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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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33-0655706
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Title of each class
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Trading Symbol
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Name of each exchange on which registered
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Common Stock, $0.001 par value
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INFI
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Nasdaq Global Select Market
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Large accelerated filer ¨
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Accelerated filer ý
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Non-accelerated filer ¨
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Smaller reporting
company ý
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Emerging growth company ¨
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Page No.
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Part I
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Item 1:
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Item 1A:
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Item 1B:
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Item 2:
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Item 3:
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Item 4:
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Part II
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Item 5:
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Item 6:
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Item 7:
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Item 7A:
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Item 8:
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Item 9:
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Item 9A:
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Part III
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Item 10:
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Item 11:
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Item 12:
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Item 13:
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Item 14:
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Part IV
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Item 15:
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Item 16:
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Time Period
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Multiple
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From the Takeda Amendment Effective Date until June 30, 2022
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145
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%
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From July 1, 2022 through June 30, 2023
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155
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%
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From July 1, 2023 through June 30, 2024
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165
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%
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From July 1, 2024 through June 30, 2025
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175
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%
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preclinical testing including laboratory tests, animal studies and formulation studies, which must be performed in accordance with the FDA’s good laboratory practice, or GLP, regulations and standards;
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submission to the FDA of an investigational new drug, or IND, for human clinical testing, which must become effective before human clinical trials may begin;
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approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;
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performance of adequate and well-controlled human clinical trials to establish the safety, potency and purity of the product candidate for each proposed indication, in accordance with current good clinical practices, or GCP;
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preparation and submission to the FDA of a new drug application, or NDA, for a drug product which includes not only the results of the clinical trials, but also, detailed information on the chemistry, manufacture and quality controls for the product candidate and proposed labeling for one or more proposed indication(s);
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review of the product candidate by an FDA advisory committee, where appropriate or if applicable;
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satisfactory completion of any FDA audits of the non-clinical and clinical trial sites to assure compliance with GCP and the integrity of clinical data in support of the NDA;
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compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct any post-approval studies required by the FDA;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities, including those of third parties, at which the product candidate or components thereof are manufactured to assess compliance with current good manufacturing practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; and
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payment of user fees and securing FDA approval of the NDA to allow marketing of the new drug product.
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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 trials;
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refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties.
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the required patent information has not been filed;
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the listed patent has expired;
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the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
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the listed patent is invalid, unenforceable or will not be infringed by the new product.
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the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
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the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which 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, fictitious or fraudulent or knowingly making, using or causing to made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government.
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willfully 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 respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing ·or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
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the Foreign Corrupt Practices Act, or FCPA, which prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment;
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the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-government third-party payors, including private insurers.
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an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drug agents or biologic agents, which is apportioned among these entities according to their market share in certain government healthcare programs;
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an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
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extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations, unless the drug is subject to discounts under the 340B drug discount program;
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a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
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expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers' Medicaid rebate liability;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
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new requirements under the federal Physician Payments Sunshine Act for drug manufacturers to report information related to payments and other transfers of value made to physicians and teaching hospitals as well as ownership or investment interests held by physicians and their immediate family members;
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
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creation of the Independent Payment Advisory Board, which, if and when impaneled, will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs; and
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establishment of a Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.
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the applicant must complete an identified program of studies within a time period specified by the competent authority, the results of which form the basis of a reassessment of the benefit/risk profile;
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the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and in the case of a radiopharmaceutical, by an authorized person; and
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the package leaflet and any medical information must draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects.
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Compliance with the EU’s stringent pharmacovigilance or safety reporting rules must be ensured. These rules can impose post-authorization studies and additional monitoring obligations.
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The manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice. These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical ingredients into the EU.
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The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the EU notably under Directive 2001/83EC, as amended, and EU Member State laws. Direct-to-consumer advertising of prescription medicines is prohibited across the EU.
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Name
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Age
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Position
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Adelene Q. Perkins
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60
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Chief Executive Officer
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Lawrence E. Bloch, M.D., J.D.
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54
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President and Treasurer
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Jeffery L. Kutok, M.D., Ph.D.
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53
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Executive Vice President, Chief Scientific Officer
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Seth A. Tasker, J.D.
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41
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Senior Vice President, Chief Business Officer, and Secretary
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the scope, progress, results and costs of developing IPI-549, currently in clinical development;
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the timing of, and the costs involved in, obtaining regulatory approvals for IPI-549;
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subject to receipt of marketing approval, revenue, if any, received from commercial sales of IPI-549;
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the timing and amount of additional revenues, if any, received from collaboration agreements and funding arrangements, including:
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▪
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milestone payments from entities affiliated with BVF under the funding agreement we entered into with such parties;
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regulatory and commercial-based milestone payments from PellePharm, Inc., or PellePharm, under the license agreement we entered into with PellePharm related to the development and commercialization of patidegib, the hedgehog inhibitor we licensed to PellePharm under the PellePharm Agreement; and
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milestone payments related to commercial sales of products containing duvelisib (Copiktra®), or Licensed Products, we might receive under the purchase and sale agreement, or HCR Agreement, we entered into with HealthCare Royalty Partners III, L.P., or HCR, or any additional royalties we might receive from Verastem, Inc., or Verastem, if such rights reverted to us in accordance with the HCR Agreement upon satisfaction of our obligations to HCR thereunder;
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the timing and amount of additional royalty and milestone payments owed to Takeda Pharmaceuticals Company Limited, or Takeda, based on sales of Licensed Products by Verastem;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
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any breach, acceleration event or event of default under any agreements with third parties;
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the outcome of any lawsuits that could be brought against us;
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the cost of acquiring raw materials for, and of manufacturing, IPI-549 is higher than anticipated;
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the cost or quantity required of comparator or combination drugs used in clinical studies increases;
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the effect of competing technological and market developments;
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any federal government shutdown that prevents or delays the U.S. Securities and Exchange Commission, or SEC, from processing any future registration statements we may file to register shares for capital raising purposes; and
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a loss in our investments due to general market conditions or other reasons.
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requiring us to dedicate a portion of our cash resources to the payment of interest and principal, and prepayment and repayment fees and penalties, thereby reducing money available to fund working capital, capital expenditures, product development and other general corporate purposes;
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requiring us to grant security interests on our assets;
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subjecting us to restrictive covenants that may reduce our ability to incur additional debt, make capital expenditures, create liens, redeem stock, declare dividends, and acquire, sell or license intellectual property rights, or other operating restrictions that could adversely impact our ability to conduct our business;
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limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete;
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placing us at a competitive disadvantage compared to our competitors that have less debt or better debt servicing options; and
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increasing our vulnerability to adverse changes in general economic, industry and market conditions.
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our ability to raise additional capital;
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initiation, enrollment and successful completion of clinical trials, including in combination with other agents;
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a safety, tolerability and efficacy profile that is satisfactory to the U.S. Food and Drug Administration, or FDA, or any comparable foreign regulatory authority for marketing approval;
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timely receipt of marketing approvals from applicable regulatory authorities;
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the extent of any required post-marketing approval commitments to applicable regulatory authorities;
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establishment of supply arrangements with third-party raw materials suppliers and manufacturers;
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establishment of arrangements with third-party manufacturers to obtain finished drug product that is appropriately packaged for sale;
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adequate ongoing availability of raw materials and drug product for clinical development and any commercial sales;
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obtaining and maintaining patent, trade secret protection and regulatory exclusivity, both in the United States and internationally;
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protection of our rights in our intellectual property portfolio;
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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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clinical practice patterns and standards of care that vary widely among countries;
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non-U.S. regulatory authority requirements that could restrict or limit our ability to conduct our clinical trials;
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administrative burdens of conducting clinical trials under multiple non-U.S. regulatory authority schema;
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foreign exchange fluctuations;
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diminished protection of intellectual property in some countries; and
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geopolitical actions, including war and terrorism, disease outbreak, such as the recent outbreak of a novel strain of coronavirus named COVID-19, or natural disasters including earthquakes, typhoons, floods and fires.
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unfavorable results of discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;
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delays in receiving, or the inability to obtain, required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials;
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delays in enrolling patients into clinical trials;
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a lower than anticipated retention rate of patients in clinical trials;
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the need to repeat or discontinue clinical trials as a result of inconclusive or negative results or unforeseen complications in testing or because the results of later trials may not confirm positive results from earlier preclinical studies or clinical trials;
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inadequate supply, delays in distribution or deficient quality of, or inability to purchase or manufacture drug product, comparator drugs or other materials necessary to conduct our clinical trials;
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unfavorable FDA or other foreign regulatory inspection and review of a clinical trial site, us, or a vendor of ours, or records of any clinical or preclinical investigation;
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serious and unexpected drug-related side effects experienced by participants in our clinical trials, which may occur even if they were not observed in earlier trials or only observed in a limited number of participants;
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a finding that the trial participants are being exposed to unacceptable health risks;
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the placement by the FDA or a foreign regulatory authority of a clinical hold on a trial; or
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any restrictions on, or post-approval commitments with regard to, any regulatory approval we ultimately obtain that render the product candidate not commercially viable.
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regulators or institutional review boards may not authorize us, any collaborators or our or their investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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we, or any collaborators, may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
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clinical trials of IPI-549 may produce unfavorable or inconclusive results;
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we, or any collaborators, may decide, or regulators may require us or them, to conduct additional clinical trials or abandon IPI-549;
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the number of patients required for clinical trials of IPI-549 may be larger than we, or any collaborators, anticipate; patient enrollment in these clinical trials may be slower than we, or any collaborators, anticipate; or participants may drop out of these clinical trials at a higher rate than we, or any collaborators, anticipate;
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the cost of planned clinical trials of IPI-549 may be greater than we anticipate;
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our third-party contractors or those of any collaborators, including those manufacturing IPI-549, comparator or combination drugs, or components or ingredients thereof or conducting clinical trials on our behalf or on behalf of any collaborators, may fail to comply with regulatory requirements or meet their contractual obligations to us or any collaborators in a timely manner or at all;
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patients that enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration and cost;
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we, or any collaborators, may have to delay, suspend or terminate clinical trials of IPI-549 for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of IPI-549;
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regulators or institutional review boards may require that we, or any collaborators, or our or their investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their standards of conduct, a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of IPI-549 or findings of undesirable effects caused by a chemically or mechanistically similar product or product candidate;
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the FDA or comparable foreign regulatory authorities may disagree with our, or any collaborators’, clinical trial designs or our or their interpretation of data from preclinical studies and clinical trials;
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the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we, or any collaborators, enter into agreements for clinical and commercial supplies;
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the supply or quality of raw materials or manufactured product candidates and combination or comparator drugs or other materials necessary to conduct clinical trials of IPI-549 may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; and
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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.
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the size and nature of the patient population;
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the severity of the disease under investigation;
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the nature and complexity of the trial protocol, including eligibility criteria for the trial;
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the number of clinical trial sites and the proximity of patients to those sites;
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standard of care in disease under investigation;
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the commitment of clinical investigators to identify eligible patients;
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competing studies or trials; and
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clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
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the inclusion of a placebo or comparator arm in a trial;
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possible inactivity or low activity of the product candidate being tested at one or more of the dose levels being tested;
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the occurrence of adverse side effects, whether or not related to the product candidate; and
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the availability of numerous alternative treatment options, including clinical trials evaluating competing product candidates, that may induce patients to discontinue their participation in the trial.
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timing of our receipt of any marketing approvals, the terms of any such approvals and the countries in which any such approvals are obtained;
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timing of market introduction of competitive products;
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lower demonstrated clinical safety or efficacy, or less convenient or more difficult route of administration, compared to competitive products;
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lack of cost-effectiveness;
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lack of reimbursement from government payors, managed care plans and other third-party payors;
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prevalence and severity of side effects;
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potential advantages of alternative treatment methods;
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whether it is designated under physician treatment guidelines as a first, second or third line therapy;
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changes in the standard of care for targeted indications;
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limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling;
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safety concerns with similar products marketed by others;
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the reluctance of the target population to try new therapies and of physicians to prescribe those therapies;
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the lack of success of our physician education programs; and
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ineffective sales, marketing and distribution support.
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different regulatory requirements for approval of drugs and biologics in foreign countries;
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reduced protection for intellectual property rights;
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unexpected changes in tariffs, trade barriers and regulatory requirements;
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economic weakness, including inflation, or political instability in particular foreign economies and markets;
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
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business interruptions resulting from geopolitical actions, including war and terrorism, disease outbreak, or natural disasters including earthquakes, typhoons, floods and fires.
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decreased demand for any product candidates or medicines that we may develop;
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injury to our reputation and significant negative media attention;
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withdrawal of clinical trial participants;
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significant costs to defend the related litigation;
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substantial monetary awards to trial participants or patients;
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loss of revenue;
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reduced resources of our management to pursue our business strategy; and
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the inability to commercialize any medicines that we may develop.
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does not or cannot devote the necessary resources to the development, marketing and distribution of such product or products;
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decides not to pursue development and commercialization of the program or to continue or renew development or commercialization programs, based on clinical trial results, changes in the collaborators’ strategic focus or available funding, the belief that other product candidates may have a higher likelihood of obtaining regulatory approval or potential to generate a greater return on investment, or external factors, such as an acquisition, that divert resources or create competing priorities;
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does not perform its obligations as expected;
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does not have sufficient resources necessary or is otherwise unable to carry the program through clinical development, regulatory approval and commercialization;
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cannot obtain the necessary regulatory approvals;
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delays clinical trials, provides insufficient funding for a clinical trial program, stops a clinical trial or abandons the program, repeats or conducts new clinical trials or requires a new formulation of the program for clinical testing;
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independently develops, or develops with third parties, products that compete directly or indirectly with the program;
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does not properly maintain or defend our intellectual property rights or uses our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
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infringes the intellectual property rights of third parties, which may expose us to litigation and potential liability; or
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terminates the collaboration prior to its completion.
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pay substantial damages;
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stop developing, manufacturing and/or commercializing IPI-549 or duvelisib (as applicable);
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develop non-infringing product candidates, technologies and methods; and
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obtain one or more licenses from other parties, which could result in our or Verastem paying substantial royalties or the granting of cross-licenses to our or Verastem’s technologies.
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others may be able to make products that are similar to IPI-549 or any future product candidates we may develop but that are not covered by the claims of the patents that we own or license or may own in the future;
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we, or any partners or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;
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we, or any partners or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;
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it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents;
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issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;
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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;
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we may not develop additional proprietary technologies that are patentable;
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the patents of others may have an adverse effect on our business; and
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we may choose not to file a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
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restrictions on such products, manufacturers or manufacturing processes;
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restrictions on the labeling or marketing of a product;
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restrictions on distribution or use of a product;
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requirements to conduct post-marketing studies or clinical trials;
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warning letters or untitled letters;
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withdrawal of the products from the market;
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refusal to approve pending applications or supplements to approved applications that we submit;
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recall of products;
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damage to relationships with any potential collaborators;
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unfavorable press coverage and damage to our reputation;
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fines, restitution or disgorgement of profits or revenues;
|
•
|
suspension or withdrawal of marketing approvals;
|
•
|
refusal to permit the import or export of our products;
|
•
|
product seizure;
|
•
|
injunctions or the imposition of civil or criminal penalties; and
|
•
|
litigation involving patients using our products.
|
•
|
the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation or arranging of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;
|
•
|
the federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government, with potential liability including mandatory treble damages and significant per-claim penalties, currently set at minimum of $11,181 and a maximum of $22,363 per false claim;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs to report payments and other transfers of value to physicians and teaching hospitals; and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws and transparency statutes, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.
|
•
|
an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic products;
|
•
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
|
•
|
expansion of federal healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
|
•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices;
|
•
|
extension of manufacturers’ Medicaid rebate liability;
|
•
|
expansion of eligibility criteria for Medicaid programs;
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
new requirements to report financial arrangements with physicians and teaching hospitals;
|
•
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
•
|
the results of our current and any future clinical trials of IPI-549;
|
•
|
future sales of, and the trading volume in, our common stock;
|
•
|
announcements of strategic transactions relating to our programs or our company;
|
•
|
our entry into key agreements, including those related to the acquisition or in-licensing of new programs, or the termination of key agreements, including the Takeda Agreement or the Verastem Agreement;
|
•
|
the results and timing of regulatory reviews relating to the approval of IPI-549;
|
•
|
the initiation of, material developments in, or conclusion of litigation, including but not limited to litigation to enforce or defend any of our intellectual property rights or to defend product liability claims;
|
•
|
the failure of IPI-549, if approved, to achieve commercial success;
|
•
|
the results of clinical trials conducted by others on drugs that would compete with IPI-549;
|
•
|
the regulatory approval of drugs that would compete with IPI-549;
|
•
|
issues in manufacturing IPI-549;
|
•
|
the loss of executive officers or other key employees;
|
•
|
changes in estimates or recommendations, or publication of inaccurate or unfavorable research about our business, by securities analysts who cover our common stock;
|
•
|
future financings through the issuance of equity or debt securities or otherwise;
|
•
|
healthcare reform measures, including changes in the structure of healthcare payment systems;
|
•
|
our cash position and period-to-period fluctuations in our financial results; and
|
•
|
general and industry-specific economic and/or capital market conditions.
|
•
|
delaying, deferring or preventing a change in control of our company;
|
•
|
impeding a merger, consolidation, takeover or other business combination involving us; or
|
•
|
discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.
|
•
|
MARIO-275 (IPI-549-02). MAcrophage Reprogramming in Immuno-Oncology-275, or MARIO-275, is a global, randomized Phase 2 study designed to evaluate the effect of adding IPI-549 to nivolumab, also known as Opdivo®, in approximately 160 checkpoint-naïve advanced urothelial cancer, or UC, patients whose cancer has progressed or recurred following treatment with platinum-based chemotherapy. Nivolumab is an immune checkpoint inhibitor therapy commercialized by Bristol-Myers Squibb Company, or BMS, that targets programmed death receptor 1, or PD-1, a checkpoint protein that helps regulate the body’s immune system. We entered into a clinical supply agreement in November 2018 with BMS under which BMS has agreed to supply nivolumab for our use in MARIO-275. Based on a retrospective analysis of BMS’s approval study, CheckMate-275, UC patients who had high baseline levels of myeloid-derived suppressor cells, or MDSCs, had a shorter overall survival when treated with nivolumab as a single agent. Data from our ongoing Phase 1/1b study MARIO-1, described below, have demonstrated that treatment with the combination of IPI-549 and nivolumab is associated with a reduction in blood MDSC levels. We believe that adding IPI-549 to nivolumab can potentially improve outcomes for patients with urothelial cancer. MARIO-275 patients are enrolled into either the combination arm, evaluating IPI-549 plus nivolumab, or the monotherapy arm, evaluating nivolumab plus placebo, at a ratio of two to one (combination arm to monotherapy arm). Patients who progress on the monotherapy arm of the study will have the opportunity to cross over to the combination arm. The primary objective of MARIO-275 is to compare the overall response rate of MDSC-high patients in the combination arm to MDSC-high patients in the monotherapy arm. The study design will also allow us to evaluate the benefit of IPI-549 to all patients, regardless of MDSC status, and the benefit of IPI-549 to those patients who progress on the monotherapy arm of the study and choose to cross over to the combination arm. We expect to complete enrollment for MARIO-275 in 2020.
|
•
|
MARIO-3 (IPI-549-03). MARIO-3 is a multi-arm Phase 2 study designed to evaluate IPI-549 in the front-line setting for triple negative breast cancer, or TNBC, and front-line renal cell carcinoma, or RCC. One cohort of the study is evaluating IPI-549 in combination with atezolizumab, also known as Tecentriq®, and nab-paclitaxel, also known as Abraxane®, in 60 patients with front-line TNBC. The second cohort is evaluating IPI-549 in combination with atezolizumab and bevacizumab, also known as Avastin®, in 30 patients with front-line RCC. In recent studies investigating atezolizumab and nab-paclitaxel combination therapy in front-line PD-L1 positive TNBC patients and investigating atezolizumab and bevacizumab in front-line RCC patients, complete response rates were less than 10%. MARIO-3 is intended to evaluate whether IPI-549 can improve upon the response rates of these combination therapies in patients with unmet needs. We expect to complete enrollment for and provide initial data from MARIO-3 in 2020. We entered into a clinical supply agreement with F. Hoffmann-La Roche Ltd., or Roche, in March 2019 under which Roche has agreed to supply atezolizumab for our use in MARIO-3.
|
•
|
Arcus Collaboration Trial (NCT03719326). A Phase 1/1b collaboration study being conducted by Arcus Biosciences, Inc., or Arcus, is designed to evaluate a novel triple-combination regimen of IPI-549 in combination with AB928, Arcus’s dual adenosine receptor antagonist, and liposomal doxorubicin chemotherapy, also known as Doxil®, in up to 40 patients with previously treated, advanced TNBC. AB928 is an orally bioavailable, highly potent antagonist of the adenosine 2a and 2b receptors. The activation of these receptors by adenosine interferes with the activity of key populations of immune cells and inhibits the body’s optimal anti-tumor immune response. By blocking these receptors, AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment. As both macrophages and high adenosine levels are believed to play critical roles in creating a highly immunosuppressive tumor microenvironment in cancer after treatment with chemotherapy, the novel immuno-oncology combination being evaluated in this setting represents a potentially promising approach to treating TNBC.
|
•
|
compensation of personnel associated with research and development activities;
|
•
|
clinical testing costs, including payments made to contract research organizations;
|
•
|
costs of combination and comparator drugs used in clinical studies;
|
•
|
costs of manufacturing product candidates for preclinical testing and clinical studies;
|
•
|
costs associated with the licensing of research and development programs;
|
•
|
preclinical testing costs, including costs of toxicology studies;
|
•
|
fees paid to external consultants;
|
•
|
fees paid to professional service providers for independent monitoring and analysis of our clinical trials;
|
•
|
costs for collaboration partners to perform research and development activities, including development milestones for which a payment is due when achieved;
|
•
|
depreciation of equipment; and
|
•
|
allocated costs of facilities.
|
|
|
2019
|
|
2018
|
|
% Change
|
|||||
Collaboration revenue
|
|
$
|
2,000
|
|
|
$
|
22,000
|
|
|
(91
|
)%
|
Royalty revenue
|
|
1,049
|
|
|
146
|
|
|
618
|
%
|
||
Research and development expense
|
|
(27,116
|
)
|
|
(19,758
|
)
|
|
37
|
%
|
||
General and administrative expense
|
|
(14,289
|
)
|
|
(14,248
|
)
|
|
—
|
%
|
||
Royalty expense
|
|
(7,308
|
)
|
|
(69
|
)
|
|
10,491
|
%
|
||
Investment and other income
|
|
1,116
|
|
|
769
|
|
|
45
|
%
|
||
Interest expense
|
|
(2,563
|
)
|
|
(93
|
)
|
|
2,656
|
%
|
||
Income taxes benefit
|
|
54
|
|
|
—
|
|
|
—
|
%
|
•
|
the nature, timing and estimated costs of the efforts necessary to complete the development of our programs;
|
•
|
the completion dates of these programs; or
|
•
|
the period in which material net cash inflows are expected to commence, if at all, from the programs described above and any potential future product candidates.
|
•
|
the scope, rate of progress and cost of our clinical trials that we are currently conducting or may commence in the future;
|
•
|
clinical trial results;
|
•
|
the cost of establishing clinical supplies of any product candidates;
|
•
|
the cost and availability of combination and comparator drugs;
|
•
|
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our programs under development;
|
•
|
the terms and timing of any collaborations, licensing and other arrangements that we have or may establish in the future relating to our programs under development;
|
•
|
the cost and timing of regulatory approvals; and
|
•
|
the effect of competing technological and market developments.
|
|
|
Year Ended December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
|
|
(in thousands)
|
||||||
Cash (used in) provided by:
|
|
|
|
|
||||
Operating activities
|
|
$
|
(41,530
|
)
|
|
$
|
(4,714
|
)
|
Investing activities
|
|
(12,241
|
)
|
|
13,104
|
|
||
Financing activities
|
|
27,730
|
|
|
5,619
|
|
•
|
the scope, progress, results and costs of developing IPI-549, currently in clinical development;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for IPI-549;
|
•
|
subject to receipt of marketing approval, revenue, if any, received from commercial sales of IPI-549;
|
•
|
the timing and amount of additional revenues, if any, received from collaboration agreements and funding arrangements, including:
|
▪
|
milestone payments from entities affiliated with BVF under the funding agreement we entered into with such parties;
|
▪
|
regulatory and commercial-based milestone payments from PellePharm, Inc., or PellePharm, under the license agreement we entered into with PellePharm related to the development and commercialization of patidegib, the hedgehog inhibitor we licensed to PellePharm under the PellePharm Agreement; and
|
▪
|
milestone payments related to commercial sales of products containing duvelisib (Copiktra®), or Licensed Products, we might receive under the purchase and sale agreement, or HCR Agreement, we entered into with HealthCare Royalty Partners III, L.P., or HCR, or any additional royalties we might receive from Verastem, Inc., or Verastem, if such rights reverted to us in accordance with the HCR Agreement upon satisfaction of our obligations to HCR thereunder;
|
•
|
the timing and amount of additional royalty and milestone payments owed to Takeda Pharmaceuticals Company Limited, or Takeda, based on sales of Licensed Products by Verastem;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
|
•
|
any breach, acceleration event or event of default under any agreements with third parties;
|
•
|
the outcome of any lawsuits that could be brought against us;
|
•
|
the cost of acquiring raw materials for, and of manufacturing, IPI-549 is higher than anticipated;
|
•
|
the cost or quantity required of comparator or combination drugs used in clinical studies increases;
|
•
|
the effect of competing technological and market developments;
|
•
|
any federal government shutdown that prevents or delays the U.S. Securities and Exchange Commission, or SEC, from processing any future registration statements we may file to register shares for capital raising purposes; and
|
•
|
a loss in our investments due to general market conditions or other reasons.
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
22,260
|
|
|
$
|
48,616
|
|
Available-for-sale securities
|
20,184
|
|
|
9,975
|
|
||
Prepaid expenses and other current assets
|
2,137
|
|
|
1,227
|
|
||
Total current assets
|
44,581
|
|
|
59,818
|
|
||
Property and equipment, net
|
2,186
|
|
|
28
|
|
||
Restricted cash
|
315
|
|
|
—
|
|
||
Operating lease right-of-use assets
|
1,717
|
|
|
—
|
|
||
Other assets
|
215
|
|
|
369
|
|
||
Total assets
|
$
|
49,014
|
|
|
$
|
60,215
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,621
|
|
|
$
|
1,197
|
|
Accrued expenses and other current liabilities
|
8,077
|
|
|
6,521
|
|
||
Total current liabilities
|
9,698
|
|
|
7,718
|
|
||
Liability related to sale of future royalties, net (note 9)
|
29,626
|
|
|
—
|
|
||
Operating lease liability, less current portion
|
1,926
|
|
|
—
|
|
||
Other liabilities
|
38
|
|
|
38
|
|
||
Total liabilities
|
41,288
|
|
|
7,756
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred Stock, $0.001 par value; 1,000,000 shares authorized, no shares issued and outstanding at December 31, 2019 and 2018
|
—
|
|
|
—
|
|
||
Common Stock, $0.001 par value; 100,000,000 shares authorized; 57,077,550 and 56,907,096 shares issued and outstanding at December 31, 2019 and 2018, respectively
|
57
|
|
|
57
|
|
||
Additional paid-in capital
|
733,486
|
|
|
731,178
|
|
||
Accumulated deficit
|
(725,829
|
)
|
|
(678,772
|
)
|
||
Accumulated other comprehensive loss
|
12
|
|
|
(4
|
)
|
||
Total stockholders’ equity
|
7,726
|
|
|
52,459
|
|
||
Total liabilities and stockholders’ equity
|
$
|
49,014
|
|
|
$
|
60,215
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Revenue:
|
|
|
|
||||
Collaboration revenue
|
$
|
2,000
|
|
|
$
|
22,000
|
|
Royalty revenue
|
1,049
|
|
|
146
|
|
||
Total revenues
|
3,049
|
|
|
22,146
|
|
||
Operating expenses:
|
|
|
|
||||
Research and development
|
27,116
|
|
|
19,758
|
|
||
General and administrative
|
14,289
|
|
|
14,248
|
|
||
Royalty expense (note 11)
|
7,308
|
|
|
69
|
|
||
Total operating expenses
|
48,713
|
|
|
34,075
|
|
||
Loss from operations
|
(45,664
|
)
|
|
(11,929
|
)
|
||
Other income (expense):
|
|
|
|
||||
Investment and other income
|
1,116
|
|
|
769
|
|
||
Interest expense (note 9)
|
(2,563
|
)
|
|
(93
|
)
|
||
Total other income (expense)
|
(1,447
|
)
|
|
676
|
|
||
Loss before income taxes
|
(47,111
|
)
|
|
(11,253
|
)
|
||
Income tax benefit
|
54
|
|
|
—
|
|
||
Net loss
|
$
|
(47,057
|
)
|
|
$
|
(11,253
|
)
|
Basic and diluted loss per common share
|
$
|
(0.83
|
)
|
|
$
|
(0.20
|
)
|
Basic and diluted weighted average number of common shares outstanding
|
56,983,652
|
|
|
55,411,370
|
|
||
Other comprehensive loss:
|
|
|
|
||||
Net unrealized holding gains on available-for-sale securities arising during the period
|
$
|
16
|
|
|
$
|
11
|
|
Comprehensive loss
|
$
|
(47,041
|
)
|
|
$
|
(11,242
|
)
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(47,057
|
)
|
|
$
|
(11,253
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation
|
219
|
|
|
191
|
|
||
Stock-based compensation, including 401(k) match
|
2,133
|
|
|
3,448
|
|
||
Non-cash royalty revenue
|
(555
|
)
|
|
—
|
|
||
Non-cash interest expense
|
2,563
|
|
|
—
|
|
||
Other, net
|
(216
|
)
|
|
138
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other assets
|
(756
|
)
|
|
(71
|
)
|
||
Operating lease right-of-use asset
|
364
|
|
|
—
|
|
||
Accounts payable, accrued expenses and other liabilities
|
1,550
|
|
|
2,833
|
|
||
Operating lease liability
|
225
|
|
|
—
|
|
||
Net cash used in operating activities
|
(41,530
|
)
|
|
(4,714
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(2,327
|
)
|
|
—
|
|
||
Purchases of available-for-sale securities
|
(41,864
|
)
|
|
(15,686
|
)
|
||
Proceeds from maturities of available-for-sale securities
|
31,950
|
|
|
28,790
|
|
||
Net cash provided by (used in) investing activities
|
(12,241
|
)
|
|
13,104
|
|
||
Financing activities
|
|
|
|
||||
Proceeds from sale of future royalties, net
|
27,618
|
|
|
—
|
|
||
Proceeds from common stock sales facility, net of issuance costs
|
—
|
|
|
9,330
|
|
||
Proceeds from issuances of common stock, net
|
112
|
|
|
289
|
|
||
Repayment of note payable
|
—
|
|
|
(4,000
|
)
|
||
Net cash provided by financing activities
|
27,730
|
|
|
5,619
|
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
(26,041
|
)
|
|
14,009
|
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
48,616
|
|
|
34,607
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
22,575
|
|
|
$
|
48,616
|
|
|
|
|
|
||||
Reconciliation of cash, cash equivalents, and restricted cash to the consolidated balance sheets
|
|
|
|
||||
Cash and cash equivalents
|
22,260
|
|
|
48,616
|
|
||
Restricted cash
|
315
|
|
|
—
|
|
||
Total cash, cash equivalents and restricted cash
|
$
|
22,575
|
|
|
$
|
48,616
|
|
|
|
|
|
||||
Supplemental schedule of noncash activities
|
|
|
|
||||
Assets acquired under operating lease obligation
|
$
|
1,908
|
|
|
$
|
—
|
|
Property and equipment in accounts payable and accrued expenses
|
$
|
50
|
|
|
$
|
—
|
|
Issuance of common stock for repayment of note payable, including interest
|
$
|
—
|
|
|
$
|
2,301
|
|
Issuance of common stock for compensation
|
$
|
—
|
|
|
$
|
493
|
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Income (Loss) |
|
Total
Stockholders’ Equity |
|||||||||||||
|
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance at December 31, 2017
|
|
50,761,039
|
|
|
$
|
51
|
|
|
$
|
715,213
|
|
|
$
|
(667,519
|
)
|
|
$
|
(15
|
)
|
|
$
|
47,730
|
|
Exercise of stock options
|
|
135,000
|
|
|
|
|
199
|
|
|
|
|
|
|
199
|
|
||||||||
Stock-based compensation expense
|
|
|
|
|
|
3,323
|
|
|
|
|
|
|
3,323
|
|
|||||||||
Issuance of common stock related to sales facility, net of issuance costs
|
|
4,461,893
|
|
|
5
|
|
|
9,325
|
|
|
|
|
|
|
9,330
|
|
|||||||
Issuance of common stock related to repayment of note payable
|
|
1,134,689
|
|
|
1
|
|
|
2,300
|
|
|
|
|
|
|
2,301
|
|
|||||||
Issuance of common stock, net
|
|
414,475
|
|
|
|
|
818
|
|
|
|
|
|
|
818
|
|
||||||||
Unrealized gain on marketable securities
|
|
|
|
|
|
|
|
|
|
11
|
|
|
11
|
|
|||||||||
Net loss
|
|
|
|
|
|
|
|
(11,253
|
)
|
|
|
|
(11,253
|
)
|
|||||||||
Balance at December 31, 2018
|
|
56,907,096
|
|
|
$
|
57
|
|
|
$
|
731,178
|
|
|
$
|
(678,772
|
)
|
|
$
|
(4
|
)
|
|
$
|
52,459
|
|
Exercise of stock options
|
|
2,188
|
|
|
|
|
|
3
|
|
|
|
|
|
|
3
|
|
|||||||
Stock-based compensation expense
|
|
|
|
|
|
2,133
|
|
|
|
|
|
|
2,133
|
|
|||||||||
Issuance of common stock, net
|
|
168,266
|
|
|
|
|
172
|
|
|
|
|
|
|
172
|
|
||||||||
Unrealized gain on marketable securities
|
|
|
|
|
|
|
|
|
|
16
|
|
|
16
|
|
|||||||||
Net loss
|
|
|
|
|
|
|
|
(47,057
|
)
|
|
|
|
(47,057
|
)
|
|||||||||
Balance at December 31, 2019
|
|
57,077,550
|
|
|
$
|
57
|
|
|
$
|
733,486
|
|
|
$
|
(725,829
|
)
|
|
$
|
12
|
|
|
$
|
7,726
|
|
Computer equipment and software
|
|
3 to 5 years
|
Leasehold improvements
|
|
Shorter of lease term or useful life of asset
|
Furniture and fixtures
|
|
7 to 10 years
|
|
Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Research and development
|
$
|
491
|
|
|
$
|
553
|
|
General and administrative
|
1,642
|
|
|
2,895
|
|
||
Total stock-based compensation expense
|
$
|
2,133
|
|
|
$
|
3,448
|
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||
Risk-free interest rate
|
2.3
|
%
|
|
2.5
|
%
|
Expected annual dividend yield
|
—
|
|
|
—
|
|
Expected stock price volatility
|
99.4
|
%
|
|
96.9
|
%
|
Expected term of options
|
5.9 years
|
|
|
5.7 years
|
|
•
|
Risk-free interest rate: The yield on zero-coupon U.S. Treasury securities for a period that was commensurate with the expected term of the awards.
|
•
|
Expected annual dividend yield: The estimate for annual dividends was zero because we have not historically paid a dividend and do not intend to do so in the foreseeable future.
|
•
|
Expected stock price volatility: We determined the expected volatility by using our available implied and historical price information.
|
•
|
Expected term of options: The expected term of the awards represents the period of time that the awards were expected to be outstanding. We use the simplified method to estimate expected term, whereby, the expected life equals the average of the vesting term and the original contractual term of the option.
|
|
Stock Options
|
|
Weighted-
Average
Exercise Price
|
|
Weighted-Average
Remaining
Contractual Life
(years)
|
|
Aggregate
Intrinsic Value
(in millions)
|
|||||
Outstanding at January 1, 2019
|
8,151,608
|
|
|
$
|
5.36
|
|
|
|
|
|
||
Granted
|
2,199,596
|
|
|
1.30
|
|
|
|
|
|
|||
Exercised
|
(2,188
|
)
|
|
1.24
|
|
|
|
|
|
|||
Forfeited
|
(465,405
|
)
|
|
1.73
|
|
|
|
|
|
|||
Expired
|
(307,292
|
)
|
|
5.87
|
|
|
|
|
|
|||
Outstanding at December 31, 2019
|
9,576,319
|
|
|
$
|
4.58
|
|
|
6.6
|
|
$
|
—
|
|
Exercisable at December 31, 2019
|
7,789,517
|
|
|
$
|
5.31
|
|
|
6.1
|
|
$
|
—
|
|
|
December 31, 2019
|
||||||||||||||
|
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
||||||||
|
(in thousands)
|
||||||||||||||
Cash and cash equivalents
|
$
|
22,260
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
22,260
|
|
Available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury securities due in one year or less
|
8,244
|
|
|
4
|
|
|
—
|
|
|
8,248
|
|
||||
U.S. government-sponsored enterprise obligations due in one year or less
|
11,928
|
|
|
8
|
|
|
—
|
|
|
11,936
|
|
||||
Total available-for-sale securities
|
20,172
|
|
|
12
|
|
|
—
|
|
|
20,184
|
|
||||
Total cash, cash equivalents and available-for-sale securities
|
$
|
42,432
|
|
|
$
|
12
|
|
|
$
|
—
|
|
|
$
|
42,444
|
|
|
|
|
|
|
|
|
|
||||||||
|
December 31, 2018
|
||||||||||||||
|
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
||||||||
|
(in thousands)
|
||||||||||||||
Cash and cash equivalents
|
$
|
48,616
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
48,616
|
|
Available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury securities due in one year or less
|
4,988
|
|
|
—
|
|
|
(2
|
)
|
|
4,986
|
|
||||
U.S. government-sponsored enterprise obligations due in one year or less
|
4,991
|
|
|
—
|
|
|
(2
|
)
|
|
4,989
|
|
||||
Total available-for-sale securities
|
9,979
|
|
|
—
|
|
|
(4
|
)
|
|
9,975
|
|
||||
Total cash, cash equivalents and available-for-sale securities
|
$
|
58,595
|
|
|
$
|
—
|
|
|
$
|
(4
|
)
|
|
$
|
58,591
|
|
|
December 31, 2019
|
||||||
|
Level 1
|
|
Level 2
|
||||
|
(in thousands)
|
||||||
Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
20,860
|
|
|
$
|
1,400
|
|
U.S. Treasury securities
|
—
|
|
|
8,248
|
|
||
U.S. government-sponsored enterprise obligations
|
—
|
|
|
11,936
|
|
||
Total
|
$
|
20,860
|
|
|
$
|
21,584
|
|
|
|
|
|
||||
|
December 31, 2018
|
||||||
|
Level 1
|
|
Level 2
|
||||
|
(in thousands)
|
||||||
Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
48,616
|
|
|
$
|
—
|
|
U.S. Treasury securities
|
—
|
|
|
4,986
|
|
||
U.S. government-sponsored enterprise obligations
|
—
|
|
|
4,989
|
|
||
Total
|
$
|
48,616
|
|
|
$
|
9,975
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Prepaid expenses
|
$
|
1,680
|
|
|
$
|
641
|
|
Other current assets
|
457
|
|
|
586
|
|
||
Total prepaid expenses and other current assets
|
$
|
2,137
|
|
|
$
|
1,227
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Computer equipment and software
|
$
|
1,893
|
|
|
$
|
1,814
|
|
Furniture and fixtures
|
446
|
|
|
—
|
|
||
Leasehold improvements
|
1,735
|
|
|
16
|
|
||
|
4,074
|
|
|
1,830
|
|
||
Less accumulated depreciation
|
(1,888
|
)
|
|
(1,802
|
)
|
||
|
$
|
2,186
|
|
|
$
|
28
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Accrued compensation and benefits
|
$
|
3,055
|
|
|
$
|
2,630
|
|
Accrued clinical and development
|
3,793
|
|
|
2,656
|
|
||
Operating lease liability, current
|
381
|
|
|
—
|
|
||
Other
|
848
|
|
|
1,235
|
|
||
Total accrued expenses
|
$
|
8,077
|
|
|
$
|
6,521
|
|
Time Period
|
Cap Amount
|
|
From the HCR Closing Date until June 30, 2022
|
145
|
%
|
From July 1, 2022 through June 30, 2023
|
155
|
%
|
From July 1, 2023 through June 30, 2024
|
165
|
%
|
From July 1, 2024 through June 30, 2025
|
175
|
%
|
|
December 31, 2019
|
||
|
(in thousands)
|
||
Liability related to sale of future royalties - beginning balance
|
$
|
—
|
|
Proceeds from sale of future royalties
|
30,000
|
|
|
Debt discount and issuance costs
|
(2,382
|
)
|
|
Non-cash royalty revenue
|
(555
|
)
|
|
Non-cash interest expense recognized
|
2,563
|
|
|
Liability related to sale of future royalties - ending balance
|
$
|
29,626
|
|
|
December 31, 2019
|
||
Assets
|
(in thousands)
|
||
Operating lease right-of-use assets
|
$
|
1,717
|
|
Liabilities
|
|
||
Accrued expenses and other current liabilities
|
$
|
381
|
|
Operating lease liability
|
1,926
|
|
|
Total lease liabilities
|
$
|
2,307
|
|
|
Operating Leases
|
||
|
(in thousands)
|
||
2020
|
$
|
700
|
|
2021
|
660
|
|
|
2022
|
640
|
|
|
2023
|
658
|
|
|
2024
|
334
|
|
|
Total future minimum lease payments
|
2,992
|
|
|
Less: lease incentive allowance
|
(83
|
)
|
|
Less: imputed interest
|
(602
|
)
|
|
Total lease liability
|
$
|
2,307
|
|
Time Period
|
Multiple
|
|
From the Takeda Amendment Effective Date until June 30, 2022
|
145
|
%
|
From July 1, 2022 through June 30, 2023
|
155
|
%
|
From July 1, 2023 through June 30, 2024
|
165
|
%
|
From July 1, 2024 through June 30, 2025
|
175
|
%
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Expected federal tax benefit
|
$
|
(9,893
|
)
|
|
$
|
(2,363
|
)
|
Permanent differences
|
352
|
|
|
337
|
|
||
State taxes, net of the deferred federal benefit
|
(2,905
|
)
|
|
(621
|
)
|
||
Tax credit carryforwards
|
(738
|
)
|
|
(450
|
)
|
||
Adjustments to deferred tax assets and deferred tax liabilities
|
265
|
|
|
1,073
|
|
||
Other
|
8
|
|
|
(24
|
)
|
||
Change in valuation allowance
|
12,857
|
|
|
2,048
|
|
||
Income tax expense (benefit)
|
$
|
(54
|
)
|
|
$
|
—
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Deferred tax assets (liabilities):
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
145,024
|
|
|
$
|
139,690
|
|
Tax credit carryforwards
|
41,730
|
|
|
40,977
|
|
||
Intangible assets
|
18,977
|
|
|
20,336
|
|
||
Accrued expenses
|
590
|
|
|
48
|
|
||
Stock-based compensation
|
5,661
|
|
|
5,698
|
|
||
Sale of future royalties
|
8,088
|
|
|
—
|
|
||
Other
|
(98
|
)
|
|
366
|
|
||
Valuation allowance
|
(219,972
|
)
|
|
(207,115
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
•
|
Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;
|
•
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
|
•
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
|
|
|
|
Page number
|
|
|
|
|
Incorporated by Reference
|
|||||||
Exhibit No.
|
|
Description
|
|
Form
|
|
SEC
Filing
date
|
|
Exhibit
Number
|
|
Filed
with
this
10-K
|
|
|
|
10-Q
|
|
8/9/2007
|
|
3.1
|
|
|
|
||
|
|
8-K
|
|
3/17/2009
|
|
3.1
|
|
|
|
||
|
|
10-K
|
|
3/14/2008
|
|
4.1
|
|
|
|
||
|
|
|
|
|
|
|
|
|
X
|
||
Collaboration Agreements
|
|
|
|
|
|
|
|
|
|||
|
|
10-K
|
|
3/5/2013
|
|
10.4
|
|
|
|
||
|
|
10-Q
|
|
11/10/2014
|
|
10.1
|
|
|
|
||
|
|
10-Q
|
|
11/9/2016
|
|
10.1
|
|
|
|
||
|
|
10-Q
|
|
11/7/2017
|
|
10.1
|
|
|
|
||
|
|
10-Q
|
|
5/7/2019
|
|
10.1
|
|
|
|
||
|
|
10-Q
|
|
11/7/2017
|
|
10.2
|
|
|
|
||
|
|
10-K
|
|
3/14/2017
|
|
10.4
|
|
|
|
||
|
|
8-K
|
|
7/19/2012
|
|
10.2
|
|
|
|
||
|
|
8-K
|
|
7/19/2012
|
|
10.3
|
|
|
|
||
Financing Agreements
|
|
|
|
|
|
|
|
|
|||
|
|
10-Q
|
|
5/6/2014
|
|
10.2
|
|
|
|
||
|
|
10-Q
|
|
5/7/2019
|
|
10.2
|
|
|
|
||
|
|
10-Q
|
|
5/7/2019
|
|
10.3
|
|
|
|
||
|
|
8-K
|
|
6/28/2019
|
|
1.1
|
|
|
|
||
|
|
8-K
|
|
7/30/2019
|
|
1.1
|
|
|
|
||
|
|
|
|
|
|
|
|
X
|
|||
|
|
|
|
|
|
|
|
X
|
|||
Leases
|
|
|
|
|
|
|
|
|
|||
|
|
10-Q
|
|
5/7/2019
|
|
10.4
|
|
|
|
|
|
|
Incorporated by Reference
|
|||||||
Exhibit No.
|
|
Description
|
|
Form
|
|
SEC
Filing
date
|
|
Exhibit
Number
|
|
Filed
with
this
10-K
|
|
Equity Plans
|
|||||||||||
|
|
S-1
|
|
5/9/2000
|
|
10.59
|
|
|
|
||
|
|
8-K
|
|
9/18/2006
|
|
10.32
|
|
|
|
||
|
|
10-Q
|
|
8/9/2007
|
|
10.1
|
|
|
|
||
|
|
S-8
|
|
5/23/2008
|
|
99.4
|
|
|
|
||
|
|
8-K
|
|
9/18/2006
|
|
10.33
|
|
|
|
||
|
|
8-K
|
|
9/18/2006
|
|
10.34
|
|
|
|
||
|
|
8-K
|
|
5/28/2010
|
|
10.1
|
|
|
|
||
|
|
8-K
|
|
5/28/2010
|
|
10.2
|
|
|
|
||
|
|
8-K
|
|
5/28/2010
|
|
10.3
|
|
|
|
||
|
|
10-K
|
|
3/14/2017
|
|
10.23
|
|
|
|
||
|
|
10-K
|
|
3/14/2017
|
|
10.24
|
|
|
|
||
|
|
8-K
|
|
12/14/2010
|
|
99.2
|
|
|
|
||
|
|
8-K
|
|
5/18/2012
|
|
99.1
|
|
|
|
||
|
|
8-K
|
|
6/13/2013
|
|
10.1
|
|
|
|
||
|
|
8-K
|
|
6/13/2013
|
|
10.1
|
|
|
|
||
|
|
8-K
|
|
6/16/2015
|
|
10.1
|
|
|
|
||
|
|
10-Q
|
|
5/4/2016
|
|
10.1
|
|
|
|
||
|
|
|
|
|
|
|
|
X
|
|||
|
|
|
DEF14A
|
|
4/24/2019
|
|
A
|
|
|
|
|
|
|
|
10-Q
|
|
7/30/2019
|
|
10.3
|
|
|
|
|
|
|
|
Incorporated by Reference
|
|||||||
Exhibit No.
|
|
Description
|
|
Form
|
|
SEC
Filing
date
|
|
Exhibit
Number
|
|
Filed
with
this
10-K
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agreements With Executive Officers
|
|||||||||||
|
|
8-K
|
|
7/25/2012
|
|
10.1
|
|
|
|
||
|
|
8-K
|
|
9/18/2006
|
|
10.11
|
|
|
|
||
|
|
8-K
|
|
10/30/2007
|
|
99.5
|
|
|
|
||
|
|
10-K
|
|
3/14/2017
|
|
10.34
|
|
|
|
||
|
|
10-K
|
|
3/14/2017
|
|
10.35
|
|
|
|
||
|
|
10-K
|
|
3/14/2017
|
|
10.36
|
|
|
|
||
|
|
10-K
|
|
3/14/2017
|
|
10.37
|
|
|
|
||
|
|
8-K
|
|
2/12/2013
|
|
10.1
|
|
|
|
||
|
|
10-Q
|
|
11/5/2018
|
|
10.2
|
|
|
|
||
Subsidiaries
|
|||||||||||
|
|
|
|
|
|
|
|
X
|
|||
Consent
|
|||||||||||
|
|
|
|
|
|
|
|
X
|
|||
Certifications
|
|||||||||||
|
|
|
|
|
|
|
|
X
|
|||
|
|
|
|
|
|
|
|
X
|
|||
|
|
|
|
|
|
|
|
X
|
|||
|
|
|
|
|
|
|
|
X
|
|||
101
|
|
The following materials from the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2019, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations and Comprehensive Loss, (iii) the Consolidated Statements of Cash Flows, (iv) the Consolidated Statements of Stockholders’ Equity, and (v) Notes to Consolidated Financial Statements. Filed herewithin.
|
|
|
|
|
|
|
|
X
|
†
|
Confidential treatment has been requested and/or granted as to certain portions, which portions have been filed separately with the Securities and Exchange Commission.
|
‡
|
Complete exhibit filed herewith, replacing the incomplete exhibit previously filed on July 30, 2019 in our Form 10-Q for the quarter ended June 30, 2019.
|
*
|
Indicates management contract or compensatory plan
|
|
INFINITY PHARMACEUTICALS, INC.
|
|
|
|
|
Date: March 3, 2020
|
By:
|
/s/ ADELENE Q. PERKINS
|
|
|
Adelene Q. Perkins
Chief Executive Officer
(Principal Executive Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ ADELENE Q. PERKINS
Adelene Q. Perkins
|
|
Chief Executive Officer; Chair of the Board of Directors
|
|
March 3, 2020
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
||
/s/ LAWRENCE E. BLOCH, M.D., J.D.
Lawrence E. Bloch, M.D., J.D.
|
|
President
|
|
March 3, 2020
|
|
|
(Principal Financial Officer, Principal Accounting Officer)
|
|
|
|
|
|
||
/s/ SAMUEL AGRESTA, M.D, M.P.H.
Samuel Agresta, M.D., M.P.H
|
|
Director
|
|
March 3, 2020
|
|
|
|
|
|
/s/ DAVID BEIER, J.D.
David Beier, J.D.
|
|
Director
|
|
March 2, 2020
|
|
|
|
|
|
/s/ JEFFREY BERKOWITZ, J.D.
Jeffrey Berkowitz, J.D.
|
|
Director
|
|
March 3, 2020
|
|
|
|
|
|
/s/ ANTHONY B. EVNIN, PH.D.
Anthony B. Evnin, Ph.D.
|
|
Director
|
|
February 26, 2020
|
|
|
|
|
|
/s/ MICHAEL G. KAUFFMAN, M.D., Ph.D.
Michael G. Kauffman, M.D., Ph.D.
|
|
Director
|
|
March 3, 2020
|
|
|
|
|
|
/s/ NORMAN C. SELBY
Norman C. Selby
|
|
Director
|
|
March 3, 2020
|
|
|
|
|
|
/s/ MICHAEL C. VENUTI, PH.D.
Michael C. Venuti, Ph.D.
|
|
Director
|
|
March 3, 2020
|
•
|
convert the stock into any other security;
|
•
|
have the stock redeemed;
|
•
|
purchase additional stock; or
|
•
|
maintain their proportionate ownership interest.
|
•
|
a merger with, disposition of significant assets to or receipt of disproportionate financial benefits by the interested stockholder, and
|
•
|
any other transaction that would increase the interested stockholder’s proportionate ownership of any class or series of our capital stock.
|
•
|
prior to the time that any stockholder became an interested stockholder, the board of directors approved either the business combination or the transaction in which such stockholder acquired 15% or more of our outstanding voting stock, or
|
•
|
the interested stockholder owns at least 85% of our outstanding voting stock as a result of a transaction in which such stockholder acquired 15% or more of our outstanding voting stock. Shares held by persons who are both directors and officers or by some types of employee stock plans are not counted as outstanding when making this calculation.
|
•
|
for any breach of the director’s duty of loyalty to us or our stockholders;
|
•
|
for acts or omissions by the director not in good faith or which involve intentional misconduct or a knowing violation of the law;
|
•
|
for declaring dividends or authorizing the purchase or redemption of shares in violation of Delaware law; or
|
•
|
for transactions where the director derived any improper personal benefit.
|
(k)
|
Intellectual Property.
|
(c)
|
Transferred Patents.
|
(e)
|
With respect to the Transferred Patents:
|
(c)
|
as to termination by Buyer only, a Company Trigger Event; or
|
(iv)
|
for regulatory, tax or customs purposes;
|
|
Infinity Pharmaceuticals, Inc.
|
|
|
By:
|
/s/Adelene Perkins
|
|
|
Name: Adelene Perkins
Title: Chief Executive Officer
|
|
BVF Partners L.P.
|
|
|
By:
|
/s/Mark Lampert
|
|
|
Name: Mark Lampert
Title: President BVF Inc., General Partner BVF Partners L.P.
|
|
Royalty Security, LLC
|
|
|
By:
|
/s/Spike Loy
|
|
|
Name: Spike Loy
Title: President
|
ASSIGNOR:
|
|
ASSIGNEE:
|
||
|
|
|
|
|
Infinity Pharmaceuticals, Inc.
|
|
Royalty Security, LLC
|
||
|
|
|
|
|
By:
|
|
|
By:
|
|
Name:
|
|
|
Name:
|
|
Title:
|
|
|
Title:
|
|
|
Infinity Pharmaceuticals, Inc.
|
|
|
By:
|
|
|
|
Name:
Title:
|
|
Royalty Security, LLC
|
|
|
By:
|
|
|
|
Name:
Title:
|
Company:
|
INFINITY PHARMACEUTICALS, INC., a Delaware corporation
|
Number of Shares:
|
[●]1
|
Type/Series of Stock:
|
Common Stock, par value $0.001 per share.
|
Warrant Price:
|
[●]2
|
Issue Date:
|
[●]
|
Expiration Date:
|
[●]3
|
Funding Agreement:
|
This Warrant to Purchase Common Stock (“Warrant”) is issued in connection with that certain Funding Agreement, dated January 8, 2020, among the Company, BVF Partners, L.P. and Royalty Security, LLC (as modified, amended and/or restated from time to time, the “Funding Agreement”).
|
|
|
|
1
|
Pursuant to Section 4.01 of the Funding Agreement, the number of shares shall be equal to 50% of the number of shares sold by the Company in excess of the Warrant Threshold (as defined in the Funding Agreement).
|
2
|
Pursuant to Section 4.01 of the Funding Agreement, the warrant price shall be equal to 1.5 times the price per share of the shares issued by the Company in excess of the Warrant Threshold (as defined in the Funding Agreement).
|
3
|
5th anniversary of the later of the date of issuance or the date on which the warrant becomes exercisable pursuant to Section 1.1 of the warrant.
|
4
|
To be included only to the extent the issuance of the warrant is triggered by an issuance of common stock (or the equivalent) at a discount to the Minimum Price.
|
Y =
|
the number of Shares with respect to which this Warrant is being exercised (inclusive of the Shares surrendered to the Company in payment of the aggregate Warrant Price);
|
A =
|
the Fair Market Value (as determined pursuant to Section 1.3 below) of one Share; and
|
1.4
|
Limitation on Number of Shares Issuable.
|
1.7
|
Treatment of Warrant Upon Acquisition of Company.
|
3.2
|
Notice of Certain Events. If the Company proposes at any time to:
|
INFINITY PHARMACEUTICALS, INC.
|
|
||
By:
|
|
|
|
Name:
|
|
|
|
|
(Print)
|
|
|
Title:
|
|
|
|
[BVF PARTNERS, L.P.]
|
|
||
By:
|
|
|
|
Name:
|
|
|
|
|
(Print)
|
|
|
Title:
|
|
|
|
|
|
|
|
|
Holder's Name
|
|
|
|
|
|
|
|
|
|
|
|
(Address)
|
|
|
|
HOLDER:
|
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
Date:
|
|
|
Name:
|
[TRANSFEREE]
|
|
Address:
|
|
|
Tax ID:
|
|
|
|
[●]
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
|
Title:
|
|
Date:
|
|
|
|
(b)
|
the following paragraphs shall be inserted as new Section 4.01(e):
|
|
Infinity Pharmaceuticals, Inc.
|
|
|
By:
|
/s/Adelene Perkins
|
|
|
Name: Adelene Perkins
Title: CEO
|
|
Royalty Security Holdings, LLC
|
|
|
By:
|
/s/Spike Loy
|
|
|
Name: Spike Loy
Title: Chief Executive Officer and President
|
|
Royalty Security, LLC
|
|
|
By:
|
/s/Spike Loy
|
|
|
Name: Spike Loy
Title: Chief Executive Officer and President
|
|
BVF Partners L.P.
|
|
|
By:
|
/s/Mark Lampert
|
|
|
Name: Mark Lampert
Title: President BVF Inc., General Partner of BVF Partners L.P.
|
Company:
|
INFINITY PHARMACEUTICALS, INC., a Delaware corporation
|
Number of Shares:
|
[●]1
|
Type/Series of Stock:
|
Common Stock, par value $0.001 per share.
|
Warrant Price:
|
[●]2
|
Issue Date:
|
[●]
|
Expiration Date:
|
[●]3
|
Funding Agreement:
|
This Warrant to Purchase Common Stock (“Warrant”) is issued in connection with that certain Funding Agreement, dated January 8, 2020, among the Company, BVF Partners, L.P. and Royalty Security, LLC (as modified, amended and/or restated from time to time, the “Funding Agreement”).
|
|
|
|
1
|
Pursuant to Section 4.01 of the Funding Agreement, the number of shares shall be equal to 50% of the number of shares sold by the Company in excess of the Warrant Threshold (as defined in the Funding Agreement).
|
2
|
Pursuant to Section 4.01 of the Funding Agreement, the warrant price shall be equal to 1.5 times the price per share of the shares issued by the Company in excess of the Warrant Threshold (as defined in the Funding Agreement).
|
3
|
5th anniversary of the later of the date of issuance or the date on which the warrant becomes exercisable pursuant to Section 1.1 of the warrant.
|
4
|
To be included only to the extent the issuance of the warrant is triggered by an issuance of common stock (or the equivalent) at a discount to the Minimum Price.
|
Y =
|
the number of Shares with respect to which this Warrant is being exercised (inclusive of the Shares surrendered to the Company in payment of the aggregate Warrant Price);
|
A =
|
the Fair Market Value (as determined pursuant to Section 1.3 below) of one Share; and
|
1.4
|
Limitation on Number of Shares Issuable.
|
1.7
|
Treatment of Warrant Upon Acquisition of Company.
|
3.2
|
Notice of Certain Events. If the Company proposes at any time to:
|
INFINITY PHARMACEUTICALS, INC.
|
|
||
By:
|
|
|
|
Name:
|
|
|
|
|
(Print)
|
|
|
Title:
|
|
|
|
[BVF PARTNERS, L.P.]
|
|
||
By:
|
|
|
|
Name:
|
|
|
|
|
(Print)
|
|
|
Title:
|
|
|
|
|
|
|
|
|
Holder's Name
|
|
|
|
|
|
|
|
|
|
|
|
(Address)
|
|
|
|
HOLDER:
|
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
Date:
|
|
|
Name:
|
[TRANSFEREE]
|
|
Address:
|
|
|
Tax ID:
|
|
|
|
[●]
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
|
Title:
|
|
Date:
|
|
|
|
(1)
|
Registration Statement (Form S-3 No. 333-224545) of Infinity Pharmaceuticals, Inc.,
|
(2)
|
Registration Statement (Form S-3 No. 333-230258) of Infinity Pharmaceuticals, Inc.,
|
(3)
|
Registration Statement (Form S-8 No. 333-44850) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. Employee Stock Purchase Plan (formerly named the Discovery Partners International, Inc. 2000 Stock Incentive Plan and the Discovery Partners International, Inc. Employee Stock Purchase Plan, respectively),
|
(4)
|
Registration Statement (Form S-8 No. 333-97173) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. 2000 Employee Stock Purchase Plan (formerly named the Discovery Partners International, Inc. 2000 Stock Incentive Plan and the Discovery Partners International, Inc. 2000 Employee Stock Purchase Plan, respectively),
|
(5)
|
Registration Statement (Form S-8 No. 333-138248) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. Pre-Merger Stock Incentive Plan,
|
(6)
|
Registration Statements (Form S-8 Nos. 333-145306, 333-151135, 333-156641 and 333-164207) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan,
|
(7)
|
Registration Statements (Form S-8 Nos. 333-167488 and 333-182005) pertaining to the Infinity Pharmaceuticals, Inc. 2010 Stock Incentive Plan,
|
(8)
|
Registration Statements (Form S-8 Nos. 333-189342 and 333-205585) pertaining to the Infinity Pharmaceuticals, Inc. 2010 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. 2013 Employee Stock Purchase Plan, and
|
(9)
|
Registration Statement (Form S-8 No. 333-232110) pertaining to the Infinity Pharmaceuticals, Inc. 2019 Equity Incentive Plan and the Infinity Pharmaceuticals, Inc. 2013 Employee Stock Purchase Plan;
|
/s/ Ernst & Young LLP
|
|
|
|
|
Date: March 3, 2020
|
|
|
/S/ ADELENE Q. PERKINS
|
|
|
|
Adelene Q. Perkins
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
Date: March 3, 2020
|
|
|
/s/ LAWRENCE E. BLOCH, M.D., J.D.
|
|
|
|
Lawrence E. Bloch, M.D., J.D.
|
|
|
|
President
|
|
|
|
(Principal Financial Officer and Principal Accounting Officer)
|
|
|
|
|
Date: March 3, 2020
|
|
|
/S/ ADELENE Q. PERKINS
|
|
|
|
Adelene Q. Perkins
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
Date: March 3, 2020
|
|
|
/s/ Lawrence E. Bloch, M.D., J.D.
|
|
|
|
Lawrence E. Bloch, M.D., J.D.
|
|
|
|
President
|
|
|
|
(Principal Financial Officer and Principal Accounting Officer)
|