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 ...

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, 2021 or Delaware 47-1187261 6200 Lookout Road, Boulder, CO 80301 (Address, including zip code, of principal executive offices) (720) 643-5200 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: ☐ TRANSITION REPORT PURSUANT TO S ...

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, 2020 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 VIRIDIAN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporatio ...

Table of Contents or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 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, 2020 Commission File No. 001-36483 MIRAGEN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-1187261 ( ...

miRagen Therapeutics, Inc. (MGEN) Q2 2020 Earnings Conference Call August 5, 2020 4:30 PM ET Company Participants Dan Ferry – Managing Director-LifeSci Advisors Bill Marshall – President and Chief Executive Officer Diana Escolar – Chief Medical Officer Jason Leverone – Chief Financial Officer Conference Call Participants Jonathan Miller – Evercore ISI Andreas Argyrides – Wedbush Securities Trevor Allred – Oppenheimer Operator Greetings, and welcome to the miRagen Therapeutics Q2 2020 Earnings Conference Cal ...

Revenue and Expenses - Revenue decreased to $0.2 million during the three months ended June 30, 2020, from $2.5 million during the same period in 2019, primarily due to reduced research and development activities reimbursable by Servier[167]. - Research and development expenses were $3.8 million for the three months ended June 30, 2020, down from $8.6 million in the same period in 2019, reflecting a $4.8 million decrease attributed to reduced clinical activities[168]. - General and administrative expenses were $2.7 million for the three months ended June 30, 2020, compared to $2.9 million in the same period in 2019, mainly due to decreased personnel-related costs[169]. - For the six months ended June 30, 2020, revenue was $1.0 million, down from $2.9 million in the same period in 2019, again primarily due to decreased reimbursable research and development activities[171]. - Research and development expenses for the six months ended June 30, 2020, were $9.9 million, compared to $17.4 million in the same period in 2019, a decrease of $7.5 million attributed to reduced clinical and manufacturing activities[173]. - General and administrative expenses for the six months ended June 30, 2020, were $5.4 million, down from $6.2 million in the same period in 2019, primarily due to decreased personnel-related costs[174]. Cash Flow and Financial Position - As of June 30, 2020, the company had $30.6 million in cash and cash equivalents, expected to fund operations into Q3 2021[175]. - Net cash used in operating activities was $15.2 million for the six months ended June 30, 2020, a decrease of $3.8 million compared to the same period in 2019[188]. - Net cash provided by investing activities was $2.0 million for the six months ended June 30, 2020, down from $10.2 million in the same period in 2019[189]. - Net cash provided by financing activities was $19.0 million for the six months ended June 30, 2020, compared to $0.2 million in the same period in 2019[190]. - The company generated an accumulated deficit of $182.7 million since inception, primarily due to research and development expenses[181]. Restructuring and Operational Changes - The company implemented a cost restructuring plan in August 2019, eliminating approximately 44 positions, or 50% of its workforce[186]. - Cumulative restructuring expenses recorded through June 30, 2020, amounted to approximately $2.3 million, with an expected additional $0.1 million[186]. - The company expects to incur significant expenses and increased operating losses for several years as it continues clinical development[183]. Product Development and Clinical Trials - Cobomarsen is currently being evaluated for the treatment of patients with miR-155 elevated hematological malignancies, including CTCL and ATLL[148]. - MRG-229 is a miR-29 mimic being developed for the treatment of pathological fibrosis, with preclinical data showing efficacy in various fibrotic conditions[149]. - The company plans to meet with the FDA to discuss the development path for cobomarsen in ATLL before the end of 2020[149]. - The company anticipates that research and development expenses may increase in the foreseeable future as it continues ongoing clinical trials and initiates new ones[159]. - The company has not generated any revenue from product sales and has no products approved for commercial sale[181]. Impact of COVID-19 - The COVID-19 pandemic may adversely affect the company's liquidity and operational results, impacting clinical trial enrollments and financing capabilities[180].

Restoring Biological Harmony for Patients with Debilitating Disease 1 miRagen Therapeutics NASDAQ: MGEN Jefferies Virtual Healthcare Conference June 2 – June 4, 2020 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements relating to Miragen 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 regulat ...