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New words:
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Financial report summary
?Competition
Celgene • Incyte • Geron • CTI BioPharma • Novartis • Morphosys • Takeda Pharmaceutical • Abbvie • Imago BioSciences • Nuvation Bio Inc - Ordinary SharesRisks
- The announcement and pendency of the Merger could adversely affect our business.
- The parties must obtain certain regulatory approvals in order to complete the transactions contemplated by the Merger Agreement; if such approvals are not obtained or are obtained with conditions, the acquisition may be prevented or delayed or the anticipated benefits of the acquisition may be reduced.
- The failure to complete the Merger could adversely affect our business.
- The Merger Agreement limits our ability to pursue alternatives to the proposed acquisition.
- Litigation may arise in connection with the Merger, which could be costly and divert management’s attention and otherwise materially harm our business.
- We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses for the foreseeable future.
- Our business is highly dependent on the success of momelotinib. If we are unable to prepare and timely submit the planned NDA for momelotinib and successfully obtain regulatory approval for and commercialize momelotinib, or experience significant delays in doing so, our business will be materially harmed.
- If further preclinical development or clinical trials of momelotinib, or any other future product candidates that we may develop or acquire fail to demonstrate acceptable safety and efficacy or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of current or future product candidates.
- If we encounter difficulties enrolling patients in future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- We plan to develop product candidates in combination with momelotinib, which can expose us to additional risks.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted and are subject to audit and verification procedures that could result in material changes in the final data.
- We may expend our limited resources to pursue a particular product candidate, such as momelotinib, and fail to capitalize on product candidates that may later prove to be more profitable or for which there is a greater likelihood of success. In addition, we may intentionally halt or terminate programs in order to conserve capital and focus on our remaining program or programs, which may increase our reliance on those programs to be successful.
- We may form or seek strategic alliances, licensing arrangements or other collaborations in the future or enter into a strategic transaction. We may be unable to form or enter into such alliances or arrangements, and we may not realize the expected benefits of any such transaction.
- Past and future acquisitions could disrupt our business and harm our financial condition and operating results.
- Provisions of any debt instruments, including the Loan and Security Agreement, may restrict our ability to pursue our business strategies.
- The manufacturing of our product candidates may require outsourced, custom manufacturing and we may encounter difficulties in production, particularly with respect to formulation, process development or scaling up of our manufacturing capabilities. If our third-party manufacturers or suppliers encounter such difficulties, our ability to provide supply of our product candidates for preclinical studies, clinical trials or our products for patients, if approved could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
- Our reliance on third-party manufacturing partners or suppliers may cause our supply of research and development, preclinical and clinical development materials as well as future commercial product to become limited or interrupted or fail to be of satisfactory quantity or quality.
- Our product candidates may cause undesirable side effects or have other properties that could halt their development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
- We may need to obtain additional capital to complete the potential commercialization of momelotinib and the development and potential commercialization of any future product candidates.
- We do not have our own laboratory facilities. We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize momelotinib.
- Even if we receive regulatory approval to market momelotinib, the market may not be receptive to our product.
- We may be subject to requests for access to momelotinib. Demand for compassionate use of our unapproved therapies could strain our resources, delay our drug development activities, negatively impact our regulatory approval or commercial activities, and result in losses.
- We face significant competition from other hematology and oncology companies, and our operating results will suffer if we fail to compete effectively.
- We are dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- We may encounter difficulties in managing our expected growth and in expanding our operations successfully.
- If we are unable to adequately prepare the market for the potential future commercialization of a product, we may not be able to generate product revenue once marketing authorization is obtained. We are currently establishing our marketing and sales organization and have limited experience in marketing products. If we are unable to successfully establish marketing and sales capabilities or enter into agreements with third parties to market and sell momelotinib or any future product candidates, we may not be able to generate product revenue.
- We depend on our information technology and infrastructure.
- Our internal information technology systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches and other security incidents.
- Unstable or unfavorable global market and economic conditions may have adverse consequences on our business, financial condition and stock price.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of momelotinib.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be significantly limited, or entirely restricted.
- Our quarterly operating results may fluctuate significantly, which may cause our stock price to fluctuate or decline.
- Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
- A Fast Track designation by the FDA, as granted for momelotinib or if granted for any future product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that such product candidates will receive marketing approval.
- If we or any of our independent contractors, consultants, collaborators, manufacturers, vendors or service providers fail to comply with healthcare, privacy and data security laws and regulations, we or they could be subject to enforcement actions, which could result in significant penalties and affect our ability to develop, market and sell momelotinib or any future product candidates and may harm our reputation.
- The insurance coverage and reimbursement status of newly approved products is uncertain. Any products we develop may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, thereby harming our business.
- Obtaining and maintaining regulatory approval for momelotinib or any future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of any of our product candidates in other jurisdictions.
- If we or our third-party manufacturers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
- The Tax Cuts and Jobs Act could increase our tax burden and adversely affect our business and financial condition.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect momelotinib.
- If we do not obtain patent term extension and data exclusivity for any therapeutic candidate or product we may develop, our business may be materially harmed.
- We or any future strategic partners may become subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights.
- We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful.
- We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
- If we fail to comply with our obligations under our strategic agreements, we may be required to pay damages.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- The issuance or sale of shares of our common stock, or rights to acquire shares of our common stock could depress the trading price of our common stock.
- We incur significantly increased costs and devote substantial management time as a result of operating as a public company.
- Provisions in our restated certificate of incorporation and restated bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock.
- Certain of our 5% stockholders in the aggregate hold a majority of the voting power and may therefore, in effect, be able to exert significant control over matters subject to stockholder approval.
- Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or momelotinib.
- Shares of our common stock are subordinate to any preferred stock we may issue and to any current and future indebtedness.
- We may be unable to adequately protect our information technology systems from cyberattacks and other security breaches or incidents, which could result in the disclosure of confidential information, damage our reputation, and subject us to significant financial and legal exposure.
- Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
- We face risks related to securities litigation that could result in significant legal expenses and settlement or damage awards.
- If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.
Management Discussion
- Research and development expenses increased $3.6 million, from $14.0 million for the three months ended March 31, 2021 to $17.6 million for the three months ended March 31, 2022. The increase primarily related to a $2.6 million increase in personnel-related and allocated overhead costs, a $1.6 million increase in third-party manufacturing costs of which $0.9 million pertained to momelotinib, and a $0.2 million increase in other research and support costs. These increases were partially offset by a $0.8 million decrease in clinical trial and development costs primarily for momelotinib.
- General and administrative expenses increased $4.5 million, from $5.9 million for the three months ended March 31, 2021 to $10.3 million for the three months ended March 31, 2022. The increase was due to a $3.2 million increase in personnel-related and allocated overhead costs, of which $0.9 million related to severance and a stock-based compensation charge pursuant to a transition agreement with a former executive, and a $1.2 million increase in professional fees, primarily relating to pre-commercial costs for momelotinib.
- Since our inception, we have never generated product revenue and have incurred significant net losses. We have funded our operations to date primarily from the issuance and sale of our common stock, pre-funded warrants and convertible voting preferred stock and accompanying warrants through public offerings (including ATM equity offerings), our convertible and redeemable convertible preferred stock in private financings and, to a lesser extent, through exercises of our stock options and warrants. Our net losses were $27.9 million and $19.9 million for the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, we had an accumulated deficit of $969.2 million, of which approximately $428.0 million pertained to the revaluation and conversion of redeemable convertible preferred stock upon our initial public offering in July 2015, $37.2 million related to changes in fair value of our Series A and Series B warrant liabilities until their reclassification to equity, and $12.0 million pertained to a securities issuance obligation settled in the first quarter of 2020. Our principal sources of liquidity as of March 31, 2022 were cash and cash equivalents of $274.0 million.