UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On August 15, 2022, Viridian Therapeutics, Inc. (the “Company”), issued a press release reporting financial results for the three months ended June 30, 2022.
The press release is attached hereto as Exhibit 99.1, which is furnished under Item 2.02 of this Current Report on Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), regardless of any general incorporation language in such filing.
| Item 7.01 | Regulation FD Disclosure. |
On August 15, 2022, the Company made available an updated investor presentation. Also on August 15, 2022, the Company made available a presentation regarding, and issued a press release announcing, positive initial clinical data from its Phase 1/2 trial of VRDN-001, as well as first-in-human data from its Phase 1 trial of VRDN-002.
The investor presentation, data presentation and press release are attached hereto as Exhibit 99.2, Exhibit 99.3 and Exhibit 99.4 respectively, which are furnished under Item 7.01 of this Current Report on Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press release regarding financial results, dated August 15, 2022 | |
| 99.2 | Viridian Therapeutics, Inc. Investor Presentation, dated August 2022 | |
| 99.3 | Viridian Therapeutics, Inc. Data Presentation, dated August 2022 | |
| 99.4 | Press release regarding data, dated August 15, 2022 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Viridian Therapeutics, Inc. | ||||||
| Date: August 15, 2022 | By: | /s/ Jonathan Violin | ||||
| Jonathan Violin | ||||||
| President, Chief Executive Officer, and Director | ||||||
Exhibit 99.1
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
| • | VRDN-001 20mg/kg cohort data presentation planned for a medical meeting in the fourth quarter of 2022. VRDN-001 3mg/kg cohort is expected to deliver data in the fourth quarter of 2022 |
| • | Additional VRDN-001 chronic TED proof-of-concept cohorts now planned to launch in the fourth quarter of 2022, with data expected in the first half of 2023 |
Global VRDN-001 Phase 3 Program in Active and Chronic TED
| • | First VRDN-001 double-blind, placebo-controlled Phase 3 trial (THRIVE), in active TED patients, expected to initiate by the end of 2022, with topline data expected in mid-year 2024. The planned trial will evaluate the 10mg/kg dose, with a rapid 30-minute infusion time, in two treatment regimens: |
| • | a standard 8-infusion Q3W regimen matching Tepezza dosing regimen |
| • | an accelerated 12-week, 5-infusion Q3W regimen, offering a 43% shorter, highly differentiated dosing regimen |
| • | Second VRDN-001 double-blind, placebo-controlled Phase 3 trial (THRIVE-2), in chronic TED patients, expected to initiate in the first half of 2023 with topline data by the end of 2024 |
| • | THRIVE and THRIVE-2 trial results are expected to form the basis of both a biologics license application (BLA) in the US as well as a marketing authorization application (MAA) in the EU |
SC Program: VRDN-002 and VRDN-003
| • | VRDN-002 will advance to a proof-of-concept trial in TED, evaluating 300mg SC injection of 2mL, dosed Q2W or Q4W, with data expected in the second half of 2023 |
| • | Viridian is unveiling VRDN-003, an extended half-life version of VRDN-001. VRDN-003 builds upon the clinical performance of VRDN-001 by incorporating the same technology that enabled VRDN-002 to achieve its substantially extended half-life. VRDN-003 has similar non-human primate half-life to VRDN-002 and is expected to match the VRDN-002 human half-life. IND filing for VRDN-003 is planned for the second quarter of 2023 with proof-of-concept data expected in the fourth quarter of 2023. |
| • | By the end of 2023, the Company expects to select to advance either VRDN-002 or VRDN-003 into registrational trials based on clinical data from the two programs and plans to initiate a global Phase 3 program of a potentially best-in-class SC therapy for TED in early 2024. |
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 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
Cash 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.
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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: |
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| 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 | ||||||||||||
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| Total operating expenses |
29,820 | 19,088 | 55,925 | 39,054 | ||||||||||||
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| Loss from operations |
(29,564 | ) | (17,998 | ) | (55,453 | ) | (36,513 | ) | ||||||||
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| Other income |
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| Interest and other income |
227 | 34 | 423 | 89 | ||||||||||||
| Interest expense |
(154 | ) | — | (154 | ) | — | ||||||||||
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| Net loss |
(29,491 | ) | (17,964 | ) | (55,184 | ) | (36,424 | ) | ||||||||
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| Change in unrealized loss on investments |
(142 | ) | 9 | (920 | ) | (4 | ) | |||||||||
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| Comprehensive loss |
$ | (29,633 | ) | $ | (17,955 | ) | $ | (56,104 | ) | $ | (36,428 | ) | ||||
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| Net loss |
$ | (29,491 | ) | $ | (17,964 | ) | $ | (55,184 | ) | $ | (36,424 | ) | ||||
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| Net loss per share, basic and diluted |
$ | (1.06 | ) | $ | (2.21 | ) | $ | (2.05 | ) | $ | (5.04 | ) | ||||
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| Weighted-average shares used to compute basic and diluted loss per share |
27,762,257 | 8,106,765 | 26,948,692 | 7,226,447 | ||||||||||||
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VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(amounts in thousands)
(unaudited)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash and cash equivalents |
$ | 161,207 | $ | 196,965 | ||||
| Other assets |
8,607 | 6,744 | ||||||
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| Total assets |
$ | 169,814 | $ | 203,709 | ||||
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| Total liabilities |
27,916 | 15,993 | ||||||
| Total stockholders’ equity |
141,898 | 187,716 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 169,814 | $ | 203,709 | ||||
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Investor and Media Contact
John Jordan
Viridian Therapeutics
Vice President, Investor Relations
& Corporate Communications
617-272-4691

Exhibit 99.2 Corporate Presentation August 2022

Cautionary note regarding forward-looking statements This presentation 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 include, without limitation, statements regarding our expectations, strategies, 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. 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 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 future of ongoing clinical trials; the timing, progress and plans for our 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 our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, including VRDN-001 and VRDN-002; 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; our financial position and its projected cash runway; our future operating results and financial performance; the clinical utility of our therapeutic candidates and our intellectual property position; the timing of pre-clinical and clinical trial activities and reporting results from same; the effects from the COVID-19 pandemic on our research, development and business activities and operating results, including those risks set forth under the caption Risk Factors in our 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. The forward-looking statements in this presentation represent our views as of the date of this presentation. Neither we, nor our 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 our views as of any date subsequent to the date of this presentation. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. 2

Investment highlights 1) Large opportunity in TED and beyond • Initial focus on thyroid eye disease (TED) – Global Phase 3 registrational program in active and chronic TED to launch by YE22 to support BLA and MAA • TED is a $3.5B+ market opportunity with Europe to provide additional upside • Multiple assets for next wave of growth beyond TED 2) Best-in-class IGF-1R antibodies for TED • VRDN-001 (IV): Positive topline data from the 10mg/kg cohort in the ongoing Phase 1/2 clinical trial for TED • Phase 3 THRIVE registrational program to launch by YE22, with topline data in MY24 • VRDN-002 (SC): Extended half-life of 30-40 days supports potential best-in-class low-volume Q2W or Q4W SC profile for TED 3) VRDN-001 shows significant improvement in signs & symptoms of TED in just 6 weeks • 83% proptosis responder rate • 83% of patients achieved maximal or near-maximal therapeutic effect on the Clinical Activity Score (CAS) • 83% overall responder rate • 75% resolution of diplopia 4) Strong financial position • Cash, cash equivalents and short-term investments were $161.2M as of June 30, 2022 • $75M credit facility ($5M drawn) • Cash runway into 2024 1 2 • 43M total common shares outstanding on an as converted basis – implied market cap of $632M (1) As of July 1, 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 and 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 3 (2) As of August 12, 2022, based on a stock price of $14.73

Viridian’s discovery engine leverages core expertise in antibody discovery and engineering 1 2 3 4 5 First entrant Significant market First entrant Viridian Rapidly advance validates a new opportunity; leaves room for mechanism of serious disease improvement engineering potential best- action with limited potential best- in-class mAbs to competition in-class patients optimized mAbs 4 Strategy

Viridian development pipeline DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Milestones Rights • 20mg/kg POC data: 4Q22 • 3mg/kg POC data:4Q22 WW ex Thyroid Eye VRDN-001 • Chronic POC data: 1H23 Greater (Intravenous) Disease 1 • P3 THRIVE (Active) data: MY24 China (anti-IGF-1R mAbs)• P3 THRIVE-2 (Chronic) data: YE24 VRDN-002 WW ex • TED POC data:2H23 Greater (Subcutaneous, 1 China extended half-life) VRDN-003 WW ex (Subcutaneous, • IND: 2Q23 Greater • POC PK/PD data: 4Q23 extended half-life 1 China VRDN-001) Rare Disease • Candidate: 2023 WW VRDN-004 (Undisclosed mAb) Immunology VRDN-005• Candidate: 2023 WW (Undisclosed mAb) (1) Outlicensed greater area of China rights to Zenas BioPharma. 5

Next steps: large commercial opportunity guides our urgency Tepezza annualizing ~$2B in US 2 years after first product approval; substantial room for growth Active TED moderate to severe $3.5B+ 20-25K 35-40K 20-40% Tepezza 0% Tepezza share share today (not approved) ~$2B (2022E) Chronic TED 75K+ 150K+ moderate to severe <10% Tepezza 0% Tepezza share US sales 2 years Peak sales share today following first opportunity (not approved) product approval (not including EU) Source: Horizon Therapeutics Q2 22 earnings: peak U.S. annual net sales of >$3B and ex-U.S. estimate of >$500M peak 6 annual net sales, does not include expected entrance to Europe; Viridian-sponsored market research

VRDN-001 Potential best-in-class IV treatment for TED 7

VRDN-001 Phase 1/2 trial Population characteristics Healthy Data reported similar to Tepezza Phase 3: May 2022 volunteers • Active TED • CAS ≥4 TED 10mg/kg Data reported • Onset of active TED Q3W x2 August 15 n=6 VRDN-001 symptoms within 12 months n=2 placebo Endpoints reported today: Planned for 4Q22 • Safety/tolerability TED 20mg/kg medical meeting • Efficacy measures at 6 weeks – Overall responder rate Data expected – Proptosis responder rate TED 3mg/kg 4Q22 – Proptosis change from baseline – CAS change from baseline NEW: Chronic TED – CAS of 0 or 1 Initiation expected Data expected 4Q22 1H23 POC cohorts– Diplopia resolution 8

All VRDN-001 efficacy measures compare favorably to Tepezza Signs Symptoms Improvement in Improvement in Clinical Activity Score (CAS) proptosis and diplopia score Overall response: Proptosis: Proptosis: CAS: CAS: Diplopia: Complete Signs + symptoms Responder rate Mean change Score of 0 or 1 Mean change resolution (Improvement in (% with ≥2mm (change from (% achieving CAS of 0 (change from (% improved to a proptosis & clinical reduction from baseline to week 6) or 1 at week 6) baseline to week 6) score of 0 at week 6) activity score) baseline to week 6) VRDN-001 83% 83% -2.4mm 83% -4.3 75% (at 10mg/kg -> 10mg/kg; week 6) Tepezza 44% 56% -1.9mm 22% -2.1 36% (at 10mg/kg -> 20mg/kg; week 6) Clinical Activity Score (CAS) = a composite 0-7 scale scoring signs and symptoms of TED 9 Tepezza Phase 3 data: Douglas RS, et al, Ophthalmology 129:4, Apr 2022 FDA clinical review of Tepezza (BLA 761143)

Rapid and robust proptosis reduction in VRDN-001 treated patients Change in proptosis (mm) Reduction in proptosis Mean proptosis change Reduction in proptosis (from baseline to week 6) (from baseline to week 6) (from baseline to week 6) (from baseline to week 6) VRDN-001 Active Pla Plac cebo ebo 10mg/kg 0 50% 0% ≥3.0mm 3/6 ³ 3.0mm Placebo Placebo n=2 3 -1 n = 2 -1.0mm ≥2.5mm 67% 4/6 ³ 2.5mm 0% VRDN-001 VRDN-001 -2 10mg/kg 10mg/kg ³ 2.0mm ≥2.0mm 83% 50% 5/6 1/2* n = 6 n=6 -2.4mm -3 100% 50% 0 50% 100% W We ee ek k 0 0 W We ee ek k 6 6 * Where MRI confirmation of proptosis reduction was available, VRDN-001 proptosis responses were confirmed; proptosis response 10 in placebo patient observed by exophthalmometer was not confirmed by MRI, and CAS in this patient did not improve Change from baseline proptosis (mm)

Proptosis reduction compares favorably with Tepezza Mean proptosis change Proptosis responder rate at week 6 Proptosis response rate at week 6 (from baseline to week 6) (Proptosis Responder ≥2mm change from baseline proptosis) 83% 83% Tepezza 56% 56% 55% 55% Tepezza Phase 2 VRDN-001 Phase 3 10mg/kg -1.8mm -1.9mm -2.4mm VRDN-001 Tepezza Tepezza Tepezza Tepezza VRDN-001 10mg/kg Phas Phase e 2 2 Phas Phase e 3 3 10mg/kg Proptosis change from baseline presented as mean ± SEM Tepezza Phase 2 data: Smith TJ, et al, NEJM 376:18, May 2017, FDA clinical review of Tepezza (BLA 761143) 11 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020, Douglas RS, et al, Ophthalmology 129:4, Apr 2022 Change from baseline proptosis (mm)

Significant improvement in symptoms as measured by CAS Clinical Activity Score (CAS): a composite 0-7 scale scoring signs and symptoms of TED Change in CAS score Mean change in CAS Reduction in CAS CAS of 0 or 1 at week 6 (from baseline to week 6) Reduction in CAS score (from baseline to week 6) (from baseline to week 6) (from baseline to week 6) VRDN-001 0 10mg/kg Placebo 83% -1 Placebo 4/6 ³5 67% 0% n=2 -2 -1.5 4/6 ³4 67% 0% -3 VRDN-001 10mg/kg ³3 6/6 1/2 50% 100% -4 n=6 0% -4.3 -5 VRDN-001 Placebo Week 0 Week 6 -100% -50% 0% 50% 100% 10mg/kg 12 Change from baseline score

Symptoms improvement compares favorably with Tepezza Clinical Activity Score (CAS): a composite 0-7 scale scoring signs and symptoms of TED Mean CAS Change CAS of 0 or 1 at week 6 Mean CAS improvement at week 6 CAS of 0 or 1 at week 6 (to week 6) (Change from baseline score) Tepezza VRDN-001 Tepezza VRDN-001 Tepezza Tepezza 83% Phase 2 10mg/kg Phase 3 83% 10mg/kg Phase 2 Phase 3 -4.3 -2.5 -2.1 -2.1 -2.5 22% 21% 22% 21% -4.3 Tepezza Tepezza VRD VRDN N -0 - 0001 1 Tepezza Tepezza Phase 2 Phase 3 10mg/kg Phase 2 Phase 3 10mg/kg Tepezza Phase 2 data: Smith TJ, et al, NEJM 376:18, May 2017 13 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020 FDA clinical review of Tepezza (BLA 761143)

Significant improvement in both signs and symptoms of TED Overall response defined as reduction in proptosis of ≥2mm and reduction in CAS ≥2 points Overall response Overall response Overall response at week 6 at week 6 at week 6 (% responder) 83% 83% 3 5/6 0% 0% Tepezza Tepezza VRDN-001 Placebo VRDN-001 VRDN-001 Placebo Phase 2 Phase 3 10mg/kg 10mg/kg 10mg/kg Tepezza Phase 2 data: FDA clinical review of Tepezza (BLA 761143) 14 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020

Responses occur rapidly and compare favorably to Tepezza Mean time to response (weeks) Median time to proptosis response Mean time to overall response Mean time to response (weeks) VRDN-001 VRDN-001 VRDN-001 VRDN-001 3.0 4.8 3.0 4.8 10mg/kg 10mg/kg 10mg/kg 10mg/kg weeks weeks Tepez Tepezzz aa Tepezza Tepezza 6.4 11.2 6.4 11.2 Phase 3 Phase 2 Phase 3 Phase 2 weeks weeks Week 0 Week 3 Week 6 Week 9 Week 12 Week 0 Week 3 Week 6 Week 9 Week 12 Reported as median time to response to enable comparison to published Reported as mean time to response to enable comparison to published Tepezza data. Tepezza reported median time to proptosis response in P3 NEJM Tepezza data. Tepezza reported mean time to overall response in P2 NEJM publication. P2 NEJM publication did not report any time to proptosis response. publication. P3 NEJM publication did not report any time to overall response. Tepezza Phase 2 data: Smith TJ, et al, NEJM 376:18, May 2017 15 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020

75% of VRDN-001 patients had complete diplopia resolution at week 6 Diplopia resolution rate defined as % of patients with diplopia at baseline that improved to a score of 0 Diplopia resolution vs. Tepezza Complete diplopia resolution at week 6 Complete dip( l% op rie as r pe os no de lu rs t)ion at week 6 *Diplopia resolution (dg) 75% 75% 75% 75% 36% 36% 30% 29% 0% 0% 3/4 0/1 Tepezza Tepez Tepezzz aa V Tepez RDN-0z 01 a VRDN-001 VRDN-001 Placebo VRDN-001 Placebo Phase 2 Phase 3 10mg/kg Phase 2 Phase 3 10mg/kg 10mg/k 10mg/kg g For patients with diplopia at baseline, complete diplopia resolution defined as Gorman subjective diplopia score of zero 16 FDA clinical review of Tepezza (BLA 761143)

Favorable safety profile VRDN-001 (10mg/kg), TED patients TEPEZZA label VRDN-001 Placebo TEPEZZA Placebo 10mg/kg (n=84), n (%) (n=86), n (%) (n=2), n (n=6), n ADVERSE REACTIONS: 21 (25%) 6 (7%) Muscle spasms 2 - No serious Nausea - - 14 (17%) 8 (9%) adverse events (SAEs) Alopecia - 1 11 (13%) 7 (8%) 1* - 10 (12%) 7 (8%) Diarrhea Fatigue 1 2 10 (12%) 6 (7%) Hyperglycemia - - 8 (10%) 1 (1%) Hearing impairment 1 - 8 (10%) 0 (0%) No 7 (8%) 0 (0%) Dysgeusia - - hyperglycemia and no infusion Headache 1 1* 7 (8%) 6 (7%) reactions Dry skin - - 7 (8%) 0 (0%) - - 4% N/A Infusion reactions As of Aug. 9 cutoff, no hyperglycemia, hearing impairment, muscle spasms, infusion reactions, or SAEs in the 20mg/kg cohort Data are as of data cut-off of August 9, 2022. Other AE that occurred in more than one patient and deemed related to study drug by masked investigators was acne (n=2). Instances were mild and did not require intervention. Muscle spasms were mild and did not require intervention; hearing impairment was “ringing in the ears” which resolved within 2 weeks without intervention 17 * Deemed unrelated to study drug by the masked investigators

VRDN-001 is a more complete antagonist of IGF-1R, potentially explaining favorable clinical activity Mutational scan reveals unique signatures of IGF-1R antibodies Maximal IGF-1R inhibition (%) Residual IGF-1R activity (% Inhibition) VRDN-001 Tepezza VRDN-002 lonigutumab 10% 00% 4% 26% 24% 39% 25 7% 5% 61% VRDN-001 50 5% 0% produces 74% 76% greatest 75 2% 5% inhibition 96% 10% 90% Point mutations Domain deletion 100% 0% no binding no binding reduced binding reduced binding VRDN-001 binding modality is unique VRDN-001 is a full antagonist, unlike other anti-IGF-1R mAbs • VRDN-001 is sensitive to the same domain deletions as Tepezza and VRDN-• VRDN-001 is a full antagonist of IGF-1 mediated signaling 002 but different point mutations, suggesting a similar binding site but distinct • Tepezza and VRDN-002 are both partial antagonists, consistent with receptor interaction their similar receptor interactions • Tepezza and VRDN-002 have highly similar binding interactions • Lonigutamab binds distally and is a partial antagonist in this assay • Lonigutumab has a different, unrelated epitope vs. the other three antibodies • Full antagonism by VRDN-001 is consistent with larger increases in IGF-1 as it can bind IGF-1R simultaneously with Tepezza, VRDN-002, or VRDN-001 in VRDN-001 treated volunteers vs. other published IGF-1R antibodies 18

VRDN-001 may offer a shorter treatment course Change in proptosis from baseline Phase 3 program: standard and shortened treatment course in active and chronic TED 2023 2024 • THRIVE trial: placebo- Topline controlled, active TED Active TED (n=120) • THRIVE-2 trial: placebo- Topline controlled, chronic TED Chronic TED (n=120) Last 2 doses offer limited additional benefit • Three arms per trial: Week 12 Week 24 − Standard 8 infusions − Accelerated 5 infusions VRDN-001, Q3W 8x − Placebo VRDN-001, Q3W 5x • 24 week primary Tepezza Phase 3 data suggest limited endpoint Placebo treatment benefit after 18 weeks VRDN-001 Phase 3 will study both a standard 8 infusion course (same as Tepezza) and a shorter 5 infusion course Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020 19

VRDN-002 Potential best-in-class subcutaneous treatment for TED 20

VRDN-002 has extended half-life of 30-40 days Non-human primate PK VRDN-001 HV VRDN-002 HV Time (days) Time (days) Time (days) • VRDN-001 and Tepezza PK very similar in non-human primates: ~6 day half-life 1-6 • VRDN-001 and Tepezza PK very similar in oncology patients: ~10-11 day half-life across 6 clinical trials • VRDN-002 half-life ~3x VRDN-001 in healthy volunteers: interim analysis shows 30-40 day half-life • No SAEs, hearing impairment, hyperglycemia, muscle spasms, or infusion reactions reported as of last subject last visit for VRDN-002 HV = healthy volunteers 3) Gore L et al, Mol Cancer Ther, 8(12 Suppl), 2009 * Historical data from AVE-1642 IND 4) Faivre SJ et al, J Clin Onc, 29 (4 Suppl), February 2011 21 1) Rodon J et al, J Clin Onc, 2518 Suppl), June 2007 5) Soria JC et al, Eur J Cancer, 49 (8), 2013 2) Kurzrock R et al, Clin Cancer Res, 16(8), April 2010 6) Moreau P et al, Leukemia 25 (5), February 2011

VRDN-002 mediates IGF-1 increases similar to teprotumumab PK/PD modeling indicate potential feasibility of 2mL 300mg Q2W to Q4W SC dosing % Change from Baseline of IGF-1 in normal healthy volunteers Teprotumumab VRDN-002 Planned SC POC trial in TED Presumed Placebo Removed Randomized, double-blind trial of 2mL 300mg 1 mg/kg 3 mg/kg Q2W and Q4W SC dosing vs placebo 400 400 3 mg/kg 10 mg/kg 9 mg/kg 20 mg/kg Placebo Cohort 1 SC Q2W 6 patients 200 200 Placebo 2 patients Cohort 2 0 0 SC Q4W 6 patients 0 1 2 3 4 5 6 7 0 20 40 60 80 100 Time (days) Time (days) Placebo 2 patients ~2.5x increase in plasma IGF-1 ~2.5x increase in plasma IGF-1 published data only through Day 7 elevated through Day 84 after single dose Teprotumumab data from Kurzrock R et al, Clin Canc Res 16(8) April 2010 22 % Change from Baseline IGF-1 % Change from Baseline IGF-1

Global TED development plan To rapidly enter US and EU markets in both active and chronic TED 23

Corporate objectives in TED: Build a market-leading franchise 2 1 Launch Rapidly follow potential best- IV launch with in-class IV TED potential best- therapy in US in-class SC TED and EU therapy 24

Highlights of global IV VRDN-001 Phase 3 program plan • Designed to assess pivotal efficacy data Global registrational in active AND chronic disease 2023 2024 program for both active • Registrational program designed to enable approval in US, EU, and other and chronic TED Topline Active TED (n=120) major and emerging markets Topline Chronic TED (n=120) • Accelerated, 12 week, course of therapy − 43% shorter than Tepezza Potential improvements • Shorter infusion times (30 min for on Tepezza VRDN-001 vs. 60-90 min for Tepezza) • Faster onset and improved efficacy Week 24 Week 12 • Phase 3 program to initiate by YE22 VRDN-001, Q3W 8x • 17 sites active, 30 expected by YE22, Rapid timelines to enter expanding to >50 in 1H23 VRDN-001, Q3W 5x a multibillion $ market • Phase 3 active TED data by MY24 Placebo • Phase 3 chronic TED data by YE24 25

Viridian is poised to deliver a potential best-in-class SC TED therapy Both VRDN-002 and VRDN-003 show potential for Q2W and Q4W dosing to be tested convenient, low-volume, SC product profile • VRDN-002 epitope and in vitro profile very similar • 2mL 300mg SC Q2W compares favorably with to teprotumumab, achieves half-life ~3x first other successful SC products generation anti-IGF-1R mAbs – VRDN-001 PK/PD and efficacy data at 10mg/kg inform VRDN-002 and VRDN-003 dose selection – Interim analysis shows 30-40 day half-life – PK/PD modeling supports at least 2mL 300mg SC Q2W • Unveiling VRDN-003: extended half-life VRDN-001 profile for both VRDN-002 and VRDN-003 – Retains unique VRDN-001 binding & antagonist – VRDN-001 efficacy data at 3mg/kg to further inform properties Q4W or longer profiles for VRDN-002 and VRDN-003 – Same half-life extension technology as VRDN-002 • Launch with patient-friendly pre-filled pen device – Non-human primate data show PK expected to match VRDN-002 – Well into IND enabling activities; IND expected 2Q23; healthy volunteer PK/PD data 4Q23 Plan to choose either VRDN-002 or VRDN-003 by YE23, and initiate Phase 3 trials in early 2024 26

Q2W to Q4W TED SC program plan Clinical data allows us to select best program to start a planned Phase 3 trial in early 2024 Decision: Select one SC program to advance 2023 2024 VRDN-002 SC SC POC Q2W to Q4W Topline trial initiation SC patient data 2H23 SC Phase 3 Planned initiation Planning for active early 2024 VRDN-001 sites to roll over to SC Phase 3 program POC PK/PD HV VRDN-003 SC Submit IND single dose data extended half-life 001 Q2W to Q4W SC HV data HV multiple dose 4Q23 27

Timeline and planned milestones 4Q22 YE22 MY24 3mg/kg active TED data 20mg/kg Initiation data active TED data 1H23 YE24 upcoming medical congress Initiation data Chronic TED Chronic TED POC initiation POC data Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2022 2023 2024 SC 003 IND SC phase 3 start SC 002 TED POC data 2Q23 Early 24 2H23 SC 003 HV POC data 4Q23 28

Management team Jonathan Violin, Ph.D. President & CEO Vahe Bedian, Ph.D. Chief Scientist Kristian Humer Chief Financial & Business Officer Barrett Katz, M.D. Chief Medical Officer Carrie Melvin Chief Operating Officer Deepa Rajagopalan, M.D. SVP, New Product and Portfolio Development Janielle Newland SVP, Human Resources Lara Meisner, J.D. SVP, General Counsel Angela She, Ph.D. VP, R&D Operations 29 29

Investment highlights 1) Large opportunity in TED and beyond • Initial focus on thyroid eye disease (TED) – Global Phase 3 registrational program in active and chronic TED to launch by YE22 to support BLA and MAA • TED is a $3.5B+ market opportunity with Europe to provide additional upside • Multiple assets for next wave of growth beyond TED 2) Best-in-class IGF-1R antibodies for TED • VRDN-001 (IV): Positive topline data from the 10mg/kg cohort in the ongoing Phase 1/2 clinical trial for TED • Phase 3 THRIVE registrational program to launch by YE22, with topline data in MY24 • VRDN-002 (SC): Extended half-life of 30-40 days supports potential best-in-class low-volume Q2W or Q4W SC profile for TED 3) VRDN-001 shows significant improvement in signs & symptoms of TED in just 6 weeks • 83% proptosis responder rate • 83% of patients achieved maximal or near-maximal therapeutic effect on the Clinical Activity Score (CAS) • 83% overall responder rate • 75% resolution of diplopia 4) Strong financial position • Cash, cash equivalents and short-term investments were $161.2M as of June 30, 2022 • $75M credit facility ($5M drawn) • Cash runway into 2024 1 2 • 43M total common shares outstanding on an as converted basis – implied market cap of $632M (1) As of July 1, 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 and 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 30 (2) As of August 12, 2022, based on a stock price of $14.73

Corporate Presentation August 2022

Exhibit 99.3 VRDN-001 & VRDN-002 initial clinical data August 15, 2022

Cautionary note regarding forward-looking statements This presentation 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 include, without limitation, statements regarding our expectations, strategies, 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. 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 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 future of ongoing clinical trials; the timing, progress and plans for our 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 our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, including VRDN-001 and VRDN-002; 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; our financial position and its projected cash runway; our future operating results and financial performance; the clinical utility of our therapeutic candidates and our intellectual property position; the timing of pre-clinical and clinical trial activities and reporting results from same; the effects from the COVID-19 pandemic on our research, development and business activities and operating results, including those risks set forth under the caption Risk Factors in our 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. The forward-looking statements in this presentation represent our views as of the date of this presentation. Neither we, nor our 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 our views as of any date subsequent to the date of this presentation. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. 2

INTRODUCTION 1 Jonathan Violin, Ph.D., President and Chief Executive Officer Agenda 2 VRDN-001 PROOF OF CONCEPT RESULTS Barrett Katz, M.D., Chief Medical Officer Jonathan Violin, Ph.D. President and Chief Executive Officer Raymond Douglas, M.D., Ph.D., Director, Thyroid Eye Disease Program, Cedars-Sinai Medical Center 3 Raymond Douglas, M.D., Ph.D. TAKEAWAYS FOR VRDN-001 AND VRDN-002 DATA; PHASE 3 AND SC PLANS Director, Thyroid Eye Disease Program, Cedars-Sinai Medical Center Jonathan Violin, Ph.D., President and Chief Executive Officer 4 Barrett Katz, M.D. SECOND QUARTER FINANCIALS Chief Medical Officer Kristian Humer, Chief Financial and Business Officer Kristian Humer 5 Chief Financial and Business Officer Q&A Jonathan Violin, Ph.D., President and Chief Executive Officer Raymond Douglas, M.D., Ph.D., Director, Thyroid Eye Disease Program, Cedars-Sinai Medical Center Barrett Katz, M.D., Chief Medical Officer Kristian Humer, Chief Financial and Business Officer 3 3

VRDN-001 treated TED patients had rapid, significant response on a wide array of endpoints Two infusions of VRDN-001 10mg/kg three weeks apart resulted in rapid, significant improvements in proptosis, Clinical Activity Score (CAS), and diplopia at week 6 The initial dataset compares favorably to clinical data generated by Tepezza® At week 6, patients treated with VRDN-001: Overall Proptosis change Proptosis Median time to response from baseline responder rate proptosis response weeks 83% -2.4 83% 3 (5/6 patients) mm (5/6 patients) CAS Score Mean change Diplopia 0 or 1 in CAS resolution 83% -4.3 75% (5/6 patients) points (3/4 patients) Note: all third-party clinical data in this presentation is based on third-party studies, which are in different stages of development, and not our own. 4 Conclusions are company estimates and are not based on head-to-head results with Horizon Therapeutics’ Tepezza or any other third party product

All VRDN-001 efficacy measures compare favorably to Tepezza Signs Symptoms Improvement in Improvement in Clinical Activity Score (CAS) proptosis and diplopia score Overall response: Proptosis: Proptosis: CAS: CAS: Diplopia: Complete Signs + symptoms Responder rate Mean change Score of 0 or 1 Mean change resolution (Improvement in (% with ≥2mm (change from (% achieving CAS of 0 (change from (% improved to a proptosis & clinical reduction from baseline to week 6) or 1 at week 6) baseline to week 6) score of 0 at week 6) activity score) baseline to week 6) VRDN-001 83% 83% -2.4mm 83% -4.3 75% (at 10mg/kg -> 10mg/kg; week 6) Tepezza 44% 56% -1.9mm 22% -2.1 36% (at 10mg/kg -> 20mg/kg; week 6) Clinical Activity Score (CAS) = a composite 0-7 scale scoring signs and symptoms of TED 5 Tepezza Phase 3 data: Douglas RS, et al, Ophthalmology 129:4, Apr 2022 FDA clinical review of Tepezza (BLA 761143)

VRDN-001 Phase 1/2 trial Population characteristics Healthy Data reported similar to Tepezza Phase 3: May 2022 volunteers • Active TED • CAS ≥4 TED 10mg/kg • Onset of active TED Q3W x2 Reporting today n=6 VRDN-001 symptoms within 12 months n=2 placebo Endpoints reported today: Planned for 4Q22 • Safety/tolerability TED 20mg/kg medical meeting • Efficacy measures at 6 weeks – Overall responder rate Data expected – Proptosis responder rate TED 3mg/kg 4Q22 – Proptosis change from baseline – CAS change from baseline NEW: Chronic TED – CAS of 0 or 1 Initiation expected Data expected 4Q22 1H23 POC cohorts– Diplopia resolution 6

VRDN-001 proof of concept results Raymond Douglas, M.D., Ph.D., Director, Thyroid Eye Disease Program, Cedars-Sinai Medical Center 7

Baseline patient characteristics similar to Tepezza trials VRDN-001 Placebo Tepezza Ph2 Tepezza Ph3 n 42 41 6 2 23.4 22.6 Proptosis, mean (SEM) 24.8 (1.2) 22.5 (4.5) CAS, mean (SEM) 5.1 5.1 5.2 (0.3) 5.5 (1.5) 38 (90%) 28 (67%) Diplopia, n (%) 4 (67%) 1 (50%) Diplopia, mean (SEM) 1.8 Not reported 1.3 (0.5) 1.5 (1.5) Months since onset of TED signs/symptoms, 4.7 6.2 7.3 (1.7) 11.9 (0.3) mean (SEM) Age, years 51.6 51.6 38.7 (5.2) 47.5 (11.5) Female, n (%) 4 (67%) 28 (65%) 29 (71%) 1 (50%) SEM = Standard error of the mean Tepezza Phase 2 data: Smith TJ, et al, NEJM 376:18, May 2017 8 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020 FDA clinical review of Tepezza (BLA 761143)

Significant improvement in both signs and symptoms of TED Overall response defined as reduction in proptosis of ≥2mm and reduction in CAS ≥2 points Overall response Overall response Overall response at week 6 at week 6 at week 6 (% responder) 83% 83% 3 5/6 0% 0% Tepezza Tepezza VRDN-001 Placebo VRDN-001 VRDN-001 Placebo Phase 2 Phase 3 10mg/kg 10mg/kg 10mg/kg Tepezza Phase 2 data: FDA clinical review of Tepezza (BLA 761143) 9 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020

Rapid and robust proptosis reduction in VRDN-001 treated patients Change in proptosis (mm) Reduction in proptosis Mean proptosis change Reduction in proptosis (from baseline to week 6) (from baseline to week 6) (from baseline to week 6) (from baseline to week 6) VRDN-001 Active Pla Plac cebo ebo 10mg/kg 0 50% 0% ≥3.0mm 3/6 ³ 3.0mm Placebo Placebo n=2 3 -1 n = 2 -1.0mm ≥2.5mm 67% 4/6 ³ 2.5mm 0% VRDN-001 VRDN-001 -2 10mg/kg 10mg/kg ³ 2.0mm ≥2.0mm 83% 50% 5/6 1/2* n = 6 n=6 -2.4mm -3 100% 50% 0 50% 100% W We ee ek k 0 0 W We ee ek k 6 6 * Where MRI confirmation of proptosis reduction was available, VRDN-001 proptosis responses were confirmed; proptosis response 10 in placebo patient observed by exophthalmometer was not confirmed by MRI, and CAS in this patient did not improve Change from baseline proptosis (mm)

Proptosis reduction compares favorably with Tepezza Mean proptosis change Proptosis responder rate at week 6 Proptosis response rate at week 6 (from baseline to week 6) (Proptosis Responder ≥2mm change from baseline proptosis) 83% 83% Tepezza 56% 56% 55% 55% Tepezza Phase 2 VRDN-001 Phase 3 10mg/kg -1.8mm -1.9mm -2.4mm VRDN-001 Tepezza Tepezza Tepezza Tepezza VRDN-001 10mg/kg Phas Phase e 2 2 Phas Phase e 3 3 10mg/kg Proptosis change from baseline presented as mean ± SEM Tepezza Phase 2 data: Smith TJ, et al, NEJM 376:18, May 2017, FDA clinical review of Tepezza (BLA 761143) 11 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020, Douglas RS, et al, Ophthalmology 129:4, Apr 2022 Change from baseline proptosis (mm)

Significant improvement in symptoms as measured by CAS Clinical Activity Score (CAS): a composite 0-7 scale scoring signs and symptoms of TED Change in CAS score Mean change in CAS Reduction in CAS CAS of 0 or 1 at week 6 (from baseline to week 6) Reduction in CAS score (from baseline to week 6) (from baseline to week 6) (from baseline to week 6) VRDN-001 0 10mg/kg Placebo 83% -1 Placebo 4/6 ³5 67% 0% n=2 -2 -1.5 4/6 ³4 67% 0% -3 VRDN-001 10mg/kg ³3 6/6 1/2 50% 100% -4 n=6 0% -4.3 -5 VRDN-001 Placebo Week 0 Week 6 -100% -50% 0% 50% 100% 10mg/kg 12 Change from baseline score

Symptoms improvement compares favorably with Tepezza Clinical Activity Score (CAS): a composite 0-7 scale scoring signs and symptoms of TED Mean CAS Change CAS of 0 or 1 at week 6 Mean CAS improvement at week 6 CAS of 0 or 1 at week 6 (to week 6) (Change from baseline score) Tepezza VRDN-001 Tepezza VRDN-001 Tepezza Tepezza 83% Phase 2 10mg/kg Phase 3 83% 10mg/kg Phase 2 Phase 3 -4.3 -2.5 -2.1 -2.1 -2.5 22% 21% 22% 21% -4.3 Tepezza Tepezza VRD VRDN N -0 - 0001 1 Tepezza Tepezza Phase 2 Phase 3 10mg/kg Phase 2 Phase 3 10mg/kg Tepezza Phase 2 data: Smith TJ, et al, NEJM 376:18, May 2017 13 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020 FDA clinical review of Tepezza (BLA 761143)

75% of VRDN-001 patients had complete diplopia resolution at week 6 Diplopia resolution rate defined as % of patients with diplopia at baseline that improved to a score of 0 Diplopia resolution vs. Tepezza Complete diplopia resolution at week 6 Complete dip( l% op rie as r pe os no de lu rs t)ion at week 6 *Diplopia resolution (dg) 75% 75% 75% 75% 36% 36% 30% 29% 0% 0% 3/4 0/1 Tepezza Tepez Tepezzz aa V Tepez RDN-0z 01 a VRDN-001 VRDN-001 Placebo VRDN-001 Placebo Phase 2 Phase 3 10mg/kg Phase 2 Phase 3 10mg/kg 10mg/k 10mg/kg g For patients with diplopia at baseline, complete diplopia resolution defined as Gorman subjective diplopia score of zero 14 FDA clinical review of Tepezza (BLA 761143)

Favorable safety profile VRDN-001 10mg/kg TED cohort TEPEZZA label VRDN-001 Placebo TEPEZZA Placebo 10mg/kg (n=84), n (%) (n=86), n (%) (n=2), n (n=6), n ADVERSE REACTIONS: 21 (25%) 6 (7%) Muscle spasms 2 - No serious Nausea - - 14 (17%) 8 (9%) adverse events (SAEs) Alopecia - 1 11 (13%) 7 (8%) 1* - 10 (12%) 7 (8%) Diarrhea Fatigue 1 2 10 (12%) 6 (7%) Hyperglycemia - - 8 (10%) 1 (1%) Hearing impairment 1 - 8 (10%) 0 (0%) No 7 (8%) 0 (0%) Dysgeusia - - hyperglycemia and no infusion Headache 1 1* 7 (8%) 6 (7%) reactions Dry skin - - 7 (8%) 0 (0%) - - 4% N/A Infusion reactions As of Aug. 9 cutoff, no hyperglycemia, hearing impairment, muscle spasms, infusion reactions, or SAEs in the 20mg/kg cohort Data are as of data cut-off of August 9, 2022. Other AE that occurred in more than one patient and deemed related to study drug by masked investigators was acne (n=2). Instances were mild and did not require intervention. Muscle spasms were mild and did not require intervention; hearing impairment was “ringing in the ears” which resolved within 2 weeks without intervention 15 * Deemed unrelated to study drug by the masked investigators

Takeaways for VRDN-001 and VRDN-002 Data Jonathan Violin, Ph.D., President and Chief Executive Officer 16

All VRDN-001 efficacy measures compare favorably to Tepezza Signs Symptoms Improvement in Improvement in Clinical Activity Score (CAS) proptosis and diplopia score Overall response: Proptosis: Proptosis: CAS: CAS: Diplopia: Complete Signs + symptoms Responder rate Mean change Score of 0 or 1 Mean change resolution (Improvement in (% with ≥2mm (change from (% achieving CAS of 0 (change from (% improved to a proptosis & clinical reduction from baseline to week 6) or 1 at week 6) baseline to week 6) score of 0 at week 6) activity score) baseline to week 6) VRDN-001 83% 83% -2.4mm 83% -4.3 75% (at 10mg/kg -> 10mg/kg; week 6) Tepezza 44% 56% -1.9mm 22% -2.1 36% (at 10mg/kg -> 20mg/kg; week 6) Clinical Activity Score (CAS) = a composite 0-7 scale scoring signs and symptoms of TED 17 Tepezza Phase 3 data: Douglas RS, et al, Ophthalmology 129:4, Apr 2022 FDA clinical review of Tepezza (BLA 761143)

VRDN-001 is a more complete antagonist of IGF-1R, potentially explaining favorable clinical activity Mutational scan reveals unique signatures of IGF-1R antibodies Maximal IGF-1R inhibition (%) Residual IGF-1R activity (% Inhibition) VRDN-001 Tepezza VRDN-002 lonigutumab 10% 00% 4% 26% 24% 39% 25 7% 5% 61% VRDN-001 50 5% 0% produces 74% 76% greatest 75 2% 5% inhibition 96% 10% 90% Point mutations Domain deletion 100% 0% no binding no binding reduced binding reduced binding VRDN-001 binding modality is unique VRDN-001 is a full antagonist, unlike other anti-IGF-1R mAbs • VRDN-001 is sensitive to the same domain deletions as Tepezza and VRDN-• VRDN-001 is a full antagonist of IGF-1 mediated signaling 002 but different point mutations, suggesting a similar binding site but distinct • Tepezza and VRDN-002 are both partial antagonists, consistent with receptor interaction their similar receptor interactions • Tepezza and VRDN-002 have highly similar binding interactions • Lonigutamab binds distally and is a partial antagonist in this assay • Lonigutumab has a different, unrelated epitope vs. the other three antibodies • Full antagonism by VRDN-001 is consistent with larger increases in IGF-1 as it can bind IGF-1R simultaneously with Tepezza, VRDN-002, or VRDN-001 in VRDN-001 treated volunteers vs. other published IGF-1R antibodies 18

Responses occur rapidly and compare favorably to Tepezza Mean time to response (weeks) Median time to proptosis response Mean time to overall response Mean time to response (weeks) VRDN-001 VRDN-001 VRDN-001 VRDN-001 3.0 4.8 3.0 4.8 10mg/kg 10mg/kg 10mg/kg 10mg/kg weeks weeks Tepez Tepezzz aa Tepezza Tepezza 6.4 11.2 6.4 11.2 Phase 3 Phase 2 Phase 3 Phase 2 weeks weeks Week 0 Week 3 Week 6 Week 9 Week 12 Week 0 Week 3 Week 6 Week 9 Week 12 Reported as median time to response to enable comparison to published Reported as mean time to response to enable comparison to published Tepezza data. Tepezza reported median time to proptosis response in P3 NEJM Tepezza data. Tepezza reported mean time to overall response in P2 NEJM publication. P2 NEJM publication did not report any time to proptosis response. publication. P3 NEJM publication did not report any time to overall response. Tepezza Phase 2 data: Smith TJ, et al, NEJM 376:18, May 2017 19 Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020

VRDN-001 may offer a shorter treatment course Change in proptosis from baseline Phase 3 program: standard and shortened treatment course in active and chronic TED 2023 2024 • THRIVE trial: placebo- Topline controlled, active TED Active TED (n=120) • THRIVE-2 trial: placebo- Topline controlled, chronic TED Chronic TED (n=120) Last 2 doses offer limited additional benefit • Three arms per trial: Week 12 Week 24 − Standard 8 infusions − Accelerated 5 infusions VRDN-001, Q3W 8x − Placebo VRDN-001, Q3W 5x • 24 week primary Tepezza Phase 3 data suggest limited endpoint Placebo treatment benefit after 18 weeks VRDN-001 Phase 3 will study both a standard 8 infusion course (same as Tepezza) and a shorter 5 infusion course Tepezza Phase 3 data: Douglas RS, et al, NEJM 382:4, Jan 2020 20

VRDN-002 has extended half-life of 30-40 days Non-human primate PK VRDN-001 HV VRDN-002 HV Time (days) Time (days) Time (days) • VRDN-001 and Tepezza PK very similar in non-human primates: ~6 day half-life 1-6 • VRDN-001 and Tepezza PK very similar in oncology patients: ~10-11 day half-life across 6 clinical trials • VRDN-002 half-life ~3x VRDN-001 in healthy volunteers: interim analysis shows 30-40 day half-life • No SAEs, hearing impairment, hyperglycemia, muscle spasms, or infusion reactions reported as of last subject last visit for VRDN-002 HV = healthy volunteers 3) Gore L et al, Mol Cancer Ther, 8(12 Suppl), 2009 * Historical data from AVE-1642 IND 4) Faivre SJ et al, J Clin Onc, 29 (4 Suppl), February 2011 21 1) Rodon J et al, J Clin Onc, 2518 Suppl), June 2007 5) Soria JC et al, Eur J Cancer, 49 (8), 2013 2) Kurzrock R et al, Clin Cancer Res, 16(8), April 2010 6) Moreau P et al, Leukemia 25 (5), February 2011

VRDN-002 mediates IGF-1 increases similar to teprotumumab PK/PD modeling indicate potential feasibility of 2mL 300mg Q2W to Q4W SC dosing % Change from Baseline of IGF-1 in normal healthy volunteers Teprotumumab VRDN-002 Planned SC POC trial in TED Presumed Placebo Removed Randomized, double-blind trial of 2mL 300mg 1 mg/kg 3 mg/kg Q2W and Q4W SC dosing vs placebo 400 400 3 mg/kg 10 mg/kg 9 mg/kg 20 mg/kg Placebo Cohort 1 SC Q2W 6 patients 200 200 Placebo 2 patients Cohort 2 0 0 SC Q4W 6 patients 0 1 2 3 4 5 6 7 0 20 40 60 80 100 Time (days) Time (days) Placebo 2 patients ~2.5x increase in plasma IGF-1 ~2.5x increase in plasma IGF-1 published data only through Day 7 elevated through Day 84 after single dose Teprotumumab data from Kurzrock R et al, Clin Canc Res 16(8) April 2010 22 % Change from Baseline IGF-1 % Change from Baseline IGF-1

VRDN-001 demonstrated rapid, significant Key improvement across all efficacy measures in takeaways TED at week 6, surpassing prior TED trials from today’s VRDN-001 produces more complete IGF-1R data inhibition via unique receptor interaction VRDN-001 was well tolerated with favorable safety profile VRDN-002 triples half-life with strong PD, potentially enabling Q2W to Q4W low volume SC dosing 23 23

Phase 3 and SC Plans Jonathan Violin, Ph.D., President and Chief Executive Officer 24

Next steps: large commercial opportunity guides our urgency Tepezza annualizing ~$2B in US 2 years after first product approval; substantial room for growth Active TED moderate to severe $3.5B+ 20-25K 35-40K 20-40% Tepezza 0% Tepezza share share today (not approved) ~$2B (2022E) Chronic TED 75K+ 150K+ moderate to severe <10% Tepezza 0% Tepezza share US sales 2 years Peak sales share today following first opportunity (not approved) product approval (not including EU) Source: Horizon Therapeutics Q2 22 earnings: peak U.S. annual net sales of >$3B and ex-U.S. estimate of >$500M peak 25 annual net sales, does not include expected entrance to Europe; Viridian-sponsored market research

Corporate objectives in TED: Build a market-leading franchise 2 1 Launch Rapidly follow potential best- IV launch with in-class IV TED potential best- therapy in US in-class SC TED and EU therapy 26

Highlights of global IV VRDN-001 Phase 3 program plan • Designed to assess pivotal efficacy data Global registrational in active AND chronic disease 2023 2024 program for both active • Registrational program designed to enable approval in US, EU, and other and chronic TED Topline Active TED (n=120) major and emerging markets Topline Chronic TED (n=120) • Accelerated, 12 week, course of therapy − 43% shorter than Tepezza Potential improvements • Shorter infusion times (30 min for on Tepezza VRDN-001 vs. 60-90 min for Tepezza) • Faster onset and improved efficacy Week 24 Week 12 • Phase 3 program to initiate by YE22 VRDN-001, Q3W 8x • 17 sites active, 30 expected by YE22, Rapid timelines to enter expanding to >50 in 1H23 VRDN-001, Q3W 5x a multibillion $ market • Phase 3 active TED data by MY24 Placebo • Phase 3 chronic TED data by YE24 27

Viridian is poised to deliver a potential best-in-class SC TED therapy Both VRDN-002 and VRDN-003 show potential for Q2W and Q4W dosing to be tested convenient, low-volume, SC product profile • VRDN-002 epitope and in vitro profile very similar • 2mL 300mg SC Q2W compares favorably with to teprotumumab, achieves half-life ~3x first other successful SC products generation anti-IGF-1R mAbs – VRDN-001 PK/PD and efficacy data at 10mg/kg inform VRDN-002 and VRDN-003 dose selection – Interim analysis shows 30-40 day half-life – PK/PD modeling supports at least 2mL 300mg SC Q2W • Unveiling VRDN-003: extended half-life VRDN-001 profile for both VRDN-002 and VRDN-003 – Retains unique VRDN-001 binding & antagonist – VRDN-001 efficacy data at 3mg/kg to further inform properties Q4W or longer profiles for VRDN-002 and VRDN-003 – Same half-life extension technology as VRDN-002 • Launch with patient-friendly pre-filled pen device – Non-human primate data show PK expected to match VRDN-002 – Well into IND enabling activities; IND expected 2Q23; healthy volunteer PK/PD data 4Q23 Plan to choose either VRDN-002 or VRDN-003 by YE23, and initiate Phase 3 trials in early 2024 28

Q2W to Q4W TED SC program plan Clinical data allows us to select best program to start a planned Phase 3 trial in early 2024 Decision: Select one SC program to advance 2023 2024 VRDN-002 SC SC POC Q2W to Q4W Topline trial initiation SC patient data 2H23 SC Phase 3 Planned initiation Planning for active early 2024 VRDN-001 sites to roll over to SC Phase 3 program POC PK/PD HV VRDN-003 SC Submit IND single dose data extended half-life 001 Q2W to Q4W SC HV data HV multiple dose 4Q23 29

Timeline and planned milestones 4Q22 YE22 MY24 3mg/kg active TED data 20mg/kg Initiation data active TED data 1H23 YE24 upcoming medical congress Initiation data Chronic TED Chronic TED POC initiation POC data Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2022 2023 2024 SC 003 IND SC phase 3 start SC 002 TED POC data 2Q23 Early 24 2H23 SC 003 HV POC data 4Q23 30

Second Quarter Financials Kristian Humer, Chief Financial and Business Officer 31

Q2 2022 Financial Results CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS CONDENSED CONSOLIDATED BALANCE SHEET DATA (amounts in thousands, except share and per share data) (amounts in thousands) (unaudited) (unaudited) June 30, December 31, Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 2022 2021 Cash and cash equivalents $ 161,207 $ 196,965 Revenue: Other assets 8,607 6,744 Collaboration Revenue - related party $ 256 $ 1,090 $ 472 $ 2,541 Total assets $ 169,814 $ 203,709 Operating Expenses: Total liabilities 27,916 15,993 Research and development 21,712 12,565 39,458 26,371 Total stockholders’ equity 141,898 187,716 General and administrative 8,108 6,523 16,467 12,683 Total liabilities and stockholders’ equity $ 169,814 $ 203,709 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) • As of 2Q 2022, cash, cash equivalents Change in unrealized loss on investments (142) 9 (920) ( 4) Comprehensive loss $ (29,633) $ ( 17,955) $ ( 56,104) $ ( 36,428) and short-term investments of $161M, in addition to $75M credit facility, 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) provide cash runway into 2024 Weighted-average shares used to compute basic and diluted loss per share 27,762,257 8,106,765 26,948,692 7,226,447 • 43M total common shares outstanding 1 on an as converted basis 1) As of August 12, 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 and 32 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

Q&A 33

Thank you! 34
Exhibit 99.4
NEWS RELEASE
Viridian Announces Positive Initial Clinical Data from Ongoing Phase 1/2 Trial
Evaluating VRDN-001 in Patients with Thyroid Eye Disease (TED)
- Significant and rapid improvement in both signs and symptoms of TED at week 6 after two infusions of 10mg/kg VRDN-001 -
- Proptosis response achieved by 83% of patients with a mean reduction of 2.4mm from baseline -
- Clinical Activity Score (CAS) of 0 or 1 achieved by 83% of patients with a mean reduction of 4.3 points from baseline -
- Complete resolution of diplopia achieved by 75% of patients with diplopia at baseline -
- VRDN-001 demonstrated a favorable safety and tolerability profile with no reported SAEs, no hyperglycemia, and no infusion reactions -
- 20mg/kg cohort enrollment nearly complete, with planned data presentation at a medical meeting in 4Q22; 3mg/kg cohort is on track for data in 4Q22 -
- 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 -
- Viridian to host investor conference call and webcast today at 8:00 a.m. ET -
Waltham, MA — 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 positive initial clinical data from the 10mg/kg cohort in its ongoing Phase 1/2 clinical trial of VRDN-001, an anti-IGF-1R antibody, in patients with active thyroid eye disease (TED). TED is a rare autoimmune disease in which the body’s own immune system attacks the tissues around and behind the eyes causing inflammation, swelling, and damage, which develops into signs and symptoms of double vision, bulging eyes, and ocular pain. The double-blind, placebo-controlled Phase 1/2 trial is evaluating two infusions of VRDN-001 administered intravenously. The inclusion and exclusion criteria and the baseline patient characteristics for this trial are similar to prior TED clinical trials. Efficacy measurements include proptosis (bulging eyes), Clinical Activity Score (CAS), and diplopia (double vision), which are the same endpoints as measured in the clinical development of Tepezza®, the only approved therapy targeting IGF-1R in patients with TED.
“TED is a severe, debilitating eye disease that threatens patients’ vision and overall quality of life,” said Raymond Douglas, M.D., Ph.D., director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center and an investigator on the VRDN-001 trial. “In this trial, rapid and significant improvement in a broad set of efficacy measures suggests that VRDN-001 may have a differentiated profile that could offer meaningful benefits to patients.”
Data from ongoing VRDN-001 Phase 1/2 proof-of-concept trial
This ongoing trial is evaluating two infusions of VRDN-001, three weeks apart, with efficacy measured 6 weeks after the first dose. Each dose is evaluated in a cohort of 8 patients, randomized so that 6 patients receive VRDN-001 and 2 patients receive placebo. The first cohort evaluated a dose of 10mg/kg, with initial clinical data being reported today. The second cohort is evaluating a dose of 20mg/kg and enrollment is nearly complete, and the Company plans to report results at an upcoming medical meeting in the fourth quarter of 2022. A third cohort will evaluate a dose of 3mg/kg, with data anticipated in the fourth quarter of 2022.
Initial VRDN-001 Safety Data
VRDN-001 was well-tolerated by all patients treated at the 10mg/kg dose. There were no reported serious adverse events (SAEs), no patient discontinuations, and no hyperglycemia or infusion reactions as of August 9, 2022, the cutoff date for follow up observation. Two cases of mild muscle spasm were reported and did not require intervention. There was one report of “ringing in the ears” which resolved within two weeks without intervention.
In the ongoing second TED cohort, which is evaluating two infusions of 20mg/kg of VRDN-001, no adverse events of hyperglycemia, muscle spasm, hearing impairment, infusion reactions, or any serious adverse events were reported as of the cutoff date of August 9, 2022.
Initial VRDN-001 Clinical Activity Data
All patients in the 10mg/kg cohort were treated for two full cycles and were evaluated for proptosis, clinical activity score (CAS), and diplopia.
The following clinical activity was observed at week 6:
Proptosis
| • | 83% proptosis responder rate, defined as a ≥2mm reduction in proptosis from baseline |
| • | Rapid reduction with a median time to proptosis response of 3 weeks |
| • | 2.4mm mean reduction in proptosis from baseline |
Clinical Activity Score (CAS)
| • | 83% of patients achieved maximal or near-maximal therapeutic effect on CAS, defined as reaching a CAS of 0 or 1 on a 7-point composite measure of signs and symptoms of TED |
| • | 4.3 point mean reduction in CAS from baseline |
Overall response
| • | 83% overall responder rate, defined as a ≥2mm reduction in proptosis and a ≥2 point reduction in CAS |
Diplopia
| • | 75% complete resolution of diplopia, defined as patients with baseline diplopia who achieved a score of 0 on the Gorman Subjective Diplopia scale |
“These data exceeded our expectations and compare very favorably to Tepezza, the only approved therapy in TED. The significant improvement in signs and symptoms observed after only two infusions of VRDN-001 is remarkable. We plan to accelerate the start of our Phase 3 THRIVE program, now starting later this year, in a broad TED population of both active and chronic disease,” said Barrett Katz, MD, MBA, Chief Medical Officer at Viridian. “We believe VRDN-001 could show a more rapid onset of action and afford a shorter course of treatment with the potential for a differentiated profile versus other TED therapies, due to its full antagonism of IGF-1R.”
First-in-human data for VRDN-002
Earlier this year, Viridian initiated a first-in-human Phase 1 clinical trial of VRDN-002, a novel monoclonal antibody that incorporates half-life extension technology and is designed to support administration as a convenient, low-volume, subcutaneous (SC) injection for the treatment of TED patients. This single ascending dose trial explored safety, tolerability, pharmacokinetics and pharmacodynamics of intravenously administered VRDN-002 at doses of 3, 10, and 20mg/kg in 12 healthy volunteers.
The following results were observed:
| • | VRDN-002 achieved a substantially extended half-life of 30-40 days |
| • | After a single IV dose of VRDN-002, plasma IGF-1 levels increased approximately 2.5-fold and were sustained throughout the measurement period of 84 days |
| • | PK/PD analysis demonstrates the feasibility of a convenient, low-volume, subcutaneous injection paradigm of 2mL 300mg dosed Q2W or Q4W |
| • | VRDN-002 was generally well tolerated with no reported adverse events of hyperglycemia, hearing impairment, muscle spasm, infusion reactions, or any SAEs |
Clinical plan and future milestones for Viridian TED programs
Additional VRDN-001 Phase 1/2 Cohorts
| • | VRDN-001 20mg/kg cohort data presentation planned for a medical meeting in the fourth quarter of 2022. VRDN-001 3mg/kg cohort is expected to deliver data in the fourth quarter of 2022 |
| • | Additional VRDN-001 chronic TED proof-of-concept cohorts now planned to launch in the fourth quarter of 2022, with data in the first half of 2023 |
Global VRDN-001 Phase 3 Program in Active and Chronic TED
| • | First VRDN-001 double-blind, placebo-controlled Phase 3 trial (THRIVE), in active TED patients, expected to initiate by the end of 2022, with topline data expected in mid-year 2024. The trial will evaluate the 10mg/kg dose, with a rapid 30-minute infusion time, in two treatment regimens: |
| • | a standard 8-infusion Q3W regimen matching Tepezza dosing regimen |
| • | an accelerated 12-week, 5-infusion Q3W regimen, offering a 43% shorter, highly differentiated dosing regimen |
| • | Second VRDN-001 double-blind, placebo-controlled Phase 3 trial (THRIVE-2), in chronic TED, expected to initiate in the first half of 2023 with topline data by the end of 2024 |
| • | THRIVE and THRIVE-2 trial results are expected to form the basis of both a biologics license application (BLA) in the US as well as a marketing authorization application (MAA) in the EU |
SC Programs: VRDN-002 and VRDN-003
| • | VRDN-002 will advance to a proof-of-concept trial in TED, evaluating 2mL 300mg SC injection of 2mL, dosed Q2W or Q4W, with data expected in the second half of 2023. Viridian is unveiling VRDN-003, an extended half-life version of VRDN-001. VRDN-003 builds upon the clinical performance of VRDN-001 by incorporating the same technology that enabled VRDN-002 to achieve its substantially extended half-life. VRDN-003 has similar non-human primate half-life to VRDN-002 and is expected to match the VRDN-002 human half-life. IND filing for VRDN-003 is planned the second quarter of 2023 with proof-of-concept data expected in the fourth quarter of 2023 |
| • | By the end of 2023, the Company will select to advance either VRDN-002 or VRDN-003 into registrational trials based on clinical data from the two programs and plans to initiate a global Phase 3 program of a potentially best-in-class SC therapy for TED in early 2024 |
“The data we are sharing today puts Viridian in a very strong position to succeed in our mission to deliver improved therapeutic options to TED patients suffering from this serious disease,” said Jonathan Violin, Ph.D., President and CEO of Viridian Therapeutics. “With VRDN-001 and our subcutaneous programs, we believe our strategy enables us to rapidly deliver differentiated products to a broad population of TED patients across the globe and across all settings of care.”
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 Viridian management team will be joined by Raymond Douglas, M.D., Ph.D., Director of the Thyroid Eye Disease 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.
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.
Investor and Media Contact
John Jordan
Viridian Therapeutics
Vice President, Investor Relations
& Corporate Communications
617-272-4691
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