UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) VIRIDIAN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-1187261 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) For the six months ended June 30, 2023, Viridian Therapeutics reported a net loss of $123.2 million, a significant increase from the $55.2 million loss in the same period of 2022, driven by substantial rises in R&D and G&A expenses [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets were $351.5 million, a decrease from $435.1 million at December 31, 2022, primarily due to a reduction in cash, cash equivalents, and short-term investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $87,082 | $155,579 | | Short-term investments | $247,209 | $268,971 | | **Total Assets** | **$351,467** | **$435,091** | | **Liabilities & Equity** | | | | Total Liabilities | $35,610 | $40,027 | | Total Stockholders' Equity | $315,857 | $395,064 | | **Total Liabilities & Stockholders' Equity** | **$351,467** | **$435,091** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $55.1 million for the three months and $123.2 million for the six months ended June 30, 2023, representing a significant increase in losses compared to the same periods in 2022, driven by higher research and development and general and administrative expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | 6 Months 2023 | 6 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $72 | $256 | $170 | $472 | | Research and Development | $40,083 | $21,712 | $90,823 | $39,458 | | General and Administrative | $19,264 | $8,108 | $41,095 | $16,467 | | Loss from Operations | $(59,275) | $(29,564) | $(131,748) | $(55,453) | | Net Loss | $(55,063) | $(29,491) | $(123,214) | $(55,184) | | Net Loss Per Share | $(1.27) | $(1.06) | $(2.88) | $(2.05) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities was $107.2 million, with net cash provided by investing activities of $27.4 million and financing activities of $11.3 million, resulting in a net decrease in cash and cash equivalents of $68.5 million Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(107,187) | $(39,128) | | Net Cash Provided by Investing Activities | $27,418 | $22,826 | | Net Cash Provided by Financing Activities | $11,272 | $5,296 | | **Net Decrease in Cash** | **$(68,497)** | **$(11,006)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's rare disease focus, particularly VRDN-001 for TED, confirm sufficient cash to fund operations for at least the next twelve months, and outline key agreements including collaborations, license obligations, and an upsized term loan facility - The company is a biopharmaceutical firm focused on rare diseases, with its most advanced program, VRDN-001, targeting Thyroid Eye Disease (TED) - As of June 30, 2023, the company had an accumulated deficit of **$611.4 million** and expects to continue generating operating losses. However, with approximately **$334.3 million** in cash, cash equivalents, and short-term investments, management expects to fund operations for at least the **next twelve months**[26](index=26&type=chunk)[28](index=28&type=chunk) - In April 2022, the company entered into a loan agreement with Hercules Capital for up to **$75.0 million**, drawing an initial **$5.0 million**. In August 2023, this was amended to increase the available principal to **$150.0 million**, with an additional **$15.0 million** drawn[79](index=79&type=chunk)[82](index=82&type=chunk)[85](index=85&type=chunk) - The company has several key license agreements with potential future milestone payments, including up to **$48.0 million** to ImmunoGen, and up to **$45.0 million** to Enable Injections, plus potential commercial milestones and royalties for both[97](index=97&type=chunk)[102](index=102&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights significant progress in clinical programs for Thyroid Eye Disease (TED), with a net loss increase to $123.2 million for the first six months of 2023, and expects current cash of $334.3 million to fund operations into the second half of 2025 [Overview and Recent Developments](index=34&type=section&id=Overview%20and%20Recent%20Developments) The company focuses on developing best-in-class medicines for rare diseases, with its lead program VRDN-001 targeting Thyroid Eye Disease (TED), showing positive clinical proof-of-concept data and advancing into Phase 3 trials, while also progressing subcutaneous candidates - VRDN-001 has established clinical proof-of-concept in both active and chronic Thyroid Eye Disease (TED)[140](index=140&type=chunk) - Key upcoming milestones include topline results from the THRIVE Phase 3 trial (active TED) in **mid-2024** and the THRIVE-2 Phase 3 trial (chronic TED) by **year-end 2024**[140](index=140&type=chunk) - The company is advancing **three subcutaneous (SC) candidates** and plans to select a lead program by **year-end 2023** to move into a pivotal trial in **mid-2024**[141](index=141&type=chunk)[144](index=144&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) For the three and six months ended June 30, 2023, the company experienced a significant increase in operating expenses, primarily driven by higher R&D costs due to milestone/license fees, manufacturing, and personnel, alongside increased G&A expenses from personnel costs Comparison of Operating Expenses - Three Months Ended June 30 (in thousands) | Expense Category | 2023 | 2022 | Increase | | :--- | :--- | :--- | :--- | | Research and development | $40,083 | $21,712 | $18,371 | | General and administrative | $19,264 | $8,108 | $11,156 | - The Q2 2023 increase in R&D expenses was driven by higher costs for manufacturing (**$4.5M**), clinical trials (**$5.0M**), personnel (**$5.0M**), and milestone fees (**$2.0M**)[163](index=163&type=chunk) Comparison of Operating Expenses - Six Months Ended June 30 (in thousands) | Expense Category | 2023 | 2022 | Increase | | :--- | :--- | :--- | :--- | | Research and development | $90,823 | $39,458 | $51,365 | | General and administrative | $41,095 | $16,467 | $24,628 | - The six-month increase in R&D expenses was primarily due to a **$14.5M** net increase in milestone/license fees, a **$12.3M** increase in manufacturing costs, and a **$9.7M** increase in personnel costs[169](index=169&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had $334.3 million in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations into the second half of 2025, despite an accumulated deficit of $611.4 million and the need for substantial additional capital - The company has **$334.3 million** in cash, cash equivalents, and short-term investments as of June 30, 2023, which is expected to fund operations into the **second half of 2025**[173](index=173&type=chunk) - The company has an accumulated deficit of **$611.4 million** as of June 30, 2023, and has not generated any revenue from product sales[174](index=174&type=chunk) - In August 2023, the company amended its loan agreement with Hercules Capital, increasing the total available principal from **$75.0 million** to **$150.0 million** and drew an additional **$15.0 million**[181](index=181&type=chunk) - The company has a **$175.0 million** At-The-Market (ATM) agreement with Jefferies, under which no shares were sold in the first six months of 2023[182](index=182&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Viridian Therapeutics is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[192](index=192&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023, with no material changes in internal control over financial reporting during the most recent fiscal quarter - Management concluded that the company's disclosure controls and procedures were effective at a reasonable level of assurance as of the end of the quarter[194](index=194&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[195](index=195&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that it believes would have a material adverse effect on its business, financial condition, or results of operations - The company is not currently involved in any material legal proceedings[197](index=197&type=chunk) [Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial condition, the uncertain outcomes of product development and clinical trials, regulatory approvals, reliance on third parties, and intellectual property protection [Risks Related to Financial Condition and Capital Requirements](index=44&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) The company has a history of significant losses, with an accumulated deficit of $611.4 million as of June 30, 2023, and will need to raise substantial additional capital, with potential future financing causing dilution or operational restrictions - The company will need to raise additional capital to fund operations and service obligations; failure to do so when needed could prevent it from continuing as a going concern[199](index=199&type=chunk) - The company has a limited operating history, has historically incurred significant losses (**$611.4M** accumulated deficit as of June 30, 2023), and anticipates continued losses[203](index=203&type=chunk) - Raising additional capital may cause dilution to stockholders, involve restrictive debt covenants, or require relinquishing valuable rights to technologies or product candidates on unfavorable terms[213](index=213&type=chunk)[214](index=214&type=chunk)[215](index=215&type=chunk) [Risks Related to Product Candidate Discovery and Development](index=49&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) The company's success is heavily dependent on its early-stage product candidates, with clinical trials being expensive, time-consuming, and uncertain, carrying a high risk of failure, potential for undesirable side effects, and challenges in patient enrollment for rare diseases - Clinical development is expensive, time-consuming, and involves significant risk; a failure of one or more clinical trials can occur at any stage[219](index=219&type=chunk) - The company is heavily dependent on the success of its product candidates, which are in early stages of development, and cannot guarantee that data will be sufficient for regulatory approval[226](index=226&type=chunk) - Early positive results from preclinical studies and clinical trials are not predictive of future results in larger, later-stage trials[230](index=230&type=chunk) - Difficulty enrolling and maintaining patients in clinical trials for rare diseases could delay or prevent the completion of these trials[232](index=232&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=54&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) The company's biologic product candidates may face competition from biosimilars, may not receive special regulatory designations, and will be subject to extensive ongoing regulatory requirements and healthcare reform measures, alongside stringent fraud, abuse, and data privacy laws - Product candidates regulated as biologics may face competition from biosimilars sooner than anticipated under the BPCIA, which allows for an abbreviated approval pathway for competing products[241](index=241&type=chunk) - The company may not receive or maintain expedited regulatory designations such as Orphan Drug, Breakthrough Therapy, or Fast Track, which could hinder development timelines[244](index=244&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk) - Even if a product is approved, the company will remain subject to ongoing and extensive regulatory requirements for manufacturing, labeling, and marketing, and failure to comply can lead to significant penalties[250](index=250&type=chunk) - The company is subject to various federal and state healthcare laws, including anti-kickback, false claims, and data privacy regulations (e.g., GDPR), with non-compliance carrying substantial penalties[255](index=255&type=chunk) [Risks Related to Reliance on Third Parties](index=59&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Viridian heavily relies on third-party CROs for clinical trials and CMOs for manufacturing, lacking internal capabilities, making it vulnerable to supply chain disruptions, regulatory non-compliance, and complex biologic manufacturing issues that could harm development and commercialization - The company relies on third-party CROs for clinical trials and CMOs for manufacturing, and is responsible for their compliance with regulatory standards like GCP and cGMP[262](index=262&type=chunk) - The company lacks internal manufacturing capabilities and relies on a limited number of third-party suppliers, making it vulnerable to supply chain disruptions which could delay clinical trials[266](index=266&type=chunk)[271](index=271&type=chunk) - The manufacturing process for biologic product candidates is complex and prone to issues like contamination or variability, which could lead to product loss, delays, and harm the company's reputation[267](index=267&type=chunk)[268](index=268&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In May and July 2023, the company issued a total of 243,902 shares of common stock to two accredited investors as partial consideration for certain licenses and rights, relying on the exemption from registration provided by Section 4(a)(2) of the Securities Act - On May 22, 2023, and July 14, 2023, the company issued a combined **243,902 shares** of common stock to two accredited investors as partial consideration for licenses and rights granted to the company[377](index=377&type=chunk) [Defaults Upon Senior Securities](index=82&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable - There were no defaults upon senior securities during the period[378](index=378&type=chunk) [Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - The company has no mine safety disclosures to report[379](index=379&type=chunk) [Other Information](index=83&type=section&id=Item%205.%20Other%20Information) On August 7, 2023, the company amended its Loan and Security Agreement with Hercules Capital, Inc., increasing the total term loan facility from $75 million to $150 million, secured by substantially all of the company's assets excluding intellectual property - On August 7, 2023, the company amended its loan agreement with Hercules Capital, increasing the aggregate term loan facility available from **$75 million** to **$150 million**[380](index=380&type=chunk) [Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including corporate governance documents, material contracts such as the amended loan agreement, and certifications from the principal executive and financial officers - The report includes several exhibits, notably the First Amendment to the Loan and Security Agreement with Hercules Capital, Inc., and required officer certifications[383](index=383&type=chunk)

Viridian Therapeutics, Inc. (NASDAQ:VRDN) Q1 2023 Results Conference Call May 9, 2023 4:30 PM ET Company Participants Louisa Stone - Manager, IR Scott Myers - President and CEO Kristian Humer - Chief Financial and Business Officer Dr. Thomas Ciulla - Chief Development Officer Todd James - SVP, Corporate Affairs and IR Conference Call Participants Derek Archila - Wells Fargo Gavin Clark-Gartner - Evercore ISI Thomas Smith - SVB Securities Laura Chico - Wedbush Securities Kalpit Patel - B. Riley Securities Ja ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-36483 VIRIDIAN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-1187261 (State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36483 221 Crescent Street, Suite 401, Waltham, MA 02453 (Address of principal executive offices) Registrant's telephone number, inclu ...

Viridian Therapeutics, Inc. (NASDAQ:VRDN) Q4 2022 Earnings Conference Call March 8, 2023 8:00 AM ET Company Participants Louisa Stone - Manager, Investor Relations Scott Myers - President and Chief Executive Officer Kristian Humer - Chief Financial Officer Deepa Rajagopalan - Chief Product and Strategy Officer Todd James - Senior Vice President, Corporate Affairs and Investor Relations Conference Call Participants Gavin Clark-Gartner - Evercore ISI Laura Chico - Wedbush Securities Jason Butler - JMP Securit ...

%VIRIDIAN J.P. Morgan 41st Annual Healthcare Conference January 9, 2023 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 "woul ...

Financial Data and Key Metrics Changes - As of September 30, 2022, cash, cash equivalents, and short-term investments were $431 million, compared to $197 million as of December 31, 2021, indicating a significant increase in liquidity [58] - The company believes that its current cash position will be sufficient to fund operations into the second half of 2025 [58] Business Line Data and Key Metrics Changes - The IV VRDN-001 program showed promising results, with a 75% proptosis responder rate compared to 56% for TEPEZZA, and a 4.0-point improvement in Clinical Activity Score (CAS) [22][35] - The 20 mg per kg cohort demonstrated a mean change in proptosis of 2.04 millimeters, which is higher than the mean changes reported for TEPEZZA [34] Market Data and Key Metrics Changes - The Thyroid Eye Disease (TED) market is currently valued at $2 billion in the U.S. and is expected to grow to over $4 billion globally [8] - The company aims to capture a significant share of this market with its differentiated product offerings [55] Company Strategy and Development Direction - The company is focused on delivering a complete portfolio of products for the treatment of TED, including both intravenous and subcutaneous options [7][55] - The Phase 3 program consists of two pivotal efficacy studies, THRIVE and THRIVE-2, expected to read out in mid and late 2024, respectively [45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy of VRDN-001, highlighting its potential to offer a shorter treatment course and faster symptom relief compared to existing therapies [44] - The company is well-funded and positioned to advance its portfolio rapidly, with a strong foundation for future growth in the TED market [56] Other Important Information - The company reported that the 3 mg per kg cohorts for VRDN-001 are fully enrolled, with top-line data expected in early January 2023 [11] - VRDN-002 has shown a half-life of up to 43 days, significantly better than TEPEZZA, positioning it well for upcoming trials [15] Q&A Session Summary Question: Can you provide more color on the discrepancy in the percent of patients who achieve a CAS of zero or one between the 10 and 20 mg per kg cohorts? - Management explained that both cohorts had a higher percentage of patients achieving CAS of zero or one compared to TEPEZZA, with baseline characteristics influencing the observed differences [62] Question: Is there any scenario where you would consider adding a weekly dosing cohort for the subcutaneous TED proof-of-concept trial? - Management indicated confidence in the every-other-week dosing paradigm and is exploring the potential for even less frequent dosing based on upcoming data [74] Question: Can you clarify what the mean proptosis reduction was in the placebo patients with this updated data set? - The mean proptosis change in the placebo group was an improvement of 0.5 millimeters, consistent with TEPEZZA studies [80] Question: What can you say about the ongoing 3 mg/kg cohort at this point? Any color on safety or tolerability? - No serious adverse events have been reported in the 3 mg/kg cohort so far [84] Question: Could you offer any additional color on the hyperglycemia event in the 20 mg/kg cohort? - Management clarified that variability in glucose measures was consistent with the underlying diabetes condition of the patient and not drug-related [90] Question: Will you require a comparison to active drug in the Phase 3 study? - Management confirmed that the study design includes two active arms and one placebo arm, with no requirement for comparison to an active drug [92] Question: What gives you the confidence for selecting either VRDN-002 or VRDN-003 for Phase III development by early 2024? - Management stated that both candidates are expected to perform similarly in terms of efficacy, allowing for a robust choice based on pharmacokinetic data [100]

Viridian Therapeutics, Inc. (NASDAQ:VRDN) Q2 2022 Earnings Conference Call August 15, 2022 8:00 AM ET Company Participants John Jordan - VP of IR Jonathan Violin - President and CEO Barrett Katz - Chief Medical Officer, Raymond Douglas - Director of Thyroid Eye Disease Kristian Humer - CFO and Chief Business Officer Conference Call Participants Chris Howerton - Jefferies Thomas Smith - SVB Securities Gavin Clark-Gartner - Evercore ISI Rami Katkhuda - LifeSci Capital Laura Chico - Wedbush Securities Kalpit P ...

| --- | --- | |-----------------------------------------------------------------------------|-------| | | | | ENGINEERING MEDICINES | | | TO IMPROVE PATIENT CARE *VIRIDIAN 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, "anti ...