Sesen Bio Reports First Quarter 2019 Financial Results and Updated, Preliminary Primary and Additional Secondary Endpoint Data from Phase 3 VISTA Trial for High-Risk Non-Muscle Invasive Bladder Cancer
Company Announces Confirmed Meetings with the
Management to Host a Business Update Call Today at
“We are very encouraged by the most recent analysis of our 12-month
Phase 3 VISTA trial data, which will be the basis for our meetings with
Phase 3 VISTA Trial Progress and Updates
- Updated, Preliminary VISTA Trial Data Reported in BCG-unresponsive
NMIBC: In March,
Sesen Bioannounced updated preliminary data from its ongoing Phase 3 VISTA trial, a single-arm, multi-center clinical trial designed to support the approval of Vicinium for the treatment of patients with high-risk, BCG-unresponsive NMIBC. The trial completed registration in the second quarter of 2018, with a total of 133 patients across three cohorts based on histology and time to disease recurrence after adequate BCG treatment (at least two courses of BCG with at least five doses in the first course and two doses in the second course). Primary endpoints include complete response rate and duration of response for patients in Cohort 1. Secondary endpoints include time to disease recurrence for patients in Cohort 3, and time to cystectomy, progression-free survival, event-free survival, and overall survival for all patients across cohorts. As of the March 1, 2019data cutoff, updated preliminary primary and secondary efficacy data for each of the trial cohorts were as follows:
|Cohort 1 (n=86) Complete Response Rate|
|Complete Response Rate|
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred within six months of their last course of adequate BCG
|Cohort 2 (n=7) Complete Response Rate|
|Complete Response Rate|
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred after six months, but less than 11 months, after their last course of adequate BCG
|Pooled Cohorts 1 and 2 (n=93) Complete Response Rate|
Complete Response Rate
(95% Confidence Interval)
|3-months||n=93||39% (29%- 49%)|
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred less than 11 months, after their last course of adequate BCG
- Duration of Response: The median duration of response for patients in Cohort 1 (n=86) is 287 days (95% CI, 127-NA), using the Kaplan-Meier method. Additional ad hoc analysis of pooled data for all patients with Carcinoma in situ (Cohorts 1 and 2, n=93) shows that among patients who achieved a complete response at 3 months, 54% had a complete response for a total of 12 months or longer after starting therapy, using the Kaplan-Meier method.
- Time to Disease Recurrence: High-risk papillary (Ta or T1) NMIBC is associated with higher rates of progression and recurrence. Therefore, time to disease recurrence is a key secondary endpoint for patients with high-risk papillary-only NMIBC. The median time to disease recurrence for patients in Cohort 3 (n=40) is 402 days (95% CI, 170-NA), using the Kaplan-Meier method.
- Time to Cystectomy: The
FDAguidance states that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy. Therefore, time to cystectomy is a key secondary endpoint in the VISTA trial. Across all 133 patients treated with Vicinium, >75% of patients are estimated to remain cystectomy-free at 2.5 years, using the Kaplan-Meier method. Additional ad hoc analysis of responders and non-responders for all patients shows that responders are approximately 15 times more likely to remain cystectomy-free at 2.5 years compared to non-responders.
- Additional Secondary Endpoint Data from Phase 3 VISTA Trial Support
a Growing Body of Evidence Demonstrating the Durable Anti-tumor
Activity of Vicinium: Since the last data update reported in
Sesen Biohas completed preliminary analyses of the remaining secondary endpoints in the VISTA trial, including progression-free survival, overall survival, and event-free survival, as measured across all patient cohorts. Reported data is as of the March 1, 2019cutoff:
- Progression-Free Survival: >85% of all 133 patients treated with Vicinium are estimated to remain progression-free at 2 years, using the Kaplan-Meier method. Progression-free is defined as the time from the date of first dose of study treatment to disease progression (e.g. T2 or more advanced disease) or death as a first event.
- Event-Free Survival: 30% of all 133 patients treated with Vicinium are estimated to remain event-free at 12 months, using the Kaplan-Meier method. Event-free survival is defined as the time from the date of first dose of study treatment to disease recurrence, progression, or death as a first event.
- Overall Survival: 91% of all 133 patients treated with Vicinium have an overall survival of >2.5 years, using the Kaplan-Meier method. Overall survival is defined as the time from the date of first dose of study treatment to death from any cause.
- Vicinium Continues to be Well-tolerated by Patients Treated in the
Phase 3 VISTA Trial: As of the
March 1, 2019data cut off, in patients across all cohorts (n=133), 78% of adverse events were Grade 1 or 2. The most commonly reported treatment-related adverse events were dysuria (13%), hematuria (12%) and urinary tract infection (11%) – all of which are consistent with the profile of bladder cancer patients and the use of catheterization for treatment delivery. These adverse events were determined by the clinical investigators to be manageable and reversible, and only five patients (4%) discontinued treatment due to an adverse event. Serious adverse events, regardless of treatment attribution, were reported in 14% of patients. There were four treatment-related SAEs reported in three patients including acute kidney injury (Grade 3), pyrexia (Grade 2), cholestatic hepatitis (Grade 4) and renal failure (Grade 5). There were no age-related increases in adverse events observed in the Phase 3 VISTA trial.
- Positive Data and Safety Monitoring Board (DSMB) Review of Phase 3 VISTA Trial Data: In March, the independent DSMB completed its ninth planned safety review for the Phase 3 VISTA trial and recommended the trial continue without modification.
- Completion of Full-Scale GMP Manufacturing Run at
FUJIFILMProvides Encouraging Preliminary Results, Supporting Analytical Comparability Plan to be Reviewed with the FDA: In October 2018, Sesen Bioentered into an agreement for the manufacturing process and technology transfer of Vicinium production with FUJIFILM Diosynth Biotechnologies U.S.A., Inc.( FUJIFILM). In April 2019, the first full, commercial-scale GMP run was completed at FUJIFILM. Preliminary indicators of success, including the bacterial growth and purification profiles, support FUJIFILM’S ability to produce the bulk drug substance form of Vicinium for commercial purposes if Sesen Bioreceives regulatory approval to market Vicinium. Full quality release testing is underway, and results are expected to be completed in May 2019.
- Updated Phase 3 VISTA Trial Data Along with Closely Matched Phase 2
Clinical Trial Data to Serve as Basis for Upcoming FDA Meetings:
- Type C CMC Meeting Scheduled for
May 20, 2019. In conjunction with the technology transfer of Vicinium production with FUJIFILM, the Company will seek alignment with the FDAon an analytical comparability plan that can be used to assess comparability between the supply used in clinical trials and the potential commercial supply produced by FUJIFILM.
- Pre-BLA Meeting Scheduled for
June 6, 2019: In concurrence with the FDA’s recommendation that the Company schedule a meeting in mid-2019, Sesen Biohas confirmed a meeting date with the FDAin June to discuss its intended registration strategy for Vicinium for the treatment of high-risk NMIBC.
- Type C CMC Meeting Scheduled for
First Quarter 2019 Financial Results
- Cash Position: Cash and cash equivalents were
$42.4 millionas of March 31, 2019, compared to $50.4 millionas of December 31, 2018, and $19.7 millionas of March 31, 2018, the comparable period one year ago.
- Revenue: No revenue was recorded for the three months ended
March 31, 2019, nor for the same period in 2018.
- R&D Expenses: Research and development (R&D) expenses for
the first quarter of 2019 were
$4.7 millioncompared to $3.3 millionin R&D expenses for the same period in 2018. The increase was primarily due to $1.7 millionin costs related to the ongoing manufacturing process and technology transfer with FUJIFILM, and increased internal and external staffing costs, partially offset by reduced expenses related to the Phase 3 VISTA trial.
- G&A Expenses: General and administrative expenses for the
first quarter of 2019 were
$3.1 millioncompared to $2.0 millionfor the same period in 2018. The increase was primarily due to higher legal costs, an increase in professional fees and market research costs.
- Net Loss: Net loss was
$6.5 million, or $0.08per share, for the first quarter of 2019, compared to $4.0 million, or $0.11per share, for the first quarter of 2018.
- Financial Guidance: Based on its current operating plans,
Sesen Biobelieves it will have capital sufficient to fund its current operating plan into 2020.
Conference Call Information
To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 7176228. 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, or 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 receive 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.
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
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: the uncertainties inherent in the
initiation and conduct of clinical trials, the possibility that the
preliminary data of the Phase 3 VISTA trial are not indicative of final
clinical results and final clinical trial results may not be positive
with regard to the safety or efficacy of Vicinium, our ability to
successfully develop our product candidates and complete our planned
clinical programs, expectations regarding our upcoming
|SESEN BIO, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except per share data)|
|Three Months Ended March 31,|
|Research and development||4,686||3,255|
|General and administrative||3,055||1,952|
|Gain from change in fair value of contingent consideration||(1,000||)||(1,200||)|
|Total operating expenses||6,741||4,007|
|Loss from operations||(6,741||)||(4,007||)|
|Other income, net||261||44|
|Net loss and comprehensive loss||$||(6,480||)||$||(3,963||)|
|Net loss per share —basic and diluted||$||(0.08||)||$||(0.11||)|
|Weighted-average number of common shares used in net|
|loss per share —basic and diluted||77,458||35,674|
|SESEN BIO, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||42,437||$||50,422|
|Prepaid expenses and other current assets||3,014||1,334|
|Total current assets||45,451||51,756|
|Property and equipment, net||272||321|
|Liabilities and stockholders' equity|
|Other current liabilities||136||-|
|Total current liabilities||7,053||6,113|
|Deferred tax liability||12,528||12,528|
|Additional paid-in capital||230,487||230,154|
|Total stockholders' equity||38,060||44,207|
|Total liabilities and stockholders' equity||$||105,439||$||111,561|
Erin Clark, Executive Director, Strategic Planning & Investor Relations