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SESN Sesen Bio

Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer. The Company's lead program, Vicineum™, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2020, the Company completed the BLA submission for Vicineum to the FDA. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China and the Middle East and North Africa (MENA), for which the Company has partnered with Qilu Pharmaceutical and Hikma Pharmaceuticals, respectively, for commercialization. Vicineum is a locally administered targeted fusion protein composed of an anti-EpCAM antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A for the treatment of high-risk NMIBC.

Company profile

Ticker
SESN
Exchange
CEO
Thomas Cannell
Employees
Incorporated
Location
Fiscal year end
Former names
Eleven Biotherapeutics, Inc.
SEC CIK

SESN stock data

(
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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

10 May 21
27 Jul 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from Sesen Bio earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 109.99M 109.99M 109.99M 109.99M 109.99M 109.99M
Cash burn (monthly) (positive/no burn) (positive/no burn) 18.41M 9.81M 6.16M 3.37M
Cash used (since last report) n/a n/a 71.65M 38.18M 23.97M 13.12M
Cash remaining n/a n/a 38.33M 71.81M 86.01M 96.87M
Runway (months of cash) n/a n/a 2.1 7.3 14.0 28.7

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
20 Jul 21 Peter Honig Stock Option Common Stock Grant Aquire A No No 3.86 185,000 714.1K 185,000
20 Jul 21 Michael A. S. Jewett Common Stock Common Stock Grant Aquire A No No 3.86 185,000 714.1K 185,000

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

23.2% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 76 57 +33.3%
Opened positions 24 12 +100.0%
Closed positions 5 2 +150.0%
Increased positions 35 16 +118.8%
Reduced positions 10 12 -16.7%
13F shares
Current Prev Q Change
Total value 104.36M 30.81M +238.8%
Total shares 40.14M 22.82M +75.9%
Total puts 963.1K 119.6K +705.3%
Total calls 757.3K 15.8K +4693.0%
Total put/call ratio 1.3 7.6 -83.2%
Largest owners
Shares Value Change
Vanguard 7.2M $18.71M +22.1%
TRV GP 4.09M $10.64M NEW
Renaissance Technologies 3.75M $9.75M +28.7%
Schonfeld Strategic Advisors 3.35M $8.72M +860.6%
Two Sigma Investments 3.22M $8.37M +441.6%
Two Sigma Advisers 2.98M $7.75M +314.3%
BLK Blackrock 2.92M $7.6M +53.4%
Millennium Management 1.62M $4.23M +155.1%
Kingdon Capital Management, L.L.C. 1.31M $3.41M -23.4%
Geode Capital Management 1.3M $3.39M +58.8%
Largest transactions
Shares Bought/sold Change
TRV GP 4.09M +4.09M NEW
Schonfeld Strategic Advisors 3.35M +3M +860.6%
Two Sigma Investments 3.22M +2.62M +441.6%
Two Sigma Advisers 2.98M +2.26M +314.3%
MS Morgan Stanley 5.38K -1.74M -99.7%
Eversept Partners 0 -1.56M EXIT
Vanguard 7.2M +1.3M +22.1%
BLK Blackrock 2.92M +1.02M +53.4%
Millennium Management 1.62M +987.93K +155.1%
DB Deutsche Bank AG - Registered Shares 980.42K +954.35K +3660.3%

Financial report summary

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Risks
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included elsewhere in this Annual Report on Form 10-K.
  • Future sales and issuances of shares of our common stock or rights to purchase shares of our common stock, including common stock purchase warrants and stock options, could result in additional dilution of the percentage ownership of our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We are dependent on our lead product candidate, Vicineum for the treatment of BCG-unresponsive NMIBC. If we are unable to obtain marketing approval for or successfully commercialize our lead product candidate, either alone or through an out-license or a commercialization partnership, or experience significant delays in doing so, our business could be materially harmed.
  • Vicineum for the treatment of BCG-unresponsive NMIBC may cause undesirable side effects, serious adverse events or have other properties that could delay or halt clinical trials, delay or prevent its regulatory approval, limit the commercial profile of its labeling, if approved, or result in significant negative consequences following any marketing approval.
  • The marketing approval process is expensive, time-consuming and uncertain. As a result, we cannot predict when or if we, or any licensees or partners, will obtain marketing approval to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC or any other product candidate.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad, and any approval we are granted for our product candidates in the United States would not assure approval of product candidates in foreign jurisdictions.
  • Our commercial success depends upon attaining significant market acceptance of Vicineum for the treatment of BCG-unresponsive NMIBC, if approved, among physicians, patients, third-party payors and the medical community.
  • The market opportunity for Vicineum may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
  • If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in commercializing Vicineum for the treatment of BCG-unresponsive NMIBC, if and when it is approved.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Our product candidates for which we intend to seek approval as biological products may face competition from biosimilar products.
  • Even if we are able to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC, it may become subject to unfavorable pricing regulations, third-party coverage or reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of Vicineum for the treatment of BCG-unresponsive NMIBC, if approved.
  • We will depend on Qilu for the development and commercialization of Vicineum in the greater China region.
  • We depend on the Roche License Agreement for the development and commercialization of EBI-031.
  • We may enter into additional commercialization partnerships or out-license agreements with third parties for the commercialization or development of our product candidates. If our commercialization partnership or out-licenses are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • If we are not able to establish additional commercialization partnerships, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • We rely on third parties to conduct our pre-clinical 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 for or commercialize our product candidates.
  • If we lose our relationships with CROs, our product development efforts could be delayed.
  • Our experience manufacturing Vicineum is limited to our pre-clinical studies and clinical trials. We have no experience manufacturing Vicineum on a commercial scale. We are dependent on third parties for our supply chain, and if we experience problems with any such third parties, the manufacturing of Vicineum could be delayed.
  • If we are unable to obtain and maintain patent protection for our technology and products, or if our licensors are unable to obtain and maintain patent protection for the technology or products that we license from them, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We have not yet registered our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business.
  • We depend on our license agreements with Zurich, Micromet and XOMA, and if we cannot meet the requirements under the agreements we could lose important rights to Vicineum, which could have material adverse effect on our business.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, 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.
  • We may be subject to claims by third parties asserting that our employees, consultants, independent contractors or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Even if we obtain marketing approvals for one or more of our product candidates, the terms of such approvals, ongoing regulations and post-marketing restrictions may limit how we manufacture and market such products, which could materially impair our ability to generate revenue.
  • Any product candidate, including Vicineum for the treatment of BCG-unresponsive NMIBC, for which we obtain marketing approval will be subject to a strict enforcement of post-marketing requirements and we could be subject to substantial penalties, including withdrawal of our product from the market, if we fail to comply with all regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
  • Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
  • Our relationships with customers and third-party payors may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of our product candidates, including Vicineum for the treatment of BCG-unresponsive NMIBC, and affect the prices we may obtain.
  • If we participate in the MDRP and fail to comply with our reporting and payment obligations under that or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs.
  • The consequences of the United Kingdom’s withdrawal from the E.U. may have a negative effect on global economic conditions, financial markets and our business.
  • 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 significant costs.
  • Our employees may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • The COVID-19 coronavirus could adversely impact our business.
  • Our future success depends on our ability to attract, retain and motivate qualified personnel.
  • We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • If we expand our development and regulatory capabilities or implement sales, marketing and distribution capabilities, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could materially adversely affect our business.
  • 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 management.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
Management Discussion
  • Revenue for the year ended December 31, 2020 was $11.2 million, which was due to the recognition of revenue pursuant to our commercialization partnership agreements, specifically the Qilu License Agreement. The Company did not record any revenue for the year ended December 31, 2019.
  • Research and development expenses were $29.2 million for the year ended December 31, 2020 compared to $24.7 million for the year ended December 31, 2019. The increase of $4.5 million was due primarily to increased costs associated with technology transfer and manufacturing scale-up for commercial supply ($6.0 million), license milestone fees ($1.2 million), and professional fees in support of regulatory activities ($0.4 million), partially offset by lower employee-related compensation ($1.1 million), lower clinical trial expenses ($1.6 million) as a result of the Company’s Phase 3 VISTA Trial winding down, and other decreases ($0.4 million).
  • General and administrative expenses were $14.3 million for the year ended December 31, 2020 compared to $12.2 million for the year ended December 31, 2019. The increase of $2.1 million was due primarily to increases in employee-related compensation ($1.3 million), insurance ($0.5 million), legal fees ($0.6 million), and other increases ($0.2 million), partially offset by lower market research ($0.5 million).
Content analysis
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H.S. junior Avg
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