UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2018
MERSANA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-38129 |
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04-3562403 |
(State or other jurisdiction of |
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(Commission File Number) |
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(IRS Employer |
840 Memorial Drive |
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Cambridge, MA |
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02139 |
(Address of principal executive offices) |
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(Zip Code) |
(Registrants telephone number, including area code): (617) 498-0020
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 2.02 Results of Operations and Financial Condition.
On May 14, 2018, Mersana Therapeutics, Inc., issued a press release announcing its financial results for the quarter ended March 31, 2018. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press Release issued by Mersana Therapeutics, Inc., on May 14, 2018. |
EXHIBIT INDEX
No. |
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Description |
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99.1 |
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Press Release issued by Mersana Therapeutics, Inc., on May 14, 2018. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MERSANA THERAPEUTICS, INC. | |
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By: |
/s/ Anna Protopapas |
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Anna Protopapas |
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President and Chief Executive Officer |
Date: May 14, 2018
Mersana Therapeutics Announces First Quarter 2018 Financial Results and Provides Business Updates
Phase 1 Dose Escalation Trials Progressing for Lead Programs XMT-1522 and XMT-1536
Presented Data of Dolaflexin® Platform Unique DolaLock Technology and XMT-1522 Synergy with a Checkpoint Inhibitor at AACR 2018
CAMBRIDGE, Mass., May 14, 2018 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Dolaflexin® and other proprietary platforms, today reported financial results and a business update for the first quarter ended March 31, 2018.
During the quarter, we continued to execute our clinical development plans for our innovative ADC therapeutics, said Anna Protopapas, President and CEO of Mersana Therapeutics. Both of our lead product candidates are currently progressing through dose escalation, and we are excited to be presenting our first interim data for XMT-1522 at the upcoming ASCO 2018 medical meeting.
Recent Highlights and Updates
Clinical Programs
· Continuing dose escalation in the ongoing Phase 1 study of XMT-1522. XMT-1522 is a Dolaflexin ADC targeting all types of HER2-expressing breast cancer, non-small cell lung cancer (NSCLC) and gastric cancer. Once MTD is established, enrollment will begin in the next portion of the trial, which will establish efficacy in distinct expansion cohorts. Mersana will present XMT-1522 early dose escalation data in June at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
· Continuing dose escalation in the ongoing Phase 1 study of XMT-1536. XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous NSCLC, as well as several other rare tumor types. XMT-1536 is progressing quickly through the dose escalation phase of the trial, and Mersana intends to present an update at a future medical meeting.
· Presented data on XMT-1522 synergy with a checkpoint inhibitor at the American Association for Cancer Research (AACR) Annual Meeting 2018. Mersana co-authored a study with its partner Takeda characterizing the ability of both XMT-1522 and the free AF-HPA payload to induce immunogenic cell death. In a novel syngeneic mouse model expressing HER2, XMT-1522 and Kadcyla were compared in combination with a checkpoint inhibitor. The XMT-1522 combination showed significantly better anti-tumor efficacy than the Kadcyla combination, resulting in multiple complete responses.
Discovery & Platform Progress
· Presented a more in-depth characterization of the Dolaflexin platform DolaLock technology at the AACR Annual Meeting 2018. Mersana scientists demonstrated the intra-tumor cell conversion of the initial drug release product, AF-HPA, to AF. AF-HPA is a cell-permeable auristatin
drug payload and has bystander-killing capabilities. This allows for the diffusion of the payload to adjacent tumor cells and enhances efficacy. AF-HPA converts to AF, which is non-cell permeable, highly potent and is not a substrate for drug efflux pumps. This unique design of the payload can result in improved efficacy and tolerability of Mersanas ADC candidates by locking the payload into the tumor.
· Mersana continues to expand its patent portfolio. U.S. Patent No. 9849191, entitled Protein-Polymer-Drug Conjugates was recently awarded. This patent provides Mersana broad coverage for its Fleximer polymer-based Dolaflexin platform comprising its proprietary auristatin payload. Mersana currently has 14 issued US patents and 27 issued foreign patents across its platforms and programs.
Upcoming Events
· The Company will present its first interim clinical data for XMT-1522 at the upcoming American Society of Clinical Oncology (ASCO) 2018 medical meeting on June 4 in Chicago.
· The Company will give a corporate presentation at The Jefferies 2018 Global Healthcare Conference, which will take place from June 5-8 in New York City.
Financial Results
· Cash, cash equivalents and marketable securities as of March 31, 2018 were $108.0 million, compared to $88.5 million as of March 31, 2017. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into the second half of 2019.
· Collaboration revenue for the first quarter 2018 was approximately $3.1 million, compared to $4.3 million for the same period in 2017, primarily due to reduction in efforts required to support collaboration activities.
· Research and development expenses for the first quarter 2018 were approximately $12.3 million, compared to $10.1 million for the same period in 2017, driven by increases in expenses supporting the Companys two lead programs, including headcount, research expenses related to platform expansion, offset by a $1.5m milestone payment in 2017.
· General and administrative expenses for the first quarter 2018 were approximately $3.6 million, compared to $2.3 million for the same period in 2017, driven by headcount, and external costs incurred as Mersana scales as a public development stage company.
· Net loss for the first quarter 2018 was $12.4 million, or $0.54 per share, compared to a net loss of $8.1 million, or $6.02 per share, for the same period in 2017. Weighted average common shares outstanding for the quarter ended March 31, 2018 were 22,816,521 and 1,388,475 for the quarter ended March 31, 2017.
· Additionally, resulting as part the adoption of the new revenue recognition guidance, an increase of $2.0 million in deferred revenue and accumulated deficit was recorded as of January 1, 2018.
Conference Call
Mersana Therapeutics will host a conference call and webcast today at 5:00 p.m. ET to report financial results for the first quarter 2018 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 7589367. A live
webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.
About Dolaflexin
The Dolaflexin platform is designed to increase the efficacy, safety, and tolerability of ADCs by overcoming key limitations of existing technologies based on direct conjugation of a payload molecule to an antibody. Dolaflexin consists of Fleximer, a biodegradable, highly biocompatible, water soluble polymer, to which are attached multiple molecules of Mersanas proprietary auristatin drug payload using a linker specifically optimized for use with Mersanas polymer. The high water-solubility of the Fleximer polymer compensates for the low solubility of the payload, surrounding the payload and protecting it from aggregation and maintaining stability in circulation. Multiple molecules of this Dolaflexin polymer-drug conjugate can then be attached to an antibody of choice, which significantly increases the payload capacity of the resulting ADC. This approach differs from most other ADC technologies that conjugate the payload directly to the antibody. Using its Dolaflexin platform, Mersana has been able to generate ADCs with a very high Drug-to-Antibody Ratio (DAR), between 12 to 15, while maintaining desirable pharmacokinetics and drug-like properties in animal models. This represents a three to four-fold increase in DAR relative to traditional ADC approaches. The Dolaflexin platform also incorporates DolaLock technology, an engineered controlled bystander effect. AF-HPA, the initial auristatin drug release product, is freely cell permeable and has bystander-killing capabilities. Intra-tumor metabolism then facilitates the conversion of AF-HPA to AF, which is non-cell permeable, highly potent, and locked into the tumor. This enhancement improves both the efficacy and tolerability of Mersanas ADC candidates.
About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical company using its differentiated and proprietary ADC platforms to develop highly targeted drugs with increased tolerability and expanded opportunities to deliver meaningful clinical benefit to patients. Mersanas first product candidate XMT-1522 is in Phase 1 clinical trials in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer. Mersanas second product candidate, XMT-1536, is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC and other rare cancers. In addition, multiple partners are using Mersanas platform to advance their ADC pipelines.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. These are not statements of historical facts and are based on managements beliefs and assumptions and on information currently available. They are subject to risks and uncertainties that could cause the actual results and the implementation of the Companys plans to vary materially. These risks are discussed in the Companys SEC filings including, without limitation, the Companys Annual Report on Form 10-K filed on March 28, 2018. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
Mersana Therapeutics, Inc
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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March 31, 2018 |
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December 31, 2017 |
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Cash, cash equivalents and marketable securities |
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$ |
107,959 |
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$ |
125,216 |
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Working capital (1) |
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82,021 |
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85,662 |
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Total Assets |
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115,755 |
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130,715 |
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Total stockholders equity |
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56,547 |
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69,994 |
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(1) The Company defines working capital as current assets less current liabilities. See the Companys 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)
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Three months ended |
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March 31, |
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March 31, |
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2018 |
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2017 |
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Collaboration revenue |
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$ |
3,064 |
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$ |
4,290 |
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Operating expenses: |
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Research and development |
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12,256 |
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10,106 |
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General and administrative |
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3,571 |
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2,296 |
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Total operating expenses |
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15,827 |
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12,402 |
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Other income |
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360 |
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51 |
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Net income (loss) |
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$ |
(12,403 |
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$ |
(8,061 |
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Net income (loss) per share attributable to common stockholders basic and diluted |
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$ |
(0.54 |
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$ |
(6.02 |
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Weighted-average number of common shares used in net loss per share attributable to common stockholders basic and diluted |
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22,816,521 |
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1,338,475 |
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Media Contact
Paul Kidwell
pkidwell@mersana.com
617-680-1088
Investor Contact
Stern Investor Relations, Inc.
Christina Tartaglia
christina@sternir.com
212-362-1200