SESN Sesen Bio Inc.

1.05
0  0%
Previous Close 1.05
Open 1.03
52 Week Low 0.37
52 Week High 1.54
Market Cap $123,030,218
Shares 117,171,636
Float 117,100,757
Enterprise Value $85,289,217
Volume 706,596
Av. Daily Volume 1,344,520
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Non-muscle invasive bladder cancer (NMIBC)
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Latest News

  1. On-track to complete BLA submission in the US in the fourth quarter of 2020

    Entered into a license agreement with Qilu Pharmaceutical for the development and commercialization of Vicineum™ in Greater China with $12M upfront payment

    Manufacturing of PPQ campaign drug substance batches has been completed

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the second quarter ended June 30, 2020. The Company also provided an update on recent business development activities and the progress of manufacturing activities related to the PPQ campaign. The Company's lead program, Vicineum, also known as VB4-845, is currently…

    On-track to complete BLA submission in the US in the fourth quarter of 2020

    Entered into a license agreement with Qilu Pharmaceutical for the development and commercialization of Vicineum™ in Greater China with $12M upfront payment

    Manufacturing of PPQ campaign drug substance batches has been completed

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the second quarter ended June 30, 2020. The Company also provided an update on recent business development activities and the progress of manufacturing activities related to the PPQ campaign. 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 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review.

    "We are extremely pleased with the progress at Sesen Bio over the past quarter," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We signed our first licensing agreement for Vicineum outside the US with Qilu Pharmaceutical, which is a strong sign of confidence in our mission to bring this innovative therapy to more patients in need. We expect to sign additional partnerships over the next six months. Equally important, we have now completed the manufacturing of the PPQ campaign drug substance batches at Fujifilm, an important milestone in our path to completion of the BLA submission. We are currently in an exciting phase at Sesen Bio and we remain as driven as ever to bring Vicineum to market to save and improve the lives of patients with cancer."

    US and European Regulatory Update

    US:

    • On June 17, 2020, Sesen received conditional acceptance of the proprietary brand name Vicineum for the Company's product candidate, oportuzumab monatox. The Company believes Vicineum is a name with strong marketing potential that is also consistent with the FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the Vicineum brand name is conditional on FDA approval of the Company's product candidate. The conditional acceptance of Vicineum is an important milestone in commercial readiness in the US. The Company remains on track to complete the BLA submission in the fourth quarter of 2020 and anticipates potential approval in mid-2021.

    Europe:

    • Sesen Bio concluded a five-month scientific opinion process in Europe and received positive Scientific Advice for both clinical and CMC. Importantly, the Committee for Medical Products for Human Use ("CHMP") agreed that the nonclinical and clinical pharmacology studies, and safety database are all sufficient to support a Marketing Authorization Application ("MAA") submission for Vicineum and no additional clinical trials were requested. Additionally, the CHMP agreed that the CMC comparability plan provides a strong analytical package, and no additional clinical trials to establish comparability are deemed necessary at this time. Based on the guidance received, the Company expects to submit the MAA for Vicineum to the EMA in early 2021 with potential approval anticipated in early 2022.
    • On July 3, 2020, the Company received a product-specific pediatric waiver from the EMA for Vicineum. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a Pediatric Investigation Plan ("PIP") that outlines the clinical development strategy for studying the investigational product in the pediatric population. In some instances, a waiver from required pediatric studies for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate. The PIP waiver from the EMA applies to Vicineum across all subsets of the pediatric population for the treatment of urothelial carcinoma. The receipt of the waiver will allow the Company to submit a MAA for Vicineum to the EMA without the requirement to conduct clinical studies in a pediatric population either pre-approval or post-approval.

    Business Development Update

    On July 30, 2020, Sesen Bio and Qilu Pharmaceutical signed a license agreement for the commercialization of Vicineum in Greater China. Under the terms of the agreement, Sesen granted Qilu Pharmaceutical a license to manufacture, develop and commercialize Vicineum for the treatment of NMIBC and other types of cancer in China, Hong Kong, Macau and Taiwan ("Greater China"). Key terms of the deal include:

    • Financial terms include significant sources of non-dilutive capital
      • Upfront payment of $12M in cash
      • Eligibility to receive up to $23M in regulatory and tech transfer milestones in addition to sales royalties for at least 12 years
    • Qilu will be the Marketing Authorization Holder and will have the exclusive rights to develop, manufacture and commercialize Vicineum in Greater China
      • Qilu will be responsible for all expenses related to these activities
      • Sesen retains full development and commercialization rights in the US and the rest of world excluding Greater China
    • Terms of the agreement include tech transfer, creating an opportunity for future CMO partnership to meet significant global demand forecasts

    Manufacturing Update

    Sesen Bio completed the manufacturing of the PPQ campaign drug substance batches at Fuji on schedule. Release testing is underway, and upon completion, the drug substance will be shipped to Baxter to finish the PPQ campaign for drug product, which is anticipated to be completed in September 2020. Comparability data from the PPQ campaign for drug substance and drug product are the last material deliverables before submitting the BLA in the fourth quarter of 2020.

    Second Quarter 2020 Financial Results

    • Cash Position: Cash and cash equivalents were $37.7 million as of June 30, 2020, compared to $48.1 million as of December 31, 2019.
    • R&D Expenses: Research and development expenses for the second quarter of 2020 were $4.6 million compared to $7.9 million for the same period in 2019. The second quarter decrease was due primarily to timing of costs related to the ongoing technology transfer process and commercial manufacturing, in addition to lower employee compensation and lower clinical expenses related to the Phase 3 VISTA trial for Vicineum.
    • G&A Expenses: General and administrative expenses for the second quarter of 2020 were $3.3 million compared to $2.6 million for the same period in 2019. The second quarter increase was due primarily to increases in employee compensation, and legal and insurance costs, offset by slightly lower audit and professional fees.
    • Net Income (Loss): Net loss was $26.3 million, or $0.24 per basic and diluted share, for the three months ended June 30, 2020, compared to a net loss of $54.3 million, or $0.67 per basic and diluted share, for the same period in 2019. The change was primarily the result of the non-cash change in fair value of contingent consideration due to significantly higher discount rates associated with market conditions related to the COVID-19 pandemic.

    About VicineumTM

    Vicineum, a locally administered fusion protein, is Sesen Bio's lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca's immune checkpoint inhibitor durvalumab.

    About the VISTA Clinical Trial

    The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicineum™ as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicineum twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

    About 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 a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. 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. For more information, please visit the company's website at www.sesenbio.com.

    COVID-19 Pandemic Potential Impact

    Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on our Company. The Company has not yet experienced any disruptions to our operations as a result of COVID-19, however, we are not able to quantify or predict with certainty the overall scope of potential impacts to our business, including, but not limited to, our ability to raise capital and, if approved, commercialize Vicineum. Sesen Bio remains committed to the health and safety of patients, caregivers and employees.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our ability to successfully develop our product candidates and complete our planned clinical programs, expectations regarding the impact of the COVID-19 pandemic, expectations regarding the timing or amounts of any payments by Qilu Pharmaceutical, expectations regarding additional partnerships for the commercialization of Vicineum outside of the US, expectations regarding the timing of completion of our BLA submission for Vicineum, expectations regarding the timing of potential approval of our BLA submission by the FDA, expectations regarding the timing of the submission of our MAA for Vicineum to the EMA, expectations regarding the timing of potential approval of our MAA submission by the EMA, expectations regarding the need for any additional clinical trials, expectations regarding the potential successful launch of Vicineum, if approved, our ability to obtain marketing approvals for our product candidates, and other factors discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    SESEN BIO, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF INCOME (OPERATIONS) AND COMPREHENSIVE INCOME (LOSS)

    (In thousands, except per share data)

    (Unaudited)

     
     

    Three Months ended

     

    Six Months ended

    June 30,

     

    June 30,

    2020

     

    2019

     

    2020

     

    2019

    Operating expenses:
    Research and development

    $

    4,562

     

    $

    7,944

     

    $

    13,429

     

    $

    12,630

     

    General and administrative

     

    3,318

     

     

    2,617

     

     

    6,766

     

     

    5,672

     

    Change in change in fair value of contingent consideration

     

    18,480

     

     

    44,000

     

     

    (35,220

    )

     

    43,000

     

    Total operating expenses

     

    26,360

     

     

    54,561

     

     

    (15,025

    )

     

    61,302

     

    Income (Loss) from Operations

     

    (26,360

    )

     

    (54,561

    )

     

    15,025

     

     

    (61,302

    )

    Other income (expense):
    Other income, net

     

    16

     

     

    226

     

     

    195

     

     

    487

     

    Net Income (Loss) and Comprehensive Income (Loss)

    $

    (26,344

    )

    $

    (54,335

    )

    $

    15,220

     

    $

    (60,815

    )

     
    Net income (loss) per common share - basic

    $

    (0.24

    )

    $

    (0.67

    )

    $

    0.13

     

    $

    (0.77

    )

    Weighted-average common shares outstanding - basic

     

    112,569

     

     

    80,739

     

     

    111,189

     

     

    79,107

     

    Net income (loss) per common share - diluted

    $

    (0.24

    )

    $

    (0.67

    )

    $

    0.11

     

    $

    (0.77

    )

    Weighted-average common shares outstanding - diluted

     

    112,569

     

     

    80,739

     

     

    111,203

     

     

    79,107

     

    SESEN BIO, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share data)

    (Unaudited)

    June 30,

    December 31,

    2020

    2019

     
    Assets
    Current assets:
    Cash and cash equivalents

    $

    37,741

     

    $

    48,121

     

    Prepaid expense and other current assets

     

    3,727

     

     

    6,326

     

    Total current assets

     

    41,468

     

     

    54,447

     

    Restricted cash

     

    20

     

     

    20

     

    Property and equipment, net

     

    185

     

     

    238

     

    Intangibles

     

    46,400

     

     

    46,400

     

    Goodwill

     

    13,064

     

     

    13,064

     

    Other assets

     

    76

     

     

    196

     

    Total Assets

    $

    101,213

     

    $

    114,365

     

    Liabilities and Stockholders' Deficit
    Current liabilities:
    Accounts payable

    $

    1,274

     

    $

    1,902

     

    Accrued expenses

     

    4,866

     

     

    6,169

     

    Other current liabilities

     

    373

     

     

    446

     

    Total current liabilities

     

    6,513

     

     

    8,517

     

    Contingent consideration

     

    84,800

     

     

    120,020

     

    Deferred tax liability

     

    12,528

     

     

    12,528

     

    Total Liabilities

     

    103,841

     

     

    141,065

     

    Commitments and contingencies
    Stockholders' Deficit:
    Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at June 30,
    2020 and December 31, 2019; no shares issued and outstanding at June 30, 2020 and December 31, 2019
    Common stock. $0.001 par value per share; 200,000,000 shares authorized at June 30,
    2020 and December 31, 2019; 116,627,653 and 106,801,409 shares issued and
    outstanding at June 30, 2020 and December 31, 2019, respectively

     

    116

     

     

    107

     

    Additional paid-in capital

     

    275,560

     

     

    266,717

     

    Accumulated deficit

     

    (278,304

    )

     

    (293,524

    )

    Total Stockholders' Deficit

     

    (2,628

    )

     

    (26,700

    )

    Total Liabilities and Stockholders' Deficit

    $

    101,213

     

    $

    114,365

     

     

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  2. August 5, 2020 – Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced it will be featured as a presenting company at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020. The Company will provide an update on the regulatory process in the US and Europe, and the BD process outside the US.

    Event: Canaccord Genuity 40th Annual Growth Conference
    Date: August 13, 2020
    Time: 11:00-11:25 AM ET

    A live webcast of the Company's presentation will be accessible from the Investors & Media section of Sesen Bio's website, www.sesenbio.com. An archived replay of the webcast will be available on the Company's website for…

    August 5, 2020 – Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced it will be featured as a presenting company at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020. The Company will provide an update on the regulatory process in the US and Europe, and the BD process outside the US.

    Event: Canaccord Genuity 40th Annual Growth Conference

    Date: August 13, 2020

    Time: 11:00-11:25 AM ET

    A live webcast of the Company's presentation will be accessible from the Investors & Media section of Sesen Bio's website, www.sesenbio.com. An archived replay of the webcast will be available on the Company's website for 90 days after the conference.

    About 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 a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, for which the Company has partnered with Qilu Pharmaceutical 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. For more information, please visit the company's website at www.sesenbio.com.

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  3. Sesen to receive $12 million upfront and $23 million in potential regulatory and tech transfer milestone payments

    Sesen eligible to receive royalties on net sales in China

    Sesen to host conference call Friday, July 31st at 8:00 a.m. EDT

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Qilu Pharmaceutical, a leading vertically integrated pharmaceutical company in China specializing in the manufacturing and marketing of active pharmaceutical ingredients and drug products, today announced that the companies have entered into an exclusive licensing agreement for the manufacture, development and commercialization of Vicineum for the treatment…

    Sesen to receive $12 million upfront and $23 million in potential regulatory and tech transfer milestone payments

    Sesen eligible to receive royalties on net sales in China

    Sesen to host conference call Friday, July 31st at 8:00 a.m. EDT

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Qilu Pharmaceutical, a leading vertically integrated pharmaceutical company in China specializing in the manufacturing and marketing of active pharmaceutical ingredients and drug products, today announced that the companies have entered into an exclusive licensing agreement for the manufacture, development and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and other types of cancer in China, Hong Kong, Macau and Taiwan ("Greater China").

    "As a leader in the Chinese pharmaceutical industry, we believe there is no better company than Qilu suited to support the expansion of our development and commercialization efforts for Vicineum," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Qilu is well-respected for their commercialization and manufacturing expertise, and this partnership marks an important milestone not only in realizing what we believe to be a significant market opportunity for Vicineum, but in strengthening our balance sheet through nondilutive capital while we remain focused on pursuing regulatory approval in the United States and the European Union. Additionally, we are thrilled to have completed this agreement completely virtually, despite the current COVID-19 pandemic, which speaks volumes to the strong execution capabilities of the Sesen team. This reinforces our focus on continuing to pursue additional business development opportunities for Vicineum outside the US in this manner."

    "Sesen is the ideal partner for us, given their expertise in NMIBC and our complementary skillsets and the different geographic focus between our two companies," said Yan Li, chief executive officer of Qilu Pharmaceutical. "We look forward to working with Sesen and The National Medical Products Administration to bring Vicineum to patients who urgently need better therapies for BCG unresponsive non-muscle invasive bladder cancer in China."

    "Vicineum is a potential first-in-class, highly differentiated product candidate that can address a significant unmet need in China," said Oliver Kong, M.D. chief medical officer, corporate vice president of Qilu Pharmaceutical. "The unique mechanism of action of Vicineum and associated strong clinical data position Vicineum to make a meaningful impact on the lives of patients."

    Under the terms of the agreement, Sesen granted Qilu Pharmaceutical an exclusive license to develop and commercialize Vicineum in Greater China. Sesen will receive an upfront payment of $12 million and is eligible to receive up to an additional $23 million in technology transfer and regulatory milestone payments. Upon commercialization in Greater China, Sesen is also entitled to receive royalties on net sales in Greater China. Sesen retains full development and commercialization rights for Vicineum for the treatment of NMIBC in the US and the rest of the world excluding Greater China. The terms of the agreement also include the transfer of the Vicineum manufacturing technology to Qilu Pharmaceutical, whose world-class manufacturing expertise represents a future opportunity for production expansion to meet the anticipated significant global demand for Vicineum for the treatment of NMIBC.

    Torreya acted as a financial advisor and Hogan Lovells acted as a legal advisor to Sesen for this transaction.

    Conference Call Information

    Members of the Sesen management team will host a conference call and webcast Friday, July 31, 2020 at 8:00 AM EDT to provide an overview of the partnership with Qilu Pharmaceutical. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2177393. The webcast can be accessed in the Investor Relations section of the company's website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company's website at www.sesenbio.com for 60 days following the call.

    About Vicineum™

    Vicineum, a locally administered fusion protein, is Sesen Bio's lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca's immune checkpoint inhibitor durvalumab.

    About the VISTA Clinical Trial

    The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicineum™ as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicineum twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

    About 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 a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. 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. For more information, please visit the company's website at www.sesenbio.com.

    About Qilu Pharmaceutical

    Qilu Pharmaceutical is one of the leading vertically integrated pharmaceutical companies in China focusing on the development, manufacturing and marketing of active pharmaceutical ingredients (APIs) & finished formulations. Qilu currently has 12 subsidiaries, 10 manufacturing sites and over 23,000 employees worldwide. Qilu ranks No.8 in Chinese pharmaceutical industry by sales revenue in 2019. Dedicated to offering more affordable medicines to the world and improving people's well-being, Qilu has exported its products to over 70 countries. Qilu has always maintained an innovative development strategy guided by the market demand and is achieving its organic growth strategy utilizing a strong pool of 2000+ scientists spread across 5 R&D platforms based in the US (Seattle WA, Boston MA, San Francisco CA) and China (Shanghai, Jinan). To date, Qilu has launched 200+ products with 30+ products "First to launch" in China and 3 products "D181 launch" in US. The company also has a robust pipeline, including 200+ generic products, 20+ biosimilar products and 50+ innovative products. Qilu's finished formulations and APIs have been approved by US FDA, European Medicines Agency (EMA), Therapeutic Goods Administration (TGA) of Australia, Medicines and Healthcare products Regulatory Agency (MHRA) of UK, PMDA of Japan and other national regulatory authorities.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our ability to successfully develop our product candidates and complete our planned clinical programs, expectations regarding the safety and efficacy of Vicineum, expectations regarding possible milestone and royalty payments under the license agreement with Qilu, expectations regarding Qilu's ability to manufacture, develop and commercialize Vicineum in Greater China, expectations regarding potential partnerships to develop and commercialize Vicineum outside of the US, and other factors discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

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  4. Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that Company management will host a conference call and webcast on Friday, July 31, 2020 at 8:00 a.m. EDT to provide an Outside the US ("OUS") and general business update.

    To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2177393. The webcast can be accessed in the Investor Relations section of the company's website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company's website at www.sesenbio.com for 60 days following the call.

    About Sesen

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that Company management will host a conference call and webcast on Friday, July 31, 2020 at 8:00 a.m. EDT to provide an Outside the US ("OUS") and general business update.

    To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2177393. The webcast can be accessed in the Investor Relations section of the company's website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company's website at www.sesenbio.com for 60 days following the call.

    About 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 a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. 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. For more information, please visit the company's website at www.sesenbio.com.

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  5. Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced it will be featured as a presenting company at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020.

    Event: Jefferies Virtual Healthcare Conference

    Date: June 2, 2020

    Time: 8:30 - 8:55 AM ET

    A live webcast of the Company's presentation will be accessible from the Investors & Media section of Sesen Bio's website, www.sesenbio.com. An archived replay of the webcast will be available on the Company's website for 90 days after the conference.

    About Sesen Bio

    Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment…

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced it will be featured as a presenting company at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020.

    Event: Jefferies Virtual Healthcare Conference

    Date: June 2, 2020

    Time: 8:30 - 8:55 AM ET

    A live webcast of the Company's presentation will be accessible from the Investors & Media section of Sesen Bio's website, www.sesenbio.com. An archived replay of the webcast will be available on the Company's website for 90 days after the conference.

    About 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, Vicinium, 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 2019, the Company initiated the BLA submission for Vicinium to the FDA under Rolling Review. Vicinium 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. For more information, please visit the company's website at www.sesenbio.com.

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