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Fusion Pharmaceuticals (FUSN)

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

FUSN stock data

Calendar

9 Aug 22
15 Aug 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 62.97M 62.97M 62.97M 62.97M 62.97M 62.97M
Cash burn (monthly) (no burn) (no burn) 6.58M 6.45M 5.77M 5.84M
Cash used (since last report) n/a n/a 10.04M 9.83M 8.8M 8.91M
Cash remaining n/a n/a 52.93M 53.14M 54.17M 54.06M
Runway (months of cash) n/a n/a 8.0 8.2 9.4 9.3

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
11 Aug 22 Gannon Steven Common Stock Buy Acquire P No No 2.03 44,400 90.13K 56,400
14 Jun 22 Cagnoni Pablo J Stock Option Common Stock Grant Acquire A No No 3.6 17,000 61.2K 17,000
14 Jun 22 Duncan Barbara Gayle Stock Opion Common Stock Grant Acquire A No No 3.6 17,000 61.2K 17,000
14 Jun 22 Gannon Steven Stock Option Common Stock Grant Acquire A No No 3.6 17,000 61.2K 17,000
14 Jun 22 Chau Quang Khuong Stock Option Common Stock Grant Acquire A No No 3.6 17,000 61.2K 17,000
86.0% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 29 34 -14.7%
Opened positions 0 2 EXIT
Closed positions 5 10 -50.0%
Increased positions 4 6 -33.3%
Reduced positions 4 8 -50.0%
13F shares Current Prev Q Change
Total value 359.16M 256.07M +40.3%
Total shares 37.3M 36.86M +1.2%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners Shares Value Change
HealthCap VII 3.81M $66.51M 0.0%
JNJ Johnson & Johnson 3.67M $28.52M 0.0%
VAR Varian Medical Systems 3.26M $38.27M 0.0%
FMR 3.25M $25.26M +0.6%
Orbimed Advisors 3.22M $25.06M 0.0%
Canada Pension Plan Investment Board 3.12M $24.22M 0.0%
FHI Federated Hermes 3.06M $23.74M +94.1%
Adams Street Partners 2.95M $22.91M 0.0%
TPG GP A 2.55M $19.83M 0.0%
Seroba Life Sciences Management 2.02M $35.32M 0.0%
Largest transactions Shares Bought/sold Change
FHI Federated Hermes 3.06M +1.48M +94.1%
Point72 Asset Management 350K -698.96K -66.6%
Woodline Partners 25.7K -217.64K -89.4%
AlphaCentric Advisors 0 -100K EXIT
Victory Capital Management 183.69K -66.69K -26.6%
MS Morgan Stanley 103.98K +26.37K +34.0%
UBS UBS Group AG - Registered Shares 21.3K +21.25K +45219.1%
FMR 3.25M +20.87K +0.6%
Ergoteles 0 -11K EXIT
Bank Julius Baer & Co. Ltd, Zurich 0 -2K EXIT

Financial report summary

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Risks
  • Risks Related to Our Financial Condition and Capital Requirements
  • We have incurred significant losses since inception, and we expect to incur losses over the next several years and may not be able to achieve or sustain revenues or profitability in the future.
  • We will require substantial additional financing, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • We have not generated any revenue from product sales to date and may never be profitable.
  • Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations.
  • Risks Related to the Development of Our Product Candidates
  • Our approach to the discovery and development of product candidates represents a novel approach to radiation therapy, which creates significant and potentially unpredictable challenges for us.
  • We are very early in our development efforts. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or if we experience significant delays in doing so, our business will be materially harmed.
  • Our business is highly dependent on our lead product candidates, FPI-1434 and FPI-1966, as the lead investigational assets for our TAT platform and Fast-Clear linker technology, and we must complete preclinical studies and clinical testing before we can seek regulatory approval and begin commercialization of any of our other product candidates. If we are unable to obtain regulatory approval for, and successfully commercialize FPI-1434 or FPI-1966, our business may be materially harmed and such failure may affect the viability of our other product candidates.
  • Clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
  • We expect to develop FPI-1434 and FPI-1966, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.
  • We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization of our product candidates and adversely impact our potential to generate revenue, our business and our results of operations.
  • Our preclinical studies and clinical trial may fail to adequately demonstrate the safety, potency and purity, or safety and effectiveness, of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization.
  • The results of preclinical studies and early-stage clinical trials may not be predictive of future results. Initial success in our ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials.
  • Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time 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.
  • We have never commercialized a product candidate and may experience delays or unexpected difficulties in obtaining regulatory approval for our current and future product candidates.
  • Since the number of patients that we plan to enroll in our ongoing Phase 1 clinical trials of FPI-1434 and FPI-1966 are small, the results from such clinical trials, once completed, may be less reliable than results achieved in larger clinical trials, which may hinder our efforts to obtain regulatory approval for our product candidates.
  • Our product candidates may cause adverse events, undesirable side effects or have other properties that could halt their preclinical or clinical development, prevent, delay, or cause the withdrawal of their regulatory approval, limit their commercial potential, or result in significant negative consequences, including death of patients. If any of our product candidates receive marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability, or that of any potential future collaborators, to market the biologic or drug could be compromised.
  • The ongoing COVID-19 pandemic may materially and adversely affect our business and financial results.
  • The market opportunities for our product candidates may be smaller than we anticipated or may be limited to those patients who are ineligible for or have failed prior treatments. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • We may encounter difficulties enrolling patients in our clinical trials, and our clinical development activities could thereby be delayed or otherwise adversely affected.
  • We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved for commercial sale, we may not be able to generate product revenue.
  • We may expend our resources to pursue a particular product candidate and forgo the opportunity to capitalize on product candidates or indications that may ultimately be more profitable or for which there is a greater likelihood of success.
  • We currently conduct and may in the future conduct clinical trials for our product candidates outside the United States, and the FDA and similar foreign regulatory authorities may not accept data from such trials.
  • Risks Related to Our Reliance on Third Parties and Manufacturing
  • Presently, some of our product candidates are biologics and the manufacture of such product candidates is complex. Until we complete the construction of our own manufacturing facility, we rely, and will continue to rely, on third parties to manufacture our lead product candidates for our ongoing clinical trials and our preclinical studies as well as any preclinical studies or clinical trials of our future product candidates that we may conduct. We also expect to rely on third parties for the commercial manufacturing process of our product candidates, if approved. Our business could be harmed if those third parties fail to provide us with sufficient quantities of product supplies or product candidates, or fail to do so at acceptable quality levels or prices.
  • We are currently in the process of establishing our own manufacturing facility and infrastructure in addition to relying on CDMOs for the manufacture of our product candidates, which will be costly, time-consuming, and which may not be successful.
  • We do not have experience as a company managing a manufacturing facility.
  • We rely on third parties to conduct our current and planned clinical trials and plan to rely on third parties to conduct future clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
  • The strategic collaboration agreement with AstraZeneca is important to our business. We may depend on AztraZeneca or additional third parties for the development and commercialization of our other programs and future product candidates. Our current and future collaborators may control aspects of our clinical trials, which could result in delays or other obstacles in the commercialization of the product candidates we develop. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • If the antibody targets or de novo radioconjugates subject to the AstraZeneca Collaboration Agreement fail to advance or experience unacceptable safety or efficacy results if clinically developed, this could adversely impact the reputation of our Fast-Clear technology and our ability to engage in future collaborations.
  • We may form or seek additional collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
  • If we or third parties, such as CROs or CMOs, use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Risks Related to Government Regulation
  • The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.
  • We may seek orphan drug designation for product candidates we develop, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • A fast track designation by the FDA, even if granted for FPI-1434, FPI-1966 or any other future product candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • Accelerated approval by the FDA, even if granted for FPI-1434, FPI-1966 or any other future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway sooner than anticipated.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Disruptions at the FDA, the SEC and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our relationships with healthcare providers and physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Even if we receive marketing approval, coverage and adequate reimbursement may not be available for FPI-1434, FPI-1966 or our other product candidates, which could make it difficult for us to sell the product profitably.
  • Legislative or regulatory healthcare reforms in the United States and other countries may make it more difficult and costly for us to obtain regulatory clearance or approval of FPI-1434, FPI-1966 or our other product candidates and to produce, market and distribute our products after clearance or approval is obtained.
  • If we 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.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize any product candidates we may develop, and our technology may be adversely affected.
  • We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
  • If we fail to comply with our obligations under our patent licenses with third parties, we could lose license rights that are important to our business.
  • If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • Obtaining and maintaining our patent protection depends on 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 for non-compliance with these requirements.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
  • Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • If we do not obtain patent term extension and data exclusivity for any of our current or future product candidates, our business may be materially harmed.
  • Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Risks Related to Employee Matters and Managing Growth
  • We are highly 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 will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • The price of our common shares may be volatile, and you could lose all or part of your investment.
  • An active trading market for our common shares may not develop or be sustainable, and you may not be able to resell your shares at or above the purchase price.
  • If securities analysts publish negative evaluations of our stock, the price of our stock could decline.
  • We do not intend to pay dividends on our common shares, so any returns will be limited to the value of our common shares.
  • Our principal shareholders and management own a significant percentage of our shares and will be able to exert significant influence over matters subject to shareholder approval.
  • We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common shares less attractive to investors.
  • We have incurred, and will continue to incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.
  • Sales of a substantial number of our common shares by our existing shareholders in the public market could cause our share price to fall.
  • Our by-laws and certain Canadian legislation contain provisions that may have the effect of delaying, preventing or making undesirable an acquisition of all or a significant portion of our shares or assets or preventing a change in control.
  • Our by-laws designate specific courts in Canada and the United States as the exclusive forum for certain litigation that may be initiated by our shareholders, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
  • Because we are a Canadian company, it may be difficult to serve legal process or enforce judgments against us.
  • If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
  • If we or our non-U.S. subsidiary is a CFC there could be materially adverse U.S. federal income tax consequences to certain U.S. Holders of our common shares.
  • We may be or become a passive foreign investment company, which could result in adverse U.S. federal income tax consequences to U.S. Holders.
  • We may be exposed to financial risk related to the fluctuation of foreign exchange rates and the degrees of volatility of those rates.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, vendors and other agents may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • If our security measures are breached or unauthorized access to individually identifiable health information or other personally identifiable information is otherwise obtained, our reputation may be harmed, and we may incur significant liabilities.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • Our business may be impacted by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties beyond our control.
Management Discussion
  • Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
  • You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes appearing in Part I, Item I of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and notes thereto for the year ended December 31, 2021, included in our Annual Report on Form 10-K filed on March 17, 2022 with the U.S. Securities and Exchange Commission, or the SEC.
  • Our actual results and timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report on Form 10-Q, they may not be predictive of results or developments in future periods. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Content analysis

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Readability
H.S. senior Avg
New words: backend, cadence, complementary, coupled, flexibility, indexed, inflation, language, merge, Niowave, pledged, repayment
Removed: advancement, careful, clinic, file, found, implementing, inhibiting, kill, mechanism, outbreak, pathway, payload, remotely, signaling, transitioned, unsuccessful