Viridian Therapeutics May 2022 %VIRIDIAN Cautionary note regarding forward-looking statements This presentation contains forward-looking statements relating to Viridian Therapeutics, Inc., including statements about our plans to obtain funding, develop and commercialize our therapeutic candidates, our planned clinical trials, the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, the clinical utility of our therapeutic candidates and our intellectual proper ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows, along with detailed notes explaining significant accounting policies, collaboration agreements, commitments, capital structure, and subsequent events [CONDENSED CONSOLIDATED BALANCE SHEETS](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :--------------------------------- | :----------------------------- | :----------------------------- | | Total assets | $183,165 | $203,709 | | Cash and cash equivalents | $30,858 | $42,299 | | Short-term investments | $144,570 | $154,666 | | Total liabilities | $16,523 | $15,993 | | Total stockholders' equity | $166,642 | $187,716 | - Total assets decreased by **$20.5 million** from December 31, 2021, to March 31, 2022[15](index=15&type=chunk) - Total stockholders' equity decreased by **$21.1 million** over the same period[15](index=15&type=chunk) [CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :--------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Collaboration revenue - related party | $216 | $1,451 | | Research and development expenses | $17,746 | $13,806 | | General and administrative expenses | $8,359 | $6,160 | | Loss from operations | $(25,889) | $(18,515) | | Net loss | $(25,693) | $(18,460) | | Comprehensive loss | $(26,471) | $(18,473) | | Net loss per share, basic and diluted | $(0.98) | $(2.91) | | Weighted-average shares outstanding | 26,126,092 | 6,336,347 | - Collaboration revenue decreased significantly by **$1.2 million (85%)** year-over-year[17](index=17&type=chunk) - Net loss increased by **$7.2 million (39%)** year-over-year, while net loss per share decreased due to a substantial increase in weighted-average shares outstanding[17](index=17&type=chunk) [CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20STOCKHOLDERS'%20EQUITY) | Metric | December 31, 2021 (in thousands) | March 31, 2022 (in thousands) | | :--------------------------------- | :----------------------------- | :---------------------------- | | Total Stockholders' Equity | $187,716 | $166,642 | | Accumulated Deficit | $(358,300) | $(383,993) | | Additional Paid-in Capital | $412,101 | $439,187 | | Series A Preferred Stock (Amount) | $118,164 | $96,442 | | Common Stock (Shares) | 23,924,004 | 27,169,422 | - During Q1 2022, **47,871 shares** of Series A Preferred Stock were converted into **3,191,555 shares** of common stock[20](index=20&type=chunk) - Share-based compensation expense contributed **$4.7 million** to additional paid-in capital[20](index=20&type=chunk) [CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS](index=9&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) | Cash Flow Activity | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :--------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Net cash used in operating activities | $(21,042) | $(11,539) | | Net cash provided by investing activities | $8,863 | $10,872 | | Net cash provided by financing activities | $738 | $1,259 | | Net increase (decrease) in cash and cash equivalents | $(11,441) | $592 | | Cash and cash equivalents at end of period | $30,858 | $46,489 | - Net cash used in operating activities increased by **$9.5 million** year-over-year[24](index=24&type=chunk) - The company experienced a net decrease in cash and cash equivalents of **$11.4 million** in Q1 2022, compared to a net increase of **$0.6 million** in Q1 2021[24](index=24&type=chunk) [NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS](index=10&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) [1. DESCRIPTION OF BUSINESS](index=10&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS) - Viridian Therapeutics is a biotechnology company focused on developing new treatments for serious diseases, particularly **Thyroid Eye Disease (TED)** with product candidates **VRDN-001** and **VRDN-002**[26](index=26&type=chunk) - The company has an accumulated deficit of **$384.0 million** as of March 31, 2022, and expects to continue generating operating losses[27](index=27&type=chunk) - As of March 31, 2022, the company had **$175.4 million** in cash, cash equivalents, and short-term investments, which are expected to fund operations for at least the next twelve months[29](index=29&type=chunk) [2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=11&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - The unaudited condensed consolidated financial statements are prepared in conformity with **U.S. GAAP** for interim financial reporting[32](index=32&type=chunk) - The company operates in **one segment**, focusing on developing and commercializing novel therapeutics[34](index=34&type=chunk) - Revenue is recognized following a **five-step model** when the customer obtains control of promised goods or services, with variable consideration constrained if a significant revenue reversal is probable[43](index=43&type=chunk)[44](index=44&type=chunk)[47](index=47&type=chunk) - Research and development costs, including upfront and milestone payments for licensed technology, are **expensed as incurred** if future economic benefit is uncertain[54](index=54&type=chunk)[55](index=55&type=chunk) - The COVID-19 pandemic has **not materially impacted** the company's financial condition or operations as of March 31, 2022, but potential future disruptions are acknowledged[37](index=37&type=chunk) [3. FAIR VALUE MEASUREMENTS](index=18&type=section&id=3.%20FAIR%20VALUE%20MEASUREMENTS) | Investment Category | March 31, 2022 (Fair Value, in thousands) | December 31, 2021 (Fair Value, in thousands) | | :--------------------------------- | :---------------------------------------- | :----------------------------------------- | | Money market funds (Level 1) | $30,758 | $42,199 | | U.S. treasury securities (Level 2) | $27,109 | $22,161 | | U.S. corporate paper and bonds (Level 2) | $112,923 | $127,917 | | International corporate bond holdings (Level 2) | $4,538 | $4,588 | | **Total cash equivalents and short-term investments** | **$175,328** | **$196,865** | - The company considers unrealized losses in its investment portfolio to be **temporary**, with the intent and ability to hold investments until recovery[82](index=82&type=chunk) - All investments have contractual maturity dates of **less than 24 months**[82](index=82&type=chunk) [4. ACCRUED LIABILITIES](index=21&type=section&id=4.%20ACCRUED%20LIABILITIES) | Accrued Liability | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :--------------------------------- | :----------------------------- | :----------------------------- | | Accrued outsourced clinical trials and preclinical studies | $8,647 | $6,316 | | Accrued employee compensation and related taxes | $1,548 | $3,652 | | Operating lease liability, short-term | $579 | $520 | | Accrued legal fees and expenses | $272 | $80 | | Other accrued liabilities | $414 | $350 | | **Total accrued liabilities** | **$11,560** | **$11,018** | - Total accrued liabilities increased by **$0.5 million** from December 31, 2021, to March 31, 2022[85](index=85&type=chunk) - The primary driver of the increase was a **$2.3 million** rise in accrued outsourced clinical trials and preclinical studies[85](index=85&type=chunk) [5. COLLABORATION AGREEMENTS](index=21&type=section&id=5.%20COLLABORATION%20AGREEMENTS) - The company has a license agreement with **Zenas BioPharma** for exclusive rights to develop and commercialize **IGF-1R antibody products in China**, with potential milestone and royalty payments[86](index=86&type=chunk)[87](index=87&type=chunk) - Collaboration revenue from Zenas BioPharma decreased from **$1.5 million** in Q1 2021 to **$0.2 million** in Q1 2022 due to the timing of activities[89](index=89&type=chunk) - In January 2022, the company entered an antibody and discovery option agreement with Paragon Therapeutics, paying a **non-refundable $2.5 million fee** recorded as R&D expense[91](index=91&type=chunk)[92](index=92&type=chunk) [6. COMMITMENTS AND CONTINGENCIES](index=23&type=section&id=6.%20COMMITMENTS%20AND%20CONTINGENCIES) - The ImmunoGen License Agreement involves potential future development milestone payments up to **$48.0 million** and commercial milestone payments up to **$95.0 million**, plus **mid-single digit royalties**[94](index=94&type=chunk) - The 2021 Xencor License Agreement involved issuing **394,737 common shares** (valued at **$7.5 million**) and includes potential future milestone payments up to **$27.8 million** plus **mid-single digit royalties**[95](index=95&type=chunk) - Consolidated future minimum lease payments for office and lab spaces were approximately **$1.8 million** through **2025** as of March 31, 2022[100](index=100&type=chunk) [7. CAPITAL STOCK](index=24&type=section&id=7.%20CAPITAL%20STOCK) - The company is authorized to issue **200,000,000 shares** of common stock and **5,000,000 shares** of preferred stock[103](index=103&type=chunk) - As of March 31, 2022, no shares have been sold under the November 2021 ATM Agreement, which allows for sales of up to **$75.0 million** in common stock[105](index=105&type=chunk) - During Q1 2022, **47,871 shares** of Series A Preferred Stock were converted into **3,191,555 shares** of common stock, leaving **212,566 Series A shares** outstanding[113](index=113&type=chunk) [8. WARRANTS](index=27&type=section&id=8.%20WARRANTS) | Warrant Type | Number of Underlying Shares (March 31, 2022) | Weighted-Average Exercise Price (March 31, 2022) | | :--------------------------------- | :------------------------------------------- | :----------------------------------------------- | | Liability-classified warrants | 781 | $127.95 | | Equity-classified warrants | 419,848 | $15.70 | | **Total warrants** | **420,629** | **$15.91** | - **No warrants were exercised** during the three months ended March 31, 2022[117](index=117&type=chunk) [9. SHARE-BASED COMPENSATION](index=28&type=section&id=9.%20SHARE-BASED%20COMPENSATION) | Metric | March 31, 2022 | | :--------------------------------- | :------------- | | Total Stock Options Outstanding | 4,801,711 | | Weighted-Average Exercise Price | $17.34 | | Weighted-Average Grant-Date Fair Value (Q1 2022) | $13.43 | | Weighted-Average Grant-Date Fair Value (Q1 2021) | $19.56 | | Share-Based Compensation Expense | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :--------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Research and development | $1,545 | $1,111 | | General and administrative | $3,114 | $2,064 | | **Total** | **$4,659** | **$3,175** | - As of March 31, 2022, the company had **$56.3 million** of total unrecognized share-based compensation costs, expected to be recognized over a weighted-average remaining period of **3.18 years**[126](index=126&type=chunk) [10. NET LOSS PER SHARE](index=30&type=section&id=10.%20NET%20LOSS%20PER%20SHARE) - Basic and diluted net loss per share were **$(0.98)** for Q1 2022 and **$(2.91)** for Q1 2021[17](index=17&type=chunk) - The weighted-average shares used to compute net loss per share significantly increased from **6,336,347** in Q1 2021 to **26,126,092** in Q1 2022[17](index=17&type=chunk) - Potentially dilutive securities, totaling **20,935,925** as of March 31, 2022, were **antidilutive** due to the company's net loss position[128](index=128&type=chunk) [11. SUBSEQUENT EVENTS](index=30&type=section&id=11.%20SUBSEQUENT%20EVENTS) - On April 1, 2022, the company entered into a loan and security agreement with Hercules Capital, Inc., providing access to a term loan of up to **$75.0 million** in four tranches, with an initial draw of **$5.0 million**[129](index=129&type=chunk)[130](index=130&type=chunk) - The Term Loan bears a floating interest rate (greater of **7.45%** or **4.2%** above Prime Rate, not exceeding **8.95%**) with interest-only payments through **April 1, 2024**, extendable based on development milestones[131](index=131&type=chunk) - On April 13, 2022, a second amendment to the Massachusetts office lease was executed, adding **2,432 sq ft**, terminating **1,087 sq ft**, and extending the lease term for existing space[132](index=132&type=chunk)[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic focus on developing treatments for serious diseases, particularly Thyroid Eye Disease (TED) with VRDN-001 and VRDN-002. The analysis covers financial performance for Q1 2022, highlighting decreased collaboration revenue, increased R&D and G&A expenses, and details on liquidity, capital resources, and recent financing activities [Overview and Recent Developments](index=32&type=section&id=Overview%20and%20Recent%20Developments) - Viridian Therapeutics is a biotechnology company developing **VRDN-001** and **VRDN-002** for **Thyroid Eye Disease (TED)**[135](index=135&type=chunk)[136](index=136&type=chunk) - Top-line clinical data for **VRDN-001** (10 mg/kg and 20 mg/kg cohorts) is expected in **Q3 2022**, with a 3 mg/kg cohort data expected in **Q4 2022**[136](index=136&type=chunk)[138](index=138&type=chunk) - **VRDN-002**, designed for subcutaneous injection, has completed dose escalation in its Phase 1 trial, with top-line data expected in **Q3 2022**[139](index=139&type=chunk)[140](index=140&type=chunk) - The company is expanding its pipeline with discovery-stage programs **VRDN-004** and **VRDN-005** for undisclosed rare diseases[141](index=141&type=chunk) [The COVID-19 Pandemic](index=33&type=section&id=The%20COVID-19%20Pandemic) - The COVID-19 pandemic has **not materially impacted** the company's business, financial condition, or results of operations to date[142](index=142&type=chunk) - **Potential future risks** include disruptions to the supply chain, delays in clinical trials, and impacts on capital raising[142](index=142&type=chunk) [Financial Operations Overview](index=33&type=section&id=Financial%20Operations%20Overview) - Revenue has historically consisted of **upfront license payments, milestone payments, and R&D services**, with future revenue expected from similar sources, product sales, and royalties[143](index=143&type=chunk)[145](index=145&type=chunk) - Research and development expenses include personnel costs, CRO fees, manufacturing, regulatory activities, and license fees, all **expensed as incurred**[146](index=146&type=chunk)[147](index=147&type=chunk) - General and administrative expenses primarily cover **salaries, benefits, share-based compensation, professional fees** (auditing, tax, legal), and other administrative costs[151](index=151&type=chunk) - Other income, net, is mainly derived from **interest income on short-term investments** and non-recurring items[152](index=152&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - There were **no changes** to the company's critical accounting policies during the three months ended March 31, 2022, as disclosed in its 2021 Annual Report on Form 10-K[153](index=153&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Increase (Decrease) (in thousands) | | :--------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :--------------------------------- | | Collaboration revenue - related party | $216 | $1,451 | $(1,235) | | Research and development expenses | $17,746 | $13,806 | $3,940 | | General and administrative expenses | $8,359 | $6,160 | $2,199 | | Other income, net | $196 | $55 | $141 | - Collaboration revenue decreased by **$1.2 million** due to the timing of activities under the Zenas BioPharma agreement[155](index=155&type=chunk) - Research and development expenses increased by **$3.9 million**, primarily due to higher personnel costs, a **$2.5 million license fee** to Paragon Therapeutics, and increased clinical trial expenses for **VRDN-001** and **VRDN-002**[156](index=156&type=chunk)[157](index=157&type=chunk) - General and administrative expenses increased by **$2.2 million**, driven by higher personnel, board of directors, and professional expenses[158](index=158&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) | Cash Flow Activity | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Increase (Decrease) (in thousands) | | :--------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :--------------------------------- | | Operating activities | $(21,042) | $(11,539) | $(9,503) | | Investing activities | $8,863 | $10,872 | $(2,009) | | Financing activities | $738 | $1,259 | $(521) | | **Total** | **$(11,441)** | **$592** | **$(12,033)** | - As of March 31, 2022, the company had **$175.4 million** in cash, cash equivalents, and short-term investments, expected to fund operations into **2024**[167](index=167&type=chunk) - The company entered into a loan and security agreement with Hercules Capital, Inc. on April 1, 2022, providing access to a term loan of up to **$75.0 million**, with an initial draw of **$5.0 million**[172](index=172&type=chunk) - The November 2021 ATM Agreement allows for the sale of up to **$75.0 million** in common stock, with no shares sold as of March 31, 2022[174](index=174&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Viridian Therapeutics is not required to provide detailed quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is **exempt from providing detailed quantitative and qualitative disclosures** about market risk[180](index=180&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective at a reasonable level of assurance as of March 31, 2022. There were no material changes in internal control over financial reporting during the quarter - Disclosure controls and procedures were evaluated and deemed **effective at a reasonable level of assurance** as of March 31, 2022[182](index=182&type=chunk) - **No changes in internal control over financial reporting** occurred during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[183](index=183&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings that are expected to have a material adverse effect on its business, financial condition, or results of operations - The company is **not a party to any legal proceedings** that are believed to have a material adverse effect on its business, financial condition, or results of operations[185](index=185&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021 - **No material changes** from the risk factors disclosed in Item 1A of the Annual Report on Form 10-K for the year ended December 31, 2021[186](index=186&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable to the company for the reporting period - This item is **not applicable**[187](index=187&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - This item is **not applicable**[188](index=188&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - This item is **not applicable**[189](index=189&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) On May 11, 2022, the company's board of directors approved an amendment and restatement of the Bylaws, clarifying stockholder voting standards for non-director matters and the chairman's power to adjourn meetings in the absence of a quorum - The company's Bylaws were amended and restated on **May 11, 2022**[190](index=190&type=chunk) - Amendments **clarify the voting standard for stockholders** (majority of votes cast for non-director matters) and the **chairman's power to adjourn meetings** in the absence of a quorum[190](index=190&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report, including corporate governance documents, preferred stock designations, warrant forms, and certifications required by the Securities Exchange Act - Exhibits include the **Second Restated Certificate of Incorporation, Second Amended and Restated Bylaws, Certificates of Designation for Series A and B Preferred Stock, and Form of Warrant to Purchase Common Stock**[192](index=192&type=chunk) - **Certifications of the Principal Executive Officer and Principal Financial Officer** (pursuant to Rule 13a-14(a) and 18 U.S.C. 1350) are included[192](index=192&type=chunk) - **XBRL Instance Document and Taxonomy Extension Documents** are furnished as part of the exhibits[192](index=192&type=chunk)

Financial Data and Key Metrics Changes - The company ended Q1 2022 with $175 million in cash, cash equivalents, and short-term investments, positioning it strongly for future program advancements [32] - Research and development expenses increased to $17.7 million in Q1 2022 from $13.8 million in the same period last year, driven by personnel-related costs and clinical trial expenses [35] - General and administrative expenses rose to $8.4 million in Q1 2022 compared to $6.2 million in the prior year, attributed to personnel-related costs and consulting expenses [36] - The net loss for Q1 2022 was $25.7 million, up from $18.5 million in the same quarter of 2021, primarily due to increased operating costs and lower collaboration revenue [37] Business Line Data and Key Metrics Changes - The company is advancing its lead candidates for Thyroid Eye Disease (TED), specifically VRDN-001 and VRDN-002, with significant progress in clinical trials [9][25] - VRDN-001 is positioned as a differentiated intravenous product with higher affinity and potency compared to TEPEZZA, the only FDA-approved therapy for TED [10][22] - VRDN-002 is designed for convenient subcutaneous administration and incorporates half-life extension technology, potentially allowing for less frequent dosing [25][26] Market Data and Key Metrics Changes - The TED market is rapidly growing, currently annualizing at $2 billion in the U.S. just two years post-launch of TEPEZZA [21][22] - The company aims to establish VRDN-001 and VRDN-002 as meaningful therapeutic advancements in treating TED, competing across all settings of care [29] Company Strategy and Development Direction - The company is preparing VRDN-001 for pivotal trials, assuming positive proof-of-concept data, and plans to assess multiple dosing regimens in parallel [23] - The strategy includes advancing both intravenous and subcutaneous options for TED, with a focus on reducing patient burden through less frequent dosing [25][29] - The company is also expanding its pipeline with next-generation antibodies for other indications, while maintaining a strong focus on the TED portfolio [30] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement for upcoming data readouts that are expected to confirm the potential of their antibodies in treating TED [8] - The company is confident in its enrollment projections for ongoing trials and anticipates sharing top-line data in the third quarter [13][17] - Management highlighted the importance of demonstrating proof-of-concept data similar to TEPEZZA as a major value-creating event [22] Other Important Information - The company entered into a credit facility with Hercules for up to $75 million, enhancing its financial strength and operational flexibility [33][34] - The ongoing trials for VRDN-001 and VRDN-002 are designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics, with top-line data expected soon [27][28] Q&A Session Summary Question: Clarification on healthy volunteers data - Management clarified that the data presented is from an interim analysis and that the top dose cohort is still ongoing, affecting the data consistency observed [42] Question: Dosing comparison between VRDN-001 and VRDN-002 - Management indicated that while both molecules have similar receptor affinity, pharmacokinetics will differ, with VRDN-002 expected to have a longer half-life due to its design [44] Question: Impact of competitor's subcutaneous formulation - Management discussed the potential implications of a competitor's high concentration formulation but emphasized their focus on developing a low-volume, less frequent subcutaneous product [47][51] Question: Safety data on hypertension and hyperglycemia - Management noted that reported cases of hypertension and hyperglycemia were mild and deemed unrelated to the study drug [54] Question: Patient enrollment and study design - Management confirmed that enrollment is proceeding as expected, with a focus on enrolling patients likely to benefit from the treatment [56][60] Question: Plans for subcutaneous formulation of VRDN-001 - Management expressed optimism about advancing a subcutaneous formulation quickly, with no significant hurdles anticipated [61] Question: Timing for VRDN-002 data readout - Management clarified that the readout for VRDN-002 is now expected in the third quarter, with dose escalation completed [67] Question: Pharmacokinetic data for VRDN-001 - Management stated that pharmacokinetic data is still being collected, but initial results are promising and consistent with previous oncology data [68][70] Question: Dosing frequency for subcutaneous formulation - Management indicated that it is too early to determine the exact dosing frequency for a subcutaneous formulation, pending further data [84]

Viridian Therapeutics April 2022 %VIRIDIAN Cautionary note regarding forward-looking statements This presentation contains forward-looking statements relating to Viridian Therapeutics, Inc., including statements about our plans to obtain funding, develop and commercialize our therapeutic candidates, our planned clinical trials, the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, the clinical utility of our therapeutic candidates and our intellectual prop ...

Viridian Therapeutics March 2022 %VIRIDIAN Cautionary note regarding forward-looking statements This presentation contains forward-looking statements relating to Viridian Therapeutics, Inc., including statements about our plans to obtain funding, develop and commercialize our therapeutic candidates, our planned clinical trials, the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, the clinical utility of our therapeutic candidates and our intellectual prop ...

Part I [Item 1. Business](index=5&type=section&id=ITEM%201.%20BUSINESS) The company develops 'fast-follower' therapies for serious diseases, with a primary focus on Thyroid Eye Disease (TED) [Company Overview and Strategy](index=5&type=section&id=Company%20Overview%20and%20Strategy) The company's strategy is to develop 'fast-follower' and 'bio-superior' therapies for clinically validated targets - Viridian's business model is to develop 'fast-follower' and 'bio-superior' therapies for diseases with existing proof-of-concept, aiming to improve upon first-generation drugs in efficacy, safety, or convenience[18](index=18&type=chunk) - The company's primary focus is on **Thyroid Eye Disease (TED)**, a debilitating autoimmune disease[21](index=21&type=chunk)[28](index=28&type=chunk) - Key strategic elements include rapidly advancing VRDN-001 for quick market entry, developing the more convenient subcutaneous VRDN-002, and expanding the portfolio beyond TED[29](index=29&type=chunk) [Thyroid Eye Disease (TED) and Market Potential](index=7&type=section&id=Thyroid%20Eye%20Disease%20(TED)%20and%20Market%20Potential) TED is a sight-threatening autoimmune disorder with a significant market validated by the success of Tepezza® - TED is a sight-threatening autoimmune disorder causing inflammation, proptosis (bulging eyes), double vision, and potential blindness[31](index=31&type=chunk)[32](index=32&type=chunk) - The only FDA-approved therapy for TED is Horizon Therapeutics' Tepezza® (teprotumumab), an anti-IGF-1R antibody, which **validates the mechanism of action** for Viridian's candidates[21](index=21&type=chunk)[37](index=37&type=chunk) TED Market Potential | Metric | Value | | :--- | :--- | | Annual Incidence (U.S.) | Over 60,000 patients | | Patients Requiring IV Treatment (U.S.) | 20,000 - 25,000 annually | | Tepezza® 2021 Net Sales | $1.66 billion | [Product Candidates](index=8&type=section&id=Product%20Candidates) The company's pipeline is led by VRDN-001 (intravenous) and VRDN-002 (subcutaneous) for Thyroid Eye Disease - **VRDN-001:** The most advanced program, an intravenous (IV) anti-IGF-1R monoclonal antibody, with initial Phase 1/2 data expected in Q2 2022[23](index=23&type=chunk)[46](index=46&type=chunk) - **VRDN-002:** A next-generation anti-IGF-1R antibody designed for low-volume subcutaneous injection, with initial Phase 1 data expected mid-2022[24](index=24&type=chunk)[47](index=47&type=chunk) - **VRDN-003:** An exploratory program evaluating hypotheses that may yield a product profile differentiated beyond VRDN-002[48](index=48&type=chunk) [Intellectual Property, Competition, and Licensing](index=10&type=section&id=Intellectual%20Property%2C%20Competition%2C%20and%20Licensing) The company protects its candidates with patent applications and navigates a competitive landscape through strategic licensing - As of December 31, 2021, the company has multiple patent applications for VRDN-001 and VRDN-002, with potential **expirations no earlier than 2041**[49](index=49&type=chunk)[50](index=50&type=chunk) - Key competitors in the TED space include **Horizon Therapeutics plc (Tepezza®)**, Immunovant, Inc, Novartis International AG, Harbour BioMed, and Valenza Bio Inc[51](index=51&type=chunk) - The company has key licensing agreements with ImmunoGen for VRDN-001 technology and Xencor for IGF-1R antibody technology[52](index=52&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) [Government Regulation and Manufacturing](index=12&type=section&id=Government%20Regulation%20and%20Manufacturing) The company is subject to extensive government regulation and relies entirely on third-party contract manufacturing - The company is subject to extensive regulation by the FDA and comparable foreign authorities, governing all stages of product development[58](index=58&type=chunk)[83](index=83&type=chunk) - The company may seek expedited development pathways such as **Orphan Drug Designation, Fast Track, and Breakthrough Therapy Designation**[73](index=73&type=chunk)[76](index=76&type=chunk)[78](index=78&type=chunk) - Viridian does not own manufacturing facilities and is **entirely dependent on third-party CDMOs** for the production of its product candidates[124](index=124&type=chunk)[125](index=125&type=chunk) [Item 1A. Risk Factors](index=24&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant financial, clinical development, third-party reliance, and competitive risks - **Financial Risk:** The company has a history of losses (**$79.4 million in 2021**) and an accumulated deficit of **$358.3 million**, requiring additional capital to fund operations beyond 2024[133](index=133&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - **Clinical Development Risk:** The company is heavily dependent on the success of its early-stage product candidates, and clinical trial outcomes are uncertain[153](index=153&type=chunk)[159](index=159&type=chunk)[164](index=164&type=chunk) - **Third-Party Reliance Risk:** Viridian relies on CROs and CMOs to conduct clinical trials and manufacture its products, and any failure by these parties could harm development[194](index=194&type=chunk)[196](index=196&type=chunk) - **Commercial and Competitive Risk:** The company faces substantial competition from larger companies, and success depends on market acceptance, pricing, and reimbursement[251](index=251&type=chunk)[256](index=256&type=chunk) [Item 1B, 2, 3, 4](index=59&type=section&id=ITEM%201B%2C%202%2C%203%2C%204) The company reports no unresolved SEC comments, leases office space, and has no material legal proceedings - The company has no unresolved SEC staff comments[296](index=296&type=chunk) - Leased properties include approximately 4,371 sq ft of office space in Waltham, MA and 27,128 sq ft of office and lab space in Boulder, CO[297](index=297&type=chunk) - The company is not currently a party to any material legal proceedings[298](index=298&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=60&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's stock trades on Nasdaq, it does not pay dividends, and it recently issued shares in a private placement - Common stock is traded on The Nasdaq Capital Market under the symbol **"VRDN"**[302](index=302&type=chunk) - The company has never paid dividends and does not anticipate paying them in the foreseeable future, retaining earnings for business development[303](index=303&type=chunk) - On December 2, 2021, the company issued **394,737 shares** of common stock to Xencor in a private placement as an upfront payment for licensed rights[304](index=304&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=60&type=section&id=ITEM%207.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) The company's net loss decreased in 2021 due to a non-recurring R&D expense, while operating expenses increased [Results of Operations](index=65&type=section&id=Results%20of%20Operations) Operational results for 2021 show a lower net loss compared to 2020, driven by a non-recurring IPR&D expense Comparison of Years Ended December 31, 2021 and 2020 (in thousands) | Financial Metric | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Revenue | $2,963 | $1,050 | $1,913 | | Research and development expenses | $56,886 | $28,304 | $28,582 | | General and administrative expenses | $25,805 | $13,265 | $12,540 | | Acquired in-process R&D expense | $0 | $69,861 | ($69,861) | | Net loss | ($79,413) | ($110,715) | $31,302 | - The **$28.6 million increase in R&D expenses** in 2021 was primarily due to a $22.8 million increase in preclinical outsourcing and manufacturing for VRDN programs[343](index=343&type=chunk) - The **$12.5 million increase in G&A expenses** in 2021 was mainly driven by a $9.6 million increase in personnel-related costs due to higher headcount[346](index=346&type=chunk) - Acquired IPR&D expense of **$69.9 million** was recorded in 2020 related to the acquisition of Private Viridian, with no corresponding expense in 2021[345](index=345&type=chunk) [Liquidity and Capital Resources](index=66&type=section&id=Liquidity%20and%20Capital%20Resources) The company has sufficient cash to fund operations into 2024, supported by recent financing activities - As of December 31, 2021, the company had **$197.0 million in cash**, cash equivalents, and short-term investments, which is expected to fund planned operations into 2024[347](index=347&type=chunk) - The company has an accumulated deficit of **$358.3 million** as of December 31, 2021[348](index=348&type=chunk) Cash Flow Summary (in thousands) | Activity | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($54,581) | ($29,779) | | Net cash used in investing activities | ($74,292) | ($50,481) | | Net cash provided by financing activities | $125,275 | $101,311 | - Financing activities in 2021 were primarily driven by net proceeds of **$107.3 million** from the sale of common stock and **$15.7 million** from the sale of Series B Preferred Stock[363](index=363&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=69&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, this disclosure is not required - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[365](index=365&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=69&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section presents the company's audited consolidated financial statements and related notes for 2021 and 2020 [Report of Independent Registered Public Accounting Firm](index=77&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor issued a clean opinion and identified accrued clinical trial costs as a critical audit matter - The auditor, KPMG LLP, issued an opinion that the consolidated financial statements **present fairly**, in all material respects, the financial position of the company[400](index=400&type=chunk) - A critical audit matter was identified related to the evaluation of **accrued outsourced clinical trials and preclinical studies** due to subjective judgment required[406](index=406&type=chunk)[407](index=407&type=chunk) [Consolidated Financial Statements](index=80&type=section&id=Consolidated%20Financial%20Statements) This section provides key data from the company's balance sheets and statements of operations Consolidated Balance Sheet Data (in thousands) | Metric | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $196,965 | $127,639 | | Total Assets | $203,709 | $131,255 | | Total Liabilities | $15,993 | $11,218 | | Total Stockholders' Equity | $187,716 | $120,037 | Consolidated Statement of Operations Data (in thousands) | Metric | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Total Revenue | $2,963 | $1,050 | | Research and Development | $56,886 | $28,304 | | General and Administrative | $25,805 | $13,265 | | Net Loss | ($79,413) | ($110,715) | | Net Loss Per Share | ($6.66) | ($31.13) | [Notes to Consolidated Financial Statements](index=87&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section details key accounting policies, including asset acquisition and revenue recognition - The October 2020 acquisition of Private Viridian was accounted for as an asset acquisition, resulting in a **$69.9 million charge for acquired IPR&D**[485](index=485&type=chunk)[486](index=486&type=chunk) - In 2021, the company recognized **$3.0 million in collaboration revenue** related to its license agreement with Zenas BioPharma[490](index=490&type=chunk) - As of December 31, 2021, the company had federal net operating loss carryforwards of approximately **$157.8 million**[555](index=555&type=chunk)[556](index=556&type=chunk) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=69&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) The company reported no disagreements with its accountants on accounting and financial disclosure - None[367](index=367&type=chunk) [Item 9A. Controls and Procedures](index=69&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and internal controls over financial reporting were effective - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2021[368](index=368&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2021[371](index=371&type=chunk)[373](index=373&type=chunk) [Item 9B. Other Information](index=71&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) The company updated its registered agent and office in Delaware - On March 9, 2022, the company changed its registered agent and registered office in Delaware[375](index=375&type=chunk) Part III [Items 10, 11, 12, 13, and 14](index=72&type=section&id=ITEMS%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Required information on governance and compensation is incorporated by reference from the upcoming proxy statement - Information for Items 10, 11, 12, 13, and 14 is **incorporated by reference** from the company's 2022 Proxy Statement[380](index=380&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk) Part IV [Item 15. Exhibits, Financial Statement Schedules](index=73&type=section&id=ITEM%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists the financial statements and exhibits filed with the annual report - This item contains the index to the consolidated financial statements and a list of all exhibits filed with the report[386](index=386&type=chunk)[387](index=387&type=chunk) [Item 16. Form 10-K Summary](index=75&type=section&id=ITEM%2016.%20FORM%2010-K%20SUMMARY) The company has not provided a Form 10-K summary - None[395](index=395&type=chunk)

Viridian Therapeutics, Inc. (NASDAQ:VRDN) Q4 2021 Earnings Conference Call March 10, 2022 4:30 PM ET Company Participants John Jordan – Vice President-Investor Relations and Corporate Communications Jonathan Violin – President and Chief Executive Officer Kristian Humer – Chief Financial Officer and Chief Business Officer Conference Call Participants Chris Howerton – Jefferies Thomas Smith – SVB Leerink JP Solomon – Evercore ISI Rami Katkhuda – LifeSci Capital Laura Chico – Wedbush Jason Butler – JMP Securit ...

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 September 30, 2021 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 ju ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Viridian Therapeutics, Inc. as of June 30, 2021, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets from **$131.3 million** at the end of 2020 to **$118.2 million** as of June 30, 2021, primarily due to reduced cash and cash equivalents, while total liabilities increased and stockholders' equity decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $27,704 | $45,897 | | Short-term investments | $81,597 | $81,742 | | Total current assets | $115,462 | $129,611 | | **Total assets** | **$118,202** | **$131,255** | | **Liabilities & Equity** | | | | Total current liabilities | $16,830 | $10,674 | | **Total liabilities** | **$19,290** | **$11,218** | | **Total stockholders' equity** | **$98,912** | **$120,037** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of **$18.0 million** for Q2 2021, a significant increase from **$6.4 million** in Q2 2020, with the six-month net loss growing to **$36.4 million** in 2021 from **$14.5 million** in 2020, driven by higher R&D and G&A expenses Statement of Operations Highlights (in thousands) | Metric | Q2 2021 | Q2 2020 | H1 2021 | H1 2020 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $1,090 | $168 | $2,541 | $996 | | Research and development | $12,565 | $3,836 | $26,371 | $9,939 | | General and administrative | $6,523 | $2,706 | $12,683 | $5,429 | | **Net loss** | **$(17,964)** | **$(6,435)** | **$(36,424)** | **$(14,479)** | | Net loss per share | $(2.21) | $(1.82) | $(5.04) | $(4.41) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for the six months ended June 30, 2021, increased to **$26.2 million** from **$15.2 million** in the prior year, resulting in a net decrease in cash and cash equivalents of **$18.2 million** and an ending balance of **$27.7 million** Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(26,170) | $(15,248) | | Net cash (used in) provided by investing activities | $(333) | $2,001 | | Net cash provided by financing activities | $8,311 | $18,983 | | **Net (decrease) increase in cash** | **$(18,192)** | **$5,736** | | **Cash and cash equivalents at end of period** | **$27,704** | **$30,582** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on developing treatments for Thyroid Eye Disease (TED) with VRDN-001, highlight the October 2020 acquisition and **$91.0 million** financing, and confirm **$109.3 million** in cash and investments are expected to fund operations into 2024 - The company's most advanced program, VRDN-001, is an intravenously administered IGF-1R monoclonal antibody being developed for thyroid eye disease (TED)[30](index=30&type=chunk) - In October 2020, the company acquired Private Viridian and concurrently raised approximately **$91.0 million** through a private placement of Series A Preferred Stock[31](index=31&type=chunk)[33](index=33&type=chunk) - As of June 30, 2021, the company had approximately **$109.3 million** in cash, cash equivalents, and short-term investments, which is expected to be sufficient to fund operations into 2024[39](index=39&type=chunk) - During the six months ended June 30, 2021, the company recognized **$2.5 million** in collaboration revenue related to its license agreement with Zenas BioPharma[98](index=98&type=chunk) - The company has license agreements with ImmunoGen and Xencor, which require future potential milestone payments of up to **$48.0 million** and **$30.0 million**, respectively, plus commercial milestones and royalties[112](index=112&type=chunk)[113](index=113&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing treatments for Thyroid Eye Disease (TED) with VRDN-001 and VRDN-002, noting a significant increase in operating expenses and net losses for Q2 and H1 2021, while confirming **$109.3 million** in cash and investments are expected to fund operations into 2024 [Overview and Recent Developments](index=34&type=section&id=Overview%20and%20Recent%20Developments) The company is focused on developing therapeutics for Thyroid Eye Disease (TED), with lead program VRDN-001 on track for an IND filing in Q4 2021 and initial proof of concept data in Q2 2022, and VRDN-002 also expected to file an IND by year-end 2021 with Phase 1 data by mid-2022 - The company's lead candidate, VRDN-001, is being developed for Thyroid Eye Disease (TED), with an Investigational New Drug (IND) application planned for Q4 2021 and initial patient data expected in Q2 2022[152](index=152&type=chunk) - A second candidate, VRDN-002, is designed for subcutaneous injection and is also on track for an IND filing by the end of 2021, with Phase 1 data expected by mid-2022[153](index=153&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) For Q2 2021, revenue was **$1.1 million** and net loss was **$18.0 million**, compared to a **$6.4 million** loss in Q2 2020, driven by an **$8.8 million** rise in R&D and a **$3.8 million** increase in G&A costs, leading to a H1 2021 net loss of **$36.4 million** versus **$14.5 million** in 2020 Comparison of Operating Results (in thousands) | Metric | Q2 2021 | Q2 2020 | Change | H1 2021 | H1 2020 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | $1,090 | $168 | +$922 | $2,541 | $996 | +$1,545 | | R&D Expenses | $12,565 | $3,836 | +$8,729 | $26,371 | $9,939 | +$16,432 | | G&A Expenses | $6,523 | $2,706 | +$3,817 | $12,683 | $5,429 | +$7,254 | | **Net Loss** | **$(17,964)** | **$(6,435)** | **+$(11,529)** | **$(36,424)** | **$(14,479)** | **+$(21,945)** | - The increase in R&D expenses in Q2 2021 was primarily due to an **$8.3 million** increase in preclinical outsourcing and manufacturing for lead candidates VRDN-001 and VRDN-002[182](index=182&type=chunk) - The increase in G&A expenses in Q2 2021 was mainly driven by a **$2.0 million** increase in personnel-related costs and a **$1.0 million** increase in consulting and recruiting fees[183](index=183&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company had **$109.3 million** in cash, cash equivalents, and short-term investments, projected to fund operations into 2024, but with an accumulated deficit of **$315.3 million**, substantial additional capital will be required, potentially causing stockholder dilution - The company had **$109.3 million** in cash, cash equivalents, and short-term investments as of June 30, 2021, with a projected cash runway into 2024[189](index=189&type=chunk) - In April 2021, the company entered into an Open Market Sale Agreement (ATM) with Jefferies to sell up to **$50.0 million** of its Common Stock, selling **403,868 shares** for net proceeds of approximately **$7.1 million** through June 30, 2021[122](index=122&type=chunk)[195](index=195&type=chunk) - Net cash used in operating activities increased to **$26.2 million** for the first six months of 2021, up from **$15.2 million** in the same period of 2020, primarily due to a higher net loss[201](index=201&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is a smaller reporting company and is therefore not required to provide the information requested under this item - As a smaller reporting company, Viridian is not required to provide quantitative and qualitative disclosures about market risk[206](index=206&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 the end of the quarter, 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 June 30, 2021[208](index=208&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, internal controls[209](index=209&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=45&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 reports no material legal proceedings as of the filing date[212](index=212&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section details numerous risks that could materially affect the company's business, including the need for additional capital, a history of significant losses, dependence on early-stage product candidates, clinical trial risks, reliance on third parties, and potential competition [Risks Related to Financial Condition and Capital Requirements](index=46&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) The company faces significant financial risks, including the need to raise additional capital to fund operations beyond its current runway into 2024, a history of incurring net losses (**$36.4 million** in H1 2021), and potential dilution to existing stockholders from future capital raises - The company will need to raise additional capital to fund operations beyond its current cash runway (into 2024) and to continue as a going concern[216](index=216&type=chunk) - The company has a history of significant net losses, with an accumulated deficit of **$315.3 million** as of June 30, 2021, and anticipates continued losses for the foreseeable future[220](index=220&type=chunk)[221](index=221&type=chunk) - Raising additional capital may cause dilution to stockholders, restrict operations through covenants, or require relinquishing valuable rights to product candidates[232](index=232&type=chunk) [Risks Related to Product Candidate Discovery and Development](index=50&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, which face costly, lengthy, and uncertain clinical development, with inherent risks of trial failure, undesirable side effects, and difficulty in patient enrollment, where early promising results may not predict future success - Clinical trials are expensive, time-consuming, and inherently risky, with a high potential for failure at any stage of development[239](index=239&type=chunk) - The company is heavily dependent on the success of its early-stage product candidates, and there is no assurance that they will receive regulatory approval[247](index=247&type=chunk) - Product candidates may cause undesirable side effects that could delay or prevent regulatory approval or limit commercial viability[244](index=244&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=56&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) The company faces extensive regulatory hurdles, including potential competition from biosimilars for its biologic product candidates, ongoing stringent regulatory requirements post-approval, and compliance with complex healthcare fraud and abuse laws and data privacy regulations like GDPR and CCPA, with non-compliance leading to significant penalties - Biologic product candidates may be subject to competition from biosimilars, which could be approved 12 years after the reference product's approval, potentially shortening market exclusivity[261](index=261&type=chunk) - Even if a product is approved, the company will remain subject to ongoing and stringent regulatory requirements for manufacturing, marketing, and safety reporting[271](index=271&type=chunk) - The company is subject to numerous fraud and abuse laws, as well as data privacy regulations like GDPR and CCPA, and non-compliance could lead to substantial penalties and sanctions[281](index=281&type=chunk)[287](index=287&type=chunk) [Risks Related to Reliance on Third Parties](index=64&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The company heavily relies on third-party CROs for clinical trials and CMOs for manufacturing, where any failure to perform, comply with regulations, or avoid disruptions (e.g., from COVID-19) could substantially harm development timelines, regulatory approval, and supply for trials or commercialization - The company relies on third-party CROs to conduct clinical trials and CMOs to manufacture product candidates; failure of these parties to perform adequately could substantially harm the business[305](index=305&type=chunk) - The manufacturing process for biologic product candidates is complex and susceptible to production failures, contamination, and other disruptions that could delay or prevent supply for trials or commercialization[309](index=309&type=chunk) - Business operations could be adversely affected by health epidemics like the COVID-19 pandemic, which could disrupt clinical trials and the manufacturing supply chain[300](index=300&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for this reporting period - The company reports no unregistered sales of equity securities for the period[414](index=414&type=chunk) [Defaults Upon Senior Securities](index=87&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for this reporting period - The company reports no defaults upon senior securities[415](index=415&type=chunk) [Mine Safety Disclosures](index=87&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for this reporting period - The company has no mine safety disclosures to report[416](index=416&type=chunk) [Other Information](index=87&type=section&id=Item%205.%20Other%20Information) There is no other information to report for this period - The company reports no other information under this item[417](index=417&type=chunk) [Exhibits](index=87&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and XBRL data files - Lists all exhibits filed with the quarterly report, including corporate agreements, certifications, and interactive data files[418](index=418&type=chunk)[419](index=419&type=chunk)

Viridian Therapeutics June 2021 Cautionary note regarding forward-looking statements This presentation contains forward-looking statements relating to Viridian Therapeutics, Inc., including statements about our plans to obtain funding, develop and commercialize our therapeutic candidates, our planned clinical trials, the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, the clinical utility of our therapeutic candidates and our intellectual property positi ...