Mersana Therapeutics Provides Business Update and Announces Third Quarter 2023 Financial Results
07 November 2023 - 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 third quarter ended
September 30, 2023.
“Our team has made considerable progress on multiple fronts in
recent months as we seek to demonstrate the clinical potential of
our next-generation ADC platforms,” said Martin Huber, M.D.,
President and Chief Executive Officer of Mersana Therapeutics.
“With recent clinical presentations at the European Society of
Medical Oncology (ESMO) Congress 2023 affirming B7-H4 as an
intriguing oncology target, we are advancing XMT-1660 in Phase 1
dose escalation with plans to initiate dose expansion in 2024.
Additionally, we are now preparing to resume enrollment in our
Phase 1 clinical trial of XMT-2056, a novel HER2-directed
STING-agonist ADC product candidate. We believe this progress and
the actions we have taken to right-size the company provide an
exciting opportunity to advance our clinical assets to their next
milestones.”
Mersana’s Recent Activities and Strategic
Priorities
Advance XMT-1660 and Mersana’s Dolasynthen
Platform: Dolasynthen is Mersana’s next-generation
cytotoxic ADC platform that is designed to generate site-specific,
homogeneous ADCs, utilizes a proprietary auristatin payload and has
the ability to match the drug-to-antibody ratio (DAR) to specific
targets. The company is currently advancing a Phase 1 trial of
XMT-1660, a B7-H4-directed Dolasynthen ADC with a precise,
target-optimized DAR 6, and it has begun to enroll patients in
backfill cohorts at clinically relevant doses as part of the dose
escalation design. Mersana expects to complete the dose escalation
portion of this Phase 1 clinical trial by the end of 2023 and
initiate the dose expansion portion of the trial in 2024.
Additionally, Mersana is supporting Janssen Biotech, Inc. under a
collaboration and license agreement focused on discovering novel
Dolasynthen ADCs for up to three targets. In the third quarter of
2023, Mersana received $6 million in milestone payments from this
agreement.
Advance XMT-2056 and Mersana’s Immunosynthen
Platform: Immunosynthen is Mersana’s proprietary
STING-agonist platform that is designed to generate systemically
administered ADCs that locally activate STING signaling in both
tumor-resident immune cells and in antigen-expressing cells to
unlock the anti-tumor potential of innate immune stimulation.
Mersana recently announced the lifting of the U.S. Food and Drug
Administration’s clinical hold on the Phase 1 clinical trial of
XMT-2056, the company's lead Immunosynthen ADC candidate that
targets a novel HER2 epitope, and work is now underway to resume
enrollment in the trial. In August 2022, Mersana entered into a
global collaboration providing GSK plc with an exclusive option to
co-develop and commercialize XMT-2056. GSK has not exercised this
option to date. Additionally, Mersana is supporting Merck KGaA,
Darmstadt, Germany under a collaboration and license agreement that
focuses on discovering novel Immunosynthen ADCs for up to two
targets.
UPLIFT Data Analysis
In the third quarter of 2023, the company reported top-line data
from UPLIFT, its Phase 2 clinical trial of upifitamab rilsodotin
(UpRi), that showed the trial did not meet its primary endpoint.
UpRi is an ADC targeting the sodium-dependent phosphate transport
protein NaPi2b that was developed utilizing the company’s
first-generation Dolaflexin platform. Mersana is completing its
analysis of UPLIFT results and plans to share detailed efficacy and
safety data with the medical and scientific community in the first
half of 2024.
Third Quarter 2023 Financial Results
- Net cash used in operating
activities for the third quarter of 2023 was $46.1 million.
- Cash, cash equivalents and
marketable securities as of September 30, 2023 were $241.0 million,
compared to $280.7 million as of December 31, 2022. Mersana expects
that its available funds will be sufficient to support its current
operating plan commitments into 2026.
- Collaboration revenue for the third
quarter of 2023 was $7.7 million, compared to $5.6 million for the
same period in 2022. The year-over-year increase was primarily
related to Mersana’s collaboration agreement with Merck KGaA,
Darmstadt, Germany.
- Research and development (R&D)
expenses for the third quarter of 2023 were $30.5 million, compared
to $50.6 million for the same period in 2022. The decline in
R&D expenses was primarily related to reduced manufacturing and
clinical costs related to UpRi and XMT-2056 and reduced employee
compensation. Included in third quarter 2023 R&D expenses were
$2.2 million in non-cash stock-based compensation expenses.
- General and administrative (G&A)
expenses for the third quarter of 2023 were $12.9 million, compared
to $14.6 million during the same period in 2022. The year-over-year
decline in G&A expenses was primarily related to reduced
consulting and professional services fees and reduced employee
compensation. Included in third quarter 2023 G&A expenses were
$1.8 million in non-cash stock-based compensation expenses.
- Mersana incurred $8.2 million in
restructuring expenses for the third quarter of 2023 related
primarily to severance-related costs and contract termination
expenses.
- Net loss for the third quarter of 2023 was $41.7 million, or
$0.35 per share, compared to a net loss of $59.8 million, or $0.61
per share, for the same period in 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 third quarter 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;
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 occurrence of
impediments to Mersana’s ability to execute its planned
restructuring and strategic reprioritization as currently
contemplated; the risk that restructuring expenses may be higher
than expected; 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 August
8, 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)
|
September 30,2023 |
|
December 31, 2022 |
|
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
240,986 |
|
|
$ |
280,712 |
|
Working capital(1) |
181,805 |
|
|
227,686 |
|
Total assets |
262,904 |
|
|
334,340 |
|
Total stockholders'
equity |
52,195 |
|
|
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 |
|
Nine months ended |
|
September 30,2023 |
|
September 30,2022 |
|
September 30,2023 |
|
September 30,2022 |
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
7,698 |
|
|
|
$ |
5,573 |
|
|
|
$ |
26,154 |
|
|
|
$ |
11,893 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
30,531 |
|
|
|
50,639 |
|
|
|
126,774 |
|
|
|
127,676 |
|
|
General and administrative |
12,894 |
|
|
|
14,573 |
|
|
|
49,409 |
|
|
|
42,158 |
|
|
Restructuring expenses |
8,214 |
|
|
|
— |
|
|
|
8,214 |
|
|
|
— |
|
|
Total operating expenses |
51,639 |
|
|
|
65,212 |
|
|
|
184,397 |
|
|
|
169,834 |
|
|
Total other income (expense),
net |
2,285 |
|
|
|
(172 |
) |
|
|
6,117 |
|
|
|
(1,347 |
) |
|
Net loss |
|
(41,656 |
) |
|
|
|
(59,811 |
) |
|
|
|
(152,126 |
) |
|
|
|
(159,288 |
) |
|
Net loss per share — basic and
diluted |
$ |
(0.35 |
) |
|
|
$ |
(0.61 |
) |
|
|
$ |
(1.33 |
) |
|
|
$ |
(1.75 |
) |
|
Weighted-average number of
common shares — basic and diluted |
120,521,985 |
|
|
|
97,641,936 |
|
|
|
114,595,910 |
|
|
|
91,173,989 |
|
|
Contact:Jason Fredette
617-498-0020jason.fredette@mersana.com
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