Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2021 with Webcast and Conference Call Today at 4:30 p.m. ET
Enanta Pharmaceuticals reported fiscal Q1 2021 revenues of $27.6 million, primarily from royalty revenue linked to AbbVie’s MAVYRET. R&D expenses surged to $48.5 million, reflecting increased clinical study support. The net loss widened to $30.1 million, or $1.48 per share. The company has completed enrollment in its Phase 2b study of EDP-938 for RSV, with topline data expected in Q2 2022. Additionally, they are set to begin a Phase 1 trial for EDP-235, an oral treatment for COVID-19, this month.
- Royalty revenue of $27.6 million for Q1 2021.
- Initiation of Phase 1 study for EDP-235 in COVID-19 this month.
- Completion of enrollment in RSV Phase 2b study with EDP-938.
- Expected topline data from RSVP study in Q2 2022.
- Strong cash position with $347.7 million as of December 31, 2021.
- Net loss increased to $30.1 million for Q1 2021.
- R&D expenses rose significantly to $48.5 million, indicating higher spending.
- Royalty revenue decreased from $31.7 million in Q1 2020.
- Expects to Begin Dosing in a First-in-Human Study of EDP-235, an Oral 3CL Protease Inhibitor Specifically Designed for the Treatment of COVID-19, This Month
- Completed Enrollment in RSVP, a Phase 2b Study of EDP-938 in Adults With Community-Acquired Respiratory Syncytial Virus (RSV); Expects Topline Data in the Second Quarter of 2022
- Plans to Initiate a Phase 1 Study of EDP-323, an RSV L-Protein Inhibitor, in the Second Half of 2022
-
Royalty Revenue for the Quarter was
$27.6 Million
“We are excited to begin dosing subjects this month with EDP-235, our SARS-CoV-2 3CL protease inhibitor specifically designed as a once-daily, orally-dosed treatment for COVID-19. As the COVID-19 pandemic continues, demand for a convenient, once-daily therapeutic is stronger than ever, and we look forward to advancing EDP-235 as a COVID-19 treatment option based on its potential best-in-class preclinical profile,” said
Fiscal First Quarter Ended
Total revenue for the three months ended
Research and development expenses totaled
General and administrative expenses totaled
Enanta recorded a minor income tax benefit related to the release of a state tax reserve for the three months ended
Net loss for the three months ended
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled
Pipeline Update and Business Review
Respiratory Syncytial Virus (RSV)
-
EDP-938, an N-protein inhibitor with Fast Track Designation by the
U.S. Food and Drug Administration (FDA), is designed to target the two major types of RSV, A and B. It is being evaluated in a broad clinical development program in multiple patient groups, consisting of three ongoing Phase 2 trials: RSVP, RSVPEDs and RSVTx. - RSVP is a Phase 2b study designed to confirm the results of the challenge study in the setting of community-acquired RSV infection in an otherwise healthy adult population. Enanta recently announced enrollment is complete in this study and plans to report topline data in the second quarter of calendar 2022.
- RSVPEDs, a Phase 2 randomized, double-blind, placebo-controlled study in 90 hospitalized and non-hospitalized pediatric RSV patients and RSVTx, a Phase 2b, randomized, double-blind, placebo-controlled study in 200 adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection, are ongoing. Enanta expects these studies to continue into at least 2023.
- Enanta recently introduced its newest clinical candidate for RSV, EDP-323, which is a novel oral, direct-acting antiviral selectively targeting the RSV L-protein, a viral RNA-dependent RNA polymerase that contains multiple enzymatic activities required for RSV replication. EDP-323 has shown sub-nanomolar potency against RSV-A and RSV-B in vitro and is not expected to have cross resistance to other classes of inhibitors. EDP-323 could be used as a monotherapy or in combination with other RSV mechanisms, such as EDP-938, to potentially broaden the addressable patient populations or their treatment windows. Enanta expects to initiate a Phase 1 study in healthy volunteers in the second half of 2022.
COVID-19 (SARS-CoV-2)
- Enanta is on track to begin dosing subjects this month in a Phase 1 study of EDP-235, its oral, coronavirus 3CL protease inhibitor (also known as Mpro or main protease) specifically designed for the treatment of COVID-19. Preclinical data demonstrate that EDP-235 potently blocks the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells with an EC90 of 33 nanomolar, positioning EDP-235 among the most potent direct-acting antivirals currently in development for SARS-CoV-2 infection, with the potential for convenient once-daily dosing. Importantly, EDP-235 has shown good exposure after oral administration without ritonavir boosting and favorable distribution into lung cells as well as other key target tissues. EDP-235 has demonstrated potent antiviral activity across a range of currently circulating SARS-CoV-2 variants, including Omicron and Delta. Additionally, EDP-235 is active against all other known human coronaviruses, providing the potential for a pan-coronavirus treatment.
Hepatitis B Virus (HBV)
- Enanta remains focused on identifying additional compounds with different mechanisms of action to develop in combination with EDP-514, its potent core inhibitor, as a functional cure for chronic HBV patients. EDP-514, which has Fast Track Designation from the FDA, has displayed a good safety profile and robust antiviral activity in multiple HBV patient populations, with declines in HBV DNA among the best published to date for core inhibitors.
Human Metapneumovirus (hMPV)
- Enanta continues to progress nanomolar inhibitors of hMPV through preclinical development, and clinical candidate selection is planned for the second half of 2022. hMPV is a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
About
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta’s research and development programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta’s clinical programs in RSV, SARS-CoV-2 and HBV and its preclinical program in hMPV. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, SARS-CoV-2 and HBV; the discovery and development risks of Enanta’s programs in RSV, SARS-CoV-2, HBV and hMPV; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on business operations and clinical trials; Enanta’s lack of clinical development experience; Enanta’s need to attract and retain senior management and key research and development personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal year ended
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| UNAUDITED | ||||||||
| (in thousands, except per share amounts) | ||||||||
Three Months Ended |
||||||||
|
||||||||
2021 |
|
2020 |
||||||
| Revenue | $ |
27,648 |
|
$ |
31,743 |
|
||
| Operating expenses | ||||||||
| Research and development |
|
48,549 |
|
|
36,665 |
|
||
| General and administrative |
|
9,508 |
|
|
7,377 |
|
||
| Total operating expenses |
|
58,057 |
|
|
44,042 |
|
||
| Loss from operations |
|
(30,409 |
) |
|
(12,299 |
) |
||
| Other income, net |
|
258 |
|
|
677 |
|
||
| Loss before income taxes |
|
(30,151 |
) |
|
(11,622 |
) |
||
| Income tax benefit |
|
36 |
|
|
3,294 |
|
||
| Net loss | $ |
(30,115 |
) |
$ |
(8,328 |
) |
||
| Net loss per share | ||||||||
| Basic | $ |
(1.48 |
) |
$ |
(0.41 |
) |
||
| Diluted | $ |
(1.48 |
) |
$ |
(0.41 |
) |
||
| Weighted average common shares outstanding | ||||||||
| Basic |
|
20,388 |
|
|
20,093 |
|
||
| Diluted |
|
20,388 |
|
|
20,093 |
|
||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| UNAUDITED | ||||||
| (in thousands) | ||||||
|
|
|
||||
2021 |
|
2021 |
||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ |
99,068 |
$ |
57,206 |
||
| Short-term marketable securities |
|
159,984 |
|
186,796 |
||
| Accounts receivable |
|
27,648 |
|
23,576 |
||
| Prepaid expenses and other current assets |
|
11,506 |
|
14,188 |
||
| Income tax receivable |
|
28,751 |
|
37,255 |
||
| Total current assets |
|
326,957 |
|
319,021 |
||
| Long-term marketable securities |
|
88,668 |
|
108,416 |
||
| Property and equipment, net |
|
5,435 |
|
5,943 |
||
| Operating lease, right-of-use assets |
|
18,834 |
|
4,711 |
||
| Restricted cash |
|
608 |
|
608 |
||
| Other long-term assets |
|
92 |
|
92 |
||
| Total assets | $ |
440,594 |
$ |
438,791 |
||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ |
7,841 |
$ |
9,540 |
||
| Accrued expenses and other current liabilities |
|
26,580 |
|
22,429 |
||
| Operating lease liabilities |
|
3,469 |
|
4,203 |
||
| Total current liabilities |
|
37,890 |
|
36,172 |
||
| Operating lease liabilities, net of current portion |
|
15,958 |
|
1,126 |
||
| Series 1 nonconvertible preferred stock |
|
1,506 |
|
1,506 |
||
| Other long-term liabilities |
|
856 |
|
558 |
||
| Total liabilities |
|
56,210 |
|
39,362 |
||
| Total stockholders' equity |
|
384,384 |
|
399,429 |
||
| Total liabilities and stockholders' equity | $ |
440,594 |
$ |
438,791 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20220208005331/en/
Media and Investor Contact:
617-744-3848
jviera@enanta.com
Source:
FAQ
What are the financial results for Enanta Pharmaceuticals in Q1 2021?
When does Enanta expect to report topline data for EDP-938?
What is EDP-235 and when is its Phase 1 study starting?
What was the cash position of Enanta Pharmaceuticals as of December 31, 2021?
How did royalty revenue change compared to last year?
