Strengthened balance sheet: $98 million in cash and cash equivalents as of February 28, 20211<\/sup><\/i><\/p>\n Biologics License Application accepted by the FDA under Priority Review<\/i><\/p>\n Marketing Authorization Application submitted in Europe with potential approval in early 2022<\/i><\/p>\n \n\u00a0Company to host conference call at 8am ET<\/i><\/p>\n CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–Sesen Bio<\/b> (Nasdaq: SESN<\/a>), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the fourth quarter and full-year ended December 31, 2020. The Company\u2019s 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 BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum under Priority Review.\n<\/p>\n \n\u201cWe continue to make tremendous progress on our regulatory path with potential US approval later this year,\u201d said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. \u201cOur talented and growing team is laser-focused on bringing a best-in-class treatment to the market that has the potential to improve patient outcomes while reducing healthcare costs. With a strong balance sheet and clear regulatory path forward in both the US and Europe, we are positioned to fully realize the potentially significant global opportunity for Vicineum. We expect 2021 to be a transformative year for Sesen Bio and the patients we serve.\u201d\n<\/p>\n US and European Regulatory Update<\/b><\/p>\n US:<\/b><\/p>\n Europe:<\/b><\/p>\n 1<\/sup>This amount is preliminary and is subject to change upon completion of the Company\u2019s financial statements for the quarterly period ended March 31, 2021.\n<\/p>\n Business Development Update<\/b><\/p>\n Middle East and North Africa (MENA):<\/b><\/p>\n China:<\/b><\/p>\n Leiden University Medical Center (LUMC):<\/b><\/p>\n Commercial Update<\/b><\/p>\n Fourth Quarter and Full-Year 2020 Financial Results<\/b><\/p>\n Conference Call and Webcast Information<\/b><\/p>\n \nSesen Bio will host a conference call and webcast today at 8:00 AM ET with Dr. Neal Shore, medical director of the Carolina Urologic Research Center, who will provide a clinical perspective on Vicineum for the treatment of BCG-unresponsive NMIBC, and members of the management team who will provide a corporate update. Dr. Shore is a paid consultant to Sesen Bio and served as a clinical investigator for the Phase 2 and Phase 3 clinical trials of Vicineum. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2441628. The webcast can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com<\/a>.<\/span> The replay of the webcast will be available in the investor section of the Company\u2019s website at www.sesenbio.com<\/a> for 60 days following the call.\n<\/p>\n About Vicineum\u2122 <\/b><\/p>\n \nVicineum, a locally administered fusion protein, is Sesen Bio\u2019s 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 FDA accepted for filing the Company\u2019s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a 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\u2019s immune checkpoint inhibitor durvalumab.\n<\/p>\n About Sesen Bio <\/b><\/p>\n \nSesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer. The Company\u2019s lead program, Vicineum\u2122, also known as VB4-845, 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 for filing the Company\u2019s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China and the Middle East and North Africa (MENA), for which the Company has partnered with Qilu Pharmaceutical and Hikma Pharmaceuticals, respectively, for commercialization. Vicineum is a locally administered targeted fusion protein composed of an anti-EpCAM antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A for the treatment of BCG-unresponsive NMIBC. For more information, please visit the company\u2019s website at www.sesenbio.com<\/a>.\n<\/p>\n COVID-19 Pandemic Potential Impact<\/b><\/p>\n \nSesen 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.\n<\/p>\n Cautionary Note on Forward-Looking Statements<\/strong><\/p>\n Any statements in this press release about future expectations, plans and prospects for the Company, the Company\u2019s strategy, future operations, and other statements containing the words \u201canticipate,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201cpotential,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201ccould,\u201d \u201cshould,\u201d \u201ccontinue,\u201d 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: the timing for the FDA\u2019s decision on the Company\u2019s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC based on the FDA granting the BLA Priority Review, the PDUFA date of August 18, 2021 and the need for an advisory meeting on the BLA, the Company\u2019s expectations regarding Vicineum\u2019s potential to improve patient outcomes and reduce healthcare costs, the Company\u2019s ability to realize the global opportunity of Vicineum, the timing of approval of the Company\u2019s MAA with the EMA if at all, the Company\u2019s expectations regarding its partnership with Hikma to commercialize Vicineum in the MENA markets, the timing of the technology transfer with Qilu, possible approval of the IND for Vicineum by the CDE in China and receipt by the Company of any related milestone payments, the ability of the Company\u2019s CMO partners to provide reliable supplies of Vicineum, expectations regarding the timing of our next clinical trial in connection with the LUMC agreement, expectations regarding timing and readiness of the Company\u2019s supply chain readiness to support commercialization of Vicineum, if approved, 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, and other factors discussed in the \u201cRisk Factors\u201d section of the Company\u2019s 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\u2019s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company\u2019s 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\u2019s views as of any date subsequent to the date hereof. <\/span><\/strong><\/p>\n 2020<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2019<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2020<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2019<\/b><\/p>\n<\/td>\n<\/tr>\n \n$ –\n<\/p>\n<\/td>\n \n$ –\n<\/p>\n<\/td>\n \n$ 11,236\n<\/p>\n<\/td>\n \n$ –\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n \n11,236\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n<\/tr>\n \n$ 5,566\n<\/p>\n<\/td>\n \n5,420\n<\/p>\n<\/td>\n \n29,191\n<\/p>\n<\/td>\n \n24,663\n<\/p>\n<\/td>\n<\/tr>\n \n$ 3,421\n<\/p>\n<\/td>\n \n3,298\n<\/p>\n<\/td>\n \n14,302\n<\/p>\n<\/td>\n \n12,208\n<\/p>\n<\/td>\n<\/tr>\n \n$ 5,640\n<\/p>\n<\/td>\n \n25,020\n<\/p>\n<\/td>\n \n(11,180)\n<\/p>\n<\/td>\n \n71,620\n<\/p>\n<\/td>\n<\/tr>\n \n14,627\n<\/p>\n<\/td>\n \n33,738\n<\/p>\n<\/td>\n \n32,313\n<\/p>\n<\/td>\n \n108,491\n<\/p>\n<\/td>\n<\/tr>\n \n(14,627)\n<\/p>\n<\/td>\n \n(33,738)\n<\/p>\n<\/td>\n \n(21,077)\n<\/p>\n<\/td>\n \n(108,491)\n<\/p>\n<\/td>\n<\/tr>\n \n$ (69)\n<\/p>\n<\/td>\n \n185\n<\/p>\n<\/td>\n \n125\n<\/p>\n<\/td>\n \n991\n<\/p>\n<\/td>\n<\/tr>\n $ (14,696)<\/b><\/p>\n<\/td>\n $ (33,553)<\/b><\/p>\n<\/td>\n $ (20,952)<\/b><\/p>\n<\/td>\n $ (107,500)<\/b><\/p>\n<\/td>\n<\/tr>\n \n$ (313)\n<\/p>\n<\/td>\n \n$ –\n<\/p>\n<\/td>\n \n$ (1,445)\n<\/p>\n<\/td>\n \n$ –\n<\/p>\n<\/td>\n<\/tr>\n $ (15,009)<\/b><\/p>\n<\/td>\n $ (33,553)<\/b><\/p>\n<\/td>\n $ (22,397)<\/b><\/p>\n<\/td>\n $ (107,500)<\/b><\/p>\n<\/td>\n<\/tr>\n \n$ –\n<\/p>\n<\/td>\n \n$ –\n<\/p>\n<\/td>\n \n$ (147)\n<\/p>\n<\/td>\n \n$ –\n<\/p>\n<\/td>\n<\/tr>\n $ (15,009)<\/b><\/p>\n<\/td>\n $ (33,553)<\/b><\/p>\n<\/td>\n $ (22,544)<\/b><\/p>\n<\/td>\n $ (107,500)<\/b><\/p>\n<\/td>\n<\/tr>\n \n$ (0.11)\n<\/p>\n<\/td>\n \n$ (0.32)\n<\/p>\n<\/td>\n \n$ (0.19)\n<\/p>\n<\/td>\n \n$ (1.18)\n<\/p>\n<\/td>\n<\/tr>\n \n131,522\n<\/p>\n<\/td>\n \n103,848\n<\/p>\n<\/td>\n \n118,221\n<\/p>\n<\/td>\n \n90,929\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n 2020<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2019<\/b><\/p>\n<\/td>\n<\/tr>\n \n$ 52,389\n<\/p>\n<\/td>\n \n$ 48,121\n<\/p>\n<\/td>\n<\/tr>\n \n7,478\n<\/p>\n<\/td>\n \n6,326\n<\/p>\n<\/td>\n<\/tr>\n \n3,000\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n<\/tr>\n \n62,867\n<\/p>\n<\/td>\n \n54,447\n<\/p>\n<\/td>\n<\/tr>\n \n20\n<\/p>\n<\/td>\n \n20\n<\/p>\n<\/td>\n<\/tr>\n \n123\n<\/p>\n<\/td>\n \n238\n<\/p>\n<\/td>\n<\/tr>\n \n46,400\n<\/p>\n<\/td>\n \n46,400\n<\/p>\n<\/td>\n<\/tr>\n \n13,064\n<\/p>\n<\/td>\n \n13,064\n<\/p>\n<\/td>\n<\/tr>\n \n349\n<\/p>\n<\/td>\n \n196\n<\/p>\n<\/td>\n<\/tr>\n $ 122,823<\/b><\/p>\n<\/td>\n $ 114,365<\/b><\/p>\n<\/td>\n<\/tr>\n \n$ 3,102\n<\/p>\n<\/td>\n \n$ 1,902\n<\/p>\n<\/td>\n<\/tr>\n \n3,973\n<\/p>\n<\/td>\n \n6,169\n<\/p>\n<\/td>\n<\/tr>\n \n1,500\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n<\/tr>\n \n8,985\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n<\/tr>\n \n489\n<\/p>\n<\/td>\n \n446\n<\/p>\n<\/td>\n<\/tr>\n \n18,049\n<\/p>\n<\/td>\n \n8,517\n<\/p>\n<\/td>\n<\/tr>\n \n99,855\n<\/p>\n<\/td>\n \n120,020\n<\/p>\n<\/td>\n<\/tr>\n \n1,500\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n<\/tr>\n \n12,528\n<\/p>\n<\/td>\n \n12,528\n<\/p>\n<\/td>\n<\/tr>\n \n118\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n<\/tr>\n \n132,050\n<\/p>\n<\/td>\n \n141,065\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n<\/tr>\n \n140\n<\/p>\n<\/td>\n \n107\n<\/p>\n<\/td>\n<\/tr>\n \n306,554\n<\/p>\n<\/td>\n \n266,717\n<\/p>\n<\/td>\n<\/tr>\n \n(315,921)\n<\/p>\n<\/td>\n \n(293,524)\n<\/p>\n<\/td>\n<\/tr>\n \n(9,227)\n<\/p>\n<\/td>\n \n(26,700)\n<\/p>\n<\/td>\n<\/tr>\n $ 122,823<\/b><\/p>\n<\/td>\n $ 114,365<\/b><\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210315005210\/en\/<\/a><\/span><\/p>\n Erin Clark, Vice President, Corporate Strategy & Investor Relations KEYWORDS:<\/b> United States North America Massachusetts<\/p>\n INDUSTRY KEYWORDS:<\/b> Biotechnology Pharmaceutical Health Oncology<\/p>\n\n
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\n SESEN BIO, INC.<\/b><\/td>\n<\/tr>\n \n CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS<\/b><\/td>\n<\/tr>\n \n (In thousands, except per share data)<\/b><\/td>\n<\/tr>\n \n (Unaudited)<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n Three Months ended<\/b><\/td>\n \n Twelve Months ended<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n December 31,<\/b><\/td>\n \n December 31,<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Revenue<\/td>\n \n \n \n \n \n \n \n \n \n \n \n <\/tr>\n \n \n License revenue<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n Total revenue<\/td>\n \n \n \n \n \n \n \n \n \n \n Operating expenses:<\/td>\n \n \n \n \n \n \n \n \n <\/tr>\n \n \n Research and development<\/td>\n \n \n \n \n \n \n \n \n \n \n General and administrative<\/td>\n \n \n \n \n \n \n \n \n \n \n Change in change in fair value of contingent consideration<\/td>\n \n \n \n \n \n \n \n \n \n \n \n Total operating expenses<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n Loss from operations<\/td>\n \n \n \n \n \n \n \n \n \n Other income (expense):<\/td>\n \n \n \n \n \n \n \n \n <\/tr>\n \n \n Other income (expense), net<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n Net loss and comprehensive loss, before taxes<\/b><\/td>\n \n \n \n \n \n \n \n \n \n \n Provision for income taxes<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n Net loss and comprehensive loss<\/b><\/td>\n \n \n \n \n \n \n \n \n \n \n Deemed dividend on adjustment of exercise price of certain warrants<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n Net loss and comprehensive loss available to common stockholders<\/b><\/td>\n \n \n \n \n \n \n \n \n \n Net loss per common share – basic and diluted<\/td>\n \n \n \n \n \n \n \n \n \n Weighted-average common shares outstanding – basic and diluted<\/td>\n \n \n \n \n \n \n \n \n \n
\n SESEN BIO, INC.<\/b><\/td>\n<\/tr>\n \n CONSOLIDATED BALANCE SHEETS<\/b><\/td>\n<\/tr>\n \n (In thousands, except share and per share data)<\/b><\/td>\n<\/tr>\n \n (Unaudited)<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \n December 31,<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Assets<\/b><\/td>\n \n \n \n \n \n \n \n \n \n <\/tr>\n \n Current assets:<\/td>\n \n \n \n \n \n \n \n \n <\/tr>\n \n \n Cash and cash equivalents<\/td>\n \n \n \n \n \n \n \n \n Prepaid expense and other current assets<\/td>\n \n \n \n \n \n \n \n Restricted Cash<\/td>\n \n \n \n \n \n \n \n \n \n \n Total current assets<\/td>\n \n \n \n \n \n \n \n Restricted cash<\/td>\n \n \n \n \n \n \n \n \n \n Property and equipment, net<\/td>\n \n \n \n \n \n \n \n Intangibles<\/td>\n \n \n \n \n \n \n \n \n \n \n Goodwill<\/td>\n \n \n \n \n \n \n \n \n \n \n \n Other assets<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Total Assets<\/b><\/td>\n \n \n \n \n \n \n Liabilities and Stockholders’ Deficit<\/b><\/td>\n \n \n \n \n <\/tr>\n \n Current liabilities:<\/td>\n \n \n \n \n \n \n <\/tr>\n \n \n Accounts payable<\/td>\n \n \n \n \n \n \n \n \n \n Accrued expenses<\/td>\n \n \n \n \n \n \n \n \n \n Deferred revenue<\/td>\n \n \n \n \n \n \n \n \n \n Contingent consideration<\/td>\n \n \n \n \n \n \n \n \n Other current liabilities<\/td>\n \n \n \n \n \n \n \n \n \n Total current liabilities<\/td>\n \n \n \n \n \n \n \n Contingent consideration, net of current portion<\/td>\n \n \n \n \n \n \n Deferred revenue, net of current portion<\/td>\n \n \n \n \n \n \n Deferred tax liability<\/td>\n \n \n \n \n \n \n \n \n Other liabilities<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n Total Liabilities<\/td>\n \n \n \n \n \n \n Commitments and contingencies<\/td>\n \n \n \n \n \n <\/tr>\n \n Stockholders’ Deficit:<\/td>\n \n \n \n \n \n \n <\/tr>\n \n \n Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at<\/td>\n \n \n \n \n <\/tr>\n \n \n December 31, 2020 and December 31, 2019; no shares issued and outstanding at December 31,<\/td>\n \n \n \n <\/tr>\n \n \n 2020 and December 31, 2019<\/td>\n \n \n \n \n \n \n \n Common stock. $0.001 par value per share; 200,000,000 shares authorized at<\/td>\n \n \n \n \n <\/tr>\n \n \n December 31, 2020 and December 31, 2019; 140,449,647 and 106,801,409 shares issued and<\/td>\n \n \n \n <\/tr>\n \n \n outstanding at December 31, 2020 and December 31, 2019, respectively<\/td>\n \n \n \n \n \n \n \n Additional paid-in capital<\/td>\n \n \n \n \n \n \n \n \n Accumulated deficit<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n Total Stockholders’ Deficit<\/td>\n \n \n \n \n \n \n \n \n \n \n \n Total Liabilities and Stockholders’ Deficit<\/b><\/td>\n \n \n \n \n \n <\/p>\n
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ir@sesenbio.com<\/a><\/strong><\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20210315005210\/en\/718592\/3\/Sesen_Logo.jpg\"){kind=logo}
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