Viridian Therapeutics Highlights Recent Progress and Reports First Quarter 2024 Financial Results
- THRIVE VRDN-001 global phase 3 clinical trial in active thyroid eye disease (TED) completed and exceeded its target for enrollment in March 2024; topline readout expected in September 2024 -
- THRIVE-2 VRDN-001 global phase 3 clinical trial for patients with chronic TED remains on track for topline readout by year-end 2024 -
- Positive VRDN-003 Type C meeting held with the US Food and Drug Administration (FDA); pivotal program on track to start mid-year 2024 -
- VRDN-006 FcRn inhibitor remains on track for Investigational New Drug $(IND.AU)$ submission by year-end 2024; non-human primate data expected for VRDN-008, a half-life extended FcRn inhibitor, in the second half of 2024 -
- Conference call today at 8:00am ET -
WALTHAM, Mass.--(BUSINESS WIRE)--May 08, 2024--
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the first quarter ending March 31, 2024.
"It has been a remarkable first quarter of execution as we made progress across our TED and neonatal Fc receptor (FcRn) inhibitor programs," said Steve Mahoney, Viridian President and Chief Executive Officer. "Rapidly completing and exceeding enrollment in THRIVE demonstrates the demand for new therapeutic options in TED and reflects our team's ability to execute as we look forward to delivering on the exciting catalysts in the year ahead. We remain on track for our key milestones across the portfolio as we aim to deliver on our corporate priorities for the benefit of patients and our other stakeholders."
RECENT PROGRESS
Thyroid Eye Disease Portfolio
VRDN-001, an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody
-- THRIVE Enrollment Completed in March 2024, Topline Data Expected
September 2024: The THRIVE phase 3 clinical trial in patients with active
TED completed enrollment in March 2024, meeting and exceeding its
enrollment target of 90 patients with patient demand driving a total
enrollment of 113 patients. Approximately half of the enrolled patients
were from the US and half from Europe.
-- THRIVE-2 Topline Data On Track for Year-End 2024: The THRIVE-2 phase 3
clinical trial in patients with chronic TED continues to enroll and
remains on track for topline readout by year-end 2024.
-- VRDN-001 Safety Database and Preparation For Second Half 2025 Biologics
License Application $(BLA.AU)$ Filing: To meet the safety database requirement
for BLA filing, Viridian is actively enrolling patients into the recently
initiated STRIVE clinical trial. STRIVE is a global study of VRDN-001 in
TED patients that utilizes broad inclusion criteria (e.g., any severity
or duration of disease) and is randomized 3:1 (10 mg/kg IV with an active
control of 3 mg/kg IV). Viridian is also enrolling patients in an open
label extension study for non-responders in THRIVE and THRIVE-2. Viridian
anticipates filing a BLA in the second half of 2025, pending data, for
marketing approval in TED and expects that its data package will support
a marketing authorization application in Europe.
VRDN-003, a potential best-in-class, subcutaneous, half-life extended anti-IGF-1R product candidate designed to be a low-volume and infrequent subcutaneous injection
-- Pivotal Program On Track For Mid-Year 2024 Initiation Following
Positive FDA Meeting: Viridian completed a positive Type C meeting with
the FDA to discuss the VRDN-003 pivotal development plan. The pivotal
program remains on track to start mid-year 2024, and Viridian plans to
provide additional details, including study designs, prior to the start
of the program.
FcRn Inhibitor Portfolio
VRDN-006, a highly selective anti-FcRn Fc fragment designed to be a convenient subcutaneous and self-administered option for patients
-- IND On Track for Year-End 2024: Viridian is on track to submit an IND
application for VRDN-006 by year-end 2024.
VRDN-008, a half-life extended FcRn inhibitor designed to prolong IgG suppression and provide a potentially best-in-class subcutaneous option for patients
-- NHP Data On Track for Second Half 2024: Viridian is on track to provide
VRDN-008 non-human primate data, including PK and PD data, in the second
half of 2024.
-- Potential Best-in-Class Profile: As a half-life extended FcRn inhibitor,
VRDN-008 has the potential to enable deeper and more durable suppression
than existing therapies targeting FcRn.
FINANCIAL RESULTS
-- Cash Position: Cash, cash equivalents, and short-term investments were
$613.2 million as of March 31, 2024, compared with $477.4 million as of
December 31, 2023. The company believes that its current cash, cash
equivalents, and short-term investments will be sufficient to fund its
operations into the second half of 2026.
-- R&D Expenses: Research and development expenses were $40.9 million
during the quarter ended March 31, 2024, compared to $50.7 million during
the quarter ended March 31, 2023. The decrease in research and
development expenses was driven by a $15 million license fee incurred
during the quarter ending March 31, 2023. This decrease was partially
offset by increased clinical trials costs associated with our ongoing
THRIVE and THRIVE-2 clinical trials, as well as increased personnel
costs.
-- G&A Expenses: General and administrative expenses were $15.0 million
during the quarter ended March 31, 2024, compared to $21.8 million during
the quarter ended March 31, 2023. The decrease in general and
administrative expenses was driven by a reduction in severance and
share-based compensation costs related to separation agreements with
former executive officers entered into during the quarter ending March
31, 2023.
-- Net Loss: The company's net loss was $48.5 million for the first
quarter ended March 31, 2024, compared with $68.2 million for the same
period last year.
-- Shares Outstanding: As of March 31, 2024, Viridian had approximately
83,863,339 shares of common stock outstanding on an as-converted basis,
which included 63,798,536 shares of common stock and an aggregate of
approximately 20,064,803 shares of common stock issuable upon the
conversion of 157,435 and 143,522 shares of Series A and Series B
preferred stock, respectively.
CONFERENCE CALL AND WEBCAST
Viridian will host a webcast and conference call to discuss its first quarter 2024 financial results and provide a corporate update today, May 8, at 8:00 a.m. ET.
The webcast can be accessed under "Events and Presentations" on the Investors section of the Viridian website at viridiantherapeutics.com. To participate in the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference code 7373356. A replay of the webcast will be available following the completion of the event.
About Viridian Therapeutics
Viridian is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for VRDN-001, including two global phase 3 clinical trials (THRIVE and THRIVE-2) to evaluate its efficacy and safety in patients with active and chronic TED. Viridian's goal is to advance VRDN-001 as a potential best-in-class intravenous therapy followed by VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED.
In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases.
Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical and clinical development of Viridian's product candidates VRDN-001, VRDN-003, VRDN-006 and VRDN-008; anticipated start dates of studies, including the initiation date of the VRDN-003 pivotal program; alignment with regulatory authorities and anticipated regulatory submissions, including the anticipated IND submission for VRDN-006 and the anticipated BLA submission for VRDN-001; Viridian's expectation that its data will support a BLA in the second half of 2025, pending data, for marketing approval in TED for VRDN-001; Viridian's expectation that its data package will support a marketing authorization application in Europe for VRDN-001; anticipated study designs and their disclosure; enrollment in Viridian's clinical studies;
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