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 |
British Columbia, |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
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☒ |
Accelerated filer |
☐ | |||
Non-accelerated filer |
☐ |
Smaller reporting company |
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Emerging growth company |
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7 |
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Item 1. |
7 |
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Item 1A. |
30 |
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Item 1B. |
75 |
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Item 2. |
75 |
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Item 3. |
75 |
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Item 4. |
76 |
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77 |
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Item 5. |
77 |
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Item 6. |
85 |
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Item 7. |
87 |
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Item 7A. |
99 |
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Item 8. |
101 |
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Item 9. |
146 |
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Item 9A. |
146 |
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Item 9B. |
147 |
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148 |
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Item 10. |
148 |
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Item 11. |
148 |
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Item 12. |
148 |
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Item 13. |
148 |
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Item 14. |
148 |
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149 |
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Item 15. |
149 |
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Item 16. |
153 |
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154 |
• | the size of our addressable markets and our ability to commercialize product candidates; |
• | the achievement of advances in and expansion of our therapeutic platforms and antibody engineering expertise; |
• | the likelihood of product candidate development and clinical trial progression, initiation or success; and |
• | our ability to predict and manage government regulation. |
• | our ability to manage our growth effectively; |
• | the absence of material adverse changes in our industry or the global economy; |
• | our ability to understand and predict trends in our industry and markets; |
• | our ability to maintain good business relationships with our strategic partners; |
• | our ability to comply with current and future regulatory standards; |
• | our ability to protect our intellectual property rights; |
• | our continued compliance with third-party license terms and the non-infringement of third-party intellectual property rights; |
• | our ability to manage and integrate acquisitions; |
• | our ability to retain key personnel; and |
• | our ability to raise sufficient debt or equity financing to support our continued growth. |
• | our ability to obtain regulatory approval for our product candidates without significant delays; |
• | the predictive value of our current or planned clinical trials; |
• | delays with respect to the development and commercialization of our product candidates, which may cause increased costs or delay receipt of product revenue; |
• | our, or any of our partners’, ability to enroll subjects in clinical trials and thereby complete trials on a timely basis; |
• | the design or our execution of clinical trials may not support regulatory approval, including where clinical trials are conducted outside the United States; |
• | the Fast Track designations for any of our product candidates may not expedite regulatory review or approval; |
• | The U.S. Food and Drug Administration (“FDA”) may not accept data from trials we conduct outside the United States; |
• | our discretion to discontinue or reprioritize the development of any of our product candidates; |
• | the potential for our product candidates to have undesirable side effects; |
• | no regulatory agency has made a determination that any of our product candidates are safe or effective for use by the general public or for any indication; |
• | our ability to face significant competition; |
• | the competitive threat of biosimilar products; |
• | the likelihood of broad market acceptance of our product candidates; |
• | our ability to obtain Orphan Drug Designation or exclusivity for some or all of our product candidates; |
• | our ability to commercialize products outside of the United States; |
• | the outcome of reimbursement decisions by third-party payors relating to our products; |
• | our expectations with respect to the market opportunities for any product that we or our strategic partners develop; |
• | our ability to pursue product candidates that may be profitable or have a high likelihood of success; |
• | our ability to use and expand our therapeutic platforms to build a pipeline of product candidates; |
• | our ability to meet the requirements of ongoing regulatory review; |
• | the threat of product liability lawsuits against us or any of our strategic partners; |
• | changes in product candidate manufacturing or formulation that may result in additional costs or delay; |
• | the potential disruption of our business and dilution of our shareholdings associated with acquisitions and joint ventures; |
• | the potential for foreign governments to impose strict price controls; |
• | the risk of security breaches or data loss, which could compromise sensitive business or health information; |
• | current and future legislation that may increase the difficulty and cost of commercializing our product candidates; |
• | economic, political, regulatory and other risks associated with international operations; |
• | our exposure to legal and reputational penalties as a result of any of our current and future relationships with various third parties; |
• | our ability to comply with export control and import laws and regulations; |
• | our history of significant losses since inception; |
• | our ability to generate revenue from product sales and achieve profitability; |
• | our requirement for substantial additional funding; |
• | the potential dilution to our shareholders associated with future financings; |
• | restrictions on our ability to seek financing, which may be imposed by future debt; |
• | unstable market and economic conditions; |
• | currency fluctuations and changes in foreign currency exchange rates; |
• | our ability to maintain existing and future strategic partnerships; |
• | our ability to realize the anticipated benefits of our strategic partnerships; |
• | our ability to secure future strategic partners; |
• | our reliance on third-party manufacturers to produce our clinical product candidate supplies and on other third parties to store, monitor and transport bulk drug substance and drug product; |
• | risk related to the manufacture of product candidates and difficulties in production; |
• | our reliance on third parties to oversee clinical trials of our product candidates and, in some cases, maintain regulatory files for those product candidates; |
• | our reliance on the performance of independent clinical investigators and contract research organizations (“CROs”); |
• | our reliance on third parties for various operational and administrative aspects of our business including our reliance on third parties’ cloud-based software platforms; |
• | the risk that natural disasters, public health crises, political crises, and other catastrophic events may damage the facilities or disrupt the operations of third parties upon which we rely; |
• | our ability to operate without infringing the patents and other proprietary rights of third parties; |
• | our ability to obtain and enforce patent protection for our product candidates and related technology; |
• | our patents could be found invalid or unenforceable if challenged; |
• | our intellectual property rights may not necessarily provide us with competitive advantages; |
• | we may become involved in expensive and time-consuming patent lawsuits; |
• | the risk that the duration of our patents will not adequately protect our competitive position; |
• | our ability to obtain protection under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Amendments”) and similar foreign legislation; |
• | we may be unable to protect the confidentiality of our proprietary information; |
• | our ability to comply with procedural and administrative requirements relating to our patents; |
• | the risk of claims challenging the inventorship of our patents and other intellectual property; |
• | our intellectual property rights for some of our product candidates are dependent on the abilities of third parties to assert and defend such rights; |
• | patent reform legislation and court decisions can diminish the value of patents in general, thereby impairing our ability to protect our products; |
• | we may not be able to protect our intellectual property rights throughout the world; |
• | we will require FDA approval for any proposed product candidate names and any failure or delay associated with such approval may adversely affect our business; |
• | the risk of employee misconduct including noncompliance with regulatory standards and insider trading; |
• | our ability to market our products in a manner that does not violate the law and subject us to civil or criminal penalties; |
• | if we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected; |
• | our ability to retain key executives and attract and retain qualified personnel; |
• | our ability to manage organizational growth; |
• | additional costs and expenses related to no longer being considered an emerging growth company or a smaller reporting company; |
• | our exposure to potential securities class action litigation; and |
• | if securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline. |
Item 1. |
Business |
• | Azymetric |
• | ZymeLink, |
• | EFECT, |
• | initiate ZW25 registration-enabling studies in 2 nd line HER2-positive BTC and 1st line HER2-positive GEA; |
• | report ZW49 Phase 1 dose-escalation data and initiate expansion cohorts; |
• | expand ZW25 clinical development into additional HER2-expressing cancers; |
• | report ZW25 Phase 2 chemotherapy combination data from 1 st line HER2-positive GEA; and |
• | continue building a strong preclinical pipeline through internal R&D and external partnerships. |
• | cross-linked trans HER2 binding and HER2 receptor clustering; |
• | enhanced antibody internalization and HER2 downregulation; |
• | increased maximum binding density and potent effector function-mediated cytotoxicity; and |
• | enhanced blockade of ligand-dependent and ligand-independent tumor growth. |
• | NCT02892123 – Phase 1 study to evaluate the maximal tolerated dose, optimal biological dose or other recommended dose, and overall safety and tolerability of ZW25 in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancers. |
• | NCT03929666 – A multicenter, global, Phase 2, open-label, two-part, 1st line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 plus physician’s choice of combination chemotherapy in HER2-expressing GEA. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA. |
• | NCT04224272 – A multicenter, global, Phase 2, open-label, two-part study. Part one of the study will evaluate the safety and tolerability of ZW25 in combination with palbociclib and fulvestrant and identify the recommended doses (“RD”) of ZW25 and palbociclib. Part two of the study will evaluate anti-tumor activity at the RD level. |
• | Increased maximum HER2 binding density |
• | Unique biparatopic-induced HER2 receptor clustering |
• | Increased HER2-mediated ADC internalization |
• | Enhanced toxin-mediated cytotoxicity and tumor growth inhibition |
• | secure, maintain and enforce patent and other proprietary protection for our core technologies, inventions and know-how; |
• | obtain and maintain licenses to key third-party intellectual property owned by such third parties; |
• | preserve the confidentiality of our trade secrets; and |
• | operate without infringing upon valid, enforceable third-party patents and other rights. |
• | We own the ZW25 and ZW49 patent portfolio, including an international patent application filed under the Patent Cooperation Treaty (“PCT”) that is now in the national phase with applications pending in Australia, Brazil, Canada, China, Europe, India, Japan, Korea, Mexico, Russia and the United States. This application relates to the composition of matter, methods of making and uses of biparatopic anti-HER2 bispecific antibodies and ADCs, and if issued, is expected to expire in 2034, absent any adjustments or extensions. One U.S. patent has issued. An additional PCT application in the national phase in Australia, Canada, Europe, Japan and the U.S. is directed to treatment methods using ZW25. |
• | We have filed a PCT application covering ZW49 composition of matter and methods of making and using ZW49. Any patents that issue from national phase filings are expected to expire in 2039, absent any adjustments or extensions. |
• | Both ZW25 and ZW49 are also protected by our two patent families relating to the Azymetric Fc, as described below. ZW 49 is also protected by one of the ZymeLink patent families, as described below. |
• | Azymetric: |
• | ZymeLink: |
Europe, India, Israel, Japan, Korea, Mexico, South Africa and the United States, and are directed to novel hemiasterlin toxin derivatives, novel linker compositions, hemiasterlin-linker compositions, and antibody-hemiasterlin conjugate compositions, one of which has issued in the United States. An additional PCT application is directed to novel auristatin derivatives, auristatin-linker compositions and antibody-auristatin conjugates and is in the national phase in Australia, Brazil, Canada, China, Europe, India, Israel, Japan, Korea, Mexico, Russia, Singapore and the United States. Two U.S. patents have issued. Any patents that may issue from these families are expected to expire between 2034 and 2037, absent any adjustments or extensions. |
• | EFECT: g R-binding and Fc effector function is protected by two PCT patent applications that we own, both of which are in the national stage with one application pending or issued in Australia, Canada, Mexico and the U.S. and the other pending or issued in Australia, Brazil, Canada, China, Europe, India, Japan, Russia and the United States. One patent has issued in the United States. These patent families are directed to compositions of matter and methods of making Fc constructs with altered Fcg R-binding and Fc effector function; if issued, they are expected to expire between 2031 and 2034, absent any adjustments or extensions. |
• | Computational Chemistry: |
• | HER2 targeted therapies: |
• | Non-HER2 targeted therapies. non-HER2 targeting monoclonal antibodies on the market that may have activity on tumors expressing low levels of HER2, including Merck’s Keytruda, BMS’s Opdivo, Roche’s Tecentriq, Merck KGaA’s Bavencio and AstraZeneca’s Imfinzi. Since ZW25 has been relatively well-tolerated and has a different and potentially complimentary mechanism of action to these non-HER2 targeted therapies, we believe they could potentially be used in combination with ZW25 to achieve even higher response rates and durability. |
• | completion of extensive nonclinical, sometimes referred to as preclinical, laboratory tests and preclinical animal trials and applicable requirements for the humane use of laboratory animals and formulation studies in accordance with applicable regulations, including good laboratory practices (“GLP”); |
• | submission to the FDA of an IND application, which must become effective before human clinical trials may begin; |
• | performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as current good clinical practice (“cGCP”) regulations and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use. The FDA may also impose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or noncompliance. If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA. |
• | submission to the FDA of a Biologics License Application (“BLA”) for marketing approval that includes substantive evidence of safety, purity, and potency from results of nonclinical testing and clinical trials; |
• | satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity; |
• | potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA; and |
• | FDA review and approval, or licensure, of the BLA. |
• | Phase 1. |
• | Phase 2. |
• | Phase 3. |
Item 1A. |
Risk Factors |
• | successfully completing preclinical studies, including product chemistry, toxicity and formulation studies; |
• | completing clinical trials that demonstrate the efficacy and safety of our product candidates; |
• | preparation and submission to the appropriate regulatory authorities of an application for marketing approval that includes substantial evidence of safety, purity and potency from results of nonclinical testing and clinical trials; |
• | establishing commercial manufacturing capabilities; |
• | a potential pre-approval audit of the nonclinical and clinical trial sites that generated the data in support of the marketing application; and |
• | launching commercial sales, marketing and distribution operations. |
• | further discussions with the FDA or other regulatory agencies regarding the scope or design of our clinical trials; |
• | the limited number of, and competition for, suitable sites to conduct our clinical trials, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; |
• | any delay or failure to obtain approval or agreement to commence a clinical trial in any of the countries where enrollment is planned; |
• | inability to obtain sufficient funds required for a clinical trial; |
• | clinical holds on, or other regulatory objections to, a new or ongoing clinical trial; |
• | delay or failure to manufacture sufficient supplies of the product candidate for our clinical trials; |
• | delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs; |
• | delay or failure to obtain IRB approval to conduct a clinical trial at a prospective site; |
• | slower than expected rates of patient recruitment and enrollment; |
• | failure of patients to complete the clinical trial; |
• | the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects; |
• | unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths; |
• | lack of efficacy during clinical trials; |
• | termination of our clinical trials by one or more clinical trial sites; |
• | inability or unwillingness of patients or clinical investigators to follow our clinical trial protocols; |
• | inability to monitor patients adequately during or after treatment by us or our CROs; |
• | our CROs or clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; |
• | the inability to address any noncompliance with regulatory requirements or safety concerns that arise during the course of a clinical trial; |
• | the need to repeat or terminate clinical trials as a result of inconclusive or negative results or unforeseen complications in testing; and |
• | our clinical trials may be suspended or terminated upon a breach or pursuant to the terms of any agreement with, or for any other reason by, current or future strategic partners that have responsibility for the clinical development of any of our product candidates. |
• | regulatory authorities may require us to take our approved product off the market; |
• | regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies, or impose a risk evaluation and mitigation strategy that includes restrictions and conditions on product distribution, prescribing and/or dispensing; |
• | we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product; |
• | we may be subject to limitations on how we may promote the product; |
• | sales of the product may decrease significantly; |
• | we may be subject to litigation or product liability claims; and |
• | our reputation may suffer. |
• | limitations or warnings contained in the approved labeling for a product candidate; |
• | changes in the standard of care for the targeted indications for any of our product candidates; |
• | limitations in the approved clinical indications for our product candidates; |
• | demonstrated clinical safety and efficacy compared to other products; |
• | sales, marketing and distribution support; |
• | availability of coverage and extent of reimbursement from managed care plans and other third-party payors; |
• | timing of market introduction and perceived effectiveness of competitive products; |
• | the degree of cost-effectiveness of our product candidates; |
• | availability of alternative therapies at similar or lower cost, including generic and over-the-counter products; |
• | the extent to which the product candidate is approved for inclusion on formularies of hospitals and managed care organizations; |
• | whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular diseases; |
• | whether the product can be used effectively with other therapies to achieve higher response rates; |
• | adverse publicity about our product candidates or favorable publicity about competitive products; |
• | convenience and ease of administration of our products; and |
• | potential product liability claims. |
• | restrictions on the marketing or manufacturing of the product; |
• | withdrawal of the product from the market or voluntary or mandatory product recalls; |
• | fines, warning letters or holds on clinical trials; |
• | refusal by the FDA, EMA or another applicable regulatory authority to approve pending applications or supplements to approved applications filed by us or our strategic partners, or suspension or revocation of product license approvals; |
• | product seizure or detention, or refusal to permit the import or export of products; and |
• | injunctions or the imposition of civil or criminal penalties. |
• | decreased demand for any future approved products; |
• | injury to our reputation; |
• | withdrawal of clinical trial participants; |
• | termination of clinical trial sites or entire trial programs; |
• | increased regulatory scrutiny; |
• | significant litigation costs; |
• | substantial monetary awards to, or costly settlement with, patients or other claimants; |
• | product recalls or a change in the indications for which they may be used; |
• | loss of revenue; |
• | diversion of management and scientific resources from our business operations; and |
• | the inability to commercialize our product candidates. |
• | disruption in our relationships with existing strategic partners or suppliers as a result of such a transaction; |
• | unanticipated liabilities related to acquired companies; |
• | difficulties integrating acquired personnel, technologies and operations into our existing business; |
• | retention of key employees; |
• | diversion of management time and focus from operating our business to management of strategic alliances or joint ventures or acquisition integration challenges; |
• | increases in our expenses and reductions in our cash available for operations and other uses; and |
• | possible write-offs or impairment charges relating to acquired businesses. |
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | differing regulatory requirements for drug approvals in foreign countries; |
• | potentially reduced protection for intellectual property rights; |
• | difficulties in compliance with non-U.S. laws and regulations; |
• | changes in non-U.S. regulations and customs, tariffs and trade barriers, including any changes that China may impose as a result of political tensions between Canada and China or the United States and China; |
• | regulatory changes and economic conditions leading up to and following the United Kingdom’s withdrawal from the EU and uncertainty related to the terms of the withdrawal; |
• | changes in non-U.S. currency exchange rates and currency controls; |
• | changes in a specific country’s or region’s political or economic environment; |
• | trade protection measures, import or export licensing requirements or other restrictive actions by U.S. or non-U.S. governments; |
• | differing reimbursement regimes, including price controls; |
• | negative consequences from changes in tax laws; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States; |
• | difficulties associated with staffing and managing foreign operations, including differing labor relations; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
• | business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires; and |
• | supply and other disruptions resulting from the impact of public health epidemics on our strategic partners, third-party manufacturers, suppliers and other third parties upon which we rely, including the novel coronavirus (COVID-19). |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid; |
• | federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, impose criminal or civil penalties, as applicable, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government (including the Medicare and Medicaid programs) or other third-party payor claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; |
• | HIPAA, which among other things, imposes criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g. public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of or payment for healthcare benefits, items or services relating to healthcare matters; |
• | HIPAA, as amended by HITECH, and its implementing regulations, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without the appropriate authorization by entities subject to the law, such as health plans, healthcare clearinghouses and healthcare providers and their respective business associates; |
• | the federal Open Payments program under the Physician Payments Sunshine Act, created under Section 6002 of the PPACA and its implementing regulations, requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to “payments or other transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors and, effective in 2022, advanced practice nurses and physician assistants) and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to HHS ownership and investment interests held by physicians (as defined above) and their immediate family members; and |
• | analogous state and foreign laws and regulations, including: state anti-kickback and false claims laws that 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 state governmental and non-governmental third-party payors, including private insurers); state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government; state laws that require drug manufacturers to track gifts and other remuneration and items of value provided to healthcare professionals and entities and file reports relating to pricing and marketing information; and |
state and foreign laws that govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts. |
• | the number and characteristics of other product candidates that we pursue; |
• | the scope, progress, timing, cost and results of research, preclinical development, and clinical trials; |
• | the costs, timing and outcome of seeking and obtaining FDA and non-U.S. regulatory approvals; |
• | the costs associated with manufacturing our product candidates and establishing sales, marketing and distribution capabilities; |
• | our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense and enforcement of any patents or other intellectual property rights; |
• | our need and ability to hire additional management, scientific and medical personnel; |
• | the effect of competing products that may limit market penetration of our product candidates; |
• | our need to implement additional internal systems and infrastructure, including financial and reporting systems; and |
• | the economic and other terms, timing of and success of our existing strategic partnerships, and any collaboration, licensing, or other arrangements into which we may enter in the future, including the timing of receipt of any milestone or royalty payments under these agreements. |
• | strategic partners have significant discretion in determining the efforts and resources that they will apply to these partnerships; |
• | strategic partners may not perform their obligations as expected; |
• | strategic partners may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the partners’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; |
• | strategic partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
• | strategic partners could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the strategic partners believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than our product candidates; |
• | product candidates discovered in collaboration with us may be viewed by our strategic partners as competitive with their own product candidates or products, which may cause strategic partners to cease to devote resources to the commercialization of our product candidates; |
• | a strategic partner with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product candidates; |
• | disagreements with strategic partners, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; |
• | strategic partners may not properly maintain or defend our 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 or proprietary information or expose us to potential litigation; |
• | strategic partners may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; |
• | strategic partnerships may be terminated for the convenience of the partner and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates. For example, each of our collaboration and license agreements with Merck, Lilly, BMS, GSK, Daiichi Sankyo, Janssen, LEO, BeiGene and Iconic may be terminated for convenience upon the completion of a specified notice period; and |
• | we may elect to enter into additional licensing or collaboration agreements to partner our product candidates in territories we currently retain, and in the event we grant exclusive rights to such partners, we would be precluded from potential commercialization of our product candidates within the territories in which we have a partner. |
• | we or our strategic partners may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third parties, to obtain a judgment that our products or processes do not infringe those third parties’ patents or to obtain a judgement that those parties’ patents are unenforceable; |
• | if our competitors file patent applications that claim technology also claimed by us or our licensors, we or our licensors may be required to participate in interference, derivation or opposition proceedings to determine the priority of invention, which could jeopardize our patent rights and potentially provide a third party with a dominant patent position; |
• | if third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights or initiating other proceedings, including post-grant proceedings and inter partes |
• | if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our processes or products infringe or misappropriate their patent or other intellectual property rights and/or that we breached our obligations under the license agreement, and we and our strategic partners would need to defend against such proceedings. |
• | others may be able to make compounds that are similar to our product candidates but that are not covered by the claims of the patents that we or our strategic partners own or have exclusively licensed; |
• | others may independently develop similar or alternative technologies without infringing our intellectual property rights; |
• | issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; |
• | we may obtain patents for certain compounds many years before we obtain marketing approval for products containing such compounds, and because patents have a limited life, which may begin to run prior to the commercial sale of the related product, the commercial value of our patents may be limited; |
• | 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 fail to develop additional proprietary technologies that are patentable; |
• | the laws of certain foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States, or we may fail to apply for or obtain adequate intellectual property protection in all the jurisdictions in which we operate; and |
• | the patents of others may have an adverse effect on our business, for example by preventing us from marketing one or more of our product candidates for one or more indications. |
• | we or our strategic partners may initiate litigation or other proceedings against third parties to enforce our patent and trade secret rights; |
• | third parties may initiate litigation or other proceedings seeking to invalidate patents owned by or licensed to us or to obtain a declaratory judgment that their product or technology does not infringe our patents or patents licensed to us; |
• | third parties may initiate opposition or reexamination proceedings challenging the validity or scope of our patent rights, requiring us or our strategic partners and/or licensors to participate in such proceedings to defend the validity and scope of our patents; |
• | there may be a challenge or dispute regarding inventorship or ownership of patents or trade secrets currently identified as being owned by or licensed to us; |
• | the USPTO may initiate an interference between patents or patent applications owned by or licensed to us and those of our competitors, requiring us or our strategic partners and/or licensors to participate in an interference proceeding to determine the priority of invention, which could jeopardize our patent rights; or |
• | third parties may seek approval to market biosimilar versions of our future approved products prior to expiration of relevant patents owned by or licensed to us, requiring us to defend our patents, including by filing lawsuits alleging patent infringement. |
• | others may be able to develop a platform that is similar to, or better than, ours in a way that is not covered by the claims of our patents; |
• | others may be able to make compounds that are similar to our product candidates but that are not covered by the claims of our patents; |
• | we might not have been the first to make the inventions covered by patents or pending patent applications; |
• | we might not have been the first to file patent applications for these inventions; |
• | any patents that we obtain may not provide us with any competitive advantages or may ultimately be found invalid or unenforceable; or |
• | we may not develop additional proprietary technologies that are patentable or that afford meaningful trade secret protection. |
• | providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; |
• | reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; |
• | engaging in off-label promotion; |
• | submitting inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates; and |
• | providing funding to third-party charitable foundations in order to offset patient co-payment obligations. |
• | results and timing of our clinical trials and clinical trials of our competitors’ products; |
• | failure or discontinuation of any of our development programs; |
• | issues in manufacturing our product candidates or future approved products; |
• | regulatory developments or enforcement in the United States and foreign countries with respect to our product candidates or our competitors’ products; |
• | competition from existing products or new products that may emerge; |
• | developments or disputes concerning patents or other proprietary rights; |
• | introduction of technological innovations or new commercial products by us or our competitors; |
• | announcements by us, our strategic partners or our competitors of significant acquisitions, strategic partnerships, joint ventures, or capital commitments; |
• | changes in estimates or recommendations by securities analysts that cover our common shares; |
• | fluctuations in the valuation of companies perceived by investors to be comparable to us; |
• | public concern over our product candidates or any future approved products; |
• | litigation; |
• | future sales of our common shares; |
• | share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; |
• | additions or departures of key personnel; |
• | changes in the structure of health care payment systems in the United States or overseas; |
• | failure of any of our product candidates, if approved, to achieve commercial success; |
• | economic and other external factors or other disasters or crises; |
• | period-to-period fluctuations in our financial condition and results of operations, including the timing of receipt of any milestone or other payments under commercialization or licensing agreements; |
• | general market conditions and market conditions for biopharmaceutical stocks; |
• | overall fluctuations in U.S. equity markets; and |
• | other factors that may be unanticipated or out of our control. |
• | a limited availability of market quotations for our securities; |
• | a determination that our common shares is a “penny stock”, which will require brokers trading in our common shares to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our common shares; |
• | a limited amount of news and analyst coverage for our company; and |
• | a decreased ability to issue additional securities or obtain additional financing in the future. |
• | delaying, deferring, or preventing a change in control; |
• | entrenching our management or the board of directors; |
• | impeding a merger, takeover, or other business combination involving us; or |
• | discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us. |
• | shareholders cannot amend our articles unless such amendment is approved by shareholders holding at least a majority of the shares entitled to vote on such approval; |
• | our board of directors may, without shareholder approval, issue preferred shares having any terms, conditions, rights, preferences and privileges as the board of directors may determine; and |
• | shareholders must give advance notice to nominate directors or to submit proposals for consideration at shareholders’ meetings. |
Item 1B. |
Unresolved Staff Comments |
Item 2. |
Properties |
Item 3. |
Legal Proceedings |
Item 4. |
Mine Safety Disclosures |
Item 5. |
Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities |
NYSE |
TSX |
|||||||||||||||
High |
Low |
High |
Low |
|||||||||||||
US$ |
C$ |
|||||||||||||||
Quarter Ended |
||||||||||||||||
December 31, 2019 |
45.83 |
24.00 |
n/a |
n/a |
||||||||||||
September 30, 2019 |
29.75 |
21.52 |
39.10 |
29.64 |
||||||||||||
June 30, 2019 |
23.17 |
14.65 |
30.43 |
19.75 |
||||||||||||
March 31, 2019 |
17.30 |
13.96 |
23.02 |
18.73 |
||||||||||||
December 31, 2018 |
15.73 |
10.72 |
20.52 |
14.34 |
||||||||||||
September 30, 2018 |
16.88 |
12.15 |
21.69 |
15.84 |
||||||||||||
June 30, 2018 |
29.00 |
10.37 |
30.36 |
13.37 |
||||||||||||
March 31, 2018 |
14.00 |
7.69 |
17.31 |
9.62 |
||||||||||||
December 31, 2017 |
9.33 |
6.87 |
11.60 |
9.00 |
||||||||||||
September 30, 2017 |
9.12 |
6.25 |
11.48 |
8.05 |
||||||||||||
April 28, 2017 to June 30, 2017 |
14.25 |
7.24 |
19.55 |
10.50 |
Item 6. |
Selected Financial Data |
Year Ended December 31, |
||||||||||||||||||||
2019 |
2018 |
2017 |
2016 |
2015 |
||||||||||||||||
(dollars in thousands except share and per share amounts) |
||||||||||||||||||||
Consolidated Statement of Operations Data |
||||||||||||||||||||
Revenue |
$ | 29,544 |
$ | 53,019 |
$ | 51,762 |
$ | 11,009 |
$ | 9,660 |
||||||||||
Operating Expenses: |
||||||||||||||||||||
Research and development |
115,900 |
56,926 |
41,144 |
35,551 |
24,403 |
|||||||||||||||
General and administrative |
64,177 |
29,457 |
18,550 |
12,554 |
5,217 |
|||||||||||||||
Impairment on acquired IPR&D |
768 |
— |
1,536 |
768 |
— |
|||||||||||||||
Total operating expenses |
180,845 |
86,383 |
61,230 |
48,873 |
29,620 |
|||||||||||||||
Loss from Operations |
(151,301 |
) | (33,364 |
) | (9,468 |
) | (37,864 |
) | (19,960 |
) | ||||||||||
Other income (expense), net |
5,282 |
(1,021 |
) | (494 |
) | (1,020 |
) | 824 |
||||||||||||
Loss before income taxes |
(146,019 |
) | (34,385 |
) | (9,962 |
) | (38,884 |
) | (19,136 |
) | ||||||||||
Net income tax recovery (expense), net |
582 |
(2,171 |
) | (444 |
) | 5,075 |
(34 |
) | ||||||||||||
Net loss |
$ | (145,437 |
) | $ | (36,556 |
) | $ | (10,406 |
) | $ | (33,809 |
) | $ | (19,170 |
) | |||||
Net loss per common share (basic) (1) |
(3.83 |
) | (1.26 |
) | (0.51 |
) | (2.65 |
) | (1.70 |
) | ||||||||||
Net loss per common share (diluted) (1) |
(3.83 |
) | (1.26 |
) | (0.64 |
) | (2.65 |
) | (1.70 |
) | ||||||||||
Weighted-average number of common shares (basic) (1) |
38,022,014 |
29,089,896 |
21,249,414 |
12,736,567 |
11,266,451 |
|||||||||||||||
Weighted-average number of commons shares (diluted) (1) |
38,022,014 |
29,089,896 |
21,321,209 |
12,736,567 |
11,266,451 |
(1) | See “Notes to the Consolidated Financial Statements—Summary of Significant Accounting Policies—Net Income (Loss) Per Share” for an explanation of the method used to calculate basic and diluted net income (loss) per common share and the weighted-average number of common shares used in computation of the per common share amounts. |
Year Ended December 31, |
||||||||||||||||
2019 |
2018 |
2017 |
2016 |
|||||||||||||
(dollars in thousands) |
||||||||||||||||
Consolidated Balance Sheet Data |
||||||||||||||||
Cash and cash equivalents |
$ | 128,451 |
$ | 42,205 |
$ | 35,946 |
$ | 16,437 |
||||||||
Short-term investments |
170,453 |
157,959 |
51,851 |
23,824 |
||||||||||||
Working capital |
229,278 |
174,383 |
77,674 |
29,928 |
||||||||||||
Long-term obligations |
39,972 |
34,001 |
866 |
9,577 |
||||||||||||
Total assets |
368,205 |
244,477 |
131,955 |
93,995 |
||||||||||||
Total liabilities |
122,524 |
63,987 |
15,527 |
26,133 |
||||||||||||
Total shareholders’ equity |
245,681 |
180,490 |
116,428 |
9,002 |
Item 7. |
Management’s Discussion and Analysis of Financial Condition and Results of Operation |
• | initiate ZW25 registration-enabling studies in 2 nd line HER2-positive BTC and 1st line HER2-positive GEA; |
• | report ZW49 Phase 1 dose-escalation data and initiate expansion cohorts; |
• | expand ZW25 clinical development into additional HER2-expressing cancers; |
• | report ZW25 Phase 2 chemotherapy combination data from 1 st line HER2-positive GEA; and |
• | continue building a strong preclinical pipeline through internal R&D and external partnerships. |
• | employee-related expenses such as salaries and benefits; |
• | employee-related overhead expenses such as facilities and other allocated items; |
• | share-based compensation expense related to employees and consultants engaged in research and development activities; |
• | depreciation of laboratory equipment, computers and leasehold improvements; |
• | fees paid to third-party manufacturers to produce our clinical product candidate supplies and on other third parties to store, monitor and transport bulk drug substance and drug product; |
• | fees paid to consultants, subcontractors, CROs, and other third-party vendors for work performed under our clinical trials and preclinical studies, including but not limited to laboratory work and analysis, database management, statistical analysis, and other items; and |
• | Amounts paid to vendors and suppliers for laboratory supplies. |
Year Ended December 31, |
||||||||||||||||||||
2019 |
2018 |
2017 |
Change 2019 – 2018 |
|||||||||||||||||
(dollars in millions) |
||||||||||||||||||||
Revenue from research and development collaborations |
$ | 29.5 |
$ | 53.0 |
$ | 51.8 |
$ | (23.5 |
) | (44 |
%) |
Year Ended December 31, |
||||||||||||||||||||
2019 |
2018 |
2017 |
Change 2019 – 2018 |
|||||||||||||||||
(dollars in millions) |
||||||||||||||||||||
Total research and development expense |
$ | 115.9 |
$ | 56.9 |
$ | 41.1 |
$ | 59.0 |
104 |
% |
Year Ended December 31, |
||||||||||||||||||||
2019 |
2018 |
2017 |
Change 2019 – 2018 |
|||||||||||||||||
(dollars in millions) |
||||||||||||||||||||
General and administrative expense |
$ | 64.2 |
$ | 29.5 |
$ | 18.6 |
$ | 34.7 |
118 |
% |
Year Ended December 31, |
||||||||||||||||||||
2019 |
2018 |
2017 |
Change 2019 – 2018 |
|||||||||||||||||
(dollars in millions) |
||||||||||||||||||||
Other income (expense), net |
$ | 5.3 |
$ | (1.0 |
) | $ | (0.5 |
) | $ | 6.3 |
630 |
% |
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(dollars in millions) |
||||||||||||
Net cash provided by (used in): |
||||||||||||
Operating activities |
$ | (81.8 |
) | $ | 24.2 |
$ | 0.2 |
|||||
Investing activities |
(25.6 |
) | (109.0 |
) | (30.9 |
) | ||||||
Financing activities |
193.7 |
91.4 |
50.0 |
|||||||||
Effect of exchange rate changes on cash and cash equivalents |
(0.0 |
) | (0.3 |
) | 0.2 |
|||||||
Net increase in cash and cash equivalents |
$ | 86.3 |
$ | 6.3 |
$ | 19.5 |
||||||
Payments due by period |
||||||||||||||||||||||||
Less Than 1 Year |
1 to 2 Years |
2 to 3 Years |
3 to 4 Years |
Thereafter |
Total |
|||||||||||||||||||
(dollars in thousands) |
||||||||||||||||||||||||
Capital lease obligations |
$ | 31 |
$ | 16 |
$ | 6 |
$ | 3 |
$ | 1 |
$ | 57 |
||||||||||||
Operating lease obligations |
1,438 |
2,076 |
1,007 |
991 |
1,019 |
6,531 |
||||||||||||||||||
Total contractual obligations |
$ | 1,469 |
$ | 2,092 |
$ | 1,013 |
$ | 994 |
$ | 1,020 |
$ | 6,588 |
||||||||||||
Item 7A. |
Quantitative and Qualitative Disclosure About Market Risk |
Item 8. |
Financial Statements and Supplementary Data |
Page |
||||
102 |
||||
106 |
||||
107 |
||||
108 |
||||
109 |
||||
110 |
December 31, |
||||||||
2019 |
2018 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | |
$ | |
||||
Short-term investments (note 5 ) |
|
|
||||||
Accounts receivable |
|
|
||||||
Prepaid expenses and other current assets |
|
|
||||||
Total current assets |
|
|
||||||
Deferred financing fees |
|
|
||||||
Long-term prepaid assets |
|
|
||||||
Deferred tax asset (note 15) |
|
|
|
|
|
|
| |
Property and equipment, net (note 7 ) |
|
|
||||||
Operating lease right-of-use assets (note 16 ) |
|
— |
||||||
Intangible assets, net (note 8 ) |
|
|
||||||
Acquired in-process research and development (note 6 ) |
|
|
||||||
Goodwill (note 6) |
|
|
|
|
|
|
|
|
Total assets |
$ | |
$ | |
||||
Liabilities and shareholders’ equity |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued liabilities (note 9 ) |
$ | |
$ | |
||||
Fair value of liability classified options (note 17 ) |
|
|
||||||
Current portion of operating lease liability (note 1 6 ) |
|
— |
||||||
Current portion of deferred revenue (note 1 3 ) |
— |
|
||||||
Other current liabilities |
|
|
||||||
Total current liabilities |
|
|
||||||
Long-term portion of operating lease liability (note 1 6 ) |
|
— |
||||||
Long-term portion of deferred revenue (note 1 3 ) |
|
|
||||||
Other long-term liabilities ( note 9 ) |
|
|
||||||
Deferred tax liability (note 15) |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
||||||
Shareholders’ equity: |
||||||||
Common shares, 1b ) |
|
|
||||||
Additional paid-in capital |
|
|
||||||
Accumulated other comprehensive loss |
( |
) | ( |
) | ||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total shareholders’ equity |
|
|
||||||
Total liabilities and shareholders’ equity |
$ | |
$ | |
||||
|
|
|
|
|
|
| ||
Research collaboration and licensing agreements (note 1 3 ) |
||||||||
Commitments and contingencies (note 1 8 |
||||||||
Subsequent event (note 1 9 |
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Revenue: |
||||||||||||
Research and development collaborations (note 1 3 ) |
$ | |
$ | |
$ | |
||||||
Operating expenses: |
||||||||||||
Research and development , net of government grants and c redits |
|
|
|
|||||||||
General and administrative |
|
|
|
|||||||||
Impairment on acquired IPR&D (note 6) |
|
— |
|
|||||||||
Total operating expenses |
|
|
|
|||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ||||||
Other income (expense): |
||||||||||||
Interest and other income |
|
|
|
|||||||||
Other expense, net (note 14) |
( |
) | ( |
) | ( |
) | ||||||
Total other income (expense), net |
|
( |
) | ( |
) | |||||||
Loss before income taxes |
( |
) | ( |
) | ( |
) | ||||||
Income tax recovery (expense), net (note 15) |
|
( |
) | ( |
) | |||||||
Net loss and comprehensive loss |
$ | ( |
) | $ | ( |
) |
$ | ( |
) | |||
Net loss per common share (note 4): |
||||||||||||
Basic |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Weighted-average common shares outstanding (note 4 ): |
||||||||||||
Basic |
|
|
|
|||||||||
Diluted |
|
|
|
|
Rede emable Convertible C lass A Preferred shares |
|
|
Com mon s hares |
|
|
Accumulated |
|
|
Accumulated o thercomprehensive |
|
|
A dditionalpaid-i n |
|
|
T otal shareholders' |
| |||||||||||||||||||
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
deficit |
|
|
loss |
|
|
capital |
|
|
equity |
| |||||||||||||
Balance at December 31, 2016 |
|
$ |
|
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
$ |
|
||||||||||||||||||||
Issuance of common shares on exercise of options |
— |
— |
|
|
— |
— |
( |
) |
|
|||||||||||||||||||||||||||
Issuance of common shares on exercise of warrants |
— |
— |
|
|
— |
— |
— |
|
||||||||||||||||||||||||||||
Fair value adjustments upon reclassification of options to liabilities |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | ||||||||||||||||||||||||||
Stock -based compensation |
— |
— |
— |
— |
— |
— |
|
|
||||||||||||||||||||||||||||
Beneficial conversion feature recognized on the conversion of redeemable convertible class A preferred shares (note 11 ) c |
— |
— |
— |
— |
( |
) |
— |
|
— |
|||||||||||||||||||||||||||
Conversion of redeemable convertible class A preferred shares to common shares in connection with initial public offering (note 11c ) |
( |
) |
( |
) |
|
|
— |
— |
— |
|
||||||||||||||||||||||||||
Issuance of common shares in connection with initial public offering, net of offering costs (note 11 a) |
— |
— |
|
|
— |
— |
— |
|
||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
( |
) |
— |
— |
( |
) | ||||||||||||||||||||||||||
Balance at December 31, 2017 |
|
$ |
|
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
$ |
|
||||||||||||||||||||
Issuance of common shares on exercise stock options(note 1 1 ) e |
— |
— |
|
|
— |
— |
( |
) |
|
|||||||||||||||||||||||||||
Issuance of common shares through employee stock purchase plan (note 11 ) f |
— |
— |
|
|
— |
— |
— |
|
||||||||||||||||||||||||||||
Stock -based compensation |
— |
— |
— |
— |
— |
— |
|
|
||||||||||||||||||||||||||||
Issuance of common shares on exercise of warrants (note 10 ) |
— |
— |
|
|
— |
— |
— |
|
||||||||||||||||||||||||||||
Issuance of common shares in connection with public offering, net of offering costs (note 11a ) |
— |
— |
|
|
— |
— |
— |
|
||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
( |
) |
— |
— |
( |
) | ||||||||||||||||||||||||||
Balance at December 31, 2018 |
— |
$ |
— |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
$ |
|
||||||||||||||||||||
Issuance of common shares on exercise of options (note 1 1 ) e |
— |
— |
|
|
— |
— |
( |
) |
|
|||||||||||||||||||||||||||
Issuance of common shares through employee share purchase plan (note 1 1 ) f |
— |
— |
|
|
— |
— |
— |
|
||||||||||||||||||||||||||||
Fair value adjustments upon reclassification of options to liabilities |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | ||||||||||||||||||||||||||
Stock -based compensation |
— |
— |
— |
— |
— |
— |
|
|
||||||||||||||||||||||||||||
Issuance of common shares and pre-funded warrants in connection with public offering, net of offering costs (notes 11a and 11d) |
— |
— |
|
|
— |
— |
|
|
||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
( |
) |
— |
— |
( |
) | ||||||||||||||||||||||||||
Balance at December 31, 2019 |
— |
$ |
— |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
$ |
|
||||||||||||||||||||
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | |||
Items not involving cash: |
||||||||||||
Depreciation of property and equipment |
|
|
|
|||||||||
Amortization of intangible assets |
|
|
|
|||||||||
Impairment on acquired IPR&D |
|
— |
|
|||||||||
Stock-based compensation (note 11 e ) |
|
|
|
|||||||||
Amortization of operating lease right-of-use assets |
|
— |
— |
|||||||||
Deferred income tax (recovery) expense |
( |
) |
( |
) |
|
|||||||
Change in fair value of contingent consideration (note 18 ) |
|
|
|
|||||||||
Change in fair value of warrant liabilities (note 10) |
— |
|
( |
) | ||||||||
Accretion on long-term debt |
— |
— |
|
|||||||||
Loss on debt extinguishment |
— |
— |
|
|||||||||
Unrealized foreign exchange loss/(gain) |
|
( |
) |
( |
) | |||||||
Changes in non-cash operating working capital: |
||||||||||||
Accounts receivable |
( |
) |
( |
) |
|
|||||||
Prepaid expenses and other current assets |
( |
) |
( |
) |
( |
) | ||||||
Accounts payable and accrued liabilities |
|
|
( |
) | ||||||||
Operating lease liabilities |
( |
) |
— |
— |
||||||||
Deferred revenue |
( |
) |
|
— |
||||||||
Income taxes payable |
( |
) |
|
( |
) | |||||||
Net cash (used in) provided by operating activities |
$ |
( |
) |
$ |
|
$ |
|
|||||
Cash flows from financing activities: |
||||||||||||
Proceeds from initial public offering, net of issuance costs (note 11a) |
— |
— |
|
|||||||||
Proceeds from subsequent public offerings, net of issuance costs (note 11a ) |
|
|
— |
|||||||||
Issuance of common shares on exercise of options (note 1 1 ) e |
|
|
|
|||||||||
Issuance of common shares on exercise of warrants (note 10 ) |
— |
— |
|
|||||||||
Issuance of common shares through employee stock purchase plan (note 11 ) f |
|
|
— |
|||||||||
Repayment of debt (note 10 ) |
— |
— |
( |
) | ||||||||
Deferred financing fees |
( |
) |
( |
) |
— |
|||||||
Finance lease payments |
( |
) |
( |
) |
( |
) | ||||||
Net cash provided by financing activities |
$ |
|
$ |
|
$ |
|
||||||
Cash flows from investing activities: |
||||||||||||
Purchase of s hort-term investments |
( |
) |
( |
) |
( |
) | ||||||
Acquisition of property and equipment |
( |
) |
( |
) |
( |
) | ||||||
Acquisition of intangible assets |
( |
) |
( |
) |
( |
) | ||||||
Net cash used in investing activities |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | |||
Effect of exchange rate changes on cash and cash equivalents |
|
( |
) |
|
||||||||
Net change in cash and cash equivalents |
|
|
|
|||||||||
Cash and cash equivalents, beginning of year |
|
|
|
|||||||||
Cash and cash equivalents, end of year |
$ |
|
$ |
|
$ |
|
||||||
Supplemental disclosure of non-cash investing and finance items: |
||||||||||||
Leased assets obtained in exchange for operating lease liabilities |
$ |
|
$ |
— |
$ |
— |
||||||
Acquisition of property and equipment in accounts payable and accrued liabilities |
|
|
|
|||||||||
Cashless exercise of warrants (note 10 ) |
— |
|
— |
• |
non-refundable, upfront license and platform technology access fees; |
• |
research, development and regulatory milestone payments; |
• |
research support payments; and |
• |
royalties and commercial milestone payments. |
• |
completion of preclinical research and development work leading to selection of product candidates; |
• |
initiation of Phase 1, Phase 2 and Phase 3 clinical trials; and |
• |
achievement of certain other technical, scientific or development criteria. |
• |
filing of regulatory applications for marketing approval in the United States, Europe or Japan, including Investigational New Drug (“IND”) applications and Biologics License Application (“BLA”); and |
• |
marketing approval in major markets, such as the United States, Europe or Japan. |
Asset Class |
Rate | |
Computer hardware |
| |
Office equipment |
| |
Furniture and fixtures |
| |
Laboratory equipment |
| |
Leasehold improvements |
|
• |
Upon the change of the compensation currency for certain executives from Canadian dollars to U.S. dollars effective January 1, 2017 ,held by such executives which were previously classified as equity awards per ASC 718 with a total fair value of $on January 1, 2017 have been reclassified as liability awards of which $ ASC 718 , upon the change in classification, the change in fair value of the options while they were classified as equity is recorded as an adjustment to the statement of loss . |
• |
Upon the change of the compensation currency for a certain executive from Canadian dollars to U.S. dollars effective January 1, paid-in capital and the remaining $ |
December 31, 2018 |
Adjustments Due to the Adoption of Topic 842 |
January 1, 2019 |
||||||||||
Operating lease right-of-use assets(1) |
$ |
— |
$ |
|
$ |
|
||||||
Total lease inducements (2) |
|
( |
) |
— |
||||||||
Total operating lease liabilities (3) |
— |
|
|
(1) |
Right-of-use assets include operating leases. Right-of-use assets for finance leases are included in property and equipment |
(2) |
Included in current and long-term other liabilities (note 9) |
(3) |
Includes current and non-current operating lease liabilities |
As reported |
Effect of Adoption of Topic 842 Higher / (Lower) |
Balances Without the Adoption of Topic 842 |
||||||||||
Operating expenses for the year ended December 31, 2019 |
$ |
|
$ |
|
$ |
|
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Numerator |
||||||||||||
Net loss attributable to common shareholders: |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Deemed dividend due to beneficial conversion feature |
— |
— |
( |
) | ||||||||
Basic |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Adjustment for change in fair value of ASC 815 liability classified stock options and warrant |
— |
— |
( |
) | ||||||||
Diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Denominator: |
||||||||||||
Weighted-average common shares outstanding: |
||||||||||||
Basic (*) |
|
|
|
|||||||||
Adjustment for dilutive effect of liability classified stock options and warrants |
— |
— |
|
|||||||||
Diluted |
|
|
|
|||||||||
Net loss per common share – basic |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Net loss per common share – diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) |
Acquired IPR&D |
Accumulated Impairment |
Net |
||||||||||
Balance at December 31, 2016 |
$ |
|
$ |
( |
) |
$ |
|
|||||
Change during the period |
— |
( |
) |
( |
) | |||||||
Balance at December 31, 2017 |
$ |
|
$ |
( |
) |
$ |
|
|||||
Change during the period |
|
|
— |
|||||||||
Balance at December 31, 2018 |
$ |
|
$ |
( |
) |
$ |
|
|||||
Change during the period |
— |
( |
) |
( |
) | |||||||
Balance at December 31, 2019 |
$ |
|
$ |
( |
) |
$ |
|
|||||
December 31, |
||||||||
2019 |
2018 |
|||||||
Computer hardware |
$ | |
$ | |
||||
Furniture and fixtures |
|
|
||||||
Office equipment |
|
|
||||||
Laboratory equipment |
|
|
||||||
Leasehold improvements |
|
|
||||||
Construction in progress |
|
|
||||||
Property and equipment |
$ |
|
$ |
|
||||
Less accumulated depreciation |
( |
) | ( |
) | ||||
Property and equipment, net |
$ | |
$ | |
||||
December 31, |
||||||||
2019 |
2018 |
|||||||
Computer software and research license |
$ | |
$ | |
||||
Less accumulated amortization |
( |
) | ( |
) | ||||
Intangible assets, net |
$ | |
$ | |
||||
December 31, |
||||||||
2019 |
2018 |
|||||||
Trade payables |
$ | |
$ | |
||||
Accrued research expenses |
|
|
||||||
Employee compensation and vacation accruals |
|
|
||||||
Accrued legal and professional fees |
|
|
||||||
Other |
|
|
||||||
Total |
$ | |
$ | |
||||
December 31, |
||||||||
2019 |
2018 |
|||||||
Liability for contingent consideration (note 18 ) |
$ | |
$ | |
||||
Lease inducements |
|
|
||||||
Finance lease liability (note 1 6 ) |
|
|
||||||
Total |
$ | |
$ | |
||||
Year ended December 31, 2017 |
||||
Long term debt at January 1, 2017 |
$ | |
||
Less: unamortized debt issue costs at January 1, 2017 |
( |
) | ||
Long term debt at January 1, 2017, net of deferred charges |
$ | |
||
Accretion during the period up to the Repayment Date |
|
|||
Amortization of debt issue costs during the period up to the Repayment Date |
|
|||
Carrying value of long term debt on the Repayment Date, net of deferred charges |
$ | |
||
Repayment, including repayment premium and expenses |
( |
) | ||
Loss on debt extinguishment |
$ | ( |
) | |
a. |
Equity Offerings |
b. |
Authorized |
c . |
Preferred Shares and Redeemeable Convertible Class A Preferred Shares |
d . |
Pre-Funded Warrants |
e |
Stock-Based Compensation |
Number of Options |
Weighted- Average Exercise Price (C$) |
Weighted- Average Exercise Price ($) |
Weighted- Average Contractual Term (years) |
Aggregate intrinsic value (C$) |
Aggregate intrinsic value ($) |
|||||||||||||||||||
Outstanding, December 31, 2017 |
|
|
|
|
|
|
||||||||||||||||||
Granted |
|
|
|
|||||||||||||||||||||
Expired |
( |
) | |
|
||||||||||||||||||||
Exercised |
( |
) | |
|
||||||||||||||||||||
Forfeited |
( |
) | |
|
||||||||||||||||||||
Outstanding, December 31, 2018 |
|
|
|
|
|
|
||||||||||||||||||
Granted |
|
|
|
|||||||||||||||||||||
Expired |
( |
) | |
|
||||||||||||||||||||
Exercised |
( |
) | |
|
||||||||||||||||||||
Forfeited |
( |
) | |
|
||||||||||||||||||||
Outstanding, December 31, 2019 |
|
|
|
|
|
|
||||||||||||||||||
December 31, 2019 |
||||||||||||||||||||||||
Exercisable |
|
|
|
|
|
|
||||||||||||||||||
Vested and expected to vest |
|
|
|
|
|
|
Number of Options |
Weighted- Average Exercise Price ($) |
Weighted- Average Contractual Term (years) |
Aggregate intrinsic value ($) |
|||||||||||||
Outstanding, December 31, 2017 |
|
|
|
|
||||||||||||
Granted |
|
|
||||||||||||||
Expired |
— |
— |
||||||||||||||
Exercised |
|
|
||||||||||||||
Forfeited |
( |
) | |
|||||||||||||
Outstanding, December 31, 2018 |
|
|
|
|
||||||||||||
Granted |
|
|
||||||||||||||
Expired |
|
|
||||||||||||||
Exercised |
( |
) | |
|||||||||||||
Forfeited |
( |
) | |
|||||||||||||
Outstanding, December 31, 2019 |
|
|
|
|
||||||||||||
December 31, 2019 |
||||||||||||||||
Exercisable |
|
|
|
|
||||||||||||
Vested and expected to vest |
|
|
|
|
|
Number of options |
Weighted-average date (C$) |
Weighted- average date (US$) |
||||||||||
Non-vested, December 31, 2018 |
|
|
|
|||||||||
Options granted |
|
|
|
|||||||||
Options vested |
( |
) | |
|
||||||||
Options forfeited and cancelled |
( |
) | |
|
||||||||
Non-vested, December 31, 2019 |
|
|
|
|||||||||
Number of options |
Weighted- average grant date fair value (US$) |
|||||||
Non-vested, December 31, 2018 |
|
|
||||||
Options granted |
|
|
||||||
Options vested |
( |
) |
|
|||||
Options forfeited and cancelled |
( |
) |
|
|||||
Non-vested, December 31, 2019 |
|
|
||||||
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Research and development expenses: |
||||||||||||
Stock-based compensation for equity classified instruments |
$ | |
$ |
|
$ | |
||||||
Change in fair value of liability classified equity instruments |
|
|
|
|||||||||
$ |
|
$ | |
$ |
|
|||||||
General and administrative expenses: |
||||||||||||
Stock-based compensation for equity classified instruments |
$ | |
$ | |
$ | |
||||||
Change in fair value of liability classified equity instruments |
|
|
|
|||||||||
$ | |
$ | |
$ | |
|||||||
Finance expense (income): |
||||||||||||
Stock-based compensation for equity classified instruments |
$ | |
$ | |
$ | — |
||||||
Change in fair value of liability classified equity instruments |
|
|
( |
) | ||||||||
$ | |
$ | |
$ | ( |
) |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Dividend yield |
|
% | |
% | |
% | ||||||
Expected volatility |
|
% | |
% | |
% | ||||||
Risk-free interest rate |
|
% | |
% | |
% | ||||||
Forfeiture rate |
|
|
|
% |
|
|
|
% |
|
|
|
% |
Expected average life of options |
|
|
|
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Dividend yield |
|
% | |
% | |
% | ||||||
Expected volatility |
|
% | |
% | |
% | ||||||
Risk-free interest rate |
|
% | |
% | |
% | ||||||
Forfeiture rate |
|
|
|
% |
|
|
% |
|
|
% | ||
Expected average life of options |
|
|
|
December 31, 2019 |
December 31, 2018 |
||||||||
Dividend yield |
|
% | |
% |
|||||
Expected volatility |
|
% | |
% |
|||||
Risk-free interest rate |
|
% | |
% |
|||||
Forfeiture rate |
|
|
|
% |
|
|
|
% |
|
Expected average option term |
|
|
|||||||
Number of liability classified share options outstanding |
|
|
f |
Employee Stock Purchase Plan: |
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
SR&ED credits (expense), net |
$ | |
$ | ( |
) | $ | |
|||||
IRAP credits |
— |
— |
|
|||||||||
Total |
$ | |
$ | ( |
) | $ | |
|||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Janssen: |
||||||||||||
Recognition of upfront fee |
$ |
— |
$ |
— |
$ |
|
||||||
Merck: |
||||||||||||
Milestone revenue |
|
— |
— |
|||||||||
Lilly: |
||||||||||||
Milestone revenue |
|
|
— |
|||||||||
BMS: |
||||||||||||
Option exercise fee |
|
|
— |
|||||||||
Daiichi Sankyo: |
||||||||||||
Technology access fee |
— |
|
— |
|||||||||
Milestone revenue |
— |
— |
|
|||||||||
Commercial license option fee |
|
|||||||||||
LEO: |
||||||||||||
Recognition of upfront fee |
— |
|
$ |
— |
||||||||
BeiGene: |
||||||||||||
Recognition of upfront fee |
|
|
$ |
— |
||||||||
Iconic: |
||||||||||||
Milestone revenue |
|
— |
$ |
— |
||||||||
Research support payments and other payments |
|
|
|
|||||||||
$ |
|
$ |
|
$ |
|
|||||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Foreign exchange (loss) gain |
$ |
( |
) |
$ |
|
$ |
|
|||||
Change in fair value of warrant liabilities (note 10) |
— |
( |
) |
|
||||||||
Loss on debt extinguishment (note 10) |
— |
— |
( |
) | ||||||||
Accretion expense |
— |
— |
( |
) | ||||||||
Other |
( |
) |
( |
) |
( |
) | ||||||
$( |
$( |
$( |
||||||||||
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Current income tax expense |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Deferred income tax recovery (expense) |
|
|
( |
) | ||||||||
Income tax recovery (expense) |
$ |
|
$ |
( |
) |
$ |
( |
) | ||||
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Computed taxes at Canadian tax rate |
$ | |
$ | |
$ | |
||||||
Non-deductible expenses |
( |
) | ( |
) | ( |
) | ||||||
Difference between domestic and foreign tax rate |
|
|
|
|||||||||
Effect of change in tax rates |
( |
) | ( |
) | |
|||||||
Adjustments to prior year |
( |
) | ( |
) | |
|||||||
Change in valuation allowance |
( |
) | ( |
) | ( |
) | ||||||
Share issuance costs in equity |
|
|
|
|||||||||
Change in recognition and measurement of tax positions |
( |
) | ( |
) | — |
|||||||
Changes due to SR&ED |
|
|
|
|||||||||
Other |
( |
) | ( |
) | |
|||||||
Income tax recovery (expen se) |
$ | |
$ |
( |
) | $ | ( |
) | ||||
December 31, 2019 |
December 31, 2018 |
|||||||
Deferred tax assets: |
||||||||
Non-capital losses carried forward |
$ | |
$ | |
||||
Deferred revenue |
|
|
||||||
Share issue costs |
|
|
||||||
Property and equipment |
|
|
||||||
Research and development deductions and credits |
|
|
||||||
Contingent consideration |
|
|
||||||
Stock options |
|
|
||||||
Operating lease liability |
|
|
|
|
|
|
— |
|
Other |
|
|
||||||
$ | |
$ | |
|||||
Deferred tax liabilities: |
||||||||
Property and equipment |
( |
) | ( |
) | ||||
IPR&D |
|
|
( |
) |
|
|
( |
) |
Operating lease right-of-use assets |
( |
) | — |
|||||
Other |
( |
) | ( |
) | ||||
$ | ( |
) | $ | ( |
) | |||
|
|
|||||||
Less: valuation allowance |
( |
) | ( |
) | ||||
Net deferred tax assets (liabilities) |
$ | |
$ | |
||||
Deferred tax asset |
|
$ |
|
|
|
$ |
|
|
Deferred tax liability |
|
|
( |
) |
|
|
( |
) |
Net deferred tax assets (liability) |
|
$ |
|
|
|
$ |
|
|
Expiry date |
Investment tax credits |
Non-capital losses |
||||||
|
|
— |
||||||
|
— |
— |
||||||
|
— |
— |
||||||
|
— |
— |
||||||
|
— |
— |
||||||
|
|
— |
||||||
|
|
|
||||||
|
|
|
||||||
|
|
|
Expiry date |
Investment tax credits |
Non-capital losses |
||||||
|
|
— |
||||||
|
|
|
||||||
$ |
|
$ |
|
|||||
Year Ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Balance, beginning of year |
$ | |
$ | |
$ | |
||||||
Increases related to prior year tax positions |
|
|
|
|||||||||
Increases related to current year tax positions |
|
|
|
|||||||||
Balance, end of year |
$ | |
$ | |
$ | |
||||||
December 31, 2019 |
December 31, 2018 |
|||||||
Operating lease liabilities: |
||||||||
Current portion |
$ | |
$ | — |
||||
Long-term portion |
|
— |
||||||
Total operating lease liabilities |
|
$ | — |
|||||
Finance lease liabilities: |
||||||||
Current portion included in other current liabilities |
|
|
||||||
Long-term portion included in other long-term liabilities |
|
|
||||||
Total finance lease liabilities |
|
|
||||||
Total lease liabilities |
$ | |
$ | |
||||
Operating leases |
||||
Within 1 year |
$ | |
||
1 to 2 years |
|
|||
2 to 3 years |
|
|||
3 to 4 years |
|
|||
4 to 5 years |
|
|||
Thereafter |
|
|||
Total operating lease payments |
|
|||
Less: |
||||
Imputed interest |
( |
) | ||
Operating lease liabilities |
$ | |
||
Finance leases |
||||
Within 1 year |
$ | |
||
1 to 2 years |
|
|||
2 to 3 years |
|
|||
3 to 4 years |
|
|||
4 to 5 years |
|
|||
Thereafter |
|
|||
Total finance lease payments |
|
|||
Less: |
||||
Imputed interest |
( |
) | ||
Finance lease liabilities |
$ | |
||
• |
Level 1 inputs are unadjusted quoted market prices for identical instruments available in active markets. |
• |
Level 2 inputs are inputs other than Level 1 prices, such as prices for similar asset or liability that are observable either directly or indirectly. If the asset or liability has a contractual term, the input must be observable for substantially the full term. An example includes quoted market prices for similar assets or liabilities in active markets. |
• |
Level 3 inputs are unobservable inputs for the asset or liability and will reflect management’s assessment about market assumptions that would be used to price the asset or liability. |
December 31, 2019 |
Level 1 |
Level 2 |
Level 3 |
|||||||||||||
Liabilities |
||||||||||||||||
Liability classified stock options |
$ |
|
$ |
— |
$ |
— |
$ |
|
||||||||
Liability for contingent consideration |
|
— |
— |
|
||||||||||||
Total |
$ |
|
$ |
— |
$ |
— |
$ |
|
||||||||
December 31, 2018 |
Level 1 |
Level 2 |
Level 3 |
|||||||||||||
Liabilities |
||||||||||||||||
Liability classified stock options |
$ |
|
$ |
— |
$ |
— |
$ |
|
||||||||
Liability for contingent consideration |
|
— |
— |
|
||||||||||||
Total |
$ |
|
$ |
— |
$ |
— |
$ |
|
||||||||
Liability at the beginning of the period |
Increase (decrease) in fair value of liability for contingent consideration |
Liability at end of the period |
||||||||||
Year ended December 31, 2019 |
$ |
|
$ |
|
$ |
|
||||||
Year ended December 31, 2018 |
$ |
|
$ |
|
$ |
|
Liability at the beginning of the period |
Reclassification to liability from equity |
Increase (decrease) in fair value of warrant liabilities |
Exercise of warrants |
Liability at end of the period |
||||||||||||||||
Year ended December 31, 2019 |
$ |
— |
$ |
|
$ |
— |
$ |
— |
$ |
|
||||||||||
Year ended December 31, 2018 |
$ |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
Liability at beginning of the period |
Reclassification to liabilities from equity |
Increase (decrease) in fair value of liability classified stock options |
Exercise of options |
Unrealized foreign currency loss (gain) |
Liability at end of the period |
|||||||||||||||||||
Year ended December 31, 2019 |
$ |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
$ |
|
|||||||||||
Year ended December 31, 2018 |
$ |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure |
Item 9A. |
Controls and Procedures |
Item 9B. |
Other Information |
Item 10. |
Directors, Executive Officers and Corporate Governance |
Item 11. |
Executive Compensation |
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters |
Item 13. |
Certain Relationships and Related Transactions and Director Independence |
Item 14. |
Principal Accounting Fees and Services |
Item 15. |
Exhibits, Financial Statement Schedules |
Exhibit No. |
Description | |||
3.1 |
||||
3.2 |
||||
4.1 |
||||
4.2 |
||||
4.3 |
||||
10.1# |
||||
10.2# |
||||
10.3# |
||||
10.4# |
Exhibit No. |
Description | |||
10.5# |
||||
10.6# |
||||
10.7# |
||||
10.8# |
||||
10.9# |
||||
10.10† |
||||
10.11† |
||||
10.12† |
||||
10.13† |
||||
10.14† |
||||
10.15† |
||||
10.16† |
Exhibit No. |
Description | |||
10.17† |
||||
10.18† |
||||
10.19† |
||||
10.20 |
||||
10.21# |
||||
10.22† |
||||
10.23† |
||||
10.24† |
||||
10.25† |
||||
10.26† |
||||
10.27† |
||||
10.28† |
||||
10.29 |
Exhibit No. |
Description | |||
10.30# |
||||
10.31* |
||||
10.32* |
||||
10.33# |
||||
10.34 |
||||
21.1 |
||||
23.1 |
||||
31.1 |
||||
31.2 |
||||
32.1 |
||||
32.2 |
||||
99.1† |
||||
99.2† |
||||
99.3† |
||||
99.4* |
||||
99.5* |
Exhibit No. |
Description | |||
99.6* |
||||
99.7* |
||||
101 |
The following materials from the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2019, formatted in Inline XBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as at December 31, 2019 and 2018, (ii) Consolidated Statements of Loss and Comprehensive Loss for the years ended December 31, 2019, 2018 and 2017, (iii) Consolidated Statements of Changes in Redeemable Convertible Preferred Shares and Shareholders’ Equity for the years ended December 31, 2019, 2018 and 2017, (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2019, 2018 and 2017 and (vi) Notes to Consolidated Financial Statements. | |||
104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
† | Registrant has omitted portions of the referenced exhibit pursuant to a request for confidential treatment under Rule 246-2 promulgated under the Securities Exchange Act. |
* | Certain portions of this exhibit (indicated by “[…***…]”) have been omitted as Zymeworks has determined (i) the omitted information is not material and (ii) the omitted information would likely cause harm to Zymeworks if publicly disclosed. |
# | Indicates management contract or compensatory plan. |
Item 16. |
Form 10-K Summary |
ZYMEWORKS INC. | ||||
By: |
/s/ Ali Tehrani | |||
Name: |
Ali Tehrani | |||
Title: |
President and Chief Executive Officer and Director (Principal Executive Officer) |
Signature |
Title |
Date | ||
/s/ Ali Tehrani Ali Tehrani |
President and Chief Executive Officer and Director (Principal Executive Officer) |
March 2, 2020 | ||
/s/ Neil Klompas Neil Klompas |
Executive Vice President, Business Operations and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
March 2, 2020 | ||
/s/ Troy M. Cox Troy M. Cox |
Director |
March 2, 2020 | ||
/s/ Kenneth Hillan Kenneth Hillan |
Director |
March 2, 2020 | ||
/s/ Susan Mahony Susan Mahony |
Director |
March 2, 2020 | ||
/s/ Hollings C. Renton Hollings C. Renton |
Director |
March 2, 2020 | ||
/s/ Natalie Sacks Natalie Sacks |
Director |
March 2, 2020 | ||
/s/ Lota Zoth Lota Zoth |
Director |
March 2, 2020 |