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Share Name | Share Symbol | Market | Type |
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Ambrx Biopharma Inc | NYSE:AMAM | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 10.13 | 0 | 01:00:00 |
☐ | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Title of each class |
Trading Symbol |
Name of each exchange on which registered | ||
American Depositary Shares (ADSs), each representing seven ordinary shares, par value $0.0001 per ordinary share |
AMAM |
The New York Stock Exchange | ||
Ordinary shares, par value $0.0001 per share * |
The New York Stock Exchange * |
* | Not for trading, but only in connection with the registration of the American Depositary Shares. |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Emerging growth company | ☒ |
U.S. GAAP ☒ | International Financial Reporting Standards as issued | Other ☐ | ||||||
by the International Accounting Standards Board | ☐ |
Audit Firm ID: 34 | Auditor Name: Deloitte & Touche LLP | Auditor Location: San Diego, California, United States |
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• | the timing, progress and results of preclinical studies and clinical trials for our product candidates, including our product development plans and strategies; |
• | the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; |
• | the potential benefits and market opportunity for our product candidates and technologies; |
• | expectations regarding the size, scope and design of clinical trials; |
• | our manufacturing, commercialization, and marketing plans and strategies; |
• | our plans to hire additional personnel and our ability to attract and retain such personnel; |
• | our estimates of the number of patients who suffer from the diseases we are targeting and potential growth in the patient populations; |
• | our expectations regarding the approval and use of our product candidates as first, second or subsequent lines of therapy or in combination with other drugs; |
• | our competitive position and the development and impact of competing therapies that are or may become available; |
• | expectations regarding future events under licensing and research and development agreements, including potential future payments, as well as our plans and strategies for entering into further licensing and research and development agreements; |
• | our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; |
• | the rate and degree of market acceptance and clinical utility of our product candidates we may develop; |
• | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
• | our future financial performance; |
• | the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; |
• | the impact of laws and regulations; and |
• | the impact of the COVID-19 pandemic and actions to slow its spread. |
• | We have incurred net losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, may not be able to sustain it. |
• | We will need to obtain substantial additional funding to complete the development and commercialization of our product candidates. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate our product development programs or other operations. |
• | We are early in our development efforts and have a limited history of conducting clinical trials to test our product candidates in humans. |
• | Our business is highly dependent on our lead product candidate, ARX788, and we must complete additional clinical testing before we can seek regulatory approval and begin commercialization of ARX788 for any indication. If we are unable to obtain regulatory approval for, and successfully commercialize, ARX788, our business may be materially harmed and such failure may affect the viability of our other product candidates. |
• | Preclinical and clinical development is a lengthy, expensive and uncertain process. The results of preclinical studies and early clinical trials are not always predictive of future results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate. |
• | Our product candidates are based on novel technologies, making it difficult to predict the timing, results and cost of product candidate development and likelihood of obtaining regulatory approval. |
• | We may encounter substantial delays in initiating or completing our clinical trials. |
• | Serious adverse events, undesirable side effects or other unexpected properties of our product candidates may be identified during development or after approval, which could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product candidates thereby limiting the commercial potential of such product candidate. |
• | We rely on third parties to conduct, supervise, and monitor our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects. |
• | We are currently party to several in-license agreements under which we acquired rights to use, develop, manufacture and/or commercialize certain of our platform technologies and resulting product candidates. If we breach our obligations under these agreements, we may be required to pay damages, lose our rights to these technologies or both, which would adversely affect our business and prospects. |
• | We are dependent on our license agreements and R&D Agreements with various partners to develop and commercialize products using our technologies in various fields and indications as well as certain of our product candidates in certain geographies. The failure to maintain our R&D Agreements with our collaboration partners or the failure of our partners to perform their obligations under our R&D Agreements with them, could negatively impact our business. |
• | We face substantial competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. |
• | If we are unable to obtain and maintain sufficient intellectual property protection for our platform technologies and product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected. |
A. |
[Reserved] |
B. |
Capitalization and indebtedness. |
C. |
Reasons for the offer and use of proceeds. |
D. |
Risk Factors. |
• | the initiation, trial design, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of our product candidates, and in particular the clinical trials for ARX788; |
• | the number and characteristics of product candidates that we pursue, as well as the indications for which we develop our product candidates; |
• | the length of our clinical trials, including, among other things, as a result of delays in enrollment, difficulties enrolling sufficient subjects or delays or difficulties in clinical trial site initiations; |
• | the outcome, timing and costs of seeking regulatory approvals for our product candidates; |
• | the costs of manufacturing our product candidates, in particular for clinical trials in preparation for marketing approval and in preparation for commercialization; |
• | the costs of any third-party products used in our combination clinical trials that are not covered by such third party or other sources; |
• | the costs associated with hiring additional personnel and consultants as our preclinical, manufacturing, regulatory and clinical activities increase; |
• | whether and when we receive marketing approvals and revenue from any commercial sales of any of our product candidates, if approved; |
• | the cost of commercialization activities for any of our product candidates, if approved, including marketing, sales and distribution costs; |
• | the emergence of competing therapies and other adverse market developments; |
• | the ability to establish and maintain strategic collaboration, licensing or other arrangements and whether and when we receive or are obligated to make payments under such arrangements; |
• | the extent to which we in-license or acquire other products and technologies and the terms of these transactions; |
• | the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; |
• | our need and ability to retain key management and hire scientific, technical, business, and medical personnel; |
• | our implementation of additional internal systems and infrastructure, including operational, financial and management information systems; |
• | the costs associated with expanding our facilities or building out our laboratory space; |
• | the extent of the impacts and duration of the COVID-19 pandemic; and |
• | the costs of operating as a public company. |
• | successful completion of preclinical studies; |
• | submission of Investigational New Drug (IND) or other regulatory applications to allow for initiation of our planned and future clinical trials and authorizations from regulators to initiate clinical trials; |
• | successful initiation, execution and completion of, planned and future clinical trials and achieving positive results from such trials; |
• | demonstrating a risk-benefit profile acceptable to regulatory authorities; |
• | clinical trial data that are sufficient to support marketing approvals from applicable regulatory authorities; |
• | and obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates and avoiding infringement of third party intellectual property rights. |
• | incur unplanned costs; |
• | be delayed in or prevented from continuing clinical development and obtaining marketing approval for our product candidates; |
• | obtain approval for indications or patient populations that are not as broad as intended or desired; |
• | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings or contraindications; |
• | be subject to changes or limitations in the way the product is administered; |
• | be required to perform additional preclinical studies or clinical trials to support approval or be subject to additional post-marketing testing requirements; |
• | have regulatory authorities withdraw their approval of the product, if granted, or impose restrictions on its distribution in the form of a Risk Evaluation and Mitigation Strategy (REMS); |
• | become subject to litigation; or |
• | experience damage to our reputation. |
• | delays in reaching a consensus with regulatory authorities on trial design; |
• | delays in reaching agreement or failing to agree on acceptable terms with prospective contract research organizations (CROs) and clinical trial sites; |
• | delays in opening sites, including delays in obtaining required approvals from institutional review boards (IRBs) and recruiting suitable patients to participate in our clinical trials; |
• | delays in enrolling patients in our clinical trials; |
• | failure by our CROs, other third parties or us to adhere to the trial protocol or applicable regulatory requirements, including the FDA’s good clinical practices (GCPs) or applicable regulatory requirements in other countries; |
• | regulatory authorities finding deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we or any of our potential future collaborators contract for clinical supplies; |
• | delays in the testing, validation, manufacturing and delivery of our product candidates to the treatment sites, including due to a facility manufacturing any of our product candidates or any of their components being ordered by the FDA, NMPA, EMA or comparable regulatory authorities to temporarily or permanently shut down due to violations of current good manufacturing practices (cGMP) regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process; |
• | imposition of a clinical hold by institutional review boards (IRBs) or regulatory authorities as a result of a serious adverse event (SAE), concerns with a class of product candidates, after an inspection of our clinical trial operations or trial sites, or for other reasons; |
• | suspensions or terminations by us, the IRBs of the institutions at which such trials are being conducted, by the Safety Review Committee or Data Safety Monitoring Board, for such trial or by regulatory authorities due to a number of factors, including those described above; |
• | patients not completing participation in a trial, returning for post-treatment follow-up or otherwise failing to adhere to clinical trial protocols; |
• | lack of adequate funding; or |
• | changes in regulatory requirements and guidance that require amending or submitting new clinical protocols. |
• | the size and nature of the patient population; |
• | the severity of the disease under investigation; |
• | eligibility criteria for the trial; |
• | the proximity of patients to clinical sites; |
• | the design of the clinical protocol; |
• | the ability to obtain and maintain patient consents; |
• | the ability to recruit clinical trial investigators with the appropriate competencies and experience; |
• | the risk that patients enrolled in clinical trials will drop out of the trials before the administration of our product candidates or trial completion; |
• | reporting of the preliminary results of our clinical trials; |
• | the number of competing clinical trials; |
• | the availability of new drugs approved for the indication the clinical trial is investigating; |
• | clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies; and |
• | other factors we may not be able to control. |
• | regulatory authorities may suspend, withdraw or limit approvals of such product; |
• | regulatory authorities may require additional warnings on the label, including a “boxed” warning or contraindication, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; |
• | regulatory authorities may require a REMS plan to mitigate risks; |
• | we may be required to change the way a product is distributed or administered, conduct additional clinical trials, or change the labeling of the product; |
• | the product may become less competitive, and our reputation may suffer; |
• | we may decide to remove the product from the marketplace; and |
• | we may be subject to regulatory investigations and government enforcement actions, including fines, injunctions or the imposition of civil or criminal penalties. |
• | such authorities may disagree with the design or implementation of our clinical trials; |
• | negative or ambiguous results from our clinical trials or results may not meet the level of statistical significance required by the FDA, NMPA, EMA or comparable regulatory authorities for approval; |
• | serious and unexpected product-related side effects may be experienced by participants in our clinical trials or by individuals using biological products similar to our product candidates; |
• | the population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; |
• | such authorities may not accept clinical data from trials which are conducted at clinical facilities or in countries where the standard of care is potentially different from that of the United States; |
• | we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks or that a product candidate is safe and effective for its proposed indication; |
• | such authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | such authorities may not agree that the data collected from clinical trials of our product candidates are acceptable or sufficient to support the submission of an application for regulatory approval or other submissions or to obtain regulatory approval in the United States or elsewhere, including due to clinical trial issues encountered as a result of COVID-19 pandemic, and such authorities may impose requirements for additional preclinical studies or clinical trials; |
• | such authorities may disagree regarding the formulation, labeling and/or the specifications of our product candidates; |
• | approval may be granted only for indications that are significantly more limited than what we apply for and/or with other significant restrictions on distribution and use; |
• | such authorities may fail to approve any required companion diagnostics to be used with our product candidates; |
• | such authorities may find deficiencies in the manufacturing processes or facilities of our third-party manufacturers with which we or any of our potential future collaborators contract for clinical and commercial supplies; or |
• | the approval policies or regulations of such authorities may significantly change in a manner rendering our or any of our potential future collaborators’ clinical data insufficient for approval. |
• | issuing warning or untitled letters or holds on clinical trials; |
• | mandating modifications to promotional materials or require us to provide corrective information to healthcare practitioners, or require other restrictions on the labeling or marketing of such products; |
• | seeking an injunction or imposing civil or criminal penalties or monetary fines; |
• | suspension or imposition of restrictions on operations, including product manufacturing or marketing or withdrawal of the product from the market; |
• | seizure or detention of products, refusal to permit the import or export of products or voluntary or mandatory product recalls; |
• | suspension, modification or revocation of our marketing approvals; |
• | suspension of any ongoing clinical trials; |
• | refusal to approve pending applications or supplements to applications submitted by us; |
• | imposition of a REMS, which may include distribution or use restrictions; or |
• | requiring us to conduct additional post-market clinical trials, change our product labeling or submit additional applications for marketing authorization. |
• | our inability to design such product candidates with the properties that we desire; or |
• | potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance. |
• | inability to meet our product specifications and quality requirements consistently; |
• | an inability to initiate or continue clinical trials of our product candidates under development; |
• | delay in submitting regulatory applications, or receiving marketing approvals, for our product candidates, if at all; |
• | loss of the cooperation of future collaborators; |
• | subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities; |
• | requirements to cease development or to recall batches of our product candidates; and |
• | in the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product or any other future product candidates. |
• | efficacy and potential advantages compared to alternative treatments; |
• | our ability to offer our products for sale at competitive prices; |
• | convenience and ease of administration compared to alternative treatments; |
• | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
• | the availability of coverage and adequate reimbursement from government and commercial third-party payors, and the willingness of patients to pay out of pocket for our products, once approved, in the absence of adequate third party payor reimbursement; |
• | the strength of marketing and distribution support; and |
• | the prevalence and severity of any side effects. |
• | a covered benefit under its health plan; |
• | safe, effective and medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; and |
• | neither experimental nor investigational. |
• | our inability to recruit and retain adequate numbers of effective sales and marketing personnel; |
• | the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future products; |
• | the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product portfolios; and |
• | unforeseen costs and expenses associated with creating an independent sales and marketing organization. |
• | litigation involving patients taking our products; |
• | restrictions on such products, manufacturers or manufacturing processes; |
• | restrictions on the labeling or marketing of a product; |
• | restrictions on product distribution or use; |
• | requirements to conduct post-marketing studies or clinical trials; |
• | warning or untitled letters; |
• | withdrawal of the products from the market; |
• | refusal to approve pending applications or supplements to approved applications that we submit; |
• | recall of products; |
• | fines, restitution or disgorgement of profits or revenue; |
• | suspension or withdrawal of marketing approvals; |
• | suspension of any ongoing clinical trials; |
• | damage to relationships with any potential collaborators; |
• | unfavorable press coverage and damage to our reputation; |
• | refusal to permit the import or export of our products; |
• | product seizure; or |
• | injunctions or the imposition of civil or criminal penalties. |
• | our collaboration partners may not comply with applicable regulatory requirements with respect to developing or commercializing products under our agreements with them, which could adversely impact development, regulatory approval and eventual commercialization of such products. For example, our collaboration partners’ failure to comply with existing or future laws and regulations related to the management of human genetic resources (including materials and information) in China could lead to government enforcement actions, which could include fines, suspension of related activities and confiscation of related human genetic resources and gains generated from conducting these activities, or breach liability. Compliance or the failure to comply with such laws could increase the costs of, limit and cause significant delay in their clinical studies and research and development activities, which could materially and adversely affect our business and prospects as well; |
• | we and our collaboration partners could disagree as to future development plans and our partners may delay initiation of or cease research efforts, preclinical studies or clinical trials; |
• | there may be disputes between us and our collaboration partners, including disagreements regarding the terms of the applicable agreement or scope of the license, that may result in the delay of or failure to |
achieve development, regulatory and commercial objectives that would result in milestone or royalty payments to us, the delay or termination of any future development or commercialization of our product candidates or other product candidates using our technology, and/or costly litigation or arbitration that diverts our management’s attention and resources; |
• | our collaboration partners may not provide us with timely and accurate information regarding development progress and activities under the applicable agreement, which could adversely impact our ability to report progress to our investors and otherwise plan our own development activities; |
• | business combinations or significant changes in our collaboration partners’ business strategy may adversely affect their ability or willingness to perform their obligations under the applicable agreement; |
• | collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration; |
• | a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution; |
• | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; |
• | our collaboration partners may not properly maintain or defend our licensed intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential litigation; and |
• | the royalties we are eligible to receive from our collaboration partners may be reduced or eliminated based upon their and our ability to maintain or defend our intellectual property rights. |
• | interruption or delays in our operations, which may impact our ability to conduct and produce preclinical results required for submission of an IND; |
• | delays in receiving authorizations from local regulatory authorities to initiate our planned clinical trials; |
• | delays or difficulties in enrolling patients in our clinical trials due to patients’ concerns of contracting COVID-19 while visiting hospitals, including patients with cancer who may be immunocompromised during the COVID-19 pandemic; |
• | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
• | delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials, including interruption in global shipping that may affect the transport of clinical trial materials; |
• | changes in local regulations as part of a response to COVID-19 which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
• | interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data; |
• | interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines; |
• | risk that participants enrolled in our clinical trials will contract COVID-19 while the clinical trial is ongoing, which could impact the results of the clinical trial, including by increasing the number of observed adverse events; and |
• | refusal of the FDA to accept data from clinical trials in affected geographies outside the United States. |
• | impairment of our business reputation; |
• | withdrawal of clinical trial participants; |
• | costs due to related litigation; |
• | distraction of management’s attention from our primary business; |
• | substantial monetary awards to patients or other claimants; |
• | the inability to commercialize our product candidates; and |
• | decreased demand for our product candidates, if approved for commercial sale. |
• | identify, recruit integrate, maintain and motivate additional qualified personnel; |
• | manage our development efforts effectively, including the initiation and conduct of clinical trials for our product candidates, both as monotherapy and in combination with other therapeutics; and |
• | improve our operational, financial and management controls, reporting systems and procedures. |
• | the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act or federal civil money penalties statute. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand, and prescribers, purchasers, and formulary managers on the other. Although there are several statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution, they are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; |
• | the U.S. federal false claims, including the False Claims Act, which can be enforced through whistleblower actions, and civil monetary penalties laws, which, among other things, impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. Manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. Companies that submit claims directly to payors may also be liable under the False Claims Act for the direct submission of such claims. The False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the False Claims Act and to share in any monetary recovery. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; |
• | the U.S. federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, (HITECH), and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses and their respective business |
associates that perform services for them that involve the use, or disclosure of, individually identifiable health information as well as their covered subcontractors, relating to the privacy, security, and transmission of such individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; |
• | the U.S. Federal Food, Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; |
• | the U.S. federal legislation commonly referred to as Physician Payments Sunshine Act, enacted as part of the ACA, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; |
• | analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state and local laws requiring the registration of pharmaceutical sales representatives; and |
• | European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers. |
• | if and when patents may issue based on our patent applications; |
• | the scope of protection of any patent issuing based on our patent applications; |
• | whether the claims of any patent issuing based on our patent applications will provide protection against competitors; |
• | whether or not third parties will find ways to invalidate or circumvent our patent rights, including designing around our patents; |
• | whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; |
• | whether we will need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights which will be costly whether we win or lose; and/or |
• | whether the patent applications that we own or in-license will result in issued patents with claims that cover our product candidates or uses thereof in the United States or in other foreign countries. |
• | others may be able to make product candidates that are similar to ours but that are not covered by the claims of the patents that we own or have exclusively licensed by designing around features of our product candidates; |
• | we or our licensors or future collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; |
• | we or our licensors or future collaborators might not have been the first to file patent applications covering certain of our inventions; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; |
• | it is possible that noncompliance with the USPTO and foreign governmental patent agencies requirement for a number of procedural, documentary, fee payment and other provisions during the patent process can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; |
• | it is possible that our pending patent applications will not lead to issued patents; |
• | issued patents that we own or have exclusively licensed may be revoked, modified, or held invalid or unenforceable, as a result of legal challenges by our competitors; |
• | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
• | we may not develop additional proprietary technologies that are patentable; |
• | we cannot predict the scope of protection of any patent issuing based on our patent applications, including whether the patent applications that we own or in-license will result in issued patents with claims that directed to our product candidates or uses thereof in the United States or in other foreign countries; |
• | there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; |
• | countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates; |
• | the claims of any patent issuing based on our patent applications may not provide protection against competitors or any competitive advantages, or may be challenged by third parties; |
• | if enforced, a court may not hold that our patents are valid, enforceable and infringed; |
• | we may need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights which will be costly whether we win or lose; |
• | we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property; |
• | we may fail to adequately protect and police our trademarks and trade secrets; and |
• | the patents of others may have an adverse effect on our business, including if others obtain patents claiming subject matter similar to or improving that covered by our patents and patent applications. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | the sublicensing of patent and other rights; |
• | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
• | the ownership of inventions and know-how resulting from the creation or use of intellectual property by us alone or with our licensors and partners; |
• | the scope and duration of our payment obligations; and |
• | the priority of invention of patented technology. |
• | positive or negative results from preclinical studies and clinical trials by us, our collaborators or competitors; |
• | concerns regarding the safety of our product candidates or ADCs in general; |
• | the timing of commencing, enrolling and announcing results from clinical trials; |
• | decisions as to which product candidates, indications or discovery programs we chose to pursue; |
• | announcements regarding competitive products or technologies or the biologics industry in general; |
• | actions taken or guidance provided by regulatory agencies with respect to our clinical trials or regulatory submissions; |
• | changes or developments in laws or regulations applicable to our product candidates and our markets, including in the United States and China; |
• | changes to our relationships with collaborators, manufacturers or suppliers; |
• | the loss of any of our key scientific or management personnel; |
• | changes in the structure of healthcare payment systems; |
• | actual or anticipated fluctuations in our operating results; |
• | changes in financial estimates or recommendations by securities analysts; |
• | potential acquisitions, financing, collaborations or other corporate transactions; |
• | the loss of rights under license, strategic or other research and development agreements; |
• | the results of our efforts to discover, develop, acquire or in-license additional product candidates; |
• | the trading volume of our ADSs on the NYSE; |
• | sales of our ADSs or ordinary shares by us, members of our senior management and directors or our significant shareholders or the anticipation that such sales may occur in the future; |
• | general economic, geopolitical, and market conditions and overall fluctuations in the financial markets in the United States or China, including due to civil or political unrest (such as the ongoing conflict between Ukraine and Russia), terrorism, insurrection or war, man-made or natural disasters; |
• | stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biologics industry; |
• | investors’ general perception of us and our business; |
• | public health pandemics or epidemics, including the ongoing and future impact of the COVID-19 pandemic and actions taken to slow its spread; and |
• | other events and factors, many of which are beyond our control. |
• | only one of our three classes of directors will be elected each year; |
• | shareholders are entitled to remove directors only for cause; |
• | shareholders are not be permitted to take actions by written consent; and |
• | shareholders must give advance notice to nominate directors or submit proposals for consideration at annual general meetings. |
A. |
History and development of the company. |
B. |
Business overview. |
• | Our proprietary technology platform of expanded the genetic code allows us to incorporate SAAs, in a site-specific manner into proteins within living cells, including both bacterial and mammalian cells. |
• | The site-specifically incorporated SAA creates a unique and predictable attachment point for our conjugations, allowing us to obtain over 90% homogeneity. |
• | We have a wide range of proprietary payloads and linkers for site-specific conjugation to achieve the designed biological functions for our EPBs. |
(1) | Our synthetic amino acids (SAAs) |
(2) | Our orthogonal tRNA synthetase |
(3) | Our orthogonal transferring RNA (tRNA) |
only be recognized by our imported orthogonal tRNA synthetase and loaded with the specific SAA corresponding to the orthogonal tRNA synthetase. |
(4) | Our unique codon |
(5) | Our precision engineered protein incorporated with site-specific SAA: pre-identified location. Using this process, protein synthesis continues until the entire desired protein is synthesized. We have developed systems to incorporate SAAs into proteins in industry standard cell lines, including E.coli |
* | NovoCodex is our commercial and development partner in China for ARX788 and ARX305, where we continue to use data generated by NovoCodex to support our clinical development and regulatory filings. See “Business overview – Collaborations – License Agreement with NovoCodex (ARX788)” for more information on our agreement with NovoCodex, including our rights to use such data. |
• | ACE-Breast-01: |
• | ACE-Breast-02: |
• | ACE-Breast-03: single-arm global trial for HER2-positive metastatic breast cancer patients whose diseases have failed T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. |
• | ACE-Breast-08: |
• | ACE-Pan tumor-01: Phase 1 dose escalation and expansion trial in the United States and Australia for patients with various tumors with HER2 expression. Cohorts in the expansion phase include HER2 |
positive breast cancer, HER2 low breast cancer, HER2 positive gastric/GEJ, HER2 overexpressing solid tumors, HER2 mutated solid tumors. |
• | ACE-Pan tumor-03: Phase 1b/2 single arm basket trial in China for HER2-positive solid tumor patients who have failed standard of care treatment. |
• | ACE-Gastric-01: |
• | ACE-Gastric-02: Global Phase 2/3 randomized trial initially in China for patients with HER2-positive gastric/GEJ cancer. |
• | ACE-Breast-06: |
• | ACE-Breast-07: HER2-low breast cancer, which is anticipated to start in 2022. |
• | DREAM-02: Phase 2 single arm trial in China of pyrotinib maleate combined with ARX788 as neoadjuvant therapy in the treatment of HER2-positive stage II-III breast cancer. First patient dosed in November 2021. |
• | I-SPY 2.2 trial sponsored by Quantum Leap Healthcare Collaborative for HER2 positive breast cancer patients in US in neoadjuvant setting for ARX788 as single agent as well as in combination with anti-PD-1 |
• | ACE-Combo-02: Phase 1 clinical trial in China evaluating ARX788 combined with toripalimab in patients with HER2-expressing or mutated advanced solid tumors, which is anticipated to start in 2022. |
• | Extend our leadership position in EPBs. |
• | Expeditiously advance our lead ADC clinical program, ARX788, through clinical development for HER2-positive breast and gastric cancer, including at the GEJ. Breast-03 clinical trial results, studying the activity of Enhertu compared to Kadcyla in second line metastatic breast cancer. With statistically significant and clinically meaningful improvement in the primary endpoint progression free survival over Kadcyla, both National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) soon revised the HER2+ metastatic breast cancer treatment guideline to displace Kadcyla with Enhertu as the new standard of care in second line HER2+ breast cancer. Accordingly, we revised our clinical plan and focus on studying ARX788 activity in breast cancer patients who have failed Enhertu. We plan to utilize the benefits of Fast Track designation, including more frequent interactions with the FDA and the ability to use rolling submissions for both BLAs and sBLAs, to expeditiously advance ARX788 for breast cancer through clinical development. In addition, we have ongoing collaborations with academic key opinion leaders to study ARX788 in early stage HER2 positive breast cancer in the neoadjuvant setting and in HER2-low metastatic breast cancer. In January 2021, the FDA granted ARX788 Orphan Drug designation for the treatment of gastric cancer, including at the GEJ. In May 2021, the NMPA granted ARX788 Breakthrough therapy designation for the second-line treatment of HER2-positive metastatic breast cancer. |
• | Expand the impact of ARX788 by advancing ARX788 clinical programs for other HER2-expressing or HER2–mutated tumors. HER2-low cancers. Additionally, we believe that our site-specific conjugation capabilities can create predictable and highly stable chemical bonds, which may reduce toxicity and make ARX788 an attractive candidate for use in combination with earlier- line |
standard of care therapeutics. These strategies may increase ARX788’s addressable patient population, maximizing patient impact and commercial opportunity. |
• | Continue to develop and expand our oncology-focused ADC and IOC franchises and platform technology. |
• | Maximize the potential of our pipeline and technology platform by selectively entering strategic collaborations or partnerships. program-by-program |
• | Confirmed ORR of 66% (19 of 29 patients) and disease control rate (DCR) of 100% in the 1.5 mg/kg cohort and confirmed ORR of 50% (8 of 16 patients) and DCR of 88% in the 1.3 mg/kg cohorts, in the ACE-Breast-01 |
• | Confirmed ORR of 67% (2 of 3 patients) and DCR of 100% (3 of 3 patients) in the 1.5 mg/kg dose escalation cohort, and no confirmed responses (0 of 8 patients) and DCR of 100% (8 of 8 patients) in the 1.3 mg/kg dose escalation cohort, in the ACE-Pan tumor-01 trial. |
• | Confirmed ORR of 43% (3 of 7 patients) in the 1.7 mg/kg cohort, 46% (6 of 13 patients) in the 1.5 mg/kg dose escalation cohort and confirmed ORR of 43% (3 of 7 patients) in the 1.3 mg/kg cohort, in the ACE-Gastric-01 |
• | Anti-tumor activity observed in patients with tumors resistant and refractory to approved HER2-targeting regimens. |
• | The median duration of response (mDOR) at the 1.5 mg/kg dose and 1.3 mg/kg dose was 14.4 months and 12.9 months, respectively, and the median progression-free survival (PFS) at the 1.5 mg/kg dose was 17.0 months in the ACE-Breast-01 |
• | Generally well-tolerated with most adverse events being mild (Grade 1) or moderate (Grade 2) and manageable and with an aggregate of eight drug-related SAEs reported from the 183 patients dosed with ARX788 in the ACE-Breast-01, ACE-Pan tumor-01 and ACE-Gastric-01 |
Dose Level |
Evaluable Patients (N=69) |
Confirmed ORR |
DCR |
|||||||
0.33 mg/kg and 0.66 mg/kg |
N = 6 | 0 | % | 83 | % | |||||
0.88 mg/kg |
N = 7 | 14 | % | 86 | % | |||||
1.1 mg/kg |
N = 11 | 27 | % | 100 | % | |||||
1.3 mg/kg |
N = 16 | 50 | % | 88 | % | |||||
1.5 mg/kg |
N = 29 | 66 | % | 100 | % |
Dose Level |
Evaluable Patients (N = 20) |
Confirmed ORR |
DCR |
|||||||
1.3 mg/kg |
N = 7 | 43 | % | 57 | % | |||||
1.5 mg/kg |
N = 13 | 46 | % | 46 | % | |||||
1.7 mg/kg |
N=7 |
43 |
% |
86 |
% |
Dose Level |
Evaluable Patients (N = 28) |
Confirmed ORR |
DCR |
|||||||
0.66 mg/kg |
N = 5 | 20 | % | 60 | % | |||||
0.88 mg/kg |
N = 9 | 11 | % | 78 | % | |||||
1.1 mg/kg |
N = 3 | 33 | % | 67 | % | |||||
1.3 mg/kg |
N = 11 | 0 | % | 91 | % | |||||
1.5 mg/kg |
N = 3 | 67 | % | 100 | % |
ACE-Breast-01 (N=69), n (%) |
ACE-Pan tumor-01 (N=67), n (%) |
ACE-Gastric-01 (N=30), n (%) |
||||||||||
All AEs (regardless of causality) |
69 (100.0%) | 61 (91.0%) | 29 (96.7%) | |||||||||
Drug-related AEs (any grade) |
67 (97.1%) | 48 (71.6%) | 28 (93.3%) | |||||||||
All AEs Grade 3 and Grade 4 |
16 (23.2%) | 23 (34.3%) | 10 (33.3%) | |||||||||
Drug-related Grade 3 and Grade 4 AEs |
8 (11.6%) | 8 (11.9%) | 4 (13.3%) | |||||||||
All SAEs |
8 (11.6%) | 17 (25.4%) | 7 (23.3%) | |||||||||
Drug-related SAEs |
2 (2.9%) | 5 (7.5%) | 2 (6.7%) | |||||||||
Drug-related AEs leading to discontinuation |
3 (4.3%) | 6 (9.0%) | 2 (6.7%) | |||||||||
Drug-related Deaths |
0 | 0 | 0 |
All AEs from ARX788 Systemic Toxicity (all cohorts) Number of Patients (%) | ||||||||||||
ACE-Breast-01 (N=69) |
ACE-Pan tumor-01 (N=67) |
ACE-Pan tumor-01 (N=30) | ||||||||||
All Grades |
Grade 3 or 4 |
All Grades |
Grade 3 or 4 |
All Grades |
Grade 3 or 4 | |||||||
Nausea |
3 (4.3%) | 0 | 16 (23.9%) | 2 (3.0%) | 2 (6.7%) | 0 | ||||||
Vomiting |
4 (5.8%) | 0 | 8 (11.9%) | 1 (1.5%) | 4 (13.3%) | 1 (3.3%) | ||||||
Constipation |
6 (8.7%) | 0 | 11 (16.4%) | 0 | 2 (6.7%) | 0 | ||||||
Diarrhea |
4 (5.8%) | 0 | 9 (13.4%) | 1 (1.5%) | 9 (30%) | 0 | ||||||
Neutropenia |
14 (20.3%) | 1 (1.4%) | 3 (4.5%) | 0 | 7 (23.3%) | 0 | ||||||
Decreased WBC |
14 (20.3%) | 0 | 4 (6.0%) | 0 | 8 (26.7%) | 0 | ||||||
Thrombocytopenia |
10 (14.5%) | 1 (1.4%) | 6 (9.0%) | 0 | 11 (36.7%) | 0 | ||||||
Anemia |
6 (8.7%) | 0 | 9 (13.4%) | 3 (4.5%) | 16 (53.3%) | 3 (10%) | ||||||
Fatigue |
20 (29%) | 0 | 22 (32.8%) | 2(3.0%) | 5 (16.7%) | 0 | ||||||
Neuropathy |
0 | 0 | 3 (4.5%) | 0 | 0 | 0 | ||||||
Dizziness |
2 (2.9%) | 0 | 7 (10.4%) | 1 (1.5%) | 2 (6.7%) | 0 | ||||||
Headache |
3 (4.3%) | 0 | 12 (17.9%) | 0 | 2 (6.7%) | 0 |
ACE-Breast-01 (N=69) |
ACE-Pan tumor-01 (N=67) |
ACE-Pan tumor-01 (N=30) | ||||||||||
All Grades |
Grade 3 or 4 |
All Grades |
Grade 3 or 4 |
All Grades |
Grade 3 or 4 | |||||||
Pneumonitis/lLD |
25(36.2%) | 2 (2.9%) | 2 (3.0%) | 1 (1.5%) | 7 (23.3%) | 1 (3.3%) | ||||||
AST increase |
47 (68.1%) | 0 | 7 (10.4%) | 0 | 14 (46.7%) | 0 | ||||||
ALT increase |
38 (55.1%) | 0 | 5 (7.5%) | 1 (1.5%) | 13 (43.3%) | 0 | ||||||
Dry eye |
15 (21.7%) | 0 | 14 (20.9%) | 0 | 16 (53.3%) | 0 | ||||||
Blurred vision |
15 (21.7%) | 2 (2.9%) | 10 (14.9%) | 0 | 8 (26.7%) | 1 (3.3%) | ||||||
Keratopathy |
32 (46.4%) | 3 (4.3%) | 4 (6.0%) | 0 | 8 (26.7%) | 0 | ||||||
Eye discomfort |
2 (2.9%) | 0 | 1 (1.5%) | 0 | 0 | 0 |
• | Pursue indications with the greatest unmet needs to improve the lives of breast cancer patients. HER2-low metastatic breast cancer and advanced breast cancer with brain metastases. |
• | Leverage the anti-tumor activity and tolerability profile of ARX788 to move into earlier lines of therapy for breast cancer and seek combination therapy with other agents. head-to-head T-DM1 in HER2-positive metastatic breast cancer. We also plan to conduct trials in combination with synergistic agents from other potential collaborators to investigate the ability to improve therapeutic effects in difficult-to-treat |
• | Expand ARX788’s clinical impact beyond breast cancer by conducting trials in additional HER2-overexpressing or HER2-mutated cancers |
• | Continue to pursue expedited regulatory programs. |
1. | Enhanced anti-tumor activity in preclinical studies as a single agent compared to T-DM1 in HER2-positive cancersT-DM1 resistant tumors. |
2. | Encouraging single-agent anti-tumor activity in both high- and low-HER2-expressing cancer modelsHER2-low patients and more difficult-to-treat |
3. | Enhanced anti-tumor activity when combined with an anti-PD-1 |
4. | Improved tolerability profile in preclinical studies when compared to a conventional cysteine-conjugated HER2 ADC |
• | A Fab region of an anti-CD3 mAb is chemically linked, via the two site-specifically incorporated SAAs (one of each on the heavy and the light chains), to two small molecule folic acid ligands. Each ligand is also linked to a PEG (Bifolate-BiPeg). |
• | An anti-CD3 Fab arm can recruit T cells for tumor killing. Two folic acids can bind strongly and specifically to a folate alpha receptor which is overexpressed in multiple cancer types. |
• | Two linker-PEGylation branches can extend the short in vivo half-life time associated with Fab. |
• | completion of extensive preclinical laboratory tests and animal studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice (GLP) requirements; |
• | submission to the FDA of an investigational new drug application (IND), which must become effective before human clinical trials may begin; |
• | approval of the protocol and related documentation by an institutional review board (IRB) or independent ethics committee at each clinical trial site before each clinical trial may be commenced; |
• | performance of adequate and well-controlled human clinical trials in accordance with applicable FDA regulations, including good clinical practice (GCP) requirements and any other clinical trial-related regulations for the protection of human research subjects and their health information and to establish the safety and efficacy of the investigational product for each proposed indication; |
• | preparation and submission to the FDA of a BLA for marketing approval that includes sufficient evidence of establishing the safety, purity, and potency of the proposed biological product for its intended indication, including from results of preclinical testing and clinical trials; |
• | payment of any user fees for FDA review of the BLA; |
• | a determination by the FDA within 60 days of its receipt of a BLA to accept the filing for review; |
• | satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the biological product, or components thereof, will be produced to assess compliance with current good manufacturing practice (cGMP) requirements to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity; |
• | satisfactory completion of any potential FDA audits of the clinical trial sites that generated the data in support of the BLA to assure compliance with GCP requirements and integrity of the clinical data; |
• | FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee, where appropriate and if applicable; and |
• | compliance with any post-approval requirements, including a risk evaluation and mitigation strategy (REMS) plan, where applicable, and post- approval studies required by the FDA as a condition of approval. |
• | Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the dosing tolerance, pharmacokinetics, pharmacologic action, side effect tolerability, safety of the product candidate, and, if possible, early evidence of effectiveness. |
• | Phase 2 clinical trials generally involve studies in disease-affected patients to evaluate proof of concept and/or determine the dosing regimen(s) for subsequent investigations. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. |
• | Phase 3 clinical trials generally involve a large number of patients at multiple geographically dispersed trial sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product labeling. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the biologic. |
• | restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls; |
• | safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; |
• | mandated modification of promotional materials and labeling and issuance of corrective information; |
• | fines, warning or other enforcement-related letters or holds on clinical trials; |
• | refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product approvals; |
• | product seizure or detention, or refusal to permit the import or export of products; |
• | injunctions or the imposition of civil or criminal penalties; or |
• | consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs. |
• | The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act or federal civil money penalties statute. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. |
• | Federal civil and criminal false claims laws, such as the False Claims Act (FCA), which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. Manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. |
• | The Health Insurance Portability and Accountability Act of 1996 (HIPAA), among other things, imposes criminal liability for knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, or knowingly and |
willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, (HITECH), and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information as well as their covered subcontractors, relating to the privacy, security, and transmission of such individually identifiable health information. |
• | Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers. |
• | The federal transparency requirements under the Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act (the Affordable Care Act or ACA), which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members. Effective January 1, 2022, applicable manufacturers also will be required to report such information regarding its relationships with certain other healthcare professionals, including physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year. |
• | Federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs. |
• | Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers. |
• | State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers, and state laws that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information. |
• | State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; and state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes. |
• | increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program; |
• | established a branded prescription drug fee that pharmaceutical manufacturers of certain branded prescription drugs must pay to the federal government; |
• | expanded the list of covered entities eligible to participate in the 340B drug pricing program by adding new entities to the program; |
• | established a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, effective as of 2019) point-of-sale discounts |
• | extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
• | expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; |
• | created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected; |
• | established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; |
• | established a Center for Medicare and Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; and |
• | created a licensure framework for follow-on biologic products. |
• | a covered benefit under its health plan; |
• | safe, effective and medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; and |
• | neither experimental nor investigational. |
C. |
Organizational structure. |
Name |
Place of Incorporation |
Date of Incorporation | ||
Ambrx Biopharma Inc. |
Cayman Islands |
May 2015 | ||
Biolaxy Pharmaceutical Hong Kong Limited |
Hong Kong |
February 2016 | ||
Ambrx Australia Pty Limited |
Australia |
March 2017 | ||
Ambrx, Inc. |
Delaware |
January 2003 | ||
Shanghai Ambrx Biopharma Company Limited |
People’s Republic of China |
July 2005 |
D. |
Property, plants and equipment. |
A. |
Operating results. |
• | expenses incurred under agreements with third parties, including CROs and other third parties conducting preclinical research and development activities and clinical trials on our behalf; |
• | costs of developing and scaling our manufacturing process and manufacturing drug products for use in our preclinical studies and future clinical trials, including the costs of CMOs that will manufacture our clinical trial material for use in our preclinical studies and potential future clinical trials; |
• | costs of outside consultants, including their fees and related travel expenses; |
• | costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials; and |
• | license payments for intellectual property used in research and development activities. |
• | personnel costs, which include salaries, benefits, and other employee related costs, including share-based compensation, for personnel engaged in research and development functions, and |
• | facility, depreciation, amortization and equipment related costs, which include depreciation and amortization costs and expenses for rent and maintenance of facilities and other operating costs if specifically, identifiable to research and development activities. |
• | uncertainties in clinical trial design; |
• | per patient trial costs; |
• | the number of trials required for approval; |
• | the number of sites included in the trials; |
• | the number of patients that participate in the trials; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible patients; |
• | the drop-out or discontinuation rates of patients, particularly in light of the continued COVID-19 pandemic environment; |
• | the safety and efficacy profiles of our product candidates; |
• | the timing receipt, and terms of any approvals from applicable regulatory authorities including the FDA and non-U.S. regulators; |
• | maintaining a continued acceptable safety profile of our product candidates following approval, if any, of our product candidates; |
• | significant and changing government regulation and regulatory guidance; |
• | establishing clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully; |
• | the impact of any business interruptions to our operations or to those of the third parties with whom we work, particularly considering the COVID-19 pandemic environment; |
• | the expense of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights; and |
• | the extent to which we establish additional strategic collaborations or other arrangements. |
For the Year Ended December 31, |
||||||||||||||||
2021 |
2020 |
$ Change |
% Change |
|||||||||||||
Revenue |
$ | 7,455 | $ | 13,671 | $ | (6,216 | ) | (45.5 | %) | |||||||
Operating expenses |
||||||||||||||||
Research and development |
54,808 | 20,433 | 34,375 | 168.2 | % | |||||||||||
General and administrative |
17,071 | 6,353 | 10,718 | 168.7 | % | |||||||||||
|
|
|
|
|||||||||||||
Total operating expenses |
71,879 | 26,786 | ||||||||||||||
|
|
|
|
|||||||||||||
Loss from operations |
(64,424 | ) | (13,115 | ) | ||||||||||||
Other expense, net |
||||||||||||||||
Interest income |
— | 27 | ||||||||||||||
Other, net |
40 | (4,750 | ) | |||||||||||||
Change in fair value of redeemable noncontrolling interests |
(3,903 | ) | — | |||||||||||||
|
|
|
|
|||||||||||||
Total other expense, net |
(3,863 | ) | (4,723 | ) | 860 | 18.2 | % | |||||||||
|
|
|
|
|||||||||||||
Loss before provision for income taxes |
(68,287 | ) | (17,838 | ) | ||||||||||||
Provision for income taxes |
(1 | ) | (1 | ) | — | 0.0 | % | |||||||||
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (68,288 | ) | $ | (17,839 | ) | $ | (50,449 | ) | |||||||
|
|
|
|
|
|
2021 |
2020 |
$ Change |
% Change |
|||||||||||||
License fees |
$ | 3,533 | $ | 10,992 | $ | (7,459 | ) | (67.9 | %) | |||||||
Reimbursements |
1,850 | 448 | 1,402 | 312.9 | % | |||||||||||
Research and development services |
2,072 | 2,231 | (159 | ) | (7.1 | %) | ||||||||||
|
|
|
|
|
|
|||||||||||
Total revenues |
$ | 7,455 | $ | 13,671 | $ | (6,216 | ) | (45.5 | %) | |||||||
|
|
|
|
|
|
2021 |
2020 |
$ Change |
% Change |
|||||||||||||
Direct costs: |
||||||||||||||||
Clinical programs |
$ | 21,912 | $ | 1,977 | $ | 19,935 | 1,008.3 | % | ||||||||
Preclinical programs |
3,816 | 3,459 | 357 | 10.3 | % | |||||||||||
Indirect costs: |
||||||||||||||||
Personnel and related costs |
23,153 | 10,159 | 12,994 | 127.9 | % | |||||||||||
Facility, depreciation, amortization and equipment related |
5,926 | 4,838 | 1,088 | 22.5 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total research and development expenses |
$ | 54,808 | $ | 20,433 | $ | 34,375 | 168.2 | % | ||||||||
|
|
|
|
|
|
B. |
Liquidity and capital resources. |
• | Under our license agreements and R&D Agreements, we have payment obligations, which are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones and are required to make royalty payments in connection with the sales of products developed under those agreements. For additional details regarding these agreements, see the section titled “Business overview—Research and Development Agreements” and Note 6 – Commitments and Contingencies |
• | Obligations under contracts which are cancelable without significant penalty. |
• | Purchase orders issued in the ordinary course of business as they represent authorizations to purchase the items rather than binding agreements. |
• | Contracts in the normal course of business with clinical supply manufactures and with vendors for preclinical studies, research supplies and other services and products for operating purposes. These contracts generally provide for termination after a notice period, and therefore are cancelable contracts and are not included in the table above. |
• | The scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our product candidates; |
• | The costs, timing and outcome of regulatory review of our product candidates; |
• | The costs of establishing or contracting for sales, marketing and distribution capabilities if we obtain regulatory approvals to market our product candidates; |
• | The costs of securing and producing drug substance and drug product material for use in preclinical studies, clinical trials and for use as commercial supply; |
• | The costs of securing manufacturing arrangements for development activities and commercial production; |
• | The scope, prioritization and number of our research and development programs; |
• | The extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under future collaboration agreements, if any; |
• | The extent to which we acquire or in-license other product candidates and technologies; and |
• | The costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims. |
2021 |
2020 |
2019 |
||||||||||
Operating activities |
$ | (44,640 | ) | $ | (20,576 | ) | $ | (2,765 | ) | |||
Investing activities |
(3,206 | ) | (252 | ) | (48 | ) | ||||||
Financing activities |
127,427 | 95,678 | — | |||||||||
Effect of exchange rate changes on cash |
47 | 165 | (38 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total |
$ | 79,628 | $ | 75,015 | $ | (2,851 | ) | |||||
|
|
|
|
|
|
• | the recoverability of long-lived assets; |
• | estimating our clinical trial expenses; |
• | periods over which revenue should be recognized; and |
• | assumptions used in estimating the fair value of share-based compensation expense. |
• | Fair Value of Ordinary Shares |
• | Expected Term out-of-the in-the-money, |
• | Risk-Free Interest Rate zero-coupon issues with a term equivalent to that of the expected term of the share-based awards. |
• | Expected Volatility |
• | Dividend Yield |
C. |
Research and development, patents and licenses, etc. |
D. |
Trend information. |
E. |
Critical accounting estimates. |
A. |
Directors and senior management. |
Name |
Age |
Position(s) | ||
Executive Officers: |
||||
Feng Tian, Ph.D. | 54 | President, Chief Executive Officer and Chairman of the Board of Directors | ||
Sonja Nelson | 49 | Chief Financial Officer | ||
Non-Employee Directors: |
||||
Xiao Le | 33 | Director | ||
Xiaowei Chang, C.F.A. | 39 | Director | ||
Paul Maier (1)(2) | 74 | Director | ||
Katrin Rupalla, Ph.D. (2)(3) | 54 | Director | ||
Olivia C. Ware, M.B.A. (1)(2)(3) | 65 | Director |
(1) | Member of the audit committee |
(2) | Member of the compensation committee |
(3) | Member of the nominating and corporate governance committee |
B. |
Compensation. |
Name |
Grant Date |
Number of Ordinary Shares Underlying Stock Option |
Number of Equivalent ADSs Underlying Stock Option |
Equivalent Exercise Price per ADS |
Stock Option Expiration Date |
|||||||||||||||
Feng Tian, Ph.D. |
6/3/2016 | 1,337,170 | 191,024 | $ | 1.316 | 6/3/2026 | ||||||||||||||
8/2/2019 | 4,217,003 | 602,428 | $ | 1.316 | 8/2/2029 | |||||||||||||||
12/27/2020 | 1,405,668 | 200,809 | $ | 1.22 | 12/27/2030 | |||||||||||||||
12/27/2020 | 7,384,607 | 1,054,943 | $ | 1.22 | 12/27/2030 | |||||||||||||||
Sonja Nelson |
9/2/2021 | 2,574,596 | 367,799 | $ | 2.56 | 9/1/2031 |
Name |
Grant Date |
Number of Ordinary Shares Underlying Stock Option (2) |
Number of Equivalent ADSs Underlying Stock Option |
Equivalent Exercise Price per Share |
Stock Option Expiration Date |
|||||||||||||||
Chris Nolet (1) |
1/06/2021 | 50,000 | 7,142 | $ | 1.22 | 1/6/2031 | ||||||||||||||
3/17/2021 | 200,000 | 28,571 | $ | 1.28 | 3/17/2031 | |||||||||||||||
Katrin Rupalla |
4/29/2021 | 200,000 | 28,571 | $ | 1.83 | 4/29/2031 | ||||||||||||||
Olivia C. Ware |
4/29/2021 | 200,000 | 28,571 | $ | 1.83 | 4/29/2031 |
(1) |
Mr. Nolet resigned from our Board on November 16, 2021. In connection with his resignation, his options to purchase ordinary shares were cancelled. |
(2) |
Granted under our Share Incentive Plan. |
• | an annual cash retainer of $40,000; |
• | an additional annual cash retainer of $7,500, $5,000 and $4,000 for service as a member of the audit committee, compensation committee and the nominating and corporate governance committee, respectively; |
• | an additional annual cash retainer of $15,000, $10,000 and $8,000 for service as chairman of the audit committee, chairman of the compensation committee and chairman of the nominating and corporate governance committee, respectively (in lieu of the committee member retainer above); |
• | an initial share option grant to purchase 210,000 ordinary shares, vesting in 36 equal monthly installments; and |
• | an annual share option grant to purchase 105,000 ordinary shares, vesting on the earlier of (i) the one year anniversary of the date of grant and (ii) the day before the next annual meeting; provided that if an |
eligible director is elected or appointed for the first time between annual meetings, then the eligible director will be granted a prorated share option grant. |
• | arrange for the assumption of an award by the surviving or acquiring entity, the replacement of an award with a comparable award of the surviving or acquiring entity, or replaced by the surviving or acquiring entity by a cash incentive program; |
• | arrange for outstanding awards to terminate at a specific time in the future and give each effected participant the right to exercise such awards during a period of time as determined by the administrator; |
• | provide for the purchase of any award for an amount of cash equal to the amount that could have been attained upon the exercise of such award or realization of the participant’s rights had such award been currently exercisable or payable or fully vested; or |
• | arrange for the replacement of awards with other rights or property as selected by the administrator in their sole discretion. |
• | recipients; |
• | the exercise, purchase or strike price of share awards, if any; the number of shares subject to each share award; |
• | the vesting schedule applicable to the awards, together with any vesting acceleration; and |
• | the form of consideration, if any, payable on exercise or settlement of the award. |
• | Under the 2021 Plan, the board of directors also generally has the authority to effect, with the consent of any adversely affected participant: |
• | the reduction of the exercise, purchase, or strike price of any outstanding award; |
• | the cancellation of any outstanding award and the grant in substitution therefore of other awards, cash, or other consideration; or |
• | any other action that is treated as a repricing under generally accepted accounting principles. |
C. |
Board practices. |
• | conducting and managing the business of our company; |
• | representing our company in contracts and deals; |
• | appointing attorneys for our company; |
• | selecting and removing senior management; |
• | providing employee benefits and pensions; |
• | managing our company’s finance and bank accounts; |
• | evaluating the performance and determining the compensation level of chief executive officer; |
• | exercising the borrowing powers of our company and mortgaging the property of our company; and |
• | exercising any other powers conferred by the shareholders meetings or under our Articles. |
• | selecting the independent auditor; |
• | pre-approving auditing and non-auditing services permitted to be performed by the independent auditor; |
• | annually reviewing the independent auditor’s report describing the auditing firm’s internal quality control procedures, any material issues raised by the most recent internal quality control review, or peer review, of the independent auditors and all relationships between the independent auditor and our company; |
• | review responsibilities, budget, compensation and staffing of our internal audit function; |
• | reviewing with the independent auditor any audit problems or difficulties and management’s response; |
• | reviewing and, if material, approving all related party transactions on an ongoing basis; |
• | reviewing and discussing the annual audited consolidated financial statements with management and the independent auditor; |
• | reviewing and discussing with management and the independent auditors major issues regarding accounting principles and financial statement presentations; |
• | reviewing reports prepared by management or the independent auditors relating to significant financial reporting issues and judgments; |
• | discussing earnings press releases with management, as well as financial information and earnings guidance provided to analysts and rating agencies; |
• | reviewing with management and the independent auditors the effect of regulatory and accounting initiatives, as well as off-balance sheet structures, on our consolidated financial statements; |
• | discussing policies with respect to risk assessment and risk management with management and internal auditors; |
• | timely reviewing reports from the independent auditor regarding all critical accounting policies and practices to be used by our company and all other material written communications between the independent auditor and management; |
• | establishing procedures for the receipt, retention and treatment of complaints received from our employees regarding accounting, internal accounting controls or auditing matters and the confidential, anonymous submission by our employees of concerns regarding questionable accounting or auditing matters; |
• | such other matters that are specifically delegated to our audit committee by our board of directors from time to time; and |
• | meeting separately, periodically, with management, internal auditors and the independent auditor. |
• | reviewing, evaluating and, if necessary, revising our overall compensation policies; |
• | reviewing and evaluating the performance of our directors and chief executive officer and determining the compensation of relevant senior officers; |
• | reviewing and approving our senior officers’ employment agreements with us; |
• | reviewing and approving performance targets and objectives for other executive officers and relevant senior management and determining the compensation and other terms of employment of these other executive officers and senior management; |
• | appointing, selecting, retaining and terminating any compensation consultants; |
• | administering our equity-based compensation plans in accordance with the terms thereof; and |
• | such other matters that are specifically delegated to the compensation committee by our board of directors from time to time. |
• | selecting and recommending to our board of directors nominees for election by the shareholders or appointment by the board; |
• | reviewing periodically the performance of our board of directors and the current composition of our board of directors and each committee with regards to characteristics such as independence, knowledge, skills, experience and diversity; |
• | reviewing periodically the processes and procedures that we use to provide information to our board of directors and its committees and recommending improvements as appropriate. |
• | reviewing periodically with our chief executive officer the plans for succession to the officers of our company’s chief executive officer and other key executives and making recommendations to our board of directors with respect to the selection of appropriate individuals to succeed these positions; and |
• | advising our board of directors periodically with regards to significant developments in the law and practice of corporate governance as well as our compliance with applicable laws and regulations, and making recommendations to the board on all matters of corporate governance and on any remedial action to be taken. |
D. |
Employees. |
As of December 31, |
||||||||
2021 |
2020 |
|||||||
Function: |
||||||||
Research and development |
64 | 45 | ||||||
General and administrative |
17 | 10 | ||||||
|
|
|
|
|||||
Total |
81 |
55 |
||||||
|
|
|
|
E. |
Share ownership. |
A. |
Major shareholders. |
• | Each of our executive officers and directors; and |
• | All of our executive officers and directors as a group. |
Name of Beneficial Owner |
Number of Ordinary Shares Beneficially Owned |
Equivalent Number of ADSs beneficially owned |
Percentage of Shares Beneficially Owned |
|||||||||
Executive Officers and Directors: |
||||||||||||
Feng Tian, Ph.D. (1) |
14,556,634 | 2,079,519 | 5.1 | % | ||||||||
Sonja Nelson |
— | — | — | |||||||||
Xiaowei Chan g |
— | — | — | |||||||||
Xiao Le |
— | — | — | |||||||||
Katrin Rupalla, Ph.D |
— | — | — | |||||||||
Olivia C. Ware, M.B.A. |
— | — | — | |||||||||
All current executive officers and directors as a group (6 persons) (2) |
14,556,634 | 2,079,519 | 5.1 | % | ||||||||
5% or Greater Shareholders |
||||||||||||
HOPU Reunion Company Limited (3) |
38,982,409 | 5,568,915 | 14.4 | % | ||||||||
Entities affiliated with WuXi (4) |
29,267,687 | 4,181,098 | 10.8 | % | ||||||||
FMR LLC (5) |
26,985,175 | 3,855,025 | 9.9 | % | ||||||||
Entities affiliated with Cormorant (6) |
17,243,051 | 2,463,293 | 6.4 | % | ||||||||
HBM Healthcare Investments (Cayman) Ltd. (7) |
16,856,567 | 2,408,081 | 6.2 | % | ||||||||
Adage Capital (8) |
14,191,043 | 2,027,291 | 5.3 | % |
(1) | Consists of (i) 1,530,000 ordinary shares and (ii) 13,026,634 ordinary shares underlying options that are exercisable within 60 days of December 31, 2021. |
(2) | Consists of (i) 1,530,000 ordinary shares and (ii) 13,026,634 ordinary shares underlying options that are exercisable within 60 days of December 31, 2021. |
(3) | Consists of 38,952,409 ordinary shares held by HOPU Reunion Company Limited. The address for HOPU Reunion Company Limited is Floor 4, Willow House, Cricket Square, Grand Cayman KY1-9010, Cayman Islands. |
(4) | Consists of (i) 7,996,920 ordinary shares held by Wuxi AppTec (Hong Kong) Holding Limited and (ii) 21,270,767 ordinary shares held by Wuxi PharmaTech Healthcare Fund I L.P. The address for WuXi AppTec (Hong Kong) Holding Limited and WuXi PharmaTech Healthcare Fund I, L.P. is 288 Fute Zhong Road, Pudong New Area, Shanghai 200131, China. The foregoing information is based on a Schedule 13G filed on February 8, 2022 and information known to us. |
(5) | Consists of 26,985,175 ordinary shares beneficially owned, or may deemed to be owned, by FMR LLC, certain of its affiliates and other companies as reported on Schedule 13G filed on March 10, 2022, by FMR LLC. Abigail P. Johnson is a Director, the Chairman and the Chief Executive Officer of FMR LLC. Members of the Johnson family, including Abigail P. Johnson, are the predominant owners, directly or through trusts, of Series B voting common shares of FMR LLC, representing 49% of the voting power of FMR LLC. The Johnson family group and all other Series B shareholders have entered into a shareholders’ voting agreement under which all Series B voting common shares will be voted in accordance with the majority vote of Series B voting common shares. Accordingly, through their ownership of voting common shares and the execution of the shareholders’ voting agreement, members of the Johnson family may be deemed, under the Investment Company Act of 1940, to form a controlling group with respect to FMR LLC. Neither FMR LLC nor Abigail P. Johnson has the sole power to vote or direct the voting of the shares owned directly by the various investment companies registered under the Investment Company Act advised by Fidelity Management & Research Company LLC, a wholly owned subsidiary of FMR LLC, which power resides with the Fidelity Funds’ Boards of Trustees. Fidelity Management & Research Company carries out the voting of the shares under written guidelines established by the Fidelity Funds’ Boards of Trustees. The business address of FMR LLC is 245 Summer Street, Boston, Massachusetts 02210. The foregoing information is based on a Schedule 13G filed on February 9, 2022 and information known to us. |
(6) | Consists of (i) 7,514,416 ordinary shares held by Cormorant Global Healthcare Master Fund, LP (Cormorant Master Fund) and (ii) 9,728,635 ordinary shares held by Cormorant Private Healthcare Fund III, LP (Cormorant III) Cormorant Global Healthcare GP, LLC (Global GP) is the general partner of Cormorant Master Fund and Cormorant Private Healthcare GP III, LLC (Private GP) is the general partner of Cormorant III. Bihua Chen serves as the managing member of both Global GP and Private GP. Cormorant Asset Management LP (Cormorant Management) serves as the investment manager to Cormorant Master Fund, Cormorant III and CRMA, and Ms. Chen serves as the managing member of Cormorant Asset Management. Ms. Chen may be deemed to beneficially own the shares held by the Cormorant Funds. The address for Ms. Chen and Cormorant Master Fund, Cormorant III, and CRMA is 200 Clarendon Street 52 nd Floor Boston, Massachusetts 02116. The foregoing information is based on Schedule 13G filed on February 14, 2022 and information known to us. |
(7) | Consists of 16,856,567 ordinary shares held by HBM Healthcare Investments (Cayman) Ltd. The address for HBM Healthcare Investments (Cayman) Ltd. is Governors Square, Suite #4-212-2, KY1-1204, Cayman Islands. The foregoing information is based on Schedule 13G filed on February 11, 2022 and information known to us. |
(8) | Consists of 14,191,043 ordinary shares held by Adage Capital Partners, L.P. The address for Adage Capital Partners, L.P. is 200 Clarendon Street, 52 nd Floor Boston, Massachusetts 02116. The foregoing information is based on a Schedule 13G filed on January 18, 2022 and information known to us. |
B. |
Related party transactions. |
C. |
Interests of experts and counsel. |
A. |
Consolidated statements and other financial information. |
B. |
Significant Changes. |
A. |
Offer and listing details. |
B. |
Plan of distribution. |
C. |
Markets. |
D. |
Selling shareholders |
E. |
Dilution. |
F. |
Expenses of the issue. |
A. |
Share capital. |
B. |
Memorandum and articles of association. |
• | the instrument of transfer is lodged with us, accompanied by the certificate for the ordinary shares to which it relates and such other evidence as our board of directors may reasonably require to show the right of the transferor to make the transfer; |
• | the instrument of transfer is in respect of only one class of ordinary shares; |
• | the instrument of transfer is properly stamped, if required; |
• | in the case of a transfer to joint holders, the number of joint holders to whom the ordinary share is to be transferred does not exceed four; and |
• | a fee of such maximum sum as the NYSE may determine to be payable or such lesser sum as our directors may from time to time require is paid to us in respect thereof. |
• | the designation of the series; |
• | the number of shares of the series; |
• | the dividend rights, dividend rates, conversion rights, voting rights; |
• | the rights and terms of redemption and liquidation preferences; and |
• | any other powers, preferences and relative, participating, optional and other special rights. |
• | authorize our board of directors to issue preference shares in one or more series and to designate the price, rights, preferences, privileges and restrictions of such preference shares without any further vote or action by our shareholders; and |
• | limit the ability of shareholders to requisition and convene general meetings of shareholders. |
• | does not have to file an annual return of its shareholders with the Registrar of Companies; |
• | is not required to open its register of members for inspection; |
• | does not have to hold an annual general meeting; |
• | may obtain an undertaking against the imposition of any future taxation (such undertakings are usually given for 20 years in the first instance); |
• | may register by way of continuation in another jurisdiction and be deregistered in the Cayman Islands; |
• | may register as a limited duration company; and |
• | may register as a segregated portfolio company. |
• | the statutory provisions as to the required majority vote have been met; |
• | the shareholders have been fairly represented at the meeting in question and the statutory majority are acting bona fide without coercion of the minority to promote interests adverse to those of the class; |
• | the arrangement is such that may be reasonably approved by an intelligent and honest man of that class acting in respect of his interest; and |
• | the arrangement is not one that would more properly be sanctioned under some other provision of the Companies Act. |
• | a company acts or proposes to act illegally or ultra vires; |
• | the act complained of, although not ultra vires, could only be effected duly if authorized by more than a simple majority vote that has not been obtained; and |
• | those who control the company are perpetrating a “fraud on the minority.” |
C. |
Material contracts. |
D. |
Exchange controls. |
E. |
Taxation. |
F. |
Dividends and paying agents. |
G. |
Statement by experts. |
H. |
Documents on display. |
I. |
Subsidiary Information. |
Item 11. |
Quantitative and Qualitative Disclosures about Market Risk. |
A. |
Interest Rate Risk |
B. |
Foreign Currency Exchange Risk |
C. |
Effects of Inflation |
A. |
Debt Securities. |
B. |
Warrants and Rights. |
C. |
Other Securities |
D. |
American Depositary Shares. |
• | Cash. If exchange rates fluctuate during a time when the depositary cannot convert a foreign currency, you may lose some or all of the value of the distribution. |
• | Shares. |
• | Rights to receive additional shares. |
• | Other Distributions. |
equitable and practicable or (ii) to the extent the depositary deems distribution of such securities or property not to be equitable and practicable, sell such securities or property and distribute any net proceeds in the same way it distributes cash. |
• | Elective Distributions |
• | temporary delays caused by closing our transfer books or those of the depositary or the deposit of shares in connection with voting at a shareholders’ meeting, or the payment of dividends; |
• | the payment of fees, taxes and similar charges; or |
• | compliance with any U.S. or foreign laws or governmental regulations relating to the ADRs or to the withdrawal of deposited securities. |
• | to receive any distribution on or in respect of deposited securities, |
• | to give instructions for the exercise of voting rights at a meeting of holders of shares, |
• | to pay any fees, expenses or charges assessed by, or owing to, the depositary for administration of the ADR program as provided for in the ADR, or |
• | to receive any notice or to act in respect of other matters, |
• | all subject to the provisions of the deposit agreement. |
• | a fee of U.S. $0.05 or less per ADS held for any cash distribution made, or for any elective cash/share dividend offered, pursuant to the deposit agreement; |
• | an aggregate fee of U.S. $0.05 or less per ADS per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and shall be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year and shall be payable in the manner described in the next succeeding provision); |
• | a fee for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian and expenses incurred on behalf of ADR holders in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) in connection with the servicing of the shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary’s or its custodian’s compliance with applicable law, rule or regulation (which fees and charges shall be assessed on a proportionate basis against ADR holders as of the record date or dates set by the depositary and shall be payable at the sole discretion of the depositary by billing such ADR holders or by deducting such charge from one or more cash dividends or other cash distributions); |
• | a fee for the distribution of securities (or the sale of securities in connection with a distribution), such fee being in an amount equal to the $0.05 per ADS issuance fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities (treating all such securities as if they were shares) but which securities or the net cash proceeds from the sale thereof are instead distributed by the depositary to those ADR holders entitled thereto; |
• | share transfer or other taxes and other governmental charges; |
• | cable, telex and facsimile transmission and delivery charges incurred at your request in connection with the deposit or delivery of shares, ADRs or deposited securities; |
• | transfer or registration fees for the registration of transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities; and |
• | fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement. |
• | amend the form of ADR; |
• | distribute additional or amended ADRs; |
• | distribute cash, securities or other property it has received in connection with such actions; |
• | sell any securities or property received and distribute the proceeds as cash; or |
• | none of the above. |
• | payment with respect thereto of (i) any share transfer or other tax or other governmental charge, (ii) any share transfer or registration fees in effect for the registration of transfers of shares or other deposited securities upon any applicable register and (iii) any applicable fees and expenses described in the deposit agreement; |
• | the production of proof satisfactory to it of (i) the identity of any signatory and genuineness of any signature and (ii) such other information, including without limitation, information as to citizenship, residence, exchange control approval, beneficial or other ownership of, or interest in, any securities, compliance with applicable law, regulations, provisions of or governing deposited securities and terms of the deposit agreement and the ADRs, as it may deem necessary or proper; and |
• | compliance with such regulations as the depositary may establish consistent with the deposit agreement. |
• | incur or assume no liability (including, without limitation, to holders or beneficial owners) if any present or future law, rule, regulation, fiat, order or decree of the United States, the Cayman Islands or any other country or jurisdiction, or of any governmental or regulatory authority or securities exchange or market or automated quotation system, the provisions of or governing any deposited securities, any present or future provision of our charter, any act of God, war, terrorism, nationalization, epidemic, pandemic, expropriation, currency restrictions, work stoppage, strike, civil unrest, revolutions, rebellions, explosions, computer failure or circumstance beyond our, the depositary’s or our respective agents’ direct and immediate control shall prevent or delay, or shall cause any of them to be subject to any civil or criminal penalty in connection with, any act which the deposit agreement or the ADRs provide shall be done or performed by us, the depositary or our respective agents (including, without limitation, voting); |
• | incur or assume no liability (including, without limitation, to holders or beneficial owners) by reason of any non-performance or delay, caused as aforesaid, in the performance of any act or things which by the terms of the deposit agreement it is provided shall or may be done or performed or any exercise or failure to exercise discretion under the deposit agreement or the ADRs including, without limitation, any failure to determine that any distribution or action may be lawful or reasonably practicable; |
• | incur or assume no liability (including, without limitation, to holders or beneficial owners) if it performs its obligations under the deposit agreement and ADRs without gross negligence or willful misconduct; |
• | in the case of the depositary and its agents, be under no obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities the ADSs or the ADRs; |
• | in the case of us and our agents, be under no obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities the ADSs or the ADRs, which in our or our agents’ opinion, as the case may be, may involve it in expense or liability, unless indemnity satisfactory to us or our agent, as the case may be against all expense (including fees and disbursements of counsel) and liability be furnished as often as may be requested; |
• | not be liable (including, without limitation, to holders or beneficial owners) for any action or inaction by it in reliance upon the advice of or information from any legal counsel, any accountant, any person presenting shares for deposit, any registered holder of ADRs, or any other person believed by it to be competent to give such advice or information and/or, in the case of the depositary, us; or |
• | may rely and shall be protected in acting upon any written notice, request, direction, instruction or document believed by it to be genuine and to have been signed, presented or given by the proper party or parties. |
• | be a party to and bound by the terms of the deposit agreement and the applicable ADR or ADRs, |
• | appoint the depositary its attorney-in-fact, with |
• | acknowledge and agree that (i) nothing in the deposit agreement or any ADR shall give rise to a partnership or joint venture among the parties thereto, nor establish a fiduciary or similar relationship among such parties, (ii) the depositary, its divisions, branches and affiliates, and their respective agents, may from time to time be in the possession of non-public information about us, ADR holders, beneficial owners and/or their respective affiliates, (iii) the depositary and its divisions, branches and affiliates may at any time have multiple banking relationships with us, ADR holders, beneficial owners and/or the affiliates of any of them, (iv) the depositary and its divisions, branches and affiliates may, from time to time, be engaged in transactions in which parties adverse to us, ADR holders, beneficial owners may have interests, (v) nothing contained in the deposit agreement or any ADR(s) shall (a) preclude the depositary or any of its divisions, branches or affiliates from engaging in any such transactions or establishing or maintaining any such relationships, or (b) obligate the depositary or any of its divisions, branches or affiliates to disclose any such transactions or relationships or to account for any profit made or payment received in any such transactions or relationships, (vi) the depositary shall not be deemed to have knowledge of any information held by any branch, division or affiliate of the depositary and (vii) notice to an ADR holder shall be deemed, for all purposes of the deposit agreement and the ADRs, to constitute notice to any and all beneficial owners of the ADSs evidenced by such ADR holder’s ADRs. For all purposes under the deposit agreement and the ADRs, the ADR holders thereof shall be deemed to have all requisite authority to act on behalf of any and all beneficial owners of the ADSs evidenced by such ADRs. |
A. |
Disclosure controls and procedures. |
B. |
Management’s annual report on internal control over financial reporting. |
C. |
Attestation report of the registered public accounting firm. |
D. |
Changes in internal control over financial reporting. |
Year Ended December 31, |
||||||||
Fee Category |
2021 |
2020 |
||||||
(in thousands) |
||||||||
Audit fees |
$ | 1,213 | $ | 1,356 | ||||
Audit-related fees |
— |
— |
||||||
Tax fees |
174 | 149 | ||||||
|
|
|
|
|||||
All other fees |
— |
— |
||||||
|
|
|
|
|||||
Total |
$ |
1,387 |
$ |
1,505 |
||||
|
|
|
|
• | We do not intend to follow NYSE Rule 302.00, which requires that we hold an annual general meeting of shareholders and NYSE Rule 401.02 that requires we provide notice thereof to NYSE. Such annual general meeting requirement is not required under Cayman Islands law nor our Amended and Restated Memorandum and Articles of Association, and we may convene an annual general meeting of shareholders at its discretion. |
• | We do not intend to follow certain provisions of NYSE Rule 312.03, which requires shareholder approval for certain issuances of our securities, including: (a) issuances where the issued common stock will equal 20% or more of the number of shares of common stock or voting power outstanding before the issuance, except if the issuance is (i) a public offering for cash or (ii) any other financing (that is not a public offering for cash) in which we sell securities for cash, if such financing involves a sale of common stock, or securities convertible into or exercisable for common stock, at a price at least as great as the official closing price of our ADSs immediately preceding the signing of any binding agreement or the average official closing price for the five trading days immediately preceding such signing, provided that if the securities in such financing are issued in connection with an acquisition of the stock or assets of another company, shareholder approval will be required if the issuance of such securities alone or when combined with any other present or potential issuance of common stock, or securities convertible into common stock in connection with such acquisition, is equal to or exceeds either 20% of the number of shares of common stock or 20% of the voting power outstanding before the issuance and (b) approvals of equity compensation plans. Such shareholder approval requirements are not required under Cayman Islands law nor our Amended and Restated Memorandum and Articles of Association, and instead our board of directors may decide to proceed with issuances under (a) or (b), in its sole discretion, or if our board of directors so chooses, it may receive prior approval from our shareholders by ordinary resolution. |
• | We do not intend to follow NYSE Rule 313.00, which requires that voting rights of existing shareholders of publicly traded registered common stock cannot be disparately reduced or restricted through any corporate action or issuance. Such voting rights are not required under Cayman Islands law nor our Amended and Restated Memorandum and Articles of Association, and instead we may issue shares with rights which are preferential to those of our currently issued ordinary shares, and the rights of such preferred shares may include the order of, or restriction on, the voting rights of the holders thereof. |
• | We do not intend to follow NYSE Rule 303A.01, which requires that we have a majority of independent directors. Such independence requirement is not required under Cayman Islands law nor our Amended and Restated Memorandum and Articles of Association. |
• | We do not intend to follow NYSE Rule 303A.07, which requires that our audit committee must have a minimum of three members. Such requirement is not required under Cayman Islands law nor our Amended and Restated Memorandum and Articles of Association. |
• | Exemption from filing quarterly reports on Form 10-Q or provide current reports on Form 8-K, disclosing significant events within four days of their occurrence. |
• | Exemption from Section 16 rules regarding sales of common shares by insiders, which will provide less data in this regard than shareholders of U.S. companies that are subject to the Exchange Act. |
Incorporated by Reference | ||||||||||
Exhibit |
Description |
Schedule/ Form |
File Number |
Exhibit |
Filed Date | |||||
101.LAB* |
Inline XBRL Taxonomy Extension Labels Linkbase | |||||||||
101.PRE* |
Inline XBRL Taxonomy Extension Presentation Linkbase | |||||||||
104 |
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
* | Filed herewith. |
** | Furnished herewith. |
† | Indicates a management contract or any compensatory plan, contract or arrangement. |
# | Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of this document. |
+ | Certain portions of this exhibit (indicated by “[***]”) have been omitted as we have determined (i) the omitted information is not material and (ii) the omitted information would likely cause harm to us if publicly disclosed. |
AMBRX BIOPHARMA INC. | ||||||
Date: April 26, 2022 | By: | /s/ Feng Tian, Ph.D. | ||||
Feng Tian, Ph.D. | ||||||
President, Chief Executive Officer and Chairman of the Board of Directors |
Page |
||||
F-2 | ||||
F-3 |
||||
F-4 |
||||
F-5 |
||||
F-6 |
||||
F-7 |
December 31, 2021 |
December 31, 2020 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 170,064 | $ | 90,462 | ||||
Restricted cash |
842 | 816 | ||||||
Accounts receivable, net |
1,239 | 428 | ||||||
Prepaid expenses and other current assets |
4,661 | 1,371 | ||||||
|
|
|
|
|||||
Total current assets |
176,806 | 93,077 | ||||||
Property and equipment, net |
2,984 | 850 | ||||||
Right-of-use |
12,737 | 2,641 | ||||||
Intangible assets, net |
35,962 | 36,829 | ||||||
Other long-term assets |
530 | 624 | ||||||
|
|
|
|
|||||
Total assets |
$ | 229,019 | $ | 134,021 | ||||
|
|
|
|
|||||
Liabilities, Redeemable Noncontrolling Interests, Convertible Preferred Shares and Shareholders’ Equity (Deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 5,272 | $ | 2,820 | ||||
Accrued liabilities |
14,125 | 2,375 | ||||||
Operating lease liabilities, current portion |
915 | 1,595 | ||||||
Deferred revenue, current portion |
4,267 | 6,470 | ||||||
|
|
|
|
|||||
Total current liabilities |
24,579 | 13,260 | ||||||
Operating lease liabilities, net of current portion |
12,212 | 1,598 | ||||||
Accrued liabilities, net of current portion |
— | 138 | ||||||
Deferred tax liabilities |
880 | 880 | ||||||
Deferred revenue, net of current portion |
1,381 | 3,261 | ||||||
|
|
|
|
|||||
Total liabilities |
39,052 | 19,137 | ||||||
Commitments and contingencies (Note 6) |
||||||||
Redeemable noncontrolling interests |
— | 1,287 | ||||||
Convertible preferred shares, $0.0001 par value; no shares authorized at December 31, 2021; 217,575,009 shares authorized at December 31, 2020 |
||||||||
Series A convertible preferred shares, no shares designated at December 31, 2021; 160,000,000 shares designated at December 31, 2020; no shares and 135,936,550 shares outstanding at December 31, 2021 and December 31, 2020, respectively; $0 and $176,396 liquidation preference at December 31, 2021 and December 31, 2020, respectively |
— | 157,689 | ||||||
Series B convertible preferred shares, no shares designated at December 31, 2021; 57,575,009 shares designated at December 31, 2020; no shares and 57,575,008 shares outstanding at December 31, 2021 and December 31, 2020, respectively; $0 and $100,000 liquidation preference at December 31, 2021 and December 31, 2020, respectively |
— | 95,342 | ||||||
Shareholders’ Equity (Deficit): |
||||||||
Ordinary shares, par value $0.0001; 500,000,000 and 282,424,991 shares authorized at December 31, 2021 and December 31, 2020, respectively; 270,120,548 and 170,000 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively |
27 | — | ||||||
Additional paid-in capital |
404,362 | 6,805 | ||||||
Accumulated other comprehensive loss |
(790 | ) | (686 | ) | ||||
Accumulated deficit |
(213,632 | ) | (145,553 | ) | ||||
|
|
|
|
|||||
Total shareholders’ equity (deficit) |
189,967 | (139,434 | ) | |||||
|
|
|
|
|||||
Total liabilities, redeemable noncontrolling interests, convertible preferred shares and shareholders’ equity (deficit) |
$ | 229,019 | $ | 134,021 | ||||
|
|
|
|
Years Ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
Revenues |
$ | 7,455 | $ | 13,671 | $ | 10,311 | ||||||
Operating expenses: |
||||||||||||
Research and development |
54,808 | 20,433 | 26,383 | |||||||||
General and administrative |
17,071 | 6,353 | 6,400 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
71,879 | 26,786 | 32,783 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(64,424 | ) | (13,115 | ) | (22,472 | ) | ||||||
Other (expense) income, net: |
||||||||||||
Interest income |
— | 27 | 195 | |||||||||
Other income (expense), net |
40 | (4,750 | ) | (38 | ) | |||||||
Change in fair value of redeemable noncontrolling interests |
(3,903 | ) | — | — | ||||||||
|
|
|
|
|
|
|||||||
Total other (expense) income, net |
(3,863 | ) | (4,723 | ) | 157 | |||||||
|
|
|
|
|
|
|||||||
Loss before benefit from income taxes |
(68,287 | ) | (17,838 | ) | (22,315 | ) | ||||||
(Provision for) benefit from income taxes |
(1 | ) | (1 | ) | 2 | |||||||
|
|
|
|
|
|
|||||||
Net loss |
(68,288 | ) | (17,839 | ) | (22,313 | ) | ||||||
Less: net loss attributable to the redeemable noncontrolling interests |
209 | 1,296 | 2,251 | |||||||||
|
|
|
|
|
|
|||||||
Net loss attributable to Ambrx Biopharma Inc. shareholders |
$ | (68,079 | ) | $ | (16,543 | ) | $ | (20,062 | ) | |||
|
|
|
|
|
|
|||||||
Net loss per share attributable to Ambrx Biopharma Inc. ordinary shareholders—basic and diluted |
$ | (0.48 | ) | $ | (0.14 | ) | $ | (0.15 | ) | |||
|
|
|
|
|
|
|||||||
Weighted-average ordinary shares used to compute net loss per share attributable to ordinary shareholders basic and diluted |
143,175,224 | 115,677,467 | 136,103,550 | |||||||||
|
|
|
|
|
|
|||||||
Other comprehensive loss, net of tax: |
||||||||||||
Net loss |
$ | (68,288 | ) | $ | (17,839 | ) | $ | (22,313 | ) | |||
Foreign currency translation adjustment |
(18 | ) | 177 | (41 | ) | |||||||
|
|
|
|
|
|
|||||||
Comprehensive loss |
(68,306 | ) | (17,662 | ) | (22,354 | ) | ||||||
Less: comprehensive loss attributable to the redeemable noncontrolling interests |
208 | 1,276 | 2,257 | |||||||||
|
|
|
|
|
|
|||||||
Comprehensive loss attributable to Ambrx Biopharma Inc. |
$ | (68,098 | ) | $ | (16,386 | ) | $ | (20,097 | ) | |||
|
|
|
|
|
|
Redeemable Noncontrolling Interests |
Series A Preferred Shares |
Series B Preferred Shares |
Additional Paid- in-Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total |
||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Ordinary Shares |
Par Value |
|||||||||||||||||||||||||||||||||||||||
Balance as of January 1, 2019 |
$ | 4,820 | — | $ | — | — | $ | — | 136,103,550 | $ | 14 | $ | 161,432 | $ | (808 | ) | $ | (108,948 | ) | $ | 51,690 | |||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | 1,831 | — | — | 1,831 | |||||||||||||||||||||||||||||||||
Foreign currency translation adjustments |
(6 | ) | — | — | — | — | — | — | — | (35 | ) | — | (35 | ) | ||||||||||||||||||||||||||||||
Net loss |
(2,251 | ) | — | — | — | — | — | — | — | — | (20,062 | ) | (20,062 | ) | ||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Balance as of December 31, 2019 |
2,563 | — | — | — | — | 136,103,550 | 14 | 163,263 | (843 | ) | (129,010 | ) | 33,424 | |||||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | 1,217 | — | — | 1,217 | |||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon exercise of options |
— | — | — | — | — | 3,000 | — | — | — | — | — | |||||||||||||||||||||||||||||||||
Redesignation of ordinary shares into preferred shares |
— | 135,936,550 | 157,689 | — | — | (135,936,550 | ) | (14 | ) | (157,675 | ) | — | — | (157,689 | ) | |||||||||||||||||||||||||||||
Issuance of Series B Preferred Shares |
— | — | — | 57,575,008 | 95,342 | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||
Foreign currency translation adjustments |
20 | — | — | — | — | — | — | — | 157 | — | 157 | |||||||||||||||||||||||||||||||||
Net loss |
(1,296 | ) | — | — | — | — | — | — | — | — | (16,543 | ) | (16,543 | ) | ||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Balance as of December 31, 2020 |
1,287 | 135,936,550 | 157,689 | 57,575,008 | 95,342 | 170,000 | 0 | 6,805 | (686 | ) | (145,553 | ) | (139,434 | ) | ||||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | 11,856 | — | — | 11,856 | |||||||||||||||||||||||||||||||||
Conversion of preferred stock into ordinary shares upon closing of initial public offering |
— | (135,936,550 | ) | (157,689 | ) | (57,575,008 | ) | (95,342 | ) | 193,511,558 | 19 | 253,012 | — | — | 253,031 | |||||||||||||||||||||||||||||
Issuance of ordinary shares and overallotment option in an initial public offering for cash |
— | — | — | — | — | 49,000,000 | 5 | 113,149 | — | — | 113,154 | |||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon exercise of overallotment option |
— | — | — | — | — | 6,249,817 | 1 | 14,946 | — | — | 14,947 | |||||||||||||||||||||||||||||||||
Issuance of ordinary shares for cash |
— | — | — | — | — | 21,189,173 | 2 | 20,493 | — | — | 20,495 | |||||||||||||||||||||||||||||||||
Accretion of redeemable noncontrolling interests to fair value |
42,324 | — | — | — | — | — | — | (42,324 | ) | — | — | (42,324 | ) | |||||||||||||||||||||||||||||||
Settlement of redeemable noncontrolling interests |
— | — | — | — | — | — | — | 85 | (85 | ) | — | — | ||||||||||||||||||||||||||||||||
Reclassify NCI to current liability |
(43,403 | ) | — | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Reclassify freestanding forward sale contract upon settlement of redeemable noncontrolling interests |
— | — | — | — | — | — | — | 26,340 | — | — | 26,340 | |||||||||||||||||||||||||||||||||
Foreign currency translation adjustments |
1 | — | — | — | — | — | — | — | (19 | ) | — | (19 | ) | |||||||||||||||||||||||||||||||
Net loss |
(209 | ) | — | — | — | — | — | — | — | — | (68,079 | ) | (68,079 | ) | ||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Balance as of December 31, 2021 |
$ | — | — | $ | — | — | $ | — | 270,120,548 | $ | 27 | $ | 404,362 | $ | (790 | ) | $ | (213,632 | ) | $ | 189,967 | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (68,288 | ) | $ | (17,839 | ) | $ | (22,313 | ) | |||
Noncash adjustments reconciling net loss to cash flows from operating activities: |
||||||||||||
Depreciation and amortization |
550 | 492 | 602 | |||||||||
Amortization of intangible assets |
1,604 | 1,451 | 1,451 | |||||||||
Loss on impairment of intangible assets |
513 | — | — | |||||||||
Change in fair value of redeemable noncontrolling interests |
3,903 | — | — | |||||||||
Noncash lease expense |
1,582 | 1,478 | 1,477 | |||||||||
Loss on disposal of property and equipment |
— | — | 11 | |||||||||
Share-based compensation expense |
11,856 | 1,217 | 1,831 | |||||||||
Changes in operating assets and liabilities: |
||||||||||||
Accounts receivable, net |
(811 | ) | 415 | (762 | ) | |||||||
Prepaid and other current assets and other long-term assets |
(2,629 | ) | (961 | ) | 1,491 | |||||||
Accounts payable |
2,403 | (3,247 | ) | 3,776 | ||||||||
Accrued liabilities |
10,502 | (610 | ) | 302 | ||||||||
Deferred revenue |
(4,083 | ) | (1,280 | ) | 11,011 | |||||||
Operating lease liabilities |
(1,742 | ) | (1,692 | ) | (1,642 | ) | ||||||
|
|
|
|
|
|
|||||||
Net cash used in operating activities |
(44,640 | ) | (20,576 | ) | (2,765 | ) | ||||||
|
|
|
|
|
|
|||||||
Cash flows from investing activities: |
||||||||||||
Purchases of property and equipment |
(1,956 | ) | (252 | ) | (48 | ) | ||||||
Acquisition of intangible assets |
(1,250 | ) | — | — | ||||||||
|
|
|
|
|
|
|||||||
Net cash used in investing activities |
(3,206 | ) | (252 | ) | (48 | ) | ||||||
|
|
|
|
|
|
|||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from issuance of convertible preferred stock, net of issuance costs |
— | 95,678 | — | |||||||||
Proceeds from issuance of ordinary shares, net of issuance costs |
148,732 | — | — | |||||||||
Proceeds from payroll protection program loan |
— | 1,339 | — | |||||||||
Payments to acquire the Shanghai noncontrolling interests |
(20,966 | ) | — | — | ||||||||
Repayment of payroll protection program loan |
— | (1,339 | ) | — | ||||||||
Payments of costs for the issuance of Series B preferred shares |
(339 | ) | — | — | ||||||||
|
|
|
|
|
|
|||||||
Net cash provided by financing activities |
127,427 | 95,678 | — | |||||||||
|
|
|
|
|
|
|||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
47 | 165 | (38 | ) | ||||||||
|
|
|
|
|
|
|||||||
Net increase in cash, cash equivalents and restricted cash |
79,628 | 75,015 | (2,851 | ) | ||||||||
Cash, cash equivalents and restricted cash, beginning of period |
91,278 | 16,263 | 19,114 | |||||||||
|
|
|
|
|
|
|||||||
Cash, cash equivalents and restricted cash, end of period |
$ | 170,906 | $ | 91,278 | $ | 16,263 | ||||||
|
|
|
|
|
|
|||||||
Supplemental information: |
||||||||||||
Cash paid for interest |
$ | — | $ | 7 | $ | — | ||||||
|
|
|
|
|
|
|||||||
Cash paid for income taxes |
$ | 1 | $ | 1 | $ | 1 | ||||||
|
|
|
|
|
|
|||||||
Noncash investing and financing activities: |
||||||||||||
Deferred initial public offering costs in accounts payable and accrued liabilities |
$ | 136 | $ | — | $ | — | ||||||
|
|
|
|
|
|
|||||||
Property and equipment costs in accounts payable and accrued liabilities |
$ | 727 | $ | — | $ | — | ||||||
|
|
|
|
|
|
|||||||
Conversion of convertible preferred shares into ordinary shares |
$ | 253,031 | $ | — | $ | — | ||||||
|
|
|
|
|
|
|||||||
Accretion of redeemable noncontrolling interests to fair value |
$ | 42,324 | $ | — | $ | — | ||||||
|
|
|
|
|
|
|||||||
Reclassification of redeemable noncontrolling interests from temporary equity to current liabilities |
$ | 43,403 | $ | — | $ | — | ||||||
|
|
|
|
|
|
|||||||
ROU assets and lease liabilities obtained through reassessment of an existing lease |
$ | 11,455 | $ | — | $ | — | ||||||
|
|
|
|
|
|
|||||||
Reclassification of accumulated other comprehensive loss upon settlement of redeemable noncontrolling interests |
$ | 85 | $ | — | $ | — | ||||||
|
|
|
|
|
|
|||||||
Reclassification of ordinary shares proceeds associated with the designation of ordinary shares into Series A preferred shares |
$ | — | $ | 157,689 | $ | — | ||||||
|
|
|
|
|
|
|||||||
Preferred issuance costs in accounts payable |
$ | — | $ | 339 | $ | — | ||||||
|
|
|
|
|
|
1. |
Description of Business and Basis of Presentation |
2. |
Summary of Significant Accounting Policies |
December 31, |
||||||||
2021 |
2020 |
|||||||
Cash and cash equivalents |
$ | 170,064 | $ | 90,462 | ||||
Restricted cash |
842 | 816 | ||||||
|
|
|
|
|||||
Total cash, cash equivalents, and restricted cash presented in the consolidated statements of cash flows |
$ | 170,906 | $ | 91,278 | ||||
|
|
|
|
Laboratory Equipment | 5 years | |
Computer, software and office equipment | 3 – 8 years | |
Furniture and fixtures | 5 years |
3. |
Balance Sheets Details |
December 31, |
||||||||
2021 |
2020 |
|||||||
Prepaid R&D costs |
$ | 2,467 | $ | 508 | ||||
Prepaid insurance and service contracts |
1,860 | 118 | ||||||
Tax receivable |
104 | 554 | ||||||
Other |
230 | 191 | ||||||
Total |
$ | 4,661 | $ | 1,371 | ||||
December 31, |
||||||||
2021 |
2020 |
|||||||
Laboratory equipment |
$ | 6,851 | $ | 4,345 | ||||
Computers, software and office equipment |
489 | 438 | ||||||
Leasehold improvements |
384 | 295 | ||||||
Office furniture and fixtures |
126 | 88 | ||||||
7,850 | 5,166 | |||||||
Accumulated depreciation and amortization |
(4,866 | ) | (4,316 | ) | ||||
Total |
$ | 2,984 | $ | 850 | ||||
December 31, |
||||||||
2021 |
2020 |
|||||||
Accrued R&D costs (1) |
$ | 9,043 | $ | 418 | ||||
Accrued compensation |
3,664 | 790 | ||||||
Accrued audit, tax and filing fees |
556 | 381 | ||||||
Accrued other |
862 | 786 | ||||||
Total |
$ | 14,125 | $ | 2,375 | ||||
(1) |
Includes $250 and $168 of accrued R&D costs due to related parties as of December 31, 2021 and 2020, respectively. |
4. |
Intangible Assets, Net |
Weighted- Average Remaining Contractual Life (in Years) |
Gross Carrying Amount |
Additions |
Impairment |
Accumulated Amortization |
Intangible Assets, net |
|||||||||||||||||||
Acquired technologies |
9.7 | $ | 23,870 | $ | 1,250 | $ | (513) | $ | (9,585) | $ | 15,022 | |||||||||||||
IPR&D |
20,940 | — | — | — | 20,940 | |||||||||||||||||||
Total |
$ | 44,810 | $ | 1,250 | $ | (513) | $ | (9,585) | $ | 35,962 | ||||||||||||||
Weighted-Average Remaining Contractual Life (in Years) |
Gross Carrying Amount |
Accumulated Amortization |
Intangible Assets, net |
|||||||||||||
Acquired technologies |
11.2 | $ | 23,870 | $ | (7,981 | ) | $ | 15,889 | ||||||||
IPR&D |
20,940 | — | 20,940 | |||||||||||||
Total |
$ | 44,810 | $ | (7,981 | ) | $ | 36,829 | |||||||||
Year ending December 31, |
||||
2022 |
$ | 1,681 | ||
2023 |
1,681 | |||
2024 |
1,681 | |||
2025 |
1,681 | |||
2026 |
1,416 | |||
Thereafter |
6,882 | |||
Total |
$ | 15,022 |
5. |
Fair Value Measurements |
Level 1 |
Inputs based on quoted market prices for identical assets or liabilities in active markets at the measurement date. | |||
Level 2 |
Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. | |||
Level 3 |
Inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. The inputs are unobservable in the market and significant to the instrument’s valuation. | |||
6. |
Commitments and Contingencies |
7. |
Leases |
Years Ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
Operating lease expenses R&D |
||||||||||||
Operating lease costs |
$ | 1,203 | $ | 1,243 | $ | 1,242 | ||||||
Variable lease costs (1) |
1,190 | 1,087 | 1,051 | |||||||||
Operating lease expenses G&A |
||||||||||||
Operating lease costs |
232 | 235 | 235 | |||||||||
Variable lease costs (1) |
231 | 206 | 199 | |||||||||
Total operating lease expense |
$ | 2,856 | $ | 2,771 | $ | 2,727 | ||||||
(1) |
Includes short-term lease costs which are immaterial. |
December 31, |
||||||||
2021 |
2020 |
|||||||
ROU assets, net |
$ | 12,737 | $ | 2,641 | ||||
Operating lease liabilities, current |
915 | 1,595 | ||||||
Operating lease liabilities, net of current |
12,212 | 1,598 |
Year ending December 31, |
||||
2022 |
$ | 1,875 | ||
2023 |
2,814 | |||
2024 |
2,896 | |||
2025 |
2,982 | |||
2026 |
3,071 | |||
2027 |
2,892 | |||
16,530 | ||||
Less interest expense |
(3,403 | ) | ||
Present value of future lease payments |
$ |
13,127 |
8. |
Convertible Preferred Shares and Ordinary Shares |
9. |
Revenue |
Timing of Transfer of Goods or Services |
License Fees |
Reimbursements |
Milestones |
R&D Services |
Total |
|||||||||||||||
Over time |
||||||||||||||||||||
2021 (1) |
$ | 3,533 | $ | 1,850 | $ | — | $ | 2,072 | $ | 7,455 | ||||||||||
2020 |
10,992 | 448 | — | 2,231 | 13,671 | |||||||||||||||
2019 |
2,283 | 2,782 | 3,500 | 1,746 | 10,311 |
(1) | 2021 license fees i nclude a cumulative catch-up adjustment reducing revenue by approximately $1.4 million with an equal increase in total contract liabilities, for changes in total estimated effort to be incurred in the future to satisfy the performance obligation. |
January 1, 2020 |
December 31, 2020 |
December 31, 2021 |
||||||||||
Receivables, included in accounts receivable, net |
$ | 843 | $ | 428 | $ | 1,239 | ||||||
Contract assets, included in prepaid expenses and other current assets |
— | 98 | 149 | |||||||||
Contract liabilities included in deferred revenue, current and deferred revenue net of current portion |
11,011 | 9,731 | 5,648 |
December 31, 2021 |
December 31, 2020 |
|||||||
Beginning balance |
$ | 9,731 | $ | 11,011 | ||||
Upfront fees: |
||||||||
License fees |
— | 10,000 | ||||||
Recognized as revenue: |
||||||||
License fees |
(3,548 | ) | (10,992 | ) | ||||
Reimbursements |
(535 | ) | (288 | ) | ||||
Ending balance |
$ | 5,648 | $ | 9,731 | ||||
10. |
Share-Based Compensation |
Total Options |
Weighted- Average Exercise Price- |
|||||||
Balance at January 1, 2021 |
28,377,521 | $ | 1.26 | |||||
Granted |
12,591,974 | $ | 1.72 | |||||
Cancelled |
(6,689,307 | ) | $ | 1.25 | ||||
Exercised |
(79,212 | ) | $ | 1.32 | ||||
|
|
|||||||
Balance at December 31, 2021 |
34,200,976 | $ | 1.43 | |||||
|
|
Stock Options |
ESPP |
|||||||||||||||||||||||
2021 |
2020 |
2019 |
2021 |
2020 |
2019 |
|||||||||||||||||||
Expected volatility |
80.5 | % | 79.0 | % | 68.3 | % | 74.6 | % | — | % | — | % | ||||||||||||
Risk-free interest rate |
1.0 | % | 0.5 | % | 1.8 | % | 0.2 | % | — | % | — | % | ||||||||||||
Dividend yield |
— | % | — | % | — | % | — | % | — | % | — | % | ||||||||||||
Expected term (in years) |
6.0 | 6.3 | 10 | 1.3 | — | — |
2021 |
2020 |
2019 |
||||||||||
Research and development |
$ | 9,001 | $ | 824 | $ | 1,491 | ||||||
General and administrative |
2,855 | 393 | 340 | |||||||||
|
|
|
|
|
|
|||||||
Total share-based compensation expense |
$ | 11,856 | $ | 1,217 | $ | 1,831 | ||||||
|
|
|
|
|
|
11. |
Defined Contribution Plan |
12. |
Income Taxes |
2021 |
2020 |
2019 |
||||||||||
U.S. operations |
$ | (61,541 | ) | $ | (17,041 | ) | $ | (20,996 | ) | |||
Non-U.S. operations |
(6,746 | ) | (797 | ) | (1,319 | ) | ||||||
|
|
|
|
|
|
|||||||
Loss before provision for income taxes |
$ | (68,287 | ) | $ | (17,838 | ) | $ | (22,315 | ) | |||
|
|
|
|
|
|
2021 |
2020 |
2019 |
||||||||||
Current: |
||||||||||||
U.S. |
$ | — | $ | (71) | $ | (74) | ||||||
State and local |
1 | 1 | 1 | |||||||||
|
|
|
|
|
|
|||||||
Total current |
1 | (70) | (73) | |||||||||
|
|
|
|
|
|
|||||||
Deferred: |
||||||||||||
U.S. |
— | 71 | 71 | |||||||||
|
|
|
|
|
|
|||||||
Total deferred |
— | 71 | 71 | |||||||||
|
|
|
|
|
|
|||||||
Total provision for (benefit from) income taxes |
$ | 1 | $ | 1 | $ | (2 | ) | |||||
|
|
|
|
|
|
2021 |
2020 |
2019 |
||||||||||
Income tax benefit at Cayman statutory rate |
0.00 | % | 0.00 | % | 0.00 | % | ||||||
U.S. and non-U.S. rate differential |
19.49 | % | 20.96 | % | 21.34 | % | ||||||
State taxes |
3.94 | % | 5.13 | % | 0.90 | % | ||||||
R&D credits |
3.00 | % | 3.31 | % | 4.20 | % | ||||||
Change in valuation allowance |
(25.79 | %) | (22.72 | %) | (25.25 | %) | ||||||
Non-deductible equity issuance costs |
— | % | (5.49 | %) | — | % | ||||||
Share-based compensation |
(0.66 | %) | (0.90 | %) | (1.03 | %) | ||||||
Other, net |
0.02 | % | (0.29 | %) | (0.15 |
% ) | ||||||
|
|
|
|
|
|
|||||||
Effective tax rate |
0.00 | % | 0.00 | % | 0.01 | % | ||||||
|
|
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
Deferred tax assets: |
||||||||
Net operating loss carryforwards |
$ | 48,179 | $ | 34,149 | ||||
R&D credits |
14,317 | 12,524 | ||||||
Lease liabilities |
3,662 | 710 | ||||||
Share-based compensation |
3,223 | 408 | ||||||
Deferred revenues |
1,575 | 2,163 | ||||||
Other |
1,047 | 208 | ||||||
|
|
|
|
|||||
Total deferred tax assets |
72,003 | 50,162 | ||||||
Deferred tax liabilities: |
||||||||
IPR&D |
(5,841 | ) | (4,655 | ) | ||||
Right-of-use |
(3,553 | ) | (587 | ) | ||||
Intangible assets |
(2,445 | ) | (2,359 | ) | ||||
|
|
|
|
|||||
Total deferred tax liabilities |
(11,839 | ) | (7,601 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets |
60,164 | 42,561 | ||||||
Less: valuation allowance |
(61,044 | ) | (43,441 | ) | ||||
|
|
|
|
|||||
Total net deferred tax liabilities |
$ | (880 | ) | $ | (880 | ) | ||
|
|
|
|
December 31, |
||||||||
2021 |
2020 |
|||||||
Beginning balance |
$ | 2,282 | $ | 1,973 | ||||
Additions based on tax positions related to the current year |
485 | 309 | ||||||
|
|
|
|
|||||
Ending balance |
$ | 2,767 | $ | 2,282 | ||||
|
|
|
|
13. |
Related Party Transactions |
December 31, 2021 |
December 31, 2020 |
|||||||
Balances: |
||||||||
Prepaid R&D expenses |
$ | 55 | $ | 11 | ||||
Accounts payable |
167 | 118 | ||||||
Accrued liabilities |
250 | 168 |
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
Year-to-date |
||||||||||||
Amounts paid |
$ | 515 | $ | 2,881 | $ | 670 | ||||||
R&D expense recognized |
520 | 271 | 1,920 |
1 Year Ambrx Biopharma Chart |
1 Month Ambrx Biopharma Chart |
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