Post by icemandios on Aug 9, 2021 12:51:44 GMT
Sesen Bio Reports Second Quarter 2021 Financial Results and Significant Global Progress for Vicineum™
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
August 09, 2021 07:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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”
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“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.
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
August 09, 2021 07:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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”
Tweet this
“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.