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Celldex Therapeutics (CLDX)

Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly effect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer.

Company profile

Ticker
CLDX
Exchange
Website
CEO
Anthony Marucci
Employees
Incorporated
Location
Fiscal year end
Former names
AVANT IMMUNOTHERAPEUTICS INC, T CELL SCIENCES INC
SEC CIK
Subsidiaries
Celldex Therapeutics Switzerland GmbH ...
IRS number
133191702

CLDX stock data

Analyst ratings and price targets

Last 3 months
Current price
Average target
$68.50
Low target
$64.00
High target
$73.00
SVB Leerink
Maintains
Outperform
$64.00
9 Aug 22
HC Wainwright & Co.
Maintains
Buy
$73.00
1 Jul 22

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

8 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 Dec 20 Dec 19 Dec 18
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) 28.4M 28.4M 28.4M 28.4M 28.4M 28.4M
Cash burn (monthly) (no burn) 1.25M 12.13M 8.4M 7.41M 6.47M
Cash used (since last report) n/a 1.79M 17.37M 12.03M 10.61M 9.27M
Cash remaining n/a 26.61M 11.03M 16.37M 17.79M 19.13M
Runway (months of cash) n/a 21.2 0.9 1.9 2.4 3.0

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
16 Jun 22 Marino James J NQSO Common Stock Grant Acquire A No No 22.48 13,600 305.73K 13,600
16 Jun 22 Cohen Cheryl NQSO Common Stock Grant Acquire A No No 22.48 27,200 611.46K 27,200
16 Jun 22 Neil Garry Arthur NQSO Common Stock Grant Acquire A No No 22.48 27,200 611.46K 27,200
13F holders Current Prev Q Change
Total holders 167 178 -6.2%
Opened positions 19 40 -52.5%
Closed positions 30 23 +30.4%
Increased positions 64 59 +8.5%
Reduced positions 52 49 +6.1%
13F shares Current Prev Q Change
Total value 1.77B 2.45B -27.6%
Total shares 49.39M 46.09M +7.2%
Total puts 1.04M 885.5K +17.4%
Total calls 1.61M 1.99M -19.2%
Total put/call ratio 0.6 0.4 +45.3%
Largest owners Shares Value Change
FMR 7.01M $238.77M +0.2%
Wellington Management 3.53M $120.23M +61.5%
RTW Investments 3.08M $105.05M -21.4%
BLK Blackrock 3.05M $103.77M -1.7%
STT State Street 2.68M $91.37M +13.3%
Vanguard 2.43M $82.89M +0.9%
Ra Capital Management 2.08M $70.68M +15.0%
Redmile 2.05M $69.7M -5.5%
Viking Global Investors 1.85M $62.9M +143.7%
Eventide Asset Managment 1.45M $49.24M +16.7%
Largest transactions Shares Bought/sold Change
Wellington Management 3.53M +1.34M +61.5%
Viking Global Investors 1.85M +1.09M +143.7%
RTW Investments 3.08M -837.36K -21.4%
MS Morgan Stanley 1.02M +713.09K +233.1%
Opaleye Management 195.5K -648.5K -76.8%
Kynam Capital Management 753.03K +526.31K +232.1%
Cowen And 0 -466.59K EXIT
Tri Locum Partners 383.32K +383.32K NEW
Fred Alger Management 155.8K -346.32K -69.0%
Woodline Partners 579.19K +319.3K +122.9%

Financial report summary

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Risks
  • We currently have no product revenue and will need to raise capital to operate our business.
  • We expect to incur future losses and we may never become profitable.
  • We will need additional capital to fund our operations, including the development, manufacture and potential commercialization of our drug candidates. If we do not have or cannot raise additional capital when needed, we may be unable to develop and ultimately commercialize our drug candidates successfully.
  • Our stockholders may be subject to substantial dilution if we elect to pay future milestone consideration to the former Kolltan stockholders in shares of common stock. If we elect to pay future milestone consideration in cash we would likely need to raise additional capital.
  • U.S. federal income tax reform could adversely affect us.
  • Our long term success depends heavily on our ability to fund and complete the research and development activities and obtain regulatory approval for our program assets.
  • Our drug candidates are subject to extensive regulatory scrutiny.
  • If our drug candidates do not pass required tests for safety and effectiveness, we will not be able to obtain regulatory approval and derive commercial revenue from them.
  • Success in early clinical trials does not ensure that later clinical trials will be successful, and we cannot assure you that any of the clinical trials that we may conduct will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval.
  • Product testing is critical to the success of our drug candidates but subject to delay or cancellation if we have difficulty enrolling patients.
  • We may have delays in commencing, enrolling and completing our clinical trials, and we may not complete them at all.
  • If serious adverse or unacceptable side effects are identified during the development of our drug candidates, we may need to abandon or limit our development of some of our drug candidates.
  • We may expend our resources to pursue a particular drug candidate or indication and forgo the opportunity to capitalize on drug candidates or indications that may ultimately be more profitable or for which there is a greater likelihood of success.
  • We may be unable to manage multiple late-stage clinical trials for a variety of drug candidates simultaneously.
  • Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics for our drug candidates, if needed, could harm our drug development strategy and operational results.
  • Any delay in obtaining regulatory approval would have an adverse impact on our ability to earn future revenues.
  • We may enter into collaboration agreements for the licensing, development and ultimate commercialization of some of our drug candidates including, where appropriate, for our lead drug candidates. In such cases, we will depend greatly on our third-party collaborators to license, develop and commercialize such drug candidates, and they may not meet our expectations.
  • We may face delays, difficulties or unanticipated costs in establishing sales, marketing and distribution capabilities or seeking a partnership for the commercialization of our drug candidates, even if regulatory approval is obtained.
  • If our drug candidates for which we obtain regulatory approval do not achieve broad acceptance from physicians, patients and third-party payors, we may be unable to generate significant revenues, if any.
  • Even if any of our drug candidates receive FDA approval, the terms of the approval may limit such drug’s commercial potential. Additionally, even after receipt of FDA approval, such drug would be subject to substantial, ongoing regulatory requirements.
  • Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance of any of our drug candidates. If there is not sufficient reimbursement for our future drugs, it is less likely that such drugs will be widely used.
  • Other factors could affect the demand for and sales and profitability of any drug candidates that we may commercialize in the future.
  • Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.
  • If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
  • We rely on third parties to plan, conduct and monitor our clinical tests, and their failure to perform as required would interfere with our product development.
  • We rely on contract manufacturers over whom we have limited control. Should the cost, delivery and quality of clinical materials manufactured by us in our Fall River facility or supplied by contract manufacturers vary to our disadvantage, our business operations could suffer significant harm.
  • We may need to rely on third-party collaborators to develop and commercialize companion diagnostic tests for our drug candidates.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • We may expand our clinical development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We may not be able to successfully integrate our existing technology or to modify our technologies to create new immunotherapeutic drugs.
  • Our internal computer systems, or those of our CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug development programs.
  • Our business requires us to use hazardous materials, which increases our exposure to dangerous and costly accidents.
  • We face the risk of product liability claims, which could exceed our insurance coverage, and product recalls, each of which could deplete our cash resources.
  • We license technology from other companies to develop products, and those companies could influence research and development or restrict our use of it. In addition, if we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • Our ability to successfully develop and, if regulatory approval is obtained, commercialize our drug candidates may be materially adversely affected if we are unable to obtain and maintain effective intellectual property rights for our drug candidates and technologies.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • We may be unable to protect the confidentiality of our trade secrets, thus harming our business and competitive position.
  • We may become involved in lawsuits to protect or enforce our patents, 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.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
  • Any fast track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates. Additionally, our product candidates may treat indications that do not qualify for priority review vouchers.
  • Any breakthrough therapy designation granted by the FDA for our 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 our processes and systems are not compliant with regulatory requirements, we could be subject to delays in submitting BLAs, NDAs or restrictions on marketing of drugs after they have been approved.
  • We have conducted and are conducting clinical trials outside the United States and anticipate conducting additional clinical trials outside the United States, and the FDA may not accept data from such trials.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • Even if we receive regulatory approval for a drug 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.
  • We may be subject, directly or indirectly, to federal and state health care fraud and abuse laws, false claims laws, transparency and pricing laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Compliance with laws and regulations pertaining to the privacy and security of health information may be time consuming, difficult and costly, particularly in light of increased focus on privacy issues in countries around the world, including the U.S. and the EU.
  • Changes in health care law and implementing regulations, including government restrictions on pricing and reimbursement, as well as health care policy and other health care payor cost-containment initiatives, may have a material adverse effect on us.
  • Our history of losses and uncertainty of future profitability make our common stock a highly speculative investment.
  • We completed a reverse stock split in order to regain compliance with the listing requirements of NASDAQ. However, the reverse stock split may not result in our stock price remaining compliant with the minimum price requirements of NASDAQ.
  • Our share price has been and could remain volatile.
  • We completed the reverse stock split of our shares of common stock, which may reduce and may limit the market trading liquidity of the shares due to the reduced number of shares outstanding, and may potentially have an anti-takeover effect.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. sophomore Avg
New words: AEs, antihistamine, ASC, assigned, backpain, brought, CFT, CTT, decision, deem, deprioritize, discretion, dismissal, endpoint, Friction, group, headache, Hive, joint, jointly, lowest, markedly, meaningful, mg, moderate, neutropenia, numeric, parallel, paralleled, pattern, percentage, pipeline, prejudice, randomly, ratio, replace, replaced, resolved, resource, reviewed, scale, Score, Stipulation, suboptimal, subtype, successor, term, tract, unrelated, urinary, vi, Worst
Removed: achievement, adjusted, calculating, closing, conventional, CR, determined, dispute, follicular, hematopoietic, highest, Immunotherapy, intolerance, KEYTRUDA, matter, mediation, merit, METRIC, monotherapy, objection, outcome, partnership, preliminary, recommended, resolution, scheduled, shrinkage, stable, TAM, uniquely