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VIRIDIAN THERAPEUTICS REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATES - Positive initial clinical data from ongoing Phase 1/2 Trial evaluating VRDN-001 in patients with Thyroid Eye Disease (T

Key Takeaway: VIRIDIAN THERAPEUTICS REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATES - Positive initial clinical data from ongoing Phase 1/2 Trial evaluating VRDN-001 in patients with Thyroid Eye Disease (TED) - - VRDN-002 achieved a substantially extended half-

Full Press Release Details

VIRIDIAN THERAPEUTICS REPORTS SECOND QUARTER 2022
FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATES
- Positive initial clinical data from ongoing Phase 1/2 Trial evaluating VRDN-001 in patients
with Thyroid Eye Disease (TED) -
- VRDN-002 achieved a substantially extended half-life of
30-40 days in healthy volunteers with a sustained IGF-1 response and a favorable safety and tolerability profile -
- Ended 2Q 2022 with cash, cash equivalents and short-term investments of $161 million, in addition to $75M credit facility, provide
cash runway into 2024
- Conference call today at 8:00 a.m. ET -
Waltham, Mass., August 15, 2022 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 second quarter ending June 30, 2022 and provided corporate updates.
Earlier today in a separate news release, the Company announced positive initial clinical data from the first cohort of the ongoing Phase 1/2 clinical trial
of VRDN-001, an IGF-1R antibody, in patients with thyroid eye disease (TED). In addition, Viridian announced positive topline data from a
first-in-human Phase 1 clinical trial of intravenously administered VRDN-002 in healthy volunteers.
We believe today s positive initial VRDN-001 data for the treatment of Thyroid Eye Disease is
transformative for Viridian and significantly advances our goal of improving patient care in TED. VRDN-001 delivered a rapid, compelling and clinically meaningful improvement at week 6 across all efficacy
measures of TED: proptosis, clinical activity score, and diplopia, exceeding results from any prior TED trials, said Jonathan Violin, Ph.D., President and CEO of Viridian Therapeutics. We look forward to quickly advancing VRDN-001, which we believe can be a best-in-class IV therapy for patients, to Phase 3. In addition, promising initial VRDN-002 data, together with the unveiling of VRDN-003, an extended half-life version of VRDN-001, significantly advances our
subcutaneous (SC) strategy. We expect to advance either VRDN-002 or VRDN-003 into registrational trials by year end 2023 based on clinical data from the two programs and
expect to initiate our SC Phase 3 program in early 2024.
Clinical plan and future milestones for Viridian TED programs
Additional VRDN-001 Phase 1/2 Cohorts
Global VRDN-001 Phase 3 Program in Active and Chronic TED
SC Program: VRDN-002 and VRDN-003
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 Viridian management team will be joined by Raymond Douglas, M.D., Ph.D., Director of the Thyroid Eye Disease Program at Cedars-Sinai Medical
Center. 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 13730501. 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.
Second Quarter 2022 Financial Results
Position: Cash, cash equivalents and short-term investments were $161.2 million as of June 30, 2022, compared with $197 million as of December 31, 2021. The Company believes that its current cash, cash equivalents and
short-term investments, in addition to its $75M credit facility, will be sufficient to fund its operations into 2024.
During the second quarter 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 $21.7 million during the second quarter
of 2022, compared with $12.6 million for the same period last year. The increase in research and development expenses was primarily driven by personnel related costs, license fees and clinical trial costs for
VRDN-001 and VRDN-002, as well as costs related to our preclinical programs. These increases were offset by expenses related to manufacturing costs for VRDN-001 and VRDN-002 that were incurred in the second quarter of 2021. Research and development expenses were $39.5 million during the six months ended June 30,
2022, compared with $26.4 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. These increases were offset by expenses related to manufacturing and IND-enabling studies for VRDN-001 and VRDN-002 that were incurred in the same period last year.
G&A Expenses: General and administrative expenses were $8.1 million during the second quarter of 2022, compared with $6.5 million for the
same period last year. The increase in general and administrative expenses was driven by increases in personnel-related costs, including severance, share-based compensation charges, and consulting expenses.
General and administrative expenses were $16.5 million during the six months ended June 30, 2022, compared with $12.7 million for the same
period last year. The increase in general and administrative expenses was driven by increases in personnel-related costs, including severance, share-based compensation charges, and consulting expenses.
Net Loss: The Company s net loss was $29.5 million for the second quarter of 2022, compared with $18.0 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 June 30, 2022, Viridian
had approximately 42,909,027 shares of common stock outstanding on an as-converted basis, which included 28,463,980 shares of common stock outstanding and an aggregate of approximately 14,445,047 shares of
common stock issuable upon the conversion of 193,539 and 23,126 shares of Series A and Series B preferred stock, respectively.
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
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)
Three Months Ended June 30, Six Months Ended June 30,
2022 2021 2022 2021
Revenue:
Collaboration Revenue - related party $ 256 $ 1,090 $ 472 $ 2,541
Operating Expenses:
Research and development 21,712 12,565 39,458 26,371
General and administrative 8,108 6,523 16,467 12,683
Total operating expenses 29,820 19,088 55,925 39,054
Loss from operations (29,564 ) (17,998 ) (55,453 ) (36,513 )
Other income
Interest and other income 227 34 423 89
Interest expense (154 ) (154 )
Net loss (29,491 ) (17,964 ) (55,184 ) (36,424 )
Change in unrealized loss on investments (142 ) 9 (920 ) (4 )
Comprehensive loss $ (29,633 ) $ (17,955 ) $ (56,104 ) $ (36,428 )
Net loss $ (29,491 ) $ (17,964 ) $ (55,184 ) $ (36,424 )
Net loss per share, basic and diluted $ (1.06 ) $ (2.21 ) $ (2.05 ) $ (5.04 )
Weighted-average shares used to compute basic and diluted loss per share 27,762,257 8,106,765 26,948,692 7,226,447
VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(amounts in thousands)
June 30, December 31,
2022 2021
Cash and cash equivalents $ 161,207 $ 196,965
Other assets 8,607 6,744
Total assets $ 169,814 $ 203,709
Total liabilities 27,916 15,993
Total stockholders equity 141,898 187,716
Total liabilities and stockholders equity $ 169,814 $ 203,709
Investor and Media Contact
Viridian Therapeutics
Vice President, Investor Relations
& Corporate Communications
Last updated: Aug 15, 2022