ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
Address Not Applicable1
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Zip Code Not Applicable1
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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(The Nasdaq Global Select Market)
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Large accelerated filer
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☐
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Accelerated filer
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☐
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☒
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Smaller reporting company
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Emerging growth company
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Page
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PART I
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Item 1.
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3
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Item 1A.
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19
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Item 1B.
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78
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Item 1C.
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78
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Item 2.
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79
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Item 3.
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79
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Item 4.
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79
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PART II
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Item 5.
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80
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Item 6.
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[Reserved]
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80
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Item 7.
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81
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Item 7A.
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92
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Item 8.
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93
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Item 9.
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117
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Item 9A.
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117
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Item 9B.
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117
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Item 9C.
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Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 117 |
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PART III
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Item 10.
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118
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Item 11.
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123
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Item 12.
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132
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Item 13.
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135
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Item 14.
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137
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PART IV
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Item 15.
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138
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Item 16
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138
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141
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our expectations related to the Agreement and Plan of Merger, dated as of February 16, 2024 (the Merger Agreement), among us, XOMA Corporation, a Delaware corporation (XOMA), and XRA 1 Corp., a Delaware
corporation and a wholly-owned subsidiary of XOMA (Merger Sub), including regarding the ability of the parties to complete the transactions contemplated by the Merger Agreement, the ability of the parties to satisfy the conditions to the
consummation of the tender offer contemplated by the Merger Agreement (the Offer) and the other conditions set forth in the Merger Agreement, the possibility of any termination of the Merger Agreement, our ability to retain key personnel,
the expected timetable for completing the transactions contemplated by the Merger Agreement, our and XOMA’s beliefs and expectations and statements about the benefits sought to be achieved by XOMA’s proposed acquisition of us, the
potential effects of the acquisition on both us and XOMA and whether or not the conditions for payment in respect of contingent value rights (CVRs) pursuant to the Contingent Value Rights Agreement that we expect to enter into with a
rights agent and a representative, agent and attorney-in-fact of the holders of the CVRs at or prior to the completion of the Offer will be met;
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the timing of and steps to implement our Strategic Plans (as defined below);
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the ability of any future preclinical studies and clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
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the timing, progress and results of any future preclinical studies and clinical trials for our product candidates, including statements regarding the timing of initiation and completion of preclinical
studies or clinical trials and related preparatory work, the period during which the results of the preclinical studies or clinical trials will become available;
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the timing, scope and likelihood of regulatory filings and approvals, including timing of investigational new drug applications (INDs) and final approval by the U.S. Food and Drug Administration (FDA) of
our current product candidates and any other future product candidates;
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the timing, scope or likelihood of foreign regulatory filings and approvals;
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our ability to develop and advance any future product candidates and programs into, and successfully complete, clinical trials;
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our manufacturing, commercialization, and marketing capabilities and strategy;
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the need to hire additional personnel and our ability to attract and retain such personnel;
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our competitive position and the success of competing therapies that are or may become available;
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our plans relating to the further development of our product candidates;
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existing regulations, regulatory developments and the outcome of related litigation in the United States, Europe and other jurisdictions;
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our expectations regarding the impact of public health concerns, supply chain disruptions, inflation and other drivers of macroeconomic volatility on our business;
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our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates and other future 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;
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our continued reliance on third parties to conduct any future preclinical studies and clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and
clinical trials;
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our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product
candidates;
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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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our financial performance;
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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;
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the impact of laws and regulations;
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our expectations regarding the period during which we will remain an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act); and
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our anticipated use of our existing resources.
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Item 1. |
Business
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Pursue another strategic transaction. We may resume the process of evaluating a potential strategic transaction in order to attempt another strategic transaction like
that contemplated by the Merger Agreement.
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Operate our business. Our board of directors may elect to seek new product candidates for development.
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Dissolve and liquidate our assets. If, for any reason, the transactions contemplated by the Merger Agreement do not close, our board of directors may conclude that it is
in the best interest of stockholders to dissolve the company and liquidate our assets. In that event, we would be required to pay all of our debts and contractual obligations, and to set aside certain reserves for potential future claims.
There would be no assurances as to the amount or timing of available cash remaining to distribute to stockholders after paying our obligations and setting aside funds for reserves.
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completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice (GLP);
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submission to the FDA of an IND, which must become effective before human clinical trials may begin;
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approval by an independent institutional review board (IRB), or ethics committee at each clinical trial site before each clinical trial may be initiated;
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performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice (GCP) requirements and other clinical trial-related regulations to establish substantial evidence
of the safety and efficacy of the investigational product for each proposed indication;
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submission to the FDA of an NDA after completion of all pivotal clinical trials;
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determination by the FDA within 60 days of its receipt of an NDA to accept the filing for substantive review;
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satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements assuring that the facilities, methods and controls are
adequate to preserve the drug’s identity, strength, quality and purity;
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potential FDA audit of the preclinical study and/or clinical trial sites that generated the data in support of the NDA filing;
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FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the United States; and
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compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (REMS), and the potential requirement to conduct post-approval studies.
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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 metabolism, pharmacologic action, tolerability and safety of the drug.
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Phase 2 clinical trials involve studies in disease-affected patients to determine the dose and dosing schedule required to produce the desired benefits. 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.
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Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use and its safety in use, and to
establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. These clinical trials may include comparisons with placebo and/or other comparator treatments. The duration of treatment is
often extended to mimic the actual use of a product during marketing.
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market, or product recalls;
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fines, warning letters, or holds on post-approval clinical studies;
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refusal of the FDA to approve pending applications or supplements to approved applications;
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suspension or revocation of product approvals;
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product seizure or detention;
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refusal to permit the import or export of products; and
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injunctions or the imposition of civil or criminal penalties.
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The federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is
intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Moreover, the ACA
provides that 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 civil False Claims Act.
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The federal false claims, including the civil False Claims Act that can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties prohibit individuals or entities from, among other
things, knowingly presenting, or causing to be presented, to the federal government, 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, and/or impose exclusions from federal health care programs and/or penalties for parties who engage in such prohibited conduct.
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The Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating
to healthcare matters.
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations also impose obligations on covered entities such as health insurance plans, healthcare clearinghouses, and
certain health care providers and their respective business associates, including mandatory contractual terms as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually
identifiable health information.
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The federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program,
with specific exceptions, to annually report to Centers for Medicare & Medicaid Services (CMS), an agency within the U.S. Department of Health and Human Services (HHS), information regarding certain payments and other transfers of
value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others), and teaching
hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members;
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Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental
third-party payors, including private insurers, state laws that require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal
government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and require the registration of
their sales representatives, state laws that require biotechnology companies to report information on the pricing of certain drug products, and state and foreign laws that govern the privacy and security of health information in some
circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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The Community MA is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP), of the EMA, and is valid throughout the entire territory of the
EEA. The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered
medicines and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions and viral diseases. The Centralized
Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public
health in the EU.
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National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure.
Where a product has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member States through the Mutual Recognition Procedure. If the product has not received a National MA in
any Member State at the time of application, it can be approved simultaneously in various Member States through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities
of each of the Member States in which the MA is sought, one of which is selected by the applicant as the Reference Member State (RMS). The competent authority of the RMS prepares a draft assessment report, a draft summary of the product
characteristics (SmPC), and a draft of the labeling and package leaflet, which are sent to the other Member States (referred to as the Member States Concerned) for their approval. If the Member States Concerned raise no objections, based
on a potential serious risk to public health, to the assessment, SmPC, labeling or packaging proposed by the RMS, the product is subsequently granted a national MA in all the Member States (i.e., in the RMS and the Member States
Concerned).
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Item 1A. |
Risk Factors
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The Offer and the Merger are subject to a number of conditions beyond our control. Failure to complete the Offer and the Merger within the expected time frame, or at all, could have a material adverse effect on our business, operating
results, financial condition and our share price.
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The consideration payable to holders of our Common Stock pursuant to the Merger Agreement will be adjusted if our net cash amount exceeds a certain threshold but will not otherwise be adjusted for changes in our business, assets,
liabilities, prospects, outlook, financial condition or results of operations, or in the event of any change in our share price.
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Our stockholders may not receive any payment on the CVR and the CVR may expire valueless.
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The Merger Agreement contains provisions that could discourage a potential competing acquirer.
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Stockholder litigation could prevent or delay the consummation of the Offer and the Merger or otherwise negatively impact our business, operating results and financial condition.
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We may become involved in securities class action litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.
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Our executive officers and directors may have interests in the Offer and the Merger that are different from, or in addition to, those of our stockholders generally.
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While the Offer and the Merger are pending, we are subject to business uncertainties and contractual restrictions that could disrupt our business, and the Offer and the Merger may impair our ability to attract and retain qualified
employees or retain and maintain relationships with our suppliers and other business partners.
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We have incurred, and will continue to incur, direct and indirect costs as a result of the Offer and the Merger.
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If we are not able to complete the Offer and the Merger, we will likely pursue other strategic alternatives. We may not be successful in identifying and implementing any strategic business combination or other transaction and any
strategic transaction that we may consummate in the future could have negative consequences. There can be no assurance that the terms of any such other transaction will be favorable.
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We may not realize any additional value in a strategic transaction.
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If a strategic transaction is not consummated, our board of directors may decide to pursue a dissolution and liquidation. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the
timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.
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Our ability to consummate the Offer and the Merger or complete another strategic transaction or a dissolution and liquidation of the Company depends on our ability to retain our employees and engage other advisors and consultants
required to consummate such transactions.
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Our principal stockholders and management, if they choose to act together, will have the ability to significantly influence all matters submitted to stockholders for approval.
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We are early in our development efforts and have a limited operating history and no products approved for commercial sale.
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We have incurred significant net losses and expect to continue to incur significant net losses for the foreseeable future.
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If the Merger is not completed, we will reconsider our strategic alternatives, including dissolving and liquidating our assets, pursuing another strategic transaction, or operating our business. Our future capital requirements depend
on many factors, and adequate additional financing may not be available to us on acceptable terms, or at all.
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We will require substantial additional capital to finance our operations.
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Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates.
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The outcome of testing and early clinical trials may not be predictive of the success of later clinical trials.
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The regulatory approval processes of regulatory authorities are lengthy, time consuming and unpredictable.
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We have no experience as a company in conducting clinical trials to completion.
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Our product candidates may cause significant adverse events, toxicities or other undesirable side effects.
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Data from our preclinical studies and clinical trials may change as more data become available and are subject to verification.
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We could experience delays or difficulties in the enrollment or maintenance of patients in clinical trials.
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We face substantial competition which may result in others discovering, developing or commercializing products before us.
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Our product candidates may not achieve adequate market acceptance among the medical community.
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The market opportunities for our product candidates may be limited to certain smaller patient subsets.
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We may be unable to obtain regulatory approval and be unable to commercialize our product candidates.
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Regulatory authorities may not accept data from clinical trials conducted in locations outside of their jurisdiction.
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Obtaining regulatory approval in one jurisdiction does not mean we will be successful in other jurisdictions.
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Any product candidates that receive regulatory approval will be subject to post-marketing regulations.
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Where appropriate, we plan to secure approval from regulatory authorities through accelerated registration pathways. If we are unsuccessful, we may be required to conduct additional preclinical studies or clinical trials.
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We may seek, but not obtain, additional Fast Track designations from the FDA for our product candidates.
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A Breakthrough Therapy designation by the FDA may not lead to a faster review or approval process.
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We may not be able to obtain orphan drug designation or maintain orphan drug exclusivity for one or more of our product candidates.
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In September 2023, we began implementing the Strategic Plans. If the Strategic Plans are unsuccessful, our business may be harmed.
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Our success is highly dependent on our ability to attract, hire and retain highly skilled executive officers and employees.
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Our operations are vulnerable to interruption by natural disasters, war, terrorist activity, pandemics and other events.
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Our success depends on our ability to protect our intellectual property and our proprietary technologies.
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The scope of our patent protection may not be sufficiently broad, or we could lose patent protection.
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We may not be successful in obtaining or maintaining rights to our future product candidates.
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We may be involved in lawsuits to protect or enforce our patents or our future licensors’ patents.
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The outcome of derivation proceedings may require us to cease using or attempt to license the related technology.
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We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
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Patent terms may be inadequate to protect our competitive position on our product candidates.
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If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
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We may not be able to protect our intellectual property rights throughout the world.
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We rely on third parties to conduct our preclinical studies and clinical trials, and they may not perform satisfactorily.
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We contract with third parties for the manufacture of our product candidates for preclinical studies and clinical trials and expect to continue to do so for additional preclinical studies, clinical trials and ultimately for
commercialization.
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The market price of our common stock is volatile, which could result in substantial losses for investors.
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If securities analysts do not publish research or reports about our business, or if they publish adverse reports regarding us, our stock price and trading volume could decline.
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successful and timely completion of clinical development of product candidates and preclinical and clinical development of product candidates from our research programs;
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establishing and maintaining relationships with contract research organizations (CROs) and clinical sites for the clinical development of product candidates;
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timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;
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developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale;
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establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical
development and meet the market demand for our product candidates, if approved;
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successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators;
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a continued acceptable safety profile following any marketing approval of our product candidates;
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commercial acceptance of our product candidates by patients, the medical community and third-party payors;
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satisfying any required post-marketing approval commitments to applicable regulatory authorities;
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identifying, assessing and developing new product candidates;
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obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;
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defending against third-party interference or infringement claims, if any;
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entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
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obtaining coverage and adequate reimbursement by third-party payors for our product candidates;
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addressing any competing therapies and technological and market developments; and
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attracting, hiring and retaining qualified personnel.
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approval of INDs for our planned clinical trials and future clinical trials;
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addressing any potential delays resulting from factors related to public health concerns, such as COVID-19;
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successful initiation and completion of clinical trials;
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successful and timely patient selection and enrollment in and completion of clinical trials;
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maintaining and establishing relationships with CROs and clinical sites for the clinical development of our product candidates both in the United States and internationally;
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the frequency and severity of adverse events in clinical trials;
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demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any other comparable foreign regulatory authority for marketing approval;
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the timely receipt of marketing approvals from applicable regulatory authorities;
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the timely identification, development and approval of companion diagnostic tests, if required;
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the extent of any required post-marketing approval commitments to applicable regulatory authorities;
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the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of our
product candidates;
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obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;
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the protection of our rights in our intellectual property portfolio;
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the successful launch of commercial sales following any marketing approval;
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a continued acceptable safety profile following any marketing approval;
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commercial acceptance by patients, the medical community and third-party payors; and
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our ability to compete with other therapies.
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failure of our product candidates in preclinical studies or clinical trials to demonstrate safety and efficacy;
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receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials;
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negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain research and/or drug development programs;
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the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at
a higher rate than anticipated;
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third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
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the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or
other unexpected characteristics or risks;
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the cost of clinical trials of our product candidates being greater than anticipated;
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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and
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regulators revising the requirements for approving our product candidates.
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generating sufficient data to support the initiation or continuation of preclinical studies and clinical trials;
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addressing any potential delays resulting from factors related to public health concerns, such as the COVID-19 pandemic;
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obtaining regulatory permission to initiate clinical trials;
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contracting with the necessary parties to conduct clinical trials;
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successful enrollment of patients in, and the completion of, clinical trials on a timely basis;
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the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and
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adverse events in clinical trials.
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the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;
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the FDA, EMA or other comparable foreign regulatory authorities may determine that we have not demonstrated the safety and efficacy of our product candidates, or that they have undesirable or unintended
side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;
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the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;
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the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
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the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we
contract for clinical and commercial supplies;
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the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests required for our product candidates; and
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the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
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size and nature of the patient population;
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severity of the disease under investigation;
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availability and efficacy of approved drugs for the disease under investigation;
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patient eligibility criteria for the clinical trial in question as defined in the protocol, including biomarker-driven identification and/or certain highly-specific
criteria related to stage of disease progression, which may limit the patient populations eligible for our clinical trials to a greater extent than competing clinical trials for the same indication that do not have biomarker-driven
patient eligibility criteria;
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perceived risks and benefits of the product candidate under study;
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clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved or other
product candidates being investigated for the indications we are investigating;
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clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials;
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patient referral practices of physicians;
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the ability to monitor patients adequately during and after treatment;
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proximity and availability of clinical trial sites for prospective patients; and
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the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion or, because they may be late-stage cancer patients, will
not survive the full terms of the clinical trials.
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delays or difficulties in clinical site initiation, such as our experience with our KN-8701 clinical trial, including difficulties in recruiting clinical site investigators and clinical site staff;
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delays or difficulties in enrolling and retaining patients in any clinical trials, particularly elderly subjects, who are at a higher risk of severe illness or death;
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difficulties interpreting data from our clinical trials due to the possible confounding effects on patients;
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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 clinical
trials;
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• |
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;
|
• |
interruption or delays in the operations of the FDA, EMA or other regulatory authorities, which may impact review and approval timelines;
|
• |
limitations in resources that would otherwise be focused on the conduct of our business, our preclinical studies or our clinical trials, including because of sickness or the desire to avoid contact with large
groups of people or as a result of government-imposed “shelter in place” or similar working restrictions;
|
• |
interruptions, difficulties or delays arising in our existing operations and company culture as a result of our employees working from home or in a hybrid model;
|
• |
delays in receiving approval from regulatory authorities to initiate our clinical trials;
|
• |
delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;
|
• |
interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such studies;
|
• |
interruption in global freight and shipping that may affect the transport of clinical trial materials, such as investigational drug product to be used in our clinical trials;
|
• |
changes in regulations in response to public health concerns, which may require us to change the ways in which our clinical trials are to be conducted, or to discontinue the clinical trials altogether, or
which may result in unexpected costs;
|
• |
delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor
personnel; and
|
• |
refusal of the FDA, EMA or other regulatory authorities to accept data from clinical trials in affected geographies outside of their respective jurisdictions.
|
• |
the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;
|
• |
the timing of market introduction of the product candidate as well as competitive products;
|
• |
the clinical indications for which a product candidate is approved;
|
• |
restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any,
which may not be required of alternative treatments and competitor products;
|
• |
the potential and perceived advantages of our product candidates over alternative treatments;
|
• |
the cost of treatment in relation to alternative treatments;
|
• |
the availability of coverage and adequate reimbursement by third-party payors, including government authorities;
|
• |
the availability of an approved product candidate for use as a combination therapy;
|
• |
relative convenience and ease of administration;
|
• |
the willingness of the target patient population to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic
tests;
|
• |
the effectiveness of sales and marketing efforts;
|
• |
unfavorable publicity relating to our product candidates; and
|
• |
the approval of other new therapies for the same indications.
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may determine that we have not demonstrated the safety and efficacy of our product candidates, or that they have undesirable or unintended side
effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;
|
• |
the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
|
• |
we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we
contract for clinical and commercial supplies; and
|
• |
the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
• |
delays in or the rejection of product approvals;
|
• |
restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned clinical trials;
|
• |
restrictions on the products, manufacturers or manufacturing process;
|
• |
warning or untitled letters;
|
• |
civil and criminal penalties;
|
• |
injunctions;
|
• |
suspension or withdrawal of regulatory approvals;
|
• |
product seizures, detentions or import bans;
|
• |
voluntary or mandatory product recalls and publicity requirements;
|
• |
total or partial suspension of production;
|
• |
imposition of restrictions on operations, including costly new manufacturing requirements;
|
• |
revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings;
|
• |
imposition of a REMS, which may include distribution or use restrictions; and
|
• |
requirements to conduct additional post-market clinical trials to assess the safety of products.
|
• |
the demand for our product candidates if we obtain regulatory approval;
|
• |
our ability to set a price that we believe is fair for our products;
|
• |
our ability to obtain coverage and reimbursement approval for a product;
|
• |
our ability to generate revenue and achieve or maintain profitability;
|
• |
the level of taxes that we are required to pay; and
|
• |
the availability of capital.
|
• |
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or
rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, 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 a federal healthcare program, such as the Medicare and Medicaid programs. 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. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs.
In addition, 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 False Claims Act (FCA). 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, including the FCA, which can be enforced through civil “qui tam” or “whistleblower” actions, and civil monetary penalty laws, impose criminal and civil penalties
against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent;
knowingly making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing such an
obligation. 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 FCA also permits a private
individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an entity is determined to have violated the federal civil FCA, the
government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;
|
• |
HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or 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. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it;
|
• |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their respective implementing regulations, which 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 individually identifiable health information without appropriate authorization. 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 federal Physician Payments Sunshine Act, created under the ACA and its implementing regulations, which require applicable manufacturers of covered drugs, devices, biologicals or 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 in the previous year to covered recipients,
including physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others) and teaching
hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
|
• |
analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices,
including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial 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 federal government that otherwise restricts payments that may be
made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts,
compensations and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the
privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
|
• |
identifying, recruiting, integrating, maintaining, retaining and motivating our current and additional employees;
|
• |
managing our internal development efforts effectively, including the preclinical, clinical, FDA, EMA and other comparable foreign regulatory authorities’ review process for our product candidates, while
complying with any contractual obligations to contractors and other third parties;
|
• |
managing increasing operational and managerial complexity; and
|
• |
improving our operational, financial and management controls, reporting systems and procedures.
|
• |
differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being
more costly than obtaining approval in the United States;
|
• |
foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from preclinical studies or clinical trials;
|
• |
approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval;
|
• |
unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
|
• |
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
• |
compliance with legal requirements applicable to privacy, data protection, information security and other matters;
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
• |
foreign taxes, including withholding of payroll taxes;
|
• |
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
• |
difficulties staffing and managing foreign operations;
|
• |
complexities associated with managing multiple payor reimbursement regimes and government payors in foreign countries;
|
• |
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
• |
potential liability under the FCPA or comparable foreign regulations;
|
• |
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United
States;
|
• |
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad (such as the ongoing conflicts in the Middle East and between Ukraine and Russia, including the
sanctions imposed by the United States, the European Union and others on Russia and other related parties); and
|
• |
business interruptions resulting from geo-political actions, including war and terrorism, trade policies, treaties and tariffs.
|
• |
the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which
can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;
|
• |
patent applications may not result in any patents being issued;
|
• |
patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;
|
• |
our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that
will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates;
|
• |
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; and
|
• |
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.
|
• |
others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license;
|
• |
we or our future licensors or collaborators might not have been the first to make the inventions covered by the issued patents or patent application that we own or license;
|
• |
we or our future licensors or 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 the pending patent applications we own or license will not lead to issued patents;
|
• |
issued patents that we own or license may be 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;
|
• |
the patents of others may have an adverse effect on our business; and
|
• |
we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
|
• |
result in costly litigation that may cause negative publicity;
|
• |
divert the time and attention of our technical personnel and management;
|
• |
cause development delays;
|
• |
prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law;
|
• |
require us to develop non-infringing technology, which may not be possible on a cost-effective basis;
|
• |
subject us to significant liability to third parties; or
|
• |
require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining
access to the same technology.
|
• |
the scope of rights granted under the license agreement and other interpretation-related issues;
|
• |
whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
|
• |
our right to sublicense patents and other rights to third parties;
|
• |
our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
|
• |
our right to transfer or assign the license;
|
• |
the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners; and
|
• |
the priority of invention of patented technology.
|
• |
the failure of the third party to manufacture our product candidates according to our schedule and specifications, or at all, including if our third-party contractors give greater priority to the supply of
other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them;
|
• |
the reduction or termination of production or deliveries by suppliers, or the raising or prices or renegotiation of terms;
|
• |
the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us;
|
• |
the breach by the third-party contractors of our agreements with them;
|
• |
the failure of third-party contractors to comply with applicable regulatory requirements, including cGMPs;
|
• |
the breach by the third-party contractors of our agreements with them;
|
• |
the failure of the third party to manufacture our product candidates according to our specifications;
|
• |
the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified;
|
• |
clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost
sales; and
|
• |
the misappropriation of our proprietary information, including our trade secrets and know-how.
|
• |
increased operating expenses and cash requirements;
|
• |
the assumption of additional indebtedness or contingent liabilities;
|
• |
the issuance of our equity securities;
|
• |
assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel;
|
• |
the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition;
|
• |
retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;
|
• |
risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products, product candidates and marketing approvals; and
|
• |
our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
|
• |
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;
|
• |
collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial
results, changes in the collaborators’ strategic focus, including as a result of a business combination or sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition
that diverts resources or creates competing priorities;
|
• |
collaborators 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;
|
• |
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are
more likely;
|
• |
to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
|
• |
a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products;
|
• |
we may grant exclusive rights to our collaborators that would prevent us from collaborating with others;
|
• |
collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or
other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings;
|
• |
disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or
arbitration that diverts management attention and resources;
|
• |
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;
|
• |
collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all;
|
• |
collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could
adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates;
|
• |
collaborators may own or co-own intellectual property covering our products or product candidates that result from our collaborating with them, and in such cases, we would not have the exclusive right to
develop or commercialize such intellectual property; and
|
• |
a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
|
• |
the timing and results of INDs, preclinical studies and clinical trials of our product candidates or those of our competitors;
|
• |
the success of competitive products or announcements by potential competitors of their product development efforts;
|
• |
regulatory actions with respect to our products or product candidates or our competitors’ products or product candidates;
|
• |
actual or anticipated changes in our growth rate relative to our competitors;
|
• |
regulatory or legal developments in the United States and other countries, including changes in leadership at various federal departments and agencies as well as new legislation, executive, and
administrative actions under the Biden administration;
|
• |
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
• |
the recruitment or departure of key personnel;
|
• |
announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;
|
• |
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
• |
fluctuations in the valuation of companies perceived by investors to be comparable to us;
|
• |
market conditions in the pharmaceutical and biotechnology sector;
|
• |
changes in the structure of healthcare payment systems;
|
• |
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
|
• |
announcement or expectation of additional financing efforts;
|
• |
sales of our common stock by us, our insiders or our other stockholders;
|
• |
expiration of market stand-off or lock-up agreements;
|
• |
the impact of any natural disasters or public health emergencies, such as COVID-19; and
|
• |
general economic, political, industry and market conditions and instability (such as those created by the ongoing conflicts in the Middle East and between Ukraine and Russia, including, without limitation,
sanctions against Russia imposed by the United States, the European Union and others, and instability in the banking sector).
|
• |
the timing and cost of, and level of investment in, research and development activities relating to our programs, which will change from time to time;
|
• |
our ability to enroll patients in clinical trials and the timing of enrollment;
|
• |
our ability to timely initiate sites for clinical trials;
|
• |
the cost of manufacturing our current product candidates and any future product candidates, which may vary depending on FDA, EMA or other comparable foreign regulatory authority guidelines and requirements,
the quantity of production and the terms of our agreements with manufacturers;
|
• |
expenditures that we will or may incur to acquire or develop additional product candidates and technologies or other assets;
|
• |
the timing and outcomes of preclinical studies and clinical trials for product candidates including from our c-MET inhibitor KIN-8741 and CDK4 selective inhibitor KIN-7324 research programs, or competing product candidates;
|
• |
the need to conduct unanticipated clinical trials or clinical trials that are larger or more complex than anticipated;
|
• |
competition from existing and potential future products that compete with our programs including, our c-MET inhibitor KIN-8741 research program or our CDK4
selective inhibitor KIN-7324 research program, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners;
|
• |
any delays in regulatory review or approval of product candidates from our programs including, our c-MET inhibitor KIN-8741 research program or our CDK4
selective inhibitor KIN-7324 research program;
|
• |
the level of demand for any of our product candidates, if approved, which may fluctuate significantly and be difficult to predict;
|
• |
the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future products that compete with our programs including, our
c-MET inhibitor KIN-8741 research program or our CDK4 selective inhibitor KIN-7324 research program;
|
• |
our ability to commercialize product candidates from our programs including, our c-MET inhibitor KIN-8741 research program or our CDK4 selective inhibitor
KIN-7324 research program, if approved, inside and outside of the United States, either independently or working with third parties;
|
• |
our ability to establish and maintain collaborations, licensing or other arrangements;
|
• |
our ability to adequately support future growth;
|
• |
potential unforeseen business disruptions that increase our costs or expenses;
|
• |
future accounting pronouncements or changes in our accounting policies; and
|
• |
the changing and volatile global economic and political environment.
|
• |
being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” disclosure in our periodic reports;
|
• |
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (SOX);
|
• |
not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report
providing additional information about the audit and the financial statements;
|
• |
reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and
|
• |
exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved.
|
• |
establish a classified board of directors so that not all members of our board are elected at one time;
|
• |
permit only the board of directors to establish the number of directors and fill vacancies on the board;
|
• |
provide that directors may only be removed “for cause”;
|
• |
authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a “poison pill”);
|
• |
eliminate the ability of our stockholders to call special meetings of stockholders;
|
• |
prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;
|
• |
prohibit cumulative voting;
|
• |
authorize our board of directors to amend the bylaws;
|
• |
establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and
|
• |
require a super-majority vote of stockholders to amend or repeal specified provisions of our amended and restated certificate of incorporation and amended and restated bylaws.
|
• |
any derivative action or proceeding brought on our behalf;
|
• |
any action asserting a claim of breach of fiduciary duty;
|
• |
any action asserting a claim against us arising under the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws; and
|
• |
any action asserting a claim against us that is governed by the internal-affairs doctrine.
|
Item 1B. |
Unresolved Staff Comments.
|
Item 1C. |
Cybersecurity.
|
Item 2. |
Properties.
|
Item 3. |
Legal Proceedings.
|
Item 4. |
Mine Safety Disclosures.
|
Item 5. |
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
|
Item 6. |
[Reserved]
|
Item 7. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
• |
resume our product discovery and development efforts and expand our pipeline of product candidates through our own product discovery and development efforts, in particular our c-MET inhibitor KIN-8741
and CDK4 selective inhibitor KIN-7324 research programs;
|
• |
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
• |
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;
|
• |
implement operational, financial and management systems;
|
• |
attract, hire and retain additional clinical, scientific, management and administrative personnel;
|
• |
maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and
|
• |
operate as a public company.
|
• |
expenses incurred in connection with the discovery, preclinical and clinical development of our product candidates, including under agreements with third parties, such as consultants and CROs;
|
• |
the cost of manufacturing compounds for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants and CMOs; and
|
• |
costs associated with consultants for chemistry, manufacturing and controls (CMC) development, regulatory, statistics and other services, including expenses for technology and facilities
|
• |
the timing and progress of preclinical and clinical development activities;
|
• |
the number and scope of preclinical and clinical programs we decide to pursue;
|
• |
our ability to maintain our current research and development programs and to establish new ones;
|
• |
establishing an appropriate safety profile with IND-enabling toxicology studies;
|
• |
successful patient enrollment in, and the initiation and completion of, clinical trials;
|
• |
per-subject clinical trial costs;
|
• |
the number of clinical trials required for regulatory approval;
|
• |
the countries in which the clinical trials are conducted;
|
• |
the length of time required to enroll eligible subjects and initiate clinical trials;
|
• |
the number of subjects that participate in the clinical trials;
|
• |
the drop-out and discontinuation rate of subjects;
|
• |
potential additional safety monitoring requested by regulatory authorities;
|
• |
the duration of subject participation in the clinical trials and follow-up;
|
• |
the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to applicable regulatory authorities;
|
• |
the receipt of regulatory approvals from applicable regulatory authorities;
|
• |
the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities;
|
• |
the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party;
|
• |
obtaining and retaining research and development personnel;
|
• |
establishing commercial manufacturing capabilities or making arrangements with CMOs;
|
• |
development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch; and
|
• |
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.
|
Years Ended December 31,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
Operating expenses:
|
||||||||||||
Research and development
|
$
|
90,767
|
$
|
88,150
|
$
|
2,617
|
||||||
General and administrative
|
28,241
|
30,371
|
(2,130
|
)
|
||||||||
Restructuring costs
|
2,168
|
-
|
2,168
|
|||||||||
Total operating expenses
|
121,176
|
118,521
|
2,655
|
|||||||||
Loss from operations
|
(121,176
|
)
|
(118,521
|
)
|
(2,655
|
)
|
||||||
Other income, net
|
8,527
|
2,250
|
6,277
|
|||||||||
Net loss
|
$
|
(112,649
|
)
|
$
|
(116,271
|
)
|
$
|
3,622
|
Years Ended December 31,
|
Increase
|
|||||||||||
2023
|
2022
|
(Decrease)
|
||||||||||
External expenses:
|
||||||||||||
RAF
|
$
|
28,289
|
$
|
23,713
|
$
|
4,576
|
||||||
FGFR
|
14,620
|
13,588
|
1,032
|
|||||||||
Other programs and other unallocated costs
|
14,854
|
16,924
|
(2,070
|
)
|
||||||||
Total external expenses
|
57,763
|
54,225
|
3,538
|
|||||||||
Internal expenses
|
33,004
|
33,925
|
(921
|
)
|
||||||||
Total research and development expenses
|
$
|
90,767
|
$
|
88,150
|
$
|
2,617
|
• |
advance the development of our programs, including our c-MET inhibitor KIN-8741 and CDK4 selective inhibitor KIN-7324 research programs;
|
• |
expand our pipeline of product candidates through our own product discovery and development efforts;
|
• |
seek to discover and develop additional product candidates;
|
• |
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
• |
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;
|
• |
implement operational, financial and management systems;
|
• |
attract, hire and retain additional clinical, scientific, management and administrative personnel;
|
• |
maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and
|
• |
operate as a public company.
|
• |
the scope, timing, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials;
|
• |
the scope, timing, progress, results and costs of researching and developing other product candidates that we may pursue;
|
• |
the costs, timing and outcome of regulatory review of our product candidates;
|
• |
the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
|
• |
the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;
|
• |
the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;
|
• |
the cost and timing of attracting, hiring and retaining skilled personnel to support our operations and continued growth;
|
• |
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
|
• |
our ability to establish and maintain collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties on favorable terms, if at all;
|
• |
the extent to which we acquire or in-license other product candidates and technologies, if any;
|
• |
the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any; and
|
• |
the costs associated with operating as a public company.
|
|
Years Ended December 31,
|
|||||||
|
2023
|
2022
|
||||||
|
||||||||
Net cash used in operating activities
|
$
|
(100,043
|
)
|
$
|
(89,034
|
)
|
||
Net cash provided by (used in) investing activities
|
109,869
|
(6,830
|
)
|
|||||
Net cash (used in) provided by financing activities
|
(7,808
|
)
|
1,160
|
|||||
Effect of exchange rate changes on cash and cash equivalents
|
(6
|
)
|
1
|
|||||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
$
|
2,012
|
$
|
(94,703
|
)
|
• |
Fair Value of Common Stock: Since the completion of our initial public offering, the fair value of each share of common stock underlying stock option grants is based on the closing price of our common
stock on the Nasdaq Global Select Market as reported on the date of grant.
|
• |
Expected Term: We have opted to use the “simplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option,
which is generally 10 years.
|
• |
Expected Volatility: Due to the limited trading history of our common stock, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical
volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. We will continue to apply this process until a
sufficient amount of historical information regarding the volatility of our own stock price becomes available.
|
• |
Risk-Free Interest Rate: The risk-free interest rates used are based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. treasury notes with maturities approximately equal to the expected term of the
stock options.
|
• |
Expected Dividend: To date, we have not issued any dividends and do not expect to issue dividends over the life of the options and therefore have estimated the dividend yield to be zero.
|
Item 7A. |
Quantitative and Qualitative Disclosures About Market Risk.
|
December 31,
|
||||||||
2023
|
2022
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Cash at consolidated joint venture
|
||||||||
Short-term investments
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Right-of-use lease assets | ||||||||
Long-term investments
|
||||||||
Restricted cash
|
||||||||
Other non-current assets
|
||||||||
Total assets
|
$
|
|
$
|
|
||||
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Current portion of operating lease liabilities | ||||||||
Total current liabilities
|
|
|
||||||
Operating lease liabilities, long-term | ||||||||
Total liabilities | ||||||||
Commitments and contingencies (See Note 13)
|
||||||||
Redeemable convertible noncontrolling interests
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $
December 31, 2023 and 2022;
and 2022
|
|
|
||||||
Common stock, $
December 31, 2023 and 2022;
and outstanding at December 31, 2023 and 2022, respectively
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated other comprehensive loss
|
(
|
)
|
(
|
)
|
||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total stockholders’ equity
|
|
|
||||||
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ equity
|
$
|
|
$
|
|
Years Ended December 31,
|
||||||||
2023
|
2022
|
|||||||
Operating expenses:
|
||||||||
Research and development
|
$
|
|
$
|
|
||||
General and administrative
|
|
|
||||||
Restructuring costs
|
||||||||
Total operating expenses
|
|
|
||||||
Loss from operations
|
(
|
)
|
(
|
)
|
||||
Other income, net
|
|
|
||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Weighted-average shares outstanding, basic and diluted
|
|
|
||||||
Net loss per share, basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Comprehensive loss: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Other comprehensive loss: |
||||||||
Currency translation adjustments | ( |
) | ||||||
Unrealized gain (loss) on investments
|
( |
) | ||||||
Total comprehensive loss |
$ | ( |
) | $ | ( |
) |
|
Common Stock
|
Additional
Paid-in |
Accumulated Other Comprehensive
|
Accumulated
|
Total
Stockholders’ |
Redeemable Convertible Noncontrolling
|
||||||||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Loss
|
Deficit
|
Equity
|
Interests
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Stock-based compensation expense
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Shares issued under equity
incentive plans
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Shares issued under employee
stock purchase plan
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
Other comprehensive loss
|
-
|
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||||||||
Balance at December 31, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Stock-based compensation expense
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Acquisition of redeemable convertible noncontrolling interests
|
( |
) | ||||||||||||||||||||||||||
Shares issued under equity incentive plans
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Shares issued under employee
stock purchase plan
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
Other comprehensive gain
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Balance at December 31, 2023
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
Years Ended December 31,
|
||||||||
2023
|
2022
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
|
|
||||||
Depreciation
|
|
|
||||||
Amortization/accretion of investments
|
(
|
)
|
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
|
|
||||||
Operating lease right-of-use assets and liabilities, net | ( |
) | ||||||
Accounts payable and accrued expenses
|
(
|
)
|
|
|||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchases of short-term and long-term investments
|
(
|
)
|
(
|
)
|
||||
Sales and maturities of short-term and long-term investments
|
||||||||
Purchases of property and equipment
|
|
(
|
)
|
|||||
Net cash provided by (used in) investing activities
|
|
(
|
)
|
|||||
Cash flows from financing activities:
|
||||||||
Acquisition of redeemable convertible noncontrolling interests
|
( |
) | ||||||
Proceeds from issuance of common stock under equity incentive plans | ||||||||
Proceeds from issuance of common stock under employee stock purchase plan | ||||||||
Payment of deferred offering costs
|
(
|
)
|
||||||
Net cash (used in) provided by financing activities
|
(
|
)
|
|
|||||
Effect of exchange rate changes on cash and cash equivalents | ( |
) | ||||||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
|
(
|
)
|
|||||
Cash, cash equivalents and restricted cash at the beginning of the period
|
|
|
||||||
Cash, cash equivalents and restricted cash at the end of the period
|
$
|
|
$
|
|
||||
Supplemental non-cash investing and financing activity:
|
||||||||
Acquisition of redeemable convertible noncontrolling interests
|
$ | $ | ||||||
Capitalized value of tenant improvement allowance | $ | $ | ||||||
Operating lease liabilities arising from obtaining right-of-use assets | $ | $ | ||||||
Write-off of deferred offering costs | $ | $ |
1) |
Organization and Basis of Presentation
|
a) |
Organization and Nature of Operations
|
b) |
Basis of Presentation
|
2) |
Summary of Significant Accounting Policies
|
a) |
Use of Estimates
|
b) |
Concentration of Credit Risk
|
c) |
Fair Value of Financials Instruments
|
d) |
Cash and Cash Equivalents
|
e) |
Investments
|
f) |
Property and Equipment, Net
|
g) |
Impairment of Property and Equipment
|
h) |
Leases
|
i) |
Research and Development
|
j) |
Redeemable Convertible Noncontrolling Interests
|
k) |
Commitments and Contingencies
|
l) |
Income Taxes
|
m) |
Stock-Based Compensation
|
n) |
Comprehensive Loss
|
o) |
Net Loss Per Share
|
Years Ended December 31,
|
||||||||
2023
|
2022
|
|||||||
Numerator
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Denominator
|
||||||||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted
|
|
|
||||||
Net loss per share, basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
Years Ended December 31,
|
||||||||
2023
|
2022
|
|||||||
Options to purchase common stock
|
|
|
||||||
Non-vested restricted stock units
|
||||||||
Total
|
p) |
Recently Issued and Adopted Accounting Standards
|
3)
|
Cash, Cash Equivalents and Restricted Cash
|
|
As of December 31,
|
|||||||
|
2023
|
2022
|
||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Cash at consolidated joint venture
|
|
|
||||||
Restricted cash, non-current
|
|
|
||||||
Total cash, cash equivalents and restricted cash reported in the Consolidated Statements of Cash Flows
|
$
|
|
$
|
|
4) |
Property and Equipment, Net
|
As of December 31,
|
||||||||
2023
|
2022
|
|||||||
Furniture and fixtures
|
$
|
|
$
|
|
||||
Computers and equipment
|
|
|
||||||
Computer software
|
|
|
||||||
Leasehold improvements
|
||||||||
Property and equipment
|
|
|
||||||
Less accumulated depreciation
|
(
|
)
|
(
|
)
|
||||
Property and equipment, net
|
$
|
|
$
|
|
5) |
Accrued Expenses
|
As of December 31,
|
||||||||
2023
|
2022
|
|||||||
Accrued research and development
|
$
|
|
$
|
|
||||
Accrued compensation
|
|
|
||||||
Accrued restructuring costs | ||||||||
Accrued legal fees
|
|
|
||||||
Other accruals
|
|
|
||||||
Total
|
$
|
|
$
|
|
6) |
Investments
|
|
December 31, 2023
|
|||||||||||||||||||
Maturity | Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||||
in Years
|
Cost
|
Gains
|
Losses
|
Fair Value
|
||||||||||||||||
Corporate debt securities
|
less than
|
$
|
|
$
|
|
$
|
|
$
|
|
|||||||||||
Commercial paper
|
less than |
( |
) | |||||||||||||||||
U.S. Agency bonds
|
less than
|
|
|
(
|
)
|
|
||||||||||||||
Asset-backed securities |
( |
) | ||||||||||||||||||
Short-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||||
|
||||||||||||||||||||
Corporate debt securities
|
|
$ | $ | $ | $ | |||||||||||||||
Asset-backed securities
|
|
|
|
(
|
)
|
|
||||||||||||||
Long-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
December 31, 2022
|
||||||||||||||||||||
Maturity | Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||||
in Years
|
Cost
|
Gains
|
Losses
|
Fair Value
|
||||||||||||||||
Corporate debt securities
|
less than |
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Commercial paper |
less than |
|||||||||||||||||||
U.S. Treasury securities
|
less than |
( |
) | |||||||||||||||||
U.S. Agency bonds |
less than |
|
|
|
|
|||||||||||||||
Short-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||||
Corporate debt securities |
$ |
$ |
$ |
( |
) | $ |
||||||||||||||
U.S. Agency bonds |
( |
) | ||||||||||||||||||
Asset-backed securities |
( |
) | ||||||||||||||||||
Long-term investments
|
$ | $ | $ | ( |
) | $ |
December 31, 2023
|
||||||||||||||||||||||||||||||||||||
Less than 12 months
|
More than 12 months
|
Total
|
||||||||||||||||||||||||||||||||||
Unrealized
|
Unrealized
|
Unrealized
|
||||||||||||||||||||||||||||||||||
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
||||||||||||||||||||||||||||
Commercial paper
|
|
|
$ |
|
$ |
(
|
)
|
|
$ |
|
$ |
|
|
$ |
|
$ |
(
|
)
|
||||||||||||||||||
U.S. Agency bonds
|
|
|
(
|
)
|
|
|
(
|
)
|
|
|
(
|
)
|
||||||||||||||||||||||||
Asset-backed securities
|
|
|
(
|
)
|
|
|
(
|
)
|
|
|
(
|
)
|
||||||||||||||||||||||||
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
December 31, 2022
|
||||||||||||||||||||||||||||||||||||
Less than 12 months
|
More than 12 months
|
Total
|
||||||||||||||||||||||||||||||||||
Unrealized
|
Unrealized
|
Unrealized
|
||||||||||||||||||||||||||||||||||
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
||||||||||||||||||||||||||||
Corporate debt securities
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
|
|
$
|
|
$
|
(
|
)
|
|||||||||||||||||||
U.S. Treasury securities
|
|
|
(
|
)
|
|
|
(
|
)
|
|
|
(
|
)
|
||||||||||||||||||||||||
U.S. Agency bonds | ( |
) | ( |
) | ||||||||||||||||||||||||||||||||
Asset-backed securities
|
|
|
(
|
)
|
|
|
|
|
|
(
|
)
|
|||||||||||||||||||||||||
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
7) |
Fair Value Measurements
|
Level 1: |
Observable inputs such as quoted prices in active markets;
|
Level 2: |
Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
|
Level 3: |
Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
|
Fair Value Measurements at December 31, 2023
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Money market funds
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Corporate debt securities
|
|
|
|
|
||||||||||||
Commercial paper
|
||||||||||||||||
U.S. Agency bonds
|
||||||||||||||||
Asset-backed securities
|
||||||||||||||||
Total cash equivalents and investments
|
$
|
|
$
|
|
$
|
|
$
|
|
Fair Value Measurements at December 31, 2022
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Money market funds
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Corporate debt securities
|
|
|
|
|
||||||||||||
Commercial paper |
||||||||||||||||
U.S. Treasury securities
|
|
|
|
|
||||||||||||
U.S. Agency bonds |
||||||||||||||||
Asset-backed securities
|
||||||||||||||||
Total cash equivalents and investments
|
$
|
|
$
|
|
$
|
|
$
|
|
8) |
Stockholders’ Equity
|
As of December 31,
|
||||||||
2023
|
2022
|
|||||||
Common stock options outstanding
|
|
|
||||||
RSUs outstanding
|
||||||||
Common stock reserved for future equity grants
|
|
|
||||||
Total common stock reserved for future issuance
|
|
|
9) |
Equity Incentive Plans and Stock-Based Compensation
|
a) |
Company Equity Incentive Plans
|
Weighted- | ||||||||||||||||
Average | Aggregate | |||||||||||||||
Weighted- | Remaining | Intrinsic | ||||||||||||||
Average | Contractual | Value | ||||||||||||||
Options
|
Exercise Price
|
Term (in years)
|
(in thousands)
|
|||||||||||||
Outstanding at December 31, 2022
|
|
$
|
|
|
$ | |||||||||||
Granted
|
|
|
||||||||||||||
Exercised | ( |
) | ||||||||||||||
Forfeited
|
(
|
)
|
|
|||||||||||||
Outstanding at December 31, 2023
|
|
$
|
|
|
$
|
|
||||||||||
Exercisable at December 31, 2023
|
|
$
|
|
|
$
|
|
|
Weighted-
|
Aggregate
|
||||||||||
|
Restricted
|
Average
|
Intrinsic
|
|||||||||
|
Stock Units
|
Grant Date
|
Value
|
|||||||||
|
Outstanding
|
Fair Value
|
(in thousands)
|
|||||||||
Outstanding at December 31, 2022
|
|
$
|
|
$
|
|
|||||||
Granted
|
|
|
||||||||||
Vested
|
(
|
)
|
|
|||||||||
Forfeited
|
(
|
)
|
|
|||||||||
Outstanding at December 31, 2023
|
|
$
|
|
$
|
|
b) |
Kinnjiu Equity Incentive Plan
|
Stock Options |
Weighted- | |||||||
Average | ||||||||
|
Shares
|
Exercise Price
|
||||||
Outstanding at December 31, 2022
|
|
$ |
|
|||||
Granted
|
|
|
|
|||||
Exercised
|
|
|
||||||
Forfeited
|
|
|
||||||
Outstanding at December 31, 2023
|
|
$
|
|
|||||
Exercisable at December 31, 2023
|
|
$ |
|
SARs | Weighted- | |||||||
Average | ||||||||
|
Shares
|
Exercise Price
|
||||||
Outstanding at December 31, 2022
|
|
$ |
|
|||||
Granted
|
|
|
||||||
Exercised
|
|
|
||||||
Forfeited
|
(
|
)
|
|
|||||
Outstanding at December 31, 2023
|
|
$
|
|
|||||
Exercisable at December 31, 2023
|
|
|
c) |
Employee Stock Purchase Plan
|
d) |
Stock-Based Compensation Expense
|
Years Ended December 31,
|
||||||
2023
|
2022
|
|||||
Expected term (in years)
|
|
|
||||
Expected volatility
|
|
|
|
|
||
Risk-free interest rate
|
|
|
|
|
||
Expected dividend
|
|
|
|
|
Years Ended December 31, | ||||||
2023 |
2022
|
|||||
Expected term (in years)
|
|
|||||
Expected volatility
|
|
|
||||
Risk-free interest rate
|
|
|
||||
Expected dividend
|
|
|
Years Ended December 31,
|
||||||||
2023
|
2022
|
|||||||
Research and development
|
$
|
|
$
|
|
||||
General and administrative
|
|
|
||||||
Total stock-based compensation
|
$
|
|
$
|
|
10) |
Related Party Transactions
|
11) |
Kinnjiu
Transaction
|
|
December 31, 2022
|
|||
Cash at consolidated joint venture
|
$
|
|
||
Prepaid expenses and other current assets
|
|
|||
Right-of-use lease assets
|
|
|||
Other non-current assets
|
|
|||
Accounts payable and accrued expenses
|
|
|||
Operating lease liabilities
|
|
12) |
Income Taxes
|
Years Ended December 31,
|
||||||||
2023
|
2022
|
|||||||
Income taxes computed at the statutory rate
|
$
|
(
|
)
|
$
|
(
|
)
|
||
State income taxes, net of federal benefit
|
(
|
)
|
(
|
)
|
||||
Permanent items
|
|
|
||||||
Stock-based compensation
|
|
|
||||||
Research credits |
( |
) | ( |
) | ||||
Other
|
|
|||||||
Change in valuation allowance
|
|
|
||||||
Provision for income taxes
|
$
|
|
$
|
|
As of December 31,
|
||||||||
2023
|
2022
|
|||||||
Deferred tax assets:
|
||||||||
Net operating loss carryforward
|
$
|
|
$
|
|
||||
Research and development credit carryforwards |
||||||||
Stock-based compensation
|
|
|
||||||
Accrued compensation
|
|
|
||||||
Capitalized research and development expenditures
|
||||||||
Other, net
|
|
|
||||||
Gross deferred tax assets:
|
|
|
||||||
Less valuation allowance
|
(
|
)
|
(
|
)
|
||||
Total deferred tax assets
|
|
|
||||||
Deferred tax liabilities:
|
||||||||
Right-of-use lease assets
|
( |
) | ( |
) | ||||
Property and equipment
|
( |
) | ( |
) | ||||
Other
|
|
|
||||||
Total deferred tax liabilities
|
( |
) | ( |
) | ||||
Net deferred tax assets
|
$
|
|
$
|
|
13) |
Commitments and Contingencies
|
|
Operating Leases
|
|||
2024
|
$ |
|
||
2025
|
|
|||
2026
|
|
|||
Thereafter
|
|
|||
Total minimum lease payments
|
|
|||
Less: imputed interest
|
(
|
)
|
||
Total operating lease liabilities
|
|
|||
Less: current portion
|
(
|
)
|
||
Lease liability, net of current portion
|
$
|
|
14) |
Employee Benefit Plan
|
15) |
Restructuring Costs
|
Year Ended
|
||||
December 31, 2023
|
||||
Accrued restructuring costs beginning balance
|
$
|
|
||
One-time employee termination benefits
|
|
|||
Amounts paid during the period
|
(
|
)
|
||
Accrued restructuring costs as of December 31, 2023
|
$
|
|
16) |
Subsequent Events
|
Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
|
Item 9A. |
Controls and Procedures.
|
Item 9B. |
Other Information.
|
Item 9C. |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
|
Name
|
|
Class
|
Age
|
Position
|
Director
Since
|
Current
Term
Expires
|
Carl L. Gordon, Ph.D., CFA(1)
|
|
I
|
59
|
Director
|
2019
|
2024
|
Helen Sabzevari, Ph.D.
|
|
I
|
62
|
Director
|
2021
|
2024
|
Jim Tananbaum, M.D.(1)
|
|
I
|
60
|
Director
|
2018(4)
|
2024
|
Jill DeSimone(1)(2)
|
|
II
|
68
|
Director
|
2023
|
2025
|
Melissa Epperly(2)
|
|
II
|
46
|
Director
|
2020
|
2025
|
Michael Rome, Ph.D.(3)
|
|
II
|
39
|
Director
|
2019
|
2025
|
Laurie Smaldone Alsup, M.D.(3)
|
|
II
|
70
|
Director
|
2020
|
2025
|
Nima Farzan
|
III
|
48
|
President, Chief Executive
Officer and Director
|
2020
|
2026
|
|
Keith Flaherty, M.D.(3)
|
III
|
53
|
Director
|
2019
|
2026
|
|
Dean Mitchell (1)(2)(3)
|
III
|
68
|
Chair and Director
|
2020
|
2026
|
(1) |
Member of our compensation committee
|
(2) |
Member of our audit committee
|
(3) |
Member of our nominating and corporate governance committee
|
(4) |
Dr. Tananbaum served on our board of directors from March 2018 to December 2019 and rejoined our board of directors in June 2020
|
Name
|
Age
|
Position
|
Nima Farzan
|
48
|
President, Chief Executive Officer and Director
|
Neha Krishnamohan
|
37
|
Chief Financial Officer and Executive Vice President,
Corporate Development
|
Mark Meltz
|
50
|
Chief Operating Officer, General Counsel and Corporate
Secretary
|
Richard Williams, MBBS, Ph.D.
|
55
|
Chief Medical Officer*
|
• |
selecting and hiring the independent registered public accounting firm to audit our financial statements;
|
• |
helping to ensure the independence and performance of the independent registered public accounting firm;
|
• |
approving audit and non-audit service and fees;
|
• |
reviewing financial statements and discussing with management and the independent registered public accounting firm our annual audited and quarterly financial statements, the results of the independent audit
and the quarterly reviews and the reports and certifications regarding internal controls over financial reporting and disclosure controls;
|
• |
preparing the audit committee report that the SEC requires to be included in our annual proxy statement;
|
• |
reviewing reports and communications from the independent registered public accounting firm;
|
• |
reviewing the adequacy and effectiveness of our internal controls and disclosure controls and procedure;
|
• |
reviewing our policies on risk assessment and risk management;
|
• |
reviewing related party transactions; and
|
• |
establishing and overseeing procedures for the receipt, retention and treatment of accounting related complaints and the confidential submission by our employees of concerns regarding questionable accounting
or auditing matters.
|
Item 11. |
Executive Compensation.
|
• |
Nima Farzan, our President, Chief Executive Officer and Director;
|
• |
Mark Meltz, our Chief Operating Officer, General Counsel and Corporate Secretary; and
|
• |
Richard Williams, MBBS, Ph.D., our Chief Medical Officer.
|
Name and Principal Position
|
Year
|
Salary ($)
|
Bonus ($)
|
Stock
Awards
($)(1)
|
Option
Awards
($)(1)
|
Non-Equity
Incentive
Plan
Compensation
($)
|
All Other
Compensation
($)
|
Total ($)
|
|||||||||||||||||||||
Nima Farzan
President, Chief Executive Officer and Director
|
2023
|
607,703
|
320,763
|
—
|
3,609,600
|
—
|
1,710
|
4,539,776
|
|||||||||||||||||||||
2022
|
583,206
|
307,038
|
—
|
2,886,280
|
—
|
1,710
|
3,778,234
|
||||||||||||||||||||||
Mark Meltz
Chief Operating Officer, General Counsel and Corporate Secretary
|
2023
|
480,725
|
184,542
|
—
|
1,034,752
|
—
|
2,622
|
1,702,641
|
|||||||||||||||||||||
2022
|
461,354
|
206,045
|
367,750
|
974,120
|
—
|
4,465
|
2,013,734
|
||||||||||||||||||||||
Richard Williams, MBBS, Ph.D.(2)
Chief Medical Officer
|
2023
|
503,437
|
192,358
|
—
|
1,034,752
|
—
|
4,902
|
1,735,449
|
|||||||||||||||||||||
(1) |
This column reflects the aggregate grant date fair value of stock and option awards granted to the officer in the applicable fiscal year, computed in accordance with FASB ASC Topic 718. See Note 2(m) to
our financial statements for the year ended December 31, 2023 included in this Annual Report on Form 10-K for a discussion of the assumptions made by us in determining the grant date fair value of our equity awards. For option awards,
our named executive officers will only realize compensation to the extent the trading price of our common stock is greater than the exercise price of such option awards.
|
(2) |
Dr. Williams was not a named executive officer in our 2023 proxy statement. Therefore, this table does not provide 2022 data for him.
|
• |
a lump-sum payment equal to 9 months (or 12 months in the case of Mr. Farzan) of the executive officer’s annual base salary as in effect immediately prior to such termination (or if
such termination is due to a resignation for good reason based on a material reduction in base salary, then as in effect immediately prior to the reduction);
|
• |
payment of premiums for coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (COBRA), for the executive officer and their eligible dependents, if any,
for up to 9 months (or 12 months in the case of Mr. Farzan); and
|
• |
vesting acceleration of any outstanding equity award that would have otherwise vested had the executive officer remained employed for another 12 months (in the case of Mr. Farzan) or 9
months (in the case of Mr. Meltz and, previously, Dr. Williams).
|
• |
a lump-sum payment equal to 12 months (or 18 months in the case of Mr. Farzan) of the executive officer’s annual base salary as in effect immediately prior to such termination (or if such termination is due
to a resignation for good reason based on a material reduction in base salary, then as in effect immediately prior to the reduction) or if greater, at the level in effect immediately prior to the change in control, based on the number
of days in such year for which the executive officer is employed by, or provided service to, us;
|
• |
a lump-sum payment equal to the sum of (x) 100% (or 150% in the case of Mr. Farzan) of the executive officer’s target annual bonus as in effect for the fiscal year in which such
termination occurs or if greater, at the level in effect, immediately prior to the change in control, plus (y) a pro-rated portion of the executive officer’s target bonus for the year in which the change of control occurs;
|
• |
payment of premiums for coverage under COBRA for the executive officer and the executive officer’s eligible dependents, if any, for up to 12 months (or 24 months in the case of Mr.
Farzan); and
|
• |
100% accelerated vesting and exercisability of all company equity awards with service-based vesting (but that are not subject to performance-based vesting) that are outstanding and
unvested as of the date of the qualifying termination.
|
|
|
Option Awards
|
Stock Awards
|
||||||||||||||||||||||
Name
|
Date of Grant
|
Number of
Securities
Underlying
Exercisable
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercisable
Options (#)
Unexercisable(1)
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
Number of
Shares or
Units of
Stock That
Have Not
Vested (#)(1)
|
Market
Value of
Shares or
Units of
Stock That
Have not
Vested ($)
|
||||||||||||||||||
Nima Farzan(2)
|
3/23/2020
|
1,281,642
|
0
|
2.57
|
3/23/2030
|
—
|
—
|
||||||||||||||||||
Nima Farzan(3)
|
8/18/2020
|
364,510
|
72,903
|
5.63
|
8/18/2030
|
—
|
—
|
||||||||||||||||||
Nima Farzan(4)
|
2/12/2021
|
194,791
|
80,209
|
35.38
|
2/12/2031
|
—
|
—
|
||||||||||||||||||
Nima Farzan(5)
|
2/11/2022
|
183,333
|
216,667
|
10.03
|
2/11/2032
|
—
|
—
|
||||||||||||||||||
Nima Farzan(6)
|
2/10/2023
|
156,229
|
593,771
|
6.78
|
2/10/2033
|
—
|
—
|
||||||||||||||||||
Mark Meltz(7)
|
4/2/2020
|
384,508
|
0
|
2.57
|
4/2/2030
|
—
|
—
|
||||||||||||||||||
Mark Meltz(8)
|
8/18/2020
|
101,252
|
20,251
|
5.63
|
8/18/2030
|
—
|
—
|
||||||||||||||||||
Mark Meltz(9)
|
2/12/2021
|
70,833
|
29,167
|
35.38
|
2/12/2031
|
—
|
—
|
||||||||||||||||||
Mark Meltz(10)
|
2/11/2022
|
61,875
|
73,125
|
10.03
|
2/11/2032
|
—
|
—
|
||||||||||||||||||
Mark Meltz(11)
|
2/10/2023
|
44,785
|
170,215
|
6.78
|
2/10/2033
|
—
|
—
|
||||||||||||||||||
Mark Meltz(12)
|
9/1/2022
|
—
|
—
|
—
|
—
|
17,188
|
40,736
|
||||||||||||||||||
Richard Williams, MBBS, Ph.D.(13)
|
6/22/2020
|
276,757
|
47,252
|
2.57
|
6/22/2030
|
—
|
—
|
||||||||||||||||||
Richard Williams, MBBS, Ph.D.(14)
|
8/18/2020
|
94,502
|
18,901
|
5.63
|
8/18/2030
|
—
|
—
|
||||||||||||||||||
Richard Williams, MBBS, Ph.D.(15)
|
2/12/2021
|
70,833
|
29,167
|
35.38
|
2/12/2031
|
—
|
—
|
||||||||||||||||||
Richard Williams, MBBS, Ph.D.(16)
|
2/11/2022
|
61,875
|
73,125
|
10.03
|
2/11/2032
|
— |
—
|
||||||||||||||||||
Richard Williams, MBBS, Ph.D.(17)
|
2/10/2023
|
44,785
|
170,215
|
6.78
|
2/10/2033
|
—
|
—
|
||||||||||||||||||
Richard Williams, MBBS, Ph.D.(18)
|
9/1/2022
|
—
|
—
|
—
|
—
|
17,188
|
40,736
|
(1) |
The unvested portion of these awards are also subject to vesting acceleration under certain circumstances, as will be more fully described below under “-Potential Payments upon Termination or Change in
Control-Change in Control and Severance Policy.”
|
(2) |
1/4th of the shares subject to the option shall vest on March 3, 2021 and 1/48th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting
date. All of the shares subject to the option may be early exercised.
|
(3) |
1/4th of the shares subject to the option shall vest on August 1, 2021 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(4) |
1/48th of the shares subject to the option shall vest on March 1, 2021 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(5) |
1/48th of the shares subject to the option shall vest on March 1, 2022 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(6) |
1/48th of the shares granted under the option shall vest on March 1, 2023, and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting
date.
|
(7) |
1/4th of the shares subject to the option shall vest on April 1, 2021 and 1/48th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting
date. All of the shares subject to the option may be early exercised.
|
(8) |
1/4th of the shares subject to the option shall vest on August 1, 2021 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(9) |
1/48th of the shares subject to the option shall vest on March 1, 2021 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(10) |
1/48th of the shares subject to the option shall vest on March 1, 2022 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(11) |
1/48th of the shares granted under the option shall vest on March 1, 2023, and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting
date.
|
(12) |
1/16th of the shares subject to the RSU award shall vest on each of March 1, June 1, September 1 and December 1 of each calendar year, beginning December 1, 2022 subject to continued service through
each such vesting date.
|
(13) |
1/4th of the shares subject to the option shall vest on the one year anniversary of July 1, 2020, the Vesting Commencement Date, and thereafter 1/48th of the shares subject to the option shall vest each
month in equal installments on the same day of the month as the Vesting Commencement Date.
|
(14) |
1/4th of the shares subject to the option shall vest on August 1, 2021 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(15) |
1/48th of the shares subject to the option shall vest on March 1, 2021 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(16) |
1/48th of the shares subject to the option shall vest on March 1, 2022 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(17) |
1/48th of the shares granted under the option shall vest on March 1, 2023, and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting
date.
|
(18) |
1/16th of the shares subject to the RSU award shall vest on each of March 1, June 1, September 1 and December 1 of each calendar year, beginning December 1, 2022 subject to continued service through
each such vesting date.
|
• |
$30,000 per year for service as chair of our board of directors;
|
• |
$15,000 per year for service as chair of our audit committee;
|
• |
$7,500 per year for service as a member of our audit committee;
|
• |
$10,000 per year for service as chair of our compensation committee;
|
• |
$5,000 per year for service as a member of our compensation committee;
|
• |
$8,000 per year for service as chair of our nominating and corporate governance committee; and
|
• |
$4,000 per year for service as a member of our nominating and corporate governance committee.
|
Name
|
Fees Earned
or Paid in
Cash ($)
|
Option
Awards ($)(1)
|
All Other
Compensation
($)
|
Total ($)
|
||||||||||||
Jill DeSimone(2)
|
43,750
|
180,240
|
—
|
223,990
|
||||||||||||
Melissa Epperly
|
55,000
|
55,280
|
—
|
110,280
|
||||||||||||
Keith Flaherty, M.D.
|
48,000
|
55,280
|
—
|
103,280
|
||||||||||||
Carl L. Gordon, Ph.D., CFA
|
52,500
|
55,280
|
—
|
107,780
|
||||||||||||
Dean Mitchell
|
84,000
|
55,280
|
—
|
139,280
|
||||||||||||
Michael Rome, Ph.D.(3)
|
—
|
—
|
—
|
—
|
||||||||||||
Helen Sabzevari, Ph.D.
|
40,000
|
55,280
|
—
|
95,280
|
||||||||||||
Laurie Smaldone Alsup, M.D.
|
44,000
|
55,280
|
—
|
99,280
|
||||||||||||
Jim Tananbaum, M.D.(3)
|
—
|
—
|
—
|
—
|
(1) |
This column reflects the aggregate grant date fair value of option awards granted to the director in the applicable fiscal year, computed in accordance with Financial Accounting
Standards Board (FASB) Accounting Standards Codification (ASC) 718, Compensation-Stock Compensation (Topic 718). See Note 2(m) to our financial statements for the year ended December 31, 2022
included in this Annual Report on Form 10-K for a discussion of the assumptions made by us in determining the grant date fair value of our equity awards. Our named executive officers will only realize compensation to the extent the
trading price of our common stock is greater than the exercise price of such stock options.
|
(2) |
Ms. DeSimone began serving as a member of our board of directors effective March 1, 2023.
|
(3) |
Drs. Rome and Tananbaum previously waived their right to receive cash compensation and the annual equity award for their service as a member of our board of directors or its
committees.
|
Option Awards
|
|||||||||||||||
Name
|
Date of Grant
|
Number of Securities Underlying Exercisable Options
|
Number of Securities Underlying Unexercisable Options
|
Option Exercise
Price ($)
|
Option Expiration Date
|
||||||||||
Jill DeSimone(1)
|
3/1/2023
|
12,500
|
37,500
|
5.21
|
3/1/2033
|
||||||||||
Melissa Epperly(2)
|
10/23/2020
|
60,751
|
0
|
8.39
|
10/23/2030
|
||||||||||
Melissa Epperly(3)
|
6/11/2021
|
20,250
|
0
|
24.46
|
6/11/2031
|
||||||||||
Melissa Epperly(4)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
||||||||||
Melissa Epperly(5)
|
6/12/2023
|
12,500
|
12,500
|
3.48
|
6/12/2023
|
||||||||||
Keith Flaherty, M.D.(6)
|
9/17/2018
|
32,064
|
0
|
0.18
|
9/17/2028
|
||||||||||
Keith Flaherty, M.D.(7)
|
2/5/2020
|
56,112
|
0
|
2.57
|
2/5/2030
|
||||||||||
Keith Flaherty, M.D.(8)
|
8/18/2020
|
9,366
|
2,025
|
5.63
|
8/18/2030
|
||||||||||
Keith Flaherty, M.D.(9)
|
6/11/2021
|
20,250
|
0
|
24.46
|
6/11/2031
|
||||||||||
Keith Flaherty, M.D.(10)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
||||||||||
Keith Flaherty, M.D.(11)
|
6/12/2023
|
12,500
|
12,500
|
3.48
|
6/12/2033
|
||||||||||
Carl L. Gordon, Ph.D., CFA(12)
|
12/2/2020
|
40,501
|
20.00
|
12/2/2030
|
|||||||||||
Carl L. Gordon, Ph.D., CFA(13)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
||||||||||
Carl L. Gordon Ph.D., CFA(14)
|
6/12/2023
|
12,500
|
12,500
|
3.48
|
6/12/2033
|
||||||||||
Dean Mitchell(15)
|
8/18/2020
|
121,503
|
0
|
5.63
|
8/18/2030
|
||||||||||
Dean Mitchell(16)
|
6/11/2021
|
20,250
|
0
|
24.46
|
6/11/2031
|
||||||||||
Dean Mitchell(17)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
||||||||||
Dean Mitchell(18)
|
6/12/2023
|
12,500
|
12,500
|
3.48
|
6/12/2023
|
||||||||||
Michael Rome, Ph.D.(19)
|
12/2/2020
|
40,501
|
0
|
20.00
|
12/2/2030
|
||||||||||
Michael Rome, Ph.D.(20)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
||||||||||
Helen Sabzevari, Ph.D.(21)
|
6/24/2021
|
33,750
|
6,751
|
24.38
|
6/24/2031
|
||||||||||
Helen Sabzevari, Ph.D.(22)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
||||||||||
Helen Sabzevari Ph.D.(23)
|
6/12/2023
|
12,500
|
12,500
|
3.48
|
6/12/2033
|
||||||||||
Laurie Smaldone Alsup, M.D.(24)
|
8/22/2020
|
60,751
|
0
|
5.63
|
8/22/2030
|
||||||||||
Laurie Smaldone Alsup, M.D.(25)
|
6/11/2021
|
20,250
|
0
|
24.46
|
6/11/2031
|
||||||||||
Laurie Smaldone Alsup, M.D.(26)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
||||||||||
Laurie Smaldone Alsup, M.D.(27)
|
6/12/2023
|
12,500
|
12,500
|
3.48
|
6/12/2033
|
||||||||||
Jim Tananbaum, M.D.(28)
|
12/2/2020
|
40,501
|
0
|
20.00
|
12/2/2030
|
||||||||||
Jim Tananbaum, M.D.(29)
|
6/13/2022
|
20,250
|
0
|
8.38
|
6/13/2032
|
(1) |
1/36th of the shares subject to the option vest on each monthly anniversary of the date of grant subject to continued service through each such vesting date.
|
(2) |
1/24th of the shares subject to the option vested on December 1, 2020 and 1/24th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting
date.
|
(3) |
1/12th of the shares subject to the option vested on July 11, 2021 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(4) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(5) |
1/12th of the shares subject to the option vested on July 12, 2023 and 1/12th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(6) |
1/48th of the shares subject to the option vested on July 1, 2018 and 1/48th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(7) |
1/48th of the shares subject to the option vested on January 19, 2020 and 1/48th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting
date.
|
(8) |
1/48th of the shares subject to the option vested on September 1, 2020 and 1/48th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(9) |
1/12th of the shares subject to the option vested on July 11, 2021 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(10) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(11) |
1/12th of the shares subject to the option vested on July 12, 2023 and 1/12th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(12) |
1/36th of the shares subject to the option vested on January 2, 2021 and 1/36th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(13) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(14) |
1/12th of the shares subject to the option vested on July 12, 2023 and 1/12th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(15) |
1/24th of the shares subject to the option vested on September 1, 2020 and 1/24th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting
date.
|
(16) |
1/12th of the shares subject to the option vested on July 11, 2021 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(17) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(18) |
1/12th of the shares subject to the option vested on July 12, 2023 and 1/12th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(19) |
1/36th of the shares subject to the option vested on January 2, 2021 and 1/36th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(20) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(21) |
1/36th of the shares subject to the option vested on July 24, 2021 and 1/36th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(22) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(23) |
1/12th of the shares subject to the option vested on July 12, 2023 and 1/12th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(24) |
1/24th of the shares subject to the option vested on September 1, 2020 and 1/24th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting
date.
|
(25) |
1/12th of the shares subject to the option vested on July 11, 2021 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(26) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(27) |
1/12th of the shares subject to the option vested on July 12, 2023 and 1/12th of the shares subject to the option vest monthly thereafter subject to continued service through each such vesting date.
|
(28) |
1/36th of the shares subject to the option vested on January 2, 2021 and 1/36th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
(29) |
1/12th of the shares subject to the option vested on July 13, 2022 and 1/12th of the shares subject to the option vested monthly thereafter subject to continued service through each such vesting date.
|
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
Plan Category
|
Number of
Securities to be
Issued upon
Exercise of
Outstanding
Options,
Restricted
Stock Units
and Rights (#)
|
Weighted
Average
Exercise Price of
Outstanding
Options
and Rights ($)
|
Number of
Securities
Remaining
Available
for Future
Issuance
Under Equity
Compensation
Plans
(Excluding
Securities
Reflected in the
first
Column) (#)
|
|||||||||
Equity compensation plans approved by security holders
|
||||||||||||
2018 Equity Incentive Plan, as Amended and Restated(1)
|
3,906,113
|
$
|
3.82
|
0
|
||||||||
2020 Equity Incentive Plan(2)
|
5,987,303
|
$
|
13.49
|
2,651,449
|
||||||||
2020 Employee Stock Purchase Plan(3)
|
0
|
$
|
0
|
1,116,217
|
||||||||
Equity compensation plans not approved by security holders
|
0
|
$
|
0
|
0
|
||||||||
TOTAL
|
9,893,416
|
$
|
9.67
|
3,767,666
|
(1) |
Our board of directors adopted, and our stockholders approved, the 2018 Equity Incentive Plan, as amended and restated (the 2018 Plan). In connection with our initial public offering and the adoption of
the 2020 Plan, we no longer grant awards under the 2018 Plan; however, all outstanding options issued pursuant to the 2018 Plan continue to be governed by their existing terms. To the extent that any such awards are forfeited or lapse
unexercised or are repurchased, the shares of common stock subject to such awards will become available for issuance under the 2020 Plan.
|
(2) |
Our board of directors adopted, and our stockholders approved, the 2020 Plan. The 2020 Plan provides that the number of shares available for issuance under the 2020 Plan will be increased on the first
day of each fiscal year beginning with the 2022 fiscal year, in an amount equal to the least of (i) 4,348,000 shares, (ii) five percent (5%) of the outstanding shares of common stock on the last day of the immediately preceding fiscal
year or (iii) such other amount as our board of directors may determine.
|
(3) |
Our board of directors adopted, and our shareholders approved, the 2020 Employee Stock Purchase Plan (the ESPP). The ESPP provides that the number of shares available for issuance under the ESPP will be
increased on the first day of each fiscal year beginning with the 2022 fiscal year, in an amount equal to the least of (i) 870,000 shares, (ii) one percent (1%) of the outstanding shares of common stock on the last day of the
immediately preceding fiscal year or (iii) such other amount as the administrator may determine.
|
• |
each of our directors and nominees for director;
|
• |
each of our named executive officers;
|
• |
all of our current directors and executive officers as a group; and
|
• |
each person or group known to us to be the beneficial owner of more than 5% of our common stock.
|
Name of Beneficial Owner
|
Number of Shares of
Common Stock
Beneficially Owned
|
Percentage of Shares
Beneficially Owned
|
||||||
Greater than 5% Stockholders:
|
||||||||
Entities affiliated with Foresite Capital(1)
|
13,718,311
|
29.0
|
%
|
|||||
Entities affiliated with OrbiMed(2)
|
8,009,729
|
17.0
|
%
|
|||||
Tang Capital Partners, LP(3)
|
2,601,647
|
5.5
|
%
|
|||||
|
||||||||
Named Executive Officers and Directors:
|
||||||||
Nima Farzan(4)
|
2,376,696
|
4.8
|
%
|
|||||
Mark Meltz(5)
|
734,738
|
1.5
|
%
|
|||||
Richard Williams, MBBS, Ph.D.(6)
|
693,154
|
1.4
|
%
|
|||||
Jill DeSimone(7)
|
19,444
|
*
|
||||||
Melissa Epperly(8)
|
124,167
|
*
|
||||||
Keith Flaherty, M.D.(9)
|
228,600
|
*
|
||||||
Carl L. Gordon, Ph.D., CFA(10)
|
8,093,396
|
17.1
|
%
|
|||||
Dean Mitchell(11)
|
184,919
|
*
|
||||||
Michael Rome, Ph.D.(12)
|
60,751
|
*
|
||||||
Helen Sabzevari, Ph.D.(13)
|
81,416
|
*
|
||||||
Laurie Smaldone Alsup, M.D.(14)
|
124,167
|
*
|
||||||
Jim Tananbaum, M.D.(15)
|
13,779,062
|
29.1
|
%
|
|||||
All current directors and executive officers as a group (thirteen persons)(16)
|
26,890,528
|
51.5
|
%
|
(1) |
Based on a Schedule 13D/A, reporting beneficial ownership as of February 16, 2024, and filed with the SEC on February 22, 2024, the shares consist of (i) 9,671,643 shares of capital
stock held by Foresite Capital Fund IV, LP (FCF IV), (ii) 3,525,957 shares of capital stock held by Foresite Capital Fund V, LP (FCF V) and (iii) 520,711 shares of capital stock held by Foresite Capital Opportunity Fund V, L.P. (FCOF
V). Jim Tananbaum, M.D., is a member of our board of directors and Chief Executive Officer and Managing Director of Foresite Capital. Foresite Capital Management IV, LLC (FCM IV), the general partner of FCF IV, may be deemed to have
sole power to vote and sole power to dispose of shares directly owned by FCF IV. Foresite Capital Management V, LLC (FCM V), the general partner of FCF V, may be deemed to have sole power to vote and sole power to dispose of shares
directly owned by FCF V. Foresite Capital Opportunity Management V, LLC (FCOM V), the general partner of FCOF V, may be deemed to have sole power to vote and sole power to dispose of shares directly owned by FCOF V. Dr. Tananbaum, the
managing member of each of FCM IV, FCM V and FCOM V, may be deemed to have sole power to vote and sole power to dispose of shares directly owned by FCF IV, FCF V and FCOF V. FCF IV and FCM IV each have sole voting power over 9,671,643
shares and sole dispositive power over 9,671,643 shares. FVC V and FCM V each have sole voting power over 3,525,957 shares and sole dispositive power over 3,525,957 shares. FCOF V and FCOM V each have sole voting power over 520,711
shares and sole dispositive power over 520,711 shares. Dr. Tananbaum has sole voting power over 13,718,311 shares and sole dispositive power over 13,718,311 shares. The address of Dr. Tananbaum and each of the entities listed above is
900 Larkspur Landing Circle, Suite 150, Larkspur, California, 94939.
|
(2) |
Based on a Schedule 13D/A, reporting beneficial ownership as of February 16, 2024, and filed with the SEC on February 21, 2024, the shares consists of (i) 4,738,453 shares of capital stock held by
OrbiMed Private Investments VII, LP (OPI VII), (ii) 1,368,338 shares of capital stock held by OrbiMed Private Investments VIII, LP (OPI VIII), (iii) 1,368,339 shares of capital stock held by OrbiMed Asia Partners IV, L.P. (OAP IV),
(iv) 84,599 shares of capital stock held by OrbiMed Genesis Master Fund, L.P. (Genesis) and (v) 450,000 shares of capital stock held by OrbiMed Partners Master Fund Limited (OPM). OrbiMed Capital GP VII LLC (GP VII) is the general
partner of OPI VII and OrbiMed Advisors LLC (OrbiMed Advisors) is the managing member of GP VII. By virtue of such relationships, GP VII and OrbiMed Advisors share power to direct the vote and disposition of the shares held by OPI VII
and may be deemed directly or indirectly to be the beneficial owners of the shares held by OPI VII. OrbiMed Capital GP VIII LLC (GP VIII) is the general partner of OPI VIII and OrbiMed Advisors is the managing member of GP VIII. By
virtue of such relationships, GP VIII and OrbiMed Advisors share power to direct the vote and disposition of the shares held by OPI VIII and may be deemed directly or indirectly to be the beneficial owners of the shares held by OPI
VIII. OrbiMed Asia GP IV, L.P. (OAP GP IV) is the general partner of OAP IV, OrbiMed Advisors IV Limited (Advisors IV) is the general partner of OAP GP IV, and OrbiMed Advisors is the advisory company of OAP IV. By virtue of such
relationships, OAP GP IV, Advisors IV, and OrbiMed Advisors share power to direct the vote and disposition of the shares held by OAP IV and may be deemed directly or indirectly to be the beneficial owners of the shares held by OAP IV.
OrbiMed Genesis GP LLC (OrbiMed Genesis) is the general partner of Genesis and OrbiMed Advisors is the managing member of OrbiMed Genesis. By virtue of such relationships, OrbiMed Genesis and OrbiMed Advisors share power to direct the
vote and disposition of the shares held by Genesis and may be deemed directly or indirectly to be the beneficial owners of the shares held by Genesis. OrbiMed Capital LLC (OrbiMed Capital) is the investment advisor of OPM. By virtue
of such relationship, OrbiMed Capital has the power to direct the vote and disposition of the shares held by OPM and may be deemed directly or indirectly to be the beneficial owner of the shares held by OPM. Carl Gordon, a member of
OrbiMed Advisors and OrbiMed Capital, serves on our board of directors. OrbiMed Advisors and OrbiMed Capital exercise voting and investment power through management committees comprised of Carl Gordon, Sven Borho and W. Carter Neild,
each of whom disclaims beneficial ownership of the shares held by OPI VII, OPI VIII, OAP IV, Genesis, and OPM. OrbiMed Advisors has shared voting power over 7,559,729 shares and shared dispositive power over 7,559,729 shares. GP VII
has shared voting power over 4,738,453 shares and shared dispositive power over 4,738,453 shares. GP VIII has shared voting power over 1,368,338 shares and shared dispositive power over 1,368,338 shares. Advisors IV has shared voting
power over 1,368,338 shares and shared dispositive power over 1,368,338 shares. OAP GP IV has shared voting power over 1,368,339 shares and shared dispositive power over 1,368,339 shares. OrbiMed Genesis has shared voting power over
84,559 shares and shared dispositive power over 84,559 shares. OrbiMed Capital has shared voting power over 450,000 shares and shared dispositive power over 450,000 shares. The address of each of the individuals and entities listed
above is 601 Lexington Avenue, 54th Floor, New York, NY 10022.
|
(3)
|
Based on a Schedule 13G/A, reporting beneficial ownership as of December 31, 2023, and filed with the SEC on February 14, 2024, the shares consist of 2,601,647 shares of capital stock held by
Tang Capital Partners, LP (Tang Capital Partners). Tang Capital Management, LLC (Tang Capital Management) serves as the general partner of Tang Capital Partners and may be deemed to beneficially own the shares held by Tang
Capital Partners. Tang Capital Management owns no securities of the Company directly. Mr. Kevin Tang is the manager of Tang Capital Management and may be deemed to beneficially own the shares held by Tang Capital Partners. Mr.
Tang owns no securities of the Company directly. Tang Capital Partners has shared voting power over 2,601,647 shares and shared dispositive power over 2,601,647 shares. Tang Capital Management has shared voting power over
2,601,647 shares and shared dispositive power over 2,601,647 shares. Mr. Tang has shared voting power over 2,601,647 shares and shared dispositive power over 2,601,647 shares. The address of each of the individuals and entities
listed above is 4747 Executive Drive, Suite 210, San Diego, CA 92121.
|
(4) |
Consists of (i) 2,186 shares of common stock directly held by Mr. Farzan and (ii) 2,374,510] shares of common stock subject to options held by Mr. Farzan that are exercisable within 60 days of March 13,
2024.
|
(5) |
Consists of (i) 11,953 shares of common stock directly held by Mr. Meltz and (ii) 722,785 shares of common stock subject to options held by Mr. Meltz that are exercisable within 60 days of March 13,
2024.
|
(6) |
Consists of (i) 51,963 shares of common stock directly held by Dr. Williams and (ii) 641,191 shares of common stock subject to options held by Dr. Williams that are exercisable within 60 days of March
13, 2024.
|
(7) |
Consists of 19,444 shares of common stock subject to options held by Ms. DeSimone that are exercisable within 60 days of March 13, 2024.
|
(8) |
Consists of 124,167 shares of common stock subject to options held by Ms. Epperly that are exercisable within 60 days of March 13, 2024.
|
(9) |
Consists of (i) 66,377 shares of common stock directly held by Dr. Flaherty and (ii) 162,223 shares of common stock subject to options held by Dr. Flaherty that are exercisable within 60 days of March
13, 2024.
|
(10) |
Consists of (i) the 8,009,729 shares of common stock described in footnote (2) above and (ii) 83,667 shares of common stock subject to options held by Dr. Gordon that are exercisable within 60 days of
March 13, 2024. Dr. Gordon disclaims beneficial ownership of the shares of common stock described in footnote (2).
|
(11) |
Consists of 184,919 shares of common stock subject to options held by Mr. Mitchell that are exercisable within 60 days of March 13, 2024.
|
(12) |
Consists of 60,751 shares subject to an option that is exercisable within 60 days of March 13, 2024. Dr. Rome has no voting or investment control over the shares held by entities affiliated with
Foresite Capital that are included in footnote (1) above.
|
(13) |
Consists of 81,416 shares of common stock subject to options held by Dr. Sabzevari that are exercisable within 60 days of March 13, 2024.
|
(14) |
Consists of 124,167 shares of common stock subject to options held by Dr. Smaldone Alsup that are exercisable within 60 days of March 13, 2024.
|
(15) |
Consists of (i) the 13,718,311 shares of common stock described in footnote (1) above and (ii) 60,751 shares of common stock subject to options held by Dr. Tanenbaum that are exercisable within 60 days
of March 13, 2024.
|
(16) |
Consists of (i) 21,882,418 shares of common stock directly or indirectly held by our current executive officers and directors and (ii) 5,008,110 shares of common stock subject to options held by our
current executive officers and directors that are exercisable within 60 days of March 13, 2024.
|
Item 13. |
Certain Relationships and Related Transactions, and Director Independence.
|
• |
the amounts involved exceeded or will exceed the lesser of (i) $120,000 or (ii) 1% of the average of our total assets at year end of the last two completed fiscal years; and
|
• |
any of our directors, nominees for director, executive officers or beneficial holders of more than 5% of our outstanding capital stock, or any immediate family member of, or person
sharing the household with, any of these individuals or entities (each, a related person), had or will have a direct or indirect material interest.
|
Item 14. |
Principal Accounting Fees and Services.
|
2023
|
2022
|
|||||||
Audit Fees(1)
|
$
|
839,338
|
$
|
832,995
|
||||
Audit-Related Fees
|
$
|
0
|
$
|
0
|
||||
Tax Fees(2)
|
$
|
47,833
|
$
|
208,673
|
||||
All Other Fees
|
$
|
0
|
$
|
0
|
||||
Total Fees
|
$
|
887,171
|
$
|
1,041,667
|
(1) |
“Audit Fees” consist of fees billed for professional services rendered in connection with the audit of our annual financial statements, reviews of our quarterly financial statements for those fiscal
years, and related services that are normally provided by the independent registered public accounting firm in connection with statutory and regulatory filings, registration statements, including comfort letters and consents, or
engagements for those fiscal years. Audit Fees include fees for services incurred in connection with our registration statement on Form S-3 filed with the SEC on January 3, 2022.
|
(2) |
“Tax Fees” consist of fees billed for professional services rendered by KPMG LLP for tax compliance, tax advice and tax planning.
|
Item 15. |
Exhibits, Financial Statement Schedules.
|
Item 16. |
Form 10-K Summary.
|
Incorporated by Reference
|
||||||||||
Exhibit
Number
|
Exhibit Description
|
Form
|
File No.
|
Exhibit
|
Filing Date
|
|||||
Agreement and Plan of Merger, dated February 16, 2024, by and among XOMA Corporation, XRA 1 Corp. and Kinnate Biopharma Inc.
|
8-K
|
001-39743
|
2.1
|
February 16, 2024
|
||||||
Asset Purchase Agreement, dated February 27, 2024, by and among Kinnate Biopharma Inc. and Pierre Fabre Médicament, SAS.
|
8-K
|
001-39743
|
2.1
|
March 1, 2024
|
||||||
Amended and Restated Certificate of Incorporation of the Registrant.
|
8-K
|
001-39743
|
3.1
|
December 8, 2020
|
||||||
Amended and Restated Bylaws of the Registrant.
|
8-K
|
001-39743
|
3.1
|
July 28, 2023
|
||||||
Amended and Restated Investors’ Rights Agreement by and among the Registrant and certain of its stockholders, dated August 24, 2020.
|
S-1
|
333-250086
|
4.1
|
November 13, 2020
|
||||||
Specimen common stock certificate of the Registrant.
|
S-1/A
|
333-250086
|
4.2
|
November 30, 2020
|
||||||
Description of Securities.
|
10-K
|
001-39743
|
4.3
|
March 28, 2022
|
||||||
Form of Indemnification Agreement between the Registrant and each of its directors and executive officers.
|
S-1
|
333-250086
|
10.1
|
November 13, 2020
|
||||||
2018 Equity Incentive Plan, as amended, and forms of agreement thereunder.
|
S-1
|
333-250086
|
10.2
|
November 13, 2020
|
||||||
2020 Equity Incentive Plan and forms of agreements thereunder.
|
S-1/A
|
333-250086
|
10.3
|
November 30, 2020
|
||||||
2020 Employee Stock Purchase Plan and forms of agreements thereunder.
|
S-1/A
|
333-250086
|
10.4
|
November 30, 2020
|
||||||
Employment Letter between the Registrant and Nima Farzan.
|
S-1
|
333-250086
|
10.5
|
November 13, 2020
|
||||||
Employment Letter between the Registrant and Mark Meltz.
|
S-1
|
333-250086
|
10.6
|
November 13, 2020
|
||||||
Employment Letter between the Registrant and Richard Williams, MBBS, Ph.D.
|
S-1
|
333-250086
|
10.8
|
November 13, 2020
|
||||||
Employment Letter between the Registrant and Neha Krishnamohan.
|
8-K
|
001-39743
|
10.1
|
June 7, 2021
|
||||||
Executive Incentive Compensation Plan.
|
S-1
|
333-250086
|
10.9
|
November 13, 2020
|
||||||
Change in Control and Severance Agreement between the Registrant and Nima Farzan.
|
S-1
|
333-250086
|
10.10
|
November 13, 2020
|
||||||
Change in Control and Severance Agreement between the Registrant and Mark Meltz.
|
S-1
|
333-250086
|
10.11
|
November 13, 2020
|
||||||
Change in Control and Severance Agreement between the Registrant and Richard Williams, MBBS, Ph.D.
|
S-1
|
333-250086
|
10.13
|
November 13, 2020
|
||||||
Change in Control and Severance Agreement between the Registrant and Neha Krishnamohan.
|
8-K
|
001-39743
|
10.2
|
June 7, 2021
|
||||||
Amended and Restated Outside Director Compensation Policy.
|
10-K
|
001-39743
|
10.14
|
March 15, 2023
|
||||||
Sales agreement, between the Company and SVB Leerink LLC, dated as of January 3, 2022.
|
S-3ASR
|
333-261970
|
1.2
|
January 3, 2022
|
||||||
Letter Agreement, dated as of November 22, 2023, by and between the Registrant and Nima Farzan.
|
SC 14D-9
|
005-91893
|
99.E(16)
|
March 4, 2024
|
||||||
Letter Agreement, dated as of November 22, 2023, by and between the Registrant and Mark Meltz.
|
SC 14D-9
|
005-91893
|
99.E(17)
|
March 4, 2024
|
||||||
Letter Agreement, dated as of November 22, 2023, by and between the Registrant and Richard Williams, MBBS, Ph.D.
|
SC 14D-9
|
005-91893
|
99.E(18)
|
March 4, 2024
|
Letter Agreement, dated as of November 22, 2023, by and between the Registrant and Neha Krishnamohan.
|
SC 14D-9
|
005-91893
|
99.E(19)
|
March 4, 2024
|
||||||
Consent of KPMG LLP, Independent Registered Public Accounting Firm.
|
||||||||||
Power of Attorney (reference is made to the signature page hereto).
|
||||||||||
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||||||||||
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||||||||||
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||||||||||
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||||||||||
Kinnate Biopharma Inc. Compensation Recovery Policy.
|
||||||||||
101.INS*
|
Inline XBRL Instance Document.
|
|||||||||
101.SCH*
|
Inline XBRL Taxonomy Extension Schema Document.
|
|||||||||
101.CAL*
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
|
|||||||||
101.DEF*
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
|
|||||||||
101.LAB*
|
Inline XBRL Taxonomy Extension Label Linkbase Document.
|
|||||||||
101.PRE*
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
|
|||||||||
104*
|
Cover Page Interactive Data File (formatted in inline XBRL and contained in Exbibit 101).
|
Kinnate Biopharma Inc.
|
||
Date: March 28, 2024
|
By:
|
/s/ Nima Farzan
|
Nima Farzan
|
||
President and Chief Executive Officer
|
||
Signature
|
Title
|
Date
|
||
/s/ Nima Farzan
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
March 28, 2024
|
||
Nima Farzan
|
||||
/s/ Neha Krishnamohan
|
Chief Financial Officer and Executive Vice President, Corporate Development (Principal Financial Officer and Principal Accounting Officer)
|
March 28, 2024
|
||
Neha Krishnamohan
|
||||
/s/ Dean Mitchell
|
Chair of the Board of Directors
|
March 28, 2024
|
||
Dean Mitchell
|
||||
/s/ Jill DeSimone
|
Director
|
March 28, 2024
|
||
Jill DeSimone
|
||||
/s/ Melissa Epperly
|
Director
|
March 28, 2024
|
||
Melissa Epperly
|
||||
/s/ Keith Flaherty
|
Director
|
March 28, 2024
|
||
Keith Flaherty, M.D.
|
||||
/s/ Carl L. Gordon
|
Director
|
March 28, 2024
|
||
Carl L. Gordon, Ph.D., CFA
|
||||
/s/ Michael Rome
|
Director
|
March 28, 2024
|
||
Michael Rome, Ph.D.
|
||||
/s/ Helen Sabzevari
|
Director
|
March 28, 2024
|
||
Helen Sabzevari, Ph.D.
|
||||
/s/ Laurie Smaldone Alsup
|
Director
|
March 28, 2024
|
||
Laurie Smaldone Alsup, M.D.
|
||||
/s/ Jim Tananbaum
|
Director
|
March 28, 2024
|
||
Jim Tananbaum, M.D.
|