Epizyme Reports Third Quarter 2018 Financial Results and Tazemetostat Progress
Enrollment in Phase 2 Cohort of Follicular Lymphoma Patients with EZH2 Activating Mutations on Track to be Completed by Year End
Updated Efficacy and Safety Data for Tazemetostat in Epithelioid Sarcoma Support Company’s Planned Submission of a New Drug Application in the First Half of 2019
Recent Financing Extends Operating Runway into the First Quarter of 2020
“2018 has been a year of important milestones. We have seen clinically
meaningful activity with tazemetostat in patients with follicular
lymphoma, both with and without EZH2 activating mutations, and are
pleased that enrollment of patients with EZH2 activating mutations has
re-opened in the U.S. With this, we remain on track with our previous
guidance of completing enrollment in our Phase 2 study by the end of the
Tazemetostat Clinical Program Updates
- Enrollment of Follicular Lymphoma Patients with EZH2 Activating
Mutations to be Completed by End of 2018: Clinical sites in the
U.S. have resumed screening patients with follicular lymphoma with
EZH2 mutations in the company’s ongoing Phase 2 study. The company is
on track to complete enrollment of this cohort by the end of 2018, in
line with previous guidance. Enrollment of patients with wild-type
EZH2 was completed in 2017.
Epizymeplans to continue engaging with FDAto refine its registration strategy in follicular lymphoma, and provide an update on its plans in early 2019.
- Positive Data in Epithelioid Sarcoma Support Planned NDA Submission:
Epizymepresented positive interim data from the fully enrolled epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat during the European Society for Medical Oncology( ESMO) 2018 Congressin October. Data as of August 21, 2018from the 62 patients enrolled showed that oral, twice daily administration of tazemetostat resulted in durable objective responses and encouraging clinically meaningful overall survival in both treatment-naive patients and patients who had been previously treated with an anticancer therapy. In addition, tazemetostat was generally well-tolerated with low rates of discontinuations due to treatment-related adverse events. The company is on-track to submit its New Drug Application for tazemetostat in epithelioid sarcoma in the first half of 2019, with a path to submission for accelerated approval.
October 2018, Epizymeannounced the closing of its underwritten public offering of 9,583,334 shares of its common stock at a public offering price of $9.00per share, which includes 1,250,000 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price, less the underwriting discount. The aggregate gross proceeds to Epizymefrom the offering, before deducting underwriting discounts and offering expenses, are $86.25 million.
Third Quarter 2018 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities
$180.8 millionas of September 30, 2018, which compares to $307.2 millionas of September 30, 2017.
- R&D Expenses: Research and development (R&D) expenses were
$27.0 millionfor the third quarter of 2018, which compares to $28.7 millionfor the third quarter of 2017. The decrease was primarily due to decreased clinical trial expenses and discovery stage research expenses offset by an increase in tazemetostat manufacturing costs.
- G&A Expenses: General and administrative (G&A) expenses
$11.5 millionfor the third quarter of 2018, which compares to $9.3 millionfor the third quarter of 2017. The increase was primarily due to increases in pre-commercialization activities and in personnel related expenses.
- Net Loss: Net loss was
$37.5 million, or $0.54per share, for the third quarter of 2018, which compares to a net loss of $37.6 million, or $0.63per share, for the third quarter of 2017.
Following its October financing,
Due to Epizyme’s recent update during
About the Tazemetostat Clinical Trial Program
Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma; and combination studies in diffuse large B-cell lymphoma and non–small cell lung cancer.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
|CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
(Amounts in thousands)
|Cash, cash equivalents, and marketable securities||$180,783||$276,439|
|Deferred revenue, net of current portion||3,806||28,809|
|Total stockholders’ equity||171,831||235,371|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVEE LOSS (UNAUDITED)
|(Amounts in thousands except per share data)|
Three Months Ended
Nine Months Ended
|Research and development||27,027||28,741||83,994||80,728|
|General and administrative||11,528||9,311||31,801||28,750|
|Total operating expenses||38,555||38,052||115,795||109,478|
|Loss from operations||(38,555||)||(38,052||)||(103,795||)||(99,478||)|
|Other income, net||1,063||455||3,110||1,335|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|