Viridian Therapeutics, Inc.DE false 0001590750 0001590750 2023-07-10 2023-07-10
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 10, 2023
![LOGO](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197g0710105212846.jpg)
VIRIDIAN THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36483 |
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47-1187261 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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221 Crescent Street, Suite 401 Waltham, MA |
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02453 |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (617) 272-4600
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, $0.01 par value |
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VRDN |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 |
Regulation FD Disclosure. |
On July 10, 2023, Viridian Therapeutics, Inc. (the “Company”) issued a press release announcing positive data from its ongoing Phase 1/2 clinical trial of VRDN-001 in patients with chronic thyroid eye disease (“TED”). The Company will host a conference call and webcast today, Monday, July 10, 2023 at 5:00 p.m., Eastern Time, to discuss the data results and other updates.
A copy of the press release is furnished and the data presentation that will be referenced during the conference call is filed as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K 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.
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.
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Viridian Therapeutics, Inc. |
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Date: July 10, 2023 |
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By: |
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/s/ Scott Myers |
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Scott Myers |
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President, Chief Executive Officer, and Director |
Exhibit 99.1
Viridian Announces Positive Data from Ongoing Phase 1/2 Trial Evaluating
VRDN-001 in Patients with Chronic Thyroid Eye Disease (TED)
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VRDN-001 data demonstrated clinically meaningful and rapid improvement in signs and symptoms of chronic TED at week 6 after receiving two infusions of VRDN-001 10 mg/kg
or 3 mg/kg
- Ongoing THRIVE Phase 3 trial in patients with active TED amended to reflect Viridians confidence in 5-dose regimen and key stakeholder feedback on evolving TED treatment paradigm -
- THRIVE-2 Phase 3 trial in patients with chronic TED expected to start in third quarter 2023
- 3 mg/kg data support low-volume subcutaneous (SC) dosing profile for Companys SC candidates
in TED -
- Viridian plans to select lead SC program candidate by year-end 2023; VRDN-001 SC IND amendment and VRDN-003 IND submitted to the FDA
- Conference call and webcast to be held today, Monday, July 10th at 5:00 p.m. ET -
WALTHAM, Mass., July 10, 2023 Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing
potential best-in-class medicines for serious and rare diseases, today announced positive preliminary data from its ongoing Phase 1/2 clinical trial of VRDN-001, an investigational full antagonist antibody to the insulin-like growth factor 1 receptor (IGF-1R), in patients with chronic thyroid eye disease (TED). The Company
also announced an amendment to its ongoing THRIVE Phase 3 trial design and provided an update on recent progress of its SC program candidates in TED.
It is quite impressive that patients in the 10 mg/kg and 3 mg/kg dose cohorts experienced reductions in proptosis as well as improvements in their
clinical activity scores after receiving just two infusions of VRDN-001, said Kimberly Cockerham, M.D., an Oculoplastic Surgeon specializing in neuro-ophthalmology, orbital oncology and oculofacial
restoration at the SENTA Clinic in San Diego, California, and an investigator on the VRDN-001 clinical trial. Importantly, VRDN-001 was generally well tolerated
among all treated patients, who will continue to be evaluated for safety and durability of response. Thus far, these data suggest that VRDN-001 has the potential to become an important new treatment option for
managing the signs and symptoms of TED.
VRDN-001 Phase 1/2 proof-of-concept trial in chronic TED
The
proof-of-concept portion of the double-masked, placebo-controlled Phase 1/2 trial evaluated two infusions of VRDN-001
administered intravenously (IV), three weeks apart, with clinical activity endpoints measured six weeks after the first infusion. VRDN-001 was evaluated at doses of 10 and 3 mg/kg, with each cohort designed to
include six patients randomized to drug, and two patients randomized to placebo.
Participant eligibility criteria included: chronic TED with documented evidence of ocular symptoms or signs
that began more than one year prior to screening (mean duration of 7.8 years), and proptosis of ≥3 mm above normal values for gender and race. Any clinical activity score (CAS, 0 7) was allowed for randomization (mean CAS was 3.3).
VRDN-001 Safety data
VRDN-001 was generally well tolerated by all drug treated patients in both dose cohorts. There were no reported serious
adverse events (SAEs), including no hearing impairment or hyperglycemia events, in patients with chronic TED treated with VRDN-001 as of May 30, 2023, the most recent cutoff date for follow-up observation. The safety and tolerability profile was generally consistent with previously reported results in patients with active TED treated with VRDN-001.
VRDN-001 Clinical activity data in chronic TED
Patients in the 10 mg/kg (n=6) and 3 mg/kg (n=6) cohorts who were treated with two doses of VRDN-001 were evaluated for
changes in proptosis, CAS, and diplopia at week 6. Proptosis changes from baseline were measured both by exophthalmometry and magnetic resonance imaging (MRI, an exploratory measure). We believe exophthalmometry and MRI together provide a robust
assessment of changes in proptosis. The following activity was observed in the 10 mg/kg cohort (n=6), 3mg/kg cohort (n=6), and across both dose groups (n=12):
Proptosis:
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Patients treated with VRDN-001 had lower mean proptosis at baseline when
compared with placebo (25.0 mm). |
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VRDN-001 10 mg/kg cohort (n = 6) |
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VRDN-001 3 mg/kg cohort (n = 6) |
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VRDN-001 combined 10 and 3 mg/kg (n = 12) |
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Mean baseline proptosis |
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21.1 mm |
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23.4 mm |
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22.2 mm |
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Mean reduction in proptosis from baseline (measured by exophthalmometry) |
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-1.8 mm |
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-1.5 mm |
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-1.6 mm |
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Mean reduction in proptosis from baseline (measured by MRI*) |
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-1.5 mm |
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-2.6 mm |
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-2.0 mm |
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Proptosis responder rate |
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50 |
% |
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33 |
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42 |
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Masked, centrally reviewed MRI; MRI data is preliminary, MRI data available for 4 of 6 VRDN-001 10 mg/kg treated patients, 4 of 6 VRDN-001 3 mg/kg treated patients, and 5 of 5 placebo-treated patients (mean reduction in proptosis by MRI = -0.2 mm for placebo). |
CAS:
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Observed a 50% to 72% reduction in mean CAS at week 6 compared with mean baseline levels in patients treated with
VRDN-001. |
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VRDN-001 10 mg/kg cohort (n = 6) |
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VRDN-001 3 mg/kg cohort (n = 6) |
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VRDN-001 combined 10 and 3 mg/kg (n = 12) |
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Mean baseline CAS |
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2.5 |
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4.0 |
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3.3 |
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Mean reduction in CAS from baseline, all patients (7-point
measure) |
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-1.8 |
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-2.0 |
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-1.9 |
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Mean reduction in CAS from baseline, patients CAS>0 at baseline* |
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-2.8 |
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-2.0 |
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-2.3 |
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2 patients from the VRDN-001 10 mg/kg cohort with CAS of 0 at
baseline excluded from calculation. |
Diplopia:
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Five out of the twelve VRDN-001 treated patients across both dose cohorts
had diplopia (double vision) at baseline. None of the patients treated with VRDN-001 achieved complete resolution of diplopia at week 6, defined as patients with baseline diplopia who achieved a score of 0 on
the Gorman subjective diplopia scale. |
We continue to be enthusiastic over the clinical trial data were compiling on VRDN-001. said Barrett Katz, M.D., M.B.A., Chief Medical Officer at Viridian. As shown previously in our proof-of-concept
study in patients with active TED, and now in those with chronic disease, VRDN-001 appears to be generally well tolerated and shows clinically meaningful changes, making it a promising lead candidate in our
mission to develop therapies to improve the lives of those with TED.
THRIVE Phase 3 trials in TED
Following recent discussions with the US Food and Drug Administration (FDA) regarding Viridians proposal to amend the THRIVE Phase 3 trial design, THRIVE
will now include the VRDN-001 5-dose treatment regimen and placebo arms only. The trial design amendment reflects Viridians confidence in the 5-dose treatment regimen of VRDN-001 and takes into consideration key stakeholder feedback from the TED community expressing preference for a shortened treatment regimen
compared to an 8-dose treatment regimen.
The primary efficacy endpoint for THRIVE, proptosis responder rate, will
be evaluated at week 15. The Company expects to announce topline results from the THRIVE Phase 3 trial in the middle of 2024.
Viridian plans to initiate
the THRIVE-2 Phase 3 trial to evaluate the safety and efficacy of VRDN-001 in patients with chronic TED in the third quarter of 2023. The Company expects to announce
topline results from the THRIVE-2 trial by year-end 2024.
Subcutaneous (SC) programs in TED
Viridian believes that data from the 3 mg/kg dose cohorts of VRDN-001 in patients with active or chronic TED validate a
low-volume, SC product profile for the Companys three SC candidates. The Companys recent progress and upcoming priorities for its SC programs, include:
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Completed the SC formulation work for all three SC programs, allowing for a concentration of 150 mg/mL for
administration of a 300 mg/2 mL dose in its SC clinical trials. |
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Filed an investigational new drug (IND) application for VRDN-003 and an
IND amendment for VRDN-001 SC with the FDA in June 2023. Following clearance of the submissions, Viridian plans to initiate Phase 1 trials of VRDN-003 and VRDN-001 SC in healthy volunteers in the third quarter of 2023, with initial data expected in the fourth quarter of 2023. |
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Completed enrollment of the Phase 1 healthy volunteer trial of VRDN-002
single IV and single SC dose cohorts. |
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Initiation of a pen device supply agreement with an experienced drug delivery device manufacturer in the second
half of 2023. |
Viridian expects to select its lead subcutaneous program by year-end 2023 and to
advance the program into a pivotal Phase 2/3 trial in the middle of 2024.
VRDN-001, -002, and -003 are investigational therapies that are not approved for any use in any country.
Conference call and webcast information
The Company will
host a conference call today at 5:00 p.m. ET to discuss the topline data and program updates in TED. The dial-in number for the conference call is 1-888-330-3622 for domestic participants and
1-646-960-0662 for international participants. The conference ID is 3961606.
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 Viridians Thyroid Eye Disease Pipeline (VRDN-001, -002, and -003)
Viridians lead product candidate, 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). In preclinical studies, VRDN-001 was shown to be a full antagonist of IGF-1R, with more complete receptor blockade than other
anti-IGF-1R antibodies, including the only currently approved TED therapy. Data from the Phase 2 portion of the ongoing trial established clinical proof-of-concept for VRDN-001 in patients with active and chronic TED. VRDN-001 was generally
well tolerated in the trial.
The THRIVE Phase 3 trial in patients with active TED is ongoing. The Company is currently planning to start
its second Phase 3 trial, called THRIVE-2, in patients with chronic TED.
The Company is also advancing three
candidates (VRDN-001 SC, VRDN-002, and VRDN-003) designed for administration as convenient,
low-volume, SC injection for the treatment of TED.
Viridians goal is to bring a best-in-class IV therapy followed by a first- and best-in-class SC therapy to the market for
the treatment of the TED.
VRDN-001, -002, and -003 are investigational therapies that are not approved for any use in any country.
About TED
TED is a serious and debilitating rare autoimmune disease that causes inflammation within the orbit of the eye that can cause double vision, pain, and
potential blindness. TED is a progressive disease consisting of an initial active phase, followed by a transition to a secondary chronic phase. More than 50,000 and 200,000 people are estimated to suffer from active and chronic TED, respectively, in
the United States and Europe.
About Viridian Therapeutics
Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridians expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously
validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the treatment of patients
with thyroid eye disease (TED). The Company recently initiated its first global Phase 3 trial called THRIVE to evaluate the safety and efficacy of VRDN-001 in patients with active TED. In addition
to its intravenously administered VRDN-001 program, the Company is advancing three candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with
TED. Viridian is developing multiple preclinical assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more
information, please visit https://www.viridiantherapeutics.com. Follow Viridian on LinkedIn.
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
Companys expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding the Companys expectations, strategies, plans and intentions. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based on the Companys 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, VRDN-002 and VRDN-003 for the treatment of TED; the relationship between the results from the positive data from the Phase 1/2 clinical trial of VRDN-001 in patients with chronic Thyroid
Eye Disease and the results of ongoing or future clinical trials; the timing, progress and plans for the Companys ongoing and future research and clinical development programs; trial protocols for ongoing or future clinical trials, including
the clinical trials for VRDN-001, VRDN-002 and VRDN-003; expectations regarding the timing for data; uncertainty and potential
delays related to clinical drug development; the duration and impact of regulatory delays in the Companys clinical programs; manufacturing risks; the Companys ability to develop an SC formulation; the Companys plans regarding a
lead SC program candidate 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 Companys financial position and its
projected cash runway; the Companys future operating results and financial performance; the timing of pre-clinical and clinical trial activities and reporting results from same; and potential addressable
market size,, including those risks set forth under the caption Risk Factors in the Companys Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC)
on May 10, 2023 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 Companys views as of any date subsequent to the date hereof.
Contacts
Investors:
Louisa Stone, 508-808-2400
Manager, Investor Relations
IR@viridiantherapeutics.com
Todd James, 617-272-4691
Senior Vice President, Corporate Affairs and Investor Relations
IR@viridiantherapeutics.com
Media:
Matt Fearer, 617-272-4605
Vice President, Corporate Communications
Media@viridiantherapeutics.com
Source: Viridian
Therapeutics, Inc.
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![Slide 1 Slide 1](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s1g1.jpg)
VRDN-001 Phase 1/2 results in patients
with chronic TED July 2023 Exhibit 99.2
![Slide 2 Slide 2](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s2g1.jpg)
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 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, VRDN-002 and VRDN-003 for the treatment of thyroid eye disease (TED); the relationship between the results from the positive data from the Phase 1/2 clinical trial of VRDN-001 in patients with chronic TED
and the results of ongoing or future clinical trials; the timing, progress and plans for the Company’s ongoing and future research and clinical development programs; trial protocols for ongoing or future clinical trials, including the clinical
trials for VRDN-001, VRDN-002 and VRDN-003; expectations regarding the timing for data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in the Company’s clinical programs;
manufacturing risks; the Company’s ability to develop an SC formulation; the Company’s plans regarding a lead SC program candidate 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; and potential addressable market size,, including those risks set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on May 10, 2023 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 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.
![Slide 3 Slide 3](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s3g1.jpg)
Opening Remarks Scott Myers, MBA,
President and Chief Executive Officer
![Slide 4 Slide 4](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s4g1.jpg)
Positive VRDN-001 preliminary data
establish proof-of-concept in chronic TED Key highlights VRDN-001 is an investigational therapy that is not approved for any use in any country. VRDN-001 data demonstrated clinically meaningful and rapid improvement in signs and symptoms of chronic
TED at week 6 after two infusions THRIVE-2 Phase 3 trial in patients with chronic TED planned to start in 3Q:2023 with topline results expected by YE:2024 Low dose data continue to support low-volume dosing profile for our subcutaneous candidates in
TED 1 3 4 Ongoing THRIVE Phase 3 trial to be amended to 5-dose VRDN-001 arm and placebo arm only to reflect our confidence and evolution of treatment landscape supported by our interactions with stakeholders 2 Important progress across subcutaneous
programs for lead program selection expected by YE:2023 5
![Slide 5 Slide 5](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s5g1.jpg)
Viridian is focused on key factors to
build a successful blockbuster product franchise in TED Best-in-class IV product Active + Chronic TED Expand prescriber base US + ex-US market access and sales First / best-in-class SC product Establish new treatment paradigms in TED Building a
blockbuster TED franchise
![Slide 6 Slide 6](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s6g1.jpg)
Building the Viridian team for
execution and growth Pre-commercial Product Development Medical Affairs Clinical Development Corporate Affairs
![Slide 7 Slide 7](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s7g1.jpg)
Today’s Presenters Kimberly
Cockerham, MD, FACS Barrett Katz, MD, MBA CHIEF MEDICAL OFFICER Thomas Ciulla, MD, MBA CHIEF DEVELOPMENT OFFICER
![Slide 8 Slide 8](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s8g1.jpg)
TED Overview and Unmet Medical Need
Kimberly Cockerham, MD, FACS
![Slide 9 Slide 9](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s9g1.jpg)
My background George Washington
Medical School: awarded a health professional scholarship from the US ARMY Fellowship-trained: Cosmetic, laser and reconstructive surgery of the face, eyelids, and eye muscles. Neuro-ophthalmology and orbital disease Former: Chief of Oculoplastics
and Orbital Disease at Walter Reed Army Medical Center; Director of Oculoplastics and Orbital Disease at UCSF Honors: two UCSF Star Awards for Excellence, American Academy of Ophthalmology Achievement Award, Senior Achievement Award, Distinguished
Service Award and a Special Recognition Award Founder of the Let’s Face It Together Foundation Principal investigator for over two dozen studies. Currently recruiting patients with thyroid eye disease for Phase 1-4 clinical trials. Adjunct
Clinical Associate Professor, Byers Eye Institute at Stanford University for 15 years Treat ~300 TED patients annually at the SENTA Clinic in San Diego, California
![Slide 10 Slide 10](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s10g1.jpg)
TED overview Autoantibodies trigger
IGF-1R/TSHR pathway1 Progressive disease consisting of an initial active phase, followed by a transition to a secondary chronic phase2 Main signs include proptosis (eye bulging), redness, swelling, diplopia (double vision), and lid retraction3
Severe cases can cause sight-threatening optic nerve compression4 Impacts more women than men, ~5 : 1 ratio5 Debilitating auto-immune disease 1. George A et al. Front. Endocrinol. 11:629925 (2021); R. S. Bahn. The New England Journal of Medicine
2010 Vol. 362 Issue 8 Pages 726-738 2. Bothun et al. Clinical Ophthalmology 2009:3 543–551. 3 Bartley GB et al. Am J Ophthalmol 1996;121:284-90. 4. Smith TJ et al. N Engl J Med. 2016;375(16):1552–1565. 5. Kendler DL, Lippa J, Rootman J.
The initial clinical characteristics of Graves' orbitopathy vary with age and sex. Arch Ophthalmol. 1993;111(2):197-201. © 2023 Viridian Therapeutics, Inc.
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Dry Eye Disease Diplopia (double
vision) Photophobia (light sensitivity) Decreased Visual Acuity Visual Field Defects Reduced Color Vision Optic Neuropathy TED is associated with significant vision-threatening impairments 1. Bartley GB. Trans Am Ophthalmol Soc (1994)
92:477–588. 2. Chin et al. Clinical Endocrinology. 2020;93:363–374. 3. Dolman PJ. Ophthalmic Plast Reconstr Surg. 2018;34(4S suppl 1):S34-S40. 4. C. Terwee, F. Dekker and P. Bossuyt. J Clin Epidemiol 2002 Vol. 55 Issue 11 Pages 1156 . 5.
Patel VK et al. Endocr Pract. 2022 Feb;28(2):159-164. doi: 10.1016/j.eprac.2021.11.080.. 6. Smith TJ et al. N Engl J Med. 2016;375(16):1552–1565. 7. Smith TJ et al. N Engl J Med. 2016;375(16):1552–1565. Vision impairment in patients with
TED
![Slide 12 Slide 12](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s12g1.jpg)
Historically described as a
biphasic disease course from active to chronic TED Modified from Wang Y, Patel A, Douglas RS. Thyroid Eye Disease: How A Novel Therapy May Change The Treatment Paradigm. Ther Clin Risk Manag. 2019;15:1305-1318 Active Phase ~18 to 24 months Chronic
Phase ~5 to 7+ years Inflammatory signs and symptoms, such as pain, redness, swelling, proptosis, diplopia, and eyelid retraction are at peak levels Inflammatory signs such as redness and swelling are reduced but the pain, proptosis, diplopia, and
eyelid retraction are persistent throughout life Signs and Symptoms Severity Time
![Slide 13 Slide 13](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s13g1.jpg)
Current treatment options for
patients with TED 1. Stan MN, et al. . Randomized controlled trial of rituximab in patients with Graves’ orbitopathy. J Clin Endocrinol Metab. 2015;100(2):432–441. doi: 10.1210/jc.2014-2572 2. Perez-Moreiras JV, et al. Efficacy of
tocilizumab in patients with moderate-to-severe corticosteroid-resistant Graves orbitopathy: a randomized clinical trial. Am J Ophthalmol. 2018;195:181–190. Intravenous steroids Low benefit-risk for patients Risks include potential liver
failure, weight gain, diabetes, hypertension, osteoporosis, and/or infections 40% to 50% chance of relapse Orbital radiation 60% effective when right patient is selected Many patients are not eligible Off-label immunosuppressive agents rituximab1
associated with AEs and has shown no benefits over placebo tocilizumab2 has not achieved clinically meaningful reductions in proptosis Intravenous IGF-1R inhibitor teprotumumab (Tepezza®) is the only approved agent for TED in the US Surgical
management Orbital decompression, extraocular muscle surgery, eyelid repositioning, and cosmetic soft tissue redraping Limited to chronic TED
![Slide 14 Slide 14](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s14g1.jpg)
Unmet medical needs More convenient
IV treatment options Availability of subcutaneous treatment option New treatment regimens to drive longer-term benefit and value for patients Achieving a similar benefit as IV with a convenient home- based subcutaneous treatment Chronic maintenance
and/or retreatment-based regimens Lower treatment burden for patients with fewer infusions Shorter infusion times
![Slide 15 Slide 15](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s15g1.jpg)
VRDN-001 Background and POC trials
in TED Barrett Katz, MD, MBA, Chief Medical Officer
![Slide 16 Slide 16](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s16g1.jpg)
VRDN-001 IV is a differentiated
full antagonist anti-IGF-1R humanized antibody in TED *Zhao Y, et al. VRDN-001, a Full Antagonist Antibody to the Insulin-Like Growth Factor Receptor-1 (IGF-1R) in Development for Thyroid Eye Disease (TED), Binds to a Distinct Epitope from
Teprotumumab, 91st ATA, October 2022 In preclinical studies*, VRDN-001: Binds to distinct epitope of IGF-1R compared to teprotumumab Binds to epitope longer compared to teprotumumab More completely inhibits IGF-1 ligand binding to IGF-1R More
completely inhibits IGF-1R proximal and distal signaling Potential areas of commercial differentiation 12-week / 5 infusion course of therapy Lower dose Infusion time of 30 minutes VRDN-001 is an investigational therapy not approved for use in any
country.
![Slide 17 Slide 17](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s17g1.jpg)
Proptosis of ≥3 mm Clinical
activity score (CAS) of ≥4 Onset of symptoms within past 12 mo. Active TED Establish proof-of-concept in active and chronic TED 1st Proptosis of ≥3 mm Any CAS (0-7) Onset of symptoms >12 months prior Chronic TED 2nd
![Slide 18 Slide 18](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s18g1.jpg)
Presentations of VRDN-001 POC data
in active TED at medical congresses in 1H:23 Presidential Poster Competition Winner
![Slide 19 Slide 19](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s19g1.jpg)
VRDN-001 Phase 1/2 trial design in
patients with chronic TED Randomized, double-blind trial vs placebo Chronic TED Proptosis of ≥3 mm CAS 0-7 Onset of TED symptoms >12 months prior VRDN-001 10 mg/kg Q3W x 2 (n=6) Placebo (n = 2) VRDN-001 3 mg/kg Q3W x 2 (n=6*) Placebo (n=3)
*In the 3 mg/kg dose cohort, seven patients were randomized to receive VRDN-001 and three patients were randomized to receive placebo. One patient randomized to receive VRDN-001 3mg/kg discontinued the trial due to leaving the country for a family
emergency prior to receiving the second dose of VRDN-001, making six patients treated with VRDN-001 3 mg/kg evaluable for the week 6 clinical endpoint analyses. Cohort 1 Cohort 2
![Slide 20 Slide 20](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s20g1.jpg)
VRDN-001 POC data in Chronic TED
Kimberly Cockerham, MD, FACS
![Slide 21 Slide 21](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s21g1.jpg)
Exophthalmometry and MRI together
provide robust assessment of proptosis Hertel Exophthalmometer Most commonly used modality for measurement of proptosis Successfully used as primary endpoint in prior clinical trials in TED Magnetic Resonance Imaging (MRI) More precise measurement
Centrally read by 2 masked reviewers Exploratory measure to potentially differentiate overall data findings Representative illustration of proptosis measurement by MRI
![Slide 22 Slide 22](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s22g1.jpg)
Evaluating symptoms of TED using
clinical activity scoring scales Clinical Activity Score (0 to 7 points) Source: Bartalena L, et al. Eur Thyroid J 2016;5:926. GO: Graves’ Orbitopathy, also known as thyroid eye disease, or TED.; Chemosis: Swelling of conjunctiva, which is the
mucous membrane that covers the front of the eye and lines the inside of the eyelids; Caruncle: Small, pink, globular nodule at the inner corner (the medial canthus) of the eye; Plica: A small fold of bulbar conjunctiva on the medial canthus of the
eye. 0 1 2 3 4 5 6 7 severity +1 point for each sign/symptom Spontaneous orbital pain Gaze evoked orbital pain Eyelid swelling due to active GO Eyelid erythema Conjunctival redness due to active GO Chemosis Inflammation of caruncle or plica No pain,
redness, or swelling
![Slide 23 Slide 23](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s23g1.jpg)
Baseline patient characteristics in
chronic TED SEM = Standard error of the mean VRDN-001 (10 and 3 mg/kg) VRDN-001 10 mg/kg VRDN-001 3 mg/kg Placebo n 12 6 6 5 Proptosis, mean (SEM) 22.2 (1.2) 21.1 (2.2) 23.4 (1.1) 25.0 (1.6) CAS, mean (SEM) 3.3 (0.8) 2.5 (1.1) 4.0 (1.0) 2.8 (0.8)
Diplopia, n (%) 5 (41.7%) 3 (50.0%) 2 (33.3%) 2 (40%) Gorman Score, mean (SEM) 0.9 (0.4) 0.8 (0.4) 1.0 (0.6) 0.6 (0.4) Months since onset of TED signs/symptoms, mean (SEM) 94.0 (33.7) 96.0 (48.2) 92.0 (51.7) 194.4 (81.2) Age in years, mean (SEM)
50.7 (3.3) 48.3 (5.6) 53.0 (3.7) 49.4 (4.4) Female, n (%) 10 (83.3%) 4 (66.7%) 6 (100.0%) 5 (100.0%)
![Slide 24 Slide 24](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s24g1.jpg)
VRDN-001 clinical activity observed
in patients with chronic TED Preliminary data - *MRI available for 4 of 6 VRDN-001 10 mg/kg treated patients, 4 of 6 VRDN-001 3 mg/kg treated patients **2 patients with CAS of 0 at baseline excluded from calculation ***Includes only participants who
had diplopia present at baseline. Diplopia was present at baseline in 5 of 12 VRDN-001 treated patients; 2 in 3 mg/kg cohort, and 3 in 10 mg/kg cohort Proptosis: Responder rate (% with ≥2 mm reduction baseline to week 6) Proptosis: Mean change
by exophthalmometry (baseline to week 6) Proptosis: Mean change by MRI* (baseline to week 6) CAS: Score of 0 or 1** (% achieving CAS of 0 or 1 at week 6) Excludes Patients CAS=0 at baseline CAS: Mean change** (baseline to week 6) Patients CAS>0
at baseline Diplopia: Complete resolution*** (% improved to a score of 0 at week 6) VRDN-001 (10 and 3 mg/kg; week 6) n=12 42% -1.6 mm -2.0 mm 40% -2.3 0% 10 mg/kg / 3 mg/kg n=6 n=6 50% 33% -1.8 mm -1.5 mm -1.5 mm -2.6 mm 50% 33% -2.8 -2.0 0% 0%
Signs Improvement in proptosis Symptoms Improvement in Clinical Activity Score (CAS) and diplopia score
![Slide 25 Slide 25](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s25g1.jpg)
Reported change in proptosis from
baseline to week 6 MRI data is preliminary. **Blinded, centrally-reviewed MRI data were available for 4 of 6 VRDN-001 10 mg/kg treated patients, 4 of 6 VRDN-001 3 mg/kg treated patients, and 5 of 5 placebo-treated patients. All MRI images were
reviewed centrally by two independent, masked readers. Individual proptosis change (by exophthalmometer) Change from baseline proptosis (mm) Individual proptosis change (by MRI**) *2 placebo and 1 VRDN-001 treated participants were responders by
exophthalmometer, but were not confirmed by MRI Placebo VRDN-001 Change from baseline proptosis (mm) Mean proptosis change (by MRI**) Time (weeks) Placebo n=5 -0.2 mm VRDN-001 n=8 -2.0 mm Change from baseline proptosis (mm) 10 mg/kg 3 mg/kg * * * 0
0
![Slide 26 Slide 26](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s26g1.jpg)
Signs and symptoms as measured by
CAS at week 6 *Includes patients with CAS > 0 at baseline only; 2 patients with CAS of 0 at baseline excluded from calculation, Baseline mean CAS for patients > 0: Placebo = 2.8 and VRDN-001 treated patients = 4.0 Mean change in CAS* (Patients
CAS > 0 at baseline) Change from baseline score Time (weeks) VRDN-001 n=10 -2.3 Placebo n=5 -1.2 Individual patient CAS change (All Patients) Change from baseline score 10 mg/kg 3 mg/kg CAS at baseline 0 0 1 1 2 5 5 6 6 6 1 6 0 0 0
![Slide 27 Slide 27](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s27g1.jpg)
VRDN-001 10 & 3 mg/kg (n=13*),
n Placebo (n=5), n Back pain 2 (15%) 0 (0%) Muscle spasms 2 (15%) 0 (0%) Headache 1 (8%) 2 (40%) Ear discomfort 0 (0%) 1 (20%) Fatigue 0 (0%) 1 (20%) Flatulence 0 (0%) 1 (20%) Pruritus 0 (0%) 1 (20%) Safety profile across all chronic TED cohorts No
serious adverse events (SAEs); no hearing impairment or hyperglycemia events Preliminary data are as of data cut-off of May 30, 2023. *Though not evaluable at week 6 for clinical activity, the 7th patient randomized in the 3 mg/kg cohort who
discontinued the trial prior to week 6 due to leaving the country for a family emergency was followed for safety until their discontinuation. Reported adverse events occurring in ≥ 10% of patients
![Slide 28 Slide 28](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s28g1.jpg)
Summary of VRDN-001 Phase 1/2 data
in patients with chronic TED With one approved medicine in TED, clinicians and patients are in need of new differentiated treatment options VRDN-001 showed improved clinical activity after 2 doses at week 6 VRDN-001 was generally well tolerated in
TED patients with substantial chronicity Clinically meaningful improvement can be achieved with fewer than 8-infusions Data and updated Phase 3 trial design are expected to be received positively by TED treater and patient communities
![Slide 29 Slide 29](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s29g1.jpg)
THRIVE Phase 3 program and SC
progress Thomas Ciulla, MD, MBA, Chief Development Officer
![Slide 30 Slide 30](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s30g1.jpg)
THRIVE Phase 3 trial design in
patients with active TED Topline results expected in the middle of 2024 *Q3W = once every three-week dosing Screening (up to 4 weeks) Double-Blind Treatment Period (15 weeks) Placebo (n=30) Active TED CAS ≥3 Proptosis of ≥3 mm Onset of
active TED symptoms within prior 15 months Randomization 2:1 N=90 VRDN-001 10 mg/kg Q3W* (n=60) Week 15 Primary Endpoint Analysis Proptosis Responder Rate
![Slide 31 Slide 31](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s31g1.jpg)
THRIVE Phase 3 amendment reflects
our confidence in 5-dose regimen and key stakeholder feedback VRDN-001 IV Q3W x 5 (12 weeks) potentially improves benefit-risk for patients VRDN-001 data demonstrated clinically meaningful and rapid improvement in signs and symptoms of TED at week 6
after 2 infusions Physician feedback suggests preference in a shortened IV dosing regimen compared to Q3W x 8 (21 weeks) dosing regimen Q3W x 5 increases IV dosing convenience for patients by eliminating 3 trips to the infusion center
![Slide 32 Slide 32](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s32g1.jpg)
THRIVE-2 Phase 3 trial design in
patients with chronic TED Trial initiation planned for 3Q 2023 with topline expected by YE:2024 *Q3W = once every three-week dosing Screening (up to 4 weeks) Double-Blind Treatment Period (15 weeks) Placebo Chronic TED Any CAS (0-7) Proptosis of
≥3 mm Onset of TED symptoms ≥15 months VRDN-001 10 mg/kg Q3W* Week 15 Primary Endpoint Analysis
![Slide 33 Slide 33](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s33g1.jpg)
Viridian is developing multiple
potential best-in-class subcutaneous (SC) programs in TED VRDN-001, -002, and -003 are investigational therapies that are not approved for any use in any country. Mechanism Full antagonist Full antagonist Partial antagonist Half-life ~10 to 11 days
Expected to match or exceed VRDN-002 up to 43 days Administration Q1W or Q2W SC Q2W or Q4W SC Q2W or Q4W SC Same extended half-life mutations Same binding domain VRDN-001 SC VRDN-003 VRDN-002
![Slide 34 Slide 34](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s34g1.jpg)
VRDN-001, VRDN-002, & VRDN-003
SC program progress and priorities SC formulation work completed for all three SC programs at 150 mg/mL concentration allowing for administration of 300 mg / 2 mL VRDN-001 SC IND amendment submitted to FDA VRDN-003 IND filing submitted to FDA
VRDN-002 Phase 1 trial with single IV and single SC dose cohorts enrolled Pen device supply partnership expected in 2H23 VRDN-001 SC Phase 1 trial initiation expected in 3Q23, with data expected in 4Q23 VRDN-003 Phase 1 trial initiation expected in
3Q23, with data expected in 4Q23 Lead SC program selection on track for year-end 2023 Lead SC program pivotal Phase 2/3 trial planned for the middle of 2024
![Slide 35 Slide 35](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s35g1.jpg)
Closing Remarks Scott Myers, MBA,
President and Chief Executive Officer
![Slide 36 Slide 36](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s36g1.jpg)
VRDN SC Potential
first/best-in-class self-administered SC pen Plan to launch with a potentially best-in-class IV followed by a self-administered SC pen in TED * Pictures used for illustrative purposes only VRDN-001 IV Potential best-in-class Q3W IV treatment for TED
2 1
![Slide 37 Slide 37](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s37g1.jpg)
Viridian is focused on key factors
to build a successful blockbuster product franchise in TED Best-in-class IV product Active + Chronic TED Expand prescriber base US + ex-US market access and sales First / best-in-class SC product Establish new treatment paradigms in TED Building a
blockbuster TED franchise
![Slide 38 Slide 38](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s38g1.jpg)
Launch potential best-in-class IV
TED therapy in US and ex-US Follow with potential best-in-class SC TED therapy Replicate drug development and launch excellence in additional autoimmune and rare diseases Our long-term vision: building a fully-integrated biopharmaceutical company
Growth Potential
![Slide 39 Slide 39](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s39g1.jpg)
Q&A Session
![Slide 40 Slide 40](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s40g1.jpg)
Q&A Session Participants Scott
Myers, MBA PRESIDENT AND CEO Thomas Ciulla, MD, MBA CHIEF DEVELOPMENT OFFICER Todd James SVP, CORPORATE AFFAIRS & IR Kimberly Cockerham, MD, FACS Barrett Katz, MD, MBA CHIEF MEDICAL OFFICER Kristian Humer CHIEF FINANCIAL & BUSINESS
OFFICER
![Slide 41 Slide 41](https://www.sec.gov/Archives/edgar/data/1590750/000119312523184757/g440197ex99_2s41g1.jpg)
Thank you!
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