Sesen Bio Reports Second Quarter 2020 Financial Results and Business Update
On-track to complete BLA submission in the US in the fourth quarter of 2020
Entered into a license agreement with
Manufacturing of PPQ campaign drug substance batches has been completed
“We are extremely pleased with the progress at
US and European Regulatory Update
US:
-
On
June 17, 2020 , Sesen received conditional acceptance of the proprietary brand name Vicineum for the Company’s product candidate, oportuzumab monatox. The Company believes Vicineum is a name with strong marketing potential that is also consistent with the FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate. The conditional acceptance of Vicineum is an important milestone in commercial readiness in the US. The Company remains on track to complete the BLA submission in the fourth quarter of 2020 and anticipates potential approval in mid-2021.
-
Sesen Bio concluded a five-month scientific opinion process inEurope and received positive Scientific Advice for both clinical and CMC. Importantly, the Committee for Medical Products for Human Use (“CHMP”) agreed that the nonclinical and clinical pharmacology studies, and safety database are all sufficient to support a Marketing Authorization Application (“MAA”) submission for Vicineum and no additional clinical trials were requested. Additionally, the CHMP agreed that the CMC comparability plan provides a strong analytical package, and no additional clinical trials to establish comparability are deemed necessary at this time. Based on the guidance received, the Company expects to submit the MAA for Vicineum to the EMA in early 2021 with potential approval anticipated in early 2022. -
On
July 3, 2020 , the Company received a product-specific pediatric waiver from the EMA for Vicineum. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a Pediatric Investigation Plan (“PIP”) that outlines the clinical development strategy for studying the investigational product in the pediatric population. In some instances, a waiver from required pediatric studies for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate. The PIP waiver from the EMA applies to Vicineum across all subsets of the pediatric population for the treatment of urothelial carcinoma. The receipt of the waiver will allow the Company to submit a MAA for Vicineum to the EMA without the requirement to conduct clinical studies in a pediatric population either pre-approval or post-approval.
Business Development Update
On
-
Financial terms include significant sources of non-dilutive capital
-
Upfront payment of
$12M in cash -
Eligibility to receive up to
$23M in regulatory and tech transfer milestones in addition to sales royalties for at least 12 years
-
Upfront payment of
-
Qilu will be the Marketing Authorization Holder and will have the exclusive rights to develop, manufacture and commercialize Vicineum in
Greater China - Qilu will be responsible for all expenses related to these activities
-
Sesen retains full development and commercialization rights in the US and the rest of world excluding
Greater China
- Terms of the agreement include tech transfer, creating an opportunity for future CMO partnership to meet significant global demand forecasts
Manufacturing Update
Second Quarter 2020 Financial Results
-
Cash Position: Cash and cash equivalents were
$37.7 million as ofJune 30, 2020 , compared to$48.1 million as ofDecember 31, 2019 . -
R&D Expenses: Research and development expenses for the second quarter of 2020 were
$4.6 million compared to$7.9 million for the same period in 2019. The second quarter decrease was due primarily to timing of costs related to the ongoing technology transfer process and commercial manufacturing, in addition to lower employee compensation and lower clinical expenses related to the Phase 3 VISTA trial for Vicineum. -
G&A Expenses: General and administrative expenses for the second quarter of 2020 were
$3.3 million compared to$2.6 million for the same period in 2019. The second quarter increase was due primarily to increases in employee compensation, and legal and insurance costs, offset by slightly lower audit and professional fees. -
Net Income (Loss): Net loss was
$26.3 million , or$0.24 per basic and diluted share, for the three months endedJune 30, 2020 , compared to a net loss of$54.3 million , or$0.67 per basic and diluted share, for the same period in 2019. The change was primarily the result of the non-cash change in fair value of contingent consideration due to significantly higher discount rates associated with market conditions related to the COVID-19 pandemic.
About VicineumTM
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicineum™ as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicineum twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.
About
COVID-19 Pandemic Potential Impact
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our ability to successfully develop our product candidates and complete our planned clinical programs, expectations regarding the impact of the COVID-19 pandemic, expectations regarding the timing or amounts of any payments by
|
|||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (OPERATIONS) AND COMPREHENSIVE INCOME (LOSS) |
|||||||||||||||||||||
(In thousands, except per share data) |
|||||||||||||||||||||
(Unaudited) |
|||||||||||||||||||||
Three Months ended |
|
Six Months ended |
|||||||||||||||||||
|
|
|
|||||||||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||||||||||
Operating expenses: | |||||||||||||||||||||
Research and development |
$ |
4,562 |
|
$ |
7,944 |
|
$ |
13,429 |
|
$ |
12,630 |
|
|||||||||
General and administrative |
|
3,318 |
|
|
2,617 |
|
|
6,766 |
|
|
5,672 |
|
|||||||||
Change in change in fair value of contingent consideration |
|
18,480 |
|
|
44,000 |
|
|
(35,220 |
) |
|
43,000 |
|
|||||||||
Total operating expenses |
|
26,360 |
|
|
54,561 |
|
|
(15,025 |
) |
|
61,302 |
|
|||||||||
Income (Loss) from Operations |
|
(26,360 |
) |
|
(54,561 |
) |
|
15,025 |
|
|
(61,302 |
) |
|||||||||
Other income (expense): | |||||||||||||||||||||
Other income, net |
|
16 |
|
|
226 |
|
|
195 |
|
|
487 |
|
|||||||||
Net Income (Loss) and Comprehensive Income (Loss) |
$ |
(26,344 |
) |
$ |
(54,335 |
) |
$ |
15,220 |
|
$ |
(60,815 |
) |
|||||||||
Net income (loss) per common share - basic |
$ |
(0.24 |
) |
$ |
(0.67 |
) |
$ |
0.13 |
|
$ |
(0.77 |
) |
|||||||||
Weighted-average common shares outstanding - basic |
|
112,569 |
|
|
80,739 |
|
|
111,189 |
|
|
79,107 |
|
|||||||||
Net income (loss) per common share - diluted |
$ |
(0.24 |
) |
$ |
(0.67 |
) |
$ |
0.11 |
|
$ |
(0.77 |
) |
|||||||||
Weighted-average common shares outstanding - diluted |
|
112,569 |
|
|
80,739 |
|
|
111,203 |
|
|
79,107 |
|
|
|||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||||||||
(In thousands, except share and per share data) |
|||||||||||||
(Unaudited) |
|||||||||||||
|
|
||||||||||||
2020 |
2019 |
||||||||||||
Assets | |||||||||||||
Current assets: | |||||||||||||
Cash and cash equivalents |
$ |
37,741 |
|
$ |
48,121 |
|
|||||||
Prepaid expense and other current assets |
|
3,727 |
|
|
6,326 |
|
|||||||
Total current assets |
|
41,468 |
|
|
54,447 |
|
|||||||
Restricted cash |
|
20 |
|
|
20 |
|
|||||||
Property and equipment, net |
|
185 |
|
|
238 |
|
|||||||
Intangibles |
|
46,400 |
|
|
46,400 |
|
|||||||
|
13,064 |
|
|
13,064 |
|
||||||||
Other assets |
|
76 |
|
|
196 |
|
|||||||
Total Assets |
$ |
101,213 |
|
$ |
114,365 |
|
|||||||
Liabilities and Stockholders' Deficit | |||||||||||||
Current liabilities: | |||||||||||||
Accounts payable |
$ |
1,274 |
|
$ |
1,902 |
|
|||||||
Accrued expenses |
|
4,866 |
|
|
6,169 |
|
|||||||
Other current liabilities |
|
373 |
|
|
446 |
|
|||||||
Total current liabilities |
|
6,513 |
|
|
8,517 |
|
|||||||
Contingent consideration |
|
84,800 |
|
|
120,020 |
|
|||||||
Deferred tax liability |
|
12,528 |
|
|
12,528 |
|
|||||||
Total Liabilities |
|
103,841 |
|
|
141,065 |
|
|||||||
Commitments and contingencies | |||||||||||||
Stockholders' Deficit: | |||||||||||||
Preferred stock, |
|||||||||||||
2020 and |
|||||||||||||
Common stock. |
|||||||||||||
2020 and |
|||||||||||||
outstanding at |
|
116 |
|
|
107 |
|
|||||||
Additional paid-in capital |
|
275,560 |
|
|
266,717 |
|
|||||||
Accumulated deficit |
|
(278,304 |
) |
|
(293,524 |
) |
|||||||
Total Stockholders' Deficit |
|
(2,628 |
) |
|
(26,700 |
) |
|||||||
Total Liabilities and Stockholders' Deficit |
$ |
101,213 |
|
$ |
114,365 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200810005288/en/
ir@sesenbio.com
Source: