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New words:
AB, Abbott, Abgenix, absenteeism, Acorda, adequacy, adjunctive, advice, advisor, affirmatively, Airport, AiRuiKa, al, Alec, Alecensa, Allergan, Alliance, analogy, analyst, Anderson, Anergen, anesthesiologist, answered, Antitrust, arm, Assembly, assumption, Atea, ATM, Atreca, attendance, Avenue, background, Baltimore, Barney, Bay, Berkeley, BET, Biden, Bingham, BioCryst, Biographical, BioTime, Black, BlackRock, bond, Boston, Box, Britain, British, Bryn, BTK, BVF, captioned, Carlson, Carol, Carolina, category, Cayman, Centre, certified, cessation, CFA, chair, Chapel, chemotherapeutic, Chiron, choice, Civik, clarifying, clean, cleaning, closure, COBRA, College, column, complaint, confidence, constitutionality, consummated, consummation, contemplated, Copenhagen, Corixa, corneal, counsel, counterparty, coupled, Cowen, customarily, customary, cybersecurity, Dayton, decade, deep, delegate, delegated, Delhi, dental, Dermira, detachment, Diamond, died, disability, disabled, disallowed, discharged, discretionary, disgorgement, disqualifying, dissemination, dissenting, distancing, diverge, divided, dividing, doctor, Dr, dry, East, economy, Elaine, Elevar, embedded, Emory, environment, EOX, epirubicin, epithelial, ESSA, Evanston, exacerbate, Exeter, expert, extinguished, eye, Facet, faculty, Fargo, fellowship, FGFR, Fish, Fisher, flight, floor, formula, Foundation, founder, Franchise, frequently, frontline, fullest, fundamental, furniture, Garry, Gate, Gavin, geographic, George, GI, Gilead, Golden, Governor, GP, GPH, Grand, Great, greatest, ground, handle, harder, harmonized, Harvard, hematologist, hematology, Hill, hospital, hot, hour, house, housing, Hyphen, IBM, Idera, impede, Indiana, inquired, Insmed, IntegenX, Interdisciplinary, InterMune, Internet, interval, intratumoral, investor, involuntary, Ireland, job, joining, Josephthal, Jude, KAPital, Kellogg, Kettering, Kezar, Kolchinsky, laid, Lampert, landscape, largest, Leader, length, Lexicon, licensee, lieu, lifted, Lincoln, literate, literature, Litowitz, loosened, Lori, lowest, lubricating, lump, Magnetar, marketplace, Maryland, master, Mawr, McCutchen, MedImmune, Mental, merger, messaging, MHRA, Micromet, Minnesota, Mirati, misleading, mission, Montgomery, Morgan, mortgage, mouse, movement, multiplied, multiplier, Narrative, nationwide, nearest, NEMO, neurology, Newsom, NextCure, Nicholson, NOL, Norbert, northern, Northwestern, Novation, nurse, occupied, occupying, OncoGenex, oncologist, online, Onyx, Orrington, OS, pace, pandemic, parachute, paragraph, parent, PDL, percentile, perspective, Peter, PFS, pharmacy, philosophy, physical, physically, plaintiff, Polytechnic, posed, preferentially, prioritization, Professor, prophylactic, prorated, punctate, purported, quotient, RA, Rajeev, ratio, reconsider, reconstituted, Redwood, reexamining, remote, remotely, rentable, Repare, repay, Replimune, rescission, rescissory, reside, residence, residency, residual, resume, resumed, retifanlimab, retired, retirement, rivoceranib, Road, Rock, Roderick, rolling, rounded, roundtrip, RRMG, RSC, RSCM, RTW, Saint, salaried, salary, Salomon, sample, Sangamo, Sanofi, Schafer, School, science, Seagen, sector, Sectoral, SFO, Shah, shelter, Sloan, slowdown, Sofinnova, sooner, specialist, spouse, spun, St, staggered, subordinate, subsidiary, Suite, Supernova, Sutro, Syntex, talent, Tarceva, tenure, Thermo, Thoratec, tie, Tocagen, Town, transportation, truthful, Ugland, unavailable, unilateral, unnecessary, unobservable, unrestricted, Urology, vacation, validly, venture, Virginia, virtual, vision, voluntarily, waiting, waivable, waived, Walking, Wang, Warburg, warm, week, WFT, White, Willamette, Wong, worsen, worsening, XTuit, YM, York
Removed:
AbbVie, Abraxane, activated, Adimab, Aron, Asian, asthma, atezolizumab, automatic, avelumab, Bavencio, bevacizumab, blocking, Bulletin, calculate, chronic, circulating, circumvent, CNS, collected, composite, computation, concurrently, COPD, customized, deficiency, endometrial, endorse, enhancing, eribulin, facilitating, focusing, function, gemcitabine, GITR, Glaxo, graph, GSK, Halaven, homology, immunologic, immunosuppressive, Immunotherapy, INBRX, index, inhibitory, Inhibrx, initiating, irrespective, Knickerbocker, language, Lynparza, mandated, mesylate, midpoint, move, muscle, Navelbine, niraparib, Obama, observe, obstructive, olaparib, overexpressing, poly, polymerase, poor, poster, principle, promised, provisional, pulmonary, ratable, reclassify, recommend, refractory, respiratory, Rubraca, rucaparib, SAB, selection, sending, signal, SITC, skeletal, stable, subset, talazoparib, tenant, tentative, top, topotecan, UCB, Unaudited, validated, veliparib, vinorelbine, weighted, Xeloda, Zejula
Financial report summary
?Competition
Infinity Pharmaceuticals • Palvella Therapeutics • PHAXIAM Therapeutics • Alpine Immune Sciences • Deciphera Pharmaceuticals • Gritstone bio • HOOKIPA Pharma • Relay Therapeutics • Evaxion Biotech A/SRisks
- The ongoing COVID-19 pandemic, and efforts to reduce the spread of COVID-19, could adversely impact our business and operations, including our clinical trials.
- If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce meaningfully positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- We and our product candidates are subject to a multitude of manufacturing risks, the occurrence of any of which could substantially increase our costs and limit supply of such product candidates.
- The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. Failure to obtain regulatory approval for our product candidates would substantially harm our business.
- Our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval, limit their commercial profiles, if approved, or result in significant negative consequences following any marketing approval.
- Certain of our product candidates, including bemarituzumab, are expected to be effective only in certain selected patient populations. If we are unable to successfully develop and obtain FDA approval for companion diagnostics for these product candidates, or experience significant delays in doing so, we may not obtain marketing approval for such product candidates or realize their full commercial potential.
- Even if our product candidates receive regulatory approval, they may face future development and regulatory difficulties, which may prevent us from commercializing our products and generating revenue.
- Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States.
- The withdrawal of the United Kingdom from the EU, commonly referred to as Brexit, may adversely impact our ability to obtain regulatory approvals for our product candidates in the United Kingdom or the EU, result in restrictions or imposition of taxes and duties for importing our product candidates into the United Kingdom or the EU and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the United Kingdom or the EU.
- We face substantial competition from third parties that may develop or commercialize products before or more successfully than we do.
- Our product candidates may not achieve the level of market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- Even if we commercialize one or more of our product candidates, these product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which could harm our business.
- Enacted and future legislation may increase the difficulty and cost of commercialization of our product candidates and affect the prices we may charge for such product candidates.
- We may become subject to product liability lawsuits, which could cause us to incur substantial liabilities and limit commercialization of any products we may develop.
- Our relationships with healthcare providers, third-party payors and customers will be subject to applicable anti-kickback, fraud and abuse, transparency, privacy and other healthcare laws and regulations, violation of which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- We must attract and retain highly skilled employees to succeed.
- Our business operations depend significantly on information technology systems, and a cyber-attack or other significant disruption or breach of our information technology systems, or those of third parties on whom we may rely or with whom we share confidential information, could cause us significant financial, legal, regulatory, business and reputational harm.
- Our employees and consultants, collaborators and other third parties may engage in misconduct or other improper activities, including insider trading and activities that violate regulatory standards and requirements.
- Zai Lab has exclusive rights to develop and commercialize bemarituzumab in Greater China. Zai Lab’s failure to timely develop or commercialize bemarituzumab would have a material adverse effect on our business and operating results.
- We may not succeed in establishing and maintaining additional license agreements or product or clinical collaborations with strategic partners, which could adversely affect our ability to generate funding or develop and commercialize product candidates.
- We may not succeed in executing strategic transactions to acquire or in-license rights to additional product candidates.
- We rely on CMOs, CROs and other third-party service providers to develop and produce drug product for and conduct our clinical trials and to conduct services related to our preclinical and late-stage research programs, and the unsatisfactory performance by such CMOs, CROs or other third-party service providers may harm our business.
- If we are unable to obtain, maintain or protect intellectual property rights, we may not be able to compete effectively in our market.
- Changes to patent laws could diminish the value of patents in general, thereby impairing our ability to protect our rights in our product candidates.
- Obtaining and maintaining patent protection requires compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
- We may need to protect or enforce our intellectual property through litigation or other proceedings, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business.
- If we breach the agreements under which third parties have licensed intellectual property rights to us, we could lose the ability to use certain of our technologies or continue the development and commercialization of our product candidates.
- Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights, or we may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by such third parties. The outcome of any of these proceedings would be uncertain and could have a material adverse effect on the success of our business.
- We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property or that such third parties own what we regard as our own intellectual property.
- Our inability to protect our confidential information and trade secrets would harm our business and competitive position.
- We will require additional capital to finance our operations, which may not be available to us on acceptable terms or at all. As a result, we may not complete the development and commercialization of our current or future product candidates.
- Raising additional capital may dilute our existing stockholders, restrict our operations or require us to relinquish rights to our technologies.
- We currently have no source of product revenue and may never become consistently profitable.
- The market price of our stock is volatile.
- We may be subject to securities litigation, which is expensive and could divert management attention.
- Our principal stockholders and management own a significant percentage of our stock and may be able to exert significant control over matters subject to stockholder approval.
- Sales of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our stock price to fall.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
Management Discussion
- Collaboration revenue and license revenue decreased by $1.7 million, or 11%, to $13.2 million for the year ended December 31, 2020 from $14.9 million for the year ended December 31, 2019. This decrease was primarily due to a $6.5 million decrease from progress made towards satisfying our performance obligation under the original cabiralizumab collaboration with BMS, a $1.4 million decrease as we completed the research term of our immuno-oncology research collaboration with BMS and a $1.1 million decrease in the reimbursement of costs incurred for the development of companion diagnostics from our China collaboration with Zai Lab. The decrease was offset by a $5.1 million increase in license revenue and other activity under the Seagen license agreement executed in February 2020 and a $2.2 million increase in collaboration revenue from our China collaboration with Zai Lab resulting from a decrease in the budgeted costs used to measure progress toward completion of the performance obligation as a result of our decision to amend the FIGHT trial from a Phase 3 design to a randomized Phase 2 trial.