SESN Sesen Bio Inc.

1.14
-0.11  -9%
Previous Close 1.25
Open 1.13
52 Week Low 0.7
52 Week High 6.04
Market Cap $223,442,987
Shares 196,002,620
Float 196,002,620
Enterprise Value $97,887,327
Volume 26,049,191
Av. Daily Volume 31,201,082
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Drug Pipeline

Drug Stage Notes
Vicinium
Non-muscle invasive bladder cancer (NMIBC)
CRL
CRL
CRL announced August 13, 2021.

Latest News

  1. Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its chemistry, manufacturing, and control (CMC) and clinical development teams with the hiring of Eun Jang as Senior Director, Analytical Sciences, and Chèrie Kaefring as Director, Clinical Operations. The addition of these new team members demonstrates Sesen Bio's strong commitment to and continued focus on the development of Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

    "I am delighted to welcome Eun and Chèrie to Sesen Bio to further strengthen our capabilities across our CMC and clinical teams," said Dr. Thomas Cannell…

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its chemistry, manufacturing, and control (CMC) and clinical development teams with the hiring of Eun Jang as Senior Director, Analytical Sciences, and Chèrie Kaefring as Director, Clinical Operations. The addition of these new team members demonstrates Sesen Bio's strong commitment to and continued focus on the development of Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

    "I am delighted to welcome Eun and Chèrie to Sesen Bio to further strengthen our capabilities across our CMC and clinical teams," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Their deep clinical and analytical expertise is the right match for our CMC and clinical needs as we chart our path forward in consultation with regulators. I am confident Eun and Chèrie will each make valuable contributions to Sesen Bio and to our mission of saving and improving the lives of patients."

    These hirings come as Sesen Bio is preparing for CMC and clinical Type A meetings with the US Food and Drug Administration (FDA) for Vicineum™. The Company has submitted a request for the CMC Type A meeting, which is anticipated to occur at the end of October, and expects the clinical Type A meeting to occur later in the fourth quarter of 2021.

    In connection with these hirings, non-statutory stock options were or will be granted. Under such grants, a combined total of up to 122,500 shares of Sesen Bio common stock are purchasable upon vesting of the stock options within each option's ten-year term. Each of the stock options vests over a four-year period, with one quarter of the underlying shares vesting on the first anniversary of the date of grant, and an additional 6.25% of the underlying shares vesting at the end of each successive three-month period following the one-year anniversary of the date of grant, subject in each case to the employee's continued service with Sesen Bio.

    Ms. Jang's non-statutory stock option was granted on October 11, 2021 and Ms. Kaefring's non-statutory stock option will be granted on October 25, 2021, and each such stock option has an exercise price equal to the closing price per share of Sesen Bio's common stock on The Nasdaq Global Market on the date of the grant. These options are being granted outside of the Company's 2014 Stock Incentive Plan and as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

    About Vicineum™

    Vicineum, a locally administered fusion protein, is Sesen Bio's lead product candidate being developed for the treatment of BCG-unresponsive 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immunooncology drugs, such as checkpoint inhibitors. For this reason, 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 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 oportuzumab monatox, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, the Middle East and North Africa (MENA) and Turkey, for which the Company has partnered with Qilu Pharmaceutical, Hikma Pharmaceuticals and Eczacibasi Pharmaceuticals Marketing (EIP), 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, which is being developed for the treatment of BCG-unresponsive 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 the 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," "expect," "intend," "may," "plan," "predict," "target," "potential," "will," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements regarding the Company's expectations, commitment to and continued focus on development of Vicineum for the treatment of BCG-unresponsive NMIBC, the Company's preparations for CMC and clinical Type A meetings with the FDA to discuss next steps for Vicineum for the treatment of BCG-unresponsive NMIBC, the Company's expectations regarding the timing of the CMC Type A meeting, the Company's expectations regarding the timing of the clinical Type A meeting with the FDA to discuss Vicineum for the treatment of BCG-unresponsive NMIBC, the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that the FDA may not schedule Type A meetings with the Company within the currently expected timing, or at all, the risk that the Company may not resume its plans to pursue regulatory approval for Vicineum in the US or Europe, the risk that clinical trials of Vicineum for the treatment of BCG-unresponsive NMIBC may fail to demonstrate safety and efficacy to the satisfaction of the FDA or the European Medicines Agency (EMA), or otherwise produce favorable results, the risk that the FDA may not approve the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC if the Company resubmits the BLA at a future time, the risk that the EMA may not approve the Company's marketing authorization application (MAA) for Vicineum for the treatment of BCG-unresponsive NMIBC if the Company resubmits the MAA at a future time, the risk that 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 by the FDA or the EMA, limit the commercial profile of its labeling, if approved, or result in significant negative consequences following any marketing approval, 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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  2. Company to host conference call on Monday, August 16 at 8:00 a.m. ET

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

    The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues…

    Company to host conference call on Monday, August 16 at 8:00 a.m. ET

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

    The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.

    "We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC," said Dr. Thomas Cannell, president, and chief executive officer of Sesen Bio. "We remain dedicated to our mission to save and improve the lives of patients by bringing new treatment options to patients, and we intend to work closely with the FDA to understand next steps."

    The Company plans to request a Type A meeting as soon as possible with the FDA to discuss the next steps that are needed before the application may be approved.

    As of June 30, 2021, the Company had $151.1 million in cash, cash equivalents and restricted cash.

    Conference Call and Webcast Information

    Members of the Sesen Bio management team will host a conference call Monday, August 16, 2021, at 8:00 AM ET. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2772032. The teleconference details can be accessed in the Investor Relations section of the Company's website at www.sesenbio.com. A replay of the teleconference 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 being developed for the treatment of BCG-unresponsive 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. 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. For this reason, 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 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 oportuzumab monatox, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, the Middle East and North Africa (MENA) and Turkey, for which the Company has partnered with Qilu Pharmaceutical, Hikma Pharmaceuticals and Eczacibasi Pharmaceuticals Marketing (EIP), 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, which is being developed for the treatment of BCG-unresponsive 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 the 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," "expect," "intend," "may," "plan," "predict," "target," "potential," "will," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements regarding the Company's expectations regarding potential FDA approval of Vicineum for the treatment of BCG-unresponsive NMIBC, the Company's ability to bring new treatment options to patients with cancer, the Company's intentions to work closely with the FDA to understand next steps for its BLA for Vicineum for the treatment of BCG-unresponsive NMIBC, the Company's plans to request a Type A meeting with the FDA to discuss next steps for Vicineum for the treatment of BCG-unresponsive NMIBC, the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that clinical trials of Vicineum for the treatment of BCG-unresponsive NMIBC may fail to demonstrate safety and efficacy to the satisfaction of the FDA or otherwise produce favorable results, the risk that the FDA may not approve the BLA for Vicineum, the risk that 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 by the FDA, limit the commercial profile of its labeling, if approved, or result in significant negative consequences following any marketing approval, 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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  3. John Knighton to join Sesen Bio as Vice President and Chief Compliance Officer

    The Company believes it remains on track for an FDA decision on its BLA for Vicineum by August 18, 2021

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its executive leadership team in support of the Company's continued transformation into a commercial-stage company with the hiring of John Knighton as Vice President and Chief Compliance Officer, effective August 16, 2021. The Company's Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the Company's lead…

    John Knighton to join Sesen Bio as Vice President and Chief Compliance Officer

    The Company believes it remains on track for an FDA decision on its BLA for Vicineum by August 18, 2021

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its executive leadership team in support of the Company's continued transformation into a commercial-stage company with the hiring of John Knighton as Vice President and Chief Compliance Officer, effective August 16, 2021. The Company's Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the Company's lead program, is currently under Priority Review with the US Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

    "At Sesen Bio, we believe a strong culture of compliance is a source of competitive advantage, because a thorough understanding of laws and regulatory guidance allows us to fully explore innovative commercial models and strategies," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "This enables us to do the right thing while maximizing launch uptake of Vicineum. As we near our PDUFA date, I am confident that John's extensive experience in establishing compliance programs and enabling the implementation of innovative commercial model elements will further position us to execute a world-class launch."

    Mr. Knighton brings over 20 years of legal and compliance experience in the life sciences industry, serving in multiple executive roles at innovative pharmaceutical and medical device companies transitioning from clinical-stage to commercialization. In these roles, he has designed and implemented multiple compliance programs and conducted business development diligence, audit and investigation projects related to the complex circumstances facing global life sciences companies. Mr. Knighton joins Sesen Bio from TherapeuticsMD, where he served as Chief Compliance Officer and supported the launch of three products between 2018 and 2020. Prior to this, he served as Head of Global Compliance at Orexigen Therapeutics, where he played a key role in the launch of an innovative telemedicine and home delivery channel, and as Chief Compliance Officer at MicroPort Orthopedics, among other roles of increasing responsibility where he provided compliance support across functions. Earlier in his career, Mr. Knighton served as a Consultant on the Life Science Compliance team at Ernst and Young, LLP. He received his Juris Doctor degree from Emory University School of Law and his Bachelor of Science in Accounting from Villanova University. He is a member of the Georgia State Bar.

    In connection with the hiring of Mr. Knighton, Sesen Bio intends to grant a non-statutory stock option. Under such grant, up to 400,000 shares of Sesen Bio common stock are purchasable upon vesting of the stock option within the ten-year term. The stock option vests over a four-year period, with one quarter of the underlying shares vesting on the first anniversary of the date of grant, and an additional 6.25% of the underlying shares vesting at the end of each successive three-month period following the one-year anniversary of the date of grant, subject to Mr. Knighton's continued service with Sesen Bio.

    The non-statutory stock option will be granted on August 16, 2021, at an exercise price equal to the closing price per share of Sesen Bio's common stock on The Nasdaq Global Market on the date of grant. The stock option will be granted outside of the Company's 2014 Stock Incentive Plan and will be granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

    About Vicineum™

    Vicineum, a locally administered fusion protein, is Sesen Bio's lead product candidate being developed for the treatment of BCG-unresponsive 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. 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. For this reason, 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 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 oportuzumab monatox, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, the Middle East and North Africa (MENA) and Turkey, for which the Company has partnered with Qilu Pharmaceutical, Hikma Pharmaceuticals and Eczacibasi Pharmaceuticals Marketing (EIP), 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, which is being developed for the treatment of BCG-unresponsive 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 the 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 "believe," "may," "target," "potential," "position," "will," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements regarding the timing for the FDA's decision on the Company's BLA for Vicineum for the treatment of BCG-unresponsive NMIBC based on the FDA granting the BLA Priority Review and the target PDUFA date of August 18, 2021, the Company's expectations to execute a world-class commercial launch of Vicineum for the treatment of BCG-unresponsive NMIBC if approved in the US, the expectation that Mr. Knighton will join the Company, and the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that clinical trials of Vicineum for the treatment of BCG-unresponsive NMIBC may fail to demonstrate safety and efficacy to the satisfaction of the FDA or otherwise produce favorable results, the risk that the FDA may not approve the BLA for Vicineum within the anticipated timing, or at all, the risk that Mr. Knighton may not join the Company within the anticipated timing, or at all, the risk that the Company may not be able to establish sales, marketing and distribution capabilities for Vicineum for the treatment of BCG-unresponsive NMIBC, the risk that the Company may not be successful in commercializing Vicineum if approved in the US, the risk that Vicineum may not gain market acceptance for the treatment of BCG-unresponsive NMIBC in the US, the risk that 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 by the FDA, limit the commercial profile of its labeling, if approved, or result in significant negative consequences following any marketing approval, 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. The Company believes it remains on track for an FDA decision on its BLA for Vicineum by August 18, 2021

    The Company also believes it remains on track for potential approval in Europe and key markets in MENA in 2022

    Strengthened balance sheet with $151M in cash and cash equivalents as of June 30, 2021

    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, 2021. The Biologics License Application (BLA) for the Company's lead program, Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), is currently under Priority Review with the US Food and Drug…

    The Company believes it remains on track for an FDA decision on its BLA for Vicineum by August 18, 2021

    The Company also believes it remains on track for potential approval in Europe and key markets in MENA in 2022

    Strengthened balance sheet with $151M in cash and cash equivalents as of June 30, 2021

    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, 2021. The Biologics License Application (BLA) for the Company's lead program, Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), is currently under Priority Review with the US Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

    "We are excited about the regulatory progress we are making across our global markets," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We remain focused on executing a world-class launch in the US if Vicineum is approved, and we also continue to support our partners outside of the United States, as part of our commitment to deliver a therapy we believe can improve patient outcomes globally while reducing overall healthcare costs for patients."

    US and Outside of the US (OUS) Regulatory Update

    US:

    • On July 13, 2021, Sesen Bio participated in a productive Late-Cycle Meeting with the FDA regarding the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC. In the meeting, the FDA confirmed that there is no Advisory Committee meeting planned at this time, and that no post-marketing requirements, including a confirmatory trial, have been identified at this time. Also in the meeting, the Company and the FDA discussed remaining questions related to manufacturing facility inspections, product quality information requests and additional information related to chemistry, manufacturing and controls (CMC), and a timeline to submit additional supporting information was agreed upon. The Company believes it remains on track for an FDA decision on its BLA for Vicineum by the target PDUFA date of August 18, 2021.

    Europe:

    • In Europe, the Company believes it remains on track for potential approval of Vysyneum™ in 2022. The Company has received the Day 80 and Day 120 questions from the European Medicines Agency (EMA) and is responding to inquiries and providing supporting information as part of the official review process.

    China:

    • On July 20, 2021, Sesen Bio and Qilu Pharmaceutical, the Company's partner in Greater China, announced that the first patient had been enrolled in China in the clinical trial to assess the efficacy and safety of Vicineum in patients with BCG-unresponsive NMIBC. The trial, which plans to enroll approximately 53 patients with carcinoma in situ (CIS), is being run at the sole cost of Qilu Pharmaceutical. If the trial is successful, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in China in 2022, with potential approval expected in 2023.

    Middle East and North Africa (MENA):

    • The Company continues to work closely with its partner in MENA, Hikma Pharmaceuticals, to submit marketing authorization applications for Vicineum in 2021 in seven key markets in the region: Kingdom of Saudi Arabia, Jordan, Morocco, Egypt, Lebanon, Kuwait and Algeria. These markets represent a significant opportunity, with some of the most advanced healthcare systems and largest economies in the MENA region. The Company believes it is on track for potential market approvals to begin in the region in 2022.

    Business Development Update

    • On June 1, 2021, the Company entered into a global supply agreement with Qilu Pharmaceutical to become part of the manufacturing network for global commercial supply of Vicineum drug substance and drug product. This was an expansion of the initial commercial manufacturing and supply framework agreement entered into by Sesen Bio and Qilu Pharmaceutical in December 2020, and sets specific terms such as capacity, forecasts, pricing and product delivery. Along with existing world-class supply partners, Sesen Bio expects the global supply agreement with Qilu Pharmaceutical will enable the Company to meet anticipated significant global demand for Vicineum.
    • On August 5, 2021, Sesen Bio announced it had entered into a licensing agreement with Eczacibasi Pharmaceuticals Marketing (EIP) for the registration and commercialization of Vicineum in Turkey. Under the terms of the licensing agreement, Sesen Bio will receive an upfront payment of $1.5 million, is eligible to receive additional regulatory and commercial milestone payments and is also entitled to receive a 30% royalty on net sales in Turkey. EIP was granted an exclusive license to register and commercialize Vicineum for the treatment of BCG-unresponsive NMIBC in Turkey, where bladder cancer is the sixth most commonly diagnosed cancer and 11th most common cause of death. This agreement represents the third OUS partnership that Sesen Bio has entered to date.

    Commercial Planning Update

    • Sesen Bio completed its commercial build phase in preparation for the anticipated launch of Vicineum, if approved, in the US, and has advanced to the implementation phase that will commence promptly, if approved, and will focus on executing the Company's commercial strategy for Vicineum. The Company has completed the hiring of ~25 talented internal employees to support the Company cross-functionally, as well as the hiring of 35 sales representatives as part of the contract sales organization who will target approximately 2,000 high-prescribers of BCG to drive awareness, trial and adoption of Vicineum for the treatment of patients with BCG-unresponsive NMIBC.

    In addition to building its sales force, as part of the Sesen Bio national speaker programs, the Company has identified and commenced training of 14 key opinion leader (KOL) speakers to educate their peers on Vicineum for the treatment of BCG-unresponsive NMIBC, if approved. Upon product availability, the Company will utilize a two-pronged market access and reimbursement strategy to ensure maximum coverage for Vicineum.

    Promotional efforts will begin immediately upon the anticipated approval of Vicineum in the US, and the Company expects Vicineum product to be available to physicians and patients in the fourth quarter of 2021.

    • Results of market research conducted by the Company show that when given the choice between the product profile of Vicineum, based on Phase III clinical trial data1, and the product profile of Keytruda®, physicians will choose Vicineum over 80% of the time. This data highlights urologists' preferences that the Company believes spans clinical, emotional and economic reasons to prescribe Vicineum. If approved by the FDA, the Company believes Vicineum could be a best-in-class treatment option for patients, and a critical step in Sesen Bio realizing its mission to save and improve the lives of patients with cancer.

    [1]The Phase III clinical data are based on the data submitted in the BLA on December 18, 2020 and are currently under review by the FDA. Final efficacy and safety data are pending.

    Second Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and restricted cash were $151.1 million as of June 30, 2021, compared to $55.4 million as of December 31, 2020.
    • R&D Expenses: Research and development expenses for the second quarter of 2021 were $7.2 million compared to $4.6 million for the same period in 2020. The increase of $2.7 million was due to increased costs associated with technology transfer and manufacturing ($1.0 million), professional services in support of regulatory activity ($0.7 million), employee-related compensation ($0.7 million), and other increases ($0.3 million).
    • G&A Expenses: General and administrative expenses for the second quarter of 2021 were $6.8 million compared to $3.3 million for the same period in 2020. The increase of $3.5 million was due primarily to increases in sales and marketing expense for Vicineum pre-commercial launch planning ($1.6 million), employee-related compensation driven by increased headcount as part of the commercial build ($1.3 million), and other increases for commercial launch preparation ($0.6 million).
    • Net Loss: Net loss was $25.4 million, or $0.15 per share, for the second quarter of 2021, compared to net loss of $26.3 million, or $0.24 per share, for the second quarter of 2020. The change was attributable to license revenue recognized ($2.2 million), offset by higher operating expenses ($1.3 million).

    About Vicineum™

    Vicineum, a locally administered fusion protein, is Sesen Bio's lead product candidate being developed for the treatment of BCG-unresponsive 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. 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. For this reason, 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 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 oportuzumab monatox, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, the Middle East and North Africa (MENA) and Turkey, for which the Company has partnered with Qilu Pharmaceutical, Hikma Pharmaceuticals and Eczacibasi Pharmaceuticals Marketing (EIP), 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, which is being developed for the treatment of BCG-unresponsive 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 the 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," "potential," "target," "strategy," "will," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements regarding the timing for the FDA's decision on the Company's BLA for Vicineum for the treatment of BCG-unresponsive NMIBC based on the FDA granting the BLA Priority Review, the target PDUFA date of August 18, 2021, successful resolution of topics discussed at the Late-Cycle Meeting (including those related to manufacturing facility inspections, product quality information requests and additional information related to CMC), no advisory committee meeting on the BLA being planned at this time, and no post-marketing requirements being identified at this time, the Company's expectations about its ability to execute a world-class launch of Vicineum in the US, if approved by the FDA, and its plans to support its OUS partners, the Company's beliefs about Vicineum's ability to be a best-in-class treatment for patients with BCG-unresponsive NMIBC, if approved, and to improve patient outcomes while reducing overall healthcare costs, the timing of approval of the Company's Marketing Authorization Application (MAA) for Vysyneum for the treatment of BCG-unresponsive NMIBC with the EMA if at all, the timing and results of any clinical trial for Vicineum in China, the timing for submission and potential approval of the product market application for Vicineum for the treatment of BCG-unresponsive NMIBC to the National Medical Products Administration (NMPA) in China if at all, the timing for submissions and any product market approvals of Vicineum for the treatment of BCG-unresponsive NMIBC in key markets in MENA, the ability of the Company's supply partners to enable the Company to meet global demand for Vicineum, the timing and receipt by the Company of any milestone payments or royalties from its OUS partner in Turkey, the Company's ability to implement its commercial strategy for Vicineum, if approved for the treatment of BCG-unresponsive NMIBC, in the US, the Company's plans to pursue certain strategies to increase market access and reimbursement to maximize coverage of Vicineum for the treatment of BCG-unresponsive NMIBC, the Company's expectations regarding the timing for commercial availability of Vicineum for the treatment of BCG-unresponsive NMIBC in the US, the Company's expectations based on its market research findings regarding preference for the profile of Vicineum over the profile of Keytruda, the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that the FDA may not approve the BLA for Vicineum within the anticipated timing, or at all, the risk that the EMA may not approve the MAA for Vysyneum within the anticipated timing, or at all, the risk that the NMPA may not approve the product market application for Vicineum within the anticipated timing, or at all, the risk that the Company may not be able to establish sales, marketing and distribution capabilities for Vicineum for the treatment of BCG-unresponsive NMIBC, if approved in the US, the risk that the Company may not be successful in commercializing Vicineum for the treatment of BCG-unresponsive NMIBC, if and when it is approved in the US, the risk that Vicineum may not gain market acceptance among physicians, patients, third-party payors or the medical community, the risk that Vicineum may become subject to unfavorable pricing regulations, third-party coverage or reimbursement practices or healthcare reform initiatives, 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 BALANCE SHEETS
    (In thousands, except share and per share data)
    (Unaudited)
     
    June 30, 2021 December 31, 2020
    Assets
    Current assets:
    Cash and cash equivalents

    $

    151,036

     

    $

    52,389

     

    Accounts receivable

     

    2,303

     

     

    -

     

    Prepaid expenses and other current assets

     

    21,760

     

     

    7,478

     

    Restricted cash

     

    -

     

     

    3,000

     

    Total current assets

     

    175,099

     

     

    62,867

     

     
    Non-current assets:
    Restricted cash

     

    20

     

     

    20

     

    Property and equipment, net

     

    109

     

     

    123

     

    Intangible assets

     

    46,400

     

     

    46,400

     

    Goodwill

     

    13,064

     

     

    13,064

     

    Long term prepaid expenses

     

    6,150

     

     

    -

     

    Other assets

     

    205

     

     

    349

     

    Total non-current assets

     

    65,948

     

    $

    59,956

     

    Total Assets

    $

    241,047

     

    $

    122,823

     

     
    Liabilities and Stockholders' (Deficit) Equity
    Current liabilities:
    Accounts payable

    $

    1,228

     

    $

    3,102

     

    Accrued expenses

     

    5,301

     

     

    3,973

     

    Deferred revenue

     

    1,500

     

     

    1,500

     

    Contingent consideration

     

    10,300

     

     

    8,985

     

    Other current liabilities

     

    498

     

     

    489

     

    Total current liabilities

     

    18,827

     

     

    18,049

     

     
    Non-current liabilities:
    Contingent consideration, net of current portion

     

    160,300

     

     

    99,855

     

    Deferred tax liability

     

    12,528

     

     

    12,528

     

    Deferred revenue, net of current portion

     

    -

     

     

    1,500

     

    Other non-current liabilities

     

    43

     

     

    118

     

    Total non-current liabilities

     

    172,871

     

     

    114,001

     

    Total liabilities

     

    191,698

     

     

    132,050

     

     
    Stockholders' Equity ( Deficit):
    Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at

    June 30, 2021 and December 31, 2020; no shares issued and outstanding at

    June 30, 2021 and December 31, 2020

     

    -

     

     

    -

     

    Common stock, $0.001 par value per share; 400,000,000 and 200,000,000 shares authorized

    at June 30, 2021 and December 31, 2020, respectively; 188,460,951 and 140,449,647 shares

    issued and outstanding at June 30, 2021 and December 31, 2020, respectively

     

    188

     

     

    140

     

    Additional paid-in capital

     

    446,036

     

     

    306,554

     

    Accumulated deficit

     

    (396,875

    )

     

    (315,921

    )

    Total Stockholders' Equity (Deficit)

     

    49,349

     

     

    (9,227

    )

    Total Liabilities and Stockholders' Equity

    $

    241,047

     

    $

    122,823

     

    SESEN BIO, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    AND COMPREHENSIVE (LOSS) INCOME
    (In thousands, except per share data)
    (Unaudited)
     
    Three Months ended June 30, Six Months ended June 30,

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    License and related revenue

    $

    2,234

     

    $

    -

     

    $

    6,544

     

    $

    -

     

     
    Operating expenses:
    Research and development

    $

    7,228

     

    $

    4,562

     

    $

    13,306

     

    $

    13,429

     

    General and administrative

    $

    6,805

     

    $

    3,318

     

    $

    12,098

     

    $

    6,766

     

    Change in fair value of contingent consideration

    $

    13,600

     

    $

    18,480

     

    $

    61,760

     

    $

    (35,220

    )

    Total operating expenses

     

    27,633

     

    $

    26,360

     

    $

    87,164

     

     

    (15,025

    )

     
    (Loss) Income from Operations

     

    (25,399

    )

    $

    (26,360

    )

    $

    (80,620

    )

     

    15,025

     

    Other (expense) income , net

    $

    (43

    )

    $

    16

     

    $

    (46

    )

    $

    195

     

    Net (Loss) Income and Comprehensive (Loss) Income Before Taxes

    $

    (25,442

    )

    $

    (26,344

    )

    $

    (80,666

    )

    $

    15,220

     

    Provision for income taxes

    $

    -

     

    $

    -

     

    $

    (288

    )

    $

    -

     

    Net (Loss) Income and Comprehensive (Loss) Income After Taxes

    $

    (25,442

    )

    $

    (26,344

    )

    $

    (80,954

    )

    $

    15,220

     

     
    Net (loss) income attributable to common stockholders - basic

    $

    (25,442

    )

    $

    (26,491

    )

    $

    (80,954

    )

    $

    14,751

     

    Net (loss) income attributable to common stockholders - diluted

    $

    (25,442

    )

    $

    (26,491

    )

    $

    (80,954

    )

    $

    12,600

     

     
    Net (loss) income per common share - basic

    $

    (0.15

    )

    $

    (0.24

    )

    $

    (0.49

    )

    $

    0.13

     

    Weighted-average common shares outstanding - basic

     

    175,393

     

     

    112,569

     

     

    166,264

     

     

    111,189

     

     
    Net (loss) income per common share - diluted

    $

    (0.15

    )

    $

    (0.24

    )

    $

    (0.49

    )

    $

    0.11

     

    Weighted-average common shares outstanding - diluted

     

    175,393

     

     

    112,569

     

     

    166,264

     

     

    111,203

     

     

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  5. Sesen Bio to receive $1.5 million upfront and is eligible for additional regulatory and commercial milestone payments

    Sesen Bio is entitled to receive a 30% royalty on net sales in Turkey

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Eczacibasi Pharmaceuticals Marketing (EIP), part of the Eczacibasi Group and one of Turkey's pioneering pharmaceutical companies with a focus on innovative, branded products, today announced that the companies have entered into a licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)1. The Company's Biologics…

    Sesen Bio to receive $1.5 million upfront and is eligible for additional regulatory and commercial milestone payments

    Sesen Bio is entitled to receive a 30% royalty on net sales in Turkey

    Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Eczacibasi Pharmaceuticals Marketing (EIP), part of the Eczacibasi Group and one of Turkey's pioneering pharmaceutical companies with a focus on innovative, branded products, today announced that the companies have entered into a licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)1. The Company's Biologics License Application (BLA) for the Company's lead program, Vicineum, is currently under Priority Review with the US Food and Drug Administration (FDA) for the treatment of BCG-unresponsive NMIBC in the US with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

    "EIP is a partner of choice in Turkey and has a proven track record and experience in marketing innovative, life-saving medicines with an expertise in oncology and urology," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "This partnership with EIP marks a further step in realizing our mission to save and improve the lives of patients, and in achieving the significant global opportunity projected for Vicineum."

    "International partnerships are a central component of EIP's growth strategy and Sesen Bio is an ideal partner given their mission and expertise in NMIBC," said Muge Satir, General Manager of EIP. "Vicineum is a potential first-in-class treatment with a differentiated clinical profile which we believe can make a significant impact on patients with NMIBC. We look forward to working with Sesen Bio closely to expeditiously bring Vicineum to patients in Turkey."

    In Turkey, bladder cancer is the sixth most commonly diagnosed cancer with about 36,000 cases, and it ranks 11th in cause of death with approximately 4,000 deaths per year. Approximately 75% of these patients are diagnosed with NMIBC, of which many will initially be treated with BCG. If BCG fails, there are no second line treatment options for patients except radical cystectomy, total surgical removal of the bladder. Additionally, over 99% of the population in Turkey is fully insured with access to medications and healthcare services. If approved in Turkey, Vicineum will be the first product approved for patients with BCG-unresponsive NMIBC in over 20 years with a high level of access to physicians and their patients anticipated.

    Under the terms of the licensing agreement, Sesen granted EIP an exclusive license to register and commercialize Vicineum in Turkey for the treatment of BCG-unresponsive NMIBC. Sesen Bio will receive an upfront payment of $1.5 million and is eligible to receive additional regulatory and commercial milestone payments. Upon commercialization in Turkey, Sesen Bio is also entitled to receive a 30% royalty on net sales in Turkey. 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 Middle East and North Africa (MENA) and Turkey.

    In the US, the Company believes it remains on track for an FDA decision on its BLA for Vicineum by the target PDUFA date of August 18, 2021.

    Hogan Lovells and Paksoy acted as legal advisors to Sesen Bio for this transaction.

    1   

    The geography under the licensing agreement includes Turkey and Northern Cyprus.

    About Vicineum™

    Vicineum, a locally administered fusion protein, is Sesen Bio's lead product candidate being developed for the treatment of BCG-unresponsive 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the US FDA accepted for filing the Company's BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. 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. For this reason, 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 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 oportuzumab monatox, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the FDA accepted the Company's BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, the Middle East and North Africa (MENA) and Turkey, for which the Company has partnered with Qilu Pharmaceutical, Hikma Pharmaceuticals and Eczacibasi Pharmaceuticals Marketing (EIP), 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, which is being developed for the treatment of BCG-unresponsive NMIBC. For more information, please visit the Company's website at www.sesenbio.com.

    About Eczacibasi Pharmaceuticals Marketing (EIP)

    Eczacibasi Pharmaceuticals Marketing is part of the Eczacibasi Group, a prominent Turkish business group established in 1942 that is active in healthcare, building products, consumer products and natural resources. Eczacibasi Pharmaceuticals Marketing has a successful track record of partnerships with leading pharmaceutical companies and thrives on making the R&D expertise of its partners accessible to patients in Turkey through high value pharmaceutical products that best serve their needs. The company is dedicated to increasing the quality of life of patients in Turkey by providing them high-quality innovative solutions with a patient-centric mindset.

    https://www.eczacibasiilac.com.tr/en

    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," "may," "project," "target," "potential," "will," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements regarding the timing for the FDA's decision on the Company's BLA for Vicineum for the treatment of BCG-unresponsive NMIBC based on the FDA granting the BLA Priority Review and the target PDUFA date of August 18, 2021, the size of the global opportunity for Vicineum for the treatment of BCG-unresponsive NMIBC and the Company's ability to achieve such opportunity, the potential for Vicineum to be a first-in-class treatment and impact patients with NMIBC, the ability of the Company and EIP to bring Vicineum to patients in Turkey, the possibility that Vicineum, if approved, will be the first product approved for patients with BCG-unresponsive NMIBC in over 20 years, the timing and amounts of any payments or royalties due to the Company under its licensing agreement with EIP, and the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that the FDA may not approve the BLA for Vicineum within the anticipated timing, or at all, the Company and EIP may not successfully obtain regulatory approval for Vicineum in Turkey, Vicineum may not gain market acceptance for the treatment of BCG-unresponsive NMIBC in Turkey, market opportunity for Vicineum in Turkey may be more limited than anticipated, competitors may develop or commercialize products before, or more successfully than, the Company and EIP, 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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