Epizyme Provides Business Update and Reports First Quarter 2019 Financial Results
Tazemetostat NDA Submissions for Epithelioid Sarcoma and Follicular Lymphoma on Track for Second Quarter and Fourth Quarter 2019, Respectively
Updated Data from Tazemetostat Development Program to be Presented in the Second Quarter
First Research Milestone Achieved in Worldwide Collaboration with Boehringer Ingelheim to Develop Novel Epigenetic Oncology Therapies
“This is an incredibly exciting time for our company, and 2019 is slated
to be one of the most important years in Epizyme’s evolution,” said
Tazemetostat Program Updates and
- NDA Submission for Epithelioid Sarcoma (ES) on Track for Second
Epizymeis well underway with its preparations to submit its first New Drug Application (NDA) for accelerated approval to the U.S. Food and Drug Administration( FDA) in the second quarter of 2019 for tazemetostat in patients with ES. This is an ultra-rare and difficult-to-treat sarcoma, and if approved, tazemetostat would be the first treatment specifically indicated for patients with ES. Updated data from the company’s ongoing Phase 2 trial in ES will be presented at the 2019 American Society of Clinical Oncology ( ASCO) Annual Meeting in Chicago; details will be disclosed at a future date.
- NDA Submission for All-Comer Follicular Lymphoma (FL) Population
Planned for Fourth Quarter:
Epizymeplans to submit an NDA for accelerated approval of tazemetostat for patients with FL, regardless of their EZH2 mutational status, who have been previously treated with two or more systemic therapies. The ongoing Phase 2 study has completed enrollment, and the company is working toward the submission of an NDA for accelerated approval in the fourth quarter of 2019 for this patient population. Updated data from the Phase 2 trial will be presented at a medical meeting in the second quarter of 2019. Details will be disclosed at a future date.
Planned Tazemetostat Clinical Studies in 2019
- a combination study of tazemetostat with the chemo-free treatment regimen “R2” (Revlimid® plus Rituxan®) for patients with relapsed/refractory FL who have received at least one prior therapy;
- a combination study of tazemetostat with Rituxan for patients with relapsed/refractory FL;
a combination study of tazemetostat with R-CHOP for front-line
patients with FL in collaboration with the
Lymphoma Study Association(LYSA);
- a combination study of tazemetostat with the standards-of-care for patients with castration-resistant prostate cancer; and
- a combination study of tazemetostat with a PARP inhibitor for patients with platinum-resistant solid tumors, such as small-cell lung cancer, triple-negative breast cancer and ovarian cancer.
Initiation of Clinical Development of EZM8266 for Sickle Cell Disease
Upon approval of an Investigational New Application (IND) for EZM8266
for the treatment of patients with sickle cell disease,
Epizymeanticipates beginning clinical development in the second half of 2019 with a Phase 1 trial of EZM8266, a novel, first-in-class G9a inhibitor.
Epizymerecently earned a $5.5 millionmilestone payment from Boehringer Ingelheim, following the selection of a lead optimization candidate for the shared program targeting an enzyme within the helicase family. The companies are jointly researching and developing this program, with both parties sharing U.S. commercialization responsibilities and Boehringer Ingelheim assuming responsibility for commercialization outside the U.S. The companies will also share research responsibilities for a histone acetyltransferase (HAT) program that is under development.
In March of this year,
Epizymeraised $172.50 millionin aggregate gross proceeds, before deducting underwriting discounts and offering expenses, from two concurrent underwritten public offerings.
First Quarter 2019 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities
$371.1 millionas of March 31, 2019, as compared to $247.9 millionas of March 31, 2018.
- Revenue: Collaboration revenue for the first quarter of
$7.9 million. There was no collaboration revenue recognized for the first quarter of 2018. The increase in collaboration revenue is due to the company’s collaboration with Boehringer Ingelheim, which was initiated in November 2018.
- R&D Expenses: Research and development (R&D) expenses
$26.9 millionfor the first quarter of 2019, compared to $25.6 millionfor the first quarter of 2018. The increase is primarily due to greater tazemetostat manufacturing costs and costs incurred in preparation for two NDA submissions offset by decreases in clinical trial expenses.
- G&A Expenses: General and administrative (G&A) expenses
$12.0 millionfor the first quarter of 2019, compared to $9.4 millionfor the first quarter of 2018. The increase is primarily due to a rise in medical affairs and commercial costs as a result of organizational development in preparation for tazemetostat commercialization.
- Net Loss Attributed to Common Stockholders: Net loss
attributable to common stockholders was
$32.3 million, or $0.39per share, for the first quarter of 2019, compared to $34.1 million, or $0.49per share, for the first quarter of 2018.
Following its March financing, and based on its current operating plan,
The company will not hold a conference call in conjunction with these results.
About the Epizyme-Boehringer Ingelheim Collaboration
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for
|CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
(Amounts in thousands)
|Consolidated Balance Sheet Data:|
|Cash, cash equivalents, and marketable securities||$||371,146||$||240,304|
|Current portion of deferred revenue||5,409||13,300|
|Deferred revenue, net of current portion||3,806||3,806|
|Total stockholders’ equity||368,353||233,009|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(Amounts in thousands except per share data)|
|Three Months Ended
|Research and development||26,896||25,622|
|General and administrative||11,986||9,360|
|Total operating expenses||38,882||34,982|
|Other income, net:|
|Interest income, net||1,658||899|
|Other (expense) income, net||(6)||18|
|Other income, net||1,652||917|
|Reconciliation of net loss to net loss attributable to common stockholders:|
|Accretion of convertible preferred stock||(2,940)||-|
|Net loss attributable to common stockholders||$||(32,279)||$||(34,065)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.39)||$||(0.49)|
|Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted||82,424||69,386|