Mersana Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2023 Financial Results
28 Febbraio 2024 - 1:00PM
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 reported financial results for the fourth quarter and full year
ended December 31, 2023.
“Mersana’s unwavering commitment to payload and platform
innovation has enabled us to enter 2024 with differentiated
clinical-stage ADC product candidates, a strong balance sheet and
forward momentum,” said Martin Huber, M.D., President and Chief
Executive Officer of Mersana Therapeutics. “We have made progress
in the dose escalation portion of our Phase 1 clinical trial of
XMT-1660 while also enrolling patients in backfill cohorts at
multiple clinically relevant dose levels, setting the stage for our
planned initial clinical data disclosure for this candidate in
mid-2024. Over the course of this year, we also look forward to
advancing dose escalation in our Phase 1 clinical trial of XMT-2056
as well as our collaborations with Johnson & Johnson and Merck
KGaA.”
Mersana’s Strategic Priorities and Expected
Milestones
XMT-1660: Mersana continues to advance its
Phase 1 clinical trial of XMT-1660, the company’s lead Dolasynthen
ADC candidate targeting B7-H4. The dose escalation portion of the
trial is ongoing, with the company having recently escalated to a
dose of 59 milligrams per meter squared. A maximum tolerated dose
has not yet been established. In addition to continuing to escalate
dosing, the company also is enrolling patients in backfill cohorts
to optimize dose and schedule. Mersana plans to initiate
tumor-specific expansion cohorts in the second quarter of 2024 and
expects to share initial dose escalation and backfill cohort data
in mid-2024.
XMT-2056: Mersana is restarting its Phase 1
clinical trial of XMT-2056, the company's lead Immunosynthen ADC
candidate targeting a novel HER2 epitope. In the fourth quarter,
the company announced the lifting of a clinical hold on the Phase 1
clinical trial of XMT-2056 by the U.S. Food and Drug
Administration. Mersana plans to advance dose escalation of this
wholly owned product candidate in 2024. GSK plc has an exclusive
global license option to co-develop and commercialize XMT-2056.
Collaborations: Mersana continues to advance
its Johnson & Johnson (formerly known as Janssen) and Merck
KGaA, Darmstadt, Germany collaborations. The Johnson & Johnson
collaboration and license agreement focuses on the discovery of
novel Dolasynthen ADCs for up to three targets. The Merck KGaA,
Darmstadt, Germany collaboration and license agreement focuses on
the discovery of novel Immunosynthen ADCs for up to two
targets.
Additional Upcoming Data Presentations: At the
European Society of Gynaecological Oncology (ESGO) 2024 Congress
from March 7-10, 2024 in Barcelona, Spain, clinical data will be
presented for Mersana’s two discontinued NaPi2b ADC product
candidates: XMT-1536 (UpRi), which was developed using the
company’s first-generation Dolaflexin ADC platform, and XMT-1592,
which was developed using the company’s next-generation Dolasynthen
ADC platform.
Fourth Quarter 2023 Financial Results
- Cash, cash equivalents and
marketable securities as of December 31, 2023 were $209.1 million.
Mersana continues to expect that its capital resources will be
sufficient to support its current operating plan commitments into
2026.
- Net cash used in operating
activities for the fourth quarter of 2023 was $32.0 million.
- Collaboration revenue for the fourth
quarter of 2023 was $10.7 million, compared to $14.7 million for
the same period in 2022. The year-over-year change was primarily
related to the timing of research activities for the company’s
Johnson & Johnson collaboration and achievement of an early
Johnson & Johnson development milestone in the fourth quarter
of 2022.
- Research and development (R&D)
expenses for the fourth quarter of 2023 were $21.5 million,
compared to $45.7 million for the same period in 2022. Included in
the fourth quarter of 2023 R&D expenses were $2.2 million in
non-cash stock-based compensation expenses and $3.7 million of
external costs related to the wind-down of UpRi-related development
activities. The year-over-year decline in R&D expenses was
primarily related to reduced manufacturing and clinical costs
related to UpRi and XMT-2056 and reduced employee compensation
costs, partially offset by increased clinical costs related to
XMT-1660.
- General and administrative (G&A)
expenses for the fourth quarter of 2023 were $10.1 million,
compared to $14.8 million during the same period in 2022. Included
in the fourth quarter of 2023 G&A expenses were $1.9 million in
non-cash stock-based compensation expenses. The year-over-year
decline in G&A expenses was primarily related to reduced
consulting and professional services fees and reduced employee
compensation as a result of the restructuring plan announced by the
company in July 2023.
- Net loss for the fourth quarter of 2023 was $19.5 million, or
$0.16 per share, compared to a net loss of $44.9 million, or $0.44
per share, for the same period in 2022.
Full Year 2023 Financial Results
- Net cash used in operating
activities for full year 2023 was $168.9 million.
- Collaboration revenue for the full
year 2023 was $36.9 million, compared to $26.6 million for 2022.
The year-over-year increase was primarily related to increased
collaboration revenue recognized under the company’s Merck KGaA
agreements and early development milestones achieved under its
Johnson & Johnson agreement, partially offset by the timing of
research activities under the Johnson & Johnson agreement.
- R&D expenses for the full year
2023 were $148.3 million, compared to $173.4 million for the full
year 2022. Included in 2023 R&D expenses were $11.0 million in
non-cash stock-based compensation expenses. The decline in R&D
expenses was primarily related to reduced manufacturing and
clinical costs related to UpRi and XMT-2056 and manufacturing costs
for the company’s Dolasynthen platform, partially offset by
increased clinical costs related to XMT-1660.
- G&A expenses for the full year
2023 were $59.5 million, compared to $57.0 million for the full
year 2022. Included in 2023 G&A expenses were $10.1 million in
non-cash stock-based compensation expenses. The year-over-year
change in G&A expenses was primarily related to increased
headcount in the first half of 2023 prior to the restructuring that
was initiated in July 2023.
- Mersana incurred $8.7 million in
restructuring expenses in the second half of 2023 related primarily
to severance-related costs and contract termination expenses.
- Net loss for the full year 2023 was $171.7 million, or $1.48
per share, compared to a net loss of $204.2 million, or $2.18 per
share, for the full year 2022.
Conference Call ReminderMersana will host a
conference call today at 8:00 a.m. ET to discuss business updates
and its financial results for the fourth quarter and full year of
2023. To access the call, please dial 877-270-2148 (domestic) or
412-902-6510 (international). A live webcast of the presentation
will be available on the Investors & Media section of the
Mersana website at www.mersana.com, and a replay of the webcast
will be available in the same location following the conference
call for approximately 90 days.
About Mersana TherapeuticsMersana Therapeutics
is a clinical-stage biopharmaceutical company focused on the
development of novel antibody-drug conjugates (ADCs) and driven by
the knowledge that patients are waiting for new treatment options.
The company has developed proprietary cytotoxic (Dolasynthen) and
immunostimulatory (Immunosynthen) ADC platforms that are generating
a pipeline of wholly-owned and partnered product candidates with
the potential to treat a range of cancers. Its pipeline includes
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). 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
Mersana’s strategic priorities; its plans regarding the clinical
development of XMT-1660 and XMT-2056, including with respect to the
resumption of Mersana’s Phase 1 clinical trial of XMT-2056 and the
progress and design of the clinical trials of these product
candidates; Mersana’s planned data presentations, including with
respect to its Phase 1 clinical trial of XMT-1660; Mersana’s cash
runway; Mersana’s collaborations with third parties; and the
development and potential of Mersana’s product candidates,
platforms, technology and pipeline of ADC candidates. 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
advancement, progression and completion of clinical trials and in
the clinical development of Mersana’s product candidates, including
XMT-1660 and XMT-2056; the risk that Mersana may face delays in
resuming its Phase 1 clinical trial of XMT-2056; the risk that
Mersana may not realize the intended benefits of its platforms,
technology and collaborations; 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, 2023, 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.
|
Mersana Therapeutics, Inc.Selected
Condensed Consolidated Balance Sheet Data(in
thousands and unaudited) |
|
|
December 31,2023 |
|
December 31,2022 |
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
209,084 |
|
$ |
280,712 |
Working capital(1) |
|
150,420 |
|
|
227,686 |
Total assets |
|
226,060 |
|
|
334,340 |
Total stockholders'
equity |
|
36,904 |
|
|
92,057 |
|
|
|
|
(1) The company
defines working capital as current assets less current
liabilities. |
|
Mersana Therapeutics, Inc.Condensed
Consolidated Statement of Operations(in thousands,
except share and per share data, and unaudited) |
|
|
Three months ended |
|
Year ended |
|
December 31,2023 |
|
December 31,2022 |
|
December 31,2023 |
|
December 31,2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
10,701 |
|
|
$ |
14,688 |
|
|
$ |
36,855 |
|
|
$ |
26,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
21,495 |
|
|
|
45,709 |
|
|
|
148,269 |
|
|
|
173,385 |
|
General and
administrative |
|
10,134 |
|
|
|
14,805 |
|
|
|
59,543 |
|
|
|
56,963 |
|
Restructuring expenses |
|
499 |
|
|
|
— |
|
|
|
8,713 |
|
|
|
— |
|
Total operating expenses |
|
32,128 |
|
|
|
60,514 |
|
|
|
216,525 |
|
|
|
230,348 |
|
Total other income (expense),
net |
|
1,883 |
|
|
|
902 |
|
|
|
8,000 |
|
|
|
(445 |
) |
Net loss |
$ |
(19,544 |
) |
|
$ |
(44,924 |
) |
|
$ |
(171,670 |
) |
|
$ |
(204,212 |
) |
Net loss per share — basic and
diluted |
$ |
(0.16 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.48 |
) |
|
$ |
(2.18 |
) |
Weighted-average number of
common shares — basic and diluted |
|
120,614,350 |
|
|
|
101,014,142 |
|
|
|
116,112,891 |
|
|
|
93,654,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:Jason
Fredette617-498-0020jason.fredette@mersana.com
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