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H.S. junior Avg
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New words:
AEs, agonist, analyze, ANCOVA, BA, batch, Canadian, Chevron, clean, closer, compressed, cybersecurity, destruction, dissemination, doubt, dual, East, ECG, Eighteen, escalate, exceeded, Florida, GIP, hardware, heightened, highlight, HT, input, insulinotropic, JCEM, LSM, Middle, Muscle, myostatin, network, Nglena, nitrogen, nominating, Notably, notification, OPCO, organizational, Page, pattern, penetration, peptide, physiological, polypeptide, prespecified, provisional, radiation, ransomware, serum, signaling, software, Sogroya, specialist, Washington
Removed:
amplified, anterior, backbone, camptothecin, caring, circuit, comparison, conjugate, contingency, discretionary, disposed, Dr, economy, emergency, Eugene, expanding, extinguished, guarantee, inclusive, infection, inhibit, initiating, installment, Kennedy, leasehold, linked, median, pace, polymer, prioritization, reaction, recoverable, reliant, resigning, selectively, separation, shorter, spread, subcontractor, surfaced, topoisomerase, ultradian, undiscounted, updated, vested, worsen, Wuhan
Financial report summary
?Competition
Bristol-Myers Squibb • Pfizer • Novo Nordisk • Geovax Labs • Incyte • Opko Health • iBio • Scorpius • Calithera Biosciences • Bioline RxRisks
- Risks Related to our Financial Condition and Capital Requirements
- Risks Related to the Development and Commercialization of our Product Candidate
- Risks Related to the Operation of our Business
- Risks Related to our Intellectual Property
- Risks Related to Government Regulation
- Risks Related to Ownership of Our Common Stock
- We currently have no source of product revenue and may never become profitable.
- We will need to raise substantial additional funds over the next few months to support our operations, and such funding may not be available to us on acceptable terms, or at all, which would force us to delay, reduce or suspend our research and development programs, including our LUM-201 Phase 3 Trial, and other operations or commercialization efforts. Raising additional capital may subject us to unfavorable terms, cause substantial dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates and technologies.
- We might not be able to continue as a going concern.
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
- Our ability to use our net operating loss carryforwards and certain other tax attributes is limited by Sections 382 and 383 of the Code.
- Accounting pronouncements may impact our reported results of operations and financial position.
- We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to meet compliance obligations.
- Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our ability to produce accurate financial statements and on our stock price.
- Changes in our effective income tax rate could adversely affect our results of operations in the future.
- Data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- As an organization, we have never conducted a Phase 3 clinical trial or submitted a New Drug Application (an “NDA”) before, and may be unsuccessful in doing so for LUM-201. We will need to raise substantial additional capital to fund our Phase 3 trial.
- Our success depends heavily on the successful development, regulatory approval and commercialization of our only product candidate, LUM-201.
- The analysis that supports our basis for pursuing development of LUM-201 for PGHD is derived from data from three clinical trials conducted by Merck in the 1990s, and a post-hoc analysis of one of the trials. Various issues relating to such trials and analysis could materially adversely impact our LUM-201 clinical trial design and our future development plans.
- Because the results of preclinical testing or earlier clinical trials are not necessarily predictive of future results and may not translate to other indications, LUM-201 may not have favorable results in later clinical trials or receive regulatory approval.
- If we make changes to our product candidate, additional clinical trials may be required resulting in additional costs and delays.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Public health crises, including pandemics or similar outbreaks, such as COVID-19, have, and could in the future, adversely impact our business, including our non-clinical studies and planned clinical trials.
- If clinical trials of LUM-201 and any future product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States or do not otherwise produce positive results, we may incur additional costs, experience delays in completing or ultimately fail in completing the development and commercialization of LUM-201 or our future product candidates.
- Even if we obtain marketing approval for LUM-201, certain factors may limit the market for LUM-201, which could materially impair our ability to generate revenue from such product.
- LUM-201 or our future product candidates may cause serious adverse events or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following any marketing approval.
- Even if our clinical trials demonstrate acceptable safety and efficacy of LUM-201 for growth in PGHD patients based on a once daily oral dosing regimen, the FDA or similar regulatory authorities outside the United States may not approve LUM-201 for marketing or may approve it with restrictions on the label, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
- Even if LUM-201 or any future product candidates receive regulatory approval, they may fail to achieve the degree of market acceptance by physicians, patients, caregivers, healthcare payors and others in the medical community necessary for commercial success.
- LUM-201 has never been manufactured on a commercial scale, and there are risks associated with manufacturing additional supply and scaling up manufacturing to commercial scale. We have arranged for production of LUM-201 by a third-party manufacturer, which may not be successful, and this could delay regulatory approval and commercialization of LUM-201.
- Our failure to successfully identify, acquire, develop and commercialize additional products or product candidates could impair our ability to grow.
- We currently have no sales or distribution personnel and only limited marketing capabilities. If we are unable to develop a sales and marketing and distribution capability on our own or through collaborations or other marketing partners, we will not be successful in commercializing LUM-201 or other future products.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
- A key part of our strategy is to evaluate and enter into strategic alliances in the future, and we may not be able to successfully identify or execute on such alliances on terms favorable to us.
- Any future collaboration agreements we may enter into for LUM-201 or any other product candidate may place the development of LUM-201 or other product candidates outside our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us.
- If we are able to commercialize LUM-201 or any future product candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business.
- Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
- We have agreed not to develop or seek to commercialize any products in the dermatological field, or the fields of Parkinson’s, Huntington’s and ALS diseases.
- Under the worldwide license and collaboration agreement between NewLink and Merck, dated November 2014 (the “NewLink Merck Agreement”), future royalty obligations may exceed any future limited revenues, if any, from any future sales of ERVEBO®.
- Some of our product candidates have been studied, or in the future may be studied, in clinical trials co-sponsored by organizations or agencies other than us, or in investigator-initiated clinical trials, which means we have little control over the conduct of such trials.
- Our business may be adversely impacted by the consequences of military conflicts.
- Our future success depends on our ability to retain our chief executive officer, president and other key members of our management team and to attract, retain and motivate qualified personnel.
- We expect to expand our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- Business disruptions could seriously harm our clinical trials, future revenue and financial condition and increase our costs and expenses.
- If we obtain approval to commercialize LUM-201 outside the United States, we will be subject to additional risks.
- Our internal computer systems, or those of our CROs or other contractors or consultants, may fail or suffer security breaches or incidents, which could result in a material disruption of our drug development programs.
- Our business and operations would suffer in the event of system failures, cyber-attacks, and security breaches or incidents.
- Our employees, independent contractors and consultants, principal investigators, CROs, CMOs and other vendors, and any future commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
- If we fail to fulfill our obligations under our contractual commitments, our counterparties could terminate the applicable agreements or make claims against us, which could have a materially adverse effect on us.
- We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
- We currently rely and may continue to rely on a single third-party CMO to manufacture and supply LUM-201. If our manufacturer and supplier fail to perform adequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts to find a new supplier or manufacturer. We may also face delays in the development and commercialization of our product candidates.
- We plan to explore strategic collaborations that may never materialize or may fail.
- We are required under the NewLink Merck Agreement, and we may be required under other collaborations, to relinquish important rights to and control over the development of our product candidates to our collaborators or otherwise be subject to unfavorable terms.
- We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive.
- Our ability to successfully commercialize our technology and products may be materially adversely affected if we are unable to obtain and maintain effective intellectual property rights for our technologies and product candidates, or if the scope of the intellectual property protection is not sufficiently broad.
- We do not have composition of matter patent protection with respect to LUM-201.
- We may become involved in legal proceedings to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position.
- We may not be able to protect and/or enforce our intellectual property rights throughout the world.
- We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we would not be able to continue developing our sole product candidate, LUM-201. If we breach the agreement under which we license the use, development and commercialization rights to our sole product candidate or technology from third parties or fail to meet certain development or payment deadlines, we could lose license rights that are important to our business.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our or our licensors’ patent protection could be reduced or eliminated for non-compliance with these requirements.
- Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of our issued patents.
- If we are unable to obtain a patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for our product candidates, our business may be materially harmed.
- The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of our product candidates.
- Even if we receive regulatory approval for a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
- Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.
- Our relationships with healthcare professionals, clinical investigators, CROs and third party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings. If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
- The biopharmaceutical industry is subject to significant regulation and oversight in the United States, in addition to approval of products for sale and marketing; our failure to comply with these laws could harm our results of operations and financial condition.
- The trading price of our common stock has been highly volatile, and could decline significantly.
- The holdings of our stockholders may be substantially diluted, and the prices of our securities may decrease, by future issuances of securities by us.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval.
- Our Bylaws designate the state courts in the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for the District of Delaware, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against us or our directors, officers, or employees.
- We do not anticipate that we will pay any cash dividends in the foreseeable future.
- Provisions in our certificate of incorporation, our Bylaws or Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
- 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
- Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
- Lumos Pharma, Inc. is a clinical-stage biopharmaceutical company. References in this Annual Report to “us,” “we,” “our,” the “Company,” or “Lumos” are to Lumos Pharma, Inc. and its wholly-owned subsidiaries. With our principal executive offices located in Austin, Texas and additional executive and administrative offices located in Ames, Iowa, we are engaged in advancing our clinical program and focused on identifying, acquiring, developing, and commercializing novel products and new therapies for people with rare diseases on a global level, for which there is currently a significant unmet need for safe and effective therapies. Our common stock is listed on the Nasdaq Global Market (“Nasdaq”) and trades under the ticker symbol “LUMO.”
- On March 18, 2020, we closed the business combination (the “Merger”) among the Company, formerly known as NewLink Genetics Corporation (“NewLink”), Cyclone Merger Sub, Inc. (“Merger Sub”), a wholly owned subsidiary of NewLink, and Lumos Pharma, Inc., (“Private Lumos”) which has since been renamed “Lumos Pharma Sub, Inc.” whereby Merger Sub merged with and into Private Lumos, with Private Lumos surviving as a wholly-owned subsidiary of the Company.