Press Releases
Epizyme, Inc. Provides Third Quarter 2013 Financial Results and Corporate Update
"2013 has been an important year for
Dr. Gould continued, "In addition, for EPZ-6438, an inhibitor of the HMT EZH2 being developed as a treatment for non-Hodgkin lymphoma patients with oncogenic point mutations in EZH2,
"Looking ahead to 2014, we plan to pursue additional clinical studies for both candidates in genetically defined cancers beyond the primary indications, including MLL-PTD for EPZ-5676 and synovial sarcoma and other INI1-deficient tumors for EPZ-6438," said Gould. "We are in a strong position to invest in
- Top-line Dose Escalation Data Expected in Fourth Quarter of 2013: The dose escalation stage of the ongoing Phase 1 study of EPZ-5676 is nearing completion, and
Epizyme plans to disclose top-line dose escalation data in the fourth quarter of 2013. - Clinical Sites Added: Five clinical sites have been added this year, bringing the total number of clinical sites participating in this study to six.
- Granted Orphan Drug Designation: EPZ-5676 was granted orphan drug designation by the U.S.
FDA inAugust 2013 . - MLL-r Restricted Expansion Cohort Stage to Begin in Fourth Quarter of 2013: Based on data from the dose escalation stage,
Epizyme plans to initiate the expansion cohort stage of the ongoing Phase 1 study in the fourth quarter of 2013. The expansion cohort will be limited to patients with MLL-r and is expected to provide an initial assessment of therapeutic effect in MLL-r patients in 2014. It will include as many as 12 sites in boththe United States andEurope .Abbott Molecular Inc. , under its collaboration withEpizyme , is developing a molecular companion diagnostic to identify eligible MLL-r patients for EPZ-5676, and the Investigational Use Only (IUO) diagnostic will be available for use in the expansion cohort. - Initiation of Pediatric MLL-r Phase 1 Study in 2014: Based on the findings to date in the Phase 1 study of EPZ-5676 in adults,
Epizyme plans to initiate a Phase 1 trial of EPZ-5676 in pediatric patients with MLL-r leukemia in the first half of 2014. The study will initially be open in approximately 5-6 investigational sites in the U.S. - Broadening Program into AML with MLL-PTD in 2014:
Epizyme plans to initiate a clinical study of EPZ-5676 in patients with AML with a genetic alteration called MLL-PTD. MLL-PTD cell lines and animal models exhibit similar sensitivity to DOT1L inhibition as seen in MLL-r pre-clinical studies. This data was presented onOctober 21, 2013 , at theAACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. MLL-PTD accounts for an estimated 5-7% of adult AML cases with an estimated annual incidence of 2,300 patients in the major markets (U.S., EU andJapan ) and represents a meaningful potential expansion of the clinical opportunity for EPZ-5676.
- Initiated Dose Escalation Study: In
June 2013 Epizyme announced the enrollment of the first patient in a Phase 1/2 study of EPZ-6438 (referred to as E7438 by Eisai). The Phase 1 dose escalation study is ongoing at two sites inFrance , and no dose-limiting toxicities have been observed to date. The companies also plan to significantly increase the number of clinical sites in 2014, and to submit an IND in the U.S., in anticipation of the Phase 2 initiation. - Phase 2 Initiation Expected in 2014: With partner Eisai,
Epizyme plans to initiate the Phase 2 portion of this study in 2014 after completion of the dose escalation phase. This phase will only enroll patients with non-Hodgkin lymphoma with oncogenic point mutations in EZH2 and is expected to provide an initial assessment of therapeutic effect. - Broadening Program into INI1-Deficient Tumors in 2014:
Epizyme plans to initiate clinical trials in patients with tumors in which there is genetically altered INI1 after completion of the ongoing Phase 1 study. EZH2 plays a driving oncogenic role in INI1-deficient tumors, as exemplified in a paper published in theApril 2013 Proceedings of theNational Academy of Sciences in whichEpizyme scientists demonstrated sustained tumor regressions in pre-clinical studies of malignant rhabdoid tumors (MRT) and in anOctober 21, 2013 presentation at theAACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics that describes the oncogenic role of EZH2 in synovial sarcomas, a malignancy in which INI1 function is altered as a result of a specific chromosomal translocation (SS18-SSX). In the major markets, synovial sarcoma has an annual incidence of 1,700 patients, and other INI1-deficient tumors together have an annual incidence of 700 patients.
Additional Business Highlights
Continued Pipeline Development of Personalized Therapeutics: Pre-clinical studies are ongoing to identify additional genetically defined cancers for potential treatment withEpizyme's therapeutic candidates. Planned clinical studies in MLL-PTD and INI1-deficient tumors, focusing on synovial sarcoma, are examples of the novel therapeutic insights provided byEpizyme's product platform.Epizyme also continues to advance the HMT targets in the GSK collaboration as well as other non-partnered HMT targets.- Strengthened Intellectual Property Portfolio: In
August 2013 , the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. Patent Application No. 13/310,157 "SUBSTITUTED PURINE AND 7-DEAZAPURINE COMPOUNDS" with claims covering the novel compound EPZ-5676. This is the first composition of matter patent for EPZ-5676 and, once issued, this patent will expire in 2032. Also inSeptember 2013 , the USPTO issued U.S. Patent No. 8,524,467 titled "Diagnostic and Therapeutic Targets for Leukemia," with claims directed to methods of identifying DOT1L inhibitor compounds for the treatment of leukemia. This patent expires in 2030.
Third Quarter 2013 Financial Results & Financial Guidance
- Cash Position: Cash and cash equivalents as of
September 30, 2013 , were$139.6 million , compared to$98.0 million as ofDecember 31, 2012 . The cash increase was driven by net proceeds of$82.5 million fromEpizyme's initial public offering inJune 2013 and a$6 million milestone achieved inJune 2013 from the Eisai collaboration for the initiation of the EPZ-6438 Phase 1/2 study. - Revenue: Collaboration revenue was
$8.4 million for the third quarter of 2013 and$32.2 million for the nine months endedSeptember 30, 2013 , compared to$15.3 million and$36.3 million for the comparable periods in 2012. Collaboration revenue includes deferred revenue from payments received in previous periods as well as payments received and recognized during the respective periods. - R&D Expenses: Research and development expenses were
$14.6 million for the third quarter of 2013 and$41.9 million for the nine months endedSeptember 30, 2013 , compared to$9.3 million and$27.4 million for the comparable periods in 2012. The increase was largely driven by the expansion ofEpizyme's product platform and costs for the clinical studies of EPZ-5676 and EPZ-6438. - G&A Expenses: General and administrative expenses were
$3.6 million for the third quarter of 2013 and$9.7 million for the nine months endedSeptember 30, 2013 , compared to$1.6 million and$5.2 million for the comparable periods in 2012. The increase was largely driven by incremental expenses to support public company operations as well as increased stock-based compensation expense and other costs to supportEpizyme's growth. - Net (Loss) Income: Net loss was
$9.7 million for the third quarter of 2013 and$19.4 million for the nine months endedSeptember 30, 2013 , compared to net income of$4.4 million and$3.8 million for the comparable periods in 2012. The 2012 net income was largely driven by the revenue recognition of a portion of the$68.0 million upfront payment received from Celgene inApril 2012 . - Shares Outstanding: Shares outstanding as of
September 30, 2013 were 28.4 million, following the sale of 5.9 million shares of common stock in the Company's initial public offering and the resulting automatic conversion of the Company's redeemable convertible preferred stock into 20.6 million shares of common stock. This compares to 1.7 million shares outstanding as ofSeptember 30, 2012 , which did not include the Company's redeemable convertible preferred stock. Basic weighted average shares outstanding for the nine months endedSeptember 30, 2013 were 13.2 million.Epizyme expects basic weighted average shares outstanding to be approximately 17 million shares for the full-year 2013. - End of Year Guidance:
Epizyme expects full-year 2013 net cash used in operating activities of approximately$60 million , full-year 2013 GAAP revenue of approximately$40 million , and to end the year with more than$115 million in cash and cash equivalents.
Conference Call Information
The archived webcast will be available on the Company's website beginning approximately two hours after the event.
About
For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
| ||||
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) | ||||
(Amounts in thousands) | ||||
|
| |||
2013 |
2012 | |||
Cash and cash equivalents |
$ 139,575 |
$ 97,981 | ||
Total assets |
147,350 |
103,511 | ||
Deferred revenue |
50,706 |
69,445 | ||
Redeemable convertible preferred stock (Series A, B and C) |
- |
76,156 | ||
Stockholders' equity (deficit) |
87,283 |
(51,126) | ||
| ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||
(Amounts in thousands except per share data) | ||||||||
Three Months Ended |
Nine Months Ended | |||||||
2013 |
2012 |
2013 |
2012 | |||||
Collaboration revenue |
$ 8,444 |
$ 15,331 |
$ 32,165 |
$ 36,327 | ||||
Operating expenses: |
||||||||
Research and development |
14,584 |
9,258 |
41,882 |
27,385 | ||||
General and administrative |
3,587 |
1,630 |
9,664 |
5,175 | ||||
Total operating expenses |
18,171 |
10,888 |
51,546 |
32,560 | ||||
(Loss) income from operations |
(9,727) |
4,443 |
(19,381) |
3,767 | ||||
Other income (expense), net |
23 |
5 |
(32) |
69 | ||||
Net (loss) income |
$ (9,704) |
$ 4,448 |
$ (19,413) |
$ 3,836 | ||||
Less: accretion of redeemable convertible preferred stock |
||||||||
to redemption value |
- |
159 |
264 |
326 | ||||
Less: income allocable to participating securities |
- |
3,972 |
- |
3,239 | ||||
(Loss) income allocable to common stockholders - basic |
(9,704) |
317 |
(19,677) |
271 | ||||
Undistributed income re-allocated to common stockholders |
- |
229 |
- |
147 | ||||
(Loss) income allocable to common stockholders - diluted |
$ (9,704) |
$ 546 |
$ (19,677) |
$ 418 | ||||
(Loss) earnings per share allocable to common stockholders: |
||||||||
Basic |
$ (0.34) |
$ 0.19 |
$ (1.49) |
$ 0.17 | ||||
Diluted |
$ (0.34) |
$ 0.18 |
$ (1.49) |
$ 0.16 | ||||
Weighted average shares outstanding: |
||||||||
Basic |
28,406 |
1,651 |
13,212 |
1,637 | ||||
Diluted |
28,406 |
3,017 |
13,212 |
2,641 | ||||
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, expectations regarding the sufficiency of the Company's cash balance to fund operating expenses and capital expenditures, milestone or royalty payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, development progress of the Company's companion diagnostics, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates or companion diagnostics and other factors discussed in the "Risk Factors" section of the Company's 10-Q filed with the
SOURCE
News Provided by Acquire Media