a
+Added: competitive advantage.
+Added: hold exclusive rights to develop AZD1656 and AZD5904 through our Global Funding Agreement with St George Street and we also own the intellectual
+Added: property and the rights to further develop co-crystals resulting from our prior research and development work on AZD1656.
+Added: currently have one pending international patent application and two pending national patent applications.
+Added: Even though we have filed patent
+Added: applications, there is no guarantee that the validity of the patents will be upheld if challenged by a third party, that patents will
+Added: be granted on the applications filed in the respective jurisdictions, or that once granted, the patents will contain claims that encompass
+Added: our commercial products.
+Added: There can be no assurance that any of our intellectual property rights will afford us any protection from competition.
+Added: following patent applications are relevant to the operation of our business:
+Added: Clinical Asset
+Added: Information and Number
+Added: Ownership/Licensing
+Added: Patent Status
+Added: Jurisdictions
+Added: of Matter Patent;
+Added: 101901 (family number)
+Added: to St George Street Capital from AstraZeneca for use in thyroiditis, uveitis, pre-term labor, renal transplant failure.
+Added: Brazil, Canada, Switzerland, China, Germany, European Procedure, Spain, France, United Kingdom, Hong Kong, India, Japan, South Korea,
+Added: Mexico, Netherlands, Russian Federation, Sweden, Turkey, United States
+Added: July 3, 2026.
+Added: 103631 (family number)
+Added: to St George Street Capital from AstraZeneca for use in thyroiditis, uveitis, pre-term labor, renal transplant failure.
+Added: and United States
+Added: February 2030.
+Added: PCT/IB2022/00075
+Added: by Conduit Pharmaceuticals.
+Added: September 2, 2022.
+Added: date September 2, 2022.
+Added: If granted, will expire September 2, 2042.
+Added: Male Infertility;
+Added: AZD5904 use patent;
+Added: 200644 (family number)
+Added: [WO/2019/016074]
+Added: to St George Street Capital from AstraZeneca.
+Added: International
+Added: July 12, 2038.
+Added: have not filed any applications for trademark protection of any names or logos for products or technologies in development.
+Added: seek trademark protection inside and outside of the United States where and when appropriate and if available.
+Added: We intend to use these
+Added: registered marks in connection with our pharmaceutical research and development, including proprietary technologies, as well as our clinical
+Added: expect to protect our products and technologies through a combination of patents, regulatory exclusivity, and potentially confidential
+Added: and proprietary know-how.
+Added: We intend to actively seek to obtain, where appropriate, the broadest commercially reasonable intellectual
+Added: property protection possible for our clinical assets and technologies, including any future clinical assets and technologies under development,
+Added: our proprietary information, and our proprietary technology through a combination of contractual arrangements and patents, in the United
+Added: States and abroad.
+Added: However, we cannot guarantee that patent protection will provide complete protection against competitors who seek
+Added: to circumvent our patents.
+Added: Regulation and Product Approval
+Added: authorities in the United States, at the federal, state, and local level, and in other countries, extensively regulate, among other things,
+Added: the research, development, clinical trials, testing, manufacture, including any manufacturing changes, authorization, pharmacovigilance,
+Added: adverse event reporting, recalls, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import
+Added: and export of pharmaceutical products and clinical assets, including clinical assets such as those we are developing.
+Added: The processes for
+Added: obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes
+Added: and regulations have no guaranteed outcomes and require the expenditure of substantial time and financial resources.
+Added: development plan for each of AZD1656 and AZD5904 is to conduct clinical trials and if those trials are successful, we will then seek
+Added: to enter into a transaction with a third party with respect to AZD1656 orAZD5904, as applicable, for the particular indication.
+Added: not intend to continue development of such clinical assets beyond Phase II clinical trials.
+Added: Accordingly, we anticipate developing clinical
+Added: assets, which we own or license from third parties, that have undergone pre-clinical and clinical trials through the Phase II stage and
+Added: then monetizing such clinical assets through a license, royalty, or other transaction.
+Added: We do not expect that we will commercialize any
+Added: clinical assets or seek marketing approval from the FDA (or similar organizations) as we intend to enter into agreements with third parties
+Added: following Phase II clinical trials for each such clinical asset that would provide that such third party would pursue the further development,
+Added: commercialization, and marketing of such assets.
+Added: following description of the process relating to obtaining regulatory approvals in the United States and in foreign countries is intended
+Added: for informational purposes only as we do not expect to continue the development of any of the clinical assets beyond the Phase II stage.
+Added: There is no assurance that any clinical trials on the assets owned or licensed by us will be successful.
+Added: States Government Regulation
+Added: the United States, the U.S.
+Added: Food and Drug Administration (“FDA”) regulates drugs under the Federal Food, Drug, and Cosmetic
+Added: Act (“FDCA”) and implementing regulations.
+Added: Failure to comply with the applicable United States requirements at any time during
+Added: the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial
+Added: sanctions, such as the FDA’s refusal to approve pending New Drug Applications (“NDAs”), withdrawal of an approval,
+Added: imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production
+Added: or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil and/or criminal penalties.
+Added: process required by the FDA before a drug may be marketed in the United States generally involves the following steps, each of which
+Added: requires the expenditure of substantial time and financial resources:
+Added: of preclinical laboratory tests, animal studies and formulation studies in compliance with good laboratory practices (“GLPs”)
+Added: and other applicable regulations;
+Added: to the FDA of an Investigational New Drug Application (“IND”), which must become effective before human clinical trials
+Added: by an independent institutional review board (“IRB”) at each clinical site before each trial may be initiated;
+Added: of well-controlled human clinical trials in accordance with good clinical practices (“GCPs”), which may include placebo
+Added: controls, to establish the safety and efficacy of the proposed drug product for each indication;
+Added: to the FDA of an NDA and payment of fees;
+Added: completion of an FDA advisory committee review, if applicable;
+Added: completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the product is produced to assess
+Added: compliance with current good manufacturing practices (“cGMPs”) and to assure that the facilities, methods and controls
+Added: are adequate to preserve the drug’s identity, strength, quality and purity;
+Added: completion of audits of clinical trial sites conducted by FDA to assure compliance with GCPs and the integrity of clinical data;
+Added: review and approval of the NDA.
+Added: studies include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies to assess potential
+Added: safety and efficacy.
+Added: Preclinical tests intended for submission to the FDA to support the safety of a clinical asset must be conducted
+Added: in compliance with GLP regulations and the U.S.
+Added: Department of Agriculture’s Animal Welfare Act.
+Added: A drug sponsor must submit the
+Added: results of the preclinical tests, together with manufacturing information, analytical data and any available ex-U.S.
+Added: clinical data or
+Added: relevant literature, among other things, to the FDA as part of an IND.
+Added: Some nonclinical testing may continue even after the IND is submitted.
+Added: An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions
+Added: related to one or more proposed clinical trials and places the clinical trial on a clinical hold.
+Added: In such a case, the IND sponsor and
+Added: the FDA must resolve any outstanding concerns before the clinical trial can begin.
+Added: As a result, submission of an IND may not result in
+Added: the FDA allowing clinical trials to commence.
+Added: A clinical hold may occur at any time during the life of an IND and may affect one or more
+Added: specific studies or all studies conducted under the IND.
+Added: the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research
+Added: subjects are being exposed to an unacceptable health risk.
+Added: Similarly, an Institutional Review Board (“IRB”) can suspend or
+Added: terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s
+Added: requirements or if the drug candidate has been associated with unexpected serious harm to patients.
+Added: trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators
+Added: in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent in writing
+Added: for their participation in any clinical trial along with the requirement to ensure that the data and results reported from the clinical
+Added: trials are credible and accurate.
+Added: Clinical trials are conducted under protocols detailing, among other things, the objectives of the
+Added: trial, the criteria for determining subject eligibility, the dosing plan, the parameters to be used in monitoring safety, the procedure
+Added: for timely reporting of adverse events, and the effectiveness criteria to be evaluated.
+Added: A protocol for each clinical trial and any subsequent
+Added: protocol amendments must be submitted to the FDA as part of the IND.
+Added: In addition, an IRB at each institution participating in the clinical
+Added: trial must review and approve the plan for any clinical trial before it commences at that institution.
+Added: about certain clinical trials and clinical trial results must be submitted within specific timeframes to the National Institutes of Health
+Added: for public dissemination on the Clinicaltrials.gov registry.
+Added: Failure to timely register a covered clinical study or to submit study results
+Added: as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant
+Added: funds from the federal government.
+Added: The government has recently begun enforcing these registration and results reporting requirements
+Added: against non-compliant clinical trial sponsors.
+Added: clinical trials are typically conducted in at least three sequential phases and occasionally four or more, which may require repetition,
+Added: or overlap or be combined:
+Added: The drug candidate is initially introduced into healthy human subjects or patients with the target disease or condition and
+Added: tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of
+Added: its effectiveness.
+Added: During Phase I clinical trials, sufficient information about the investigational drug’s pharmacokinetics and
+Added: pharmacological effects may be obtained to permit the design of well-controlled and scientifically valid Phase II clinical trials.
+Added: The drug candidate is administered to a larger, but still limited patient population to identify possible adverse effects
+Added: and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted indications and to determine dosage tolerance
+Added: and optimal dosage.
+Added: Phase II clinical trials are typically well-controlled and closely monitored.
+Added: The drug candidate is administered to an expanded patient population, generally at geographically dispersed clinical trial
+Added: sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for
+Added: approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product.
+Added: Phase III clinical trials usually involve a larger number of participants than a Phase II clinical trial.
+Added: is no guarantee that a clinical asset will successfully complete any such clinical trials.
+Added: There is no assurance that any clinical trials
+Added: on the assets owned or licensed by Conduit will be successful.
+Added: with FDA During the Clinical Development Program
+Added: the clearance of an IND and the commencement of clinical trials, the sponsor of such trial will continue to have interactions with the
+Added: Progress reports detailing the results of clinical trials must be submitted at least annually to the FDA and more frequently if
+Added: serious adverse events occur.
+Added: In addition, IND safety reports must be submitted to the FDA for any of the following:
+Added: serious and unexpected
+Added: suspected adverse reactions;
+Added: findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed
+Added: to the product;
+Added: and any clinically important increase in the occurrence of a serious suspected adverse reaction over that listed in the
+Added: protocol or investigator brochure.
+Added: addition, sponsors are given opportunities to meet with the FDA at certain points in the clinical development program.
+Added: Specifically,
+Added: sponsors may meet with the FDA prior to the submission of an IND (“pre-IND meeting”), at the end of Phase II clinical trial
+Added: (“EOP2” meeting) and before an NDA is submitted (“pre-NDA meeting”).
+Added: Meetings at other times may also be requested.
+Added: These meetings provide an opportunity for the sponsor to share information about the data gathered to date with the FDA and for the FDA
+Added: to provide advice on the next phase of development.
+Added: For example, at an EOP2, a sponsor may discuss its Phase II clinical results and
+Added: present its plans for the pivotal Phase III clinical trial(s) that it believes will support the approval of the new product.
+Added: Such meetings
+Added: may be conducted in person, via teleconference/videoconference or written response only with minutes reflecting the questions that the
+Added: sponsor posed to the FDA and the agency’s responses.
+Added: The FDA has indicated that its responses, as conveyed in meeting minutes and
+Added: advice letters, only constitute recommendations and/or advice made to a sponsor and, as such, sponsors are not bound by such recommendations
+Added: and/or advice.
+Added: Nonetheless, from a practical perspective, a sponsor’s failure to follow the FDA’s recommendations for design
+Added: of a clinical program may put the program at significant risk of failure.
+Added: successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, along with information
+Added: relating to the product’s chemistry, manufacturing, controls, safety updates, patent information, abuse information and proposed
+Added: labeling, are submitted to the FDA as part of an application requesting approval to market the clinical asset for one or more indications.
+Added: Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number
+Added: of alternative sources, including studies initiated by investigators.
+Added: To support marketing approval, the data submitted must be sufficient
+Added: in quality and quantity to establish the safety and efficacy of a drug product.
+Added: The fee required for the submission and review of an
+Added: application under the Prescription Drug User Fee Act (“PDUFA”) is substantial, and the sponsor of an approved application
+Added: is also subject to an annual program fee assessed based on eligible prescription drug products.
+Added: These fees are typically adjusted annually,
+Added: and exemptions and waivers may be available under certain circumstances, such as where a waiver is necessary to protect the public health,
+Added: where the fee would present a significant barrier to innovation, or where the applicant is a small business submitting its first human
+Added: therapeutic application for review.
+Added: FDA conducts a preliminary review of all applications within 60 days of receipt and must inform the sponsor at that time or before whether
+Added: an application is sufficiently complete to permit substantive review.
+Added: In pertinent part, the FDA’s regulations provide that the
+Added: agency may refuse to file an application if the application does not include all pertinent information and data necessary for review
+Added: In the event that the FDA determines that an application does not satisfy this standard, it will issue a Refuse to File (“RTF”)
+Added: determination to the applicant.
+Added: Typically, an RTF will be based on administrative incompleteness, such as clear omission of information
+Added: or sections of required information;
+Added: scientific incompleteness, such as omission of critical data, information or analyses needed to
+Added: evaluate safety and efficacy or provide adequate directions for use;
+Added: or inadequate content, presentation, or organization of information
+Added: such that substantive and meaningful review is precluded.
+Added: The FDA may request additional information rather than accept an application
+Added: In this event, the application must be resubmitted with the additional information.
+Added: The resubmitted application is also subject
+Added: to review before the FDA accepts it for filing.
+Added: the submission is accepted for filing, the FDA begins an in-depth substantive review of the application.
+Added: The FDA reviews the application
+Added: to determine, among other things, whether the proposed product is safe and effective for its intended use, whether it has an acceptable
+Added: purity profile and whether the product is being manufactured in accordance with cGMP.
+Added: the goals and policies agreed to by the FDA under PDUFA, the FDA has 10 months from the filing date in which to complete its initial
+Added: review of a standard application that is a new molecular entity, and six months from the filing date for an application with “priority
+Added: review.” The review process may be extended by the FDA for three additional months to consider new information or in the case of
+Added: a clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.
+Added: Despite these review goals, the NDA review process can be very lengthy, and it is not uncommon for FDA review of an application to extend
+Added: beyond the PDUFA target action date.
+Added: Most innovative drug products (other than biological products) obtain FDA marketing approval pursuant
+Added: to an NDA submitted under Section 505(b)(1) of the FDCA, commonly referred to as a traditional or “full NDA.” In 1984, with
+Added: passage of the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, that established an
+Added: abbreviated regulatory scheme authorizing the FDA to approve generic drugs based on an innovator or “reference” product,
+Added: Congress also enacted Section 505(b)(2) of the FDCA, which provides a hybrid pathway combining features of a traditional NDA and a generic
+Added: drug application.
+Added: Section 505(b)(2) enables the applicant to rely, in part, on the FDA’s prior findings of safety and efficacy
+Added: data for an existing product, or published literature, in support of its application.
+Added: Section 505(b)(2) NDAs may provide an alternate
+Added: path to FDA approval for new or improved formulations or new uses of previously approved products that would require new clinical data
+Added: to demonstrate safety or effectiveness.
+Added: Section 505(b)(2) permits the filing of an NDA in which the applicant relies, at least in part,
+Added: on information from studies made to show whether a drug is safe or effective that were not conducted by or for the applicant and for
+Added: which the applicant has not obtained a right of reference or use.
+Added: A Section 505(b)(2) applicant may eliminate or reduce the need to conduct
+Added: certain preclinical or clinical studies, if it can establish that reliance on studies conducted for a previously approved product is
+Added: scientifically appropriate.
+Added: The FDA may also require companies to perform additional studies or measurements, including nonclinical and
+Added: clinical studies, to support the change from the approved product.
+Added: The FDA may then approve the new clinical asset for all or some of
+Added: the labeled indications for which the referenced product has been approved, as well as for any new indication for which the Section 505(b)(2)
+Added: NDA applicant has submitted data.
+Added: connection with its review of an application, the FDA will typically submit information requests to the applicant and set deadlines for
+Added: responses thereto.
+Added: The FDA will also conduct a pre-approval inspection of the manufacturing facilities for the new product to determine
+Added: whether the manufacturing processes and facilities comply with cGMPs.
+Added: The FDA will not approve the product unless it determines that
+Added: the manufacturing processes and facilities are in compliance with cGMP requirements and are adequate to assure consistent production
+Added: of the product within required specifications.
+Added: FDA also may inspect the sponsor and one or more clinical trial sites to assure compliance with IND and GCP requirements and the integrity
+Added: of the clinical data submitted to the FDA.
+Added: To ensure cGMP and GCP compliance by its employees and third-party contractors, an applicant
+Added: may incur significant expenditure of time, money and effort in the areas of training, record keeping, production and quality control.
+Added: The FDA generally accepts data from foreign clinical trials in support of an NDA if the trials were conducted under an IND.
+Added: clinical trial is not conducted under an IND, the FDA nevertheless may accept the data in support of an NDA if the study was conducted
+Added: in accordance with GCPs and the FDA is able to validate the data through an on-site inspection, if deemed necessary.
+Added: Although the FDA
+Added: generally requests that marketing applications be supported by some data from domestic clinical trials, the FDA may accept foreign data
+Added: as the sole basis for marketing approval if (1) the foreign data are applicable to the United States population and United States medical
+Added: practice, (2) the studies were performed by clinical investigators with recognized competence, and (3) the data may be considered valid
+Added: without the need for an on-site inspection or, if the FDA considers the inspection to be necessary, the FDA is able to validate the data
+Added: through an on-site inspection or other appropriate means.
+Added: FDA may also refer an application, including applications for novel clinical asset which present difficult questions of safety or efficacy,
+Added: to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions.
+Added: Typically, an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews,
+Added: evaluates and provides a recommendation as to whether the application should be approved and under what conditions.
+Added: The FDA is not bound
+Added: by the recommendation of an advisory committee, but it considers such recommendations when making final decisions on approval.
+Added: from clinical trials are not always conclusive, and the FDA or its advisory committee may interpret data differently than the sponsor
+Added: interprets the same data.
+Added: The FDA may also re-analyze the clinical trial data, which could result in extensive discussions between the
+Added: FDA and the applicant during the review process or delay, limit or prevent regulatory approval.
+Added: The FDA may not grant approval on a timely
+Added: basis or at all.
+Added: FDA also may require submission of a risk evaluation and mitigation strategy (“REMS”) if it determines that a REMS is necessary
+Added: to ensure that the benefits of the drug product outweigh its risks and to assure the safe use of the product.
+Added: The REMS could include
+Added: medication guides, physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution
+Added: methods, patient registries or other risk minimization tools.
+Added: The FDA determines the requirement for a REMS, as well as the specific
+Added: REMS provisions, on a case-by-case basis.
+Added: If the FDA concludes a REMS is needed, the sponsor of the application must submit a proposed
+Added: REMS and the FDA will not approve the application without a REMS.
+Added: FDA reviews an application to determine, among other things, whether the product is safe and whether it is effective for its intended
+Added: use(s), with the latter determination being made on the basis of substantial evidence.
+Added: The term “substantial evidence” is
+Added: defined under the FDCA as “evidence consisting of adequate and well-controlled investigations, including clinical investigations,
+Added: by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which
+Added: it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have
+Added: under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”
+Added: FDA has interpreted this evidentiary standard to require at least two adequate and well-controlled clinical investigations to establish
+Added: effectiveness of a new product.
+Added: Under certain circumstances, however, the FDA has indicated that a single trial with certain characteristics
+Added: and additional information may satisfy this standard.
+Added: This approach was subsequently endorsed by Congress in 1998 with legislation providing,
+Added: in pertinent part, that “If [the FDA] determines, based on relevant science, that data from one adequate and well-controlled clinical
+Added: investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the
+Added: FDA may consider such data and evidence to constitute substantial evidence.” This modification to the law recognized the potential
+Added: for the FDA to find that one adequate and well controlled clinical investigation with confirmatory evidence, including supportive data
+Added: outside of a controlled trial, is sufficient to establish effectiveness.
+Added: In December 2019, the FDA issued draft guidance further explaining
+Added: the studies that are needed to establish substantial evidence of effectiveness, and in September 2023 it issued a draft guidance that
+Added: complements the 2019 draft guidance.
+Added: The FDA has not yet finalized either guidance.
+Added: evaluating the application and all related information, including the advisory committee recommendations, if any, and inspection reports
+Added: of manufacturing facilities and clinical trial sites, the FDA will issue either a Complete Response Letter (“CRL”) or an
+Added: approval letter.
+Added: To approve the application, the FDA must determine that the drug is effective and that its expected benefits outweigh
+Added: its potential risks to patients.
+Added: This “benefit-risk” assessment is informed by the extensive body of evidence about the product’s
+Added: safety and efficacy in the NDA.
+Added: This assessment is also informed by other factors, including:
+Added: the severity of the underlying condition
+Added: and how well patients’ medical needs are addressed by currently available therapies;
+Added: uncertainty about how the premarket clinical
+Added: trial evidence will extrapolate to real-world use of the product in the post-market setting;
+Added: and whether risk management tools are necessary
+Added: to manage specific risks.
+Added: In connection with this assessment, the FDA review team will assemble all individual reviews and other documents
+Added: into an “action package,” which becomes the record for FDA review.
+Added: The review team then issues a recommendation, and a senior
+Added: FDA official makes a decision.
+Added: CRL indicates that the review cycle of the application is complete, and the application will not be approved in its present form.
+Added: generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the
+Added: FDA to reconsider the application.
+Added: The CRL may require additional clinical or other data, additional pivotal Phase III clinical trial(s)
+Added: and/or other significant and time-consuming requirements related to clinical trials, preclinical studies or manufacturing.
+Added: issued, the applicant will have one year to respond to the deficiencies identified by the FDA, at which time the FDA can deem the application
+Added: withdrawn or, in its discretion, grant the applicant an additional six-month extension to respond.
+Added: The FDA has committed to reviewing
+Added: resubmissions in response to an issued CRL in either two or six months depending on the type of information included.
+Added: Even with the submission
+Added: of this additional information, however, the FDA ultimately may decide that the application does not satisfy the regulatory criteria
+Added: for approval.
+Added: approval letter, on the other hand, authorizes commercial marketing of the product with specific prescribing information for specific
+Added: That is, the approval will be limited to the conditions of use ( e.g.
+Added: , patient population, indication) described in
+Added: the FDA-approved labeling.
+Added: Further, depending on the specific risk(s) to be addressed, the FDA may require that contraindications, warnings
+Added: or precautions be included in the product labeling, require that post-approval trials, including Phase 4 clinical trials, be conducted
+Added: to further assess a product’s safety after approval, require testing and surveillance programs to monitor the product after commercialization
+Added: or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS which can materially
+Added: affect the potential market and profitability of the product.
+Added: The FDA may prevent or limit further marketing of a product based on the
+Added: results of post-marketing trials or surveillance programs.
+Added: After approval, some types of changes to the approved product, such as adding
+Added: new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and
+Added: FDA Expedited Review Programs
+Added: FDA is authorized to designate certain products for expedited development or review if they are intended to address an unmet medical
+Added: need in the treatment of a serious or life-threatening disease or condition.
+Added: These programs include fast track designation, breakthrough
+Added: therapy designation, and priority review designation.
+Added: The purpose of these programs is to provide important new drugs to patients earlier
+Added: than under standard FDA review procedures.
+Added: be eligible for a fast-track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat
+Added: a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need.
+Added: The FDA will determine
+Added: that a product will fill an unmet medical need if it will provide a therapy where none exists or provide a therapy that may be potentially
+Added: superior to existing therapy based on efficacy or safety factors.
+Added: Fast track designation provides additional opportunities for interaction
+Added: with the FDA’s review team and may allow for a rolling review of NDA components before the completed application is submitted,
+Added: if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines
+Added: that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.
+Added: fast track designation may be withdrawn by the sponsor or rescinded by the FDA if the designation is no longer supported by data emerging
+Added: in the clinical trial process.
+Added: addition, with the enactment of the FDA Safety and Innovation Act (“FDASIA”) in 2012, Congress created a new regulatory program
+Added: for therapeutic candidates designated by FDA as “breakthrough therapies” upon a request made by the IND sponsors.
+Added: A breakthrough
+Added: therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening
+Added: disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing
+Added: therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
+Added: The FDA must take certain actions with respect to breakthrough therapies, such as holding timely meetings with and providing advice to
+Added: the product sponsor, intended to expedite the development and review of an application for approval of a breakthrough therapy.
+Added: the FDA may designate a product for priority review if it is a drug that treats a serious condition and, if approved, would provide a
+Added: significant improvement in safety or effectiveness.
+Added: The FDA determines at the time that the marketing application is submitted, on a
+Added: case-by-case basis, whether the proposed drug represents a significant improvement in treatment, prevention or diagnosis of disease when
+Added: compared with other available therapies.
+Added: Significant improvement may be illustrated by evidence of increased effectiveness in the treatment
+Added: of a condition, elimination or substantial reduction of a treatment-limiting drug reaction, documented enhancement of patient compliance
+Added: that may lead to improvement in serious outcomes, or evidence of safety and effectiveness in a new subpopulation.
+Added: A priority review designation
+Added: is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for
+Added: taking action on a marketing application from ten months to six months for an NDA for a new molecular entity from the date of filing.
+Added: if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for
+Added: qualification or decide that the time period for FDA review or approval will not be shortened.
+Added: Furthermore, fast track designation, breakthrough
+Added: therapy designation and priority review do not change the standards for approval and may not ultimately expedite the development or approval
+Added: Approval Pathway
+Added: addition, a product studied for its safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful
+Added: therapeutic benefit over existing treatments may receive accelerated approval, meaning that it may be approved on (i) the basis of adequate
+Added: and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely
+Added: to predict clinical benefit, or (ii) on an intermediate clinical endpoint that can be measured earlier than irreversible morbidity or
+Added: mortality (“IMM”) and that is reasonably likely to predict an effect on IMM or other clinical benefits, taking into account
+Added: the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.
+Added: As a condition of approval,
+Added: the FDA may require a sponsor of a drug receiving accelerated approval to perform post-marketing studies to verify and describe the predicted
+Added: effect on IMM or other clinical endpoints, and the drug may be subject to expedited withdrawal procedures.
+Added: Drugs granted accelerated
+Added: approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.
+Added: accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval
+Added: confirmatory studies to verify and describe the drug’s clinical benefit.
+Added: As a result, a therapeutic candidate approved on this
+Added: basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials
+Added: to confirm the effect on the clinical endpoint.
+Added: Failure to conduct required post-approval studies, or to confirm the predicted clinical
+Added: benefit of the product during post-marketing studies, would allow the FDA to withdraw approval of the drug.
+Added: All promotional materials
+Added: for drug products being considered and approved under the accelerated approval program are subject to prior review by the FDA.
+Added: FDA officials, and other stakeholders have recently been evaluating the accelerated approval program and have proposed potential reforms
+Added: to improve certain aspects.
+Added: Scrutiny of the accelerated approval pathway is likely to continue and may lead to legislative and/or administrative
+Added: changes in the future.
+Added: Post-Approval
+Added: manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among
+Added: other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion
+Added: and reporting of adverse experiences with the product.
+Added: After approval, most changes to the approved product, such as adding new indications
+Added: or other labeling claims, are subject to prior FDA review and approval.
+Added: Certain modifications to the product, including changes in indications
+Added: or manufacturing processes or facilities, may require the applicant to develop additional data or conduct additional preclinical studies
+Added: and clinical trials to support the submission to FDA.
+Added: As previously noted, there also are continuing, annual user fee requirements for
+Added: any marketed products, as well as new application fees for supplemental applications with clinical data.
+Added: FDA may impose a number of post-approval requirements as a condition of approval of an NDA.
+Added: For example, the FDA may require post-marketing
+Added: testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness
+Added: after commercialization.
+Added: addition, FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs.
+Added: regulations include requirements relating to the organization of personnel, buildings and facilities, equipment, control of components
+Added: and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution,
+Added: laboratory controls, records and reports and returned or salvaged products.
+Added: Drug manufacturers and other entities involved in the manufacture
+Added: and distribution of approved drugs are required to register their establishments with the FDA and some state agencies and are subject
+Added: to periodic unannounced inspections by the FDA for compliance with cGMP requirements and other laws.
+Added: Changes to the manufacturing process
+Added: are strictly regulated and, depending on the significance of the change, may require prior FDA approval before being implemented.
+Added: regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements
+Added: upon the sponsor and any third-party manufacturers.
+Added: Accordingly, manufacturers must continue to expend time, money, and effort in production
+Added: and quality control to maintain compliance with cGMP and other aspects of quality control and quality assurance.
+Added: FDA strictly regulates the marketing, labeling, advertising and promotion of drug products that are placed on the market.
+Added: A product cannot
+Added: be commercially promoted before it is approved, and approved drugs may generally be promoted only for their approved indications and
+Added: for use in patient populations described in the product’s approved labeling.
+Added: Promotional claims must also be consistent with the
+Added: product’s FDA-approved label, including claims related to safety and effectiveness.
+Added: The government closely scrutinizes the promotion
+Added: of prescription drugs in specific contexts such as direct-to-consumer advertising, industry-sponsored scientific and educational activities,
+Added: and promotional activities involving the Internet and social media.
+Added: Although physicians may prescribe legally available products for
+Added: off-label uses, manufacturers may not market or promote such uses.
+Added: discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing
+Added: processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety
+Added: imposition of post-market studies or clinical trials to assess new safety risks;
+Added: or imposition of distribution or other
+Added: restrictions under a REMS program.
+Added: Other potential consequences of regulatory non-compliance include, among other things:
+Added: on, or suspensions of, the marketing or manufacturing of the product, complete withdrawal of the product from the market or product
+Added: of production processes, including the shutdown of manufacturing facilities or production lines or the imposition of new manufacturing
requirements;
−Removed: None of the funds held in the Trust Account will be used to purchase shares or public warrants in such transactions prior
−Removed: to completion of our initial business combination.
−Removed: purpose of any such purchases of shares could be to vote such shares in favor of the initial business combination and thereby increase
−Removed: the likelihood of obtaining stockholder approval of the initial business combination or to satisfy a closing condition in an agreement
−Removed: 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,
−Removed: where it appears that such requirement would otherwise not be met.
−Removed: The purpose of any such purchases of public warrants could be to reduce
−Removed: the number of public warrants outstanding or to vote such warrants on any matters submitted to the warrant holders for approval in connection
−Removed: with our initial business combination.
−Removed: Any such purchases of our securities may result in the completion of our initial business combination
−Removed: that may not otherwise have been possible.
−Removed: In addition, if such purchases are made, the public “float” of our shares of Class
−Removed: A common stock or warrants may be reduced and the number of beneficial holders of our securities may be reduced, which may make it difficult
−Removed: to maintain or obtain the quotation, listing or trading of our securities on a national securities exchange.
−Removed: sponsor, officers, directors and/or their affiliates anticipate that they may identify the stockholders with whom our sponsor, officers,
−Removed: directors or their affiliates may pursue privately negotiated purchases by either the stockholders contacting us directly or by our receipt
−Removed: of redemption requests submitted by stockholders following our mailing of proxy materials in connection with our initial business combination.
−Removed: To the extent that our sponsor, officers, directors or their affiliates enter into a private purchase, they would identify and contact
−Removed: only potential selling stockholders who have expressed their election to redeem their shares for a pro rata share of the Trust Account
−Removed: or vote against our initial business combination, whether or not such stockholder has already submitted a proxy with respect to our initial
−Removed: business combination.
−Removed: Our sponsor, officers, directors or their affiliates will only purchase public shares if such purchases comply
−Removed: with Regulation M under the Exchange Act and the other federal securities laws.
−Removed: purchases by our sponsor, officers, directors and/or their affiliates who are affiliated purchasers under Rule 10b-18 under the Exchange
−Removed: Act will only be made to the extent such purchases are able to be made in compliance with Rule 10b-18, which is a safe harbor from liability
−Removed: for manipulation under Section 9(a)(2) and Rule 10b-5 of the Exchange Act.
−Removed: Rule 10b-18 has certain technical requirements that must be
−Removed: complied with in order for the safe harbor to be available to the purchaser.
−Removed: Our sponsor, officers, directors and/or their affiliates
−Removed: will not make purchases of common stock if the purchases would violate Section 9(a)(2) or Rule 10b-5 of the Exchange Act.
−Removed: We expect that
−Removed: any such purchases will be reported pursuant to Section 13 and Section 16 of the Exchange Act to the extent such purchases are subject
−Removed: to such reporting requirements.
−Removed: Rights for Public Stockholders upon Completion of our Initial Business Combination
−Removed: will provide our public stockholders with the opportunity to redeem all or a portion of their shares of Class A common stock upon the
−Removed: completion of our initial business combination, including the Conduit Business Combination, at a per-share price, payable in cash, equal
−Removed: to the aggregate amount then on deposit in the Trust Account as of two business days prior to the consummation of the initial business
−Removed: combination including interest earned on the funds held in the Trust Account and not previously released to us to pay our taxes, divided
−Removed: by the number of then outstanding public shares, subject to the limitations described herein.
−Removed: The amount in the Trust Account is anticipated
−Removed: to be approximately $11.05 per public share, assuming our sponsor makes the Maximum Contribution, less any tax obligations.
−Removed: otherwise set forth herein, all references to the approximately $11.05 per share redemption amount assume that our sponsor will have
−Removed: made the Maximum Contribution and do not include any interest generated on the amounts in the trust account.
−Removed: Our sponsor, officers and
−Removed: directors have entered into a letter agreement with us, pursuant to which they have agreed to waive their redemption rights with respect
−Removed: to any founder shares and any public shares held by them in connection with the completion of our initial business combination.
−Removed: of Conducting Redemptions
−Removed: will provide our public stockholders with the opportunity to redeem all or a portion of their public shares of Class A common stock upon
−Removed: the completion of our initial business combination either (i) in connection with a stockholder meeting called to approve the initial
−Removed: business combination, as in the case of the Conduit Business Combination, or (ii) by means of a tender offer.
−Removed: The decision as to whether
−Removed: we will seek stockholder approval of a proposed initial business combination or conduct a tender offer will be made by us, solely in
−Removed: 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
−Removed: would require us to seek stockholder approval under the law or stock exchange listing requirement.
−Removed: Under Nasdaq rules, asset acquisitions
−Removed: and stock purchases would not typically require stockholder approval while direct mergers with our company where we do not survive and
−Removed: any transactions where we issue more than 20% of our outstanding common stock or seek to amend our certificate of incorporation would
−Removed: require stockholder approval.
−Removed: If we structure an initial business combination with a target company in a manner that requires stockholder
−Removed: approval, we will not have discretion as to whether to seek a stockholder vote to approve the proposed initial business combination.
−Removed: We may conduct redemptions without a stockholder vote pursuant to the tender offer rules of the SEC unless stockholder approval is required
−Removed: by law or stock exchange listing requirements or we choose to seek stockholder approval for business or other legal reasons.
−Removed: as we obtain and maintain a listing for our securities on the Nasdaq we will be required to comply with such rules.
−Removed: stockholder approval of the transaction is required by law or stock exchange listing requirement, or we decide to obtain stockholder
−Removed: approval for business or other legal reasons, we will, pursuant to our certificate of incorporation:
−Removed: the redemptions in conjunction with a proxy solicitation pursuant to Regulation 14A of the Exchange Act, which regulates the solicitation
−Removed: of proxies, and not pursuant to the tender offer rules, and
−Removed: proxy materials with the SEC.
−Removed: the event that we seek stockholder approval of our initial business combination, we will distribute proxy materials and, in connection
−Removed: therewith, provide our public stockholders with the redemption rights described above upon completion of the initial business combination.
−Removed: we seek stockholder approval, we will complete our initial business combination only if a majority of the outstanding shares of common
−Removed: stock present and entitled to vote at the meeting to approve the initial business combination when a quorum is present are voted in favor
−Removed: of the initial business combination.
−Removed: A quorum for such meeting will consist of the holders present in person or by proxy of shares of
−Removed: outstanding capital stock of the Company representing a majority of the voting power of all outstanding shares of capital stock of the
−Removed: Company entitled to vote at such meeting.
−Removed: Our initial stockholders will count toward this quorum and pursuant to the letter agreement,
−Removed: our sponsor, officers and directors have agreed to vote any founder shares held by them and any public shares acquired during or after
−Removed: our initial public offering (including in open market and privately negotiated transactions) in favor of our initial business combination.
−Removed: For purposes of seeking approval of the majority of our outstanding shares of common stock voted, non-votes will have no effect on the
−Removed: approval of our initial business combination once a quorum is obtained.
−Removed: In order to have our initial business combination approved (assuming
−Removed: only the minimum number of shares representing a quorum are voted), we would need 716,864, or approximately 33% of the 2,187,728 Class
−Removed: A common Stock public shares, to be voted in favor of an initial business combination, in addition to our initial stockholders’
−Removed: founder shares.
−Removed: We intend to give approximately 30 days (but not less than 10 days nor more than 60 days) prior written notice of any
−Removed: such meeting, if required, at which a vote shall be taken to approve our initial business combination.
−Removed: These quorums and voting thresholds,
−Removed: and the voting agreements of our initial stockholders, may make it more likely that we will consummate our initial business combination.
−Removed: Each public stockholder may elect to redeem its public shares irrespective of whether they vote for or against the proposed transaction.
−Removed: a stockholder vote is not required and we do not decide to hold a stockholder vote for business or other legal reasons, we will, pursuant
−Removed: to our certificate of incorporation:
−Removed: the redemptions pursuant to Rule 13e-4 and Regulation 14E of the Exchange Act, which regulate issuer tender offers, and
−Removed: tender offer documents with the SEC prior to completing our initial business combination which contain substantially the same financial
−Removed: and other information about the initial business combination and the redemption rights as is required under Regulation 14A of the
−Removed: Exchange Act, which regulates the solicitation of proxies.
−Removed: the public announcement of our initial business combination, we or our sponsor will terminate any plan established in accordance with
−Removed: Rule 10b5-1 to purchase shares of our Class A common stock in the open market if we elect to redeem our public shares through a tender
−Removed: offer, to comply with Rule 14e-5 under the Exchange Act.
−Removed: the event we conduct redemptions pursuant to the tender offer rules, our offer to redeem will remain open for at least 20 business days,
−Removed: in accordance with Rule 14e-1(a) under the Exchange Act, and we will not be permitted to complete our initial business combination until
−Removed: the expiration of the tender offer period.
−Removed: In addition, so that we are not subject to the SEC’s “penny stock” rules,
−Removed: we will not redeem any public shares unless (i) our net tangible assets will be at least $5,000,001 either immediately prior to or upon
−Removed: consummation of our initial business combination and after payment of underwriters’ fees and commissions or (ii) we are otherwise
−Removed: exempt from the provisions of Rule 419 promulgated under the Securities Act .
−Removed: If public stockholders tender more shares than we have
−Removed: offered to purchase, we will withdraw the tender offer and not complete the initial business combination.
−Removed: certificate of incorporation provides that we may not redeem our public shares unless (i) we are exempt from the provisions of Rule 419
−Removed: promulgated under the Securities Act other than through our net tangible assets or (ii) our net tangible assets are at least $5,000,001
−Removed: either immediately prior to or upon consummation of our initial business combination and after payment of underwriters’ fees and
−Removed: commissions (so that we are not subject to the SEC’s “penny stock” rules) or any greater net tangible asset or cash
−Removed: requirement which may be contained in the agreement relating to our initial business combination.
−Removed: For example, the proposed initial business
−Removed: 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
−Removed: working capital or other general corporate purposes or (iii) the retention of cash to satisfy other conditions in accordance with the
−Removed: terms of the proposed initial business combination.
−Removed: In the event the aggregate cash consideration we would be required to pay for all
−Removed: shares of Class A common stock that are validly submitted for redemption plus any amount required to satisfy cash conditions pursuant
−Removed: to the terms of the proposed initial business combination exceed the aggregate amount of cash available to us, we will not complete the
−Removed: initial business combination or redeem any shares, and all shares of Class A common stock submitted for redemption will be returned to
−Removed: the holders thereof.
−Removed: on Redemption upon Completion of our Initial Business Combination if we Seek Stockholder Approval
−Removed: Notwithstanding
−Removed: the foregoing, if we seek stockholder approval of our initial business combination and we do not conduct redemptions in connection with
−Removed: our initial business combination pursuant to the tender offer rules, our certificate of incorporation provides that a public stockholder,
−Removed: together with any affiliate of such stockholder or any other person with whom such stockholder is acting in concert or as a “group”
−Removed: (as defined under Section 13 of the Exchange Act), will be restricted from seeking redemption rights with respect to more than an aggregate
−Removed: of 15% of the shares sold in our initial public offering, which we refer to as the “Excess Shares.” Such restriction shall
−Removed: also be applicable to our affiliates.
−Removed: We believe this restriction will discourage stockholders from accumulating large blocks of shares,
−Removed: and subsequent attempts by such holders to use their ability to exercise their redemption rights against a proposed initial business
−Removed: combination as a means to force us or our management to purchase their shares at a significant premium to the then-current market price
−Removed: or on other undesirable terms.
−Removed: By limiting our stockholders’ ability to redeem no more than 15% of the shares sold in our initial
−Removed: public offering without our prior consent, we believe we will limit the ability of a small group of stockholders to unreasonably attempt
−Removed: to block our ability to complete our initial business combination, particularly in connection with an initial business combination with
−Removed: 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
−Removed: restricting our stockholders’ ability to vote all of their shares (including Excess Shares) for or against our initial business
−Removed: Stock Certificates in Connection with Redemption Rights
−Removed: may require our public stockholders seeking to exercise their redemption rights, whether they are record holders or hold their shares
−Removed: in “street name,” to either tender their certificates to our transfer agent up to two business days prior to the vote on
−Removed: the proposal to approve the initial business combination, or to deliver their shares to the transfer agent electronically using the Depository
−Removed: Trust Company’s DWAC (Deposit/Withdrawal At Custodian) System, at the holder’s option.
−Removed: The proxy materials that we will furnish
−Removed: to holders of our public shares in connection with our initial business combination will indicate whether we are requiring public stockholders
−Removed: to satisfy such delivery requirements.
−Removed: Accordingly, a public stockholder would have up to two days prior to the vote on the initial business
−Removed: combination to tender its shares if it wishes to seek to exercise its redemption rights.
−Removed: Given the relatively short exercise period,
−Removed: it is advisable for stockholders to use electronic delivery of their public shares.
−Removed: is a nominal cost associated with the above-referenced tendering process and the act of certificating the shares or delivering them through
−Removed: the DWAC System.
−Removed: The transfer agent will typically charge the tendering broker $80.00 and it would be up to the broker whether or not
−Removed: 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
−Removed: to exercise redemption rights to tender their shares.
−Removed: The need to deliver shares is a requirement of exercising redemption rights regardless
−Removed: of the timing of when such delivery must be effectuated.
−Removed: foregoing is different from the procedures used by many special purpose acquisition companies.
−Removed: In order to perfect redemption rights
−Removed: in connection with their business combinations, many blank check companies would distribute proxy materials for the stockholders’
−Removed: vote on an initial business combination, and a holder could simply vote against a proposed initial business combination and check a box
−Removed: on the proxy card indicating such holder was seeking to exercise his or her redemption rights.
−Removed: After the initial business combination
−Removed: was approved, the company would contact such stockholder to arrange for him or her to deliver his or her certificate to verify ownership.
−Removed: As a result, the stockholder then had an “option window” after the completion of the initial business combination during
−Removed: which he or she could monitor the price of the company’s stock in the market.
−Removed: If the price rose above the redemption price, he
−Removed: 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 stockholders were aware they needed to commit before the stockholder meeting, would become
−Removed: “option” rights surviving past the completion of the initial business combination until the redeeming holder delivered its
−Removed: The requirement for physical or electronic delivery prior to the meeting ensures that a redeeming holder’s election
−Removed: to redeem is irrevocable once the initial business combination is approved.
−Removed: request to redeem such shares, once made, may be withdrawn at any time up to the date of the stockholder meeting.
−Removed: Furthermore, if a holder
−Removed: of a public share delivered its certificate in connection with an election of redemption rights and subsequently decides prior to the
−Removed: applicable date not to elect to exercise such rights, such holder may simply request that the transfer agent return the certificate (physically
−Removed: or electronically).
−Removed: It is anticipated that the funds to be distributed to holders of our public shares electing to redeem their shares
−Removed: will be distributed promptly after the completion of our initial business combination.
−Removed: our initial business combination is not approved or completed for any reason, then our public stockholders who elected to exercise their
−Removed: redemption rights would not be entitled to redeem their shares for the applicable pro rata share of the Trust Account.
−Removed: In such case,
−Removed: we will promptly return any certificates delivered by public holders who elected to redeem their shares.
−Removed: our initial proposed initial business combination is not completed, we may continue to try to complete an initial business combination
−Removed: with a different target at the election of the Company until February 7, 2024.
−Removed: of Public Shares and Liquidation if no Initial Business Combination
−Removed: certificate of incorporation provides that we will have up to February 7, 2024 if we extend the period of time to consummate a business
−Removed: combination, at our election by separate one month extensions, subject to satisfaction of certain conditions, including the deposit of
−Removed: up to $77,000 for each one month extension, into the Trust Account, to complete our initial business combination.
−Removed: If we are unable to
−Removed: complete our initial business combination within such 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,
−Removed: payable in cash, equal to the aggregate amount then on deposit in the Trust Account including interest earned on the funds held in the
−Removed: Trust Account and not previously released to us to pay our taxes (less up to $100,000 of interest to pay dissolution expenses), divided
−Removed: by the number of then outstanding public shares, which redemption will completely extinguish public stockholders’ rights as stockholders
−Removed: (including the right to receive further liquidating distributions, if any), subject to applicable law, and (iii) as promptly as reasonably
−Removed: possible following such redemption, subject to the approval of our remaining stockholders and our board of directors, dissolve and liquidate,
−Removed: subject in the case of clauses (ii) and (iii) above to our obligations under Delaware law to provide for claims of creditors and the
−Removed: requirements of other applicable law.
−Removed: There will be no redemption rights or liquidating distributions with respect to our warrants, which
−Removed: will expire worthless if we fail to complete our initial business combination within such period.
−Removed: sponsor, officers and directors have entered into a letter agreement with us, pursuant to which they have waived their rights to liquidating
−Removed: distributions from the Trust Account with respect to any founder shares held by them if we fail to complete our initial business combination
−Removed: within 12 months from the consummation of our initial public offering (or up to February 7,
−Removed: 2024 at the election of the Company subject to satisfaction of certain conditions) .
−Removed: if our sponsor, officers or directors acquire public shares after our initial public offering, they will be entitled to liquidating distributions
−Removed: from the Trust Account with respect to such public shares if we fail to complete our initial business combination within
−Removed: 12 months from the consummation of our initial public offering (or up to February 7, 2024 at the election of the Company subject
−Removed: to satisfaction of certain conditions).
−Removed: sponsor, officers and directors have agreed, pursuant to a written agreement with us, that they will not propose any amendment to our
−Removed: certificate of incorporation (i) to modify the substance or timing of our obligation to allow redemption in connection with our initial
−Removed: business combination or certain amendments to our charter prior thereto or to redeem 100% of our public shares if we do not complete
−Removed: our initial business combination within 12 months from the consummation of our initial public offering
−Removed: (or up to February 7, 2024 at the election of the Company subject to satisfaction of certain conditions) or (ii) with respect
−Removed: to any other provision relating to stockholders’ rights or pre-initial business combination activity, unless we provide our public
−Removed: stockholders with the opportunity to redeem their shares of Class A common stock upon approval of any such amendment at a per-share price,
−Removed: payable in cash, equal to the aggregate amount then on deposit in the Trust Account including interest earned on the funds held in the
−Removed: Trust Account and not previously released to us to pay our taxes divided by the number of then outstanding public shares.
−Removed: If this optional
−Removed: redemption right is exercised with respect to an excessive number of public shares such that we cannot satisfy the net tangible asset
−Removed: requirement (described above), we would not proceed with the amendment or the related redemption of our public shares at such time.
−Removed: expect that all costs and expenses associated with implementing our plan of dissolution, as well as payments to any creditors, will be
−Removed: funded from amounts remaining out of the funds held outside the Trust Account, although we cannot assure you that there will be sufficient
−Removed: funds for such purpose.
−Removed: As of December 31, 2022, we had approximately $346,000 in cash remaining.
−Removed: We will depend on sufficient interest
−Removed: being earned on the proceeds held in the Trust Account to pay any tax obligations we may owe.
−Removed: However, if those funds are not sufficient
−Removed: to cover the costs and expenses associated with implementing our plan of dissolution, to the extent that there is any interest accrued
−Removed: in the Trust Account not required to pay taxes, we may request the trustee to release to us an additional amount of up to $100,000 of
−Removed: such accrued interest to pay those costs and expenses.
−Removed: 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
−Removed: deposited in the Trust Account, and without taking into account interest, if any, earned on the Trust Account, the per-share redemption
−Removed: amount received by stockholders upon our dissolution would be approximately $11.05, assuming our sponsor makes the Maximum Contribution
−Removed: and net of any taxes paid or payable.
−Removed: The proceeds deposited in the Trust Account could, however, become subject to the claims of our
−Removed: creditors which would have higher priority than the claims of our public stockholders.
−Removed: We cannot assure you that the actual per-share
−Removed: redemption amount received by stockholders will not be substantially less than approximately $11.05.
−Removed: Under Section 281(b) of the DGCL,
−Removed: our plan of dissolution must provide for all claims against us to be paid in full or make provision for payments to be made in full,
−Removed: as applicable, if there are sufficient assets.
−Removed: These claims must be paid or provided for before we make any distribution of our remaining
−Removed: assets to our stockholders.
−Removed: While we intend to pay such amounts, if any, we cannot assure you that we will have funds sufficient to pay
−Removed: or provide for all creditors’ claims.
−Removed: we will seek to have all vendors, service providers, prospective target businesses or other entities with which we do business execute
−Removed: 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
−Removed: of our public stockholders, there is no guarantee that they will execute such agreements or even if they execute such agreements that
−Removed: they would be prevented from bringing claims against the Trust Account including but not limited to fraudulent inducement, breach of
−Removed: fiduciary responsibility or other similar claims, as well as claims challenging the enforceability of the waiver, in each case in order
−Removed: 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
−Removed: to execute an agreement waiving such claims to the monies held in the Trust Account, our management will perform an analysis of the alternatives
−Removed: 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
−Removed: third party’s engagement would be significantly more beneficial to us than any alternative.
−Removed: Examples of possible instances where
−Removed: we may engage a third party that refuses to execute a waiver include the engagement of a third party consultant whose particular expertise
−Removed: or skills are believed by management to be significantly superior to those of other consultants that would agree to execute a waiver
−Removed: or in cases where management is unable to find a service provider willing to execute a waiver.
−Removed: Marcum LLP, our independent registered
−Removed: public accounting firm, and the underwriters of the offering, will not execute agreements with us waiving such claims to the monies held
−Removed: in the Trust Account.
−Removed: addition, 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
−Removed: out of, any negotiations, contracts or agreements with us and will not seek recourse against the Trust Account for any reason.
−Removed: has agreed that it will be liable to us if and to the extent any claims by a third party for services rendered or products sold to us,
−Removed: or a prospective target business with which we have entered into a written letter of intent, confidentiality or similar agreement or
−Removed: business combination agreement, reduce the amount of funds in the Trust Account to below the lesser of (i) $10.20 per public share and
−Removed: (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
−Removed: $10.20 per share due to reductions in the value of the trust assets, less taxes payable, provided that such liability will not apply
−Removed: to any claims by a third party or prospective target business who executed a waiver of any and all rights to the monies held in the Trust
−Removed: Account (whether or not such waiver is enforceable) nor will it apply to any claims under our indemnity of the underwriters of our initial
−Removed: public offering against certain liabilities, including liabilities under the Securities Act.
−Removed: However, we have not asked our sponsor to
−Removed: reserve for such indemnification obligations, nor have we independently verified whether our sponsor has sufficient funds to satisfy
−Removed: its indemnity obligations and believe that our sponsor’s only assets are securities of our company.
−Removed: Therefore, we cannot assure
−Removed: you that our sponsor would be able to satisfy those obligations.
−Removed: None of our officers or directors will indemnify us for claims by third
−Removed: parties including, without limitation, claims by vendors and prospective target businesses.
−Removed: the event that the proceeds in the Trust Account are reduced below (i) $10.20 per public share or (ii) such lesser amount per public
−Removed: share held in the Trust Account as of the date of the liquidation of the Trust Account, due to reductions in value of the trust assets,
−Removed: in each case net of the amount of interest which may be withdrawn to pay taxes, and our sponsor asserts that it is unable to satisfy
−Removed: its indemnification obligations or that it has no indemnification obligations related to a particular claim, our independent directors
−Removed: would determine whether to take legal action against our sponsor to enforce its indemnification obligations.
−Removed: While we currently expect
−Removed: that our independent directors would take legal action on our behalf against our sponsor to enforce its indemnification obligations to
−Removed: us, it is possible that our independent directors in exercising their business judgment may choose not to do so if, for example, the
−Removed: cost of such legal action is deemed by the independent directors to be too high relative to the amount recoverable or if the independent
−Removed: directors determine that a favorable outcome is not likely.
−Removed: We have not asked our sponsor to reserve for such indemnification obligations
−Removed: and we cannot assure you that our sponsor would be able to satisfy those obligations.
−Removed: Accordingly, we cannot assure you that due to claims
−Removed: of creditors the actual value of the per-share redemption price will not be less than $10.20 per public share.
−Removed: will seek to reduce the possibility that our sponsor will have to indemnify the Trust Account due to claims of creditors by endeavoring
−Removed: to have all vendors, service providers, prospective target businesses or other entities with which we do business execute agreements
−Removed: with us waiving any right, title, interest or claim of any kind in or to monies held in the Trust Account.
−Removed: Our sponsor will also not
−Removed: be liable as to any claims under our indemnity of the underwriters of our initial public offering against certain liabilities, including
−Removed: liabilities under the Securities Act.
−Removed: We will have access to up to approximately $1,500,000 from loans from our sponsor with which to
−Removed: pay any such potential claims (including costs and expenses incurred in connection with our liquidation, currently estimated to be no
−Removed: more than approximately $100,000).
−Removed: In the event that we liquidate and it is subsequently determined that the reserve for claims and liabilities
−Removed: is insufficient, stockholders who received funds from our Trust Account could be liable for claims made by creditors.
−Removed: the DGCL, stockholders may be held liable for claims by third parties against a corporation to the extent of distributions received by
−Removed: them in a dissolution.
−Removed: The pro rata portion of our Trust Account distributed to our public stockholders upon the redemption of our public
−Removed: shares in the event we do not complete our initial business combination within 12 months from the
−Removed: consummation of our initial public offering (or up to February 7, 2024 at the election of the Company subject to satisfaction
−Removed: of certain conditions) , may be considered a liquidating distribution under Delaware law.
−Removed: the corporation complies with certain procedures set forth in Section 280 of the DGCL intended to ensure that it makes reasonable provision
−Removed: for all claims against it, including a 60-day notice period during which any third-party claims can be brought against the corporation,
−Removed: a 90-day period during which the corporation may reject any claims brought, and an additional 150-day waiting period before any liquidating
−Removed: distributions are made to stockholders, any liability of stockholders with respect to a liquidating distribution is limited to the lesser
−Removed: of such stockholder’s pro rata share of the claim or the amount distributed to the stockholder, and any liability of the stockholder
−Removed: would be barred after the third anniversary of the dissolution.
−Removed: if the pro rata portion of our Trust Account distributed to our public stockholders upon the redemption of our public shares in the event
−Removed: we do not complete our initial business combination within 12 months from the consummation of our
−Removed: initial public offering (or up to February 7, 2024 at the election of the Company subject to satisfaction of certain conditions),
−Removed: is not considered a liquidating distribution under Delaware law and such redemption distribution is deemed to be unlawful (potentially
−Removed: due to the imposition of legal proceedings that a party may bring or due to other circumstances that are currently unknown), then pursuant
−Removed: to Section 174 of the DGCL, the statute of limitations for claims of creditors could then be six years after the unlawful redemption
−Removed: distribution, instead of three years, as in the case of a liquidating distribution.
−Removed: If we are unable to complete our initial business
−Removed: combination within 12 months from the consummation of our initial public offering (or up to
−Removed: February 7, 2024 at the election of the Company subject to satisfaction of certain conditions), we will:
−Removed: (i) cease all operations except
−Removed: for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the public
−Removed: shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account including interest
−Removed: earned on the funds held in the Trust Account and not previously released to us to pay our taxes (less up to $100,000 of interest to
−Removed: pay dissolution expenses), divided by the number of then outstanding public shares, which redemption will completely extinguish public
−Removed: stockholders’ rights as stockholders (including the right to receive further liquidating distributions, if any), subject to applicable
−Removed: law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of our remaining stockholders and
−Removed: our board of directors, dissolve and liquidate, subject in the case of clauses (ii) and (iii) above to our obligations under Delaware
−Removed: law to provide for claims of creditors and the requirements of other applicable law.
−Removed: Accordingly, it is our intention to redeem our public
−Removed: shares as soon as reasonably possible up to the 24th month from the closing of our initial public offering at the election of the Company
−Removed: subject to satisfaction of certain conditions or as extended by the Company’s stockholders in accordance with our certificate of
−Removed: incorporation) and, therefore, we do not intend to comply with those procedures.
−Removed: As such, our stockholders could potentially be liable
−Removed: for any claims to the extent of distributions received by them (but no more) and any liability of our stockholders may extend well beyond
−Removed: the third anniversary of such date.
−Removed: we will not be complying with Section 280, Section 281(b) of the DGCL requires us to adopt a plan, based on facts known to us at such
−Removed: time that will provide for our payment of all existing and pending claims or claims that may be potentially brought against us within
−Removed: the subsequent 10 years.
−Removed: However, because we are a blank check company, rather than an operating company, and our operations will be
−Removed: limited to searching for prospective target businesses to acquire, the only likely claims to arise would be from our vendors (such as
−Removed: lawyers, investment bankers, etc.) or prospective target businesses.
−Removed: As described above, pursuant to the obligation contained in our
−Removed: underwriting agreement, we will seek to have all vendors, service providers, prospective target businesses or other entities with which
−Removed: 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
−Removed: As a result of this obligation, the claims that could be made against us are significantly limited and the likelihood that any
−Removed: claim that would result in any liability extending to the Trust Account is remote.
−Removed: Further, our sponsor may be liable only to the extent
−Removed: necessary to ensure that the amounts in the Trust Account are not reduced below (i) $10.20 per public share or (ii) such lesser amount
−Removed: per public share held in the Trust Account as of the date of the liquidation of the Trust Account, due to reductions in value of the
−Removed: trust assets, in each case net of the amount of interest withdrawn to pay taxes and will not be liable as to any claims under our indemnity
−Removed: of the underwriters of our initial public offering against certain liabilities, including liabilities under the Securities Act.
−Removed: event that an executed waiver is deemed to be unenforceable against a third party, our sponsor will not be responsible to the extent
−Removed: of any liability for such third-party claims.
−Removed: we file a bankruptcy petition or an involuntary bankruptcy petition is filed against us that is not dismissed, the proceeds held in the
−Removed: Trust Account could be subject to applicable bankruptcy law, and may be included in our bankruptcy estate and subject to the claims of
−Removed: third parties with priority over the claims of our stockholders.
−Removed: To the extent any bankruptcy claims deplete the Trust Account, we cannot
−Removed: assure you we will be able to return $10.20 per share to our public stockholders.
−Removed: Additionally, if we file a bankruptcy petition or an
−Removed: involuntary bankruptcy petition is filed against us that is not dismissed, any distributions received by stockholders could be viewed
−Removed: under applicable debtor/creditor and/or bankruptcy laws as either a “preferential transfer” or a “fraudulent conveyance.”
−Removed: As a result, a bankruptcy court could seek to recover some or all amounts received by our stockholders.
−Removed: Furthermore, our board of directors
−Removed: may be viewed as having breached its fiduciary duty to our creditors and/or may have acted in bad faith, thereby exposing itself and
−Removed: our company to claims of punitive damages, by paying public stockholders 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: public stockholders will be entitled to receive funds from the Trust Account only upon the earlier to occur of:
−Removed: (i) the completion of
−Removed: our initial business combination, (ii) the redemption of any public shares properly tendered in connection with a stockholder vote to
−Removed: amend any provisions of our certificate of incorporation (A) to modify the substance or timing of our obligation to allow redemption
−Removed: in connection with our initial business combination or certain amendments to our charter prior thereto or to redeem 100% of our public
−Removed: shares if we do not complete our initial business combination within 12 months from the consummation
−Removed: of our initial public offering (or up to February 7, 2024 at the election of the Company subject to satisfaction of certain conditions)
−Removed: or (B) with respect to any other provision relating to stockholders’ rights or pre-initial business combination activity, and (iii)
−Removed: the redemption of all of our public shares if we are unable to complete our business combination within 12 months from the consummation
−Removed: of our initial public offering (or up to February 7, 2024 at the election of the Company subject to satisfaction of certain conditions)
−Removed: , subject to applicable law.
−Removed: In no other circumstances will a stockholder have any right or interest of any kind to or in the Trust Account.
−Removed: In the event we seek stockholder approval in connection with our initial business combination, a stockholder’s voting in connection
−Removed: with the initial business combination alone will not result in a stockholder’s redeeming its shares to us for an applicable pro
−Removed: rata share of the Trust Account.
−Removed: Such stockholder must have also exercised its redemption rights as described above.
−Removed: These provisions
−Removed: of our certificate of incorporation, like all provisions of our certificate of incorporation, may be amended with a stockholder vote.
−Removed: identifying, evaluating and selecting a target business for our initial business combination, we may encounter intense competition from
−Removed: other entities having a business objective similar to ours, including other blank check companies, private equity groups and leveraged
−Removed: buyout funds, and operating businesses seeking strategic business combinations.
−Removed: Many of these entities are well established and have
−Removed: extensive experience identifying and effecting business combinations directly or through affiliates.
−Removed: Moreover, many of these competitors
−Removed: possess greater financial, technical, human and other resources than we do.
−Removed: Our ability to acquire larger target businesses will be limited
−Removed: by our available financial resources.
−Removed: This inherent limitation gives others an advantage in pursuing the initial business combination
−Removed: of a target business.
−Removed: Furthermore, our obligation to pay cash in connection with our public stockholders who exercise their redemption
−Removed: rights may reduce the resources available to us for our initial business combination and our outstanding warrants, and the future dilution
−Removed: they potentially represent, may not be viewed favorably by certain target businesses.
−Removed: Either of these factors may place us at a competitive
−Removed: disadvantage in successfully negotiating an initial business combination.
−Removed: currently have three officers.
−Removed: These individuals are not obligated to devote any specific number of hours to our matters but they intend
−Removed: to devote as much of their time as they deem necessary, in the exercise of their respective business judgement, to our affairs until
−Removed: we have completed our initial business combination.
−Removed: The amount of time they will devote in any time period will vary based on whether
−Removed: a target business has been selected for our initial business combination and the stage of the initial business combination process we
−Removed: We do not intend to have any full-time employees prior to the completion of our initial business combination.
−Removed: We do not have
−Removed: an employment agreement with any member of our management team.
+Added: warning letters or other enforcement letters or clinical holds on post-approval clinical trials;
+Added: modification of promotional materials and labeling and the issuance of corrective information;
+Added: of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;
+Added: seizure or detention, or refusal to permit the import or export of products;
+Added: or the imposition of civil or criminal penalties;
+Added: decrees, corporate integrity agreements, debarment, or exclusion from federal healthcare programs.
+Added: addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (“PDMA”)
+Added: which regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation
+Added: of drug distributors by the states.
+Added: Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples
+Added: and impose requirements to ensure accountability in distribution.
+Added: More recently, the Drug Supply Chain Security Act (the “DSCSA”),
+Added: was enacted with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United
+Added: The DSCSA mandates phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and
+Added: dispensers over a 10-year period that were expected to culminate in November 2023.
+Added: From time to time, new legislation and regulations
+Added: may be implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products
+Added: regulated by the FDA.
+Added: For example, the FDA released proposed regulations in February 2022 to amend the national standards for licensing
+Added: of wholesale drug distributors by the states;
+Added: establish new minimum standards for state licensing third-party logistics providers;
+Added: create a federal system for licensure for use in the absence of a state program, each of which is mandated by the DSCSA.
+Added: It is impossible
+Added: to predict whether further legislative or regulatory changes will be enacted, or FDA regulations, guidance or interpretations will be
+Added: changed or what the impact of such potential changes, if any, may be.
+Added: Exclusivity and Approval of Follow-on Products
+Added: addition to enacting Section 505(b)(2) of the FDCA as part of the Hatch-Waxman Amendments to the FDCA, Congress also established an abbreviated
+Added: regulatory scheme authorizing the FDA to approve generic drugs that are shown to contain the same active ingredients as, and to be bioequivalent
+Added: to, drugs previously approved by the FDA pursuant to NDAs.
+Added: To obtain approval of a generic drug, an applicant must submit an abbreviated
+Added: new drug application (“ANDA”) to the agency.
+Added: An ANDA is a comprehensive submission that contains, among other things, data
+Added: and information pertaining to the active pharmaceutical ingredient, bioequivalence, drug product formulation, specifications and stability
+Added: of the generic drug, as well as analytical methods, manufacturing process validation data and quality control procedures.
+Added: ANDAs are “abbreviated”
+Added: because they cannot include preclinical and clinical data to demonstrate safety and effectiveness.
+Added: Instead, in support of such applications,
+Added: a generic manufacturer must rely on the preclinical and clinical testing previously conducted for a drug product previously approved
+Added: under an NDA, known as the reference listed drug (“RLD”).
+Added: order for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients,
+Added: the route of administration, the dosage form, the strength of the drug and the conditions of use of the drug.
+Added: At the same time, the FDA
+Added: must also determine that the generic drug is “bioequivalent” to the innovator drug.
+Added: Under the statute, a generic drug is
+Added: bioequivalent to an RLD if “the rate and extent of absorption of the drug do not show a significant difference from the rate and
+Added: extent of absorption of the listed drug.” Unlike the 505(b)(2) NDA pathway that permits a follow-on applicant to conduct and submit
+Added: data from additional clinical trials or nonclinical studies in order to support the proposed change(s) to the reference product, the
+Added: ANDA regulatory pathway does not allow applicants to submit new clinical data other than bioavailability or bioequivalence data.
+Added: approval of an ANDA, the FDA indicates whether the generic product is “therapeutically equivalent” to the RLD in its publication
+Added: “Approved Drug Products with Therapeutic Equivalence Evaluations,” also referred to as the “Orange Book.” Physicians
+Added: and pharmacists consider a therapeutic equivalent generic drug to be fully substitutable for the RLD.
+Added: In addition, by operation of certain
+Added: state laws and numerous health insurance programs, the FDA’s designation of therapeutic equivalence often results in substitution
+Added: of the generic drug without the knowledge or consent of either the prescribing physician or patient.
+Added: part of the NDA review and approval process, applicants are required to list with the FDA each patent that has claims that cover the
+Added: applicant’s product or method of therapeutic use.
+Added: Upon approval of a new drug, each of the patents listed in the application for
+Added: the drug is then published in the Orange Book.
+Added: Drugs listed in the Orange Book can, in turn, be cited by potential follow-on competitors
+Added: in support of approval of an ANDA or 505(b)(2) NDA.
+Added: an ANDA applicant submits its application to the FDA, it is required to certify to the FDA concerning any patents listed for the reference
+Added: product in the FDA’s Orange Book.
+Added: Specifically, the applicant must certify that:
+Added: (i) the required patent information has not been
+Added: (ii) the listed patent has expired;
+Added: (iii) the listed patent has not expired but will expire on a particular date and approval
+Added: is sought after patent expiration;
+Added: or (iv) the listed patent is invalid or will not be infringed by the new product.
+Added: Moreover, to the
+Added: extent that the Section 505(b)(2) NDA applicant is relying on studies conducted for an already approved product, the applicant also is
+Added: required to certify to the FDA concerning any patents listed for the NDA-approved product in the Orange Book to the same extent that
+Added: an ANDA applicant would.
+Added: the follow-on applicant does not challenge the innovator’s listed patents, the FDA will not approve the ANDA or 505(b)(2) application
+Added: until all the listed patents claiming the referenced product have expired.
+Added: A certification that the new product will not infringe the
+Added: already approved product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification.
+Added: If the follow-on
+Added: applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification
+Added: to the NDA and patent holders once the ANDA has been accepted for filing by the FDA.
+Added: The NDA and patent holders may then initiate a patent
+Added: infringement lawsuit in response to the notice of the Paragraph IV certification.
+Added: The filing of a patent infringement lawsuit within
+Added: 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA or 505(b)(2) NDA until
+Added: the earlier of 30 months, expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable
+Added: to the ANDA or 505(b)(2) applicant.
+Added: ANDA or 505(b)(2) application also will not be approved until any applicable non-patent exclusivities listed in the Orange Book for the
+Added: referenced product have expired.
+Added: The Hatch-Waxman Amendments to the FDCA provided a five-year period of non-patent data exclusivity within
+Added: the United States to the first applicant to gain approval of an NDA for a new chemical entity (“NCE”).
+Added: For the purposes of
+Added: this provision, an NCE is a drug that contains no active moiety that has previously been approved by the FDA in any other NDA.
+Added: moiety is the molecule or ion responsible for the physiological or pharmacological action of the drug substance.
+Added: In cases where such
+Added: NCE exclusivity has been granted, an ANDA or 505(b)(2) NDA may not be filed with the FDA until the expiration of five years unless the
+Added: submission is accompanied by a Paragraph IV certification, in which case the applicant may submit its application four years following
+Added: the original product approval.
+Added: FDCA also provides for a period of three years of data exclusivity if an NDA or NDA supplement includes reports of one or more new clinical
+Added: investigations, other than bioavailability or bioequivalence studies, that were conducted or sponsored by the applicant are deemed by
+Added: the FDA to be essential to the approval of the application.
+Added: This three-year exclusivity period often protects changes to a previously
+Added: approved drug product, such as new indications, dosage forms, route of administration or combination of ingredients.
+Added: Three-year exclusivity
+Added: would be available for a drug product that contains a previously approved active moiety, provided the statutory requirement for a new
+Added: clinical investigation is satisfied.
+Added: Unlike five-year NCE exclusivity, an award of three-year exclusivity does not block the FDA from
+Added: accepting ANDAs or 505(b)(2) NDAs seeking approval for generic versions of the drug as of the date of approval of the original drug product;
+Added: rather, this three-year exclusivity covers only the conditions of use associated with the new clinical investigations and, as a general
+Added: matter, does not prohibit the FDA from approving follow-on applications for drugs containing the original active ingredient.
+Added: and three-year exclusivity also will not delay the submission or approval of a traditional NDA filed under Section 505(b)(1) of the FDCA;
+Added: however, an applicant submitting a traditional NDA would be required to conduct or obtain a right of reference to all of the preclinical
+Added: studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.
+Added: Drug Designation and Exclusivity
+Added: the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally
+Added: a disease or condition that affects either (i) fewer than 200,000 individuals in the United States, or (ii) more than 200,000 individuals
+Added: in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United
+Added: States a drug for this type of disease or condition will be recovered from sales in the United States for that drug.
+Added: Legislative proposals
+Added: are currently being considered that would revise or revoke the second option available for a drug candidate to receive an orphan designation,
+Added: the so-called “cost recovery” pathway.
+Added: Orphan drug designation must be requested before submitting an NDA.
+Added: After the FDA
+Added: grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use will be disclosed publicly by the
+Added: the posting will also indicate whether a drug is no longer designated as an orphan drug.
+Added: than one clinical asset may receive an orphan drug designation for the same indication, and the same clinical asset can be designated
+Added: for more than one qualified orphan indication.
+Added: The benefits of orphan drug designation include research and development tax credits and
+Added: exemption from FDA prescription drug user fees.
+Added: Orphan drug designation does not convey any advantage in or shorten the duration of the
+Added: regulatory review and approval process if or when an NDA for the drug candidate is filed.
+Added: a product that has orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation,
+Added: the product is entitled to orphan product exclusivity, which means that for seven years, the FDA may not approve any other marketing
+Added: applications for the same drug for the same indication, except under limited circumstances described further below.
+Added: Orphan exclusivity
+Added: does not block the approval of a different drug for the same rare disease or condition, nor does it block the approval of the same drug
+Added: for different conditions.
+Added: As a result, the FDA can still approve different drugs for use in treating the same indication or disease.
+Added: Additionally, if a drug designated as an orphan product receives marketing approval for an indication broader than what was designated,
+Added: it may not be entitled to orphan drug exclusivity.
+Added: exclusivity will not bar approval of another product with the same drug for the same condition under certain circumstances, including
+Added: if a subsequent product with the same drug for the same condition is shown to be clinically superior to the approved product on the basis
+Added: of greater efficacy or safety or a major contribution to patient care, or if the company with orphan drug exclusivity cannot assure the
+Added: availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated.
+Added: The FDA is now required to publish a summary of the clinical superiority findings when a drug is eligible for orphan product exclusivity
+Added: on the basis of a demonstration of clinical superiority.
+Added: Term Extension
+Added: patent claiming a prescription drug for which FDA approval is granted may be eligible for a limited patent term extension under the FDCA,
+Added: which permits a patent restoration of up to five years for patent term lost during product development and the FDA regulatory review
+Added: provided that certain statutory and regulatory requirements are met.
+Added: The length of the patent term extension is related to the length
+Added: of time the drug is under regulatory review while the patent is in force.
+Added: The restoration period granted on a patent covering a new FDA-regulated
+Added: medical product is typically one-half the time between the date a clinical investigation on human beings is begun and the submission
+Added: date of an application for premarket approval of the product, plus the time between the submission date of an application for approval
+Added: of the product and the ultimate approval date.
+Added: Patent term restoration cannot be used to extend the remaining term of a patent past a
+Added: total of 14 years from the product’s approval date.
+Added: Only one patent applicable to an approved drug product is eligible for the
+Added: extension, and the application for the extension must be submitted prior to the expiration of the patent in question.
+Added: A patent that covers
+Added: multiple products for which approval is sought can only be extended in connection with one of the marketing approvals.
+Added: The USPTO reviews
+Added: and approves the application for any patent term extension or restoration in consultation with the FDA.
+Added: Healthcare Laws and Regulations
+Added: Manufacturing,
+Added: sales, promotion, and other activities following product approval may also be subject to regulation by other regulatory authorities in
+Added: the United States in addition to the FDA.
+Added: Depending on the nature of the product, those authorities may include the Centers for Medicare
+Added: and Medicaid Services (“CMS”), other divisions of the Department of Health and Human Services (“HHS”), the Department
+Added: of Justice, the Drug Enforcement Administration, the Federal Trade Commission, the Occupational Safety and Health Administration, and
+Added: state and local governments.
+Added: example, in the United States, sales and marketing for prescription biopharmaceutical products must comply with state and federal fraud
+Added: and abuse laws.
+Added: These laws include the federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription
+Added: drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that
+Added: is intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular drug, for which
+Added: payment may be made under a federal healthcare program, such as Medicare or Medicaid.
+Added: Violations of this law are punishable by up to
+Added: ten years in prison, criminal fines, administrative civil money penalties and exclusion from participation in federal healthcare programs.
+Added: In addition, the Patient Protection and Affordable Care Act, or ACA, among other things, amended the intent requirement of the federal
+Added: Anti-Kickback Statute and two of the five criminal healthcare fraud statutes created by the Health Insurance Portability and Accountability
+Added: Act of 1996, or HIPAA.
+Added: A person or entity no longer needs to have actual knowledge of these two provisions in the statute or specific
+Added: intent to violate them;
+Added: specifically with respect to the prohibition on executing or attempting to execute a scheme or artifice to defraud
+Added: or to fraudulently obtain money or property of any healthcare benefit program and the prohibition on disposing of assets to enable a
+Added: person to become eligible for Medicaid.
+Added: Moreover, the government may now assert that a claim including items or services resulting from
+Added: a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
+Added: and rebate programs must comply with the Medicaid rebate requirements of the U.S.
+Added: Omnibus Budget Reconciliation Act of 1990 and more
+Added: recent requirements in the ACA.
+Added: If products are made available to authorized users of the Federal Supply Schedule of the General Services
+Added: Administration, additional laws and requirements apply.
+Added: There also are federal transparency requirements under the Physician Payments
+Added: Sunshine Act that require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid
+Added: to report, on an annual basis, to CMS information related to payments and other transfers of value to physicians, teaching hospitals,
+Added: and certain advanced non-physician healthcare practitioners and physician ownership and investment interests.
+Added: Prescription drug products
+Added: also must meet applicable child-resistant packaging requirements under the U.S.
+Added: Poison Prevention Packaging Act.
+Added: Manufacturing,
+Added: sales, promotion, and other activities also are potentially subject to federal and state consumer protection and unfair competition laws.
+Added: Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines,
+Added: or the relevant compliance guidance promulgated by the federal government, in addition to requiring drug manufacturers to report information
+Added: related to payments to physicians and other healthcare providers or marketing expenditures to the extent that those laws impose requirements
+Added: that are more stringent than the Physician Payments Sunshine Act.
+Added: State and foreign laws also govern the privacy and security of health
+Added: information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus
+Added: complicating compliance efforts.
+Added: failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or regulatory action.
+Added: on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties,
+Added: injunctions, requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal of product approvals
+Added: or refusal to allow a firm to enter into supply contracts, including government contracts.
+Added: Regulation Outside the U.S.
+Added: addition to regulations in the United States, we will be subject to a variety of foreign regulations that govern, among other things,
+Added: clinical trials and any commercial sales and distribution of our products, if approved, either directly or through distribution partners.
+Added: Whether or not we obtain FDA approval for a product candidate, we must obtain the requisite approvals from regulatory authorities in
+Added: foreign countries or economic areas, such as the European Union and the United Kingdom, among other foreign countries, before we may
+Added: commence clinical trials or market products in those countries or areas.
+Added: The foreign regulatory approval process includes all of the
+Added: risks associated with the FDA approval described above, and the time required to obtain approval in other countries and jurisdictions
+Added: might differ from and be longer than that required to obtain FDA approval.
+Added: Some foreign jurisdictions have a drug product approval process
+Added: similar to that in the U.S., which requires the submission of a clinical trial application much like the IND prior to the commencement
+Added: of clinical studies.
+Added: In Europe, for example, a clinical trial application, or CTA, must be submitted to each country’s national
+Added: health authority and an independent ethics committee, much like the FDA and IRB, respectively.
+Added: Once the CTA is approved in accordance
+Added: with a country’s requirements, clinical trial development may proceed.
+Added: To obtain regulatory approval of a medicinal product candidate
+Added: under European Union regulatory systems, we would be required to submit a Marketing Authorisation Application, or MAA, which is similar
+Added: to the NDA, except that, among other things, there are country-specific document requirements.
+Added: For countries outside of the European
+Added: Union, such as countries in Eastern Europe, Latin America or Asia, and recently the United Kingdom, the requirements governing the conduct
+Added: of clinical trials, product approval, pricing and reimbursement vary from country to country.
+Added: Regulatory approval in one country or jurisdiction
+Added: does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction
+Added: may negatively impact the regulatory process in others.
+Added: Moreover, some nations may not accept clinical studies performed for U.S.
+Added: to support approval in their countries or require that additional studies be performed on natives of their countries.
+Added: In addition, in
+Added: certain foreign markets, the pricing of drug products is subject to government control and reimbursement may in some cases be unavailable
+Added: or insufficient.
+Added: If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines,
+Added: suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.
+Added: of January 31, 2020, the United Kingdom is no longer a member state of the European Union, and therefore a separate marketing authorization
+Added: application and approval will be required to market a medicinal product in the U.K.
+Added: The Medicines and Healthcare products Regulatory
+Added: Agency, or the MHRA, is the U.K.’s standalone pharmaceutical regulator.
+Added: Trials and Regulation of Medicinal Products in Europe
+Added: in the United States, medicinal products can be marketed in the European Union only if a marketing authorization from the competent regulatory
+Added: agencies has been obtained.
+Added: Similar to the United States, the various phases of preclinical and clinical research in the European Union
+Added: are subject to significant regulatory controls.
+Added: to the European Clinical Trials Directive, a system for the approval of clinical trials in the European Union has been implemented through
+Added: national legislation of the member states.
+Added: Under this system, an applicant must obtain approval from the competent national authority
+Added: of a European Union member state in which the clinical trial is to be conducted.
+Added: Furthermore, the applicant may only start a clinical
+Added: trial after a competent ethics committee has issued a favorable opinion.
+Added: Clinical trial applications must be accompanied by an investigational
+Added: medicinal product dossier with supporting information prescribed by the European Clinical Trials Directive and corresponding national
+Added: laws of the member states and further detailed in applicable guidance documents.
+Added: In April 2014, the new Clinical Trials Regulation, (EU)
+Added: No 536/2014 (Clinical Trials Regulation) was adopted and became effective on January 31, 2022.
+Added: The Clinical Trials Regulation is directly
+Added: applicable in all the European Union Member States, repealing the prior Clinical Trials Directive 2001/20/EC.
+Added: The extent to which ongoing
+Added: clinical trials will be governed by the Clinical Trials Regulation will depend on the duration of the individual clinical trial;
+Added: clinical trial continues for more than three years from the day on which the Clinical Trials Regulation becomes applicable the Clinical
+Added: Trials Regulation will at that time begin to apply to the clinical trial.
+Added: new Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the European Union.
+Added: The main characteristics
+Added: of the regulation include:
+Added: a streamlined application procedure via a single entry point;
+Added: a single set of documents to be prepared and
+Added: submitted for the application as well as simplified reporting procedures for clinical trial sponsors;
+Added: and a harmonized procedure for
+Added: the assessment of applications for clinical trials.
+Added: obtain marketing approval of a drug in the European Union, an applicant must submit a MAA either under a centralized or decentralized
+Added: The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid
+Added: for all European Union member states, Iceland, Lichtenstein and Norway.
+Added: The centralized procedure is compulsory for specific products,
+Added: including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy
+Added: products (such as gene-therapy, somatic cell-therapy or tissue-engineered medicines) and products with a new active substance indicated
+Added: for the treatment of certain diseases.
+Added: For products with a new active substance indicated for the treatment of certain diseases and products
+Added: that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may be optional.
+Added: Under the centralized procedure the maximum timeframe for the evaluation of an MAA by the European Medicines Agency (“EMA”)
+Added: is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions
+Added: asked by the Committee for Medicinal Products for Human Use (“CHMP”).
+Added: Accelerated assessment might be granted by the CHMP
+Added: in exceptional cases, when a medicinal product is expected to be of a major public health interest, particularly from the point of view
+Added: of therapeutic innovation.
+Added: The timeframe for the evaluation of an MAA under the accelerated assessment procedure is of 150 days, excluding
+Added: decentralized procedure is available to applicants who wish to market a product in specific European Union member states where such product
+Added: has not received marketing approval in any European Union member states before.
+Added: The decentralized procedure provides for an applicant
+Added: to apply to one-member state to assess the application (the reference member state) and specifically list other member states in which
+Added: it wishes to obtain approval (concerned member states).
+Added: the European Union, only products for which marketing authorizations have been granted may be promoted.
+Added: A marketing authorization is
+Added: valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of
+Added: the risk-benefit balance by the EMA or by the competent authority of the authorizing member state.
+Added: To this end, the marketing authorization
+Added: holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy,
+Added: including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization
+Added: ceases to be valid.
+Added: Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the
+Added: competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
+Added: authorization which is not followed by the actual placing of the drug on the European Union market (in case of centralized procedure)
+Added: or on the market of the authorizing member state within three years after authorization ceases to be valid (the so-called sunset clause).
+Added: even if authorized to be marketed in the European Union, prescription medicines may only be promoted to healthcare professionals, not
+Added: the general public.
+Added: All promotion should be in accordance with the particulars listed in the summary of product characteristics.
+Added: materials must also comply with various laws, and codes of conduct developed by pharmaceutical industry bodies in the European Union
+Added: which govern (among other things) the training of sales staff, promotional claims and their justification, comparative advertising, misleading
+Added: advertising, endorsements, and (where permitted) advertising to the general public.
+Added: Failure to comply with these requirements could lead
+Added: to the imposition of penalties by the competent authorities of the European Union member states.
+Added: The penalties could include warnings,
+Added: orders to discontinue the promotion of the drug product, seizure of promotional materials, fines and possible imprisonment.
+Added: of New Drugs in the United Kingdom
+Added: United Kingdom left the European Union on January 31, 2020 (commonly referred to as “Brexit”), with a transitional period
+Added: that expired on December 31, 2020.
+Added: The United Kingdom and the European Union entered into a trade agreement known as the Trade and Cooperation
+Added: Agreement, which went into effect on January 1, 2021.
+Added: It remains to be seen how, if at all, Brexit and the Trade and Cooperation Agreement
+Added: will impact regulatory requirements for product candidates and products in the United Kingdom.
+Added: We are currently evaluating the potential
+Added: impacts on our business of the Trade and Cooperation Agreement and guidance issued to date by the United Kingdom’s MHRA regarding
+Added: the requirements for licensing and marketing medicinal products in the United Kingdom.
+Added: the regulatory framework for pharmaceutical products in the United Kingdom covering the quality, safety and efficacy of pharmaceutical
+Added: products, clinical trials, marketing authorization, commercial sales and distribution of medicinal products is derived from EU Directives
+Added: and Regulations, Brexit could materially impact the future regulatory regime which applies to such products and the approval of product
+Added: candidates in the United Kingdom.
+Added: Such outcomes could make it more difficult and expensive for us to do business in Europe, complicate
+Added: our clinical, manufacturing and regulatory strategies and impair our ability to obtain and maintain regulatory approval for, and, if
+Added: approved, commercialize, our products and product candidates in Europe.
+Added: Pharmaceutical
+Added: Coverage, Pricing and Reimbursement, and Healthcare Reform
+Added: of our products, if approved for marketing, will depend, in part, on the availability and extent of coverage and reimbursement by third-party
+Added: payors, such as government health programs, including Medicare and Medicaid, commercial insurance and managed healthcare organizations.
+Added: These third-party payors are increasingly challenging the price and limiting the coverage and reimbursement amounts for medical products
+Added: and services.
+Added: There may be significant delays in obtaining coverage and reimbursement for approved products, and coverage may be more
+Added: limited than the purposes for which the product is approved by the FDA or regulatory authorities in other countries.
+Added: It is time-consuming
+Added: and expensive to seek reimbursement from third-party payors.
+Added: Moreover, eligibility for reimbursement does not imply that any product
+Added: will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution.
+Added: Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent.
+Added: rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for
+Added: lower-cost products that are already reimbursed and may be incorporated into existing payments for other services.
+Added: Net prices for products
+Added: may be reduced by mandatory discounts or rebates required by third-party payors and by any future relaxation of laws that presently restrict
+Added: imports of products from countries where they may be sold at lower prices than in the United States.
+Added: In the United States, third-party
+Added: payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but they also have
+Added: their own methods and approval process apart from Medicare coverage and reimbursement determinations.
+Added: Accordingly, one third-party payor’s
+Added: determination to provide coverage for a product does not assure that other payors will also provide coverage for the product.
+Added: addition, the containment of healthcare costs has become a priority for federal and state governments, and the prices of drugs have been
+Added: a focus in this effort.
+Added: government, state legislatures and foreign governments have shown significant interest in implementing
+Added: cost-containment programs, including price controls, restrictions on coverage and reimbursement, and requirements for substitution of
+Added: generic products.
+Added: Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions
+Added: with existing controls and measures, could further limit our net revenue and results.
+Added: Decreases in third-party reimbursement for our
+Added: clinical assets or a decision by a third-party payor to not cover our clinical assets could reduce physician usage of the clinical asset
+Added: and have a material adverse effect on our sales, results of operations and financial condition.
+Added: Moreover, there has been heightened governmental
+Added: scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries
+Added: and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review
+Added: the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug
+Added: Individual states in the United States have also increasingly passed legislation and implemented regulations designed to control
+Added: pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access
+Added: and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and
+Added: bulk purchasing.
+Added: In December 2020, the U.S.
+Added: Supreme Court held unanimously that federal law does not preempt the states’ ability
+Added: to regulate pharmaceutical benefit managers (“PBMs”) and other members of the healthcare and pharmaceutical supply chain,
+Added: an important decision that has led to further and more aggressive efforts by states in this area.
+Added: recently, on August 16, 2022, President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA.
+Added: Among other things,
+Added: the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout
+Added: the United States.
+Added: Starting in 2023, a manufacturer of drugs covered by Medicare Parts B or D must pay a rebate to the federal government
+Added: if their drug product’s price increases faster than the rate of inflation.
+Added: This calculation is made on a drug product by drug product
+Added: basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid
+Added: for by Medicare Parts B or D.
+Added: Additionally, starting for payment year 2026, CMS will negotiate drug prices annually for a select number
+Added: of single source Part D drugs without generic or biosimilar competition.
+Added: CMS will also negotiate drug prices for a select number of Part
+Added: B drugs starting for payment year 2028.
+Added: If a drug product is selected by CMS for negotiation, it is expected that the revenue generated
+Added: from such drug will decrease.
+Added: addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.
+Added: The requirements
+Added: governing drug pricing vary widely from country to country.
+Added: For example, in the European Union, the sole legal instrument at the European
+Added: Union level governing the pricing and reimbursement of medicinal products is Council Directive 89/105/EEC (the “Price Transparency
+Added: The aim of the Price Transparency Directive is to ensure that pricing and reimbursement mechanisms established in
+Added: the European Union Member States are transparent and objective, do not hinder the free movement of and trade in medicinal products in
+Added: the European Union, and do not hinder, prevent or distort competition on the market.
+Added: The Price Transparency Directive does not provide
+Added: any guidance concerning the specific criteria on the basis of which pricing and reimbursement decisions are to be made in the individual
+Added: European Union Member States, nor does it have any direct consequence for pricing or reimbursement levels in the individual European
+Added: Union Member States.
+Added: The European Union Member States are free to restrict the range of medicinal products for which their national health
+Added: insurance systems provide reimbursement, and to control the prices and/or reimbursement levels of medicinal products for human use.
+Added: European Union Member State may approve a specific price or level of reimbursement for the medicinal product, or alternatively adopt
+Added: a system of direct or indirect controls on the profitability of the company responsible for placing the medicinal product on the market,
+Added: including volume-based arrangements, caps and reference pricing mechanisms.
+Added: Technology Assessment (“HTA”) of medicinal products is becoming an increasingly common part of the pricing and reimbursement
+Added: procedures in some European Union Member States, including France, Germany, Ireland, Italy and Sweden.
+Added: The HTA process in the European
+Added: Union Member States is governed by the national laws of these countries.
+Added: HTA is the procedure according to which the assessment of the
+Added: public health impact, therapeutic impact, and the economic and societal impact of the use of a given medicinal product in the national
+Added: healthcare systems of the individual country is conducted.
+Added: HTA generally focuses on the clinical efficacy and effectiveness, safety,
+Added: cost, and cost-effectiveness of individual medicinal products as well as their potential implications for the healthcare system.
+Added: elements of medicinal products are compared with other treatment options available on the market.
+Added: The outcome of HTA regarding specific
+Added: medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities
+Added: of individual European Union Member States.
+Added: The extent to which pricing and reimbursement decisions are influenced by the HTA of the
+Added: specific medicinal product vary between the European Union Member States.
+Added: For example, European Union Member States that have not yet
+Added: developed HTA mechanisms could rely to some extent on the HTA performed in countries with a developed HTA framework when adopting decisions
+Added: concerning the pricing and reimbursement of a specific medicinal product.
+Added: from cost containment efforts, in the United States and some foreign jurisdictions, there also have been, and continue to be, several
+Added: legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval
+Added: of product candidates or restrict or regulate post-approval activities.
+Added: The FDA’s and other regulatory authorities’ policies
+Added: may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our current
+Added: or future product candidates.
+Added: Privacy and the Protection of Personal Information
+Added: are subject to laws and regulations governing data privacy and the protection of personal information including health information.
+Added: legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy
+Added: and data protection issues which will continue to affect our business.
+Added: In the United States, we may be subject to state security breach
+Added: notification laws, state laws protecting the privacy of health and personal information and federal and state consumer protections laws
+Added: that regulate the collection, use, disclosure and transmission of personal information.
+Added: These laws overlap and often conflict and each
+Added: of these laws is subject to varying interpretations by courts and government agencies, creating complex compliance issues.
+Added: to comply with applicable laws and regulations we could be subject to penalties or sanctions, including criminal penalties.
+Added: Our customers
+Added: and research partners must comply with laws governing the privacy and security of health information, including HIPAA and state health
+Added: information privacy laws.
+Added: If we knowingly obtain health information that is protected under HIPAA, called “protected health information,”
+Added: our customers or research collaborators may be subject to enforcement, and we may have direct liability for the unlawful receipt of protected
+Added: health information or for aiding and abetting a HIPAA violation.
+Added: laws protecting health and personal information are becoming increasingly stringent.
+Added: For example, California has implemented the California
+Added: Confidentiality of Medical Information Act that imposes restrictive requirements regulating the use and disclosure of health information
+Added: and other personally identifiable information, and California has recently adopted the California Consumer Privacy Act of 2018 (“CCPA”).
+Added: The CCPA mirrors a number of the key provisions of the EU General Data Protection Regulation (“GDPR”) described below.
+Added: CCPA establishes a new privacy framework for covered businesses by creating an expanded definition of personal information, establishing
+Added: new data privacy rights for consumers in the State of California, imposing special rules on the collection of consumer data from minors,
+Added: and creating a new and potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement
+Added: reasonable security procedures and practices to prevent data breaches.
+Added: Since passage of the CCPA, several other states (Connecticut,
+Added: Colorado, Virginia, and Utah) have also enacted comprehensive consumer privacy laws that include key differences from California’s
+Added: law, further complicating compliance by industry and other stakeholders.
+Added: Other states in the U.S.
+Added: are considering privacy laws similar
+Added: Europe, the GDPR went into effect in May 2018, implementing a broad data protection framework that expanded the scope of European Union
+Added: data protection law, including to non- European Union entities that process, or control the processing of, personal data relating to
+Added: individuals located in the European Union, including clinical trial data.
+Added: The GDPR sets out a number of requirements that must be complied
+Added: with when handling the personal data of European Union-based data subjects including:
+Added: providing expanded disclosures about how their
+Added: personal data will be used;
+Added: higher standards for organizations to demonstrate that they have obtained valid consent or have another legal
+Added: basis in place to justify their data processing activities;
+Added: the obligation to appoint data protection officers in certain circumstances;
+Added: new rights for individuals to be “forgotten” and rights to data portability, as well as enhanced current rights (e.g.
+Added: the principal of accountability and demonstrating compliance through policies, procedures, training and audit;
+Added: and a new mandatory
+Added: data breach regime.
+Added: In particular, medical or health data, genetic data and biometric data where the latter is used to uniquely identify
+Added: an individual are all classified as “special category” data under the GDPR and afforded greater protection and require additional
+Added: compliance obligations.
+Added: Further, European Union member states have a broad right to impose additional conditions – including restrictions
+Added: – on these data categories.
+Added: This is because the GDPR allows European Union member states to derogate from the requirements of the
+Added: GDPR mainly in regard to specific processing situations (including special category data and processing for scientific or statistical
+Added: As the European Union states continue to reframe their national legislation to harmonize with the GDPR, we will need to monitor
+Added: compliance with all relevant European Union member states’ laws and regulations, including where permitted derogations from the
+Added: GDPR are introduced.
+Added: We will also be subject to evolving European Union laws on data export, if we transfer data outside the European
+Added: Union to ourselves or third parties outside of the European Union.
+Added: Cayman Islands Government enacted the Data Protection Act on May 18, 2017 (as amended, the “DPA”).
+Added: The DPA regulates the
+Added: processing of personal data in the Cayman Islands.
+Added: Under the DPA, the Company is a “data controller” and the Company’s
+Added: affiliates and/or its delegates may be “data processors” (or, in some circumstances, data controllers in their own right),
+Added: in respect of such personal data.
+Added: Foreign Corrupt Practices Act and Anti-bribery Regulations
+Added: general, the Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, prohibits offering to pay, paying, promising to pay, or
+Added: authorizing the payment of money or anything of value to a foreign official in order to influence any act or decision of the foreign
+Added: official in his or her official capacity or to secure any other improper advantage in order to obtain or retain business for or
+Added: with, or in order to direct business to, any person.
+Added: The prohibitions apply not only to payments made to “any foreign
+Added: official,” but also to those made to “any foreign political party or official thereof,” to “any candidate
+Added: for foreign political office” or to any person, while knowing that all or a portion of the payment will be offered, given, or
+Added: promised to anyone in any of the foregoing categories.
+Added: “Foreign officials” under the FCPA include officers or employees
+Added: of a department, agency, or instrumentality of a foreign government.
+Added: The term “instrumentality” is broad and can include
+Added: state-owned or state-controlled entities.
+Added: Importantly, United States authorities deem most healthcare professionals and other
+Added: employees of foreign hospitals, clinics, research facilities and medical schools in countries with public healthcare and/or public
+Added: education systems to be “foreign officials” under the FCPA.
+Added: When we interact with foreign healthcare professionals and
+Added: researchers in testing and marketing our products abroad, should any of our product candidates receive foreign regulatory approval
+Added: in the future, we must have policies and procedures in place sufficient to prevent us and agents acting on our behalf from providing
+Added: any bribe, gift or gratuity, including excessive or lavish meals, travel or entertainment in connection with marketing our products
+Added: and services or securing required permits and approvals.
+Added: The FCPA also obligates companies whose securities are listed in the United
+Added: States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all
+Added: transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal
+Added: accounting controls for international operations.
+Added: are also subject to U.K.
+Added: Bribery Act of 2010, which prohibits both domestic and international bribery, as well as bribery across both
+Added: private and public sectors.
+Added: In addition, an organization that “fails to prevent bribery” committed by anyone associated with
+Added: the organization can be charged under the U.K.
+Added: Bribery Act unless the organization can establish the defense of having implemented “adequate
+Added: procedures” to prevent bribery.
+Added: As we expand our operations, we are likely to be subject to additional laws and restrictions relating
+Added: to anti-bribery.
+Added: Environmental,
+Added: Health, and Safety Regulation
+Added: are subject to numerous federal, state, and local environmental, health, and safety (“EHS”) laws and regulations relating
+Added: to, among other matters, safe working conditions, product stewardship, environmental protection, and handling or disposition of products,
+Added: including those governing the generation, storage, handling, use, transportation, release, and disposal of hazardous or potentially hazardous
+Added: materials, medical waste, and infectious materials that may be handled by our partner research laboratories.
+Added: Some of these laws and regulations
+Added: also require us to obtain licenses or permits to conduct our operations.
+Added: If we fail to comply with such laws or obtain and comply with
+Added: the applicable permits, we could face substantial fines or possible revocation of our permits or limitations on our ability to conduct
+Added: our operations.
+Added: Certain of our development and manufacturing activities may involve, from time to time, use of hazardous materials, and
+Added: we believe we are in compliance with the applicable environmental laws, regulations, permits, and licenses.
+Added: However, we cannot ensure
+Added: that EHS liabilities will not develop in the future.
+Added: EHS laws and regulations are complex, change frequently and have tended to become
+Added: more stringent over time.
+Added: Although the costs to comply with applicable laws and regulations, have not been material, we cannot predict
+Added: the impact on our business of new or amended laws or regulations or any changes in the way existing and future laws and regulations are
+Added: interpreted or enforced, nor can we ensure we will be able to obtain or maintain any required licenses or permits.
+Added: of December 31, 2023, we had a total of seven full-time employees and two consultants.
+Added: currently rely on several consultants who provide services to our Company.
+Added: None of our employees are represented by a labor union or
+Added: covered by collective bargaining agreements.
+Added: We consider our relationship with our employees to be good.
+Added: We anticipate that the number
+Added: of employees will increase as we continue to develop the assets in our pipeline and other clinical assets that we seek to develop.
+Added: Additionally,
+Added: we utilize and expect to continue to utilize clinical research organizations and third parties to perform our pre-clinical studies, clinical
+Added: studies, and manufacturing.
+Added: were incorporated under the name “Murphy Canyon Acquisition Corp.” in October 2021 under the laws of the State of Delaware
+Added: for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business
+Added: combination with one or more businesses.
+Added: We changed our name to “Conduit Pharmaceuticals Inc.” in connection with the completion
+Added: of the Business Combination in September 2023.
+Added: principal executive offices are located at 4995 Murphy Canyon Road, Suite 300, San Diego, CA 92123.
+Added: Our telephone number is +1 (760)
+Added: 471-8536, and our website can be found at https://www.conduitpharma.com .
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.