Manufacturing and release testing of the
Fujifilm pre-PPQ batch completed successfully
Positive Interactions with EMA on Regulatory
Pathway for Vicinium® in Europe
Market research conducted in 1Q 2020 supports
Urologists prefer Vicinium to Keytruda®
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
first quarter ended March 31, 2020. The Company also provided an
update on the progress of manufacturing activities related to
demonstrating analytical comparability between clinical batches of
Vicinium and validation batches of Vicinium intended for potential
future commercial use. The Company’s lead program, Vicinium, 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 Vicinium to the FDA under
Rolling Review.
“In the first quarter of 2020, we successfully completed
manufacturing of the pre-PPQ batch at Fujifilm,” said Dr. Thomas
Cannell, president and chief executive officer of Sesen Bio. “We
believe the commercial-scale cGMP batches of Vicinium manufactured
to date at our CMOs are comparable to Vicinium previously
manufactured by Sesen for use in our clinical trials. This
reinforces our confidence in the upcoming PPQ campaign and our
ability to demonstrate analytical comparability between clinical
and commercial drug supply. The Company’s focus for 2020 remains
the flawless execution of the PPQ campaign and the finalization of
Module 3 to complete the Vicinium BLA submission.”
Manufacturing Update
- In February 2020, manufacturing of the pre-PPQ bulk drug
substance batch was completed at Fujifilm. In April, quality
release testing of the bulk drug substance from this batch was
completed and all quality acceptance criteria were met. The Company
believes these data de-risk the PPQ campaign and increase the
likelihood of demonstrating analytical comparability. In addition,
in April 2020, this batch from Fujifilm was used to manufacture the
first PPQ drug product batch at Baxter and release testing is
currently underway. The Company remains on track to complete the
Vicinium BLA submission in the second half of 2020 and anticipates
potential approval in first half of 2021. At this time, the Company
does not expect any impact to the manufacturing activities or
regulatory processes related to Vicinium due to COVID-19.
CHMP Scientific Advice Update
- On May 7, 2020 the Company received clinical Scientific Advice
from the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) stating that the Committee
agreed that the Company’s nonclinical, clinical pharmacology and
safety database are all sufficient to support a marketing
authorization application (MAA). Furthermore, additional clinical
trials were not requested by the CHMP in support of the MAA
submission for Vicinium. Based on the guidance received, the
Company expects to submit the MAA for Vicinium to the EMA in early
2021, with potential approval anticipated in early 2022.
Commercial Opportunity
- In the first quarter of 2020, the Company conducted 30-minute
interviews with 34 randomly selected, high-prescribing Urologists
to assess their views of a blinded clinical profile of Vicinium as
well as an unblinded profile of Keytruda, which was recently
approved by the FDA for BCG-unresponsive NMIBC patients with
carcinoma in situ (CIS) with or without papillary tumors who are
ineligible for or have elected not to undergo cystectomy. The
research revealed that, when prescribing a branded agent,
Urologists would prescribe Vicinium to 83% of their patients
compared to 17% for Keytruda. The overall preference for Vicinium
was driven by comparable efficacy data to Keytruda with a favorable
safety profile and mode of administration that would allow
physicians to easily integrate Vicinium into their practices. We
believe these data support the potential for a successful launch
characterized by rapid uptake and growth of Vicinium.
First Quarter 2020 Financial Results
- Cash Position: Cash and cash equivalents were $42.5 million as
of March 31, 2020, compared to $48.1 million as of December 31,
2019.
- R&D Expenses: Research and development expenses for the
first quarter of 2020 were $8.9 million compared to $4.7 million
for the same period in 2019. The first quarter increase was due
primarily to costs related to the ongoing technology transfer
process as we scale-up for commercial manufacturing, in addition to
increased regulatory costs partially offset by lower employee
compensation and lower clinical expenses related to the Phase 3
VISTA trial for Vicinium.
- G&A Expenses: General and administrative expenses for the
first quarter of 2020 were $3.4 million compared to $3.1 million
for the same period in 2019. The first quarter increase was due
primarily to increases in professional fees and employee
compensation, offset by reduced market research costs.
- Net Income (Loss): Net income was $41.6 million, or $0.31 per
basic share and $0.31 per diluted share, for the three months ended
March 31, 2020, compared to a net loss of $6.5 million, or $0.08
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 current market conditions related to
the COVID-19 pandemic.
Conference Call and Webcast Information
Members of the Sesen Bio management team will host a conference
call and webcast today at 8:00 AM ET to review the Company's
financial results and provide a general business update. To
participate in the conference call, please dial (844) 831-3025
(domestic) or (315) 625-6887 (international) and refer to
conference ID 3780957. The webcast can be accessed in the Investor
Relations section of the company's website at www.sesenbio.com. The
replay of the webcast will be available in the investor section of
the company’s website at www.sesenbio.com for 60 days following the
call.
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
Vicinium® 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 Vicinium 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 Vicinium®
Vicinium, 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). Vicinium 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.
Vicinium 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 Vicinium 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 Vicinium promote an anti-tumor immune
response that may potentially combine well with immuno-oncology
drugs, such as checkpoint inhibitors. The activity of Vicinium 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, Vicinium®, 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 Vicinium to the FDA under Rolling Review.
Vicinium 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 Vicinium. 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 our PPQ manufacturing
runs, expectations regarding the timing of completion of our BLA
submission for Vicinium, 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 Vicinium to
the EMA, expectations regarding the timing of potential approval of
our MAA submission by the EMA, expectations regarding the potential
successful launch of Vicinium, 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
OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (In thousands,
except per share data) (Unaudited) Three
Months ended March 31,
2020
2019
Operating expenses: Research and development
$ 8,867
$ 4,686
General and administrative
3,448
3,055
Change in change in fair value of contingent consideration
(53,700)
(1,000)
Total operating expenses
(41,385)
6,741
Income (Loss) from Operations
41,385
(6,741)
Other income (expense): Other income, net
179
261
Net Income (Loss) and Comprehensive Income (Loss)
$ 41,564
$ (6,480)
Net income (loss) attributable to common stockholders -
basic
$ 34,407
$ (6,480)
Net income (loss) attributable to common stockholders - diluted
$ 34,408
$ (6,480)
Net income (loss) per common share - basic
$ 0.31
$ (0.08)
Weighted-average common shares outstanding - basic
109,808
77,458
Net income (loss) per common share - diluted
$ 0.31
$ (0.08)
Weighted-average common shares outstanding - diluted
109,823
77,458
SESEN BIO, INC. CONSOLIDATED BALANCE SHEETS (In
thousands, except share and per share data) March
31, December 31,
2020
2019
(Unaudited) Assets Current assets: Cash and cash
equivalents
$ 42,463
$ 48,121
Prepaid expense and other current assets
2,420
6,326
Total current assets
44,883
54,447
Restricted cash
20
20
Property and equipment, net
207
238
Intangibles
46,400
46,400
Goodwill
13,064
13,064
Other assets
91
196
Total Assets
$ 104,665
$ 114,365
Liabilities and Stockholders' Equity (Deficit) Current
liabilities: Accounts payable
$ 2,068
$ 1,902
Accrued expenses
4,893
6,169
Other current liabilities
405
446
Total current liabilities
7,366
8,517
Contingent consideration
66,320
120,020
Deferred tax liability
12,528
12,528
Total Liabilities
86,214
141,065
Commitments and contingencies Stockholders' Equity (Deficit):
Preferred stock, $0.001 par value per share; 5,000,000 shares
authorized at March 31, 2020 and December 31, 2019; no shares
issued and outstanding at March 31, 2020 and December 31, 2019
Common stock. $0.001 par value per share; 200,000,000 shares
authorized at March 31, 2020 and December 31, 2019; 109,991,553 and
106,801,409 shares issued and outstanding at March 31, 2020 and
December 31, 2019, respectively
110
107
Additional paid-in capital
270,301
266,717
Accumulated deficit
(251,960)
(293,524)
Total Stockholders' Equity (Deficit)
18,451
(26,700)
Total Liabilities and Stockholders' Equity (Deficit)
$ 104,665
$ 114,365
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200511005145/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From Apr 2024 to May 2024
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From May 2023 to May 2024