On-track to
complete BLA submission in the US in the fourth quarter of
2020
Entered into
a license agreement with Qilu Pharmaceutical for the development
and commercialization of Vicineum™ in Greater China with $12M
upfront payment
Manufacturing
of PPQ campaign drug substance batches has been
completed
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today reported operating results for the
second quarter ended June 30, 2020. The Company also provided an
update on recent business development activities and the progress
of manufacturing activities related to the PPQ campaign. The
Company’s lead program, Vicineum, also known as VB4-845, is
currently in the follow-up stage of a Phase 3 registration trial
for the treatment of high-risk, BCG-unresponsive non-muscle
invasive bladder cancer (“NMIBC”). In December 2019, the Company
initiated the BLA submission for Vicineum to the FDA under Rolling
Review.
“We are extremely pleased with the progress at Sesen Bio over
the past quarter,” said Dr. Thomas Cannell, president and chief
executive officer of Sesen Bio. “We signed our first licensing
agreement for Vicineum outside the US with Qilu Pharmaceutical,
which is a strong sign of confidence in our mission to bring this
innovative therapy to more patients in need. We expect to sign
additional partnerships over the next six months. Equally
important, we have now completed the manufacturing of the PPQ
campaign drug substance batches at Fujifilm, an important milestone
in our path to completion of the BLA submission. We are currently
in an exciting phase at Sesen Bio and we remain as driven as ever
to bring Vicineum to market to save and improve the lives of
patients with cancer.”
US and European Regulatory Update
US:
- On June 17, 2020, Sesen received conditional acceptance of the
proprietary brand name Vicineum for the Company’s product
candidate, oportuzumab monatox. The Company believes Vicineum is a
name with strong marketing potential that is also consistent with
the FDA’s goal of preventing medication errors and potential harm
to the public by ensuring that only appropriate proprietary names
are approved for use. Final approval of the Vicineum brand name is
conditional on FDA approval of the Company’s product candidate. The
conditional acceptance of Vicineum is an important milestone in
commercial readiness in the US. The Company remains on track to
complete the BLA submission in the fourth quarter of 2020 and
anticipates potential approval in mid-2021.
Europe:
- Sesen Bio concluded a five-month scientific opinion process in
Europe and received positive Scientific Advice for both clinical
and CMC. Importantly, the Committee for Medical Products for Human
Use (“CHMP”) agreed that the nonclinical and clinical pharmacology
studies, and safety database are all sufficient to support a
Marketing Authorization Application (“MAA”) submission for Vicineum
and no additional clinical trials were requested. Additionally, the
CHMP agreed that the CMC comparability plan provides a strong
analytical package, and no additional clinical trials to establish
comparability are deemed necessary at this time. Based on the
guidance received, the Company expects to submit the MAA for
Vicineum to the EMA in early 2021 with potential approval
anticipated in early 2022.
- On July 3, 2020, the Company received a product-specific
pediatric waiver from the EMA for Vicineum. As part of the
regulatory process for the registration of new medicines with the
EMA, pharmaceutical companies are required to provide a Pediatric
Investigation Plan (“PIP”) that outlines the clinical development
strategy for studying the investigational product in the pediatric
population. In some instances, a waiver from required pediatric
studies for certain conditions may be granted by the EMA when
development of a medicine for use in children is not feasible or
appropriate. The PIP waiver from the EMA applies to Vicineum across
all subsets of the pediatric population for the treatment of
urothelial carcinoma. The receipt of the waiver will allow the
Company to submit a MAA for Vicineum to the EMA without the
requirement to conduct clinical studies in a pediatric population
either pre-approval or post-approval.
Business Development Update
On July 30, 2020, Sesen Bio
and Qilu Pharmaceutical signed a license agreement for the
commercialization of Vicineum in Greater China. Under the terms of
the agreement, Sesen granted Qilu Pharmaceutical a license to
manufacture, develop and commercialize Vicineum for the
treatment of NMIBC and other types of cancer in China, Hong Kong,
Macau and Taiwan (“Greater China”). Key terms of the deal include:
- Financial terms include significant sources of non-dilutive
capital
- Upfront payment of $12M in cash
- Eligibility to receive up to $23M in regulatory and tech
transfer milestones in addition to sales royalties for at least 12
years
- Qilu will be the Marketing Authorization Holder and will have
the exclusive rights to develop, manufacture and commercialize
Vicineum in Greater China
- Qilu will be responsible for all expenses related to these
activities
- Sesen retains full development and commercialization rights in
the US and the rest of world excluding Greater China
- Terms of the agreement include tech transfer, creating an
opportunity for future CMO partnership to meet significant global
demand forecasts
Manufacturing Update
Sesen Bio completed the manufacturing of the PPQ campaign drug
substance batches at Fuji on schedule. Release testing is underway,
and upon completion, the drug substance will be shipped to Baxter
to finish the PPQ campaign for drug product, which is anticipated
to be completed in September 2020. Comparability data from the PPQ
campaign for drug substance and drug product are the last material
deliverables before submitting the BLA in the fourth quarter of
2020.
Second Quarter 2020 Financial Results
- Cash Position: Cash and cash equivalents were $37.7 million as
of June 30, 2020, compared to $48.1 million as of December 31,
2019.
- R&D Expenses: Research and development expenses for the
second quarter of 2020 were $4.6 million compared to $7.9 million
for the same period in 2019. The second quarter decrease was due
primarily to timing of costs related to the ongoing technology
transfer process and commercial manufacturing, in addition to lower
employee compensation and lower clinical expenses related to the
Phase 3 VISTA trial for Vicineum.
- G&A Expenses: General and administrative expenses for the
second quarter of 2020 were $3.3 million compared to $2.6 million
for the same period in 2019. The second quarter increase was due
primarily to increases in employee compensation, and legal and
insurance costs, offset by slightly lower audit and professional
fees.
- Net Income (Loss): Net loss was $26.3 million, or $0.24 per
basic and diluted share, for the three months ended June 30, 2020,
compared to a net loss of $54.3 million, or $0.67 per basic and
diluted share, for the same period in 2019. The change was
primarily the result of the non-cash change in fair value of
contingent consideration due to significantly higher discount rates
associated with market conditions related to the COVID-19
pandemic.
About VicineumTM
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is
comprised of a recombinant fusion protein that targets epithelial
cell adhesion molecule (EpCAM) antigens on the surface of tumor
cells to deliver a potent protein payload, Pseudomonas Exotoxin A.
Vicineum is constructed with a stable, genetically engineered
peptide tether to ensure the payload remains attached until it is
internalized by the cancer cell, which is believed to decrease the
risk of toxicity to healthy tissues, thereby improving its safety.
In prior clinical trials conducted by Sesen Bio, EpCAM has been
shown to be overexpressed in NMIBC cells with minimal to no EpCAM
expression observed on normal bladder cells. Sesen Bio is currently
conducting the Phase 3 VISTA trial, designed to support the
registration of Vicineum for the treatment of high-risk NMIBC in
patients who have previously received a minimum of two courses of
bacillus Calmette-Guérin (BCG) and whose disease is now
BCG-unresponsive. Additionally, Sesen Bio believes that cancer
cell-killing properties of Vicineum promote an anti-tumor immune
response that may potentially combine well with immuno-oncology
drugs, such as checkpoint inhibitors. The activity of Vicineum in
BCG-unresponsive NMIBC is also being explored at the US National
Cancer Institute in combination with AstraZeneca’s immune
checkpoint inhibitor durvalumab.
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase
3 clinical trial evaluating the efficacy and tolerability of
Vicineum™ as a monotherapy in patients with high-risk, bacillus
Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder
cancer (NMIBC). The primary endpoints of the trial are the complete
response rate and the duration of response in patients with
carcinoma in situ with or without papillary disease. Patients in
the trial received locally administered Vicineum twice a week for
six weeks, followed by once-weekly treatment for another six weeks,
then treatment every other week for up to two years. To learn more
about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov
and search the identifier NCT02449239.
About Sesen Bio
Sesen Bio, Inc. is a late-stage clinical company advancing
targeted fusion protein therapeutics for the treatment of patients
with cancer. The Company’s lead program, Vicineum™, also known as
VB4-845, is currently in a Phase 3 registration trial for the
treatment of high-risk, BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC). In December 2019, the Company initiated the
BLA submission for Vicineum to the FDA under Rolling Review.
Vicineum is a locally administered targeted fusion protein composed
of an anti-EpCAM antibody fragment tethered to a truncated form of
Pseudomonas Exotoxin A for the treatment of high-risk NMIBC. For
more information, please visit the company’s website at
www.sesenbio.com.
COVID-19 Pandemic Potential Impact
Sesen Bio continues to monitor the rapidly evolving environment
regarding the potential impact of the COVID-19 pandemic on our
Company. The Company has not yet experienced any disruptions to our
operations as a result of COVID-19, however, we are not able to
quantify or predict with certainty the overall scope of potential
impacts to our business, including, but not limited to, our ability
to raise capital and, if approved, commercialize Vicineum. Sesen
Bio remains committed to the health and safety of patients,
caregivers and employees.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, the Company’s strategy, future
operations, and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: our ability to
successfully develop our product candidates and complete our
planned clinical programs, expectations regarding the impact of the
COVID-19 pandemic, expectations regarding the timing or amounts of
any payments by Qilu Pharmaceutical, expectations regarding
additional partnerships for the commercialization of Vicineum
outside of the US, expectations regarding the timing of completion
of our BLA submission for Vicineum, expectations regarding the
timing of potential approval of our BLA submission by the FDA,
expectations regarding the timing of the submission of our MAA for
Vicineum to the EMA, expectations regarding the timing of potential
approval of our MAA submission by the EMA, expectations regarding
the need for any additional clinical trials, expectations regarding
the potential successful launch of Vicineum, if approved, our
ability to obtain marketing approvals for our product candidates,
and other factors discussed in the “Risk Factors” section of the
Company’s Annual Report on Form 10-K, Quarterly Reports on Form
10-Q and other reports filed with the Securities and Exchange
Commission. In addition, the forward-looking statements included in
this press release represent the Company’s views as of the date
hereof. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date hereof.
SESEN BIO, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF INCOME (OPERATIONS) AND COMPREHENSIVE INCOME
(LOSS)
(In thousands, except per
share data)
(Unaudited)
Three Months ended
Six Months ended
June 30,
June 30,
2020
2019
2020
2019
Operating expenses: Research and development
$
4,562
$
7,944
$
13,429
$
12,630
General and administrative
3,318
2,617
6,766
5,672
Change in change in fair value of contingent consideration
18,480
44,000
(35,220
)
43,000
Total operating expenses
26,360
54,561
(15,025
)
61,302
Income (Loss) from Operations
(26,360
)
(54,561
)
15,025
(61,302
)
Other income (expense): Other income, net
16
226
195
487
Net Income (Loss) and Comprehensive Income (Loss)
$
(26,344
)
$
(54,335
)
$
15,220
$
(60,815
)
Net income (loss) per common share - basic
$
(0.24
)
$
(0.67
)
$
0.13
$
(0.77
)
Weighted-average common shares outstanding - basic
112,569
80,739
111,189
79,107
Net income (loss) per common share - diluted
$
(0.24
)
$
(0.67
)
$
0.11
$
(0.77
)
Weighted-average common shares outstanding - diluted
112,569
80,739
111,203
79,107
SESEN BIO, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(In thousands, except share
and per share data)
(Unaudited)
June 30,
December 31,
2020
2019
Assets Current assets: Cash and cash equivalents
$
37,741
$
48,121
Prepaid expense and other current assets
3,727
6,326
Total current assets
41,468
54,447
Restricted cash
20
20
Property and equipment, net
185
238
Intangibles
46,400
46,400
Goodwill
13,064
13,064
Other assets
76
196
Total Assets
$
101,213
$
114,365
Liabilities and Stockholders' Deficit Current liabilities:
Accounts payable
$
1,274
$
1,902
Accrued expenses
4,866
6,169
Other current liabilities
373
446
Total current liabilities
6,513
8,517
Contingent consideration
84,800
120,020
Deferred tax liability
12,528
12,528
Total Liabilities
103,841
141,065
Commitments and contingencies Stockholders' Deficit: Preferred
stock, $0.001 par value per share; 5,000,000 shares authorized at
June 30, 2020 and December 31, 2019; no shares issued and
outstanding at June 30, 2020 and December 31, 2019 Common stock.
$0.001 par value per share; 200,000,000 shares authorized at June
30, 2020 and December 31, 2019; 116,627,653 and 106,801,409 shares
issued and outstanding at June 30, 2020 and December 31, 2019,
respectively
116
107
Additional paid-in capital
275,560
266,717
Accumulated deficit
(278,304
)
(293,524
)
Total Stockholders' Deficit
(2,628
)
(26,700
)
Total Liabilities and Stockholders' Deficit
$
101,213
$
114,365
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200810005288/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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