Mersana Therapeutics Provides Business Update and Announces Strategic Objectives and Expected Milestones
January 06 2023 - 7:00AM
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 provided a business update
and announced strategic objectives and expected milestones for
2023.
“Following a year of tremendous accomplishment in 2022, we are
now approaching top-line data from our first registrational trial
of UpRi, which we believe will provide an opportunity to further
demonstrate Mersana’s increasing role as an ADC leader,” said Anna
Protopapas, President and Chief Executive Officer of Mersana
Therapeutics. “The data we expect to report from our UPLIFT
clinical trial in mid-2023 will represent the most significant
milestone to date in our effort to establish UpRi as a foundational
medicine for patients with ovarian cancer. Assuming positive data,
we plan to target the submission of a BLA around the end of 2023
and prepare for a potential U.S. commercial launch in 2024. We will
also continue to advance our UP-NEXT and UPGRADE-A trials of UpRi
in earlier lines of treatment.”
“Beyond UpRi, our efforts to expand the reach of all three of
our fully-scaled ADC platforms, each supported by substantial data,
will remain a central theme in 2023,” continued Ms. Protopapas. “We
will work aggressively to progress our two next-generation ADCs,
XMT-1660 and XMT-2056, in Phase 1 trials and establish proof-of
concept. Additionally, exploring new collaborations will remain a
core component of our strategy as we seek to build upon Mersana’s
recent business development successes.”
Strategic Objective: Establish UpRi as a Foundational
Medicine in Ovarian Cancer
2022 Accomplishments
- Completed enrollment in UPLIFT, the company’s single-arm
registrational trial of UpRi in platinum-resistant ovarian
cancer
- Initiated Phase 3 UP-NEXT clinical trial of UpRi as a
maintenance monotherapy in recurrent platinum-sensitive ovarian
cancer
- Neared completion of dose escalation in Phase 1 UPGRADE-A trial
of UpRi in combination with carboplatin in platinum-sensitive
ovarian cancer
- Announced that the European
Commission has designated UpRi as an orphan medicinal product for
the treatment of ovarian cancer
Expected Milestones
- Report top-line data from UPLIFT in mid-2023
- Assuming positive data, submit a biologics license application
(BLA) to the U.S. Food and Drug Administration (FDA) around the end
of 2023
- Prepare for potential U.S. accelerated approval and commercial
launch in 2024
- Significantly advance enrollment of UP-NEXT in 2023
- Initiate dose expansion portion of UPGRADE-A in the first
quarter of 2023 and report interim data from UPGRADE-A in the
second half of 2023
Strategic Objective: Advance Clinical-Stage
Pipeline
2022 Accomplishments
- XMT-1660: Initiated multicenter Phase 1 clinical trial in
patients with previously treated breast, endometrial and ovarian
cancers
- XMT-1660: Announced Fast Track designation for the treatment of
adult patients with advanced or metastatic triple-negative breast
cancer
- XMT-2056: Announced FDA orphan drug
designation for the treatment of gastric cancer
Expected Milestones
- XMT-1660: Complete dose escalation portion of Phase 1 clinical
trial in 2023
- XMT-2056: Initiate Phase 1 clinical trial in the first quarter
of 2023
Strategic Objective: Position Mersana as the ADC
Partner-of-Choice
2022 Accomplishments
- Entered into the following agreements that collectively
provided Mersana with $170 million in upfront payments and an
opportunity for more than $3 billion in milestones, plus royalties:
- An Immunosynthen research collaboration and license agreement
with Merck KGaA, Darmstadt, Germany for two targets, which
includes a $30 million upfront payment to Mersana and the potential
for up to $800 million in total potential milestones, plus tiered
royalties up to the low double-digits on net sales
- A collaboration, option and license agreement with
GlaxoSmithKline plc (GSK) for the co-development and
commercialization of XMT-2056, which provided Mersana with a $100
million upfront option purchase fee and the potential to receive up
to $1.36 billion in the form of an additional option exercise fee
and milestone payments, plus an option for Mersana to retain a U.S.
profit share and tiered royalties on net sales outside of the
United States or to receive tiered royalties up to the mid-twenties
on global net sales
- A Dolasynthen research collaboration
and license agreement with Janssen Biotech, Inc. for three targets,
which provided Mersana with a $40 million upfront payment and the
potential to receive over $1 billion in total potential milestones,
plus tiered royalties up to the low double-digits on net sales
Expected Milestones
- Pursue impactful new collaborations
- Execute against existing collaboration agreements
Financial Update
Mersana estimates that its cash, cash equivalents and marketable
securities as of December 31, 2022 were approximately $280 million.
This figure is preliminary and unaudited. The company expects to
report its audited cash, cash equivalents and marketable
securities, as well as other information necessary for a complete
understanding of its financial position, in its Annual Report on
Form 10-K for the year ended December 31, 2022. The company expects
that its available funds, together with the $30 million upfront
payment due from Merck KGaA, Darmstadt, Germany under the
collaboration and license agreement referenced above, will be
sufficient to support its operating plan commitments into the
second half of 2024.
About Mersana TherapeuticsMersana Therapeutics
is a clinical-stage biopharmaceutical company using its
differentiated and proprietary ADC platforms to rapidly develop
novel ADCs with optimal efficacy, safety and tolerability to
meaningfully improve the lives of people fighting cancer. Mersana’s
lead product candidate, upifitamab rilsodotin (UpRi), is a
Dolaflexin ADC targeting NaPi2b that is being studied in UPLIFT, a
single-arm registrational trial in patients with platinum-resistant
ovarian cancer; UPGRADE-A, a Phase 1 clinical trial evaluating UpRi
in combination with carboplatin; and UP-NEXT, a Phase 3 clinical
trial of UpRi as monotherapy maintenance following treatment with
platinum doublets in recurrent platinum-sensitive ovarian cancer.
Mersana is also advancing XMT-1660, a Dolasynthen ADC targeting
B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope
of human epidermal growth factor receptor 2 (HER2), in addition to
other earlier-stage assets. In addition, multiple partners are
using Mersana’s platforms to advance their ADC pipelines. Mersana
routinely posts information that may be useful to investors on the
“Investors & Media” section of its website at
www.mersana.com.
Forward-Looking StatementsThis press release
contains “forward-looking” statements and information within the
meaning of the Private Securities Litigation Reform Act of 1995.
These statements may be identified by words such as “aims,”
“anticipates,” “believes,” “could,” “estimates,” “expects,”
“forecasts,” “goal,” “intends,” “may,” “plans,” “possible,”
“potential,” “seeks,” “will” and variations of these words or
similar expressions, although not all forward-looking statements
contain these words. Forward-looking statements in this press
release include, but are not limited to, statements concerning the
therapeutic potential of Mersana’s product candidates; the
potential of Mersana’s platforms and technology; the design,
progression, timing and objectives of Mersana’s clinical trials and
the release of data from those trials, including UPLIFT; Mersana’s
potential BLA submission for UpRi and, if approved, potential U.S.
commercial launch of UpRi; the ability of trial results to support
marketing approvals, including accelerated approval, or other
objectives; the development and potential of Mersana’s pipeline of
ADC candidates; Mersana’s expected cash runway; the receipt of a
$30 million upfront payment from Merck KGaA, Darmstadt, Germany;
potential option exercise, milestone, royalty and/or profit-sharing
revenues under Mersana’s collaboration and license agreements;
Mersana’s ability to realize the benefits of existing
collaborations and enter into new collaborations; and Mersana’s
strategic priorities and objectives. Mersana may not actually
achieve the plans, intentions or expectations disclosed in these
forward-looking statements, and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions and expectations
disclosed in these forward-looking statements as a result of
various factors, including, among other things, uncertainties
inherent in research and development, in the initiation and
advancement of clinical trials and in the clinical development of
Mersana’s product candidates; the risk that Mersana may not realize
the intended benefits of its platforms, technology and
collaborations; whether the outcomes of preclinical studies will be
predictive of clinical trial results; whether initial or interim
results from a clinical trial will be predictive of the final
results of the trial or the results of future trials; the risk that
clinical trial data may not support regulatory applications or
approvals; risks to clinical trial site initiation, patient
enrollment and follow-up, as well as to Mersana’s and its
collaborators’ abilities to meet other anticipated deadlines and
milestones, whether presented by the ongoing COVID-19 pandemic or
otherwise; the risk that Mersana’s projections regarding its
expected cash runway are inaccurate or that the conduct of its
business requires more cash than anticipated; the risk that any of
Mersana’s collaborators fail to make any payments owed to Mersana;
and other important factors, any of which could cause Mersana’s
actual results to differ from those contained in the
forward-looking statements, that are described in greater detail in
the section entitled “Risk Factors” in Mersana’s Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission
(“SEC”) on November 7, 2022, as well as in other filings Mersana
may make with the SEC in the future. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Mersana expressly disclaims any obligation to update any
forward-looking statements contained herein, whether because of any
new information, future events, changed circumstances or otherwise,
except as otherwise required by law.
Contact:Jason Fredette
617-498-0020jason.fredette@mersana.com
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