Viridian Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Updates

Rhea-AI Summary

Viridian Therapeutics (NASDAQ: VRDN) reported significant progress in its Phase 1/2 trial of VRDN-001 for thyroid eye disease (TED), showing rapid clinical improvement after two infusions. The company has initiated the global Phase 3 THRIVE clinical program. As of September 30, 2022, cash and equivalents totaled $431 million, extending its financial runway into the second half of 2025. The third-quarter net loss increased to $28.9 million, up from $14.0 million year-over-year, primarily due to rising R&D and administrative expenses.

Positive

• Successful topline results from VRDN-001, showing significant symptom improvement in TED.
• Initiation of the global Phase 3 THRIVE clinical program, indicating the advancement of the pipeline.
• Strong cash position of $431 million, ensuring operational funding into H2 2025.

Negative

• Increased net loss of $28.9 million for Q3 2022, compared to $14.0 million last year.
• R&D expenses surged to $22.1 million for Q3 2022, up from $8.1 million, raising concerns about rising operational costs.

- Significant and rapid improvement in both signs and symptoms of TED at week 6 after two infusions of 20 mg/kg VRDN-001; generally consistent with 10mg/kg results at week 6 -

- Global Phase 3 THRIVE clinical program initiated -

- Ended 3Q 2022 with cash, cash equivalents, and short-term investments of $431M providing cash runway into the second half of 2025 -

- Conference call today at 8:00 a.m. ET -

WALTHAM, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by current therapies, today announced financial results for the third quarter ending September 30, 2022 and provided corporate updates.

Earlier today in a separate news release, the Company announced topline clinical data from the first two cohorts in its ongoing Phase 1/2 clinical trial of VRDN-001, an IGF-1R antibody, in patients with thyroid eye disease (TED).

“The positive VRDN-001 clinical data reported today reinforces our conviction in the potential for VRDN-001 to deliver improved care for patients suffering with TED. Across all efficacy measures, VRDN-001 continues to deliver a rapid, compelling, and clinically meaningful improvement for patients after just two infusions,” said Jonathan Violin, Ph.D., President and CEO of Viridian Therapeutics. “We have continued our rapid momentum with the recent initiation of our Phase 3 THRIVE program as we accelerate our portfolio of IV and SC TED assets towards approval.”

Third Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and short-term investments were $431.3 million as of September 30, 2022, compared with $197 million as of December 31, 2021. 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 2025.

In August 2022, the Company offered and sold 11,352,640 shares of the Company’s common stock at a public offering price of $23.50 per share, and 28,084 shares of Series B non-voting convertible preferred stock, par value $0.01 per share, at a public offering price of $1,566.745 per share. The gross proceeds to the Company from the offering were approximately $311.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Earlier in 2022, the Company entered into a debt financing agreement with Hercules Capital, Inc. for up to $75 million. Under the terms of the agreement, Viridian drew an initial $5 million at closing. An additional $20 million is available at the Company’s request through June 15, 2023, with an additional $25 million available upon the Company’s achievement of certain milestones, and the remaining $25 million available subject to final lender approval. The Company is under no obligation to draw funds in the future.

R&D Expenses: Research and development expenses were $22.1 million during the third quarter of 2022, compared with $8.1 million for the same period last year. The increase in research and development expenses was primarily driven by personnel related costs, clinical trial costs for VRDN-001 and VRDN-002, as well as costs related to our preclinical programs and manufacturing costs for all of our programs. Research and development expenses were $61.6 million during the nine months ended September 30, 2022, compared with $34.5 million for the same period last year. The increase in research and development expenses was primarily driven by personnel related costs, license fees, clinical trial costs for VRDN-001 and VRDN-002, as well as costs related to our preclinical programs.

G&A Expenses: General and administrative expenses were $8.9 million during the third quarter of 2022, compared with $6.2 million for the same period last year. The increase in general and administrative expenses was driven by increases in personnel-related costs, including share-based compensation charges, as well as higher consulting expenses, and professional and license fees.

General and administrative expenses were $25.3 million during the nine months ended September 30, 2022, compared with $18.9 million for the same period last year. The increase in general and administrative expenses was driven by increases in personnel-related costs, including share-based compensation charges, as well as an increase in consulting expenses and professional service fees.

Net Loss: The Company’s net loss was $28.9 million for the third quarter of 2022, compared with $14.0 million for the same period last year. The increase in net loss was driven by increased operating costs, as described above.

Shares Outstanding: As of September 30, 2022, Viridian had approximately 56,217,886 shares of common stock outstanding on an as-converted basis, which included 40,244,355 shares of common stock outstanding and an aggregate of approximately 15,973,531 shares of common stock issuable upon the conversion of 188,381 and 51,210 shares of Series A and Series B preferred stock, respectively.

Conference call and webcast
The Company will host a conference call today at 8:00 a.m. ET to discuss the topline data for VRDN-001 and VRDN-002. The dial-in number for the conference call is 1-877-407-0789 for domestic participants and 1-201-689-8562 for international participants. The conference ID is 13732927. A live webcast of the conference call can be accessed through the “Events” page in the Investors section of the Viridian Therapeutics website. Following the live webcast, an archived version of the call will also be available on the website.

About Viridian Therapeutics
Viridian Therapeutics is a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by current therapies. Viridian’s most advanced program, VRDN-001, is a differentiated monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of thyroid eye disease (TED). VRDN-002 is a distinct anti-IGF-1R antibody and incorporates half-life extension technology. VRDN-003 is an extended half-life version of VRDN-001. Both VRDN-002 and VRDN-003 are designed for administration as convenient, low-volume, subcutaneous injections. TED is a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye which can cause double vision, pain, and potential blindness. Viridian is based in Waltham, Massachusetts.

Note Regarding 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 the Company’s expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding the Company’s expectations, strategies, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations, and assumptions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: the potential efficacy and safety of VRDN-001 and VRDN-002 for the treatment of TED; the relationship between the results from the positive data from the ongoing Phase 1/2 clinical trial of VRDN-001 and the first-in-human Phase 1 clinical trial of VRDN-002 and results of ongoing and future clinical trials; the timing, progress and plans for the Company’s ongoing and future research and clinical development programs; trial protocols for ongoing clinical trials, including the clinical trials for VRDN-001 and VRDN 002; expectations regarding the timing for data, including the expected timing of additional data from the ongoing Phase 1/2 clinical trial of VRDN-001 and the first-in-human Phase 1 clinical trial of VRDN-002; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in the Company’s clinical programs; manufacturing risks; competition from other therapies or products; other matters that could affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations; the Company’s financial position and its projected cash runway; the Company’s future operating results and financial performance; the timing of pre-clinical and clinical trial activities and reporting results from same; the effects from the COVID-19 pandemic on the Company’s research, development and business activities and operating results, including those risks set forth under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 11, 2022 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(amounts in thousands, except share and per share data)
(unaudited)

	Three Months Ended September 30,								Nine Months Ended September 30,
		2022				2021				2022				2021
Revenue:
Collaboration Revenue - related party	$	1,195			$	208			$	1,667			$	2,749
Total revenue		1,195				208				1,667				2,749
Operating Expenses:
Research and development		22,119				8,121				61,577				34,492
General and administrative		8,861				6,221				25,328				18,904
Total operating expenses		30,980				14,342				86,905				53,396
Loss from operations		(29,785	)			(14,134	)			(85,238	)			(50,647	)
Other income
Interest and other income		1,044				91				1,467				180
Interest expense		(164	)			—				(318	)			—
Net loss		(28,905	)			(14,043	)			(84,089	)			(50,467	)
Change in unrealized loss on investments		137				9				(783	)			5
Comprehensive loss	$	(28,768	)		$	(14,034	)		$	(84,872	)		$	(50,462	)
Net loss	$	(28,905	)		$	(14,043	)		$	(84,089	)		$	(50,467	)
Net loss per share, basic and diluted	$	(0.86	)		$	(1.25	)		$	(2.88	)		$	(5.95	)
Weighted-average shares used to compute basic and diluted loss per share		33,742,076				11,183,578				29,238,247				8,487,485

VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(amounts in thousands)
(unaudited)

	September 30,			December 31,
		2022			2021
Cash and cash equivalents	$	431,322		$	196,965
Other assets		9,258			6,744
Total assets	$	440,580		$	203,709
Total liabilities		31,573			15,993
Total stockholders’ equity		409,007			187,716
Total liabilities and stockholders’ equity	$	440,580		$	203,709

Investor and Media Contact
John Jordan
Viridian Therapeutics
Vice President, Investor Relations
& Corporate Communications
617-272-4691
IR@viridiantherapeutics.com

FAQ

What are the latest clinical results for VRDN-001 from Viridian Therapeutics?

The latest results from the Phase 1/2 trial of VRDN-001 showed significant improvement in symptoms of thyroid eye disease after two infusions.

What financial position does Viridian Therapeutics hold as of Q3 2022?

As of September 30, 2022, Viridian Therapeutics reported cash and equivalents of $431 million, providing a runway into the second half of 2025.

What is the net loss reported by Viridian Therapeutics for Q3 2022?

Viridian Therapeutics reported a net loss of $28.9 million for the third quarter of 2022, an increase from $14.0 million in the same period last year.

When was the Phase 3 THRIVE clinical program initiated by Viridian Therapeutics?

The global Phase 3 THRIVE clinical program was initiated recently, as part of the company's efforts to advance its TED treatment pipeline.