Strategic Objectives, 2022 Accomplishments and Expected 2023
Milestones
On January 6, 2023, the
Company announced the following strategic objectives, 2022 accomplishments and expected 2023 milestones:
Strategic Objective: Establish Upifitamab
Rilsodotin (“UpRi”) as a Foundational Medicine in Ovarian Cancer
2022 Accomplishments
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Completed enrollment in UPLIFT, the company’s single-arm registrational trial of UpRi in platinum-resistant ovarian cancer |
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Initiated Phase 3 UP-NEXT clinical trial of UpRi as a maintenance monotherapy in recurrent platinum-sensitive ovarian cancer |
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Neared completion of dose escalation in Phase 1 UPGRADE-A trial of UpRi in combination with carboplatin in platinum-sensitive ovarian
cancer |
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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
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XMT-1660: Initiated multicenter Phase 1 clinical trial in patients with previously treated breast, endometrial and ovarian cancers |
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XMT-1660: Announced Fast Track designation for the treatment of adult patients with advanced or metastatic triple-negative breast cancer |
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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
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| · | XMT-2056: Initiate Phase 1 clinical trial in the first quarter of 2023 |
Strategic Objective: Position Mersana as
the Antibody-Drug Conjugate (“ADC”) Partner-of-Choice
2022 Accomplishments
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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: |
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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 |
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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 |
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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
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Pursue impactful new collaborations |
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Execute against existing collaboration agreements |
Additionally,
the Company announced that as of January 6, 2023, it expects that its available funds, together with the $30 million upfront payment due
to the Company from Merck KGaA, Darmstadt, Germany under the collaboration and license agreement referenced above, will be sufficient
to support the Company’s operating plan commitments into the second half of 2024.
Forward-Looking Statements
This Current Report on Form 8-K
(this “Report”) 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 Report include, but are not limited to, statements concerning the therapeutic potential of the Company’s product candidates;
the potential of the Company’s platforms and technology; the design, progression, timing and objectives of the Company’s clinical
trials and the release of data from those trials, including UPLIFT; the Company’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 the Company’s pipeline of ADC candidates; the Company’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 the Company’s collaboration and license agreements; the Company’s ability to realize
the benefits of existing collaborations and enter into new collaborations; and the Company’s strategic priorities and objectives.
The Company 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 the Company’s
product candidates; the risk that the Company 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 the Company’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 the Company’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 the Company’s collaborators fail to make any payments owed to
the Company; and other important factors, any of which could cause the Company’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 the Company’s
Quarterly Report on Form 10-Q filed with the SEC on November 7, 2022, as well as in other filings the Company may make with the
SEC in the future. Any forward-looking statements contained in this Report speak only as of the date hereof, and the Company 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.