Mersana Therapeutics Announces First Quarter 2019 Financial Results and Provides Business Updates
May 09 2019 - 6:00AM
Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage
biopharmaceutical company focused on discovering and developing a
pipeline of antibody drug conjugates (ADCs) targeting cancers in
areas of high unmet medical need, today reported financial results
and a business update for the first quarter ended March 31, 2019.
“We have continued to make important progress in
advancing XMT-1536, our first-in-class ADC clinical candidate
targeting NaPi2b. We are very pleased with the safety, efficacy,
and duration of treatment seen to date in unselected and heavily
pretreated ovarian cancer and NSCLC adenocarcinoma patients. This
profile provides us with the confidence to move forward with
expansion studies in these two indications with high unmet medical
need. We look forward to presenting interim data from the dose
escalation phase of the study at the upcoming ASCO 2019 annual
meeting,” said Anna Protopapas, President and CEO of Mersana
Therapeutics. “We also continue to advance our earlier-stage ADC
programs and remain on track to disclose our next clinical
candidate in the fourth quarter of 2019. With our successfully
completed financing, we have the resources necessary to drive these
promising programs forward.”
Recent Highlights and
Updates
Clinical Program
- The Phase 1 dose escalation
study of XMT-1536 for the treatment of NaPi2b-expressing cancers
remains ongoing. XMT-1536 is a first-in-class
Dolaflexin ADC targeting NaPi2b, which is broadly expressed in
epithelial ovarian cancer and non-small cell lung cancer (NSCLC)
adenocarcinoma. The data to date from the ongoing XMT-1536 dose
escalation study indicate that the trial has reached clinically
relevant dose levels, starting at 20 mg/m2 but has not yet reached
a maximum tolerated dose. The Company continues to evaluate
patients in the 36 mg/m2 once-every-four-week dosing cohort.
Mersana plans to present data from the once-every-three-week dosing
schedule and from patients dosed up to and including, the 30 mg/m2
dose cohort in the once-every-four-week dosing schedule, at the
upcoming ASCO Annual Meeting in June 2019.
- Site initiation for the
dose expansion portion of the XMT-1536 Phase 1 study is
underway. Mersana is in the process of initiating
additional sites in anticipation of dosing patients in two
expansion groups in the third quarter of 2019. In the first group,
the Company plans to enroll platinum-resistant ovarian cancer
patients who have failed standard therapy. The second patient group
will enroll NSCLC adenocarcinoma patients who have failed front
line platinum-based chemotherapy as well as anti-PD-1 or anti-PDL-1
therapy.
Discovery & Platform Progress
- On track to disclose its
next ADC clinical candidate in the fourth quarter of 2019, further
strengthening its scientific leadership in ADC
development. The Company is targeting the filing of an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) in the first half of 2020.
- Presented data on its novel
Dolasynthen platform and modular Synthemer scaffold at the American
Association for Cancer Research (AACR) Annual Meeting in April
2019. Key details of the data presented are summarized
below:
- The presentation, titled
"Dolasynthen - A Novel, Homogeneous Auristatin F Hydroxypropyl
Amide Antibody-Drug Conjugate Platform” provided an overview of
Dolasynthen, Mersana’s novel, fully synthetic, structurally
homogeneous drug conjugation platform with a tunable
drug-to-antibody ratio (DAR) from 2 to 24. Precisely defined
ADCs created for multiple targets displayed excellent drug-like
properties, as well as potent activity, excellent tolerability, and
a broad therapeutic index in preclinical in vivo models,
demonstrating the significant potential for clinical application
and differentiation.
- The poster, titled “An
Antibody-Drug Conjugate Carrying a Microtubule Inhibitor and a DNA
Alkylator Exerts Both Mechanisms of Action on Tumor Cells”
characterized Mersana’s use of its modular Synthemer platform to
engineer a dual-payload ADC to deliver two mechanistically distinct
payloads simultaneously to each target cell. This data further
demonstrates the flexibility of the modular Synthemer approach and
its potential to address a broad set of set of applications.
Corporate Updates
- Successful completion of
equity financing further strengthens balance sheet. On
March 5, 2019, the Company announced the closing of a public
offering with aggregate gross proceeds from the offering
of approximately $97.8 million.
- Completed non-dilutive debt
financing for additional financial flexibility. On May 8,
2019, the Company completed a non-dilutive debt financing with
Silicon Valley Bank (SVB) that provides Mersana with the ability to
draw up to $20.0 million, the proceeds of which will be used for
general corporate and working capital purposes. The first tranche
of $5.0 million was drawn down by the Company upon execution of the
relevant Loan and Security Agreement, and under the terms of the
Agreement, the Company has the option to draw additional advances
over time. Further information describing the Agreement with SVB
will be included in the Form 10-Q to be filed by Mersana with the
Securities and Exchange Commission.
Upcoming Events
- The Company will present interim
Phase 1 dose escalation clinical data for XMT-1536 at the upcoming
American Society of Clinical Oncology (ASCO) 2019 medical meeting
on June 1, 2019 in Chicago, IL. The presentation format will be a
poster, followed by a poster discussion.
2019 Financial Results
Cash, cash equivalents and marketable securities
as of March 31, 2019, were $137.3 million, compared to $70.1
million as of December 31, 2018. On March 5, 2019 the Company
completed a public equity offering with gross proceeds of $97.8
million. The Company expects that its cash, cash equivalents
and marketable securities will enable it to fund its operating plan
into at least mid-2021.
First Quarter 2019
- Collaboration revenue for the first
quarter 2019 was approximately $41.0 million, compared to $3.1
million for the same period in 2018. The increase in collaboration
revenue was primarily due to the recognition of the remaining $40.0
million in deferred revenue associated with the discontinuation of
the XMT-1522 program and Takeda collaboration announced in January
2019.
- Research and development expenses
for the first quarter 2019 were approximately $15.1 million,
compared to $12.3 million for the same period in 2018, driven
primarily by an increase in external costs for the manufacturing
activities for XMT-1536 and the Company’s next clinical candidate
as well as modest increases in headcount and facilities costs. The
increase was offset by a decrease in external clinical and
regulatory expenses due to the discontinuation of the XMT-1522
clinical program.
- General and administrative expenses
for the first quarter 2019 were approximately $4.4 million,
compared to $3.6 million for the same period in 2018, driven
primarily by increased employee-related expenses due to an increase
in headcount and increased professional fees.
- Net income for the first quarter
2019 was $21.9 million, or $0.72 per share, compared to a net loss
of $12.4 million, or $0.54 per share, for the same period in
2018. Net income for the first quarter 2019 was driven by
recognition of the remaining $40.0 million in deferred revenue
associated with the discontinuation of the XMT-1522 program and
Takeda collaboration announced in January 2019. Weighted average
common shares outstanding for the quarters ended March 31, 2019 and
March 31, 2018, were 30,299,650 and 22,816,521 respectively.
Conference Call
Mersana Therapeutics will host a conference call
and webcast today at 8:00 a.m. ET to report financial results for
the first quarter of 2019 and provide certain business updates. To
access the call, please dial 877-303-9226 (domestic) or
409-981-0870 (international) and provide the Conference ID 1378664.
A live webcast of the presentation will be available on the
Investors & Media section of the Mersana website at
www.mersana.com.
About XMT-1536
XMT-1536 is a Dolaflexin ADC targeting the
sodium-dependent phosphate transport protein (NaPi2b) and is
comprised of an average of 10-15 DolaLock payload molecules
conjugated to XMT-1535, a proprietary humanized anti-NaPi2b
antibody. NaPi2b is an antigen highly expressed in the majority of
non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian
cancer. XMT-1536 is in Phase 1 clinical trials in patients with
tumors expressing NaPi2b, including ovarian cancer, NSCLC
adenocarcinoma and other cancers. More information on the
ongoing Phase 1 clinical trial can be found at
clinicaltrials.gov.
About Mersana
TherapeuticsMersana Therapeutics is a clinical-stage
biopharmaceutical company using its differentiated and proprietary
ADC platforms and its modular Synthemer scaffold to develop highly
targeted drugs with increased tolerability and expanded
opportunities to deliver meaningful clinical benefit to cancer
patients. Mersana’s lead product candidate, XMT-1536, is in a Phase
1 clinical trial in patients with tumors expressing NaPi2b,
including ovarian cancer, NSCLC adenocarcinoma, and other cancers.
In addition, multiple partners are using Mersana’s platform to
advance their ADC pipelines.
Forward-Looking Statements
This press release contains “forward-looking”
statements within the meaning of federal securities laws.
These forward-looking statements are not statements of historical
facts and are based on management’s beliefs and assumptions and on
information currently available to management. Forward-looking
statements include information concerning the Company’s business
strategy and the design, progression and timing of its clinical
trials. Forward-looking statements generally can be identified by
terms such as “anticipates,” “believes,” “could,” “seeks,”
“estimates,” “intends,” “may,” “plans,” “potential,” “predicts,”
“projects,” “should,” “will,” “would” or similar expressions and
the negatives of those terms. Forward-looking statements represent
management’s beliefs and assumptions only as of the date of this
press release. The Company’s operations involve risks and
uncertainties, many of which are outside its control, and any one
of which, or combination of which, could materially affect its
results of operations and whether the forward-looking statements
ultimately prove to be correct. Factors that may materially
affect the Company’s results of operations and whether these
forward-looking statements prove to be correct include, among other
things, that preclinical testing may not be predictive of the
results or success of ongoing or later preclinical or clinical
trials, that the development and testing of the Company’s product
candidates and new platforms will take longer and/or cost more than
planned and that the identification of new product candidates will
take longer than planned, as well as those listed in the Company’s
Annual Report on Form 10-K filed on March 8, 2019, with the
Securities and Exchange Commission (“SEC”) and subsequent SEC
filings. Except as required by law, the Company assumes no
obligation to update these forward-looking statements publicly, or
to update the reasons actual results could differ materially from
those anticipated in the forward-looking statements, even if new
information becomes available in the future.
Mersana Therapeutics,
Inc.Selected Condensed Consolidated Balance Sheet
Data(in
thousands)(unaudited)
|
|
|
|
|
March
31,2019 |
|
December
31,2018 |
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable
securities |
$ |
137,279 |
|
$ |
70,131 |
Working capital (1) |
|
|
|
|
118,478 |
|
|
4,880 |
Total assets |
|
|
|
|
149,388 |
|
|
78,502 |
Total stockholders' equity |
|
|
|
124,072 |
|
|
8,795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The Company defines working capital
as current assets less current liabilities. See the Company's
condensed consolidated financial statements for further detail
regarding its current assets and current liabilities. |
Mersana Therapeutics,
Inc.Condensed Consolidated Statement of
Operations(in thousands, except share and per
share data)(unaudited)
|
Three months
ended |
|
|
March
31, |
|
March
31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
41,035 |
|
$ |
3,064 |
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
15,143 |
|
|
12,256 |
|
|
General and administrative |
|
4,443 |
|
|
3,571 |
|
|
Total operating expenses |
|
19,586 |
|
|
15,827 |
|
|
Other income |
|
452 |
|
|
360 |
|
|
Net income (loss) |
$ |
21,901 |
|
$ |
(12,403 |
) |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
8 |
|
|
(13 |
) |
|
Comprehensive income (loss) |
$ |
21,909 |
|
$ |
(12,416 |
) |
|
|
Net income (loss) attributable
to commonstockholders — basic and diluted |
$ |
21,901 |
|
$ |
(12,403 |
) |
|
|
Net income (loss) per
share attributable tocommon stockholders — basic |
$ |
0.72 |
|
$ |
(0.54 |
) |
|
|
Net income (loss) per share
attributable tocommon stockholders — diluted |
$ |
0.70 |
|
$ |
(0.54 |
) |
|
|
Weighted-average number of
shares ofcommon stock used in net income (loss) pershare
attributable to common stockholders —basic |
|
30,299,650 |
|
|
22,816,521 |
|
|
|
Weighted-average number of
shares ofcommon stock used in net income (loss) pershare
attributable to common stockholders —diluted |
|
31,461,696 |
|
|
22,816,521 |
|
|
Contact:
Investor & Media Contact Sarah Carmody,
617-844-8577scarmody@mersana.com
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