What changed in this filing

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Item 2. Management’s Discussion and Analysis

2020-08-05 compared with 2020-05-08 · 67 added, 76 removed, 136 unchanged (51% of the section changed)

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Cobomarsen is an inhibitor of miR-155, which is found at abnormally high levels in malignant cells of several blood cancers.

We are also developing remlarsen and MRG-229, which are product candidates being developed for the potential treatment of patients with pathological fibrosis.

These product candidates are replacements for miR‑29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as in systemic sclerosis.

MRG-110, an inhibitor of microRNA-92, or miR‑92, is our product candidate for the treatment of heart failure, wound healing, and other ischemic disease.

We are also developing remlarsen and MRG-229 for the potential treatment of patients with pathological fibrosis.

Both remlarsen and MRG-229 are replacements for microRNA-29, or miR-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as in systemic sclerosis.

Remlarsen is our product candidate for local administration in cutaneous fibrosis and ocular fibrosis, while MRG-229 is our lead preclinical state compound for the potential systemic treatment of pulmonary, renal, and hepatic fibrosis.

Finally, MRG-110, an inhibitor of microRNA-92, or miR-92, is our product candidate for the treatment of heart failure, wound healing, and other ischemic disease.

We believe our experience in microRNA biology and chemistry, drug discovery, bioinformatics, translational medicine, and drug development allows us to identify and develop microRNA-targeted drugs that are designed to regulate gene pathways to return diseased tissues to a healthy state.

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As a result of the COVID-19 pandemic, we have seen an impact on clinical activities at some sites where the SOLAR trial is being conducted.

While most clinical sites in the SOLAR trial remain active and over half of the patients had been on the trial for a sufficient period of time to provide topline data prior to the escalation of the COVID-19 pandemic, other patients have missed, or are at risk for missing, doses or in-person site visits for the collection of primary endpoint patient data.

We have implemented home infusion services for this trial, as needed, and activated these services for those patients who could not receive the infusions at their clinical site.

This is intended to mitigate some of the impact of the COVID-19 pandemic on the SOLAR trial.

However, the collection of primary endpoint patient data requires in-person visits at clinical trial sites, which may require patients to be on the trial longer.

We are actively monitoring the effects of the COVID-19 pandemic on the SOLAR trial but cannot predict at this time when we will be able to collect uninterrupted endpoint data, with consistent dosing, in all remaining patients in the SOLAR trial.

Accordingly, we no longer expect to report topline data from the SOLAR trial in the third quarter of 2020.

However, with a majority of patients in the SOLAR trial continue to receive uninterrupted treatment and evaluation for clinical response, the impact has been limited to a small number of patients.

As of July 17, 2020, 34 of the 37 CTCL patients are being followed for a response, and 32 have continued to receive uninterrupted treatment.

• Adult T-Cell Leukemia/Lymphoma (ATLL):

In January 2020, we announced positive data for cobomarsen in ATLL patients with residual disease from this first-in-human Phase 1 clinical trial.

In this trial, cobomarsen was observed to prolong disease stabilization and median survival time in aggressive ATLL patients with persistent residual disease after chemotherapy and other therapies.

The disease stabilization in these patients is marked by a decrease in biomarkers of tumor cells activation and proliferation, providing evidence of the biological mechanism effect of cobomarsen on disease stabilization.

Based on these results, we announced that we are focusing our cobomarsen expansion indication efforts on ATLL and expect to request a meeting with the FDA in the second quarter of 2020 to explore a potential expedited

development path for cobomarsen in ATLL.

Under normal circumstances, we would expect to meet with the FDA in the third quarter of 2020.

However, as the FDA prioritizes its efforts on COVID-19, it is uncertain if the meeting will occur on the standard FDA timeline.

We therefore cannot provide assurances that the meeting will occur as originally expected in the third quarter of 2020.

Remlarsen and MRG-229 are miR-29 mimics, or replacements for miR-29, a microRNA that is found at abnormally low levels in a number of pathologic fibrotic conditions.

Idiopathic Pulmonary Fibrosis (MRG-229):

In December 2019, we announced that our preclinical pipeline development efforts will be primarily focused on the development of MRG-229 as a potential treatment for patients with idiopathic lung fibrosis, or IPF.

We believe that the efficacy and safety profile of MRG-229 we have observed in preclinical studies positions it as a potentially differentiated approach for IPF.

This program is supported in part by a grant in collaboration with the National Institutes of Health, or NIH, and Yale University.

During the first quarter of 2020, we made progress in our preclinical studies leading to the release of additional funding by the NIH in April 2020.

We expect to report additional preclinical safety and efficacy data for MRG-229 during the second quarter of 2020.

Cutaneous and Ocular Fibrosis (Remlarsen):

We are currently working to complete our analysis of the one-year primary endpoint data for our Phase 2 clinical trial of remlarsen.

Due to the potential impact of the COVID-19 pandemic on clinical sites, we cannot accurately predict when we will report the final topline data from this clinical trial, which was previously expected to be released in the second half of 2020.

We are also evaluating remlarsen in ocular fibrotic indications, such as corneal injury and keratitis.

In preclinical studies, we have observed that topical administration of remlarsen to an injured rat cornea resulted in faster healing of the cornea and reduced scarring/hazing.

Remlarsen has also been observed in in vitro studies to regulate miR-29 pharmacodynamic biomarkers in the cornea.

We intend to seek a collaboration partner for the future development of remlarsen in cutaneous and ocular fibrotic indications.

MRG-110 is an inhibitor of miR-92, a microRNA expressed in endothelial cells, which has been observed in preclinical studies to be a regulator of new blood vessel creation and other wound healing processes.

Tissue Repair:

During the fourth quarter of 2019, we announced data from two Phase 1 clinical trials of MRG-110 in normal human volunteers, in which administration of MRG-110 was observed to increase angiogenesis, as demonstrated by increased perfusion and histological markers of neoangiogenesis, and to reduce alpha-smooth muscle actin (α-SMA) expression, which has been shown to correlate with activation of myofibroblasts.

A total of 65 subjects were exposed for up to three weeks.

MRG-110 was shown to be generally safe and well tolerated, with no evidence of unwanted distal angiogenesis, acute inflammatory toxicities, or significant abnormalities in laboratory tests of the liver, kidney, or blood, and no injection site reactions.

We believe that MRG-110 may have the potential to be used for the treatment of heart failure and other conditions where patients may benefit from increased vascular flow and for accelerating healing in indications such as burns, skin flaps, grafts, or laparotomy or sternotomy incisions in patients with high risk of poor wound closure.

Based on the clinical data released earlier this year, during the second quarter of 2020, we requested a meeting with the FDA to discuss the development path for cobomarsen in ATLL and plan to meet with the FDA and receive guidance on our proposed clinical path in this indication before the end of 2020.

MRG-229 is a miR-29 mimic, or replacement for miR-29, a microRNA that is found at abnormally low levels in a number of pathologic fibrotic conditions.

Idiopathic Pulmonary Fibrosis (IPF):

In June 2020, we hosted a key opinion leader (KOL) webcast to discuss the current and increasing unmet medical need in treating patients with IPF and reported additional preclinical rodent safety and in vitro human efficacy data for MRG-229.

In summary, the latest preclinical observations were:

• Next-generation targeted miR-29 mimics demonstrated down-regulation of targeted genetic pathways and anti-fibrotic effects including decreased collagen secretion in diseased lung fibroblasts in vitro , highlighting functional activity in addition to molecular readouts.

• Anti-fibrotic activity of next-generation miR-29 mimics in mouse bleomycin-induced pulmonary fibrosis was observed for both intravenous and subcutaneous routes of administration.

• Next-generation targeted miR-29 mimics demonstrated efficacy in ex vivo profibrotic-induced human precision cut lung slices.

• Exploratory toxicity studies in rodents showed that MRG-229 treatment resulted in no adverse effects on organ histology, hematology, clinical chemistries, coagulation, or urinalysis.

Based on these results, we have initiated a non-human primate toxicology study and expect to report additional preclinical safety and efficacy data before the end of 2020.

Financial Operations Overview

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In the future, we may generate revenue from a combination of license fees and other up-front payments, payments for research and development services, milestone payments, product sales, and royalties in connection with strategic alliances.

We expect that any revenue we generate will fluctuate from quarter to quarter as a result of the timing of our achievement of preclinical, clinical,

regulatory, and commercialization milestones, the timing and amount of payments relating to such milestones, and the extent to which any of our products are approved and successfully commercialized by us or our strategic alliance collaborators, if any.

We expect that any revenue we generate will fluctuate from quarter to quarter as a result of the timing of our achievement of preclinical, clinical, regulatory, and commercialization milestones, the timing and amount of payments relating to such milestones, and the extent to which any of our products are approved and successfully commercialized by us or our strategic alliance collaborators, if any.

If our strategic alliance collaborators do not elect or otherwise agree to fund our development costs pursuant to our strategic alliance agreements, or we or our strategic alliance collaborators, if any, fail to develop product candidates in a timely manner or to obtain regulatory approval for them, then our ability to generate future revenue, and our results of operations and financial position would be adversely affected.

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We consider future economic benefits from acquired contractual rights to licensed technology to be uncertain until such a drug candidate is approved by the FDA, or when other significant risk factors are abated.

We expect our research and development expenses to increase for the foreseeable future as we continue to conduct our ongoing clinical trials, initiate new clinical trials, and advance our preclinical research programs.

Our research and development expenses may increase for the foreseeable future as we continue to conduct our ongoing clinical trials, initiate new clinical trials, and advance our preclinical research programs.

The process of conducting clinical trials and preclinical studies necessary to obtain regulatory approval is costly and time consuming.

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The timing and amount of expenses we incur through our external service providers depend on a number of factors, such as site initiation, patient screening, enrollment, delivery of reports, and other events.

In accruing for these activities, we obtain information from various sources and estimate the level of effort or expense allocated to each period.

In accruing for these activities, we obtain

information from various sources and estimate the level of effort or expense allocated to each period.

Adjustments to our research and development expenses may be necessary in future periods as our estimates change.

Results of Operations

Comparison of the Three Months Ended March 31, 2020 and 2019

Comparison of the Three Months Ended June 30, 2020 and 2019

Three Months Ended

(in thousands)

Revenue $ 168 $ 2,514

Research and development expenses 3,836 8,599

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Other income (expense), net (61) 46

Revenue was $0.8 million during the three months ended March 31, 2020 , compared to $0.4 million during the three months ended March 31, 2019 .

The increase in revenue was due primarily to an increase in grant revenue of $0.1 million and an increase in research and development and other activities reimbursable to us under the Servier Collaboration Agreement of $0.3 million during the three months ended March 31, 2020 , compared to the three months ended March 31, 2019 .

Net loss $ (6,435) $ (8,896)

Revenue decreased to $0.2 million during the three months ended June 30, 2020, from $2.5 million during the three months ended June 30, 2019.

The decrease in revenue was primarily due to a decrease in research and development activities r eimbursable to us by Servier under the Servier Collaboration Agreement.

Research and Development Expenses

Research and development expenses were $6.1 million during the three months ended March 31, 2020 , compared to $8.8 million during the three months ended March 31, 2019 .

The decrease in research and development expenses of $2.7 million in 2020 was driven primarily by:

decreased personnel-related costs of $1.4 million related to share-based compensation charges and consulting and contract labor costs due to a reduction in employee headcount;

decreased clinical development and related manufacturing expenses of $0.9 million, primarily related to reduced expenses incurred in connection with the clinical development of cobomarsen in the three months ended March 31, 2020;

decreased other miscellaneous expenses of $0.3 million associated with the reduction in headcount, travel, and other research activities.

Research and development expenses were $3.8 million during the three months ended June 30, 2020, compared to $8.6 million during the three months ended June 30, 2019.

The $4.8 million decrease in research and development expenses was primarily attributable to a decrease in clinical and related manufacturing development activities associated with the Phase 2 SOLAR clinical trial of cobomarsen, personnel-related costs, and other miscellaneous expenses during the second quarter of 2020.

General and Administrative Expenses

General and administrative expenses were $2.7 million during the three months ended March 31, 2020 , compared to $3.4 million during the three months ended March 31, 2019 .

During the three months ended March 31, 2020 , our general and administrative costs decreased as compared to the three months ended March 31, 2019 primarily due to decreased personnel-related costs of $0.4 million, decreased legal expense of $0.3 million, offset by increased other professional fees of $0.1 million.

General and administrative expenses were $2.7 million during the three months ended June 30, 2020, compared to $2.9 million during the three months ended June 30, 2019.

The decrease in general and administrative expenses was due primarily to decreased personnel-related costs, which were partially offset by increased legal costs during the second quarter of 2020.

Results of Operations

Comparison of the Six Months Ended June 30, 2020 and 2019

Six Months Ended

(in thousands)

Revenue $ 996 $ 2,886

Research and development expenses 9,939 17,350

General and administrative expenses 5,429 6,214

Other income (expense), net (107) 153

Net loss $ (14,479) $ (20,525)

Revenue was $1.0 million during the six months ended June 30, 2020, compared to $2.9 million during the six months ended June 30, 2019.

The decrease in revenue was primarily due to a decrease in research and development activities r eimbursable to us by Servier under the Servier Collaboration Agreement.

Research and Development Expenses

Research and development expenses were $9.9 million during the six months ended June 30, 2020, compared to $17.4 million during the six months ended June 30, 2019.

The $7.5 million decrease in research and development expenses was primarily attributable to a decrease in clinical and related manufacturing development activities associated with the Phase 2 SOLAR clinical trial of cobomarsen, personnel-related costs, and other miscellaneous expenses during the six months ended June 30, 2020.

General and Administrative Expenses

General and administrative expenses were $5.4 million during the six months ended June 30, 2020, compared to $6.2 million during the six months ended June 30, 2019.

The decrease in general and administrative expenses was due primarily to decreased personnel-related costs and legal costs, which were partially offset by increased other miscellaneous expenses during the six months ended June 30, 2020.

Liquidity and Capital Resources

We have funded our operations to date principally through proceeds received from the sale of our common stock and other equity securities, debt financings, and from amounts received under the Servier Collaboration Agreement.

As of March 31, 2020 , we had $36.1 million in cash and cash equivalents.

Based on our current operating plans, we believe that our cash and cash equivalents, combined with the effect of the six-month deferral of interest-only payments and the maturity date related to the amended SVB Loan Agreement in April 2020, will be sufficient to fund our operations for the period one year following the issuance of the accompanying condensed consolidated financial statements in this Quarterly Report.

As of June 30, 2020, we had $30.6 million in cash and cash equivalents.

Based on our current operating plans, we believe that our cash and cash equivalents will be sufficient to fund our operations for the period one year following the issuance of the accompanying condensed consolidated financial statements in this Quarterly Report.

We expect that our current resources will be sufficient to fund our current operations into the third quarter of 2021.

In March 2017, we entered into a Common Stock Sales Agreement, or the ATM Agreement, with Cowen and Company, LLC, or Cowen, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million through Cowen as our sales agent.

Cumulative net proceeds received from the sale of 2,846,449 shares of our common stock through April 30, 2020 were approximately $11.6 million , after giving effect to commissions to Cowen as sales agent and initial expenses for executing the “at the market offering.”

In August 2018, we and the Leukemia and Lymphoma Society, or LLS, entered into a Common Stock Purchase Agreement, or the LLS Stock Purchase Agreement, for the sale of up to $5.0 million of shares of our common stock, or the LLS Offering, to LLS and its affiliates under the LLS Purchase Agreement.

Cumulative net proceeds received from the sale of 2,846,449 shares of our common stock through July 31, 2020 were approximately $11.6 million, after giving effect to commissions to Cowen as sales agent and initial expenses for executing the “at the market offering.”

In August 2018, we and the Leukemia and Lymphoma Society, Inc., or LLS, entered into a Common Stock Purchase Agreement, or the LLS Stock Purchase Agreement, for the sale of up to $5.0 million of shares of our common stock, or the LLS Offering, to LLS and its affiliates under the LLS Purchase Agreement.

In October 2019, the LLS Stock Purchase Agreement was assigned to LLS TAP Miragen, LLC, or LLS TAP.

Under the terms of the LLS Stock Purchase Agreement, we may raise up to approximately $5.0 million in gross proceeds by selling shares of our common stock to LLS and its affiliates, including LLS TAP, in up to five separate closings upon the achievement of specified development milestones.

At the initial closing in August 2018, we issued 150,987 shares of our common stock to LLS under the LLS Stock Purchase Agreement for net proceeds of $0.9 million .

Subsequently, on October 31, 2019, we issued 606,364 shares of common stock to LLS TAP for net proceeds of $0.5 million in a subsequent closing.

We have received net proceeds of $1.4 million , in the aggregate to date under the LLS Stock Purchase Agreement.

The price per share of our common stock to be sold in any subsequent closing will be equal to the average of the volume weighted-average prices of a share of our common stock on the Nasdaq Capital Market for the three trading days beginning with the first trading day after the date of achievement of the relevant milestone for each such closing.

Each closing is subject to our achievement of specified operational milestones under the LLS Stock Purchase Agreement and other customary closing conditions, provided, however, that each such closing must be completed prior to December 31, 2021.

Since the initial closing in August 2018, we issued 757,351 shares of our common stock to LLS under the LLS Stock Purchase Agreement for net proceeds of $1.4 million.

As a result of the modifications of the SOLAR trial we announced in December 2019, we do not anticipate meeting the milestones under the LLS Stock Purchase Agreement and as such, do not expect we will receive the remaining proceeds available under the LLS Stock Purchase Agreement unless the agreement is amended, which we can provide no assurances will occur.

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In January 2020, we sold to Aspire Capital 2,200,000 shares our common stock at a weighted-average price of $1.84 per share for proceeds of $4.1 million.

In July 2020, we sold to Aspire Capital an additional 3,532,806 shares of our common stock at a weighted-average price of $1.25 for proceeds of $4.4 million.

After giving effect to these sales, we may sell an additional $10.5 million to Aspire Capital.

Under the Aspire Agreement, we have the right, in our sole discretion, on any trading day selected by us, and within certain specified limitations, to present Aspire Capital with a purchase notice, directing Aspire Capital (as principal) to purchase up to 200,000 shares of our common stock per business day, up to $20.0 million of our common stock, in the aggregate and inclusive of the Initial Purchase Shares, at a per share price equal to the lesser of (i) the lowest sale price of our common stock on the purchase date or (ii) the average of the three lowest closing sale prices for our common

stock during the 10 consecutive business days ending on the business day immediately preceding the purchase date.

Under the Aspire Agreement, we have the right, in our sole discretion, on any trading day selected by us, and within certain specified limitations, to present Aspire Capital with a purchase notice, directing Aspire Capital (as principal) to purchase up to 200,000 shares of our common stock per business day, up to $20.0 million of our common stock, in the aggregate and inclusive of the Initial Purchase Shares and subsequent purchases, including those sold in July 2020, at a per share price equal to the lesser of (i) the lowest sale price of our common stock on the purchase date or (ii) the average of the three lowest closing sale prices for our common stock during the 10 consecutive business days ending on the business day immediately preceding the purchase date.

We also have the right to require Aspire Capital to purchase up to an additional 30% of the trading volume of the shares for the next business day at a purchase price, or the VWAP Purchase Price, equal to the lesser of:

(i) the closing sale price of the shares on the purchase date, or (ii) ninety-seven percent (97%) of the next business day’s volume weighted average price, or each such purchase, a VWAP Purchase.

(i) the closing sale price of the shares on the purchase date, or (ii) ninety-seven percent (97%) of the next business day’s volume weighted average price, or each such purchase, a VWAP

We have the right, in our sole discretion, to determine a maximum number of shares and set a minimum market price threshold for each VWAP Purchase.

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If the pandemic continues to be a severe worldwide crisis, it could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

The financial statements included with this quarterly report on Form 10-Q do not reflect any adjustments as a result of the COVID-19 pandemic.

We have no products approved for commercial sale and have not generated any revenue from product sales.

Since our inception and through March 31, 2020 , we have generated an accumulated deficit of $176.2 million .

Since our inception and through June 30, 2020, we have generated an accumulated deficit of $182.7 million.

Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

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The eliminated positions were primarily related to research and development and corresponding project, general, and administrative support.

Through March 31, 2020, we had recorded cumulative restructuring expense of approximately $2.2 million and we expect to incur approximately $0.2 million in additional restructuring expense, primarily related to retention, during the remainder of 2020.

Summarized cash flows for the three months ended March 31, 2020 and 2019 are as follows:

Three Months Ended

Through June 30, 2020, we had recorded cumulative restructuring expense of approximately $2.3 million and we expect to incur approximately $0.1 million in additional restructuring expense, primarily related to retention, during the remainder of 2020.

Summarized cash flows for the six months ended June 30, 2020 and 2019 are as follows:

Six Months Ended

(in thousands)

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Financing activities 18,983 179

Total $ 5,736 $ (8,599)

Operating Activities

Net cash used in operating activities was $8.5 million for the three months ended March 31, 2020 , compared to $11.8 million for the three months ended March 31, 2019 .

The $3.3 million decrease in the three months ended March 31, 2020 was primarily the result of a $3.6 million decrease in net loss, offset by a $0.2 million decrease in payments of current liabilities and receipts associated with accounts receivable and prepaid expenses and other assets and a $0.1 million decrease in non-cash expenses during the three months ended March 31, 2020 compared to the three months ended March 31, 2019 .

Net cash used in operating activities was $15.2 million for the six months ended June 30, 2020, compared to $19.0 million for the six months ended June 30, 2019.

The $3.8 million decrease in the six months ended June 30, 2020 was primarily the result of a $6.0 million decrease in net loss, partially offset by a $2.0 million decrease in payments of current liabilities and receipts associated with accounts receivable and prepaid expenses and other assets and a $0.2 million decrease in non-cash expenses during the six months ended June 30, 2020 compared to the six months ended June 30, 2019.

Investing Activities

Net cash provided by investing activities was $2.0 million during the three months ended March 31, 2020 compared to net cash used in investing activities of $2.8 million during the three months ended March 31, 2019 .

The change in cash flow from investing activities was driven primarily by a $23.8 million decrease in purchases of short-term investments and a $19.0 million decrease in the related maturities of short-term investments during the three months ended March 31, 2020 compared to the three months ended March 31, 2019 .

Net cash provided by investing activities was $2.0 million during the six months ended June 30, 2020 compared to $10.2 million during the six months ended June 30, 2019.

The change in cash flow from investing activities was driven primarily by a $37.0 million decrease in the related maturities of short-term investments and a $28.7 million decrease in purchases of short-term investments during the six months ended June 30, 2020 compared to the six months ended June 30, 2019.

Financing Activities

Net cash provided by financing activities was $17.7 million for the three months ended March 31, 2020 , compared to $0.2 million during the three months ended March 31, 2019 .

During the three months ended March 31, 2020 , we received net proceeds from the sale of our common stock and warrants in a public offering of $14.0 million .

Additionally, during the three months ended March 31, 2020 , we received higher net proceeds from other sales or issuances of common stock by $4.5 million compared to the same period in 2019, and we made higher payments of principal of notes payable by $1.0 million compared to the same period in 2019.

Net cash provided by financing activities was $19.0 million for the six months ended June 30, 2020, compared to $0.2 million during the six months ended June 30, 2019.

During the six months ended June 30, 2020, we received net proceeds from the sale of our common stock and warrants in a public offering of $13.9 million.

Additionally, during the six months ended June 30, 2020, compared to the same period in 2019, we received higher net proceeds from other sales or issuances of common stock by $4.2 million, we received higher proceeds from notes payable by $1.7 million, and we made higher payments of principal of a notes payable by $1.0 million.

Contractual Obligations and Commitments

As of March 31, 2020 , we had no material commitments other than the liabilities reflected and commitments disclosed in our condensed consolidated financial statements.

As of June 30, 2020, we had no material commitments other than the liabilities reflected and commitments disclosed in our condensed consolidated financial statements.

Off-Balance Sheet Arrangements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis