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Werewolf Therapeutics (HOWL)

Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer. The company is leveraging its proprietary PREDATOR™ platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Its INDUKINE™ molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. Its most advanced product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2), and Interleukin-12 (IL-12) INDUKINE molecules for the treatment of solid tumors.The company is continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

HOWL stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

11 Aug 22
12 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
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) 147.01M 147.01M 147.01M 147.01M 147.01M 147.01M
Cash burn (monthly) (no burn) 3.13M 4.99M 5.17M 101K 3.28M
Cash used (since last report) n/a 4.54M 7.25M 7.51M 146.69K 4.76M
Cash remaining n/a 142.47M 139.76M 139.51M 146.86M 142.25M
Runway (months of cash) n/a 45.6 28.0 27.0 1454.1 43.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
1 Jun 22 Chulani Karunatilake Stock Option Common Stock Grant Acquire A No No 3.43 136,000 466.48K 136,000
1 Jun 22 Sherman Michael A. Stock Option Common Stock Grant Acquire A No No 3.43 11,600 39.79K 11,600
1 Jun 22 Alon Lazarus Stock Option Common Stock Grant Acquire A No No 3.43 11,600 39.79K 11,600
1 Jun 22 Meeta Chatterjee Stock Option Common Stock Grant Acquire A No No 3.43 7,733 26.52K 7,733
1 Jun 22 Morrison Briggs Stock Option Common Stock Grant Acquire A No No 3.43 11,600 39.79K 11,600
13F holders Current Prev Q Change
Total holders 53 55 -3.6%
Opened positions 6 12 -50.0%
Closed positions 8 3 +166.7%
Increased positions 16 21 -23.8%
Reduced positions 15 8 +87.5%
13F shares Current Prev Q Change
Total value 207.25M 351.25M -41.0%
Total shares 28.99M 29.11M -0.4%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners Shares Value Change
Ra Capital Management 4.29M $18.88M 0.0%
MPM Asset Management 4.28M $18.85M 0.0%
MPM BioVentures 2014 3.21M $51.53M 0.0%
MPM Oncology Impact Management 2.39M $10.51M 0.0%
Taiho Ventures 2.07M $33.17M 0.0%
Arkin Moshe 2.05M $0 0.0%
Longwood Fund III GP 1.68M $26.88M 0.0%
BLK Blackrock 1.28M $5.65M +0.6%
Adage Capital Partners GP, L.L.C. 975.6K $4.29M +1.6%
Deerfield Management 958.13K $4.22M 0.0%
Largest transactions Shares Bought/sold Change
Avidity Partners Management 0 -485K EXIT
Partner Fund Management 585.33K +185.33K +46.3%
FMR 518.64K +147.9K +39.9%
STT State Street 335.09K +75.46K +29.1%
Geode Capital Management 288.31K +74.08K +34.6%
Soleus Capital Management 0 -64.59K EXIT
Sphera Funds Management 584.2K -64.19K -9.9%
Caas Capital Management 101.6K -61K -37.5%
Millennium Management 42.4K +42.4K NEW
Granite Point Capital Management 55K +40K +266.7%

Financial report summary

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Risks
  • We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.
  • We have no products approved for commercial sale and have not generated any revenue from product sales. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it.
  • We will need to obtain substantial additional funding to finance our operations and complete the development and any commercialization of WTX-124, WTX-330 and any future product candidates. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate one or more of our research and development programs or other operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our platform technology or product candidates.
  • We have a term loan facility that requires us to comply with certain operating covenants and places restrictions on our operating and financial flexibility.
  • Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • We are early in our development efforts and our current product candidates will require successful completion of preclinical and clinical development before we can seek regulatory approval for any product candidates.
  • Our business is highly dependent on the success of our initial INDUKINE molecules, which are in the early stages of development and will require significant additional preclinical and clinical development before we can seek regulatory approval for and launch a product commercially.
  • Our approach to the discovery and development of product candidates based on our PREDATOR platform is unproven, and we do not know whether we will be able to develop any products of commercial value.
  • Manufacturing INDUKINE molecules is subject to risk since they are a novel class of multi-domain biologics that include protease cleavable linkers, and they have never been produced on a clinical or commercial scale. We may be unable to manufacture INDUKINE molecules at the scale needed for clinical development and commercial production on a timely basis or at all, which would adversely affect our ability to conduct clinical trials and seek regulatory approvals or commercialize our programs, which would have an adverse effect on our business.
  • 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.
  • Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.
  • Preclinical studies and clinical trials are expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials.
  • We may encounter substantial delays in the commencement or completion, or termination or suspension, of our clinical trials, which could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Our product candidates may cause undesirable or unexpectedly severe side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • The COVID-19 pandemic or any future surges, including as a result of new variants and subvariants of the virus, or a similar pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates.
  • 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 expect to develop WTX-124 and WTX-330, and potentially future product candidates, in combination with third-party drugs, some of which may still be in development, and we will have limited or no control over the safety, supply, regulatory status or regulatory approval of such drugs.
  • We may not be successful in our efforts to identify or discover additional product candidates.
  • We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or following commercial sale, and any product liability insurance we may obtain may not cover all damages from such claims.
  • We have never commercialized a product candidate and we may lack the necessary expertise, personnel and resources to successfully commercialize any products that receive regulatory approval, either on our own or together with collaborators.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • The sizes of the potential markets for our product candidates are difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.
  • The successful commercialization of our product candidates will depend in part on the extent to which we obtain and maintain favorable coverage, adequate reimbursement levels and pricing policies with third party payors.
  • Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community necessary for commercial success.
  • We expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated.
  • We rely, and expect to continue to 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 or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any product candidates.
  • The manufacturing of biologics is complex and we do not have our own clinical manufacturing capabilities. We will rely on third parties to produce preclinical, clinical and commercial supplies of all current and any future product candidates.
  • We have entered into, and may in the future seek to enter into, collaborations or other similar arrangements for our product candidates. If we are unable to enter into such collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • If we are unable to obtain and maintain patent protection for any product candidates we develop or for our PREDATOR platform and other proprietary technologies we may develop, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates and technology similar or identical to our product candidates and technology, and our ability to successfully commercialize any product candidates we may develop, and our technology may be adversely affected.
  • We rely on the Harpoon Agreement for patent rights with respect to our product candidates and may in the future acquire additional third-party intellectual property rights on which we may similarly rely. We face risks with respect to such reliance, including the risk that we could lose these rights that are important to our business if we fail to comply with our obligations under these licenses.
  • If our efforts to protect the proprietary nature of the intellectual property related to our technologies and product candidates are not adequate, we may not be able to compete effectively in our market.
  • Our proprietary position in part depends upon patents that are manufacturing, formulation or method-of-use patents, which may not prevent a competitor or other third party from using the same product candidate for another use.
  • 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 or technology 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 damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information 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.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
  • Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and in which territories, we will obtain marketing approval to commercialize a product candidate.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. Any approval we may be granted for our product candidates in the United States would not assure approval of our product candidates in foreign jurisdictions and any of our product candidates that may be approved for marketing in a foreign jurisdiction will be subject to risks associated with foreign operations.
  • We may not be able to obtain orphan drug designation or orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving competing products.
  • Any product candidate for which we obtain marketing approval is subject to ongoing regulation and could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements, when and if any of our product candidates are approved.
  • We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review designations, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • We may seek PRIME Designation in the EU for one or more of our product candidates but we might not receive such designations and, even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • We and our contract manufacturers are subject to significant regulation. The manufacturing facilities on which we rely may not continue to meet regulatory requirements, which could materially harm our business.
  • We intend in the future to conduct, clinical trials for certain of our product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations and the conduct of trials outside the United States could subject us to additional delays and expense.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, including from the COVID-19 pandemic, 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.
  • Current and future legislation may increase the difficulty and cost for us to obtain reimbursement for any of our candidate products that do receive marketing approval.
  • Current and future legislative efforts may limit the costs for our products, if and when they are licensed for marketing, and that could materially impact our ability to generate revenues.
  • We may be subject to certain healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, fines, disgorgement, exclusion from participation in government healthcare programs, curtailment or restricting of our operations, and diminished profits and future earnings.
  • Compliance with state, national and international privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to a variety of harms, including significant fines and penalties, litigation and reputational damage, any of which may have a material adverse effect on our business, financial condition or results of operations.
  • We are subject to U.S. and certain foreign export control, import, sanctions, anti-corruption, and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
  • 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 harm our business.
  • Our employees, independent contractors, CROs, consultants, commercial partners, vendors and principal investigators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • We expect to grow our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We depend on our information technology systems, and any failure of these systems could harm our business. Security breaches, loss of data, inability to access systems, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • A variety of risks associated with marketing our product candidates internationally, if approved, could materially adversely affect our business.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • An active trading market for our common stock may not continue to develop or be sustained and our stockholders may not be able to resell their shares of our common stock.
  • The price of our common stock could be subject to volatility related or unrelated to our operations.
  • If securities or industry analysts do not publish or cease publishing research or reports about our company, or if they issue unfavorable or inaccurate research regarding our business, our share price and trading volume could decline.
  • Our principal stockholders and management own a significant percentage of our common stock and will be able to exert significant control over matters subject to stockholder approval.
  • We have broad discretion regarding use of our cash and cash equivalents, and we may use them in ways that do not enhance our operating results or the market price of our common stock.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management has devoted and will continue to be required to devote substantial time to new compliance initiatives and corporate governance practices.
  • In the past, we have identified material weaknesses in our internal control over financial reporting, and if we are unable to implement and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock may be materially adversely affected.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management.
  • Our restated certificate of incorporation designates the Court of Chancery of the State of Delaware and the federal district courts of the United States of America as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers and employees and increase the costs to our stockholders of bringing such claims.
Management Discussion
  • Research and development expenses for the year ended December 31, 2021 were $35.3 million, compared to $16.6 million for the year ended December 31, 2020. The increase of approximately $18.6 million was primarily due to:
  • •$7.3 million of increased manufacturing expense related to costs incurred with contract manufacturing organizations to support the production of preclinical and future clinical trial materials associated with our product candidates WTX-124, WTX-330 and WTX-613;
  • •$5.0 million of increased personnel costs, including $1.3 million of increased stock-based compensation expense, primarily due to increased headcount associated with expanded discovery efforts as well as the hiring of a clinical development team;

Content analysis

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Legalese
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Readability
H.S. junior Avg
New words: affiliated, analogy, Anaveon, ATM, Biopharma, Bioscience, chair, component, Crossbow, Cue, deferral, deposit, distinct, drawdown, estate, Evnin, expedient, fulfilled, Hedging, implicit, input, iv, landlord, leasehold, Luke, marked, nonrefundable, occupied, predominant, rational, reclassified, repair, RSA, RSU, standalone, sublease, subleased, tenant, unamortized, vi, weighted
Removed: award, investor, leukemia, targeting, vest