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Viridian Therapeutics(VRDN) - 2021 Q1 - Quarterly Report
2021-05-07 10:04
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 ...
Viridian Therapeutics(VRDN) - 2020 Q4 - Annual Report
2021-03-26 20:16
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 ...
Viridian Therapeutics(VRDN) - 2020 Q3 - Quarterly Report
2020-11-12 12:04
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 ( ...
Viridian Therapeutics(VRDN) - 2020 Q2 - Earnings Call Transcript
2020-08-05 23:21
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 ...
Viridian Therapeutics(VRDN) - 2020 Q2 - Quarterly Report
2020-08-05 21:08
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].
Miragen Therapeutics (MGEN) Presents At Jefferies Healthcare Conference - Slideshow
2020-06-03 22:14
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 ...
Viridian Therapeutics(VRDN) - 2020 Q1 - Earnings Call Transcript
2020-05-10 04:08
Financial Data and Key Metrics Changes - The company ended Q1 2020 with $36.1 million in cash and cash equivalents, an increase from $26.8 million at the end of 2019 [29] - Revenue for the quarter was $0.8 million, up from $0.4 million in Q1 2019, primarily due to increases in grant revenue and collaboration agreements [30] - Net loss for Q1 2020 was $8 million, or $0.18 per share, compared to a net loss of $11.6 million, or $0.38 per share, in Q1 2019 [31] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $6.1 million in Q1 2020 from $8.8 million in Q1 2019, attributed to reduced personnel costs and clinical activities [30] - General and administrative expenses were $2.7 million for the quarter, down from $3.4 million in the same period last year, mainly due to decreased personnel costs [30] Market Data and Key Metrics Changes - The company is facing challenges in clinical activities due to the COVID-19 pandemic, impacting patient visits and data collection for trials [11][14] - The SOLAR Phase II clinical trial for cobomarsen has completed enrollment of 37 patients, but the pandemic has affected data collection and patient dosing [12][14] Company Strategy and Development Direction - The company has streamlined its development strategy to focus on long-term shareholder value, adapting to the challenges posed by the COVID-19 pandemic [10] - There is an ongoing evaluation of cobomarsen for treating miR-155 elevated blood cancers, with plans to request a meeting with the FDA regarding expedited development for ATLL [20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertainty caused by COVID-19 on clinical trials and the inability to predict milestone achievements [11][26] - The company remains confident in its ability to deliver important results from its programs despite the pandemic's impact [26] Other Important Information - The company is developing two distinct microRNA-29 mimics for treating various forms of pathological fibrosis, with a focus on MRG-229 for idiopathic pulmonary fibrosis [21][22] - The company plans to report additional preclinical safety and efficacy data for MRG-229 in Q2 2020 [23] Q&A Session Summary Question: How should we think about operating expenses in 2Q and the rest of the year versus Q1 given the COVID delays? - The CFO indicated that operating expenses are expected to decrease on a quarterly basis due to lower workforce expenses and reduced costs associated with the SOLAR trial [34] Question: What types of results could we see in the MRG-229 preclinical data, and could there be potential use for COVID-19? - Management discussed ongoing exploratory toxicology and efficacy studies, expressing interest in the antifibrotic activity of MRG-229 and cobomarsen in the context of COVID-19 [36][38] Question: Can you clarify the delays in the SOLAR trial and the FDA meeting timeline? - Management confirmed that while patient dosing continues, data collection has been impacted, and they cannot guarantee the timing of the FDA meeting due to COVID-19 prioritization [45][49]
Viridian Therapeutics(VRDN) - 2020 Q1 - Quarterly Report
2020-05-08 20:17
Revenue and Financial Performance - Revenue for the three months ended March 31, 2020, was $0.8 million, an increase from $0.4 million in the same period of 2019, primarily due to a $0.1 million increase in grant revenue and a $0.3 million increase in reimbursable research and development activities under the Servier Collaboration Agreement[188][189] - The net loss for the three months ended March 31, 2020, was $8.0 million, compared to a net loss of $11.6 million for the same period in 2019[188] - Net cash used in operating activities was $8.5 million for the three months ended March 31, 2020, a decrease of $3.3 million compared to $11.8 million in the same period of 2019[204] - Net cash provided by investing activities was $2.0 million for the three months ended March 31, 2020, compared to a net cash outflow of $2.8 million in the same period of 2019[205] - Net cash provided by financing activities was $17.7 million for the three months ended March 31, 2020, significantly higher than $0.2 million in the same period of 2019[206] - As of March 31, 2020, the company had $36.1 million in cash and cash equivalents, which is expected to fund operations into the third quarter of 2021[192] - The company generated an accumulated deficit of $176.2 million through March 31, 2020, with substantial operating losses primarily from research and development expenses[198] Expenses - Research and development expenses for the three months ended March 31, 2020, were $6.1 million, a decrease from $8.8 million in the same period of 2019[188] - General and administrative expenses for the three months ended March 31, 2020, were $2.7 million, down from $3.4 million in the same period of 2019[188] - Research and development expenses decreased to $6.1 million for the three months ended March 31, 2020, down from $8.8 million in the same period of 2019, a reduction of approximately 30.7%[190] - General and administrative expenses were $2.7 million for the three months ended March 31, 2020, compared to $3.4 million in the same period of 2019, reflecting a decrease of about 20.6%[191] Clinical Development and Research - Cobomarsen is being developed for the treatment of patients with certain cancers, including cutaneous T-cell lymphoma and adult T-cell leukemia/lymphoma, with ongoing clinical trials impacted by the COVID-19 pandemic[171] - MRG-110 has shown potential in increasing angiogenesis and is being evaluated for heart failure and wound healing applications, with data from Phase 1 trials indicating safety and tolerability[175] - Remlarsen is being evaluated for ocular fibrotic indications, with preclinical studies showing faster healing of corneal injuries[174] - MRG-229 is focused on idiopathic pulmonary fibrosis, with ongoing preclinical studies supported by a grant from the NIH and Yale University[178] - The company anticipates an increase in research and development expenses as it continues clinical trials and preclinical research programs[182] - The company expects to incur significant expenses and increased operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for its product candidates[200] Impact of COVID-19 - The COVID-19 pandemic may adversely affect the company's liquidity and results of operations, with potential delays in clinical trials and financing[197] Cost Restructuring - The company began implementing a cost restructuring plan in August 2019, identifying approximately 44 positions for elimination, or about 50% of its workforce[202] Future Revenue Expectations - Future revenue generation is expected to fluctuate based on the timing of achieving clinical and regulatory milestones, as well as the success of product commercialization[179]
Viridian Therapeutics(VRDN) - 2019 Q4 - Annual Report
2020-03-12 21:39
Part I [Business](index=5&type=section&id=ITEM%201.%20BUSINESS) Miragen Therapeutics is a clinical-stage biopharmaceutical company developing RNA-targeted therapies for high unmet medical needs, with a pipeline of three clinical-stage candidates and a strategy focused on microRNA expertise, expedited regulatory pathways, and strategic collaborations [Company Overview and Product Pipeline](index=5&type=section&id=Company%20Overview%20and%20Product%20Pipeline) Miragen is a clinical-stage biopharmaceutical company developing proprietary RNA-targeted microRNA therapies, with three clinical-stage product candidates for cancers, pathological fibrosis, and heart failure - The company's core focus is on RNA-targeted therapies, specifically microRNAs, for diseases with high unmet medical needs[20](index=20&type=chunk) Clinical Stage Product Candidates | Product Candidate | Target MicroRNA | Indication(s) | | :--- | :--- | :--- | | **Cobomarsen** | miR-155 (Inhibitor) | Cutaneous T-cell lymphoma (CTCL), Adult T-cell leukemia/lymphoma (ATLL) | | **Remlarsen / MRG-229** | miR-29 (Replacement) | Pathological fibrosis (e.g., Idiopathic Pulmonary Fibrosis - IPF) | | **MRG-110** | miR-92 (Inhibitor) | Heart failure, wound healing, ischemic disease | [Our Strategy](index=6&type=section&id=Our%20Strategy) The company's strategy leverages microRNA expertise to advance lead candidates, utilize FDA rare disease pathways, and seek collaborations for pipeline expansion and new target identification - A core part of the strategy is to utilize FDA's rare disease development pathways (orphan drug, fast track, breakthrough therapy) to potentially streamline clinical development and reduce time to market for its product candidates[23](index=23&type=chunk) - The company plans to continue developing its lead candidates: cobomarsen for blood cancers like CTCL and ATLL, and remlarsen/MRG-229 for pathological fibrosis, with a specific focus on MRG-229 for Idiopathic Pulmonary Fibrosis (IPF)[23](index=23&type=chunk) - Miragen intends to seek collaborations with other biotechnology and pharmaceutical companies to develop additional product candidates, particularly for disease areas where development costs would exceed its resources[23](index=23&type=chunk) [Our Product Candidates](index=6&type=section&id=Our%20Product%20Candidates) The company's clinical pipeline includes cobomarsen for CTCL/ATLL, remlarsen/MRG-229 for pathological fibrosis, and MRG-110 for heart failure, with key milestones anticipated for 2020 Anticipated Milestones for Product Candidates | Milestone | Product Candidate | Indication | Expected Timing | | :--- | :--- | :--- | :--- | | Report preclinical safety & efficacy data | MRG-229 | IPF | Q2-2020 | | Meet with FDA for expedited path | Cobomarsen | ATLL | Q3-2020 | | Report topline data from Phase 2 trial | Cobomarsen | CTCL | Q3-2020 | | Report primary endpoint data from Phase 2 trial | Remlarsen | Cutaneous Fibrosis | 2H-2020 | - Enrollment in the Phase 2 SOLAR trial for cobomarsen in CTCL was stopped to allow for an interim analysis of 37 patients, with topline data expected in Q3 2020[36](index=36&type=chunk)[37](index=37&type=chunk) - Following positive interim Phase 1 data in ATLL, the company is focusing its expansion efforts for cobomarsen on this indication and plans to meet with the FDA to discuss an expedited development pathway[26](index=26&type=chunk)[27](index=27&type=chunk) - The collaboration with Servier for MRG-110 was terminated in February 2020, resulting in Miragen regaining full global rights. The company is exploring potential new collaborations for its future development[52](index=52&type=chunk) [Strategic Collaborations and License Agreements](index=13&type=section&id=Strategic%20Collaborations%20and%20License%20Agreements) The company relies on key collaborations and license agreements, including a terminated Servier agreement, and ongoing agreements with the University of Texas, RICC, and Yale, involving milestone and royalty payments - The collaboration agreement with Servier for MRG-110 was terminated in February 2020. This agreement was a significant source of revenue, generating **$4.3 million** in 2019 and **$7.4 million** in 2018[72](index=72&type=chunk) - The company has an exclusive patent license with the University of Texas, requiring potential future milestone payments up to ~**$0.6 million** for clinical trial initiations and **$2.5 million** upon regulatory approvals in the U.S. and other regions, plus low-single-digit royalties[76](index=76&type=chunk) - Under a license agreement with Roche Innovation Center Copenhagen (RICC), Miragen is obligated to make milestone payments up to **$5.2 million** per licensed product and pay mid-single-digit royalties on net sales[80](index=80&type=chunk)[82](index=82&type=chunk) - A subcontract with Yale University, funded by an NIH grant, supports the development of a miR-29 mimic for IPF. Miragen retains rights to its solely developed IP and has an exclusive option to license IP developed by Yale under the agreement[86](index=86&type=chunk)[87](index=87&type=chunk) [Manufacturing, Sales, and Marketing](index=16&type=section&id=Manufacturing%2C%20Sales%2C%20and%20Marketing) Miragen fully outsources manufacturing and has not yet established a commercial strategy, considering future partnerships or an in-house sales force - The company fully outsources its manufacturing, relying on third-party contract manufacturers for all required materials and finished product candidates for clinical trials[97](index=97&type=chunk) - No commercial strategy for sales, marketing, or distribution has been defined, as all product candidates are still in development. Future options include strategic partnerships or establishing an in-house commercial force[98](index=98&type=chunk) [Intellectual Property](index=16&type=section&id=Intellectual%20Property) As of December 31, 2019, Miragen's IP portfolio includes 298 patents and applications, with key U.S. patents for lead candidates expiring between 2033 and 2036 - As of year-end 2019, the company's patent portfolio consists of 298 patents and applications, of which 216 are issued or allowed[99](index=99&type=chunk) Key U.S. Patent Expiration Outlook | Product Candidate | U.S. Patent(s) | Projected Expiration Year | | :--- | :--- | :--- | | **Cobomarsen** | 9,771,585; 9,994,852 | 2036 | | **MRG-110** | 9,803,202 | 2033 | | **Remlarsen** | 9,376,681; 9,994,847 | 2035 | [Competition](index=17&type=section&id=Competition) Miragen faces intense competition from other microRNA and oligonucleotide developers, as well as major pharmaceutical companies treating the same diseases - Competition is categorized into three groups: other microRNA-targeted developers, other oligonucleotide therapeutic developers, and companies treating the same diseases with different modalities[108](index=108&type=chunk)[112](index=112&type=chunk) - Major pharmaceutical companies with marketed or developing therapies for CTCL include Bristol-Myers Squibb, Merck, Takeda, and Novartis[108](index=108&type=chunk) - Key competitors with marketed therapeutics for pulmonary fibrosis include Boehringer Ingelheim and F. Hoffmann-La Roche[109](index=109&type=chunk) [Government Regulation](index=18&type=section&id=Government%20Regulation) The company's operations are extensively regulated by the FDA and other authorities, covering drug development, approval, and post-market compliance, including various expedited programs and healthcare laws - The FDA drug approval process requires extensive preclinical studies, an effective IND application, and adequate and well-controlled human clinical trials (typically Phases 1, 2, and 3) to establish safety and efficacy before an NDA can be submitted and approved[112](index=112&type=chunk)[113](index=113&type=chunk)[120](index=120&type=chunk) - The company may seek Orphan Drug Designation for products treating rare diseases (affecting <**200,000** people in the U.S.), which can provide benefits like seven years of market exclusivity upon approval[127](index=127&type=chunk)[129](index=129&type=chunk) - Expedited FDA programs such as Fast Track, priority review, accelerated approval, and Breakthrough Therapy Designation are available for drugs that treat serious conditions and address unmet medical needs, potentially speeding up the development and review process[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) - The business is subject to numerous healthcare regulations, including the federal Anti-Kickback Statute, False Claims Act, HIPAA for patient data privacy, and the Physician Payments Sunshine Act for reporting payments to healthcare professionals[143](index=143&type=chunk)[144](index=144&type=chunk)[145](index=145&type=chunk)[150](index=150&type=chunk) [Risk Factors](index=27&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks related to its financial viability, product development uncertainties, regulatory hurdles, intellectual property, reliance on third parties, and potential impacts from health epidemics like COVID-19 - The company needs to raise additional capital to continue as a going concern. Current resources are projected to fund operations only into the third quarter of 2021[169](index=169&type=chunk) - The company has a history of significant net losses (**$41.9 million** in 2019) and an accumulated deficit of **$168.2 million** as of December 31, 2019, with no products approved for sale[175](index=175&type=chunk) - The therapeutic approach using microRNAs is novel and unproven, with no such products yet approved by the FDA, making the development timeline, cost, and likelihood of approval highly uncertain[197](index=197&type=chunk)[199](index=199&type=chunk) - The business could be adversely affected by health epidemics like the COVID-19 outbreak, which could disrupt clinical trial sites, patient enrollment, and third-party manufacturing operations[314](index=314&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk) [Unresolved Staff Comments](index=66&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) The company reports that it has no unresolved staff comments from the SEC - None[401](index=401&type=chunk) [Properties](index=66&type=section&id=ITEM%202.%20PROPERTIES) The company leases 27,128 square feet of office and laboratory space in Boulder, Colorado, under a lease expiring in December 2020 - The company leases **27,128** sq. ft. of office and lab space in Boulder, CO, with the lease expiring in December 2020[402](index=402&type=chunk) [Legal Proceedings](index=66&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any legal proceedings that would materially adversely affect its business or financial condition - The company is not currently a party to any material legal proceedings[403](index=403&type=chunk) [Mine Safety Disclosures](index=66&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - Not applicable[404](index=404&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=67&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on The Nasdaq Capital Market under 'MGEN', with no dividends paid or anticipated, as earnings are retained for business growth - Common stock is traded on The Nasdaq Capital Market under the symbol MGEN[407](index=407&type=chunk) - The company has not paid and does not anticipate paying dividends, intending to retain all future earnings for business development[409](index=409&type=chunk) [Selected Financial Data](index=67&type=section&id=ITEM%206.%20SELECTED%20FINANCIAL%20DATA) This item is not applicable to the company - Not applicable[410](index=410&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=67&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) The company reported an increased net loss of **$41.9 million** in 2019, with decreased revenue and higher R&D expenses, and projects current capital to fund operations into Q3 2021 [Results of Operations](index=71&type=section&id=Results%20of%20Operations) For 2019, revenue decreased to **$4.5 million** due to a non-recurring milestone, while R&D expenses increased to **$34.8 million**, resulting in a net loss of **$41.9 million** Comparison of Operations (2019 vs. 2018) | Financial Metric | 2019 (in thousands) | 2018 (in thousands) | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $4,461 | $8,386 | ($3,925) | | **Research and development expenses** | $34,794 | $30,421 | $4,373 | | **General and administrative expenses** | $11,646 | $11,049 | $597 | | **Net loss** | ($41,873) | ($32,703) | ($9,170) | - The decrease in revenue was primarily due to a €3.0 million (**$3.7 million**) development milestone payment from the Servier Collaboration Agreement in 2018 that did not recur in 2019[433](index=433&type=chunk) - The increase in R&D expenses was driven by a **$3.4 million** rise in clinical development and manufacturing costs for cobomarsen and a **$2.5 million** increase in personnel-related costs, including restructuring charges[434](index=434&type=chunk) [Liquidity and Capital Resources](index=71&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2019, the company held **$26.8 million** in cash, projecting funds to last into Q3 2021, and has utilized various equity financing vehicles - As of December 31, 2019, the company held **$26.8 million** in cash, cash equivalents, and short-term investments[435](index=435&type=chunk) - The company projects its current cash resources, supplemented by recent stock sales, will be sufficient to fund operations into the third quarter of 2021[435](index=435&type=chunk) - In February 2020, the company raised approximately **$14.0 million** in net proceeds from a public offering of common stock and warrants[439](index=439&type=chunk) - In December 2019, the company entered into a common stock purchase agreement with Aspire Capital for up to **$20.0 million**, of which **$5.1 million** had been raised as of January 2020[438](index=438&type=chunk) [Cash Flows](index=73&type=section&id=Cash%20Flows) In 2019, net cash used in operating activities increased to **$36.1 million**, while investing activities provided **$28.2 million**, and financing activities provided only **$0.1 million** Summarized Cash Flows (2019 vs. 2018) | Activity | 2019 (in thousands) | 2018 (in thousands) | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($36,056) | ($26,844) | | **Net cash provided by (used in) investing activities** | $28,226 | ($29,907) | | **Net cash provided by financing activities** | $70 | $41,916 | [Quantitative and Qualitative Disclosures About Market Risk](index=74&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This item is not applicable to the company - Not applicable[452](index=452&type=chunk) [Financial Statements and Supplementary Data](index=74&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) The required financial statements and supplementary data are provided elsewhere in the report, starting on page F-1 - The financial statements are located in Part IV, Item 15(a)(1) of the Annual Report[453](index=453&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=74&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) This item is not applicable to the company - Not applicable[454](index=454&type=chunk) [Controls and Procedures](index=74&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2019, with an unqualified opinion from KPMG LLP - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2019[455](index=455&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2019[458](index=458&type=chunk) - The independent registered public accounting firm, KPMG LLP, issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2019[459](index=459&type=chunk) [Other Information](index=75&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) This item is not applicable to the company - Not applicable[461](index=461&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=76&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%2C%20AND%20CORPORATE%20GOVERNANCE) Information for this item is incorporated by reference from the definitive proxy statement for the 2020 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2020 annual meeting of stockholders[464](index=464&type=chunk) [Executive Compensation](index=76&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Information for this item is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[466](index=466&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=76&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Information for this item is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[467](index=467&type=chunk) [Certain Relationships and Related Transactions and Director Independence](index=76&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%20AND%20DIRECTOR%20INDEPENDENCE) Information for this item is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[468](index=468&type=chunk) [Principal Accounting Fees and Services](index=76&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Information for this item is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[469](index=469&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=77&type=section&id=ITEM%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) The financial statements are submitted separately, financial statement schedules are omitted, and a list of exhibits is referenced - The financial statements are submitted in a separate section beginning on page F-1[472](index=472&type=chunk) - Financial statement schedules have been omitted[473](index=473&type=chunk) [Form 10-K Summary](index=77&type=section&id=ITEM%2016.%20FORM%2010-K%20SUMMARY) The company reports that there is no Form 10-K summary - None[475](index=475&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=82&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) KPMG LLP issued unqualified opinions on the consolidated financial statements and the effectiveness of internal control over financial reporting for 2019, noting the adoption of ASC Topic 606 - KPMG LLP issued an unqualified opinion on the consolidated financial statements[486](index=486&type=chunk) - KPMG LLP issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2019[487](index=487&type=chunk)[494](index=494&type=chunk) [Consolidated Financial Statements](index=84&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements present the company's financial position and results for 2019 and 2018, showing a net loss of **$41.9 million** in 2019 and decreased cash and equivalents Consolidated Balance Sheet Data (as of Dec 31) | Account | 2019 (in thousands) | 2018 (in thousands) | | :--- | :--- | :--- | | **Total Assets** | $30,262 | $66,147 | | **Total Liabilities** | $14,508 | $14,803 | | **Total Stockholders' Equity** | $15,754 | $51,344 | Consolidated Statement of Operations Data (Year Ended Dec 31) | Account | 2019 (in thousands) | 2018 (in thousands) | | :--- | :--- | :--- | | **Total Revenue** | $4,461 | $8,386 | | **Total Operating Expenses** | $46,440 | $41,470 | | **Net Loss** | ($41,873) | ($32,703) | | **Net Loss Per Share** | ($1.34) | ($1.10) | [Notes to Consolidated Financial Statements](index=89&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail the company's liquidity, accounting policy changes, a 2019 restructuring, the termination of the Servier collaboration, loan agreements, and capital stock transactions
Viridian Therapeutics(VRDN) - 2019 Q4 - Earnings Call Transcript
2020-03-12 01:31
miRagen Therapeutics, Inc. (MGEN) Q4 2019 Earnings Conference Call March 11, 2020 4:30 PM ET Company Participants Dan Ferry - Managing Director of LifeSci Advisors Bill Marshall - President and CEO Diana Escolar - Chief Medical Officer Jason Leverone - CFO Conference Call Participants Kambiz Yazdi - Wedbush Securities Jonathan Miller - Evercore ISI Operator Greetings. Welcome to miRagen Therapeutics Fourth Quarter 2019 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I w ...