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 provided a business update for the fourth quarter and full year
ended December 31, 2021.
“We are executing on a differentiated UpRi
development plan with the potential for a BLA submission in 2023
based on UPLIFT data, and we are progressing further development
into earlier lines of therapy with UP-NEXT and UPGRADE, all in
support of our goal of building UpRi into a foundational therapy in
ovarian cancer. Leveraging our three innovative platforms, the
advancement of XMT-2056, XMT-1660 and XMT-1592 provides additional
opportunities to have a meaningful impact on patient outcomes. Our
recently announced Janssen partnership further validates our
differentiated Dolasynthen platform and highlights the strategic
importance placed by major oncology players on ADC innovation,”
said Anna Protopapas, President and Chief Executive Officer of
Mersana Therapeutics. “With our enhanced capital position and
meaningful clinical progress, we stand well positioned for the
future, as we strive to transform Mersana into a commercial stage
company with a deep pipeline of first in class molecules.”
Recent Highlights and Anticipated
Milestones
Upifitamab Rilsodotin (UpRi), first-in-class
Dolaflexin ADC targeting NaPi2b:
- Analysis
from expansion cohort of UpRi Phase 1 trial accepted for oral
presentation at Society of Gynecologic Oncology (SGO) Annual
Meeting on Women’s Cancer on March 19, 2022. The Company
plans to present further detail of its analysis of almost 100
patients with ovarian cancer from the June 10th, 2021 data cut
(previously disclosed in September 2021) which supported the
decision to select 36 mg/m2 as the recommended Phase 2 dose for
UPLIFT.
- UPLIFT, a single-arm
registration trial in platinum-resistant ovarian cancer, remains on
track to complete enrollment during 3Q 2022. UPLIFT is
enrolling a broader population of patients with platinum-resistant
ovarian cancer than other studies in this indication through more
flexible inclusion criteria with respect to lines of therapy and
underlying comorbidities. UPLIFT utilizes our novel diagnostic
assay to identify patients with NaPi2b high expressing tumors,
which we believe to represent two thirds of ovarian cancer
patients. UPLIFT’s primary endpoint will evaluate efficacy in the
NaPi2b high population, and the secondary endpoint will evaluate
efficacy in the overall population. The Company plans to enroll
approximately 100 patients with high NaPi2b expression and up to
180 patients overall.
- UP-NEXT, a Phase 3 trial of
UpRi monotherapy maintenance, informed by FDA and CHMP feedback,
expected to initiate enrollment in 2Q 2022. UP-NEXT has
the potential to serve as a confirmatory trial, and support global
registrations, positioning UpRi as the potential next novel
targeted agent, and the first ADC, to launch into the platinum
sensitive space. UP-NEXT will evaluate UpRi as a maintenance agent
following treatment with platinum doublets in recurrent
platinum-sensitive ovarian cancer. Watch-and-wait remains the
standard of care for patients who have previously received or are
poorly served by existing maintenance agents, as well as patients
who achieve only stable disease after receiving platinum doublet
therapies. UP-NEXT is designed to provide data to address these
unmet needs.
- UPGRADE, the Company’s
Phase 1/2 combination umbrella trial, is currently in dose
escalation and remains on track to disclose interim data during 2H
2022. The dose escalation portion of this trial is
intended to determine the recommended Phase 2 dose of UpRi in
combination with carboplatin. The expansion portion of the trial is
intended to provide proof of concept for a potential new standard
of care for platinum-sensitive ovarian cancer, earlier in the
disease by demonstrating that the combination of UpRi with platinum
followed by UpRi monotherapy continuation could result in improved
efficacy and tolerability with the ultimate goal of improving
clinical benefit for patients. UPGRADE will inform further
development of UpRi in this broader and earlier line patient
population.
XMT-1592, first Dolasynthen ADC targeting
NaPi2b:
- XMT-1592, a Dolasynthen ADC
targeting NaPi2b, continues in dose exploration. The
Company plans to provide an update on next steps for XMT-1592,
which is currently in Phase 1 dose exploration, in the second half
of 2022. XMT-1592 was designed to provide Mersana with a second
shot on goal in non-small cell lung cancer adenocarcinoma based on
the differentiated preclinical data in this indication.
XMT-1660, Dolasynthen ADC targeting B7-H4:
- Investigational New Drug
(IND)-enabling studies of XMT-1660 progressing with Phase 1 trial
expected to start in mid-2022. B7-H4 is expressed in high
unmet need tumors such as breast, endometrial and ovarian cancers
and is expressed on both tumor cells and immunosuppressive
tumor-associated macrophages (TAMs). Targeting this antigen
provides the potential for both a direct, cytotoxic antitumor
effect as well as delivering additional payload directly to the
tumor microenvironment. The Company conducted preclinical
drug-to-antibody-ratio (DAR) ranging studies and compared XMT-1660
to other B7-H4 ADCs with different DARs and found that XMT-1660
DAR-6 consistently outperformed these other ADCs in in vivo models
and demonstrated a favorable pharmacokinetic and tolerability
profile in mice and non-human primates.
XMT-2056, the Company’s first
Immunosynthen STING-agonist ADC targeting HER2:
- IND-enabling studies of
XMT-2056 progressing with Phase 1 trial expected to start in
mid-2022. In vitro and in vivo studies demonstrate that
Immunosynthen STING-agonist ADCs activate the STING pathway in both
tumor-resident immune cells and tumor cells, offering the potential
for an increased therapeutic index and an advantage over other
innate immune activating pathways. The Company developed XMT-2056
based on its differentiated anti-HER2 antibody that binds to a
novel epitope, providing the opportunity for both monotherapy and
combinations with well-established anti-HER2 therapies. In both
high and low HER2 models, XMT-2056 monotherapy demonstrated
increased efficacy in comparison to benchmark agents such as a
trastuzumab-TLR7/8 agonist ADC as well as a small molecule
systemically-administered STING agonist. XMT-2056 was generally
well-tolerated in non-human primate studies with no clinical signs
and no adverse findings in clinical pathology or histopathology
after single and repeat IV doses.
Strategic Partnerships:
- Collaboration with Janssen
leverages Mersana’s ADC expertise and innovative Dolasynthen
platform and further enhances financial position. In
February, the Company announced a research collaboration and
license agreement with Janssen Biotech, Inc. to discover novel ADCs
for up to three targets by leveraging Mersana’s ADC expertise and
the Dolasynthen platform with Janssen’s antibodies. As part of the
agreement, Mersana received $40 million in an upfront payment with
the potential for more than $1 billion in total milestone payments
and mid-single-digit to low double-digit percentage royalties on
future net sales.
Strengthened Financial Position:
- Entered into a new line of
credit for increased financial flexibility. In October
2021, the Company entered into a new credit facility for up to $100
million with Oxford Finance LLC (Oxford) and Silicon Valley Bank
(SVB), drawing $25 million at signing. An additional $35 million is
available at the Company’s option, with the remaining balance
available primarily upon achievement of certain pipeline and UpRi
development milestones. In connection with this new facility, the
Company retired the prior debt financing agreement with Silicon
Valley Bank.
- Raised $45.6 million from
At-The-Market (ATM) facility in Q1 2022 with significant
participation from existing long-term investors.
- The Company believes its
current cash and cash equivalents plus available borrowing under
its line of credit will be sufficient to fund its current operating
plan commitments into the second half of 2023. As of
December 31, 2021, the Company had cash and cash equivalents of
$177.9 million and subsequently received a $40 million upfront
payment under the Janssen collaboration agreement and $45.6 million
of net proceeds from sales of the Company’s common stock under its
ATM. In addition, the Company currently has the option to borrow
$35 million under the new line of credit with Oxford &
SVB.
Upcoming Events
- Mersana plans to participate in a
corporate panel discussion on ovarian cancer at the Cowen 42nd
Annual Health Care Conference scheduled for March 9, 2022.
- Mersana plans to present at the SGO
Annual Meeting on Women’s Cancer (Society of Gynecologic Oncology)
on March 19, 2022.
Fourth Quarter 2021 Financial
Results
- Net cash used in operating
activities in the fourth quarter of 2021 was $42.4 million.
- Research and development expenses
for the fourth quarter of 2021 were $37.4 million, compared to
$22.9 million for the same period in 2020. The difference was
primarily due to an increase in manufacturing and clinical costs on
the UpRi program, an increase in headcount and an increase in
research and manufacturing costs on preclinical programs. Non-cash
stock-based compensation expense included in these research and
development expenses was $2.6 million.
- General and administrative expenses
for the fourth quarter of 2021 were $10.7 million, compared to $5.9
million during the same period in 2020 primarily due to an increase
in headcount and consulting and professional fees. Non-cash
stock-based compensation expense included in these general and
administrative expenses was $2.3 million.
- Net loss for the fourth quarter of
2021 was $49.0 million, or $0.68 per share, compared to net loss of
$28.8 million, or $0.42 per share, for the same period in 2020.
Weighted average common shares outstanding for the quarter ended
December 31, 2021, and December 31, 2020, were 71,921,322 and
68,630,078, respectively.
Full Year 2021 Financial
Results
- Research and development expenses
for the full year 2021 were $132.0 million, compared to $67.0
million for the full year 2020. The difference was primarily due to
an increase in manufacturing and clinical development activities,
an increase related to preclinical and discovery stage programs,
and an increase in headcount. Non-cash stock-based compensation
expense included in these research and development expenses was
$10.0 million.
- General and administrative expenses
for the full year 2021 were $36.9 million, compared to $21.9
million during the full year 2020. The difference was primarily due
to an increase in headcount and consulting and professional fees.
Non-cash stock-based compensation expense included in these general
and administrative expenses was $8.4 million.
- Net loss for the full year 2021 was
$170.1 million, or $2.41 per share, compared to net loss of $88.0
million, or $1.43 per share, for the full year 2020. Weighted
average common shares outstanding for the periods ended December
31, 2021, and December 31, 2020, were 70,580,949 and 61,485,205,
respectively.
- Cash and cash equivalents as of
December 31, 2021, were $177.9 million, compared to $255.1 million
in cash and cash equivalents as of December 31, 2020.
Conference Call Details
Mersana Therapeutics will host a conference call
today at 8:00 a.m. ET to report financial results for the fourth
quarter and full year 2021 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 7999454.
A live webcast of the presentation will be available on the
Investors & Media section of the Mersana website at
www.mersana.com.
About Mersana Therapeutics
Mersana 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 and is
being studied in UPLIFT, a single-arm registrational trial in
patients with platinum-resistant ovarian cancer, as well as in
UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi in combination
with other ovarian cancer therapies. XMT-1592, Mersana’s second ADC
product candidate targeting NaPi2b-expressing tumors, was created
using Mersana’s customizable and homogeneous Dolasynthen platform
and is in the dose exploration portion of a Phase 1 clinical trial.
The Company’s early-stage programs include XMT-1660, a Dolasynthen
ADC targeting B7-H4, as well as XMT-2056, a STING-agonist ADC
developed using the Company’s Immunosynthen platform and targeting
a novel epitope of human epidermal growth factor receptor 2 (HER2).
In addition, multiple partners are using Mersana’s platforms to
advance their ADC pipelines. Mersana Therapeutics was recently
named among the 2021 Top Places to Work in Massachusetts by the
Boston Globe. The Company routinely posts information that may be
useful to investors on the “Investors and Media” section of our
website at www.mersana.com.
Forward-Looking Statements
This press release
contains “forward-looking” statements and information within the
meaning of The Private Securities Litigation Reform Act of 1995.
These forward-looking statements are not statements of historical
facts and are based on management’s beliefs and assumptions.
Forward-looking statements in this press release include statements
concerning the Company’s business strategy and the design,
progression and timing of its clinical trials or preclinical
studies and the release of data from those studies, the completion
of enrollment in the UPLIFT trial, the development and potential of
our pipeline of innovative ADC candidates, expectations regarding
future clinical trial results, including with respect to the timing
of the commencement and future disclosures, and the sufficiency of
the Company’s cash on hand and funds available through its debt
financing agreement with Oxford Finance and Silicon Valley Bank.
Forward-looking statements generally can be identified by terms
such as “aims,” “anticipates,” “believes,” “contemplates,”
“continues,” “could,” “designed to,” “estimates,” “expects,”
“goal,” “intends,” “may,” “on track,” “opportunity,” “plans,”
“poised for,” “possible,” “potential,” “predicts,” “projects,”
“promises to be,” “seeks,” “should,” “strategy,” “target,” “will,”
“would” or similar expressions and the negatives of those terms.
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, that the results of the Company’s ongoing or future
clinical trials may be inconclusive with respect to the efficacy of
the Company’s product candidates, that the Company may not meet
clinical endpoints with statistical significance or there may be
safety concerns or adverse events associated with its product
candidates, that preclinical testing or early clinical results may
not be predictive of the results or success of ongoing or later
preclinical studies or clinical trials, that the identification,
development and testing of the Company’s product candidates and new
platforms will take longer and/or cost more than planned,
availability of funding sufficient for the Company’s foreseeable
and unforeseeable operating expenses and capital expenditure
requirements, and that the Company’s clinical trials may not be
initiated or completed on schedule, if at all, as well as those
listed in the Company’s Quarterly Report on Form 10-Q filed on
November 9, 2021, with the Securities and Exchange Commission
(“SEC”), and subsequent SEC filings that the Company may make in
the future.
Mersana Therapeutics,
Inc.Selected Condensed Consolidated Balance Sheet
Data(in
thousands)(unaudited)
|
December 31,2021 |
|
December 31,2020 |
|
|
|
|
Cash and cash equivalents |
$ |
177,947 |
|
|
$ |
255,094 |
|
Working capital(1) |
141,375 |
|
|
228,577 |
|
Total assets |
206,111 |
|
|
273,399 |
|
Total stockholders'
equity |
121,741 |
|
|
228,087 |
|
|
|
|
|
(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 |
|
Year ended |
|
December 31,2021 |
|
December 31,2020 |
|
December 31,2021 |
|
December 31,2020 |
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
11 |
|
|
$ |
10 |
|
|
$ |
43 |
|
|
$ |
828 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
37,368 |
|
|
22,858 |
|
|
132,013 |
|
|
67,036 |
|
General and administrative |
10,674 |
|
|
5,914 |
|
|
36,888 |
|
|
21,902 |
|
Total operating expenses |
48,042 |
|
|
28,722 |
|
|
168,901 |
|
|
88,938 |
|
Total other income (expense),
net |
(952 |
) |
|
(82 |
) |
|
(1,202 |
) |
|
65 |
|
Net loss |
$ |
(48,983 |
) |
|
$ |
(28,844 |
) |
|
$ |
(170,060 |
) |
|
$ |
(88,045 |
) |
Net loss per
share attributable to common stockholders — basic and
diluted |
$ |
(0.68 |
) |
|
$ |
(0.42 |
) |
|
$ |
(2.41 |
) |
|
$ |
(1.43 |
) |
Weighted-average number of
common shares used in net loss per share attributable to common
stockholders — basic and diluted |
71,921,322 |
|
|
68,630,078 |
|
|
70,580,949 |
|
|
61,485,205 |
|
Contact:Investor & Media ContactJames
Salierno, 617-498-0020jsalierno@mersana.com
Mersana Therapeutics (NASDAQ:MRSN)
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